Biomedical Research and the Public Conference Report

SE
c
. H 88:B 52 l'TEE PRINT
RESEARCH Af.."TI TB E: PUBLIC
PREPARED FOR THE
SUBCO:\fifITTEE ON
IIE,\LTJI AND SCI ENTII<IC RESEARCII
OF THE
ON I-IU1IAN RESOURCES
UNITED STATES SENATE
82-201
ll.\Y 19ii
Printed for the use of the Committee on Ruman Resources
U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1977
For kale by tho Superintendent ot Document&. U.S. Govcrumcot Printing O!Ht-e
Woahlngton, O.C. 20102
r1 1nal from
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COMMITTEE ON HUMAN RESOURCES
HARRISON A. WILLIAMS, Ja., New Jeree:y,
JENNI NGS RANDOLPH, West JACOB K. J'AVITS, New York
CLAIBORNE PELL, Rhode Island RICHARD s. SCHWEIKER, Penns7lanla
EDW ABD M. KENNl!lDY, Massacbusetts ROBERT T. STAFFORD, Vermont
GAYLORD NELSON, Wisconsin ORRIN G. HATCH, Utah
THOMAS F. EAGLETON, Missouri JOHN H. CHAFEE, Rhode bland
ALAN CRANSTON, California S. I. HAYAKAWA, California
WILLIAM D. HATHAWAY, M1tlne
DONALD W. RIEGLE, Ja., Michigan
STE.PB&N J. PARADI.Sll, GenBrat OorlnBel and Staf! Director
MBJOBI& M. Chit/ Clerk
JAY B. COTLBB, Minorit11 Ooun1el
Stmco:a.n.UTTEE oN HEr.rx AND SCIENTIFIC REsEABCH
EDWARD M. KENNEDY, Massachusetts, Ollalrma
CLAIBORNE PELL, Rhode Island RICHARDS. SCHWEIKER. Penna7Jvanla
GAYLORD NELSON, Wisconsin JACOB K. JAVITS, New York
WILLI AM D. HATHAWAY, Maine JOHN H. CHA.FEE, Rhode Ialand
HARRISON A. WILLIAMS, Ja., New Jerse:y
(ex oftlclo)
LAWRNcm BonowIT2, Professional Stall Me1nber
JAY B. CUTLER, M1t.orfty Oou1iBel
(_ \
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FOREWORD
. .
The role of the public with respect to biomedical research has been
di8cuSsed more and more widely in recent months as a result of grow-
ing concerns with the individual rights of research subjects and with
general public safety in the face of new research technologies such as
those employed in recombinant DNA experiments. In October 1975t
members of the Committee on Labor and Public 'Velfare request.ea
Case Western Reserve University and the Institute of Society, Ethics
and the Life Sciences to convene a conference at \vhich issues regarding
biomedical research and the public could be discussed, and explored in
a.n informal setting by experts from a variety of backgrounds and
disciplines. I am pleased that the proceedings of this conference
printed in this volume are filled with perspectives and ideas which
will prove useful to the public debate of these issues and help pattern
our committee's future legislative activities in these areas. .
The Committee on Human Resources and the Congress in gen-
eral are always greatly assisted by the thoughtful of
experts willing to address difficult policy matters which are still so
much Jn the formulative stage that legislators are hard pressed to
define the issues clearly. The Committee is to the sponsors of
this conference and to the participants for their help.
..

HAmusoN A. WnJJAM:S, Jr.,
Chairman, Oorrvmi,ttee on Htuman Resources.
(ID)
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January 10 , 1977
The Honorable Harrison A. \(illiams, .J r .
United States Senate
Washington, D. C. 20510
Dear Senator
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ln April 1976 , a group of eminent scientists , ethicists.
and health systems experts met at Air l ee house to discuss
the role of the public i n the governance of bi omedical re-
search . The meeting was joint ly sponsored by Case w,stern
Reserve University and the Institute of Society , Ethics,
and the Life Sciences. The purpose of the conference was to
explore what impor tant issues remnirled to be studied in
this important area and offer guid'1nce to the llealth Sub-
committee and the Congress on legislative activities.
requested tha t this conf er ence be convened as a
follow- up to the Subcommittee hear ings in t he fall of
1975 on genetic engineer ing. Many important issue' were
raised at that hearing which needed f urther exploration in
an informal, non-legislative setting 1<here ideas could be
expressed, and critiqued ntore ireely.
A report of the proceedings of that .conference has been
completed by the two sponsors and forwarded to the commi ttee
for our use. It is an exce ll ent document and will be help-
ful to all parties interested in following the growing de-
bate in the area o _f public governance and biomedi cal research.
We request that th is report be printed as a Commit tee on Labor
and Publi c Welfare document so that it may be distributed to
the public and _)rve as a basis for futher Subcommittee hearings.
. /,,/'/ /
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.I t' ;
I . '1,
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aco k' .*av1ts,
inority Member
c. mittee on
Labor an Publ ic Welfare
MK/sbjs
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PURDUE UNIVERSITY
BIOMEDICAL RESEARCH AND THE PUBLI C
EDITED BY TABITHA M. POWLEDGE AND LESLIE DACH
A conference co-sponsored by the
INS'flTU'l'E OF SOCIETl'., ETHICS AND THE LIFE SCIENCES
Hastings-on-Hudson, New York
and
CASE WESTERN RESERVE UNIVERSITY
Cleveland, Ohio
Airlie HOU8e, Warrenton, Virginia, April 1-S, 1976
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INTRODUCTION
This volume is the edited transcript of a conference on the relation-
ship between biomedical research and the public. Co-sponsored by the
Institute of Society Ethics and the Life Sciences and Case Western
Reserve University Medical School, the conference was made possible
by a grant from the New York Foundation and took place from
April 1 through 3, 1976, at Air lie House, a conference center near "\>Var-
renton, Virginia.
On October 29, 1975, two members of the Senate Subcommittee on
Health, Ed,vard lit!. J{ennedy (D.-Mass.), chairman, and Jacob l{.
Javits (R.-N.Y.), ranking minority member, wrote as follows to "\Vil-
lard Gaylin, M.D., President of the Institute:
The recent hearings before the Subcommittee on Health of
the Commit.tee on Labor and Public Welfare suggest a grow-
ing strain in the relationship bet,veen biomedical research
scientists and the general public. As legislators who have long
been concerned with national health problems, and particu-
larly the support of basic biomedical research, we find dis-
q u i t i n ~ both the tone and direction of some of the current
discussion about the public role in the establishment of science
policy.
On one hand, it seems to be well understood on all sides that
biomedical research has made and will continue to make
significant contributions in satisfying the health needs of the
country. On the other hand, it seems equally well understood
that the public, which provides a considerable portion of all
biomedical research funds, has an important role to play in
the allocation of these funds and in the formation of judg-
ments on the potential benefits of research. Yet, these under-
standin85 seem to break down in practice. There are
suggestions that the scientists may not appreciate adequately
the public interest and its role in decision-making; and
eq_ually that the public may not adequately understand the
scientist, his disciplines and approaches to problems, and the
significance of what he does for society.
There is evident and increasing need for both sides to get to-
gether to discuss and define the issues in reasonable fashion
and to identify mechanisms to educate one another. More than
this, it becomes increasingly important to society that the seri-
ous problems which arise at the interface between science and
society be carefully identified, and that mechanisms and
models be devised for the solution of these problems.
Certainly, continuation of the present misunderstandin,,,<YS
can only lead to increased polarization between Congress and
the research community. There is already evidence of such
strain. P&haps as the relationship between science and the
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public has evolved and changed in recent years, all parties
have failed t-0 understand both what is happening and what,
ideallj", ought to happen in the future.
We believe it might be useful if an interdisci_plinary group
of leaders in biomedical research could join with a group of
nonscientists devoted to the public pohcy area to sit down
quietly and privately and t.alk through some of these issues.
We are confident that such a meeting could be fruitful in
initiating such a dialogue, and, perhaps through the mecha-
nism of treatment of specific cases, could begin to identify the
nature of the problems which face us and the direction in
which some solutions might be found.
Both the Hastings Institute of Society, Ethics and the Life
Sciences, and Case vVestern Reserve University Afedical Cen-
ter seem to be in a particularly advantageous position-as
groups concerned with various aSJ?ects of the interaction of
science and society-to convene jomtly a meeting to initiate
such discussions.
We would very much appreciate hearing from you as to
whether :you would be willing to participate in such a joint
undertaking. Please let us know when you believe the meeting
should be held, and what specific items you feel should be
discussed.
Also, please let us h.-now how we might best assist you in
arranging this endeavor.
The conference was thus arranged at their request. The transcript
has been condensed and edited for readability, and the last session, in
which only about a third of the original group participated, has
been swrunarized.
The editors are grateful for suggestions from Daniel Callahan, Wil-
lard Gaylin, and Peter Steinfels. They also thank Eva Mannheimer
for her extensive help with the manuscript at every step, and Vickie
Venne for her research assistance.
TABITHA M. POWLEDGE.
LESLIE DACH,
JiASTINGS-ON-HUDSoN, N.Y., Autumn, 1976.
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CoNFERENCE PARTICIPANTS
LAWRENCE ALTMAN, M.D.
Reporter
New York Times
0
STUABT AUEABACH
Reporter
Washington Post
DAVID BALTIMORE, M.b.
Professor of Biology
Massachusetts Institute of Tech
. nology
PATRICIA BAUJdAN
Subcommittee on Health of the
!)ommittee on tabor and Public
Welfare
ROBERT w. BERLINER, M.D.
Dean
. . Yale University School of !-ledlclne
WILLIAM A. Pb. D.
Head, Division of Public Sector
Programs
:American Association for the Ad
. . vancement of Scl.ence
BEllTRAM S . BBOWN, M.D.
Director
National Institute of Mental Health
ROBERT A. BURT, LL.B.
Professor of Law In Psychiatry
. Uni verslty of Michigan Law School
DANIEL CALLAR.AN, Pb. D.
Director
Institute of Society, Ethics and the
LI fe Sciences
A.LEX.ANDER M. CAPRON, LL.B.
Associate Professor of Law
University of Pennsylvania Law
. School
ELOISE E. CLARK, Pb. D.
Acting Assistant Dir ector
Biological, Behavioral and Social
. Sciences Division
National Science Foundation
BARBARA J. CULLITON
Reporter
Science
JAY CUTI.ER
Committee on Labor and Public
Weitare
. United States Senate
EMn.IO DADD.ARIO
DI rector
..._ Office of Technology Assessment
l:lABOl'..D EDGAB, LL.B.
.Associate Professor ot Law
Columbia Law School
DONALD S. FBEDBICB:SON, M.D.
Director
National Institutes of Health
WILLAllO GAYLIN, M.D.
President
Institute of Society, Ethics and the
Life Sciences
WILLIAM GOLDEN
Vice President
American Museum of Natural His
tory
HAllOLD P . GREEN, J.D.
Professor of Law
The National Law Center
George Washington University
DANIEL GREENBERG
Publisher
Science and Government Report
PHILIP HANDLER, Pb. D.
President
National Academy of Sciences
RUTH S. HANFr
Senior Research Associate and
Study Director
Institute ot lliedlclne
National Academy of Sciences
A NDRE E. HELLEGEBS, M.D.
Director
The Joseph and Rose Kennedy In
stitute for the Study of Buman
Reproduction and Bioethics
HOWAJID H. HIATT, M.D.
Dean
&:boo! of Public Health
Harvard Medical School
HALSTED R. HOLMAN,
Professor of Medicine
Stanford University School of
i!tiedlclne
LAWRENCE HOROWITZ, l\1.D.
Welfare
PETER BARTON HUTT, LL.l\f.
Attorney
Covington & Burley
FRANZ J . !NGELFINGEB, M.D.
Editor
New England Journal of Medicine
JACOB K. JAVITS
ANITA JOHNSON
Statr Attorney
Health Research Group
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4
RANs JONAS, Ph. D.
Alvin Johnson Professsor of Pbilc>-
sophy
Graduate Faculty
New School for Social Research
STANLEY JONES
'Velfare
EDWARD lll. KENNEDY
SEYMOUR S. KETY, 111.D.
Professor of Psychiatry
Harvard ll1edical School
JONATHAN KING
Associate Professor of Biology
Massachusetts Institute of Tech-
nology;
Member, Genetics and Society
Group
Science for the People
GERALD L. KLERMAN, M.D.
Professor of Pi;ychiatry
.Harvard Medical School
SAMUELL. KOUNTZ, M.D.
Professor and Chairman
Department ot Surgery
State University of New York
Downstate llledlcal Center
MATHILl>E KRIM, Ph.D.
Associate Member
Sloan-Kettering Institute tor Can-
cer Research
M. NEIL MACINTYRE, Ph. D.
Professor of Anatomy and Human
Genetics
Case Western Reserve University
School of llledlclne
ROBERT Q. MARSTON, M.D.
President
University of Florida
ALAN McGOWAN
President
Scientists' Institute for Public In-
formation
ROBERT S. MORISON, ?.!.D.
Class of 1949 Visiting Professor
Massachusetts Institute of Tech-
nology
AllNO G. ?.IOTUUlKY, l\!.D.
Professor of :Medicine and Genetics
University of Washington
LAURA NADER, Pb. D.
Professor of Anthropology
University of California, Berkeley
GEBARD PIEL
Publisher
Scientific American
JUDITH RANDAL
i\Vashlngton Science Editor
New York Daily News
FREDERICK c. ROBBINS, M.D.
Dean
l\ledlcal School
MICHAEL ROGERS
Associate Editor
Rolling Stone
ALBERT ROSENFELD
Science Editor
Saturday Review
KENNETH J. RYAN, M.D.
Kate l\Iacy Ladd Professor of
Obstetrics and Gynecology
Harnu'd Medical S-chool;
Chairman, Commission for the Pro-
tection of Human Subjects of Bio-
medical and Behavioral Research
BELDING H. SCRIBNER, M.D
Professor of Medicine
University of \Va.sbington
DANIEL lf. S l ~ G R
Attorney.
Fried, Frank, Harrls, Shriver &
Kiampelman
l.lixINE F. SINGER, Pb. D
National Oancer Institute
ROBERT L. StNSBEIMER, Ph. D.
!Professor of Biophysics
California I nstitute of Technology
JEBJl:MY STONE, Pb. D.
Director
The Federation of American
!Scientists
STEPHEN P. STRICKLAND, Pb. D.
Washington Study Group, Health
Policy Program
Uni versl:ty of Oalifornla, San
Francisco School ot Medicllle
CARL TAYLOR
Health Program Manager
omce of Technology Assessment
STEPHEN TOULMIN, Ph.D.
Professe>r of Social Thought and
Philosophy
University of Chicago
JAME8 D. WATSON, Pb. D.
Cold Spring Hnrbe>r Da.'boratory
SAMUEL WHITMAN
Associate Dean
School of J\1edlcine
Press Arrangements : Ta.bitba lo!. Powledge.
Rapporteur: Peter Stelnfels.
Research : Leslie Dacll.
Institute of Society, Ethtcs and the Lite Sciences.
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BIOMEDICAL RESEARCH AND THE PUBLIC
AGENDA
3:00 pm,-3:30 pm
THUBSDAY, APBIL 1
Introduction to Conference. Willard Gaylin-Instltute ot Society, Ethics and
the Lile Sciences.
3:30 pm-4:10 pm
The Congress and Biomedical Research : The Changing Relationship. Chair-
man: Daniel Callahan, Institute of Society, Ethics and the Life Sciences. Speaker:
Stephen P. Strickland, University of California, San Francisco School of Medicine.
Respondents: Robert Q. Marston, University ot Florida; n d r ~ Hellegers, The
Joseph and Rose Kennedy Institute tor the Study of Human Reproduction and
Bioethics.
.+:10 pm-4:40 pm
Open discussion
.+:40 pm--5:05 pm
Declslonmaklng :Biomedical Research and the Public. Speaker: Ruth S. Hanft,
Institute of Medicine, National Academy of Sciences.
6:05 pm-5:30 pm
Open discussion.
8:00 prrH!:50 pm
Freedom of Scientific Inquiry and the Public. Chairman : Robert S. Mol'ison,
Massachusetts Institute of (l'echnology Speaker Hans Jonas, The New School
tor Social Research. Respondents: .Alexander M. Capron, University of Penn-
sylvania Law School; Gerard Piel, ScienWlc American; Robert Sinsheimer,
California Institute ot Technology.
8:50 pm-9:45 pm
Open discussion.
FBlDAY, APBIL 2
9:00 ani-10:30 anr.
Legislative Perspectives. Chairman: Willard Gaylin. Speaker: Edward M..
Kennedy, United States Senate.
10:45 am-11:45 anr.
Sources of Tension. Chairman: Willard Gaylin. Panelists: Howard H. Hiatt,
Harvard School ot Public Health; Stanley Jones, United States Senate Health
Subcommittee ; Jonathan King, Science for the People.
11 :45 am-1!:30 pnr.
Open dlseusalon.
1!:30 pm-!:00 pm
Luncheon. Speaker: Jacob K. Javits, United States Senate.
!:00 pm--5:00 pm
Mechanisms for Public Participation and Declsionmaklng. Chairman: Fred-
erick C. Robbins, Case Western Reserve University Medical School.
!:00 pm-!:45 ptn
General Mechanisms. Available Governmental Procedures. Bertram S. Brown,
National Institute of Mental Health.
Legislation. Peter Barton Hutt, Covington & Burling.
Litigation. Robert A. Burt, University of Michigan Law School.
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!:45 pm-3 :15 pm
Open discussion.
3 :30 pm,-4 :SO pm
Other Mechanisms.
6
Scientific Organl7.ations. William A. Blanpied, American Association for the
Advancement of Science.
Asll9mar. Maxine F. Singer, National Cancer Institute; David Baltimore, :r.ras-
sachusetts Institute of Technology; Harold P. Green, The National Law Center,
George Washington University.
National Commissions. Kenneth J. Ryan, Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research.
4:30 prn-5:00 pm
Open discussion.
5 :00 prn-5 :SO pm
Summary and Synthesis. Gerald L. Klerman, Harvard Medical School.
8AT1J'BDA.Y, APRIL 3
9:30 am-11:30 am
Statements, Declarations and Future Options. Chairman : Frederick C. Robbins.
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BIOMEDICAL RESE .\.RCH AND THE PUBLIC.
THURSDA y' APRIL 1
INTRODUCTION TO THE CONFERENCE
WILLARD GAYLIN. I '\Tant to briefly go 01er the planning, the forn1at,
and the expectations for this
In every phase of the planning it seems we ran into some trouble.
the title was "Biomedical Research and the Public I nter-
est.' With the possible exception of the conjunction "and" we had trou-
ble with every one of those words. Someone wanted to know what we
ineant by bwmedical research. I tried feebly to explain that I didn't.
think we should invite metallurgists and astrophysicists.
We wanted representatives of Congress; we 11oped we 'vould get 25
percent representation from that group. Then people said, "they're not
the public," although in a democracy one tends to think of them as at
least representing the public. We also wanted people who were asso-
ciated with public interest in biomedical research, but perhaps from
different disciplines, so we thought about having about 25 percent par-
ticipation from fields like la'" and sociology. And then ''"e thought
there ought to be 25 percent participation ron1 the research commu-
Since we were limited t-0 about 50 people, it became very difficult.
We invited what some people thought was a disproportionately large
percentage of people fro1n genetics and molecular biology. That was
done purposely, because '\Te felt their experience with Asilomar
1
would
be helpful. On the other hand, research did not mean to us just basic
laboratory research. I ndeed, the problems with the public, the delight
of the public, and the anxieties of the public are often most strongly
felt at times of application. Because of our \vork at the Institute, we
1 Asilomar ls a conferen<-e ctnter on Cnlltorntas Monterey Pentnaula, where, from
February 24 tbrougb 27, 197G, approxlmately 140 molecular biologists met wit h a handful
ot lawyers to hammer out draft guidelines goernlng the safety of a new line ot re-search
on wblch they were embarking. Known Popularly as f,eoetlc engineering, the work lnolve$
the Insertion of genetic material from one organism nto another, resulting In the creation
of a new organism which does not exist In nature. and le called by the scientists recom
blnant DNA (tor deoxyribonucleic acid, tbe material trom wblcb genes are made) . Most
of the work bas been done w!tb viruses and bacteria, particularly a laboratory version ot
the bacterium Eacherfc1i-ia col.f> a normal resident of the human Intestinal tract. Excep.
1-atety pre-cauttons were deemed desirable by many molecular biologists because
they thought there might be a chance that tbe new organism. (ca_rrytug, for instance. a
newly lngerted tumor \"lrus or a gene for resistance to antibiotics) might Infect lnborato!')T
workers or even the world outside tbe lab. The word "Aetlomar" bas corne to refer not to
the meeting Itself. but to tbe entire process leading up to the meetlnir and still golni: on.
In wblcb scientists-for the first time In history-attempted to anticipate a po$slble 111
etrect from their work and make provision for lt ahead ot tlme. lo adclltiou, a vol 11ntary
moratorium on this work- whose theoretical and practical ramtflcatlons are tho\1,ght to
be ot immense importance--waa requested by a. small group ot prestlgtous molecnlnr
hlologl$ta and baa apparently been largely complied with throughout the world. ThP.
J)roce&s bas received wide coverage lo both the la7 and sctentlflc preas. and fig,1rec1
beavilv In the discussions at this meeting on bloo:iedlcal research and the publfc. 1tt wblcb
a number of Asilomar participants wPre present. For a description of the Asilomar mee-t-
Ing Itself. see Stuart Auerbacb. And Man Created Risks. T/1.8 Woal>lngtcm Pott, March 9.
1915. p. Bl. For a posittl'"e view of recombinant DNA research, see Joshua Lederberg. DN.:\
Splicing: WUI Fear Rob Us of Its BeneOts? Prlm, November 1Q76, p. For a negative
see Liebe F. Cavalieri. New Strains ot Llte--or Death. 'I'he New Yori Time Maoazin41,
August 22, 1976, o. 8.
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8
felt certain areas were extremely sensitive, such as the use of behavior-
controlling drugs. We wanted some representation from that group.
Then we wanted another group of people who are in the medical (I
hate to use the word) establishment-teachers, funders, and others who
are instrumental in direct or indirect ways. As you can see, when you
try to balance in this way, at every point some group is under-
represented.
We were very gratified at the response we got from invitees, since we
were making an llllposition on busy people in a short time. If we could
have kept tliis to a group of 15, we would have had no formal agenda.
But beCause we simply couldn't conceive of fewer than 50 people
achieving any kind of representation, we have a program which sounds
very formal and heavy. It is not so intended. We have asked all the
presenters to be as informal as possible, and the respondents are rig-
idly limited to five minutes. We have left open Saturday morning for
anyone here who would like to make a staten1ent.
Now, as to our expectations: I really don't feel we expect any
answers. We hope that certain kinds of questioning will take place.
We hope that perhaps by the last day there will be a sense of whether
a dialog of this sort should be ongoing. Perhaps there will be some
ideas from the group as to how best to continue an easy conversation
among legislators, representatives of the public interset and the bio-
medical community. We hope for the end of a certain kind of rhetoric.
'!'here is recogtrition, I think, on the part of the senators who brought
us here and ill the participants, that these are not issues that ought
to be approached in an adversarial fashion or exploited for rhetorical
purposes. We've seen a lot of crises, and we have a feeling that if
some easy access to communication can O<J<?ur, perhaps some of these
problems can be better handled ahead of time than after the fact, in
newspapers and magazines.
THE CONGRESS AND BIOMEDICAL RESEARCH: THE CHANGING RELATIONSHIP
DANIEL CALLAHAN. We thought we'd begin with some history. Ste-
phen Strickland will address the question of the historical relationship
between Congress and the bion1edical research community, with em-
phasis on wllat seems to be happening now. The respondents will be
Robert Marston and Andre Hellegers. We'll then move on to Ruth
Hanft, who will try to lay out some of the economic issues.
STEPHEN STRICKLAND. For about 15 years, from the early 1950's
the middle 1960's, national medical research policy has formu-
lated ma friendly environment. Those were the good old days, when
a few members of the United States Congress specifically including
Senator Lister Hill (D-Ala.) and Representative John Fogarty
(D.-R.I.) respo_nsibility for seeing to. it that the biomedical
research enterpnse flourlShed. In that era, policy makers--especia.lly
those in Congress-were predisposed to accept on value assess-
ment of research possibilities and resource needs advanced by medical
scientists or their spokesmen.
In those golden days of federal support, the operating imperatives
?f the U.S. medical research enterprise scientific, political, and eth-
ical-were roughly in balance. And the managerial iinperative had
not come strongly to the fore.
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9
The scientific imperative of which I speak is simply that which
impels the researcher forward from his latest finding and enlarged
understanding via the most recent clue, to the next ,Problem. It is an
unceasing quest for fact and truth. As it relates to biomedical science,
the scientific imperative, for many researchers, has as a premise a view
stated by Lewis Thomas: that disease is "fundamentally unnatural"
and that therefore disease mechanisms are "quite open to intelligent
intervention and reversal whenever we learn more about how they
opeTrahte.'' l " 1 h hi h k bli ffi I "t
e po it1ca Imperative is t at w c ma es pu co c1a s mevi a-
bly think in terms of practical effects and benefits. It seeks the greatest
good for the greatest number, which sometimes gets interpreted as
the quickest good for the most visible number. It encompasses con-
siderations of cost and efficiency as well as results, and the less obvious
and immediate the results, the more weight given to costs and effi-
ciency-in short, to management.
This imperative has been articulated in a number of ways, for ex-
ample in President Johnson's provocative question of 1965, as to
whether any practical medical secrets remained locked up behind lab-
oratory doors. It is illustrated in what Science magazme described
last year as the prevailing philosophy at the Office of Management and
Budget: "that science, like everything else, should pay off if it is
going to !!'et public support."
The t ~ i c a imperative as it relates to biomedical science tradition-
ally has been more generalized, seeking to assure that the ends be
beneficient and the means harmle..oS.
The management imperative is the fuzziest in definition-with
attendant controversy not only over its proper role but over what
it means vis-a-vis science. At the very least, the management impera-
tive in almost anyone's terms implies systems for insuring that funds
are spent wisely and well in accordance with authorized mission and
stated policy goals.
In recent yeaTS, new questions have been 1raised as to whether we
have been sufficiently conscious of ethical issues relating to biomedic8.l
innovations and even biomedical research. The management imperative
has been asserted more strongly than ever, perhaps because scientific
progress has seemed slow to those reviewing budgets and trying to
"1nanage by directive.'' Meanwhile, the very concept of managing
science is derided by some scientists. The political and scientific im-
peratives are sometimes in conflict.
But I would question any assumption that a direct tension is
buHding between the general 'JlUblic on one side and biomedical scien-
tists on the ot her. Some small, particular publics undoubtedly have
discrete concerns about the application of ne'v medical technologies
stemming from science, but overall there is considerable evidence the
public is supportive of both the political and scientific imperatives.
And the public is willing to leave to scientists and elected officials
decisions ebout funding levels, program priorities, and organizational
mechanisms. This posture puts them in the middle when polit ical and
scientific forces pull in different directions.
Concerted efforts to line up public SU_{lport-meaning support from
"larious publics-is tantamount to political activity, whether those
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engaging .in it are scientists or senators. Yet I also d,o believe
that tbe difference between today's research policy arerui. and that of.
yesterday is simply "politics." In the Nixon years, there clearly
inore decisions at levels that more political than formerly
was the case, But it is not the essential nature of the process that has.
changed. Instead, what has changed are: a) the particular actors
and their special predilections, b) the fiscal or budgetary ot
the federal government, and c) the balance among the operating "im-
peratives"- scientific, political, and ethical-all of which
affect research policy and the research enterprise.
Clearly, many of the recent tensions in the biomedical research
community and among the decision makers in Washington-tensions
concerning policy premises, program directions and priorities-are
the inevitable result of shrinking budgets. The potential conflicts in-
vited by the National Institutes of Health (NIH) charter of 1930.
and the National Cancer Institute charter of 1937 were for man>'
years avoided because rapidly growing budgets permitted wide lati-
tude about what research to support and how to support it.
Beyond these factors, NIH has always had to operate within a pol-
itical context and always will, basically because the allocation of pub-
lic resources is always a political process in a democracy. This means.
among other thing$ that resources are assigned to given activities.
or areas of endeavor according to convictions about how much those.
endeavors 'vill contribute to the public good. It is of course not a
perfect process, and may sometimes seem to produce results that nre
unwise or inequitable. Overall, however, I think most of us would
favor the fundamental proc!!SS above any other alternative, even as
it functions in relation to biomedical science.
Second, while it is true that biomedical research has fe,ver un-
questioning friends holding high policy positions today-in Con-
gress and the Executive-than in the past, the basis on which impor-
tant friends of former days made favorable decisions was not purely
Platonic or passive. Decisions of the 1950's and '60's, which added
millions of additional dollars to the federal commitment to medicn1'
research, including programs for biomedical trn.ininl! and research
facilities, were clearly affected by a generous spirit. But those deci-
sions were firmly grounded in pragmatism. In the early '60's John
Fogarty made sure the National Institute of Arthritis and Meta-
bolic Diseases (as it was then called) got an extra few hundred
thousand dollars to begin a program in ulcerative colitis. He was
persuaded that this particular enlargement of the was de-
sirable not just because he had empathy for the thousands of victims
of the disease, but also because the director of the institute certified to..
him (in response to a. query), that the resea.rch .field was
ready for fuller investigation, that there were. specific research lend
that needed greater attention, and that good people could be at-
tracted to do good work.
Friendly policy makers in the good old days, like less friendy ones.
toda.y, naturally had one eye focused on potential constituencies. So
cancer nnd heart disease always had an easier time than microbiology,
and l!astroenterology, and they probably always will. Yet policy
ers also had an eye out for good ideas, which were justified by scien-
tists. There were no millions dying of Tay-Si:h!; f!Jld the.
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number of infants afflicted by retrolental fibroplasia was not enor-
mous, but key of Congress encouraged spending research
funds on problems relating directly or indirectly to those afflictions.
There are some similarities in the medical research policy arena. of
the '{>resent a.nd that of 15 years ago Congress, then as now, tends to
dommate the Executive. For the first several years of the Nixon Presi-
dency, the Secreta.rr of Health, Education and Welfare, like earlier
secretaries in the Eisenhower administration, was largely outside the
decision-making process when it came to the big issues-for example
the launching of the new war against cancer. As in the earlier period,.
executive influence over medical research policy was, with the excep-
tion of cancer, exerted through budgetary controls.
But the differences in the two eras are really more striking then the
similarities. Recent congressional support of NIH has largely been
restricted to interceding to protect it against executive politicization.
And the fundamental difference between the present period and that
when Lister Hill and John Fogarty were the chief congressional policy
makers is that there was then, but recently there has not been,
mutual feelings of trust and confidence among Congress\ medical
science administrators, and the medical research community. In a
sense, those who led NIH and Congress in medical research in the
earlier period reached their maturity together. A new set of actors
in both camps inherited a legacy of cooperation, but have sometimes
felt constrained to assert independence from it. Some members off
Congress who have been most interested in medical research, namely
Senators Edward Kennedy (D-Mass.) and J a.cob J avits (R-NY) and
Representative Paul Rogers (D- Fla.), in essence have attempted to
change congressional rules and traditions, in order more stronaly to
assert a. strong congressional-medical research relationship. peci-
fically, to exercise the supportive and protective leadership they think
Congress should have. they haYe sought to reclaim jurisdiction over
medical research for their legislative committees, and a.way from the
appropriations committees.
It is inevitable that the distinctive thrusts of the scientific, political,
management, and ethical imperatives will continue occasionally to.
result, as they have in the past, in a. practical pulling and tugging over
the direction and pace of a biomedical scientific enterprise. It should
not be inevitable that they be manifested in fights between scientists
and policy makers, in disjointed policies and contradictory programs,
in dysfunctions in scientific progres.s. For they are not inherently theo-
retically incompatible.
Now is the time for n new maturity on the part of nll t.hose who
take part directly and indirectly in the making of medical research
policy for our nation . '\. maturity involves, first, recognition that each
of the imperatives-political, scientific, mana.gerial and
ethical-is legitimate, and, second, recognition that medical science
is most likely to progress when these imperatives are operating in
relative harmony.
RoBF.RT MARSToN. I 'll replv by adding a couple of emphases I think
deserve some attention, whicn Stephen Strickland either didn't touch
on, or didn't touch on very heavily. The first one has to do with the
relationship of national biomedical research and the .institutions ia
which research is done. When I first went to Nm as an associate direc-.
82-20i-77-2
(,oogh.:
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tor in 1965, the major concern was the impact of the Fountain com-
The people a.t NIH had the feeling that the scientific com-
munity did not rise up to defend NIH at that time. Also, the Fountain
committee's impact on NIH exemplified particularly well the public's
difficulty in understanding how science is done, and the scientist's
difficulty in explaining in a short period of time what takes his whole
life to work out.
The second point is the impact of that critical 1968 budget, the
Nixon-Johnson budget. All of a sudden, the scientific community (as
\veil as the rest of the country) faced the necessity of expenditure
containments. We all thou1?ht it was a one-year event, but the next
year we found we were still negotiating downward. It really wasn't
until 1970, in a very dramatic four-hour discussion, that Elliot Rich-
ardson, then Secretary of Health, Education, and Welfare said, "OK,
all of the fat that was in there is out now, and we will go back to 100
percent funding of moral commitments." That immediately raised the
question of what you do about the percentage of new grants. I t was
nbout that time that the question of training grants came up, and I've
never known in my own mind whether that came up as a matter of
policy, or a matter of trying to find a big hunk of money once the
moral commitment on it was closed off.
I think Strickland has correctly pointed out the third major event;
thnt is, the cry f rom the public and Congress for more relevance. It
was an increasing call, if not for practical results, then at least for
results in highly visible areas. Examples are the National Science
Foundation's Research Applied to National Needs program, and the
national cancer program.
I don't nj?ree quite as much with Strickland on Congressional per-
sonalities. Although there have been personnel changes in the appro-
priations committees, I think the big thing was development of inter-
est by the health committees, by Kennedy and Javits in the Senate, and
by Rogers and his committee in the House.
Working with them is a different ball game from working under
oven-ended, no-dollar limitations with the appropriations committees.
First, it requires rejustification in greater detail of ongoing research,
and second, it eats into the directors' time. The amount of time the
director of NIH and the directors of the institutes spend, year after
year, before committees is completely out of balance with the magni-
tude of the money appropriated.
There is only one other point I will comment on, a,nd I really don't
know what can be done about it. When one starts talking about really
serious science, then I think nln1ost always t here is an opportw1ity for
a,n nwfnl Jot of miscommunicntion.
I think one sees in almost every discussion of this type a question of
priorities, a difference between talking about whether one is going to
1 In the early tbP. Houee Oovernment Ooer,atlons Intergot'ernmental RelAtlons Sub-
committee. be.arled by Represent.atlve L. H. Fountain (D.-N.C.). expressed criticism ot
some facets ot NIH p0Ucy and administration. In a report Issued In 1961. the subcommittee
argued that NIH was not organled to administer Its grant programs adequately. and
that It failed to provide proper review ot reaearcb and to malntID enougb wltb
to determine the proper degree ot continuing support. In 1962, o. second report
found ltttJe improvement. It concluded ''Congreu ba8 been over-zealou& In appropr1atlntt
money for health re11earcb.
1
NIH subaequentl1 Issued new policy regulations. man7 of
which alfeeted the WBTS In which grant money may be spent See Oongrurional Quar.erl11
Alma11ao, Vol. XIX, p. 1G4, 1963.
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13
immunize the nation with the flu vaccine versus what the real poten-
tials of genetic manipulations are. Strickland didn't emphasize this
point greatly, although he has at other times. It has a lot to do with
who manages what at what time; that is, are you trying to do long-
range science or short-range implementation
ANDR:E liELLEGERS. This is a nonresponse to a non paper. It will be my
thesis that Congress follows the people, rather than leading them.
There has been a confluence of a series of trends in the 1960's which
bring us to the subject of this conference. The trends are reflected in
questioning two aspects of research: the means and the ends.
The means of research are the major component of the debates on
medicine, law and ethics. Here the trends have been extension of legal
rights and services to larger masses and the development of a con-
.Sumers' movement, with truth-in-lending and truth-in-packaging.
Medical research is becoming a subject of the same movement. There
has also been in decline in authority, belief in Establishments and pa-
ternalism, and the medical profession is subject to the same trend.
There may be a similar decline in Congress, so that Hills and Fogartys
are difficult to replace. There is also an increasing tension between
means and ends in many sectors. For example:
The influence of environmentalists IS increasing;
There is a question of the value of growth and "progress;" and
In philosophical circles there is a1so a debate :between deon-
tology (means orientation) and teleology (ends orientation).
\ As for the ends of research, here the t rends of importance have
been : general disenchantment with funded programs that do not y.ield
early, visible results; conversely great and more obvious needs in the
health care area; some realiza,tion that the fruits of research are often
expensive technologies in health care; and an increasing demand for
"releva;nce" of research to health care. This is often 'backed by spurious
compa.risons of U.S. statistics with foreign ones, as if Luxembourg
can 'be compared with the whole U.S. in perinatal death statistics.
Under the influence of these trends, there is a questioning as to
whether funds should not be moved from "basic" to "applied" research.
I think that would be IUl error. It sometimes scares the bezaz out of me
to think what would happen if the cancer and heart programs were to
be successful. The assumption behind the priority is that life is eternal.
It is not. It is presently genetically limited. I think if cancer and heart
disease were conquered, the alternative methods of dying might well be
more expensive in health care costs, if that be the primary justification.
And \ve would then have little of a 'basic scientific base on which to
tackle the new clinical problems.
In the light of all these trends and problems, I think the process of
'Wmmunication between the biomedical community and the Congre&9
may never have been worse.
STRICKLAND. Hellegers and Marston have said some things I would
have said if I had five or ten more minutes, although I think we are
not at an all-time low in communication. In fact, I think we may be
on the way back up. There are several reasons why I believe this. One
is that there seems to me to be developing a new consensus about the
relevance of fundamental 'biomedical science research. A lot of people
these days are talking about the critical importance of.basic research. I
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think that bodes well. I see, despite the emphasis on categoricall
diseases, greater indications of cooperation bet,veen and among insti-
tutes in NIH right now than I've seen for a while. I think that bodes.
well, too. I disagree with the fear expressed that answers to cancer-
and heart disease might ultimately be found. I personally hope they
will be, and the sooner the better. I think it would have very healt.hy
effects if, for example, the Cancer Institute \vould support research.
wich led to amelioration of diabetes, and something out of the Insti-
tute of General Sciences turned out to be a clue to one of the
more than one hundred forms of cancer. I think that would 'be pro-,
foundly important to everybody in the n1edical research area.
Even without that, I think it's possible we may see a little more
flexibility about funding on the part of policy-makers in Congress and
the Executive, giving a little more latitude to those in day-to-day
charge of the medical enterprise. I hope that's true. On the other hand,
there is one very persistently troubling thing to me about Congress.-
although I am generally sympathetic with the Congressional role in.
biomedical policymaking.
I fault it primarily, at this moment, on the fact that it continues to
berate our medical science managers about managing science a:nd yet it
has been unwilling to delineate where the role of NIH should stop
when it comes to the delivery of research results. For example, t here is.
confusion over the role of congressionally-mandated local research.
centers. I think Congress has caused more problems than they solved
in this case. I also think they have done very poorly in recognizing the
critical managerial relationship between Iarge dollar programs and
adequate personnel. In short, I think it's failing in the area it's been
most critical of, that is in the area of manage1nent of science. In one
case it's not delineated policy clearly enough for those who are re-
SJ?Onsible for implementing it, and in the second it's simply failed to
grve adequate resources.
):!ARSTON'. I'd like to question some of the assumptions on which
this conference is based. Look at the science indicators from the
National Science Foundation a.nd the proposed budget for this year,.
and then look at .fields other than biomedical science; for example, the
social dynamite of large numbers of unemployed citizens in the future.
Do we really have a serious problem coming up in terms of the public's.
appreciation for and support for biomedical science, or the Congress'
appreciation for and support of biomedical science
lf.ELLEGERS. Yes, I see -a problem in terms of support of basic science.
I hope that some of the cancer and heart and lung money can be
shuffled into basic science.
I do in fact get worried about the general assumption I made;
namely, that you can knock down one disease after another and have
eternal life. I would worry if heart and lung diseases and cancer were
successfully "conquered" that you would not have the basic science
base to deal with the conditions you would then have created through
resolution of those diseases. There is an inherent danger in switching
too large a section of the away from basic science, lest you be
successful with your applied science program.
ALBERT RosENFELD. Stephen Strickland expressed his feeling that
we're in a new era of trust. I wonder if Donald Fredrickson would

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DoNALD FREDRICKSON. J'i{y opinion is that probably Strickland is
to be somewhat optimistic. I left the encounter with the appro-
priations pr<>ees:'I about eight ago and i:eentered .that _field .in
-the course of this year. Congress is most certainly not 1gnonng bio-
medical science. I t cannot and will not, for two major reasons, both
<>f which have been alluded to. One is that Congress is deeply concerned
about, and frustrated by, the cost of health. It is seeking in every way
to be sure that two things hapJ_>en: that biomedical resear ch is duly
responsive to the same anxieties it is, and that those who participate in
and speak for and have some management role in science clearly indi-
Cate that they, too, are concerned. I think this is proper and necessary.
Secondly, they want to be sure that somewhere the answer to this
problem has not been overlooked. .
Science is increasing its power. There are quantum jumps through-
<>ut the history of science. Everybody always starts back in the 17th
-century. I think that Newton's laws were extraordinarily important,
but the discovery didn't change the gross national product by one
pound either way. Probably Copernicus' findings did have some ef-
fect on the marine budget of Spain and Portugal and other countries.
But it's in the latter day where high technology has had some re-
markable unit effect.s on expenditures for health, although whether
it has really changed the total cost of health is quite a different issue.
The power of science to do things means that Congress has to listen
to science, a11d a new kind of partnership has t o be created. I think
we're beginning to see some of that evolve. It began with atomic
fission. when the atomic physicists had to make a partnership, unfor-
tunately, with the manufacturers and those who had to make decisions
about weapons-but there was no turning back from that relationship.
And we see similar changes now in biolol?J. Perhaps we exaggerate,
but I 'm not sure we can overemphasize the fascinating potential in
genetic research, a.nd in all kinds of technology. We expect in the next
five years to have to spend a billion dollars a year maintaining people
on dialysis, n situation that will probablv continue for some time. There
is still a possibility that a more-or-less-permanently implantable artifi-
-cial heart would be constructed. If the artificial kidney is a shadow,
then behind it rises a specter that is fantastic.
To sum up, I think my perception is that Congress is attentive to
-science. I haven't perceived in the last eight vears any less under-
standing of the fact that we have to support fundamental research.
The conversation between science and the Congress is often uneven.
I t's never easy, but it certainly is there.
lliLLEGERS. Are you saying that if you came out with a totally im-
plant.able artificial heart or good artificial kidney, that such develop-
ments would be responsive to the costs of health Ca.re, or do you think
it would increase That is fundamentally the question I was
tryinp; to get at; whether it wouldn't actually lead to forms of diseases
that would be much more costly, by removing the safety valves through
which we die.
FREDERICKSON. I think that is such a. special case that it would take
a conference to do justice to it. But no, I didn't say t hat ,
you did.
IIELLEOER. Do vou think it will or will not?
. .
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FREDRICKSON. I think that immediately it will have a. pronounced
effect on the cost of medical health care. It will increase it. But I
prefer not to get into that debate because I don't think we have time
for it, although it is indeed a fascinating question.
HELLEGERS. But do you not at NIH have demographic data on what
would happen if somebody did not die from a particular disease t
There must be techniques for working out what the trade-offs are.
FREDRICKSON. Yes, there are, if you assume there is a point at
there will be an ultimate upward inflection of the curve of dying.
Is that what you
HErJ.EGERS. yes.
FREDRICKSON. But I think we are not going to change the point of
inflection of that curve bv this kind of research.
HELLBOERS. But what happens to costs of care when you do that'?'
FREDRICKSON. They might become extremely high. But I didn't rise
to debate that particular technical issue, which I think nevertheless
needs thorough debate.
GAYLIN. I wanted to ask Robert 1liarston to describe the advantages
and disadvantages of funding by one committee as opposed to fund-
ing by numbers of committees and subcommittees.
MARSTON. I think the big thing the shift does is give the same people
less time to talk to each other. The natural partners have been Con-
gress and NIH, and the natural antagonists have been NIH and the
Executive. Obviously, you do better if you can sit down witJi the same
people in the House and Senate and, year after year, spend one or
two weeks talking to that group and lmowing whn.t they expect nncI
saying what you expect, than if you have to go before four
tees. If you've got a product that's good to sell, then the more time
you have to talk to a small group of people the better your chance of
either prevailing or of channg your direction, because you under-
stand what it is that the small group of people want.
GATLIN. So you're saying that the smaller a group of people you
consult, the easier it is for you in an administrative role. Now do you
see advantages or disadvantages in terms of public policy?
MAnsroN."Now you're getting into a very key point, and that is the
role of the expert in decision-making processes. Not entirely fa-
cetiously, I've said that you get better results if you start from ig-
norance; that is, if you minimize the role of the expert and you use
the general manager. I am a strong advocate of using the expert in
arriving at decisions-not necessnrily taking the expert's opinion but
always starting from a substantive knowledge base.
DANIEL GREENBERG. Aren't there opportnnities to tr:v to cultivate
similar relationships with people in the Executive, let's sav at the
Office of llinn,,aement and Budget ( OMB) or the Domestic Council r
MARSTON. I can onlv talk to you up to the end of 1972. BaRically
I think there's a problem if :vou have a span of control as broad as
the Executive has, versus the Congressional committee structnre whicT1
circumscribes that span of control to a considerable degree. It's easier
for Congress to spend the time.
SEYMOUR KETY. I 'm surprised t.hat Andre Hellejrers' gloom:v pre
diction about what would happen if it were pos.<>ible to eradicate heart
disease and cancer hasn't been challenged. I think one should chal-
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lenge it, because I don't see the prospect as gloomily as he does. These
diseases are not merciful killers of the aged. In most cases, they lead
to premature and painful deuths.
li.ELLEOERS. I'm arguing against the position that what we need is
not basic research, but applied programs to get rid of diseases which
are costing so much. I'm simply questioning whether if you do clob-
ber those diseases you won't wind up with worse problems.
FREorucKSON. But I think you're permittino- yourself to get into an
argument about "hether the targeted researcli is the best way to go
!I-bout curing cancer and heart disease, which I think is an irrelevant
issue.
HAU!TEAD HOLMAN. I wonder if Robert Marston could provide us
with his perception of why the OMB has had the attitude it's had
over recent years?
MARSTON. I think the real lesson of recent years, especially in this
country, is that you can't do everything that's good, and you have to
start making some choices. I think the 1968 budget was really the
first time that, as a nation, we came to grips with that. We couldn't
fi"ht a war in Vietnam and do domestic too. I think this
whole business of making choices among desirable things is a very,
very key one, and I think OMB spends more time asking that type of
question than people who are interested in medicine, because that's
not our job. And it's a good question; I just didn't like some of the
answers.
FRANZ INGELFINGER. Has it been a bad thing that one has to re-
think and make decisions since 1968 on the basis of a financial squeeze i
It seems to me that it made people sit down and balance costs against
l'isks. On the whole it seems to me that it was beneficial rather than
harmful. Let me hear your reaction. Has it beea bad or good?
MARSTON. I think it's inevitable. It's not a question of whether it's
or bad. I t hink that in a world that's increasingly constrained,
it's inevitable that one's going to have to answer these questions.
INGELJ<'INGER. Should we be too excited about the inevitable? The
question is, is this we should I think there is a certain
oenefit to this. The same decisions will have to be made about the
artificial heart as were made about the SST.
GERARD PIEL. It's too bad that we have to look to OMB for questions
of priority in the scientific community. This is the kind of thing that
ought to be drafted as policy in the university, without the hel.P of
OMB. Because Congress has been so enormously generous to medicine
we have seen the medical schools of our country inflate to enormous
size. Substantial portions of basic biology would be much better off
in faculties of arts and sciences, where the practitioners would be
teaching undergraduates as well as graduate students. I think I can
make a case that the of the medical school, including pre-
clinical or basic science, 1s at the expense of biology.
Our country is the only country in the world that spends ten percent
of its gross national product on health care, which reflects the fact
that we've got a gigantic middle class and a lot of middle-aged people.
vVe spend more of it on medicine than we spend on education. But
we're living in a world in which two-thirds of mankind goes to bed
liungry. A good question that ought to be raised in the university
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community is whether we've got a strong enough agricultural research
and development program, because the feeding of the three billion
people that are going to arrive on earth between now and the end
of this century is going to be a question of enormous domestic political
consequences. I wish this kind of issue was considered in the faculty
of arts and sciences before it had to be raised by OMB.
HELLEGERS. Being interested in reproductive biology, I would agree
with you that much more could have been done on contraceptives.
PIEL. Well, actually it may turn out that pediatrics will have more
to do with population control than gynecology.
HELLEOERS. It may. It may.
PIEL. But those surviving babies provide an enormous motivation.
JiEJ,LEGERS I would question seriously whether the universities are
capable of setting these priorities. In fact, it seems to me that with
the tenure system the university would be the last place to set them.
PIEL. Well, as a matter of fact, I think you're something pro-
found there. The universities of today are the product of 25 years
of fragmentation by external, project-oriented grant support, '8.lld
so-if they ever were-they certainly no longer are forums in which
issues of that kind (jet deliberated. I guess that brings me back to the
beginning of my discussion-we need OMB to settle these questions.
STEPHEN I think several people in this discussion have
put their on something. From the outsider's point of view,
biomedical science seems to be the branch of the natural sciences which,
at the moment, has least to worry about. If people raise the question
in general terms whether there is public distrust of science, whether
there is Congressional understandfug of science, whether the institu-
tional machinery exists for sure that some sense of public
priorities is translated into OMB action and Congressional appropria-
tion. I should have thought the biomedical area. was the last area one
would look at to find trouble. I think that if one looks at the rest of
natural science, the situation is far, far worse. Indeed, one might well
look to biomedical sciences to get some hints about how we ought to
be proceeding in other areas.
It's clear that in the biological areas there's a consensus about the
desirability of abolishing cancer and heart disease (leaving Andre
Hellegers' heretical views aside for the moment). It's poimole f or a
great deal of pure biological research to get funded, so to speak, on
the coattails of this agreement about priorities. There is no general
-agreement about priorities in terms of overall national aims, if we
-can still use that phrase. We talked about national goals in the '50's
and early '60's, but we don't seem to talk so much about national goals
these days, and that's an interesting historical fact. There's no con-
sensus enabling one to lay down priorities justifying public support
and Congressional a_{>propriations for the other sciences. It may well
be t.hat even in the biomedical area there are structural problems still
to be dealt with, for example, the precise nature and institutionaliza-
tion of relations between Congress and NIB. But it seems to me that
support and undeTStanding of the biomedical area are pretty healthy
by comparison with the rest of science, which seems to me to be in
much direr trouble.
CALLAHAN. I am surprised to hear this great sense of optimism,
since one of the premises behind this conference was that at least
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couple of Senators are unhappy about what they see as 'a growing
sense of strain and difficulty. I suspect they will say tomorrow that
things aren't all that happy. AJJ.yway, our next speaker is Ruth Hanft.
DECISIONMAXING : BIOMEDICAL RESEARCH AND THE PUBLIC
Rom HANFT. After accepting the invitation to speak on decision
making, biomedical research and the public, and later seeing the invi
tation list. I spent quite some time having second thoughts ana wonder-
ing why I had been asked. Since I am not a scientist, my remarks
derive from the frustrating experiences of trying to get answers to
resource allocation questions from Nill in both a Democratic and
Republican administration (and failing miserably) and my general
interest in health and the public policy process. .
The following remarks should be taken therefore as the perspective
of a consumer wbo knows about medical care and who earns
a living from public policy analysis and resource analysis. So I have
both a special interest, and a "political" interest, as does everyone in
this room.
Until very recently, the public role in biomedical research, except for
the appropriations process, was minimal. While many
private mterest groups testified on behalf of what they perceived as
the public interest in setting up research institutes, supporting medical
and educational institutions engaged in research, other categorical
research programs, and in increasing research funding, the public at
large was minimally and probably badly informed and rarely heard.
The decisionmaking process was not terribly visible until 1968. The
National Institutes of Health and health interest groups played the
leading role in Congressional interactions. The role of HEvV as a
department was limited, as was the 01.iB's.
In the last sever.al years, with the combination of inflation, recession
and the multiplying health care costs, the concern for overspecializa.-
tion of physicians, and the general freedom-of-information climate,
the role and scope of biomedical research has begun to enter the arena
of public debate.
Before discussing the reasons for the emergence of biomedical
research as a public policy issue, and the issues t hemselves, I think it
only fair to you to start with my personal biases on the role of the
public in biomedical decisionmaking.
Contrary to the position taken by many scientists and academicians,
the scientists are not the only ones who can understand resource allo-
ca.tions in science. The public must ultimately make the decisions,
through the political process, that affect their society, their lives and
their pocketbooks. To do this wisely, there must be a free and frank
exchange of information between the scientific and public communi-
ties, as complex and inexact as the information may seem to be.
Decisionmaking in biomedical research has been and will continue
to be political, even though the academicians may prefer to think the
decisions are based on perceived needs, scientific feasibility and excel-
lence. I need not remind the audience of the substantial role pl ayed
by private interest groups-including scientists. clinicians, and de.ans
of medical schools-in lobbying for support of one or another cate-
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gorical p r w ~ or research institution, based on their research iJ?--
terests, service interests and personal concerns. The cancer program is
an examI?le. The clash of competing interests is an integral part of ~ r
pluralistic democratic process.
Biomedical research can no longer be viewed in :isolation. De,cisions
made at the bench ripple through the system in terms of manpower,
equipment and health care expenditures, and ultimately affect health
status.
Resource allocation in biomedical research should be subject to cost-
benefit analysis, however crude the state of the art, with the recognition
that pain and suffering are not quantifiable and the sudden strokes of
genius that produce fundamental breakthroughs in knowledge are not
predictable.
The following is a brief review of why the issue of the public role
in biomedical decisionmaking has movecl into the political and news
arenas.
National expenditures for research grew from $110 million in 1950
to $1.8 billion in 1968, declined slightly in 1969 and rose to $2. 75 billion
in 1975. The OMB estimates that the federal government will spend
$3 billion on biomedical research in 1977. The bulk of recorded bio-
1nedical research expenditures come from federal general revenues.
Some funds come through state appropriations to medical schools.
There are additional expenditures in unknown quantities made by
drug and other medical supply companies and reflected in drug and
equipment prices. There are also expenditures for research that are
supported through patient care funds. These latter sources of support
are indirect and include faculty salaries and supporting services pro-
vided in educational and patient care settings. There may be, for exam-
pl e. small sums from the department practice plans that support an
additional research technician or allow a clinician some time for his
own research. Patient care reimbursement for a joint patient care/
research activity also supports clinical research.
The biomedical research expenditures, however, constitute a l ittle
more than t,vo percent of total national health expenditures, about
seven Percent of federal l1e11,lth expenditures nnd an infinitesimal
pa.rt of the gross national product;. Why then all llhe concern i
The first reason is related to the general economic climate and the
rea.lization that the ra:pid expansion of expenditures o'f public dollars
that started in the '60's cannot continue at the same pace. This means
that federal expenditures more and 1nore will be subject to con-
straints on gTOWth and to competition among 'f1he various social goods.
With the recognition that income, environment and ihousing may
have as much if not more to do with iheal.th st!lltus as clinical medicine,
health must compete with other social proirrams, 1and within the
hea.Jt,h sect.or biomedical research wall compete with healtJh ca.re de-
li very. environmental a:nd preventive services and 11ealith care
financing.
Tihe second factor is the tmderst.'tnding, only very recently articu-
lated, that biomedioal rese.a.rch and its results flow without coordina-
tion into the health oare delivery and manpower systems and play a
large role in the dramatic increases in 11ealth en.re expendi.tures and
health ca.re costs.
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T.he third i-eason is to some ex<ent rui outgrowth of the second end
.11.ffeot.s. the first. Ma.ny of the biomedioe.l research developments ha.ve
resulted in expensive new mid-level teohnologies, whose benefits in
improved and mo1ta.lirt:f indica.tors may he only
Many critics suggest that the namQll would be better off !l'edirectmg
some of the do1fars spent on these toward increa.sed
income for low-income people or greaiter environmental protootion,
of which may have ia. fur grewter long-<term e:ffoot on health
status than coronary 1bypRS> surgery, ia.rtificial hear.ts or organ trans
plants.
TJ:xe final reason rel'81tes .to the current debate on health manpower.
When the federal government decided in the 1940's, with the aid of
the scientists, to place the national biomedical iresea.rch capability in
the medical schools, the decision inevatalbly influenced the environ-
ment for the training of physicians. '11he schools were provided with
the wherewithal to expand ;tthe soope Ml.d specializ&lion of f11.0ulty.
The Sputnik era reinforoed the trends tow.a.rd increased research and
technology and the prestige thnlt MCrued to the scientist-resea.reher.
As you are all a.ware, the role model and the prestige for faculty in
the medical schools has accrued to the researcher. The clinical train-
ing site for future .physicians has ibeen the ,ter.tiary care fo.oility with
sophisticated diagnostic and treaitiment facilities. The current public
and legislative ooncern is to produce primary care m-a.npower.
\Vith :the mpid rise in the GNP spent for hea1th, a. major question
to be faced by S<?ciety, including the public tJhe scientists,
much of our nat1ona.l resources Should be allocated to hea.ltih. W1thm
the health sector of the economy, how much should be spent on bio-
medical research i This decision will be a political and economic one,
and will be based on avail.able a"eSOUrees 8Jld the eloquence oft.he dif-
ferent public and private interests oompeting for these resources.
EX'acerbating the substantive problems of how much and for what
purpose is it.he fact that in the last several ye11>rs many of the public
policy-makers .in the execu<llive and legisI.ative branches of govern-
ment and in the news ,media have .been irritated by what it.hey per
ceive as a somewhat a.J.'ll'og&nt and self-serving attitude of scientist.a
and academicilllilS. The almost lmeejerk ireaotion of the executives in
science to legitimaJte questions about judgment fin :biomedical research
resource allocation or the peer 'l'eview .pr<>CESS has been that those deci-
are the business of scientists, that non-scientists .can't make the
Judgments, and that the scientists are not reflecting self-interest, but
only the public good.
\Vhile I ,believe there is no one right a.newer as to 'ho'v much
enough and how it should be a.Uocated (and tln ithe case 'Of how much, I
would settle for an arbitrary percentage) , fillere a.re some guides ,that
can help in tihe dialogue which the scientific and pU'blic communities
have not adequately explored.
For example, there has not yet .been an adequate discussion :that :re-
lates or justifies biomedical research expenditures for certain diag-
noses to the economic costs of ithese diagnoses or diseases. The Social
Administration recently published an article, "The Eco-
nomic Oost of Illness Revisited." Oancer research in 1975 received
Social Securlt11 Bulletin. February 1976.
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18 percent of federal research dollars "even though the disease repre-
sents only 9 percent" of the total cost of illness. The exiplanation
offered in the article is that '"the pa.in connected with cancer w partly
responsible for the :relatively large appropriation of federal funds
to this disease." On the other hand, mental illness accounted for 7
percent of the cost of illness and received slightly more than 4 per-
cent of federal research dollars. Diseases of the lheart a.re by far the
lea.ding ca.uses of death, but .the biomedical research allocaition an 1975
is only more than 10 of the totia.l. Fourteen percent
of .the total economic costs of illness are due to a.ccidents, poisoning
and violence. There are no data that sho\v aggregate research re-
sources allocated to these diagnoses.
T.b.e Social Security study states "In and out of government de-
termining .the oost of illness is a major concern. Tlie allocation of
health ca.re resources and the evaluation of current research and
gram efforts depend in large measure on such information." Isn t it
time we began to use such information, however crude, in our

Economics alone obviously can't provide all the answers or be the
sole justification for resource allocation. Such factors as the popula-
tion affected (whether aged or young) , other value judgments, and
the state of the science and art in different fields of research must be
included in the equations. By and large, however, the economics have
been ignored.
The definition of biomedical research should include research in the
social and behavioral sciences. Yet none of our accounting processes
provide data on the extent of support for social and behavioral re-
search. With the current emphasis and consensus on the relationship
between an individual's behavior and health, the extent of support of
social and behavioral research is important.
The ripple effect of biomedical research on the rest of the health
ca.re system has entered the discussion only recently and largely due
to the continued double digit inflation in health care costs. These in-
creases have 'been most strongly felt in the federal budget through
Medicare and Medicaid. The projected annual increase in these two
programs, $5.2 billion in 1977, will probably exceed the rest of the
HEW health budget a.nd far exceed the research budget. The same
phenomenon is occurring in the private sector. The reasons for these-
enormous increases are two-fold: higher unit prices und the use of
more resources in the health care sector, particularly resources related
to new technology. In testimony before the President's Biomedical
Research Panel, the Social Security Administration has estimated
that fiscal year 1977, $7.9 billion of Medicare and Medicaid funds will
go for a level of service that did not exist in fiscal yenr 1967.
While much of this increase has meant improved services and relief
of pain and suffering, how much of it has actually resulted in im-
proved health status, now much has resulted in marginal change, and
how much has meant perhaps nlore suffering through prolongation
of life through use of mechanical life support systems i
It is indeed difficult to predict when an expenditure for research will
result in life-saving and cost-saving fundamental brenk-throughs, like
the Salk or measles vaccines, or instead in mid-level, high-cost tech
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nologies. But there has been insufficient attention pa.id by the re-
-sea.rcn, health service -and financing communities to consequences of
the introduction of new technological and research developments.
There has been inadequate analysis of the efficacy and cost-benefits of
Certain treatments and the alternative modes of treatment by the bio-
medical research community and the public before new methods of
treatment have been widely introduced. And there has been inade-
qua.te communication a.s to risks, costs and efficacy of different proce-
<lures to the consumer. We rapidly proliferated coronary ca.re units
and coronary bypass surgery at enormous cost, yet today the experts
are questioning the efficacy of these treatments. Once given the Good
Housekeeping seal of the community, it is very difficult to withhold
introduction of a new technology into the health services system, even
when efficacy and costs have not been established. We require efficacy
studies of drugs but not of other research developments.
Our third party payment systems and the nature of nonprofit insti-
tutions and physician training do not provide any brakes either. Ret-
rospective cost reimbursement for hospitals provides no incentive to
resist introduction of new developments. Payments to hospitals do not
place a constraint on pressures exerted by physicians t-0 add new equip-
ment and new services. The new health systems agencies may provide
some external constraints, but it is too soon to tell.
The training of the physician is geared toward doing the maximum
for the individual patient and the site of physician training is focused
in institutional tertiary ca.re settings where the student sees and uses
the most advanced technology.
The consumer also contri'tutes to the problem. In most instances he
-does not feel the costs directly. These costs a.re spread through pre-
miums and subsidies shared by the employer or government. Finally,
the problem of malpractice insurance acts as a further incentive to use
every known diagnostic and treatment modality. When in doubt, try
ilverything.
Political pressures also limit the ca.pa.city to say stop. It is my con-
stituent, friend, relative or child who may die if we don't try it or have
it. While the new health systems agencies may provide some con-
straints, they will be subject to many local pressures from consumers
-and providers.
Unless HEW has changed substantially since I was there, there is
no dialogue among NIH
1
the Social Security Administration, other
third party payers, hospitals and community physicians on the con-
.sequences of introducing a new high-cost
The public must lbecOme involved in a discussion of the impact
-of the introduction of these research developments on health status
and cost and the trade-offs with other goods and services. The re-
search community and clinicians, combined with social scientists,
i::honld begin to institute more systematic methods for assessing new
techniques, their efficacy and their costs, before these techniques are
widely dispersed. Many of these new techniques are not merely
costly because of their initial capital or the additional
manpower required to operate the machinery, but also because their
use tends to expand even when tha.t use is questionable. There are also,
-of course, serious cost and quality consequences of under-utilized
l1igh technology-oriented services.
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Efficacy and cost considerations become everr more important if we-
consider the trade-off on as crass a basis as the difference between.
spending the $1.75 billion the Institute of Medicine estimates is the
cost of implanting an artificial heart and spending the same amount
on adequate nutrition for low-income pregnarrt women and children.
$1.75 billion is a:bout 25 percent of the cost of the total food stamp-
program nationally. We will spend only $335 million in fiscal yeal
1977 on health care for Indians, whose average life expectancy is
64.6 years, almost eight years less than the general population.
Finally, biomedical research has had both salutary and question-
able effects on the training of physicians. Our medica.l school facul-
ties are primarily oriented toward research and graduate medical
They could not be otherwise considering the policy deci-
sions made in the '40's, '50's and '60's on research support. This orient a-
tion and the ethics of medicine reinforce the emphasis on saving the
individual, using every device, however marginal, to prolong life and
reduce pain, and using the most sophisticated, newest methods of treat.-
ment. The sources of support of health care nnd, indirectly, medical
education reinforce this orientation. You get paid less for doing less.
Our third party payment systems provide less support for the out-
pat ient, for preventive and Jo,v-technolozy care, and encourage pro-
cedure-oriented and institutional care. Our biomedical research in
the past 20 years, whet.her by accident or design, except for a f ew
notable items, has produced mid-level technology. The combination
of the lack of planning for the introduction of new technoloes and
the way we pay for care has ske,ved the syste1n further in these di-
rections. The public wants access to primary care, but we are produc-
ing emergency, high-cost and tertiary care, in resea.rch, manpo,ver
and financing.
l Tn less we begin coordinating the views of the public with decisions
made in research, manpower and financing, as costs continue to
the reactions of the public may be draconian.
GERALD I was going to comment on how a good deal of
vour analysis picks up on Lewis Thomas' corrcept of technology. If
I understand the first pa1t of yonr argument is that the emphasis
of the research co1nmtu1ity on developing high-cost, low-yield tech-
no}ogies has <'Ontributed to t he escnlation of costs.
HANFT. A.bsolutely.
I want' to question two mntters of fact there. One I f<'el"
some certainty abont, t he ot her I "nnt to fi!!nre out. Firf't , how
is the evidence t hat it is the high-cost, low-yield mid-level technology
thR.t. raises rosts?
HANFT. There nre data; thev're basically from the Social
Administrn.t.ion National Healt h Expenditures ser ies and the '\:\
1
a...:e
and Pril'e Control Councils that have divided the increase in costs
over t.he la.c;t 20 years into several factors. They include the increase
due to utilizat ion and the in population. which of
course is a factor that has to be counted 1n. They can subtract out .
the increases due to rises in wages and in prices for the s.<tme thing.
They then have a figure they ca.II "greater intensity of service," whi ch
'f,pwls Thoma. Tbe Technology ot Medicine. New England Journal ot ol
2$G, December 9, 1971, p, 1366. ' "
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includes mid-level technology, and it has 'been responsible for ap-
pro::rimately 38 percent of the rise in costs of medical care.
KLERMAN. that's true, 11.nd you h'ave the data that seem
to indicate it is, I think if you were to poll the leadership of the
biomedical cominunity, some of which is represented here, the souree
of their anxiety about possible constraints on. research would not so
much revolve around that type of research. It seems to me that there
may be a disparity among the scientific community, the political oom-
munity and maybe Congress and elsewhere in perception of what's
valued and what's low priority. It may well be that artificial kidneys
and coronary bypasses are technically very sexy on TV sho,vs and
when paraded before a Congressional committee. But most of the
scientists I kno'v do not regard those as the areas where they feel
fiscal constraints are most acute.
HANFT. I made two points. One is that in the last 20 years, mid-level
technology is what's come out of the pipeline, by and large. It's not
necessarily what the scientists wanted to happen. The second point,
which I think is equally critical and even more important : when one
of those things is developed, do you introduce Is any discussion
held with the public as to what i<ts efficacy may be 1 Is it just amarginal
change versus what the costs may bei Is there any dialogue, for ex-
ample-and I'll ask Donald Fredrickson to respond to this now-
between NIH and the third party payers when one of these things
comes barreling down the track
FREDRICKSON. I've just been advised by counsel that I can take the
Fifth Amendment! You've said a lot of things. Some of it has been
said before, and there's an element of truth in all that you say. I don't
think we're IJOing to have any debate here that we haven't paid ade-
quate attention in the past to the impact of new technology, or t.ha.t
we've done our collective best to anticipate and understand the ef-
fects of technological development. But. the cogency of your argu1ncnt
depends on one's preconceptions of many One, what can yon
really do by free analysis? There are extraordinary limitations, and
there are measurements that you can't make. Ho'v much is three years
of life w-0Ith to am.an who's had that life extended by ditilysis 1 I don't
know. I can't measure it. So it is very much more d.ifficult than one
inight guess to make the estimates you need for your analysis.
Now in specific answer to your question. '"ea.re taking overt steps
toward opening up that kind of analysis. We are really trying to find
out how far we can go, how rational we can n1ake the process .. of tech-
nology assessment and choice. Today, for example, the National E:ve
Institute announced an in1portant new advance in mid-level tech-
nology- the use of a laser or an argon light to burn ne'v blood vPssels
that occur in the eyes of diabet:ics, which produce blindness. If the
treament is done, it has been discovered that there is three times the
usual chance of a.voiding blindness. There are some risks to the treat-
ment. This technique will cost $400 to $2,000 for a sitting. How im-
portant is one eye to a I don't know.
I don't mean to pretend, bec.-iuse these subjective judgments are so
very hard to put a number on. thnt we can't do better than ''"e have. I
t.hink we are beginning; we are inrorested. But let's not deceive our-
selves that it's something that hasn't been tried. You know ns well as
I that it's extraordinarily difficult to make it a meaningful exercise.
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RoBERT SINSHEIMER. It's di.ffi.cult to defend wh8it is. It seems at first
glance to be inefficiency. But there seems to be an a priori assumption
that if we spend 80 percent of the gross n11;tional product on health
care, that is a bad thing. That's not necessarily true. It depends on
what alternative ways you would spend it. Health care in itself is a.
good way to spend it. It's nonpolluting, it's non-energy-wasting, it's
not particularly aggressive.
I!ANFr. 'rhsit's questionable!
SrnsHEIMER. It provides, obviously, some form of what might be
.called gt"&tification 'for a lot of people. I 'm not being fBiCetious here.
Gerard P iel has that one a1tern11;tive would be to spend it
on agriculture, a.nd that's a discussable issue. But in that case you can
also discuss other ways we spend the gross national product (cos-
metics, for instance) that one should put into a,,,oriculture instead. I
don't believe we can discuss this quite in such a fashion.
HANFT. I don't think that was my intent. What I was trying to say
is that health, like everything else-like air, like agriculture, like en-
vironment, like cosmetics-is going to have to compete for the con-
strained dollar. I don't know whether eight percent of the GNP or
ten per cent of the GNP or five percent of the GNP is the right number,
and I don
1
t think those decisions are necessarily based on costs or bene-
fits. They come out of the political process and what people's values are,
combined with what they think the ultimate value to society would be.
What I'm saying is that for many years there was no lid. Now there's
a lid, and health has to get into the dialogue with everything else:
energy, environment, defense, you name it. They're all out there com-
peting for X number of dollars.
PIEL. Are you implying something nlore, I s it that the develop-
ment of such mid-level technology forces a misallocation of funding
toward high-cost procedural medicine versus the primary health care
that so many members of the population appear to think they are
deniedi
HANFT. I don't know how much research contributes to it, except
that the technologies are out there, and the financing mechanisms pay
for them at a higher rate and a higher proportion than they do for
outpatient services or for a lot of the mental health services, for ex-
ample. Those technologies tend to get used. For example; a physician
doing an endoscopy earns a higher fee for a 20- or 30-minute procedure
than he earns under any of the third party payments for a. aoocl.
thorough history and physical that may take him an hour or an hour
and fifteen minutes. I don't know which is reinforcing which, but
you've got a definite skew to the system in the financing 1nechanism.
How ARD H1A'IT. I'd like to focus on a couple of questions that Ruth
Hanft has just put before us. Franz I ngelfinger suggested earlier that
so.me of the fiscal 001'1.Straints are good, and I agree. I think the critical
question is how .successful we have been in setting priorities within
the constraints that now exist. I think that thnt could possibly occnpy
some of our attention in the next few days. Donnld Fredrickson has
-0ffered us reassurance that mechanisms are now being sought. Ob,,i-
ously it's going to be rough to achieve mechanisms for obtaining the
data required for inteUigent decision-making. I think acquiring the
data is th4' function of the biomedical research commu-
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nity, and of others whose command of expertise would be valuable. But
once those data are available, then who ought to be the decisions
with respect to priorities, and how should those priorities be set 1 It's
traditionally largely been the prerogative of the biomedical research
community, with the outcome a function of the success with which
've've been able to sell this to a generally friendly Congress. But "'e'ro
living in a world in which decision-making has become much more
widely shared, and I would think it profitable for us to consider what
mechanisms society needs to make these decisions.
CAIJ.AHAN. We will be getting to that tomorrow. .
ALEXANDER CAPRON. I wondered whether the dilemma Gerald Kler-
man pointed to really was a dilemma, if the researchers in this room
would not identify the kind of midway technologies that seem to be
the most costly and of CJ.Uestionable efficacy as the ones they would like
to pursue. I also wonder if Ruth Hanft's identification of the third
J>&rty payer as the essential part of the problem is complete. It's as
though the third party payment system were not part of our medical
system. The system is the result of Blue Cross/Blne
Shield payments, which are in turn an outgrowth of the Ainerican
liospital Association.
There are a couple of interesting points here. One is that at the Uni-
versity of Pennsylvania we are presently considering 'vhether or not
the faculty should have a dental plan. It turns out that the Blue Cross
dental plan covers 100 percent of any preventive measure; you go to
the dentist for a checkup and it's paid 100 percent. But it pays only 50
percent of anything that would be called treatment or catastrophic.
Does this reflect a general difference between medicine and
Do people think that dentists really know how to prevent the illnesses
they deal with, but physicians and surgeons Or that a patient
complies with dental advice That would be a to come up
with a Crest for our various illnesses; people would go right along.
We're talking about biomedical research here, but perhaps we should
be talking much more about the payment system.
The other point made in passing was the effect of malpractice litiga-
Olli excessive I'm _dubious a?out this
it's always made and it certainly is somethmg that phys1c1ans will
testify to. But it doesn't take into account two things. First is that the
Standard that is established is, after all, the standard in the medical
community. It wasn't lawyers or courts who thought up those tests
and automated them and made them fairly cheap (although not as
.cheap as they probably could be, and not as cheap on the bills as they
actually a;re). But is usually not the patient who is the generator of
the idea, either. It's seldom that the doctor says t.o the patient, "Look,
I can run ten more 'blood chemistries on you but I don't think I'll make
.anything useful out of this. It's very likely that you have one abnormal
finding at the present moment, but I don't think it will indicate any-
thing, and with your consent I'd just as soon forego it." I wonder "if
that's not a reflection, in a small way, of the suggestion you made that
there is more need for talking with the public. Here is the doctor, face
to face with the public, his own patient. He has the opportunity to talk
to that p1J1blic, and he also has the opportunity to protect himself by
getting agreement that such testing is not necessary.
82-201-77.,....-3
(,oogh.:
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HANF!'. Let me start with the first point, on dental care. I think
third party payers hire the Health Insurance Associa,tion of America,
and Blue Cross/Blue Shield would admit that medical health insur-
e.nee is skewed. I think t'vo things happened with the dental plan. In
medicine the insurers began working from the highest costs back
down. They started with catastrophic costs and hospital insurance,
then surgical costs
1
!lnd only gradually. working
down into the physician-Vls1t area. When des1gn1ng the dentistry plan,
they
1
had already ha.d that experience in medicine. They also had very
strong input from dentists who said that much orthodontia is cosmetic
and of concern largely .to middle class farnilies. Periodontal disease,
ho,vever, is a function to a large extent of prevention and home care.
So t hey put the incentive on prevention. And they even worked out
some complicated schemes which I don't think are actually in practice
yet, where Y?U ?re penalized for certain kinds of disorders _be-
cause you d1dnt follow through on home care practices. So I think
insurers learn from their past experience. The dentists really did pro-
vide a very stron.,. input on covering preventive measures fully, par-
ticularly for chila'.ren, and letting the consumer pay for those things
that he was in part responsible for.
On the malpractice a.rgument, I 'm not a clinician. I can only tell you
what I hear from surgeons. I 'll cite you a good example. A doctor
friend of mine has some question about how good mammography is.
IJowever, he gets a patient in with cystic mastitis who has read in the
ne\vspaper that there is this marvelous new diagnostic thing to tell
whether it may or may not be malignant. If he doesn't send her for the
mammography, and it does turn out to be malignant you can bet your
bottom dollar he's going to be slapped with a malpractice suit. I think
it's a very complicated problem. I don't know what the clinical an-
swers are. The same thing is happening with the whole body scan and
the brain scans. Get a concussion, and doctors are afraid, they're really
afraid, even if they think it's nothing more than a concussion. This is
what I've heard fro1n the clinicians. I f there are clinicians here who
would ljke to contradict me, please feel free to do so.
HAROLD GREEN. You have suggested that biomedical research is
engaged in political competition for available limited resources. I
suppose that, given the ethnocentric nature of this gathering, a legiti-
rr1ate question arises: is there any qualitative difference between bio-
medical research and the things with which biomedical research
competes that would justify an attempt to shield biomedical research
f1om this competition, or perhaps give it some kind of a preference
in that
&\NFT. Why What is more qualitative aibout 'biomedical research
than, for example, breakthroughs in economic research and the be-
havior of the economic system i What is more qualitative than astron-
omy I don't know. I'm a. consumer and I'm just responding as a
consumer. No one has shown me what is qualitatively different about
science as science or about that and other goods and services.
PmL. I don't think the question gets put that way, where it becomes
11n issue of the value of the dollar spent for astronomy versus the one
for biomedical research. The effect of the constraints of penury in the
federal government is to force concentration on results. When that
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29
happens, the political impulse is to press for results and to siu:rifice the
long term to the short term.
BERTRAM BROWN. My question to you is, as we look at the gro,vth of
the health bill, taking $30-$40 billion after World War II to $120 bil-
lion now, how much is due to ideology in medical practice, that is
in-patient care versus other forms of care, and how much is due to
technology costs i
HANFT. The biggest part of the health dollar is the hospital cost,
which constitutes a. little more than 40 -percent of expenditures. That's
the most rapidly risin.,. cost in the health sector. It's rising more rap-
idly than physicians' fees, although this last yearphysicians' fees kept
up a pret ty good pace. A large part of that cost, that 30 some-odd
percent I was about earlier, is due to l:P'eater intensity of care.
It is not due to rises in wages. It is not due to increases in the prices of
supplies. Now part of that greater intensity is mid-level technology.
How much I don't know.
K:ETY. I wonder if we aren't oversimplying things if we equate the
thrust of biomedical research to what I would call the gimmickry of
the artificial heart. As a biomedical research person, I decry as much as
any one the emphasis on the artificial heart instead of the basic re-
search in arteriosclerosis which some day would make t he artificial
heart unnecessary. But I think we must not overlook the important;
benefits which may not be accountable in terms of cost or dollar savings
that come from even this mid-level technology. I remember the n10St
wonderful teacher I had as a high school student., who died of pneumo-
coccal meningitis a few years before antibiotics came out. I don't kno'v
what the cost of that death "ould be in the Social Security Adminis-
tration's report.
HANFT. When I look as a consumer and a. public policy analyst at
how much we're putting into cancer research versus how much we're
putting into mental health research, considering the economic costs of
mental illness, I ll'ant to ask the scientists why have those judgments
been made? Give me reasons why you have decided to put so much
more into cancer than heart disease?
HIATT. I think one problem that seems to me in our discus-
sion is our :failure to SeJ?arate fundamental and applied research. I
think it would be interest1n0' to know how well fundamental biologicnl
research has fared. I would' endorse Seymour l{ety's earlier rema.t>ks
except I don't know what basic research on arteriosclerosis is right
now. We've got because we're constantly :forced by the system
we've developed, with the categorical disease emphasis, to justify
fundamental research as having payoffs with respect to cancer, or heart
disease, or mental disease, or else.
ALAN McGowAN. As a nonexpert in biomedical research, looking at
it almost :from the consumer point of view, I think the most impo1tant
mechanism to be discussed is how to communicate some of these things
to the public. The mechanism of explaining to the public is extraordi-
narily difficult, and you can't do it with a simple-minded cost-benefit;
analysis. But it has to be done. You can use anecdotes to illustrate the:
problem, but some generalized mechanism has to be developed to give
the date to the public, because otherwise the scientific community n.ncT
the biomedical community are going to suffer from the. same lack of
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30
confidence as other institutions in society. Right now I think scientists
in general are held in rather high esteem, at least to the
esteem in which other institutions are held. I think 've're in danger of
losing that unless we're pretty honest with the public in discussing
what can be done and what cannot be done.
GAYLIN. I'd like to ask Howard Hiatt to e:-!:pand on the differences
between the purposes and intentions of pure iesearch and applied re-
search. I 'm not sure that the distinction is as elaborate or elegant as you
imply. As far as I can see, the ultimate values that define pure re-
search would seem to me to fall into only two categories. One is the
:applic.ation that pure research leads to, and another is the aesthetics
-0f kno,vledge. Isn't pure research always either sold, or appreciated, or
valued, in terms of the broad range of its applications 1
HIA'IT. I didn't want to get involved in that very complex area now.
I was really referring to the dilemma that is created when we lun1p to-
,gether fundamental and applied research; under those cirumstances
fundamental research almost inevitably suffers when there is emphasis
-0n solving applied problems.
GAYLIN. But would not that lead to the conclusion that fundamental
research becomes appreciated or valued by the public as it becomes
applied?
HIA'IT. Perhaps the most important development in our attempts to
identify environmental carcinogens in the last couple of decades, as
everybody in this room knows, is the test Bruce Aines ca1ne upon as a
result of his research in Salmwnella, where he was looking at the
genetics and biochemistry of the synthesis of amino acids. I don't
know who funded that project. I suspect it wasn't the Cancer I nstitute.
It had no apparent relevance to cancer at the time, and surely he had
no interest in that project as a means of helping solve the proble1n of
cancer. There would have been no way to predict the ultimate useful-
ness of that information. All one knew was that here 'vas a first-rate
scientist undertaking a study of a serious problem. The dilem1nn t o
which I was referring is that if we insist, as I think we increasingly do,
that research spin off immediate developments, we r isk a lessened en1-
phasis on this kind of work, at a time when our kno,vledge of ftmdi1-
mental life processes is extremely limited.
HOLMAN. Policymaking in medical school currently fl.o,vs from peo-
ple who are engaged in what we call bio1nedicnl research. It seems to
me it's important for us to ask how broad is biomedical research, and
how broad should it be if we are to ans,>rer questions about disease? To
be specific, one can ask whether the problem of coronary occlusion cnn
be resolved by studying the biochemistry of cholesterol. I t hink the bio-
chemist1y of cholesterol should be studied. I also think that there is
now abundant evidence that such study alone, as a pure biological
phenomenon in animals or isolated human beings, is almost certainly
not going to lead to an answer.
'By using a atraln of the bacterium Salmonella t11phlmurlum, Bn1ce N. Ames,
professor of biochemistry at the University of California, Berkeley. developed a practlc.al,
Qttlck, inexpensive test whlcb measures the mutagenlc (a.nd thns carclnogentc) power ot a
substance. The number ot colonies of bacteria Indicates the ability of the test aubstnnce
to al ter bacterial DNA structure and lnlllct a potential metabolic or genetic aberrntlon.
This test Is thus capable ot Identifying cbemlcale-tood additives, pesticides. Industrial
chamlcnle--wbtch are PGtentJally cancer-cauetng or may result tn genetic chnnc::es. See
Bruce N. Amee. Carcinogens are Mutagens: Their Detection and Environ
mental Health Perspectlvee, experimental Issue No. 6: 111!-8. December, 1973.
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The work of cultural anthropologists and other suggests that
a rise in cholesterol level may be decisively conditioned by the envi-
ronmental circumstances of the people in whom the rise is observed.
Yet within our medical schoolS, at least the one I'm at, with 300
faculty people, there's not. a single epidemiologist, not a single econ-
omist, not a single cultural anthropologist, not a. single sociologist.
There's nobody who can int eract with those of us who wear the chev-
rons of biomedical research in such a way as t.o enrich the content of
biomedical research.
The argument I 'm forward is that it's not just a question of
biomedical research competing as an interest group with other poten-
tial users of public money. It is also a question of the content of the
research itself and the types of people that a medical school is re-
quired t.o have on its faculty t.o address the questions of ca.use of
disease.
HANFT. I agree.
Jr..REMY STONE. 'Ve're discussing decisionma.king in the biomedical
communit:y, and I'm stunned by the fact that at most levels discussed
so far dec1sionmaking in the biomedical community seems t.o me a lot
better off than it is in most of the other communities I work with.
l3efore describing where I t.hink the problem is, I would like t.o say
a few things about why many of these strains, which have been refer-
red t.o twice in both letters of invit.ation 've got, soom to be so in
this community. It seems t.o me that the biomedical has
tremendous clout over on the Hill. It has a product evervone is inter-
ested in. 'Vhen you look at lawyers, "ho yesterday were no-
fault insurance, you see a real conflict between a community anct the
public. If you look at the farmers trying to raise prices for their prod-
ucts you see another case of real strains in the community. The bio-
medical community doesn't have this proble1n. Look at the polls and
you see that scientists and doct.ors are held in very high esteem indeed.
Certainly that's the case on Capit.ol Hill, one of the )ast places in the
country where being called doctor still means something. (which is
why I. a mathematician, masquerade as a doct.or on CaJ?itol Hill.)
I t also seems to me that the fact that basic research is really neces-
sary for biomedical research is well understood, even to the point
where in some areas gross distortions in favor of basic research are
tolerated by everyone quite well. I don't think those are the problem
areas.
I also think the problem can be illustrat.ed by the highest example
of Bruce Ames. I t wasn't really because Bruce Ames was working in
basic research that he made the important discovery he did. It's be-
cause he had personal qualities, and interests in applying the basic
research he was working on t.o human problems. He began'by looking
at the packages for the potato chips his children "'ere eatina. seeing
the ingredients on them and wondering what in fact was in 'the1n. It
doesn't seem t.o me so unfair t-0 expect large numbers of people who
were working 'vit.h bactP.l'ia mnch earlier to hn \'e thought "'vh:v don't
we feed some of these ingredients t.o the bacteria and see exactly what.
thev mig-ht produce"
I think the fundamental problem here is one that ca.nnot be sohed
at the university level in the way Gerard Piel suggested, but it can be
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solved at the university level in a different way. The scientists in uni-
.varsity communities have got to keep in the backs of their minds-if
:not in the fronts-the and necessity of applying these
things in some societal way. If they begin to apply for grants that
do make some useful application of their work, if they keep in mind
the importance of eventually applying their work, I think people
won't ask of them that they switch from basic to applied research.
W11at I think is really necessary is a certain new spirit among younger
scientists, recognizing that there are problems in the country itnd in
the rest of the world, that science has to be applied to them eventually,
. and that if there's anything they're doing, a portion of which might
.be really useful, thel ought to try to move the work somewhat in that
..direction. I think its a spiritual revolution. It's certainly not a money
shortage. I think, therefore, the problem is really one that's reduced
to focusing on the individual scientist.
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TuunSDAY EVENING, APRIL 1
FREEDOM OF SCIENTIFIC INQUIRY AND TBE PUBLIC
RoBERT MoRISON. This evening we come to a more theoretical dis-
cussion than we had this afternoon. We started, as practical men, with
practical questions of relations among the scientific community and
the political and Congressional community, and the problem of deci-
sion-making in the real world. But lurking behind these practical deci-
sions is ahvays some sort of theoretical principle.
Those of us who've grown up in the academic environment set a great
deal of store by this particular problem we're dealing with tonight,
which is the question of freedom of scientific inquiry. I n my childhood
at Harvard !lfedical School, it would never have occurred to me to ask
if there should be or should not be such a thing as freedom of inquiry
for biomedical scientists. We were dimly aware that people in other
spheres of knowledge had to worry about their freedom of inquiry.
We knew that economists, for example
1
faced the question of whether
they would get tenure if they had particular views on Karl Marx. \Ve
were aware that three or four hundred years ago people with different
views on the Trinity or transubstantiation had some questions raised
about their freedom of inquiry. But the idea that there should be some
question about whether biolowsts were free to inquire into the nature
of the biological world would have been very out of line.
We did have plastered on the wall in the particular laboratory where
I worked a set of regulations a:bout the propriety of working on ani-
mals; you could only do it under certain circumstances. But there was
nothing, so far as I remember, about working on human :beings. '.I'hat
was left to our own consciences.
We seem to have come into a different world. Behind the discussion
this afternoon was the question of \Vhether or no't one ought to consider
the long-term results of inquiry. Should one work on something <that
might increase the cost of medical care wivhout a requisite
benefit'! If anyone had raised such a question when I was a medical
he would have been. la1rghed out of court. We are
a conflict bet.ween the pra'Ot1cal world and 'a very long-standmg ph1 -
osophical position that there's something peculiar iabout human neings,
that they Ieel an urge to inquire into the world in which they are born
and, for better or for worse, must live. We've defended for a long time
the idea that this sort of inquiry is a very natural 1aotivity. There are
people who have thought wbout this a great deal more than !have. One
of them is our first speaker, philosopher Hans Jonas.
IIANs JoNAB. Freedom of inquiry and the idea of it are precious to
the Western World as part of its general regard for freedom. Freedom
of inquiry is claimed, granted, and cherished as unqualified on the
premise that inquiry as such raises no moral problems. Let us take a
look at this all-im_(>ortant premise, hearing 1n mind that "inquiry"
today means preemmently sci,entific inquiry in the technical sense.
(88)
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What are the points of control between science and morals i At fil'st
glane.e there seem to be none, beyond the internal morality of keeping
faith with the standards of science itself. Its sole value is truth, its sole
aim the knowledge of truth, its sole 'business the pursuit of knowledge.
This, to be sure, unposes its own code of conduct ca.n be
the terrirorial morals of the scientific realm : abiding by the rules of
evidence and method, not cheating oneself -and others, for emmple,
by sloppy reasoning or experiment, let '&lone falsifying the latter's
outcome-in short, being rigorous and intellectually honest. Ethically
this amounts to no more than the command to be a good rather than a
bad scientist (that is, when a. scientist, -be a scientist I) and implies no
extrascientific oommitment. The same is true for the personal virtues of
dedication, persistence, discipline, 'and the strength to resist one's O\Vn
prejudices-again simply conditions of success within the vocation, if
also praiseworthy qualities in general. Finally, the duty of sharing
one's results and evidence with the scientific community seem to lend n.
social and public dimension to intrascientific morals; but in fact, given
the increasingly collective nature of the scientific enterprise, intercom-
munication for the individual investign;tor-to the tech-
nical conditions of science well: it still leaves the scientific moral-
ity strictly "territorial' and as yet stipulates no oblig111tion of the
scientific fraternity beyond itself.
We feel, of course, that this cannot be the whole truth. It may have
been true as long as the contemplative sphere and the active sphere
were cleanly separate (as they were in yremodern times), and pure
theory did not intervene in the practica affairs of men. Knowledge
could then be considered a private good to the kno,ver, which-being
merely a state of mind-could do no harm to the good of others, as
it sought only to comprehend but not to change the state of things.
Its dissemination, indeed, was sometimes regarded by public powers
(such as the Church, but sometimes also the state) as dangerous to the
good of the many, for example, by undermining their faith; but a quasi-
automatic protection against this lay already in the esoteric char-
acter of higher learning as such, which confined its reception to the
few; and those few had mainly to defend the right to their own thought
against custodial claims on their souls, seeing that it did not trespass
on things in the outer world. And, after all, even broadcast widely
among the untutored, ideas have at most persuasive and not coercive
force.
All this lapsed with the rise of natural science at the beginning of
the modern age, which entirely altered the traditional relation of
theory and practice, making them merge ever more intimately. Even
so, the fiction of "pure theory" and its essential "innocence" persisted:
under the banner of the general freedom of thought and speech, as dis-
tinct from deeds, scientific inquiry too claimed untrammeled freedom
for itself on the same distinction- in curious concurrence with the
promise of eventual usefulness, which contradicts the plea of theo-
retical insularity. It took the Industrial Revolut.ion to fulfill the prom-
ise of usefulness on a large scale. Until then, the social charter of
science still rested on the inherited dignity of "lmowledge for its own
sake,'' now joined with the principle of toleration for all thought and
belief (including the right to err) . So deeply is this twofold respect in-
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35
grained in the modern mind that even;in today's vastl y changed situa-
tion, few things sound more odious to Western ears than "interference
with the freedom of inquiry."
Sincere as this 'homage to disinterested knowledge may often 'be,
it would be hypocritical to deny that in fact the emphasis in the case
for science has heavily shifted to its practical benefits. From sometime
in the nineteenth century onward, and accelerating in ours, there was
an increasingly irresistible spill-over from theory, however pure, into
the vulgar field of practice rn the shape of scientific technology. Be-
and almost suddenly, Francis Bacon's (1561-1626) precocious
directive to science to aim at power over nature for the sake of raising
mRJJ.'s material estate had become working truth beyond all expecta-
tions.
Though the "esotericism" of the proliferating branches of lmowl-
edge has even heightened and keeps heightening to the point of virtual
inaccessibility to all but the insiders on each twig, yet the public im-
pact of their recondite cerebrations is enormous: an impact not, as it
was at most before, on opinions but on conditions and ways of life.
And therewith the subject of "science and morals" begins in earnest.
For whatever of human doini:r impinges on the real world and thus
on the welfare of others is subject to moral assessment. As soon as
there is power and its use, morality is involved. The very praise of
the benefits of science exposes science to the question of whether all of
its works are beneficial. I t is then no longer a question of good or bad
science, but of good or ill effects of science (and only "good science"
can be effectual at all). Is it responsible for either? Clearly, taking
credit for the benefits means also taking blame for the damages; it
would be better for science to do neither, but this option may be closed.
Apportioning praise and blame can be an idle exercise, but it is not
when a social privilege-and the freedom of inquiry is nothing else-
is implicated in it. Thus it is not idle to ask: if technology, the off-
spring, has its dark sides, is science, the progenitor, to blame?
The simplistic answer is that the scientist, having no control over
the application of his theoretical findings, is not responsible for their
n1isuse. His product is knowledge and nothing else: its use-potential is
there for others to take or lea.ve, to exploit for good or for evil, for
serious or for frivolous ends. Science by itself is innocent and some-
how beyond good and evil. Plausible, but too easy: witness the soul-
searching of atomic scientist.s a.fter Hiroshima. We must take a closer
look at tlie interloc.king of theory nnd practice in the actual way science
is nowadays "done" and essentially must be done. We shall then see
that not only have the boundaries between theory and practice become
blurred, but that the two are now fused in the very heart of science
itself, so that the ancient alibi of pure theory and with it the moral
im1nunity it provided no hold.
The first patent observation is that no branch of science remains
whose discoveries are de,oid of some technological applicability. The
only exception I cnn think of is cosmology : tne expanding universe,
the evolution of galaxies, big bang and black holes-these are matters
for knowing only and for no possible doing on our part. I t is worth
our reflection, and surely no accident, that the first science of all, as-
tronomy, the contemplation of the heavens, is also the last to be purely
(,oogh:
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36
science. Every other unraveling of nature by science now invites some
translation of itself into some possibility or othez:, often
even starts off a \vhole technolo<zy not conceived of before. If this were
all, the theoretician might still argue his sanctuary this side of the
step into action: "That threshold is crossed after my work is done
and, as far as I am concerned, could as well be left uncrossed." But we
must re1nind him that he could not have done the first, "pure" part
without massive arrangements from outside under whose broader roof
his role becomes part of a contrn.ctual division of labor. What is the
true relationship r
First, much of science now lives on the intellectual feedback from
precisely its technological application. Second, it receives its assign-
ments :from there: in what direction to search, what problems to solve.
Third, for solving them, and generally for its o\vn advance, it uses
advo.nced technology itself: its physical tools become ever more de-
manding. In this sense, even J?Urest science has now a stake in tech-
nology, as technology has in science. Fourth, the cost of those physical
tools and their staffing must be underwritten :from outside: the mere
economics of the cnse calls on the public purse or other sponsorship;
and this, in :funding the scientist's project (even with "no strings at-
tached") naturally does so in the expectation of some future return
in the practical sphere. Here there is mutual understanding. With
nothing shamefaced about it, the anticipated payoff is put forward as
the recommending tationale in seeking grants or is specified outright
as t he purpose in offering them. In sum, it has come to be that the
tasks of science are increasingly defined by extraneous interests rather
than its o\vn internal logic or the free curiosity of the investigator.
This is not to disparage those extraneous interests nor the fact that
science has become their servant, that is, part of the social enterprise.
But it is to sav that the acceptance of tliis functional role (without
which there would be no science of the advanced type we have, but
also not the type of society living by its fruits) has destroyed the alibi
of pure, disinterested t heory and put science squarely in the realm
of social action where every agent is accountable for his deeds. Add
to this the pervasive experience that the pragmatic implications of
scientific discoveries prove irresistible to the marketplace- that what
they show can be done wfll be done, with or without a prior compact-
nnd it is abundantly clear that no insularity of the theoretical realm
still sa,es the scientist from bein"' the generntor of enormous conse-
quences. While technica.lly it is stilf true that one can be a good scientist
without being a good person
1
it is no longer true that being a good per-
son begins :for him outside his professional work; the very doing of it
entails moral questions already inside the sacred precinct.
How much "inside" becomes clear when we reflect on the third
point in our list, the employment of physical tools-that is, on ho10
the scientist gets his knowledge. It is then borne in on us that doing
science already includes physical action; that thinking and doing inter-
penetrate in the very procedures of inquiry, and thus the division of
"theory and practice" breaks down within theory itself. This has an
important bearing on the hallowed "freedom of inquiry," after inquiry
has become essent.ially "research." There was a time when the seekers
after knowledge did: not need to dirty their ha.nds; of this noble breed
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37
the mathematician is the sole survivor. Modern natural science arose
with the decision to wrest knowledge from nature by actively operat-:
ing on it
1
that is, by intervening in the objects of knowledge. The name
for this mtervention is "experiment," vital to all modern science. Ob-
servation here involves manipulation. But the of freedom
to thought and speech, from v.hich that of inquiry denves, does not
cover action, even if subsidia.ry to thought. Action is always subject
to legal and moral restraints. IIowever, two properties of classic ex-
perimentation still ensured the "innocence" of this kind of action
mternal to scientific inquiry: that it dealt with inanimate matter, and
on a small scaile. Not rea.I thunderstorms but discharges from con-
densers are genernted to learn about Simulating models, con-
tainable witbin the laboratory, substitute for the thing. In that
respect, the insulation of the cognitive arena from the real world still
holds.
Both these guarantees of harmlessness and therefore of freedom in
experimentation 'have lnpsed with certain more recent developments
in science. As to scale, an atomic explosion, be it merely done for the
sake of theory, affects the whole atmosphere and possibly many Jives
now or later. The world itself has become the laboratory. One finds
out by doing in earnest what, having found out, one might wish not
to have done. And as to experimentation on animate objects, \vhich
came with the younger biological sciences, no surrogate will do, no
vicarious model, but the original itself must serve, and ethical neutral-
ity ceases at the latest when it comes to human subjects.
What is done to them is a real deed, for whose morality the interest
of knowledge is no blanket warrant. In either case of experimentation,
that of excessive magnitude and that. perf?rmed on pers<?ns, which
others could be added, the protective line between 'vicanous and
genuine action is obliterated in the execution of research itself-
rendering somehow obsolete the conventional distinction of "pure"
and "applied" science. Not only the "what," already the "how" of
cognition straddles the line. Af,plication takes place in the inquiry it-
self. (Where it does not direct y; as in theoretical physics, the experi-
mental base is vitally drawn upon.) It follows that the "freedom of
inquiry" cannot be unqualified.
We are with reason touchy about interference with this freedom,
not only because it had once painfully to be wrested from earlier
thought control and is thus a precious and vulnerable possession, but
also because we have before our eyes its shameful repression in the
East. Yet we must remember that the high privilege of theory had
its own theoretical foundation in the distinction of "thought and action
and is really conditioruil on it. Never has absolute freedom been claimed
for action, and surely never has it been accorded to action. Thus to
the extent that the operation of science becomes shot through with
action, it comes under the same rule of law, social censorship, moral
ap(>roval or disapproval, to which any outward acting is exposed in
cnr1l society. And, of course, its 6wn internal morals cea:se to be yurely
"territorial": the very means of to lmow can raise mora qu!!S-
tions before the "extraterritorial' question of how to use the lmowledge
so obtained poses itself. .
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It would weaken the case to illustrate it only with notorious atroci-
ties. It is easy to elicit unanimity on such examples: that one must not,
in order to find out ho'v people behave under torture (which may be of
.interest to a theory of man) t ry out torture on a subject; or kill in order
to determine the limit of tolerance to a :poison, and the like. We a.re
.referring, of course, to the deeds of physicians (some of them promi-
nent ones!) in N a.zi concentration camps. Here was "freedom' of in-
1.J.Uiry as shameful as its worst suppression. But we know too well, or
believe we know, that the perpet rators of such scientific experiments
(yes, scientific they could have been) were despicable and their mo-
tives base, and we can wash our hands of them. We may go further
and question whether in these cases the knowledge sought after is
a legitimate scientific aim in the first place; and if we conclude that
it is not (for which there would be good reasons) then we could say
that we are not really dealing with a case of science but with one of
human depravity. But our problem is not with crooked or perverted
science but with bona fide, regular science. l{eeping, t hen, to indubi-
tably legitimate and even praiseworthy goals. we ask whether in their
pursuit one may, for example, cancer cells into noncancerous sub-
jects, or (for control purposes) withhold treatment from syphilitic
patients-both actual occurrences in this country and both presumably
helpful to a desirable end. I do not rush into an answer, but I do say
that here moral and legal issues arise in t he inner workings of science,
long before the question of application arises-issues that crash
through the ter ritorial barriers of scierrce and present themselves be-
fore the general court of ethics and law. To the public authority of that
court even t h<' vaunted :freedom of inquiry must bow.
MORISON. You have spared me the difficulty of introducing the next
.speaker, because you've made a distinction between freedom of thought
,and freedom of action. But you've also shown that there is a relation-
. ship between thought and action, and I take it that Alexander Ca.pron,
: as a. lawyer, is devoting his life to the shaping of action by thought
: and the restriction of by action.
CAPRON. Since I agree with the notion that the impact of biomedical
research on the ptrblic may call for the exercise of restraint, by scien-
tists and others, what I have to say may seem unexceptionable. I've
been wrong on this point before, however. I t hought, for example, that
the remarks I addressed to the conferees at Asilomar last February
would not excite them-when, in fact, they stirred up quite a storm
over what some called "scientific freedom." Since the topic for
this evening is Freedom of Scientific Inquiry and the Public," the
most appropriate title for these brief comments would probably be
"From Asilomar to Airlie"- to reflect some of the distance travelled in
the past year on the question of scientific responsibility.
I start from the premise that much if not all of tne rhetoric about
improper interference with scientific freedom is misguided. To say
this is not to question the centrality for science of the freedom of
ideas-meaning both the pursuit of knowledge and its communica-
tion. (Parenthetically, we must remember that society at large is not
as fully committed to such freedom, in the area of science or elsewhere,
as our public documents profess.) Nevertheless, while I 11.m perhaps
too much a. literal-minded lawyer, I've always thought that your free-
dom sti:ip!5 where my noee begins.
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The reason we're gathered here is that the public has found increas-
ingly that its collective nose is endangered by what it had assumed was
purely beneficial research, of which the work on recombinant DNA is
only one instance. Yet the change in the work and even the attitudes of
all scientists reflected in the examples that will be discussed at this con-
ference goes beyond these individual examples. As Bertrand Russell
observed nearly fifty years ago, the development of science over the
past several centuries is a "passage from contemplation to manipulu-
tion." Scientists don't just think about human beings, they use human
beings-so the rest of us are properly concerned about the scientific
enterprise, which can no longer find immunity under a cloak of "scien-
tific freedom."
Although some of you may disagree with my conclusion, this does
not get to the crux of the problem facing us. That crux I "' ould locate
in tlie difficulty of from philosophy to practice, in finding
means to translate policies into procedures.
Without going into much detail, I submit that we are thus faced with
four present paradigms, which I'll call:
(1) Do nothing, that is, putting no controls on biomedicine,
( Lonely man, controls based solely on individual scientists' moral
scruples,
(3) Asil.omar, extraordinary decisions by collective scientific
groups, and
(4) Pulling oiit the rug, sudden withdrawals of implicit consent by
a public body, which is likely to be reacting to a real or perc<'ived crisis.
None of these four seems adequate. The do nothing alternative of no
controls is a dangerous abdication, for the reasons I 've already spelled
out. The second and third choices rely too heavily on scientific values
which, as Iians Jonas has already pointed out, may diverge from
values preferred by other groups in society. In some instances, the exer-
cise of responsibility may cause individual scientists to abandon or
delay their research or may pron1pt a collective moratorium, such as
the one that preceded the Asilomar conference. Yet even in such in-
stances-and in the far more freguent cases when scientists will believe
it to be their duty to pursue their research despite possible risks-the
only formal guidance is from the norms of science, not of the larger
society. Finally, pulling out the illustrated recently by the ban
on fetal research inserted into the .National Research Act of 1974 dur-
ing the debate on the Senate floor. Such actions are often based on
insufficient information. (Even then, it was only the deft footwork of
Senator Kennedy that kept the research ban from being a. permanent
one, rather than of limited duration.)
If none of these four paradigms which come immediawly to hand is
very helpful, we will have to look further afield for analogies. Natur-
ally, we are tempted next to look to medicine, the field in the life sci-
ences that has the richest literature in the ethical and legal areas. For
many years the accepted guideposts here were the conscience of the
individual physician as informed by ethical commentary from theol-
ogy and from a few "wise men" of medicine. Recently, total reliance
on the training and conscience of "ethical physicians," with minor.
policing by peers, has been replaced by an emphasis on what patients,
mdividually or collectively, define as being best. Of course, this
(,oogh:
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orieJ!-tation must i:ot be allowed to eclipse the importance of a
phys1c1an's independent about the propriety of his or her
own conduct. Rather, \vhat is being sought by the law in the newly-
.redefined relationship is an interaction in which both the physician and
the j?atient give "informed consent" to the n1edical intervention.
Similar reasoning has been applied to medical interventions of an
experimental cast. Indeed, concern with the rules of human experi-
.mentation-which has received much attention from the federal gov-
ernment as well as the commentators in the past decade-has spurred
-on the development of "informed consent" doctrines in the therapeutic
.context. In human research there is additional reliance on review com-
mittees, since e.xperimental procedures often involve a higher degree of
risk and less well-established benefits.
Yet the 1nedical model won't take us very far since the "patienti
subject " of the biomedical researcher is really all of society, which is
uninformed and unable to give consent. It wouldn't even be enou[h for
Paul Berg and his colleagues to run an article in the Palo Alto '.rimes
and then hold a referendum on their DNA research, since the immedi-
ate biohazards and the eventual implications of their work obviously
portends extremely important consequences for many people besides
those on the mid-Peninsula.
The failure of these five paradig1ns- which often occur as a hybrid
rather than as a J?Ure type-has driven decisionrnakers toward a sixt11
paradigm. This is the one which seems to be emerging as the new
dominant mode, and- although I think we ought to avoid it-I suspect
it is the one which would be most agreeable to t he people in this room.
Indeed, 1nost of us participate in it in some n1anner. It can be called
the cownterva:iling experts paradigm. As we abandon the "science
knows best" attitude that underlay the second and third paradigms, we
have been reluctant to push the scientists out of decisionmaking corn
.pletely (as happens in the fourth case, pullin[J out the rug). Iiistead,
new experts-who usually get called "bioeth1cists" but who come in
boxes labelled "philosopher,'' "public policy analyst," "theologian,"
"lawyer,'' and sometimes even "physician"-are called into the process
to "balance" the biomedical scient ists. There are certainly some good
.aspects to this development. Foremost is that the process is likely to be
much better informed. Moreover, sometimes the clash between the ex-
perts-if it occurs in a conspicuous enough forum- ,vill draw public
attention to the issues at stake. Yet this also sug<rests a major draw-
back-that discus.sions a1nong experts, even intel'disciplinary ones, so
often tend to be esoteric and somewhat incomprehensible to lay people;
even worse, these discussions are often held out of real public view.
. This is ironic, since the whole purpose in searching for a new
paradigm was to involve the general society in matters of great conse-
quence to it. That it is possible to do this is illustrated, at least in a
rudimentary f3$hion, by P.ublic involvement in the environmental field.
. Perhaps I can most easily illustrate the l'roblems I see in the counter-
vailing experts :paradigm by contrasting it with the alternative that I
would endorse mstead-. For want of a better name, let's call it the
OSTA-Oongreasional paradigm. There are three major components
here. First, we need an "early warning system" of scientists-probably
tnembers of university faculties and research institutions, but retained
. .
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on an ongoing basis by the Office of Technology Assessment:--to select
out from the technical literature those developments which may pose
in1mediate hazards or seem likely to have the greatest impact. Of course,
this is not .a simple task-it will require experience, creative imagina-
tion, and that elusive quality, judgment. It is not for all scientists--
indeed, it should involve only a small cadre.
The second component would be an Office of Technology Assessment
with an expanded mandate to include science assessment as well (thus,
an Office of Science and Assessment) . .1- \.lthough it's very
hard, on either theoretical or practical grounds, to draw lines between
science and technolos-y today, the 1972 Technology Act
tried to do so-by limiting the purview of the OTA to examining "tech-
nological applications." This limitation makes life easier for the OTA.
If there is a distinction between science and technology, it may be that
things called "technological applications" are much easier to monitor
because of the greater visibility that a development gains as someone,
probably a commercial concern, gears up to manufacture it or other-
wise to take advantage of its economic potential. Nevertheless, the
OTA should be broadened so that it can supervise the work of the sci-
ence assessment groups that provide the early warnings.
The third part of this paradigm would be the Congressional com-
mittees on science and health to which the OSTA would channel its
reports. These bodies would stimulate, digest and then act upon the
public viewpoints related to such scientific information. The difference
between this paradigi:ri and the countervailing experts one is that the
scientists would be called upon to provide scientific descriptions of the
developments and their probable consequences-but not to be "expert"
on the importance of the developments in social terms. The scientists
may, of course, want to express their views about the relative benefits
and costs of following various courses. But these ought not to be pre-
sented as matters of expert opinion, any more than the bioethicists
should testify "as experts" on the conclusions to be reached, (although
they may command expertise on the issues that are raised and are in
need of examination by the representatives of the public).
To illustrate this point, let me return to the Asilo1nar conference,
which was intended to develop appropriate ways of dealing with the
biohazards of recombinant DNA research. It seems plain to me that to
talk about physical and biological containment of these experiments is
to talk expense and inconvenience. The justification for such costs is
some benefit to someone. Yet the framing of objectives nnd balancing
them costs are dependent upon the values of the person making
the decisions. If the decisions reached are to serve the public well, the
values must be those of broadly-based decisionn1akers who/articipate
in a J?Olitical process (in the good sense of that word), an not solely
the views of small groups of experts, scientific or otherwise.
MORISON. At this juncture, I'd like to remind us of the title of this
symposium, "Biomedical Research and the Public." I think it comes
about because some biomedical researchers feel their communication
with the public has not been quite as complete as it should be. Research-
ers, as Hans Jonas has already pointed out, tend to get absorbed in
what they are doing themselves and only re1nember occasionally that
the people who are at risk and who are also paying for it are indeed the
public. That is one of the things I think is different from when I was a
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boy-the public is paying much more for biomedical research than it
was when I did 10 years of work with one grant fro1n the Milton Fund
for $600. I guess a major purpose of this meeting is to try to set up an
atmosphere in which the public can express some of its anxieties and
wishes and in which the biomedical community will expose itself in a
more sensitive way to the public and its representatives. This is all by
way of a rather laborious introduction to an outstanding intermediary
between the public and the scientific community, Gerard Piel.
PIEL. I want to say .first that I 'm distressed at the notion that free-
dom applies only to thought, and that it applies only to innocent
thought. Our founders were natural philosophers, and they had no
misunderstanding at all about the effective social, political, and moral
implications of thought. Benjamin Franklin, long before the Declara-
tion of Independence, founded the American Philosophical Society,
and its charter says, "To be held in Philadelphia for promoting useful
knowledge."
They perfectly well understood that this kind of activity was a
revolutionary activity with moral and social consequences; that knowl-
edge is useful because objective, verifiable knowledge confers control.
As Thomas Jefferson, the third president of the American Philo-
sophical Society as well as the United States, put it, "So long as we may
think as we will, and speak as we think, the condition of man will pro-
ceed in improvement." 1'hat proposition has been well demonstrated
by the fact that all of t hose slaves and indentured servants who made
up such a large percentage of the Colonial labor force when these prop-
ositions were being put forward have now become fully-functioning
sovereign citizens of a self-governing nation.
\>Ve all know that science is a highly public activity, that work that
comes out of that activity doesn't have any at all if it doesn't
challenge anybody to disprove it. It has to be sufficiently interesting
to colleagues in the field to make them come out of their corners and
challenge it. It gets meaning only from the degree to which it stretches
the web of understanding out of which it comes and the degree to which
it presses forward new inquiry and asks new questions. In that descrip-
tion of what the process is, it seems to me, there is a description of
whence comes its control. It comes out of the self-governing democracy
of the scientific com1nunity, which no matter how fallible and error-
prone and ridden with clique and fashion and nonsense it is, provides
a kind of knowledge that 1s verifiable and objective. Nobody can be a
crook, to quote a recent national leader. Murder will out.
When it comes to evaluating ongoing work in science, we're relying
on an extension of this democratic in the peer review system.
The peer review system, for all its failings and f railties, is a new inven-
tion in self-government, one which makes it possible for the enormous
financial power of the federal government to be decoupled from the
support of science. The peer review group removes an authority ex-
ternal to science from the decisions that are made about its ongoin.,.
work. We begin to see that this is a process that can only be conductea'.
by self-governing people.
So to answer the issues and questions raised today by the scale a.nd
rate at which science moves forward, I say the ground on which we
must build is the ground on which our self-governing society is built:
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the self-governing community of independent sovereigns who are citi-
zens and scientists. A scientist can acceJ?t no authority but his own
judgment and conscience, just as a sovereign citizen must be an auton-
omous self-governing member of society. I say that this is the ideal
to which we aspire and which we must seek.
We have horrendous examples before us of what can happen when
external authorities are brought into the making of those decisions.
One of them was mentioned by Hans Jonas. I think the answer to the
Nazi doctor proposition is that the experiments they proposed to
undertake fit no context whatever, belong nowhere in the history and
ongoing work of science. They were ideas and propositions that oc-
curred to lunatics, and could only have been approved by a govern-
ment such as the Nazi government. The Soviet Union today contends
with a collapse of its agricultural economy because Soviet genetics was
destroyed by the infatuation of a dictator with a country doctor like
Lysenko. I've no answers here; I'm saying that our society is con-
fronted with questions that reach for the essence of the propositions on
which we, as a self-governing democracy, r est. They are put to us in.
the most profound and acute way by the issues that arise in the work
of science.
The moral and ethical consequences of science reside not only in the
applications of science, they arise also out of our new understanding
of our identity as human beings, and of our place in the universe.
Those ideas are just asJrofoundly revolutionary, or just as value-
laden, as the technologic consequences of science.
J\{oRISoN. Just a second, Jonathan. I think we ought to have the
fourth speaker here. I know that you're going to want to respond to
that, but ...
JONATHAN Krno. It's a very quick point. I 'd just like to say that.
this kind of glorification and romanticization of the arrogation of spe-
cial ,Privileges to the scientific community is just one of the sources of
tension we're going to be talking about tomorrow.
MonxsoN. I share Gerard Piel's admiration for the peer review sys-
tem, but I just want to be sure that he and I see eye to eye on this.
My view of the peer review system is that it's focused on whether or not
a particular piece of research is a good piece of science. The way he
put it, it sounded as though he was also thinking that the peer review
system was a good way of deciding strategy for science; in other
words what things should be studied, and what not.
PIEL. I 'm an innocent romantic absolutist, and I guess now I've
bean so identified. on questions of principle. The peer review group
must be broad within a discipline. We're confronted with the fact
t.hat proponents of an odd view of the nature of heritability have
now got themselves organized as a peer review group, about to be
validated for public support of what I think is mischievous re-
search. If that peer review group included people who understood
population genetics, the general proposition on which they're pro-
ceeding would not stand up. Ultimately, peer review has got to
include the Senate and the House, when it comes to mounting a gigan-
tic ent erprise . .
MORISON. I wanted to get that clear, because when I think of peer
review I think of a study section of NIH. I have a limited view. Be-:
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fore we open discussion, I think we ought to hear at least one scien-
tist. We have a brilliant example of one here, Robert Sinsheimer.
RoBERT SrnsHEIMER. I'm not sure there's that much more to add to
"' hat's been said, but as a semi-retired scientist, I do tend to see these
discussions from a slightly different perspective than I think has been
presented.
The right of free inquiry was hard won. It has served us well. Surely,
any who would restrain inquiry should give full cause.
Indeed, for a scientist to challenge freedom of inquiry is akin to
heresy-if not suicide. But is inquiry itself to be exempt from inquiry
The stage of history does change. When knowledge was scant and
technology feeble and the art of inquiry itself an infa,nt, full freedom
of inquiry could be readily championed. Today science and technol-
ogy-born, t-0 be sure, of free inquiry-have transformed our world
ancl have given us great powers. The art of inquiry itself is now mature
and deeplv penetrating. And a sober and reflective reevaluation of the
purposes and consequences of inquiry may well be in order.
It may be that the highest wisdom is to recognize that we should
not trust ourselves to civilize the course of inquiry. Human history
from the Inquisition to Lysenko suggests the probability of abuse of
such power.
But it is at least instructive to consider the alternative and it just
may be imperative. Restraint can mean guidance and pacing, not eter-
nal prohibition. Curiosity is not necessarily the highest vi.rtue-and
science, the distillate of curiosity, may not merit total commitment.
To be meaningful, an inquiry into inquiry should provide specific
instances. From such instances some generalizations may be possible.
For what specific purposes might we wish to limit inquiry? Do we
wish to cure only the means or even the ends of n q u r y ~ I expect each
person mif,rht devise his own list but let me advance some suggestions.
One is the preservation of human dignity. We should not do ex-
periments that involuntarily make of man a means rather than an
end. The ethics of human experimentation are, I think. now rather
''ell understood-even though it must be recognized that such re-
straints blunt pure inquir:v.
Another reason to limit at least the means of inquiry is the avoid-
ance of involuntary hazard, physical or biological. As might be ex-
pected, the level of hazard which demands restraint "ill be arguable.
We have already one instance of such limitation in the-not univer-
sally accepted- ban on atmospheric nuclear testing. We can all recall
the controversy which preceded adoption of this ban.
The field of recombinant DNA research has an analogous potential
for widespread, inadvertent danger from the leak-out of possibly toxic
organisms; a danger even more difficult to qun.ntitate, so that the
limited precautions already proposed are certain to be the subject of
continued controversy. T his hazard-posed by the invention of syn-
thetic biology-has a novel aspect. Unlike fallout or DDT, it is po-
tentially irreversible, for synthetic living organisms are, by definition,
self-reproducing,
We may be lucky; Nature may again protect us from our ignorance.
I personally dislike to leave such a grave consequence in hostage to
fortune.
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Yet another reason to limit inquiry may be the sheer cost of a. re-
search project . This issue introduces a new perspective. In the pre-
instan<:e;S we were concerned only the means of inquiry and
did not question the ends. The constramts suggested to be imposed
upon inquiry derive from commonly accepted ethical principles, al-
as always, one might quarrel with their specific application;
By mtroducing the element of cost one asks if tbe primary conse-
quence of the inquiry- the knowledge to be gained- is worth the ex-
penditure of talent and time and resource. Decisions as to the alloca-
tion of resources are usually, and properly, left to the political sphere;
However, scientists are also citizens-and despite our enthusiasms we
should endeavor to be at least dimly aware of the realities of competing
concerns. For instance, I would find it difficult in today's world to
justify, in terms of the benefit to science, the expenditure of 100 billion
dollars to land a man on the Martian planet. Such extreme enthusi-
nsn1s might at least be tempered with common sense.
Progressing ever deeper into controversy, one may extend inquiry
into t he ends of inquiry to guestion, in particular instances, whether
we want to know the answer in a.ny case-whether the secondary conse-
quences of such kno,vledge-given the nature of man and of human
society-are, on balance, likely to be beneficial.
Here it ma.y be that the highest wisdom is to recognize that we are
not wise enough to know what we do not want to know-and thus to
leave the ends of inquiry unrestrained. Indeed, I expect there are only
a few instances where prudence would be in order. But the set may not
be null-let me present a few examples for consideration.
I would suggest that the temporal order of scientific inquiry de-
serves some thought. It is usually conceived that the stream of scien-
tific advance follows a linear course, dictated by the internal logic of
each discipline-that is, by the availability at any time of knowled,.,o-e
:ind technique. To which I would add, also by the available inspira-
t-ion which in turn is closely couoled to motivation. And to this extent
I conceive that the pattern of development of sciences is not wholly in-
nate or preordained- that we are not tracing out in an inevitable web.
If so, then in particular it would seem to me desirable to keep some
proportion between our predictive capabilities and our deflective ca-
pabilities. I s it useful to be able to predict the latent consequences of
.a:enetic defects if we cannot avert or mitigate their effects1 Is it useful
to be able to predict the approximate date of an earthquake if we
cannot appreciably spare its consequence? And reciprocally, we have
need to be able better to predict the aftermath of our interventions
into Nature before they become too gross-as with fiuorcarbon propel-
lants or perhaps with recombinant DNA.
But some directions of inquiry cnrry within t hemselves the seeds of
"hich I would label social hazard or. perhaps, just plain mischief. In
this case the inquiry itself is not renll:v hazardous, but the almost cer-
t.a.in social consequence most it$uredl:v is. And this hazard would seem
likP.ly to far outweigh any foreseeable social benefits.
Now there is a hallowed and traditional point of view that it is the
business of the scientist to inquire, to discover new knowledge. I t is not
onr concern but society's what use, if any. to make of that knowledge.
In my Yiew, in our world as it is. snch a oosition is very largely a
cop-out.: In general. our society lncks both the means and the will to
avC'rt the development and use of the products of scientific disovery.
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We live in a. free enterprise society. Any development tha.t provides
gratification or yield a profit or is deemed to strengthen the na-
tiona.l defense, will most often be aocepted, frequently with remark-
able speed. And I am not sure we would care for, nor science thrive in,
a society had the extensive control system necessary to prevent
such applications.
At the same time, we do live in a strained society of uncertain elas-
ticity. It is a. part of rationality to recognize that man.kind harbors al-
ways the potential and the realtiy of irrationality. There a.re arsonists
and assassins, terrorists and tyrants.
Let me give four selected illustrations of research whose likely conse-
quences would seem to me to be major and to be at this time in our
society of appreciably less advantage than harm. It may be that these
are but personal crotchets. But I believe these merit discussion, before
the experiments are done. One example is from radioastronomy, ontt.
from p11ysics, two from biology.
We have heard many proposals that we should attempt to contact
presumed "extraterrestrial intelligences." I 'vonder if the authors of
such experiments have ever considered what might be the impact upon
the human spirit if it should develop that there are other forms of life,
to whom we are, for instance, as the chimpanzee is to us. Especially dev-
astating, it seems to me, would be the impact upon science itself, once
it were realized someone already knew the answers to our questions.
We know in our own history the shattering consequence of the im-
pact of more advanced cililizations upon the less advanced. Jn my
view the human race has to make it on its own-for our own self-
respect.
Research upon improved, easier, simpler, cheaper methods of isotope
separation. Result: slightly cheaper power, far easier bombs. Is that,
on balance, in anyone's best interest i
R.esearch upon a simple means for predeterminat ion of the sex of
children. Result: some boon to animal husbandry; boys or girls upon
parental request-and the potential for a major imbalance in t.he hu-
man sex ratio. Is this disruption of a balance already provided by Na-
ture really a desirable
Indiscriminate research upon the aging process. What is the long-
rn.nge purpose of aging research? The purpose of cancer research is
clear-the eradication of cancer. Is the purpose of aging research the
eradication of aging None would quarrel with research to relieve the
infirmities of old age. But in the section, "Purpose of Legislation" in
the House Committee statement accompanying the Research on Aging
Act of 1974, it is stat,ed that, "This Institute (the National Institute of
Aging) will provide a natur11;l focus for the research to
-acilieve the great goal of keeping our people as young as possible as
long as possible." Is this on a goal
Bv now I have probably cited enough instances to have trod on nt
least one toe of everyone 'present-thereby proving the truth of my
earlier cautions. But more seriously the point is that the role of
science (which is our principe.l organ of systemaitic inquiry), the
role of science in society has changed in the course of the 20th cen-
tury, although our perceptions have not kept pace. It has changed
because of the success of science itself. In the nucleus of the atom and
the nucleic acids of 0the cell we have discovered the oore o'f ma.tter and.
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Wlergy and the core of life. These discoveries place in our hands im-
mense powers, far beyond human scale and experience.
In consequence, I think there are limits to the extent to which we
can rely upon the resilience of Nature or of social institutions to
protect us from our follies and our finite vision. Our thrusts of inquiry
should not too far exceed our perception of their consequence. There
are time constants and momenta in human affairs. We need to recog-
nize th'Slt the grea.t forces we now wield might drive us too swiftly to-
ward some unseen chasm.
The very success of science has ended its pleasant isolation. The
impact of science and the increasing coupling of science to human
:affairs do encumber us with new responsibilities. Yet at the same t1me
're do not wish to shackle inquiry with the bonds of responsibility.
-Someho'v we need to find a way to be doubly responsible, both to man-
kind and to science, as one of man's finest creations. That " ill not be
easy.
Let me add an far more pervasive (and insidious)
rationale for the -restraint of scientific inquiry \vill likely derive from
the phase transition from the spontaneous to the planned society, from
past loose-jointed self-reliance to future tightly-integrated interde-
pendence. Plo.nning is invasive; once begun in one sector it tends to
expand inexorably <to adjacent sectors of the social enterprise, lest
their unplanned fiuotuations perturb the -adopted plan.
In the fully planned society change a.nd 1nnov11;tion must be regu-
lated, and thus science itself- as the fountainhead of change-will be
carefully channeled and metered.
Spontaneity-essential to the scientific enterprise a.nd crystal-
1inity-essentia.l to the planned society-ean only coexist within nar-
rowly determined conditions. It may become a most important task
for scientists to help define those conditions.
JONAS. I have to address to Alexander Capron and Gerard Piel both,
a. question which they have not dealt with in considering the possible,
advisable a.nd promising internal controls of the scientific commu-
nity. That is the question of enforcement. Your suggestions were es-
sentially predicated on advice and consent and the internal autonomy
n.nd ,Presumed resonableness of the members of that privileged com-
munity, the scientific one. Of course, in Gerard P iel's presenOOtion
this was particularly strong. It demonstrated a. great f&lith, really a
great faith, and it is wonderful to live with faith. But a.s Ito the sov-
ereignty of the scientific conscience, good God, not even sovereign
st.ates are nowadays s.ccorded absolute sovereignty! We have decided
that they should be, in some of their which have a
bearing, for instance, on the condition of the planet-subject to some
higher or more comprehensive authority.
In matters which concern the commonweal, it is ultimately politics,
with its means of compliance, that must play a role. I don't
think one can get around it . With regard, for instance, to regulation
of experimentation on human subjects, something of that sort does
already exist, some protection of hums.n subjects by the principle of
informed consent and volunta.riness. A real fraud comrmtted on un-
knowing, unwilling, uniformed subjects would probably co1ne under
:some laws.
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One may also have a case where not only because of the means of in-
quiry but perhaps even because of the ends of inquiry one may judge
certain lines of research inadmissible. In human experimentation, n
point may be reached where cerlain research stra,tegies become inad-
missible because they reqnire inadmissible experiments. l\. case in point
is genetic research, when it seeks to determine, for instance, whether
human cloning is possible, or 'vhether there cnn be improvement of the
human t.ype by genetic surgery; that is, modifying the gene composition
in reproductive cells. At least one try at clonin$, and probably many
more than one, ending in producing a geneticauy-ordered individunl,
is necessary to find out. The deed eventually to be decided upon in the
light of knowledge is already committed in the night of ignorance, but
the first clone or genetic freak experimentally produced IS as real and
definitive as any mdividual brought forth into the world. Even dis-
the risk of beginning "'ith monstrosities
before tne technique is pertected, and without tbe moral freedom of
automotive engineering to scratch the failures or to recall them to the
factory for repair, there is simply no way to experiment on the unborn.
They are non-consenting by definition. For this reason alone the whole
venture is ethically unsound.
Having said tha.t, one can turn to the goal itself, apart from the
inadmissible experiments it requires.
One may argue-and I would be willing to argue, but it would take
much too long-that the goal itself may raise such grave doubts about
whether it should be done at all that one may say this line of research
should bo:1 closed. There are eager biolosts who want to pursn<>
it and it. would certainly not be prevented by any disapproval or cen-
sure of peer groups. There is no legislation on the books to protect the
unborn future individual.
CAPRON. When I found myself for a moment being grouped with
Gerard Piel-well, I guess in most cases I would be very compli-
mented. But since he was being identified with the absolute sover-
eignty of science, I shuddered that what I had said had somehow
been so inarticulate. But I found that obviously there was subliminal
education going on, because what I had regarded as rather a ringing
call for public participation in decisions about science was exactly
what I heard you reiterating. I honestly agree with that. The question
of enforcement, since I 'va.s instructed to keep the remarks rather
brief, I leave 'til tomorrow.
Afy comments were limited to identification of important scientific
discoveries. Your further comments though, and the comments of
Robert Sinsheimer, raised the question of whether or not in most case!'
it is the knowledge that is f eared. The example that Gerard Piel gave
of research on heritability of intelligence, and particularly a racial
link, would strike me as an example of a case in which the results of
nn experiment, particularly one which it was feared was improperly
conducted, would in themselves be potentially very pernicious.
Aside from that, I don't think it is knowledge that IS feared., but the
uses of that lmowledge. And here I think it is our uncertainty about
our ability to control the uses to which knowledge will be put once it
is devE>loped that threatens the freedom of the scientist. The concern
is, since we can't stop sometime later in the process, that we've got to
control the things which the scientist is going to seek.
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MORISON . .Ate you taking a position on
CAPRON. I think we will find the idea that what can be done will be
done is a false notion. As people concerned with public policy, the
work we should engage in during this conference is seeing whetl1er or
not we can agree, oy looking at cases, that stops can be put to the use
of lmowledge when that use is inappropriate or dangerous to society.
I disagree with what I understood Robert Sinsheimer to be saying:
that not only are we uncertain about our ability to do that but that
we really shouldn't be doing that because the ability to stop the uses
threatens the freedom in which a scientist has to work. I think it's
our feared inability to stop that threatens the scientist, and that sci-
entists should join wit.h others in finding ways to control the uses to
which lmowledge is put., because that ,..,.ill protect their freedom to
search widely.
fur.. I mean to maintain my polar position here, and to say that I
regard the sovereignty and independence of the scientist as an exten-
sion of my own independence and sovereignty as a citizen . .Any quali-
fication of it threatens me, and I think 1t threatens everybocl'y here.
The answers to the questions we are fa.ced with here are to be found
through the extension of the pragmatic and decent and humane pro-
cedures and methods that have been developed in the scientific com-
1nunity, about which the at large and our political apparatus is
just beginning to learn. ile it is easy to conjure up the notion of
the experiment on the clone, that would only occur t.o Frederick Wil-
liam the First with his 6'7" Potsdam guards. I bet he would have
loved t-0 have clones of them; that's the kind of political order and
the kind of human being to which that proposition would occur.
The more.I me.aning of science in our society is one that says we work
differently. I agree that there are horrendous possibilities. We must
rely on building from that base of respect for the independence and
sovereignty of the individual inquiring human being. Galileo got
locked up 'for mucking around in the ends of lmowledl!e, and we're
going to face more questions like that in our time. They already really
shake our society. What I think we're confronted with here is the fact
that because of what society lmows scientists lmow, the old absolutes
and the old arrangements under which people found their security
and their peace of mind are missing. We must agree to a new approach
to life which insists that there n,ren't any absolute answers, that lmowl-
erlge is tentative, and that values a.re going to change as our lmowl-
edire increases.
In Asilomar, we have an example of how the moral responsibility
of scientists awoke in them instantlv all across the world. In every
Jn,b where this kind of work was going on, the same kinds of ques-
t.jons occurred to the same kinds of decent people. and they met to do
snmethinl? about it. Maybe they didn't have the full answer in the way
they did it, but the model they gave us and the one that comes out of
the history of science is the one we should be working with, not the
discovery of some way in which some externn,l authority jg going to
be imuosed.
Sxwsm:n.rER. Alexander Capron defined the issue very clearly:
whether the controls should be imposed at the level of inquiry or at the
level of the use of the inquiry. But the point I was trying to make
(,oogh.:
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was that I can envision certain kinds of research which, once the
knowledge was obtained, would require social controls of a very in-
iquitous nature far out of proportion to any benefit the knowledge
provide to society. In such a case, it would seem to me to be the
course of wisdom to try to cut it off at the first level rather than the
second.
HELLEGERS. The question Hans Jonas begs is the one I tried to raise
this afternoon, the distinction between those who would ethically op-
pose experiments deontologically and those who would oppose them
teleolgically. Hans Jonas is a strong deontologist.
What seems to me important is Alexander Capron's comment about
bioethicists. I am struck by the fact that more than 60 of us were in-
Yited to this conference, but Hans Jonas is going to be the only prof-
sional ethicist to speak, the only one. I attended a t'vo-day forum of the
National Academy of Sciences on the same issue at which no ethicist
spoke. I was surprised by your comment that these ideas would be
esoteric, because they seemei:l to me to go precisely to the heart of the
question. The ethicist formulates the questions to be addressed so much
more sharply than most scientists. I'm surprised that you would have
thought that there was no place in the final solution for a bioethicist.
CAPRON. That's precisely what I said. "Bioethicist" is the term that
l1as no'v come to encompass many people like myself. I do not call my-
self an ethicist, but I get called upon to participate as a "bioethicist,"
as do people who are theologians, people who are public policy anal-
yst-5, people who are economists, and others. I'm using the term in that
way: if you think it's inappropriate, it's only descriptive. But what I
said is that they may be very, very useful in the process of identifying
the issues. That is different from calling them in- as has happened time
after time- under this rubric of bioethics, to give the ans,vers as
though they arc somehow going to be matched up against the scientists
and have a head-on collison, like trial by co1nbat, and the result will be
a public policy decision. That's what I was objecting to; the idea that
this is a process for which we, for instance, at House would de-
cide, rather than much more broadly-based, slightly less well-informed
public bodies.
l-lELLEGEns. Well then, let me .respond that my great fear is that you
and I are called bioethicists "'hen we have no right to practice ethics.
I have yet to meet an ethicist who alleges that he has the solution. He
is the man who asks the questions. All sorts of people are practicing
"ithout a license, and giving answers ethicists would never give.
CAPRON. I don't disagree with you at all. I disavo'v the term when-
ever it's applied to me. But I think it is the rubric which is applied in
this area.
GAYLIN. Hans Jonas, yon said at one point that the scientist must be
responsible not just for the intention of his theoretical research but also
for its application. I would like to ask you the same question you put to
_\lexander Capron. Since it is the nature of fundamental research to
' lead to all sorts of intriguing serendipitous results-indeed, some of
the greatest benefits of science-how 1n the world do you expect ac-
connta:bility Do you really mean the scientist is accountable for ap-
. plications of his work beyond any J>OSSible expectation of
Second, for Gerard Piel, I'm really confused by your statement, and
(,oogh.:
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I want you to clarify it. I f I understood what ;vou said, it was that in
an evil and lunatic society, scientists do lunatic but that in a
good and moral society we can depend on the good will and sanity of
the scientific community. Now I would like to know whether you would
say the same thing to distinguish the business community in a lunatic
environment from the business comnnmity in a moral I presume
you define our society as moral. I must say I was mystified by your use
of the term "sovereign." I'm aware that the First Amendment covers
sovereignty of ideas, but not of action. Couldn't you then extend your
concept of sovereignty to the business community, the commercial en-
terprise, manufacturing, law, medicine, engineering, drug manufactur-
ing1
JONAS. How can the scientist be accountable when the results of his.
basic research could not have been For instance, the nu-
clear scientists, are they responsible for the atomic The question
is, how basic is the research? We can hardly make the discoverers of
classical mechn.nics, including Galileo and Newton, responsible for the
use that has been made of that kind of mechanics. I was much more
thinking of scientific projects which have in them a certain direction
toward particular practices. This is a matter of degree. In the exan1ple
I gave about biological engineering, the scientist himself will have in
mind in doing his research certain things that are predictable.
MORISON. To be specific, would you have stopped Gurdon fro1n doing
the original experiment on the frog, where he took the somatic nucleus.
and put it int.o the
8
Would you have stopped that 'because
sometime somebody mig11t do it in a man
,TONAS. No, but there is then a really critical step from there int.o the
'vhere human genetics and human cloning becomes a kind of
VlSlOn.
MORISON. Then you and Alexander Capron are together on this, ,
that the question is where you draw the line and how you do it i
.ToN AS. Yes.
PIEL. I make this distinction: that our freedom, when we seek our
personal ends, is governed by the Fifth Amendment and the due proc-
ess clause. We, as sovereign governors of a self-governing society, are
nlso the governed citizens thereof. So long as we are private.
ends, we are properly subject to public regulation. That applies to the
corporation and all those other mischievous fellows you've spoken of.
is. another matter. Inquiry is a sovereign process. It is by
the increase of human understanding that we shape the ends of so-
ciety and make human purpose-and incidentally, because the kind
of knowledge we'r:e talking about here is useful knowledge, provide .
the means for attamment of those ends. And there I say that the free-
'John Gurdon, an Oxton! biologist. did hie wort-known popularly as clonlnJ?- wlth nn
African horned toad, a creature known tor tta regeneration capacities. Radtntton "'ns
used to destroy the nucleus ot an egg cell, and that nt1cleus was replaced with one from n11
ordinary body wbtcb bad a complete chromosome complement. assumf'd that Rll
body cell nuclei contained the latent potential for reproduction of a dltrerenttat ed. nrnltl-
cellular adt1lt. and tbat the new cell would be equivalent to a fertilized eJ?S! and
capable of producing au adult form. The reaultlng embryos did In fact achieve the
mlng tadpole stage of development. It la thna theoretically poaslblc to nroduc a J? ntl-
cally Identical copy of any organism with this technique, although to elate moat of this .
work baa been done on plants. Partly tor te-chnJcal reasona, tt has not yet been
fnlly l\chleved In lllalDmale lucludlnir Homo 1ap1.,.,,. Soe J. B. Gurdon. and R. A. LnkY.
The transplantl\tlou of nuclei from elnsle cultured cello lute enucleate trogs' eggs. 1ournal '.
of Embryologlc and Eperlmental Morphology. voL 24, 1970, p. 227.
(,oogh.:
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do1n of the citizen pursuing the public welfare and concerned with the
ends and the purposes of government and the operations of govern-
rnent is absolute. I disagree strongly with Justice Holmes, who finally
up disagreeing with himself when he balanced national security
ngainst individual liberty. There is this of the col-
lision of absolutes and what marvelous and difficult kinds of problems
thiit gives us. It doesn't give me any problem at all, because govern-
1ncnt is subject to the sovereignty of the citizenry. I say that science
re'lnires the extension of that, and it's the most sovereign enterprise
of :ill.
Now we come to how vou do it in the real world. I think it's to be
attained by t he same kind of adjustment of pragmatic institutions
that we find in the peer review group, 'vhere the model of the tactical
decision becomes broadened to take on the strategic decision. We can
so beyond that to include still larger elements in the social order .
.l say that the principle we must bear in mind in doing so is the sov-
ereign principle of freedom of inquiry. I'1n not bothered at all by
Hans Jonas' problem of the Potsdam guards. That's not the kind of
proposition tliat arises in any natural and decent way. We are talking
about a moral society. This is. And the scientific enterprise is a nloral
enterprise.
CAPRON. I think it is true that the First Amendment may give
protection to the thoughts and communications of scientists. But the
Fifth Amendment does not oive any protection to him when he claims
he is serving the public ends; indeed, the F ifth Amendment places
lin1itations on state action, not on individual action.
LAunA NADER. I'd like to rnise two questions, one addressed to
Robert Sinsheimer and the second addressed to Alexander Capron.
The first has to do with :freedom and the social organization of the
scientific workplace. I'm really impressed that whenever I hear scien-
tists talking about scientific freedom and freedom of inquiry, they're
always talking on the ideal level about what should be in order that
science should operate. I am very concerned, as I watch scientific work-
places, such as for example the Lawrence R,adiation Laboratory at
Berkeley, that with increased scarcity people are really coming out
in their underwear. We've got to begin to realize that scientists are
employees now. They work for laboratories, they work :for departments
in universities, they have the :fears of employees, they are censored
like employees.
l\ilost of these organizations are shtiped like a pyramid, and the
people who have the freedom of inquiry, who decide where inquiry
should go, are at the top of that pyramid. I :f you want to talk about
freedom of inquiry in the scientific community, you're talking mainly
about the three percent of the scientific community that have it and
that decide it for the rest. The second question has to do with accounta-
bility.
CAPRON. I think peof.le are listening for the first question.
NADER. Well, what Im asking Robert Sinsheimer here is, do you
think scientists have the freedom Gerard Piel
SmsHEIMER. I donlt know how the radiation laboratory at Berkeley
works. I do know that I 'm chairman of the Division of Biology at
Cal Tech, and i:f that's a hierarchical organization it's been concealed
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from me for a long time. Our faculty members are completely free,
once they're on the facultyJ in their choice of research.
NADER. I would be mucn more comfortable if you were an assistant
professor stating that.
SmsuEI:r.1ER. They are constrained externally, because they have to
get money to do what they want to do. That gets back to problems of
the resources available to the National I nstitutes of Health and
National Science Foundation, and that in turn I suppose gets back
to Congress. But those are really quite external to the institutions.
KEN'NE'l'H RYAN. It may be that scientists themselves hold back
science more than religion or any external government agency. I've
heard that Helmholtz,' who complained when he was a young man
that he was held back, held back other people when he became famous.
It's this voice of authority within scientists then1selves. It's not neces-
sarily hierarchical within your department, but within science itself.
I think we have to be aware of this, otherwise we're kidding ourselves.
NADER. I think departments are probii,bly better than laboratories,
which are run more or less like military organizations. My second
question has to do with accountability. I think people who got human
experimentation committees started on campuses would be very con-
cerned to see how they're operating. Student clinics around the
country are places where preswnably no biomedical research is
done; that is nobody would assume that there is biomedical researcn
being done there. On the other hand there is plenty of evidence that
there are pharmaceutical companies .that are experimenting widely
in student clinics all across tlie country; that is, students are being
used as guinea I s that biomedical How do you hold
those people legally accountable if they don't call it biomedical re-
search but call it treatment.
CAPRON. Tell me what you mean; I didn't understand.
The point is that when scientists on campus are d?ing
a piece of research, and the people on the exper1nientat1on comm1ttee
are trying to decide how to protect subjects in this research and they're
not sure about how to do it, they very often will send it up to the medics
at the student hospital and ask them to okay the research.
MorusoN. That's a strange thing to say; it can't be done.
CAPRON. It can't be done. We can have someone from NIH testify
about this. The regulations say that if research is carried out in an
institution-which includes all the departments and campuses and
different divisions, including the student health service conducted
under the institutional aegis-it must be in compliance with the assur-
ance which the institution has filed with NIH that it is following the
government guidelines on human experimentation. If they're using
students as subjects, students are as much human beings as anybody
else.
NADER. But it's not called research.
CAPRON. It doesn't make any difference what you call it. You can
have an experimental treatment. For instance, the research that was
'Hermann Ludwig Ferdinand von Helmholtz (1821-94), German physiologist and
physicist, Invented the ophthalmoscope, did extensive wort on mechanisms ot Tllon and
hearing. Is one ot three men credited with the theory of conservaUon ot eneri;y, worked
"" several aapecte ot electl'lclty and electromagnetism, and made a host ot other contl'I
buttons to 19th century science and phllosoph;r of science.
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done on the so-called "1norning-after" pill was largely done in student
health clinics because students happen to be a population at risk. They
have more mornings after-and more nights before. But that research
is research therapeutic research. It's research on something poten-
tially beneficial to the subject. It has to be conducted after peer review
or institutional review, \v1th the same kinds of informed consent pro-
cedures you would do if you 'vere doing it in the university hospital
or in a clinic or anywhere else. If it's not done that way, they'1e in
violation of the HEW regulations and they will have all their federal
money taken away.
HAROLD GREEN. There's so much meat in this I don't know where to.
begin. I find everything Robert Sinshei1ner says acceptable. I wish I
coiild say it as well and translate it into la,v. I was trying to relate
Hans Jonas' comments to constitutional law, the First Amend1nent_
I think what he said ''"as entirely consistent with First Amendment
principles. There is a distinction between speech and action. Of course.
in all those kinds of speech, like obscenity and fraud and extortion and
what not, you are not protected by the First Amendment. But other-
wise you have an absolute right to speak. But there is not an absolute
right to action. The difficulty is whe.re the line is drawn between speech
and action. I have no problem w.jth saying there's an absolute right
constitutionally to scientific inquiry so long as it involves conte1npln-
tion or communication of ideas. When, however, a scientist starts fool-
ing around with anima1s
1
let alone human beings, or when he causes
obnoxious odors or exploSJons or something to emanate from his labora-
tory, that is definitely subject to regulation, \vhate\er kind of regula-
tions society decides to impose.
I thoroughly agree with Alexander Capron's diagnosis. I have son1e
problems with his prescription, however. He seems to be talking about
substituting a la.yer of elite quasi-scientists who are not scientists for
scientific judgment.
W.jth respect to Gerard P iel, I find his notion-I don't Imo" how
to say this gracefully-a relic from the 18th and 19th centuries.
PIEL. That's graceful !
GREEN. I have no difficulty with agreeing wholeheartedly, to my last
breath, with the principle he enunciates. My problem is that the fact
of the matter is that science and scientists today are not autonomous.
They are attached to an umbilical cord running from their laboratories
to the United States Treasury. Once they see that the public pays, they
have lost their autonomy, they become subject to an absolute extent
to the play of the political process, as Ruth Hanft mentioned this
afternoon. There simply is no way to escape that problem. Science has
lost its virginity. I suspect from this point on and forevermore it is
inextricably enmeshed in the rough-and-tumble of the political proc-
ess, and there is no escape.
l'l{orusoN. I 'll give Gerard Piel 12 hours to invent a "morning-after"
pill for this loss of
BROWN. I 'll start with a question that's directed a.tall four speakers.
but it's stimulated by Gerard Piel. The question is, what are the inter-
national implications of what :vou said Let me carry the question
just a bit further. We were all obviously struck by your phrases about
the self-governing community of independent sovereigns, and your
desire to take peer review and broaden it.
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Does this imply that eventually we will have a self-governing com-
munity of independent sovereigns that is world,vide, that essentially
the scientific peer community will be a united nations of scientists 1
Because, as R-0bert Sinsheimer so nicely said, we change the nature of
the world by our knowledge of the atom and the cell, is this really the
forerunner of a new government system for our Can you carry
your notions of the self-governing system of sovereigns to a new inter-
national order of control 1
PIEL. Well, in this case the model I'm talking about is one that ulti-
mately includes all of society in the self-governing enterprise of science.
We're already inventing ways, because science is on the
public purse to support the sovereign enterprise of individual inquiry.
As to the international implications, the only international social order
we have is the international social order of science. It stands in the
world as the model to which we could hope that the present anarchy
of international states may evolve. The hope and promise that that
might happen is the fact tha.t the industrial revolution is spreading.
l\fcGowAN. Are there things people might want to know, that the
scientific establishment in its infinite wisdom might not have thought
iinportant, things that are in fact important for the public
Doesn't that mandate direct involvement of the public in determina-
tion of which scientific questions shall be asked-to benefit them,
been.use they're paying for it ? Shouldn't we be considering those
mechanisms, so that public interests and public questions can stimu-
late research 1
CAPRON. I would think that the answer is clearly yes, and we've al-
ready had examples of that. The crusade against. cancer forced scien-
tists who were doing one kind of research to adapt themselves to a
public expression of interest, largely originating in the lay community
through its public officials, to address other questions. Scientists here
who have spoken about that have suggested ways in which they are
in fact. able to modify the public request to come a little closer to what
they think a.re really the relevant questions. So it's clearly a situation
-0f give and take. The. suggestion I put forward about assessment doesn't
mean assessment only to stop. I suppose if you were havi!J.g someone
on an international, not just a nat ional basis, developments in
basic science at an early stage so we can get a handle on what's com-
ing down the pike, we might well say we've got to make one of these
things com!' down th1> pike fast,er because we need it very badly.
Scientists might not be particularly devoted to that area, so there
you get into research training grants and so forth, to stimulate an
area.
PIEL. I w11nt to say that cancer is a fine example of how the external
apparatus of society is not yet ready to ask intelligent questions and
hn.s diverted the work of scientists into blind alleys. I mentioned this
a.fternoon that the .dominance over biology by questions of medicine
in .\.merican society has diverted a Jot of marvelous biological talent
into medicine that in t en years we'll kno'v should have been devoted
to agriculture.
MORISON. The chair will rule that you have breakfast with James
w ntson nnd discnss that question.
Pn:L. ThnVs a hard rule.
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HOLMAN. I wanted to comment on Alan McGowan's question about
what the public might want to support. I'm surprised by the idea of
the cancer crusade as an example of public support; I'm doubtful
that's really true. But I think there is a real problem in our assess-
ment of scientific goals in terms of what the public might or might
not want. At the moment, by and large, our goals are set internally
by the scientific community. In a recent issue of Federation Proceed-
ings are the slightly abridged texts of the t estimony of Leonard Wood-
cock and Leo Perhs, from the labor movement, on what they see as
the issues that should be explored by science.
8
These are extraor-
dinarily well-argued statements, in my view, with many issues raised
demonstrating a concrete refutation of what I heard Gerard Piel
to be saying, that the public couldn't understand the issues. Quite
the contrary. I think they were substantially in advance of some of our
perceptions of what should be done. They serve as indications of
whether a particular type of representative of the public could state
what should be done, if given an opportunty to interact with
scientists.
Another example pertains to our discussion about medical educa-
tion and medical research. By and large, we devote money to tertiary
and secondary care. There is very little research done on crucial issues
in primary health cnre, though those issues comprise at least 80 per-
cent of the visits of peo:ple to doctors.
There are two very vivid examples of this. One is a very well-studied
subject, hypertension. It's exceedingly difficult for anyone to get a
definitive answer out of the plethora. of articles a.bout management of
essential hypertension. Another one is a common illness, vaginitis, in
which the literature will tell you nothing about the natural history
of the disease, the nature of the organisms involved in the infection,
or the efficacy of treatment in any controlled way. You can look in
the literature if you disbelieve what I say, but I think I'm accurate.
Why haven't these been studied? Why don't we have definitive answers
about the nature of hypertension or vaginitis and their control? In
one case, we've had a lot of effort, and in the other we haven't had any
effort at all. In neither case do we have answers. If the public, who
experience these conditions, were to put some priorities in front of us,
they might ask the scientific community to address what appear to be
mundane issues. I t seems to me that when we begin to talk in these
rather large terms about scientific freedom and the scientific estate
and its own capacity to generate self-government, we also should in-
troduce into the question what Alan McGowan said, namely, what
does the public need answered? Can they help us to
MORISON. I certainly agree with you in J?rinciple. I would like a
few words from Andre Hellegers about vagin1tis.
HELLF,GERS. I once had 100 women in Johns Hopkins Hospital we
had them do vaginal douches for one straight year. We scienti;d' the
dickens out of them, and the conclusion was that we didn't think we
harmed them any.
MoRISON. But you did make the effort.
r,.,,,nnrcl Woodcock. of the United Auto Workers. and Leo Perils, ot the AFL-CIO. hn<l
tetlfled January 26, 1976. before the Prealdent's Biomedical ResearchPanel u on research
Rfl hy organtzed lnhor. Exeerptts from their appeared In Feder&
!Ion Proceedings, Vol 85, March 15. 1076, pp. I-Tiii.
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liARoLD EDGAR. I'd like to return from public initiative to public
restrictions. I t seems to me that the hardest question we face is whether
or not obtaining knowledge ought to be in any circumstances regarded
as a species of reckless endangerment, rather like letting the bacteria
out frorn the lab. The tradition is surely not to so regard it. The ques-
tion is whether the risks involved have now o-otten so great that we
have to, or else face an alternative of placing other sorts of restrictions
on us that are even worse. The question 1s for Alexander Capron,
because I thought in his first description of his model, by
the sco,pe to science and technology assessment, his plan conternplatect
public mquiry into what science 11as planned, with the possibility of
public restramt. But then-and I may be restating his position- it
seemed to me as ii he was backing away and saying he would only
intervene at the moment when a person sought to make application of
knowledge discovered.
CAPRON. I think the distinction is between the most basic research
nnd the next, more applied steps. The example is given in the environ-
mental area of something like the Supersonic Transport, in which t here
has been an assessment of a highly de\'eloped technology, and a restric-
tion on its use at that point. I guess the concern is, is it ever possible to
restrict medical technology once it gets to that I do doubt that,
so I think :you have to move back. I don't ki1o'v enough about
aerodynamics to go into the SS.t" but it's obvious that at some stage
very early on you can say you have Jmo,vledge that indicates an ability
to build a plane like this, and then you start 1noving t.o develop means
of doing it. As a lawyer, I prefer to deal case-by-case with examples.
I can't well describe where that gray area is between something that is
basic enough to be allowed to develop freely and then applied enough
to be restricted. Maybe it's the first step with a frog. If it's the first time
that anybody has ever attempted to see what cell differentiation means,
and he comes up with what turns out to be an ability to clone, that's
basic. But it borders very close to applied, and you stop there.
EooAR. I see. But in any event you would pern1it stopping before anv
application which directly threatened the social interest.
CAPRON. Yes, even though that would amount in some cases to an
interference with the scientific freedom that's talked about a lot.
A:!Ax1NE SINGER. I'd just like to make a few comments on Laura.
Nader's remarks, because I 'm uneasy at leaving us with that descrip-
tion of American science, which is a remarkable institution. One is
sonal, and one more general. First of all, I have spent my entire scien-
tific life working in a United States governn1ent laboratory, and for
almost all of that time, about 19 years, 'vithout any kind of administra-
tive status of any sort. On the other hand, I was nlwa_ys totally free to
carry out my own investigations in the laboratory, and I never had any
impression of any particular direction being put on me. Secondly, and
more generally, I think that it's really very widely recognized among
foreign scientists that the great strength of American science con1es
very specifically from lack of a hierarchical structure, and from the
kind of opportunity that young American scientists have, which most
young foreign scientists don't have, for undertaking independent
research.
NADER. Could I just speak one line and then return to I think
how laboratories operate in periods of afiluence is very different from
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.how they operate in periods of scarcity. 'Vhat I see happening in the
laboratory over the past five years is things falling into shape and the
<leadwood being shaken out. The decisions a.re bard to make, ana
they're always made by a few people because they know what is best
for American science.
l\:IorusoN. I think the very large physics laboratories, which depend
On machines and scheduling and so on, are different from the kinds
of things Maxine Singer and I have experience with in biological labo-
ratories, which have not yet really developed this big team research. My
daughter, who has been in two well-known laboratories, has never had
anybody tell her to do anything from the time that she got her Ph. D.
onward. I think that experience can be duplicated over a number of
places.
KING. I think a lot of the discussion is very useful, but time and
ti1ne it stops at a certain point. It's as if all the problems and
i;onstraints in the scientific endeavor are in the realm of metaphysics
so1nehow. Let's pick up the discussion on _public input, for example
'Yoodcock's testunony. Ile talks very eX'phcitly. He says his people
on the assembly line are getting poisoned by lead. They're not too
confused about that . You go back to the history of the asbestos story
in Texas and the l\:Iidwest; the people 'vho worked in those plants
knew they were getting sick from asbestos poisoning. Their fathers
had gotten sick before them. They also knew they could expect little
relief if they went to the medical school and they 8aid, "Ifey, I don't
feel good. I 've been breathing this stuff." In recent years, the front
edge of the medical profession h>\S to rocognize that it's true
that, for example, workers in the leat11er industry in Massachusetts
knew they were probably being poisoned by solvents from the glue.
And it's true that when they came into the hospital the young physi-
cians didn't pay any attention to them, because occupational medicine
was not stylish and their careers couldn't be forced in that direction,
and it didn't fit into the tradition of American heaJth care.
It's as if fashions come out of nowhere, out of the heads of doctors.
But fashions come from social forces at work. It's very clear why it
"'asn't fashionable to work in occupational medicine. It means going
into those asbestos factories, and running up against powerful eco-
non1ic forces. I t was very, very difficult.
vVe're not about some internal ethic. We're talking about
the fact that the scientific endeavor is embedded in the structure of
society, and that all the conflicts in society are working there. If there
is a conflict in the factory bet,veen the UAW and the people who
direct the labor of those people on the assembly line, that conflict is
reflected in the scientific endeavor so that the subset of activities which
doesn't rub up against the powers that be is OK. But that subset of
acti".ities that is going to rock the boat-for example to ask them to
put in $200 million worth of air pollution control equipment, which
will cut down profit margins-that kind of stuff doesn't get done.
It's not because scientists are evil or not evil, or moral or not moral.
I t's because we're subject to the sa1ne forces as everybody else.
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I t happens that it's useful to educate scientists to believe that such
is not the case. It's clear that some of this has to do with the employ-
n1ent of scientists in the war industry. It's very hard to take young
scientists brought up on Gera.rd Piel's ethics of the beauty of the
scientific endeavor, and have them work on missiles that are desiwied
to kill people, without them being upset. So you have to train tnem
so that they identify that activity as fluid dynamics. I was a graduate
student in Robert Sinsheimer's department at Cal Tech before he
"'as chairman, and ''"e \Vere surrounded by missile engineers. W11en
those of us who were biologists raised the question, "Hey, what are
you doing? You kno'v what they're going to do with those things,"
they would say, "No, no, I 'm not in the 'veapons indugtry. I'm just
pursuing the freedom of inquiry into the motion of Jong projectiles
an ill-defined liquid medium." And personally, historically
I thinlc that \vas a good thing to do.
If you rea.d Irvin&_ Stewart, who was the administrative he1td of the
Office of Scientific .ttesearch during World War II, he talks about
the fact that they recognized that we live in a technolo!!'ical world,
that there were going to be technological wars, that we n;ded a stand
ing population of scientists. It doesn't matte.r what they do, give them
money, tell them they're Americans and believe in basic research, even
though there is no American Yankee tradition whatsoever of basic
iJ'lilirect research. Keep them happy. Most of us were brought up in
that tradition. "\Ve weren't even told t hat in fact we were paid for
and supported by legislation which was really a substitute for the lack
of national health insurance.
l\{orusoN. Hans J onas, you had the first word and you can have the
last.
JON.AS. Two brief Tema.rks. Immanuel Kant has said the best consti-
tution is that which works even with a society of devils. He didn't
think that hum1U1 society consisted of devils, but he was also very
n.ware that it doesn't consist of saints. The scientific community cer-
tainly is not one of devils, but neither is i t one of saints. Even if they
were all saints, it may be that the views of sainthood would not agree
with the views of the rest of us. But the point of my paper is that
a constit ution is needed which works with these conditions.
Second, some years ago I heard a very prominent molecular biolo-
remark, at an inte1national conference under the auspices of the
l{ennedy Foundation in Washington, on certain potentia.l implications
of molecular biology: "Wllen I think of it, it gives me the creeps."
The name.of man was James Watson. I heard you say that, Dr.
Watson, "1t gives me the creeps." Wllat I am saying is that we want
to oo shnrers in your creeps . .And possibly, if nccossnry, do something
n bout it. That is the public interest.
82- 201- 77-5
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FRIDAY MORNING. APRIL 2
LEGISLATIVE PERS.PECTIVES
GATLIN. I would like, before we start, to summarize briefly what
the progreai was the first day, for those who either were not here or
thought there was no progress. One of the advantages of a summarizer
is that he can endow a meeting with progress when it may not have
existed. I think there was a kind of movement during the day, and with
my to the speakers for a 30-second abstract of their brilliant
presentations, I think it went something like this :
Stephen Strickland started by giving us an excellent historical ap-
proach, fact rather than opinion. He introduced a concept new to some
of us, that of the good old days, meaning pre-1968, during which fewer
questions were asked, and friends of the science community were
evidently everywhere in Congress. Robert Marston, having experi-
enced it personally, talked a.bout the delights of being a. health a.dlnin-
istrator in that period. I t was easier because there was only a. congres-
sional appropriations committee, which gave you money, evidently in
those days, all you wanted. What you did with it was then between you
and the Maker. It was something like the Protestant Reformation, I
guess, where the middlen1an was removed. He found that a much more
amiable procedure, expressing his opinion that, with fewer people to be
accountable to, a. deeper dialogue and a rapproachement could be
maintained. Franz I ngelfinger, from the floor, then asked whether that
was really better, and for the first time raised the question of the value
of accountability. We seemed to end the first part of the discussion with
the consensus that things were indeed simply splendid between Con-
gress and the biomedical community, whereupon I was faced wit.h the
decision of whether to suspend the meeting and send us all home.
Fortunately, at that point two people raised 9uestions. Stephen
Toulmin and Gerard Piel, both from different points of view, ques-
tioned whether things are that good. Gerard Piel asked whether bio-
medicine was not getting an unfair percentage of the science budget,
and whether the sweetheart contract that may have existed was an
ideal mechanism. Ruth Hanft then gave her presentation. She took the
position that 1968 was not Armageddon necessarily_, but may have
indeed been a turning point for good. She based that on the fact
that there is more visibility, and more visibility is a good thing. She
introduced to this meeting the concept that resource allocations in
science a.re not scientific issues, but political issues. She went on to say
that constraints on growth require competition among the various
goods, and that indeed the question of what is good and bad is not
nearly so interesting as when you have a number of goods. Where then
do you place the priorities She mentioned that environment and eco-
nomics may influence health more than biomedical research, and she
also said cost-benefit analysis, which involves public representation, is
necessary in describing various values among the goods.
(61)
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Howard Hiatt picked up from this and raised the question of who
should establish these priorities. 'fhe mechanism of decisionmaking be-
caine a crucial issue in the discussion from that point for,vard, and the
opinion of the majority of the group 'vas that no longer will it be ex-
clusively the prerogative o{ the .scientist, qeca1:1se the decisions have
ceased to be a i_f they Harold Green
asked whether 1s .. quabta,t1vely d1ff!)rent in some way that
would allow it to be shielded fro1n'the same kind of scrutiny other in-
stitutions ot our society get. Ruth Hanft ans,vered, it was not: Some of
the other inembers of the group, by their silence, seemed to argue,that
it. is. . . . : : :
.)Ve then ca.me to.Hans Jonas' presentation. Most of yo.. were here,
and I to sum1narize it because l felt it was so explicit; hut in
essence he 'wllS maliing -the same kind of claim for science. that certain
constitutional lawyershave made about the First Amendment. these
days-that .we have come to a point where clear distinctions.:between
theory and practice, or in First Amendment terms, idea and act, are
now blurred. While there is great protection in our Conptitution for
freedom of th.ought, when thought gets translated into action. a whole
set of new: rules and regulations come into play. He then:poj.nt.ed out
how hist-OticaUy, the confusion of act and id!\&; of. theory -and.fia,ct; came
The.concept of freedom of in.qiry had meaning to :him.when
inquiry, :was the isolated scientist thinking in his astronomy labor:atory,
or the mathematician, but became some,vhat different with 'the.intro-
duction of the: concept of experimentation. Experimentation, he said,
introduced manipulation of the environment, and research .then went
beyond the right of total freedom that inquiry was presumed tl>:have.
Alexander Capron agreed on the public's right to control science,
and asked what procedures of control are. This brought us very close to
what the heart of this conference was intended to be. He mentioned
four, which he called "no hands," "lonely man," and !'rug-
pulling," and he rejected all of them. One of the easy things for .all of
us to do is.to reject current solutions, so he came up with some tentative
solutions of his own. His rejection of present solutions achie:ved, it
.seemed, unanimous affirmation from the group. His ne.\v. solutions,
however, also seemed to be rejected out of hand, which is roughly the
state of things this morning. We are all p:oo<l critics. '\Ve are all
l{OOd analysts of what has been done wro!1g who have.done
it to us. We tend to be somewhat Jess effective m s.'l.y1ng whatwe.wonld
do were we in their place. The discussion then went. to.some:.o'f the
things which shpuld be the work of this conference, suggestions o_f
where. we go from here. !
Gerard Piel then gave us a romantic interlude; away fr.om;th.:e prac-
,tioaJ, with an impassioned and touching plea to aporeciate. liow we
have benefited from the free inquiry of science in a free society. This
received, it seemed to me, a great deal of criticism rathe-r .than sym-
pathy in the group. Most people tended to feel that those days were
gone forever. The discussion then moved to the fact that now, not
because of the failure of science, but as a tribute to its .. success, it
becomes pa.rt of public policy and part of the public domain. Alan
McGowan broadened the discussion by asking why are we:only ad-
dressing ourselves to the limits of scientific pursuit and.to limiting
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directions which might be hazardous. Ought we not be directing it to
areas of concern to the Jonathan King terminated the meeting
by that directions were determined by broader values of society
which; willy-nilly, are operating on everyone, the scientist '18 well as
the .. To think they are value-.free is to th.econditions of
sociaJ life, a,nd the way in which values are inculcated by indirect,
rather.than' il.irect, forces. .
left s, I think, with two is5ues clearly enunciated and with
the we h11.ye !1.day and a 'I'.he i.ssues are: (1)
q?eat1.oi;i of pr1or1ties,. The frontier is closed. We do not have
unll.IliJ:tf.\l We will never have them agai?\. liow then.do you
establish P,r1onties for the goods 1 Who. to. establish such _{lriorities1
which .. W.ill determine the direction and the ainount' of b1omedica1
researeh . whether primacy or applied Y The que8tion of distribution
between P.rimary researcl,l and applied research is implicit in th11,t.
(2) How, ctoes one deal with the question of potentially high-gain, but
reasonably high-risk, research
Implicit in both of those is who is to make the decision, .and how.
'\Vhatjs F.he,mechanism This leads me, then, to what I assume is (after
our .brilliant beginning of yesterday), the problem of todii.y. Assuming
there a ,public interest, who is the public, what a:re its instrumenta-
tions, ho'v and at 'vhat point should that interest of the public be
exercised 1 All we have to do for the next day and a half is come up
'vit.h spme sug-gestions as to how the public ought to exercise what
seems to be a fairly general right, its interest in these issues .
<\.s far as substance is concerned, let me say this: I think there has
been a Jl}ii;;take in understanding, perhaps because I didn't set the tone
properly. at the beginninf<T, If so, I apolpgize. This ii:; not a panel of
experts.up. here.in front o an audience. This is a commupity of experts,
aconurnJnity of interested people. You do not have to ask questions of
the pe.ople mak:ing the address. You don't have to go through that
social game of making your brilliant, prepared or spontaneous state-
ment in the form of a pertinent question. You are free to ignore the
presenters, with the possible exception of thismorni?\g's presenter, and
make: your articulations and your statements. This is, in a sense, a
seminar, 9, the w}lole. Please .feel free to address yourselves directly

bt keep in mind what.our purposes,are. _If there is a public
interest, it. is.not enough t o wave the flag and !;lay that there is. Te.JI us
how .you think it should be exercised, at what points, with what
methodologies, and what safeguards. By doing that you will have
effectively also defined what :you mean by the public.
Your speaker for this 1norn1ng is Senator Edward Kennedy, Demo-
crat. of Massachusetts. I was going to introduce him as an hqnored
gues.t; but I realize that is a mistake. He is not our honored guest, he is
our host. We are his guests, since it was he and Senator J a vi ts at whose
request this meeting was convened. So I will no'v turn over this part
of the meeting to our host.
EDWARD KENNEDY. Thank you very much, to you and all the partici-
pants at the conference. First of all, I want to personally express my
thanks to Willard Gaylin and Frederick Robbins, who have been kind
enough to bring us all together. It's rather an unusual request, in the
sense not only of the issue that we're considering, but also in the way
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that this particular meeting was structured. We tried to leave both
the participants and the areas to be discussed as open as possible, but
nonetheless we hope we'll be able to derive some very useful and help-
ful and recommendations as the result of this conference.
I 'd like to talk very briefly about the origins of the concern that our
committee in the United States Senate has had, and then a little bit
about why this conference came about, and ilien, finally, what we hope
to get out of it. A little over two years ago, in our inquiry in the Senate
Health Committee on quality of heaith care, we got very rapidly into
questions of testing drugs, psrchosurgery, and medical devices, some
of which has led, I think, to unportant and useful legislation. As we
proceed ilirough these inquiries, there were really two central trends
we could see, which I think reached out to all of us on the committee.
First of all, there was very little in the way of consent that was being
given by those who were subjects of the various kinds of research.
Secondly, there was very little being done in terms of
ethical considerations for research. I think these were presented 1n
dramatic ways, splashed over newspapers and on television screens all
over the country. For example, ilie study in Alabama of untreated
syphillis over the last 25 to 30 years, the sterilization of two young
retarded girls, and also drug research with the institutionalized men-
tally retarded.
During this time, we found NIH was similarly concerned about
these particular problems, and we t ried t o work very closely with then1
in fashioning what could be our appropriate response in the Congress.
We came up with the Protection of Human Subjects legislation-cre-
ating the National Com1nission for the Protection of Human Subjects
of Biomedical and Behavioral Research. In our attempt to try to make
sure these issues were going to be given adequate consideration, we
insisted the 1najority of those who would participate on the National
Commission panel would not be scientists but would include ethicists,
philosophers, theologians and physicians as well as scientists, to try
and provide at least some guidance, some help, both to us as an inst1
tution and also to the American people. We were hoping that particu-
lar organization would try to look at some of the immediate problems
we were going to be .aced with as a society and as a Congress. We
wanted them to guide us with the long-range implications and long-
range issues and long-range questions, t-0 try and anticipate, to be an
early warning system, so that we could begin to address these issues
in a responsible way rather than with the emotion which surrounded
some of these questions, for example the bnnning of fetal research.
9
I
think this gives you some idea of where we've been and where we are
today. Parenilietically, we are extending that panel not only to NIH
but also to. include the Department of Defense and also the Central
Intelligence Agency.
Now, why are we at this conference, and what do we hope to
We have on our comlnittee tried, in SJ?ite of the establishment of this
commission, to continue our own inqwry into some of these areas. ''Ve
had the hearings on the right to die, because there was so much con-
cern. Constituents were talking to their Members of Congress, to their
Charles U. Lowe, an4 Barbara l!'rle<lmao HlahtlD. Science Fiction or Non-Fiction?
Trial, November/December, 1975, p. 22.
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Senators, and to NIH about what kind of help could be given, what
kind of guidelines, what kind of moral and ethical assistance could be
given the American public. We saw this anxiety reflected in our panels
on the right to die.
We had two mothers whose children had been in automobile acci-
dents, one in Ohio and one in Maryland. The laws regarding the right
to die differed markedly in the two states: one state saying that i f there
are vital signs you cannot end extraordinary care, the other state say-
ing that if there is effective brain deat}i. then there is no more obliga-
tion or responsibility to continue extraordinary means. Here you 'had
two women who were going through extraordinary anxiety which
surrounds any human problem of this type, but, 'because of the state
laws, two entirely different solutions. Both of the people on the panel
and all of us listeners wondered, "Is there, or isn't there a role for any
kind of federal legislation" At the end of that particular meeting I
knew that if there was any time when federal and national legiSla-
tion was not needed it was at ti.lat particular time. But the anxiety of
the difference, the confliet, the human tragedy was presented in a most
dramatic way, and it was apparent that there was very little that any of
us could do to help.
We in Congress, therefore, see that we are in very great need of
guidance, assistance and help on these issues. In t he Congress we are
basically all generalists on every different issue, whether it's in health,
education, housing or the problem of the cities. I also think the Na-
tional Commission itself needs this kind of guidance and additional
public input. I think the advisory commissions that have been estab-
lished within the NIH, all of which are attempting to try to find out
\vhat should be the role of the .Public, need to examine how we're going
to bring the public into important decisionmak:ing.
I have reservations about whether scientists alone ought to make
final decisions in these areas that have ethical considerations. We have
to ask ourselves really how \Ve're going to get surrogate input into
these areas that are being publicly underwritten in an important way.
In this decisionmaking, I think it's imperative to pomt out that,
speaking for myself, (but again I think on this issue I speak for the
great majority of the members of the Senate), we're not interested in
terminating any kind of research ; we're not interested in ending any
areas of inquiry. What we are trying to say is that, in any of the areas
of scientific inquiry that can have important public implications, there
ought to be some opportunity f or public participation. I was extremely
critical of the Buckley a1nendment to ban fetal research, and really led
the fight for political intervention by introducing a substitute bill sa.y-
ing that the research will be banned until the Commission promul-
gated regulations for fetal .research- That allowed members of Con-
gress, feeling the extraordinary pressure from their constituents to do
something about fetal researeh, to vote Yea, but in effect they voted
Nay on a permanent ban. Similarly, we were able to forestall the Bell
amend-ment, which would have terminated
Another eoncern I have about this whole area arises in many other
public policy issues; that is, how are we to take the specialized
kno,vledge which exists within this room ana apply it to really im-
portnnt, commanding issues of ethical research, and make it avallable
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to Congress and tot.he American I think this is imperative. As
someone 'vho is attempting to deal with public :eolicy questions, it's
my impression that the issues are so extraordinarily complex that, as
you go into them, in too many instances they get so specialized that it
makes it extremely difficult for us in Cqngress to be able to make intel-
lil,!ent and informed judj?Illents.
Let ine that the public has an enormous interest in all of these
areas: !' don t think there has been set of C?ur. committee
has .conducted that has gotten the kind of pubhc reaction that these
reeeived. Any of you that 11.re interested- I doubt whether
rou might be, but perhaps you are-:--and 'vant to spend a fe,v days go-
mg thr6gh that mail and getting the sense of coricern of the public
on this, and their 'villingness and desire to attempt to partici-
pate in these decisions, will recognize the real challenge for us. in these
areas.
I'm hopeful that, as a result of this conference, you can m&ke some
recommendations, not just about how we're ultimately going to resolve
these particular issues. First of all, are we asking the right questions
in terms of trying to involve the public sector in them? What is the
best way of dealing effectively with them from a public point of vie'v?
What kind of guidance can 've receive in the public sector to deal 'vith
these which are of such extraordinary concern to the Ametican
people, and in which I think they have such legitimate interest? ''r e'ro
hopeful, as a result of this conference, that we will perhaps gain some
ideas, some suggestions, some recommendations about how we might
proceed in the future. I hope that can be a part of the goal of this
particular conference.
J AME.s WATSON. I think we o've a great debt to Senator Kennedy for
dealing _,vith the abuses of experimentation. I think there iS anoth{'r
pointt\:>. consider. On the whole, 've're doing experiments because some-
thing.is wrong. '1\Te're trying to correct these abuses; we're not trying
to stad still. Anything we do is going t-0 involve further risks; we
can't cut our risks to zero, so we have to have much public discussion.
I don't think we should be defeatists and decide to do nothing because
so1nething is going .to involve some risk to so1neone. I think we've got
to have a balance that maintains this sense that the scientific commu-
nity earl something- for.society' " ith the realization that in attempt-
i do something 'for society you're necessarily going to have risks,
either to the experiinenter or to the general population: You "ant to
keep to a. minimum, but I think one has to be very careful that
one qoesn't end up 'vith an attempt to protect the people, a situation
which would mean preserving the status quo, which we think right
now is quite unsatisfactory.
M4.TI;ULDE Km:&r. I sh11;re James Watson's thanks to Senator Ken-
nedy for taking an interest in these questions and bringing them up
for diS!::ussion. I think there is great merit in recognizing the ethical
content of many of the political decisions that have to be made. I also
agree that the public has an enormous interest and wants to participate
in the Congressional decisionmaking process, and that there is no
mechanism for that today, except for hearings. There may.be a need for
a body representing the citizenry, which would bring together some
public laymen, but also representatives of the research coIWnunity,
(,oogh.:
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the medical community and those who represent the ethical profes-
sions-religion, philosophy and so forth-to advise Congress in mak-
ing important decisions that have consequences for the public and
that '"ould impinge on behavior and ethical questions.
'VILLI.All! GoLDEN. I nm very reluctant to see new organizations
established and thereby introduce ne\v impediments into processes
that, for all their faults, seem to work. I would like to ask the Senator
whether the mechanism of the press, with quick publication, available
advocacy and debate, is perhaps the very best Secondly
and more specifically, but I think less importantly, I 'd like to mention
something which the Senator is also very much interested in-the re-
establishment of the President's science advisor, who could serve as
an early warning as well as a channel of communication and
adveisary consideration within the scientific community. .
KENNEDY. Well, let me say as far as the science advisor is concerned,
we had a conference on it yesterday and there are only two minor
issues yet to be resolved, so I think we'll have it on the President's desk
by the end of next week.
But I'm not sanguine at all about press reaction. I think that, obvi-
ously, the press, in so many instances, such as its recent performance,
has really preserved the union, and I think all of us have an enor-
rnous understanding and appreciation for that fact emerging from
''ratergate. And I also think there has been some very thoughtful
,..-ork done on these kinds of issues from the press' point of view. But
I think we make a very serious mistake to think that it can be the safe-
:rnard against emotionalism that surrounds many of these issues. The
clearest example is in the area of fetal research where there was no
question that when this matter 'vas brought up, kcause of some news
stories that certainly should have been written, reactions within the
Congress were overwhelming to ban that research. I t hink if we had
voted on the floor of the Senate you would have been lucky if you got
fewer than ten votes not to prohibit it. People didn't understand it.
People were e.xtremely emotional about it. Yet we have this new insti-
tution. the National Commission for t he Protection of Human Sub-
jects, that has this kind of an input, a broad base of lawyers, ethicists
and doctors, and it's working. Their guidelines
10
in the area of fetal
researc.h have dampened, if not ended, that kind of emotional out-
burst in Congress, which reflected, I think, serious anxieties in the
people, and I daresay that that will be true about psychosurgery as well.
That instit.ut.ion, I think, is I t's a new one, it's feeling it.Q
way. I t's working now in the area, of .the ethics of prison resel!-rch, and
also research on children. I think it's trying to get' ahead of these
issues. If you offered an amendment on our health bill to ban any
kind of research on children, that would pass 95 to 5 this afternoon,
too, But fortunately. this group is getting ahead on .that pli:rticular
issue and is 11:oing to be able to provide at least some broadly accepted
kind of guidelines, ,
In this particular instance I'd be the .first to admit they've got prob-
lems. But unless "'e're able to inform both tbe public and Congress in
,. Nntlonal Commission for the Protection of ,Human Subjects ot Biomedical and
Tlhnvlorl Research, Deliberations and Conclusions, Hastings Center Report, vol. June
1975, p. 41.
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wa,ys they can understand. I'm concerned about the basic kinds 0 dis-
trust that may very well come into being. But as I say, that mechanism
is difficult for me to be able to formulate, at least here. Maybe as a
result 0 this conference, it's going to be clear that it's just too difficult
to attempt.
Tom:.mN. Willard Gaylin began by asking this morning how and
at 'vhat point should the interests of the public be represented and
exercised. I think it's clear that the question he asked encompasses
at least these two questions and probably more. Yesterday we were
talking about \vhat one can call decisions about resource allocation,
priorities among different kinds of scientific projects. Ruth Hanft
presented what we could call the economics of the scientific iesearch
enterprise.
The Senator this morning was talking very niuch about the public's
concern 'vith what it sees as the ethics of scientific research. As the
Senator pointed out-and I think this is a very important point-there
is a tendency, especially in the press and to a certain extent in Congress,
to think of ethics as concerned 'vith a rather labile state 0 public
feeling.
I think one of the great merits of the National Commission's opera-
tion is that it has brought ethics back into its proper territory, where
it's concenied with realistic assessments of risks, opportunities, conse-
quences, and productiveness, and I mean genuine objective issues and
not just how people happen to feel sentimentally in the face of some
kind of horror story they read in the press. The Commission is a good
step, but there still seen1s to me to be a third question we're missing.
And that has to do not 'vith \\'hat one calls the economics of science
or the ethics of science, but the politics of science. We need toques-
tion how scientific research in general and biomedical rese.arch in
particular can be mobilized in support of desirable social policies.
_<\ud in this area it cloes seem that we don't have any institutional
answers yet.
RYAN. It has seemed to me that the interaction between the public
and legislative bodies has been largely influenced by lobbying groups.
The individual citizen feels powerless and cynical, although the public
hearings that are conduc.ted allow the individual, if he has enough
money or if he has a typewriter or if he can go to Washington or to
some of these local meetings, to have his input.
The thing that has impressed me most in the experience of the Com-
mission is a realization that we are a diverse society, even scientists
are diverse, and you're not going to get a uniform opinion about any-
thing from this group here, either. In functioning in a diverse society,
we have to realize how we come to conclusions about priority-setting
that makes the most good for the most J>Wple. I think it's important
that the federal government finance .P.ublic input, divorced from the
powerful lobby groups, into the legislature. The Commission has in
fact been involved.in a lot of that. We have people penning us letters
saying, "I hope you'll be 'villing to take my testimony," and we send
someone out to help with the typewriter an.d to get her or his input
into the public debate.
In the conduct of our business, the one thing ''<' try to do is to get
facts, and to replace rurnor with fact. '\'\
7
e'r e tried to get redundancy as
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a tribute to a diverse society. When we ask ethicists to speak to us, we
get an ethical opinion extending from right to left.
1Vhat you're really talking about is ho\v to develop a public lobby,
a.nd how that lobby can interact with Congress, not only in the area of
biomedical research hut in so many other areas. Perhaps public bodies
representing diverse of society with federal support can be a
bridge between the legislature a.nd the public. I think it can work.
We're now dealing with the prison research issue, and we're almost
in the frying pan there because, as you know, there have been Con-
gressional hearings and the director of the federal penal system has
already made a statement about it. After the fact, we're t7-ing to bring
our facts and reflections and testimony to bear on this. We re also going
to do this with research on children. .<\.11 this indicates to me that
democracy can in fact work, that there are mechanisms for developing
a public lobby.
GAYLIN. You sa.y there are mechanisms to develop. \Vould you list
some of the mechanisms which you see as options for
RYAN. Number one, the question of education. The Commission is
one prime example. It sits in public, it discusses things in public, every-
thing we say is taped, and believe me, what '""e say comes back to us
the next day from the press or from the public in tons of m.a.il.
GAYLIN. Are you conceiving of a commission. on research, let's say,
that's analogous or patallel to the commission on exP.erimentation i
RYAN. Well, there have heen commissions on civil rights, there
have been commissions on all sorts of things; some of them have
functioned better than others. There has been the President's Bio-
medical Research Panel.
11
I don't know if anyone is going to speak
to that. It was supposed to address some of the things talking
about here, and I was hoping someone would tell us what it has been
doing. I think this is a. mechanism that can work, and the press can
play a very important role.
BROWN. I'd like to get the Senator's reaction to a different question,
:ind that is when Congress is not in the business of expressing con-
cern, but when it issues a directive to scientists to do something and
to do it fast. Often this places unrealistic demands on the research
enterprise.
Let me give you an example. This particular story has to do with
Sena.tor Charles Mathias rwming Barbara. Mikulski for the
Senate in Maryland. Because of the importance of the women's move-
ment, raJ?C, rape prevention and concern about rape was a very big
and hot issue. Senator Mathias thus proposed a national center on
rape and rape control that got attached to the Committee on ?.i ental
Health Centers bill. I n the end, the National Institute of lt{ental
Health was in charge of .a national center for the prevention and con-
trol of rape-not just studies of rape, nor research on rape, but a na-
tional center f or the prevention and control of rape. The three or four
pnrngra.phs call for research in legal, medical,. behavioral, and bio-
medical aspects of rape and extend it to rape in prisons and homo-
sexual rape.
u !larbnra .J. Culliton. Blomedlcnl Panel : Report Says the Enterprise ls !lnsleally
Sound. Science, voL 192, May 21, 1976, p. 762.
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That charge clearly would take a $50 million or $100 million effort
to make a contribution. We were given no people. $3 million was
amended on the floor, out of the same political processes that led to it,
the subcommittee had turned it down. At no point in this process
<lo I kno'v whether the scientific community was called on to say what
'<)Ould or could not 'be done.
Occasionally, then, it is not a question of scientists overpromising.
lVe have public demands that get expressed through Congress to tlie
scientific community to deliver the goods. I think in this particular
case it's right in our ballpark, and I'm very troubled by it.
KENNEDY. Well, if you're saying that \Ve pass things we shouldn't,
if you knew the amount of time that went into selecting a title for a
bill, that 'vould defy your imagination as 'vell. I 'm not n:bout to get
into defending the indefensible. I do think that, in terms of public
policy, rape has been an area where, not only from the medical point
of view but also from the crime point of view, there was an enormous
sense of frustration about how to deal effectively with it. This 'Was
an inadequate response to reflect that need. Last night 'We t.11.lked about
the dangers of toxic agents and unsafe water, and reference was made
to Leonard Woodcock's comments. These are funda.ment.11.l and basic
areas about which the public is going to give some kind of expression
of concern. Obviously, those matters ought to have some priority in
research.
Senator, you' \e been very posit ive in your remarks this
mo1ning about expertise in the community of scientists. At other times,
you've been less positive about the same people. I wonder if you could
elaborate on how you see the relationship of the research effort to two
other areas that I know yon have opinions and important ideas about,
namely training of researchers and clinical people, medical students
and residents, and accessibility of adequate health care. We heard
yesterday that these matte1s are all locked up together, that as the
health care dollar gets called upon to do more and more, the part of
it allocated to research gets squeezed. I wotrder if you could comment
about. what you think the scientific and the academic community could
be doing about how research relates to training or to health care.
1\:ENXEDY. There's about four or five questions in that comment. Ob-
viously, biomedical Tesearch has profound and significant impact
on the training of health personnel, and I think that any medical
school official or dean understands that. What we're attempting to do
with the President's Biomedical Research Panel is to understand that
better. I really reserve judgment on those impressions until we have
the report., which is going to be in anQther four or five weeks. Franklin
Murphy " is in charge of that, and I understand he was supposed to
be here and was not able to come at the last moment.
1'Te've attempted. over the period of the formulation of that Panel,
to raise some questions with them on the whole biomedical research
where are its strengths, where are its
I think it was unrealistic to believe that Congress was going to be
taking the hard look that it is at every aspect of public expenditure
and not think that it was going t.o take a look at biomedical research.
u Chief Executive Oflleer, Times Mirror Corp., Los Angeles, and chairman ot the Bio
medical Research Panel.
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If you look at what's happened to the National Science Foundation,
the kind of target it's becOme, that kind of iob has not really been done
on biomedical research. But I hope that with the report of the Panel
and other information that can be develpped, we're going, in a con-
structive and positive way, to understand its strengths and begin to
develop further public support to justify public expenditu1-es, and to
point up some of the areas where there ought to be alterations and
change.
As for the inore narrow area you mentioned, hen.Ith manpo,ver, we've
specificallj passed a health manpower bill out of our suboommittee
to the ful corrunittee, and I hope we'll act next week on that. But I
think we've tried to build into it a variety of different ways of achiev-
ing our objectives. Whet.her ''"e can co1ne out of a conference with
some of those 'provisions intact is another question again.
In the area of technology and research, we've got a good vice-chair-
man of the Office of 'fechnology Assessment. The chairmanship rotates
bet,veen House and Senate; it's in the House now, but it will be in the
Senate next year a:nd I'll be chairman again.
I think we had an earlier comment here today that we hadn't really
gotten into ethical considerations of allocation of resources, which I
recognize and which I think is very much tied into technology. Under
our health ca.re system, it's open-ended, and you use a highly expensive
technological kind of a system. Yet, we don't fund preventive health
measures, health education, or things that can probably, in many in-
stances, make a greater contribution in terms of our health needs than
technolo1-,ry. "\Ve now provide renal dialysis, at o. cost of billions of
dollars, to maintain a few thousand people in our society, and yet we're
not feeding kids in the ghetto. How nlany of those minds and bodies
are going to be warped What a.re the ethical implications of that 1 But
we're attempting to try to analyze the technological implications, try-
ing to encourage research into that 1."ind of area, to try and provide
some assistance to us.
INOELFINOER. My question is in a way an extension of Kenneth
Ryan's remark. Sena.tor Kennedy, you indicated a major objective was
to promote understanding of the issues here discussed by the American
people. Everybody here speaks, I think rather glibly, of the P!!Qlic.
But I 'm concerned thateven though..w!l'alLhere represent many diverse
interests . and skil:ls arid be.ckgrourids, we're :also an elite
,group .. I f you: mean .by the pul:ilic :theman in .. the 4e doesn't
particula..rly lui.ve a VOiCe!here, : ' . " . ", , . I ... . : .
I wonder what luck you'v.e had, or whether you you've had any
iriearis .of communicating in .your with -representathes. of the
great majority of the voters and interested people. I c11-n see labor
union leaders as possibly such representatives, but, except for that, or
except for devices such as suggested by J{enneth Ryan, have you been
able to ascertain opinions from what I call the man in the street, or is
this still something we have to strive for
KENNEDY. I think we basically have to strive for it. We drafted legis-
lation on the neighborhood health care centers and commtmitv mental
health to insure a certain amount of consumer participation. But even
the person who is going to be the consumer representative is rather
professional too. Robert Marston can. tell you about the NIH. report
about neighborhood health centers wlnch showed that the boards were
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dominated by professional consun1ers. So I'd agree with you. But I
don't think that should stop you from reaching out and trying to make
the system responsive.
There are a number of things going on to try to get the public
much, much more involved. We've got, for example attorneys' fees
legislation for the Federal Trade Commission. \.Velva got whistle-
blowing protection for individuals, so if you have governmental offi-
cials who blow the whistle on some actions which are arbitrary, capri-
cious, or flagrant, they're not going to be fired from their jobs. That's
part of the whole failure of the development of Watergate; there were
too many people who were inside. Some of these people want to do the
right thing. They see abuses, but they're also feeding five kids.
We're attempting now to do competitive environmental impact
statements to make agency decisions more responsible. There are a lot
of these small slices of the bologna that are going to try and restructure
the system. What can you suggest with regard to these particular
areas
HOLMAN. !.y comment flows from Franz Ingelfinger's I think and
deals specifically with the issue of involvement of J>eOple at the local
level, and it also relates to the responsibilities of these of us in bio-
medical research activities. I wonder if I could ask Samuel Kountz
to relate a story he told us at breakfast and then tell you a similar
one, very quickly, that demonstrates specific ways in \vhich this issue
might be approached at the local level.
SAMUEL KOUNTZ. 'Vell, I'd like to comment on the public input.
I think one thing could be that the scientific community should open
its doors to the public. I think the public can understand these issues.
I'm a surgeon, for example, and I 've been experimenting with letting
the public see operations. I find they have less a.nxiety and are less
likely to institute malpractice suits. I think the public is much smarter
than we give it credit for. I'm not interested in legislation, but I cer-
tainly understood what was going on in the impeachment proceedings.
I wonder if you could comment on how, at your level, you could help
the scientific community open up its doors to the public
K E ~ N E D Y That's what I want to hear; tell your story of this
morning.
KoUNTZ. We did a kidney transplant on TV and, as I said at break-
f ast, the only criticism I got was from my colleagues in surgery.
HOLMAN. "The reason I asked him to talk about this is tliat we've
had a somewhat analogous experience that I think raises certain po-
tP-ntial ways in which we can grapple with this question of our rela-
tionship with the public. Three months ago, we started a new health
plan owned by its patients, which approaches the problem of health
care by attemptinj? to reduce hospitalizations, reduce the use of spe-
cial personnel, minimize 1mnecessary diagnostic procedures and the use
of drugs. The reason I raise this is that it's the result of three years
of discussions among a very representative group of people, the
average citizen in Franz Ingelfinger's terms, from many different
walks of life, with only a small number of professionals.
This health plan, owned by the patients, hires its own professional
personnel and so forth. But I would l ike to stress one other point;
not only did it emerge from discussions that these average citizens
could read about and come to understand the type of issues we're talk-
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ing about, but they have now formally voted to have teaching and
research conducted within the health plan in relationship to Stanford
Medical School. The conclusions I draw are twofold: first; the public
can understand if the scientific and medical personnel work with
them in the community where they all have similar roots and share
similar problems; and second, when that is done their confidence
in and willingness to participate in teaching and research is not
diminished but, on the contrary, is heightened.
KING. 'I'd Jike to come 'back to the question of fetal research and
respectfully disagree with Senator Keillledy's view on the matter.
It see1ns to me it was extremely important that it came out on the
floor of the House. The reason for the "emotionalism" was that it
was a very emotional issue, an issue that people had very deep feelings
about. People felt experimenting on fetuses was an invasion of hu-
man dignity, tampering; it was very profound. The emotionalism on
the House floor reflected the malaise in the community.
As extremely emotional as the House of Representatives debate
was, it didn't compare to the fetal researchers, who were screaming
bloody murder at any suggestion that there should be some controls
on the research. I think that, had that not come out on the floor
of the House, the Commission would have gone the way of other com-
missions. A bunch of professionals would have been appointed, they
would have written a report, and that report would have gone nowhere.
I t seems to me that that's a model for a lot of other cases, that many,
many 1nore decisions exist that professionals have feared to see come
out in public because there'd be a lot of emotionalism; for example,
genetic engineering. Those kinds of things have to take place in puolic,
out on the Ifouse floor or on the Senate floor, otherwise there's no
way that the rational man's mechanisms, such as a commission of
learned and well-to-do people; will have any punch at all. The legis-
lature may not have the wisdom of the whole society, but it's got
more wisdom than the scientific community. Also, it's subject to ac-
countability-you can mount a campaign against your representative
if he votes no. As for the Commission, there's no way we can get
l{enneth Ryan off it; most people don't know how to get on it.
As to mechanisms, I'd like to suggest two. One is that research pro-
posals, even in the biomedical area, have to have a major impact state-
ment. If it's true that research is acting for society, then there's no
reason not to. It's just like a nuclear power plant. If you're going to do
a screening program or a new surgical procedure, you should liave to
do an impact statement.
Secondly, there should be some mechanism of local community
control which would be parochial in Congress, some way in which
a community can say, "Yeah, that's to benefit the whole nation but
we don't want it in our community. If it's going to give so much
benefit to the nation put it somewhere else." Our experience is that
generally a community says yes for economic reasons ; it wants the
jobs. A 'Inb is money in the community. But we should give them a
mecha.nis1n to say no on those cases where they feel very strongly,
let's sny in a. very strongly Catholic community that really didn't
want f etnl research. It seems to me the model of the environmental
movement is a perfectly good model for regulating biomedical re-
search.
(,oogh.:
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KENNEDY. Let me ask you a question. Are you going to ban abor-
tions in Catholic hosi;>itals
KlNo. No. No one 1s saying that that is not a very complicated area.
IU:NNEDY. Are you going to ban fetal research in Catholic hos-
pitals, are you going to ban abortions i I don't kno'v how you can
come down on one hand and say you're going to do it on fetal research
and not do it on abortion. But I'd just ns soon stay off that subject.
Andre Hellegers will tell my sister, and I 'll be in trouble.
DAVID BALTIMORE. Since you raised the question. I 'm curious about
what percentage of the mail you were talking about relates to the
overall issues engendered by the emotionalis1n surrounding the abor-
tion issue and not around research issues, and what is the contt>nt of
\vorry from the public that you would identify as not having to do
with human
IU:NNEDY. Well, it's primarily in the area of human experimentation,
but I 'vould say that the right-to-die hearings got easily ns much 1nail
as any other kind of issue, three to four ti1nes as 1nuch as any of the
other kind of public hearings. I'd say 80 to 90 percent of the mai l
concerned wanting to try and wit.h this particular qnestion.
I don't diminish the emotion that's obviously tied into the abortion
issue. But obviously people are going to be the most concerned about
what's going to happen in research, because 1nany of these issues in-
volve cliildren, or the 1nentally retarded, and people react to that. But
I da.resay thnt it's n much broader base than just questions of abortion,
nit.hough that obviously is s, hot item.
BALTill!ORE. What I really wanted to b1ing into this discussion is
something that it seems to 1ne has been lacking. From my own paro-
chial position, I see the fount of progress in biomedical research ancl
in biological understanding to be not the directed research that. we've
all talked a.bout in one form or another, but a. strong measure of undi-
rected resea.rch that arises from the interests of scientist.a. It's a very
old position that I'n1 taking; it's not even a position, it's n very old
worry that I have.
I see young scientists coming along at young graduate stu-
dents, as very different people than they \Ve.re a number of years ago.
They're .much more interested in the manipulations 'of politics and
in grants; they're much more worried about prestigeand society iin-
pinging on them than they are in expressing themselves. It's been
my experience that the really exciting things that happen..in science,
that produce new leads to 1nove in new directions, to give us ne,,,. capa-
bilities, ultimately come from the type of people w.J.io are l"eally out-
side society, who are outside societal pressures, who are working froin
their own mner motivation.
I think it's very important to maintain a place for thnt enterprise.
I haven't heard a word about that. I don't for a minute 1nean to sug-
t?est that we should stop trying to move rociety in useful directions,
but there is a base we shouldn't forget about, and that's the base of
people doing their own tiring fot their own reasons.
GAYLIN. Are you suggesting that it's your soc.iological observation
that the current generation of young scientists is more prestige-oriented
than J ames Watson's generation? of us rec.nll the great ple.asure
of his book ...
13
13
James Watson. The Double Hellr. (Jlleotor- New Amerlean Library, New York, 1969).
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I
I
I
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715
BALTIMORE. That's another discussion. I don't feel his book reprc-
the science I grew up in or the scientific atmosphere I grew
Up Ill.
HELLEGERS. Senator, with all due respect to you; sister, I'd to
back to fetal research for a moment because 1t see1ns there 1s a
1eeson to be learned in how that actually did dampen the emotionalism.
I think the Commission did a superb job, but if one looks at where
the solution came from, .I think those of us who read all the papers
would say it was largely a Stephen Toulmin modification u of the work
by LeRoy 'Valters
15
and Richard '" 'vhich in es.c;encc
found a middle grotmd. The solution came from the humanities; it
did not come out of the sciences.
This raises a very serious problem; universities, llgencies, govern-
n1ents are so compartmentalized that verv often the responsibi1itv for
doing this kind of work falls between all the departments or a11 the
schools in the university or all the agencies in government. I'in wonder-
ing if you're interested in advancing some kind of dialogue bet,veen
the sciences and humanities to the benefit of How can Congress
structurally set this I go to NSF, and they say, yes, they're inter-
ested in science and values but health is really NIH. I f!O to NIH,
and they say their mandate is not really being managed. ''re find our-
selves in essence frozen. There is some need to break down barriers.
KENNEDY. I'd be interested in what ideas or recommendations you'd
have. That problem doesn't just exist on questions of ethical issues. "\Ve
have research delivery and education being considered in our
health committee. Finance has the financing mechanisn1. If you're
going to have a health insurance program that's going to build on the
insurance companies, that's going to be considered in the commerce
committee. If you're about environmental health, that's the
interior committee. So you've got all those different committees, all
of which are related to the sa1ne kind of subject matter. In the con-
ference on the President's science advisor, we have three com1nittees:
we h!'-ve the space committee, which has in t.he area
of science and research; the. commerce committee on science and tech-
nology, and our .has So .w.e
have same J?ria.of a I think
've're m -a years Qld and com-
pletely inadeq'?'ate. to _<],ea.I with tl;ie of ,today: .. . .
: N .... !>:ER." I think O\a.n:Y. of the questions lia.ve rn:ised this
tnonnng reflect a. genera.I character of American society to integrate
11).Qre and more horizontally and less and less vertically. I was struck,
Sena.tor Kennedy, by the way in which you put .the. question, "How do
you take specialized knowledge and make it understnndable to the
American public" I t reminded" me of a talk given by a Chinese chemist
a few months ago. I asked her the following <J,Uestion: "We live in a
society where there is a wide between scientists and the public, and
apparently you live in a S0C1ety where you have managed to develop
some mecahnisms to cross that gap. What were some oI those mecha-
,. Stephen Toulmin. E:rplorlnr the Moderate Consensus. Hastings Center Report, Vol. 5,
June 1976, p. 31.
,. LeRoy Walten. Fetal Research and the Ethical Issues. Hastings Center Report, Vol. 5,
June. 1976'. p. 18.
,. Richard McCormick. Fetal Research, .Mcirallt7, and Public Policy. Hastings Center
Report, Vol. 5, 1une, 1976, p. 26. . ,. " "
82- 201-77 8
. . . . . . . . . . . . .
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nisms She then pointed out that during the process of training,
scientists in China. were sent out to the rural areas to learn.
So the question maybe should be, to parallel your first question, how
can we take the genera.list understanding of 'vhich is ter-
ribly important, and make it understandable to American scientists
I've thought of one mechanism we might use. I think one place 'vhere
it 'vas proposed was the National I nstitute of Mental Health; it was
proposed for students. This is the pay-back plan, the idea that students
'v ho received money from the NIMH should then pay back in service in
someway.
To get a. from the U.S. government, you would have to pay
back in some form. It may in the form of 20 articles for the San
Francisco Chronicle on fetal research, or it might be teaching in the
schools, or it might be any way to increase direct dialogue between
t.he scientists and the public.
KENNEDY. I'm fascmated by it. We do it in an important way now
in our new health education program, giving students a year's tuition
plus $4,500 in return for a l.ear of service. We've had that concept
before; it's an old one, but its never really been put into full practice.
I think it's an interesting one and one for which I find a good deal of
sympathy. I don't know how it would be structured so it would be ac-
ceptable within the community. This would be a group that ought
to react to it. But I think it has got an important attraction to it.
BELDING SCRIBNER. Senator, I-want to go back to James Watson's
point about the price you may pay for overcontrol. In this group I hate
to bring up dialysis, but my example comes from that. We're going to
end up with about isoiooo people on dialysis within the next five or ten
years. If those peop e a.re treated at centers it's going to cost $600
1nillion a year more tha.n if those people are treated at home. The point
I'm trying to make is that you, the Congress, is passing or has passed
legislation in this very important area of medical devices. If that
legislation had been on the books in the mid-'60s, I never would ha.ve
dared to .Put an artificial kidney into the home. This is the price you
ma.y pay m many areas by overr0gula.tion.
KEmm>Y. I don't see why i there's nothing: in that legislation that
would prohibit it. Peter Hutt mows all about 1t.
PETER HU'IT. I agree completely, Senator Kennedy, that the legisla-
tion would not imt:>6de such a step in the slightest.
KENNEDY. If tfiat particular artificial kidney has met one of the
three different kinds of criteria in the medical device bill, there is
absolutely nothing to prohibit you from using it in a home setting.
Absolutely nothing. What we hoped to do was provide some protec-
tion for those millions of women who use the Dalkon Shield and a.11
the other kinds of t hings out there on the market which don't provide
adequate protection.
17
But we worked very closely with the adminis-
tration and industry and the medical profession to try and minimize
risks for the consumer.
"The Dalkon Shield, 6rst marketed In late 1970 by the A. II. Robins Co .. Is an Intra
11terlne contraceptive device '"hlcb bas been used by an esttmnted 1.3 to 2.2 million women.
Becnuse of reports of 86 cases of septic. spontaneous abortion (four resulting In maternal
death). tbe Food and Drur Administration suspended further distribution of tbe device
in 1974. New testing procedutts for other medical devices wett also developed because of
problems with the Dalton Shield. See II. 1. Tatum et aL The Dalkon Shield Controversy.
Journal of the American Medical Association, Vol. 231. Feb. 17. 197G. p. 711, and Bubara
J. Culliton and D. s. Koopman. Dalkon Bnleld Affair: A Bad Lesson In Science and
DeclslonMaktng. Science, Vol. 18G, September 8, 1974, p. 889.
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7.7
Laura Nader said almost exactly what I had written
do,vn. I'm the fact that :ve are constantly .talking_ a!J?ut
control and lim1tat1ons that the public would put on research. I tlunk
that we need, as scientists and as members of the scientific community,
to develop ways of what the public feels, needs and
wants and translating that into issues that could be developed and
researched by the scientific community. Perhaps a way to start is to
look at the mail Congress receives and do even a preliminary analysis
of the kinds of questions that are raised that have a scientific basis.
I think if you do that, you'll find a lot of those letters are simply
reacting to issues. I think that demonstrates a failure, in that the pub-
lic is not well enough educated to raise issues. They don't understand
son1e of the issues well enough to raise stimulating points, and I think
we have to educate the public enough so they can participate in this
kind of policy decision.
l 'n1 struck also by the discussion of the inner motivation of scien-
tists. I think no one is arguing against the notion that the scientist has
to sit 'vith himself or herself and develop his own ideas and their
programs. But the idea that such inner motivation comes in isolation
and is not a reflection of that person's interaction with the rest of the
world is a myth. What we're trying to do is develop ways of making
more realistic that interaction. It does happen. There's no such thing
as completely isolated inner motivation. We need mechanisms in order
to take the concerns of the public and translate them into scientifically
researchable ideas.
STONE. I want to raise a point about how public involvement
be encouraged. It might be called public interest tax liberation. 1 at
I have in n1ind can be illustrated by what's in this building
right now. The Atomic I ndustrial Forum is meeting upstairs, and we
are n1eeting down here. The companies that participate in that Forum
\vrite off as business expenses their efforts to affect legislation. But if
people at the New York Foundation, which sponsored this meeting,
discovered we had joined together to announce that Senator Kennedy
should be urged to do such and such and we would like legislation
along certain lines, it would blow their minds and probably tlieir tax
certificate. Even a former director of the IRS has written articles
protesting and explaining how it could be changed.
It's a double standard, in which peoJ:>le with vested financial interest
get tax breaks which people in the public interest do not. It has a very
unfortunate effect in the public interest sector . .Afiluent groups like
this are in some sense castrated by this restriction. On the other hand,
you can be poor 'but relatively effective by going without the tax deduc-
tion and trying to get by with membersli1p dues or some other way.
The qua.lit)'. of the advice to the Senate and the House would be much
improved if there were a. flow of funds from this tax-deductible sector
that already exists.
There's a very large sum of money already in the foundations, and
a large amount of money would be given directly from the public to
groups in the public interest if they could get a. tax deduction for it.
It seems to me strikingly anomalous that we give a charter to the New
York Foundation, for example, to help the poor in many ways, but
tell it if you want to do the most important thing to help the poor, that
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is shape legislation, that we don't permit you to do it. I think \Vhat
might be done is some kind of legislation that would allow an organiza-
tion that had been in business for a few years nnd had a certificate as
an organization that was tax-exempt for doing some good work, to tako
tax-deductible funds from the public or from foundations. This is
l'P.ally exactly what the Director of the IRS proposed in his own article.
The thing Congress would have to be assured of is that this would not
involve electioneering in any \vay, that these funds would not be used
to defeat Senators or Congressmen, or to move against them in cnn1-
paigns, but simply for educational legislative lobbing.
KENNEDY. Sounds good to me.
CALLAHAN. Senator Kennedy, Inst spring at the Harvard School of
Public Health, you gave an address which deeply disturbed 1nany
people in the biomedical research com1nunity, as I think you probably
kno,v. I 'believe the issue then \Vas \vhethcr medical schools ""ere suf-
ficiently addressing themselves to the distribution of medical person-
nel, and were perhaps overworried about esoteric rose.arch matt ers. I f
they did not address themselves to the problem of maldistribution. yon
had a feeling Congress ''"ould feel itself forced to do so. I think there
was a feeling on the part of many 1esearchers of threat and i1nplied
coercion. I wonder how you feel no\v about that issue?
l(ENNEDY. Let me state what the theme of that speech "as. In con-
sideration of health manpower, I think "'e've got a number of prob-
lems. But two of the most eriticn.l ones 11.re the types of mllnJ?O\ver that
are coming through our medical educiitional centers, and chst1ibution
of that manpower. What I was pointing out was that it's rare not to
find a medical dean who just wants the federal dough and doesn't want
to care very much about it, and I say thnt very sincerely. As I pointed
out there, I don't think we can expect medical schools to resolre that
particular problem. But what I did say is that I expected a partner-
ship to emerge in terms of helping us to meet basic and fundamental
national health manpo,ver policy objectives.
The schools can play an. imJ?Ortant role, with Con-
gress, trying to make some contnbut1on towardsredress1ng the bal-
ance of physicians in underserved areas. I was indicating that unless
we got some kind. o.f cOoperatiop with that,pri>blem, .we're going to
have to make dec1s1ons on our own. I am thankfal we':ve gotten a
dramatic response from m"{lny of the most important medical schools
'ii\ this coU.ntry; and we've been able to fashion -legislation which I
think is a vehicle sensitive to their needs and also sensitive to national
needs. We've gotten good" support from a number of different medical
schools, and we're getting good support from the students themselves.
think we've moved a long way down the road on that particular
issue.
* * *
GAYLIN. Well, the Senator has left, and with him, I suspect, acer-
tain reticence and decorum on the part of the group. There is some-
thing about Senators that 'brings out the politeness in j?roup dynamic.'>.
Our next session is entitled Sources of Tension. I'd like to make this
more of a group discussion, and I would also like to make it more
goal-directea. I would really like the panelists, when they discuss
sources of tension, to discuss them in terms of their suggestions for
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79
solutions, specifically recommendations about where \Ve might go in
the future. Presumably we are here as people \vho have thought about
these issues and discussed them over relatively significant periods of
time. Our first panelist is Howard H. Hiatt. His talk will be followed
by one by Stanley Jones, and we will finish with some thoughts from
Jonathan King; '
HIAT!'. Let me cite certain sources of tension, and then say a few
\VOrds about their possi:ble causes and oonsequences, and even fewer
about possi'ble methods for their amelioration.
At the root of certain problems the isolation of university com-
ponents from one another and from outside arenas, where graduates use
the skills they have acquired and where proposed "solutions" to health
problems are tested.
The difficulty is compounded by -an erroneous but prevalent tend-
ency to equate health and medicine, which often leads society to seek
help for health problems not from the university at but from
its school. and, less frequently, its school of public health.
and pubhc health schools are even more autonomous than
most other university units. Thus, even when their limitations are rec-
ognized, their isolatl<>n discourages the effective interdisciplinary ap-
proaches that most health problems require.
For these and other reasons, the complexity of health issues has
usually not 'been fully appreciated. Input to the decision-makers from
the universities, even when actively solicited, has often been dis-
appointing. Decision-makers, for their part, have often posed key
health questions inaccurately, incompletely or prematurely. Societ.y
has expanded enormous sums for goals that were not realistic and,
therefore, could not be reached.
1. The choice of problemf! by the bwmedical research commvunity
The rrincipallmedical conditions now attracting- attention in the
medica research community are those seen in #!featest number in the
hospitals. However, while 70 percent of our population seeks
medical care each year and 10 percent is hospitalized, only one percent
is admitted oo teachinp: hospitals.
Therefore, the medical investigator is little exposed to the most
prevalent health problems afflicting the American people. Most
chronic illnesses, most problems of the aged, the care of patients with
mental disease and mental deficiency are in the neglected category.
The medical school commun!ty hns even less to consider
problems of access to,. q11ahty 9f, and costs of medical care. How
should primary ?rganized How 'do we get doctors i;nto un-
derserved areas i It is ofinterest that the recently-created Institute on
Aging, .with a broad manda.te covering biological' nnd social services
research, has an appropriation of $16 .million in the current fiscal
year, while the National C.ancer Ihstitufe and National Heart and
Lung Institute together receive over one billion dollars.
To focus on a wider range of pressing health problems will require
the extension of research and teaching programs beyond the confines
of the teachinp: hospital to those places where pat.ients with the prin-
cipal causes of disability and discomfort are seen. A second way to
pursue this goal would be the creation of university-wide mechanisms
(,oogh.:
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80
to address certain health problems. For example, better distribution
of medical services will require experiments involving not only physi-
cians but experts in lawi economics, sociology,
ing, and many other disciplines. A tnird would be a continumg re-
evaluation of spending priorities, with an attempt to achieve a better
balance between allocation of research funds and problems prevalent
in the health care system.
c01tCeming fundamental, and appli,ed research
The fact that conditions such as mental illness, mental deficiency, the
problems of aging, and many other chronic illnesses have been
neglected surely reflects in part a realistic sense of frustration on the
part of the biomedical investigator. Indeed, any applied research
presently possible could at best lead to amelioration. This is obviously
not an argument for continued neglect. But it underlines the critical
need for continuing support for fundamental research.
I believe it appropriate for us as a nation to commit the larger frac-
tion of our research resources to applied work. However, it is equally
important that a constant and predictable fraction of our health care
expenditures be committed to basic research, and to the continuing
renewal of our research scientist pool.
In my view, it is essential that the public and its representatives
have major inputs in the selection of areas for applied research, and
in judgments concerning the outcome of that applied research. The
applied research worker should be required to spell out in advance his
goals, his success should be measured in large part in terms of those
goals, and his continued financial support Should be determined ac-
cordingly. It is also appropriate, it seems to me, for the public and
its representatives to make the ultimate decision as to what fraction
of public funds should be committed to basic research. However, the
complexities of fundamental science lead me to feel that pri-
ority-setting with respect to specific projects and investigators and
judgments concerning research results should be left largely in the
hands of peers.
8. Public understanding of science, heaJ,th, and medicine
Our educational system, precollege and college, is notoriously weak
in programs in human biology and in health, science, and pol-
icy. In part, this reflects a tradition of leaving decision-ma g in the
health area in the hands of the biomedical community. The atypical
nonscientist or nonphysician bold enough to enter health fields in the
past did so knowing that without the credential (an M.D. or less
often, a. Ph.D.) the chances for being heard, much less achieving an
influential position, were not great. What emerged, then, was a self-
renewing cycle consisting of informed, even if narrowly so, decision-
making largely in the hands of physicians and other biomedical scien-
tists on the one hand, and ns a result of limited background, often
poorly-informed input from people "outside." This led to seeming
confirmation of the need to confine decisions to people "within" the
fold .
<\.II of us nre here in part because of a desire to improve those im-
balances in the process that are not in the public
interest. Surely nobody would ctispute the argument that critical de-
(,oogh.:
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81
cisions should be made by people with access to relevant
information. Therefore, as the a.ecision-making process is broadened,
we must give high priority to strengthening educational programs in
science, medicine, and health for the public and for their representa-
tives. This must include creating and improving programs not only for
young people in our schools and universities, but also for older people
who are not the traditional of educational programs. The roles
of the schools, the universities and the media must be greatly
increased.
Within the biomedical community, a broadening of education is
equally important. Greater exposure lS needed in public policy, ethics,
law and 'other subjects for those in medicine and sciontific research, to
accompany the greater access to programs in science and health for
people in other professions. In this way continuing meaningful and
productive discourse will be insured between the two now largely sep-
arate cultures.
4. The aeparation of fwndamental, from applied reaearch
There is much criticism at a national level of the quality of applied
health research, particularly with respect to environmental problems.
Witness the current debates concerning the health effects of food addi-
tives and of our energy policy. It is easy for us in the university com-
munity to cast stones at the quality of work in such agencies as the
Food and Drug Administration, the Environmental Protection
Agency, and the National Institute for Occupational Safety and
Health. Criticism is leveled both at the decisions that are made and
inethods of a.nd at the quality of the information on
which decisions are based. However, if it is not the role of the univer-
sity community (Note.-I did not say biomedical community) to par-
ticipate in the examination, and, where appropriate, the improvement
of the quality of educational programs for both social and natural sci-
entists going into these areas, with whom does the responsibility rest
In this regard
1
I believe that the separation of the fundamental from
the applied sciences in the university has been unfortunate.
Two classes of scholarship exist, 'vith greater numbers of able people
generally going into fundamental areas than into the applied, and lit-
tle communication between the two. This separation has slowed the
application of new knowledge to societal problems. By the same token,
the failure of the fundamental scientist to appreciate fully the gaps in
knowledge confronting apP.lied scientists inhibits focusing on ques-
tions that might more readily fill those gaps.
Within the university, the separation of medicine and the natural
sciences from the social sciences has other negative effects. The lawyer,
policy analyst, economist, and manager often are unaware that the pos-
sible contribution of their disciplines to preventive medicine may be ns
great as that of the physician instance, on the subject of mine
safety).
5. Diffuaion of wnproven procedures
When patients are subjected to a. diagnostic or therapeutic procedure
that is not fully proven, should thev not he inforn1ecl that they are
really taking part in an experiincnt? Is it fair to ('harge such proce-
dures to patient care dollars? Let me cite ns exan1ples patients under-
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82
going radiologic examinations by the compute1ized axial tomograph
(CAT scanner) or subjected to coronary artery bypass graft surgery.
In Sweden, the latter procedure is still considered experimental, and
has been carried out in only a fe,v _J>atients, all of who1n have been told
they are entering a therapeutic trial. In the United States, the proce-
dure is now widely accepted as therapeutic. Patients may or may not
be told that the procedure is experimental, but the cost is almost uni-
versally borne by third parties. We need 1nechanisms for protecting
against premature dissemination of procedures, particularly those that
are. costly in l ives, suffering, and/or money. How much should the
patient about to be exl?osed to such a procedure be told i What role
should the public play in deciding whether and when such procedures
cease to be experimental and may be considered proven i Is it fair to
leave the decision to the individual physician whose access to relevant
information is limited, but who may be confronted by a patient insist-
ing upon the procedure in response to premature publicity in the r s s ~
Fortunately, these problems are now receiving the attention of the
Office of Technology .i\.ssessment.
Here, then, are a few sources of tension. None can be corrected easily
or quickly. On the other hand, their recognition does give us the oppor-
tn111ty to consider possible causes and remedies. Perhaps the strongest
argument to seek such opportunities is the recognition that if we do
not. we and future generations may be deprived of the luxury of such
clelibernte discussions as those initiated here by Senators J{ennedy and
.Javits. One further reason for seeking mechanisms to deal with those
problems is the fact that misunderstandings that are so rampant in
the health field exist in many others. If we can be wise enough to find
useful approaches, they or similar ones mnv be applicable in approaches
to n1any other societal problems.
STANLEY .JONES. What I would like to do is offer you some perspec-
tive rather than analysis, and in particular the perspective of someone
sitting in what is essentially a political position 1n t.he Senate and hear-
ing fro1n the public. To some extent I know what I'm going to describe
ns sources of tension and pressures is not complete as a result of that.
But perhaps just that perspective will be of some help to you.
First of all, politicians do hear from people about things like medic.al
research, and they hear from then1 in close personal terms when they're
shaking hands and going from schoolhouse to schoolhouse, and social
r lub to social club. in the process of trying to get votes and get.reelected.
They hear from them in letters, in barrages of letters every time there
i ~ an article in the newspaper about a new piece of knowledge o.r a new
breakthrough in medical research. They hear from them in organized
cnn1paigns when one or another of the agencies devoted to one or an-
other disease underta.kes to mobilize the troops and increase the re-
sources allocated fo.rthat particular interest.
Those letters and that input, I think, can be characterized in the
following ways (and I belie,e these in fact are the sources, or at least
parts of the explanation of, the tensions as we experience them). First,
it may seem elementary but it's distinctive to health to some degree that
the amount of emotion attached to communications to politicians about
health care is extreme and profound. 'What we hear from people is
essentially a longinJt to be released from some of the most traJ!ic aspects
of the human condition. People don't want to get sick. They don't want
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their children to get sick. They don't want to die and, especially, they
don't want to die painfully. The message that co1nes across is emotion-
laden, loaded and urgent.
Second:; people in general expect and believe that medical .scienro can
do s6mething to relieve the terrible problems of their human condition.
They't.e So convinced of it, in fact, that a good deal of out corre::;pond-
enoo insiilts:that there is a cure out there if only he or his family had
the money to afford it, or the wisdom to loo!{ in the right medical cen-
t.er, or.knew the right people. A good deal of the correspondence also
insists thatjf only there were more money, more time invested, then a
cure:would befound and medical science could in fact deliver us from
such,triwls. That conviction is strong enough that the American public
iswillitig arid ready toinvest enormous amounts of money in medical
resear<ih ... :Allusions were made last hight to the war on cancer. Believe
1ne, thei-e is no doubt in the mind of any politician on Capitol Hill
about . where the public stands on its willingness to invest in research
on cancer .. There isn't a handful of Senators or Congressmen who'd be
'villing to. vot.e conspicuously against an outright attempt to iret money
for cancel'; especially if there's been a couple of newspaper articles that.
inflame .. and enliven people's hopes. . . . .
The result of those two factors is that.this is an area ripe for overly
exaggerated expectations, ripe for people pursuing their careers, in-
terested In shaping public expectations rather than educating the
public's expectations. And, I submit, a lot of that goes on. Part of
the tension comes from that. For example, .there are 1nany people 'vho
benefit, perhaps appropriately, from a good deal of public attention
on -accomplishments in research. The laboratory where the work has
been.d1:>ne is certainly not hurt by a front page article in the New
York Times, or iri other papers, saying a breakthrough. has .been
accomplis)ied. The himself is certainly not hurt. The re-
port.er may make. page one with the story. The disease society in
Washington, constantly lobbying to get more resources for that par"
ticular area, is far from hurt. People in those societies, and in agencies
we hear from daily, make their money and careers out of the existence
of Ii hu_ge problen1 and the imminence of a. solution. I f we didn't
believe disease can be cured the whole lobby establishment \vould fall
rt
. .
apa . . . .. ... 4 . . :
No.w; ifrankly, I 'don't think all those factors are necessaril;r bad.
What .we're talking about is a volatile situation in which people are
trying to accomplish something, and get personal and career rewards
for what they do, and assure that more societal resources are chan-
nelled into what they think is o. good project-whether it's good for
them; or if it's good because from the standpoint of medical science,
it's the right area at the right time to work in.
That lobbying effort, and the problem of shaping the public's ex-
pectatit>ns versus educati:ng the public, first came home to me when
I went to work at NIH 13 years ago as a management intern. My first
assignment was in the Office of Program Planning. I was told to
write, as my first assignment, an explanation of recent work in genetics
for insertion into the record of hearings being held by the committee
I now work for. I was given that by the Office of Pro-
gram Planning with a great sense of senousness, and told how impor-
tant, it :was to do it right because, aft.er all, these are the people who
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authorize the dollars that eventually are appropriated to NIH. But
\vhen I went out into the laboratory to get some input I was greeted,
as you might guess, \vith some sarcasm and amusement over the fact
that the whole project had to be done in the first place. I 'm afraid
there was also a good deal of disdain a.bout the fact that the scientists
had to contribute to it. It did get written, however, and it did ire(; put
in the record, and a1_>parently Sena.tor Hill, who had asked Ior the
explanation, was satisfied.
The reason f or the story is that there is an interface between science
and the public's expectations which is filled with tension, and it's a.
very difficult J.>lace to stand. The administration of NIH has to stand
there all the time. Other agencies that relate to the Senate and to the
House have to stand there all the time. But it's a. difficult place because
very of.ten the fa.ces of people in the scientific community are turned
and looking the other \va.y, disdainful of the interface that has to exist.
I n the meantime, Congressmen and Senators a.re increasingly bel-
ligerent, and I think standing in that tense place is going ifx> get worse.
The reason I think it's going to get worse is that money is going to
be tight for a time. I personally believe tha.t, even 1f the Demo-
crats are elected 1n November, what we face is five years of tough
budgets. What's going on in the health care budget is serious in ways
that the st.aite of the economy as a whole is not serious. There is no
real expectation that if we set our economy right in other sectors infla-
tion in ilea.Ith care is going to stop. '!'he projections we deal with sho'v
total federal spending for health care going up from around $31 bil-
lion this year to around $51 billion in 1981. There is no doubt in my
mind that those spell increasing pressure on medical research,
on medical education, and every other grant program before Congress.
Every year we'll have to fight to get the little bit we can set aside
for those programs, which is to say the tension arising out of justifying
the research to the public for that resource allocation decision is going
to get stronger.
In closing, let 1ne offer just one more objective, less personal, anec-
dote. What happens when no one steps in to relieve that Some
suggestions have been n1ade that Congress properly stands in that
tense place, and I believe that's true. But Congx-ess is clumsy at best
in handling tensions like that. If you'd like to see a. case in point, look
at the manpower bill. Congress, in its handling of medical education
and health professional education in general, essentially said, "The
public wants something and we're determined to give it to them. When
\Ve look at the institutional scene, no one seems to be the obvious group
or institution to fix this problem. But "e, above all, cannot fix it, so
what we're going to do is use our clumsiest instrument of all, namely
dollars, to sa.y someone has to step forward." Th.at was done fiveyears
ago, really; the medical schools were invited.at th.at .point to do som.e
new things, and .it \VllS hinted that if it's not done in three yeai:s, . the
time the legislation came up, Congress would have to look harder.
The legislation can1e up again a. year and a half ago, and Congress
is no'v essentially saying that the institutions closest to the problem
are the medical schools.
They may '.feel it's not appropriate for them. By tradition and history
it may be nearly i1npossible for them to affect a lot of these things but
they're the closest. And if they can't cha.nge institutionally, adjust
(,oogh.:
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and 1nove into that sector in our society, we're simply going to say to
the1n, "Stretch and stretch, and until you do, the money will stop
flo,ving." That's how clumsy Congress is, but it's the way it works. l\fy
greatest fear is that in the medical research area over the next year the
same kind of clumsy mechanism be into play.
K.rna. I'm to try to do two things. One is lay out six discrete
areas where theres actual current tension !between some real .public
and some real -biomedical community. And two is try to, in some small
sense, use this conference itself as a little bit of an experiment to see
if the naming of those tensions is accurate. I'd better say that I"m 'here
repre.<>enting Science for the People, a loose group of about 3,000 peo-
ple across the country, but concentrated in the Northeast, compOsed
of some working scientists, a lot of high school and junior high school
science teachers, computer programmers, support personnel in la:bora-
tories (for example, secretaries, technicians, dishwashers, etc.) and
a substantial population of unem(>loyed scientists. To be accurate, the
professioruil scientists a re what is euphemistically described in .. the
literature as the activist faction. The analysis I'll present wa8 developed
over the last two or three years by a group of about 25 or 30 people
working in Boston, about two-thirds of whom are professionals, and
the other one-third people employed in the area.
Before I begin, I tlunk Stephen Strickland left out what I would
consider the central 1nessage of his analysis of the development of the
bio1nedical research com1nunity. After World '\Var II, efforts to sup-
port increased aid for health care, national health insurance, hospitals
and training of physicians were blocked by very active organized
efforts of the ilt:A. Most of you were already adults when socialized
medicine was a major danger to America, made so by a campaign
done by a particular public relations com_pany hired by the AMA.
The thousand-fold increase in funding of biomedical research from a
few million dollars in 1949 to $1.8 billion in 1967 was really Congress
trying to slip money into the health care system via this back door to
get. a.round the lobbying against socialized medicine; to put it as
Strickland does, federal support of research was the only way a Con-
gressman could cast a vote for health care.
Now, of course, nobody told the scientists during their that
this was going on. As a matter of fact, it's clear that in the '50's it was
important not to sa.y that precisely because of the argument that
federal support of research was a form of socialized medicine. Sci-
entists were fed, clothed, bottled and put to bed by federal money.
They were salaried during their post-doctoral years and professional
years andf'ven grant money, all from federal funds, which were corn-
ing out o taxpayers' pockets. in order to improve the health care
system. But scientists were not educated that way. Certainly, in my
generation, not a soul among us was told we were public servant.s. As
far as we knew, we were carrying on the great Western tradition of
sovereign individuals searching for knowledge. "\Vhere the money
came from was off in the corner.
As this biomedical community has grown fro1n childhood into not
what I would call maturity, but into a kind of adolescence, yelling and
screaming whenever anybody tries to infringe a little bit, there have
arisen problems, and the insulation between the scientific community
.
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and the public has eroded a'vay as the distinction between basic re-
search and applied research has ceased to exist.
Here. are the six discrete examples. First is genetic screening pro-
grams, I would say there are four very good examples of that. One is
screening, for Tay-Sachs disease, which is a genetic defect that has a
high frequency among .Je,vs of Ashkenazi origin. Recently, at least
two cqmmunities, Dayton, Ohio and St. J..ouis, Missour.i, have refused
to let.screening programs for Tay-Sachs disease go on. The first-con1-
munity, where one . was instituted, Baltimore and Washington, was
unableto.say no because there wasn't any mechanism. It was a research
program; there was a guy-doing research and setting up a screening
program; f.eople could come in or not come in. But the-.community
couldn't say; "We don't want this screening program operating in our
comm1init;)'.1.'
A second case where clearly there's been tension would be screening
for newborn. males with an extra Y chromosome, and the follow-up
to see, if there are behavioral disorders associated with that chromo-
some. A third would be the complications over screening for sickle ceH
anemia;:The fourth would be the recent rise, as Tabitha Powledge of
the Ha.stings Institute has shown,1
8
of screening programs to analyze
workers for susceptibility to certain industrial toxins. That is, rather
than remove asbestos from the environment, the plan is to screen those
workers who are sensitive and re1nove them from the workplace.
Eventually, of course, we can engineer their genes because we'll have
the technology to do that.
You're not familiar with Science for the P<'ople because we don't
work a.mong professionals, but we do a lot of 'vork organizing con-
ferences .among "'or.king people. By the \'l"ay, 'vhen I say the public I
mean.working people. We would not call l3enno Schmidt:1
9
the public's
member: We don't call Laurance Rockefeller
20
the public's member.
And we don't call, for example, Howard l-Iiatt the public. I'm not here
as the public either. There is no doubt that the only reason I'm here is
not because I fron1 Science for the People but because I 11111 an
associate professor at 1.1IT. I'm not here us the public, nor do I prop-
erly represent the public.
GA:YLIN. Quite the contrary, for the record, you're not here
lin associate professor, you are here because you are fro1n Sci-
ence fGr the People.
K1No. OK. The genetic screening coses all show the same general
character: You have a set of investigators 'vho believe that all they're
doing -is pursuing some small area of genetic knowledge that is going
to enhance human understanding of disease. They're just innocent.
What's actually going on is that they're there in the community giving
a message. In the Tay-Sachs case they're doing 'a big public ?du?a.tion
program t.o teach people that they have to worry about genetic disease,
that they should come in and be screened, because then they con be
helped, they can bet.old whether they carry a genetic defect; genet.ic
diseases are very important.
is Tabitha Powleillre, Can Genetic Screening Prevent Occupational Disease? New Sclentlt.
Vol. 71, Sept. 2. 1976, p. 486. b
,. Jllanall'!nl!' partner. 1. H. Whitney & Co.; member, President's Biomedical Resenrc
PnnPJ :.head. Pre$1.dent'e Ca-acer Panel.
"Chairman. Rockefeller Bros. Fund; chairman, Memorial Sloan-Kettering Cancer
Center.
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The stune.thing is t1ue in the XYY case. There is 12 pencent unem-
in Ma.ssachusetts. The crime rate is going up. What you.have
here 1s a research program that generates. I\O professional :publications
but, over a six-yeai: period, half a dozen newspaper headJ.mes .. thittsay,
teses:rchers study relationships; between chromos9ines and
erlme
" .. . . . .
' . ' . ' . . . . . : 1: .
Now.if you:don't.think that that policy hi:
about rehabilitation of .prisoners or. what should be do:ne.ab:>\t. 'crime,
whether the money should
'research, then you're out of touch '\vith political realities .. w llether or
not the individual '. investigator is. pursuing the fine structlire,of the
extra Y cht'omosom.e, the fact of the matter is that the exist,ellce:of the
program has a very different impact. In the. case of screening :W.ork.ers
to see.if they?re susceptible, it's clear which side the inve$tigators are
on, 'vhether or not they know it. . . ' : .. , . ".
Our experience is that the publi(; understands those programs really
aren't helping them. Most of those people have enough problems. so
that when somebody corn es along and tells them, "!icy, your pr.obJe1n is
that. there's wrong with your genes,'' .or the they're
getting asbestosis is not because they're breatlung 5 milhgrs.ms per
million.,.of .asbestos, beeause they have. a genetic to
they un'!-erstand something wrong; wip;h
their money lS going. The biomedicitl people a.re lool!mg fl,t their
genetic susceptibility to asbestosis rather than t.'l.lking to .factory, man-
agement a.bout levels of asbestos. " . . :
These a.re all examples of "blame the victim." You lodge, the bla.me
for your.illness in the genes of the individuals; it's not fault,
it's the individual's fault.
The second case I won't go into was the experimentation Cin:fetuses.
Our experience was that many of the investigators showed: a. !?hocking
disregard for the people who. were concerned about expenimentation
on fetuses. They just ascribed it to ignorance and prejudice. 1 was at
many a conference where people. were really concerned. that t;o: do an
experiment on a fetus was a dangerous step. They werent people who
'vere anti-abortion. They just tliought we should examine .that step
very closely and were really offended by being treated as: know-
nothings. , : .
Number three is experirnentation on humans. has
already referred to thjs. Of course, experimentation on Unmans has
ahvays on the disadvantaged, bliteks, j the poor
get experimented on, but the fancy technologies are availab e only to
tho rich and well-to-do. That's an old story in' the American health
care system. I note that even though this has been a very.big part of
the public tension, thore is nobody at this meeting representing any of
t.hose groups, such as the New England Prisoner Association,, any of
the groups that were actively involved in pressing for clianges in
human experimentation legislation. Neither, of course, is there .any-
body here from the United Auto Workers nor from the coal miners;
they sent a delegation of people with black lung to the 'New York
Academy of Sciences' conference on occupational health anti safety
21
. .
..
n The conference was held In New York City September 13-17, 1971. See Irving J.
Sellkotr, Marcua M. Key and Douglas H. K. IA'e (e<le.). Coal Workers' Pneumocontosls .
.:i.onals ot tile New York Academ,y of Sclen<:ff, vol. 200, December 29, 1972.
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becauss they thought there was a lot of waffling among professionals
nbout to what extent black lung was due to exposure in cool mines. So
miners went to the meeting; there was no doubt that they were angry
and they felt their interests weren't being attended to.
Occupational health and safety is the fourth example. I think as it
becomes more and more clear th'at people get sick in large part because
of exposure to toxins that are the result of industria.lizat1on and that
never before existed at the concentrations they exist now, they're
going to get a little angry when they hear that these things weren't
attended to because they weren't interesting, weren't the business of
the medicaJ community, weren't the business of the resea.rch com-
munity. We heard a.n example here of kidney dialysis. Kidney dialysis
is something you do when you have kidney failure. You know, I have
never really heard a very cogent discussion of why kidneys fail.
I believe kidneys fail because they get overstressed due to what they
have to handle, and one of the things kidneys have to handle is various
toxic substances. You very rarely hear kidney and liver people tall..-ing
about cutting down kidney and liver disease by cutting down the total
level of toxins in the environment, so that people's kidneys and livers
won't have to deal with those stresses.
Fifth is cancer research. If there is one I think is going to be a
growing tension between the public and the biomedical research com-
munity it's cancer research. Think of the articles you've read in the
newspapers about cancer and viruses and the new breakthroughs and
how we're to find a cure and we're going to find a vaccine.
There's no time here to into a scientific debate about this. I would
say that here it would oe the Science for the People position that
cancer is a. disease of industrialized society, that among humans the
highest frequency of cancer is due to exposure to toxins. In humans,
the only cause of cancer for which evidence exists is chemical. There
are large numbers of cases where it's known clearly that people have
died fro1n cancer that's.due to exposure to .a particular set of
cals, for example, arsenic, dyes, vinyl chloride, and asbestos. There is
no such evidence for viruses.
I t's understandable why the biomedical community went in that
direction. As Watson and Baltimore have often pointed out, there
were intellectual models, you could work in that direction. But when
the public discovers that it doesn't have to die from some of these
diseases, that they could be prevented, that the causative agents could
be removed from the environment, it's going to be a little annoyed at
the research community, especially if the research community con-
tinues to deny that it made a. mistake.
One characteristic of the American biomedical research community
is that it's flawless. If the research didn't produce the right result,
it's because historically we weren't ready for it. If we went off in the
wrong direction, there was no other direction we could go off in. You
never hear someone say, "Well, we were bought off, we were influenced,
we were just wrong, we didn't want to know about it, we were paying
attention to the wrong things." Here the Science for the People posi-
tion would be tl1e same as on genetic It's very understand-
able that the whole community went in the direction of viruses. No-
body is against viruses. Viruses lodge the problem in the individual
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and takes it out of society; you it f1om other people, or you get
it vertically, etc. You're not rocking any boats, no boats whatsoever.
When you talk about chemicals, you're talking about looking where
they're coming from, you're talking about factories, you're talking
about tackling very, very powerful economic forces. People who've
messed with that have discovered that it's a very rough business, as
the few scientists who've moved into the area of vinyl chloride or
asbestos have found out. It's very unpleasant. You have to leave the
laboratory. You get involved in public battles. You get defamed. You
can't just work afong and do your thing. I think unless the biomedical
community realizes that there were economic and social factors in its
missing the boat, and states that clearly, we are all going to suffer
for it.
The sixth and last case is the area of genetic engineering. Here you
have the same model: a small number of professional scientists stating
that their interests are extraordinary and can make great contributions
to human understanding, totally avoiding the f act that people have
very worries about manipulating the human pool
1
and even
about doing that kind of operation on animals. It 1s a certain kind of
sacrilegious thing; it's a tampering with nature. We've tampered be-
fore, but that's not an argument that future tampering is not very
dangerous. The fact that we've been careless in the past is not a reason
to be careless in the future.
Our feeling is that there are very deep feelings against t.his kind
of technology out there, really rooted deep down m people's guts, be-
cause they know you can't trust the scientists. They know that scien-
tists are an isolated, insular, arrogant community that believes its
view on things is the only one. One of the things I've been very im-
pressed by here is how much you people believe we have the answer
among us, and how much you think the r,ublic doesn't have it, that the
public is ignorant, that the public doesn t know what the problems are,
that the public doesn't know anything. My personal experience is just
the opposite. I n talking with workers, for example, glassware washers,
who work in laboratones, I find they understand very clearly a whole
lot of things that are going on. They understand that the idea of scien-
tific freedom is a total myth. I've been at meetings where professors
t alked about the sovereignty of the scientific endeavor. Then you see
the women sitting there, the women who have to wash the glassware
day after day; if they said, ''Well, today I'm not interested in washing
bottles, today I'd like to pursue the question of "(JJ,'' they'd just get
fired. Sure, professors can pursue whatever they want. Technicians
can't pursue whatever they want; technicians pursue what professors
want.
Workers understand what is going on, they understand that they're
probably poisoned by the toluene in the scintillation vials, not
because the scientist is not a good moral person, but because he or she
hns to make a living, has to get grants, has to get research done, and
that doesn't have to do with poisoning by toluene. If you
talk to workers in industnal plants, they know what they're getting
sick from. They know what's going on. And they know very n.ccurately
that the reason it's not being changed is because the power is not in
their hands, the power is in other people's hands. They know that you
(,oogh.:
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can't leave it to the doctors, because the doctors are on one side and
not on the other.
And of course, we see at a like this 'vhat side we're on and
what side we're not on. It really coi:nes down, in the end,. not .to .an
academic question about what needs :to be done about bion1edical
iesearch; but which. side are you on. Are we going to put. our
1
e-.fforts
l1nd resoU:ices. an<l t hinb.-ing into;a; direction tl\at be.nefits large masses
of.people in .terJhs of ,vhere.-theil'" Or are we going; to con-
tinue to be a vested interestgroup"\\rhose primary interestis t{>:maintain
our own privileged position, getting position;:.isolated
from problems of toluene :1nha1at1on, uncohnected to. the. real
problems i '
RYAN. I really "'ant to respond to the last comments, because I .think
we shouldn't have to sithere and argue about facts. It does<cli&turb
me when someone makes generalizations about who research is done on.
For exa1nple,'we have been to prjsons and have information O)l who
in prisons are research subjects. In fact, although the population in
prisons is largely black, it's the whites who are usually the subjects of
"prison research. You can look at that two ways, and one is.tha't blacks
are denied the benefits of participation. But that's not whatyou,said.
As you bring science to .the people; I hofe you bring good.science
and good facts to them. It's not fair t-0 la.be kidney dialysis as ai;;olu-
tion t-0 kidney failure based on pollutants in the atmosphere if 'you
don't in fact understand the roots of renal disease. There' ate people
here who can us those facts so that we'll understand them. But I
think it's terribly important to them right, because our olljectives
are similar; our techniques are different.
I want to finish with one very interesting experience on representa-
tion of the public. Our Commission felt we had an obligation to the
minorit y voice in this.country; so we asked the National Urban Coali-
tion to a and run it. They are supposed.to represent
all the mmor1t1es in this country, not only one group. vVe hadour con-
ference. I t went very well, and at the end there was a minority caucus
within the minority conference claiming that certain group's, 'Such as
Pacific islandei-s and ,\sian An1ericans, were not represented.' so you
have a tough problem when you ask who the public is. .
But the one thing I would make a plea for is that, as -we go: to t he
public, we try to be honest with one another and get our
Sometimes we pick up and promulg:it.e as facts things we've heaid that
are not precisely true. I know as well as youdo that in.certain large
cities research is done in teaching hospitals where there:are poor
people. On'theQther hand, you know rich
person, not the poor person, not the black. So1ne of the blacks were say-
ing at this minority conference, "Hey, maybe we ought to have some."
I 'm being a little facetious .about that, but 've do have t o' ke"ep some
perspect.ive. I agree with you that the public can. be infornied; aJ1d it
will respond.
GAYL!N. One set of facts Jonathan King presented is exactly alien
n.nd opposite to one we deal with. He said the public knows it can't trust
physicia.ns and scientists. I n our research on consent, the problem we
find is t.hat there is such a,,vesome trust and res{>ect for the physician
and scientist. Yon may say the public has been miseducated, but I think
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the public would be much extreme in its readiness to delegate its
proxy to the scientist or physician over the legislator, the judge, or
even the public advocate. 'Ve have struggled with the problem of how
to demythologize scientists, and you, in a sense, have said, "Oh, there's
an answer, don't worry about it. The average person is skeptical about
science and the medical community."
KING. No, no, I didn't mean to say that. It's clearly true that when
you leave a person helpless, without his own source 0 information,
he has to leave himself or herself in the hands 0 the 1,>hysician. I am
talking about the situation where one has let out the information, or
the public has managed to get a hold 0 it.
GAYLIN. It wasn't quite what you said. You said the public at large
knows it cannot trust scientists.
KrNG. Tay-Sachs was meant to be an example there. The com-
munity at firat didn't know anything about the actual nature 0 such
a screening program, except that it was told it was beneficial. Later
on, a second and third community could look at the experience 0 the
first community before deciding. I don't mean to deny that there are
tremendous J?roblems of communication, especially if the biomedical
community lSil't so interested in having this information available.
Certainly, or most clinical investigators, informed consent means yes,
because if the subjects say no, he or she can't carry on his or her clinlcal
investigation. So often the self-interest there is not to tell the subjects
everything you might, because they Inight say no and then you won't
be able to do your experiment.
JUDITH RANDAL. Three of us back here are wondering what the ob-
jections a.re against the Tay-Sachs screening program when it is not
an invasive procedure. Aren't you talking about
22
KING. Now, wait. I t is not an invasive procedure or a single in-
dividual. But do you really think that 30 years after World War II, if
you have an Ashkenazi Jewish community and an investigator comes
in and sets up an educational program that says Jews have a very high
frequency of some particular genetic defect (which is the of
the Tay-Sachs screening program) and they should come in and have
their genes screened because some of them may carry this defective
gene, don't you think that might ring any bells
RaNDAL. I was on the Washington Star when this happened in that
community, and I was very, very careful to point out when I wrote my
stories that there are different ethnic groups with different problems,
and that there are certain diseases which affect the population as a
'vhole. I agree with you that there could be a problem if you pick out
just Jews. But it needn't be done that way.
KING. But it was in that case, and the two other communities decided
against it.
GAYLIN. I'm going to interrupt this dialogue so that we can continue,
because we have just a short time left. Again, it is a question of fact.
We've heard at other meetings the complaint that the Tay-Sachs
screening emanates from the disproportionate influence of
.Jews on the scientific community, since it is a disease which is relatively
,. Amniocentesis ls a form of prenat.l diagnosis for a llmlted number of blrtb defects.
most of them Inherited. Including Tay-Sachs disease. It Is performed at about 16 :weeks'
gestation, early enough to permit a legal abortion If a disorder ts detected.
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unimportant st atistically. That a.rgument has always held a little n1ore
weight in my mind. I suspect if you polled the J ewish community,
which is not as disestablished as the black community, you would find
enormous enthusiasm for Tay-Sachs screening.
CAPRON. J onathan King's comments, in talking about Tay-Sachs,
tw<;> problem One is the of :ocience
with basic science. He said here we have a sc1ent1st who is going out
after knowledge, but I think that is not an accurate characterization
of the primary thrust of the Tay-Sachs screening program.
The second question is always, who is the pu'blic and how do we know
what it thinks The interesting t hing about the Tay-Sachs screening
program in Baltimore was that it was not conducted at ,Tohns Hopkins
University, it was conducted in the synagogues and Jewish community
centers and so forth. Maybe the rabbis, the community leaders and the
Jewish people who ran the Tay-Sachs foundation, who got the pro-
grams into the community, who persuaded community people "ho had
no knowledge of it that it was worthwhile, don't speak for the public.
I t seems to me that we can't have every single person deciding every
issue except as to his or her participation. to the question of
individual participation, perhaps there we have social sanction. I t was
the message given by Jewish leaders to the Jewish population of the
area that to be a good Jew you should be
screened, that this is a responsible thing to do because you are at risk
and your children may he at risk.
KING. The only trouble with that is, that according to the descrip-
tion given by the group that carried on the screening progra.1n,
KabaCk and associates, it was funded by NIH, and they felt they had
to write it up. They went into the community and took as their first
responsbility the education of the community to this danger that the
community wasn't aware of. They went around and educated the
rabbis.
CAPRON. But the only way they were able to carry out that progra111
was by going- to the leaders of the Jewish community and educating
them. And tnose leaders said, "Yes, we want to participate, we will
have the screening in our synagogue." I don't know what other public
participation you could talk about. If you talk about Tay-Sachs screen-
ing, it seems to me you've got an example of something where the pub-
lic, the affected public, participated. In other communities, as you
pointed out, the Jewish population inay hnve decided otherwise. I don't
see that that indir.ates that the Baltimore-Washington experience ''as
11 fraud.
1\J:No. Well, let me ask 11 question. The subject of this session is
sources of tension. Two communities rejected the screening progran1.
Now we can ask 'vhy did they reject
ARNO MOTULSKY. They rejected it because they said it was too rare.
There weren't enough Jews to find that 1 in 4,000 that was affected ;
that's the reason they rejected it.
ICING. That was part one; the second part was the burden on the car-
riers, the heteroz1gotes. The psychological problem they would have
because they get identified would be too high.
Ill. Kaback, Jllarshall B. Becker and M. Vlra1nla Rath. Soclologlc Studies In
Humo11 Genetics: I. Compliance Factors tn a Voluntary Beterozsgote Screening Progrnm.
Jn: Ethical, Social and Legal D'memiotts oJ Screening for Buman Genetic Diseaae, Birtl'
Defects Original 4rticle1 Serie1, X: 4, 1974.
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CAPRON. I think that point is very well illustrated by whnt happened
in the sickle cell experience. There, too much of the initial thrust camo
from the black population, and they saw it, very interestingly, as a way
into health care : if we can get money spent on sickle cell screening then
we can get more money spent in these same community centers on our
other health needs. Those were very smooth legislative decisions, polit-
ical decisions. But then there was no follow-up help. You can't give
amniocentesis to the identified carriers. You can only tell them they're
labeled as carriers, their insurance may get cut off, their kids may get
screwed up in school; 've have examples of all those kinds of things.
Then the black community turned around and said, "''re withdra'v our
consent. You're not giving us a benefit. You're only identifying us.
And for the moment, until you can give us more, it's not a price \Ye
want to pay." I think that's a better example of the point, nnd shows,
really, how we go through an educational process; it takes time before
the public gets more information and changes its mind.
MoTULSKY. I'm very much in sym:pathy with 'vhat Jonathan ~ i n g
said yesterday evening, that science IS part of society. 'lire cannot ch-
vorce science from society. But I'm extremely upset by what he said
just now because it had many, many factual errors.
I refer you to the March issue of th11 American Journal of Human
Genetics
2
for the evidence that the XYY 1nan in fact mny be a little
different from others, and that we need to find out \vhat" differences
individuals of that sort have. This is the kind of science I'd like to
bring to the people, to tell them 'vhat the facts are rather than criticize
things, saying scientists are doing horrible things.
You talk about cancer, and certainly I agree with you, much of can-
cer is in fact probably environmental. i\nd there are various reasons
why viruses were stressed. But as for the other argument you made,
that now they're doing genetic screening and trying to put the blame
on the people, it ignores the fact that such work may be extremely itn-
portant for understanding environmental carcinogenesis, because it's
not everyone who gets a cancer. There is good evidence that there are
genetically determined biochemical mechanisms which may change
one's chances, so 've need more of this research. But your kind of ptop-
aganda will wipe it out if people listen to it.
BALTD!ORE. Jonathan l{:ing sta.rts "ith the thesis that everybody is
a victim of capitalism, a victim of industry, a victi1n of ra1npant
individualism.
And then he takes a whole series of exa1nples every one of which is
arguable down to the most basic facts. I t's really a most inappropriate
way to[rove a thesis. Not that I disagree \vith the thesis, and not that
most o the people in the room disagree 'vith the thesis. But the facts
are all wrong, and unless he can prove it in a better way, he does a dis-
service to the thesis.
KING. There is a tendency, when people say things not within the
generally accepted fashion, to reply, "You don't have the facts, you
have the facts \vrong." I would say that I have not said a single scien-
tific thing wrong, and I can use all the tools and resources and creden-
tials of everybody here to make the same points. I don't believe any of
the facts I've put forwa.rd are wrong .
.. 1ohn L. Hamerton. Homan Population Cytogenetlcs: DUemmas and Problems. Ameri-
can Journnl ot Human Genetics, vol. 28, March 1976, p. 107.
(,oogh.:
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RYAN. But so1ne of the facts your group has cit.cd \Vere wrong, about
different social classes and things like that.
K1NG. Now look, that is just absurd. These argu1nents come out of
hard facts.
BArlrillIORE. The arguments about cancer don't come out of hard
facts. Those I know, those are the only ones I kno'v.
WATSON. I nlean, really.
luNG. I f someone would pick out some particular fact I'll respond
to it, because this is a kind of slander. You criticize the position by say-
ing the person doesn't have the facts, or he's saying untruths, or he's
saying half-truths. That's how you go about the argument.
RYAN . i\.s for kidney disease, we have the facts, on the basis of
people going on renal diialysis.
I\:1No. Would the experts here on renal failure please tell us what
is the reason for 90 percent of the renal failures in the United States
Could someone here tell us
SCRIBNER. Autoimmune and polycystic disease are the two major
causes and defects in the plumbing.
KING. Autoimmune disease is a very interesting disease. Now what
would you say is the etiology of autoimmune
ScRIDNER. I really wish we knew.
K1No. Aha., okay, so . . .
I t really would be much more helpful to Jona-
than King's cause if he would show that a lot of things that are re-
spectable to say .are no better founded in facts than the things he says.
RoSENFELD. I agree that ons should not proceed in 11. high-handed
or cavalier fashion to do anything to people which they have <loop feel-
ings against. I just want to emphasize th11;t the fact that doop feelings
exist does not mean they are valid or right. I n f act, where do people
get their deep feelings-often from misinformation, prejudice, from a
kind of cultural conditioning, sources that victimize them. I think edu-
cating people out of their deep feelings, if we think those are wrong
feelings, against t heir best interests, is a valid thing to pursue. In fact,
if we are hopeless about educating people into overcoming t heir deep
feelings, then I 'vouldn't have much hope about solving any of our

NADER. I have a couple of things to say. One, I wanted to comment
that after the session earlier .t.his morning, severa.1 peoJ?le asked me if
I hadn't realized that Senator Kennedy was involved 1n the payback
idea. It was interesting to me that these people did not hear what l\:en-
nedy said here, which was to talk about the payback idea for students.
What I was saying was that it should not be just for students, it ought
t.o be also for researchers. That's an example of selective listening,
which is a response to tension that proba.bly exists in this group.
I would also like to elaborate on a thought that Jonathan King and
Howard Hiatt brought up tocl&y, about setting priorities and how you
decide 'vha.t's -an import.ant piece of science to do. Hiatt pointed out
the difference bet,veen basic and applied .. I was reminded of the old
distinction that if you do research on Drosophila it's considered basic,
and if you do it on humans it's considered applied. I {)all think of four
a.reas of research r('cently at the University of California which f or
one reason or another, 'vsre thought to be not worthy of scientific
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attention because there was no "theory" involved. One was in the
area. of pollution, another was in the anthropology of food, and an-
other was in the area of power. Finally there was the research I had
done cross-culturally on judicial and extra.judicial mechanisms; it was
not considered anthropology somehow. Now one of the things that is
absolutely clear to me from that research is that there is something in
this society, not just in the science of it but much more pervasive in this
society, that leads us away from studying the preventive, away from
studying class phenomena.
Every single judicial complaint mechanism we looked at was pretty
good at handling individual complaints and absolutely terrible at
knowing what to do with general complaints. We looked at a group in
Illinois that was set up in the Attorney General's office to cleanse the
state of Illinois of fraud cases once and for all. What they started
out to do was a preventive job, but 'vithin 10 years that
turned into one handling fraud cases one by one. Take education. We're
good at looking at what we should do to help blacks learn better, but
we do not look at the larger social structureJ which relates occupational
distribution of blacks and how blacks may do in schooL
KETY. I simply have t\VO comments to make. I wanted to reinforce
what Howard H1abt said regarding the wisdom of the :people, in terms
of focusing attention on areas of applied research. I think it's only the
people 'vho can decide what are the iinportant priorities in terms of
heart disease, cancer, mental illness, defense, or what have you.
But then he made another very important point, which was that
in the area. of basic research-nnd I would broaden that to include the
strategy of research- the people may be wise if t hey delegate respon-
sibility for decisions to those who have been specially trained and are
specially competent to make the judgment of what directions to 1ro in.
The best person to make that decision, I think, is the individu;J. sci-
entist, who kno,vs his O\Yn competence and who kno,vs the next steJ?
I think it was a wise idea to have Science for the People on this
program concerned with sources of tension, because I think this is
one of the main sources of tension. I detect a ce1tain cynicism in the
approach of Jonathan King. It isn't so much that he is concerned with
the dangers or the risks of biomedical science compared with the
benefits. Somehow I have the feeling that he is using biomedical sci-
ence for some completely other c111sade, and this, I think, is cynical.
And I also think that the arguments that he used were inappropriate
and biased and inaccurate-deliberately inaccurate.
GAYLIN. Excuse me, Dr. Kety, I really would prefer that we direct
our questions and our comments to statements and arguments and
logic and leave the presumed intentions of the person out.
KETY. I was -about to do that. With regard to the XYY work, the
statement was made that the scientists who hadn't published anything
on this got into the newspapers a great deal. I wonder how they got
into the newspapers, and who was responsible for their getting into
the newspapers W When it comes to getting into the newspa:pers, I
remember a colleague of Jonathan King's, who made a very impor-
tant basic contribution at Harvard Medical School and called a press
conference about it, at the end of which, of course, he pointed out
how terribly guilty he felt because he was making available to this
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evil society a means of genetic engineering.2$ As for this business with
Tay-Sachs disease and sickle cell anemia, why didn't he mention phen-
ylketonuria
26
screening Was it because it didn't have some racial
overtones i 'Vith regard to medical research and clinical investigation,
a lot of the things he said were more calculated to arouse emotion
t.han they were to inspire constructive thinking. For example, the
clinical investigations carried out on prisoners, blacks and women;
you h.-now most clinical investigation talks about healthy young men
as the 1naterial being used.
STONE. I wonder if someone can say something in Jona.than King's
behalf, in view of the number of ad hominem remarks that have been
inade. It's really unfair to make a person defend himself alone against
ad 11ominem charges. I t wasn't very many years ago when the Fed-
eration of A.merican Scientists attacked Science for the People at an
AA.A.S meeting for what 've felt were its efforts to suppress dissident
points of view about the Vietnamese 'var. It was not a group that
Jonathan IGng was associated with. But I feel the same imperative
in defending liim and his group in this case, because it seems to me
that it is always very difficult to bring new approaches to a problem.
I think it is very clear that the principles he has been espousing, quite
apart fro1n the concrete examples, about which I have no expertise
and no way of judging accuracy, are ones we should be concerned
about.. That is especially true in a group that, I think we all recognize,
is short on fresh approaches and is mdeed short on public partici-
pation.
So if it is tn1e- as I think it is-that we could as a group concoct
exarnples that would fit the principles he is talking about, then he has
already made a contribution to our group by rai91ng these principles.
"\V'hile it's certainly fair to attack all the examples lie's given with all
the expertise available here, and he, I'm sure, expects it, it seems to
me it should not degenerate into ad hominem attacks and slurs on
him personally. And it seems to me we also should recognize the
importance of t.1-eating with special courtesy any views which are in
the n1inority. That ce1tainly is the American way.
l uxe. I think it would bE1 very sad, and I hope it's not the case, t'hat
I'm cynical. But, you're right. My concerns a?'e far outside science.
I would like to see a better society than the one I grew up in. It's not
a bad one, it's a good one. I love it. But it seems to me it could be made
better. I think the research com1nunity is a beneficent, beneficial com-
s In late 1969, a group of researchers at Harvard Medical School announe{l;d the Isola
tlon. for the ftrst time, of a alDgle gene, one cont1'0lllng the ability of the bcterlum
E1tch.erlcha coli to metabolize the suitar known as lactose. At the ea.me time, mfl'mbers of
the team publicly expreeaed worry about the posalble use to which orene Isolation tech
nlqus mll?ht eventually be put. The .team leader, Jonathan Beckwith. "'as quote<! ns
8n;irlnir. "The steps do not exist now, but It ls not lnconcetvable that within not too Joni:
tt rould be used, and It becomes more and more when we see 'vork
tn hto1ogy 11sed by onr government In Vietnam aild In devtalnsr chemical o.nd hloloj?'lc.nl
\\'enpons.'' Another team member, .rames Shapiro, concurred. '
1
Tbe work we have done
mnr hnve bnd conseq11ences over which we have no control. The t1se by the ttovernment ta
the thing tbnt u." See Robert Reinbold. Scientists Iso!Rte a Gene: Step In
H""'lit;v Control. The New York Tlmea, November 23, 1969. pp. 1 72.
Ph.,nylketonurta (PKU) ts a rare metabolic dlBorder resnlttng tn severe mental
rPtftrdatlt1n. Thi& can he to some ex-tent by a dtetat';v begnn
Ahortly after birth. ThulJ most North American new borne are screened for PKU, often by
<'f'IJnpntsor:v ln.w. PKU tnvolvea tbe search for a person attectPd by a trentahle
rli R<'l1Sf', while Tay-Sacha and al ctle cell screening involves the search for a oeron who
tin not have ., dlaeaae, bot who may be at risk for having a child with one. !ile Tbltba
M. I'owl e<lJ!. Genetic Screening as a Polltlcal and Social Development. Jn : Ethical.
" '"l Dlmnslons ot Screening tor Human Disease, Birth Dufects Original Articles
X: 4, 1974.
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munity. If you look at the results achieved by the biomedical commu-
nity, they're wonderful. It's like manna compared to the other major
American researdh effort weapons production. I apologize if I ap,Pear
cynical. It seems to me that, quite the contrary, tliere rev.lly is within
the medical research community the possibility of ma.king extraor
dinary contributions to American life in areas like occupational
health and public health. But that will only come if we begin to under-
stand the actual factors that operate. 'Ve have to have accurate social
theories just as we have to have accurate scientific theories. If we have
the wrong theory about what determines the direction in which re-
search goes, then we're not going to be able to make the contributions
'"e need to make.
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FBIDAY NooN, APBIL 2
THE CHALLENGE OF ACCOUNTABILlTY
ROBBINS. We are delighted that Senator Jacob Javits, Republican
of New York, can now jom us.
JACOB J A VITS. I am sorry I couldn't be with you this morning because
of Senate business. No one could be happier that you have an afternoon
session and that you didn't have anyone to speak at lunch. I'm sure
you could live without it very easily, but I took the opportunity to
come for two reasons. One, to thank Frederick Robbins and Villard
Gaylin and all of those Who are participating in the program for their
willingness to cooperate.
I'm well aware that great scientific findings and important social
results are brought about by conferences such a.s this one. As a matter
of fact, I'm so interested in the subject that I attended one myself, not
too unlike this one, at R-0ckefeller University, which took place about
two weeks ago. The title of that was "Beyond Tomorrow-Trends and
Prospects in Medical Science,'' somewhat the same thing we're doina
here today. So I came to thank you for participating and in o p ~
anticipation of results.
This is also a unique experiment for two senators who have posi-
tions of considerable authority in this field. Senator Kennedy, whom
you've heard this morning, dashed back to conduct a hearing on in-
flated costs of medical care, which interests me very greatly because
I'm devoted to the concept of national health insurance, just as <he is.
He's the chairman of the health subcommittee; I'm the ranking mem-
ber of the whole committee. But he and I have collaborated, for exam-
ple, in development of the cancer research panel and in many other
joint activities.
I have a very pleasant and interesting speech, which I will promptly
throw away because it will be a bore to you to hear the mechanics, but
I will introduce it into the annals of this discussion.
21
But I do want
t-0 emphasize to you what troubles me, and what I 'hope we can get
some light on.
I say it's a unique experiment because it is not often that senators
are able to get a group together to thoroughly air a subject, over a
period of days, in a setting which lends itself to conclusions.
I just saw your program, and I'm planning to come out tomorrow,
Saturday morning, to hear the conclusions. But in any case, both
Senator Kennedy and myself have our eyes and ears'here, and it would
be a tremendous source of gratification to me if we could take what
you do and translate it into legislative action. Senator Kennedy and
I have quite a g-ood record on bringing into law what we both believe
in. I predict a law on national health insurance will come in '77, and
it will begin in '78. Everything we've done is a threshold for that,
"'For Senator Javlts' pr<!par<!d text. aee Appendix 1.
(99)
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including support for health maintenance organizations and similar
activities.
We have a very great paradox in t'his field. In the first place, the
whole area in which you're engaged, the life processes and the really
big breakthroughs in respect to a totally ne'v universe in medicine, is
of enormous public interest. I recall 'vith great interest that when
vVillard Gaylin testified before the Senate health subcommittee, 'he
underlined the fact that your very success, for all practical purposes,
put you in the public domain, and that if you were the important
factors in controlling the survival of the human species, then you at
the same time became the servants of t11e very society to which you
made those revelations, rather than its masters. He -also said in that
testimony that there were no villains and no heroes, but that "arro-
gance and ignorance are the only enemies." :s I've taken that very, very
much to heart.
Now, w'hat do we hope to learn from your discussion and from the
tension produced by that In my judgment, tension created
when individual expertise and experience rub up against other com-
parable expertise and experience is the greatest means for revelation.
First, I hope there will be a new dedication, a new means for at-
taining knowledge. I'd like to tell you my favorite doctor story. I
served in World vVar II in the Chemical Corps of the United States
Anny; I was not a foxhole soldier, as is clear. As a matter of fact. I
was overage for the purpose even then, but I was very in the
command structure all over the world. The man I served with was
C. P. Rose of the Sloan-Kettering Institute, who was the head of the
medical division of the Chemical Corps. He \Vas a marvelous human
being, and a wonderful doctor. Even in those days, he said if he could
have enough people and enough money to knock down maybe t"o
million hypotheses, he could break through and find the essential
riddle of cancer. He was confident, I'm sure, that there might be an-
other Jonas Salk who could do it, by sinking his chin in liis cupped
hand and thinking it through, but he said we couldn't wait for that.
It was to me a tremendous concept. It has inspired me all these years
in the crash program for cancer. But anyho'v, first and foremost, there
is the pursuit of new knowledge.
. Second. I hope there will be some effort to deal with the ethical prob-
lems involved, because in this field. those nre uniquely a problem. nnd
they are, as you all know, a mixed problem of religion, of social or-
ganization, and of politics. This is the area, to my mind, where we
need the greatest amount of guidance from such a combined gronp
representing every discipline as this one, including, of course, the
professional disciplines.
And lastly, what are the implications of the new technologies we
For example, if you can make a human being in whatever
una_ge you choose, what does that mean. not only in the way of con-
trolling the process through social and political means, but also in
terms of its impact upon economics, society, family planning. food,
and a million other aspects of our lives on which it will directly im-
"Willard Oaylln, M.D. Testimony before the Senate Subcommittee. April 22.

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pact. We don't want- to use a visual example-any more skeletons
of unused buildings simply because of human fallibility.
This third aspect is a really critically important one. I know Sen-
ator Kennedy is very sympathetic to what I nm about to say; I'm
engaged in a process with Senator Hubert Humphrey, an effort to
develop mechanisms for our nation which will look at least
ten years down tne road, happilv more, in order to plan for a future
that becomes more and more, as "your "'Ork proceeds, ascertainable.
So those are the issues that concern me very deeply: basic research
and the J?roblems that inhere in t hat research and the treatment of hu-
man subjects. For example, the famous and by now rather hackneyed
phrase who lives or dies, who decides who gets what, what are the im-
pacts of advances in biology and medicine on our society, how should
our society be prepared to meet them with the minimum possible waste
of already very scarce We in Congress have an enor-
mous role to play in this. And we will, because I'm deeply convinced
that all the sound and fury about national planning and national
health insurance, a balanced economy, full employment and so on, will
result in action. We are merely the froth on the wave. I have no illu-
sions ns to our importance. We are compelled to develop all these orig-
inal ideas with great initiative for the ne-xt election because society
and human events-and you're such a critical part of it-propel it in
those directions. So as long as we're going to do it anyhow, we might
as well do our utmost to do it right, and that's where you come in.
Now, really that's all that I had in mind to say to you. You're de-
positing your intelligence and vour effort in a very good bank, and OUT
job is to see that it is used to the utmost effectiveness for the purpose
of doinl! the job the people have designated us to do. Now you aJso
have a aichotomy. So many of you are professionals in this general
field. Your dichotomy is that you're scientists and specialists but als<>
ordinary John Q. Citizens. I really could not fail to urge you to d<>
your best in both roles. We should not surrender to you our fate be-
cause you are the scientists who produce our fate, but rather do our
utmost to regulate and direct it for the highest social purpose in the
interests of all the people. At the same time. you should not give up
your participation in the social and political aspects of these activi-
ties. You're a scientist, or whatever particular discipline you follow,
but you also have very valuable things to contribte as an individual
citizen and a member of the social order. I hope very much that all
of you will have that verv, very much in mind. The final development
o_f 'vhat you're engaged in, in my will write the prescrip-
tion for the new ''orld. whatever it ma:v be. IIence, I can't tell you
the pleasure and excitement, I find in havinl? some participation in this
part of the process as well as in the legislative process.
There's one particular point I'd like to report to you, and that is
that I want to see the National Institutes of Health 11ssume a leader-
ship role int.he field of technology nssess1nent, in 01der to determine
what technologies may be distributed, what technologies are perhaps
being distributed too quickly, before we have adequate validation of
either their safety or their efficacy. So I've asked Dr. Donald Fred-
e1ickson. the Director of the Nat'ional I nstitutes of Health, t-0 form
a 'broad-based special committee under NIH auspices to examine the
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ethical, social, economic and technical issues in medical care evalua-
tion or technology assessment. He has been kind enough to allow me
to share this concept with you, and I hope very much that you will
keep this concept in mind as you continue in these discussions and do
your work.
I end as I began; I'm here primarily to thank you for what you're
doing, and to express the hope and expectation that it will be very
important and useful to us in our work, to briefly sketch for you the
horizon towards which we look, and finally to assure you that insofar
as governmental means allow, we will do our utmost to put to effective
use 'vhat you will produce. Finally, and perhaps most importantly of
all, I \Vant to share with you some sense of the humility we men of
po,ver feel. It's by no means confined to me. Because of the awesome
nature of the forces you are placing at the disposal of mankind and
society, we share with you the great feeling, almost a religious feeling,
of trusteeship in terms of the public accountability in the utilization
of these forces. The universe which mankind can ascend to in terms
of the decency, the beauty, the creativity of life, in my judgment, is
just as infinite as the universe outside, and we appreciate so much
the gratification of climbing at least a few of those steps with you.
'!'hank you very much.
vVaTSON. I think all of us in this room are familiar with assessments
done by government agencies. 1'here is a need for them, but they have
often proved slow and cumbersome. Can this change i
JAVITS. Well, Dr. Watson, everything you say about the need for
this kind of assessment is absolutely correct. The Food and Drug Ad-
ministration is too slow, and it doesn't turn out results promptly
enough to serve humankind. In some cases, it takes seven years to de-
termine whether a :particular compound is safe or not safe. There could
be very important input from the NIH in drug regulation and indeed
there is. The difficulty is that the NIH too, could be overwhelmed by
the volume which the FDA has. Also there are tremendous private
iesources which are perfectly dependable but are not as yet effectively
utilized because of Food and Drug Administration suspicion of them.
We are trying. We have just reported out of committee a cosmetic act
as well as a food additive act which endeavor to reconcile these three
means : the FDA itself, the NIH, and the private sector. And perhaps
we can have from you or others here some helpful suggestions as to
these measures.
BROWN. What is the outlook for fundinO' for biomedical research 1
J AVITS. The political solution for research catching up with clinical
expenditures is national health insurance, because then you will have
a big enough pot to draw on. National health insurance is an important
solution for medical care itself. I n my view, its most important com-
ponent is preventive medical care. I think that's the big deficiency in
medical care in our country; there are lots of other troubles, but that
to me is the overwhelming one. People simply can't afford what pre-
Yentive medical care calls for unless the expenses are mutua.lized.
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FRIDAY AFTERNOON, APRIL 2
MECHANISMS FOR PUBLIC l'Aln'ICIPATION
ROBBINS. In some sense, to discuss whether there should be public
participation in scientific research is to discuss a dead issue. We all
know that scientific research is already subject to public scrutiny and
regulation, both express and implied, through a. number of formal
and informal mechanisms. This afternoon, then, we will consider such
mechanisms, how they are being used now and how they could or should
be used in the future. These will include governmental procedures
already embodied in such organizations as the regulatory agencies, or
in internal mechanisms various federal agencies possess for self-regu-
lation, and external regulation such as that set up by Congress, typified
by the National Commission for the Protection of fluman Sub]ects of
Biomedical and Behavioral Research. There are also legal avenues like
litigation and legislation. Finall;r, there are self-regulatory mech-
anisms, such as established scientific organizations, and the more in-
formal self-examination that has come to be known as ;\.silomar. Ea,ch
of these mechanisms will be described briefly this afternoon by people
~ o have been intimately involved with them.
Available Government Procedures
BERTRA11r BnowN. The most important thing I can say has nothing
to do with the assigned topic, but does have to do with the live inter-
face at this meeting among real Senators, their staffs, and the media.
I feel it is essential that the national health insurance issue debate be
enriched by attention to the funding of biomedical and behavioral
research.
Simply put, I have in mind t'vo dimensions of this issue, both
equally important. One entails providing a fixed percentage of na-
tional health insurance revenues for the liealth research enterprise in
order to promote stability. The second involves development of mecha-
nisms and institutional forms of the nation's health care system to
interact with the shape, direction and strategy of the biomedical re-
search effort.
It's refreshing to me to 'be at a meeting where Kn.nt and Spinoza nre
spoken of comfortably. The philosophers I've studied are eight secre-
taries of HEW, and the most profound remark has been "I'd rather
have a bad law administered by good people than a good law ad1nin-
istered by bad people."
l\{y topic of available governmental mechanisms covers a list that
is tenibly familiar to all of you, and the bottom line is that we have
not approached anywhere near the limit of the availa'ble mechanisms.
For example, the initial review group could be more than a group of
peer scientists. I t could have a consumer or a philosopher. It might
even have ns many as a third of such people, and the scientific debate
on merit would not be destroyed. On our own national advisory council,
(103)
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the National Association for Mental Health, which is the formal con-
sumer group, sits 'vith some provi der groups. Public participation
docs 'vork. I also say that when these meetings are opened to the
public, the panic and consternation that is often predicted has not
occurred.
Having served as staff director and executive director to three presi-
dential panels, I know the potentialities there. In sum, the current
mechanisms, of which there are several others I haven't mentioned,
could be easily enriched.
Legislation
PETER IIUTr. Let me state how I come at this problem. I spent fout
years as a aovernn1ent regulator, as FDA counsel, and my job was to
write for science and scientists, and to put scientists in
jail if they did not follow the regulatory reguirements. As part of that,
I also spent four years dealing with confhcts between scientists who
'vere being regulated and the pu'blic. My J?remise is that the scientific
enterprise, and I include in that most basic science as well ns applied
science, is no different fro1n the pharmaceutical industry or the rail-
road industry or anything else. The only issue is the extent to 'vhich
it impacts on the public. If it does impact on the public, it is as vulner-
able to public governmental regulation as the railroad industry or the
pharmaceutical industry. Since public money is being used by scien-
tists for all forms of science and very difficult health and safety issues
are arising out of basic science, such as recombinant DNA, it seems
to me that 'vhat ''"e have got to look at is what form public regulation
will take, not whether that public regulation is going to come.
There ,is one alternative to the government intervening through
legislation-scientific self-regulation. I am very cynical about that. I
have seen self-regulation work in many different contexts only where
there are sanctions of one sort or another to back it up. One sanction
in the scientific world could be that a scientist 'vho f ailed to follow
proper ethics would be ostracized.
As a citizen, I find that not sufficient protection. Another sanction
is that if the scientific enterprise does not engage in realistic self-
rcgulation, it would inevitably lead to governmental strangulation
through regulation. Again, I'm not sure in all instances that such a
sanction is really enough. The history of government regulation of
business is the history of the failure of various human enterprises to
regulate themselves. Whether you start with the Interstate Commerce
Commission, the Food and Drug Administration, or the Federal Trade
Commission, you can go back and find very specific v,iolations 'by in-
dustry that led to a Congressional response. The real issue that we're
facing is whether scientists can re,g"ttlate themselves and prevent that.
The reason I don't think the scientific enterprise can do that is because
one of the most fundamental aspects of self-regulation would be to
allow-as Bertram Brown just got finished saying, and Senator .Javits
and others have said-the rest of the world to participate. What is
needed is a reaching out by the scientific community in many different
wa:vs. opening up all your deliberations to public participation, so they
feel they are part of the process and can have some say in one form
ot another.
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I recently had a. debate with my good friend Philip Handler over
the question of whether-and I don't like to single out the National
Academy of Sciences-any prestigious organization engaging in scien-
tific policy-making should or should not hold all of its deliberative
sessions in public. That is the issue Bertram Brown just dealt 'vith.
best judgment is that if it does not come voluntarily, it will come
as a statutory requirement by Congress, .a.nd wiill be a good dea,l more
onerous. I .fear it might go a good deal further. ThlS oould mea.n a
virtual certainty of federal regitlation, because I do not see the scien-
tific enteI'prise pul,ling iitself together enough on this issue to avoid it.
There are two types of legislation. One type would impose proce-
dural requirements upon the scientific entevprise. It 'vould say to the
scientific world, "You 1nay continue to regulate yourselves, but we
in Congress
1
and in the public will tell you how you ara going to do
it." I'1n talking about legislation like the Federal Advisory Committee
Act, or through Peer Standards Review Organizations, or the Pro-
tection of Human Subjects Commission. Those have been establishing
governmentally-imposed procedural requirements. If scientists are
lucky, this is all that will be required. I have some doubts that it will
go no further than that, bec.'luse I think there are serious questions of
conflicts of interest when scientists try to regulate themselves.
I'm reminded of two that I will throw out and expect people
here to take up. The co=ttee that is currently on the re-
combinant DNA guidelines consists of scientists who worll:: on recom-
binant DNA. The co1nmittee I serve on in the National Academy,
dealing with the question of research training in the scientific world,
is comprised, except for me and the chairma.n, of people from insti-
tutions who receive training and f ellowship funds from the govern-
ment. I see a problem for the government if it allows scientists to get
away with this kind of conflict of interest in the future.
What will happen if Congress There are any number
of models for government regulation that could be imposed. Some are
not too bad but some would be horrendous. The first example is that
of huinan experimentation, where informed consent is required. A
second one that's being considered now, because of concern about over-
prescription of drugs, would be for every doctor to be required, when-
ever he prescribes a drug, to give the patient a little brochure, which
in effect will tell the patient that if the doctor hasn't first done the
following ten things, he's a lousy doctor. One possible further step is
that if tlie doctor prescribes a drug outside the governmental guide-
lines, the doctor goes to jail. He is a. criminal, whether he did it
knowingly or not. The patient package insert concept is a half-,vay
mark; by no mea.ns the worst the government is considering in terms
of re!!'lllation.
I it would be impossible to go down all the alternatives. I
\vould merely like to refer to various models that were brought up by
Alex Capron. He discussed seven, and I think anyone in this room
could add a large number of others. The point is that it is utterly
irnpossible, from my perspective as a regulator, to say ahead of time
that any one model should be used for any given situation. Each one
has to be developed on an ad hoc basis. Indeed, sometimes within a
giYen problem you have to separate out sub-problems and use different
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regulatory models in to with them. Someti1nes
ban is absolutely essential. Sometunes you can get away with doing
nothing, and in between. The National Commission ap-
proach works wonders in some areas and would be absurd in others.
So trying to fit everything into one great mold, while it would simpli fy
our lives, in my judipnent is absolutely impossible. What you have to
do is agree on one tundamental principle, and that is that in every
instance you pick the least restrictive form of public regulation that
will do the job you're trying to do.
The real issue is one of leadership, leadership in the scientific com-
munity, to try to pull together the scientific ente.rprise and prevent
what I fear could happen over the next 25, or 40 years; namely, far
more restrictive regulation than is necessary or justified. It's got to
come from NIH, from the universities, from the National Academy,
the Institute of Medicine-all the groups that we all kno'v about. I
don't think you can set up one group that will provide that sort of
leadership. I t is going to have to be done on a much more ad hoc
basis. I don't look to Congress for that leadership, been.use the job
of Congress is quite different. When you get to Congress you're in
extremis.
Litigation
ROBERT BunT. If, as Peter Hutt has just said, 'vhen you get to Con-
gress you're in extremis, then when you get to litigation, you're in
rigor mortis ! That sums up my basic proposition about the role of l iti-
gation as a regulatory technique and a mode for having public involve
ment in the kinds of medical issues we've been talking about here.
To an extraordinary degree it seen1s clear to me that the courts
are now wading into this area, and are willing to resolve issues that
10 years ago would have seemed just inconceivable to be resolvable
through litigative modality. I'd hke t-0 set up a model of the kind
of re,,,"'lllatory process that I think is called for in the kinds of issues
we've been talking about, and then indicate why I think the litigntive
model is very, very far from this more appropriate decisionmaking
model. I was particularly struck bv Senator Kennedy's conclusion,
which I think was a very sensible one, that there's certainly no federal
called for in the definition-of-death and right-to-die areas,
'vnich is another way of saying who knows what to do about this enor-
mously complex, troublesome, difficult issue except keep it in high
visibility.
Then he talked about the ban on fetal research, and there, too, the
strategy he described I think was n sensible one-not to resolve the issue
flat out, once and for all, but instead to bring it into high visibility and
then start a kind of Or, to put it another way, to keep the
issue in a state of creative irresolution over a significant enough period
of time to permit different kinds of constituencies to realize that t hey
have an interest in coming forward, and then permit regulatory bodies
to try out mechanisms of regulation.
vVell, that's my model. however you design social inachinery around
t.hat. If that is your model as well, I think it will become evident that
litigation is the worst possible way to approximate that model, because
(,oogh.:
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the judiciary behaves much like f r Anthony, the Answer f a n on the
old radio show. Mr. Anthony would have gotten no brownie points at
all i he had said, "Gee, that's a hard one, you know. I don't know the
ans,ver. I think we're gonna have to wait several years, get a lot 0
different people to think about it and then come back."
What the courts have to do is come up with an answer. They are
forced to by a whole variety of institutional mechanisms. They also
temporize, it's true, but it's much harder for courts to ten1porize, and
much harder for these different constituencies to form over time and
have different views reflected.
Scie-Mific OrganizatWw
WILLIA:&! BLANPIED. I'll use as a starting point .\.lexander Capron's
suggestion that one needs to find new mechanisms or build existing
mechanisms to look at questions of regulation, public participation,
interfacing with Cofie<>TesS and so forth. I want to thro'v into the dis-
cussion the possible roles and limitations of private professional so-
cieties for being one element in these processes.
We've talked about universities, government institutions and so
forth. However, scientific societies are one important set of institu-
tions that, in one form or another, represent t.he scientific community
and perform a service to the scientific community. The question is, can
that service, can that type of representation be broadened, and to what
degree, so that it can help with public participation
There are an enormous number of scientific societies. To the extent
that the scientific society represents the scientific community, the fact
that there is such a range of them indicates that there is no one scientific
community. There are 298 societies affiliated with the American Asso-
ciation for the Advancement of Science alone, and there are others be-
yond that. Therefore I cannot say I represent the scientific societies. I
am a high-energy physicist and a sometimes historian who wandered
into being a scientific administrator in the AAAS. The AAAS is ab-
normal, at least in the sense that it has an executive officer who is a
non-scientist and a president-elect who is a non-scientist. However, I
take those two facts to indicate that there may be some willingness on
the J?art of scientific societies to involve themselves in some sort of
public participation. The executive officer of the AAAS, after all, was
appointed by an elected board of representatives that contains a ma-
jority of scientists.
Historically, if we go back to the Royal Society in 1660 as the arche-
type of a scientific society, there was a feeling t'hat the emerging sci-
entific community should have some sort of private 11.S.<;oeiatlon that
would represent it and do certain things to advance science in some
way. Traditionally, then, using Gerard Piel's metaphor of last night,
the sovereign scientists surrendered a certain amount of their sov-
ereignty to an organization in exchange for certain services that were
to be rendered by that organization, and that organization saw itself
as sovereign. It got a charter from Charles II to do specific things,
to publish journals and hold meetings where scientists could com-
municate. In later years it's done some additional things, namely out
82-201-77- 8
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together co1nn1ittees. So I would argue t.hat those thini;s scientific
societies can do in any realm, including public parti.c1pation, are
limited to these three functions: publishing journals, holding meetings,
and convening committees. But I would also argue that these can be
extremely powerful functions.
They a:re functions that are flexible and can be used as one type of
input into the problems we're talking about here. For example, take
the po,ver of a journal. Scientists, to achieve academic advancement,
have to publish articles in a recognized, refereed journal. The peer
review system in fact grew up in order to referee jour nal articles for
quality control.
There is no reason why the peer review process cannot be extended
to cover other areas besides t he publication of papers. Then there are
different types of journals a society can publish. For example, Smeru:e,
the journal of the A_US, is not a house organ of the AA.AS and is
not seen as a house organ. Smeru:e has a wide variety of input, can get
controversial, and has thrived just because it does that. This indicates
t.hat a scientific society can have a considerable amount of leeway in
the type of journal it publishes. I would claim that in publishing
Scieru:e, a great deal is done with public participation on one level,
although a very s1nall public. However, it is able to air so1ne of these
problems. Recall a letter 1\faxine Singe1 and Dieter Soll published in
Science, which was rather crucial in the early days of the Asilomar
n1ovement.
Second, scientific societies hold and they can hold different
types of meetings besides simply those w11cre scientists exchange tech-
nical information. They can hold meetings in which the public is
involved.
Finally, scientific societies can establish committees. In the last few
years, some of the committees have had rather interesting results. I
\vould call to your attention the American Physical Society's reactor
l'<afety committee, which raised some Yery critical points about the
Rasmussen report
30
on reactor safety.
1'his caused Congress to ask that the report be revised. The A.:A..<\.S,
a few years a"'o, did a famous study
31
on the use of herbicides in
' 'ietnam, which then convinced the National Academy to do a more
detailed study
32
on the problem. More recently, the AAAS has done
a study on scientific freedom and responsibility.
33
And it's about to
establish a committee, with a staff and some teeth in it, which will
try to take a broad look throughout the community at some of these
issues. Scientific societies are not the only answer, but they are tradi-
tional mechanisms I think can be pushed a considerable distance.
,. Maxine Singer and Dieter Soll. Guidelines tor DNA Hybrid Molecules. Science, Vol.
September 21. 1&73, p. llli. Thia letter was the tint public dlscualon ot po$$lble
dang..,. ot work with recombinant DNA, wblch led ultimately to the Asilomar conference.
"'This three year tudy, done tor the Atomic Energy Commissi on by Norman C. Ras
mti<en of the Massachusetts Institute ot Technology, was released In October 1975, and
confirmed previous A.EC llndlng11 "that the likelihood of a serious nuclear accident with
<-0nsequences f'or the public . . . was extremely small'' See Oon.qruaUJna.i Quar-
terl11 Almanac, Vol. XXXI, 197G. p. 276.
11
See Deborah Shapley. Herbicides : A.AAS Study Finds Dioxin In Vietnamese Fish.
Vol. 180. Anrll 20, 1ll78. J>. .
., !lee Deborah Shapley. Herbicides : Academy Finds Damage In Vietnam after a Fight
ot Its Own. Science, Vol. 18S. March 22, 1974, p. 1177 .
., .Tohn T. Edsall. So!entl/lo ll'reMom and .Rpo11llJillt11. (Washington, D.C., 1975 :
ADlerlcao Association for the Advancement of Science).
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1-09
I 'vould add that, among scientific organizations, we should consider
those that are quite frankly advocacy organizations of one type or
another. In that I include the Federation of American Scientists,
and the fact that the FA'S has been created is an indication that scien-
tists wish to iret themselves involved in same way in the political
process. I woii'id also include Science for the People. So one has a
broad range of private scientific societies, which indicates the con-
siderable power and pluralism in the scientific community. I am con-
vinced that, if there is a will in the com.munity to use these organiza-
t ions for better public participation, they can be used in this way.
ROBBINS. Would you be willing to comment on the
BLANPIED. To the extent that scientists are willing to delegate a
little bit more sovereignty to the societies, to tolerate societies' getting
into the public policy business and making controversial statements,
and to the extent that scientific societies are willing to work together,
we can see change. As one example, yesterday afternoon I was struck
bv the fact that I have heard discussions about OMB setting
priorities before, in an ener'P' conference with physicists. They say,
"'vhen are we going to convince 01\iB to give us the proper amount
of 1noney in basic nuclear research rather than in new research"
The physicists are talking about getting more out of 01\iB, just as the
biomedical community is, and the oceanographers are talking. Several
scientific societies could some of their sovereignty and join
f orces to discuss priority setting with O?iiB, so that we can talk about
t he unthinkable, setting priorities between biomedical research and
energy, and not let OMB do it alone.
Asilomar
SINGER. I'd like to review a. process that is being called
Asilomar, but which is really not represented by the conference at
Asilomar. The conference at Asilomar 'vas part of a process which
began before that time and which is still continuing now, and I don't
think that one can evaluate this particular process only by consider-
ing the meeting at Asilomar.
This process really started with a recognition that we had a prob-
lem. That recognition came at a. scientific meeting, and it came from
scientists who were involved in the recombinant DNA research. That
was not an appropriate forum, partly
1
because of time, partly because
of other reasons, to discuss the problem in depth; but the group at
that meeting voted, by a democratic procedure, to choose the forum
they considered a suitable one-the National Academy of Sciences. The
reason for choosing a forum from within the scientific community was
that it wasn't clear what kind of a problem there was, and at that point
it wasn't even absolutely clear that what we were worrying about was
a real worry. It needed more thought, and careful thought, before
the problem was brought to any public arena. So the groups voted to
g_o to the National Academy and ask the Academy to set up a group
t nat would study the problem, which the Academy did.
That committee is what has been called the Berg Committee. They
discussed the at hand came to the.conclusion that there
was a real poss1b1hty that these kinds of expenments presented po-
tential hazard. It also recognized that unless it did something iin-
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mediately, the question might be moot. And so, simply on the basis of
their own personal clout within the scientific community, the members
asked for a moratorium on the experiments. That's not all they did
at that point. They also asked that the Academy convene a larger
group, with a different representation and with different kinds of ex
perts in order to discuss it further. The recognized that the problem
was an international one, and required the input and concerns of our
colleagues all over the world. They also, at that point, recognized that
the problem was not one that should be discussed only within the com-
mWlity of investigators who were concerned with this area of science.
And they asked in the same Berg Jett.er that the National Institutes of
Health set up a mechanisn1 for a publicly responsible discussion of
t.he issue. All of those things were in the Berg letter, in addition to a
request for a moratorium.
The Asilomar conference was the conference that was set up in
response to that re1111est.. The NIH Advisory Committee on Recom-
binant DNA is NIH's response to the request in that letter. The re-
sponse on the part of the scientific community to the moratorium has
been, by and large, a very cooperative one.
There are a couple of things I'd like to point out about this process.
First of all, it is not meant to be a model for anybody else's process
with any other problem. It was not set up by people who have any
experience in public policy. It was set up by a group of :r;>eople who were
concerned about a specific problem and felt a responsibility t-0 do some-
about it. It differs from a lot of the problems you've all been
talking about in that it was an anticipatory response. It wasn't a re-
sponse to a terrible event. It wasn't a response to a. known ha.zard. It
anticipat.ed certain problems, and to this day we don't know if these
problems will ever arise. It was conduct.ed tote.Hy outside the public
policy community, on an ad hoc, volWltary basis, and in the context
of our own society's tradition of private initiative. I think that's a very
important matter, because we have to that, in addition to aJI
the mechanisms we've been talking about tor the last day and a half,
our whole society depends to a very large extent on responsible private
initiative that may ultimately Tesult in government action. The gov-
ernment itself depends on it and it's important, no matter what kind
of governmental action we have, to preserve an atmosphere t hat en-
courages sue!:} private responsibility and initiative. This was certainly
one of the things that was commented on by our European colleagues.
The process we had gone through and the response we had gotten
'vas not the kind of thing most of them could have done within the
context of their own national societies.
Another point I'd like to make about this whole process is that it
was public right from the first letter the Academy to set
up the committee. The same group that voted to send that letter to
N AS also voted in a democrat1c process, to send that letter to Science,
in order that public discussion could begin immediately. That openness
has charactenzed every step of the way. The Berg letter was published,
and a press conference was held by the Academy. The Asilomar con-
ference was open to the press, and there was indeed a most extraordi-
nary level of coverage of the proceedings of that conference. This at-
tention to keeping the discussion public was maintained because the
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group of people involved recognized that there were public issues, and
in a sense that it was a request for serious public participation. 'fhat
participation has, in fact, been very slow in coming, and I think it's a
question to consider why it has been so slow, and why there has
oeen so little public participation.
BALTIMORE. In spite of the fact that Maxine Singer says the Asilomar
process wasn't a model, let me consider it as a model from the followinfi"'
point of view. What were the dynarr1ics of what has gone on and is sti
going on The dynamics were really that scientists were acting as
public advocates. I think we have to ask what are the uses of public
advocacy by a professional organization, and what are its limits?
It's difficult to argue that scientists (although I speak as one and
therefore may be suspect) are in the same position as Standard Oil
was when the necessity for the Sherman Antitrust Act came, or that
we meet the criteria Peter Hutt suggested 'vere necessary or led to
legislation to regulate specific groups. Scientists get very little in the
way of personal profit, that is, monetary profit, from what they are
doing, and in general are extremely responsive to what they see are
the needs of the public. One can argue with what they see, and I think
there's a oood argument to be made there. In the case of the Asilomar
process, tl1e scientists were acting in no way in their own interests,
'vhich has been borne out extensively as the issue has evolved, but were
acting in response to what they saw as a potential danger to the public
and one that only they could see at that point. Alexander
Capron tried to present a model in which you could, w1th some kind
of teclmology assessment, look for a problem of this sort, it couldn't
have been found there because it occurred at a scientists' meeting, the
Gordon conferences, which has no published proceedings. I t 'vould
not have been known to anybody scanning the literature until it was
too late-until the papers had appeared in the Proceedings of the Na
ti<mal Academy of SC'iences, by which time the Berg Committee had
already met and made its decision.
The second level of the Asilomar process, that is the Asilomar 1neet
ing itself, was also held within the scientific community. We had the
press and a number of people with a law background present, but
basically it was a meeting within the scientific community. But it was
still designed to ask a scientific question-to what extent is there a
problem, and to what extent is that problem one that could be handled
within the mechanisms of science?
The Asilomar meeting had absolutely no force of law behind it. It
could not pass regulations; it was an ad hoc kind of thing. At the
stage the Asilomar process reached the point of considering real regu-
lations, that is the NIH committee responsible for producing guide-
lines, one could argue strongly that there should have been more exten
sive public participation than has happened. I think one can go right
back to the initial Berg .report to look for the problem there. The prob-
lem is that at that point we did not see the need for public involvement,
largely out of naivete, and also out of a lack of recognition of the ex-
tent to which the public might be interested. Although it has taken a
long time, it's clearly true now that there's extensive public interest.
So if I were to consider Asilomar a model, I would apply it like this.
example would be somebody learning, within the next five years,
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as I _suspect someone will, to put a specific gene into a nlammaliau
cell, into a human cell, so that the concept of correcting a specific ge-
n_eti_e defect becomes a reality. We'll be faced with some problems very
s1m1lar. to the ones we were with the initial discovery of
reron1b1nant although I think t he eth1caJ problem at that point
will be more pressing. 1-Vhat should the response
I think the response could be similar to the Asilomar process: that
is, n. group of people saying, okay, we can do it, but we have to sit
back and decide the extent to which \Ve \vant to see it done, the extent
to 'vhich it is safe to do it. That could onlv be done under the condi-
tions of a moratorium, because once it is possible to do something, it
can happen extremely fast. A couple of new tricks co1ne by-, and in
a fe\v \veeks things are going at a rate nobody ever imagined. So the
moratorium is a necessary part of the pr ocess, and the discussions
within the scientific community are an imnortant part of the process.
And of course the most important part of the process is the whistle-
blower; that is, the time at which somebody says, "it's hapj)ened, I can
forsee a problem and I want to see that problem dealt with before it
happens." So the whistle-blowing becomes very critical, and I'm glad
to see that the Academy has now said that we are all now covered in
caSf\ we do that.
1-Ve can see elements of the Asilomar process and structure as models
for the future, both in positive and negative terms. It's worked out
J"llasonably well, but the extent to which it can be used in circumstnnr.Nl
that do not come out of basic science, that are more involevd with
health problems, I really don't know.
GREEN. I don't much care to add to what has been said. I
would say essentially the same thing, that some of our work at Asilo-
mar had nothing to <Io wit.h the public participating. I g;uess Asilomar
possible alternative ways that it might have been done so it
would involve public participation, but I see no point in burdening the
progrn.m with my comments.
National Oornnnissi<ms
RYAN. I'm going under the assu.mption that everyone knows what
the Com.mission does .and how it operates. I 'd be happy bo ans1Yer
quest,ions with respect to this. because it has been a public body which
iinterfaced between ;t.he scirnt.ific and nonscientific worlds.
ROBBINS. Would you just '!lddress yourself to one thing. and that is
the general applicability of the commission approach tlO this problem
we face.
RYAN. Well, I think it's one mechanism that obviously coulrl be
used, but I think thait the individual \vho made .t.hf.> comment that
there is no one mechanism a.Dplicable t-0 a.H si.tuati<1ns is absolutely
r.orrect. There's no ouestion that such a device can be used to inter-
face between the public n.nd the scientific community and the legis-
lature. I think the difficu1tv mth some. of the priv>ate institutions. t.hr
scientJific instit.ntions, the Institute of Medici-ne perhaps, the Nat.ional
Science Foundation. and so on. is that thev've lost a certaln amount
of cre<libilit.y with the public. Thl>.se o.re organizations that are de.al-
insr 'vith scientific matters, that do have .advisory bodies that could
address some of the questions tha.t 'We're asking. Con,..<J!I'ess could tum
to them, an the expectation t.hnt thc>y wonl<l speak in the pulbli<: inter-
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est and for ithe geneml good. The question is, w'hy don't they For
instance, on the rrupe issue, why didn't Con.,OTeSS go to some group 111nd
say, "Is this a. good bill i" rather than push!ing I'm not
trying to .imipugn any of ithese organizations. miat I 'm trying to say
is thit ithey\re not being used. The Congress very often doesn'ti tum
to them, and sometimes I think a inatter of credibility.
You asked me 'vhe1heT or not what we at .the Commission are doing
with respect to the ethical issues in research is a.pplica.ble a.ta broader
level. I think it is possible.
RoBBINs. What a.re the problems with the corrun:ission approach
RYAN. Well, one of the things is that you're not to satisfy
everyone. A lot the.t looked at
have altea.dy cnt1cized it because they cla.llffi it 1s elitist. One I
will aay for the Commission is itha.t there's not .a, majority of scientists
on it. There is a. broader public representa.tion, butitheminority groups
sand, "Hey, we don't like the Commission because there a.re no poor
people on it." So you have that iproblem. And then of course lb11.ere's
the sheer size; how large a oommission can be effective
I think the fe.ct that we have functioned in public mdicates th-at it
can 'be done.
RoBBINS. 'That has not been inhibitory to your deliberations
RYAN. I don't believe so. We've tried to seek out e.dequate public
responses by orga.ruizing .the minority conference, for example, bnt
even there we were criticized for not o},l of the people involved.
Another thing that I like a.bout the Comnussion is that we've had the
ability t.o con.tract 'for paipers. We've boon aible ;to go hroa.dly and .t1-y
and get fucts and data, and to base our decisions as much as we pos-
sibly can on this. That has been extremely helpful
RoBBINS. If a Commission is going to work, it's got to be funded
-and staff ed.
RYAN. Yes, it's got_ to be funded. You've got tobe blessed with a ve1-y
effective staff, and then you've got to have the right mix of people
funoti.oning on it.
Ronerns. You also have to 'have .an audience, somebody who is going
to use your product.
RYAN. You're right. It is an import.mt pa.rt of the Commission's
Jllt),lldete under the la.w that our rooommendaAlions are to be published
in the Federal, Regi,ater by the Secretary of DREW and he must re-
spond t<> them in public, either cairry them out or tell why he's not going
to carry them out. Now I don't know how you can get better view than
that. And if we're not satisfied, we can go to Congress. We have nn
invitation to present anything not under the Secreto.ry's jurisdiction
to Congress.
I have to .moot of my colJea.gues on .the Commission, and I
feal very strongly, that to the extent to which we can come to
some kind of an agreement on these very troublesome issues, we're
ID)Jcli etrecmve when we speak with one voice than if weihave six
mmonty reports. Those don't help Congress or e.nybody else. Finding
a base for is not always easy, ibut it to be sought.
RoBBrns. Could you give examples of the eft'eotB the non-scientist
members 'he.ve h1l.d on your group that would <not iha.ve occurred if the
group "'11.S oompoeed only of scientists
<. > I
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RYAN. Well, number one, we 'have ,to educate one another. The scien-
tist may think that research is second nature, but we get gue.stions like,
""\Vhat do you mean by vVe'haveto start defining our terms.
We stop being sloppy. We try not to mix up discussion of therapeutic
research with discussions of non-therapeutic researoh. We try not to
confuse fundamental with -applied research. vVe're trying to get into
that very fuzzy borderline between therapy, the practice of medicine,
and research in the so-called innovative therapies. The nonscientific
members help us focus on sharper definitions, they eduoa.te .us with re-
spect to the .tecJmiques that a biochemist or philosopher would use in
approaching a problem, and I think we complement one another.
RoBBINS. Could you oive an exaimple of a decision that might have
gone the other way if there weren't lay people on the
RYAN. I think our entire fetal research report might have gone any
one of a number of ways. It's the only thing we've produced so far,
and there's no question that it is a document. It's hard to
single out which points were added by a given person. But they all
contributed mightily to the final document.
HAROLD EDGAR. vVhen you speak about involving the public, one
thing that concerns me is whether on most of these questions the pub-
lic has any view that's substantially different from tl1e scientific com-
munity. In your two references to the lawyer and the bioethicist--
there again, you're talking about professional skills, rather than gen-
eralized p,ublic "public" people raising points so that
you say, 'Gee, I never would have thought of
RYAN. We don't pretend we are a sitting body that represents the
public (although that is what we're supposed to do), because of the
small size of the Commission and the expertise of its various com-
ponents. But there's no question thait we do get the attitudes of the
public. I was amazed, for instance, in the deliberations and public
hearings on feW research, to hear a young woman from Right-To-
Life in Maryland-I think she had three children, all with cystic
fibrosis-who said, "I don't understand much about this research
business. I want lit done humanely and with dignity, and I don't want
to do anything wrong, but we do need research!" I think that's very
evocative. We have other individuals coming with comments, and I
think the site visits we've made-we've been in prisons and we've
talked to prisoners-tell us something different f rom what someone
outside the prisons tells us. I think that kind of education is terribly
important for us. I 'd never been in a prison before, and it is interest-
ing to do these kinds of things; Does that shape the kind of document
we create i It should, and I think it does.
EDGAR. That's not quite my point. My point is the value spectrum
that's achieved when you convene a of bioethicists, lawyers,
people with general "expert" mentality. Does the range of values
presented by that group give you a reasonably accurate mapping of
the range of values when you go out and see the world? Now granted,
seeing the worl d is tremendously important in order to find out what
happened, but what I'm trying to get a sense of is whether you think
there's a discontinuity in value bet,veeen the attitudes of professionals
and against the attitudes of everyday people you talk to.
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RYAN. I really can't give you a good answer to that question. We try
to not have discontinuity
1
and we test ourselves via the public hearings.
EoGAR. I didn't mean it as a test, though. I was just wondering, be-
cause the supposition of so many of the public is that the
public really feels differently about these issues than the experts.
RYAN. Okay, how do you know what the public The only
way we can know is to read the letters we get and ask people to come
and testify in front of us.
EDGAR. But what's your ;perception Do you get 11.ppreciably differ-
ent from the public than you do from this range of experts 1
RYAN . .No. No . . We get some impressions sometimes. We have
a wide range within our group. If you look at the composition of our
group. there are three women, two black women, three attorneys.
There's a broad human experience in that group. They're not that
shielded from society.
ANITA JOHNSON. My question is for Bertram Brown. Are there actual
decisions which have differed at your Institute because of the partici-
pation of non-scientists
BROWN. Yes.
JOHNSON. What are
BROWN. I'll give you an example :from one of the few official review
groups. We got a paraprofessional on the review committee who was
knowledgeable abOut paraprofessionals. That one person has signifi-
cant impact on which grants are funded or not.
JOHNSON. What i.mpa.oti
BROWN. Well, you Jmo1v, X grant was funded instead of Y. He
would perceive the grant as good or bad. He had some perceptions on
merit that the experts or tM.iners of paraprofessionals did not.
Rosn1Ns. I'd like to suggest that we try to zero in, and think in
fairly concrete tenns 11.bout what we can do and what we should do.
I 'm making an assumption that public participation in decision-
making is oocurring, and needs to oocur to a greater extent. I don't
think we should debate that issue any more, but if you \vant to dis-
agree with me, you can.
It's been brought up on a number of occasions, and it seems self-
evident to me, that we're really talking about decisionmaking in a
number of areas
1
decisionmaking that to a large extent involves
ethical considerations. We are miking about decisionmaking that has
to do with public policy, about how we allocate funds. We are talking
about the whole prionty issue; that is, what needs to be done with
limited funds. Then there is the issue of how you mobilize science,
medical science in thtls instance, to tackle the problems that have been
determined to be high priority issues. These are all areas where the
public has an important role to play, some public, in some way, and
it isn't necessarily the same mechanism in each instance.
It also isn't necessarily the same mechanism when you're thinking
about more local issues, when you're thinking about review of experi-
mentation at a local level, and when you're thinking about matters at
higher levels involving larger groups of people. At meetings like this,
we have no difficulty telling the federal government what to do, but
we sort of make a big jump, and leap over the State and local govern-
ments, which frequently can be very critical in these issues. We've
really sai d practically nothing about this.
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KrNo. There is a certain agreement here that decisionmakiug has
to move toward a democratic model rather than an elitist model. The
com1nission model is not in the direction of the democratic model. It's
appointed body that moves one step a'vay, in fact, from full partic-
ipatory democracy. It seems to me we can lay out five areas whe1e this
participatory model might be generated .
. . In the legislative a1ea, we need some kind of national health prior-
ities act, some or some Congressional discussion
that lays out priorities over a period of five years-some period . .As it
stands now, the public can't find out what priority any given item has
been assigned
1
and therefore it's ho.rd for the1n to try and lobby either
for a high priority or a low priority.
The second component is much more participation of consumers.
The third case, which is very different, is the training of scientists,
so that they are sensitive to these issues. It seems to me reasonable
to ask the 95 percent of the biomedical graduate student population
\\hose training is supported by f ederal funds to educate themselves
in certain areas.
The fourth is that in the laboratories themselves, where the re-
search is being done, we can ask for a certain democratization. For
exa.mple, in the Asilomar case, we have institutional committees that
are supposed to review safety precautions. I n most institutions those
committees will be committees of professors and medical professionals.
1' hey ought to include technicians, dishwashers, and graduate students,
n.U of whom .are as much at risk and know as much about what is ac-
hu\lly going on as the professionals.
The last thing is a mechanism of redress for the public if it believes
its interests are not being followed. For instance, there could be a re-
qni rement for publication of what you're attempting, and what you
think the dangers are, so if one of these agencies is not doing its job
and a group of people think this is a problem, they have access to that
information.
NADER. A number of ntecho.nisms we mentioned since yesterday
'vonl<l help increase public participation. We talked about informed
consent, which gets doctors and patients into a different relationship.
' Ve've talked about se.rvice work on con1mittees and commissions and
n<l v:isor:v groups, and we just barely mentioned payback or service.
All of these would have an important effect, broaden the ex-
perience of t.he scientists, and inform them.
I thought I would give one further mechanism. I rlon't know of any
<'Xnmple in hard science, but I can give a.n example from law.
It can be called something like participant observation . .Although I
find f.his a very :f'orward-lookinl! irronp. when some irrita.nts appear,
evrrvbodv sort of comes out in their underwear. I think there is such
n thing nS awarene.<is nt a level that is onl:v surface, and f.hen there is
deener awareness. In Reno, Nevadn. we wanted to bring to the attention
(lf i11dl)'P.'l the fa.ct that thev'rP not. too nwnre of what happe,ns to the
Jleople f.hev pass sentence i1non. So we took a group of eight judges
into a nightclub (this wns all videotaped) where they were to talk to
!'On1e prostitutes. It was all programmed ahe11d of time for somebody
to start. a flf'ht. ThP. iud!"I'" were and toltl t.o nnt thi>.ir hnnds
11p on the doors of the pnd<ly wagon. Thev went in kicking and seream-
ing. "b,v tomorrow we'll have your jobs!"
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The first judge into the tank started to scream at the top of his
voice, "Where's the chair ' Vhere the hell is the goddam chair" And
the next morning I said to him, "What else did you learn about jails
last night besides the fact that there aren't any This is a man
who's been on the bench for twenty years. He said to me, "I learned
these people kept coming up to us and saying
1
'what are you guys doing
in here, you guys got These were eight out of 60 The
other judges participated in lectures, and in encounters with prisoners,
and in visits to prisons and so forth. But the eight judges who were
"arrested" were clearly affected in a way that the other 52 were not.
In fact, the 52 wanted to hang the people who perf ormed that experi-
ment, but the eight judges who were "arrested" felt they had seen
something they had never seen before and didn't feel hostile at all.
I think that we need some creative thin.king about ho\v to jump the
process of sensitizing people, creating a kind of empathy that can
then lead us into very creative science.
HANDLER. Is that a statement by ethicists about how you do re-
search Y I hate to .remind you that that kind of experiment is what
you don't want doctors to do ! It's uninformed consent, that's clear!
NADER. I leave it open for you to discuss.
IIELI.E<JERB. How would you apply this example to biomedical re-
senrch Could you give it an application Y
NADER. What I am saying is that we have got to think of some
acceptable mechanisms, accept.able in this culture, that have the same
function as the practice in China of sending scientists into the rural
areas to learn. I cite this as an example of something that had an im-
mediate impact on judges. I don't think you need to follow that exact
pattern in other areas. But you need some creative t hinking that will
shake people out of their modes of thinking, get people outside of
t.hemselves. An anthropologist will do field work to 11.CCOmplish this.
But the idea of sending people into the the fields for a year's work
is not acceptable here. So thinking along these lines is something we
n1ight wa.nt to take up.
HANDLER. You boggle my mind.
Br,.\NPIBD. I just hope a papc1 on this never gets offered to the
Proceedings of the Academy.
ROBBINS. This It doesn't sound likely.
ToULl\llN. I t doesn't sound as though it had the human experi-
mentation committee's approval beforehand. I think the reaction
of the other 52 judges to Laura Nader's experiment is very significant
here.
NADER. This was an experiment of the Nevada state trial judges
association, not my experiment.
TOULMIN. I do think we need to understand a bit better why there
is going to be a lot of hostility from the other 52 scientists, even if
tl1e eight 11;0 to them and say they have been persuaded that the public
ought to be allowed int.o many more meetini.rs of the National Acad-
e1nv of Sciences and other crucial decisionmaking forums.
I want to say something about what rea.llv seems to be going on
h're. It's often seemed to me that a lot of difficulties that arise about
the relat.ions between the scientific community and the rest of society
nt the p1-esent time have important and significant parallels with the
medieval problem of relations between church and state. During the
(,oogh.:
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1.18
!fiddle Ages, the Church had a monopoly on a certain kind of learn-
ing, and it claimed to exercise all kinds of rights to control its own
affairs because of its monopoly. 'here was a system of ecclesiastical
courts from which lay people were excluded, set up so that not only
the affairs of the Church itself were regulated, but also, unde.r certain
circumstances, people who were in the priesthood could claim benefit
of clergy and have themselves tried in the ecclesiastical courts in con-
nection with causes that were really the public's business.
The question became very difficult, and at the time of the Reforma-
tion a cause of great acrrmony and even bloodshed. The question
was: at what point did the legithnate territory of ecclesiastical courts
begin to overlap the territory of the civil courts Eventually; of course,
the system of ecclesiastical courts was highly circumscribe<t, and lim-
ited to matters merely doctrinal, trials for heresy, for wearing the
wrong kind of vestment, for hearing a particular liturgy, for having
the wrong size candles on the altar, and things of this kind.
It sec111s to me what 've're faced \vith in t11e present state of rela-
tions between science and the rest of society, not only in this country
but in other countries, is the Protestant Reformation. What we're
faced with is a demand from the rest of the society to be let in on the
whole system of the ecclesiastical courts. They're not interested in let-
ting scientists have benefit of clergy anymore. I think they suspect
that the closure of the mechanisms of discussion is, in effect, a way of
keeping them from debates about things 'vhich are really their busi-
ness.
I've been watching the institutional review board machinery at
the University of Chicago. There are three such boards. The chair-
man of one of the IRB's does nothing to disguise his feeling that he
regards the whole I RB machinery as what he calls the public's un-
warranted intrustion into the affairs of the medical profession. As for
the second of the IRB's, all I need say about it is that it's operated up
to now on staff secrecy principles. Members of the faculty have not
even been allowed to know what the membership of that particular
IRB is. It was only at the last meeting that it was finally decided that
there could be no object.ion to other faculty members finding out who
the members of the board were, though no steps should be taken
needlessly to advertise the membership.
That there are strong forces that continue to lead members of the
academic profession generally, and scientists in particular, to seek
to keep their affairs out of the public view, I think is a fact about the
present situation which we have to recognize, and which we have
ourselves-if we mean what we've been saying at this meeting-to
be prepared to go out and confront and deal with. I was very im-
pressed by Brown's remarks about how very little harm it does to
invite the public to come into meetings, even meetings of peer groups
and so on. There really is very little harm it can possibly do. If
members of the public don't understand what's going on, they can't
accept what's going on. To the extent that they do understand it, what
they have t-0 contribute 1nay well be helpful. Unless they're people
who come in with disruptive intentions, it's really going to do no
harm to let them in.
vVhat we need to go out of here saying is that from now on, we're
going to change the direction in which the burden of proof lies when
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11.9
a question arises about whether something is a matter of peer review
a.Ione or a matter where the public is entitled to be let in. When we
seek to draw the line between the issues to which the undiluted peer
review system is appropriate, and to which it is not, we should let
the burden of proof be on the scientist. Some of you will know the
story about that highly manipulative woman, Beatrice Webb. Some-
body ~ k e ~ how Beatnce and Sidney Webb, the English socialists at
the beg1nn1ng of the century, managed to carry on successful profes-
sional careers while being married, and who made the decisions.
Beatrice answered, "Well, it's quite simple. Sidney makes all the
important decisions, and I make all the unimportant decisions. But
I decide which decisions are important and which decisions are unim-
portant." Fro1n what was said about the Asilomar procedure, the
public is entitled to suspect that, within the scientific profession, sci-
entists are still deciding themselves which are the unimportant deci-
sions. The presumption is that until they've decided that this is an
affair that must be opened up to the public, they can keep it am.ong
themselves. But decisions should be taken in closed session only where
it can be positively shown that some good purpose is served by keeping
the discussion closed. Otherwise, the presumption should be that peo-
ple can come in and listen. I'm not saying participate on equal terms,
but at any rate listen t-0 what is going on.
1i{. S1NOER. I want to clarify something. What I was directing
myself to was the question of trying to evaluate whether there was
even a danger involved. It wasn't a question of leaving the public
out of considering a problem that existed, it was more a question of
crying wolf. A scientific judgment needed to be made that there was
even a problem.
TouLmN. What I said was not in any way intended as a criticism.
M. SINGER. I understood that, but I was really trying to clarify it.
When one has a technical problem like this, one has to decide whether
there is a problem.
KING. Other people may not think it is so technical. Many people
ought to have the opportnnity of deciding whether there is a problem.
1.{. SINGER. But you need certain technical information in order to
do that. If I tried to flresent this for public consideration, the proper
question I would get is, "vVhat is the evidence that this is going to be
dan!\"erous or not going to be dangerous W" I can't answer it to this day.
KING. I would like to submit that before those technical demands
were ever made, a number of people had written on the question of
social problems that are going to come up when genetic engineering
comes of nge. There were many people who had said that it was a
problem, regardless of whether It's a public health problem.
1.1. SINGER. The social problems you raised, I agree, are totally for
publ ic discussion. You and I know that we have not, within the sci-
entific community talked about this. It's one of the reasons we've
made everything public now, because we believe that discussion quite
properly belongs elsewhere. And in fact. no one has really addressed
himself seriously to that particular problem j it remains ahead of us.
I t hasn't been raised here. But that's not the problem I was talking
about. I was talking very specifically about the questions of safety,
not about the much more serious and much more difficult problems
that are still to come.
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T OULMIN. Could I just add a quick con1ment, really very short. l'1n
sorry I mentioned Asilomar.
RoBBINS. Well, actually Asilomar had a good deal to do with why
this meeting was called, to be honest.
ToULJ\IIN. I think the important thing in this situation is not just
what ho.ppens, but how other people perceive what is happening.
Therefore I don't think Bertram Brown need worry about the fact
that the public cloesn't actually come in large nwnbers to the NIMH
council meetings. The point is that nobody nas any right to suppose
that people are being keI?t out of the Nl?i{H decisionmaking proce-
dure. The opportunity exists for them to participate if they so clesire.
The fact that they don't may just be a sign that things are going
along very ''ell.
HANFT. I think \ve're looking at .:\.silon1ar back,vards. I would like
to 1.-no"' \vhnt woulcl he the harm to the scientists if, when you decided
there might be a tcchnica.l question, the public or a nonbiomedical
scientist, or t'vo or three of the1n, had been included in the delibera-
tions, even though they couldn't contribute to the technical
BALTI:i\IORE. There '"ould be no hann. But there were several re-
porters ...
ICING. Thero 'vas a reporter for e\erv ei o-ht scientists.
IlALTIJ\fORE. And there "ere a number there. There was a
"hole session devoted to nonscientific aspects of the question. The
nleeting 'vas not closed; it ''as ''ide open insofar as it was reported.
I t was not "ide open to participation by everybody who wanted to
co1ne, because '"e would have had probably a. thousand people there.
'\Ve had to keep out easily t"o or three tlmes ns many scientists as
ca.1ne, never 1nind everybody else \vho to co1ne. That "'as a
logistics proble1n that \vas solved by assuming the press represented the
public nnd that there " (' re so1nc la,Yy(',rs. Other than that, we couldn't
do anything at the time. Since then. as I said "hen I made my presenta-
tion, it has con1e into a true regulator) phese. When it came to the
regulatory phase there "as inc-reasing public participation, and with
the recognition that there is a lot of public interest there is increasing
public participation. I think it "ill continue to be very appropriate.
I\:1xo. If you're going to generalize, I think that it's important to
realize that the press reports to the public, but doesn't represent the
public.
Ronn1xs. Thnt. I t.hink, " e all a re a\Yare of.
!Iu'l''.l'. I 'vould like to folio" up on what David Baltimore said.
because it's terribly important for everyone to understand what dicl
happen Asilomar, namely \\hat happened t'"o months ago. NIH
held a public hearing
3
' and ca.lied in an advisory group that, as one
can always say, never represented the whole 'vorld, but wns widely rep-
resentative of different points of vie,v. It included people like David
Bn.zelon
35
, Esther Peterson
36
, myself ancl various other people. Some
of us had never heard of the problem. literally, until that meeting, and
I inclu<le myself. I approached it as a completely new issue. I knew
only what had been 1n the ne,vspaper, but I had never studied the
""nde. Nicholas. ''Recomblnnnt DNA: Guidelines Debnted at Publlc Besr!ng.
1
' Scie11ce,
Vol. 191. Februar:v 27, 1976. p. 834.
"Chlet Judg<>. U.S. Court ot Appeals tor the District ot Columbia Circuit.
.. President, National Consumers League.
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issue seriously. Every member of the public invited to come in and
make a presentation. Consu1ner groups ''l"ere told about it explicitly,
were v;ritten and requested to come in if they had anything to say.
No one was an c:ipportunit;>: to pa1ticipate in a most meaningful
way. Now that 1s the kind of public procedure, at the regulatory stage,
that should serve as a model, ru1d there.fore should be used in the future
'vhen public decisions of that kind, affecting basic biomedical science,
are made.
HELLEGERS. I think the problein is partially what I tried to say quick-
ly last night. There are t"o concerns. One is 'vith the ends of research,
the other is with the means of research. It seems to me it is the publics
business to be generally incorporated, by whatever mechanism, into
the ends of research. Quite different is the issue of the means by which
the research is done. I 've ahYays said I thought the Asilomar experi-
ence was the hallmark of scientific responsibility. Those scientists
"'ere trying to deal fundamentally ''l"ith 'vhether there was a problem
'vith the means. Had .they said there was a problem with the means,
I think the public question might have arisen; namely, should we pro-
ceed or should we Much could be said on both sides. But, if we're
going to sta.rt thinking in general about how we can have input, I
suggest it may be helpful to keep the ends and the means separate.
GAYI,IN. I would like to tr'' to put forward a suggestion of where to
go in the future, a suggestion, not an absolute solution. I start with
.Jonathan King's presentation of fivl'. things we ought to do. In express-
ing the "oughts," he remains true to his role as the leading moralist
of this conference, and brings us to "hat we ought to do. I 'll just
add!ress myself to the first of them. Ile feels we ought to legislate. I
was testifying at the hearing about legal definitions of death to which
Senator I\:ennedy alluded, and it "as one of the n1ost painful experi-
ences of my life.
At the time, when asked what I 'vould do, I said I felt there was a
precipitous flight into leo-islation and litigation in certain of these
issues. We at .the Institute have been spending a couple of years tryin"'
to think of the problem of rights 1\S one means of mora'l
questions. Interestingly, Jonathan ICing rarely refers to rignts; he
talks of moral oughts, which I find more sympathetic. One of the
problems of rights talk is that, while it may be necessary, it t ends to
drive you to an adversarial solution to problems that might
be handled in a moral way. Legislaitors are begging us not to rush into
legislation and litigators are begging us not to rush into litigation.
Wha.t can be done may not be able to be done by this group, so we
need to ask, as a minimal question, what can this group I tried to
listen to what hap.Pened over the last two days. I think the Senators
are indirectly saying, and when Senators talk we ought to listen-
that there are multiple institutions that could or should be able
to handle problems that come up, but, for some reason, with no dis-
credit to those institutions, they do not see1n to be taking the initiative
to handle these problems. J..eg1Slators are in awe of some of the prob-
lems and 11.re frightened to move, and yet for some reason a.re not turn-
iniz to the institutions that ought to be iable to give us the answers.
I think that what legislators are asking from us is mnybe to net once
again for the esta.blislrment of an advisory board, which would serve
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the legislature, not the President. Perhaps it could help in drafting
new legislation, or inhibiting mischievous legisl1l>tion, or at least giving
more systeinatic adv.ice. So I am suggesting one of the things we might
come up with is a. reco1nmendation for a congressional advisory com-
mission which would 'be much more broadly based than the Presiden-
tis.l panel, which would have more open proceedings, perhaps modeled
on the National Commission. 1.-I.any of us have been tremendously im-
pressed by the integrity of the Commission's people, their sincerity and
their results. I offer this as '8. possible solution to one small pal't of the
problem.
PIEL. I am encouraged to speak because what David Baltimore haa
to say before lunch persuades me that I'm not the only romantic
here.
ROBBINS. I think we're all romantics or we wouldn't be here.
PIEL. I would like to speak for a neglected institution that I think
has a great deal to do with the problems at issue here, and that is our
nniversities. That may sound as roma,ntic as my invocation of the
founders' documents last night, but I think it is very real.
In t he first place, the issue that transcends all others is whether our
country will, the next time it's got a great big problem on its hands,
have the resources of knowledge to meet the problem
1
to recognize
the problem. The only safe way, I think, to insure that is to place the
1not1vntion of science and work in science where it belongs, and that is
with the scientists. We are at the end of a period of 26 years in which
the motivation has come increasingly from Washington. The financing
of science in our universities has come 95 percent from mission-ori-
ented agencies. In the National Sicence Foundation, Research Applied
to National Needs is the only project t.hs.t's got new money. In bio-
n1E-,dical research it's cancer and heart disease. History shows us that
the great work in science has always come not from anybody's plan
and not from outside motivation but from the individual inquiry of
41.ble people who, because they are able and free, turn to important ques-
tions. Our experience shows us that the university is the only institu-
tional custodian got for that kind of enterprise. Howard Hiatt
talked this morning about the kinds of things he's been doing at Har-
vard that to happen spontaneously in 11. strong university com-
munit.v, and that is cross talk between the f.aculties and within the
fiiculties about the issue of our society and about the course and
tions of the enterprising inouirv.
proposal is that we seek in Washington the means to secure sup-
port of our universities as national resources, as institutions, not mak-
ing them dependent on the dough they're able to stE-al from ad hoc
project grants to individual scientific entrepreneurs. Universities get
50 percent of those grants for overhead, (a figure that's under threat
from OMB at the moment,) representing for the 20 largest universi-
ties in our country their biggest sonrce of unrestricted funds. We ought
to do business honestly, I think. The institutions are already in place,
or would be if they could be restored as communities of scholars; they
are vessels, by design, for the consideration of the questions that
are before us here.
HUTT. I don't regard that as a real proposal. How is it going to
worki I heard nothing that said who's going to do what to whom 1
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. PIEL. The proposal is that, through an agency to be designed-and
it \vould take the wisdom of men and women of good will to design the
agency-institutional grants would be made to our universities.
HU'IT. This is a government agency that's going to be designed like
the University Grants Committee in England f
PIEL. Yes, that's a model to work from.
ToULMIN. I wouldn't recommend working from that one. It was fine
in the first few years but disastrous in the Jong run.
PIEL. Well, that's true of everything. The initial effect wears off.
!{Ru(. If a. good case can be made for support of the university as a
valuable national institution, I don't see why a group like this could
not actually promote this question here and be very useful.
Hoiau.N. My specific proposal is that there be some form of federal
encouragement, including grants, to explore the ways in which the
public can be brought into various types of scientific and medical
research decisionmaking. .
I'd like to illustrate what I mean with a specific and, in a sense, per
sonal example. It doesn't have to do with basic research but rather
with medical research in relationship to patient understanding and
certain consequences which fl.ow from it. Long ago, I was working in a
research institute where the patients' beds were next to the laboratory
and patients were hospitalized for a long time. By chance, some of the
patients on whose tissues we were working came into the lab. At first
\ve ''"ere a little concerned about this, but \ve act ually involved them in
the "ork. 'Ve observed that, even though the illnesses they had were
serious and sometimes fatal, their tranquility in the face of their fate
'vas much greater the more they lmew what was going on, even about
our lack of knowledge. When they understood 'vhat we knew and
didn't know, they were able to take the circumstances more readily.
We subsequently translated that into some operating J:>rinciples on the
way we practiced medicine with them, which was to involve them not
only in reading the medical literature, but in participating with us in
decisionmaking about their cases.
It quickly became apparent that this reduced the number of visits
they made to the clinic, because it was possible to discuss problems over
the telephone. We even involved them in doing minor physico.l em.mi
nations on themselves or letting their spouses do it, and reporting the
results. We knew we could trust them; we acted on this information
and could reduce the number of visits.
'''hen I left that environment and went out to a regular practice u1
the university, at first other people said it couldn't be done. We none
theless did it; in this case, patients didn't come into the laboratory, but
literature written for the lay person and concise medical summaries
\vere given to every patient. Some of them took advantage of it, and
some didn't. We found that the same thing happened in the university
clinic; we could substantially reduce then umber of clinic visits because
we could do more over the telephone. Now in this health plan that I
mentioned earlier, we are trying to institutionalize that type of ap
proach. As the p<>tential patients have come to understand it, it has
been translated into afolicy in which there are discussions with them
about the reliability o different diagnostic and treatment procedures
and the costs associated with each. The early evidence fro1n this plan
82-201-77-9
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indicates that we can cut down substantially the technological inter
ventions in individual illnesses, well below those in the comparable
university clinics in which we work. What I am sa.ying is the public
can come to understand and a.ct on practical medical and scientific
knowledge. Let me just stress the final point. The net product of this
is probably a more efficient practice of medicine that begins to deal
with a substantial number of the cost-benefit questions people were
raising earlier in this meeting.
KING. How about if we add a. proposal that, in the area of biomedi-
cal research, not through NSF but through NIH, there be set up
some pilot program wherein local communities or citizens' groups
can apply directly to the government for sums to help it input either
into the research community or back into government about things
that it considers local health problems. They don't have to be a big
money operation; if there's a group in a community that feels lead
poisoning is not being dealt with, it can apply for a little seed money
and organize itself for that.
SToNE. I see now why this meeting was exiled to Airlie House fron1
Washington, because it violates the first rule in Washington, which
is never to call a committee together if haven't deciaed what it
is you're supposed to conclude. I think its going to be difficult indeed
to reach a firm conclusion on most of those proposals, although not all.
Many of them will require more information than we now have. And
oertainly even the largest number of proposals we might accumulate
over the next few minutes would not fulfill the mandate, which is, as
I understand it, to get the scientific community in gear to talk about
public participation in a great many different areas. Various models
will be necessary, not only one. I think what needs to be proposed is
some mechanism for addressing these specific problems in the time
that they deserve. I noticed that among things suggested as future
options were other mechanisms to pursue the issues and ways of
keeping the dialogue I n the spirit of those I sug-
gest the followin11:: if the .New York Foundation which funded this
conference, is willing, it seems to me there could be, from time to time,
one-day conferences on specific issues. At the end of a day you could
at least entertain the notion that you've given the issue sufficient
thought to reach a sensible conclusion. What I had in mind is that in
the morning people would discuss the issue, at lunch they could talk
it over, in the afternoon have organized discussion of whether it's
feasible and sensible, and at the end of the day they would have
reached certain conclusions about how to address the problem. These
could then be printed.
I think many of the solutions for public participation don't rE'quire
legislation. Many of the people "ho attended this conference will be
delighted to implement su.,.gestions of feasible methods of improvin"'
public participation, and ta.ve the power to do it. By a certain
of peer and nonpeer pressure, and by just having a day's exposure to
the issues, perhaps many of the goals could be achieved ..
CAI.LAH'.AN. In the spirit of not introducing precipitous legislation,
I feel that if one wants to talk about a C<ingress1onal commission,
there should be some time lag for more groups, of the sort
Jeremy Stone has mentioned, to meet so that when theres a discussion
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in the legislature, it will be a good discussion. I'd hate to see something
start up next week. I think it would probably be a mess; it \Yould have
very little chance of working.
DANIEL SINGER. I have a question that would help me clarify m;v
own thoughts. I found Stephen Toulmin's discussion of the ecclesiasti-
cal courts a very challenging notion. I would like to ask him, laid
against Howard Hiatt's remarks this morning, what he sees as the
current legitimate boundaries of the ecclesiastical courts in
you defining the ecclesiastical courts now as the community of
scientists, and in particular basic .
TOULMIN. There clearly are questions that are in a sense as tech-
nically internal to biochemistry as the question what is or is not
.heretical is technically internal to ecclesiastical affairs. I think I'm
suggesting we should work with the assumption that where an issue
looks in any way like an issue of public policy, the presun1ption is
that it's a trans-scientific question unless other\Yise proved.
EooAit. I just would like to make one con1ment about the ecclesiasti-
cal court analogy. The thing that ultimately led ecclesiastical courts
to break down was that anyone could plead benefit of clergy if he could
prove he could read. I hope that does not happen to the scientific
community, the notion that by allowingfublic participation the pub-
lic somehow becomes competent to dea with technical questions . . I
agree with a lot of what's been said. Opening up things does not hurt
at all, precisely because it's not likely to make a great deal of difference.
It's a public relations problem. At "' hat point do you come to grips
with the reality that talented people's time is not a free good and
public relations is terribly important. If scientists don't recognize
that fact they are going to lose in the funding strnggles. But it ought
to be seen as a problem of time. It does take an enormous a1no\mt of
time to go through a series of reviews, et cetera, et cetera, and one ought
to be aware of the costs of requiring people to f50 through those reviews.
RoBBINS. That's/art of the cost-benefit ratio.
NADER. Before boggled Philip Handler's mind and he boggled
mine, I wanted to make a point. Maybe I can add it here. It has.been
my experience that \vhen you bring citizens in t-0 operate in our setting,
they often can't operate very well. It's part of the point I'n1 trying
to make that it's a two-way process, we want to inform the1n and we
want to be informed.
BALTDtORE. If there is a revolutionary idea anywhere in here, it's
the idea that there is a responsive science someplace that is different
from the biomedical science we're doing now. That responsive science
is not be be discovered by a group of bnsica.lly science-oriented
people getting together and discus.sing their own discipline. I
like to make a specific proposal that there be a conference to detei:mine
an agenda for a responsive science, in which a group of people
are basically not scientists, but who come from the legal profession,
and more important from the labor unions and the poor people's
movement, get together and decide what they would consider to be
appropriate end products of science and medicine. If that can be gen-
erated, we can compare it to the actual practice of science and medi-
r.ine.today as a way of trying to fuse 'vhat are perceived needs with
the productions of the profession.
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ROBBINS. How do they make contact with the scientific
BAr.Tr1110RE. What I 'm suggesting is that they not make contact 'vi th
the scientific world, that they not take our advice about what should
bo clone. They should generate it for themselves.
ROBBINS. But can they ask for
BALTDIOIIB. They can do anything they wish.
ROBBINS. Have they shown any interest in doing
l{ING. Yes. Woodcock's speech speaks out against a notion that ideas
in basic science must arise in the mind of the investigator, and that
ideas arising in 59meone else's mind are applied and: therefore less
'vorthy of investigation. He goes on to say that it's about time we set
up 1nechanisms so that the ideas that guide scientific research would
be 1nore responsive to society's needs.
RYA!\". I think that when you make this plea for public meetings, you
ought to keel? in mind that, for example, until the Commission con-
ye11l'd, the m1nol'ity people said they had never recognized this as a
special problem for them. We created a problem, which they then
discussed. I think i f you ask the American public, it is les.<i
in ''hat we're talking about than it is in health care. Aside from the
ethical issues associated with biomedical research, they don't give a
hoot about it. It represents a small amount of money with respect to
the total health care dollar. The minority conference said, "We're con-
cerned about health care more than anything else." When we asked
then1 to look at research, they said, "We're concerned about Medicaid
programs, about health care programs, about our quality of life." So
I think the thing you have to be sure of is that when you call these
meetings, they're really interested in what you are. What Woodcock
says and what someone on the assembly line says may not be the same
thing. Labor leaders are just as professional as you or I.
J{ixG. Can I correct that i I 'd like to bring in my special expertise.
I hnppen to know something about the prepal'ation of that speech. It
did not come from Woodcock down, it came from the bottom up. It
was ""ritten for him out of the Occupational Health and Social Se-
curity Office because of problems in the foundry plants and in the
1nanufacture of batteries, where it 'vas very clear that there were
special diseases which no one knew anything about. When workers
'vent to get health care, people 'vould tell them, "We can't treat you,
quit the job." It's not that there isn't some gTass roots interest.
Prnr,. Jonathan !Cini? is going to change the name of his organiza-
tion to Science from the People.
JOHNSON. There are now peer review committees of all sorts. NAS
committees, NIH working gTOups, institutional review committees
for experimentation, and it seems to me that it would be good for us
to 1nake recommendations about how they should be operating, be-
cause they already are in effect and because they have established their
own cultures. In the drug area, for which there is a certain amount
of published literature now, these committees are operating verv
poorly indeed. Two-thirds of the committees approve 100 percent 0f
drug protocols. Of those, 90 percent are unanimously approved ; ap-
proximately 20 percent of the committees have no outsiders on them.
The way they define outsiders is an M.D. researcher from another
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institution. I think we could make recommendations or what an out-
sider should be on these committees. Do we want them to be lawyers
and other professional people who can stand up to the venerable M.D.'s
on these committeesV Do we want them to be members of the Catholic
populations that were worried about abortion What type of people
are going to make an impact on decisionmaking?
I think it is very important that we not see this as a public rela.tions
problem. I feel somehow offended by that. I think we're not just trying
to put on a good show for the public. I think we're really trying to get
a new angle on things that we don't have right now. Doctors hnxe nn
ideology which is very opposed to any kind of intervention. 1\. tloctor
is educated to rely very strongly on his clinical impressions and his own
personal experiences m his practice, and he doesn't really think any-
one can tell him to do something with his own patient. I t.l1ink this
really extends to his supervisory capacities on committees, and it makes
a doctor a peculiarly unqualified person to exercise judgment on the
conduct of his peers, because he essentially doesn't believe that he hns
a right to oversee other doctors. Therefore he is the last person in the
world who should be on these con1mittees. And yet these com1nittees are
composed almost entirely of those very people who don't believe in out-
side intervention no matter what.
I think also that we need to devise 'vays to make n1embers of these
com.mittees legally accountable for t he decisions that they 1nake. I am a
lawyer with the Health Research Group, and when I 'vas hired I was
told to look after the Food and Drug Administration and try to
agitate consumer interest in it. One of the things I've seen in looking
at what goes on there is that people will make decisions in groups that
they would never make on their own. They will approve drugs in a
group that no individual 'vould ever gil'e his approval to.
ROBBINS. What's the obvious implication of that observation?
JOHNSON. I think that somehow we have to do as we do with tr.ustees
of institutions. There's a whole new area of law now, where if yon are a
trustee of an and the organization gets into trouble, you
can get sued. Its a judicial responsibility for' what the group does.
EDGAR. No one would serve unless they were insured against it.
JoHNso:N:One of the things we talked about here is opening np nll
meetings. I think people behave more sloppily in private, so it's very
important to make all these meetings open. It's very important to keep
transcripts of meetings, not so much so outsiders can see what hap-
pened in the meeting, but so that meeting participants know that son1e
time in the future some historian or scientist can point a finger nt
them. I think thnt's good for all of ns; I know it's good fot: m('. 'Vitho11t
transcripts and without some record of who was decisive in turninS? the
decision a particular way, people will continue to perfor1n poorly. l\{y
spe?ific sugg<;Stion is that we make recommendations for existing peer
review comm1t.tees.
Hon. I'd like t.o support whnt Anitn Johnson so.i d. I think there is
too much emphasis here about thinking up new committees, ne\\' com-
missions, new projects. 'Ve hnve a lot of existing institutions. nnd it
would take a long time to create new ones that could do the iob. Specif-
icallv. this Congressional medical research advisory commit.tee. nppnlls
n1e. We would set up n 'vliole ne'v group that would become politicized
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as part of another process. 'Ve have so1nething called the National
Academy of Sciences, chartered by Congress to do that job. If it isn't
doing the job well, we ought to work on it 11.nd make it work well. But
I 'm n.ot prepared to give up all of the existing institutions. I'd hope to
try to reform them. If we can't reform them, if we have no way of im-
proving them, then perhaps we have to give them up and toss then1
to the wind. But I'd much rather do what Anita Johnson suggests,
work on the existing structure, reform it and see if we can attack it
that way.
RosENFELD. The several hours of discussions that we've been having
here, although they've been of high quality and very stimulating, have
also been quite scattered and amorphous. It reveals to me what we
already know, which is how much we don't lmo'v about this subject.
If we are trying to convey the idea that people should not act precipi-
tously without careful deliberation, the fact that we are even con-
templating trying to come up, on the basis of these discussions, with a
specific proposal to hand to the two Senators, creates a very bad model
indeed.
GAYLIN. If I read the group correctly, .there's a sense that it would be
precipitous and premature to make any hard suggestions, but that this
dialogue which has started now must be continued, sharpened, focused
in a series. I thought J eremy Stone's suggestion was an extremely
good one, to cut off pieces of it to a larger population, to take 11. small
agenda and see whether the kinds of mechanisms we have only pro-
posed now could be developed at some future date. Is that the feeling
oft.he r o u p ~
HU'IT. Except there seems to he some consensns-<>r maybe there
isn't-that existinl? institutions need to be improved.
GATLIN. What there is no consensus about is whether that is at all
possible. _
Krno. I haven't heard anybody speak cogently against making the
decision-making process more democratic.
Hurr. I think there is a consensus that it iR a worthwhile process.
KING. On the proposal for particular meetings: this is a very high-
clas.c; m1>etin1?. I guess WI\ i;ret paid for this on!'.., but for many others we
won't. Working people just can't go to many of these kinds of meet-
in1?S. For example, Peter Hutt talked abOut the Washington one.
There were a dozen people in Boston, technicians and working people,
who wanted to go to that. They just couldn't afford to fly do-ivn, they
couldn't take a day off. The very structure excludes people who have
to work five days a week to make a living. I think we really have to be
careful not to set up a model where there are academic meetings in dis-
tant places, because 'l\e're just going to select for a small subset of
professionals.
ROBBINS. It's even hard to get all the professionals.
Smtl\!ARY AND SYNTHESIS
We will end t.he more formal part of the conference with a sum-
mary of what we've said. what we've done, and perhaps a brief glimpse
of what remains to be said and done.
KLERMAN. When Daniel Callahan invited me to prepare the sum-
n1ary and synthesis for today's discussion, I reflected as to how I
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might use my skills as a psychiatrist in this responsibility. There are
different types of psychiatrists: psychoanalysts, psychopha.rmacol<r
gists, and social and community psychiatrists. The insights of the psy-
choanalyst a.re not appropriate here ; analyses of motivations and
unconscious meanings are not pertinent in open discussions of public
policy. Similarly, although my own research has been in psychophar-
1nacology, I do not think that administration of more drugs will add
much to a discussion of policy is.sues, since there has been ample in-
gestion of caffeine, tobacco and alcohol at this conference.
However, there is a branch of psychiatry-social and community
psychiatry- whose perspective can, I believe, offer some assistance to
t.he deliberations of thls conference. It has been my conclusion that
much of what has transpired over the past few days has been a form
of grou\> dynamic or transaction between the biomedical research
con1munity, whose leadership is represented here, and representatives
of Congress and of the larger public.
It is my general thesis that there is under way a renegotiation of the
implicit contract between the larger society and the biomedical re-
search community. Indeed, there is a renegotiation of the contract be-
tween our society and all the professions-medicine, law, the Inilitary
and education. In thls renegotiation, there are new alliances and new
communication patterns. And in all transactions between groups, emo-
tional feelings, attitudes, perceptions, understandings! and misunder-
standings frequently get m the way of the successfu negotiation of
agreements and alliances. If the goals of this conference include con-
tributing to the renegotiation of our relationship with the public and
to creation of new forms of communication, understanding and de-
cision-making between the biomedical research community and the
l r ~ r public, progress toward that goal can be facilitated by a clarifi-
cation of the issues and by a better understanding of the attitudes,
ernotions, and perceptions of the parties involved.
THE CONTRACD BEl'WEN THE RESEARCH COMMUNITY AND THE LARGER
80Cll!11'!
As was pointed out by Stephen Strickland in the opening session,
there was a golden era after World War II, when the biomedical re-
search community, along with all the other scientific communities, and
perhaps most of the professions, had a very comfortable and easy re-
lationship with the larger public. As he said, that period came to an
c>nd between 1968 and 1970. We are now attempting a reestablishment
of this relationship and a renegotiation of the contract.
Differences of opinion exist as to the basis for t hat era of good feel-
ings. Gerard Piel has given us the noble, even romantic view, of the
free scientist engaged in the search for truth, and a justification of
'vhat Alexander Capron called the hands off policy; what I call the
laiYsez faire philosophv. In Piel's view, the scientist is best able to
determine both the ends and the means of research, and the larger so-
ciety's role is to make available the sanction to pursue inquiries wher
ever it may take the scient ist, and to provide the resources necessary
for its conduct-however expensive it may be. In contrast to this noble
view has been a cynical, quasi-Marxist view, expressed by Jonathan
J{ing, which regards the period after World War II as one in whlch
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the scientific com.1nunity was the kept handmaiden of the military-in-
dustrial complex, engaged in research to expand the military and eco-
nomic power of the nation's ruling classes. In this view, one of the
goa.ls of the research conducted during this period was to enhance
the military capability of the nation through missiles research, chem-
ical warfare, et cetera; another was to enhance the nation's industrial
wealth. King has proposed that one consequence of this was the
emphasis on a virus etiology of cancer and the shunting aside of
hypotheses relating environmental toxins to cancer.
Whatever may have been the basis of that era of good feeling, it
clearly has come to an end. Since 1970, funds have be(>n short and there
is competition between biomedical research and other research fields,
and between research, housing, education, and other human needs, for
the shrinkino-, inflated dollar. Moreover; the biomedical research com-
n1unity has been placed on the defensive by the revelations of abuses
in human experimentation and the resultant de1nands f or restrictions
on research in prisons, use of fetal subjects, et cetera. Furthermore, the
unintended consequences of the environmental impacts of technology
have generated an ambivalent attitude on the part of the public. In-
stead of science being seen as an undiluted benefit, there is now an
image of the scientist as F rankenstein, technologies 'vhich
can poison the waters and the environment. And, in addition, we heard
yesterday from Ruth Hanft of the unintended economic consequences
engendered by the mid-level technologies, low in yield for prolonging
life but high m cost, expandng the already-inflated health care dollar.
Given tliis situation, there seems to be a need to ease intergroup ten-
sions. The letter froin Senators ICennedy and .Javits convening this
conference made reference to strains between Congress and the bio-
1nedical community, and one of the purposes of this conference is to
identify these strains and find ways to reduce them .
.
WliO ARE TiiE PUBLICS? WHO ARE THE SCIENTISTS?
One of the difficulties faced by participants in this conference has
been that the representatives of the biomedical community, who pre-
dolninate here; have not known with 'vhom they have been interacting .
this meeting has been convened by Senators I\:ennedy nnd
Javits, it has not been made clear that the focus of the should
be on relations with Congress or that Congress is the ma.jar public"
specified in the title of the conference. it has been difficult
to engage in a. true dialogue bec.'l.use the Senn.tors have been here only
f or brief periods, and the members of their staffs who have been pres-
ent have been, for the nlost part, nlute, at least in public.
However, there are suggestions tha.t a number of importn.nt policy
issues which are not directly biomedical research issues do bear on
Congressional decision-making. One issue is the rising cost of health
care. '\Ve have been made painfttlly aware that unless there is so1ne
restriction on health ca.re costs funds for research '"ill b"' under fur-
ther budgetary pressure. Anotl1er policy issue is tha.t of health 1nan-
po,ver. In other Senator Kennedy has expressed his distress
that the medica.l schools are not more responsive to the public's need
for care ph,ysicians, an.d for the geographic 111a.ldistribnt!on
of physicians. Existing mechanisms have not been sufficient to bring
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about a in the geographic distribution .pf physicians, OJ: a re-
striction on the number of specialty residencies. The veiled threat is
that unless . the biomedical, academic, and professional communities
can achieve self regulation, extra-professional (that is, government)
regu!at.ion will be brought to bear. . . : . .
Although it can be a.greed that manpower issues are separate from
those of research, the same individuals at this conference who are
leaders in the research community are, for the most po.rt, also lea.9-ers in
schools, academic centers, and professional groups where they
n.lso have responsibility for policies related to medical student a.clmis-
sions, curriculum, and advanced training in medical and surgical resi-
dencies.
A. The lt/1tltiple Publics
'Jl{e have also been told that the public is not unitary, and perhaps
the title of this conference should have been "publicB." A list of non-
repre.scnted publics can be compiled from the discussion. Various
participants have identified working men and wo1nen as represented
by the labor unions; consumers concerned about food additives and
drug toxicity; ethnic, religious, and racial minority groups; women;
nnd public interest law firms. Industry a.nd business is one _poup not
represented here that is felt to be adequately re,Presentea in other
settings. In fact, it is claimed that without conscious awareness, the
biomedical research com1nunity too often has a.clopted policies and
pri?rities in line. witih the interests of industrial concerns and the
business commun1tr.
Although there is a great deal of focus on government, Congress,
and the national interest, "e should not forget that governmental
leadership is not nnity. One strongly placed and articulate gToup is
forn1ed of those with fiscal and buclireta.ry responsibilities, such as the
Office of and Budget ( OMB). or Congressional budgetary
staff. They are concerned witli cost-benefit analysis and the develop-
ment of c.riteria for resource allocation. This way of thinldng is often
alien tot.he bio1nedical research community, which has difficulty even
contemplating the exercise of developing criteria for the alloeation
of a fixed resea.rch dollar. However, it is clear to me that this exercise
can!1ot be avoided, either as an intellectual challenge or as a real policy
choice.
One of the interesting suggestions made at the conference was pro-
posed by David Baltimore: that a meeting of under-represented groitps
be c-0nvened, where representatives of labor unions, minority .groups,
\romE>.n, n.nd so forth, would be given an opportnnit.y t-0 develop their
agenda for prioritv areas of relevant research, including ot:her p1oblem
areas where they feel they and other publics should be able to partici-
pate in decisionmak:ing in the research enterprise.
At various points, mention has been made of "the public at large."
"the 1nan in the streEt" and "the public lobby." It is likely that these
are social fictions: there is no one single public. Depending on the
issue or the intereSts concerned. there are multiple publics, with fluid
alliances. in different relationships t-0 one another.
It. is also apparent that the public-either totally or in various sub-
publics-does not net en masse, but rather through some form of
representation, via surrogates or delegates. In the case of elected offi-
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cials in Congress or other legislatures, this legitima.cy is established
by law and by the electoral process. However, in the case of other
publics, the question often is raised as to the legitimacy of the repre-
senting surrogates or delegates.
Most of the special pu61ics are pla.ced in the large, national scene.
But King and Holman have drawn our attention to local com-
munity settings in which an interface exists between the biomedical
research community and local needs, as in the Boston controversy
around the XYY chromosomes, cases of environmental or industrial
pollution, or genetic programs in a specific locality. In such
instances, the larger national issues become particularized into spe-
cific local issues.
B. The Divisions within the Biomedical Research, Community
Just as the public is not a unity, and there are multiple publics, so the
:;cientific community is not a unity. Practitioners or proponents of one
type of research usually do not publiclv advocate its funding at. the
expense of another. In addition. within the scientific community, there
are various trainees and junior'fa.culty persons not represented, whose
interests may or may not coincide with those of the senior and e1ninent
leadership here represented.
There have been many splits within the biomedical research co1n1nu-
nity, and at least three have emerged that have not been discussed
adequately. These are:
(1) Basic (or fundamental) research versus applied research,
(or technology and development).
(2) "Liberal" scientists prepared to accept more public pa1-
ticipation, and "conservative" scientists hoping to restrict the pub-
lic's role and fearful of any degree of public participation except
for public relations purposes.
(3) Advocates of various catep-orical disease constit.uencil's such
as cancer, heart disease, mental illnes.5 and birth defects.
CLARIFICATION OF THE IssUEs
Another way by which the social psychiatrist can assist in the trans-
actions between conflicting groups is to clarify the issues about \vhich
the groups are in or dispute.
During our discuss1ons, a number of areas have been identified where
differences of opinion have been expressed as to the legitimacy of par-
ticipation by the public at large, or by one or another of its surrogates,
in decisions relevant to the conduct of biomedical research. Various
participants have expressed diver#!"ing opinions about these issues, and
one agenda for future meetings might be to clarify the issues in order
to promote a clearer focus on areas of agreement and disa#!"reement t.hat
'vill enhance understanding, compromise, and the ultimate resolution
of dispute and minimization of conflict.
To assist in categorizing these different nrcns, I have divided the
decisions into three categories. as follows :
A. inputs required by the biomedical research community;
B. the poceaa intrinsic to biomedicn ! research ; and
C. outputs; namely, information and t<.>chnology.
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Let me discuss each of these in some detail to identify what the issues
are and the extent to which it is clear which of the parties holds which
views.
A. INl'tJTS
In order to conduct biomedical research, there are a number of inputs
required. Hans Jonas has pointed out that as modem science has pro-
ceeded from the world of ideas to the world of act.ion, scientists need
new capacity to intervene in natural processes to conduct their research.
Among the various inputs are the following:
1. Mandate and Encouragement
Among the most important inputs that biomedical scientist.s require
are the socially-supported mandate and psychological support, encour-
agement and reinforcement. Scientists need to oe told over and over
again that they have a special mission in history and a unigue contri-
bution to make to Amencan society. This provides them with a sense
of their role in the larger society that is particularly important because
it may be difficult to sustain scientific research in the long periods when
delay occurs before results appear.
One of the important functions of conferences like this is to reaffirm
the interest of prominent public leaders like Senators in this mandate,
and to provide encouragement and psychological support. Scientists,
like other folks, need many strokes; it is important that they be told
they are special, that they are a particularly chosen lot, that they have
a uni9ue place in the history of mankind overall, and the history of the
U.S. in particular, and that they have the mandate, mission and sanc-
tion to perform their activities not only for personal and private gain
and for individual intellectual stimulation but because research con-
tributes to the larger social good and the national interest.
r!. Reaoorce .Allocati<>n
The most controversial and difficult input issues have to do with the
decision-making associated with resource allocation. Almost all the
scientists at this conference have acknowledged that the ultimate deci-
sions regarding resource allocation are to be made by the public's repre-
sentatives. Inasmuch as the vast predominance (85 percent or more) of
biomedical research funding comes from federal sources, the ultimate
and major determinant of resource allocation decisions is the U.S.
Congress. Ruth Hanft's talk identified this issue, but the discussion
that followed did not, in my opinion, distinguish sufficiently among
three separate though related aspects. These are as follows:
(a) What portion of the GNP sh<J'Uld be allocated to healthf We are
a.ware that the percentage of the GNP allocated to health has gone up
since 1950. There is a fear among scientists that there will be a fixed
dollar ceiling on health research and service. Ho,vard Hiatt noted that
the public is unclear as to whether it wants an improvement of the
nation's health status or whether it wants an increase in the availability
of personal medical care. He pointed out that these two goals are far
from synonymous; additional expenditures for personal medical care
are unlikely to contribute proportionately to the improvement of the
health status of the nation as a whole. Tlus trend is most dramatically
illustrated by the costs of the mid-level technologies described by Lewis
(,oogh.:
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Thomas which are high cost but have low effect on prolongation of
life or reduction of mortality.or of disability.
( b) Within the health dollar, what proportion slwtild be allowed
to 1esearch? As health care costs increase, there is pressure for cost
reduction, and t raining and research expenditures are among the few
areas where there are 110 obligated rises and \vhere there are opportu-
nities for cuts-or at least no increases. This possibility generates
a.n:.iety and tension within the biomedical research community. We do
not have any agreed-upon criteria for arriving at a reasonable formula
for resonl'ce allocation. One recent proposal has been that a fixed pcr-
eentage, i.e., 3-5 percent, of total health care costs be allocated to re-
search, and as the health dollar increases, so \vould the funds available
for research and develop1nent.
( c) lVithin the 1esea1ch dollar allocation, hoio should funds be allo-
cated.? By ioho1n? By what critel'ia? By what mechani.$m? Up to now
the nuijor mcchanisn1 for funding has been by vocal and pow-
erful citizen g1'0ups, usually org11nized by categorical disease entities,
e.g. cancer, 01 heart. An1ong the principles for allocation that concern
this grouli' is the need to support basic or funda1nental research. The
Presiclents Bioinedical Research Panel has pointed out that dispropor-
tionate fnncls are allocated to cancer relative to cancer's impact on
national health disability, \Yhile there is underfunding of less influen-
tial areas, snch as inental health or preventive medicine.
S. Trainees
Health n1anpo,ver is one of the in1portant unresolved conflict areas,
Senator ICennedy, in other settings, has indicated his concern that this
prohlen1 be solved. There is an apparent impasse bet\veen the acaden1ic
1nedical school leadership and the Congress, .o\lthough it is not openly
on our agenda, this issue may be 1nasking r esolution of other issues
through its indirect ilnpact upon the dialogue. Trainees are necesssary
to replenish the innnpo,'l"er pool of future researchers. The presence of
trainees a.ud research felJO\'l"S stimulates ne" ideas and new approach<:>s .
.i\lost 1esearch discoveries are uuide by the relatively young scientist .
On the other hand, there is concern lest there be a production of excess
icsenrchers who cannot be absorbed into the economy and for whom
there "ill be no employ1nent. Payback plans and forms of quotas for
nssi[!nnient of n1edical students to p1imary care or for geographic re-
distribution have not n1et 'vith consensus. Until this issue 1s resolved,
I suspect that our progress in other a rens "ill be seriously i1npedecl.
4. Subjects
Res<'archers need subjects for investigation, pa1ticularly biomedical
investigat.ion, and among the important subjects are animals tnd
humans. Access to subjects nncl their \velfare has been the subject '.>f ii
great deal of public concern, which need not be elaborated upon here.
5. !11fo11nat.ion
1\ccess to information has been one of the traditional concerns of
scientists. In previous eras, nnd in other nations, interfer-
ence via censorship and restriction of freedoin ot speech or press has
been evident and scientists have been greatly concerned about access to
infor1nntion. In the U.S. the protection of the First .Amendment and
other rights does not 1nake this a matter of current concern.
Lwls Thonin. The Tchnology of lledlclue, !"ew England Journal ot l!edlclne, Vol.
2S5. 1971, p. 1366.
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.
B. TIIE l'nOCESS OF RESEAllOII
. .
. . .
1. Setting of Pri01'ities
The classic model of science leaves it to the scientist to dctt'rn1inc the
areas of his or her investigation. This is the noble, or ro1nnntic, or
laissez faire vie\v that the scientist, left to his intellectual curiosit.:v,
the lines of inquiry. The 'vith
view is that there 1s seldom a goodness-of-fit bet\veen ind1v1dunl scien-
tist's interests, the fashions of the field at a particular nlon1ent, und
t he needs of society . i\.ttempts have been inade to develop n1ission-
orientoo .or research 'vhere ate problems of social con-
cern: '.fh1s area 1s one of the enduring tensions betwe.cn bnsic
and 'applied science an!f the scientifi<: .com1nunity nnd the
which is prepared to initiate "'arson crusades
on Cltncer, or something ori the model of the Project. Tliei-e
seems robe a need for some 1ncchanism for setting' pri()rities in vrhich
representatives of society as a whole or its subgroups identify areas of
Concern, and interact \Vith scientists to specify pioblems Capable of
being solved within available relative to other needs.
. Prote(!tion of tlte Rights of Hu1nan Subjects, and tlie 1V e.lfaie of
Animal-8 .
3. Deliberatiis of Resea1ch Oowmitiees .
The peer group process in NIH has qcen e>pened up for public
scrutiny.-.The question arises whether or not ptofessional and scientific
societies will also come under pressure to open. '\>Vithin this area, t he
boundary between the secular and the ecclesiastical courts, as.discussed
by Toulmin, \Vas of particular interest to many participants.
. .
C. OUTPUTS
The two main outputs of scientific research are (1) information,
and (2) technology.
1. As regards information, scientists are concerned with the free-
dom of expression of their information and of dissemination of find-
ings. On the other hand, there are a number of situations which have
arisen which indicate son1e possible constraints upon this freedom.
For example-when fu open up results of clinical clin-
ical.trials are kept secret, i.e. double-blind,, until completion. What are
the ethical and social responsibilities if either one of the treatments
is highly unsafe, or if one of the treatments proves highly
Who is to make this How much is the information to be

There are also proposals that scientific journals not accept for pub-
lication results from experiments that do not meet criteria for pro-
tection of the rights of subjects. .
2. Effecta on the biological environment.-Recently, scientists are
being called to task for the environmental impact of technology de-
rived from their discoveries. The Asilon1ar conference is one effort to
deal with this type of impact.
3. Economic costs.-What is the effect on the health care expenditure
of the development of ne\v technologies? What about moral and so-
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cial Concern for new forms of contraception and steriliza-
tion are examI?les of concern on the part of the community about
1noral and social iinpacts of science and technology. In the recent
XYY chromosome conflict in Boston, the Science for the People group
raised 11. new type of impact , namely the impact on the family of being
labeled as having a child with potential antisocial tendencies.
SUGGESTED MECHANISMS
I have identified eight mechanisms proposed here for involving the
public in decision-making on scientific efforts: (See Table l, below).
These range from those requiring the least amount of public involve-
ment to those the most. An example of the former would be
the laissez-faire situation of the self-regulating, autonomous scientist,
and of the latter, litigation in the courts. This listing also groups the
mechanisms from the least to the most restrictive as to impact on sci-
entific autonomy and initiative.
TABLE 1
Suggested mec1ur,ri,Wna for public participatU:m
1. Self-regulation by the individual scientist or by the scientific
professional.
2. "Whistle-blowing" by the press, or public outcry.
3. Self-regulation by a professional group (as in the case of the
Asilomar conference).
4. Standing advisory committees to government agencies such as
NIB Councils.
5. Ad lwo public commissions such as the National Commission and
the Biomedical Research Panel.
6. Regulatory agencies.
A. National- FD,<\..
B. Local-Institutional review committees for
htm1an ethics.
7. Legislation.
8. Litigation.
As Peter Hutt has indicated, there are multiple mechanisms that
exist in a pluralistic society such as ours, and no one mechanism can
apply or should apply to a!I types of problems and concerns. His gen-
eral principle is that, wherever possible, the least restrictive mecha-
nisms be put into play first. and movement to the more restrictive mech-
anism be delayed until it is clearly apparent that the least restrictive
mechanisms have failed.
I need only say a few words about each of these mechanisms.
As regards the first, self-regulation by the individual scientist, this
approach is being supported by Gerard Piel, but it has not met with
much enthusiasm. I t now appears agreed that there is a potential
conflict of interests between individual scientists, or the scientific
group as a. whole, and society. Furthermore, there may be adverse.
consequences on the search for scientific truth; research may impinge
upon the rights of others insofar as it calls upon national resources
or funds, or it may have undesirable in1pact upon the social or bio-
logical environment.
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"Whistle-blowing," by the press or other muckrakers such as the
Ralph Nader group, has great po,ver but also serious limitations. It
can result in bans on certain types of research or in moratoria. How-
ever, there is the danger of crying wolf, and also a limit to the number
of times this mechanism can be used. When the blowing has an all-or-
none quality, it tends to place the scientific community in opposition
to the rest of the public.
Self-regulation by professional groups has been the classic claim of
t.he professions. The novel approach represented by the Asilomar con-
ference was described by Maxine Singer and David Baltimore. It has
a number of interesting features: it was initiated within the scientific
community and led to a self-imposed temporary moratorium. It was
an a,d hoc mechanism based upon private initiative, but with govern-
1nent SUJ?port. The scientists at Asilomar, however, took pains to insure
that their deliberations were subject to public scrutiny or public wit-
ness by the presence of the press, but there was limited public par-
ticipation. Harold Green noted that public witness by the press, or
other forms of reporting, is only a lilnited form of public participation.
There a.re public members on advisory committees, such as NIH
councils. However there is a question as to the extent to which they
are working. Have they failed Are new efforts being ma.de 9 Have
the public members been co-opted by the Or is it that these
1nechanisms are working relatively well in most instances 1
The ad hoc public commissions, such as were reported upon by
Kenneth Ryan, seem to have had recent successes. Commissions offer a.
period of delay in decisionmaking, and thus allow debate to be kept
open while a comprolnise can be worked upon. By working in public
with high visibility, it is hoped that all the parties involved can arrive
at compromise and develop areas of consensus.
The use of mechanisms 6, 7 and 8, re!rulatory agencies, legislative
power and litigation, involve potentiafiy the most restrictive and
legally binding mechanisms. Again as Peter Hutt mentioned, they
should be called upon only when alternative mechanisms have failed.
New mechanisms are being developed, such as scientific advisory
functions to Congress through its Office of Technology Assessment
(OTA). The proposal to revive the office of Presidential science advi-
sor is another potential opportunity for improving public participa-
tion by communication.
Peter Hutt J?Olnted out that use of Congressional legislation is in-
dicative of a situation in e:vtremis. In response to this, Robert Burt
stated that if the use of Conwessiona.J legislation indicates a situation
in extremi.8, then litigation involves a situation close to rigor m<>rti.8.
SOCIAL PSYCHOLOGICAL ASPECTS OF THE D IALOGUE Bm-WEEN SCIENTISTS
AND PuBLIC BODIES
Before concludina my remarks, I wish to point to the role that emo-
tions, attitudes and' perceptions can play in communication and re-
negotation. At least two speakers, Ruth Hanft and Stanley Jones,
made reference to what many felt to be the arrogant and complaining
at titudes expressed by scientists when faced 'vith some difficult deci-
sions, particularly about funding and resource allocation. As a psy-
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chiatrist, I am awal'e of the extent to which attitudes, emotions and
n1isunderstandings can interfere with intergroup relations, and limit
the capacity for dialogue and renegotiation .
.\.mong some scientists, a sense of entitlement has arisen, pa1ticnlnrly
in those scientists trained since the Sputnik era. This attitude mav con-
tribute t-0 difficulty in the dialogue. Scientists as a lP'oup are highly in-
telligent and feel they have special expertise. Scientists were ahvays
felt to have a special mission in history and a special place in society.
Ho,vever, the danger is .that this attitude will lead to an elitist stance,
and that the scientists will communicate a disdain for public officials
and public at large. "When confronted with proposed changes in
the arrangements, they are concerned about what is being done
to Thei:e is often outcry and pain at reduction of awards. In this
resp.opse scientists may be behaving like the rats and pigeon$ in Skin-
neria1,1_schedules of reinforcement when there is a change in the sched-
ule qf :.reinforce1nent. Depression, anger and frustratjon appear in
as part of change in behavior. Often the scientific community
will b_e a loss of ninds, t hat research in certain sensitive
a1'eas will 'Qe stopped, and that too many public representatives wilt be
involye,d:-in decisions scientists feel will limit their aut<>roony and
creatintY .
On the.other h11-nd, scientists have been slow to realize that the public
also has.fears; founqed or unfounded, rational or irrational. The pub-
lic has fears that it will be used as h1ima.n guinea pigs. Just as there is
an image of the scientist as the benevolent miracle man, an alternative
imn.ge has emerged of the scientist as Frankenstein. SOme citizens be-
lieve toO much money has been appropriated, much of it wasted on con-
ference$, travel and special privilege; that the scientists have become
elitist and aloof and disdainful of the rest of the population. Rather
than being grateful and appreciative of the special .role the larger
society-.has provided for them, scientists in general-:and university
scientists.in particular-have come to appear to be acting like spoiled
children .. The public at large, particularly its legislative representa-
tives i1,1 Congress, often feel like parents who have indulged their chil-
dren, and expecting gratitude and appreciation, but dismayed
and angerea 'by what 'they feel is the sense of entitlement and com-
plaint expl'llSSed by scientists when fiscal reality limits wishes.
I am not certain of the extent to which these emotional and attitu-
dinal andperceptu111l processes are really involved in the current diffi-
cult strains. They have been too little discussed openly at this confer-
ence. Only. two speakers have mentioned them during sessions, but I
have heard this issue mentioned over coffee or in the informal dis-
cussion. Perhaps the topic can be explored in private consultations,.
and a.n assessment made .of the extent to which these emotional and
attitudinal factors in1pede the dialogue.
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CoNCLUSIONS
As Frederick Robbins stated, there seems growing consensus among
scientists that the future will bring greater public participation in
decision-making in biomedical research. However, beyond this general
consensus there is little agreement at the present time as to the specific
areas in "' hich the public will participate and the mechanisms through
which this participation will take place. The biomedical scientists here
were most hesitant about regulatory agencies, legislation and litigation,
and looked to various ad hoc commissions, advisory groups, and in-
formal mechanisms.
Ultimately, there is the ho:pe that a new equilibrium 'vill be estab-
lished which, while it will involve greater public participation in
decision-making, will still leave major areas of scientific endeavor open
to the autonomy and initiative of the scientist. Ho'v this boundary
will be defined is unclear, and many in the group, including myself,
were intrigued by the parallels to drawing the boundary between
church and secular domains in medieval times, brought to our atten-
tion by Stephen Toulmin.
Lacking further explanation of the specifi c concerns of t he Senators
''ho c-0nvened the meeting, or by members of their staff, the group of
biomedical scientists assembled here were often frustrated in their
attempts to clarify the issues, to focus the discussion, and to generate
specific proposals.
Perhaps one next step would be for informal consultations and group
deliberations, to develop future agendas around focused topics where
small groups could carry the dialogue further.
I have attempted to summarize the conference by arguing that there
is a process of renegotiation under way in the contract l>etween the
scientific community and the larger society. The process of this renego-
tiation is a special form of intergroup dynamic or transaction, in
which emotions, attitudes and misunderstandings can often impede
rational negotiation of compromise and new mechanisms.
I have attempted to use the insights of the social and community
psychiatrist to identify the :parties involved, to unmask the differences
\Vithin the :publics and within the biomedical research communities, to
clarify the issues in terms of inputs, process, and outputs, and to order
the various mechanisms proposed on a hierarchy from least to most
restrictive.
It is my hope that these clarifications will facilitate the dialogue,
ultimately leading" to a new social contract and another era of good
feeling, nllo,ving the biomedical community to use its creative talents
for public good nnd the enhancement of scientific knowledge.
8 2 2 0 1 ~ 7 7 ~ 1 0
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SATURDAY APRIL 3
Saturday morning the meeting ended with an informal session de-
voted to conclusions about the conference and specific suggestions for
the future. About twenty people took part. Because many conference
participants were not at the Saturday session, its deliberations were
not considered to represent a consensus of the whole group, or to serve
as a final report.
.<\.lbert R-Osenfeld began the discussion with a call for improved
communication of the aesthetic aspects of scientific research to give
the public a feeling of the joys and delights of the scientific process.
In the aesthetic area, he maintained, the public might be content to
leave decision-making to the scientist. But in order to monitor the
transition of a particular piece of scientific inquiry from the purely
aesthetic to the possibly threatening, Rosenfeld stressed the need for
some sort of early warning system.
87
Agreeing that the public should be shown that some scientific re-
search should be carried out for the sake of scientific knowledge itself,
Arno Motulsky likened scientific pursuit to the cathedral bwlding of
the Middle Ages-a testament to the nobler spirits of the time. "I
think we're too defensive in having to sar, we're doing it because it
'viii lead to better health or better bombs,' he said. Cathedrals, Wil-
liam Blanpied pointed out, were built for public use, "but scientists
"'ere very often reluctant to let outsiders in." Alan McGowan argued
that science can be useful to a society in the same way that opera and
dance and plays and sym1;>hony orchestras are useful, "because they
feed into the aesthetic fabric of the nation and develop a more uplifted
civilization." But, he argued, "it can only be viewed in that way if
ngitre.ssive measures are taken to include more people."
Public participation can then only follow upon public witness.
Rosenfeld offered the environmental movement as proof of the public's
ability to be effec.tive in areas where it has sufficient inform11.tion. But
one stumbling block to improved reporting, he said, is the difficulty
of convincing editors and news directors to devote space to science.
Lawrence Altman agreed, pointing to the fact that newspapers tend
to treat science as a political story, rather t'han as a separate subject.
Yet another barrier to effective reporting wns pinpointed by M. Neil
Macintyre-the refusal of many scientists to spend time explaining
their work to media people. He called for "us scientists to look within
ourselves and quit behaving like a bunch of arrogant, pompous, ill-
mannered children." Franz however, cautioned against
a precipitous rush into print. "The way the science publishing estab-
lishment is set up,'' he said, "is that we base publishin!! decisions on
evaluative reports. If you connect the scienti!'t and the newsmn.n
directly and bypass the refereeing system ... I think it 'vould be
chaotic."
"' See Appendix 2.
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If public farticipation is to be achieved, ho\'; shall we nchieve it?"
A number o specific SU"'gestions were made. University research and
medical programs could reach out more into their local communities,
getting in touch con1111unity organizations to find out their needs
and wants, said Halsted Holman. W1l lia1n Blanpied suggested a look
at all the existing mecha1iisms of public participation " 'ith an eye
toward improving them. Andre I-Iellegers put for,viird the idea that
NIH should establish, as a kind of lightning rod, an office of public
consumers, modeled on the National Con1rnission for the Protection
of Human Subjects of Biomedical and Behavioral Research. Researcl1
on mechanisms of public participation should be funded by t:he-
federal government, argued Leslie Dach. Krin1 suggested
an informal citizen group on bio1nedical research. that would be
res11onsi:ve to requests from Congress.
Harold P. Greenmaintained t hat thete was no need t.o de,elop new
mechanisms for public participation. "Nobody would deny the real-
ity," he 5aid, "that the public participates toda,v in the 1110.king of
decisions about tax policy, agriculture policy, all kinds of policy; a:ncr
it. ca.Ii participate in to precisely the same :extent. It does not
have to be any more; it should not be any less. I .don't tt1ink ''e need'
a to pinpoint exactly what members of the public need
.to go where and do what. As far as I'm concerned, public participa-
tion means nothing inore than goinl? to the polls and voting, writing
letters to the editors of newspapers, forming citizens' action groups to
bring political pressure t.o bear for or against the right to life, things
of th.at ki.nq.''. that radical new apprO!).ches to.regulation and
pubbc participation were not necessary, Beldmg Scribner declared.
"My feeling is tl1a.t we have a pretty exemplary record." He disagreed
strongly that Asilomar should be looked at as a failure of the scientific
community. "As I understand the scientific and ethical implications
of that issue," he went on, "they were handled in a very exemplary
wa:v. It wasn't a disaster; it was done well."
Robert !:lorison. while convinced that the public Should be n.
g-reater role in policy, cautioned against being.too "starry-eyed" about
the eventual level of public interest. He recalled "experiences in the
universities where there was a :;rreat to-do about getting students in
on the matter of appointments, but within two years one was having:
to struggle to get opinions out of them." Morison also called for
increased public witness in areas w'here participation might be
unca.Iled for. He felt that "it is just as iinportant to see that justice
is bt>ing clone as it is that justice is done."
The problem of keeping the cost of medical care down by limiting
the introduction of high-cost, medium-yield medical devices or proce-
dures was raised by Franz lngelfinger. He described the develop-
ment of endoscopy, flexible tubini:i: that, inserted directly into the pa-
tient. allows the physician to see the gastrointestinal tract directly. It
wa..'! his feeling that endoscopy is "overused and abused," interferes
with gastrointestinal research, 'llJl.d SimJ?lY costs far too much com-
pared with its return. To prevent similar occurrences, Ingelfinger
called for an early impact mechanism that would restrain, through
financial incentives employed by third party payers, the introduction
of new technologies, probably -at the point of commercial clevelop-
1nent.
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Daniel Callahan commented that \vhat he felt was a surprising lack
<Jf disagreement with Hans Jonas' position on freedom of inquiry
represented "a major historical revolution, which ought not to go un-
noticed." Some discussants disagreed with Callahan's assessment, argu-
ing that much of the disagreement had not surfaced during the dis-
cussion. There did seem to be agreement that the question of freedom
of inquiry needed further study. Morison felt "the discussion should
be followed up by some smaller standing group, because the issues are
very difficult ... I don't think (it) has been discussed fully even among
experts, and it certainly isn't understood by the public or by me or
by many other people. I would like to see us really 'vorry about that
one."
IIarold Edgar questioned the ability of any group to identify areas
of research that may he potentially too dangerous to pursue. He sug-
gested that "it would be good for a small group to work through a
couple of case studies to see whet her it is a realistic expectation that
the funding process can be utilized to stop things."
So1ne participants expressed a degree of uncertainty about what the
Senators who asked for the meeting expected this group to produce.
Andre Hellegers said he thought the Senators were looking for "a
group of scientists to advise tliem. However, I do not think there is
unifonnity a1nong the scientists that they would want any such thing,"
11e said.
There 'vas also some feeling that legislators should be specifically
"arned about the complexities of the issues and the need to refrain
from precipitous action. Said Belding Scribner, "I would stress that
t.he theme of our response to the Senators should be one of real con-
cern, a willingness to look into the problem and to try to define it bet-
ter, but to ask for some time." Daniel Callahan agreed: "I get a strong
sense that there is enthusiasm for legislation on the part of the sena-
torial staff, a feeling that thev've got to take some action. My own ~
strong feeling is a word of c:'tution: don't always rush to legislation.'
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APPENDIXES
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APPENDIX 1
REMARKS OF U.S. SENATOR JACOB I\:. JAVITS (Rr-NY) BEFORE THE
CONFERENCE ON BIOMEDICAL RESEARCH AND THE PtmLIC, Amr.IE
HousE, WARRENTON, VA., APRIL 2; 1976
BIOMEDICAL RESEARCH AND THE P'CBLIC : THE CHALLENGE OF
ACCOU!ll"TABILITY
I am pleased to have the opportunity to listen----and to learn from
you-the distinguished of the biomedical research commu-
nity, ethicists, Tu.wyers, journalists, citizens-and to share with you
iny perspectives 'vith respect to our mutual problems, challenges and
opportunities.
I congratulate Dr. Gaylin and Dr. Robbins for their successful
efforts in organizing this conference, and in so eloquently 'llrt.iculating
the compleXIty of the major social policy issues be.fore us.
The very title of this conference-Biomedical. Research and the Pub-
lic-underlines the central concern of us all, namely : the challenge of
public acoountability.
of modern medicine are indeed impressive and
a we-msp1nng:
. We have seen surgeons life by transplanting a heart or a
kidney from one human being to another.
We have seen scientists begin to unravel the mysteries of the
process and d.Jil:amic of the transinission of genetic informa.tion
and characteristics.
We have seen breakthroughs in the treatment of some forms of
cancer, which provides new life to previously doomed victims of
this killer disease.
We all can agree that the responsibility for the ethical and moral
dilemma-who shall live and who shall die1--ean not be the socinl
judgment of scientists only.
When Dr. Ga.ylin testified before the Senate Health Subcommittee,
he underlined the paradox that the very success of biomedical research
has put it into the public domain. He noted the irony that arises when
those who control the essentia.ls for survival in 4t democracy-and bio-
medicine is such an essential-become the servants of :that society, and
not its masters. There are few villains and few heroes; rather, as Dr.
Gaylin wisely stated "Arrogance and ignorance fl.re the only enemies."
I believe we must address our considered, collective efforts to three
general, thouirh overlapping areas. The first is the pursuit of new
knowledge to improve our understanding of basic disease proce.sses in
order to ' prevent them, and the related questions of whether and to
what extent such research can or should be planned.
Second, we must exainine the ethical, procedural and technical
problems with respect to the appropriate means of testing and validat-
(147)
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ing basic research findings 'vhen applied to individuals and to
populations.
Third, I believe the most important and difficult task before us is
\reighillg social, economic and ethical risks and benefits of introducing
and diffusing new technologies-the fruits of biomedical research. We
need to know more about the impaot thait these new technologies ma,r
have in the short run and in the long run on health outcomes, on soci-
etal expectations, and on investment and resource allocation decisions
and priority-setting.
I cannot stress strongly enough my belief that the t hree comple,x
and interlocking areas-support for basic research, testing of the find-
ings of that research, and technology assessment-are issues of public
accountability. These are issues which require public involvement with
t he scientific community in an open and ongoing process. They are by
no means purely-or even mostly-technica.lfroblems.
The decisions with respect to the future o biomedical research, the
determination of priorities, the weighing of the non-quantifia:ble social
costs and benefits of medical techriology-these decisions are in fact
political because they involve the entire body politic, including, of
course, the research community itself. A scientist is no more trained to
decide finally the moral and political implications of his or her work
than the public-and its elected representatives-is trained to decide
finally on scientific
'\Vhen the public abdicates its responsibility to participate in these
issues, or 'vhen scientists arc un,vilhng to share as one among equals
with the public in this process. then history shows us that the public
becomes angry, frustrated and disillusioned.
I t then becomes altogether too easy to avoid the complexity of an
ongoing process of broad public participation in biomedical research
by. turning to legislation, bans, and constraints. But I
Unnk that precipitous responses to the tensions I ba,ve a.llu&d to--
and which will continue to be discussed throughout this conference-
'voukl be harmful to science and ''ould not remedy the difficulties we
face as a society.
The way to restore public trust-an outcome I know all of us here
today 'vould support-is to build n. mechanism for openness and shar-
ing, even the sharing of our mutual uncertainties.
As spokesmen for the American people, the members of Congress
can and do register their priorities with respect to the outcome they
hope the research community will achieve. They do so, of course. in
great measure b:v the appropriations process, e.g. more than $2 billion
annually to NIH. The federal government presently fund$ approxi-
mately 63 percent of all biomedical research.
I do not think it is possrble or desirable for Congress to dictate the
contents of basic research nor the overlapping, hard to define bal-
ance between so-called basic research and mission-oriented research.
I do think it right and proper tha.t we in the Congress look care-
fully at how the money we appropriate for biomedical and behavioral
research funded through the executive branch is actually spent.
I am well aware that ideas do not readily lend themselves to cate-
as boxes on nn organization chart or line items in a 'budget.
Kevertheless, I 'believe we in the Congress should continue to make a
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greater effort to inform ourselves, through public hearing$, with
respect to resource allocation decisions and research strategies within
:NIH to meet the outcomes that concern the American people the
most.
I would like to emphasize that I believe Senate Labor and Publi.c
' Velfare Committee hearings in this area are informational and are in a
public setting, and not an adversary process seeking to undermine
the organizational structures or funding stability for biomedical re-
search. Nor are their purposes to legislate the contents of research. I
think that would be dangerous.
It is, of course, imperative to assure safety in certain types of basic
research when the research itself may pose danger to the broad society
or t.o the resea.rchers themselves. The scientific community has been
increasingly responsible in this regard, but I do not believe only sci-
entists themselves are qualified to comprehend the general nature of
the research and its social implications. This, after all, is the meaning
of the Asilomar conference last year, with its limited public
involvement.
The recent broader public participation meetings sponsored by NIH
with p e t to controls to deal with dangers arising from recombinant
DNA experiments are a more responsible step.
I do not pretend to understand the technical problems of DNA re-
search- which involves the use of recently discovered! enzymes to re-
arrange the genetic material of living organisms in novel combinations
\vhich may never before have occurred in nature. But I can certainly
grasp the issue that recombinant DNA molecules might escape from
the laboratory with consequences which include creating unique and
uncontrollable epidemics.
In the area of the protection of human subjects in biomedical and
behavioral research, the litany of ethical disasters is all too famil-
iar. It is for this reason that Senator Kennedy and I fought for the
establishment of the National Commission to deal--0penly, publicly
and forthrightly-with the prevention of abuse and with new ethical
issues that have arisen or are likely to arise as testing follows the
progress of research. Recent hearings before the Senate Health Sub-
committee have brought out serious biomedical ethics problems with
the CIA and Department of Defense .. Senator Kennedy and I will
therefore seek to extend the purview of the National Commission to
all government agencies-not just HEW-in this session of Congress.
It seems to me that a comnussion approach is the m09t appropriate
one for such a. problem. I think legislation would be heavy-handed,
but I think that legislative oversight of m.hical issues in biomedical
and behavioral research testing is absolutely essential. We plan to
c-0ntinue our public convel'S811iions that ha.ve already been so produc-
tive. This sort of public consciousness-raising is the best antidote to
abuses or to the need for drastic legislative intervention.
The theme of public accounmbility is a familiar one in all areas
of our social life today. Its importance in biomedical research is par-
ticularly striking with respootto the assessment of its outcomes. Medi-
cine is perhaps unique in that the lines between research and appli-
cation of research to human populations and the health care system
are so hard to draw.
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I believe tha.t NIH-where a. significant proportion of such innovn-
tions are developed-has the opportunity to assume a leadership role
in tackling the major problems of technology assessment. On the one
hand, there is a problem, perceived by the public, when research find-
ings of potential value have not been disseminated as rapidly or effec-
tively as they might have been. The other problem is perhaps more
serious: in some cases procedures, techniques, drugs---technologies-
are aocepted throughout the medical care system too quickly, without
adequate validation of their sa.fety, or rela.tive efilcncy.
With 'a view to embarking on an open partnership with respect to
these issues, I have written to Dr. Donald Fredrickson, Director of the
National Institutes of Health, urging him to fonn a broad-based
special committee under NIH a.usp1ces to examine the ethical, social,
economic and technical issues in medical care evaluation or technology
assessment.
Dr. Fredrickson has graciously given me permission to shnre t his
letter with you todny, and I an1 confident that your inputs will be of
enormous value to him in developing the possible structure and process
for such an ongoing role.
We need thoughtful answers if we are to determine the most app10-
priate legislative response to .technology assessment.
I am hopeful that an ongoing committee with NIH leadership
could, in fact, preclude the necessity for specific legislation at this
time.
Together, we can assure that current n1edical practice is on ns firn1
a scientific basis as possible, and that the cost-benefit equation of pres-
ent and future technologies is a positive one in human as well as
monetary terms.
Uncertainty is a fact of li'fe, but together we must attempt to pre-
dict the i ~ p c t of medical technologies on society, and thus prevent
negative results to the best of our collective ability.
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APPENDIX 2
AN EARLY-ALERT TASK FoRCE FOR THE Pu:suc
(By Albert Rosenfeld)
On Saturday morning at Air lie House, during the last session of our
conference on Biomedical Research and the Public, I made a brief,
fuzzy suggestion to the effect that we should consider a
kind of permanent, floating Early Warning Task Force, whose mission
it would be to keep track of science with a view to alerting the public-
that is, alerting all of the interested publics-to both the benefits and
the hazards implied in biomedical research. (Perhaps "Early Alert"
\vould be a better designation, since "'varning" is more loaded with
negative connotations.) I believe that such a task force might well be
housed at the National Institutes of Health (though not necessarily
under the jurisdiction of NIH) because that seems to be a first-rate
vantage point from which to keep an effective radar-scan on biomedical
research. In any case, because there was so little time left on Saturday
morning, Dr. Robbins, chairman of the session, asked if I could put
down the idea in a memo that would be sent to him and Dr. Gaylin.
l\fy suggestion was the almost accidental outcome of thinking about
'vhat had gone before during the conference. Three separate themes,
for instance, had arisen on the previous days.
(1) There was a general feeling that many agencies already exist--
in and out of government-that could and should be performing this
function. Perhaps some of them are performing it better than we lmow
1
hnt the general suspecion was that nobody is really doing it adequately.
There was a further feeling that all relevant agencies need to be iden-
tified, and we should properly understand their functions, real and
assigned.
(2) At the Thursday evening session. Hans .Jonas, the principal
advocated that freedom of scientific inquiry be limited. Seem-
ingly at opposite poles from him was Gerard Piel, who felt that
.freedom of scientific inquiry should not be limited. There were many
in-between views. But conversations with Jonas, Piel, and others after-
"'ard CQnvinced me that they were really not too far apart in their
views. Much depended on one's definition of "scientific inquiry." I
would define "inquiry" as, say, Einstein calculating E= mc
7
, or perhaps
Hahn and Strassmann doing their atom-splitting experiments in the
laboratory. Anything further would be an advance bey<J1Ul inquiry
as the atomic physicists themselves soon discerned-which is why they
went to President Roosevelt with warnings about an A-bomb. In
biology, one could say, for instance, that it is within the re1tlm of in-
quiry when Crick and Watson work on the structure of the DNA
molecule; and stilJ inquiry Monod and Jacob figu!e out the
operation theory of gene regulation. But once we start crea.t1nJ? Tecom-
binant DNA molecules. we are going beyond inquiry into areas that be-
gin to affect the public directly.
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. Hans Jonas had said, in discussing inquiry, that one could not, for
mstance, freely explode an A-bomb in the atmosphere. Well, Gerry
Piel, though he is l!-ll for freedom of inquiry, would also be very much
opposed to exploding an A-bomb in the atmosphere. To him, this is
beyond inquiry. So I do think the major point of disagreement
lunges on the definition of the \vord inquiry. Any line of inquiry may,
of cour:se, reach a poin.t where it goes inquiry and becomes
something that can seriously affect the pubhc, both beneficially and
hazardously. Hans Jonas recognized this, and commented that the only
sciences he could think of that \Vere "pure" and were exempt fron1
tJ1is were probably cosmology and mathematics; I would not
exempt even these disciplines. They, too, may have a very direct im-
pact on the public.
(3) Jonathan King of MIT, representing Science for the People,
\Vas militant in his insistence that, before any decisions were made
scientifically that wou'ld affect the public, the public ought to have some
input; that all segments of the public might be affected should have
some say in the decisions before they were made; and, further, should
be able to make some suggestions about research-not merely research
that ought not be done, but research that ought to be done, that perhaps
the scientists themselves might not have thought of.
On Saturday morning, with these prior happenings in mind, I
started to make two suggestions:
One was that there are perhaps areas of science, especially those
areas of research usually thought of as "P,ure" or "basic," and hence
definable as "inquiry,'' which can be considered mainly aesthetic and
cultural-analogous, say, to art museums, ballet troupes, opera com-
panies, symphony orchestras, or even to the theater and sports events-
activities which the public supports (though in another fashion) for
the sheer joy, entertainment, or aesthetics involYed. In this area of
science. I think there should be freedom of inquiry; perhaps the public
wouldn't be so concerned about its input any more than the public
would be overly concerned about telling a museum director what pic-
t.ures he ought' to bu:v and exhibit, or "'hich ballets or operas ought
to be performed. Unlike these other acthities. however, science may
have further practical consequences, and this is of course what wor-
ries-and gives hope to-so many people. This does put science in a.
separate category: thus, once it leaves this area of basic inquiry after
truth (and even beaut:v), it is no longer merely a cultural pursuit which
ont?ht to be supported bv the public like nny other cultural pursuit,
nnd 1>nters t.he realm of either dnngerous or meaningful experiment, or
a.pplied science and technolot?Y. That is the point at which it becomes
no lonl!er free int'luir:v. the point beyond which it should not go without
the beginnin,gs of public awareness and input.
A second point I made was that, while everyone was talkint? nbont
!!ettinl! input from the public, nobody was talking about getting in-
formation to the public. This seems of paramount importance, I'm con-
vinced that the public usually can take action to influence public policy.
even in matters of science, when it possesses information on 'vhich to
base its feelings. The big problem, however, is how to get the infor-
1nntion to the public, often a difficult matter. I think that anything we
"nggest with regard to biomedical research and the public must include
so1n0 acknowledgement of the fact that better mechanisms are required
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3 2754 076 292 139
to infotm the public, so the public may act on t he basis o
1nation and not just on its raw and perhaps uninforn1ed
misinformed) feelings.
Now, back to the idea of the Early .\lert Task Force. What sho its
functions bet How should it
1
be I t seems to me that it should
be as small, mobile and tight as possible. I ts members, though not
necessarily full-time, should make a long-term commitn1ent, because
their function would be to keep a continuing radar-scan on science all
the way from the time thnt it. is pnre, bnsic science, where it is whnt
falls into the catCl!'.ory of free inquiry, of cultnral pursuit, etc .. but to
be watchful for the 1noment when-let's say E = mc reaches what we
might call the "Hahn-Strnssmann threshold," ready to pass into the
atomic-energy phase; or when DNA research suddenly provides the
knowledge to ma.ke recombinant molecules. This Early Alert Task
Force sliould keep an eye out for all signs, as early as possible, of
benefits that should be pursued on behalf of the public (which might
not otherwise be pursued, or might be overlooked, or simply not of
great interest to any given scientist) , as well as potential hazards and
risks.
The task force should have working for it a small, permanent, hil!h-
onality full-time sta1f, which, as I might be housed at NIH.
The task force could add to its membership for short terms any experts
it needed for advice on a given problem. They would have access to
members of the President's advisory commit tees, to congressional staffs,
as well as to of 8ennte nnrl Congress, such as Senators
J(ennedy- and Javits who called this conference. They would also have
the freedom to poke around almost any agency, not in the role of
muckrakers or investigative reporters, but simply to discover what
goes on in those agencies, what their function is, who's doing what.
They should httvt\ a lot of freerlom ns \vell to call on whatever help
they need for their purposes at any time.
I t would seem advisable that the task force members should have no
authority whatsoever; persuasion. influence, yes--but no power to
execute what they recommend. This would leave them free to observe,
report, be as creative as they wruit in trying to forecast the con-
sequences or further progress of whn.tever research thev are observing.
They would submit reports periodically to interested agencies or men1-
bers of ConP.'ress. thev <'nnld sng::rest to various existing agencies how
these agencies might help carry out this function themselves : in fact,
not be averse tn putting themselves out of business if these agencies did
the iob superbly well.
The task force would be responsible to the public. I t would dis-
seminate its information, its hopes, qualms and fears to the appropriate
commi.ttees inside and outside the government, and perhaps periodi-
cally issue reports to the press, or hold press conferences, or see thnt
t.he media are informed; in a word, do whatever is neces.')Q.rv to inform
the public. As this task force keeps its radar-scan on scienee, it ouirht
to be able, at any point, to J>ull in members or representatives of those
of the public which it believes might be affected by what's
7oing on. I think it would be unwieldly and inadvisable to t ry to have
all of the publics represented on the permanent floating task force,
though certainly the public should somehow be represented.
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134
time giYen groups of the public may appear t.o be either
Jeneficiaries or ,ictin1s of "hat is going on, those groups
. called in as far in ad ,auce as possible. (For in:;tance, any
a ,,, having to do ""ith sickle-cell anemia should have input fro1n
the black comrnunity long before anyone n1akes anv decisions abont
screening, testing, and the like.) \ VhcrcYer possible, the task force
should also have a 1nechanis1n for encouraging input to itself for sug-
gesting to the ,arious sciences and scientific agencies research that
shotdd perhaps be done that is not being clone--or at least, to call
it to their attention so that it can be seriously considered.
'''hen "-e t:i.lk about inforn1ing the public u'nd seeing that the public
has a chance to ha Ye its input in all decision-inaking that concerns it,
I think \\e should be careful ahout trying to over-protoct, in this
sense: }fans Jonas, for instance. a. point at which expcri-
1ncntation in cloning should corne to a halt. \ Vhether it's cloning, or
any other line of investigation. just as \YC insist that scientists should
not decide to take risks on the public's behalf 'vithout the public's
kno,vledge nnd appro,-a]. should rthirists not put the1nsclvcs in the
position of protecting the public fro1n something that maybe the
public 1nay not ""ant to be protertetl J'ro1n. Tn other \\"Ords, the public
ought to have input as to \Yhether or not it belie,es a l?iven line of
re.search has benefits for \\hich it is 'villini:r to take risks before any-
body derides to put a ban on a gi,en line of resl'arch. J<:ither \YC trust
the public all the \Yity. or ".<' tlont. I think what I sai<l should
hold \vb ether we trust the public or not.
.\ct.ually, this early idert systen1 l'hould not be too difficult to carry
out. In a very rough-and-ready \\'ay. l (and 1111 s ure it's true of many
journalists) have done this in n1y journalistic practice, consciously
trying to keep track of "hat seen1s imporhint in science, and trying to
forecast its in1plications an(l alert the public as early as possible, in
111, limited "av. "ith mv limited kno,vledii:e anct resources.
we certainlv.ha10 a 1no'del for this kind of activitv at The National
Foundation-:\Iarch of Din1es, \vliere ''"e try to keep an eye on basic
biomedical research for the possibilities it offers to prevent or arneli-
orate birth defects: in that "ay, "e can encourage the acceleration of
r<'Search where it looks hopeful toward a. gi,en goal, and at the sa1ne
time \\arn our bioethics ad1isors as e:uI ,. as possible about boob>trnps
\VO spot, in order to get them thinking' as far in ad\ance as p0ssible
about "' hat the bioethical ha;r.ards might entail.
To sum up. I believe such an early-alert task force could S-Orve both
science and the public. and could specificallv help 1nembers of Con-
i:rrcss decide \\hnt guidelines 01' Jegislati\e actions need to be takPn
in order t.o see that the public interest is ser\ecl, and that the public
has a voico in what happens.
'
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Biomedical Research and the Public Conference Report

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