October 2, 2002

Steven Peckman, Associate Director

Human Subjects Research
Office for the Protection of Research Subjects
University of California Los Angeles
10945 LeConte Ave., suite 2107
Los Angeles, CA 90095
Dear Mr. Peckman:
This letter is to express my concern regarding UCLA's support and
participation in experimental AIDS research trials using human
subjects that have been carried out in Guangzhou, China, since 1994.
These experiments consist of giving malaria to people already
suffering from HIV and full-blown AIDS.
It is unclear how UCLA can maintain an Office for the Protection of
Research Subjects, meanwhile participating in ongoing offshore
human experiments which have been denounced as medical atrocities
by the World Health Organization, Public Citizen, and prominent
bioethics professionals. Yet numerous documents indicate the
participation of UCLA researchers, the use of school lab facilities, and
the use of UCLA's name for fundraising for this discredited work.
As your office must be aware, these experiments have been conducted
under the direction of Dr. Henry J. Heimlich, known for the Heimlich
maneuver, with the participation of two UCLA researchers, Dr. John
L. Fahey and Dr. Najib Aziz. The project director in China is a
former UCLA postdoctoral student, Dr. Xiao Ping Chen.
At least three clinical trials have taken place and three scientific
articles have been submitted to international AIDS conferences
describing the research. These papers acknowledge the participation
of Drs. Fahey and Aziz and the use of UCLA laboratories, as well as
the financial support of Dr. Fahey.
Meanwhile, Dr. Heimlich, the Heimlich Institute, and Deaconess
Hospital Associations, all of Cincinnati, Ohio, aggressively promote
and fundraise for this work and enthusiastically tout their affiliation
with UCLA and Dr. Fahey.

Since the early 1980s, Dr. Heimlich has advocated an experimental

treatment which he calls "malariotherapy," based on the theory that
raising the body's temperature stimulates the immune system. To
accomplish this, malarial human blood is injected into patients to
bring on a high fever, causing body temperatures as high as 105
degrees. After several weeks of induced malarial fevers, the subject's
malaria is treated with medication.
At various times, Heimlich, who has no training or background in
immunology, has promoted "malariotherapy" as a multipurpose
treatment to cure cancer, Lyme disease, and AIDS.
(As the source of his theories, Heimlich cites Austrian psychiatrist
Julius Wagner-Jauregg. In the early 1900s, Dr. Wagner-Jauregg
advanced fever therapy as a cure for neurosyphilis in the days before
antibiotics. In 1927, he won the Nobel Prize for this work, although
more recent research has questioned the reliability of his studies and
conclusions. Later in life, Wagner-Jauregg became a Nazi eugenicist.)
Heimlich has engaged in "malariotherapy" experiments outside of
U.S. borders. According to an article in the Cincinnati Post, "In
December 1987, (Heimlich) treated three advanced cancer patients in
a Mexico City hospital by infecting them with malaria." In the early
1990s, Heimlich conducted additional human studies in Mexico, this
time injecting malarial blood into Americans suffering from Lyme
disease. The Centers for Disease Control warned against Heimlich's
Lyme disease theory as ineffective and dangerous.
In the 1990s, Heimlich promoted "malariotherapy" for Lyme disease
in numerous articles in the popular press. However, Heimlich's
current fundraising materials and web site contain no mention at all
of Lyme disease. The outcome of Heimlich's Lyme disease and cancer
patients is unknown and no information is presented in his current
online materials. Searches on Medline and PubMed produced no
journal articles on his "malariotherapy" trials for Lyme disease or
cancer. It is unknown whether Heimlich continues to advocate
"malariotherapy" for Lyme disease or if he has chosen to drop that
disease from his list.
In the early 1990s, Heimlich proposed that induced malaria should be
tested as a treatment for AIDS. On April 29, 1993, the Centers for
Disease Control issued a public health alert which stated "the use of
induced malaria infection in HIV-infected individuals cannot be
justified." A 1994 article in the Los Angeles Times described in detail
Heimlich's methods and fundraising. The article also included critical
comments from AIDS experts such as Dr. Anthony Fauci from the

National Institutes of Health who called Heimlich's malaria

treatments "quite dangerous and scientifically unsound." (This article
also contained angry comments from American Lyme disease patients
who had undergone Heimlich's "malariotherapy" in Mexico.)
The China "malariotherapy" experiments using HIV-positive subjects
have been ongoing since the mid-1990s and appear to be growing
more extreme. The most recent "malariotherapy" research paper
states that malaria had been induced in a patient with full-blown
AIDS who was suffering from additional complications:
Case 12 was a full-blown AIDS patient with complicated ulcer of
external genitalia, pneumocystis carinii pneumonia (PCP, clinical
diagnosis) with dispnea, needed oxygen inhalation. (From "Impact of
Acute Vivax Malaria on the Immune System of HIV-Positive
Subjects" by Chen et al, 2001, which acknowledges the participation
of Drs. Heimlich, Fahey, and Aziz.)
The Heimlich Institute is a nonprofit corporation promoting
Heimlich's work and is a member organization of Deaconess
Associations Inc., a hospital and health care services provider in
Cincinnati. The China malaria experiments, along with the
participation of UCLA and Dr. Fahey, are promoted on the Heimlich
Institute web site, in interviews with Heimlich, and in online
fundraising newsletters for the Heimlich Institute.
From the Heimlich Institute web site:
Our clinical studies in China continue to prove the benefits that
malariotherapy has for HIV patients and to elucidate the interaction of
malaria with HIV. To this end, the Heimlich Institute is working in
conjunction with UCLA, gathering and analyzing data to show what
immunological factors are responsible for the benefits derived from
malariotherapy for HIV.
From a 1998 interview with Heimlich by Dr. John McDougall, a wellknown advocate of so-called alternative therapies:
Heimlich: We have an AIDS project now in China. We presented the
results in 1996 at the National Institutes of Health and then at the AIDS
Conference in Vancouver. As a matter of fact, UCLA has just joined
with us in this project.
(Later in the interview) McDougall: Can you say (the patients) are
cured?

Heimlich: We can say that the immune cells, which fight off the virus in
AIDS, but ordinarily gradually diminish year after year, have increased
and stay increased. Now, with UCLA working with us doing viral loads,
measuring the actual virus, within the next five to six months, we should
know that answer. The patients are in China, the blood is being analyzed
at UCLA. We want to treat the next 100 patients immediately. We are
now seeing funds, grants, to do that.
From "Caring World," the Heimlich Institute's online fundraising
newsletter, Fall 1999:
HOW YOU CAN HELP SAVE LIVES: MALARIOTHERAPY
RESEARCH TO TREAT HIV/AIDS ($1.2 MILLION) Since 1994, Dr.
Heimlich and his colleagues at the University of California at Los
Angeles (UCLA) have been piloting the use of malariotherapy as a
potential cure for HIV infection...To date, 18 patients are in various
stages of malariotherapy treatment. Follow-up data collected shows a
substantial increase in CD-4 T-cell levels, and patients have remained
asymptomatic for more than three years. The malariotherapy treatment
takes only three weeks and no additional treatment has been required.
To validate and replicate these findings, Dr. Heimlich's research team
requires support that will enable them to offer this potentially invaluable
treatment to additional patients. At $10,000 per patient, $1,200,000
would provide funds to test another 120 patients, and validate the use of
malariotherapy to treat HIV.
In 1996, Professor John Fahey, of UCLA, asked to join the Heimlich
Institute in this research project. UCLA is currently conducting our
laboratory studies. Having recently returned from visiting our
colleagues in China, Dr. Fahey is very positive about the results of these
three-year clinical studies....The Heimlich Institute plans to extend
malariotherapy to the treatment of cancer and other diseases that may
be curable by strengthening the immune system
From "Caring World," Winter 1998:
After Dr. Heimlich presented the Heimlich Institute's results of
treatment at the National Institutes of Health (NIH) and at the XI
International Conference on AIDS in Vancouver, UCLA requested to
join the Heimlich Institute in this project. Since then, the Heimlich
Institute and our colleagues in China are working closely with John L.
Fahey, MD, director for the Center for Interdisciplinary Research in
Immunology and Disease at UCLA. Dr. Fahey's laboratories are
carrying out independent verification of the immunological results
obtained in China as well as providing technical support. Recently, Dr.

Fahey visited Dr. Chen and found patients' treatment progressing

extremely well.
Dr. Fahey and Dr. Aziz's contributions to the Chine se
"malariotherapy" projects are also acknowledged in the following
scientific articles:
From Chen, Heimlich, et al: "Phase-1 Studies of Malariotherapy for
HIV Infection" Chinese Medical Sciences Journal, Dec. 1999:
p.228
Acknowledgments - Many special thanks are given to Dr. John L. Fahey
for providing a part of financial support, suggestions, and comments, to
Dr. Najib Aziz, Dr. Pari Nishanian, and Mrs. Haripi Nishanian for
many helps in testing of cytokine, activation markers, and HIV P24
antigen.
p.225
HIV P24 antigen (immuno-complex dissociation method, abbreviated to
ICD, Coulter Corporation, USA) were measured by ELISA in the
University of California at Los Angeles (UCLA), USA
From Chen et al: "Impact of Acute Vivax Malaria on the Immune
System of HIV-Positive Subjects" Presented at 6th International
Conference on AIDS in Asia and the Pacific, Melbourne, Australia,
Oct. 5-11, 2001
Acknowledgments - Our special thanks should be given to Dr. John L.
Fahey for his helps (sic) in research design, generous donation of
reagents for flow cytometry and cytokine quality control measurement
and for review of the manuscript to Dr. Naji Aziz for technological
guidance of cytokine measurement; both work at Center for
Interdisciplinary Research in Immunology and Disease, Departments of
Medicine and of Microbiology and Immunology, UCLA School of
Medicine, Los Angeles.
On his web site, Heimlich states that he obtained institutional review
board approval for these experiments:
Institutional Review Board approval was obtained for this
study...Informed consent to participate in this clinical prospective study
of malariotherapy for HIV infection was obtained.
The facts are not so simple. In May 1994, for his first experiments in
China, Heimlich obtained Institutional Review Board (IRB) approval
from the Great Lakes College of Clinical Medicine (GLCCM), a

center for so-called "alternative health" therapies, with whom

Heimlich had close ties. On March 9, 2000, The Food and Drug
Administration (FDA) issued a 14 page warning letter to GLCCM.
This letter detailed a variety of IRB procedural failures and
prohibited the GLCCM IRB from approving new studies and from
adding new subjects to ongoing studies.
Heimlich states that he obtained informed consent from the research
study's Chinese subjects. Yet a number of the FDA criticisms of the
GLCCM IRB were directed at whether these subjects in Heimlich's
China "malariotherapy" studies were adequately informed before
providing their consent to participate in the study. From the FDA's
warning letter to GLCCM:
The consent form does not adequately describe the procedures to be
followed. The actual procedure involves injection of blood from a
malaria-infected person into the study subjects. There is no description
of the steps taken to screen malaria parasite donors for pathogens.
The duration of the study is described as unlimited. The longterm risks
of the study and the frequency of follow up are not defined.
The risks of receiving blood from another person are not described. The
possibility of receiving blood-borne pathogens is not discussed.
There is no description of the consequences of a subject's decision to
withdraw from the research, such as during the stage of malaria
infection.
There is no description of the lifelong risks associated with malarial
infection, other than ruptured spleen and death.
The consent form lacks the identity of whom to contact in the event of
research-related injury to the subject.
The consent form lacks an explanation of whom to contact for answers
to questions about research subjects rights.
Use of the wording You understand, is inappropriate. The subjects may
certify that they understand the statements in the consent form and are
satisfied with the explanation provided by consent process, but many will
not comprehend the underlying scientific and medical significance of all
the statements, nor are they in a position to judge whether the
information provided is complete. Subjects should not be required to
certify such understanding or completeness of disclosure.

The consent form contains exculpatory language in which the

prospective subject is made to waive or appear to waive any of the
subject's legal rights, or releases or appears to release the investigator,
the sponsor, the institution, or its agents from liability for negligence.
Heimlich responded to the FDA criticisms in a May 4, 2000 letter,
obtained through the Freedom of Information Act. In his letter,
among other criticisms, Heimlich challenges the FDA's authority as
well as accusing the FDA investigator of "ethnic bias" for questioning
the conditions under which Chinese research subjects were injected
with malaria.
Heimlich also states:
In 1996, following presentations at the NIH (Bethesda, MD) and the
12th World AIDS Conference (Vancouver), a leading AIDS authority, a
professor from a major U.S. university's immunology department, asked
to join this effort. Their doctors also made regular trips to the research
site in ________ (FDA redaction) to provide independent evaluation of
the quality of research being done by our colleagues in _______. They
also provided independent corroboration of the results from ______.
Heimlich's previously cited quote from "Caring World" makes it
reasonably certain that he was referring to UCLA and Dr. Fahey.
Here, in his letter to a federal agency, Heimlich claimed these
affiliations in order to legitimize his project.
In May 2000, GLCCM terminated IRB approval of Heimlich's project
and, shortly thereafter, the GLCCM IRB itself ceased operation. None
of this information is provided on the Heimlich Institute or Deaconess
web sites. As cited above, the Heimlich Institute web site continues to
advertise that his study has IRB approval, despite having lost this
approval over two years ago.
Meanwhile, criticism of the Heimlich-UCLA "malariotherapy"
experiments by the legitimate medical community has not been timid,
both in the US and abroad.
From the New England Journal of Medicine, September 18, 1997:
Acceptance of a standard of care that does not conform to the standard
in the sponsoring country results in a double standard in research. Such
a double standard, which permits research designs that are unacceptable
in the sponsoring country, creates an incentive to use as research
subjects those with the least access to health care. What are the potential
implications of accepting such a double standard? Researchers might

inject live malaria parasites into HIV positive subjects in China in order
to study the effect on the progression of HIV infection, even though the
study protocol had been rejected in the United States and Mexico.
(Citation: Heimlich HJ, Chen XP, Xiao BQ, et al. CD4 response in HIV
positive patients treated with malaria therapy. Presented at the 11th
International Conference on AIDS, Vancouver, B.C., July 7-12, 1996.
abstract)
From a 1999 letter to the World Medical Association from Drs. Peter
Lurie and Sidney Wolfe of Public Citizen:
We are writing to express alarm at the current draft revised version of
the Declaration of Helsinki....The proposed Declaration is stunningly
complacent. There seems to be no recognition of recent abuses in
international research (e.g., Dr. Henry Heimlich's injection of live
malaria into HIV-positive persons in China after the study was opposed
in the United States, (and) the well-documented failings of Institutional
Review Boards (IRBs)....
From "Human Subject Research, Ethics and the Developing World"
by Dr. Farhat Moazam, Aga Khan University Hospital, Karachi:
In another study in 1997, patients with HIV infection were deliberately
inoculated with plasmodium vivax to produce symptomatic malaria. The
objective was to study the effects on their immune systems. This was a
collaborative research undertaken by two hospitals in China and the
Heimlich Institute in Cincinnati. As part of the protocol, subjects could
not participate in any HIV therapy for the duration of the study and the
follow-up period. Institutional Review Boards of the host country had
approved the research as ethical, something that would have been highly
unlikely if the study had been undertaken in the sponsoring country.
From Ethics in International Health Research: A Perspective from
the Developing World, by Dr. Z. Ahmed Bhutta, World Health
Organization Working Paper Report, Commission on
Macroeconomics and Health, 2002:
The fact remains that doctors are every bit as human or inhuman as
other inhabitants on this planet and come in all shades and colors. The
recent guidelines for regulation of human experimentation must be seen
in the backdrop of atrocities committed by doctors upon vulnerable
subjects within recent memory. The highly controversial trials of
induction of malaria in HIV patients (Heimlich et al 1997) and the
trovafloxacin trial in Nigeria (Boseley 2001, Stephens 2000 & 2001) are
two recent examples. Few also recognize that Radovan Kradzik, who
stands accused of master minding the worst possible mass genocide in

Europe in the post second world war era, is also a psychiatrist by

training. Thus the regulation of human subjects research would require
more than an appeal to basic human good and abject faith in the
beneficence of the medical profession.
Clearly unscrupulous and opportune research which exploits the
vulnerability and want of a given population, must be condemned. The
case of the Trovan drug trial in the midst of a meningitis outbreak in
Nigeria (Stephens 2000) and the induction of malaria in HIV patients (
Heimlich et al 1997) are examples where the need for ethical guidelines
and minimal universal ethical standards for research becomes absolute.
From "International Research Ethics Guidelines Under Threat," Udo
Schuklenk, Issues in Medical Ethics, July-September 1999:
A number of international clinical research efforts have disregarded the
currently applicable international research ethics guidelines in vital
respects. More than once, researchers have been caught red-handed and
often red-faced by an alert international community of activists,
concerned medical professionals and bioethicists. Unfortunately, the
powerful US bioethics community's response has been to propose
further dilutions of ethical standards in research instead of improving
the standards of research clinical trials undertaken in developing
countries. A US-based researcher, Henry Heimlich, injected live malaria
parasites into HIV-infected people in the People's Republic of China
after his research proposal was denied approval in the USA. This
contravened CIOMS guidelines requiring that western researchers in
developing countries provide clinical care meeting the standards of care
in their home country.
UCLA cannot be unaware of the discrimination facing AIDS patients
in China. Having AIDS in China brings with it a terrible stigma.
Those infected with HIV and AIDS are often rejected by their families
and ostracized by their community. Medical care is either unavailable
or of poor quality. These are terribly vulnerable people. Under these
circumstances, protecting the rights of experimental research subjects
becomes that much more crucial.
Are Heimlich and his colleagues adequately protecting the rights of
their subjects? If the FDA criticisms of the GLCCM IRB and their
consent forms are any indication, that protection is in doubt.
Furthermore, injecting malaria into people already sick with another
disease, meanwhile denying them access to other AIDS treatments, is
reminiscent of the Tuskegee syphilis research atrocities. Yet,
according to Heimlich, Chen, et al, denying other treatments to their

Chinese research subjects was a condition of participation in their

study:
Criteria for acceptance included asymptomatic HIV infection, absence
of other concurrent infections and willingness to not participate in other
HIV therapies for duration of the treatment and follow-up period.
(Emphasis added)
Staging such experiments in the United States or in any developed
country is unimaginable. Not only would the research be condemned
immediately, but the organizers would be discredited and held legally
accountable. However, when it comes to these research subjects in
China, it is a different story.
International criticism of these experiments has not affected
fundraising for "malariotherapy." From the Deaconess web site:
With your support, the Heimlich Institute can continue its important
research into treatment for HIV/AIDS, cancer, cystic fibrosis, asthma
and many other health conditions. We already have evidence that these
methods work, but further studies are needed to substantiate these
procedures and treatments. The Institute, which is a non-profit
organization, depends on funds from free-thinking individuals and
organizations to continue its commitment to saving lives.
A visitor to the Heimlich Institute/Deaconess web sites, which are
linked together, would have to go elsewhere to learn about the
condemnation that has greeted the Heimlich malaria experiments. It
appears not even potential donors are entitled to informed consent.
Given the nature of these studies, it is startling that this work is being
used as a fundraising vehicle. For a major hospital and health services
provider to do so places that institution in conflict with its
fundamental purpose, which is to provide medical care. And
Deaconess cannot claim any separation from the Heimlich fundraising
since all funds raised by the Heimlich Institute are directly paid to
Deaconess.
For UCLA to lend its name and credibility to the fundraising by
Heimlich and Deaconess since 1994 is incomprehensible. How much
money has been raised to carry on these grotesque experiments? Also,
the 1999 paper by Chen, Heimlich, et al, states:
Funding for this study was provided by Eleanor Dana Charitable Trust,
David Mahoney, Chairman.

Was UCLA involved in obtaining the Dana Trust funding? And, since
Dr. Fahey has been acknowledged as providing financial support, are
UCLA funds being used to finance these research trials? Are
California taxpayers aware that their public university is affiliated
with medical atrocity experiments?
Heimlich is now expanding his "malariotherapy" trials into Africa.
(See "Caring World," Spring 99, Summer 01). At the end of this
month, he is making a keynote presentation at the PanAfrica AIDS
Conference in Nashville, Tennessee. Is UCLA partnering with
Heimlich's "malariotherapy" experiments on desperate African AIDS
patients?
It goes without saying that the global AIDS emergency calls for
creative responses by the medical community. Yet this very urgency
has created opportunities for the exploitation of vulnerable
populations by researchers whose ambition may blur their ethical
judgement.
That human experiments of this kind were conceived, let alone
carried out, is reason enough to justify the need for strict
international research standards and oversight. The fact that a
leading American university and a major hospital continue to
participate in such notorious work, long after that work has been
overwhelmingly denounced, only reinforces that need.
I respectfully urge UCLA, Dr. Fahey, and Dr. Aziz to reconsider their
participation in these shameful experiments and to sever ties with
them. I also request that UCLA make an immediate statement
regarding its participation in this work and to fully disclose all
financial and scientific records associated with these experiments.
In order to protect my privacy and that of my colleagues, I prefer to
submit this letter under a pseudonym.
Thank you for your attention to these concerns. I look forward to
your reply.
Sincerely,
"Dr. Bob Smith"
email: bob-smith@volny.cz
voicemail & FAX: (978)477-8349

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