Beruflich Dokumente
Kultur Dokumente
11 October 2010
Center for Vaccine Ethics & Policy
http://centerforvaccineethicsandpolicy.wordpress.com/
A program of
- Center for Bioethics, University of Pennsylvania
http://www.bioethics.upenn.edu/
- The Wistar Institute Vaccine Center
http://www.wistar.org/vaccinecenter/default.html
- Children’s Hospital of Philadelphia, Vaccine Education Center
http://www.chop.edu/consumer/jsp/microsite/microsite.jsp
This weekly summary targets news and events in the global vaccines field gathered
from key governmental, NGO and company announcements, key journals and
events. This summary provides support for ongoing initiatives of the Center for
Vaccine Ethics & Policy, and is not intended to be exhaustive in its coverage.
Vaccines: The Week in Review is now also posted in a blog format at
http://centerforvaccineethicsandpolicy.wordpress.com/. Each item is treated as an individual
post on the blog, allowing for more effective retrospective searching. Given email
system conventions and formats, you may find this alternative more effective. This
blog also allows for RSS feeds, etc.
Comments and suggestions should be directed to
David R. Curry, MS
Editor and
Executive Director
Center for Vaccine Ethics & Policy
david.r.curry@centerforvaccineethicsandpolicy.org
Events/Conference Watch
[Editor’s Note]
Vaccines: The Week in Review is now monitoring key events and conferences
and will include summaries of key announcements and other content. Event
Watch is not intended to be exhaustive, but indicative of themes and
issues the Center is actively tracking. If you would like to suggest events
and conferences for coverage, please write to David Curry at
david.r.curry@centerforvaccineethicsandpolicy.org
Journal Watch
[Editor’s Note]
Vaccines: The Week in Review continues its weekly scanning of key journals
to identify and cite articles, commentary and editorials, books reviews and
other content supporting our focus on vaccine ethics and policy. Journal
Watch is not intended to be exhaustive, but indicative of themes and
issues the Center is actively tracking. We selectively provide full text of
some editorial and comment articles that are specifically relevant to our
work. Successful access to some of the links provided may require
subscription or other access arrangement unique to the publisher. Our initial
scan list includes the journals below. If you would like to suggest other titles,
please write to David Curry at
david.r.curry@centerforvaccineethicsandpolicy.org
Human Vaccines
Volume 6, Issue 10 October 2010
http://www.landesbioscience.com/journals/vaccines/toc/volume/6/issue/10/
[Reviewed last week]
JAMA
Vol. 304 No. 13, pp. 1413-1514, October 6, 2010
http://jama.ama-assn.org/current.dtl
Special Communications
Evaluating the Risks of Clinical Research
Annette Rid; Ezekiel J. Emanuel; David Wendle
Abstract
The ethical appropriateness of clinical research depends on protecting
participants from excessive risks. Yet no systematic framework has been
developed to assess research risks, and as a result, investigators, funders,
and review boards rely only on their intuitive judgments. Because intuitive
judgments of risk are subject to well-documented cognitive biases, this
approach raises concern that research participants are not being adequately
protected. To address this situation, we delineate a method called the
systematic evaluation of research risks (SERR), which evaluates the risks of
research interventions by comparing these interventions with the risks of
comparator activities that have been deemed acceptable. This method
involves a 4-step process: (1) identify the potential harms posed by the
proposed research intervention; (2) categorize the magnitude of the potential
harms into 1 of 7 harm levels on a harm scale; (3) quantify or estimate the
likelihood of each potential harm; and (4) compare the likelihood of each
potential harm from the research intervention with the likelihood of harms of
the same magnitude occurring as a result of an appropriate comparator
activity. By explicitly delineating, quantifying, and comparing the risks of
research interventions with the risks posed by appropriate comparator
activities, SERR offers a way to minimize the influence of cognitive biases on
the evaluation of research risks and thereby better protect research
participants from excessive risks.
The Lancet
Oct 09, 2010 Volume 376 Number 9748 Pages 1195 - 1272
http://www.thelancet.com/journals/lancet/issue/current
Comment
Academic medicine must take its global role: the M8 Alliance of
Academic Health Centers and Medical Universities
Mazda Adli, Sabine Kleinert, Stephen K Smith, Detlev Ganten
Preview
At the inaugural World Health Summit in 2009, the M8 Alliance of Academic
Health Centers and Medical Universities was formed to lead intensified
international debate about research and education in global health
challenges. The idea was to create an international forum that seeks
discussions with governmental representatives, policy makers, non-
governmental organisations, civil society, and the health-related industry to
initiate cross-sectoral solutions for the most pressing global health
challenges.
Global health governance—the response to infectious diseases
Rose Gana Fomban Leke
Preview
The burden of disease that affects the developing world has grown from a
high prevalence of communicable infectious diseases1 to new additions of
emerging infections plus an increasing problem of non-communicable
diseases.2,3 Most infectious diseases are largely specific to the world's
poorest regions, and sub-Saharan Africa bears a great burden of these
diseases.4 Bilateral and multilateral institutions, followed by organisations
and many new initiatives including advocates for health, make up the
multiple actors that are responding to the increasing threats of such a crisis
in infectious disease.
Review
Financing of HIV/AIDS programme scale-up in low-income and
middle-income countries, 2009–31
Robert Hecht, John Stover, Lori Bollinger, Farzana Muhib, Kelsey Case, David
de Ferranti
Summary
As the global HIV/AIDS pandemic nears the end of its third decade, the
challenges of efficient mobilisation of funds and management of resources
are increasingly prominent. The aids2031 project modelled long-term funding
needs for HIV/AIDS in developing countries with a range of scenarios and
substantial variation in costs: ranging from US$397 to $722 billion globally
between 2009 and 2031, depending on policy choices adopted by
governments and donors. We examine what these figures mean for individual
developing countries, and estimate the proportion of HIV/AIDS funding that
they and donors will provide. Scenarios for expanded HIV/AIDS prevention,
treatment, and mitigation were analysed for 15 representative countries. We
suggest that countries will move in increasingly divergent directions over the
next 20 years; middle-income countries with a low burden of HIV/AIDS will
gradually be able to take on the modest costs of their HIV/AIDS response,
whereas low-income countries with a high burden of disease will remain
reliant upon external support for their rapidly expanding costs. A small but
important group of middle-income countries with a high prevalence of
HIV/AIDS (eg, South Africa) form a third category, in which rapid scale-up in
the short term, matched by outside funds, could be phased down within 10
years assuming strategic investments are made for prevention and efficiency
gains are made in treatment.
Nature
Volume 467 Number 7316 pp633-738 7 October 2010
http://www.nature.com/nature/current_issue.html
[No relevant content]
Nature Medicine
October 2010, Volume 16 No 10
http://www.nature.com/nm/index.html
[No relevant content]
New England Journal of Medicine
October 7, 2010 Vol. 363 No. 15
http://content.nejm.org/current.shtml
[No relevant content]
Pediatrics
October 2010 / VOLUME 126 / ISSUE 4
http://pediatrics.aappublications.org/current.shtml
Articles
Prenatal and Infant Exposure to Thimerosal From Vaccines and
Immunoglobulins and Risk of Autism
Cristofer S. Price, William W. Thompson, Barbara Goodson, Eric S. Weintraub,
Lisa A. Croen, Virginia L. Hinrichsen, Michael Marcy, Anne Robertson, Eileen
Eriksen, Edwin Lewis, Pilar Bernal, David Shay, Robert L. Davis, and Frank
DeStefano
OBJECTIVE Exposure to thimerosal, a mercury-containing preservative that
is used in vaccines and immunoglobulin preparations, has been hypothesized
to be associated with increased risk of autism spectrum disorder (ASD). This
study was designed to examine relationships between prenatal and infant
ethylmercury exposure from thimerosal-containing vaccines and/or
immunoglobulin preparations and ASD and 2 ASD subcategories: autistic
disorder (AD) and ASD with regression.
METHODS A case-control study was conducted in 3 managed care
organizations (MCOs) of 256 children with ASD and 752 controls matched by
birth year, gender, and MCO. ASD diagnoses were validated through
standardized in-person evaluations. Exposure to thimerosal in vaccines and
immunoglobulin preparations was determined from electronic immunization
registries, medical charts, and parent interviews. Information on potential
confounding factors was obtained from the interviews and medical charts. We
used conditional logistic regression to assess associations between ASD, AD,
and ASD with regression and exposure to ethylmercury during prenatal, birth-
to-1 month, birth-to-7-month, and birth-to-20-month periods.
RESULTS There were no findings of increased risk for any of the 3 ASD
outcomes. The adjusted odds ratios (95% confidence intervals) for ASD
associated with a 2-SD increase in ethylmercury exposure were 1.12 (0.83–
1.51) for prenatal exposure, 0.88 (0.62–1.26) for exposure from birth to 1
month, 0.60 (0.36–0.99) for exposure from birth to 7 months, and 0.60 (0.32–
0.97) for exposure from birth to 20 months.
CONCLUSIONS In our study of MCO members, prenatal and early-life
exposure to ethylmercury from thimerosal-containing vaccines and
immunoglobulin preparations was not related to increased risk of ASDs.
PLoS Medicine
(Accessed 10 October 2010)
http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-
1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1
&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1
c2a2501181c#results
Reflections on Pandemic (H1N1) 2009 and the International
Response
Gabriel M. Leung, Angus Nicoll
Summary Points
- Many of the initial responses to the 2009 H1N1 pandemic went well but
there are many lessons to learn for future pandemic planning.
- Clear communication of public health messages is crucial, and should not
confuse what could happen (and should be prepared for) with what is most
likely to happen.
- Decisions regarding pandemic response during the exigencies of a public
health emergency must be judged according to the best evidence available
at the time.
- Revising pandemic plans—to be more flexible and more detailed—should
wait for WHO leadership if national plans are not to diverge. Surveillance
beyond influenza should be stepped up, and contingencies drawn up for the
emergence or re-emergence of other novel and known pathogens.
- Data collection and sharing are paramount, and include epidemiological and
immunological data. Clinical management of severe influenza disease should
not be limited to the current antiviral regimen, and include the development
of other therapeutics (e.g., novel antivirals and immunotherapy).
- Greater and more timely access to antivirals and influenza vaccines
worldwide remains an ongoing challenge.
Science
8 October 2010 Vol 330, Issue 6001, Pages 137-280
http://www.sciencemag.org/current.dtl
[No relevant content]
Vaccine
http://www.sciencedirect.com/science/journal/0264410X