By Kelli Ann Davis
Last week, I wrote an open letter to Drs. Fineberg and Salerno of the Institute of Medicine (IOM) in regards to a notice I received announcing a new IOM Committee to Review Adverse Effects of Vaccines: (HERE)
• Health Resources and Services Administration (HRSA) has contracted with the Institute of Medicine (IOM) to review the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the Vaccine Injury Compensation Program. The vaccines to be reviewed are varicella zoster vaccine, influenza vaccines, hepatitis B vaccine, and human papillomavirus vaccine. Other vaccines could be added if additional funding is secured. The committee will author a consensus report with conclusions on the evidence bearing on causality and the evidence regarding the biological mechanisms that underlie specific theories for how a specific vaccine is related to a specific adverse event.
HRSA, as I outlined in my article yesterday, has been designated as a lead agency in a bill “to provide for enhanced treatment, support, services, and research for individuals with autism spectrum disorders and their families” which was introduced by Senators Durbin, Casey and Menendez last week. And as you may recall, HRSA has already stated its position regarding any possible link between vaccines and autism in a Press Release from
March 3, 2008:
• HRSA has reviewed the scientific information concerning the allegation that vaccines cause autism and has found no credible evidence to support the claim. Accordingly, in every claim submitted under the Act, HRSA has maintained and continues to maintain the position that vaccines do not cause autism, and has never concluded in any case that autism was caused by vaccination.
Considering the fact that the official Charge to the IOM Committee is still under development by HRSA (autism could end up on the list of adverse events to be studied) and HRSA’s current stance on vaccines and autism, I believe it is imperative for our community to submit comments to the IOM website in an effort to help shape the roster and Charge as indicated below:
• Please note that the appointments made to this committee are provisional, and changes may be made. No appointment shall be considered final until we have evaluated relevant information bearing on the committee's composition and balance. This information will include the confidential written disclosures to The National Academies by each member-designate concerning potential sources of bias and conflict of interest pertaining to his or her service on the committee; information from discussion of the committee's composition and balance that is conducted in closed session at its first meeting and again whenever its membership changes; and any public comments that we have received on the membership during the 20-calendar day formal public comment period. If additional members are appointed to this committee, an additional 20-calendar day formal public comment period will be allowed. It is through this process that we determine whether the committee contains the requisite expertise to address its task and whether the points of views of individual members are adequately balanced such that the committee as a whole can address its charge objectively.
Call to Action – Wednesday and Thursday ONLY:
• Access the IOM website here (HERE)
• Scroll down to the bottom and click the “Feedback” button
• In Subject box enter: “IOM Committee to Review Adverse Effects of Vaccines”
• Enter your e-mail address
• In Comment box cut and paste the following information and enter into the box:
The inclusion of Huge A. Sampson, a vaccine patent holder, is a gross conflict of interest for a Committee that is focused on determining whether certain adverse events resulted from the administration of a vaccine and his immediate removal from the Committee is warranted and necessary.
The inclusion of Anthony L. Komaroff, founding editor of Journal Watch (which is produced by the publishers of the New England Journal of Medicine – a publication which receives advertising funds from pharmaceutical companies) should be disqualified from this Committee due to this inherent and on-going conflict of interest.
I’d like to see experts who view, study, and/or treat autism as a whole-body, biological condition incorporated into the Committee. Possible candidates:
Mark Noble – Professor of Genetics, Neurobiology and Anatomy, Department of Biomedical Genetics, University of Rochester Medical Center, Rochester, NY.
Martha Herbert – Assistant Professor of Neurology at Harvard Medical School, a Pediatric Neurologist at the Massachusetts General Hospital in Boston, a member of the MGH Center for Morphometric Analysis, and an affiliate of the Harvard-MIT-MGH Martinos Center for Biomedical Imaging.
Alan Greene – Clinical Professor of Pediatrics at Stanford University School of Medicine, an attending Pediatrician at Packard Children’s Hospital, and a Senior Fellow at the University California San Francisco Center for the Health Professions. Dr. Greene is a regular columnist for Kiwi Magazine, and is the online Pediatric Expert for WebMD, Rob Reiner’s ParentsAction.org, Better Homes and Gardens, Family Circle, Lady’s Home Journal, Healthy Kids, and American Baby – in addition to his own award-winning website. He is also the Pediatric Expert for The People’s Pharmacy (as heard on NPR).
Lawrence D. Rosen – Chief of Pediatric Integrative Medicine at Hackensack University Medical Center, a board certified general pediatrician, and a founding member of the American Academy of Pediatrics Provisional Section on Complementary, Holistic and Integrative Medicine. He is a frequent speaker at both professional and consumer gatherings, discussing topics such as holistic care of the newborn and the integrative management of autism.
Bob Sears – Board certified pediatrician in private practice with his father, Dr. Bill Sears, and brother, Dr. James Sears, in San Clemente, CA. He is affiliated with Mission Hospital and Children’s Hospital at Mission, Saddleback Memorial Hospital, San Clemente Hospital and South Coast Medical Center. He has co-authored several books including: The Baby Book 2003 Revised Edition, ThePremature Baby Book 2004, The Baby Sleep Book 2005, and Father’s First Steps 2006: 25Things Every New Dad Should Know. Dr. Sears has also written for Contemporary Pediatrics and Newsweek Japan.
Issac Pessah -- Director, UC Davis Center for Children’s Environmental Health, Professor, Department of Molecular Biosciences, School of Veterinary Medicine.
Irva Hertz-Picciotto – UC Davis Department of Public Health Sciences (formerly Dept Epidemiology and Preventive Medicine). Her research interests are in environmental exposures (metals, pesticides, PCBs, air pollution), pregnancy outcomes (spontaneous abortion, fetal growth, early child development), and epidemiologic methods (left truncation in survival analysis, the ‘healthy worker survivor bias,’ timing issues, and use of epidemiologic data in quantitative risk assessment). Chaired the U.S. Institute of Medicine/ National Academy of Sciences Committee on the Health Effects in Vietnam Veterans of Exposure to Agent Orange and other Herbicides in 2000 and 2002. Deputy Director of the Children’s Center for Environmental Health at UC Davis, focused on autism and other neurodevelopmental disorders.
Since this Committee is slated to look at “adverse health events associated with specific vaccines covered by the Vaccine Injury Compensation Program (VICP)” the Charge should accurately reflect the VICP’s burden of proof which is biological plausibility and not biological mechanisms as currently stated. In the absence of clear definitions for biological mechanisms which are associated with autism, all of the science being reviewed (under the current Charge) would be theoretical. As such, it will be impossible for any of the studies to meet the standard of proof, thus predetermining the outcome: No evidence of a causal relationship.
Therefore, I’d like to have a legal expert who is familiar with VICP explain the legal burden of proof to the Committee and outline the differences between mechanisms and plausibility before the Committee begins its work; it is imperative that the process for deliberations be consistent with the goals specified in the Charge.
Given the serious nature of this issue, the automatic “weight” of any report which is released by this Committee, and the misconceptions surrounding the “findings” of the 2004 IOM VSR Report, we would like the Charge to specifically state that a pronouncement will only be made when the evidence is sufficient to determine plausibility; otherwise if the evidence is insufficient, then the Committee should identify the gaps, call for further research into those areas and leave any decision regarding plausibility with VICP based on the individual merits of each case.
Since the Department of Health and Humans Services (HHS) is the defendant in Vaccine Court and the current IOM Committee is going to produce a Report on adverse events associated with vaccines which may be used in determination decisions by this agency, it seems reasonable to insist that government funded studies be disqualified from consideration in Committee deliberations.
To ensure this happens, we would like all Committee deliberations and meetings to be open to the public.
• Click on Submit button.
Thank you and I will keep the community updated on any developments regarding this important Committee!
Kelli Ann Davis is the D.C. Political Liaison for Generation Rescue