April 1, 2009
Dear Drs. Fineberg and Salerno,
On Friday, March 20th, Generation Rescue received the following notice from the Institute of Medicine (IOM) regarding a new Committee to Review Adverse Effects of Vaccines:
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.
As you may know, Generation Rescue is a parent-founded, parent-led organization of more than 900 mentor families and leading researchers and clinicians from around the globe working to not only discover the potential cause of ASD but also focusing on effective treatments. We also represent tens of thousands of parents who identify with our mission and who support Jenny McCarthy and Jim Carrey as front-line spokespersons for their cause. Since this IOM Committee is tasked to review adverse events associated with vaccines it is only fitting that our voice be heard on this very important matter as it pertains to possible IOM “outcomes” which could affect the lives of tens of thousands of children with autism.
In October 2006, I had the opportunity to meet with you Dr. Fineberg and at that time you stated “the success of the IOM is in its ability to remain impartial and transparent.” In 1997, The Federal Advisory Committee Act (FACA) was amended to establish criteria for ensuring that any advice or recommendations from the IOM to government agencies would be the result of an unbiased and transparent process:
The Academy shall make its best efforts to ensure that (A) no individual appointed to serve on the committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable, (B) the committee membership is fairly balanced as determined by the Academy to be appropriate for the functions to be performed, and (C) the final report of the Academy will be the result of the Academy's independent judgment. The Academy shall require that individuals that the Academy appoints or intends to appoint to serve on the committee inform the Academy of the individual's conflicts of interest that are relevant to the functions to be performed.
On March 23rd, I had a chance to discuss this current IOM project with Dr. Stratton. From that conversation, it is my understanding the official “Charge” is still under development and autism could end up on the list of adverse events the Committee will consider during its deliberations.
As such, it is imperative that immediate changes be made to the composition of the Committee (HERE) and its Charge in order to adequately prepare for this possible scenario:
(A) No individual appointed to serve on the committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable.
• 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 Englan 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.
(B) The committee membership is fairly balanced as determined by the Academy to be appropriate for the functions to be performed.
• Autism is dominating the news and capturing the attention of parents, health officials and government leaders throughout the country. The fact that tens of thousands of parents witnessed their child’s regression shortly after vaccination is a story that is not dying down nor going away. As such, it is certainly not a stretch to assume autism will be a topic of discussion for this Committee.
Recent clinical investigations have identified numerous co-morbid disease states in children with autism, including impaired gastrointestinal function, inflammatory bowel disease, immune dysfunction, chronic viral, fungal, and bacterial infections, evidence of increased oxidative stress, severely disordered serum chemistries, decreased elimination of toxins, methylation impairment, mitochondrial dysfunction, and microglial activation in the brain.
As such, we’d like to see experts who view, study, and/or treat autism as a whole-body, biological condition incorporated into the Committee. Some possible candidates are listed below:
1. Mark Noble – Professor of Genetics, Neurobiology and Anatomy, Department of Biomedical Genetics, University of Rochester Medical Center, Rochester, NY.
2. 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.
3. 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).
4. 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.
5. 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.
6. Issac Pessah -- Director, UC Davis Center for Children’s Environmental Health, Professor, Department of Molecular Biosciences, School of Veterinary Medicine.
7. 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.
(C) The final report of the Academy will be the result of the Academy’s independent judgment.
• According to the notice I received, “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.”
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, we’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.
In closing, I’d like to leave you with the words of President Obama regarding transparency, open government and scientific integrity:
“My Administration is committed to creating an unprecedented level of openness in Government. We will work together to ensure the public trust and establish a system of transparency, public participation, and collaboration.”
“The public must be able to trust the science and scientific process informing public policy decisions.”
It’s a new day and it’s time for a change. We’d like the IOM to step forward and make the changes outlined in this letter to ensure that this Committee and its work will be a solution to the problem – rather than another hurdle to overcome in the future.
Thank you Drs. Fineberg and Salerno and I look forward to your speedy reply,
Kelli Ann Davis
D.C. Political Liaison
PS…Tune in to Larry King Live this Friday night to catch Jenny, Jim, JB and Jerry Kartzinel as they speak out about the tens of thousands of parents who are recovering their children from autism.