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Saturday, Jul 4, 2009
The Institute of Medicine's president criticizes "Deadly Immunity," and Robert F. Kennedy Jr. responds.
Jun 22, 2005 | [Read "Deadly Immunity," by Robert F. Kennedy Jr.]
A commentary on vaccine safety issues written by Robert F. Kennedy Jr. that appeared in Salon and Rolling Stone is rife with factual errors and distortions. Although there are numerous errors in Kennedy's piece that deserve correction and clarification, this letter focuses only on the errors pertaining to the Institute of Medicine.
Commentators and publications should take great care to ensure that their stories dealing with health provide parents with verifiable facts and reliable scientific evidence. Providing any less can lead to unwarranted fears and anxiety.
The Centers for Disease Control and Prevention and the National Institutes of Health asked the Institute of Medicine in 2000 to provide an independent and objective review of a series of vaccine safety concerns. This review resulted in a total of eight reports (for a full list see the IOM's Immunization Safety Review Web site). The charge to the study committee is a matter of public record and was discussed in a public meeting on Jan. 10, 2001.
Sponsors of IOM studies provide funding and their perspectives on what committees convened to carry out the studies should be charged to do. For example, in the case of IOM's studies of vaccines and autism, the CDC discussed what would make the committee's conclusions and recommendations most useful and understandable to policymakers, such as outlining specific research needs rather than giving a general recommendation that more research is needed. However, no organizations -- neither the CDC, nor the NIH, nor medical associations, nor parent groups, nor any others -- have control over committee members' conclusions and recommendations. The only factor that influences IOM committees' conclusions and recommendations is the evidence.
This is borne out by the results of IOM's first look at the thimerosal question in 2001. For those who are not aware, IOM visited the thimerosal question twice in its series on vaccine safety. At that time, the committee concluded that although there was not solid evidence linking thimerosal to brain disorders including autism, neither was the evidence sufficient to rule out a link. This would hardly seem to be a conclusion that would be reached by a committee that was "instructed to produce a report debunking the link," as Mr. Kennedy erroneously wrote. In addition, the committee in that report supported a call by the American Academy of Pediatrics for thimerosal to be removed voluntarily from vaccines.
Mr. Kennedy sought to buttress his misrepresentation of the purpose of the IOM studies by selectively using and fabricating quotations from the transcript of an organizational meeting held by the committee. He took words and phrases out of context, combined them and misrepresented them as direct quotes. The discussions recorded in this transcript focus on the committee members' efforts to make sure that they fully understood their charge and had reached agreement on the best way to conduct their study. Part of the discussions focused on the concerns, interests and stakes held by various parties, including both the CDC and parents.
For example, Mr. Kennedy used this partial quote from Dr. Marie McCormick: The CDC "wants us to declare, well, these things are pretty safe." Here is the full quote from Dr. McCormick: "I took away [from the previous day's discussion] actually an issue that we may have to confront, and that is actually the definition of what we mean by safety. It is safety on a population basis, but it is also safety for the individual child. I am wondering, if we take this dual perspective, we may address more of the parent concerns, perhaps developing a better message if we think about what comes down the stream as opposed to CDC, which wants us to declare, well, these things are pretty safe on a population basis." The full quote is part of a discussion of the need of parents to know if a vaccine is safe for an individual child (or if the vaccine is a danger for an ill child) compared with the public health community's need to know if vaccines pose risks to a whole population. In fact, Dr. McCormick proposed that the committee consider addressing the parental concerns about the health of an individual child -- not just the CDC's concern about population-wide effects.
In its 2004 report, the committee concluded that the totality of the evidence available indicated that neither thimerosal nor the measles-mumps-rubella vaccine is associated with autism. Contrary to Mr. Kennedy's assertions, the report clearly recommends that research continue to seek the cause or causes of autism, but that finite resources should be directed toward the most promising paths, and a significant investment in studies of the theoretical vaccine-autism connection is not useful at this time. The exact text of the IOM report reads: "The committee urges that research on autism focus more broadly on the disorder's causes and treatments for it. Thus, the committee recommends a public health response that fully supports an array of vaccine safety activities. In addition the committee recommends that available funding for autism research be channeled to the most promising areas." In addition, the committee recommended that trends in autism incidence in the United States be closely tracked now that thimerosal has been largely eliminated from routine immunizations. The report offers nine specific recommendations for research on autism, thimerosal and vaccine safety in general.
To reach its conclusions about the possible links between thimerosal and the MMR vaccine and autism, the committee reviewed a large amount of literature on this topic -- more than 215 references are cited in the 2004 report. The committee members based their conclusions on the whole body of the evidence, including toxicology studies, not just four epidemiological studies. The committee included several experts in epidemiology, pediatrics, clinical medicine, statistics and other relevant fields who reviewed and discussed in detail the strengths and weaknesses of the epidemiological, clinical and biological evidence pertaining to thimerosal and autism. Their detailed analysis of these strengths and weaknesses is included in their report, which is a public document available to anyone who wishes to read it. Mr. Kennedy did not offer a detailed analysis of why he views four of the studies reviewed by the committee as flawed.
In addition, Mr. Kennedy erroneously conflates the work of two entirely separate IOM committees. The IOM entered into a contract with the CDC in 2004 to assess the Vaccine Safety Datalink data-sharing program. (The VSD is a large, linked database of patient information such as vaccination histories, health outcomes and other characteristics that can be used to study whether health problems are associated with vaccinations.) As an independent, nongovernmental organization, the IOM cannot be forced to take on any particular study, nor was there pressure from Congress, parents or others to conduct this study. The Committee on the Review of the National Immunization Program's Research Procedures and Data Sharing Program did not review the work of the IOM Immunization Safety Review Committee, which wrote the report on vaccines and autism. The committee that reviewed the data-sharing program released a report in February 2005 that was directed to the CDC and others involved with the VSD, not to the IOM's Immunization Safety Review Committee.
Mr. Kennedy's piece does not mention that the IOM's studies on vaccines and autism -- like all IOM studies -- were peer reviewed (the equivalent of fact checking in the scientific community) by a group of outside experts before being approved for publication. The IOM, a branch of the National Academies, also follows stringent policies for reviewing the potential conflicts of interest or biases of individuals who are chosen to serve on its study committees. The members selected for the committee that reviewed vaccine safety issues had no links to the CDC, vaccine manufacturers, vaccine-related litigation or advocacy groups, and they had received no recent funding from the sponsors of the study. They received no remuneration for their work on the committee. The reputation of the National Academies for objectivity, integrity, independence and competence has been earned through numerous studies, and it is one of our most important assets.
Our corrections are only a subset of the many factual misstatements and errors contained in Mr. Kennedy's commentary. In the interests of accuracy and fairness -- and to alleviate unsubstantiated anxiety that this piece may have raised among readers -- we call upon Salon and Rolling Stone to publish this full letter and to run a complete correction of the many other errors contained in Mr. Kennedy's commentary.
-- Harvey V. Fineberg, M.D., Ph.D.
President, Institute of Medicine of the National Academies
