Omnibus Court Rules against Autism-Vaccine Link

Omnibus Court Rules against
Autism-Vaccine Link

Stephen Barrett

The U.S. Court of Federal Claims has found no link between autism and vaccination. In a stunning trio of decisions, Special Masters have concluded that no credible evidence exists that MMR (measles/mumps/rubella) or thimerosal-containing vaccines can combine to to cause autism. The decisions also criticized doctors who base their treatments on these notions. More than 5,000 families who claim that vaccines caused their children to become autistic are seeking compensation under the National Vaccine Injury Compensation Program (VICP). The decisions came in three cases selected to "test" how similar cases should be handled.

Background Information

The VICP is a federal no-fault program enacted in 1986 (and since amended) that was designed to deal with an epidemic of lawsuits that threatened the continued availability of childhood vaccines nationwide. Rather than suing a manufactuer or provider through the civil tort system, claimants must petition for “no-fault” compensation with the U.S. Court of Federal Claims. The petition must also be served upon the Secretary of Health and Human Services, who replaces the vaccine manufacturer or administrator to defend the claim. Claimants need not prove negligence, failure to warn, or other tort causes of action; they only need to prove that a vaccine caused injury. The VICP now covers vaccines against 12 diseases: diphtheria, tetanus, pertussis, measles, mumps, rubella (German measles), polio, hepatitis B, hemophilus influenza type b (Hib), varicella (chicken pox), rotavirus, and the annual influenza (flu) vaccine.

The Act also created the Office of Special Masters within the Court of Federal Claims. The Special Masters function as trial judges with final decision-making authority. Their rulings can be appealed to the Court on an “arbitrary and capricious” standard, with further review available through higher federal courts. The VICP is funded by a 75¢-per-dose excise tax that goes into a trust that covers awards and administrative costs. The program provides compensation for past and future medical expenses; rehabilitation; therapies; special education; equipment; placement; pain and suffering ($250,000 limit); lost earnings; and vaccine-related death ($250,000).

In 2001, parents began filing petitions alleging that MMR vaccinations, the thimerosal ingredients in certain other vaccines, or a combination of factors might be causing or contributing to autism. When it became clear that thousands of cases would have similar allegations, the Omnibus Autism Proceeding was established. To proceed efficiently, the parties agreed to process "test cases" for each "general causation" theory presented by the Petitioners’ Steering Committee. Ultimately, two such theories were advanced:

MMR vaccines and thimerosal-containing vaccines can combine to cause autism.
Thimerosal-containing vaccines can cause autism.

Three Special Masters were each assigned one case for each theory. Evidentiary hearings on the first theory were conducted in 2007, after which the parties filed additional documents and briefs. In addition to 5,000 pages of transcripts and well over 700 pages of post-hearing briefs, the records in these three cases contain 939 medical articles (a typical vaccine case presents about 10). A total of 50 expert reports were filed and 28 experts testified, whereas typical vaccine cases present 2-6 experts. The first set of Special Master decisions was issued in February 2009. Evidentiary hearings on the second causation theory were conducted in 2008. Post-hearing briefing is expected to conclude by the early summer of 2009, after which the Special Masters will consider the evidence and issue their respective opinions.

The First Set of Rulings

On February 12, 2009, all three Special Masters ruled that the MMR vaccine, whether administered alone or together with thimerosal-containing vaccines, was not a causal factor in the development of autism or autism spectrum disorders. The decisions completely debunked the notions and implied that doctors who base their treatments on them are unscientific and unethical.

In the case of Colten Snyder, Special Master Denise K. Vowell concluded.

Page 2: After careful consideration of all of the evidence, it was abundantly clear that petitioners’ theories of causation were speculative and unpersuasive. Respondent’s experts were far more qualified, better supported by the weight of scientific research and authority, and simply more persuasive on nearly every point in contention.

Page 208: Doctor Rust used the term “scientific fraud” in describing the information upon which the MMR theory of causation is based. While noting that scientists are very careful about using that term, he testified that there was “abundant evidence” of scientific fraud in the body of evidence developed to support the MMR-autism hypothesis. Sadly, the petitioners in this litigation have been the victims of bad science, conducted to support litigation rather than to advance medical and scientific understanding of ASD.

Page 278: To conclude that Colten’s condition was the result of his MMR vaccine, an objective observer would have to emulate Lewis Carroll’s White Queen and be able to believe six impossible (or, at least, highly improbable) things before breakfast. The families of children with ASD and the court have waited in vain for adequate evidence to support the autism-MMR hypothesis. Although I have the deepest sympathy for families like Colten’s, struggling emotionally and financially to find answers about ASD’s causes, and reliable therapies to treat ASD’s symptoms, I must decide Colten’s case based on the evidence before me. That evidence does not establish an adequate factual basis from which to conclude that Colten’s condition was caused by his vaccines.

In the case of William Yates Hazlehurst, Special Master Patricia E. Campbell-Smith concluded:

Page 19: Petitioners’ expert witnesses . . . were not as disciplined in their discussion of topics where differences mattered, specifically, in degree of produced impairment, in type of mercury or type of measles virus (whether wild-type or vaccine-strain), and in exposure dosage. Additionally, when referring to the filed medical literature, petitioners’ experts tended to assign greater weight to speculative conclusions offered by the investigators involved in the studies than did the investigators themselves. Petitioners’ experts also urged reliance on a few carefully selected sentences from particular articles which, when considered in the proper context of the referenced articles, did not support the propositions advanced by the witnesses. Moreover, because petitioners’ experts relied on a number of scientifically flawed or unreliable articles for several important aspects of their causation theory, their testimony on those aspects of their offered theory could not be credited as sound or reliable. Finally, petitioners’ experts made several key acknowledgments during testimony that rendered their proposed theory of vaccine causation much less than likely.

In the case of Michelle Cedillo, Special Master George L. Hastings, Jr. concluded:

Page 2: The evidence was overwhelmingly contrary to the petitioners’ contentions. The expert witnesses presented by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts, concerning most of the key points. The numerous medical studies concerning these issues, performed by medical scientists worldwide, have come down strongly against the petitioners’ contentions. Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. \

Page 173: The reports and advice given to the Cedillos by Dr. [Arthur] Krigsman and some other physicians, advising the Cedillos that there is a causal connection between Michelle’s MMR vaccination and her chronic conditions, have been very wrong. Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment.

Public health officials and other knowledgeable observers hope these rulings will reassure parents that vaccination is safe. Arthur Allen, author of Vaccine: The Controversial Story of Medicine's Greatest Lifesaver, placed the situation in further perspective in an article titled In Your Eye, Jenny McCarthy.

Surveys of U.S. parental opinion conducted for the American Medical Association in 2006 and 2008 show growing concern about the safety of vaccines. A study done by APCO Insight found that about 18 percent of parents had changed their vaccination practices out of safety concerns—compared with 12 percent in 2006. There's hope that today's ruling will reverse that trend. It won't affect the true believers. The notion that a government-backed, pharmaceutical-company-enriching program damaged their children has become a crusade and hobby and hangout for thousands of people, including movie stars like Jenny McCarthy and Jim Carrey, as well as doctors, lawyers, businessmen, and even a few scientists. An industry of hucksters, personal-injury lawyers, and clueless alternative-medicine practitioners has fed off of the desperation of parents of autistic children. Many parents, frantic to alter their children's diagnosis, turn to untested drugs, foods, vitamins, and extracts that promise to halt, or even reverse, autism—promising claims that some parents cling to.

The Special Masters' decisions were appealed to the U.S. Court of Federal Claims, which upheld them.

For Additional Information

This article was revised on August 19, 2009.