In the latest in a series of blows to the anti-vaccine movement, three judges ruled Friday in three separate cases that thimerosal, a common preservative found in some vaccines up until January 2003, does not cause autism. The three rulings are the second step in the Omnibus Autism Proceeding begun in 2002 in the United States Court of Federal Claims. The proceeding combines the cases of more than 5,000 families with autistic children seeking compensation from the National Vaccine Injury Compensation Program.
In the U.S., because of rising litigation that jeopardized the vaccine program and threatened to drive pharmaceutical companies out of the vaccine business, Congress passed the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660), which created the National Vaccine Injury Compensation Program (VICP).
The idea was to create an alternative to the tort system through which people injured by vaccines could be efficiently compensated. Vaccine litigants, if denied compensation, could still sue in conventional courts, but all claims for compensation had to go first through the VICP.
Beginning in 2001, parents, with the assistance of a blooming cottage industry of personal-injury lawyers, began filing petitions with the Secretary of Health and Human Services under the Vaccine Injury Compensation Program (VCIP), for compensation for harm to their children from vaccines. Parents were alleging that certain childhood vaccinations might be causing or contributing to autistic spectrum disorder.
Specifically, it was alleged that cases of autism, or neuro-developmental disorders similar to autism, may be caused by the MMR vaccination, by thimerosal, or by some combination of the two.
As the number of litigants claiming that vaccines caused their children’s autism ballooned to close to 5000, threatening to bankrupt the VICP unless massive infusions of new money from Congress were provided, the Office of Special Masters (OSM) of the U.S. Court of Federal Claims held a series of meetings in mid-2002, resulting in its issuance of Autism General Order #1 in July 2002, in which the OSM established the procedure for addressing the Omnibus Autism Proceeding (OAP).
As part of this proceeding, litigants were to choose what they considered to be the best cases representing their hypothesis of causation by which vaccines could produce autism and other neurodevelopmental disorders. The court would hear these cases, make rulings, and then these rulings would be used as the basis for all similar cases that would follow.
In the end, over 5300 cases alleging a causal relationship between such vaccinations and autism disorders were filed in the Program. The first evidentiary hearing for test cases was held in June 2007, then again in October and November 2007. Final hearings were held in July 2008.
A decision was rendered in February 2009. In all three test cases, despite the "best" that the anti-vaccine litigants could throw at the courts, the Special Masters decisively rejected all three hypotheses of causation.
In a 174-page decision, Special Master George Hastings rejected all of Petitioners’ contentions, observing that "this case is not a close case. The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories." A more emphatic refutation is hard to imagine.
Regarding some 23 expert witnesses who testified or submitted reports, Special Master Hastings stated that "[t]he 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 Special Master concluded, "the petitioners have . . . failed to demonstrate that vaccinations played any role at all in causing problems."
A Federal Appeals Court ruled, in August 2009, that "...Petitioners’ arguments linking injuries to thimerosal and the MMR vaccine are without merit. Accordingly, the Court affirms the Special Master’s February 12, 2009 decision."
The latest ruling would seem to put the lid on the proverbial Pandora's Box that was opened wide in 1998, when a British physician by the name of Andrew Wakefield joined twelve co-authors in publishing a report in the British medical journal The Lancet describing twelve children with an ASD and gastrointestinal symptoms. In eight cases, parents reported that the symptoms began within two weeks after the children received the MMR vaccine.
Wakefield and his colleagues hypothesized that this might be a new type of autism, characterized by gastrointestinal symptoms and developmental regression caused by the MMR vaccine. No proof was offered of a link, and the study group was so small as to be almost meaningless. Nevertheless, the news media picked up the title of the report ("Vaccine may trigger disease linked to autism"), and the rest, as they say, is history.
Many have heard some version of this basic storyline: Hero physician finds that autism is linked to a vaccination, and is blacklisted by the medical profession for daring to report it. Most, however, do not know what happened next.
In 2004, ten of Wakefield’s co-authors formally retracted their hypothesis, assuring the public that no link between MMR and autism was established. In January 2010, the General Medical Council, which
oversees doctors in Britain, found that Wakefield "showed a callous disregard" for the "distress and pain" of children, and found that in regards to his study his "conduct...was dishonest and irresponsible.
Finally, in February 2010, The Lancet formally retracted Wakefield’s controversial paper. Dr. Richard Horton, editor of The Lancet, said in retracting the paper that "it’s the most appalling catalog and litany of some of the most terrible behavior in any research and is therefore very clear that it has to be retracted."
Wakefield was found to have taken well over a million dollars from a personal-injury lawyer representing parents with children diagnosed with an ASD. Wakefield lost his medical license in the United Kingdom, and has since joined a fringe religious group in the United States that pushes scientifically ridiculous therapies for autism.
Yet as a result of Wakefield’s claim, the MMR scare attracted so much media attention that MMR immunization rates fell in a number of countries, leading to subsequent outbreaks of mumps and measles in Great Britain, Germany, Switzerland, and the U.S. Hundreds have been hospitalized, and up to a dozen deaths from measles have been reported.
Like the claim against thimerosal, Wakefield’s claim against the MMR vaccine made little intuitive sense to scientists and doctors. After all, autism rates in the United Kingdom had already been on the rise prior to the introduction of the MMR vaccine in 1988.
His claim that the virus in the vaccine caused injury to the gut, allowing proteins to pass into the bloodstream that then harmed the brain, could never be demonstrated, despite many tests on the brain and spinal fluid of autistic children. And study upon study – from locales as diverse as the UK, Finalnd, California, Georgia, Denmark, and Japan – has confirmed that the rate of autism is the same in populations of children having received and having not received the MMR vaccine.
Besides, if the administration of the MMR vaccine led to the development of an ASD, why is it that in not one of the very many countries where MMR is given to children are we seeing an epidemic of autism occurring in four and five year-olds after receiving their second MMR vaccination?
In the United Kingdom, MMR vaccination rates dramatically fell to 81% in the years after Wakefield’s fraudulent "study" was published, and are only now beginning to increase. Rates need to be consistently above 95% to create "herd immunity". Meanwhile, measles cases in England and Wales are still on the rise, affecting more than 1000 children annually. Several dozen children whose parents elected not to immunize them against measles have died as a result.
Study after study has exonerated MMR. More than 20 subsequent studies from around the globe have been conducted since Wakefield’s paper – ALL consistently found no link. There is no "controversy".
What About Thimerosal?
Thimerosal (sodium ethylmercury thiosalicylate; a.k.a. Mercurochrome, and Merthiolate) is an organic mercury-containing preservative that was used from the 1940s until 2001 as an additive to vaccines. It was very effective at preventing bacterial and fungal contamination, which was especially important for multidose vials entered and re-entered by medical professionals.
It is still found today in many other medications and products, including some throat and nose sprays, and some brands of contact lens solution.
Interestingly, before the reduction of thimerosal in the United States, the maximum allowable exposure for infants, as set by the FDA, was 187.5 micrograms; the most thimerosal that children would receive in getting their entire complement of childhood vaccinations was 137.5 micrograms.
Many routinely recommended childhood vaccines have never contained thimerosal, including the MMR (measles-mumps-rubella) vaccine, IPV inactivated polio vaccine), the varicella (chickenpox) vaccine, and the pneumococcal (Prevnar) vaccine. Some brands of Haemophilus influenzae type b (Hib) and diphtheria-tetanus-pertussis (DTaP) vaccines also have never contained thimerosal as a preservative.
Despite years of study in countries from around the globe, there has been found no evidence of a link between thimerosal in vaccines, and autistic spectrum disorders. Even still, as a precautionary measure thimerosal was removed in 2001 from all routinely recommended vaccines manufactured for administration to infants in the U.S.
The last batches of thimerosal-containing vaccines expired in January 2003.
Despite that thimerosal has disappeared, autism remains. Since 2003 the number of cases of children with autistic spectrum disorders has continued to rise. No better proof of the lack of a link between thimerosal and autism could indeed exist.
Consider this: If cars are an important cause of auto-related deaths, removing them from the highway ought to significantly decrease them. If thimerosal was a strong driver of autism rates, removing it from vaccines ought similarly to result in a significant decrease in autistic spectrum disorders. It has not.
As it was, the thimerosal-autism link never made much sense to scientists. Thimerosal contains ethyl mercury, which is different from the methyl mercury that we all think of when we think of "mercury". If the addition of a single consonant seems to matter little, consider the headaches and hangovers caused by the ethyl alcohol contained in beer and wine, and the blindness and death caused by methyl alcohol, otherwise known as wood alcohol.
These two forms of natural mercury differ greatly. Ethyl mercury decomposes much more quickly than methyl mercury. It is cleared from the body seven times faster. And it is too large a molecule to easily pass into the brain, whereas methyl mercury passes with much less difficulty.
In (methyl) mercury poisoning, the characteristic motor findings are ataxia (inability to walk) and dysarthria (difficulty with speech), along with tremors, muscle spasms and pain, and weakness.
Autism has no motor findings in common with mercury poisoning; in fact, no motor findings are common among autistic spectrum disorders, excepting occasional clumsiness and low muscle tone.
Methyl mercury poisoning also causes a classic constriction of the victim’s vision. Victims also suffer from peripheral neuropathy, causing pain and numbness in the hands and feet. Skin eruptions are common, as is a very low platelet count. The victim’s kidneys and the immune system can also be damaged.
None of these symptoms are known in autistics, and none of these organ systems are affected.
We are right to worry about mercury. Methyl mercury exists in too high an amount in some types of fish, and ingesting too much mercury can cause permanent brain and organ damage. But parents should be reassured that autism was not caused by exposure to the low amounts of ethyl mercury in vaccinations. All children, including siblings of autistic children, should be vaccinated, as there is absolutely no evidence of mercury poisoning in children.