On Thursday, a special US federal court ruled in the case of three children that vaccines did not cause their autism; their families were claiming that the measles mumps rubella (MMR) vaccine, which contained the mercury-based preservative thimerosal, had caused their children to develop autism and several other conditions, including inflammatory bowel disease.
According to the Associated Press (AP), more than 5,500 claims have been filed by families hoping to get compensation through the government's Vaccine Injury Compensation Program, and this ruling comes as a blow to them and thousands of others who believe there is a link between childhood vaccines and autism.
The claims are filed with the "people's court", the US Court of Claims in Washington. This court is different to many others in that the claimants don't have to prove that the vaccines caused the autism, just that they probably did.
But Special Master George Hastings Jr, whose ruling in the case of one of the children, Michelle Cedillo of Yuma, Arizona, extended to 183 pages, said:
"Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment."
He said he had to decide the case by analyzing the evidence and not on sentiment. The Cedillos had claimed that a measles vaccine given to Michelle when she was 15 months old had triggered her autism, inflammatory bowel disease and other disorders that have left her considerably disabled.
The worldwide controversy about whether vaccines cause autism was triggered in 1998 by an article in The Lancet, where lead author Andrew Wakefield, a UK scientist, and colleagues linked developmental delays in children with the MMR vaccine. 10 of the 13 authors have sinced retracted the paper; Wakefield is among those who have not. A recent investigation by the UK paper the Sunday Times has alleged that Wakefield changed and misreported results in his research, creating the appearance of a possible link with autism.
The Sunday Times investigation team said that evidence presented to the General Medical Council (GMC) confirmed that in most of the 12 cases reported in the 1998 paper, the children's conditions, as described in the paper, were different from the descriptions in their hospital and GP medical records. The journal article claimed that the symptoms appeared within days of receiving the vaccines, whereas the records showed this was only true in one case, and in many of the other cases concern over the symptoms had been logged in the records before the vaccines had been given.
Lawyers for the three families whose claims have been rejected said they would be appealing against the Special Masters' decision.
The Cedillo family was represented by Kevin Conway of Boston; he told AP that they thought their evidence was "solid":
"There was certainly no scientific proof that vaccines caused autism, but that's not the standard; the standard is likelihood."
Another attorney, Tom Powers of Portland, Oregon, who is overseeing all the claims said the ruling was discouraging and it was a big step, but "it's not the last step".
Consumer groups who support the view that the vaccines caused autism were also not deterred by the ruling and continue to assert their case. Head of the National Vaccine Information Center, Barbara Loe Fischer said she thought it was a mistake to think that because these three families have not won their claim it has been decided that vaccines don't play a role in the development of autism.
There are other cases in the pipeline that argue a different connection. They will say that it was the preservative thimerosal, which contains mercury, and has since been all but phased out of vaccines, that caused their children's autism and other disorders. Powers told AP that these families are hoping to succeed.
SafeMinds, an autism advocacy organization, issued a statement following the court ruling. They said the ruling was based on "inadequate vaccine safety science available to the court" and said there was a conflict of interest in that the Department of Health and Human Services (HHS) is both the "defendant in court" and also responsible for carrying out the vaccine safety research. They said this conflict of interest was sufficient to cast doubt on the "integrity of the National Immunization Program".
Director of SafeMinds and an advisor to the Petitioners Steering Committee of the US Federal Court of Claims, Jim Moody, said:
"The government has its thumb on the scales of justice."
"The Vaccine Injury Compensation Act passed in 1986 gave immunity to vaccine manufacturers and removed the incentive to create safer products. Meanwhile, the law only gives the illusion that parents will have their day in court. The process is dysfunctional."
SafeMinds says that the US Centers for Disease Control and Prevention (CDC) spends billions of dollars expanding immunization programs, and the HHS gives billions of dollars to pharmaceutical companies to produce vaccines for profit, and yet the CDC spends only 20 million on safety studies, which incidentally the families' lawyers have no access to and yet the government lawyers do.
Executive director of SafeMinds, Sallie Bernard, said:
"A neutral agency must initiate an extensive safety program, including studies of the health outcomes in vaccinated and unvaccinated groups."
"Otherwise, trust in immunization will continue to deteriorate," she added.
The statement from the HHS said that the cases showed there is no doubt that autism places a heavy burden on families and that is one reason why the HHS:
"Continues to support research to better understand the cause of autistic disorders and develop more effective methods of treatment."
"The medical and scientific communities have carefully and thoroughly reviewed the evidence concerning the vaccine-autism theory and have found no association between vaccines and autism," said the HHS statement, which ends with:
"Hopefully, the determination by the Special Masters will help reassure parents that vaccines do not cause autism."
In 2009, the US government's Vaccine Injury Compensation Program agreed to compensate a 9-year girl, Hannah Poling from Georgia, whose family claimed her autism was triggered by vaccines she received as a baby. In that case the federal officials said that the vaccines had exacerbated a rare mitochondrial disease; but it gave hope to thousands of families who believe their children's autism was caused by vaccines.
According to US News and World Report, John Gilmore, executive director of Autism United, an association of advocacy groups based in Hicksville, New York, said that the Special Masters' ruling was "disappointing on a number of different levels". He said not enough research has been done either on vaccine safety or the causes of autism, and that the ruling gives a message that:
"Families that want to seek redress in the vaccine court have an extraordinarily high level of proof that they have to meet, which I don't think was the original intent of the legislation."