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Glenn D. Braunstein, M.D. Headshot

Andrew Wakefield's Vaccination and Autism Study: Allegations of Fraud With Financial Motivations

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Although I've written about vaccines and autism before, new reports in the medical community have prompted me to reiterate my stance on the subject. In early January, the British Medical Journal called the 1998 study by Andrew Wakefield, which proposed a link between the measles, mumps and rubella (MMR) vaccine, gastrointestinal problems and autism, "an elaborate fraud." According to Fiona Godlee, the journal's editor-in-chief, "It's one thing to have a bad study... In this case we have a very different picture of what seems to be a deliberate attempt to create an impression that there was a link by falsifying the data."

I don't know how many different ways the medical community can say this: Childhood vaccinations do not cause autism. As any competent researcher will tell you, the facts speak for themselves. The facts concerning Wakefield's activities were described in great detail by an investigative reporter, Brian Deer, in two articles published this month in the British Medical Journal ("How the case against the MMR vaccine was fixed" published on January 5 and "How the vaccine crisis was meant to make money" published on January 11). All the medical histories of the mere 12 children in Wakefield's study had been altered or misrepresented. Despite Wakefield's claim that all the children were normal until they had the MMR shot, five of them had previously been documented to have developmental problems. Timelines were falsified to create the appearance of cause and effect. Children had been subjected to unnecessary procedures like a colonoscopy and lumbar puncture. The findings of the study have never been able to be confirmed or reproduced by other researchers. Ten other authors of the study withdrew their names from it in 2004. Exhaustive investigations into Wakefield's methods by the British General Medical Council (GMC) proved dozens of charges against him including dishonesty and ethical violations including abuse of developmentally challenged children. The study was also formally retracted last year by the medical journal that originally published it, the Lancet.

The investigation by London Sunday Times reporter Brian Deer revealed payments to Wakefield in excess of £435,000 (approximately $674,000) from lawyers who were preparing lawsuits against drug companies that manufactured the vaccines, creating "experimenter bias" even before the study began. In addition, Deer reported that Dr. Wakefield had filed a patent for a new measles vaccine and proposed to develop a new company that would develop new diagnostic tests and therapeutics including vaccines. In 2010, after the GMC's most exhaustive fit-to-practice hearing in its history, Wakefield was banned from practicing medicine in Britain.

In attempting to explain a 13-year process of unmasking this vaccine hoax, the British Medical Journal cited the unfortunate disparity between scientific skepticism concerning factual error and its trusting nature regarding the possibility of fraud. According to the journal, "Never has this been truer than of the 1998 Lancet paper that implied a link between the measles, mumps and rubella (MMR) vaccine and a 'new syndrome' of autism... Clear evidence of falsification of data should now close the door on this damaging vaccine scare."

I wish it were that simple. Despite Wakefield's apparent fraud and his profile as the worst kind of snake oil salesman, the worldwide health scare that has resulted from his hoax continues to put children at risk. Parents who are either unaware of the facts of the case or who choose to ignore its irrefutable evidence are exposing their own and other children who have been not been vaccinated to crippling and potentially fatal diseases that were halted more than a hundred years ago.

I say "halted" not "defeated" because without vaccinations, these diseases return. In California, pertussis (whooping cough) has reappeared at its highest levels since 1958. Outbreaks of measles are reoccurring. Most parents have never seen the disease or realize that 242,000 children a year worldwide die from it, so they underestimate the risk of not vaccinating. Between 2005 and 2010 the rates of unvaccinated children in New York and Connecticut doubled. In New Jersey, that rate is up 800 percent. Across America, vaccinations have fallen below the acceptable "herd immunity" rate of 90 percent. In Minnesota, an outbreak of the Hib (Haemophilus influenza type B) meningitis virus killed an infant whose parents were against vaccinations. In the UK, vaccination rates fell from 92 to 73 percent. In 2008, measles was declared endemic in England and Wales. In northern Germany, an outbreak of mumps in a school where the parents opposed vaccinations revealed that of the 71 children infected, 68 hadn't been immunized.

The Scientific Way vs. Wakefield's Way

Science recognizes multiple methods of data collection. The best is a randomized clinical trial in which a hypothesis is tested on a sampling of a population, with only one half receiving the drug or intervention being tested. Ideally, it should be double-blinded in which neither the subject nor the researcher knows which is the active drug and which is placebo or a comparative drug. But since you can't give people a disease, the next best method is a case control study in which a group that has a particular condition or disease is studied and compared to a control group without the disease to look for what factors are different between them. The least reliable method is a simple case series. This method, which Wakefield employed, is described in a new book by Seth Mnookin, The Panic Virus: A True Story of Medicine, Science, and Fear, as "oftentimes nothing more than an interesting phenomenon someone happened to notice," and Wakefield's use of it has been characterized as "possibly one of the weakest studies ever published in the history of science" -- and that was the criticism of the study made by scientists before the fraud was uncovered.

So why do parents still believe it? The answer has a lot of moving parts. One is that immunization is a counter-intuitive notion -- that the cause of a disease can create immunity from it. Another is that anecdotes are more accessible and satisfying than rigorous experimental methodology; the scientific community took so long to respond adequately -- even though UK health officials immediately denounced the study's recommendations -- and the media became so good at telling the bad story and so bad at telling the real story.

Most understandable, though, is any parent's need to know why -- why something as inexplicable as autism has happened to their child. But autism existed long before the MMR vaccine was introduced, and hundreds of millions of children have had the vaccine without any problems, much less autism.

Ironically, one the biggest casualties of the Wakefield hoax has been autism itself. Significant time, energy and financial resources that could have gone toward finding real root causes or effective new treatments for autism have been wasted while parents, influenced by an apparent premeditated fraud, pursue a policy of protest and no protection that, as I've already said in this forum, is setting the medical clock back more than a century.

In the interest of public health, public trust and public safety, and appropriate accountability, the alleged intentional and knowingly dangerous behavior of Andrew Wakefield should reviewed in the British justice system. He has already been found unfit to practice medicine in Britain. However, both as punishment for what is likely an intentional endangerment of children and a means for publicizing the fraud (thereby educating parents of the safety of the vaccines), Wakefield should face not just professional discrediting and public derision, but other sanctions available under British and international law.