The doctor behind the study linking vaccines to autism accused of 'Deliberate Fraud'. British report in medical journal alleges he twisted facts on cases involving 12 children.
An in-depth investigation just published in a prominent medical journal alleges that a decade-long effort to link childhood vaccinations with autism was really an elaborate hoax perpetuated by a British doctor who has since been banned from practicing medicine in that country.
The doctor's original research, first published in 1998, turned many parents away from immunizing their children, which some experts now link to recent outbreaks of illnesses that had once been well under control.
"The MMR [measles-mumps-rubella vaccine] scare was based not on bad science but on a deliberate fraud," Dr. Fiona Godlee, editor-in-chief of the BMJ, which published details of the new investigation on Jan. 5, said in a statement. "Such clear evidence of falsification of data should now close the door on this damaging vaccine scare."
The story began with the publication in 1998 of a study led by Dr. Andrew Wakefield. Appearing in the prestigious British medical journal The Lancet, the report connected the MMR vaccine to autism and stomach problems in 12 children, a supposed new bowel-brain "syndrome."
That set off a worldwide furor, with many researchers condemning the finding as shoddy science. But parents of children with autism rallied around the main researcher. The result: immunization rates in both the United States and Britain fell while the number of new cases of measles—one of the infections the MMR shot is designed to thwart—climbed.
After closely re-examining the data, The Lancet issued a formal retraction of Wakefield's research last year. In May of 2010, Britain's General Medical Council barred Wakefield from practicing in the United Kingdom.
According to the new BMJ report, Wakefield—a gastroenterologist, not a pediatrician or neurologist -- identified the new "syndrome" before he even began to collect data. By his account, the MMR vaccine caused both gut problems and regressive autism in children.
The BMJ investigation alleges that this hypothesis only emerged after Wakefield had been retained, with compensation, to work on a lawsuit to sue the maker of the vaccine.
In the Lancet study, Wakefield described the experiences of 12 children who supposedly had regressive autism, where a child seems to be developing normally but then regresses.
However, according to the BMJ report, only one child in the sample was diagnosed with this form of autism, and three of the 12 didn't have any autism diagnosis at all.
Nor did the children come from a random sample, as Wakefield had claimed. According to the BMJ article, all participants were selected based on having symptoms consistent with the "syndrome" and some seemed to have been recruited by anti-vaccination activists.
And the report further alleges that when children's symptoms didn't fit the hypothesis, timelines were fudged so it looked as if autism symptoms developed soon after MMR vaccination, even when parents and others said that the children were showing signs of autism prior to the shot.
In some cases where Wakefield claimed that problems emerged after the vaccine, he shrank the timeline so it would look as if they emerged within days, as opposed to months after, according to the BMJ report. And gastrointestinal symptoms were also made to appear more significant than they were.
One girl who appeared to have slowed development turned out to have a coarctation of the aorta, a genetic condition in which the aorta leading out of the heart narrows, the report stated, and once that was fixed her speech and behavior resumed at a normal pace.
"This is about as unethical as you can get," said Dr. Max Wiznitzer, a child neurologist with Rainbow Babies & Children's Hospital, University Hospitals Case Medical Center, in Cleveland.
"It's a very, very sad story. It was sad enough that the data in this paper was published and influenced scientists and governments and families to make decisions that just weren't right. But now to find out that the data was actually falsified makes it even worse," added Keith A. Young, vice chair for research in the department of psychiatry and behavioral science at Texas A&M Health Science Center College of Medicine.
"This really, really is one of the worst scenarios that's ever happened with scientific misconduct," he said.
And besides harming those children who got sick after not receiving a vaccine, the alleged fraud may have even set back autism research, experts noted.
"We had a measles epidemic in Britain, a drop in immunization rates in [the United States]. I personally know of children who were brain-damaged as a consequence of their parents deferring immunization as a result of this concern," Wiznitzer said. At the same time, he said, "[autism] research monies were diverted to disprove a hypothesis that was never proven [in the first place] rather than invested in exploring issues that would be of benefit to the public and to children with the condition."
When the BMJ investigators showed study data to parents who were involved in Wakefield's study, they said many parents were shocked and insisted that his versions of their children's cases were patently wrong. For instance, Wakefield sometimes claimed that the child's development was normal before the vaccine when, in some cases, it was not.
"[They're] claiming that he altered data and, from a science standpoint, you can't get any worse than to deliberately and knowingly change the data so that it fits your preconceived notion," Wiznitzer said.
Although the author of the BMJ piece, British investigative journalist Brian Deer, seems to suggest that greed motivated Wakefield to act as he did, Wiznitzer said that may not be the whole story.
"I think he truly believes what he's doing," Wiznitzer said.
As for Wakefield, his Web site shows him as currently living in Austin, Texas, promoting a book published last year, Callous Disregard: Autism and Vaccines, The Truth Behind the Tragedy, and going on speaking engagements.
Speaking in May on NBC's Today show, soon after British authorities stripped him of his right to practice medicine, Wakefield called the ban "a little bump in the road" and said his research would continue. "I am most certainly not going away," he said.
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