On Feb. 28, 1998, The Lancet published a research paper entitled "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children."
It was a blockbuster.
Gastroenterologist Andrew Wakefield and associates examined the cases of 12 children with bowel disease, nine of whom suffered "behavioural abnormalities" shortly after receiving the measles, mumps and rubella vaccine.
The paper suggested that the MMR vaccine triggered autism, particularly in children with intestinal abnormalities. The "new syndrome" they had discovered was named enteritis/disintegrative disorder.
Dr. Wakefield said the vaccine was dangerous and called for an end to MMR vaccination – the cornerstone of childhood immunization programs. He wanted it replaced by three separate shots.
The media – and Britain's infamous tabloids in particular – were all over it.
It was a perfect storm of a story, coming as it did when autism rates were soaring, parents were tiring of seeing their children become pin-cushions for vaccines, and a new communications tool called the Internet was booming.
Scientists around the world diligently tried to reproduce the findings but never found any evidence of a link between MMR vaccine and autism.
With the passage of time, it became abundantly clear that the research was profoundly flawed, scientifically and ethically.
Still, Dr. Wakefield became the darling of anti-vaccinationists and a hero to parents desperately searching for answers to their children's autism. He painted himself as a pioneering scientist who was being persecuted by Big Bad Pharma.
Dr. Wakefield, it turns out, was something else altogether. He was on the payroll of a group that has launched a lawsuit against manufacturers of the MMR vaccine – at $230 an hour – and his research was going to be the centrepiece of their claim. He patented a measles vaccine that he wanted to replace the MMR shot. (Later, he founded an autism research centre in Texas.) We know this, in large part, because of the diligent work of a single investigative journalist.
In 2004, Brian Deer of The Sunday Times published damning evidence about Dr. Wakefield's ties to the lawsuit, showing that the children in the study were recruited unethically, and exposing other flaws in the published study.
As a result of that exposé, Dr. Wakefield was eventually investigated by Britain's General Medical Council and stripped of his licence to practise because of dishonesty. (The second author, Dr. John Walker-Smith, also lost his licence to practise medicine.) In February, 2010, the original Lancet paper was retracted. But Dr. Wakefield continues to insist the findings are valid and that he is the victim of a vast conspiracy. Yet he has never been able to reproduce the findings.
Now, thanks again to Brian Deer, we know why.
In this week's edition of the British Medical Journal, the journalist shows, beyond a shadow of doubt, that Dr. Wakefield's work was not just scientifically flawed but "an elaborate fraud."
It is troubling enough that so much credence was given to a study that involved only 12 children from a single clinic in the first place. But it turns out that Dr. Wakefield recruited them selectively to fit his thesis – largely from members of an anti-vaccination group called JABS.
Mr. Deer found that every single one of the 12 cases reported in the original Lancet paper was misrepresented; medical records, diagnoses and medical histories were altered to ensure that the symptoms of autism arose within two weeks of MMR vaccination.
Three of the nine children reported with regressive autism did not have autism at all. Despite the claim that all 12 children were "previously normal," five had documented developmental problems long before their shots. In nine cases, the children did not have bowel abnormalities but the records were altered.
Remember, the paper claimed that all the symptoms began, on average, within six days of MMR vaccination. In fact they occurred months, sometimes years, before and after vaccination.
Parents of 11 of the 12 children blamed MMR vaccine for their children's health problems before they were recruited. In fact, all were referred by anti-vaccine campaigners and the study was commissioned and funded by a lawyer who planned a class-action lawsuit.
Perhaps most damning of all is the revelation that two years before the Lancet paper was published, Richard Barr, the lawyer who hired Dr. Wakefield to help with the class-action lawsuit against vaccine makers, sent a letter to his clients looking for children with bowel disorders and autism.
In other words, Dr. Wakefield already had the makings of a syndrome he was going to "discover" two years later – and the "proof" he needed for a lawsuit – and recruited study participants accordingly.
Research fraud happens, though rarely on this scale. The real tragedy is that many otherwise intelligent people have come to believe the purported MMR-autism link, and the health of a lot of children has been endangered as a result.
In Britain, childhood vaccination rates fell to as low as 80 per cent, allowing a return of measles, mumps and rubella. Thankfully, those rates are climbing back up again.
It is hard to imagine that the greed and arrogance of one man could do so much damage.
Hopefully, the diligent work of Mr. Deer has put the final nail in the coffin of Dr. Wakefield's career of fraud and deception.
André Picard