The prime instigator of claims that the measles-mumps-rubella (MMR) vaccine is linked to autism has been accused of falsifying his research.
In an editorial published in the British Medical Journal on January 7, 2011, BMJ editor in chief Fiona Godlee says that “Clear evidence of falsification of data should now close the door on this damaging vaccine scare.”
“Few people could deny that [Wakefield’s research] was fatally flawed both scientifically and ethically,” she says. “But it has taken the diligent scepticism of one man, standing outside medicine and science, to show that the paper was in fact an elaborate fraud.”
That “one man” is British journalist Brian Deer. In an article published in the same issue of the BMJ, he describes his investigation of claims – or suggestions – made by Andrew Wakefield and others. The full article – the first in a series – can be found here.
The original paper by Wakefield et al was published in The Lancet in 1998. Ten of the paper’s co-authors later withdrew their names from it, and early last year The Lancet itself issued a full retraction of the paper, stating that “It has become clear that several elements of the 1998 paper by Wakefield et al are incorrect. … Therefore we fully retract this paper from the published record.”
This was soon followed by the results of an investigation by the British General Medical Council, which found Wakefield to be “dishonest”, “irresponsible” and guilty of putting children through painful and unnecessary tests.
Deer says that “The [GMC] regulator’s main focus was whether the research was ethical. Mine was whether it was true. So as a five member disciplinary panel trawled through the records, with five Queen’s counsel and three defendant doctors, I compared them with what was published in the journal.”
What he found was that “The Lancet paper was a case series of 12 child patients; it reported a proposed ‘new syndrome’ of enterocolitis and regressive autism and associated this with MMR as an ‘apparent precipitating event’.” But in fact:
• Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism.
• Despite the paper claiming that all 12 children were “previously normal”, five had documented pre-existing developmental concerns.
• Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination.
• In nine cases, unremarkable colonic histopathology results—noting no or minimal fluctuations in inflammatory cell populations—were changed after a medical school “research review” to “non-specific colitis”.
• The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations—all giving times to onset of problems in months—helped to create the appearance of a 14 day temporal link.
• Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation.
“So that is the Lancet 12: the foundation of the vaccine scare,” Deer says. “No case was free of misreporting or alteration. Taken together, NHS records cannot be reconciled with what was published, to such devastating effect, in the journal.”
Godlee asks: “Who perpetrated this fraud? There is no doubt that it was Wakefield. Is it possible that he was wrong, but not dishonest: that he was so incompetent that he was unable to fairly describe the project, or to report even one of the 12 children’s cases accurately? No. A great deal of thought and effort must have gone into drafting the paper to achieve the results he wanted: the discrepancies all led in one direction; misreporting was gross.”