Before The Lancet published the now-discredited 1998 paper alluding to a link between childhood vaccines and autism, its main author had secret business deals aimed at exploiting the public fears that his work would create, the BMJ charged.
In the second of a three-part series in the BMJ, journalist Brian Deer described patent filings and startup companies that Andrew Wakefield, MBBS, established before publishing the Lancet study of 12 children who supposedly developed gastrointestinal and behavioral abnormalities soon after measles-mumps-rubella (MMR) vaccination.
The article also provided additional details of Wakefield's relationship with a law firm that was suing vaccine manufacturers, which Deer had reported previously.
In an opening salvo published last week in BMJ, Deer -- who has been investigating Wakefield's claims since 2004 for the Times of London and British television as well as for BMJ -- compared the children's descriptions in the 1998 Lancet paper with their original medical records and information provided by their caregivers.
The findings were so discrepant, according to Deer and BMJ editor Fiona Godlee, MB, BChir, BSc, that Wakefield must have committed deliberate fraud. The Lancet formally retracted the paper last year, saying that "several elements ... are incorrect."
Deer's second installment in the BMJ exposé suggested that the fraud was part of a money-making scheme, under which he and certain associates -- including the father of one of the 12 children in the Lancet paper -- would sell diagnostic tests for vaccine-induced diseases as well as "safe" vaccines and therapies based on "transfer factor."
Prospectuses for these ventures distributed to potential investors promised profits in the tens of millions of dollars, Deer found.
According to one of these documents, "It is estimated that the initial market for the diagnostic will be litigation driven testing of patients with AE [autistic enterocolitis] from both the UK and the USA." Within three years of startup, the document continued, revenues of more than $40 million could be expected.
Also in on the deal, at least initially, Deer found, was Wakefield's employer, the Royal Free and University College Medical School in London.
Wakefield was already a media celebrity in Britain after he had gone on television to claim an association between MMR vaccines and Crohn's disease. In fact, the research that ended up as the 1998 Lancet paper had started out as an effort to identify children with inflammatory bowel disease following vaccination.
When this proved to be impossible, Wakefield called the children's condition "autistic enterocolitis" -- although Deer charged that even that was largely a fabrication.
The Royal Free agreed to act as a conduit for payments from Richard Barr, the plaintiffs' lawyer in the vaccine litigation, which helped fund the research leading to the Lancet paper and subsequent studies that Wakefield undertook.
According to Deer, Barr's firm had fronted Wakefield about $80,000 to support his initial research. Wakefield eventually took a total of more than $650,000 from the firm, the later money coming from legal settlements with vaccine makers.
The Royal Free also agreed to partner with Wakefield in the diagnostic, therapeutic, and vaccine ventures, under option arrangements that it never exercised.
Wakefield's relationships with the law firm and his other business enterprises were not disclosed in the 1998 Lancet paper, the press conference that accompanied it, or anywhere else until Deer uncovered them.
According to Deer, the whole deal fell apart in 1999 when the Royal Free brought in a new head of medicine, Mark Pepys, MD, PhD, who was skeptical of Wakefield's research and the proposed commercial ventures.
At Pepys's urging, the school ordered Wakefield to publish the scientific results that were supposed to power the startup companies. When he had made no move to do so after nearly two years, "we paid him to go away," Deer quoted Pepys as saying.
"In October 2001, Wakefield was shown the door," Deer wrote. "As I understand it, he got two years' money, a statement clearing him of misconduct, the intellectual property for £10 ($16), uncollected, and a gag on Royal Free comment."
But although the Royal Free had severed its ties with Wakefield, it still tried to thwart Deer's efforts to follow the money trail back to the school, he charged. He wrote that it took three years of freedom-of-information requests and a government order before he was allowed to see the contracts and memoranda related to the business deals.
Wakefield, who emigrated to the U.S. after his departure from the Royal Free, could not be reached for comment. Last week, in an interview with CNN, he denied fabricating data and insisted his research was sound.
BMJ plans to publish the final part of Deer's investigation next week.