Last week, Brian Deer published an article in the BMJ How the case against the MMR vaccine was fixed. In it he lays out how data were misreported in Andrew Wakefield’s now retracted 1998 article in The Lancet. The BMJ editors published an editorial coincident with the Deer article, Wakefield’s article linking MMR vaccine and autism was fraudulent.
In his latest article in the BMJ, Brian Deer lays out: Secrets of the MMR scare How the vaccine crisis was meant to make money
Andrew Wakefield had plans to make money. A lot of money. He created a business to produce diagnostic testing kits. He applied for a patent for a therapeutic agent and a proposed vaccine to prevent measles infections. This in addition to the money he was collecting as a paid expert to the MMR litigation in the UK.
On the diagnostic testing kit. Mr. Deer obtained the prospectus for the company that was formed to develop and market it:
“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,” said a 35 page “private and confidential” prospectus, which was passed to me [Brian Deer] by a recipient.
He predicted £28,000,000 in revenue from the therapeutic and diagnostic products from his company.
Mr. Wakefield used a laboratory in Ireland, Unigenetics, headed by John O’Leary, to test tissue samples for measles virus. This is well known. Mr. Wakefield was a director of that laboratory.
The work by Unigenetics was key to the company’s success. Mr. Wakefield predicted–apparently in September 1996, before the research was completed–that Unigenetics would provide “unequivocal evidence for the presence of the vaccine derived measles virus in biopsy samples”
“Once the work of Professor O’Leary and Dr Wakefield is published, either late in 1999 or early in 2000, which will provide unequivocal evidence for the presence of the vaccine derived measles virus in biopsy samples,” the prospectus said, “the public and political pressure for a thorough, wide ranging investigation into the aetiology of the bowel conditions will be overwhelming.
“As a consequence of the public, political and legal pressures brought to bear, the demand for a diagnostic able to discriminate between wild type and vaccine derived measles strains will be enormous.”
That paper has since been discredited. First, a major attempt to replicate it failed. More importantly, Stephen Bustin, perhaps the world’s foremost expert on the methodology used (PCR), found that the Unigenetics laboratory’s methods were so seriously flawed as to make any results worthless (good summary here). Also, it was found that PCR data from Mr. Wakefield’s own research group were negative for measles virus, and that Mr. Wakefield buried those negative results.
It was because of these (and more) conflicts of interest that he was let go from the Royal Free Hospital (long before the Brian Deer investigation). Mr. Wakefield’s claim that his departure from the Royal Free was because his “research was unpopular”. Contrary to this position, the Royal Free had offered Mr. Wakefield the opportunity to prove his hypothesis.
But the paperwork does not show this. Despite all that had happened, UCL volunteered to support his work. It offered him continuation on the staff, or a year’s paid absence, to test his MMR theories. He was promised help for a study of 150 children (to try to replicate his Lancet claims from just 12) and, in return for withdrawing from the January London conference, he would be given the intellectual property free.
“Good scientific practice,” the provost’s letter stressed, “now demands that you and others seek to confirm or refute robustly, reliably, and above all reproducibly, the possible causal relationships between MMR vaccination and autism/“autistic enterocolitis”/inflammatory bowel disease that you have postulated.”
Yes, Mr. Wakefield had an offer on the table to take a year to prove his hypothesis. The Royal Free already had their doubts, and even more doubts about Mr. Wakefield’s conflicts of interest. And, yet, it would take a few more years before Brian Deer would make this public.
At first Mr. Wakefield agreed to the Royal Free’s proposal. But he never put the plan into action. When it became clear that he had no intent to follow through, he was let go from the Royal Free.
One defintion I found (the top definition at dictionary.com) defines fraud thus:
deceit, trickery, sharp practice, or breach of confidence, perpetrated for profit or to gain some unfair or dishonest advantage.
As presented last week by Mr. Deer, data were manipulated to “fix” the results of Mr. Wakefield’s research. This week’s installment discloses how Mr. Wakefield sought to profit from this work. Pretty clear to this reader that this meets the definition of fraud.
Here is how the BMJ summarized the article:
Andrew Wakefield, the disgraced doctor who claimed a link between MMR and autism, planned secret businesses intended to make huge sums of money, in Britain and America, from his now-discredited allegations.
The Wakefield scheme is exposed today in the second part of a BMJ series of special reports, “Secrets of the MMR scare”, by investigative journalist Brian Deer. Last week we revealed the scientific fraud behind the appearance of a link between the vaccine and autism. Now Deer follows the money.
Drawing on investigations and documents obtained under the Freedom of Information Act, the report shows how Wakefield’s institution, the Royal Free Medical School in London, supported him as he sought to exploit the MMR scare for financial gain.
It reveals how Wakefield met with medical school managers to discuss a joint business even while the first child to be fully investigated in his research was still in the hospital, and how just days after publication of that research, which triggered the health crisis in 1998, he brought business associates to the Royal Free to continue negotiations.
One business, named after Wakefield’s wife, intended to develop Wakefield’s own “replacement” vaccines, diagnostic testing kits and other products which only stood any real chance of success if public confidence in MMR was damaged.
Documents reveal the planned shareholdings of Wakefield and his collaborators, and how much Wakefield expected to receive personally. Financial forecasts made available for the first time today show Wakefield and his associates predicting they could make up to £28 million ($43,367,082; €33,290,350) a year from the diagnostic kits alone.
“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,” said a 35 page “private and confidential” prospectus obtained by Deer, aimed at raising an initial £700,000 from investors. “It is estimated that by year 3, income from this testing could be about £3,300,000 rising to about £28,000,000 as diagnostic testing in support of therapeutic regimes come on stream.”
Deer’s investigation also reveals today that Wakefield was offered support to try to replicate his results, gained from just 12 children, with a larger validated study of up to 150 patients, but that he refused to carry out the work, claiming that his academic freedom would be jeopardised. His research claims have never been replicated.
There will be at least one more installment in this series by Brian Deer in the BMJ.