Dr. Wakefield, who, as we know was ultimately paid £435,643 in fees, plus £3,910 expenses by Barr. But that was chump change compared to the amount of money that Wakefield and his cronies envisioned based on the work they were doing at the Royal Free Hospital. Even while Child 2 was still in the hospital undergoing a grueling workup including an MRI of his brain (which, for children that young usually requires general anesthesia), electroencephalography and evoked potentials, a radioactive Schilling test, blood and urine tests, and a lumbar puncture, all of which had been specified in an agreement with Barr. Then, while the child was still in hospital (as the British say), having just undergone an ileocolonoscopy two days before that 14 years later the British General Medical Council would conclude had not been medically indicated, this happened:
And on Wednesday, with the news that the boy–still on the ward–might have Crohn’s disease, the doctor produced a remarkable document. It was an 11 page draft of a scheme behind the vaccine scare, now revealed for the first time in full.
The document was headed “Inventor/school/investor meeting 1.”15 Based on a patent Wakefield had filed in March 1995 claiming that “Crohn’s disease or ulcerative colitis may be diagnosed by detecting measles virus in bowel tissue, bowel products or body fluids,”16 it proposed starting a company that could reap huge returns from molecular viral diagnostic tests. It predicted a turnover from Britain and America of up to £72.5m a year.
“In view of the unique services offered by the Company and its technology, particularly for the molecular diagnostic,” the document noted, “the assays can command premium prices.”
To help finance the scheme, Wakefield looked to the government’s legal aid fund–meant to give poorer people access to justice. For the previous seven months, child 2 had been enrolled with Barr’s firm,17 which since February 1996– two years before the paper’s publication– had been paying the researcher undisclosed fees of £150 an hour, plus expenses.8
Wow.
£72.5 million a year. That’s a lot of cash that Wakefield was planning on trying to make using his patent claiming that detecting measles virus in the gut is diagnostic for Crohn’s disease. Indeed, where other researchers saw suffering children they wanted to try to help, Wakefield apparently saw an amazing profit opportunity. Indeed, he even cranked out the prospectus for this amazing profit opportunity while investigating children referred to him by trial lawyers. This is a massive undisclosed conflict of interest (COI) that beggars imagination. It’s huge compared to most COIs that individual investigators who seek to commercialize their products have, because most such investigators don’t envision making anywhere near as much money as Wakefield apparently thought he could make from developing a diagnostic test. He even wrote that “the ability of the Company to commercialise its candidate products depends upon the extent to which reimbursement for the cost of such products will be available from government health administration authorities, private health providers and, in the context of the molecular diagnostic, the Legal Aid Board.” In other words, Wakefield was already thinking of ways to obtain reimbursement from third party payers for his device, recognizing quite correctly that the success of any such test is utterly dependent upon this.
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