The BMA answered fully the following March, after its ethics committee had considered the issue. It said that money could be accepted provided there was proper research oversight and transparency over funding and patient sources.
But the dean remained concerned and so made an arrangement with the hospital’s chief executive, Martin Else, who managed a charity called the Special Trustees. Else, now chief executive of the Royal College of Physicians (who told me that he was “not aware of any significant issue being raised”), agreed that the charity could take Barr’s payment and hold it as a grant for Wakefield. So the legal money (which eventually totalled £50,000 and seed funded the business scheme) was moved from the medical school into a numbered hospital charity account and then paid out for Wakefield’s research on the MMR vaccine—back in the medical school.
“Further to our conversation regarding the establishment of a fund with the Special Trustees for your income and expenditure associated with the MMR research,” Else wrote to Wakefield, “I can confirm that a grant will be established for the purpose, given your written confirmation that there is no conflict of interest involved.”
Wakefield obliged, but the arrangement raised issues about the two institutions’ involvement in the vaccine crisis. For when the Lancet paper was published, in February 1998, and the scare was launched at a televised press conference, nobody was aware that Wakefield was receiving substantial personal payments from Barr. But both the medical school’s dean and the hospital’s chief executive knew that his research was part funded through a lawyer.
The paper itself, meanwhile, included a funding statement, which Else later told me he did not notice. “This study was supported by the Special Trustees,” it said, with no mention of legal aid or Barr.
The lawyer, however, was forthright when later asked. He said he paid for the Lancet research. “I remember noting at the time that the funding acknowledgment wasn’t there,” he told me. “But it didn’t seem to be a big deal, because it just wasn’t a big deal in those days.”
Behind the press conference
Neither school nor hospital stood on the sidelines. They threw their weight behind Wakefield. In the build-up to the press conference, they installed extra phone lines and answering machines to field the expected panic, and distributed to broadcasters a 23 minute video news release showcasing Wakefield’s claims. “There is sufficient anxiety in my own mind for the long term safety of the polyvalent vaccine—that is, the MMR vaccination in combination—that I think it should be suspended in favour of the single vaccines,” he said, in one of four similar formulations on the videotape.
The press conference and video boosted the commercial plans, which were moving forward behind the scenes. The following week, Wakefield brought two associates to the school for an already scheduled meeting with the finance officer Tarhan. One was the father of child 10 in the paper. The other was a venture capitalist. And two days after the meeting, they submitted a 13 page proposal to launch a joint business with the school. It would be focused on a new company, Immunospecifics Biotechnologies Ltd, aiming not only to produce a diagnostic test, as proposed 18 months earlier, but also “immunotherapeutics and vaccines.”
Given the previous week’s publicity drive, the vaccine plans were sensitive. But the school had long known of this ambition. First surfacing in Wakefield’s 1995 patent for a diagnostic test for Crohn’s disease, it had been fleshed out in 1997, eight months before the press conference, in a patent for a “safer” single measles shot.
The revised business plan was ambitious and detailed, aiming to raise £2.1m from investors. It spanned the detection of Crohn’s disease, the treatment of autism, and “a replacement for attenuated viral vaccines.”
The methods for the molecular test for Crohn’s disease were newish. But those for the treatment and vaccines were dated. They relied on transfer factor, a largely abandoned fringe technology to move immune cells from person to person.
Nevertheless, the school remained interested, and a two year courtship ensued. Even as the vaccine scare escalated, triggering a deluge of referrals to Walker-Smith, staff at Freemedic, the commercial arm of what was now the merged Royal Free and University College Medical School, poured over contracts and plans.
Trading was to be fronted by Carmel Healthcare Ltd—named after Wakefield’s wife. Firmly rooted in Barr’s lawsuit, which eventually paid Wakefield £435,643, plus expenses, the business was to be launched off the back of the vaccine scare, diagnosing a purported—and still unsubstantiated—“new syndrome.” This, Wakefield claimed, comprised both brain and bowel diseases, which, after Crohn’s disease was not found in any of the Lancet children, he dubbed “autistic enterocolitis.”
“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 by a recipient. It aimed at raising an initial £700,000 from investors and forecast extraordinary revenues. “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.”
Carmel was registered in the Irish Republic, where Wakefield would also become a director of another business. This was Unigenetics Ltd, incorporated in February 1999 with a Dublin pathologist, John O’Leary. After Wakefield submitted a confidential report to the Legal Aid Board, Unigenetics was awarded—without checks—£800,000 of taxpayers’ money to perform polymerase chain reaction tests on bowel tissue and blood samples from children passing through Malcolm ward.
The key players in Carmel were the same as in the first company, Immunospecifics, with their planned equity now set out. Wakefield would get 37%, and the father of child 10 22.2%. The venture capitalist would get 18%, Pounder 11.7%, and O’Leary 11.1%.
Some would also be awarded extra money in advance, in proposed “executive and non-executive staff costs.” Wakefield was set to get £40,000 a year, in addition to his legal earnings and medical school salary, with an annual travel budget of £50,000 for the business.
Here was another striking conflict of interest, but Wakefield had long made clear his expectations. “The Company will endeavour to ensure that the principal members of its management and scientific team are suitably incentivised by the allocation of Equity and stock options,” he had written in September 1996, when child 2 was still on the ward.
Carmel was to be based at the Coombe Women’s Hospital, Dublin, where legal aid money paid for a laboratory. A prospectus described a public relations effort aimed at two “target” audiences: “parent groups and lawyers representing affected individuals” and “major pharmaceutical companies.”
“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.”
Keeping it secret
To facilitate negotiations, letters and draft contracts went back and forth to the Royal Free. A principal document was finished in the autumn of 1999, naming Wakefield, Pounder, Carmel, Immunospecifics Biotechnologies (IB Ltd), the medical school, Freemedic, an American foundation called Neuro Immuno Therapeutics, and its head, Hugh Fudenberg, an immunologist.
“Royal Free and Immuno entered into the Letter Agreement (as defined in this Agreement),” began a typically meaty clause. “Under its terms Royal Free was to assign to Immuno the intellectual property rights subsisting in the Inventions. In consideration of this assignment Immuno was to pay £10,000 to Royal Free, and was to grant Freemedic an option, over shares representing 10% of Immuno’s issued share capital.”