In the second part of a special BMJ series, Brian Deer reveals a secret scheme to raise huge sums from a campaign, launched at a London medical school, that claimed links between MMR, autism, and bowel disease
John Walker-Smith, professor of paediatric gastroenterology, hurried to Malcolm ward on the sixth floor of the Royal Free Hospital, London, with what any doctor would think was bad news. An 8 year old boy, admitted for five days of investigations, had been provisionally diagnosed with Crohn’s disease. But when the child’s mother—here anonymised as “Mrs 2”—years afterwards recounted what happened, she seemed pleased to have received information she expected and made it sound as if Walker Smith was glad too.
“He skipped into that room like a 2 year old,” she told me. She remembered he said: “[Mrs 2], you were right.”
Brightly painted with murals, Malcolm ward was Walker-Smith’s. It came with his employment contract. Exactly one year previously, in September 1995, he had been lured to the Royal Free with many perks, of which this was one. Previously the hospital had no children’s bowel service, but with him it had a chance of the best.
The initiative to recruit him, however, had not come from management. It came from an academic researcher in the gastroenterology department: a former trainee surgeon, Andrew Wakefield. He wanted Walker-Smith, who would bring access to children’s gastrointestinal tracts, to help him prove a personal theory. This was that Crohn’s disease was caused by persisting measles virus infections—most notably, he came to suggest, from vaccines.
“You used to hear Wakefield’s people talking about how they would win the Nobel Prize for this,” remembers Brent Taylor, the Royal Free’s head of community child health, who frequently clashed with the pair. “The atmosphere here was extraordinary.”
But instead of honours, the two men reaped disgrace. In January and May 2010, the UK’s General Medical Council found them guilty of a raft of charges over a project involving child 2. Wakefield, now 54, was judged by a five member panel to be guilty of some 30 charges, including four counts of dishonesty and 12 of causing children to be subjected to invasive procedures that were clinically unjustified; Walker-Smith, 74, was deemed irresponsible and unethical. Both were struck off the medical register and have since filed High Court appeals.
Working on a lawsuit
Their misconduct arose out of a fishing expedition, in which Malcolm ward was the pond for the measles theory. Since February 1996, seven months before child 2’s admission, Wakefield had been engaged by a lawyer named Richard Barr, who hoped to bring a lawsuit against vaccine manufacturers. Barr was a high street solicitor, and an expert in home conveyancing, but also acted for an anti-vaccine group, JABS. And, through this connection, the man nowadays popularly dubbed the “MMR doctor” had found a supply of research patients for Walker-Smith.
“The following are signs to look for,” Barr wrote in a newsletter to his vaccine claim clients, mostly media enlisted parents of children with brain disorders, giving a list of common Crohn’s disease symptoms. “If your child has suffered from all or any of these symptoms could you please contact us, and it may be appropriate to put you in touch with Dr Wakefield.”
The first to be admitted—in July 1996—was a 3 year old boy with autism. But, according to his records, reviewed by the GMC panel, he was so constipated that, despite two attempts, the endoscopist could not reach his small intestine. So child 2, who had diarrhoea (found to be constipation overflow) was the first to have his ileum intubated.
Child 2 also had autism, the first signs of which came on “a few months” after MMR vaccination. His mother was referred to Wakefield by the JABS organiser, and the boy would not only be the lead test case in Barr’s eventual, failed, lawsuit but would feature with 11 other children in a now notorious, retracted, Lancet paper linking the vaccine with bowel and brain problems.
He was admitted on Sunday 1 September 1996 and endured a gruelling battery of investigations. These included magnetic resonance imaging of his brain, electroencephalography and evoked potentials, radioactive Schilling test, blood and urine tests, and lumbar puncture—all specified in an agreement with Barr.
A viral diagnostic
The following day, Monday, child 2 had an ileocolonoscopy, which, in common with seven other children reported in the paper, the GMC panel would find was not clinically warranted. Tuesday was Wakefield’s 40th birthday. 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.” 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,” 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, which since February 1996— two years before the paper’s publication— had been paying the researcher undisclosed fees of £150 an hour, plus expenses.
“The ability of the Company to commercialise its candidate products,” the draft plan continued, “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.”
As it turned out later, child 2 did not have Crohn’s disease, but three weeks after drafting the plan, Wakefield met three others to discuss it. One was his mentor, Roy Pounder, the Royal Free’s professor of gastroenterology and later vice president of the Royal College of Physicians. The others were Bryan Blatch, the medical school’s secretary, and Cengiz Tarhan, its finance officer.
Money from the lawyer
Discussions about the business continued over the following years, but Wakefield’s involvement with Barr was quickly noted. In October 1996, the medical school’s dean, Arie Zuckerman, a virologist, was told that the lawyer had offered to pay the school for a “clinical and scientific study,” and had sent a first instalment of £25,000. This was held in suspense while Zuckerman sought confidential ethical advice from the British Medical Association, although Wakefield had already started spending it.
“Arising from recent widespread publicity given to this research,” Zuckerman (who told me he does not want to discuss these matters) wrote of Wakefield’s already televised claims about Crohn’s disease, “the Legal Aid Board has provided funding through a firm of solicitors representing Crohn’s disease sufferers and we have been asked to make an appointment to the staff of the Medical School, specifically to undertake a pilot study of selected patients.”