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Secrets of the MMR scare

The Lancet's two days

to bury bad news

His claims were false. He was personally paid more than £435,000 through the lawyer, according to accounts I later obtained. And a corresponding “clinical and scientific study,” with the same protocol and principal authors as the paper, had been submitted to the UK Legal Aid Board for funding before the first of the 12 children was admitted. He had hired himself out explicitly to make a case against the vaccine, as a secret grant application revealed.

“The objective,” he and his retaining solicitor had written in the application to the legal board, “is to seek evidence which will be acceptable in a court of law of the causative connection between either the mumps, measles and rubella vaccine or the measles/rubella vaccine and certain conditions which have been reported with considerable frequency by families of children who are seeking compensation.”

At their meeting with Horton, the paediatric gastroenterologists Walker-Smith and Murch also denied impropriety. I had claimed that some children were solicited, rather than spontaneously referred. This was denied. I said there was no ethical approval. Denied. In short, there was nothing wrong, apart from Wakefield’s conflict of interest. They agreed to issue statements through the journal to make things clear.

“It was a difficult but useful meeting today,” Walker-Smith wrote that evening as he minuted their discussion, in one of a flurry of emails among the doctors. “I have been asked to write something about referral for our combined statement to the Lancet . . . Simon I believe you will answer in detail the charge of deception in relation to the Ethical Committee, the most serious charge of all and indeed for us all. Andy you will deal with the legal issues.”

The next morning, Thursday, Wakefield responded with a draft of his contribution. It was addressed to Walker-Smith, Murch, and Horton—plus Wakefield’s personal MMR campaign publicist, Abel Hadden of Bell Pottinger Communications in Mayfair. “Abel,” this said in an addendum. “I have not got to your changes yet.”

Meanwhile, elsewhere other events were unfolding that would shortly shine light on Horton’s mindset. The day before our meeting, I had visited Evan Harris, at the time member of parliament for Oxford West and Abingdon. He was a doctor and member of the British Medical Association’s ethics committee, and had an interest in the MMR controversy. He had then turned up to observe my presentation to the Lancet, and afterwards requested copies of my documents.

At 13.16 Thursday, I emailed my agreement, and Harris bounced this forward to the journal. “Please see below for authorisation to send me Brian’s papers on the research ethics,” he wrote to Horton, 13 minutes later, planning to rely on the same material as the editor. “He wants me to give him an opinion and I explained I needed the papers. Hope they can be faxed forthwith under authority of one of your colleagues as you are out.”

Horton, at the time, was at the Royal Free with Walker-Smith, Murch, and Humphrey Hodgson, the vice-dean. In Hodgson’s basement office they “reviewed the allegations,” Horton told the GMC panel, and “decided on a course of action.” Then “we all went up to the department of paediatric gastroenterology,” where the doctors “investigated” the children’s records. He explained that Walker-Smith went to look at a biopsy book “to establish questions about referral patterns.” Then “a view was formed about the evidence in support of, or not, the allegations.”

In short, the accused were investigating themselves—an investigation that Horton would say “cleared Wakefield.”

“I think you said Professor Walker-Smith looked back at the biopsy book,” Sally Smith asked him.

“He looked back at the biopsy book, as I recall,” replied Horton, editor of the journal since 1995. “Dr Murch and Professor Walker-Smith together looked at the case notes. I will be honest and say I cannot remember whether Dr Wakefield did or did not look at the case notes himself.”

In fact, Wakefield was not invited on to the Royal Free’s campus, having been constructively dismissed from the school two years previously. But only he knew all the names of the paper’s 12 anonymised children, and he faxed a list for the others to use.

That Thursday afternoon, Horton returned to his office, where he then dealt with the MP’s request. Photocopying my email to Harris and Harris’s to him, at 16.27 he faxed them to the medical school, with a handwritten pledge to the vice-dean. “Humphrey,” this said, referring to the documents I had agreed to be shared. “This sequence of emails demonstrates the apparent collusion between Harris and Deer. Needless to say, I have not, and will not, pass on these documents to him.”

No doctor interviewed

The Harris correspondence was not read to the panel, but members received Horton’s evidence with interest. “Is it customary,” asked Parimala Moodley, a member of the council of the Royal College of Psychiatrists, “for an investigation of possible serious research misconduct to be carried out by the people who have been so accused of the misconduct?”

Horton paused to gather his thoughts. “It is customary for the institution to lead an investigation and to gather the data which will inevitably involve those who took part in the investigation,” he replied. “It is then the responsibility of the institution to make sure that there is some kind of separation between its interpretation of those findings and those who are involved in the investigation who are being in some sense accused of a set of allegations, and once that interpretation by the institution has taken place and has been conveyed to whoever has brought the allegations to them then we can go forward. So there certainly should be some separation, which is why in the first instance I wanted to get the reaction from Dr Wakefield, Professor Walker-Smith, and Dr Murch, but after that my duty was to go to the head of the institution, the vice-dean, in this case Professor Hodgson.”

But there had been no separation and no independent inquiry—as both the hospital and medical school later confirmed. No doctor was interviewed, and no documents were generated. There was only the “informal process” just described. This, I was told, involved “discussion with clinicians,” their “review of the relevant clinical papers,” and study of an ethics committee file. “The written outcome of this process was the statements made by clinicians concerned and the Medical School published in The Lancet.”

The shallowness of this process was exposed at the GMC hearing, where the panel read the children’s hospital records. The pages were thick with evidence of orchestrated referrals and indications that the prime purpose was research. One child’s notes contained a legal aid letter, and the ethics committee file was a scorcher.

Even the patients’ referral circumstances might have alerted a dispassionate investigator to the need to dig deeper into the cases. The panel would notice that child 2 and child 9 in the paper were solicited by Walker-Smith, at Wakefield’s behest. The children 1, 5, 9, and 10, meanwhile, were referred to the Royal Free gastroenterologists without mention of any history of bowel problems. And child 4 and child 8 were referred directly to Wakefield, whose contract forbade clinical work.

“Thank you for asking to see this young boy,” child 3’s referral letter began.

“This 7¾ year autistic child’s parents have been in contact with Dr Wakefield and have asked me to refer him,” said child 5’s.

“[Child 8’s] mother has been to see me and said you need a referral letter from me in order to accept [child 8] into your investigation programme.”

Meanwhile, ethics documents, reviewed by Hodgson, did not square with what was published in the journal. The hospital’s file referred to a study of 25 children with disintegrative disorder, an exceptionally rare and serious degenerative brain condition. This affects school age children, and Walker-Smith had told the ethics committee that the prognosis for such patients was “hopeless.”

But none of the 12 children was diagnosed with this disorder: they were a heterogeneous group, mostly reported with autism. And one patient—child 7—was referred to the hospital with no developmental diagnosis.

The ethics file, which I was shown, also included correspondence generated after the Lancet publication. David Hull, a former president of the British Paediatric Association, had noted an extraordinary battery of tests endured by the children. This included ileocolonoscopy, magnetic resonance imaging brain scans, electroencephalography and evoked potentials, lumbar punctures, and barium meal and follow throughs. The paper said that these “investigations were approved” by the ethics committee, which he thought might clash with codes requiring tests on children to be clinically indicated.

In order to respond to Hull, the committee chair, Michael Pegg, had been consulted. He advised that the paper was wrong. “In his letter Professor Hull states: ‘I see that the investigations were approved by the Ethical Practices Committee,’” wrote Pegg in a memo on the file studied by Hodgson. “This is, of course, incorrect. We did not approve the investigations. We approved data collection from clinically indicated investigations. It is not, at present, the role of an ethics committee to question clinicians’ judgement as to what are and what are not clinically indicated investigations.”

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