Standing outside the General Medical Council yesterday, surrounded by crowds of supporters, Dr Andrew Wakefield appeared shell-shocked by the GMC’s damning findings that he had been “dishonest, irresponsibile and showed callous disregard for the distress and pain of children.” Rallying some of his usual bravado, he then declared himself “resolute and determined” in the face of disgrace.
“I still had a naive belief in justice, I didn’t believe it could be quite like this,” he told me when the hubbub had subsided. “I feel so sorry for the children and their parents, it’s desperate for them. But the struggle goes on.
The chap who discovered Thalidomide said this always happens and fifty years later he received an apology.”
For two and a half years a panel has been listening to arguments about whether Wakefield, and two erstwhile colleagues from the Royal Free Hospital in London – Professor John Walker-Smith and Professor Simon Murch – were guilty of unethical behaviour in the way they conducted research. At the heart of the case lies a 1998 paper, published in the medical journal The Lancet: a study of 12 patients with autism and bowel disease which might have been linked to the MMR (measles/mumps/rubella vaccine. Its publication, and the views expressed by Wakefield, a gastroenterologist, at the press conference afterwards, led to widespread panic about the safety of MMR.
The conduct of the study – not its conclusions – has been the subject of the hearing, but the paper was a landmark in the debate surrounding the safety of vaccines. It created the panic that led to a drop in uptake of the MMR, which now stands at 78 per cent, and a subsequent rise in cases of those diseases. Last year in England and Wales there were 1,143 cases of measles, which can lead to brain damage and death.
Long before the GMC concluded that Wakefield had “failed in his duties”, he was a villain to many within the medical establishment – an arrogant doctor who published his findings too soon, a man whose reputation mattered more to him than public panic and herd immunity. In 2004, 10 of the 13 authors dissociated themselves from a paper which the editor of the Lancet, Richard Horton, described as “fatally flawed”.
But to the parents who wept outside the GMC today, Wakefield is a hero, a wronged man. Among them was Polly Tommey, founder and editor of The Austim File, a magazine whose readership of 40,000 consists of parents whose children have autism combined with bowel problems. They are looking for explanations and cures. Wakefield, to them, represents hope, and it is in Tommey’s west London home that Wakefield invited me a week ago, because he wanted to explain his case.
His mood then was considerably more bullish than yesterday. Far from feeling contrite, or admitting to nerves, he was on the attack. His targets were the Government, Public Health supremos (with capital letters he later emails to make clear), the press in general and Brian Deer in particular – the journalist whose three letters of complaint to the GMC had led to the longest, and most costly, trial in that organisation’s 148-year history.
For a man who has been under intense pressure since 1998, he appeared unlined for his 53 years. In 2001, he lost his job at the Royal Free, and moved to America while his wife Carmel, also a doctor, and their four children, currently aged from 21 to 12, stayed behind in England. They joined him three years later, once he had established Thoughtful House, a research and treatment centre, in Austin, Texas. “It has been pretty terrible,” he admits and his face briefly takes on a vulnerable look, but he does not wish to dwell on personal matters.
Wakefield is a man who says what he wants to say, not what others may wish to hear. His agenda is to vindicate himself. “The GMC might find fault,” he believed before the findings were handed down. “They might find misconduct, but they won’t find serious professional misconduct.”
How seriously the GMC views yesterday findings of fact will be decided in a few months’ time, together with sanctions against the three doctors. They are likely to be struck off the medical register. Although Wakefield no longer works in England, he may find it hard to attract patients to Thoughtful House, although he believes the findings to be “unfounded and unjust” on all but one count – taking blood samples from children at one of his own children’s birthday parties.
It was a strange thing to do, without approval from the Royal Free’s ethics committee, but he wanted a control group to contrast with his sick patients. He continues to believe it was not unethical. “I had fully informed parent and child consent. The ethics committee is there to protect NHS patients, and these weren’t NHS patients.”
More seriously, he was charged with causing pain to sick children by painful, intrusive diagnostic treatments. But the researchers had ethical approval, he argues, producing a letter, dated 27 Februrary 1997, from Professor Walker-Smith, the head of the department of Paediatric Gastroenterology at the Royal Free, noting approval for biopsies and organising further approvals. Wakefield believes the letter is his smoking gun. “For some bizarre reason the GMC do not seem to have had this document. My barristers didn’t have a copy because their job is to respond to the documents presented to them.”
Other charges related to whether the research team was receiving money for the study as part of a legal action which sought to show a link with MMR. Although some of the children in the study subsequently become part of the legal action, he says they were not involved when he first examined their symptoms, and wrote the report. He saw no conflict. “The Lancet rules then were: ’What do you, the author, think determines conflict of interest?’ A year or two later the definition was changed to 'what others might perceive as conflict of interest’".
Behind his cool manner, and soft voice, lies rage. He believes he has been the victim of a media campaign. “Repeat after me: 'Wakefield discredited, Wakefield discredited,’ if you say it often enough it will stick.” But why? “There was a huge political will to prosecute. Don’t you dare challenge vaccination, was the message. The motive was not always financial. It was a belief system. I am, of course, deeply concerned with public health, but not with the structure of Public Health. I’m interested in the individual who comes in and sits down at the table and says: 'This is what happened to me or my child.’ That’s why I came into medicine.”
Between 1996 and 2000 more than 1,000 pateints were referred to the paediatric gastroenterology team at the Royal Free because Walker-Smith, now retired, was the leading light in the field. “Many of the letters from parents and doctors said the same story, that shortly after vaccination these children had suffered some kind of event that left them with autism and bowel problems. It seemed to be a new kind of autism.” As well as studying patients referred to him from all over the world, he trawled the literature on the safety of vaccines and wrote a 250-page report in which he expressed his horror at the inadequate research.
He regrets the downturn in vaccination that resulted form his work, because lack of compliance “creates a dangerous situation” but feels the Government is responsible. “We added this line to The Lancet paper: 'We do not prove an association between the MMR vaccine and the syndrome described.’ Any drug, especially one that involves three live viruses, must be considered dangerous until proven otherwise. At the press conference I said that I supported the use of single vaccines until any causal link with MMR had been investigated. But the single vaccines weren’t made available.”
Since then many studies have found no link. He remains unconvinced. “There are studies from six countries which show a link. In the US, there have been a number of court cases in which the link has been acknowledged.”
As for the epidemiological studies, he says that you can achieve any result you want by manipulating statistics. “We are not up against science, but interpretation.”
His hope now is that he can continue researching and treating children whose autism seems be at least partially alleviated through managing their gut problems, whatever the cause. “Thousands of children are presented with these problems every day. We can do a huge amount to help them. The more we can understand this disorder, the more impact we can make by practising straightforward simple medicine – and not treating these children as an anomaly or an inevitability. I’m a scientist. I ask questions, I don’t know the answers. The science will tell the story in the end.”
If so, one day, he may be vindicated. But for now he is no hero, only a maverick who put lives at risk because he did not conduct his research properly.
Vaccine - Autism Link Doctor Guilty of Misleading Conduct
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