A doctor, the distinguished journal, and a scare that need never have happened

Medicine men: the faces behind the story that caused a public health crisis
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Indy Lifestyle Online

The scare over MMR vaccine that has seen hundreds of thousands of parents reject one of the most basic safeguards for children began in 1998 at the Royal Free Hospital in London, at a press conference called to publicise a research paper in The Lancet. It turned into one of the biggest public relations disasters in medicine, for which the hospital, journal and doctors involved must all share the blame.

Andrew Wakefield, then a little-known consultant gastro-enterologist at the Royal Free, had with colleagues identified a new inflammatory bowel disorder linked to autism in 12 children. In eight of the children the bowel disorder and autism had appeared after the triple MMR (measles, mumps and rubella) vaccination.

The paper had been submitted to The Lancet in August 1997, and it was immediately clear to editors there that the findings were worrying. Over 600,000 children were routinely vaccinated against MMR each year, and The Lancet feared triggering a panic about the vaccine.

The paper was sent to four specialists for peer review and discussed by The Lancet's editorial committee on three occasions. Critics of the paper said it was based on too small a sample of patients who had been attracted to a hospital department known to have an interest in their condition and were not, therefore, a randomly selected group.

Dr Wakefield had published an earlier paper in The Lancet in 1995 suggesting a link between measles infection and Crohn's disease, and word had spread among parents who began bringing their children to him. Some complained that problems followed MMR vaccination. In January 1998, the British Medical Journal published a review of research that scotched the Wakefield hypothesis. That added to the difficulty faced by The Lancet's editors in considering the second paper.

What The Lancet did not know was that Dr Wakefield was being paid by the Legal Aid Board to investigate grounds for legal action against the vaccine manufacturers, thereby creating a conflict of interest. Had it done so, Richard Horton, editor of The Lancet, said yesterday the paper would not have been published.

But other medical editors pointed out yesterday that most authors of research papers had some conflict of interest - owning shares in a drug company, for example - and normal practice was to declare it at the end of the paper. Few journals have defined what conflict of interest would render a paper unpublishable. The New England Journal of Medicine draws the line when payments to the author from the subject of the research in the previous five years exceed $10,000 (£5,400).

When The Lancet published Dr Wakefield's paper in 1998, it also ran a highly sceptical commentary, to satisfy its critics. But it made no mention of the paper in its weekly press release,an early sign of its anxiety. A spokesman said at the time it wanted to "avoid being alarmist", but the real reason was that it hoped to distance itself from what it rightly feared would be a media frenzy.

The Royal Free decided to deal with the inevitable press interest head on. It called a press conference before a panel of five doctors, carefully selected to present a balanced view. Each was eminent in their own field but, fatally, each had a different opinion.

The five had earlier rehearsed the press conference and agreed the line they would take, which was to recommend continued use of MMR vaccine pending further research. Under questioning, however, this carefully constructed consensus fell apart.

Andrew Wakefield urged parents to give their children single vaccines at annual intervals, whereas Professor Arie Zuckerman, a virologist and dean of the medical school, insisted MMR vaccine had been given to millions of children around the world and was safe. That afternoon the Government issued what was to be the first of many statements that have desperately sought to bolster public confidence in MMR.

The rest is history. Next morning's headlines, unsurprisingly, highlighted the potential risks from MMR. In the six years since, national vaccination rates against MMR have fallen from above 90 per cent to below 80 per cent, dropping so low in some areas that measles outbreaks are threatened.

Dr Wakefield, who has left the Royal Free to work in the US, and his colleagues now face a General Medical Council (GMC) inquiry over the conduct of their research. Allegations that they failed to obtain ethical approval for invasive tests on the children, such as lumbar punctures, have been rejected by The Lancet, but they may be re-examined by GMC investigators along with claims about the conflict of interest.

The role of medical journals in publishing controversial research with public health implications is likely to come under separate scrutiny.

Dr Horton said yesterday he stood by the part of the Wakefield paper that hypothesised a link between a new kind of inflammatory bowel disease and autism, saying he believed it remained credible and should have been published. Its findings have been confirmed in other studies.

But the part suggesting a link between MMR and autism would not have been published, he said, had the editors known what they now know. Subsequent research has not proved the link, and two of the authors on the 1998 Lancet paper, Professor John Walker-Smith and a paediatrician, Dr Simon Murch, have since publicly dissociated themselves from Dr Wakefield and said MMR is safe.

Unlike most scientific controversies which flare up and die away, this one has simmered on for six years. It has been sustained by a mix of public anxiety, mistrust of government health policy after the BSE debacle, and sympathy for a lone doctor.

Parents wondering whether to vaccinate their children still have a dilemma. The possibility that the childhood vaccination programme may be causing damage to some children remains one of the most emotive in medicine.

But after six years of claim and counter-claim it is astonishing to learn that the scare might never have happened had the medical researcher who made the original allegation disclosed the full extent of his interest.

Richard Horton as the youngest editor of The Lancet, appointed eight years ago at the age of 33, he has challenged the vested interests in medicine, taking on the drug industry, the World Health Organisation and the US Food and Drug Administration. In doing so he has roused the envy of other medical editors, who rarely risk putting their heads above the parapet. But critics saythat his firebrand style of campaigning is not appropriate for the custodian of a great scientific institution, such as the Lancet.

"Secretly I admire him," one editor said, "but I do wonder if he is slipping sideways into journalism rather than scientific editorship."

Although publishers are nervous of controversy, their main interest is in preserving the reputation of their publications and the sales that flow from that. The Lancet is still one of the top three medical journals in the world and its citation index - the number of times it is mentioned by other researchers - remains at the highest level.

Dr Horton's high risk editing strategy makes him more vulnerable than some more cautious editors. But unless there is more to be revealed about the MMR paper it is unlikely to bring him down.

Andrew Wakefield has been a thorn in the side of the public health establishment since returning from Canada in 1990 where he worked as a surgeon. Disillusioned with chopping out bits of diseased bowel and wanted to know what triggered the disease in the first place.

He returned to England "in something of a crisis" and set to work at the Royal Free Hospital to test his hypothesis that the measles virus could be responsible. Parents of children with bowel disease heard about his work and flocked to see him, begging for answers.

At the time of his 1998 Lancet paper suggesting the link with MMR he said he had thought every night for 10 years about the impact his research could have on the national vaccination programme.

'My children say, "Why do you do what you do, Daddy?" and I do not know what to say. It is a moral issue for me. If am wrong I will be a bad person because I will have raised this spectre. But I have to investigate the questions my patients put to me." In the past six years, backing for his thesis and support from colleagues has has ebbed away. A committed but increasingly isolated man, he was led astray by the power of his own belief.