Junk medicine: MMR research revelations by Mark Henderson
It is probably too much to hope that the revelation of Andrew Wakefield’s conflict of interest will end controversy over the MMR vaccine. The emotional campaign against the triple jab has always owed more to faith than to facts. The past week’s reports are not, unfortunately, going to change that. The story does, however, tear down the misconception that only scientists funded by the Government or industry may have ulterior motives. And it lays bare the scandalous way in which legal aid — taxpayers’ money — is used to fund dubious and questionable science.
Few researchers are totally disinterested in their studies’ outcomes. Most would prefer to see a certain hypothesis supported, whether to please funders, secure grants, or purely for the pleasure of being right. These influences will not necessarily prejudice the work — but it is important that they be acknowledged so that referees can assess it in full possession of the facts.
That Dr Wakefield was funded by lawyers seeking to link MMR to autism does not invalidate his findings — though they have not stood up well to scrutiny in the event. A source of financial support cannot change human physiology. It can and does, however, affect the interpretations that people put on data.
Dr Wakefield’s non-disclosure left peer-reviewers bereft of the information they needed to judge bias. His key finding was anecdotal: the parents of eight of the 12 autistic children in his sample linked the symptoms to MMR. That five of these were already litigants is clearly relevant to the study’s significance. The Lancet would not have published had it known and the vaccination crisis might have been averted.
A conflict of interest does not, alone, justify ad hominem attacks on a scientist and invalidate his work. Left undeclared, however, it can impugn not only motives but also his results.
This scandal, though, does not begin and end with disclosure. Even if Dr Wakefield had made his declaration, there would remain the question of why the Legal Aid Board (LAB) ever agreed to fund his research. Most people assume that legal aid is there so that people with a strong existing claim but little money can take it to court. Yet the system can be exploited to support scientific fishing expeditions that might eventually build a half-decent case.
The MMR saga is a prime example. Over the past eight years, £15 million of legal aid has been spent on claims on behalf of autistic children. This has not been spent on legal action based on verifiable sound medical evidence. The goal has always been to establish a hunch that most scientists reject. This sum is roughly a tenth of the Medical Research Council’s annual budget for new grants. But when researchers apply for a slice of this limited pool, they compete for it under rigorous peer-reviewed criteria. Only impeccably designed proposals, based on strong preliminary evidence that there is something worth looking for, stand any chance of success.
Legal aid does not have this rigorous protection. Vast sums have been spent on studies that experts must have doubted would go anywhere. Last year, the LAB now known as the Legal Services Commission, finally turned off the MMR tap, refusing another £10 million award as the litigation was judged to stand little chance of success. Even this belated step could yet be overturned by judicial review.
It has also spent £4 million on research into Gulf War syndrome, again without revealing enough evidence to sustain a court case.
Legal aid has become a gravy train for supporting a number of daft scientific theories. If it is to back research at all it must be constrained by the same funding rules as the research councils. Before good money is spent on research, there has to be a fair chance that the study in question will accomplish something.
Dr Wakefield was wrong not to disclose his conflict of interest. But the LAB’s decision to fund him at all was just as outrageous.
Mark Henderson is The Times science correspondent
Autism: I can see clearly now . . . by Simon Crompton As the controversy about autism and the disputed link to the MMR jab resurfaces, we look at the pioneering research shedding light on this complex condition
Imagine life as a magic picture — one of those strange patterns of swirls which takes three- dimensional form only when you focus away from it. What would it be like never to be able to see anything in its entirety — only a hand or an ear at a time, never the whole body? Life would be fragmented and confusing, like living in a Picasso cubist composition, or a Hockney collage of photographs. That, according to one of America’s most pioneering researchers on the subject, is exactly what it’s like to be autistic. Mary Megson, a paediatrician, believes she has found a key to the symptoms of autism — a vitamin deficiency. What’s more, she has become convinced that the strange behaviours we associate with the condition have a simple source: the children’s inability to see normally. Treating autistic children with vitamin supplements, she says, has achieved such remarkable results that she has been able to talk to severely affected children about how the world changes once the manifestations of autism begin to diminish. “Within three days, most of the children I treat with cod liver oil regain eye contact,” says Megson, who heads the Pediatric and Adolescent Ability Centre in Richmond, Virginia. Lost eye contact is one of the main symptoms of autism, along with impaired communication and poor social interaction. “One of my young patients just stared down at his arms, and said that for the first time he was able to see his arms and his hands at the same time.”
In a week when the controversy surrounding the link between the MMR jab and autism has once again peaked, Megson’s work provides an eye-opening glimpse into the world of children affected by this mystifying condition. Like many of those investigating nutritional approaches to treating autism, Megson is a clinician who works with patients rather than a career researcher. She does not claim to have found the cause of autism, but she believes that she has pinpointed the mechanisms which cause many of the most troublesome and characteristic symptoms.
The key, she believes, lies in a deficiency of a natural form of vitamin A found in cod liver oil. In genetically susceptible children, she says, lack of this vitamin disrupts receptors in the brain causing vital mechanisms to be switched off. This blocks visual, sensory, language and attention pathways in the brain. Her theory has been backed by a recent double-blind placebo controlled trial (the scientific gold standard) of 38 children with autism, which found that those taking cod liver oil showed significant improvements in their abilities over six months.
Megson wanted to check if any genetic factors made her patients more susceptible to this deficiency, so she looked at their family histories and made a remarkable discovery. Up to three quarters of the children also had a family history of night blindness — where the eye is unable to adjust to dark conditions. “I wondered how this would affect their daytime vision. Our rod cells — which differentiate light and dark — are in the peripheral part of our eye, and cones, for colour, are in the middle,” says Megson. “My patients have poor rod function so they lose the shading and shapes of objects, and the only way for them to get that back is to concentrate on the peripheral. That’s why autistic children tend to look at you out of the corner of their eye. They ’re trying to get the facial shading.”
Other researchers have noted poor rod function in autistic children. It is also well-established that vitamin A is essential for proper rod functioning. Megson believes that a lot of what we regard as the strange symptoms of autism are, in fact, simply an attempt to interpret the world given these visual experiences. For example, a mother might take her autistic daughter to see her grandmother every week by the same route, but when she varies it because of roadworks, the child throws a tantrum. The girl, says Megson, is panicked because her pictorial world is suddenly turned upside down. She has little peripheral vision, so she sees her journey in a series of two-dimensional snapshots of the image at the centre of her vision. She has no sense of a wider picture and cannot detect movement. All she knows is that those familiar visual images she clings to have been taken away.
“Their visual field shrinks down to exactly where they are looking and everything loses subtlety, dimension and shading,” says Megson, who this month presented her observations to scientists, doctors and nutritionists at a seminar in London. This narrowing of their vision means that it is unlikely they will see something at the same time as someone is talking about it. That makes learning and understanding difficult, and is why autistic children often seem to be thinking in “monochannel”. The narrow visual field of television, however, allows them to put sounds and where they are coming from, together. That’s why the language they learn is often lifted word-for-word from TV.
Once on vitamin A, Megson says, this fragmented world begins to take shape. She recalls one ten-year-old boy who had refused to communicate since the age of four. His mother had night blindness, so Megson started the boy on cod liver oil. Within a week he noticed paintings on the wall at home. He ran across the lawn to the school bus rather than carefully following the path. Shortly after receiving another supplement to encourage brain receptor function, he pointed to a sweet jar and said: “Can I have a candy please?” It was the first time he had spoken in six years. It’s emotive and radical stuff, and it is also a hypothesis based mostly on the experiences of patients, and has yet to be proven scientifically. Yet it dovetails with other research demonstrating the benefits of fish oils and omega-3 fatty acids in moderating attention problems in children, and improving mental performance in adults. It also fits with what people with autism say about how they see their world. Temple Grandin, who has overcome autism to run a livestock business, wrote in her book Thinking in Pictures: “I create new images by taking little parts of images I have in the video library in my imagination and piecing them together.”
Paul Shattock, director of the University of Sunderland’s autism research unit, rates Megson’s work, even though it is unorthodox. His unit has now gained approval to conduct double-blind trials investigating the benefits of omega-3 and 6 oils. Her approach is useful, but not the whole answer, he says: “If cod liver oil was a cure, you wouldn’t have autism in Norway.”
Megson would agree. She’s continuing her research but it’s the response of her patients — not the demands of a research agenda — that motivates her: “I’ve been treating developmental disabilities for 25 years. The fact that I can now help people get better is wonderful.”
AUTISM FACTS
New official figures from the United States indicate that 3.4 children in every thousand now have autism. This rate is ten times higher than similar studies indicated in the 1980s and 1990s. UK studies indicate a similar rise, attributable, some say, to increased diagnosis.
Autism is a spectrum of conditions, ranging from mild to severe, characterised by difficulty in developing imagination, communication and social relationships.
There is no known cure for autism, but structured support and education can maximise a child’s skills. A range of foods and supplements have been used successfully, but most have not been rigorously researched. contact the Autism Research Unit : www.osiris.sunderland.ac.uk/autism/
February 28, 2004
MMR case parents lose legal aid fight By Nigel Hawkes, Health Editor
PARENTS who claim that their children have been damaged by the triple vaccine MMR have lost a battle for legal aid to support a claim for compensation. A High Court judge rejected yesterday an application for judicial review of a decision by the Legal Services Commission (LSC) to withdraw public funding to fight test cases.
The commission had committed £15 million to the lawsuit and has already spent £10 million on lawyers, expert opinion and research in an attempt to provide evidence. But last year it acknowledged that the cases had no chance of succeeding and withdrew support.
The parents appealed against the decision, seeking judicial review. But after a hearing held in private, Mr Justice Davis has ruled against them, upholding the LSC’s decision.
Mr Justice Davis, sitting in London, said that he could “well appreciate the decision to withdraw legal aid will have caused great dismay to the parents of the claimants”. But the Funding Review Committee of the LSC “was obliged to make a dispassionate assessment of the matter as things stood before it”.
The parents are now considering taking their legal campaign to the Court of Appeal.
The decision was made a week after editors at The Lancet, which published the scientific paper that led thousands of parents to boycott the MMR vaccine, said that they might never have published the study by Andrew Wakefield in 1998 if they had known that he was also paid £55,000 in legal aid as part of a legal action against the vaccine’s manufacturers.
Many doctors have criticised the LSC for committing so much money to a lawsuit they considered bound to fail. Public money, they argue, effectively sustained a campaign against MMR while the Government had to spend more public money arguing that it was safe.
Yesterday’s judgment concerned the lead cases in a group action involving about 1,000 claimants.
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