'MMR SAFE' DOCS HAVE LINKS WITH DRUG FIRMS
Sunday Mercury; 2/29/2004; FIONNUALA BOURKE
FOUR leading Midland doctors who deemed the controversial MMR vaccine safe have links to the drug giants who make or supply the jab. Campaigners have called for the General Medical Council to investigate the senior Government advisors, who all hold scientific posts in the Midlands and sat on key committees which declared the vaccine safe. Professor James Chipman from Birmingham University, a member of the Committee on Safety of Medicines, received research funding from GlaxoSmithKline, suppliers of the MMR vaccine Priorix.
Consultant cardiologist Dr Colin Forfar from John Radcliffe Hospital in Oxford, a shareholder in GlaxoSmithKline, is also a member of the influential committee. Professor Terence Stephenson, from the Queen's Medical Centre in Nottingham, sits on the same committee but his travel expenses are paid by the same drugs giant.
Professor Michael Langman from Birmingham University is the Chairman of the Joint Committee on Vaccination and Immunisation. His team received research support from Merck Sharp and Dohme, which manufactures MMR vaccine. Now Jonathan Harris, West Midlands campaigner for vaccination awareness group JABS (Justice Awareness and Basic Support) is calling for the GMC to investigate the work of the medics.
Only two of Mr Harris's six children had the MMR vaccine and both of them are autistic. 'A total of 19 Government experts are connected to the drugs industries that deal with the MMR vaccines,' he said. 'Shouldn't this be considered a conflict of interests? 'These experts are advising the Government about the safety of the MMR vaccine at the same time as receiving payments or holding shares in the companies selling the jab.
'The Government requested that the GMC investigate the work of Dr Andrew Wakefield, who first proposed the link between MMR and autism. 'They declared it was 'a matter of urgency' when it emerged that he had received funding from lawyers representing parents of children who felt they had been damaged by the vaccine. 'So why shouldn't they investigate these doctors who have links to the drugs industry while they are at it?'
The doctors' watchdog GMC agreed to consider a full investigation into the work of Dr Wakefield last week at the request of the Health Minister John Reid. The medical researcher provoked a furore when he first proposed a link between MMR and autism in a paper published in The Lancet magazine in 1998. In a press conference later he also recommended parents opt for single jabs.
The editor of The Lancet has since said that he would not have printed the study if he had known Dr Wakefield had received funding for it from the Legal Aid Board. It emerged that Dr Wakefield received pounds 55,000 from the Board to investigate claimsby parents that their children had been damaged by the measles, mumps and rubella jab. And the GMC has agreed to consider a full inquiry into the study following a request from the Secretary of Health John Reid stating that it 'was a matter of urgency'.
A spokesman for the GMC confirmed that the four Midland medics were registered with them but declined to say whether it would consider opening an investigation into their work and links with the drugs firms. None of the doctors were available for comment last night. Their personal and non-personal interests have all been openly declared to the independent advisory committees on which they sit.
C2004 Independent Newspapers (UK) Limited.
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PRIVATE EYE 5 March - 18 March 2004
The vilification of Dr Andrew Wakefield in recent days has been a side show to the important issue of whether the mumps, measles, and rubella triple vaccine (MMR) poses a risk to a small sub set of children. But the attacks have served a purpose. They have highlighted the need to preserve independent medical research - and reminded the public that there is one rule for an off-message messenger like Dr Wakefield and quite another for the government and drug companies.
For example, one leading health official responsible for immunisation has been working as an expert for the three defendant drug companies in the UK MMR court case since July 2002. Yet as far as the Eye can ascertain, she has never declared that potential ''conflict'' on any of her research papers.
Dr Elizabeth Miller, head of immunisation at the government''s Health Protection Agency (HPA), last year alone published three papers in the Archives of Disease in Childhood directly related to the MMR controversy. One suggested that the combined triple live virus does not overload the immune system, so there is no need for single vaccines. Two others suggested that parents have been more likely to attribute their children's autism to MMR since 1998, when Dr Wakefield and his team at the Royal Free hospital in north London published their controversial paper.
Nowhere on Dr Miller's papers does she declare that she is also an expert witness for the drug companies GlaxoSmithKline, Aventis Pasteur and Merck. Moreover, the Eye has begun trawling through scientific and medical journals to examine papers published over the last two years by other defendant drug company experts. So far we have not found a single declaration on any paper that the author also acts as an expert for the defendant drug companies - even though at least two of the experts (Dr Diane Griffin, an American, and Professor Volker ter Meulen, a German), have produced research papers directly associated with vaccination.
Unlike in the case of Dr Wakefield, there have been no screaming headlines attacking their credibility or honesty; no demands for an inquiry by the General Medical Council; no snipes at their ''fatally flawed'' research. Instead, such authors continue to enjoy the support of government and big business. By contrast, Dr Wakefield only has the support of harrassed parents who believe their children were damaged by MMR, and, until recently, the impoverished Legal Services Commission - hardly powerful or influential.
Dr Miller maintains that neither she nor her department was paid by the three pharmaceutical companies for the detailed and lengthy report she submitted on their behalf to the court last June. She prepared their evidence in her own time, her department says, and did not declare it on any papers because there was no financial interest.
Nevertheless, it is known that money from those companies finds its way into the agency, formerly the Public Health Laboratory Service, through other research channels. In a recent annual report, Dr Miller listed five ''non-personal'' interests - ie payments which benefited her department rather than herself. Two of the companies featured were MMR defendants. The rules on conflict are weak, open to interpretation and generally not enforced - so should any criticism not be dished out in equal measure? As one leading journal states ''examples of potentially conflicting interests that should be disclosed include relationships that might detract from an author's objectivity in presentation of study results and interests whose value would be enhanced by the results presented.''
How can Sir Liam Donaldson, chief medical officer, and his deputy responsible for immunisation, Dr David Salisbury, justify their attacks on Dr Wakefield for non-disclosure of an interest when their own staff appear equally compromised? No doubt Dr Miller sought clearance before agreeing to act for the defendant drug companies. But every time she now opens her mouth the question arises: Is she speaking from the ''impartial ''view of the health department, open to all new research that comes to its attention; or for that of the defendant drug companies? As Eye readers will recall, Dr Miller also conducted the first ever trial of MMR among 10,000 children before its introduction in the UK nationwide.
It is clear the medical establishment and ministers had been waiting for an opportunity to attempt to discredit Dr Wakefield. Thus they seized on the Sunday Times's resurrection of a debate about conflict which emerged in the Lancet six years ago when Dr Wakefield published his controversial 1998 study. Shortly after publication the Lancet carried a letter from Dr Wakefield on behalf of all the authors in response to suggestions that there may have been ''litigation bias'' in their paper. It said that Dr Wakefield had agreed quite separately to evaluate a small number of children on behalf of the Legal Aid Board. ''These children have all been seen expressly on the basis that they were referred through the normal channels (eg. GP, child psychiatrist or community paediatritican) on the merits of their symptoms.''
Nothing about that ''conflict'' has changed but Lancet editor Richard Horton seemed to panic in the face of more serious - and completely unsubstantiated - allegations from the Sunday Times about subjecting the children to invasive procedures without ethical approval and questions about the Lancet's role in the affair - allegations the newspaper was forced to ditch.
Interestingly, Horton's condemnation of the Royal Free paper as ''fatally flawed'' ( which gave oxygen to the Sunday Times ''scoop'') was dropped by the time the Lancet published its statement about the affair the following week. It stated that it was ''regretful'' that the Lancet had not been made aware that the parallel legal aid had not been disclosed as it should have been '' because it would have been material to our decision-making about the paper's suitability, credibility and validity for publication''. It did not withdraw the paper or say it was fatally damaged.
Of course the issue of potential conflicts of interest - whether by Dr Wakefield or those acting as experts for the defendant drug companies - only flags up the possibility of research flawed by bias. Before a study can be ''fatally flawed'', as health chiefs maintain Dr Wakefield's is, the research itself must be shown to be faulty.
Aside from the fact that even Horton accepts that the Royal Free team identified a new syndrome suffered by children with gut disease and autism ( something so scientifically and medically significant, one might think it worthy of investment and further investigation), that original paper is now the equivalent of scientific chip wrappings. Science has moved on; and the Royal Free team has published more papers detailing the unique pattern of disease in these children's guts.
In both the UK and the US, meanwhile, measles virus, some of it vaccine strain, has now been found at the site of inflammation in the guts, in the blood and in the spinal fluid of some autistic children but not in ''normal'' children. Separate studies at Utah State University have found that some autistic children have auto-antibodies which are attacking the protein sheath that protects the nerve and brain in those children, researchers found a higher level of measles virus antibodies and an ''unusual MMR'' antibody, whereas their response to other vaccines did not differ between autistic and normal children.
None of this proves causation or a link; but combined they do provide a mechanism for brain damage and one potential trigger that might lead to autism. And that surely needs further investigation. Last week, while some newspapers and the medical establishment queued up to kick Dr Wakefield, a new US study of children defined as autistic by the US department of education and the biological surveillance summaries of the Center for Disease Control found ''a biological plausibility and epidemiological evidence showing a direct relationship between... measles containing vaccines and serious neurological disorders''. It also found a relationship between mercury containing vaccines and neurological disorders, the subject of litigation in the US. At the top of the study the authors, Dr Mark Geier and David Geier, both declare a potential conflict of interest in that they have been expert witnesses or consultants in areas involving adverse reactions to vaccines in civil litigation.
In May last year Dr Miller - in her role as head of immunisation at the HPA, rather than as an expert for the drug companies - was critical of the Geiers' earlier work. As indeed was Britain's Committee on Safety of Medicines, which found ''serious methodological'' flaws. But as the Daily Mail and other newspapers reported last week, that committee and the Joint Committee on Vaccination and Immunisation is packed with experts who either have shares in the defendant drug companies, receive funding for research from them or are paid advisers to them.
As the Eye reported in 2002, three of the members who sat on the Medical Research Council's review of the ten-fold rise in autism were advisers to the defendant drug companies. Even the chair had shares in one of the companies. The point is that potential conflicts of interest are common in medical and scientific research and development and Dr Wakefield's is but a puff in the wind. Ninety percent of research depends on big business and the pharmaceutical companies - and this is set to rise. The big companies already have a direct line to the prime minister through the Pharmaceutical Industry Competitive Task Force (PICTF), which Tony Blair set up after a meeting with the heads of AstraZeneca, GlaxoWellcome and SmithKlineBeecham.
The companies have already stated that they see the NHS as a huge unexploited resource. And the government's own reforming NHS Plan 2000 states that; ''The pharmaceutical industry is a UK success story, employing over 60,000 skilled workers and maintaining an annual trade surplus of over £2 billion. The industry is also the UK's leading investor in research and development. The NHS has a major role to play in ensuring that the UK remains an attractive base for the industry.''
Hence it has set about removing barriers to big business in the drug industry, encouraging hospitals and universities to enter into joint ventures and create mini-companies to exploit their research. They will inevitably become even more dependant on drug company influence - and even more at risk of serious conflicts of interest. Yet no one is shouting about that.
Make sure you look at the competing interest at the bottom of the page
MMR: Science and Fiction. Exploring the Vaccine Crisis; MMR and Autism: What Parents Need to Know
The publication in 1998 of an article in the Lancet proposing a new syndrome of autistic enterocolitis should have attracted little publicity ( Lancet 1998;351: 637 [CrossRef] [ISI][Medline]). The authors, researchers at the Royal Free Hospital, stated clearly in the article that "We did not prove an association between measles, mumps, and rubella [MMR] vaccine and the syndrome described." However, the first author surprised his colleagues by suggesting at a subsequent press conference that children should be offered the three vaccines individually with an interval of a year between each dose. This, unlike the article, was "news." The ensuing media frenzy resulted in a fall in uptake of the vaccine and led directly to the current real threat of large outbreaks of measles in the United Kingdom.
These two books, written by supporters of the vaccine, describe the MMR story and its context. Although both authors are doctors who have played a major part in events, the accounts are written from very different perspectives. Richard Horton, as editor of the Lancet, could be said to deserve some of the blame for the current situation. Michael Fitzpatrick, on the other hand, is a general practitioner in north London and father to a son whose autism began to manifest itself a few months after receiving the MMR vaccine.
Fitzpatrick describes how in the 1990s "popular confidence in science, medicine and government was already running low and anxieties over health issues were running high." At the same time as people were turning away from conventional medicine, the media and complementary practitioners were blaming "immune dysfunction" for an increasing number of disorders. This was all fertile ground for the rapid growth of a scare story. The Lancet paper was the necessary seed.
As a result of the MMR story, many parents are once again being made to feel responsible for their child's condition—in this case, by accepting the MMR vaccine. Meanwhile, other parents are nervously watching their healthy MMR vaccinated children for signs of autism. This is an additional but little recognised consequence of the health scare that has caused immense grief and anxiety to some parents.
Richard Horton, as editor of the Lancet, could be said to deserve some of the blame for the current situation Michael Fitzpatrick points out that the original "science" behind the Lancet paper was poor, and was recognised at the time to be so in an accompanying commentary by Robert Chen and Frank DeStefano. Richard Horton, on the other hand, makes a lot of the revelations earlier this year that one of the researchers had received funding from the then Legal Aid Board to ascertain whether the children's problems were a result of the vaccine. This, he claims, throws into question the validity of the original paper and casts doubt on the selection of the children included in the study.
However, the potential bias had already been clearly pointed out in the commentary at the time. More importantly, Chen and DeStefano had voiced concerns about the potential effect of this paper on public confidence in the vaccine and the consequences that might result. Although subsequent events have not been quite as bad as they predicted, their final statement has unfortunately proved to be well founded: "This painful history was shared by the UK (among others) over pertussis in the 1970s after another similar case-series was widely publicised, and it is likely to be repeated all too easily over MMR. This would be tragic because passion would then conquer reason and the facts again in the UK."
Richard Horton proposes the setting up of an independent body—National Agency for Science and Health (NASH)—to act as a forum in which to "debate and judge conflicting evidence concerning the health effects and ethical implications" of many of the contentious issues of what is essentially public health. He is also very sympathetic to concerns about supposed conflicts of interest in this story, referring to "The Dawn of McScience," and suggests the setting up of a Council for Research Integrity. However, to concentrate on the financial conflicts so much is probably too simplistic as for most researchers this is a minor consideration. Much more important is the esteem in which they are held by their colleagues and a genuine desire to do good for their fellow man. Sometimes the former may get out of hand and a rush for publications of low quality may result, but fraud is still uncommon. As Horton so rightly points out, without any trace of irony, the peer review system is not perfect, but he does not really come up with a better option. It is debatable whether the setting up of more bodies will help significantly.
Both books offer a useful and interesting insight into the MMR vaccine story. If you had to choose only one to read which would it be? For parents it has to be Mike Fitzpatrick's. For healthcare professionals, his account is probably still the more valuable, but if you want an insight into medical publishing it has to be Richard Horton's. While we would not agree with everything either of them says, we recommend reading both.
David Elliman, consultant in community child health Islington Primary Care Trust and Great Ormond Street Hospital, London
Helen Bedford, lecturer in children's health
Institute of Child Health, London
Competing interests: DE and HB have in the past received funding from vaccine manufacturers Wyeth,Aventis Pasteur MSD,and GlaxoSmith-Kline to attend symposiums and conduct research.
MMR researcher paid by vaccine makers
by Maxine Frith, Medical Reporter
A scientist researching the controversial MMR jab for the Government is also being employed by a drug company that makes the vaccine, the Evening Standard has learned.
Campaigners who are concerned that there could be a link between MMR and autism in children said it was "disgraceful" that Dr Phil Minor was being paid by pharmaceutical giant Glaxo-SmithKline (GSK) while also being employed as an independent expert.
Dr Minor, who works for the Government's National Institute for Biological Standards and Control (NIBSC) is also working for GSK in a legal test case being brought by eight families who say their children were damaged by MMR.
Julie Kirkbride MP said: "This news will hardly inspire public confidence. It is a pity that the Government could not find doctors who the public would believe are more open."
GSK is one of three MMR manufacturers being sued by the parents of children who were allegedly damaged by the jab. The other two companies are Aventis Pasteur MSD and Merck & Co.
More than 1,000 children are involved in the legal action. Eight are being used in a legal test case due to come before the High Court in October next year.
Last week it was announced that the Department of Health had given £300,000 to fund an NIBSC study which will attempt to copy research by Dr Andrew Wakefield, who has suggested that there is a link between MMR and autism. The three-year study is part of continuing research into MMR by the NIBSC. Dr Minor is a key member of the team.
He is an expert virologist and also sat on the Medical Research Council's recent review body into autism which last December said that there was "no evidence" to support a link between the condition and MMR.
All the experts and lay members on the review body were asked to declare their interests. In documents seen by the Evening Standard, Dr Minor said he had no commercial-or academic interestsbut under "others" stated he was an "expert adviser on molecular virology in MMR-autism cases".
He did not state whether he was working for a specific company. But today a spokesman for GSK confirmed that Dr Minor is retained by the company.
Dr Minor was unavailable for comment but Dr Stephen Inglis, director of the NIBSC, said: " I would object extremely strongly to any suggestion that our work is not objective. Any implication that there is no objectivity in this study is outrageous."
However, Julie Loch, whose six-year-old son Oliver is one of the eight children bringing the landmark legal case, said: "It's disgraceful. We have been campaigning for independent research and that is what we thought we were getting with this new study. How can we believe that this is going to be independent when one of the main researchers is obviously on the side of the drugs companies?
"This research will be a whitewash."