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The pharmaceutical companies are in turmoil. Their hold over many previously profitable drugs has loosened, their place being taken by generic equivalents. The industry is in a state of transition, stuck between short term ‘cures’ and condition specific drugs, and new ideas about how the psychology of the individual might be affected by chemically manufactured substances. As well as this, the industry is assaulted on all sides by a growing understanding about natural therapies such as homeopathy and nutrition.
There is, however, one area in which the pharmaceutical industry is making considerable profit and where their products do not discriminate for those who have specific illnesses; vaccination. A prophylactic, vaccination can be forced onto it’s subjects, in the name of community responsibility. There can of course be little moral or social objection to this, we would all want to make the small sacrifice of an hour or so, to have an injection and help the community stay healthy — Wouldn’t we?
The success of the vaccine market, however, does not just depend upon the subjects acceptance of herd immunity, it depends as well on selling the history of vaccines as an effective and safe ‘treatment’ and extolling the virtues of those who believe in it. But the matter of adverse reactions, introduces serious complications into the issue of vaccination. Governments buy vaccines and then prescribe them, governments have considerable power by which they can enforce vaccination. Whose responsibility is it to look after and care for those damaged by vaccines? In this area, the pharmaceutical companies will not argue responsibility, instead they claim that there are no adverse reactions.
The traditional way in the UK of claiming for damage created by drug is the civil action in court. Civil actions, however, are very complex and the claimant has to do two things; show that the particular drug could cause the specific injury — this is done by employing expert witnesses. Secondly, show that the individual claimant was in fact injured in the way they claim.
Since the Thalidomide cases in the 1960s — most of which were not won, by the damaged claimants, as many people believe— the pharmaceutical industry has worked hard to ensure that claims for damages caused by various drugs, fail in the courts.
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From 1993 onwards, parents who considered their children to have been damaged by the MMR vaccine, began consulting with lawyers to make a claim against three vaccine manufacturers. By the year 2,000 there were over 1,000 claimants joined to this action.
One of the most devastating adverse reaction for both children who had received the MMR vaccine, and their parents was inflammatory bowel disease (IBD) which was sometimes followed by regressive autism. There were, however, other groups of adverse reaction, which stretched from deafness to epilepsy.
At the same time that the parents of vaccine damaged children gathered to begin preparing their court case, those whose children had IBD searched for a doctor who might be able to treat their children. In 1995, one of these parents found Dr Andrew Wakefield a prize winning medical research worker who specialised in the pathways of Crohn’s disease and treatments including bowel transplants.
In the early 1990s Wakefield’s work began to focus on the measles virus, both wild and incorporated in vaccinations, in Crohn’s disease. Between 1993 and 2003, he wrote 11 peer reviewed papers about the link between measles virus and Crohn’s or IBD. Wakefield’s suspicions about the measles virus, were, he wrote, ‘based upon the behaviour of the virus in the gut during the acute infection and it’s ability to persist and cause delayed disease.’ Wakefield began his collaborative studies of measles virus with researchers in Sweden.
As a consequence of the early studies, Wakefield had moved like the best of scientists into the social arena, setting up groups, both observational and active. With others he set up the UK National Twin registry of Inflammatory Bowel Disease at the Royal Free Hospital. This was the largest such registry in the world. Wakefield also organised two major data sets, The National Childhood Development Study and the British cohort Study 1970. The data bases were used for various research projects , including the effect of measles vaccination and such factors as smoking and appendicitis.
Throughout 1995 and 1996, as a growing number of parents who suspected that their children’s illness had been caused by vaccination, Dr Wakefield set up The national Register of Paediatric Inflammatory Bowel Disease. This was the first register of IBD in any country in the world.
Wakefield was so affected by the continuing stream of parents who came to visit him at the Royal Free Hospital, that he contacted the Chief Medical Officer and suggested a meeting to discuss what he suggested was a possible danger to public health. It would be six years before Wakefield was to be granted such a meeting.
In 1995, the parents court cases and the work of Dr Wakefield came together, when he was chosen to be an expert witness for the claimants in IBD and autism cases. The lawyer for the claimants at this point, asked the Legal Aid Board for Legal Aid funding so that Dr Wakefield could pursue his research upon which his expert testimony could be based. In Britain this was common practice in the mid 1990’s, although today the Legal Services Commission (LSC) has failed to give claimants funding in other cases involving drug companies.
From 1996 to 2003, there seemed to be an uneasy truce between the MMR claimants, the pharmaceutical companies and the government. The only odd thing that occurred was that a consumer affairs journalist named Brian Deer began a series of articles in the Murdoch owned Sunday Times attacking expert witnesses in previous vaccine adverse reactions trials. Deer mercilessly attacked the expert witness who had appeared for the parents in the Whooping Cough vaccine trials in the 1970s. This doctor, like Dr Wakefield, had written a case review paper and had been attacked in court on his science and his personality. Parents lost the whooping cough claims in court. However, realising that it would be politic to stop claims coming to court for vaccine damage, the government set up a Vaccine Damage Payment Unit (VDPU). The VDPU got the pharmaceutical companies off the hook, with government funded awards with small amounts of money.
In 1998, 11 doctors at the Royal Free Hospital published a case review paper, in the Lancet, it observed the cases of 12 children who had sequentially presented at the Royal Free sequentially. All of them had IBD of one kind or another and some of them had developed regressive autism. The first contact of the parents and the children was usually Dr Wakefield.
At the press briefing for the paper’s publication, called by the Royal Free Hospital, Dr Wakefield was asked what parents should now do in relation to their child’s vaccination, given the conclusions of the paper that IBD and perhaps regressive autism might be connected in some manner with the MMR? Wakefield observed that parents might be advised to use single vaccines until their research at the Royal Free was finished. This statement undermined vaccine industry and government plans; for the previous decade, the vaccine industry and the government had been working on ‘combined vaccinations’ which could, eventually, cover all known illnesses in one vaccine!
The Lancet case review paper didn’t mention MMR except when reporting concerns of some parents that their children’s bowel illnesses had occurred just after their vaccination and they wondered if there was any connection. Of course the corporate media, reported nothing of Dr Wakefield’s previous work or even a proper analysis of this case review paper. At this time, however, Wakefield couldn’t be openly attacked because he was an expert witness in the upcoming trial and all matters to do with that trial were sub judice.
Following the Lancet case review paper in 1998 which was to become the subject of the GMC trial in 2007, Wakefield began to include in his published papers, reports of studies and writing about the link between gastroenterological problems and regressive autism. In the year 2000, with Scott Montgomery, Wakefield wrote his most devastating critique of the safety of MMR, ‘Measles, mumps, rubella vaccine: through a glass darkly’, in the Adverse Drug Reactions and Toxiological Reviews, (2000; 19: 265-283)
In 2003, the Legal Aid Board a government agency, withdrew all the funding underpinning the parents’ decade long civil action. The parents appealed the decision and this appeal, heard by a judge whose brother sat on the board of GlaxoSmithKline, was turned down. The withdrawal of legal aid a — secret governmental decision — was argued publically on the grounds that the claimants were unable to prove that MMR caused autism — an argument that had never been made in the first place. When legal aid was withdrawn for the IBD/autism cases all the other cases of adverse reactions — over a thousand — also fell.
Now the court case was out of the way, the government and the pharmaceutical companies were able to turn their full attention on Dr Wakefield. A short time after the appeal against the withdrawal of legal aid, a long article by Brian Deer attacking Dr Wakefield, appeared in the Sunday Times. The article accused Wakefield of unethical research on autistic children, of using invasive procedures for research, a series of offences of dishonesty and obtaining a patent on a vaccine competing with MMR. When Deer’s article appeared, a number of Government and National Health Service personalities, including the Prime Minister Tony Bliar, commented publically on the guilt of Dr Wakefield. The following week, a complaint apparently written by Deer was presented to the General Medical Council (GMC).
The GMC is awash with conflicts of interest. The central and most important one of these is that since 1996 the GMC, which investigates and hears cases of malpractice against doctors, has accepted cases put to them and prepared by the pharmaceutical industry. These are cases which involve issues important to the pharmaceutical industry. Through a private enquiry agency which they own, the Association of British Pharmaceutical Industries (ABPI) helped Brian Deer prepare this case against Dr Wakefield.
It took the GMC four years to develop the case against Wakefield, Professor Murch and Professor Walker-Smith. When the Fitness to Practice Hearing began in 2007, it was said by the prosecution that it would last three months; it lasted three years.
At it’s end, all three defendants were found guilty of the majority of the charges, Professor Murch was admonished by the hearing but allowed to keep his registration as a doctor, Professor Walker-Smith was not found guilty of any offences of dishonesty and the hearing decided that any ‘sentence’ should await his appeal in the high court. At this appeal, Walker-Smith was completely exonerated. The hearing found Dr Wakefield guilty on all charges including ones of dishonesty and his name was ‘erased’ from the medical register. In the days following the hearing a number of his peer reviewed papers were also ‘erased’ from the medical literature.
Immediately following the hearing, Brian Deer wrote articles in the British Medical Journal (BMJ), which built on the hearing but drew more far -reaching conclusions. Deer claimed that none of the children whose cases had been recorded in the 1998 case review study, had Inflammatory Bowel Disease. That the data on the children’s condition had been manipulated by Wakefield. According to Brian Deer, there was no such thing as an adverse reaction to the MMR vaccination
These articles are presently the subject of a suit for defamation taken by Dr Wakefield against the BMJ, its editor Fiona Godlee and Brian Deer. The first part of this suit was heard in the US where the Wakefield’s now live. It was turned down by the court on jurisdicational issues and will now go to the UK.
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What were the consequences of the attack on Dr Wakefield. The consequences are both public and personal.
On the personal side:
Dr Wakefield and his family, having sought exile in the US are now without gainful employment.
4. Three generations of doctors in a British family have ended in dishonour.
On the Public side:
1. There will be no more research in Britain into the environmental causes of autism, especially measles generated IBD which might result in regressive autism.
2. There will be no research into the adverse reactions to vaccines in Britain in the near future.
3. Pharmaceutical manufacturers are now seemingly exempt from over 100 years of civil actions and claims for damages.
4. While pharmaceutically damaged claimants are no longer able to bring cases to court, the government and the medical establishment have given pharmaceutical industry the right to try doctors who they believe are acting against the interests of the pharmaceutical industry in the General Medical Council.
5. Legal Aid a traditional financial aid to poorer sections of the community will no longer be available to claimants wanting to bring cases against pharmaceutical companies.
6. The pharmaceutical company lobby groups and individual hucksters, have used Wakefield’s case to broaden their campaign to tighten up ‘ethical standards’ in research and more highly regulate research which affects the pharmaceutical companies.
As a campaigner of 40 years, I think that what surprises me most about Dr Wakefield’s case, is how easily and how completely we were defeated by the pharmaceutical companies, how over a thousand parents and children were written out of history together with their adverse drug reactions. Part of this defeat for the parents, the children and the doctors concerned was grounded in an unfortunate understanding that pharmaceutical company executives were decent people and humanitarians. In fact the pharmaceutical companies, their corporate structure and their relentless pursuit of profit, their fraudulent practices represent one of the last remaining shibboleths, in our society which need to be completely reformed, democratised, divested of vested interests and made public from top to bottom.