By the ANH Team
On the 28th January 2010, the Fitness to Practise Panels & Investigation Committee of the UK’s General Medical Council (GMC) announced its findings on Dr Andrew Wakefield. In an all-out effort to create a slur seemingly intended to force the public and medical profession to once and for all give up on the possible MMR-autism link, the GMC said that Dr Wakefield acted "dishonestly and irresponsibly" in carrying out his research. Dr Wakefield’s findings were part of a preliminary report conducted with 12 other doctors on just 12 children with autism spectrum disorder (ASD), published in the Lancet medical journal back in 1998.
These charges were used as a justification, on February 2nd, for the Lancet to publish a formal retraction of the original paper. Ironically none of the charges made by the GMC are central to the main findings of Wakefield and colleagues’ original report. And since the GMC has focused on possible improprieties of the authors of the research, there has been no focus on possible issues of questionable integrity associated with the editor of the Lancet. Nor has the integrity, motive or funding of the Sunday Times journalist, Brian Deer, whose complaint triggered the GMC hearing, come under independent scrutiny. Deer, not surprisingly, on his own website, has responded strongly to any suggestions of his impropriety in the matter.
Many might argue that it’s the very lack of independence of the GMC, and it’s strong tie with both the orthodox medical profession and the drug companies that prevent the proper independence of its inquiry.
A reading of the GMC’s adjudication in the hearing does remind one how far the orthodoxy has needed to go to destroy the credibility of a group of doctors who were simply trying to get to the bottom of a condition, the frequency of which has been rising rapidly, and that is causing devastation to children and their families. Despite the GMC’s strenuous attempt to damage Wakefield’s credibility in particular, it seems to have done nothing to dampen the resolve of the doctors to continue work in this field, in particular to help patients and their families.
It’s also worth noting that the GMC hearing concluded that monies used from the Legal Aid Board, that are central to the investigation over professional conduct, were not used for personal gain. They were used to fund further research on the issue. Yet, this is the basis for the declaration of Wakefield’s ‘dishonesty’.
The GMC Reception
In true kangaroo-court style, the GMC panel has managed to sustain charges of professional misconduct. The GMC will decide at a later date whether to have Dr Andrew Wakefield struck off the medical register.
Outside the GMC, after the verdict had been read, Dr Wakefield said he was “extremely disappointed” and that he had “still had a naive belief in justice, I didn’t believe it could be quite like this. I feel so sorry for the children and their parents, it’s desperate for them. But the struggle goes on.” His supporters claim he was the victim of a witch-hunt and there were outraged parents shouting comments such as, “this is a set-up, it’s disgusting”, and “those doctors are not guilty of anything other than saving our children. You are outrageous. This is a kangaroo-court.”
To these parents, Andrew Wakefield is a hero; the only doctor that they felt would listen to them. Many share the same story, their child showed the first signs of autism within days of them receiving the MMR (mumps-measles, Rubella) vaccination.
How it all started
Dr Wakefield was one of 13 authors who published a paper in the medical journal, The Lancet, in 1998 which formed the basis of the MMR-autism hypothesis. The paper involved a study of 12 patients with autism and bowel disease and it hypothesized that the MMR (measles/mumps/rubella) vaccine may trigger a regression into autism spectrum disorder (ASDs) accompanied by the development or worsening of gastro-intestinal symptoms categorised as a form of irritable bowel disorder (IBD). Once published, the study led to widespread panic about the safety of MMR and a dramatic drop in immunisation rates in Britain.
Wakefield and other colleagues involved in The Lancet study clarify the background of their original Lancet investigation in a subsequent report in the Journal of Pediatrics (138: 366-72)
“A preliminary report in 12 children with regressive autism described unexpected colonic inflammation in association with ileal lymphoid nodular hyperplasia. The colonic lesion of what we termed autistic enterocolitis was clearly not that of classical inflammatory bowel disease but was consistent in over 150 subsequently evaluated children with autism, in whom the main gastrointestinal presentation was abdominal pain and either constipation or diarrhea. It remains unclear whether this inflammation is characteristic for autism in general or found only in a subgroup with gastrointestinal symptoms. In view of striking recent increases in autistic spectrum disorders in both the United Kingdom and the United States, this required further study.”
In 2004, journalist Brian Deer completed a four month investigation on behalf of his newspaper, the Sunday Times, culminating in the publication of a stinging attack on Wakefield and his colleagues. Deer’s article as well as a documentary made for Channel 4 television, stimulated the investigation by the UK’s General Medical Council (GMC) into the professional conduct of Dr Wakefield and two colleagues, Professors Murch and Walker-Smith. The other 10 authors on the original paper had asked to be disassociated from the paper given Deer’s assertions that there was a conflict of interest in the funding for studies which might be harmful to the makers of the MMR vaccine, none other than the UK’s largest drug company, and the second largest in the world, namely GlaxoSmithKline (GSK).
While Deer has vigorously denied being put up to it by the pharmaceutical industry, it is noteworthy that Brian Deer is employed by James Murdoch (son of Rupert), and that James Murdoch serves on the Board of GSK, the manufacturer of the MMR vaccine used in the study.
While the GMC has restricted itself to largely procedural issues around how the research by Wakefield and colleagues was conducted, there has been on-going dispute in medical and scientific circles over what mechanism might be responsible for the adverse gastrointestinal effects and regression to autism originally reported by the researchers. These effects were initiated, according to the parents, just days following vaccination in 8 out of the 12 subjects.
One of the key issues has been whether or not nucleic acid components of the measles virus, delivered via the vaccine, could contribute to the reported adverse effects. A study published in Pediatrics by Yasmin D’Souza and others found that measles virus nucleic acid fragments did not persist in the blood of autistic children, any more than in normal (control) children. This study has been used to discredit the findings of Wakefield, Murch and Walker-Smith.
A further study by Baird and colleagues at Guy’s Hospital, London, published in 2008, has added further grist to the mill. Here, the authors found no relationship between measles vaccination and antibody response, giving the authors justification, they believe, to conclude that there is no link between vaccination and regression to autism.
Andrew Wakefield and colleagues have, however, responded with a compelling argument suggesting that the way in which Baird et al’s study was conducted, and how children were selected for the trial, would have precluded the authors from establishing any significant findings.
Ironically, a 2008 study led by Mady Hornig, published in the journal PLoS ONE, which at face value provides a ‘no association’ conclusion, actually provides data that might suggest otherwise. This at least seems to be the case in a small proportion of those vaccinated. Is it possible, as we’ve seen so often before especially in the field of vaccination, that a less common effect is being drowned by statistics associated with the majority?
A useful review by the now deceased but highly acclaimed autism researcher Dr Bernard Rimland and another colleague from the Autism Research Institute in San Diego, USA, evaluates the available evidence and demonstrates compellingly that a link may indeed exist between autism and vaccinations.
CryShame: The parents’ story
Remarkably, despite the GMC hearing being one of the longest quasi-legal ‘trials’ in British history, having spanned over 2 years, as well as being one of the most expensive, the parents of affected children have been excluded from having any input to the proceedings.
They have had no option but to tell their story in other ways. One of the ways this has been done is through the CryShame website and the release of two volumes on the subject, entitled Silent Witnesses.
Following is an extract from the CryShame website which summarises the parents’ view about the recent GMC findings:
A STATEMENT FROM PARENTS OF AUTISTIC CHILDREN TREATED BY THE THREE DOCTORS
The GMC was WRONG to find the doctors guilty on the findings of fact when no parent or patient was a complainant in this fitness to practice hearing. The Panel has chosen the facts it wants, and rejected those it doesn’t want, to find the doctors guilty on fact – facts that go back 16 years.
Parents heard the doctors put up a robust defence. Documents and evidence produced by the doctors showed:
- the 1995 ethics committee letter granting approval for the Lancet research was produced
- the research followed the terms of the approval given?the Lancet editor knew that Wakefield was doing a separate legal aided study?all the children were on the autistic spectrum?the children were recruited as described in the Lancet paper?
- the use of invasive interventions – colonoscopies, etc – was clinically justified
- no child was harmed; no parent refused consent; no parent complained
However, the GMC chose to ignore the 1995 ethical approval and substitute a 1996 approval, allowing them to reach the findings they did – a blatant disregard for justice. They also insisted that ‘pervasive developmental disorder’ was not the same as autism spectrum disorders which of course it is; and that only children who had had the measles or measles/rubella vaccine should have been admitted onto the project, not those who had had the MMR. The hearing moved the goalposts so that the doctors had no chance of overturning the serious charges against them.
This is the same GMC that missed Harold Shipman, the Bristol babies and Alder Hey. We believe it has made another blunder.
This scandalous show trial was used to mask real concerns parents have about why their children regressed into autism following MMR. The GMC and government engaged in a callous and diversionary tactic to end speculation about MMR safety and ensure scientific research into autism and bowel disease, and the role of vaccines, ended.
Parents’ requests that this research should continue fell on deaf ears. At the same time the numbers of autistic children has risen thirty-fold since the MMR was introduced in 1988 amidst the parents’ constant pleas for research into why their children were damaged. What role vaccines play in our children’s deaths (in some cases), seizures, regressive autism, bowel disease, daily pain and disability must be investigated.
The effects of the GMC hearing are to warn off doctors from expressing similar concerns about one size fits all vaccination policy and to ensure that scientists won’t investigate vaccine safety. The effect is to ensure government contracts with the large drug-makers are safeguarded and that clauses compelling government to make good their loss of earnings should MMR sales drastically fall are not activated. The commercial interests of the drug-makers take priority over research into why autism has increased dramatically.
The plan has been to “discredit” the doctors and ensure they are left undefended in the media. The press have been compelled to refer to their “discredited” work. But scientists claiming this have never fully replicated their work; the doctors’ research remains original and significant.
Independent research into why autism has increased must be funded, without powerful drug makers influencing the research agenda to keep share prices high and protect their products.
Please voice your support for the doctors with the CryShame Facebook Group
The Autism Ribbon Awareness Campaign
What the GMC found…
The hearing has lasted over two years and is the longest and most expensive hearing in the GMC’s history. The findings of the study itself have not been under scrutiny, the GMC has concerned itself instead only with the way in which the research was carried out.
In blatant contrast to the views of CryShame, the GMC has managed to level around 30 charges against Dr Wakefield. Four of these were counts of dishonesty (including money, research and public statements), while others included mistreating developmentally challenged children, carrying out invasive “high-risk” research without ethical approval, and causing children to undergo lumbar punctures without clinical reason. The parents of the children involved strenuously deny all these charges.
Along with Dr Wakefield, fellow doctors, Professors John Walker-Smith and Simon Murch have also been under the spotlight to determine whether they were guilty of unethical behaviour in the way they conducted research. They, however, faced fewer allegations.
Jackie Fletcher of the vaccination support group, Jabs, said: “The bottom line is that no parent has complained and no child has been injured.”
The GMC Hearing Room
The travesty that has been created
From ANH’s viewpoint, there are three overwhelming disappointments that emerge above all else from this dire situation.
Firstly, the real scientific debate about the relationship between gastrointestinal disease and autism, as well as the possible role of combination vaccinations triggering or worsening any of these conditions has been clouded by the extraordinary efforts on the part of the medical establishment to invalidate what were simply preliminary findings, and a hypothesis, put forward in a medical journal back in 1998.
Secondly, thousands of children who have experienced the gastrointestinal symptoms first described by Wakefield et al, which are now known to be commonly associated with autism, have been left out in the cold. Research appears to have been conducted specifically with the aim of disproving some of Wakefield’s hypotheses, rather than trying to find mechanisms that might be causing the problems. With more effort in the right direction, this should have led to the development of approaches to help resolve the very real distress and often devastation, for both patients and families, associated with autism spectrum disorder and its commonly associated gastrointestinal symptoms.
Finally, the extent to which newspapers, the orthodox medical establishment and the drug companies are prepared to collude for the purposes of discrediting and dishonouring a single doctor, or a small group of doctors and scientists, is almost unparalleled. It is perhaps meant as a lesson for those who might hold views that are contrary to the drug or vaccine industry. It is no surprise that there are a growing group of practitioners in Europe and the USA who are practicing medicine, illegally, without a license. Is this really in all of our interests? In such cases, how can patients differentiate between those good practitioners who practice medicine well, putting the patient first, "to do no harm"—obeying the Hippocratic Oath—and those that are simply bad or even dangerous practitioners of medicine?