Action For Autism

Andrew Wakefield: The Honorary Consultant

There is a mighty blog storm surrounding the announcement last week of the General Medical Council’s “finding of fact” in relation to the Fitness To Practice hearing regarding Andrew Wakefield, John Walker Smith and Simon Murch.

Liz Ditz is collating blog responses to the decision here:

Andrew Wakefield: Dishonesty, Misleading Conduct, and Serious Professional Misconduct: Blog Posts Approving of Verdict; Blog Posts Critical of Verdict

Kathleen Seidel has posted the entire ruling and for those who may not have the time or the inclination to read all 143 pages she has posted the edited highlights on her blog:

U.K. General Medical Council Rules Wakefield & Co. “Dishonest,” “Irresponsible”.

And of course Brian Deer has reported on the findings for the Sunday Times in a story headlined ‘Callous, unethical and dishonest:’ Dr Andrew Wakefield.

Among Wakefield’s supporters the reaction to the GMC’s verdict is one of disbelief.

The One Click group has been supporting for Wakefield during the GMC hearings. In April 2008 they were confident of victory.

The Defence presentation has demonstrated that the position always maintained by Dr Wakefield of there being no conflict of interest, no issues relating to funding, that the investigations of these children were clinically justified and that the research was ethically approved has been very clearly established.

Now that “clearly established” case has been dismissed we are told this is a kangaroo court and a show trial.  Government witnesses are supposed to have lied. The GMC “moved the goal posts.” According to Cry Shame

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.

An Honorary Consultant

Wakefield has never treated a child for autism. I do not know if he has ever treated a child for anything. In the UK senior hospital doctors or consultants have responsibility for patient care. Wakefield never made the rank of consultant. He was a lecturer and a researcher whose contract specifically excluded him from treating patients.

Dr Andrew Wakefield was a Senior Lecturer in the Departments of Medicine and Histopathology at the Royal Free Hospital and from 1st May 1997 a Reader in Experimental Gastroenterology. He was an Honorary Consultant in Experimental Gastroenterology with a stipulation in his contract that he had no involvement in the clinical management of patients.

Yet it was Wakefield who signed the orders for medical investigations into children, despite the clause in his contract and despite having no paediatric qualifications. The medical investigations he sanctioned were not clinically indicated but carried out purely for reasons of research. This breached medical ethics and was not in the interest of the child.

Follow the Money

Wakefield was initially paid £50000 to cover the cost of investigations into children for solicitor, Richard Barr. The money came from the Legal Aid Board (ie taxpayers’ money). However, because the children were admitted to the Royal Free as National Health Service patients, the NHS (taxpayers’ money again) picked up half the bill. Wakefield should have returned the extra £25000. Instead he used it in part to fund salaries for researchers.

Conflict of Interest

The research proposal submitted to the LAB in June 1996 for funding was judged by the Panel to be essentially the same as the project submitted to the Royal Free for ethical approval in September of that year. But the ethics committee were not informed of any involvement with MMR litigation. Nor did Wakefield inform them of the LAB funding.

Ethical Conditions

Part of the ethics committee conditions were that approval only covered children enrolled after 18 December 1996. Yet seven of the twelve children in the study had been enrolled, admitted to hospital and subjected to invasive tests before that date.

All patients had to show signs of intestinal disease or dysfunction and all procedures had to be clinically indicated - ie intended to investigate or treat the intestinal disease or dysfunction. But these procedures were not always clinically indicated even where the child did show evidence of intestinal disease or dysfunction.

Child 1 for example

Professor Walker-Smith, after his assessment of Child 1 on 19 June 1996, concluded in his letter to Dr Barrow that Child 1 had the features of “toddler’s diarrhoea” and planned to see Child 1 again in three months’ time. However, Child 1 was admitted to hospital one month later. There were no apparent clinical reasons for this change in plan. Child 1 underwent a colonoscopy, MRI scan of his brain, an EEG and a variety of blood and urine tests. These were some of the investigations listed in the programme of the project. He was further admitted on 23 October 1996 for further investigations regarding the “etiology of the autism”, again for no obvious clinical gastro-intestinal reasons.

During this admission, Child 1 underwent a barium meal and follow-through and a lumbar puncture. These were also the investigations listed in the programme of the project. The Panel has concluded that Child 1 underwent a programme of investigations for research purposes and for which there was no Ethics Committee approval.

Children enrolled in the study had to have “manifested disintegrative disorder.” I find this a bizarre construction. Childhood Disintegrative Disorder is a very rare manifestation of PDD, first identified as Heller’s Syndrome a century ago. Its diagnostic validity and its place on the autistic spectrum have both been questioned. Why not refer to regressive autism instead?

Most bizarre of all, given the consequences, MMR was not even mentioned! A condition of admission to the programme was that all children were to have  been vaccinated with the measles or measles/rubella vaccine. Thus every child in the study breached its own guidelines!

So we have an investigation into a new form of autism that manifests itself after MMR vaccination in which neither autism nor MMR are mentioned in the protocol. Were Wakefield and his team guilty of sloppy thinking and using ill defined terms or was this a deliberate attempt to mislead?

Patents and Single Vaccines

One thing I never understood about Wakefield advising parents to use single vaccines was this. If it was the measles component of MMR that did the damage why would giving it in isolation be less damaging? Of course it wouldn’t. But if the doctor who discovered the danger was able to develop a safer single vaccine it would make sense. And quel surprise! Even before he began his research, Wakefield had taken out a patent for a single vaccine that protected against measles and treated the Inflammatory Bowel Disease and Regressive Bowel Disease allegedly caused by the old vaccine. RBD refers to the autistic enterocolitis that he had not discovered yet. IBD was a reference to his previous theory that Crohns disease was caused by measles virus. This too was without foundation and may explain why he switched is attention to autism.

Wakefield began treating one of the study children, Child 10, with this transfer factor in 1997 and set up a company with the child’s father to exploit the invention. After the Lancet paper was published he applied for permission to run a clinical trial on autistic children. So he had a vested interest in damaging the reputation of the MMR vaccine and was prepared to try out his experimental treatment on Child 10 for research purposes.

Brian Deer summarized this Transfer Factor in his investigation

Recipe for madness?: Wakefield’s claims for a measles vaccine, and treatments for bowel disease and autism, were bizarre. The technology involved is of so-called “transfer factors”, a now largely abandoned fringe conjecture based on a theory that special substances can be harvested from white blood cells. The Royal Free’s recipe advised injecting mice with measles, extracting and processing white cells, injecting the result into pregnant goats, milking them after kid-birth and turning the product into capsules.

The Birthday Party

Buying blood samples from children at his son’s birthday party; this is probably the one element of the whole affair that did most to turn public opinion against Wakefield. The amazing thing is not that he did it but that he felt able to joke about it to an audience of parents who did not find it repellent.  This goes some way to explain the hubris of a man who surrounds himself with admirers who believe he can do no wrong. The GMC was more level headed in its verdict

You showed a callous disregard for the distress and pain that you knew or ought to have known the children involved might suffer,

Found proved

in the circumstances you abused your position of trust as a medical practitioner,

Found proved on the basis of the above findings.

Your conduct set out in paragraph 42.b. was such as to bring the medical profession into disrepute;’

Found proved on the basis of the above findings.

The Honorary Consultant dishonoured

The science behind Wakefield’s theory was always tentative and has been thoroughly repudiated by subsequent research. This has not always been reflected in media coverage. Journalists and the public they serve often stumble over the science. But everyone can understand dishonesty, callous disregard for the suffering of children, unethical conduct. I just find it terribly sad that Wakefield had to be discredited as a person in order for people to reject his bad science. The quacks who play by the rules and do not attract the attention of investigative journalists and professional oversight committees continue to prosper at the expense of a public who have a poor understanding of what science based medicine means. The GMC hearings have done nothing to alter that fact.

February 3rd, 2010 Posted by Mike | Andrew Wakefield, MMR | 10 comments