Wakefield says he was “careful, thorough open, and honest”
This statement, by Andrew Wakefield, was received by Brian Deer at The Sunday Times ten days before Deer’s first reports were published, revealing that Wakefield was contracted to lawyers suing MMR vaccine manufacturers, and that children in Wakefield’s now-discredited research on MMR, published in the Lancet in February 1998, were clients of those lawyers.
12.2.04
Dear Mr Deer,
I am sorry that I am writing this letter from the US and outside office hours. I hope that having read the letter, you will understand why I have written, not least so that you may be able to read this several times and give due consideration to what I have said.
At the same time I am frustrated that having requested, via Abel Hadden, written questions or allegations more than eight weeks ago, I am left to respond at a few hours notice, from Flintrock Texas, without access to the necessary paper records that are of relevance to your allegations.
Your allegations appear to focus upon two issues:
(i) the accusation of inappropriate investigation of children with autism; and,
(ii) apparent misappropriation/misuse of funds from the Legal Aid Board
I will deal with these in turn.
On the first issue you are completely mistaken. Children with developmental disorders and undiagnosed gastrointestinal symptoms were referred to Professor John-Walker Smith or his junior Consultant colleagues, and not to me. Since I was a Reader in the Department of Medicine (not Paediatric Gastroenterology) and my work was exclusively research based, with no clinical commitment, at no time was I responsible for the clinical care of these children, or for making the decision to perform ileo-colonoscopy or upper gastrointestinal endoscopy on these, or any other children.
All decisions to undertake these procedures were based solely on clinical indications due to the children’s symptoms and were not in any way influenced by whether the child was part of the MMR class action litigation. Professor Walker-Smith and his colleagues were, at this time, strongly opposed to the litigation and any involvement in it. To suggest that “these procedures were not clinically indicated” is factually incorrect and impugns the reputation of some of the country’s most respected paediatric gastroenterologists. My contract with the Legal Aid Board (LAB) was in no way, nor could it have ever been, the indication for the clinical procedures carried out on these children. Neither I nor my medical colleagues would ever countenance the clinical investigation of a patient in the absence of a clinical indication. The indications in this case were specificallv and exclusively the symptoms from which these children suffered – regressive encephalopathy and gastrointestinal symptoms, following viral exposure – and the decision to conduct these clinical investigations rested not with me, but with the paediatric gastroenterologists responsible for their care. As an indication of this, both MRIs and cerebrospinal fluid analysis were stopped during the course of the study of the first 12 children since they were not informative and therefore, deemed no longer clinically indicated.
You seem to be unaware of the fact that our collaborative effort at the Royal Free has made an important discovery – a novel inflammatory bowel disease in children with autism, a group of children that had been effectively discarded by the medical profession as hopeless and untreatable. The evidence for this discovery has been peer-reviewed and published in eminent medical journals and has been confirmed by physicians and pathologists at several centres in the US including Harvard Medical School, the University of Maryland Medical School and Lennox Hill and Mount Sinai Hospitals, New York. For your information, I have included details of these studies below’. To suggest, as you do, without qualification, that the appropriate, necessary and compassionate investigation of these children was “not clinically-indicated” is an extraordinary statement coming from a newspaper journalist and it has absolutely no basis in fact. It also explicitly accuses all the clinicians involved in the care and treatment of these unfortunate children of grossly unethical medical practice. I insist that you withdraw this accusation in its entirety.
As far as Ethical Practices Committee approval is concerned, this was sought as soon as it became apparent that the children with autism who were undergoing appropriate medical investigation for their clinical symptoms actually had an inflammatory intestinal disease. There is absolutely no requirement for Ethical Practices approval for the investigation of a patient on clinical grounds. At the point at which the clinical findings justified a more detailed study of the underlying pathology with a view to publication, the relevant approval was sought and obtained. Pending the approval of the proposed study it remained entirely reasonable to follow normal practice and continue with the clinical investigation of potentially affected children. It was, however, necessary to obtain Ethical Committee approval for the purposes of reporting our findings. This approval was duly obtained. As stated in the Lancet paper, therefore, the study of these children was approved by the Ethical Practices Committee of the Trust. This issue has been discussed by Professor Walker-Smith with the Editor of the Lancet and resolved to their complete satisfaction.
Once again, although I was involved in the preparation of the Ethical submission, the senior clinician with overall responsibility for this process was Professor Walker-Smith and it was to him that correspondence and documentation was referred. The process of designing the studies, writing and amending the Ethical Practices submission and writing the papers that derived from the studies was the shared responsibility of all of those involved, and was conducted with full cooperation of the relevant parties. To single me out in this process demonstrates a clear misunderstanding of the processes involved.
Let me now turn to the issue of my involvement with Richard Barr and the Legal Aid Board (now the Legal Services Commission).
In 1996 I was approached by Richard Barr and Kirsten Limb of Dawbarns solicitors, who had become aware of my group’s interest in children with inflammatory bowel disease, measles virus and, for some children, developmental regression leading to autism. It is important to state that the first clinical referrals of children with regressive autism and gastrointestinal symptoms to Professor Walker-Smith had started in 1995, some time before I ever became aware of the existence of Richard Barr and the MMR litigation.
Prior to meeting with Richard Barr, I had had no experience of medical litigation whatsoever. We discussed, at great length, the commonalities between the children whose parents had approached them describing regression after MMR vaccination with concomitant bowel symptoms and the children that we were seeing in the clinic at the Royal Free. Some of the children that were referred to the Royal Free for clinical investigation were also involved in the emerging litigation against the vaccine manufacturers; it was this group that was to form the basis of the LAB contract. It is important to state that by the time of my meeting with Richard Barr several children with this disorder had already been investigated and diagnosed at the Royal Free. During the course of my discussions with Richard Barr, I was asked what it would take to establish whether MMR vaccine had either caused or materially contributed to the syndrome of bowel disease and autistic regression from which these children suffered. The intestinal disease was consistent with a chronic viral pathology, a finding that has been endorsed by all of the observations made in follow-up studies cited above. The areas of swollen lymphoid tissue were potentially a nidus (nest) for the persistence of any causal virus. Measles virus can cause similar swelling of the lymph glands in the intestine and therefore this was an appropriate place to start looking for measles and other possible viral agents. I proposed that an initial scientific approach would be to use the technique of immunohistochemistry, which seeks to detect and localize specific viral proteins in the biopsy tissue. I proposed that intestinal biopsies from children with autism should be compared with similar biopsies from developmentally normal children also undergoing investigation of gastrointestinal symptoms. Richard Barr asked me what it would take to perform such studies. The simple answer was funding, in order to pay the salary of a suitably qualified laboratory scientist and cover the cost of the reagents.
I was asked to budget the likely associated costs of the viral studies, and in addition, the costs of any further expenses that might possibly be incurred in the investigation of these children and putting the relevant findings into a legal context. Since I had no experience of litigation or the Legal Aid Board (LAB), I was assisted in defining possible expenditure by Richard Barr.
Agreement was reached with John Baker of the LAB, Richard Barr and myself; a laboratory scientist was duly employed and the viral detection work was started. Ethical Committee approval for the studies was obtained and the protocol was agreed upon by the researchers involved. This work provided positive evidence of measles virus protein in the tissues of the autistic children at a significantly higher frequency than in control, developmentally normal children. Although the studies more than consumed the funding provided by the LAB, the results were sufficiently compelling that the work was expanded to involve larger numbers of children and the use of complementary viral detection techniques. The funding received by the LAB was used exclusively to fund this aspect of the study – virus detection – which, in the event was considerably underbudgeted. The confirmatory aspects of this study were subsequently funded by research grants. The results of these studies were duly presented to the LAB. In addition the results of these studies have been presented to scientific meetings following peer-review, and have been submitted for full peer-review publication and have been provisionally accepted for publication in 2004. Due acknowledgement of the funding received from the LAB for the preliminary aspects of this work and all other sources for its completion, will accompany the paper.
So far as I recall, The LAB did not fund any of the investigations reported in the Lancet 1998 publication and consequently the LAB received no acknowledgement in this paper.
It should be stated explicitly, that none of the viral investigations described above, were in any way routine services provided by the NHS, nor were they available from any routine diagnostic laboratory. These studies did not constitute part of the standard of care for children undergoing gastrointestinal investigation, nor were any of these investigations funded from NHS resources. The studies constituted strictly scientific research that was designed to test the hypothesis that measles virus protein was present in the autistic children and not in developmentally normal controls.
Absolutely no funding provided by the LAB was used for routine clinical investigations, including ileo-colonoscopy. Although this procedure was included in the comprehensive list of possible projected costings outlined to the LAB, it was clear that since the procedures were clinically indicated they were covered as part of the children’s routine investigation as NHS patients. At the conclusion of our investigations no claim for reimbursement of these aspects of the work were made, and none received. All matters related to the investigations were the subject of ongoing discussions between Richard Barr and me, as the investigations progressed. The conclusion of this aspect of work from the LAB’s perspective, was a detailed report submitted by me in 1999 that described the findings and conclusions. The LAB was fully aware of the report’s findings and appear to have been entirely satisfied with the outcome. At no time have any questions on the above matter been referred to me or received by Richard Barr. If the LAB has any questions in relation to these matters, I will be happy to deal with them directly.
In summary therefore your letter of 10th February 2004 while directed to me, contains allegations of the gravest nature. You have cast aspersions on the reputations of all the many doctors and scientists involved in this work at that time. You have called into question the moral and ethical commitment of doctors and researchers in a most critical field: appropriate and ethical investigation of autistic children who more than any others have no voice to be heard. You make the point yourself that childhood immunisation is a vital matter of public concern and that research into this area requires those involved to be careful, thorough, open and honest. I fully accept and adhere to this vital principle and continue to strive, though diligent research and publishing of papers in peer reviewed journals to elucidate the relationship between the MMR vaccination and the new variant inflammatory bowel disease identified in these children with regressive autism. Adherence to strict medical and ethical principles has cost me and my colleagues dear. I believe that a similar duty weighs on those investigating and reporting on this controversial area in the media.
You seem to imply, in closing, that the “facts” that you seek to reveal will in some way make redundant, all the science that has been conducted by me, my colleagues, and other researchers around the world and in some way influence the risk of a measles epidemic. Your demonstrably false accusations in no way diminish the scientific validity of our findings. Furthermore, it is science and science alone that is necessary in order to counter the existing basic and clinical evidence in favour of some form of an association between the MMR vaccine and autism in some children.
Yours sincerely,
Andrew J Wakefield MB.BS, FRCS, FRCPath
c.c. Richard Barr, Abel Hadden, Kirsten Limb, John Walker-Smith, Robert Sawyer,
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