[Nov 2004] Issues Raised by the Sunday Times and the Channel 4 Dispatches Programme: A statement by Dr Andrew Wakefield (original) (raw)

A statement by Dr Andrew Wakefield http://www.mmrthequestions.com/

The Sunday Times and the Dispatches programme of 18th November raise a number of issues in relation to MMR, autism and events at the Royal Free Hospital. Since many of the claims by journalist Brian Deer have been demonstrably false and there in no objectivity in the manner of their intended portrayal, I declined to participate in any way in the making of the Dispatches programme. In addition, vulnerable parents have complained of being "tricked" into participating in the programme. I was not invited to comment on the Sunday Times article prior to its publication.

The claim appears to be that, whilst at the Royal Free Hospital, I was developing a new vaccine to compete with MMR and that I conspired to undermine confidence in MMR vaccine in order to promote this new vaccine, and that this represented a conflict of interest. This is untrue. The facts are that:

• no vaccine or anything resembling a vaccine was ever designed, developed or tested by me or by any of my colleagues at the Royal Free Hospital;
• it has never been my aim or intention to design, produce or promote a vaccine to compete with MMR;
• my genuine concerns about the safety of MMR are wholly unrelated to any desire or opportunity to develop a competing vaccine;
• there was no conspiracy as insinuated by the Sunday Times article;
• there was no conflict or interest, actual or perceived.

In contrast, it was our intention, at one stage, to conduct a formal therapeutic clinical trial of a compound that might have the ability to promote the body�s immune response to measles in order to assess the effects of this therapy upon the disease in children with regressive autism and bowel disease. This compound is known as Transfer Factor and whilst there is a large scientific literature on this subject, the nature and mechanism of action of Transfer Factors are largely unknown.

The Transfer Factor that was intended for use in the trial was to be against measles virus. I have urged and continue to urge parents to have their children vaccinated against measles using the current vaccines. This would be in direct conflict with the intentions that are part of the claim that I was developing a new vaccine to bring onto the market. Whether a Transfer Factor could ever protect children against measles is entirely speculative and is something that was never studied or pursued by me or any of my colleagues.

The Channel 4 programme implies commercial aspirations for personal gain. In fact, the aim of the patent was to generate funding for the research programme and a new Centre for Gastroenterology at the Royal Free Hospital. This can be substantiated by contemporaneous documentation.

The patent application was motivated by two main factors. First, it was felt that there may be difficulty in raising traditional grant funding for cutting edge, controversial work that was vulnerable by virtue of the fact that it might conflict with perceived wisdom and the commercial interests of others. Secondly, there was, and is, a government-led emphasis on commercial exploitation of discoveries within the medical school.

Transfer Factor (TF)

• A clinical trial of measles-virus specific transfer factor was planned in order to determine whether there was benefit to children with regressive autism and inflammatory bowel disease.
• It is not known at this stage whether this therapy would work. The purpose of the trial was to start to answer exactly this question as well as to monitor the safety of TF in these children.
• This was a treatment trial, not a vaccine trial.
• A trial of TF was based upon an extensive scientific literature, demonstrating safety and efficacy of TF in different diseases. I consulted widely with experts in the UK and US on the history and scientific background to TF both prior to and in the planning of the trial.
• The protocol was extensively peer-reviewed with written endorsement from experts in the UK and US. The trial protocol was submitted to, and subsequently approved by, the Ethical Practices Committee of the Royal Free Hampstead NHS Trust.
• The trial protocol was approved by the participating physicians.
• The trial was funded by charitable foundations after independent peer-review.
• The trial was cancelled due, in part, to my departure from the Royal Free.

The Patent

• A provisional patent filing was made for the use of measles virus-specific TF in regressive autism and inflammatory bowel disease (Regressive Bowel Disease; RBD).
• The reference to the possible use of TF to protect children against measles infection � the thrust of the Sunday Times� conspiracy theory � was put in as an afterthought in the patent. It was entirely speculative and never pursued in any shape, manner or form.
• The provisional patent filing was entirely speculative and was for a possible therapy; as such, it had no bearing on the 1998 Lancet paper. It constituted no potential conflict until the patent was awarded. When the patent was later awarded, this fact was communicated directly to the Editor of the Lancet in order that it might accompany a letter, written in response to a paper by Taylor et al that claimed to find no evidence of a link between MMR vaccine and autism. The editor did not consider the patent disclosure of sufficient significance to publish it alongside my letter.
• Since it was awarded, the patent has been disclosed in relevant publications. The claims have since been abandoned.

Drs Nick Chadwick (NC) and Ian Bruce (IB): measles virus detection in intestinal biopsies.

NC was employed as a post-graduate researcher in my laboratory, studying for a PhD. He investigated various technologies for measles virus detection using gene amplification. Due to problems within the laboratory with contamination and the need for additional expertise, we collaborated with IB at the University of Greenwich. IB and NC developed a technique that increased the sensitivity of measles virus detection over standard methodology from approximately 1 million viral copies in a reaction to 10,000 copies. In other words, even with the enhanced technique, the technology could not detect this virus when present below 10,000 copies.

We published the fact that we could not detect measles virus in Crohn�s disease using this technique. This publication went ahead on my recommendation, despite some resistance to publishing negative data. I considered that failure to publish negative data was inconsistent with good scientific practice and proceeded to publication.

By the time we applied the viral detection technology to the intestinal tissues of children with autism, new and more sensitive technology had come to my attention. This includes the technique of TaqMan PCR and was state-of-the-art technology being used by a few expert centres, including that of Professor John O�Leary (JO�L), then at Cornell University in New York. I went to New York to meet with JO�L. He presented evidence that his technique could detect down to 2 viral copies, compared with NC�s 10,000. The advantages were obvious and the possibility that NC�s results were falsely negative (i.e. that the virus was present in the tissues but at very low levels that NC�s technique could not detect) could now be addressed by the new technology.

Using JO�L�s technology the virus was detected in controlled studies and these results were published. They confirmed that our previous results were falsely negative due to the limitation of the technique we were using. TaqMan PCR, one of the techniques used by JO�L to detect measles virus in the autistic children, is now the gold-standard and the technology used by NC has been abandoned. On entirely scientific grounds I was proven correct on this occasion. The facts stated above can be supported by contemporaneous documentation.

AJW