Wakefield - Callous Disregard: Autism and Vaccines: The Truth Behind a Tragedy

Letter from Dr. Peter Fletcher, Ex-Principal Medical Officer with responsibility for the UKs Committee on Safety of Medicines and later Senior Principal Medical Officer and Chief Scientific Officer

My first comment on this excellent book is in respect of whether or not this whole catastrophe could have been avoided by action taken years earlier than The Lancet paper. By about 1987 in the UK, product licence (PL) submissions for three MMR vaccines had been initiated and were the subject of discussion by the Joint Committee on Vaccination and Immunisation (JCVI). My past position of Principal Medical Officer with responsibility for the main Committee on Safety of Medicines (CSM) and its sub-Committees leads me to the conclusion that a great deal could have been done.

It would have come to my attention from minutes of the JCVI that they were urging rapid granting of PLs for the three vaccines. That news would have been alarming because the JCVI was a purely advisory committee (i.e., not a Section 4 committee under the Medicines Act) and had no powers in the granting or refusal of PLs.

In the past there would have been no way in which the CSM would have recommended the granting of PLs on such scanty evidence of safety in the submissions. By 1988/9 the only evidence available was a handful of clinical trials each having no more than 7-800 subjects and none of them conducted in the UK. Had I still been there I would have required at least 10,000 patients in each submission with active safety surveillance for a minimum of 3 months with the possibility that this could be extended if untoward findings should be reported.

This would most probably have solved our current problem as we now know that at least 35 cases of autism had been officially reported by about 1993.

My second comment is to emphasise the great importance of the positive rechallenge cases which, for all practical purposes, prove causality. The CSM has always accepted that positive rechallenge in the absence of other equivalent and credible causes has to be accepted as a causal relationship.

My third comment concerns the analysis of anaphylaxis as a serious adverse effect. This has been much neglected and carefully avoided when mortality of vaccines is discussed. This is of primary importance when benefits and risks of vaccination are considered and compared with mortality of infections. If, for example, pre-vaccination figures for annual mortality due to measles (about 50 in 1967) are to be compared with annual mortality due to vaccines then, in developed countries where improvements in social conditions and standards of health care have been achieved, the differences become uncomfortably close.

My fourth comment relates to the safety evaluation of medicinal products intended for healthy people. The two biggest examples are hormonal contraceptives and vaccines. The differences between the two are mindboggling. The contraceptives have been evaluated more intensively than any other group of medicinal products both in humans and animals. In contrast, vaccines have been minimally investigated and there seems to be no hope of an improvement in the future.

My fifth comment is related to the overall conduct of the GMC case. I have now been involved in five different legal cases, and in all I have been in varying levels of despair when faced with the medical and scientific ignorance of the lawyers (solicitors and barristers) on both sides. This is quite understandable since a medical education extends over many years and, although the lawyers do quite well on the specifics of the case, they are lost when it comes to the bigger picture. This is referred to very nicely on page 143 with Charcot et al., and to some extent, it excuses the overall feeling of the case descending into an undignified catalogue of bickering between very irritating academics.

Lastly, I would like to mention the general clinical picture(s) presented by these children which, in my view, constitutes a complex new syndrome. The differing clinical observations cannot each have a different and separated pathological cause. It may be that two or just possibly three different pathological processes are involved, but the root cause has to be a single initiating factor almost certainly vaccines.