Dr. Wakefield Responds To British Study Clearing MMR Vaccines
From a press release.
The study: "MMR Vaccination And Pervasive Developmental Disorders: A Case Control Study." By Liam Smeeth, Claire Cook, Eric Fombonne, Lisa Heavey, Laura C Rodriques, Peter G Smith, Andrew J Hall. Lancet 2004;364:963-968 plus 1.
The above paper has many failings. Two in particular are of such significance as to invalidate the conclusion; that MMR vaccine is not buttociated with onset of autism in children.
On page 967, first column, penultimate paragraph the authors state: "We were not able to separately identify the subgroup of cases with regressive symptoms to investigate the hypothesis that only some children are vulnerable to MMR- induced disease and that this is always regressive (27).
In this single statement the authors make it perfectly clear that they have not conducted an investigation of what has been referred to by the Department of Health and press commentaries as "the Wakefield hypothesis".
This hypothesis has remained unchanged since 1999, when we first described it in detail in a paper that was later published in the Israeli Medical buttociation Journal (IMAJ;1999:Vol1,1-5. The original hypothesis is restated below in lay form.
There exists a subset of children who are vulnerable to developing a particular form of regressive autism following previously normal development in combination with a novel form of inflammatory bowel disease. Onset may occur over weeks or sometimes months, and is triggered by exposure to a measles containing vaccine, predominantly the measles mumps rubella vaccine (MMR), that is in use in much of the world today. This exposure leads to long term infection with measles virus within key sites, including the intestine where it causes inflammation.
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Smeeth and colleagues were aware of the question that needed answering since they had consulted with epidemiologist, Dr Scott Montgomery and Dr Wakefield several years ago, when they were designing the current study. We made it absolutely clear then that they should specifically look at the children with regressive autism. They ignored this explicit advice.
Secondly, epidemiolgists in Sweden and Cambridge have confirmed that even if they had studied the correct group - regressive autism - the study would need to have included at least 3,500-7,000 children with autism - 3 to 6 times the actual number examined - in order for the study to have any validity at all.
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On this basis the paper cannot be said to have concluded anything of relevance to the hypothesis summarised above and has been grossly over-interpreted.
Moreover, in their conduct of the study, the authors do not even meet their own criteria set out in their previous paper 'A Case-Controlled Study of Autism and Mumps-Measles-Rubella Vaccination Using the General Practice Research Database: Design and Methodology', published in BMC Public Health (2001)1:2.
In that paper they stated in their abstract that "Children with a possible diagnosis of autism will be identified from their electronic health records. All diagnoses will be validated by a detailed review of hospital letters and by using information derived from a parental questionnaire". The second and third steps were not performed. Only 25% of cases had their records examined and no questionnaire was used. There were other substantial changes in the methodology which were also not explained in the present paper. This paper, therefore, meets neither the criteria for testing the original question nor those laid-down by the authors themselves.
The Government has chosen to rely on a series of epidemiological studies that, when subject to re-analysis, have been comprehensively criticised.
For example, readers should consider the two papers recently published in the Journal of American Physician and Surgeons, one by Dr Goldman and one by Dr Stott. These papers, demonstrated the unreliability of the recent Danish study, which was also heralded by the authorities as demonstrating the safety of the MMR vaccine.
The graph below has been reproduced from the second of these papers. It demonstrates a striking change in the number of children developing autism following the introduction and progressive increase in uptake of MMR in Danish children.
Figure 1. Autism prevalence in Denmark by year of birth, 1982-1992. Lines of best fit are shown for birth years 1982-1986 and from 1986 to 1992. Children born in 1986 were first to receive MMR in Denmark. The annual growth before MMR was -0.5% trend = -15%;95% CI, (-1.06) - (-0.76),ns, 95% CI, ).97 - 2.11). Source: Danish Psychiatric Central Register Data, with grabreastude to SafeMinds. The Visceral research program involves the meticulous clinical investigation of individual affected children, which is a far more accurate and precise way of investigating the possible relationship between MMR and regressive autism.