By John Stone
The latest study to decry a connection between vaccines and autism
was launched the week before last by the on-line journal BMJ Open, an off-shoot of British Medical Journal. The lead author of the study is none other than Brent Taylor, one of Andrew Wakefield’s principal antagonists at the Royal Free Hospital and former member of the United Kingdom’s Joint Committee on Vaccination and Immunisation (JCVI). British Medical Journal is also conflicted by its partnerships with vaccine manufacturers Merck and GlaxoSmithKline
as well as the legal suit they are currently defending against Wakefield.
While the database used - the United Kingdom’s General Practitioners’ Research Database - is beyond public scrutiny the evidence is that it contains highly inadequate data, and the study has glaring defects. For instance, the database has no systematic recording of autism cases (general practitioners do not diagnose it) and perhaps only a tenth of actual cases are included. The study examines the upward trend in autism only in relation to the introduction of MMR and ignores other increases to the vaccine schedule. The study claims that the trend in the UK in contrast to the US had levelled off by the 2001 birth cohort although it had risen by a further 60% on its own figures for 2008 with the final numbers for this late period not yet in (meanwhile the number of cases in Scottish schools – a part of the UK where cases are recorded - rose from 3919 in 2007 to 8650 in 2012, as reported in the Scottish Sunday Mail 23 December 2012).
It is likely that data on vaccine status on the database is also inadequate as is recorded in an email of 2001 between two Centers for Disease Control Officers, Thomas Verstraeten and Bob Chen disclosed in an Freedom of Information Request. Verstaeten wrote:I think two issues are important in assessing the potential strength of the GPRD study: 1. Maximum exposure and 2. Unbiased controls. The maximum exposure is indeed relatively low if that was the only (Thimerosal) containing vaccine used. My estimate is that you need at least >50 by 3 months or >100 by 6 months to see an effect if there is one which you can barely make (50 at 2 [he means 3] mo and 75 at 4 mo in the UK). The quality of the comparison group is maybe even more important if you consider all the criticism we have received of comparing high T ([thimerosal] exposure to no or low T exposure
. I am not sure if the GPRD [General Practitioners' Research Database] is that reliable that you can be sure that low exposure is really low exposure and not underascertainment in the database. I hate to say this, but given these concerns, it may not be worth doing this after all. On the other hand, maybe the grant can be given to Harald in Sweden to do his follow-up of the DTaP trial kids
(Click photo to read clearer version.)
Despite which the study, of which Brent Taylor was also senior author, went ahead. This episode is recounted in my article The British Dimension - the WHO Mercury Cover-Up and the CDC
It is remarkable given the apparent inadequacy of the database how many studies defending the reputation of vaccination in relation to autism have been based on it, and launched with maximal
publicity. Among previous authors have not only been Taylor and Hershel Jick (co-authors here) but other vaccine programme proponents Elizabeth Miller and Eric Fombonne (here
). As once again demonstrated it seems as if the quality and integrity of the studies are superfluous providing they achieve the customary widespread uncritical media attention.
In their own way the GPRD autism/vaccine studies are quite as troubling as the group of studies coordinated for the CDC in Denmark by indicted financial fraudster, Poul Thorsen
In 2004 Congressman Dr Dave Weldon told the US Institute of Medicine
:I am repeatedly informed by researchers who encounter apathy from government officials charged with investigating these matters, difficulty in getting their papers published, and the loss of research grants. Some report overt discouragement, intimidation and threats, and have abandoned this field of research. Some have had their clinical privileges revoked and others have been hounded out of their institutions.An example of the latter is Dr. Andy Wakefield who has described to me how the intellectual climate at the Royal Free in London became intolerable for him and he was forced to depart. Virtually all of his ongoing research now has to be privately funded, while those seeking to disprove him receive government money. I witnessed some of this first hand at a hearing, when a Dr Brent Taylor made repeated inappropriate comments about Wakefield and his work causing me to seriously question Dr. Taylor’s integrity and motives.
My letter to the journal regarding the new study has been published and awaits a reply. Here is the text .An old story: the GPRD does not provide credible autism dataJohn Stone, UK Editor Age of AutismThere have now been many studies using the General Practitioners' Research Database relating to autism and vaccination including by the present authors, which invariably have resulted in some reassuring conclusion. Several - like this one - have received wide media coverage, and it is therefore salutary to read the pre-publication peer reviews by Alan Emond and Katherine M Keyes  of this paper by Brent Taylor, Hershel Jick and Dean MacLaughlin  and ask why it was ever published. "4 in a 1000 boys" in 2008 is not only a lot less than "11 in a thousand boys" in the USA it is a lot a less than the 1 in 100 figure for all children in the UK suggested by National Statistics c. 2004 in a document I can no longer find on line. It is also a rise on the 2.5 boys (25 per 10,000) showing on the graph (Fig 1) for 1998-2001, apparently a rise of 60% (after it was supposed to have plateaued?). And I also note it is a lot more than the figures derived from the same database in an earlier paper by Jick which recorded "The incidence of diagnosed autism rose approximately 25%/year, from 1.6/10,000 boys born in 1993 to a peak of 9.5/10,000 boys born in 1999 (p<0.001)". Moreover, by a remarkable coincidence if you make the traditional reckoning of 4 autistic boys to 1 autistic girl then the 2.5 boys in 1000 rate proposed by Taylor et al (1998-2001) yields an autism rate of 1 in 640 which is just one tenth of the 1 in 64 rate (157 in 10,000) proposed by Baron-Cohen, based of his Cambridgeshire survey conducted in the early part of the last decade . So, a fundamental point is that despite the many and often publicised studies using the GPRD to study rates of autism [2,3,5,6,7,8,9,10,11,12) it actually only collects fragmentary data on the topic, of little or no statistical use. It is quite likely that in(a) loose way the data follows the actual trend but most of the cases are not there. It is an anomaly that while Taylor et al focus on MMR as an issue they fail to consider important confounders like the introduction of the accelerated mercury containing DPT vaccine schedule in 1990 and HiB vaccine in 1992 (although both Taylor and Jick examined the DPT/mercury issue in other papers). My attempts to raise this with Prof Taylor have so far not been successful [13, 14]. Nevertheless, the present article has been reported in many places, notably on the BBC  and in The Times : once again the world has been reasured that autism has plateaued and it never had anything to do with vaccines. But on what basis?  http://www.bmjopen.bmj.com/content/3/10/e003219.reviewer- comments.pdf  Brent Taylor, Hershel Jick and Dean MacLaughlin 'Prevalence and incidence rates of autism in the UK: time trend from 2004-2010 in children aged 8 years'BMJ Open 2013 3:e003219; doi:10.1136/bmjopen-2013-003219  Jick H, Kaye J. 'Epidemiology and possible causes of autism', Pharmocotherapy: 2003; http://www.medscape.com/viewarticle/465861_1 Baron-Cohen S, Scott FJ, Allison C, Williams J, Bolton P, Matthews FE, Brayne C, 'Prevalence of autism-spectrum conditions: UK school-based population study' http://www.ncbi.nlm.nih.gov/pubmed/19478287  Nick Andrews, Elizabeth Miller, Andrew Grant, Julia Stowe, Velda Osborne and Brent Taylor, Thimerosal Exposure in Infants and Developmental Disorders: a retrospective cohort study in the United Kingdom does not support a causal association. Pediatrics 2004; http://pediatrics.aappublications.org/content/114/3/584  Kaye JA, del Mar Melero-Montes M, Jick H, 'Mumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis' http://www.bmj.com/content/322/7284/460  Black C, Kaye JA, Jick H, 'Relation of childhood gastrointestinal disorders to autism: nested case-control study using data from the UK General Practice Research Database' BMJ. 2002 Aug 24;325(7361):419-21  Jick H, Kaye JA, Black C, 'Changes in risk of autism in the U.K. for birth cohorts 1990-1998' Epidemiology. 2003 Sep;14(5):630-2  Fombonne E, Heavey L, Smeeth L et al. Validation of the diagnosis of autism in general practitioners records. BMC Public Health 2004;4:5. http://www.biomedcentral.com/1471-2458/4/5  Smeeth L, Hall AJ, Fombonne E et al. A case control study of autism and mumps measles rubella vaccination using the general practice research database. BMC Public Health 2001;1:2 http://www.biomedcentral.com/1471-2458/1/2  Smeeth, L, Cook C, Fombonne E et al. MMR vaccination and pervasive development disorders: a case-control study. The Lancet 2004;364: 963-69  Smeeth L, Cook C, Fombonne et al. Rate at first recorded diagnosis of pervasive developmental disorders in United Kingdom general practice, 1988-2001. BMC Medicine 2004;2:39. http://www.biomedcentral.com/1741-7015/2/39 Accessed Sept. 1, 2005  John Stone, 'A missing confounder', 27 November 2006 http://adc.bmj.com/content/88/8/666.long/reply#archdischild_el_2773  John Stone, 'Re: Side effects of mercury containing vaccines like influenza', 23 November 2006 http://www.bmj.com/rapid- response/2011/10/31/re-side-effects-mercury-containing-vaccines-influenza  "UK autism cases have 'levelled off'" http://www.bbc.co.uk/news/health-24547956  Chris Smyth, 'Autism rate steady after mystery peak', http://www.thetimes.co.uk/tto/health/news/article3896569.ece Conflict of Interest: Autistic son