Recent rapid responses

Rapid responses are electronic letters to the editor. They enable our users to debate issues raised in articles published on bmj.com. Although a selection of rapid responses will be included as edited readers' letters in the weekly print issue of the BMJ, their first appearance online means that they are published articles. If you need the url (web address) of an individual response, perhaps for citation purposes, simply click on the response headline and copy the url from the browser window.

Displaying 1-7 out of 7 published

21 July 2007

It is premature of Professor Beard to comment on whether the prosecution of Dr Wakefield is warranted. And the investigation does not appear to be "a witch hunt" - many of the allegations are very serious:

From the GMC website (http://www.gmcpressoffice.org.uk/apps/news/events/index.php?key=0#), he has been accused:

"it will be alleged that some of the children did not qualify for the study on the basis of their behavioural symptoms"

I am sure the Professor would agree that knowingly including children into a study they are not eligible for is unethical behaviour?

"It is further alleged that the three practitioners permitted a programme of investigations to be carried out on a number of children as part of the research study, some of which were not clinically indicated when the Ethics Committee had been assured that they were all clinically indicated. These investigations included colonoscopies and lumbar punctures."

I am sure Professor Beard is aware of the potentially fatal complications due to colonoscopy and lumbar puncture, not to mention the pain and distress this would have caused - or if they were performed under general anaesthesia, the extra risk this would involve.

This is unethical behaviour and, arguably, child abuse.

"It is alleged that the performance of these investigations was contrary to the clinical interests of the children."

Likewise

"The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith acted dishonestly and irresponsibly in failing to disclose in the Lancet paper the method by which they recruited patients for inclusion in the research which resulted in a misleading description of the patient population in the Lancet paper. It is further alleged that Dr Wakefield gave a dishonest description of the patient population to the Medical Research Council."

Again, Professor Beard would agree that research fraud of this nature is unethical and warrants censure by the GMC?

"The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith administered a purportedly therapeutic substance to a child for experimental reasons prior to obtaining information about the safety of the substance. It is alleged that such actions were irresponsible and contrary to the clinical interests of the child."

Again, unethical behaviour that put the life of a child at risk

"The Panel will inquire into allegations that Dr Wakefield acted unethically and abused his position of trust as a medical practitioner by taking blood from children at a birthday party to use for research purposes without ethics committee approval, in an inappropriate social setting, and whilst offering financial inducement."

...

Personally, I do not care as much about the legal aid and financial implications of DR Wakefield's alleged activities. The issue is not whether the research was flawed - we know it was, and his work is completely discredited http://gut.bmj.com/cgi/content/full/56/6/886 - but whether it was conducted in an appropriate manner without endangering the lives of the children in Dr Wakefield's care.

He has only been accused, and nothing is yet proven - Dr Wakefield may be vindicated on all points.

BUT the allegations are of a very serious nature, and the GMC court hearings must be allowed to go ahead.

Competing interests: None declared

Competing interests: None declared

Richard Lindley, Liverpool

University of Liverpool

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The Cambridge University Autism Research Centre offers its assessment of Childhood Asperger Syndrome Test (CAST) on its website. The report makes it entirely clear that: "There is not currently enough evidence to recommend the use of the CAST as a screening test within a public health screening programme in the general population". The BMJ should not have reproduced this figure uncritically or without checking primary sources.

Competing interests: None declared

Competing interests: None declared

Tony Plant, Facilitator and trainer

Self-employed

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The author of the unpublished study in question, Simon Baron-Cohen, has stated that the figure of 1 in 58 has been removed from all context and is false and misleading ("Autism: the truth" in The Times, July 12th).

The study in question is a test of diagnostic methods. One pre- screening method tested, a questionnaire filled out by parents, is known as CAST (Childhood Asperger’s Syndrome Test). It is known that "positives" from this questionnaire tend to be correct in only half of all cases on genuine clinical diagnosis. Other methods tested by Baron-Cohen's group showed autism rates of closer to 1 in 200, an equal error in the opposite direction from the 1 in 58 figure given the accepted autism rate of around 1 in 100.

The BMJ should be more careful in publishing leaked, out of context data from incomplete and unpublished studies - especially when the data selected is alarmist.

Competing interests: None declared

Competing interests: None declared

Jon Curwen, Parent of vaccinated child

Home

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16 July 2007

I am sure that Andrew Wakefield will offer a detailed and effective rebuttal of all or most of these allegations, and note that apparently no complaints have been made against him by parents. Two factual errors in this report come immediately to light:

"Dr Wakefield also faces charges in relation to a research grant he received from the Legal Aid Board to investigate a possible link between the MMR vaccine and autism on behalf of parents involved in litigation.

"He failed to declare this funding to the Lancet. When the payment was exposed by the Sunday Times newspaper in an investigation in February 2004, the Lancet's editor, Richard Horton, declared it a "fatal conflict of interest.""

It is a matter of record that Wakefield declared the Legal Aid Board commission in a letter to the Lancet 2 May 1998 and this could not have come as news in February 2004, and was not exposed by the Sunday Times. Also incorrect is this statement:

"In March 2004, 10 of the 13 authors of the paper signed a statement retracting its finding of a link between MMR and autism."

There was, of course, no such finding in the paper and the 10 co- authors chose to distance themselves from Andrew Wakefield by retracting "an interpretation". How you can retract something which has never been stated, and how there could be "a fatal conflict" when it was not stated are interesting questions. There seems to be an element of building castles in the air here.

I agree with Jonathan Beard that this prosecution should never have been brought, and will not help to create public trust.

Competing interests: Autistic son

Competing interests: None declared

John Stone, none

London N22

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It is alarming that and alarmist for the BMJ to repeat the claim that "lead researcher, Simon Baron-Cohen, said that this study, which examined some 12 000 primary school children in Cambridgeshire, will conclude that one in 58 children has such a disorder". Simon Baron-Cohen said something very different to The Times, where he was quoted arguing that that the leaked draft is at a stage where it "is as accurate as jottings in a notebook". I am not sure where the BMJ got its figures from, but it is incorrect to assume that 1 in 58 figure is reliable.

Moreover, the 1 in 58 figure is taken from the use of the CAST questionnaire. This questionnaire assesses whether children are at risk of being on the autistic spectrum; it does not provide a diagnosis. It is also known to generate a high rate of false positives. Therefore, even it 1 in 58 children tested 'positive' on this questionnaire, this would not demonstrate that 1 in 58 children is on the autistic spectrum.

It is bad enough to see this type of error from the Observer, let alone the BMJ. I would suggest that you correct the misleading - and potentially alarming - figures in your article ASAP.

Competing interests: previously blogged about related issues at www.holfordwatch.info

Competing interests: None declared

Jon M Mendel, PhD Student

Durham, DH1 3LE

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It is sad that the GMC has taken the MMR debate into what appears to be a vindictive cul-de-sac. One suspects that they themselves are not very happy at having been bounced along this road, politically, and by whom? Not by parents. One can only guess that the complainants to the GMC are those who have most to lose from Wakefield's uncovering of a putative regressive autism-gut condition-measles virus linkage. How many people have actually complained? Probably just one or two, whose names may already be known to those who have followed this controversy for the past decade. We can only wonder, of course, as they are screened by anonymity.

Meanwhile, forget this side-show and get back to the science, and the uncomfortable facts. The Wakefield et al Lancet paper of February 1998 offered very strong evidence of a non-coincidental linkage between regressive autism and the gut condition ileal-lymphoid nodular hyperplasia. There are now fourteen other published studies or papers, from a plethora of authors, working in four different contries, that confirm that linkage. In 2001, the Medical Research Council stated that funding further research into the regressive autism-ILNH linkage was a priority. Six years later, not one piece of research has been funded.

Then we turn to the linkage between ILNH and measles virus. Five separate studies/papers have reported on this linkage. And five further studies/papers have linked the measles virus with MMR vaccine. These are strong clues, yet are not being followed up by other scientists. The current GMC hearing is expressly designed to discourage any further would- be researchers from going down that road.

Then we turn to MMR's safety. The Cochrane Collaboration concluded in 2003 that (verbatim quote) "the design and reporting of safety outcomes in MMR vaccine studies, both pre and post marketing, are largely inadequate". In 2005, Cochrane reported that "we found only limited evidence of safety of MMR compared to the single-component vaccine". Isn't that a little worrying? And, if MMR is so safe, how come several hundred families went to the High Court in Japan recently, and won massive damages, following adverse events (including deaths) for their children? The case went to appeal, and the families won their appeals, too. Perhaps the GMC can't read Japanese.....

Finally, we come to the explosion in autism numbers. There aren't any figures in the UK, of course - the Department of Health's fixated by suspected measles numbers, but bored by the idea of collecting data on autism (very mysterious genetic condition, = can't do anything about it, = refer callers to the National Autistic Society), but the California Department of Developmental Services has just reported an increase in full DSM-IV autism from 2,700 in 1987 to 35,000 in Spring 2007. Don't tell me, it's all down to better recognition.....

David Thrower Stockton Heath, Cheshire WA4 2DZ

Competing interests: Parent of child who regressed into autism following measles vaccination

Competing interests: None declared

David A. Thrower, Carer (brain-damaged son)

WA4 2DZ

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14 July 2007

The investigation by the GMC into the research by Dr Wakefield is yet another witchhunt against an committed and honorable doctor who's only 'crime' was to question the establishment's arrogant attitude concerning the safety of vaccines, i.e. 'we know best and you stupid people out there shouldn't question our wisdom'.

The GMC's stated aim is to 'protect patients and help doctors' You can forget the second part - its real aim seems to be to hang doctors out to dry in the hope that their aggressive attitude will protect the organisation from extinction. I think the time has come to scrap the GMC and introduce an regulatory authority that is independent of government or doctors. An added advantage is that doctors will no longer have to fund an organisation that is becoming blatantly anti-doctor.

Dr Wakefield's research may have been flawed but show me any research that, in retrospect, could not have been better performed. The Editor of the Lancet should feel ashamed that he has not defended his decision to publish this research, and I am sorry that some others involved in the research were pressured into retracting ownership.

Competing interests: A previous medical colleague of Dr Andrew Wakefield

Competing interests: None declared

Jonathan Beard, Professor of Surgical Education

University of Sheffield

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