Autism Bioethics Medicine Quackery

While we’re on the topic of autism and vaccines: Andrew Wakefield is facing charges for unprofessional conduct

When it rains it pours, eh?

While I happen to be on the topic of vaccines and autism again today, here’s a surprising story:

Andrew Wakefield, the doctor behind the scare over a potential link between the MMR jab and autism in children, is to face four charges relating to unprofessional conduct at the General Medical Council, it is reported today.

Mr Wakefield, a surgeon who became a gut specialist, could be struck off the medical register and debarred from practising in the UK if the GMC finds him guilty of serious professional misconduct.

Following the publication of a research paper in the Lancet by Mr Wakefield and colleagues in February 1998 – which suggested a tentative link between the immunisation at the age of 18 months, a bowel disorder called Crohn’s disease, and autism – many parents became anxious over the safety of the measles, mumps and rubella, or MMR, vaccine.

Indeed. Thanks to Wakefield’s junk science, a real scare took hold in the U.K., leading to decreased vaccination rates. Brian Deer has shown the full depths of how bad Wakefield’s work was, including his unstated conflicts of interest. Indeed, it got so bad that 10 of the 13 authors on the paper retracted their authorships. Sadly, like the undead, this dubious and thus far scientifically unsupported connection is being resurrected by Dr. Arthur Krigsman. A couple of weeks ago, the press was full of headlines like “Scientists fear MMR link to autism” or “US study supports claims of MMR link to autism.” Seeing these headlines, I wanted to see the study, to see if there was anything to it. The problem was (and what the papers don’t tell you) is that this study has not yet been published in any peer-reviewed poster. It was presented at a meeting. But it wasn’t even presented as a full talk, but rather only as a poster, the least prominent form of data presentation. All I can read is the abstract. Until I can see the actual paper, I can’t really say if there’s anything there or not, but Ben Goldacre makes a good point:

But let’s not forget, the Daily Mail was promoting Krigsman’s research back in 2002 as well: at that time, he was putting endoscopes into the bowels of young children with autism, and said he had found evidence of inflammation. 4 years later, looking on PubMed, the standard database for all medical papers, it seems this research still has not been published in a peer reviewed academic journal. Forgive my bluntness, but it seems a shame to go poking around up there if you’re not going to write up your findings properly.

Meanwhile the Telegraph says that Krigsman’s most recent unpublished claim is replicating similar work from 1998 by Dr Andrew Wakefield, and 2002 by Professor John O’Leary. But there is no such work from 1998 by Wakefield, at least not in PubMed (in that year he publishes his infamous, very different, and partially retracted Lancet paper on MMR, of course). Meanwhile it is well documented that other labs have tried to reproduce the 2002 O’Leary study and come out with different results, and that the protocol was likely to have problems with false positives because of the tests used: two perfect examples of the importance of research being fully written up and published, so it can be replicated and assessed. Oh, and the newspapers didn’t mention that Andrew Wakefield was also an author on the 2002 study along with O’Leary, nor that Wakefield is also very closely associated with Krigsman (they are doctors together at Thoughtful House, a private autism clinic in the USA).

I could go on, but instead, here is the news you didn’t read: this month, in the May issue of the Journal of Medical Virology, there was a very similar study, only this one has actually been published. It looked for measles RNA in children with regressive autism after MMR vaccination, much like the Krigsman story. It used tools so powerful they could detect measles RNA down to single figure copy numbers. But they found no evidence of the magic vaccine-strain measles RNA to implicate MMR, and perhaps because of that unfrightening result, the study was loudly ignored by the press.

Because it has been published in full, I can read it, and pick holes in it, and I am more than happy to do so: because science is about critiquing openly published data and methodologies, and in the real world, all studies have some flaws, to a greater or lesser extent. Often they are practical ones: here for example, the researchers couldn’t get ethics committee approval to use the tissue they ideally wanted to use (lumbar punctures and gut biopsies on children are a hard sell). And when they asked the anti-MMR lobby if they could have some of their tissue to work on, amusingly, they were ignored.

In the meantime, Dr. Wakefield is facing real charges:

According to the Independent newspaper today, the preliminary charges against Mr Wakefield will be that he published inadequately founded research, failed to obtain ethical committee approval for the work, obtained funding for it improperly, and subjected children to “unnecessary and invasive investigations”.

It was reported that GMC lawyers are preparing more detailed charges for publication later this year, and that there will be a public hearing next year.

Whatever happens to Wakefield, it’s probably too late. The damage has been done. MMR has been incorrectly linked with autism and Crohn’s disease in the minds of millions of parents, particularly in the U.K. How much other antivaccination wingnuttery has been driven by that single dubious paper by Wakefield eight years ago? How much of the unjustified suspicion of vaccines as a cause of autism driven by Wakefield led to the dubious science claiming that mercury in vaccines cause autism? We’ll probably never know. We do know one thing, as the Independent reports:

Immunisation rates fell over the next five years from more than 90 per cent nationally to a low of 78.9 per cent in early 2003. In parts of London rates fell below 60 per cent. There was a resurgence in cases of the three diseases, including rubella (German measles), according to the Health Protection Agency. The number of cases of mumps soared from 4,204 cases in 2003 to 16,436 in 2004 and to 56,390 cases last year.

Since 2003 the MMR vaccination rate has increased slightly and in mid-2005 stood at 83 per cent. A spokeswoman for the agency said: “The fear of Wakefield has dissipated a bit. The figures are coming back up.”

That being said, unless real malfeasance was committed, such as fraud, I’m a bit uncomfortable about Wakefield’s prosecution. It is possible that he is simply wrong but basically honest (although Brian Deer’s reports make that possibility seem somewhat unlikely, given his patent applications whose success depended upon discrediting MMR), as well as his financial conflict of interest that he did not report:

In 2004 it emerged that at the time he [Wakefield] was preparing The Lancet paper, Dr Wakefield was being paid by lawyers for parents of children allegedly damaged by the MMR vaccine to look for evidence that could be used to help take legal action against manufacturers of the vaccine.

He received £55,000 from the Legal Aid Board, which was paid into his research fund but which he had not disclosed to his co-researchers. At least four of the 12 children in the Lancet study were also in the Legal Aid Board funded study. He was accused by The Lancet of failing to declare a conflict of interest that could have influenced his findings.

It sounds very damning. I’m hoping that a fair and impartial hearing will allow us all to determine whether Wakefield is indeed guilty of serious misconduct or whether he’s just a true believer who happens to be very wrong. Either way, Wakefield did enormous damage with his bad science, particularly in the U.K.

Just look at the timeline as reported in the Independent:

* FEBRUARY 1998: Andrew Wakefield’s paper is published in The Lancet, linking the MMR triple vaccine with autism

* 2000: Demand for single vaccines rises

* JANUARY 2001: The Government rejects calls for a single measles vaccine on the NHS

* 2001: MMR vaccinations fall to 84.2 per cent of children, down from 92 per cent in 1996

* EARLY 2003: Immunisation rates reach low of 78.9 per cent

* NOVEMBER 2003: Dr Simon Murch says there is “unequivocal evidence that MMR is not a risk factor for autism”

* 2004: It emerges that while preparing his Lancet paper, Dr Wakefield was being paid by lawyers for parents of children allegedly damaged by MMR

* 2004: Immunisation rates rise to 81 per cent

* 2004: Number of cases of mumps: 16,436, up from 4,204 the previous year. In 2005 the number is up to 56,390

* MID-2005: Immunisation rates rise to 85 per cent

* OCTOBER 2005: Cochrane Library says there is no credible evidence that MMR harms

* APRIL 2006: A boy, 13, who had not received the MMR vaccine, becomes the first person to die of measles in 14 years

The return of mumps and measles, not any new understanding of the etiology of autism, that‘s Dr. Wakefield’s legacy.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

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