Jan 06 2011

BMJ Slams Wakefield

In 1998 Andrew Wakefield and 12 coauthors published a now infamous paper in the Lancet alleging a connection between regressive autism and nonspecific colitis (bowel inflammation). They also reported a “strong temporal association” between this alleged new syndrome and injection with the MMR vaccine. The study was based upon 12 case reports of children with this apparent syndrome. It sparked fears regarding the MMR vaccine specifically, and vaccines in general, that spread initially through the UK but then around the world, including the US. The result was a surge in the anti-vaccine movement, declining vaccine compliance – and in some communities low enough to reduce herd immunity resulting in outbreaks of vaccine-preventable diseases, like measles and whooping cough.

In early 2010 the Lancet finally retracted the paper, citing ethical concerns, and later that year the General Medical Council found that Wakefield had acted unethically. He was eventually struck off and now is self-employed in the US – professionally disgraced but he remains unrepentant and a martyr and hero of the anti-vaccine movement. Like many cranks, Wakefield hides behind a veil of accusations of conspiracies and persecution.

Despite his downfall, the damage had already been done. During this time journalist Brian Deer relentlessly investigated Wakefield and the Lancet paper. The chilling result of this investigation is now detailed in a BMJ paper (the first in a series).

Brian Deer deserves a great deal of recognition for his investigative journalism – something we don’t have enough of these days. He tracked down the 12 children in the Wakefield study, reviewed hospital records (all made available through the GMC investigation) and compared them to the Lancet paper. What he found was systematic distortion and misrepresentation of the basic facts.

In order to make his case Wakefield had to show that children with regressive autism also had symptoms of colitis and further that their symptoms began shortly after receiving the MMR vaccine. Deer found that the actual facts in the 12 cases do not support this narrative. In fact, after reviewing the records Deer could not recognize any of the study subjects by the details reported in the paper – there was simply no correlation. The paper goes into great detail, but here is the summary of the problems with Wakefield’s paper.

*Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism

*Despite the paper claiming that all 12 children were “previously normal,” five had documented pre-existing developmental concerns

*Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination

*In nine cases, unremarkable colonic histopathology results—noting no or minimal fluctuations in inflammatory cell populations—were changed after a medical school “research review” to “non-specific colitis”

*The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations—all giving times to onset of problems in months—helped to create the appearance of a 14 day temporal link

*Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation

Every aspect of the alleged new syndrome appears to have been fabricated by Wakefield. It is hard to explain this as just sloppy research. The fingerprints of deliberate fraud seem clear, in my opinion.

The last point is often a subtle problem that may be missed by how studies are reported. Wakefield alleged an association between autism and GI symptoms. In order to validate this a proper study would look at either random cases of autism or sequential cases, and then compare the rates of GI symptoms or disorders with an appropriate control population. Wakefield, however, solicited his cases through anti-vaccine networks, and specifically asked for children with autism and GI symptoms. So his methods could not help but confirm his hypothesis – and even then he had to fix the results. This is called selection bias, and is often a subtle and missed bias in case series like this.

We also see in these cases how the timing was altered. It is interesting that most of these families believed there was a connection between MMR and their child’s symptoms, even though there were clear problems prior to the vaccine in many cases. Some of these problems were significant, including dysmorphic features and clear developmental delay. What this case series unwittingly documents (after Deer’s careful investigation) is how a belief in a temporal connection and cause and effect can persist despite being out of sync with documented evidence. One father admitted: “We were just vulnerable, we were looking for answers.”

This, of course, is understandable. And the psychological effects involved are also ubiquitous – we are all prey to  false memories and faulty thinking. But the point of scientific rigor is to control for such things. Clearly that did not happen here.

Wakefield has responded to these allegations by doing what charlatans typically do – they go on the offensive against their accusers. In a CNN interview Wakefield responds:

Wakefield dismissed Brian Deer, the writer of the British Medical Journal articles, as “a hit man who has been brought in to take me down” by pharmaceutical interests.

The “Big Pharma” gambit is especially lame coming from Wakefield, who had applied for a patent for an vaccine alternative to the MMR he tried to trash in his Lancet paper. It’s always a cheap and easy dig, and plays well to the anti-vaccine crowd. Deer, meanwhile, discloses that he has no financial conflicts of interest. Unable to dig up any actual dirt on Deer defenders of Wakefield resort to claiming that he was paid to write his articles. Yeah – he is a full time journalist who makes his living by getting paid for writing.

Of course, Age of Autism is backing Wakefield and doing their typical smear campaign against Brian Deer. One comment that managed to get through (rare on AoA to let a critical comment through) sums it up nicely.

In the above comments I see lots of ad hominem attacks, blanket statements about conspiracies in the big pharma and big media, and (perhaps more substantial) concern about access to medial records, but I would like to see SPECIFIC counter-arguments against the journalist’s research and conclusions. You have to admit that all the lather of socialist-this and sinister-bastards-that don’t carry well in argument against a pretty extensively detailed piece of investigative journalism.

AoA puts up a lot of smoke and mirrors, but nothing to actually counter Deer’s investigation, or the conclusion of the GMC after an extensive ethics investigation. It’s all just plausible deniability, the last refuge of the red-handed.

Conclusion

Brian Deer and the BMJ have done good work in exposing Wakefield and the Lancet article for what it is. Hopefully this will counteract some of the damage to public health that resulted from his dubious research.

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