Jan 28 2010

Andrew Wakefield “Acted Unethically”

Andrew Wakefield, the UK researcher who sparked unwarranted fears about the risks of the MMR vaccine, has been the subject of a two-and-a-half years ethics investigation by the General Medical Council (GMC). This afternoon the GMC announced their conclusion, ruling that Wakefield acted “dishonestly and irresponsibly” in his research and with “callous disregard” for the children that were the subject of his research.

Wakefield’s Story

In 1998 Wakefield and others published a story in the Lancet where they claimed to find an association between finding the measles virus in the GI tract of children with autism following the MMR vaccine. The study itself was small – only involving 12 children, and the conclusions were modest, not specifically suggesting a link between MMR and autism. But in subsequent press conferences Wakefield raised the alarm, saying, “Urgent further research is needed to determine whether MMR may give rise to this complication in a small number of people.”

The result was a significant drop in MMR compliance and a resurgence of measles cases, as this BBC chart demonstrates.

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The original Lancet article spawned follow up research which failed to replicate Wakefield’s results. (Also see here and here.) The final disconfirmation came from a recent study finding no link between MMR, measles virus, and autism. Most significantly, the PCR technique used to detect measles virus in the original Wakefeld paper (which was itself later discredited) was performed by Professor O’Leary, who also did the PCR in the recent study contradicting Wakefield.

Doing sloppy research that is later discredited happens frequently enough in science and itself does not warrant investigation for ethics violations. That came from other accusations – specifically that Wakefield paid children 5 pounds at his child’s birthday party to participate in the study.

Further, investigative journalist Brian Deer has uncovered a host of dubious behavior on the part of Wakefield, beginning with serious conflicts of interest. These include applying for a patent on an alternate MMR vaccine – so Wakefield could potentially benefit from the results of his research. Also, Wakefield was being paid by an attorney specifically to support the claim that the MMR is linked to autism, and some of the same children whose parents were involved in such law suits were part of Wakefield’s Lancet study. These conflicts caused the Lancet to later withdraw their support from the paper.

Most recently Deer has published what he believes is evidence that Wakefield may have even faked some of the data in his original paper.

After a multi-year investigation, the GMC finds that there is some truth to the accusations against Wakefield and has ruled against him. They will now deliberate on what sanctions should result from their findings (which should take a couple of months).

MMR and Autism

But of course, conflicts of interest and unethical behavior, while it calls into question Wakefield’s research, is not the final word on the science. The question of MMR and autism has been thoroughly investigated and no link has been found. The data is very robust because we have the opportunity to observe autism diagnosis rates in various countries with differing MMR policies over time.

We now have data from Poland, the UKDenmark, Finland, and Japan (the Japan study is most interesting because there the MMR vaccine was actualy withdrawn and was not followed by any decrease in autism). These studies show a remarkable concordance of evidence – there is no association between MMR and autism. (See here for a more complete list of studies.)

Conclusion

The Wakefield story is a disturbing one. By all accounts he conducted scientifically and ethically dubious research, with undisclosed conflicts of interest, and used that to trigger fears about the safety of MMR, resulting in a demonstrable increase in disease. He also helped propel the overall anti-vaccine movement.

It is good to see that the GMC had done a thorough investigation and are now bringing Wakefield’s malfeasance to light, and I await to see what sanctions they decide are appropriate.

Meanwhile, Wakefield in unrepentant. He has moved his practice to the US where he continues to be a darling of the anti-vaccine movement. In fact, official judgments against Wakefield only serve to increase his status as a cult-hero among anti-vaccinationists.

Unfortunately, the Wakefield story is not over.

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