The GMC on Wakefield I

On January 28, 2010 the Fitness to Practice Panel ("Panel") of the General Medical Counsel (UK) handed down its findings, gleaned over more than two years and more than 140 hours of testimony, on a number of charges that have swirled around Dr. Wakefield since 1998 regarding his research method, conflicts of interest, ethical approvals and publication of an article in the Feb. 1998 edition of the Lancet. This fact-finding document is the first step in a three-step process to determine whether Dr. Wakefield would be struck from the list of medical practitioners in England. The second step is a response to the fact-finding by counsel, to be held in April, and the third step is a final decision by the GMC regarding his fitness to practice medicine in the UK. Barring an apparent act of divine intervention, it appears to me from a close reading of the 55-page fact-finding concerning Dr. Wakefield, that the GMC will find that the facts "add up" to serious professional misconduct, for which the appropriate sanction is being removed from the list of medical practitioners in England.

The purpose of this and the next essay is not to go through in detail the factual findings. I do, however, propose to lay out in this essay what I think are the four linchpins of Dr. Wakefield's case that were unconvincing to the GMC, and then, in the next essay, to point to certain factual findings that give you the "flavor" of the document. News reports always rush to the "bottom line"--I am more concerned with the basis of the case and the findings.

One other comment is appropriate at this point. In January 2009 I visited and interviewed Dr. Wakefield for 12 hours about his case. The results of that interview were published in April 2009; they are also here. My article, as it now appears to me, laid out what we lawyers call his "theory of the case." Every case is based not just on factual details but of a larger theory or approach. My point in these essays today is that the central points of that theory, which Dr. Wakefield communicated to me and I presented in the article, were not accepted by the Panel.

Four Arguments that Didn't "Wash"

Wakefield's theory of the case included four crucial elements: (1) that the study funded by Legal Aid in 1996, and which was the product of consultation between Wakefield and (Solicitor) Barr, was different from the study for which ethical approval was sought from the Royal Free Hospital Ethics Committee in 1996 (the "two studies" hypothesis); (2) that Professor Walker-Smith, the pediatric gastroenterologist in the case, had a sort of "blanket" ethical clearance to perform tests on the children, as long as they were "clinically indicated"; (3) that there were no rigid requirements or expectations requiring declarations of potential conflicts of interest when Wakefield and others submitted their article to the Lancet in 1997; and (4) that encouraging children at his son's birthday party in 1999 to donate blood was only a de minimis or minor (and perhaps even humorous) breach of professional ethics, for which no sanction was warranted.

(1) The Panel found that there was only one study or project, and that project was the one funded by Legal Aid and the one for which Wakefield and others sought ethical approval from the Royal Free Ethics committee in September 1996; this approval was not officially granted and communicated until early 1997. It was Project 172-96. Wakefield's team had pointed to Project 162-95 as the basis for its ethical approval. Though the Panel rejected that the investigations forming the basis for the Lancet article were covered by Project 162-95, on page 3, it doesn't provide reasons for this. Perhaps it was so obvious to them that it didn't call for comment. Indeed, this Internet posting helpfully gives text and the scope of 162-95. But since everything else called for detailed comment, I would have expected, even if the claim were patently fatuous, for the Panel to have pointed out why that was so..

The reason why this is a crucial factor is that it is/was in Wakefield's interest to try to separate the Barr/Legal Aid study and its connection with the vaccine litigation from his work for which he sought ethical approval. For, if they were one and the same study, any reasonable person would conclude that there was a responsibility to let the Ethics committee know of engagement with a Solicitor behind the study. You let people know this because there is a substantial possibility that if you are engaged in litigation that the data you are collecting might be collected to support or lend credence to the theory of the case that Barr was mounting-rather than simply for scientific purposes. Thus, if the "two study thesis" collapses, and it appears not only that it has in the mind of the Panel a heap of problems results for Wakefield. After further review of my article, however, I conclude that the two studies hypothesis is sound; there were two studies--the "Barr" study and the "Lancet" study. There still may be ethical issues with the "Lancet" study, but the conflict of issues interest, which would certainly be present if there was only one study, doesn't seem to be as damning against Dr. Wakefield as the GMC suggests.

If we adopted the GMC conclusion, that there was only one study, we both have a situation rife with potential conflicts of interest and an ethical approval process that only occurred after many of the subjects (children) were examined. And, indeed, the central part of the "case" of the Panel was that most of the 12 children in the Lancet study were investigated, scoped and treated before the ethical permission was granted to the investigators. That activity constitutes a recurring chorus through the report, that the children were seen before there was ethical approval for the study was secured.

If we have but one study, then there is a direct flow from Legal Aid funding to a vaccine litigation to the study that ended up in the Lancet. And, if this was the case, there would have been lots of incentive for Dr. Wakefield to "cut corners" in gathering subjects for the study. Indeed, that is what the Panel repeatedly found--that Wakefield at times was responsible for recruitment of study members, even while claiming that all the subjects came through "normal channels" to him.

(2) I didn't find any support in the GMC report for the concept of a "blanket" ethical clearance, which Dr. Wakefield mentioned to me was what allowed a lot of the work to go forward. This supposed "blanket" clearance for Dr. Walker-Smith would have included the kinds of procedures performed on many of the 12 children in the study. But if there was no such clearance, as I was led to believe, we must fall back on the only clearance that was given--the one arising from the Sept. 1996 application. And, as the Panel points out, most of the children were treated/examined before that approval was given. The question arises, however, that if all the tests on the children for the "Lancet" study were "clinically-indicated," why there was a need for ethical approval such as reflected in the submission to the ethics committee in Sept. 1996. I still can't solve that one to my own satisfaction yet..

3) This has been commented on in 1) and 2).

4) Then, his final point in his theory of his case was that causing to have blood taken from children at his son's birthday party only consisted of minor or de minimis violation, at worst an example of bad judgment. The Panel, however, was not in a lighthearted mood, and considered that in this act he "abused [his] position of trust as a medical practitioner" and, in such a way tended to "bring the medical profession into disrepute" (p. 55).

Thus, the GMC's report tried to cut the ground out from his attempt to segregate the Lancet study from the legal proceeding, to give a broader basis than the December 1996 ethical approval for the investigatory actions taken with the children before that time, to explain apparent conflicts of interest as not requiring disclosure, and to minimize the importance of causing blood to be drawn from willing children at a birthday party.

The next essay gives a few of the factual findings and then gives my comments on the case.

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