Wakefield--A Sample of the Factual Findings

The GMC Panel arranged its 55 pages of factual findings in the Wakefield case under 43 separate "headings" or topics. These factual findings will be addressed by counsel at an April meeting of the Panel, and then, probably within a few months after that, it will reach its decision on whether the findings of the Panel constituted serious professional misconduct. Using a litotes, however, the Panel concluded that these findings "would not be insufficient to support a finding of serious professional misconduct."

In order to get the flavor of the findings, let's get the "flow" of the facts. The way they introduce them is to make a statement, and then say whether it was "admitted and found proved" or "found proved" (which means that Wakefield didn't admit it) or "not found proved" (which means there wasn't a sufficient quantum of evidence supporting it). The standard for finding a fact proved is beyond reasonable doubt--which is the American criminal law standard. Thus, anything that the Panel concluded was "found proved" is something on which they are banking their considerable reputation. It isn't just "more likely than not" that it happened.

There are, as I said, 43 categories of facts. Some are more important than others for the final findings; I will highlight a few as I go along.

1-2 are simply about his background and professional competence. One of the facts in # 2 was "found proved"--which meant that he opposed it. It is that his position as an "Honorary Consultant in Experimental Gastroenterology," meant that he had no authority to be involved in a clinical management role with patients (Fact 2). We know why he opposed this conclusion--since he made clinical judgments or ordered tests, according to the Panel, in several instances.

3. This fact cluster is important because it describes the relationship with attorney Richard Barr and the request to the Legal Aid Board to fund a study on children who had three characteristics: (1) been vaccinated with measles or MR (but not MMR) vaccine; (2) had disintegrative disorder; and (3) had GI symptoms. But the problem begins in Fact cluster 4, for here the Panel concluded that the money actually secured for the Barr study, 57,000 Pounds (total), was not all spent by Wakefield for the purposes it was requested. This related to the second installment of 25,000 Pounds. But there also was a problem in that some of the money requested for lodging of children, GI scopes and MRI's was actually paid by the Royal Free Hampstead Trust. Thus, the Board found that Wakefield played a little fast and loose with the cash, though none of it went to his own pockets. The Panel concluded that this action was both misleading and dishonest. It gives no indication of how "serious" this was. Nor does it say whether this seemed to arise more from sloppiness than of willful attempts to shuffle funds from an approved use to another (staff salaries).

5. Things begin getting bad for Wakefield on this cluster, for here we are taken through the ethics approval process for the study that would eventually end up in the Lancet in 1998. The study for which they sought approval had almost the identical three elements as the ones for Barr (5c). This was significant for the Panel, allowing them to conclude (in fact cluster 7), that the Barr study and the Ethics Committee study were, in fact, the same study. There weren't two studies going on here.. A crucial point. Another crucial point was that this proposal said that the patients would be seen as "part of normal patient care" and that all actions performed on the children would be "clinically indicated." After some give and take with the Ethics committee, a letter was sent out on January 7, 1998 saying that the project was approved, but only patients enrolled after Dec. 18, 1996 would be considered in the trial. Wakefield and others accepted those terms.

Right here we have the three major problems. First, both studies required that the subjects have the same or very similar three-pronged problems: have been administered the Measles or MR vaccine, have disintegrative disorder, and have GI problems. Second, the children in the trial had to be examined after December 18, 1996. Third, the children had to have a clinical need to be examined; research interest would not be sufficent. In addition, the Panel concluded that Wakefield had an ethical duty to disclose the fact that he was working for Solicitor Barr at this point.

I stress these three problems because these are the primary way that Wakefield was found to have been dishonest or have acted contrary to the interests of the child.

For example, at least 22 of the remaining 35 or so Factual clusters are taken up with going through 10 or 11 of the children who were the actual subjects for the Lancet study. The Panel would state in one cluster the facts concerning the way the child got into the study and in the second cluster the way that some of these facts constituted a breach of duty or dishonesty or how certain actions went beyond Wakefield's role as a Responsible Consultant for the project. The two things which were most frequently cited are that the child was treated before the Dec. 18, 1996 date and that the child didn't have all of the three requisites for being in the study. Several of them, for example, were vaccinated with the MMR instead of the MR.

These may not sound like huge matters, and indeed, they may be more indicative of just sloppy or hasty work (i.e., scoping a person a month before the ethics permission was actually granted, even though it may have been after the ethics proposal was submitted) than of willful or malefic intent. But the Panel findings also list a number of times where Dr. Wakefield did two things that went beyond this. First, he was responsible for recruiting several of the children for the study, and some of these children had autistic symptoms, rather than disintegrative disorders. In other words, it seemed as if the research design changed mid-stream, when autism, which was becoming more of a household word in the mid-1990s, was brought in. Ultimately Wakefield has become known for probing the issue of a connection between the MMR and autism; this may have been the beginning of his interest. But it clearly violated the terms of the study for which he was given ethical approval. And, it had another bad effect. Since the autism interest seemed to grow, there was more of an incentive for Wakefield to try to make research, rather than clinical need, the basis of the work. In many instances the Panel charged him with doing precisely that.

Then, there is the matter where he actually was the doctor signing off on several of the tests to be administered to some of the children, when this went beyond the scope of his responsibility at the Hospital.

Conclusion

There are other factual clusters which would repay consideration, expecially those relating to the representations made in the Lancet article. But when you put this all together, you have three strategies Wakefield might pursue that emerge from the Panel's fact-finding--strategies that have to be going through his lawyers' and his mind now.

One strategy might be to accept the conclusions of the Panel but argue that in Wakefield we have a doctor who was just hasty, and sometimes careless, in what he did. By not taking counsel at crucial times with senior colleagues or exploring the meaning potential conflicts of interests or noting specific requirements for handling money or waiting until the ethical clearance actually is "in hand" before rushing ahead to the study, he was negligent. This is one approach. These kinds of "limitations" or "requirement" might have been seen as unnecessarily intrusive for a bright and ambitious 38 year-old doctor. This "reading" of his conduct then stresses his naivete and haste, and his "dishonesty" is perhaps the result of trying to do too much at once. One approach, then, is to admit negligence.

A second strategy is to take issue with some or all of the Panel's findings or, more specifically, try to resurrect some of the four major points, discussed in the previous essay, where the Panel undercut his case. I don't know how successful he would be in this.

A third strategy is to confess to many of the allegations, admitting actually that they were the product not just of neglect but of actual error and overreaching. In this regard I think the birthday party event, however small it appears, needs to be "fessed up" to. The Panel said this was the crowning instance of his "callous disregard" towards other people and processes. Agreeing with them on this point, and, as it were, falling on your sword, may not be the easiest thing to do but it may be the right thing to do. It may be right especially because Wakefield has repeatedly stressed in the last few years that he is only doing what is best for the children. Admit, then, that you made a mistake. They may still strike you from the list, but confession is sometimes the best thing to do.

I am not going to make a choice or recommendation on which strategy to pursue, but I would say that his virtue will not grow for me, or for many, if he just digs his heels into the ground on this one. Perhaps, however, he feels that he has gone too far and any kind of fault admission now will be harmful to his image (as well as not possibly true). Admission of some things, however, probably still won't save him from being struck from the list, and it may disappoint his followers, but it is probably best for the soul.

4272