Wakefield Paper: Essay Six

By mid-summer 1996, then, we have two efforts proceeding independently of each other. Study One refers to the protocol being drawn up by Dr. Wakefield at the urging of Solicitor Barr; Study Two was the clinical study, with research support from Dr. Wakefield, developed primarily by Prof. Walker-Smith. Let's leave Study Two here now, with its method and ethical approval secured, in Jan. 1997, and return to the work that Dr. Wakefield was doing with and for Richard Barr in the class action lawsuit contemplated against the vaccine manufacturers.

You recall that Dr. Wakefield signed on to work as an expert for Mr. Barr shortly after the Feb. 1996 phone call. In the first instance he needed to develop the protocol for a study designed to determine, in the first instance, whether the measles virus was present in biopsied tissues. Subsequent studies would be necessary to determine if there might be a causal relationship between the administration of a vaccine and the development of severe GI symptoms and, possibly, autism or Crohn's disease in the children. Wakefield submitted a draft of this three-page document, written in lay language and entitled "Proposed protocol and costing proposals for testing a selected number of MR and MMR vaccinated children," to Barr in June 1996. This "Proposed protocol" called for an examination of 10 children, all of whom had GI problems. Five of these 10, in addition to having GI problems, also had developed autism; the remaining and five had developed Crohn's disease. Specifically, Dr. Wakefield would analyze the biopsies already taken for clinical trials and, as ethical approval allowed, look for the presence of measles virus in the biopsies. If that virus was present, a case might begin to be made for the causal relationship between the virus and the GI and/or the autism/Crohn's conditions. With this proposal came a request for funding for the study--55,000 Pounds, 25,000 of which would fund a technician's position and the rest would be used to defray the costs of clinical examination of the tissues.

So, in June 1996 this brief proposal was forwarded to the Legal Aid Board. But it was also thought important to give the Legal Aid Board a deeper scientific understanding of the process by which Wakefield would be looking for the measles virus, so that whichever science advisor the Legal Aid Board used in examining its applications would know of his method in so doing. The only easily accessible place where the description of how to look for the virus was in a rough draft of the ethics proposal that was eventually to be submitted to the Ethics Committee in Sept. 1996 for Study Two. That is, in order to seek ethical approval for the three new procedures that Dr. Wakefield wanted to add to the clinical protocol for Study Two developed by Prof. Walker-Smith, they decided they had to let the Ethics Committee know about the full scope of the study. Indeed, you can look at the final document actually submitted to the Ethics Committee for ethical approval of additional procedures for Study Two in the footnoted document. You can easily tell that this is a "Study Two" document because it lists all the professionals needed to do the study, which precisely corresponds to the professionals who appear as contributors to the Lancet paper.

In June 1996 this "Clinical and scientific study" was in a rough-draft form, but it contained, by way of an appendix, a description of the methods to be used for determining the presence of measles virus in a biopsy. So as fully to inform the Legal Aid Board, Solicitor Barr submitted this appendix as a separate document along with the "Proposed protocol and costing proposals." But mistake and confusion were introduced here because what actually was submitted to the Legal Aid Board was the entire rough draft of the "Clinical and scientific study." Thus, a confusion that ultimately must rest somewhere in Wakefield's camp, was introduced. Instead of having the basic three-page protocol and costing proposal, with a five or six page description of how to look for the measles virus attached to it, two documents were submitted. Thus, you have both a Study One and a Study Two document submitted to the Legal Aid Board in seeking the 55,000 Pounds.

This state of affairs obviously confused not only those who have reported on Wakefield's case but also the Barristers (prosecutors) in his case before the General Medical Council. For, if you check out the charges laid against Wakefield, you have as background the submission of two documents to the Legal Aid Board in June 1996, respectively entitled "Proposed Protocol and Costing Proposals" and "Proposed Clinical and Scientific Study."

When you look at the names of the two documents sitting side by side with each other, your first reaction is, even if they were for the same study, "why is anyone submitting both of these documents for funding?" They appear redundant in part, and the second appears to provide much more detail than the Legal Aid Board required. In addition, there is some confusion in numbers between the "Proposed protocol" and the "Proposed Clinical and Scientific Study." The former called for 10 subjects and the latter for up to 25. No one would have thought that 10 becomes 25 in the same document. But an honest investigator of his case could be forgiven for concluding that these two documents, submitted together to the Legal Aid Board in June 1996 constituted just one study . In fact, they reflect two different studies; the second one was just improperly appended or, alternatively, was appended without a clarifying letter to the Legal Aid Board. There was no explanation given to the Legal Aid Board to "ignore" most of the "Proposed Clinical and Scientific Study." The only thing said at the beginning of the "Proposed protocol" was "A protocol giving the detailed technical specification is attached."

From the perspective of hindsight, this is an error, a confusion unnecessarily brought into the process. But, when you consider life from the perspective of 1996 and the haste with which things needed to be done (and often are done by all of us in life), you can understand how documents from two separate studies would be placed together, without precise delineation of why the material from the second study is included.

Wakefield Paper: Essay Six

4. Reconciling and Explaining the Two Studies