Wakefield Paper: Essay Nine

One of the allegations made by critics of Dr. Wakefield is that his motivation for opposing the MMR in the news briefing in Feb. 1998 and afterwards was that he had a financial stake in patent he was seeking at that time for an alternative vaccine which would compete with the MMR. This allegation was first made by journalist Brian Deer in Nov. 2004 and then picked up by Paul Offit in Autism's False Prophets in 2008. Offit states that Wakefield had "other financial interests" in opposing the MMR and that he was a co-holder, with the Royal Free Hospital, of the patent. In fact, Wakefield was not listed as one of the applicants in the June 6, 1997 application; almost all the royalties from whatever vaccine was to be developed would inure to the benefit of the Royal Free Hospital School of Medicine. The first applicant named on the form, then, was the Royal Free Hospital School of Medicine.

It is necessary both to put this patent application in historical context and then describe what it actually was designed to do. What no critic points out is that this patent application is the outgrowth of a March 30, 1995 letter Wakefield sent to administrators at the Royal Free Hospital proposing not simply the building of a new GI center at the School but that he, Wakefield, planned to develop "biotechnology to generate capital" to help fund that effort. In fact, there were several correspondences between Wakefield and the school administration at this point because the latter were upset regarding the magnitude of Wakefield's ambition for the center (its proposed cost was more than 23,000,000 Pounds). But Dr. Wakefield would do his part--by trying to develop some "biotechnology" in the form of patents that might raise substantial sums of money. This ambition of Wakefield dovetailed nicely with that of the Dean, Professor Zuckerman. Indeed, after securing the services of Professor Walker-Smith in 1996, and with the hoped-for visibility of the school in the wake of the 1998 Lancet paper, it seemed that everyone was "on the same page" in working for the enhancement of the Royal Free School of Medicine's reputation. Recall that Dr. Wakefield's promotion came exactly one month before the patent application.

The co-applicant on the June 6, 1997 patent was not Dr. Andrew Wakefield; it was "Neuroimmune Therapeutics Research Foundation." This imposing-sounding foundation was really the work of one man, the South Carolina immunologist Hugh Fudenberg. Wakefield wanted to include him on the application as a way of honoring his life-long work on "transfer factors," which lay at the heart of the proposed patent. This choice to include Fudenberg probably did more harm than good for Wakefield in the long run. Unbeknownst to him at the time, but rather easily discovered, was the fact that Fudenberg had been suspended from the practice of medicine in South Caroline in Nov. 1995 for "engag[ing] in the personal use of controlled substances and other drugs outside of a bona fide physician-patient relationship." Though his license had been restored by June 1997, he had significant limitations placed on his medical practice.

But some more words need to be said about money because of the allegations that Wakefield sought to and did actually profit handsomely from his patent application and expert work on the case initiated by Richard Barr. We know this isn't true with regard to the patent. It was never developed. A clinical trial of it was never held. With respect to his status as expert, however, things at first appear to look different. In documents released in Dec. 2006, Wakefield is said to have received 435,000 Pounds in his work on the lawsuit--making him the highest-paid expert in the entire case. This might be expected, since his work on Crohn's disease, the GI tract and the potential connection of the measles virus to the development of Crohn's disease was foundational for Barr's case. But a closer look at that 435,000 Pounds ($780,000) reveals less meets the eye. The court overseeing the litigation decided that it wouldn't award 100,000 of those 435,000 Pounds. Then, the Barr law firm decided to withhold about 35,000 after the highly critical Feb. 2004 stories about Wakefield began to appear. With the British tax of 40%, this brings his "earnings" down to about 180,000 Pounds for seven years of engagement in the litigation. From this he paid for a research assistant and then paid at least 100,000 Pounds to file and update the patent application. Decisions to file in jurisdictions as wide as America, Europe, England and Japan drained a good deal of the expert fee money he earned. Thus, at the end of it all, Wakefield didn't "get rich" on either the patent application or the expert fees he earned. Most of it was invested in ways that would hopefully benefit the School of Medicine and patients with intestinal disease.

Though a complete review of the patent is beyond the scope of this paper, a word should be said about the nature of the patent application. Was it actually for a competing vaccine? The patent application is quite difficult to read and make sense of for a layperson, since it seemingly has sentences suggesting the patent would be for a replacement vaccine, and other sentences emphasizing that it is vaccine/therapeutic agent which would ameliorate the potentially negative effects of a measles or MMR vaccine already administered . The quotation given by Dr. Offit in his book, which gives "replacement-type" language, appears in the section of the application relating to Crohn's disease. Dr. Wakefield stressed in my interview with him, however, that a basic knowledge of the immune system clearly pointed to the application's reference to what is called the "cellular" immune response--i.e., a response once a virus has already taken root in a person. The traditional measles vaccine injects a small and attenuated sample of the virus so that it would prevent the virus from taking root at all. The word "vaccine" is applicable both to injections that prevent the virus from taking root as well as those that root it out once it is in the body. Thus, Dr. Wakefield argues that the patent was not, in fact, for a competing vaccine to the measles or MMR vaccine. In addition, a transfer factor, which is what this vaccine would be, cannot work as a population-based vaccine because it can't stimulate the productive of protective antibodies, the cornerstone of any live viral vaccine.

If the British authorities had taken years to develop a good monovalent vaccine and years to struggle with developing a decent polyvalent vaccine, how would one lonely researcher, basing his work on the concept of "transfer factors" [which allow the "transfer" of an immunity from one source to another], think that he had developed an alternative vaccine? Such a person would be rightly dismissed by any clear-thinking scientist.

Offit, p. 47.

Ibid.

Letter of March 30, 1995, in Dr. Wakefield's possession, perused by author on January 15, 2009.

A copy of the patent application is here. http://briandeer.com/wakefield/vaccine-patent.htm

The Final Order suspending Fudenberg is here: http://www.casewatch.org/board/med/fudenberg/1995order.shtml . He was re-instated in 1996 but his authority to prescribe drugs was taken away from him.

I derived the following points from an my January 15, 2009 interview with Dr.
Wakefield. I saw the law firm billings on two large pink sheets from 2000 and 2001. A quick addition of the figures yielded nearly 100,000 pounds expended in legal fees for furthering the patent application.

The author studied some of the billing records from a prominent London patent law firm to Wakefield for their services in the late 1990s and 2000.

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