Wakefield Essay Four

An explanation needs to be provided regarding what Dr. Wakefield was signing onto in 1996 and why, indeed, it was a cause that arose in the mid-1990s. A confluence of three factors, from 1988-1994, created the conditions that led to Barr's approaching him early in 1996. They were: (a) the passage of a 1987 law which enabled class action suits like this to go forward; (b) the consolidation of what we might call "legal aid" into one national board with lots of money to support class action suits; and (c) the spotty vaccine record in England following the introduction of the MMR vaccine in 1988 as well as the controversy over a MR (measles-rubella) re-vaccination campaign promoted by the government in Nov.-Dec. 1994. In other words, the lawsuit which he was invited to join was something that probably would not have arisen had the legal, financial and vaccinological ground not been plowed in the previous several years. A word about each of these is appropriate.

The possibility of litigation against vaccine makers in England had effectively stalled by 1988 due to some adverse court decisions against plaintiffs. The reason it was so difficult to provide vaccine-maker liability for vaccine injury in the 1980s was that a central principle of tort law, the concept of vaccine-maker negligence, had to be demonstrated by a preponderance of the evidence. This meant that in order for a plaintiff to make a case successfully, s/he had to show that the vaccine makers were aware of the risks facing the vaccine, that they chose to ignore these risks, and that the damage resulting from ignoring these risks resulted in injury to the child. It is a rather steep hill to climb, and one that plaintiffs ultimately were unable to climb. Until, that is, the passage of the Consumer Protection Act ("CPA") in 1987. This act allowed for suits against "producers" of products (vaccines, of course, would be included here) but, significantly, the act lowered the quantum of evidence needed to establish liability. Instead of the traditional concept of showing negligence, the statute envisioned a regime of what is known as "strict liability." Here a plaintiff only needed to show two things: that an injury had been caused by the vaccine, and that the vaccine was "unsafe." One didn't have to try to get into the corporate decision-making process or mind-set of the vaccine-makers, even though evidence regarding their culpability would be helpful in making the case. Thus, new life was breathed into the concept of class actions regarding potentially dangerous products that consumers might use.

Second, legal aid services in England, which had been in existence for 40 years prior to the late 1980s, were now consolidated under one Legal Aid Board (renamed the Legal Services Commission in 2000), which would be the funding mechanism for those interested in pursuing class action suits, such as suits that could be brought under the CPA of 1987. As a site, entitled "Legal Aid: A History," says:

Contrary to the reality in most class action suits in the United States, where plaintiffs' attorneys work on a contingency-fee arrangement and don't usually see any money at all until the case is resolved in favor of their clients, the concept behind the Legal Aid Board in England was different. The Board administered a fund which could be tapped into through an application process by attorneys who sought to bring class action suits. Thus, the attorneys would be "paid as they went along" rather than paid only if the action was successful in the end. There are virtues and drawbacks, of course, to both systems, but the pay as you go system had just been implemented through the Legal Aid Board in England. In fact, the suit pursued by Barr against the vaccine makers was the first big class action lawsuit funded by the Legal Aid Board after its formation in 1988. Inexperience by the Board or, more charitably expressed, initial growing pains in understanding its role, led to expenditures in the case brought by Solicitor Barr that topped 14,000,000 Pounds (about $25,000,000) by the time the case was actually dropped late in 2003. It truly is an astounding amount, when you consider that no one allegedly injured by a vaccine ever received a dime for bringing the case. Most of the money was spent on legal counsel, expert witnesses and laboratory expenses.

Third, England had a rocky recent history in the administration of the vaccines that are crucial to our story. The measles vaccine by itself (the "monovalent") had been introduced in 1968, with a rubella vaccine following it a few years later and administered especially to girls or women in child-bearing years. The super-duper MMR (measles-mumps-rubella vaccine, the so-called "polyvalent") was brought online in England in 1988. It had originally been licensed in the USA in 1971, introduced in the USA in the early 1970s and in some other countries in the early 1980s. But the introduction of the MMR in Britain was attended by some difficulties. In 1992, after only four years of administration, two of the three MMR vaccines (Immravax, made by Merieux UK and Pluserix, made by Smith Kline Beecham), both of which contained the Urabe strain of the mumps vaccine, were withdrawn from the market because authorities concluded that children faced an increased risk of contracting meningitis through these vaccines. Only the brand made by Merck & Co (MMR II) was unaffected. MMR administration continued, of course, with assurances from public health officials that the remaining brand of vaccine was perfectly safe, but it certainly was not lost on the nation that there might be a problem with the MMR. The MMR vaccination rate in England began to fall in 1995, and continued falling for nearly a decade. Then, in Fall 1994, an urgent health warning was given that would require the re-vaccination of seven million English children, aged 5-16, using the MR vaccine. Why? Mathematical modeling convinced the Department of Health that without such a dramatic national campaign there might be a severe outbreak of measles in 1995. It was called a "re-vaccination" campaign because the children had already, at a younger age, been vaccinated, depending on their age, with the measles vaccine or with the MMR. This massive re-vaccination took place in Nov.-Dec. 1994.

Now, as we fast forward to January 6, 1996, when Dr. Wakefield first met Solicitor Barr and his assistant Kirsten Limb, we know that the meeting took place under the shadow of all of these events. Re-vaccination had just taken place. A new and more powerful law was set to "help" plaintiffs' attorneys and class action litigants. Money was available. Uncertainty regarding the safety of the vaccines was "in the air." And, finally, parents had begun to call Mr. Barr in great numbers, when they heard that he was the one who was taking up the cause of those potentially injured from the administration of the measles or the MR (the MMR followed later, as the legal case evolved).

Why, you may be asking, had Mr. Barr contacted Dr. Wakefield about this in the first instance? Dr. Wakefield was, at this time, a 39 year-old medical academic, who had already distinguished himself in gut surgery but who only had a relatively short tenure (seven years) by that time as a researcher and writer. His position, Senior Lecturer, is equivalent to the early stages of "Associate Professor" in an American university. Two studies, a 1993 paper entitled Evidence of Persistent Measles Virus in Crohn's Disease," and a 1995 paper entitled "Is Measles Vaccine a Risk for Inflammatory Bowel Disease?" launched his public visibility. The latter did so especially because it was published in the Lancet. America has no medical journal precisely equivalent to Lancet, which is a medical magazine both for the medical researcher and "generalist" physician but which also, at the same time, reports on ground-breaking discoveries or hypotheses that challenge the accepted consensus of the medical community. Like the medical instrument to which it points, the Lancet sought to "lance" some of the "boils" of medical knowledge and practice that needed urgent attention.

In the 1995 article Dr. Wakefield, along with his co-authors, explored the enigma of Crohn's disease, which had fascinated him since his undergraduate days at St. Mary's Hospital (University of London) in the late 1970s-early 1980s. Crohn's is a disease of the gastrointestinal tract that "shows up" with clustered cells, called granulomas, anywhere in the GI tract and, as later discovered, elsewhere in the body. The mystery of the origin and growth of these granulomas thus had occupied his mind for quite some time. In this 1995 Lancet article he advanced a hypothesis that the persistence of the measles virus in a person, either through introduction of that virus through the vaccine or through its naturally-occurring presence, may be a causal factor in the emergence of these granulomas and of Crohn's disease. This persistent virus might be stimulated by an unidentified factor or trigger that could develop into the full-blown and devastating Crohn's disease.

One source of measles virus in a person was the administration of a measles vaccine. Hence, if Barr was going to sue vaccine-makers on the safety of vaccines, he needed to get hold of a man who had spend most of his time, both in surgery and in academic medicine, thinking about the possibility of how the persistence of a virus in a person might precipitate developmental problems in children. While Crohns' disease was the focus of their first conversation, Barr became convinced that Dr. Wakefield possessed the requisite knowledge of vaccines and was already sympathetic to the role that vaccines might play in leading to debilitating problems, especially GI and developmental problems, in children. In fact, in the years immediately preceding this Jan. 1996 meeting, Dr. Wakefield had written a nearly 250-page unpublished review of everything he could find on the safety of the measles vaccine.

So, armed with this insight, and with Wakefield's assent to work with him, Barr then asked him two further questions. Would Wakefield be willing to do the same kind of vaccine safety study for the MMR that he had done for the measles vaccine? And, would he be willing to draft a proposed study protocol that would determine, first of all, if measles persisted after administration of these vaccines and, second, if the persistence of this virus could lead to GI problems and perhaps even to Crohn's or autism? In other words, Barr's interests were in trying to build what in law is called the "causal bridge" between one thing and another. In the first instance he was interested in building that bridge between vaccine administration and GI problems but, with Wakefield's work on Crohn's disease, he was further interested in the possible "causal bridge" between the GI problems and autism and/or Crohn's disease. And, again, you should know one more thing about plaintiff's lawyers. The purpose of encouraging this kind of thinking was to help in the building a "theory of the case"--a way of approaching the data that eventually might result in a financial recovery for clients.

Dr. Wakefield said that he could develop a protocol for such a trial/study and that he would be interested in updating, or expanding, his vaccine-safety report. I will refer to this trial/study as Study One (or "First Study"), and it would lead to an application to the Legal Aid Board for funding in June 1996. I will turn to a more detailed explanation of Study One below. But, we must raise a different question at this point. Is there anything wrong with what Dr. Wakefield has done so far? Or, to be even more precise, has he compromised his integrity as a scientist or his ethics as a medical professional by agreeing to meet with Barr, by agreeing to work with him or by agreeing to design the aforementioned study? The answer is a clear and unequivocal "No." Not only is there nothing wrong with this picture so far, but this is precisely the way that experts are recruited by plaintiff's lawyers all the time. The lawyer needs expertise. S/he needs the expert to conduct a study that arises out of the expert's field of study, and that study must be able to show, or at least elucidate, the problem that the lawyer wants to address. Is there anything degrading, unethical, or improper in being such an expert? Only if you think that the legal "system" is so corrupt that any participation in it you are tainted by it. But very few people take that position.

Thus, by Spring 1996 Dr. Andrew Wakefield was an expert in a case that was still in its infancy. The full contours of his involvement were not clear by this time, but he now had two clearly identifiable tasks. But even before he agreed to help Barr on the case, he began receiving phone calls from parents and others who had read his 1995 Lancet article. The evolution of those calls and how that affected Dr. Wakefield back at the Royal Free Hospital is where we now turn.

A helpful primer on Crohn's is: http://digestive.niddk.nih.gov/ddiseases/pubs/crohns/

Dr, Wakefield offered me a copy of this study on the safety of the measles vaccine when I interviewed him. I politely declined his offer.

A helpful and easily accessible history of administration of vaccines in England is "Evolution of Surveillance of Measles, Mumps, and Rubella in England and Wales," Epidemiologic Review 24 (2002), 125-136, reprinted on the Internet at:

A few words on MMR history are here: http://www.mmrthefacts.nhs.uk/library/whatinfo.php

I will say more about the range of possible defendants below, since it is an important point in understanding the Fall 1996 reaction of the Royal School of Medicine's Dean, Professor Arie Zuckerman, to Wakefield's securing 55,000 Pounds from Legal Aid for a study.

Wakefield Paper: Essay Four