Wakefield Paper--Essay Ten

Our story is just about told. What we have learned is that the facts leading to 8 the publication of the 1998 Lancet article as told here are not simply a plausible explanation for Dr. Wakefield's conduct but also a more convincing explanation at every point than the explanation of his detractors. Was there a conflict of interest [i.e., not reporting on 55,000 Pounds of funding for the Lancet study]? No, because there were two studies. Was there unnecessary invasion of vulnerable children without ethical permission? Again, no. On the one hand, a "blanket ethical permission" existed for the senior gastroenterologist, Prof. Walker-Smith, and that permission extended to those who worked with the samples he gathered from the colonoscopies and other procedures. All the procedures were said to be "clinically indicated"--i.e., they would have been performed absent any interest in the subjects for a research study/case report. Clinically indicated studies need no special permission from the ethics committee. Finally, was Dr. Wakefield's work fatally flawed because he was engaged as an expert in a long lawsuit against the manufacturers of the MMR vaccine? Well, to answer this we just have to say that if having knowledge of an area, as well as a theory, makes one unable to work as an expert witness and retain one's job, then most expert witnesses from all trials would have to be eliminated.

Our story concludes with a brief synopsis of the cluster of fast-moving events from Feb. 15 (Sun) - Feb. 22 (Sun), 2004. On that latter date the story about Dr. Wakefield's alleged conflicts of interest appeared for the first time in the English press. By this time the MMR class action lawsuit had been "defunded," in bureaucratic language. Credit should be given to reporter Brian Deer for publishing many original documents in the case beginning in 2004 on his web site, even though his interpretations of many of these documents are often highly tendentious and sensational. There is no one more impressed with his own intrepidity than Deer himself. If he had been sympathetic to the notion of two studies, which is the basis of this paper, most of his allegations would have quickly disappeared. Perhaps that is why he wasn't sympathetic to it.

It was his story in the London Times on Feb. 22, 2004, followed by a detailed letter to the GMC the next day, that led to the subsequent charges being filed against Dr. Wakefield as well as the theory of the prosecution case before the GMC. Though a few of the events of the week preceding Feb. 22 have been related by Dr. Richard Horton, editor of the Lancet periodical, justifying his "breaking" of the story on Friday, Feb. 20, another version of the story is as follows.

On or about Feb. 15, 2004 Andrew Wakefield received a communication from reporter Brian Deer with a series of questions that Deer wanted him to answer in a short space of time. The tone of the questions was harsh; it was as if Deer had already made up his mind about his theory of the case (Wakefield had a conflict of interest by not declaring his Legal Aid funding to the Lancet ) and was simply giving Wakefield the "courtesy" of a response so that he could say that he had tried to consult him for the article. Wakefield, who was in Austin, TX at the time working on the details for the opening of Thoughtful House, where he now is Executive Director, knew immediately he had to drop everything and head back to England to get to the bottom of what was happening.

He arrived in London on Tuesday, Feb. 17 without documents or help of any kind and immediately set up an appointment with editors at the Times for Wednesday morning, Feb. 18. Present at that meeting were three deputy editors as well as the editor of the special section in which the article eventually appeared. They told him that the major problem he needed to resolve was his apparent conflict of interest--receiving 55,000 Pounds from the Legal Aid Board to do a study on children who were litigants in the class action lawsuit, not informing colleagues about the money, and then publishing the results in the Lancet . As you see, the questions resulted from a failure to separate Study One and Study Two. Wakefield answered the deputy editors and the special section editor, who had not only commissioned the article but was the son of a scientist who was on the committee that approved the Urabe strain of the MMR vaccine, which was recalled in 1992. One of the deputies had to leave the meeting, and, as the story got back to Wakefield after publication of the Feb. 22 story, the deputy thought there was unanimity among the editors that the story wouldn't run. Yet Wakefield had no inkling of this as he met with them. He simply explained himself the best he could. He had no idea if his explanation had any effect on the editors.

Then, having tried to put out that fire, Wakefield hastened over to the offices of Dr. Richard Horton for an afternoon meeting at the Lancet . He was accompanied by colleagues Walker-Smith, Murch and Harvey. Horton had had a meeting that morning with reporter Brian Deer, and Horton voiced Deer's thoughts from that morning to the assembled group. Wakefield again responded to Horton that there was nothing to the idea of a conflict of interest. Horton wasn't deterred. Well, he wanted to know, if there was no conflict of interest [the Lancet's conflict of interest standard in those days was as follows: "The conflict of interest test is a simple one: is there anything that would embarrass you if it were to emerge after publication and you had not declared it?"], could someone believe that Wakefield might have a conflict of interest? Could it be perceived that there was a conflict of interest? Wakefield thought that such a retreat by Horton meant that he was subtly shifting his ground. Was the standard an actual or a perceived standard? Well, round and round they went, inconclusively. Wakefield would later say that his weariness at the time, combined with the raw power of the assault directed against him, made that Wednesday one of the worst days of his life.

At the end of the meeting, Horton assigned tasks relating to Deer's allegations to Wakefield, Murch and Walker-Smith. Wakefield needed to answer the Legal Aid Board allegations, Murch had to deal with the ethics committee approvals and Walker Smith was to handle allegations concerning the clinical indications for the investigations. They were to "report back" to Horton by first thing Friday morning, Feb. 20. The three complied with Horton's demand. These answers were then published along with Deer's allegations and Horton's conclusion that there had been a conflict of interest on the Lancet's website before the London Times story appeared on Feb. 22.

On Friday afternoon, before the publication of the Wakefield-Murch-Walker Smith answers and Horton's statement, and thus before Wakefield really knew what was going to happen, he was pleased to receive a call from Horton, in which Horton said that he had the greatest respect for Wakefield and had no doubt about his integrity, and he admired the way that Wakefield had put up with a great deal in the previous few years. Wakefield was a bit bemused by the call but chalked it up to Horton's desire to extend a peace offering to him. He called his wife Carmel and mentioned the curious call from Horton. Immediately she responded, "Oh my God. What is he up to?" Sometimes males don't have the best intuitive instincts in the world.

Well, of course her worst fears were confirmed. Horton then called a news conference and announced that the 1998 Lancet study was fatally flawed because of the undeclared conflict of interest (the 55,000 Pounds from the Legal Aid Board) behind the Article. Horton admitted that the connection between GI distress and autism was certainly a live issue, but the interpretation given to the first part of the study, of the connection of the MMR to all of this, was "fatally flawed." Combined with these words at the news conference, the online version of the Lancet, published before the Feb. 22 Times story, as mentioned above, included the allegations made by Brian Deer along with the answers of the three doctors to these allegations and an overview of the issue by Horton, in which he also concluded that Wakefield had an undisclosed conflict of interest in writing the article.

Of course, once the cat was out of the bag, and once Horton heard the whodunit, the London Times had to publish the story, which it did it its Sunday edition on Feb. 22, 2004. Wakefield and his family were then besieged by reporters over the next several days.

During the week following the Feb. 22 article, Horton came up with the idea of extending an "olive branch" to Wakefield and the co-authors. This peace sign took the form of a suggestion that they could issue a "retraction," not of what they had written in 1998 but of the interpretation that had been placed on the article after the media frenzy of Feb.-Mar. 1998.

In other words, he was giving them a chance to back off from the study. Wakefield, predictably, said there was nothing to retract. But 10 of the 13 contributors to the Lancet article (excepting Wakefield, Peter Harvey and John Linnell) signed the following statement:

"Interpretation. We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers."

The retraction stated:

" We wish to make it clear that in this paper no causal link was established between (the) vaccine and autism, as the data were insufficient. However the possibility of such a link was raised, and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent."

We should pause for a moment to consider what is happening here the week after the Times story appeared (by the way, this "retraction" wasn't published by the Lancet until March 6, 2004, which was 13 days after the Feb. 22 story). Horton was clearly giving the authors of the article a chance to separate themselves from the article. But if you look at the words bolded immediately above, you realize how confused this whole process is/was. What Horton asked the authors to do was to retract an interpretation to the article. Interpretations come in two kinds--those of the data in the article itself and those extrinsic to the article. If the interpretation that there could be a causal link between the MMR and GI symptoms and autism was actually in the article, then it would have been possible for authors and co-authors to retract an interpretation. But what Horton was asking people to do was to retract an interpretation placed on the article by others--the news media, especially. How can they do that? How can they retract an interpretive statement that someone else made? Of course, you can't.

Some may have signed the "retraction" because of fear; others because they were mad at Wakefield for drawing them into this whole mess; others because they were saddened or even chagrined that the MMR vaccination rate had fallen in response to the article. In any case, these 10 signed the retraction. While this "retraction" process was underway, Wakefield, Linnell and Harvey wrote a detailed explanation of why they could not, in good conscience, put their names on the document. This letter was not published by the Lancet until April 17, 2004. The controversy was kept alive by periodic articles published on the case by Brian Deer between 2004 and the convening of the GMC in 2007. A decision of that Council, as mentioned at the beginning of this article, is expected sometime this year, more than 11 years after the publication of the Lancet article.

Conclusion

The aims of this essay are, in fact, relatively limited. My principal focus has been to examine the charges against Dr. Wakefield of financial conflict of interest, of having performed invasive procedures on children which weren't ethically approved, and of questioning the safety of the MMR because he was secretly trying to devise an alternative vaccine which would make him rich. In my judgment, none of the arguments made by critics stands up to close scrutiny. But in the final analysis all I am trying to do here is to clear the decks so that his scientific work can be dispassionately considered. After all, you would think that this would be the interest of most scientists in the first place...

http://briandeer.com/

His book on the subject, MMR Science and Fiction: Exploring the Vaccine Crisis (2004), appeared seven months after Deer's first article.

The series of events narrated here comes from Dr. Wakefield's memory and documents, and the story will be told in more detail in a book he is writing on his role in this controversy.

For example, Dr. Murch's statement on the issue is on this website: http://briandeer.com/mmr/lancet-murch.htm.

In the years between 1999 and 2003 many studies had been published which called into question any link between the MMR and gut disease or autism. As more and more studies came out to this effect, the crescendo against Dr. Wakefield began to build. Horton's words over the phone to Wakefield are to be understood in that context.

Playing of the title of Dr. Seuss's 1954 work, Horton Hears a Who. The point of that little children's story is a "person's a person no matter how small." Sage advice for this case.

This retraction of an interpretation was published in Lancet 363 (March 6, 2004), 750.

The text of this letter is here: http://briandeer.com/wakefield/retraction-reply.htm.

Indeed, Dr. Paul Offit, one of Wakefield's bitterest critics, did make a lot of money, in the eight or even nine figures, for patenting the rotavirus vaccine. One might have thought that one who hit the jackpot on such a venture would understand another person submitting a patent for a vaccine, even if that other person might have had little personal financial stake in the outcome.

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