Wakefield accused of scientific fraud at US test cases of MMR allegations

This page is material from the award-winning investigation by Brian Deer for The Sunday Times of London, the UK’s Channel 4 TV network and BMJ, the British Medical Journal, which exposed vaccine research fraudster Andrew Wakefield | Investigation summary

In February 2009, four days after a Sunday Times report by Deer exposing discrepancies between a paper published by Andrew Wakefield in The Lancet and the true records of children in that paper, special masters in US federal courts handed down judgments on the anti-vaccine campaign. Below is an extract from the judgment of special master George L Hastings, in which he highlights allegations against Wakefield during test case hearings. Evidence from Wakefield disciple Arthur Krigsman was also considered

HASTINGS (In Cedillo v Secretary for Health and Human Services): In his expert report, Dr Krigsman indicated that he sees a causal connection between the MMR vaccine and a disease category that he described as “autistic enterocolitis.” And at the evidentiary hearing, Dr Krigsman again used the term “autistic enterocolitis” to describe the disease category that he believes to be MMR-caused.

Indeed, Dr Krigsman’s use of the term “autistic enterocolitis,” along with his assertion that Michelle Cedillo’s illness is a “classic” case of “ASD-GI disease,” perhaps might create the impression that “autistic enterocolitis” is a recognized disease category, accepted by the medical community. That, however, is not the case.

To the contrary, Dr Hanauer, very experienced in the specific area of inflammatory bowel disorders, testified that the term “autistic enterocolitis” is not utilized in any gastrointestinal textbook of which he is aware. Similarly, Dr Gershon stated that both the terms “autistic enterocolitis” and “ASD-GI” are not recognized by “gastroenterologists as a scientific community.” Dr Fombonne and Dr MacDonald both testified that there exists no evidence to support such a diagnostic category. And Dr Krigsman himself admitted that two leading textbooks on gastroenterology, which he acknowledges to be authoritative, do not use the terms “autistic enterocolitis” or “ASD-GI.”

Thus, it is clear that the diagnostic category of “autistic enterocolitis,” developed by Dr Wakefield and adopted by Dr Krigsman, is not a medically-recognized category. In fact, the record indicates that the term “autistic enterocolitis” evolved from Dr Wakefield’s above-mentioned 1998 article; the term appears in several articles published over the following years by Dr Wakefield and a small group of his followers. One such article using the term “autistic enterocolitis” was published in 2000 by Wakefield and colleagues. And it is clear that Dr Krigsman, in developing his causation theory, was influenced by those articles. For example, Dr Krigsman testified that his initial idea, that autistic children with gastrointestinal symptoms might be suffering from IBD, was triggered when he read that very Wakefield 2000 article.

Given that Dr Krigsman’s general causation theory was influenced by the “autistic enterocolitis” theory developed by Dr Wakefield and colleagues, it is fair to note that Dr Wakefield’s “autistic enterocolitis” theory, and his credibility in developing the theory, have come under severe criticism. For example, see the discussion at pp. 123-25 above concerning various committees of medical experts who have considered and rejected Dr Wakefield’s causation theory. Further, respondent’s experts in this case provided much testimony relevant to the credibility of Dr Wakefield’s procedures in developing his theory.

For example, Nicholas Chadwick in 1996 was a Ph.D. student working in a London laboratory for Dr Wakefield, performing PCR testing for measles virus. Chadwick’s interactions with Dr Kawashima’s laboratory, which was collaborating with Wakefield in the area of measles detection, convinced Chadwick that Kawashima’s positive results in measles virus testing were “false positives,” the result of contamination. Chadwick related that conclusion to Dr Wakefield. Nevertheless, Wakefield submitted for publication a manuscript relying on the purportedly positive results from Kawashima’s PCR testing. Chadwick asked that his own name be taken off the manuscript, because he was not comfortable with the data.

Dr MacDonald described the Wakefield 2000 article as “deception”, in two respects. He opined that the article deliberately described normal findings in the intestines of the autistic children as “pathology”--i.e., abnormality indicative of disease--in order to create the false impression that the autistic children had much more intestinal pathology than the non-autistic children in the study. Dr MacDonald also testified that the article misrepresented a photograph of a child’s cecum (a part of the large intestine) as being a photograph of the child’s ileum (a part of the small intestine). He opined that it was “highly unlikely” that this misrepresentation was a mistake, as opposed to deliberate deception.

Dr Rima described an interaction with Dr Wakefield, in which he informed Dr Wakefield of a specific contamination error in Wakefield’s measles detection efforts. Dr Wakefield, however, did not retract his claim that measles material had been identified.

Further, as noted above, after public criticism of the “autistic enterocolitis” theory, ten of Wakefield’s twelve co-authors on the original 1998 article published a letter in which they formally “retract[ed]” the causation interpretation suggested in the original article. At the same time, the British medical journal that published the 1998 article, the Lancet, reviewed allegations of impropriety by Dr Wakefield and his co-authors in the submission of the article. The Lancet editors noted that some of the children described in the article were also part of the legal action against the vaccine manufacturers, in which Dr Wakefield was also involved. The editors concluded that this circumstance constituted a financial conflict of interest by Wakefield, which Wakefield should have disclosed to the Lancet, but did not.

Dr MacDonald, indeed, went so far as to opine that Dr Wakefield’s “autistic enterocolitis” theory was merely an “invention” created for litigation purposes. Similarly, Dr Rust summarized Wakefield’s process of developing and disseminating his general theory, and described it as “scientific fraud.”

To be sure, the petitioners in this case have stressed that they rely upon Dr Krigsman as their expert concerning the causation of GI symptoms, not Dr Wakefield. Thus, they argue that criticisms of the personal integrity of Dr Wakefield are not relevant here. However, because Dr Krigsman’s general causation approach clearly was strongly influenced by Dr Wakefield’s theory, criticisms of Dr Wakefield’s “autistic enterocolitis” theory are relevant, and criticisms relating to Dr Wakefield’s credibility in developing that theory are of relevance as well. Therefore, it is a noteworthy point that not only has that “autistic enterocolitis” theory not been accepted into gastroenterology textbooks, but that theory, and Dr Wakefield’s role in its development, have been strongly criticized as constituting defective or fraudulent science.