StATS: Conflict of interest in the Wakefield MMR study (created 2007-07-26).

An interesting case study in conflict of interest (perhaps a bit too complex to be described fairly in this brief weblog entry) involves a controversial paper. The lead author of this paper

Wakefield A; Murch S, Anthony A, Linnell J, Casson D, Malik M, Berelowitz M, Dhillon A, Thomson M, Harvey P, Valentine A, Davies S, Walker-Smith J (February 28 1998). Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children 637-641. The Lancet - Vol. 351, Issue 9103. DOI:10.1016/S0140-6736(97)11096-0 [Medline] [Abstract] [Full text] [PDF]

is Andrew Wakefield. Dr. Wakefield has alleged on the basis of twelve children referred to his clinic that there was a link between the MMR vaccine and the development of autism. One of the recent controversies about this study was whether they were referred to him for treatment, which he later summarized in a research study or whether they were recruited for the purpose of conducting research on them. There's a subtle distinction between the two, but it is an important one. If Dr. Wakefield's intention was to perform research, then he would need to seek approval from an Institutional Review Board before approaching those patients. If his intention was to treat them, and only afterwards did he realize that these 12 cases provided information that would be of interest to the research community, then he could seek approval prior to collating the data on those 12 cases, but this could occur after the treatment itself.

Another serious issue raised is whether Dr. Wakefield had a financial conflict of interest at the time of publication of the 1998 Lancet article. He held a patent for an alternative vaccine, one that might become used more frequently if the MMR vaccine fell into disfavor. There are also allegations that a UK attorney who is suing MMR manufacturers supported research resulting in the Lancet article.

There is nothing wrong with commercial interests per se. If you have a new medical product that you believe to overcomes some of the limitations of another medical product currently being used, you can and should publicize any data that would discourage the use of the current product. And if you are trying to sue manufacturers of a medical product that  you believe has harmed some of your clients, you can and should pay for information that would bolster your claim in a court of law. The problem is not the financial incentives, but rather the failure to disclose them. Anyone reading the Lancet article needs to know whether there were some financial incentives that could potentially influence the research.

It is worth noting that many of the parents of the children treated by Dr. Wakefield are strong supporters of his work and characterize the current inquiry into ethical problems with the Lancet article as a "witch hunt."

The current controversy has not been resolved, and even after a final decision is made in the current review, it is likely that disputes will continue over what exactly happened.

There are numerous resources on the web about the current allegations. Brian Deer has written a series of articles for the London Times and a documentary for BBC Channel 4 that is sharply critical of the conduct of Dr. Wakefield. I will try to summarize some of these resources and others when I have time.

One particular webpage, however, deserves special mention, because it lends itself so well to a visual description. Apparently, Dr. Wakefield was telling a story, with the intent of entertaining his audience, of how he got some of his control samples of blood. It was at his son's birthday party.

"...but this is again my sonís birthday party, 32 healthy controls. And you line them up - with parental informed consent, of course. They all get paid £5, which doesnít translate into many dollars Iím afraid. But, and, they put their arms out and they have the blood taken. All entirely voluntary. [laughter]. And when we did this at that party, two children fainted, one threw up over his mother [laughter]." briandeer.com/wakefield/birthday-blood.htm

This apparently is a direct quote from Dr. Wakefield, though he later points out that he was exaggerating, perhaps to make the story sound more humorous. There is a sharp divide between Europe and the United States on whether it is appropriate to pay children to help out in a research study that does not directly benefit them. Even if you ignore this issue, the setting of the research study was inappropriate for a variety of reasons.

This page was written by Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Children in research, Category: Conflict of interest, or Category: Ethics in research.