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 son's birthday party, 32 healthy controls. And you line
them up - with parental informed consent, of course. They all get paid '5, which doesn't
translate into many dollars I'm 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.
07/08/2008.
