Thursday, October 25, 2007

Conflicts of Interest Rife at IOM? Maybe Not

One of the writers whom I have relied on in the past is Merrill Goozner, who works with Center for Science in the Public Interest and wrote an important book on the drug industry, The $800 Million Pill, exposing the inflated claims made by the companies for their costs of doing research. He maintains a list called "GoozNews" for his personal views. So when I read his concerns about a new conflict of interest panel being assembled by the Institute of Medicine, I took notice:

http://www.gooznews.com/archives/000842.html

The prestigious IOM appointed a 15 member committee to produce model guidelines for dealing with conflicts of interest with industry. The committee, Goozner noted, was charged with developing guidelines that would not interfere with industry relations. So right away Goozner smelled a rat. The rat got more odorous when he discovered that 3 members of the committee had to have waivers to be allowed to sit on the panel due to their own ties to industry.

Goozner went on to give a list of prestigious members of the IOM who were not invited to serve on this committee despite having written important works on conflict of interest with industry, such as Jerry Kassirer, author of On the Take. (He left me off the list but that is neither here nor there.) Why, he asked, were IOM members known for their expertise on COI not appointed to the committee, while those known to be in bed with industry were?

While I was initially alarmed, I decided to check out Goozner's link to the committee composition. I was mainly interested in whether some of the very distinguished medical ethics folks who are members of IOM were appointed to that committee. After all, a 15 member committee can afford to have a handful of people who represent the pro-industry end of the spectrum, and probably needs them for balance if their final product is to be credible. But if people with expertise in ethics are left out, then I would be really worried.

So I was relieved to see that the chair of the committee is Bernard Lo, author of the textbook of medical ethics that I use with my students; and another committee member is Jim Childress, who is co-author of the best-selling textbook of bioethics. Also a member of the panel is Dennis Thompson, who wrote a seminal piece on COI several years ago for the New England Journal (though in HOOKED I found reason to dissent from the definition of COI that he offered there).

I then went down to the list of COI waivers/disclosures and found that Jim Childress was one of those listed as having conflicts. Now, call me naive if you wish; but when someone of his stature and reputation is named to a committee like this, I am inclined to give him a pass even if he has on occasion consulted with industry.

So all in all, I believe that the IOM may have appointed a reasonable panel to address COI issues and to develop model guidelines. I agree it would have been better had at least one of those known for writing specifically about Pharma, such as Kassirer, Lisa Bero, or yours truly, been asked also to serve. But the IOM process frequently has other members review a draft report after a committee has finished their work; so we may well be asked to be reviewers at a later time.

I am most worried about the apparently slanted charge to the committee, stressing making nice with industry over scientific and profesional integrity. I hope that the ethicists on the committee will make sure that balance is restored during their process.

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