Wednesday, December 06, 2006

Conflicts of Interest on FDA Panel to Assess Drug-Eluting Stents

Bloomberg News reported (here via the Boston Globe) that a US Food and Drug Administration (FDA) panel which will re-assess the risks and benefits of drug-eluting stents (DES) for coronary artery disease will include six members with conflicts of interest. Per Bloomberg:

Six physicians with financial ties to Johnson & Johnson and other heart-device makers will be advising US regulators whether to restrict the use of some products because of potentially lethal side effects.

The panel members, listed on an FDA website Nov. 22, will include Robert Harrington, who runs a Duke University research institute funded by stent makers J&J and Boston Scientific Corp.

To allow the doctors to participate in the review, the FDA is waiving rules that bar panelists from serving in matters affecting companies in which the experts have stock ownership or consulting contracts.

Agency critics, including Republican Senator Charles Grassley of Iowa, say only advisers without financial conflicts should be chosen.

Some members of Congress, including Grassley, and consumer groups such as Public Citizen in Washington have criticized the FDA in past cases for selecting panelists with financial ties to companies whose drugs or devices are under review.

Here we go again. If some members of this panel work part-time for manufacturers of DES, how critical of DES do we really expect them to be during the proceedings of the panel? If some members of this panel work part-time for manufacturers of DES, do we really expect them to ignore the interests of their employers? Finally, why does the FDA persist in putting on supposedly impartial panels meant to protect the interests of the public employees, albeit part-time, of companies whose interests will be affected by the deliberations of these panels?

This is just another case that illustrates how pervasive conflicts of interest have become in government and other health care organizations.

In my humble opinion, government regulatory agencies that are supposed to protect the health and safety of the public ought to listen to representatives of drug, biotechnology, and device manufacturers, but should not give employees of such companies decision making power within the agencies.

Note that this is the third post this week about conflicts of interest in US government agencies that are supposed to be protecting the health and safety of the public at large (see here for post about the NIH, and here for post about the CDC). Something is going seriously wrong here.

ADDENDUM (12/7/2006) In the media today (Reuters here, HealthDay here via the Washington Post) are reports that the FDA panel discussed above did not seem all too worried about the risks of drug eluting stents. Per the latter, "While the panel of 21 experts broadly dismissed the more serious risks, they split on saying the clotting risk was real in comparison with older, bare-metal stents. They agreed only that more study of the drug-coated devices is needed...." Is this so unexpected, given that almost a quarter of the panel has conflicts of interest involving the companies that manufacture such stents?

Also, note that further detail about these conflicts of interest appear in the full story run by Bloomberg News that was excerpted above by the Boston Globe, and in a story by the Newark Star-Ledger. Here is a list of the conflicted panel members from the latter:

The waivers went to Richard Page of the University of Washington, who has unrelated consulting agreements with a maker of a drug-coated stent; George Vetrovec of Virginia Commonwealth University, who has a consulting deal with a manufacturer of drug-eluting stents; and Clyde Yancy of the University of Texas Southwestern Medical Center, who has a consulting agreement with a company that makes a drug being tested for use with drug-eluting stents.

Waivers also were granted to Judah Weinberger of Columbia University, who owns stock in companies that manufacture drug-eluting stents; JoAnn Lindenfeld of the University of Colorado Health Sciences Center, a consultant with a stent manufacturer and a firm with a competing technology; and Duke University researcher Robert A. Harrington, who has consulting arrangements with several drug manufacturers with a stake in continued use of drug-eluting stents.

The Newark Star-Ledger quoted these comments from Merrill Goozner:

There are literally thousands of experts all over this country who are well-schooled in the details of this field.

But instead of reaching out to that community to get a totally unbiased look at this question, the FDA appointed a committee on which a substantial fraction have conflicts of interest directly with manufacturers of products being evaluated. It's almost impossible to have confidence in the outcomes of this kind of deliberation.


1 comment:

Anonymous said...

I have been looking for a place to use these two recent WSJ articles. The first is by Cynthia Crossen, dated Dec 4, under "Cognitive Dissonance." When the facts and our feelings are in conflict we will manufacture a reason to justify our decisions or opinions.

The second article appeared Dec. 5 by Suzanne Sataline concerns Avandia. The short version is that metformin and glyburide, both generics, did as well in controlling blood sugar levels after five years as Avandia, but Avandia still managed, in the first nine monnths of this year, to rack up sales of $1.7B. Avandia also had some additional side effects and a number of study participants (40%) withdrew. While Avandia may in fact benefit a few specific patients, one must question the 10.5M prescriptions written to generate the above sales.

I would have to say that the NIH is suffering some form of cognitive dissonance in naming board members with obvious financial conflicts. As noted, this is not the first time this has happened, nor will it be the last as long as those in power turn to those they are most familiar with for advice. Also troubling is that under the new governance laws business people are required to report even the most minor financial conflict in any business transaction.

In both the Avandia and NIH situations, those who control the situation, are manufacturing reasons to justify their decisions, even when those decisions do not have the greater publics interest at heart. Once again the general public will be left paying the price for these decisions.

Steve Lucas