- BIOETHICS FORUM ESSAY
Industry Payola at the FDA
You can’t pay the judge who is reviewing your case. You can’t pay the critic who is reviewing your book. Sadly, you can’t even pay the dean who is reviewing your tenure application. But if you work for a pharmaceutical company, you can pay the FDA experts who are reviewing your application to sell a new drug.
For many years now, the FDA has allowed the experts on its advisory committees to accept consultancies, research funding, and lecture fees from pharmaceutical companies. In fact, not only does the FDA allow experts to accept money from the pharmaceutical companies whose drugs they are reviewing, until recently it has kept these financial arrangements carefully hidden. If you wanted to find out who is taking money from whom, you had to file a freedom of information request.
The rationale, the FDA has claimed, is expediency. “The best experts for the FDA are often the best experts to consult with industry,” FDA senior associate commissioner Linda Suydam told USA Today in 2000, when that newspaper discovered that over half of FDA advisory committee members appointed over the previous year had financial conflicts of interest. Technically, these conflicts are forbidden by government conflict of interest rules, but the FDA often lets the members with conflicts take part anyway. It simply grants them a waiver.
For a brief period last fall, it looked as if things might change. The Center for Science in the Public Interest began pressing for legislation to prohibit the most blatant conflicts of interest. But when the legislation finally passed in October 2005, it represented only a partial victory. The conflicts of interest are still allowed, but they must be disclosed. For 15 days before any FDA advisory committee meeting, you can go to the FDA website and see for yourself which panelists are on the industry payroll.
What would you find there? You would find, for instance, that five of the eleven scientists judging the safety of Tysabri, a multiple sclerosis drug, had financial ties to either the drug’s sponsors, Biogen and Elan Pharmaceuticals, or to their competitors. (Tysabri was pulled from the market recently after a small number of patients developed a rare brain disorder.) And that half the experts chosen for the committee evaluating the antibiotic Cubicin had financial ties to its maker, Cubist Pharmaceuticals, or to its competitors. This should come as no surprise. When the CSPI undertook an investigation last year into the 32 experts chosen by the FDA to evaluate Cox-2 inhibitors such as Celebrex and Vioxx, it found that 10 had affiliations with Merck, Pfizer, and Novartis, the manufacturers of the Cox-2 inhibitors. Another 17 experts had ties to other drug manufacturers.
Disclosure can be useful, but only if someone is paying attention. So far, hardly anyone is-not the press, which has barely even covered the issue; not universities, which are supplying the FDA with financially compromised experts; not even bioethicists, who have financial conflicts of their own to worry about. (Only Merrill Goozner and the CSPI remain vigilant.)
Of course, the real problem is not secrecy; it is the conflicts of interest themselves. Are there really no qualified academic medical experts in America who do not have financial ties to the pharmaceutical industry? If not, then maybe it’s time to start outsourcing the job.