June 08, 2005
House Votes Biz-Backed Scientists Off FDA Advisory Panels
The House of Representatives voted this afternoon to prohibit outside doctors and scientists who work for drug companies from sitting on Food and Drug Administration panels that pass judgment on those same companies' products.
The vote on a rider to the FDA appropriations bill was 218-210, with dozens of Republicans joining the an overwhelming Democratic party vote in favor of the measure, which was sponsored by Rep. Maurice Hinchey (D-NY). The measure now moves to the Senate where Illinois Democrat Richard Durbin is planning a similar maneuver.
The vote punctuates six months of intensive research, education and lobbying work by the Center for Science in the Public Interest's Integrity in Science project, which I direct. The issue gained national attention in February when the New York Times, relying on CSPI research, reported that 10 of 32 scientists sitting on the FDA advisory panel evaluating Cox-2 painkillers had ties to manufacturers of the drugs. Had their votes been eliminated, two of the three drugs in the class would have received a thumbs down vote from the panel.
The conflict of interest issue reared its head again in April when an FDA advisory panel evaluating the safety of silicone gel breast implants included a physician who had previously completed a video for the manufacturer touting the safety of the product. A broad coalition of consumer and women's health groups protested his presence on that panel.
Speaking on the House floor, Hinchey quoted at length from the recent Lancet editorial that took issue with the FDA's defense of hiring part-time advisers who simultaneously worked for companies with new product applications before the agency. The idea that the FDA can't find highly qualified, unconflicted scientists among the thousands of persons who teach at America's 125 medical schools or abroad "is simply ridiculous," Hinchey said.
The Democrats who spoke in favor of the measure included Bart Stupak (D-Mich.), whose son committed suicide while on Accutane, the acne drug, and Rep. Marion Berry (D-Ark.), the only certified pharmacist in Congress.
The Republican leadership, meanwhile, perhaps feeling the heat from its own ethics and conflict of interest scandals, couldn't round up anyone besides the floor leader to speak against the rider.
It's still a long way before the measure becomes law, and even then it would only be for the coming year. But Wednesday's vote represents a good start in rebuilding the public's faith in the agency, which has been badly shaken by the past year's safety scandals.
However, eliminating scientists with conflicts of interest from FDA advisory panels is only the first step in the larger project of reforming the FDA. Legislation in the Senate (Grassley-Dodd) and House (Hinchey) would give the agency's safety department more power to veto drug applications, pull drugs off the market and order new clinical trials. Until those bills pass, the American people will continue to wonder if their medicines are truly safe and effective.
Posted by gooznews at June 8, 2005 09:07 PM
The purpose of FDA Advisory Committees is to provide unbiased expert advice. Because clinical trials are largely conducted by or supported by industry--not NIH--it will be difficult to find experienced experts who have not had industry support.
Therefore an unintended consequence of forcing all industry supported scientists from such committees will be a dearth of expert opinion.
Something more reasonable might be that with regard to any particular product ,those who are involved in its assessment could be debarred from voting. All committee members who have had support from industry should be identified.
In any case it would be interesting to go thru the present roster and see what proportion would be debarred and how effectively they could be replaced.
It is of particular importance that clinical trials expertise comes from experience. Purely spectator interest does not do it.
Congratulations Gooznews on this important step in restoring needed checks and balances to the drug approval process. Dr. Klein's points are important and raise the question of how Dr.s can obtain the experience, and analytic skills to a better job then
is being currently done. My own sense is to restore the scholarship to medicine and create career tracks which are geared towards medical editorship, public health and drug approval among other things independent of Pharma. In fact these drug approval questions are often quite complex issues and the first step is to recognize the complexity and uncertainty inherent in many of these challenges.