21 mars, 2007 12:58
FDA To Act On Conflicts Of Interest
Some Doctors Advising The FDA On Medical Devices Are Taking Money From Companies They're Regulating
(CBS) This story was written by CBS News producer Laura Strickler
Stock holdings, consulting contracts and paid speaking engagements... Some physicians advising the Food and Drug Administration on medical devices are taking money from the very companies who stand to gain from their recommendations to the regulatory agency.
In recent years the FDA has approved controversial devices such as breast implants and drug-coated stents.
Since 2002, there have been 189 conflicts of interest registered by medical professionals at 86 FDA Medical Device Advisory Committee Meetings, according to meeting transcripts analyzed by CBS News. Conflicts include one physician holding stock valued between $15,000 and $25,000 in the company whose product was under consideration.
The FDA uses these committees to advise officials on approval or regulation of controversial high-risk medical devices. Committee members make recommendations for regulation — suggestions commonly adopted as FDA policy. The FDA tells CBS News the agency will announce a new approach to conflicts of interest Wednesday and chose not to comment Tuesday.
It is standard procedure at Device Advisory Committee meetings for an official to read a statement that indicates the agency forbids participation in meetings that could "affect their or their employers' financial interests." However, the statement goes on to say that if the need for those services "outweighs the potential conflict of interest involved" then the participant is issued a waiver.
FDA records show in some cases physicians registered multiple conflicts of interest at multiple meetings. For example, based on FDA transcripts, one doctor serving on the Circulatory System Devices Panel was granted five waivers for various conflicts at five separate meetings. Another physician, also on the Circulatory panel, was granted waivers for conflicts at six different meetings.
While some conflicts were registered because the physician or scientist had a relationship with a competing firm, others indicate a current financial interest that could raise red flags. A September 2006 report from the Institute of Medicine recommended the FDA establish a requirement that a substantial majority of participants in advisory meetings be conflict free.
Dr. Steven Nissen, chairman of the Cleveland Clinic's department of cardiovascular medicine, has served on FDA’s Circulatory System Devices Panel. An outspoken FDA critic, Nissen told CBS News the conflict of interest issue is challenging, adding, "I think the FDA has not always handled it well." Nissen says it should be "mandatory" that any medical professional with current conflicts of interest such as consulting contracts or paid speaking gigs should not be allowed to participate in FDA advisory meetings. Nissen himself says he does not take compensation for his research. "I’ve recognized it doesn’t matter what’s in your heart, it’s what appears to be a conflict of interest."
