FDA Experts Often Have Conflicts [WSJ]
By JENNIFER CORBETT DOOREN
April 26, 2006; Page D5
Many outside medical experts who serve on Food and Drug Administration advisory panels report holding stocks or having consulting contracts from drug companies, but are rarely excluded from voting on drugs being considered by the panels, according to a study.
The study, which was conducted by the consumer group Public Citizen and appears in today's Journal of the American Medical Association, looked at drug advisory panel votes and financial disclosure records from 2001 to 2004.
Overall, the study found a "weak relationship" between certain types of financial conflicts and voting behavior; the overall vote wouldn't have changed if members reporting conflicts were excluded.
The FDA routinely calls on outside panels of medical experts to make recommendations on whether a particular drug or medical device should be approved. While the agency usually follows its panels' advice, the FDA isn't required to do so and has the final word on product approvals. Panels are composed of standing members who typically serve for about two years, and then for specific meetings the FDA often adds voting consultants who participate on a one-time basis.
Since 2002, the FDA has required more detailed reporting of financial ties to drug companies. Panel members must complete forms that include information about whether they hold stocks in the company appearing before the panel, have consulting arrangements, or received research grants or lecture fees in the past 12 months. Panel members are also required to disclose whether they have any financial ties to direct competitors of a product appearing before a panel.
The FDA typically makes the information public 15 days before a meeting and it is also disclosed at the start of the meeting. The agency also grants waivers to panel participants who report financial ties to drug firms if the FDA believes the person can render an unbiased opinion on a given drug before a committee.
Peter Lurie, the study's lead author, said that ideally anyone reporting a financial conflict should be excluded from voting at meetings and believes it is possible for the FDA to find qualified experts to serve on their panels who are free of financial ties to drug companies.
Susan Bro, a spokeswoman for the FDA, said the agency tries to make certain that panel members will "make an unbiased, productive contribution to the scientific process." |
