Many FDA Scientists Had Drug Concerns, 2002 Survey Shows
By Marc Kaufman
Washington Post Staff Writer
Thursday, December 16, 2004; Page A01
Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality.
The survey of almost 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency's ability to assess the safety of a drug.
The results of the survey, conducted by the Department of Health and Human Services' inspector general, appear to support some portions of the controversial Senate testimony last month by FDA safety officer David J. Graham. The 20-year agency veteran told senators that the FDA was unable to keep some unsafe drugs off the market, and that scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated.
Graham's testimony, at a hearing into the sudden withdrawal from the market of the arthritis drug Vioxx, put a spotlight on the FDA's safety and management record. Top FDA officials later criticized Graham's testimony as inaccurate and unscientific, but the survey results indicate that some other agency scientists share similar views....
http://www.washingtonpost.com/wp-dyn/articles/A3135-2004Dec15.html?sub=AR