FDA Lax in Overseeing Doctors' Conflicts in Trials
The U.S. Food and Drug Administration does little to oversee financial conflicts that doctors involved in clinical trials of drugs and medical devices may have, government investigators said Monday.
In 42 percent of trials, the FDA failed to receive disclosure forms from physicians and said that efforts to police such disclosures weren't worth the effort, The New York Times reported. Results of the investigation, conducted by the U.S. Department of Health and Human Services, were expected to be released Monday and fuel an ongoing debate about how money that doctors receive for this research could skew study results, the newspaper said.
Fewer than 1 percent of the doctors helping oversee clinical trials registered with the agency -- about 206 of the 29,691 clinical investigators listed. And those who filed the required disclosures reported that they had a significant conflict of interest, the Times said. Since the FDA does not have a complete list of these physicians, the agency has no way of knowing whether every doctor required to file actually did so, the newspaper said.
Doctors have been required by the FDA since 1999 to reveal such conflicts, and companies are required to collect and to consult with the agency before trials begin to resolve outstanding problems. Previous studies have found that one-fifth to one-third of all doctors have such conflicts, according to the Times.
FDA spokeswoman Karen Riley told the newspaper that the agency opposed reviewing doctors' financial conflicts before trials because they represented just one possible source of bias.