Nearly a quarter of public speakers at meetings of a Food and Drug Administration advisory committee had conflicts of interest, about 20% of which are undisclosed, a study finds.
, PhD., of the University of Pennsylvania, Philadelphia, and his colleagues analyzed the public speakers at 15 meetings of the FDA Anesthetic and Analgesic Drug Products Advisory Committee from September 2009 to April 2017 related to the approval of drug products. (The committee advises the FDA on anesthesiology and pain management drug products.)
Investigators evaluated meeting transcripts to learn whether speakers reported chronic pain; had received the drug under review; reported an organization affiliation; reported a conflict of interest; and expressed support, opposition or were neutral with respect to drug approval. Of the 112 speakers studied, about 20% disclosed a conflict of interest, 5% had an undisclosed financial association with the sponsor that existed prior to the meeting and 13% had an undisclosed financial association of indeterminate date,the researchers reported inon April 23.
Of those 112 speakers, 20 reported having experienced chronic pain and 11 reported receiving the drug under review. Overall, about 70% of speakers (76 out of 112) supported drug approval, the study found. Speakers who disclosed a conflict of interest were significantly more likely to support drug approval. When financial associations of indeterminate date were classified as conflicts of interest, speakers with a conflict were more than eight times as likely to support drug approval.
Dr. McCoy and his colleagues noted that the findings raise concerns about pro–sponsor bias among speakers at advisory committee meetings. They propose that the FDA should require – rather than only encourage – speakers to disclose conflicts of interest at all of the agency’s advisory committee meetings.
SOURCE: McCoy MS et al. JAMA Intern Med. 2018 Apr 23.