From the Journals

Speakers at FDA advisory meetings have hidden conflicts

 

Key clinical point: A significant portion of public speakers at certain FDA advisory committee meetings have conflicts of interest.

Major finding: Of 112 speakers, about 25% had a conflict of interest, of which about 20% were undisclosed.

Study details: A study of public speakers at 15 Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) meetings from September 2009 through April 2017 related to the approval of drug products.

Disclosures: Dr. McCoy reports that his spouse is employed by a cancer patient advocacy organization. Dr Litman reports that he is a member of AADPAC. No other disclosures were reported.

Source: McCoy et al. JAMA Intern Med. 2018 Apr 23. doi:10.1001/jamainternmed.2018.1324.

View on the News

FDA can improve disclosure process

The influence of pharmaceutical companies permeates the open public hearing, even though these firms already have highlighted their products during the sponsor presentation.

Currently, pharmaceutical and medical device companies publicly report specified types of payments to physicians through the federal Open Payments program. In my view, these companies also should be required to publicly report payments to professional associations, patient groups, and other nongovernmental organizations.

Dr. McCoy and his colleagues recommend that the Food and Drug Administration require – not merely encourage – public speakers to disclose their conflicts of interest. This is a recommendation with which I disagree. Advisory committee members fill out forms related to conflicts of interest under penalty of perjury. In contrast, speakers at the open public hearing often sign up to speak on the day of the advisory committee meeting, and no documentation is provided, giving FDA staff no opportunity to corroborate any disclosures (or lack thereof). The chair of the FDA advisory committee simply encourages public speakers to disclose any conflicts. It does not seem consistent with the spirit of inclusiveness that should characterize the open public hearing to exclude a speaker who does not disclose whether he or she has conflicts. Nonetheless, the chair should directly query any speaker who fails to disclose whether he or she has conflicts and the subsequent testimony be should be considered in the light of any refusal to disclose.

Peter Lurie, MD, is president of the Center for Science in the Public Interest, Washington. Dr Lurie reports that he worked at the FDA during 2009-2017, including as associate commissioner for public health strategy and analysis from 2014 to 2017. His comments were made in an editorial accompanying Dr. McCoy’s study (JAMA Intern Med. doi:10.1001/jamainternmed.2018.1324).


 

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.

Matthew S. McCoy, 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 in JAMA Internal Medicine on 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. doi:10.1001/jamainternmed.2018.1324

Next Article: