Underreporting of Conflicts of Interests Likely at FDA Advisory Committee Meetings

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Twenty percent of conflicts of interest in speakers at FDA Anesthetic and Analgesic Drug Products Advisor Committee Meetings are not disclosed.
Twenty percent of conflicts of interest in speakers at FDA Anesthetic and Analgesic Drug Products Advisor Committee Meetings are not disclosed.

According to a research letter published in JAMA Internal Medicine,1 approximately one-quarter of public speakers presenting at Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) meetings have clear conflicts of interests, 20% of which  are not disclosed to event participants. In addition, speakers with conflicts of interest exhibit greater enthusiasm for drug approval compared with speakers declaring no conflicts.

Study investigators collected data from AADPAC meetings held between 2009 and 2017, with data obtained from transcripts of 91 speakers who reported either chronic pain experience (n=20), receipt of a drug under review (n=11), affiliation with a relevant organization (n=80), and/or a conflict of interest (n=22). In addition, investigators included speakers who reported support (n=76), opposition (n=28), or neutral (n=8) expression toward drug approval. The investigators also assessed speakers' conflict of interest via an Internet search if conflicts were not mentioned during the presentations.

A total of 15 AADPAC meetings and 112 presentations that related to drug approval were included in the analysis. Across all sessions, only 19.6% of speakers had reported a conflict of interest. A majority of speakers supported drug approval (67.9%), and speakers who reported a conflict of interest were more likely to support approval of the drug compared with individuals not disclosing a conflict of interest (odds ratio [OR], 6.07; 95% CI, 1.29-28.56; P =.02).

When financial associations were not reported as conflicts of interest, investigators found that speakers with a clear conflict of interest supported drug approval 3 times as often as speakers without a conflict (OR, 3.69; 95% CI, 1.10-12.38; P =.03). In addition, speakers with a conflict of interest were more likely to support drug approval approximately 8 times as more often as non-conflicted speakers when financial associations were designated as conflicts of interests (OR, 8.43; 95% CI, 2.57-27.63; P ≤.001).

According to an accompanying commentary,2 investigator Peter Lurie, MD, MPH, of the Center for Science in the Public Interest in Washington, DC, suggests greater interaction between committee members and speakers to ensure transparency. In addition, he suggests that the chair of the US Food and Drug Administration (FDA) Advisory Committee “should directly query any speaker who fails to disclose whether he or she has conflicts and the subsequent testimony should be considered in the light of any refusal to disclose.”

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References

  1. McCoy MS, Pagán O, Donohoe G, Kanter GP, Litman RS. Conflicts of interest of public speakers at meetings of the Anesthetic and Analgesic Drug Products Advisory Committee [published online April 23, 2018]. JAMA Intern Med. doi:10.1001/jamainternmed.2018.1325.
  2. Lurie P. Suggestions for improving conflict of interest processes in the US Food and Drug Administration Advisory Committees—past imperfect [published online April 23, 2018]. JAMA Intern Med. doi:10.1001/jamainternmed.2018.1324.
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