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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. JAMA Intern Med. 2018;178(7):996–997. doi:10.1001/jamainternmed.2018.1325
In 2017, an US Food and Drug Administration (FDA) workshop on opioid safety drew Congressional scrutiny because advocacy groups participating in the meeting had financial ties to opioid manufacturers.1 Little formal attention, however, has been paid to the possibility of such conflicts of interest among patients and advocates who appear as public speakers before the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), which advises the FDA on drug products used in anesthesiology and pain management. In addition to presentations from the sponsor of the drug under review and FDA staff, AADPAC meetings include an open hearing during which public speakers can address the committee. These speakers are encouraged, but not required, to disclose conflicts of interest.
Building on a study of public speakers at meetings of the FDA’s Oncologic Drugs Advisory Committee,2 we investigated the characteristics and conflicts of interest of public speakers at AADPAC meetings.
This study was an investigation of published reports and public websites and therefore was not subject to institutional review board approval according to federal regulations. We collected data from August through November 2017. First, we identified AADPAC meetings from September 2009 (the earliest date on the AADPAC’s primary archive page) through April 2017 related to the approval of drug products. Second, we reviewed meeting transcripts, recording whether public speakers (1) reported experiencing chronic pain; (2) had received the drug under review; (3) reported an organizational affiliation; (4) reported a conflict of interest; and (5) expressed support, opposition, or were neutral with respect to drug approval. Third, where speakers reported an organizational affiliation but disclosed no conflict of interest, we performed a Google search for evidence of financial associations between the sponsor and the speaker’s organization. We coded financial associations as existing prior to the meeting or of indeterminate date.
Using logistic regression models that accounted for clustering at the speaker level, we estimated statistical associations between whether a speaker had a conflict of interest and whether the speaker supported drug approval. We estimated 3 models, each with a different conflict of interest measure: (1) disclosed conflicts; (2) disclosed and undisclosed conflicts where undisclosed financial associations of indeterminate date were assumed to originate after testimony and, therefore, were not classified as conflicts; and (3) disclosed and undisclosed conflicts where undisclosed financial associations of indeterminate date were classified as conflicts.
From September 2009 to April 2017, there were 15 AADPAC meetings related to drug approval at which 91 individuals made 112 speaking appearances. In these appearances, 20 speakers reported having experienced chronic pain and 11 reported receiving the drug under review (Table). Of the 112 speakers, 22 (19.6%) disclosed a conflict of interest, most frequently reimbursement by the sponsor for travel or other expenses related to attending the meeting. We identified 6 of 112 speakers (5.4%) as having an undisclosed financial association with the sponsor that existed prior to the meeting and 15 of 112 speakers (13.4%) with an undisclosed financial association of indeterminate date. Overall, 76 of 112 speakers (67.9%) supported drug approval.
Speakers who disclosed a conflict of interest were significantly more likely to support drug approval (odds ratio [OR], 6.07; 95% CI, 1.29-28.56; P = .02) than those who did not. Findings were similar when undisclosed financial associations were included in the analysis. In the lower bound scenario, where financial associations of indeterminate date were not classified as conflicts of interest, speakers with a conflict were over 3 times as likely to support drug approval (OR, 3.69; 95% CI, 1.10-12.38; P = .03). In the upper bound scenario, where financial associations of indeterminate date were classified as conflicts of interest, speakers with a conflict were more than 8 times as likely to support drug approval (OR, 8.43; 95% CI, 2.57-27.63; P ≤.001).
We found that about 25% of public speakers at AADPAC meeting have conflicts of interest, which were not disclosed in about 20% of these instances. We also found that the speakers with conflicts of interest were more likely to support drug approval than those who did not, raising concerns about a prosponsor bias among speakers. At meetings of all of its advisory committees, the FDA should require rather than simply encourage speakers to disclose their conflicts of interests. During their deliberations, committee members can account for the conflicts of interest of public speakers only if they are aware of them.
Accepted for Publication: March 1, 2018.
Corresponding Author: Matthew S. McCoy, PhD, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Blockley Hall, 14th Floor, Philadelphia, PA 19104-4884 (email@example.com).
Published Online: April 23, 2018. doi:10.1001/jamainternmed.2018.1325
Author Contributions: Dr McCoy had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: McCoy, Litman.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: McCoy, Kanter, Litman.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Kanter.
Administrative, technical, or material support: McCoy, Pagán, Donohoe, Litman.
Study supervision: McCoy, Litman.
Conflict of Interest Disclosures: Dr McCoy’s spouse is employed by a cancer patient advocacy organization. Dr Litman is a member of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). No other disclosures are reported.
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