TY - JOUR
T1 - Public Speaker Characteristics at Meetings of the Dermatologic and Ophthalmic Drug Advisory Committee and the Ophthalmic Devices Panel
AU - Khattab, Mostafa H.
AU - Weaver, Michael
AU - Cook, Courtney
AU - Kinder, Nicholas
AU - Vassar, Matt
N1 - Funding Information:
Funding/Support: This research did not receive any funding or support from any government or nongovernment bodies. Financial Disclosures: None of the authors have any conflict of interest, financial or otherwise, to disclose regarding this study. MV reports receipt of funding from the National Institute on Alcohol Abuse and Alcoholism, the US Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences?all outside of the present work. All authors attest that they meet the current ICMJE criteria for authorship.
Funding Information:
Of the 41 speakers with COIs, 24 (58.5%) only reported being supported through travel compensation and 16 (39.0%) were supported by, previously funded by, or represented patient groups that were funded by the drug sponsors. Among the speakers who reported a COI, all 41 gave a positive testimony. Among the 45 speakers who did not disclose a COI, only 29 (64.4%) gave a positive testimony. Speakers affected by the disease for which the device or drug was indicated gave a positive testimony in 33 (91.7%) of 36 instances, whereas speakers who were treated with the device or drug in question gave positive testimonies in 30 (96.8%) of 31 instances. Of the 66 speakers who included a COI disclosure statement, 55 (83.3%) gave a positive testimony. Of the 20 speakers who did not include a COI disclosure statement, 15 (75%) gave a positive statement. Fisher exact analysis revealed no significant difference in the likelihood of giving a positive statement between speakers who included a COI disclosure statement and speakers who did not (P > .5).
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2021/3
Y1 - 2021/3
N2 - Purpose: We investigated meetings of the Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) and the Ophthalmic Devices Panel (ODP) of the Food and Drug Administration (FDA) to determine whether a relationship exists between receipt of industry payments by speakers of the Open Public Hearing (OPH) portion and the nature of their recommendations regarding treatment approval. Design: Cross-sectional study. Methods: We reviewed publicly available transcripts of all DODAC and ODP meetings from February 2009 to December 2019. For each meeting, information about each public speaker including presence of conflict of interest (COI) and whether their testimony regarding the drug or device was positive, negative, or neutral toward treatment approval was extracted in a blinded fashion using a pilot-tested Google Form. Results: Of the 86 speakers, 66 (76.7%) included a COI disclosure statement and 41 (47.7%) disclosed a COI. Regarding classification of the speakers' testimonies, 70 (81.4%) of 86 were positive, 9 (10.5%) of 86 were negative, and 7 (8.1%) of 86 were neutral. Each one of the 41 speakers with a COI gave a positive testimony. Speakers who disclosed a COI were significantly more likely to give a positive testimony than speakers who did not (P < .001). Conclusion: We recommend the DODAC and ODP require full disclosure of COI information and introduce stricter policies to manage COIs, allowing the committee to fully understand the context of the public speakers' comments, including the possible influence of COI on these comments.
AB - Purpose: We investigated meetings of the Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) and the Ophthalmic Devices Panel (ODP) of the Food and Drug Administration (FDA) to determine whether a relationship exists between receipt of industry payments by speakers of the Open Public Hearing (OPH) portion and the nature of their recommendations regarding treatment approval. Design: Cross-sectional study. Methods: We reviewed publicly available transcripts of all DODAC and ODP meetings from February 2009 to December 2019. For each meeting, information about each public speaker including presence of conflict of interest (COI) and whether their testimony regarding the drug or device was positive, negative, or neutral toward treatment approval was extracted in a blinded fashion using a pilot-tested Google Form. Results: Of the 86 speakers, 66 (76.7%) included a COI disclosure statement and 41 (47.7%) disclosed a COI. Regarding classification of the speakers' testimonies, 70 (81.4%) of 86 were positive, 9 (10.5%) of 86 were negative, and 7 (8.1%) of 86 were neutral. Each one of the 41 speakers with a COI gave a positive testimony. Speakers who disclosed a COI were significantly more likely to give a positive testimony than speakers who did not (P < .001). Conclusion: We recommend the DODAC and ODP require full disclosure of COI information and introduce stricter policies to manage COIs, allowing the committee to fully understand the context of the public speakers' comments, including the possible influence of COI on these comments.
UR - http://www.scopus.com/inward/record.url?scp=85097391952&partnerID=8YFLogxK
U2 - 10.1016/j.ajo.2020.09.043
DO - 10.1016/j.ajo.2020.09.043
M3 - Article
C2 - 33166500
AN - SCOPUS:85097391952
SN - 0002-9394
VL - 223
SP - 28
EP - 32
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
ER -