Cook, Courtney

Khattab, Mostafa

Kinder, Nicholas

Vassar, Matt

Weaver, Michael

English

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Association of Conflicts of Interest of Public Speakers at Meetings of the Dermatologic and Ophthalmic Drug Advisory Committee and the Ophthalmic Devices Panel of the US Food and Drug AdministrationMostafa Khattab, B.S., Michael Weaver, M.S., Courtney Cook, B.S., Nicholas Kinder, B.S., Matt Vassar, PhDINTRODUCTIONAs part of its mission, the FDA evaluates specific drugs and medical devices for safety and efficacy through meetings of special advisory committees such as the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) and the Ophthalmic Devices Panel (ODP). Included in these meetings is an Open Public Hearing (OPH) portion, during which patients, physicians, drug representatives, advocacy groups, and other parties are allowed to present opinions on the drug or device. It has recently been called into question whether conflicts of interest may sway a speaker's argument toward approval of a drug or device.OBJECTIVESOur study investigated the financial conflicts of interest of open public hearing speakers at meetings of the Dermatologic and Ophthalmic Drug Advisory Committee and the Ophthalmic Devices Panel to determine whether a relationship exists between receipt of payments by public speakers and the nature of their recommendations regarding approval for the therapy.METHODSWe identified DODAC and ODP meetings on the FDA website from February 2009 to December 2019 and reviewed the published transcripts of these meetings.We investigated DODAC and ODP meetings to evaluate the association between financial conflicts of interest and the likelihood that speakers would provide a positive testimony regarding a drug/device. Our results showed that speakers with a COI were significantly more likely to speak positively regarding the drug/device. Nearly one-half of the 86 Open Public Hearing speakers in our study had COIs involving the drug/device sponsor, with payments for travel and lodging being the most common. All of these speakers provided positive testimonies. The potential of COIs to heavily influence drug/device approval should be seriously considered by the DODAC and ODP. We recommend that the FDA require full disclosure of COI information from public speakers. Such a requirement would allow the committee to fully understand the context of the public speakers’ comments, allowing them to determine the comments’ validity.Nature of Speaker Testimonies Based on COITable 1: Characteristics of Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) and Ophthalmic Devices Panel (ODP) hearingsCONCLUSIONRESULTS1. Office of the Commissioner. What We Do. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/what-we-do. Published March 11, 2018. Accessed February 14, 2020.2. Abola MV, Prasad V. Characteristics and Conflicts of Public Speakers at Meetings of the Oncologic Drugs Advisory Committee to the US Food and Drug Administration. JAMA Intern Med. 2016;176(3):389-391.3. Arthur W, Austin J, Wayant C, Vassar M. Association of Conflicts of Interest for Public Speakers for the Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug Administration With Their Statements. JAMA Neurol. 2019;76(3):368-369.4. 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):996-997.5. Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioeth. 2010;10(10):11-17.6. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA. 2003;290(2):252-255.7. Anonymous. Getting Your Way with FDA—Or Not. MDDI Online. https://www.mddionline.com/getting-your-way-fda%E2%80%94or-not. Published March 3, 2015. Accessed February 14, 2020.8. Johnson BS, Roberts W, Riddle J, Wayant C, Scott J, Vassar M. Potential Financial Bias From Speakers at US Food and Drug Administration’s Bone, Reproductive, and Urologic Drugs Advisory Committee Meetings. Urology. January 2020. doi:10.1016/j.urology.2019.11.0429. Talati RK, Gupta AS, Xu S, Ghobadi CW. Major FDA medical device recalls in ophthalmology from 2003 to 2015. Can J Ophthalmol. 2018;53(2):98-103.10. Center for Drug Evaluation, Research. Dermatologic and Ophthalmic Drugs Advisory Committee. U.S. Food and Drug Administration. http://www.fda.gov/advisory-committees/human-drug-advisory-committees/dermatologic-and-ophthalmic-drugs-advisory-committee. Published January 12, 2018. Accessed March 4, 2020.11. Center for Devices, Radiological Health. Past Meeting Materials, Ophthalmic Devices Panel. U.S. Food and Drug Administration. http://www.fda.gov/advisory-committees/ophthalmic-devices-panel/past-meeting-materials-ophthalmic-devices-panel. Published 2019. Accessed March 4, 2020.12. Grande D. A national survey of physician-industry relationships. N Engl J Med. 2007;357(5):507-508; author reply 508.13. DeJong C, Aguilar T, Tseng C-W, Lin GA, Boscardin WJ, Dudley RA. Pharmaceutical Industry-Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries. JAMA Intern Med. 2016;176(8):1114-1122.14. Anstey A. Our judgement is influenced by conflict of interest. Br J Dermatol. 2018;178(6):1229-1232.REFERENCESAdvisory Committee Drug/Device name Pharmaceutical company# of speakers# of speakers with COIsODP Implantable Miniature Telescope (IMT) VisionCare Technologies Inc. 7 4DODAC Elyea (Aflibercept ophthalmic solution) Regeneron Pharmaceuticals, Inc. 2 1DODAC Lucentis (Ranibizumab injection) Genentech Inc. 13 3DODAC Jetrea (Ocriplasmin intravitreal injection) ThromboGenics, Inc. 5 2ODP Argus II Retinal Prosthesis System Second Sight Medical Products, Inc. 9 2ODPTrulign Toric Accommodating Posterior Chamber Intraocular Lens Bausch + Lomb 2 1ODP Visian Toric Implantable Collamer Lens STAAR Surgical Company 7 5ODP Kamra Inlay AcuFocus, Inc. 4 4DODAC Secukinumab Novartis 3 3ODPAcrySof IQ ReSTOR Multifocal Toric Posterior Chamber Intraocular Lens Alcon Inc. 8 5DODAC and ODP Riboflavin ophthalmic solutions with UV-A irradiation Avedro Inc. 14 1DODAC Deoxycholic acid injection Kythera Biopharmaceuticals 11 9DODAC Brodalumab injectionValeant Pharmaceuticals Luxembourg S.a.r.l. 1 1• Data Points of Speakers:• Affected by disease• Treated with drug or device• Reported COI• Nature of Testimony:• Positive• Negative• Neutral051015202530354045Positive Neutral Negative41 Speakers With COI0246810121416Positive Neutral Negative25 Speakers Without COI0246810121416Positive Neutral Negative20 Speakers Who Failed to Mention COI

Association of conflicts of interest of public speakers at meetings of the Dermatologic and Ophthalmic Drug Advisory Committee and the Ophthalmic Devices Panel of the US Food and Drug Administration

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Association of conflicts of interest of public speakers at meetings of the Dermatologic and Ophthalmic Drug Advisory Committee and the Ophthalmic Devices Panel of the US Food and Drug Administration

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