The 19 meetings coded at the speaker level took place between 2010 and 2020 and included 9 of the 18 medical device panels (5 Circulatory System, 4 Neurological, 3 OB/GYN, 2 General and Plastic Surgery, and one each of: Dental; Ear, Nose and Throat; General Hospital; Immunology; and Orthopedic and Rehabilitation). Five of these meetings focused on women’s devices (breast implant meetings in 2011 and 2019, surgical mesh meetings in 2011 and 2019, and a 2015 meeting on the Essure sterilization device), and the remainder were non-sex-specific (such as metal-on-metal hips, dental amalgam, and cochlear implants).
For these 19 meetings, we created a speaker-level database that recorded each contributing speaker (789 total). A contributing speaker refers to any speaker listed in the meeting agenda of the transcript, excluding press contacts and FDA panel members. Each speaker was coded by type of stakeholder as follows: patients (also including spouses or family members speaking on behalf of patients); advocates (representing a formal organization or collective, like patient support groups); solo physicians (speaking individually, from their own clinical practice experience); professional organizational physicians (representing professional organizations like the American Dental Association); researchers (including material scientists and clinical researchers); industry representatives (typically CEOs and other executives of device companies but also including physicians, researchers, patients, and advocates sponsored by industry, aligned with prior research on the topic [41 (link), 42 (link)]); and FDA representatives (typically staff members not represented on the panel). All speakers were coded based on speaker titles listed in meeting agendas and speakers’ self-introductions and disclosures of conflicts of interest, and the categories of speakers were mutually exclusive. This coding was performed with confirmatory cross-checks among all researchers.
Transcripts were coded initially to analyze the speaking time and discussion time that speakers were granted to contribute during the meeting, measured in three ways, aligned with prior research examining FDA panel proceedings [8 (link)]: (1) word count captured within a speaker’s primary substantive presentation; (2) number of exchanges between a speaker and a panelist during question and answer sections of meetings (which occur when a panelist initiates further dialogue with a speaker, typically through a question or clarifying statement); and (3) word count from the speaker that resulted from any exchange initiated by a panelist. Word counts were obtained using Microsoft Word. Exchanges were recorded in a database that noted the panelist who started the exchange, the speaker addressed, the number of exchanges between the pair, and any additional word count. Speaking time was then analyzed quantitatively by type of stakeholder.
For these 19 meetings, we created a speaker-level database that recorded each contributing speaker (789 total). A contributing speaker refers to any speaker listed in the meeting agenda of the transcript, excluding press contacts and FDA panel members. Each speaker was coded by type of stakeholder as follows: patients (also including spouses or family members speaking on behalf of patients); advocates (representing a formal organization or collective, like patient support groups); solo physicians (speaking individually, from their own clinical practice experience); professional organizational physicians (representing professional organizations like the American Dental Association); researchers (including material scientists and clinical researchers); industry representatives (typically CEOs and other executives of device companies but also including physicians, researchers, patients, and advocates sponsored by industry, aligned with prior research on the topic [41 (link), 42 (link)]); and FDA representatives (typically staff members not represented on the panel). All speakers were coded based on speaker titles listed in meeting agendas and speakers’ self-introductions and disclosures of conflicts of interest, and the categories of speakers were mutually exclusive. This coding was performed with confirmatory cross-checks among all researchers.
Transcripts were coded initially to analyze the speaking time and discussion time that speakers were granted to contribute during the meeting, measured in three ways, aligned with prior research examining FDA panel proceedings [8 (link)]: (1) word count captured within a speaker’s primary substantive presentation; (2) number of exchanges between a speaker and a panelist during question and answer sections of meetings (which occur when a panelist initiates further dialogue with a speaker, typically through a question or clarifying statement); and (3) word count from the speaker that resulted from any exchange initiated by a panelist. Word counts were obtained using Microsoft Word. Exchanges were recorded in a database that noted the panelist who started the exchange, the speaker addressed, the number of exchanges between the pair, and any additional word count. Speaking time was then analyzed quantitatively by type of stakeholder.
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