The Psychopharmacologic Drug Advisory Committee (PDAC) is one of 33 advisory committees of the Food and Drug Administration (FDA). During committee meetings, an open public hearing takes place where speakers provide testimonies about the drug in question and are asked, not required, to disclose any conflicts of interests (COIs) before speaking. These speakers may present with COIs which include, but are not limited to, reimbursement for travel and lodging by the pharmaceutical company to attend the meeting; previous or current payments for consulting from the pharmaceutical company and compensation as a paid investigator in previously conducted clinical trials for the drug under review. Our study aimed to investigate the characteristics and COIs of public speakers at PDAC meetings of the FDA. We evaluated 145 public speakers at FDA committee meetings over a 10-year period. We found a total of 52 public speakers disclosed a COI with travel and lodging being the most prominent. Among these speakers, 82.4% provided a positive testimony regarding the psychiatric drug in question. Speakers who had the condition in question were not more likely to provide a positive statement than those who did not. Our results showed that disclosing a COI was associated with increased odds of public speakers providing a favourable testimony for the recommendation of psychiatric drugs. The implications of these findings are concerning since COIs have the potential to skew public speaker’s testimonies and persuade committee members to recommend a drug through emotionally charged tactics.
- preventive medicine
- adult psychiatry
- public health
- medical ethics
- mental health
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Contributors All authors have made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, (3) final approval of the version to be submitted.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study used publicly accessible data of FDA transcripts and, thus, it did not meet the regulatory definition of human subjects research per the United States Code of Federal Regulations and did not require the oversight of an institutional review board approval.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. This study used publicly accessible data from the FDA's website and, thus, it did not qualify for institutional review board approval.
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