Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA
Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA.
BMJ Evid Based Med. 2020 Aug;25(4):145-146. doi: 10.1136/bmjebm-2019-111299. Epub 2020 Feb 4.
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.
精神药理学药物咨询委员会(PDAC)是美国食品和药物管理局(FDA)的 33 个咨询委员会之一。在委员会会议期间,公开举行公开听证会,发言人就有关药物提供证词,并被要求(但不是必需)在发言前披露任何利益冲突(COI)。这些发言人可能存在利益冲突,包括但不限于制药公司报销出席会议的旅行和住宿费用;以前或现在因制药公司而获得的咨询报酬,以及作为正在审查的药物以前进行的临床试验中的付费研究员的报酬。我们的研究旨在调查 FDA 精神药理学药物咨询委员会会议上的公开演讲者的特征和利益冲突。我们评估了 FDA 委员会会议期间的 145 名公开演讲者。我们发现,在 10 年的时间里,共有 52 名公开演讲者披露了与旅行和住宿有关的利益冲突。在这些演讲者中,82.4%对所讨论的精神药物提供了正面证词。有条件的演讲者并不比没有条件的演讲者更有可能提供积极的声明。我们的结果表明,披露利益冲突与公开演讲者提供有利于推荐精神药物的证词的可能性增加有关。这些发现的影响令人担忧,因为利益冲突有可能歪曲公开演讲者的证词,并通过情绪化的策略说服委员会成员推荐药物。