Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.
Institute for Scientific Freedom, Copenhagen, Denmark.
Epidemiol Psychiatr Sci. 2024 Mar 26;33:e17. doi: 10.1017/S2045796024000179.
We have previously described the European Medicines Agency's (EMA) and the US Food and Drug Administration's guidelines, each for a specific psychiatric indication, on how to design pivotal drug trials used in new drug applications. Here, we report on our efforts over 3 years to retrieve conflicts of interest declarations from EMA. We wanted to assess potential internal industry influence judged as the proportion of guideline committee members with industry conflicts of interest.
We submitted Freedom of Information requests in February 2020 to access EMA's lists of committee members (and their declared conflicts of interest) involved in drafting the 13 'Clinical efficacy and safety' guidelines available on EMA's website pertaining to psychiatric indications. In our request, we did not specify the exact EMA committees. Here, we describe the received documents and report the proportion of members with industry interests (i.e. defined as any financial industry relationship). It is a follow-up paper to our first report (http://doi.org/10.1017/S2045796021000147).
After 2 years and 9 months (November 2022), the EMA sent us member lists and corresponding conflicts of interest declarations from the Committee for Medicinal Products for Human use (CHMP) from 2012, 2013 and 2017. These member lists pertained to 3 of the 13 requested guidelines (schizophrenia, depression and autism spectrum disorder). The 10 remaining guidelines were published before 2011 and EMA stated that they needed to require permission from their expert members (with unknown retrieval rate) and foresaw excessive workload and long wait. Therefore, we withdrew our request. The CHMPs from 2012, 2013 and 2017 had from 34 to 36 members; 39%-44% declared any interests and we judged 14%-18% as having industry interests. For the schizophrenia guideline, we identified two members with industry interests to companies who submitted feedback on the guideline. We did not receive declarations from the Central Nervous System (CNS) Working Party, the CHMP appointed expert group responsible for drafting and incorporating feedback into the guidelines.
After almost 3 years, we received information, which only partly addressed our request. We recommend EMA to improve transparency by publishing the author names and their corresponding conflicts of interest declarations directly in the 'Clinical efficacy and safety' guidelines and to not remove conflicts of interest declarations after 1 year from their website to reduce the risk of stealth corporate influence during the development of these influential guidelines.
我们之前描述了欧洲药品管理局（EMA）和美国食品和药物管理局（FDA）的指南，每个指南针对特定的精神科适应证，介绍了如何设计用于新药申请的关键药物试验。在这里，我们报告了我们在过去 3 年中努力从 EMA 检索利益冲突声明的情况。我们希望评估潜在的内部行业影响，判断有行业利益冲突的指南委员会成员的比例。
我们于 2020 年 2 月提交了信息自由请求，以访问 EMA 网站上与精神科适应证相关的 13 项“临床疗效和安全性”指南草案所涉及的委员会成员（及其申报的利益冲突）名单。在我们的请求中，我们没有具体说明 EMA 委员会的确切名称。在这里，我们描述了收到的文件，并报告了具有行业利益的成员比例（即定义为任何金融行业关系）。这是我们第一篇报告的后续文章（http://doi.org/10.1017/S2045796021000147）。
2 年零 9 个月后（2022 年 11 月），EMA 向我们发送了人用药物委员会（CHMP）2012、2013 和 2017 年的成员名单和相应的利益冲突声明。这些成员名单涉及我们请求的 13 项指南中的 3 项（精神分裂症、抑郁症和自闭症谱系障碍）。其余 10 项指南是在 2011 年之前发布的，EMA 表示他们需要从其专家成员那里获得许可（检索率未知），并预计工作量过大且等待时间长。因此，我们撤回了请求。2012、2013 和 2017 年的 CHMP 有 34 至 36 名成员；39%-44%申报了任何利益，我们判断 14%-18%有行业利益。对于精神分裂症指南，我们确定了两名有行业利益的成员，他们是向该指南提交反馈的公司的代表。我们没有收到中央神经系统（CNS）工作组的声明，该工作组是负责起草和将反馈纳入指南的 CHMP 指定专家组。
经过近 3 年的时间，我们收到了部分满足我们请求的信息。我们建议 EMA 通过直接在“临床疗效和安全性”指南中公布作者姓名及其相应的利益冲突声明来提高透明度，并在其网站上保留利益冲突声明超过 1 年，以减少在制定这些有影响力的指南期间企业暗中施加影响的风险。
