Financial conflicts among physician speakers at the April 12, 2024 Oncology Drug Advisory Meeting: Who decided that MRD can be a novel regulatory endpoint in myeloma?

IF 2 Q3 HEALTH POLICY & SERVICES Journal of Cancer Policy Pub Date : 2024-12-06 DOI:10.1016/j.jcpo.2024.100529
Noah J. Carr , Alyson Haslam , Vinay Prasad
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Abstract

Background

In April 2024, the Oncology Drug Advisory Committee (ODAC) voted to approve minimal residual disease (MRD) as a new regulatory endpoint for multiple myeloma (MM) despite its poor trial-level surrogacy. This is expected to result in faster MM drug approvals, a potential boon for the pharmaceutical companies that make them. This study investigates the prevalence of financial conflicts of interest (FCOIs) with these companies among United States (US)-based physician speakers at the meeting.

Methods

Public data regarding the past 3 years of pharmaceutical company payments to US-based physician speakers at the ODAC meeting discussing MRD (available at https://openpaymentsdata.cms.gov/) were collected. For each general payment (GP), we recorded the amount, company payor, reason for payment, and associated products. Descriptive analyses were performed on payments from companies who manufacture MM therapeutics (MM payments).

Results

12 of the 20 physician speakers (60 %) eligible to have FCOIs recorded on the OpenPayments database received MM payments from 2021 to 2023, totaling more than $792,200. A majority of both voting and non-voting members had MM payments (median $11,800 and $764), most of which were consulting fees. Speakers earned more than 3.7 times as much from GPs associated with MM-related products compared to those associated with non-MM-related products.

Conclusion

Most US-based physician speakers at the April 2024 ODAC meeting had FCOIs from MM companies, including those with voting power.

Policy summary

Our findings highlight the need for greater policing of FCOIs among US-based physicians involved in cancer drug regulatory policy.
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在2024年4月12日的肿瘤药物咨询会议上,医生发言人之间的财务冲突:谁决定MRD可以成为骨髓瘤的新监管终点?
背景:2024年4月,肿瘤药物咨询委员会(ODAC)投票批准最小残留病(MRD)作为多发性骨髓瘤(MM)的新监管终点,尽管其试验级替代治疗效果不理想。预计这将导致更快的MM药物批准,这对生产这些药物的制药公司来说是一个潜在的福音。本研究调查了在会议上的美国(US)医生发言人与这些公司的财务利益冲突(FCOIs)的普遍性。方法:收集过去3年制药公司向在ODAC会议上讨论MRD的美国医生发言人支付的公开数据(可在https://openpaymentsdata.cms.gov/上获得)。对于每笔一般付款,我们记录了金额、付款人、付款原因和相关产品。描述性分析进行了支付的公司谁制造MM治疗(MM支付)。结果:有资格在OpenPayments数据库中记录fcoi的20名医生发言人中有12名(60%)在2021年至2023年期间收到MM付款,总额超过792,200美元。大多数有投票权和无投票权的成员都有MM付款(中位数为11,800美元和764美元),其中大部分是咨询费。演讲者从与mm相关产品相关的普通合伙人那里获得的收入是与非mm相关产品相关的普通合伙人的3.7倍以上。结论:在2024年4月的ODAC会议上,大多数美国医生演讲者都有来自MM公司的fcoi,包括那些有投票权的fcoi。政策摘要:我们的研究结果强调了在参与癌症药物监管政策的美国医生中加强fcoi监管的必要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Cancer Policy
Journal of Cancer Policy Medicine-Health Policy
CiteScore
2.40
自引率
7.70%
发文量
47
审稿时长
65 days
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