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?

Noah J Carr; Alyson Haslam; Vinay Prasad

doi:10.1016/j.jcpo.2024.100529

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?

J Cancer Policy. 2024 Dec 6:43:100529. doi: 10.1016/j.jcpo.2024.100529. Online ahead of print.

Authors

Noah J Carr¹, Alyson Haslam², Vinay Prasad³

Affiliations

¹ University of Arizona College of Medicine - Phoenix, Phoenix, AZ, USA.
² Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
³ Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA. Electronic address: Vinayak.Prasad@ucsf.edu.

PMID: 39647696
DOI: 10.1016/j.jcpo.2024.100529

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.

Keywords: FDA; MRD; Myeloma; Oncology; Surrogate.