Private equity moves into clinical trials
▻https://pestakeholder.org/news/private-equity-moves-into-clinical-trials
In addition to research sites, private equity has also expanded into institutional review boards (IRBs), a critical area of research oversight. These boards are responsible for ensuring that studies involving human participants minimize unnecessary risk and that participants are adequately informed about potential harms. According to a 2023 Government Accountability Office (GAO) report, private equity’s shift into IRBs has been accompanied by significant consolidation, driven by private equity investment. Senators Elizabeth Warren, Sherrod Brown, and Bernie Sanders raised concerns that a for-profit model might create conflicts of interest, potentially incentivizing faster approvals at the expense of thorough ethical review.
A 2024 New York Times investigation into Alzheimer’s drug trials provides an example of private equity’s impact in the clinical trial and institutional review board sectors. The report described how a controversial secrecy clause in a study involving the drug #Leqembi was approved by an IRB operated by Advarra, a company backed by private equity. The article noted that by 2021, just two private equity-backed firms, Advarra and WCG, reviewed 92 percent of drug trials overseen by independent IRBs, a concentration that could compromise objectivity. The Leqembi drug trial resulted in brain bleeding or swelling in more than 100 of the 274 trial participants. Two trial volunteers died. Advarra had approved a “secrecy provision” in the Leqembi trial where participants would be tested for genetic profiles that meant they faced higher risks of brain injuries from receiving the drugs, but not informed of the results. Alzheimer’s experts and bioethicists told the New York Times that the clauses undercut the principle of informed consent.