Public Citizen Calls for Investigation Into Alzheimer’s Drug Trials

In response to a New York Times article revealing ethical concerns in clinical trials for Alzheimer&rsquo;s drugs lecanemab (Leqembi) and donanemab-azbt (Kisunla), Public Citizen, a consumer advocacy group, has urged federal authorities to investigate these studies. TrialSite also had questioned the approval of these drugs. According to the report, trial participants were not informed about their genetic profiles, which could significantly increase their risk of brain injuries from the drugs, despite being tested for these genetic factors. Participants were required to sign consent forms acknowledging the risks without access to their test results, raising concerns about informed consent violations.
Dr. Robert Steinbrook, director of Public Citizen&rsquo;s Health Research Group, has called on the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to investigate the trials and the institutional review boards (IRBs) that approved the protocols. Public Citizen argues that withholding critical safety information undermines the principle of informed consent, which is a cornerstone of ethical research practices. Dr. Steinbrook contends that participants, had they been informed of heightened risks, might have opted out of the trials altogether.