By Sharyl Attkisson | October 30, 2024
The following information is from Public Citizen.
Public Citizen, a nonprofit consumer advocacy organization, is calling for federal officials to investigate troubling practices in recent Alzheimer’s disease drug trials. A New York Times report reveals that participants in trials for two drugs—lecanemab (Leqembi) and donanemab-azbt (Kisunla)—were not informed if their genetic profiles increased their risk of brain injuries after taking the drugs.
Participants were asked to sign consent forms acknowledging certain genetic risks, but were not given the results of tests that would have revealed if they were personally at higher risk.
“The requirement under federal regulations to obtain informed consent before involving individuals in research is a fundamental protection for research subjects. The revelations about the secrecy provisions in the Alzheimer’s disease trials suggest that the principle of informed consent was undermined.”
– Dr. Robert Steinbrook, Director, Public Citizen’s Health Research Group
Steinbrook emphasized that if participants had known about their increased risk of brain injuries, they may have opted out of the trials. Public Citizen is urging the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to investigate the conduct of the trials and the institutional review boards that allowed such secrecy.
The drugs in question—lecanemab and donanemab-azbt—were approved despite concerns about their modest clinical benefits and serious safety risks, including brain swelling and bleeding.
For more information, read the full press release here.
