Federal Officials Should Investigate Conduct of Alzheimer’s Disease Trials

October 23, 2024

Federal Officials Should Investigate Conduct of Alzheimer's Disease Trials

A disturbing New York Times articleon Wednesday revealed that during clinical trials of two recently approved drugs for Alzheimer's disease, participants were not told whether their genetic profiles increased their risks of brain injuries from receiving the drugs. According to the article, in trials of lecanemab (Leqembi) and donanemab-azbt (Kisunla) "volunteers first had to sign consent forms that said people with certain genetic profiles faced higher risks of brain injuries from receiving the drug, and that participants would be tested for them ¾but not told the results."

Dr. Robert Steinbrook, director of Public Citizen's Health Research Group, calls on the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) at the Department of Health and Human Services (DHHS) to investigate the conduct of the two trials and the actions of the institutional review boards that approved the secrecy provisions. He issued the following statement:

"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. If subjects had known that they were at higher risk of brain injuries, they might have decided not to participate in the trials. This is information potential participants would want to know."

The FDA and OHRP should formally investigate the conduct of the two trials and the actions of the institutional review boards with oversight over the studies. Both lecanemab and donanemab-azbt are drugs with very modest clinical benefits that do not outweigh their substantial safety risks, including brain swelling and bleeding. The FDA should not have approved either drug."