In a recent report by The New York Times, it was revealed that genetic testing identified potential risks for some patients participating in clinical trials for a new Alzheimer’s drug, Leqembi, developed by Eisai. Alarmingly, the company did not inform volunteers about these critical findings.
By 2021, nearly 2,000 volunteers had enrolled in clinical trials for another Alzheimer’s drug, BAN2401. If successful, Eisai could stand to gain significant profits, with researchers having spent over a century searching for effective treatments for the disease.
In evaluating the new drug’s efficacy and safety, Eisai actively recruited individuals with genetic profiles indicating a heightened risk for Alzheimer’s. However, these individuals faced a significantly increased risk of brain bleeding or swelling when using the new medication. The company informed volunteers that genetic testing would identify high-risk groups, but reassured them that results would not be disclosed.
Documents obtained by The New York Times indicated that 274 participants in the trial belonged to a particularly vulnerable high-risk group, yet Eisai failed to communicate these risks to them.
One particularly tragic case involves 79-year-old Genevieve Lane from Florida. After receiving three doses of the new drug, she experienced microbleeding in her brain, which ultimately led to her death in September 2022. An autopsy report concluded that side effects from the drug were responsible for her death, noting that Lane experienced severe tremors in her final hours, necessitating restraints to secure her to the hospital bed.
The report also mentioned that another participant in the high-risk group died after the trial, while over a hundred others experienced brain bleeding or swelling. Most cases were mild or asymptomatic, but a few involved severe complications.
Dr. Matthew Schrag, a neuroscientist at Vanderbilt University who participated in Lane’s autopsy, emphasized, “This is a drug with serious side effects, and we need to be very cautious.”
In 2023, Eisai’s Alzheimer’s drug received FDA approval, emerging under the name Leqembi. The FDA stated that the benefits of the new medication outweigh its risks, as it may help slow cognitive decline.
In July of this year, the FDA also approved a second Alzheimer’s drug, Kisunla, developed by Eli Lilly. Reports indicate that during the Kisunla clinical trials, the company similarly failed to disclose potential brain damage risks to 289 high-risk participants.
