In a recent report by The New York Times, alarming findings emerged surrounding Eisai’s new Alzheimer’s drug, Leqembi, which debuted in 2023. Genetic testing has revealed that certain patients participating in the clinical trials might face brain damage due to their genetic predispositions, yet the pharmaceutical company failed to communicate these critical risks to the volunteers involved.

By 2021, nearly 2,000 volunteers had signed up for the clinical trials of another Alzheimer’s drug, BAN2401, which, if successful, could yield significant profits for Eisai. Researchers have spent over a century attempting to find treatments for this devastating disease.

Eisai specifically targeted individuals with genetic profiles that indicate a higher susceptibility to Alzheimer’s for their trials assessing the drug’s efficacy and safety. However, these individuals faced an increased risk of brain hemorrhaging or swelling while using the new treatment.

The report indicates that Eisai informed all volunteers that genetic testing would identify high-risk groups for participation, but the results of those tests would not be disclosed to the participants.

According to documents obtained by The New York Times, 274 trial participants actually belonged to a high-risk group susceptible to brain damage, yet Eisai did not disclose this information.

One tragic example is Genevieve Lane, a 79-year-old woman from Florida. After receiving three doses of the new medication, she suffered a 51% incidence of microhemorrhaging in her brain, ultimately leading to her death in September 2022. Autopsy findings indicated that the drug’s side effects were the cause of her demise. In her final hours, Lane experienced severe tremors, requiring nurses to bind her to her bed for safety.

The report also highlighted another participant from the high-risk group who died after joining the trial, with over a hundred others suffering from brain swelling or bleeding. Most of these cases were mild or asymptomatic, but a few were severe enough to leave individuals in critical condition.

Matthew Schrag, a neurologist at Vanderbilt University who participated in Lane’s autopsy, commented, “This is a drug with serious side effects, and we have to be extremely cautious.”

In 2023, Eisai’s Alzheimer’s drug received FDA approval and launched under the name Leqembi. The FDA stated that the benefits of the new drug outweigh the risks and that it could help slow cognitive decline.

Additionally, in July of this year, the FDA approved a second Alzheimer’s drug, Kisunla, developed by Eli Lilly. Reports indicate that during its clinical trials, Lilly also failed to inform 289 participants from high-risk groups about the potential risks of brain damage associated with the treatment.