A recent investigation by The New York Times revealed that two pharmaceutical companies, Eisai and Eli Lilly, withheld critical genetic risk information from volunteers during clinical trials for Alzheimer's drugs, Leqembi and Kisunla.
The trials, conducted between 2021 and 2024, sought to test these experimental drugs designed to slow cognitive decline by removing amyloid plaque in the brain. However, the Times found volunteers with certain genetic profiles were at an elevated risk for serious brain injuries, including bleeding and swelling.
One of the volunteers, 79-year-old Genevieve Lane from Florida, died in September 2022 after experiencing severe brain hemorrhaging while participating in the Leqembi trial. Documents obtained by the Times showed that drugmaker Eisai had identified volunteers with genetic profiles that made them more vulnerable to these side effects but chose not to inform them.
In total, more than 100 participants experienced brain bleeding or swelling, with most cases deemed mild. However, two deaths, including Ms. Lane's, were linked to the drug's side effects. Despite the risks, the FDA approved Leqembi in early 2023, determining that its modest benefits outweighed its risks.
While Eisai and Eli Lilly have defended their decisions, citing the need to avoid skewing trial results, the revelations have raised questions about the balance between scientific advancement and patient safety. The investigation also casts doubt on the amyloid-targeting approach, which has dominated Alzheimer's research for decades.