Six years ago, Genevieve Lane was enjoying an active life in Florida when she began to forget her neighbors’ names and where she put her keys. At 76, she might have shrugged off these lapses as mere signs of aging, but when she began to have moments of confusion and occasionally got lost while out walking, her housemate and longtime friend Vicki Holmes told her about a nearby research center. There, a doctor diagnosed her with early Alzheimer’s disease and told her about a study testing a promising new drug. Lane enrolled, telling her daughter she wanted to have more time.
Soon after she started receiving the twice-monthly infusions, she and Holmes believed her memory was improving. “In the beginning, we really thought it was working,” said Holmes. But Lane was not on the drug; she was getting the placebo, infusions of saline. When the trial concluded after 18 months, she began receiving the real drug, brand-named Leqembi, as part of the study’s extension phase.
Six weeks later, Lane was dead.
Lane’s family asked for an autopsy. “I thought the drug killed her,” Yvonne Battaglia, her daughter, told The Lever. “I didn’t trust the drug or the drug company.” But the research firm hired by the drugmaker and the hospital where she died both said they could not conduct an autopsy. So Battaglia and her family hired an independent neuropathologist themselves.
The pathologist found Lane’s brain littered with ruptured blood vessels, widespread inflammation, and areas of dead cells. A second autopsy, performed at Vanderbilt University Medical Center, where the family donated her brain, confirmed the cause of death: severe cerebral inflammation, likely due to Leqembi.
She was not the only patient harmed while taking the drug. Although the company that makes Leqembi reported no drug-related deaths during its 18-month study, four deaths tied to the drug occurred later during the study’s extension phase, which involved 714 patients taking the drug. And death was not the only catastrophic outcome. During the main trial, at least two patients who started out with only mild memory problems were left disabled after being put on the drug, incapable of caring for themselves or recognizing their families. Twenty-two percent of patients taking Leqembi developed brain hemorrhage or swelling — more than double the 10 percent of those on the placebo.
When I am prescribed a drug for a particular reason I will always ask for an older rather than a "new and improved" alternative. One sure way of knowing this is if the drug has a generic which indicates it's been around a while; I'll let somebody else be the guinea pig.
Allowing these companies to rush medications through the approval process stating that the testing will basically be done after the drug goes on the market is a pact with the devil. How many times have we seen marketed drugs pulled off the market because of serious adverse side effects at intolerable levels. If we can’t trust the FDA we might as well pack it in and do whatever the hell makes us feel good for as long as it lasts. Drug companies should be banned from lobbying.