Regulators approved controversial therapies amid excess deaths, questionable efficacy, and conflicts of interest.
The Lever also found that three of the four FDA physician advisers who voted in favor of Leqembi had financial ties to the manufacturers or other drugmakers. What’s more, data from the clinical trials show the drugs’ effects on cognition and function may be smaller than what patients and their caregivers are typically able to perceive. When the poor results from the studies began to emerge, a panel convened by an influential patient organization tied to the drugmakers suggested a lower benchmark to measure the drugs’ effectiveness.
Buried in the nearly 1,000 pages of FDA analyses of Aduhelm were some troubling findings. When the FDA reviewers compared the amount of amyloid reduction in patients on the drugs to their cognitive function, there was no correlation. In other words, patients could experience a significant reduction of amyloid with no slowing of memory loss.