Opinion | The F.D.A.'s Approval of Biogen's Alzheimer's Drug Is a New Low

3 min read
The F.D.A.'s approval of the Alzheimer's drug aducanumab is inexplicable.
In recent years, under steady pressure from the pharmaceutical industry and the patient groups it funds, the F.D.A. has progressively lowered its standards of effectiveness and safety required for drug approvals. New drugs are now more likely to be supported by fewer studies and less adequate clinical trial designs than in the past. Worse, about two-thirds of new drugs are now approved based on what's called "surrogate endpoints" — changes in the body measured by lab tests that suggest a potential benefit — rather than whether a drug meaningfully affects how a person feels, functions or survives.

For aducanumab, the evidence that its manufacturer, Biogen, submitted to the F.D.A. showed no convincing effect on patients' cognitive decline. Its two main trials were stopped early in 2019…
Aaron S. Kesselheim, Jerry Avorn
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