Politics, Science, and Money: The Collective Meltdown Over the New Alzheimer ’s Drug

Jeffrey A. SingerOn June 22, theWall Street Journalpublished aneditorial defending the Food and Drug Administration ’s accelerated approval of the controversial new Alzheimer’s drugAduhelm. The drug has been shown to reduce the amyloid plaque that develops in the brains of Alzheimer ’s patients. However, researchers areunsure if the plaque is a cause or an effect of Alzheimer ’s disease, and if reducing the plaque will have any clinical benefit. Critics of the FDA decision claim that clinical trials have failed to produce convincing evidence that the drug does any good.In a recentblogpost I argued that the debate over the new drug misses a larger point: that it was a mistake for Congress to add the efficacy requirement for FDA approval to the agency ’s original mission of assuring safety and proper labeling. The efficacy requirement only serves to delay approval and increase the cost of new drugs. Ironically, here we have a situation in which the FDA approves a drugdespite the fact that its advisory board thinks it lacks evidence of efficacy. Yet, most other times, physicians and suffering patients wait years for the FDA to decide a drug is efficacious and permit them to use it, after which physicians are free to use the drug “off‐​label,” based upon their expertise, judgment, and knowledge of the clinical literature.Furthermore, I point out that complaints about the new drug ’s cost to Medicare should be d...

Source: Cato-at-liberty - June 29, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs