The FDA Is Broken
By Shannon Brownlee and Jeanne Lenzer,
Washington Monthly
| 07. 10. 2021
How the Food and Drug Administration messes up approval of new drugs including the new one, aducanumab, that supposedly helps Alzheimer’s disease patients.
Between 2010 and 2015, drug companies submitted data to the U.S. Food and Drug Administration (FDA) for three different drugs for Alzheimer’s disease, a devastating condition that afflicts six million Americans. The FDA rejected all three because the manufacturers failed to provide convincing evidence that their drugs actually improved symptoms of Alzheimer’s much less cured the disease. How times change. Last month, when biotech company Biogen came to the FDA with data on aducanumab, yet another Alzheimer’s drug, the evidence the company brought once again failed to show that the drug could slow or stop Alzheimer’s cognitive decline. This time, however, the FDA gave the drug a green light, prompting Michel Vounatsos, CEO of Biogen, to pronounce the decision “historic.”
It was historic all right, but not in the way Vounatsos probably meant it. The scientific data for aducanumab is so flimsy and contradictory, ten of 11 members of the FDA’s advisory committee of outside experts voted against approving the drug (the eleventh abstained). Even the FDA’s own statistician recommended the drug be rejected. When higher ups at...
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By Jacob M. Apel, The Baltimore Sun | 08.16.2024
By Neha Kondaveeti, The Austin Chronicle | 08.16.2024
It’s been a busy couple of months in biopolitics, with developments in the US, UK, China, Japan, and implicitly on Mars. Time for a brief roundup.
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Bioethics needs an update
The National Research Act is now 50 years old. It was signed into law on July 12, 1974, as a direct response to publicity about the 1932 “Tuskegee Study of Untreated Syphilis in the Negro Male.” The Hastings Bioethics Forum celebrated its anniversary with an...
Image courtesy National Human Genome Research Institute
The U.S. Food and Drug Administration (FDA) is supposed to encourage effective medical advances while also ensuring that patients and research subjects are protected. This dual mandate demands tricky judgment calls that are made more difficult by outside pressures of several kinds, political, judicial, and especially commercial. This April story at Bloomberg examines one deeply troubling pattern of regulatory capture:
Americans Are Paying Billions to Take Drugs That Don’t Work
Companies are increasingly...