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...
Related Articles
By Eric Schmidt, TIME | 04.16.2024
Imagine a world where everything from plastics to concrete is produced from biomass. Personalized cell and gene therapies prevent pandemics and treat previously incurable genetic diseases. Meat is lab-grown; enhanced nutrient grains are climate-resistant. This is what the future could...
By Harold Brubaker, The Philadelphia Inquirer | 04.04.2024
Acompany started by University of Pennsylvania scientist Jim Wilson has received FDA approval to test a form of gene editing in infants for the first time in the United States, the company said Thursday.
The Plymouth Meeting company, iECURE, is...
By Carey Gillan, UnSpun | 03.18.2024
A Mexican standoff with the United States turned into a Mexican smack-down this month with the release of Mexico’s formal rebuttal to US efforts to overturn limits Mexico has ordered on the use of genetically modified (GM) corn and the...
By Billy Perrigo, TIME | 03.11.2024
The U.S. government must move “quickly and decisively” to avert substantial national security risks stemming from artificial intelligence (AI) which could, in the worst case, cause an “extinction-level threat to the human species,” says a report commissioned by the U.S...