. . .That is why the recently released results of an investigation by two House of Representatives committees into the Food and Drug Administration’s approval of Aduhelm, a drug to treat Alzheimer’s disease, are perplexing. It found that despite significant uncertainty about whether the expensive drug worked to slow or reverse patients’ symptoms, the FDA’s process for approving it was “rife with irregularities.” It concluded that the agency’s actions “raise serious concerns about FDA’s lapses in protocol.”
The report illustrates that the FDA is having problems threading the needle between Type I and Type II errors. As a longtime veteran of the agency and the author of a favorably received book about it, I can bring some insight into the issue. Here’s the bottom line: The FDA is not following the science.
I spent 15 years as the FDA’s “biotechnology czar” at a time when many of the biopharmaceutical companies were small startups needing guidance as they negotiated the regulatory maze. However, the agency’s recent involvement with biotechnology company Biogen, the manufacturer of Aduhelm, went far beyond “guidance” and was highly unusual in many ways.
At the FDA’s urging, the drug was resurrected three months after the company had canceled clinical trials because the drug appeared not to work. Subsequent developments over the next year were marked by at least 115 meetings, calls, and email exchanges between the company and the FDA, according to the report from the Oversight and Reform and Energy and Commerce committees.
Regulators assumed a major role in rebooting the company’s narrative and the effort to get the drug approved, even though there were substantial reservations about the effectiveness of the drug among several factions within the FDA, especially its statisticians, and even within Biogen. (Read more from “With New Alzheimer’s Drug, Biden FDA Is Not Following the Science” HERE)
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