The Regulatory Capture Of The FDA

theamericanconservative.com ^ | June 12, 2021 | MAXIM JACOBS

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This week, three members of an 11 member FDA advisory committee of experts resigned in protest over the FDA’s approval of Aduhelm (aducanumab) for the treatment of Alzheimer’s disease. These resignations are extremely unusual, but in this case, understandable.

Aduhelm was approved by the agency despite the fact that both pivotal trials were stopped early because they were judged to be futile, the FDA’s own statistical reviewer did not support approval, and the FDA advisory committee reviewing the application voted it down overwhelmingly. Additionally, in a survey conducted by Endpoint News, whose readership is heavily weighted to biopharmaceutical industry staffers and executives, over 80 percent consider the approval to be a bad idea. So, how did Aduhelm’s June 7 approval happen? Two words: regulatory capture.

Regulatory capture is defined as when a supposedly objective regulatory agency ends up promoting the ends of the industries they are regulating. The FDA has been captured for quite a while. In a 2016 study published in the British Medical Journal, the majority of the FDA’s hematology-oncology reviewers who left the agency ended up working or consulting for the biopharmaceutical industry. In another investigation by Science magazine, 11 of 16 FDA reviewers who worked on 28 drug approvals and subsequently left the agency are working or consulting for the companies they recently regulated.

For example, Dr. Thomas Laughren, a former director of psychiatric products for the FDA, who had a history of less than objective actions while at the agency, left the FDA in 2012 and started a consultancy to help companies focused on psychiatric products navigate the regulator’s approval process. One of these companies is AstraZeneca, maker of Seroquel. He was instrumental in getting Seroquel a broader approval in 2009, going so far as to personally minimize questions about cardiac risk related to the drug at an FDA advisory committee meeting. After approval, however, there was no hiding from these side effects and a warning label had to be added to the drug in 2011.

Back in 2016, there was a major controversy related to the actions of Dr. Janet Woodcock, the current acting FDA commissioner, while she was the director of the Center for Drug Evaluation and Research (CDER). The FDA, at the behest of Woodcock, overruled significant internal dissension to approve Exondys, a therapy for Duchenne muscular dystrophy (DMD), a rare and severe disease which currently has an annual treatment cost of around $1 million per patient per year. Luckily for the public, the FDA published the internal dissension with their approval documents.

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ping

[Macoozie]

so why aren’t these phuckers thrown out windows or swinging from ropes?

[Jane Long]

Yet another gov’t agency bought off, or “captured”, by Big Pharma.

Reminds me of DC swamp critters who become lobbyists, or....are *beholden* to lobbyists.

Scary!

[afsnco]

This is leading up to making the experimental pokes approval as the ONLY treatment for COVID, when the emergency approval SHOULD be rescinded because of the lies about HCQ and Ivermectin. But hey, can’t make money on two drugs that are off patent, but can make a LOT of money on the pokes.

And how many people died because the demoncrats lied about the efficacy of HCQ and Ivermectin?

[zzeeman]

I emailed this out widely... not many are aware of this...