I cannot tell you how deeply concerning this all is. From cancer to Alzheimer's @FDA is now saying data-is-optional. Seriously folks, why are we paying for drugs that don't have a demonstrated clinical benefit? Why? Because it's big business, but who's making a killing? 2/
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I'll say it again, for the folks in the
@WhiteHouse like@WHCOS,@stephenscha,@AmbassadorRice. Approving drugs without clinical benefit, in which your advisory committee members are resigning, the taxpayers are going to pay a fortune for a drug is NOT something to celebrate. 3/2 replies 29 retweets 140 likesShow this thread -
This is not innovation, this is not responsible drug development: it's a race to the bottom where we know less and less about the drugs we put in our bodies and pay more and more for them. 4/
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Gregg Gonsalves Retweeted Mark Friedberg
And it simply turns drug development into wealth transfer to companies without any documented societal benefit. It's corruption and regulatory capture. And if you can't see it, you're part of it. 5/https://twitter.com/MWFriedberg/status/1402070385974251521 …
Gregg Gonsalves added,
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This has been going on for decades as Daniel Carpenter documents in "Reputation and Power, Organizational Image and Pharmaceutical Regulation at the FDA" where the agency has started shifting to the right, towards deregulation by a thousand cuts. 6/pic.twitter.com/MbEFZBafAW
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But over the past few years the
@US_FDA has developed a startling case of Stockholm syndrome and started to identify with its captors. It does industry and the deregulatory right's bidding all on its own. 7/pic.twitter.com/VGxw0pwY0u
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The Aduhelm decision is a bad one. Full stop. Let's stop making excuses. 8/pic.twitter.com/1ASXLda0PY
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@DrWoodcockFDA's role here, her role in Sarepta's Exondys, in Sprout's Addyi ("pink Viagra"), the Avandia scandal, her just frankly gonzo comments on Plan B contraception OTC as promoting sex cults, to opioid approvals makes her unsuitable to be commissioner. 9/2 replies 2 retweets 44 likesShow this thread -
In fact,
@FDA needs an overall. A big one. It's on the verge of regulatory capture, by industry, by the deregulatory right, a set of academic clinicians who are deeply implicated in all this and patients groups in hock to the companies. We are not in a good place right now. 10/3 replies 6 retweets 69 likesShow this thread -
They don't need an overall. They need an overhaul. I am laughing at myself.
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A big overall, but with no pocket for special interests to climb into!
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