Key FDA committees are well paid by pharma to approve drugs regardless of their usefulness or safety in order to boost profits, stock price and C Suite compensation.
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This is why pharma stk prices get the boost when drugs enter Phase 2...because Phase 3 is a foregone conclusion...because everyone knows it's rigged. Stk market is merely front running FDA rubber stamp that was bought by pharma.
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Not a refutation, but of note that industry seems to run more rigorous trials (on avg) than the NIH (taking blinding/randomization as proxy for rigor). IMO we need more Phase IV, higher rigor overall, but avoid more time/cost burdens on Phase I-III. https://www.bmj.com/content/361/bmj.k2130 …pic.twitter.com/QCa9vyikDU
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As an Entrepreneur-in-Residence at the FDA, one of our guiding principles was to be the “regulatory body of choice for drug and device manufacturers”. FDA approval is the Gold Standard for safety and efficacy. It'd be a shame to pass that torch to other nations’ regulators.
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I’m not following the connection as to whether FDA should require efficacy for approval.
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Best long run policy would be full deregulation. No licensure and no govt restriction on treatment. Govt as purchaser would set standards for disclosure it requires to buy for Medicare / Medicaid / VA. Otherwise allow full chaos of decentralized decision making. It works well.
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Great to finally see bigger media outlets picking up this topic!
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You might want to peel back the onion on the NSCLC approvals of Tarceva and Avastin. If EGFRmut had not been ignored in Tarceva initial approval, Avastin May never have been approved as well. These approvals were turning points in the
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We learned in the AIDS epidemic-particularly in the early days-that getting drugs on the market more quickly was grossly insufficient. 1/
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We ended up having a decade or more of broad uncertainty about the benefits of the drugs we put in our bodies. 2/
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