But what about this one? "create dual tracks, one the standard FDA process and a second observational track that would bring drugs to market more quickly with the tradeoff being fewer clinical trials..." Why do clinical trials if you can do plan B, "fewer clinical trials"? 16/
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I am all for observational studies, rigorously performed as a supplement, not a replacement for RCTs. Again, AIDS activists talked about a parallel track years ago to run along side of RCTs before approval, which was essentially a large pre-approval observational cohort. 17/
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But what we're talking about here is observation, not well-defined (hello Apple Watch!), replacing clinical trials. Is there a theme here? You bet there is? 18/
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It's faster approval--even if FDA is fastest in the world now--fewer clinical trials, less evidence. What is this really? 19/
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Yes, it's deregulation for deregulation's sake, but it's also "back to the future." What do I mean? Read your FDA history. We've been there, done that. 20/
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There was a time when FDA just made sure drugs were relatively safe, but didn't have the ability to enforce an efficacy requirement. This is where libertarians are headed. 21/
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It was the thalidomide tragedy that gave us the modern FDA and the requirement that drugs actually had to work, show clinical benefit for approval under the Kefauver Harris Amendments. 22/ https://www.fda.gov/consumers/consumer-updates/kefauver-harris-amendments-revolutionized-drug-development …
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What a lot of people don't remember though is that the FDA initiated the Drug Efficacy Study Implementation (DESI)) for drugs grandfathered into approval at the time. Many drugs were unapproved through this process. 23/ https://core.ac.uk/download/pdf/187701285.pdf …
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So, as we watched FDA stumble last year--HCQ, convalescent plasma, antibody tests--the lesson wasn't to reduce the evidentiary burden at the agency. 24/
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I think this thread would be more persuasive if you also engage with the FDA's Covid missteps which look more like over-regulation, such as disallowing LDTs for SARS-CoV-2 at the start of the pandemic and waiting more than a year before allowing home rapid Ag tests
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I agree here. The key is distinguishing what does absolutely need strict process and why from where there is over-caution or inertia—and acknowledging latter exists. (I am agreeing with Gregg some, but also, I learned the latter more from the early AIDS activists, so some irony).
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For me, the issue around not authorizing antigen tests earlier was the big misstep, and my understanding is that it had less to do with sensitivity/performance and more to do with lack of a process for evaluating how an imperfect test could have real benefits in the community
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Replying to @samhorwich @zeynep and
The mere fact that you couldn't get rapid Binax now without going through the farce of an online evaluation was proof that it needed to be approved for use in asymptomatic individuals or not authorized at all.
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