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OH CHRIST—Trump HHS just did full “power grab” takeover of all drug/vaccines. Via “stunning declaration” of authority, HHS Secretary Azar barred FDA from signing any new rules—power now “is reserved to the Secretary.” Trump now controls all of it. #COVID19 https://www.nytimes.com/2020/09/19/health/azar-hhs-fda.html
2) “Outside observers were alarmed by the new memo and worried that it could contribute to a public perception of political meddling in science-based regulatory decisions. Dr. Mark McClellan, who formerly headed the F.D.A. For Bush said the policy change was ill-timed...
3) “We’re in the midst of a pandemic, when trust in the public health agency is needed more than ever,” he said. “So, I’m not sure what is to be gained with a management change with respect to F.D.A. when they are doing such critical work.”
4) “Dr. Peter Lurie, of the @CSPI and a former associate commissioner of FDA, called the new policy “a power grab.”
Many rules issued by federal health agencies are signed by lawyers or by heads of agencies. The new memo requires Trump’s political HHS secretary to sign them.
Many rules issued by federal health agencies are signed by lawyers or by heads of agencies. The new memo requires Trump’s political HHS secretary to sign them.
5) What this means is that Trump HHS secretary now wields to power to approve/reject a drug or vaccine with an EUA (emergency use authorization). Many problem w/ vaccine EUA is once it’s approved—some: a) people hesitant, b) not want to be part of trial anymore / other trials...
6) ...which makes future vaccines much harder. Let’s say first generation vaccine maybe only 40% effective. But next generation vaccine maybe 80% effective. Instead of just proving 80% vs placebo, they also have to prove 80% is better than the 1st gen 40% vaccine. MUCH HARDER!!!
7) Which unless they invest in 2-3x the people in next gen trials, we might get actually stuck with the first gen vaccine, which we don’t know even enough about if they EUA approve it and then get murky data afterwards. And the new stopping rules are super weak...
8) as Dr Topol points out, the EUA is criteria is set so weak that HHS can declare EUA if it just “may be effective”! Which means they would only need just 26 infections to “fulfill stopping rule and support efficacy”. 26 is not many at all! https://twitter.com/erictopol/status/1307381526548504576
9) This weird stopping rule is deemed “unusual” and “aggressive”. https://twitter.com/erictopol/status/1307381524443013120
10) How weak and usual is it? It’s so weak that it’s basically something a small Phase 2 trials can do. Dr Topol even equates it to “Russian vaccine approval and roll out”. Yes. You read that right. https://twitter.com/erictopol/status/1307381531946565632
11) this minimal “may be effective” criteria is a frigging “rush job” says Topol. https://twitter.com/erictopol/status/1307381536539328512
12) And the difference isn’t like waiting months and months, to hit a good threshold for data confidence with 150-160 infection events, we only need to wait a few more weeks longer that the rushed criteria to get the better data. Just a few extra weeks. No political rush job! https://twitter.com/erictopol/status/1307381538519044097
13) We ultimately need rigorous data. “There are ways to accelerate that process, but it is important not to cut corners, lest the public lose confidence and refuse a vaccine. But that doesn’t mean compromising robust data to prove safety and efficacy.” https://www.wsj.com/articles/a-fast-coronavirus-vaccine-without-cutting-corners-11590954444?redirect=amp#click=https://t.co/CdfU6yrV5f
14) Bottomline: the trial thresholds just seems so rushed and with a super low bar. And with FDA no longer the ultimate approver — Trump HHS now holding the power to approve drugs/vaccines via a power grab — it’s quite worrying that science will lose to Trump HHS politics.
15) Clarifying non-inferiority trials—yes it is expected next gen drug need proof it’s better than the old drug—but what an early stoppage of trial for a LOW/WEAK threshold is that we don’t know what 1st gen efficacy actually is. We won’t then know 2nd gen is really 80% either.
16) Also note, @ScottGottliebMD, who preceded Dr. Hahn as FDA commissioner, “spent much of his nearly two years as head of the agency fending off the new policy, which has been on the conservative agenda for many years.”
17) “former senior officials with the F.D.A. & H.H.S. speculated that the intent was to remove rule-making power from Dr. Stephen Hahn, the F.D.A. commissioner and to send a signal to President Trump that no surprises would come from the agency in the weeks before the election.”
