In 'Power Grab,' Health Secretary Azar Asserts Authority Over F.D.A.

[Nevilledog]

Link to tweet

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https://threadreaderapp.com/thread/1307879247550316544.html

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

In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A.
Experts said the memo would make it more difficult for the F.D.A. to issue new rules, but it’s unclear how it would affect the vetting of coronavirus vaccines.
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. 🔥

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!
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9) This weird stopping rule is deemed “unusual” and “aggressive”.
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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.
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11) this minimal “may be effective” criteria is a frigging “rush job” says Topol.
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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!
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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.”

Opinion | A Fast Coronavirus Vaccine, Without Cutting Corners
Rigorous testing will ensure that Americans can trust the shot they take will be safe and effective.
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.”
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[Timewas]

1. well

I didn't trust before so this doesn't change much of anything

[Grasswire2]

4. "all drugs/vaccines"

that power grab doesn't terrify you?

[Timewas]

5. Didn't say that

I was already at my limit so anything new can't add to it any...Just trying o hang on til it is over and hope that is soon..

[hlthe2b]

15. That you don't realize this-- unbelievable orders of magnitude in terms of loss of ethical oversight

and that it marks the total dissolution of our systems of checks and balances for public health protections in regulation, I don't know WHAT to say to you. What an incredible comment for you to make. Unbelievable.

[Grasswire2]

2. terrifying.

Thanks for formatting off twitter.

[Nevilledog]

3. More

Link to tweet

Link to tweet

[Grasswire2]

6. This means all meds, medical devices, etc. are subject to his intervention.

Putin must be truly happy about the chaos this will bring.

[cayugafalls]

7. Another day, another bombshell...

The country is now in shock and they are going all in...

Too much too fast, media can't keep up.

Machine gunning the constitution. You're dead before the last shot.

[Pachamama]

8. I have assumed they were controlling it all along - now they just are confirming it

[Xolodno]

9. That'll see a court challenge.

These agencies are set up by Congress and given authority by Congress. Oh and answerable to Congress. Act of desperation from Dump. The FDA can basically take a piss on the memo.

[regnaD kciN]

13. So, the House can sue...?

Because I'm trying to figure out who has standing to challenge this.

Of course, any such suit would inevitably wind up before the Supreme Court, which, by then, will have a 6-3 right-wing majority, so they'll probably rule it just fine.

[Grasswire2]

10. How will the stock market react to this.......

...........considering that consumer confidence in a vaccine has now likely plummeted.

[PSPS]

11. This nazification is happening at DOJ too, probably everywhere

Barr (trump's ring-kissing proxy) has now insinuated himself as the sole decider of whether or not a career prosecutor can file any charges. In other words, trump decides who does or doesn't get prosecuted for their crimes. Now we learn that trump, through his ring-kissing proxy Azar, is deciding what the FDA can and can't do or approve.

[OhioChick]

12. I'm surprised this isn't front page news...

It should scare the hell out of everyone.

[Nexus2]

16. I don't know if this counts a 'front page'

But they're discussing it on Morning Joe right now. I guess give it time, its difficult to keep up. I expect to hear more about it today.

[radius777]

14. They're paving the way for a rushed vaccine,

as Trump knows he's sinking in the polls and this is his last hope - especially if mealy-mouthed Fauci gets up there and sings its praises.