Streetwise Professor

April 24, 2021

Why Is Proof of Efficacy Required for Pharmaceutical Interventions, But NOT Non-Pharmaceutical Ones?

Filed under: China,CoronaCrisis,Economics,Politics,Regulation — cpirrong @ 11:43 am

Under Federal law, a pharmaceutical intervention must be proven safe and effective before it is marketed to the public. If after introduction it proves unsafe or ineffective, the Food and Drug Administration can rescind its approval.

Note the burden of proof: the manufacturer must prove safety and efficacy. Safety and efficacy are not rebuttable presumptions.

Would the same be true of non-pharmaceutical interventions (NPIs). This neologism (neoanacronym?) is used to describe the policies that have been imposed during the Covid Era–most particularly, lockdowns and masks.

Neither had been proven safe or effective prior to their wholesale–and I daresay, indiscriminate–use. Lockdowns in particular had never been subjected to any clinical experiment or trial. Indeed, the idea had been evaluated by epidemiologists and others, and soundly rejected. But a policy first introduced in a police state–China–spread just as rapidly as the virus to supposedly non-police states despite it never having been proven efficacious or safe.

A year’s experience has produced the evidence. Greetings, fellow lab rats!

And the evidence shows decisively that lockdowns are NOT effective at affecting any medically meaningful metric about Covid. This American Institute of Economic Research piece provides an overview of the evidence through December: subsequent studies have provided additional evidence.

Furthermore, lockdowns have been proven to be unsafe. Unsafe to incomes, especially for those whose jobs do not permit working from home. Unsafe for physical health, in the form of inter alia deferred cancer diagnoses and treatment for heart attacks and strokes and greater substance abuse (with higher incidence of overdoses), as well as delayed “elective” surgeries that improve life quality. Unsafe for mental health. Unsafe for children, in particular, who have experienced debilitating social isolation and profound disruption in their educations. (Although given the trajectory of American public education, especially post-George Floyd/Derek Chauvin, feral children might be better off than those subjected to the tortures of a CRT-infused curriculum and CRTKoolAid drinking “educators.”)

Masks are not as devastating as lockdowns, but they have also been shown to be ineffective and also unsafe, especially for those who must wear them for extended stretches–which includes in particular children at school.

(Remember “For the children”? Ah, good times. Good times.)

Drug regulation was one of the first major initiatives of the Progressive Era, and the 1962 FDA Amendments that imposed the efficacy requirement were also driven by progressives. My assessment of the economic evidence (especially the literature spawned by my thesis advisor, the great Sam Peltzman) is that the efficacy requirement in particular has been harmful, on net, because it delayed and in some cases prevented the introduction of beneficial therapies.

But even if–especially if–you accept the progressive-inspired conventional wisdom regarding pharmaceutical intervention regulation, you should be dismayed and even furious that the same logic that has NOT been applied to NPIs. The underlying principle of drug regulation has been “show me”: show me something works. The underlying principle of Covid Era ukases has been: “Evidence? Evidence? I don’t have to show any stinkin’ evidence.” Indeed, it’s been worse than that: those who demand evidence, or even politely point out the lack of evidence, are branded as heretics by the very same “progressives” who believe religiously that requiring proof of efficacy of drugs is a good thing.

How to square this circle? How to explain this seeming contradiction?

I think it is as plain as the nose on your face. Power. In particular, power exercised by progressive technocratic elites. The FDA acts empower a progressive technocratic elite. Lockdowns and mask mandates empower a progressive technocratic elite–far beyond the wildest dreams of the most zealous FDA bureaucrat. (They also empower idiot politicians who imagine themselves to be part of some elite.) They are both premised on the belief that individuals are incompetent to choose wisely, and must be coerced into making the right choice. Coerced by credentialed elites who are better than you proles.

So an apparent logical inconsistency–proof of efficacy for thee, but not for me–is in fact no inconsistency at all. They are both who, whom. A soi disant elite (ha!) always pushes the alternative that gives them the most power, and deprives you of the most choice. Who (the progressives): Whom (you).

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  1. Professor: even pharmaceutical efficacy and safety of vaccines is not proven – not one of them received license from the government. They all, including pfizer, are operating under emergency mandate. Not one of them has followed established lawful procedure of proving they are safe to use and are effective against the malady they purport to eliminate.
    And now they even do not state that! They aim to milk the government and people indefinitely – by explaining the virus mutates (D’Oh!) therefore they have to adjust their concoctions and submit population to “busters” – at least annually, but who knows, maybe tomorrow they’ll “scientifically” decide we need a “booster” every month or so. While they continue misappropriate public and private funds.

    So if they don’t follow protocols for pharmaceuticals – how do you expect them to cease control via lockdowns and ritual mask-wearing? They will push, oppress and bully and increase pressure until receiving-end patience will go bump.

    They are totalitarian gang, like all champaign-socialist nomenklatura.

    Comment by Tatyana — April 24, 2021 @ 12:39 pm

  2. “boosters”, not “busters”.

    Comment by Tatyana — April 24, 2021 @ 12:40 pm

  3. David Starkey made an interesting comment on YT, “having been infected by a Chinese virus, we’ve taken Chinese measures and we’ll have a Chinese society”.

    I’ve got no argument with EUA, it’s a valid, legal process to being a medical product to market earlier. People that decry “red tape” can’t then turn around and complain when we use a process to reduce it. Better question is why all the red tape. We waived a lot DOT trucking regulations on HOS during COVID, which perhaps be the HOS all the time—be careful out there, rest when you need to and drive safely.

    Comment by The Pilot — April 24, 2021 @ 2:47 pm

  4. Sounds like you’re upset that elected governments are making policy. Elections have consequences!

    Comment by aaa — April 24, 2021 @ 11:45 pm

  5. @aaa. On the crack again, I see. As if I don’t fucking know that elections have consequences. And as if I can’t object to them.

    Comment by cpirrong — April 25, 2021 @ 2:26 pm

  6. Have you overlooked public opinion? In Britain the polls have routinely shown that much of the public supported “lockdowns”. As so often in a democracy the electorate is to blame.

    “Ah” you may say “but the electorate was subject to effective, pernicious propaganda.” I’ll give you that.

    Comment by dearieme — April 25, 2021 @ 5:16 pm

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