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Why are Standards So Lax on Covid Drug Approvals?

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Many scientists made a career fighting for better regulatory standards. Strangely, when it comes to the regulatory policy around COVID-19, they are dead quiet. 

First, consider that EUA ( emergency use authorization ) is like accelerated approval. Both require lower levels of evidence, and are predicated on the fact that we’re dealing with a situation that is dire, with few available options. That’s the justification for lower standards, including acceptance of surrogates.

Next, consider that COVID-19 is a life-threatening illness in an older person, for instance someone over the age of 80. For an older person, it rivals cancer or heart disease.

But also consider that COVID-19 is a flu-like illness for most children, particularly in the era of Omicron. It would be incorrect to say children have ever faced an ’emergency’.

Now think about what regulatory experts have said for years. We should be cautious with accelerated approval. We should use it sparingly, and when appropriate. We can’t use accelerated approval for high blood pressure.

It’s naturally follows from this logic that the use of EUA for kids was unjustified. There was no emergency in those ages. The IFR was always comparable with flu. The appropriate regulatory pathway was biological licensing authorization. However, with the exception of a single article that I co-authored in the BMJ, I’m not aware of any one making this case.

Regulatory experts have told us for year that if outcomes are generally favorable, you need a very large randomized control trial to show a benefit. You can’t use a surrogate endpoint. They say, you have to use a measure of what matters to people. This means we should not accept disease-free survival, as it is an unreliable surrogate for adjuvant breast cancer. 

But now think of boosting a 20-year-old man. Antibody titers are also an unreliable surrogate endpoint. Boosting 20-year-olds should not come under the auspices of an EUA. You should do a very large randomized trial to show it has a benefit. And if you can’t run the trial because the sample size is too large that tells you something about how marginal the effect size is.

Think about what regulatory experts said about aducanumab. They said that only 6% of all Alzheimer’s patients would be eligible for the trial. Therefore, we should be careful about generalizing. 

Similarly, take Paxlovid. The only trials that have been published to support its use are in unvaccinated people. There are zero trial data published for vaccinated people. And yet the majority of the uses in vaccinated people. 

Why are the experts who say you can’t extrapolate aducanumab to all’s Alzheimer’s patients not saying you can’t extrapolate Paxlovid to all vaccinated people?

Why are those who say accelerated approval is abused not saying that EUA authority is abused when you move to children, who face thousandfold less times the risk?

Why are the same people who say we need large randomized trials for clinical outcomes for blood pressure pills dead silent on the question of boosting adolescents?

There are at least 3 possible reasons:

Number one. They have not made the connection between the same principles in their mind. This explanation should be rejected. Because you would have to be quite dense to not see the parallels. 

Number two. They think that it is a stronger argumentative position to press the issue in the world of non COVID-19 drugs than COVID-19 drugs. This is the great blunder of their thinking. When you push for the equal application of rational principles, you must push for the equal application of rational principles. If you think you can omit or make sacrosanct some category, then you are irrational. And your opponents can rightly argue that their categories should be exempted. Why should cancer have a higher standard than COVID?

If you want to persuade people on issues, you won’t persuade them if you don’t issue principles. Consistency and clarity hallmarks of clear thinking. 

Number three: They are scared to voice their opinion on COVID-19 issues because they are afraid of the mob. Quite possibly, this is it. And this is likely paired with the fact that it is to there career benefit to not comment on issues outside their perceived scope. And thus they can go to conferences for another 40 years saying the same thing they’ve always said without any progress or advancement. Or, as a friend of mine likes to say, no new ideas. 

I’m fear the right answer is number three. Even though most of these people run large groups or have tenure. They still are thinking of themselves.

And I think it has logical consequences. It’s the reason why people don’t want to be in the academy. You don’t have the freedom, or the incentive to fight when it actually matters. You labor under a curse. You can’t speak of the things that truly matter, when they matter. Your focus is narcissistic, and you will not accomplish any meaningful goals. And we will all fail together. Because regulatory science is just going to get worse and worse.

And the industry is going to take advantage of the crack we have shown in our foundation.

Republished from the author’s Substack

Author

  • Vinay Prasad MD MPH is a hematologist-oncologist and Associate Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco. He runs the VKPrasad lab at UCSF, which studies cancer drugs, health policy, clinical trials and better decision making. He is author of over 300 academic articles, and the books Ending Medical Reversal (2015), and Malignant (2020).


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