The FDA
- Tabarrok criticisms of the FDA.
- Dr. Marty Mackary says this : "As a Johns Hopkins scientist who has conducted more than 100 clinical studies and reviewed thousands more from the scientific community at large, I can assure you that the agency’s review can be done within 24 to 48 hours without cutting any corners." [https://thedispatch.com/p/fda-career-staff-are-delaying-the "FDA Career Staff Are Delaying the Vaccine As Thousands of Americans Die: We’ve gone from ‘Operation Warp Speed’ to develop a vaccine to ‘Operation Turtle Speed’ to review It," Marty Makary ( Dec 4, 2020).
If my research team, normally tasked with analyzing data on millions of patients, was asked to review the smaller Pfizer vaccine study of 43,000 patients, it would take about one hour.
The FDA also reviews manufacturing data from Pfizer on how they made the drug. But not only can that data be reviewed in a few hours, it should have been done months ago when it was available. While the FDA was waiting for Pfizer’s long-term vaccine results to come in, the agency should have anticipated this step and done it early.
The final step of the FDA review is to look at the outcomes of the study volunteers, including rates and severity of infection and side effects in the vaccine and placebo groups. Again, there is no plausible reason why this basic analysis cannot be done in 24 hours. The FDA and external scientists have a simple task: confirm or reject the review already conducted by the trial’s independent data safety monitoring board before FDA submission.
Let me be clear: The agency should not cut any corners in its review process, just cut out the sitting-around time. FDA insiders say the agency and its approximately 17,000 employees were dark for the four-day Thanksgiving holiday, including those working on the vaccine approval. It’s time the FDA adopts a sense of urgency.
- Eliezer Yudkowsky tweet, November 2021. He also cites a good Astralcodex10 post on the situation.
FDA plans to kill 50,000 Americans over the next month - over 16X the direct casualties from 2001/9/11 - by keeping it illegal for doctors to prescribe Paxlovid. Can no one stop these homicidal supervillains?
Vaccines
"Moderna had to disclose to the FDA that one of the coronavirus vaccine patients got struck by lightning; after a review, this was declared probably unrelated." "WebMD, And The Tragedy Of Legible Expertise What does running a medical database teach you about why everything sucks?" http://astralcodexten.substack.com
Johnson & Johnson and Novavax are also safe and effective, far better than we need them to be. They both held onto their data longer than they would have in a sane world, and took longer to collect it than they would have in a sane world, but there’s nothing other than bureaucratic delays now standing in our way. Johnson & Johnson is expected to get its approval at some unspecified date, presumably this month. Yet there is no sense of urgency.
AstraZeneca is even more egregious. There are doses ready to go, it has been approved by major regulatory agencies elsewhere, and the main objections seem to be “the data isn’t from Americans” and “we’re mad at you about previous mistakes so we need to punish that somehow.” We are still going to wait until April or so for the American data, plus the delays after that, unless something changes and the new administration and/or the FDA see themselves as sufficiently blameworthy for not approving the vaccine. This badly needs more outrage. There’s an increasing amount, but so far it’s nowhere near enough.
Sputnik is the least egregious. Not using it is going to get a lot of people killed, but it’s a Russian project largely motivated by national pride, that never held out any hope of convincing us to trust it and always planned to distribute its doses in Russia and then the third world, so I can sort of understand this one. I’ll settle for the other five. https://thezvi.wordpress.com/2021/02/04/covid-2-4-safe-and-effective-vaccines-aplenty/#more-22373
If you’re running out of vials in which to put your vaccine, you should put as much as possible into each vial, and also yes more money would have accelerated vaccine production and more money still could do so. Moderna is therefore asking the FDA permission to put more doses in the vials, which somehow they need to do, and also the answer wasn’t ‘yes of course do that I know technically you had to ask but this really, really isn’t a question.’ ...
I think this is being too charitable. The correct timeline involves not having to check at all, and correct timeline where approval is necessary to avoid other stupid cases doesn’t waste the day confirming and you get a yes during the call. Also, note that this is saying the FDA could approve it within weeks, but also might not. We’re supposed to think this is fast and praiseworthy for literally ‘put more of the same liquid into the same vials.’ That’s the standards we’re judging ourselves against these days. https://thezvi.wordpress.com/2021/02/04/covid-2-4-safe-and-effective-vaccines-aplenty/#more-22373
