Thread by @Bob_Wachter

Covid (@UCSF) Chronicles, Day 218

1/ Excellent @washingtonpost piece today on Operation Warp Speed, & its (likely) success in moving us from discovery of a new virus to having one or more safe & effective vaccines available in about a year, God willing. tinyurl.com/yybpgcat

2/ Yes, that’s really me quoted below, praising the Trump administration for OSW's success. Bestowing such praise was not easy, since I agree with @KamalaHarris that our overall Covid response may well be the greatest failure of any presidential administration in U.S. history.

3/ But on this one, the administration has gotten it right. While some will quibble w/ choices of which vaccines to bet on, the investments made seem sound – particularly the choice to offer funds to decrease the risk of the companies’ vaccine development process (“de-risking”)…

4/ …& to gear up the manufacturing/distribution channels before the winners have been identified – which I liken to a relay racer getting a head start before receiving the baton. Given new evidence that Covid will result in $16 trillion in economic costs tinyurl.com/y5zcc4c9,

5/ … an investment of $10B seems wise – even if some of the dollars go to making vaccine doses that never reach a human shoulder.

Remember, prior to Covid, the land-speed record for vaccine development was 5 years (for the mumps vaccine in 1967), so this really is warp speed.

6/ It's worth noting that there may still be obstacles ahead. 2 of the vaccines (@JNJNews & @AstraZeneca) have suspended their trials due to safety concerns; today, we learned of a death in the AstraZ trial, though early reports say the person got placebo tinyurl.com/y3no9jdd

7/ But even w/ these problems, most experts believe we’re on track for at least 1 vaccine to meet the efficacy and safety end-points sometime in next 3-4 months. Given the administration’s overall Covid response, one wonders if this is a case of the blind squirrel finding a nut…

8/ …or was something fundamentally different when it came to vaccine development? My vote is for the latter. For vaccines, the government’s role was simple: To provide funding to companies that had a strong incentive to get it right, and then mostly to stay out of their way, …

9/ … which is in sync with Republicans’ instincts on regulation & corporate oversight. And while the administration has been appallingly anti-science, on vaccines it has been fine. For example, there was no hydroxychloroquine-like endorsement by Trump of one vaccine over others.

10/ While a laissez-faire approach can cause trouble, the pharma co's were under enough scrutiny to motivate them to cut no corners. A big error would have threatened their brand, a problem w/ a far greater negative effect than any short-term gain from getting a vaccine out fast.

11/ The scrutiny worked. After Pfizer’s CEO signaled he might aim for an Oct. approval tinyurl.com/y423pfr4, pushback from scientists & MDs tinyurl.com/y6x5acat led him to proceed “at the speed of science,” which meant no results before Election Day tinyurl.com/y2crr86m

12/ Moreover, Trump’s efforts to bully @US_FDA into subverting their usual approval process – which in Sept. seemed likely to work (particularly after the hydroxychloroquine & convalescent plasma debacles tinyurl.com/yxw4hdew) – were ultimately rebuffed. I’m guessing that…

13/ … @SteveFDA Hahn (my co-chief resident) looked at how other scientific/medical officials who had allowed themselves to become yes-men/-women had had their reputations tarred (Redfield, Azar, Conley, Birx…), whereas the one who stood firm had become a national hero (Fauci).

14/ With only a few weeks until an election that Trump is likely to lose, Hahn probably gambled that his & FDA’s future would be better served by defending scientific integrity, even if it led to a couple of nasty tweets. And it worked tinyurl.com/y3x6q2ob. At this point…

15/ …Trump has too many headaches to bother with FDA, and so FDA may emerge from this looking sweet – the agency's prior transgressions overlooked if it passes its final exam: a sound vaccine approval process.

This, of course, assumes Trump loses and we return to quasi-normal.

16/ What else was different about vaccines? Unlike masks, there was little cultural overlay (masks are for wimps), and no challenges to political philosophy (give me liberty or give me death, etc.). Of course, these issues may rear their heads later, when we have to sort out...

17/ … how to allocate vaccines and promote their use. That’s when we’ll hear from the anti-vaxxers, the conspiracy theorists, and the Don’t-Tread-On-Me ideologues. But this too will probably happen on Biden’s watch, and the doubters will be managed thoughtfully, informed by…

18/ ... science & history. The issues of prioritizing vaccines and promoting their use would have provided ample opportunity for Trump & Co. to cause havoc...of the masking, like-the-flu, herd immunity, bleach variety. But hopefully they won’t be around for that part of the show.

19/ One more difference re: vaccines: unlike w/ PPE & testing, where the lack of a coordinated federal response – in part owing to Republican antipathy toward big federal programs – led to local & state action (problematic as that was), for vaccines the action had to be federal.

20/ Maryland could scrounge for PPE, CA could build its own testing/contact tracing programs. But no state could develop a vaccine. If the administration wanted a vaccine (it did, once it realized Covid was real & threatened the presidency), the only path was via federal action.

21/ So the overall dynamics of the situation – a time-sensitive Manhattan Project-like undertaking that could only be accomplished by a handful of international pharma behemoths whose work required federal funding to catalyze & accelerate – mandated a federal response, and the…

22/ … response was fairly straightforward: funding, some oversight, & letting the companies do what they do well: science-based research and creating new products. You may hate pharma for overpricing or for developing me-too meds or drugs for concocted maladies, but you can’t…

23/ …argue w/ the quality of their science. They earn our scorn mostly because they respond to market signals, which often takes them down dark alleys. Here, govt. needed to provide a signal that Covid was a massive priority. And then mostly to stand aside. That's what they did.

24/ How fitting it would be if, in March 21, 1 year from when the 1st Covid cases hit our shores, tens of millions of Americans are being vaccinated, hundreds of thousands of lives are being saved, & the economy is seeing a massive reboot – all under the watch of Biden & friends.

25/ Trump, no doubt, will fume about not getting credit for Operation Warp Speed. He might be right.

But any praise for OWS will need to be tempered by knowing that his admin’s abysmal Covid response in 2020 cost tens of thousands of lives, lives that no vaccine can bring back.