@samhorwich @ezraklein I was first relieved that there at least was some pushback in the piece and it wasn’t 100% libertarian BS. But after a re-read realized it was a capitulation out of ignorance letting a purely ideological view of the regulatory state drive the narrative. 1/
@samhorwich @ezraklein The main tell here? People like Alex will always say less regulation as the answer to every question. Anyone who knows FDA, the history and politics, will realize the agency has drifted towards appeasement of its critics since the 1980s. I should know. I was one of them. 2/
@samhorwich @ezraklein Did FDA make mistakes over the past year? Surely, but in the larger context, these missteps (and even the agency’s better decision) are now being pitched by Goldwater Institute and others that it‘s now time for guess-what? More deregulation. Ezra walked straight into it. 3/
@samhorwich @ezraklein The truth? FDA is faster than its peer regulators around the world. There are myriad accelerated marketing approval mechanisms now, but we traded away the chance to get evidence about many drugs in our need for speed. 4/
@samhorwich @ezraklein Just a few months ago several companies pulled indications for cancer drugs because they didn’t show clinical benefit but fact is many still remain without proof they extend survival for patients. 5/
@samhorwich @ezraklein But the erosion in the evidence base IS the danger here. Speed of approval, pre-marketing access are victories AIDS activists and others won for patients. But deregulationists want more speed, less evidence. Just is the case. 6/
@samhorwich @ezraklein Someone sent me this yesterday as a set of serious policy proposals from the libertarian right. Let's walk through them shall we? 7/ marginalrevolution.com/marginalrevolu…
@samhorwich @ezraklein "Instituting a codified approval paradigm based on four tiered levels of clinical effectiveness (biomarkers, clinical signs and symptoms, disease modification and clinical outcomes) — with evidence regarding clinical utility progressively increasing.." 8/
@samhorwich @ezraklein "— would greatly reduce the regulatory uncertainty and subjectivity, as well as the time to approval of innovative medicines." Ugh. 9/
@samhorwich @ezraklein So, here what you really have is a cry to allow marketing approval after phase 2 testing of drugs. 'Cause saying approve with biomarkers, signs and symptoms is what you may see in phase 2. 10/
@samhorwich @ezraklein What could possibly go wrong? Well, >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. But hey we can figure it out later. 11/ bio.org/sites/default/…
@samhorwich @ezraklein "With a commitment to apply state-of-the-art technologies (Apple Watch, telemetry and other health monitoring systems) to obtain clinical evidence would allow for additional learnings from use of drugs by practicing doctors treating real world patients." Sob. 12/
@samhorwich @ezraklein Yes. Goodbye clinical trials. Hello Apple Watch! Doctors can figure it out on their own. 13/
@samhorwich @ezraklein We do clinical trials to keep from fooling ourselves. This is a call for a "Yelp" for drugs and other medical products, not a serious proposal for post-marketing evidence generation. 14/
@samhorwich @ezraklein And guess what boys and girls? Once drugs are approved post-marketing evidence generation is hard to compel and we often do not get the data we need about the drugs we put in our bodies. Just one example here. 15/ nature.com/articles/s4157…
@samhorwich @ezraklein But what about this one? "create dual tracks, one the standard FDA process and a second observational track that would bring drugs to market more quickly with the tradeoff being fewer clinical trials..." Why do clinical trials if you can do plan B, "fewer clinical trials"? 16/
@samhorwich @ezraklein I am all for observational studies, rigorously performed as a supplement, not a replacement for RCTs. Again, AIDS activists talked about a parallel track years ago to run along side of RCTs before approval, which was essentially a large pre-approval observational cohort. 17/
@samhorwich @ezraklein But what we're talking about here is observation, not well-defined (hello Apple Watch!), replacing clinical trials. Is there a theme here? You bet there is? 18/
@samhorwich @ezraklein It's faster approval--even if FDA is fastest in the world now--fewer clinical trials, less evidence. What is this really? 19/
@samhorwich @ezraklein Yes, it's deregulation for deregulation's sake, but it's also "back to the future." What do I mean? Read your FDA history. We've been there, done that. 20/
@samhorwich @ezraklein There was a time when FDA just made sure drugs were relatively safe, but didn't have the ability to enforce an efficacy requirement. This is where libertarians are headed. 21/
@samhorwich @ezraklein It was the thalidomide tragedy that gave us the modern FDA and the requirement that drugs actually had to work, show clinical benefit for approval under the Kefauver Harris Amendments. 22/ fda.gov/consumers/cons…
@samhorwich @ezraklein What a lot of people don't remember though is that the FDA initiated the Drug Efficacy Study Implementation (DESI)) for drugs grandfathered into approval at the time. Many drugs were unapproved through this process. 23/ core.ac.uk/download/pdf/1…
@samhorwich @ezraklein So, as we watched FDA stumble last year--HCQ, convalescent plasma, antibody tests--the lesson wasn't to reduce the evidentiary burden at the agency. 24/
@samhorwich @ezraklein The "I could have run the FDA analysis on the Pfizer vaccine on my laptop in 2 hours," contingent is also not credible. They are preying on people's hopes and suggesting if we embraced more deregulation we would have gotten a vaccine a few weeks faster. 25/
@samhorwich @ezraklein But none of these critics were interested in the BS happening at the agency, the political interference throughout 2020. They are looking for a test-case for more of the same. It's a one-note-samba of deregulation always, and forever. end/

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More from @gregggonsalves

1 Apr
Last note to @ATabarrok & @ezraklein. We got lucky w/ vaccines. Many other decisions @US_FDA are made at margins & the push from libertarian right to further weaken the approval process serves no one. We know less & less about what we put in our bodies, pay more & more for it. 1/
We just don't "figure it out later." As @VPrasadMDMPH, @jsross119, @akesselheim have noted evidentiary basis for drugs, etc. is getting weaker. There are opportunity costs, real human dangers about letting ineffective, poorly tested agents out on market. 2/
No one was going to suggest delaying vaccine EUAs w/ the data we saw emerge. Frankly, the process worked. It almost failed w/ hydroxychloroquine because of political pressure, notion that there were few downsides to putting the drug out there for a new indication w/o evidence. 3/
Read 8 tweets
1 Apr
Our roads & bridges are crumbling. Our transportation network: a joke. I've seen better airports in countries the size of Utah. @POTUS isn't betting on big government as @SangerNYT says. 1/ nytimes.com/2021/03/31/us/…
This framing makes it partisan, as if the key question is how big would you like your government? I'd like a 21st century nation please. With basic infrastructure up to code. Write that article. 2/
I mean for god's sake, the Mies-Van-Der-Rohe less-is-more minimalist ideology of government has ruined us. Infrastructure crumbling, public health so weak, education sub-par, inequality so deep. This is not a sign of a healthy nation. 3/
Read 13 tweets
26 Mar
So there are some ghouls on Twitter crowing that "other" states are seeing increases in #COVID19 cases this week, some substantial. The implication is look how good we're doing, compared to those "other" states. 1/
It doesn't matter who is doing it. We should not be heralding the deaths of fellow Americans as if this is some contest. 2/
Some aspects of what has happened are predictable, some are not, but to look at the differences in COVID19 rates right now and use it as a political cudgel to undermine our national response, sound public health practice is gruesome. 3/
Read 7 tweets
22 Mar
I am sympathetic to this case & know some of the authors here, but frankly people from around the world have been saying this for months now. It's largely been coming from the global South, not asking for handouts but transfer of know-how. Great to have these people on board. 1/
But let's not obscure the fact the delays in American leaders speaking out like this has cost lives. We could have had a global plan for scale-up, not a solely domestic one from the start. 2/
Now let's get down to business. @POTUS needs to tell the companies that the USG will underwrite tech transfer, scale-up of production, mobilization of precursor commodities and chemicals, now, today, not this summer. 3/
Read 13 tweets
20 Mar
.@GovRonDeSantis is a @Yale and @Harvard grad. He knows exactly what he's doing in embracing quackery & pseudo-science. It is a calculated, cynical, political move. 1/
It's an embrace of anti-scientific thinking because he thinks this is the way to power. This is his only rationale, his only desire. 2/
This man is dangerous. He would do anything to advance his career. He belongs no where near the Florida Governor's mansion, let alone the White House. He is emerging as a worse, even more scary version of Trump. 3/
Read 6 tweets
19 Mar
No @GovRonDeSantis. You got lucky. And now you're dancing on the graves of the dead. Why don't you go visit the relatives of the 32,000 dead in your state? Those among the 2M infected who will live with long-term effects of #COVID19. 1/
You miserable fuck. Never let a crisis go to waste. You see a way to profiteer from the pandemic for your political future and you're all in. 2/
Sound public health measures still apply. Widen out the lens & you'll see overall, some countries went all-in w/ containing #COVID19 in Oceania/East Asia, while many in the Western Hemisphere & Europe couldn't get it together to do that. Result? They fared better than we did. 3/
Read 11 tweets

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