The FDA's perpetual process machine

I remember a study where the lab reports were printed on there own printer. The FedEx employee showed up with a labeled box, put the huge stack in it, and left. I think that daily stack of labs cost somewhere in the five figure range each day.

Not that it's impossible that either type exists, but we know that plenty of drugs make it through the system and are regularly prescribed that nevertheless have non-trivial risks, so the idea that the FDA is only evaluating the downsides seems pretty limited in its explaining power.

And as posters frequenting HN should know, systems are hard. Good systems over a domain of any complexity aren't trivial even when incentives are aligned. Economic and political incentives in medical domains aren't always well-aligned.

I'm sure the FDA and industrial incentives could both be improved, but I think it's going to take sharper and more detailed insights than imagining a personality binary.

Political leadership in this situation involves noting the regulatory and bureaucratic hurdles to action and using your authority to supersede them when a pressing situation requires it. Someone has to sit down and say "what needs to happen, what's standing in its way? What orders have to be issue to stop this today?" Someone has to say "this priority is more important than anything else at this point", etc. Just as an example, it shouldn't be hard to notice tests are only being mailed and to stop that this case, etc.

A crisis always requires political leadership because of both the this bureaucracy and the general confusion created by crisis. Many if not all bureaucracy will act ineffectively by default unless someone forces their hand.

Which is to say that the current situation is an abject failure of leadership specifically.

The simple fact is non-partisan non-evil, simply incompetent bureaucrats at the State and Federal levels all failed to adequately prepare (PPE stockpiles) and had actively harmful policies set in place years ago which impeded the response or even actively worsened it, and too many remained in denial once community spread became apparent.

Everything from a stranglehold on testing (FDA) to bungling the test kits (CDC) to flimsy border checks, poor initial contact tracing, to forcing COVID positive patients to nursing homes (Cuomo), to politicizing the quarantine to the point where they lose credibility (open letter from ‘healthcare professionals’ supporting protests).

There’s nothing deep state or evil about it. It’s just the typical failure I expect from my government, blue or red, every time. Sad but true.

To be fair, this was basically America’s first brush with a serious contagion in the modern era. Other countries that did better have had more practice.

Frankly, I don’t think a full fledged multi-trillion dollar response (50-state hard quarantine) was politically possible on January 20th. Trump was acquitted on Feb 5, and Senators skipping impeachment hearings to get informed on COVID were literally being threatened that they would be dragged into the Senate to sit and listen to Ukraine testimony.

From what I can tell, no one in either party was calling for measures stringent enough and early enough to have stopped the situation we have now. Senator Cotton was one who pushed particular hard to ground planes and is credited for that.

Of course at the time the perplexing WHO guidance was against travel bans. Yes, the US certainly isn’t alone in the world in its missteps.

And even if the lockdown had been harder and more consistent, there was still the flubbed testing, the flubbed medical response (ventilators), and the flubbed patient management.

CDC initial tactical teams wanted to treat COVID patients like Ebola carriers, spending what looked like $100k per person in full isolation wards — I guess they were thinking this was going to be 10 or 20 people coming into the country. Then we end up sending sick people into common areas of nursing homes. Then they told people not to wear masks for weeks... Just totally nonsensical top to bottom.