In a forthcoming review [1], Prof. Rachel Sachs of WUSTL documents the ongoing destruction of FDA …
… then explores scenarios for reconstituting or replacing its functions in future:
This is a typical reactionary article. Almost none of the statisticians I’ve worked with at the FDA in the past 4 years have left. There are many talented and committed people still on task at FDA.
I should take care not to misrepresent Sachs’s argument here. She actually documents a multifaceted attack on FDA that involves more than just personnel attrition (“state capacity”).
These include:
Also, even if statisticians remain, she documents remarkable attrition in leadership:
Cutting out efficacy as a requirement would indeed be a disaster, as has happened for the supplements industry.
Hi All,
In follow up to this discussion, there is a YouTube video that was posted by StatNews (https://www.statnews.com/) this past week with some brief interviews with former FDA staff:
The video was part of an article that StatNews posted earlier in the week, however the article is only available via a subscription to their Stat+ content. Although I have followed StatNews for a number of years, I have not yet subscribed. That article is here:
I thought that the video would be of interest given the topic that was raised here.
On a related note, current FDA Commissioner Makary appears to be on his way out:
The US now represents the ultimate irony: A reason for being fired is not being bad enough.
How we might create something new and better out of the ruins? Could we reconstitute a US FDA where a debacle like Anomal Pharm: Randomized good, statistical bad would get nipped in the bud?
All going according to plan:
Totalitarianism in power invariably replaces all first-rate talents, regardless of their sympathies, with those crackpots and fools whose lack of intelligence and creativity is still the best guarantee of their loyalty
— Hannah Arendt, The Origins of Totalitarianism
