The non-Trump version of the story seems to be a disagreement inside the public health bureaucracy about the merits of approving a safe treatment whose effectiveness is unclear, part of a bigger debate about FDA procedures.
nytimes.com/2020/08/19/us/…
nytimes.com/2020/08/19/us/…
The FDA normally requires companies to demonstrate that medicines and medical devices are safe AND EFFECTIVE.
Other stuff is regulated more lightly; a dietary supplement that purports to boost the immune system needs to be safe but you don’t need to prove it actually works.
Other stuff is regulated more lightly; a dietary supplement that purports to boost the immune system needs to be safe but you don’t need to prove it actually works.
Since demonstrating efficacy is time-consuming and expensive, one view — a general view not unique to Covid — is we should shift to a pure safety standard that makes it easier to bring things to market.
If it’s safe what’s the harm?
If it’s safe what’s the harm?
The other view is that flooding the marketplace with ineffective medicines is itself dangerous even if the individual drugs are safe — it leaves doctors and patients confused about what to actually do.
A brand new pandemic somewhat shifts the calculus of course.
A brand new pandemic somewhat shifts the calculus of course.
I think the more libertarian view of this has merit, especially given the circumstances of the pandemic, but the president running around overselling the efficacy of a treatment that hasn’t been rigorously tested is *exactly* what worries people about relaxing the standard.
Letting the plasma be used more widely is harmless and possibly helpful; but letting people believe treatments are much more effective than they really are could undermine compliance with safe behaviors and do very real harm.
