3 ms·

And to think that the FDA still hasn’t given full approval to COVID-19 vaccines based on “an abundance of caution”. Where was that caution now?

CarelessExpert 5y ago
If the FDA views its role as evaluating for harms only and not efficacy, then this isn't itself necessarily a contradiction. That doesn't change the fact that this approval is deeply disheartening and tells us the FDA is cool with any random product claims so long as they don't actively hurt people. But, hey, for all those folks who glory in the good ol' days when men were men and radium was a cure-all, the good news is at this rate we'll be back to snake oil and patent medicine in no time!
adrianN 5y ago
It is unlikely that this drug will be given to a comparable number of people as the vaccines. That makes tail risks a lot less important.
CaliforniaKarl 5y ago
I strongly recommend making Derek's "In The Pipeline" column a regular read, because he provides the information that answers your question. First, there are the number of people who would take the thing. Alzheimer's is terrible, but I think many more people would take a COVID-19 vaccine than have Alzheimer's. A drug that causes problems in 0.1% of people is treated differently when the population size is 29.8 million[0] people of advanced age vs. 7.8 billion people[1] of all ages. Second, the FDA has more than one advisory committee[2]. Which makes sense; I don't expect the world expert on CPAP and BiPAP machines to also be the world export on COVID-19 vaccines. [0]: https://en.wikipedia.org/wiki/Alzheimer's_disease#cite_note-GBD2015Pre-8 https://en.wikipedia.org/wiki/Alzheimer's_disease#cite_note-... [1]: https://www.worldometers.info/world-population/ https://www.worldometers.info/world-population/ [2]: https://www.fda.gov/advisory-committees https://www.fda.gov/advisory-committees

CarelessExpert 5y ago

If the FDA views its role as evaluating for harms only and not efficacy, then this isn't itself necessarily a contradiction. That doesn't change the fact that this approval is deeply disheartening and tells us the FDA is cool with any random product claims so long as they don't actively hurt people. But, hey, for all those folks who glory in the good ol' days when men were men and radium was a cure-all, the good news is at this rate we'll be back to snake oil and patent medicine in no time!

adrianN 5y ago

It is unlikely that this drug will be given to a comparable number of people as the vaccines. That makes tail risks a lot less important.

CaliforniaKarl 5y ago

I strongly recommend making Derek's "In The Pipeline" column a regular read, because he provides the information that answers your question. First, there are the number of people who would take the thing. Alzheimer's is terrible, but I think many more people would take a COVID-19 vaccine than have Alzheimer's. A drug that causes problems in 0.1% of people is treated differently when the population size is 29.8 million[0] people of advanced age vs. 7.8 billion people[1] of all ages. Second, the FDA has more than one advisory committee[2]. Which makes sense; I don't expect the world expert on CPAP and BiPAP machines to also be the world export on COVID-19 vaccines. [0]: https://en.wikipedia.org/wiki/Alzheimer's_disease#cite_note-GBD2015Pre-8 https://en.wikipedia.org/wiki/Alzheimer's_disease#cite_note-... [1]: https://www.worldometers.info/world-population/ https://www.worldometers.info/world-population/ [2]: https://www.fda.gov/advisory-committees https://www.fda.gov/advisory-committees