3 ms·

A counter-example: Thalidomide. Refused approval by the FDA multiple times (the drug company kept resubmitting it), there were only 17 children born with Thalid

A counter-example: Thalidomide. Refused approval by the FDA multiple times (the drug company kept resubmitting it), there were only 17 children born with Thalidomide-related birth deformities in the USA. Promoted as a wonder drug for morning sickness, there were 10 thousand children born with birth deformities worldwide. https://web.archive.org/web/20090512235601/http://www.fda.gov/fdac/features/2001/201_kelsey.html https://web.archive.org/web/20090512235601/http://www.fda.go... Perhaps memories of this are shorter in the US precisely because the FDA got this right and there are fewer visible daily reminders why we need drug regulation.

anigbrowl 10y ago
Exactly. When I was growing up in teh Ireland in the 1970s I knew of several people around my (small) town that had the most horrific physical deformities as a result of their mothers' thalidomide use. Perhaps it was a little more visible in Ireland because abortion is illegal there and so pregnancies that would have been terminated in other countries were carried to term there, regardless of the known risks or consequences. But any time someone tells me we don't need something like the FDA my mind goes straight to a picture of a guy with his hands growing out of his shoulders that freaked me out when I was a kid. Anyone, and I don't care how distinguished they are, who talks about drug approval policy without examining cases like thalidomide or DES is a liar. There is no way anyone with the legal/economic insight to have a rational conversation on alternative regulatory structures is not aware of those cases.
tlb 10y ago
The FDA does excellent work on safety from a first-do-no-harm perspective. From that perspective, everything is great. Still, more than 100 million people die every year from diseases. Even with the best available health care, few live beyond 90. So the very best outcome imaginable has not been achieved. The risk with the current FDA is that by minimizing the risk of being harmed by new drugs, we've locked in the current life expectancy of ~75.
- bobwaycott 10y ago
  > Even with the best available health care, few live beyond 90. So the very best outcome imaginable has not been achieved. What if, on the other hand, we have achieved the very best outcome that is safely attainable? We certainly don't want the needle of achievement to start moving downward.
- daveguy 10y ago
  > we've locked in the current life expectancy of ~75. This is just false. The life expectancy has been rising through modern history, except a stagnation in 1993 and one this year. You can't point to 1 data point in 50+ years and say we're locked in. Look at the record with the FDA (data from world Bank) https://www.google.com/search?q=us+life+expectancy https://www.google.com/search?q=us+life+expectancy Granted UK and Japan are doing better. They also have healthier lifestyles in general and strong regulatory agencies.
maxxxxx 10y ago
My mom almost took it when she was pregnant with my sister. Pretty scary.

anigbrowl 10y ago

Exactly. When I was growing up in teh Ireland in the 1970s I knew of several people around my (small) town that had the most horrific physical deformities as a result of their mothers' thalidomide use. Perhaps it was a little more visible in Ireland because abortion is illegal there and so pregnancies that would have been terminated in other countries were carried to term there, regardless of the known risks or consequences. But any time someone tells me we don't need something like the FDA my mind goes straight to a picture of a guy with his hands growing out of his shoulders that freaked me out when I was a kid. Anyone, and I don't care how distinguished they are, who talks about drug approval policy without examining cases like thalidomide or DES is a liar. There is no way anyone with the legal/economic insight to have a rational conversation on alternative regulatory structures is not aware of those cases.

tlb 10y ago

The FDA does excellent work on safety from a first-do-no-harm perspective. From that perspective, everything is great. Still, more than 100 million people die every year from diseases. Even with the best available health care, few live beyond 90. So the very best outcome imaginable has not been achieved. The risk with the current FDA is that by minimizing the risk of being harmed by new drugs, we've locked in the current life expectancy of ~75.

bobwaycott 10y ago
> Even with the best available health care, few live beyond 90. So the very best outcome imaginable has not been achieved. What if, on the other hand, we have achieved the very best outcome that is safely attainable? We certainly don't want the needle of achievement to start moving downward.
daveguy 10y ago
> we've locked in the current life expectancy of ~75. This is just false. The life expectancy has been rising through modern history, except a stagnation in 1993 and one this year. You can't point to 1 data point in 50+ years and say we're locked in. Look at the record with the FDA (data from world Bank) https://www.google.com/search?q=us+life+expectancy https://www.google.com/search?q=us+life+expectancy Granted UK and Japan are doing better. They also have healthier lifestyles in general and strong regulatory agencies.

maxxxxx 10y ago

My mom almost took it when she was pregnant with my sister. Pretty scary.