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Ah yea, thalidomide. That drug is often used to justify poor policy decisions at the FDA. It's the reason the FDA banned women of child bearing age from clini
by elliekelly 8y ago
Ah yea, thalidomide. That drug is often used to justify poor policy decisions at the FDA. It's the reason the FDA banned women of child bearing age from clinical research.[1] In the late 80's there was even a study conducted to determine the relationship between obesity and risk for breast and uterine cancer. Guess how many women were enrolled? Zero. Thanks to the FDA's misguided knee jerk policy response to thalidomide.
It seems to me the FDA's process might "protect" a small number of people but that comes at the expense of many thousands of lives.
[1]https://www.drugwatch.com/news/2018/07/25/excluding-women-from-drug-trials-kills-people/ https://www.drugwatch.com/news/2018/07/25/excluding-women-fr...
- refurb 8y agoHey, I don’t disagree that that FDA is very conservative. My comment was more around the politics of it. Look back at the Vioxx hearings. People crapped all over the FDA because they didn’t catch an increased risk of CV issues until post-approval. If you’re the FDA, it’s “damned if you do, damned if you don’t”.
- elliekelly 8y agoThat’s fair and the struggle for all regulators I would imagine (though the stakes are higher with human health). The crypto people drive me nuts the same way. One minute they’re extolling the virtue of markets “free” from regulatory interference but the second it turns out the market was a scam they want to know what the government plans to do to get their money back.