3 ms·

> there is a reason behind much FDA bureaucracy, and it’s to protect people’s health. This is what people don't realize when they try and say the FDA is a bure

by lykr0n 8y ago

> there is a reason behind much FDA bureaucracy, and it’s to protect people’s health. This is what people don't realize when they try and say the FDA is a bureaucratic nightmare. Every process in place is designed to make sure that the drugs that hit the US market work. Look at what happened with Thalidomide. The FDA didn't allow it to hit the US market due to strict requirements about what tests and processes the drug companies were required to follow. Europe had a massive problem, while the US didn't. What most people don't realize or know, is that the FDA will readily expedite promising drugs and/or products if results are promising and the data is valid. Companies, if they have strong data from Phase I or II trials, can be bumped to the top of the review queue or be granted interim permission to sell their drugs before Phase III trials are complete. I personally think the FDA is a great example of a well designed bureaucracy. The value it adds to the public is insurmountable, while not being unreasonable.

beagle3 8y ago
Are there examples other than thalidomide? Because e.g. the FDA was just as bad with Vioxx and worse with OxyContin.
- lykr0n 8y ago
  I, personally, don't consider Vioxx a failing of the FDA. I might be wrong, but reading the Wikipedia article makes it sound like more of issues surrounding the drug's promotion and marketing- not the drug itself (considering the US and Canada both voted to allow it back on the market). And OxyContin's issues (I think) fall on the DEA and not the FDA. Oxy does what it is supposed to do really well, and the side affects are known. I just used Thalidomide as an example of where the FDA got it right. The fact that we havn't see other drugs like that pop up, tells me that the system is working.
  - beagle3 8y ago
    > I, personally, don't consider Vioxx a failing of the FDA. I was following the case in real time, and it certainly looked like a failing of the FDA and being way way too cozy with Merck about it; compared to how it looked then, the wikipedia article looks incredibly white washed. I'm not sure we read the same Wikipedia article - the one I read said that Merck withheld information from the FDA, and makes no mention of any resulting sanctions or penalties (which is exactly how I remember it). Does this sound like a working regulatory agency to you? > And OxyContin's issues (I think) fall on the DEA and not the FDA. Oxy does what it is supposed to do really well, and the side affects are known. Not at all. Perdue made false claims about how long acting OxyContin is, and as a result of the recommended prescription, many people both suffered and got hooked, see e.g. [0], which was the first result for "oxycontin perdue abuse", but by no means the only one. > I just used Thalidomide as an example of where the FDA got it right. The fact that we havn't see other drugs like that pop up, tells me that the system is working. ... to me, the fact that Thalidomide is basically the only example that everyone brings up, it means that the European system is essentially equally effective, despite your implied claim ("Europe had a massive problem, while the US didn't.") that the US one is superior. [0] https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxycontin.html https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxy...
kalleboo 8y ago
The strict requirements in the US came as a result of the Thalidomide case, not before it. Thalidomide was stopped mostly thanks to pure luck that a talented newly-hired examiner got the case, and the outcome was used by the Kennedy administration to push through the strong regulation we have today https://mobile.nytimes.com/2015/08/08/science/frances-oldham-kelsey-fda-doctor-who-exposed-danger-of-thalidomide-dies-at-101.html https://mobile.nytimes.com/2015/08/08/science/frances-oldham...
acct1771 8y ago
What is it, 1 out of every 7 person started on SSRIs ends up with a success story? And lots of ties of such drugs to mass shooters? Yeah - it's all for our safety...nothing to do with regulatory capture.

by lykr0n 8y ago

beagle3 8y ago

Are there examples other than thalidomide? Because e.g. the FDA was just as bad with Vioxx and worse with OxyContin.

lykr0n 8y ago
I, personally, don't consider Vioxx a failing of the FDA. I might be wrong, but reading the Wikipedia article makes it sound like more of issues surrounding the drug's promotion and marketing- not the drug itself (considering the US and Canada both voted to allow it back on the market). And OxyContin's issues (I think) fall on the DEA and not the FDA. Oxy does what it is supposed to do really well, and the side affects are known. I just used Thalidomide as an example of where the FDA got it right. The fact that we havn't see other drugs like that pop up, tells me that the system is working.
- beagle3 8y ago
  > I, personally, don't consider Vioxx a failing of the FDA. I was following the case in real time, and it certainly looked like a failing of the FDA and being way way too cozy with Merck about it; compared to how it looked then, the wikipedia article looks incredibly white washed. I'm not sure we read the same Wikipedia article - the one I read said that Merck withheld information from the FDA, and makes no mention of any resulting sanctions or penalties (which is exactly how I remember it). Does this sound like a working regulatory agency to you? > And OxyContin's issues (I think) fall on the DEA and not the FDA. Oxy does what it is supposed to do really well, and the side affects are known. Not at all. Perdue made false claims about how long acting OxyContin is, and as a result of the recommended prescription, many people both suffered and got hooked, see e.g. [0], which was the first result for "oxycontin perdue abuse", but by no means the only one. > I just used Thalidomide as an example of where the FDA got it right. The fact that we havn't see other drugs like that pop up, tells me that the system is working. ... to me, the fact that Thalidomide is basically the only example that everyone brings up, it means that the European system is essentially equally effective, despite your implied claim ("Europe had a massive problem, while the US didn't.") that the US one is superior. [0] https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxycontin.html https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxy...

kalleboo 8y ago

The strict requirements in the US came as a result of the Thalidomide case, not before it. Thalidomide was stopped mostly thanks to pure luck that a talented newly-hired examiner got the case, and the outcome was used by the Kennedy administration to push through the strong regulation we have today https://mobile.nytimes.com/2015/08/08/science/frances-oldham-kelsey-fda-doctor-who-exposed-danger-of-thalidomide-dies-at-101.html https://mobile.nytimes.com/2015/08/08/science/frances-oldham...

acct1771 8y ago

What is it, 1 out of every 7 person started on SSRIs ends up with a success story? And lots of ties of such drugs to mass shooters? Yeah - it's all for our safety...nothing to do with regulatory capture.