Re:FDA Approving Drugs at Breakneck Speed, Raising Alarm
by tpmoney on Saturday December 07, 2019 @01:24PM
(#21731721)
Close equivalent can still be something you can't take. For example, if you're one of the unfortunate people with no activity on your CYP2D6 enzyme, there are essentially 4 pain medications that you can take at appropriate doses once you need something stronger than advil: Morphine, Dilaudid, Oxymorphone and Fentanyl, and there are reasons why doctors prefer other narcotics before prescribing any of those 4. Other pain medications will work, but you'll likely need inappropriately higher doses[0], which can lead to other problems (like overdosing). Likewise if you process faster than a normal person (i.e. you have more activity on that enzyme) you can overdose at normal prescribing doses. Close equivalents for some people can indeed be the difference between life and death, even if the condition itself isn't life threatening.
Re:FDA Approving Drugs at Breakneck Speed, Raising Alarm
by Retric on Saturday December 07, 2019 @01:56PM
(#21731896)
That’s a very good point, but then we are talking about edge cases and a delay measured in weeks to months. So, the benefit from catching 1 bad drug could outweigh the benefits from releasing 100 drugs slightly earlier.
It’s not an easy choice, especially when the risks are often hypothetical and the benefits so clear.
It’s interesting looking at lists like this and considering where things broken down. https://en.m.wikipedia.org/wiki/List_of_withdrawn_drugs
Re:FDA Approving Drugs at Breakneck Speed, Raising Alarm
by refurb on Saturday December 07, 2019 @06:34PM
(#21733370)
The FDA already takes that into account when doing a risk/benefit assessment.
If you're looking to treat relatively health people for most of their lives (say a drug that precent type I diabetes), the FDA will scrutinize the hell out of it.
If you're looking to treat someone who is dying (e.g. metastatic cancer), then the FDA is much more lenient in their analysis.
Re:FDA Approving Drugs at Breakneck Speed, Raising Alarm
by 1123581321 on Saturday December 07, 2019 @01:05PM
(#21731620)
It is as long as the FDA can operate flexibly enough to not spend extra time where they shouldn’t. If they can’t, as seems to have been the case historically, then it’s best overall from a mortality and longevity perspective if they err on the side of faster releases. Note that faster operation also means they can more quickly act on feedback from the market and medical practitioners post release.
Taking enough time to endure a new acne medication or Viagra alternative etc is reasonably safe is very much worth spending some extra time.
Edit: This does seem to be focused on needed medications without close equivalents but that’s a fairly arbitrary line.