5 ms·
“He had the temerity to reject a drug that had lousy data…” Was that data really “lousy”? (Referencing the REPL data?) Was it a trial design issue? (which he h
by vibrio 1y ago
“He had the temerity to reject a drug that had lousy data…”
Was that data really “lousy”? (Referencing the REPL data?)
Was it a trial design issue? (which he has very strong and unconventional opinions on)
Is it the role of his position to overrule his specialist review teams ? (in the absence of any clear safety risks or malfeasance)
- terminalshort 1y ago[flagged]
- eulgro 1y agoMost people aren't equipped to be making such a decision.
- RobotToaster 1y agoDoctors are supposed to be.
- Retric 1y agoThey really aren’t, it’s the work of more than one human to keep up with this stuff. So you need a government agency or a private group doing the same functions while facing huge lawsuits and thus requiring the same or more data. Granted US doctors could use European etc guidelines, but that’s a different discussion.
- tartuffe78 1y agoYeah they loved giving people oxy
- terminalshort 1y agoIt's a risk reward tradeoff which is fundamentally not an objective decision. Nobody is equipped to make it.
- Retric 1y agoYou assume there is a benefit to be had. Most drugs fail because they don’t do the thing people want them to do. In general prescription drugs have massive downsides and they still got approved.
- bdangubic 1y agothis would lead to a whole lot of bleach drinking…
- hansvm 1y agoI hear bleach kills cancer in a petri dish.
- terminalshort 1y agoIt's a free country
- bdangubic 1y agoUSA is everything but a “free country” is absolutely not - you are too funny!
- danny_codes 1y agoThis is a terrible idea. A lot of people would certainly die if we got rid of drug certifications
- terminalshort 1y agoThey are adults, and adults should have the right to make dumb choices.
- watwut 1y agoAbsolutely nothing suggests op talks about adults only. Also, there is difference between individual dumb choice and market where bad actors are enabled and normal person have zero chance to distinguish them. It would not be just dubm choices. It would be people in set up to fail situation.
- BizarroLand 1y agoTerminal seems to think that there are no people who would intentionally lie about the effects or possible side effects of a drug in order to make millions or billions of dollars.
- jiggawatts 1y agoThat’s how you end up with snake oil, traditional medicine, herbal medicine, and people trying to cure their cancer with supplements instead of surgery and chemo. Such lax rules are invariably exploited to death (literally!) by unscrupulous profit-seekers. Even if you’re smarter than the average bear and “do your own research”, your relatives won’t all be of the same intellectual calibre and you’ll occasionally lose a loved one to a huckster selling mercury compounds as a cure all. You’ll get mad and “demand something be done.” That something looks like the FDA.
- eviks 1y ago> That’s how you end up with snake oil, traditional medicine, herbal medicine, and people trying to cure their cancer with supplements instead of surgery and chemo. So no different than with the current FDA approvals?
- jiggawatts 1y agoThose are all of the things exempt from their scope, hence the relentless useless and downright dangerous products in those categories.
- terminalshort 1y agoNo I won't. I know that trying to keep idiots from screwing themselves over is an impossible task and would never demand that. I'm not willing to be treated like a child just because some idiot might benefit from the same.
- tliltocatl 1y agoClinical trials are so expensive it only makes sense to run them if regulation mandates so. So without regulation you would never be able to tell snake oil from something that works. And then because making working drugs is more expensive than sticking a label on sugar balls they would get out-competed completely. Sadly, free market doesn't really work when the customer has no way to tell if a good is any good until it's too late.
- ropable 1y agoProfoundly misguided take. "These bureaucrats" are subject matter experts regarding the topics about which they have input. It's fine for people to do their own research about what car to drive. Which compounds they might consume to affect health issues? Not so much.
- terminalshort 1y agoIt's a risk / reward tradeoff. There is no objectively correct decision or subject matter expert in that.