Comment by vibrio 14 hours 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)
Profoundly 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.
It's a risk / reward tradeoff. There is no objectively correct decision or subject matter expert in that.
It's a risk reward tradeoff which is fundamentally not an objective decision. Nobody is equipped to make it.
They 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.
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.
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.
This is a summary of my view. The danger is an overly opinionated “leader” with strong opinions has veto power over expert fda review teams, the system fails and decisions are not made on data and consensus but rather ideology and self importance. Patients and even practicing Physicians cannot be expected to review the nuances of every aspect of clinical studies for therapies in their area. The FDA and expert advisory committees (do these still exist?) are crucial in providing a data-driven analysis. This should not be done by an outspoken “leader” that is confident that he is smarter than the rest of the field. (This isn’t limited to medicine,but that is a can of worms)
No 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.
Clinical 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.
Those are all of the things exempt from their scope, hence the relentless useless and downright dangerous products in those categories.
This is a terrible idea. A lot of people would certainly die if we got rid of drug certifications
They are adults, and adults should have the right to make dumb choices.
Absolutely 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.
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