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vibrio 2 days 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 2 days ago | parent [-]

[flagged]

ropable 2 days ago | parent | next [-]

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.

terminalshort 2 days ago | parent [-]

It's a risk / reward tradeoff. There is no objectively correct decision or subject matter expert in that.

bdangubic 2 days ago | parent | prev | next [-]

this would lead to a whole lot of bleach drinking…

hansvm 2 days ago | parent | next [-]

I hear bleach kills cancer in a petri dish.

terminalshort 2 days ago | parent | prev [-]

It's a free country

bdangubic 2 days ago | parent [-]

USA is everything but a “free country” is absolutely not - you are too funny!

eulgro 2 days ago | parent | prev | next [-]

Most people aren't equipped to be making such a decision.

terminalshort 2 days ago | parent | next [-]

It's a risk reward tradeoff which is fundamentally not an objective decision. Nobody is equipped to make it.

Retric a day ago | parent [-]

You 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.

RobotToaster 2 days ago | parent | prev [-]

Doctors are supposed to be.

Retric 2 days ago | parent | next [-]

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.

tartuffe78 2 days ago | parent | prev [-]

Yeah they loved giving people oxy

jiggawatts 2 days ago | parent | prev | next [-]

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.

vibrio 2 days ago | parent | next [-]

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)

terminalshort 2 days ago | parent | prev | next [-]

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.

tliltocatl 2 days ago | parent [-]

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.

terminalshort 2 days ago | parent [-]

So what you are saying is the majority of the public wants a faster and higher risk option for new drugs, but they should be forced to have a slower and lower risk system because that's what you want? Nobody is talking about selling sugar pills here. That's just simple fraud which always has and always will be illegal.

whatisthiseven a day ago | parent | next [-]

So, yes, you agree the "faster" market will produce a larger quantity of sugar pill fraud because you are so willing to dismiss it as "obvious", yet you won't acknowledge the other kinds of near equivalent fraud such as silver pills, horse dewormers, and more.

Sure, sometimes the FDA is slow to approve drugs that have science behind them. Or from other countries that proved efficacy and safety. But frankly people can already do whatever they want with regards to health. The wellness and alternative medicine industry is larger than the actual pharmaceutical industry. Your fears are unfounded.

terminalshort a day ago | parent [-]

No you can't do whatever you want. I have narcolepsy. There is currently a drug in development that is known to work (TAK-861). My doctor is involved in the research. It works so well that in phase 2 trials they couldn't keep them blind because the research subjects know instantly that they got the real medicine. My doctor would have prescribed it to me a year ago if he could. But he couldn't because the worthless bureaucrats at the FDA won't allow him to. I will have to suffer for another year before I can get it because of this bureaucracy. There is ample data published so far to show safety and effectiveness on top of the advice of my doctor. But I can't get it because of these worthless safetyist bureaucrats and their endless process and procedure. I demand to be treated like an adult and be allowed to judge the data for myself and take the risk rather than have the decision made for me by a bunch of government stooges. And on top of that, the drug will be much more expensive than it has to be because Takeda has to spend so much more money developing it. So I lose two ways.

https://www.takeda.com/newsroom/newsreleases/2025/takeda-ore...

tliltocatl a day ago | parent | prev [-]

> simple fraud which always has and always will be illegal

Wikipedia says homeopathy market was 2.7B in 2007 and I'm too lazy to find new data. AFAIK there has not been issued a single fraud sentence against the manufacturers. That's with a half-functioning FDA that actually made some moves to stop this. Now how bad would it be with no regulation at all? Because, again, there is no doubt that homeopathy has overwhelmingly higher profit margin compared to actual drugs.

terminalshort a day ago | parent [-]

I don't want no regulation at all. I want the regulation to stop at ensuring labeling and dosage is correct. Punishment for mislabeling medication should be medieval. If you want to buy snake oil, that's not my problem. What I care about is that the bottle that says snake oil on it actually contains snake oil.

eviks 2 days ago | parent | prev [-]

> 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 2 days ago | parent [-]

Those are all of the things exempt from their scope, hence the relentless useless and downright dangerous products in those categories.

danny_codes 2 days ago | parent | prev [-]

This is a terrible idea. A lot of people would certainly die if we got rid of drug certifications

terminalshort 2 days ago | parent [-]

They are adults, and adults should have the right to make dumb choices.

watwut 2 days ago | parent [-]

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.

BizarroLand a day ago | parent [-]

Terminal 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.