[jngreenlee]

I personally hope this shows (some) irrelevance of FDA bureaucracy...if they weren't need in the worst of times, why are they needed in the best of times?

Let entrepreneurs, doctors, and patients decide their individual risk level. I would rather have more options than less.

Edit: as an alternative to any knee jerk critism (I said "some"), why can't states handle this and the best emerge? I'm a big proponent of localism.

[Reelin]

Woah. Hold up.

I will repeatedly and loudly criticize the US government response to COVID-19 so far as inept, particularly the FDA in the early days. Brittle laws combined with their failure to move quickly hamstrung our chance at containment.

Under normal circumstances though, health and safety oriented regulatory bodies such as the FDA play an absolutely essential role in protecting us from bad actors. The only reason I have confidence when purchasing medications of any sort is because of them. They also protect our food supply from all sorts of misguided and dangerous production practices.

Even in an emergency situation, they have an essential role to play in preventing bad actors from popping up left and right peddling snake oil. There certainly needed to be more flexibility and speed in responding to the current crisis, and I'd argue that states ought to have _significantly_ more autonomy in a number of areas, but that's a far cry from calling them irrelevant.

(As an aside, I was disappointed that none of the states defied the federal government in this instance. I had hoped for a state-level authorization for established medical labs to develop in house tests, and a subsequent court case challenging federal law on the matter. As far as I understand, the FDA only derives its authority from the frequently abused interstate commerce clause.)

[tathougies]

> (As an aside, I was disappointed that none of the states defied the federal government in this instance. I had hoped for a state-level authorization for established medical labs to develop in house tests, and a subsequent court case challenging federal law on the matter. As far as I understand, the FDA only derives its authority from the frequently abused interstate commerce clause.)

Yeah, seriously. Every state is happy to defy DEA with marijuana. You'd have near universal support for defying FDA in this instance, and it would be a welcome breath of fresh air for the states, who have honestly been continuously disempowered by the federal government.

[akiselev]

The political and human consequences of ignoring the FDA if something goes wrong are far, far greater.

[Symmetry]

In general having a drug regulatory agency is a good thing, I'd certainly agree. But the FDA is known for being excessively paranoid compared to similar bodies in other countries. So we didn't have UVA sun screen until long after Europe did, basically only have Epi-Pens which are subject to price jacks when Europe has 12 competing brands, got beta-blocking drugs a decade after Europe, etc. Though in fairness we also managed to avoid thalidomide so that's a point in the FDA's favor.

[kjaleshire]

> Under normal circumstances though, health and safety oriented regulatory bodies such as the FDA play an absolutely essential role in protecting us from bad actors.

Does it though? There's a perception that government agencies are impartial watchdogs, but this belies the reality that governments have agendas of their own. The FDA is so politically removed from the people it was created to ostensibly protect that there's now little incentive for it to relieve real suffering today. A brief example:

My brother and thousands of people suffer from type-1 diabetes. We have had the technology for years now to create an artificial pancreas, but FDA and EMA regulatory procedures have stopped any device from being sold. People are creating their own DIY systems because no commercial, professionally-developed, reasonably-priced alternative exists yet.

This isn't snake oil. There are solutions for many people's ailments available today. And the FDA is a massive giant standing in the way of people living healthier, unencumbered lives.

Treat people like adults. On the whole they're pretty good at figuring out what's best for themselves and taking care of each other.

[jngreenlee]

I think you reacted too strongly, IMO. I only said some. People and their doctors are the MOST concerned with their lives...not you, not politicians, and not FDA staffers.

If I want to treat my (illegal war) PTSD, depression or anxiety with novel treatments like 2CB, LSD, or MDMA, that is my choice. It immoral to restrict my supply with the barrel of a gun.

[hcknwscommenter]

The FDA is not what is restricting your supply of 2CB, LSD, and MDMA though. I think this present crisis is a perfect illustration of why the FDA is incredibly important. Just look at all the misunderstanding about chloroquine, hyrdoxychloroquine, chloroquine sulfate, etc. flying around.

[Reelin]

I completely agree - I had (mis)interpreted what you previously wrote to mean throwing them out entirely. I just can't stress enough that despite all their issues, the FDA still plays an absolutely essential role in keeping our society functioning.

[csomar]

> People and their doctors are the MOST concerned with their lives

That's exactly what makes them the most vulnerable. They are, in extreme conditions, desperate for a medicine and they'll lose sense because of that.

[CaptSkinny]

Don't make the mistake of conflating concern for one's life with a desperation to avoid losing it. Safety concern is our own in-built countermeasure to desperate irrationally.

The fallacy that patients cannot act rationally in the face of adversity is a common excuse for compulsory regulatory bodies. While there is value in having a centralized body like the FDA provide consumers with qualified advice on drugs and food, a certification authority can provide that information for individuals to use at their own prerogative.

[landryraccoon]

You're conflating a different issue. Congress made those drugs illegal. The FDA can't unilaterally make those legal without the support off the President or Congress.

If you want that policy to change, it'll have to happen at the voting booth, not because some FDA bureaucrat decided it.

[Hello71]

the fda doesn't regulate any of those drugs, that's the dea.

[maxerickson]

"Stodgy gatekeeper" and "nothing" are not the only regulatory regimes available.

Like you could have looser requirements to enter the market and then penalize/ban companies/people that make bad/unsafe tests. (yes, I'm proposing that people involved in marketing useless medical tests be banned from doing it a second time. Might be hard to structure it, but the goal is clear enough).

[jngreenlee]

I would like this, especially for tests (I understand being more restrictive for treatment but still disagree with the winner take all corpratism that results under current regime)

[ineedasername]

I don't see all that much "winner take all" in the medical industry. There are multiple competitors for many/most products, evidenced in this situation by many companies racing to develop & compete against each other for better testing. A few weeks ago there were news stories about rapid testing w/ 1 day turn around. Now we're down to fractions of an hour.

[hprotagonist]

"Right To Try" is a return to legal snake oil. Hell no, get it out of here.

https://blogs.sciencemag.org/pipeline/archives/2018/06/21/we...

And let’s see if my nastier, more cynical Derek-Against-Humanity prediction comes true: that the next wave will not be just people who have seized on this plan opportunistically, but who have targeted it right from the start. Who will pick out terrible diseases for which there are no therapies at all, the better to insure a supply of completely desperate patients and families, and provide them with utterly useless therapies at stiff, stiff prices. Utterly harmless therapies, though – don’t want to get sued while you’re raking in the bucks. I’m talking polysaccharide therapy for pancreatic cancer, antioxidant phytonutrients for Alzheimer’s: in other words, corn starch and grape juice. What the hell. The customers are going to die, anyway. Why should they die with their money as well?

[fortran77]

This is still being done in the U.S. by "chiropractors" pushing their own mixtures of zinc lozenges and herbs. Google "chiropractor" and "COVID-19" if you want to be disgusted. And local news channels are reporting on this as if it's real.

[jMyles]

> "Right To Try" is a return to legal snake oil.

Is that really so bad in 2020, when we have access to the information we actually need to learn about snake oil?

[hcknwscommenter]

Under your scenario you will be targeted by extremely sophisticated psy-ops (think cambridge analytica *1000) to convince you that the super-snake-oil 2xt is the absolute best cure for your disease. Don't let the gov't tell you any different. Just look at this incredibly misleading data.

[SpicyLemonZest]

That is indeed a risk factor. I've seen a lot of people argue that there's no downside, that shoving the FDA out of the way would be a pure positive, and you're right to consider that very naive.

But should we expect the FDA itself to be immune to such manipulations?

[jdminhbg]

> (think cambridge analytica *1000)

Zero efficacy times a thousand equals...

[hcknwscommenter]

Your confidence is misplaced. I mean look at those nigerian scams, they nab people every day and they are the worst in terms of efficacy. Now up the monetary incentive to BILLIONS of dollars, and remove the FDA, and you will find extremely sophisticated players entering the game. I really don't know where you derive your "zero" number from, but I'm guessing you are thinking it will have no effect on YOU. I actually help run clinical trials and regularly advise on clinical trial read-outs, and I can assure you that I could be fooled by a sophisticated scam if I didn't have a governmental entity that can and will actually do inspections and their own investigations with the power of criminal penalty. I think your confidence is entirely misplaced.

[catalogia]

> I mean look at those nigerian scams, they nab people every day and they are the worst in terms of efficacy.

That seems like a bad example to support your point. Nigerian scammers don't strike at random like lightning. If you aren't really stupid or really greedy, there is zero chance that you'll get scammed by those guys. They target people with poor cognitive abilities and people who are greedy enough to think they can scam the scammers.

They run dragnets looking for the rare individuals who vulnerable to their scheme. They are powerless if tasked to target a specific person unless that specific person by chance happens to be the sort of person their scheme works on.

[mardifoufs]

Yes? Access to information does not mean access to good information. and even access to good information does not mean that people will not chose to believe debunked claims. We already have that now, but at least we can regulate what kind of claims are made and what kind of evidence is needed to make them.

I'm usually all for individual responsibility, but health is one of the rare things where you can't just rely on people being rational. It is very difficult to expect rational decision making based on evidence when it comes to a dying cancer patient desperate to find a cure. And it's very easy to see people profit from that.

[jacquesm]

Miracle cures are being hawked right here on HN. With that specific language.

[ineedasername]

Yes, because that access is not uniformly distributed. There is a lot of disinformation, and your typical person doesn't have easy access to a lot of research sitting behind paywalls. Disinformation has much less friction, and requires much less effort to ingest, than quality research.

[jancsika]

> Let entrepreneurs, doctors, and patients decide their individual risk level.

Try starting with something less dangerous first like rolling your own ciphers for use in end-to-end encryption.

[nexuist]

>why can't states handle this and the best emerge?

Is it fair to die in State X because it had more inept leaders than State Y? This isn't about long term economic or social policy, this is about an exponentially growing pandemic that doesn't respect borders.

[tathougies]

It's as fair as dying in Germany because France had inept leaders (for example, not saying either of those countries have inept or incompetent leadership). American states are way more autonomous than the regions of most countries. The populace elects the leaders they get.

[ineedasername]

It's as fair as dying in Germany because France had inept leaders

Yes, which is to say it isn't fair. You're example argues for higher level oversight and uniformity of regulation, say at the EU level, not even more balkanization of them.

[ineedasername]

I don't think that fracturing the regulations & approval processes into 50 different jurisdictions would be all that helpful. It would in fact greatly inhibit companies that do business in multiple states. Which set of rules do they follow? Lawsuits would abound whenever there's an issue and the rules of any jurisdiction they might operate within could be contrived to apply to the situation.

And consider the current circumstances: Yes, things are relaxed in an emergency. How would that be any different? State-level, or any level of oversight, would also be relaxed in an emergency. All that shows is that sensitivity to risk changes (decreases) when there is a crisis. It doesn't invalidate the greater level of care taken when there is the time to take it.

Also, no matter what level you impose oversight & regulation, patients will not be in a position to determine their desired level of risk. If it happens at the state level, there can still be plenty of people who would like a different risk threshold: They won't get it though.

Finally, it ignores the fact that what might be in the best interest of a more local jurisdiction (say, it costs less money) it might be very much against the best interests of others. A jurisdiction that decides it's comfortable with higher risk does not exist in a vacuum: It's comfort with higher risk would also bleed over into neighboring areas.

Far better to have a uniform set of guidelines and make exceptions on a case by case basis in emergencies, rather than make everything an exception, which would make coordination & consistency during a crisis a complete nightmare.

[xiphias2]

The oath ,,First do no harm'' is there for a reason: sadly for most new therapies, the alternative of using the old therapy is better in 99% of the cases. The FDA is there to make sure that companies find the remaining 1%.

The big difference here is that the speed of finding the right drug can make or break trillions of dollars and thousands of lives, so it's critical for the FDA to focus on the COVID-19 illness.

[rantwasp]

i think that in this case it's a risk trade-off. you don't want to have to make these kind of decisions daily

[jngreenlee]

I think my doctor and I can make those choices best from a wide spectrum of solutions, not only those lobbyied for by Giliad.

[mardifoufs]

Okay, so the lobbying will move to doctors. And while FDA lobbying is public, good luck guessing who gave a kick back to your doc. A single regulatory body is easier to monitor than a hundred of thousands of them. Doctors getting kickbacks is already a thing so I can't imagine how it wouldn't get worst if they had the power to prescribe anything they want, not just FDA approved meds

[Reelin]

It's worth mentioning that MDs and pharmacists in the US both have approximately 4 years of schooling (among other things) in addition to their bachelors.

[monksy]

Because that is a HUGE risk involved. You can't turn back time and undo damage or bring someone back to life.

[jMyles]

The same is true of so many of the things that are suddenly deemed unnecessary in this time of crisis. Let's be judicious about which gatekeepers and rent seekers we choose to bring back online.