Hacker News Reader

Comment by otterley | Hacker News Reader

The FDA, like other regulatory agencies, exists for a reason: to help prevent people from being ripped off, or worse, by snake oil salesmen. I’d rather we not go back to the days when hucksters and charlatans were selling marked-up dyed water or poison to desperate people out of a horse-drawn carriage.

View on HN

There is a nice paper about this question:

> One explanation for drug bans is that regulators know more than consumers about product quality. But why not just communicate the information in their ban, perhaps via a “would have banned” label? Because product labeling is cheap-talk, any small market failure tempts regulators to lie about quality, inducing consumers who suspect such lies to not believe everything they are told. In fact, when regulators expect market failures to result in under-consumption of a drug, and so would not ban it for informed consumers, regulators ex ante prefer to commit to not banning this drug for uninformed consumers.

https://philpapers.org/rec/HANWLA

Completely false comparison because the drug in question did provw safety though the clinical trial, only effectiveness that could not be determined. People should have options that are not certain death.

It’s not a false comparison. Effectiveness is what makes a drug not merely dyed water. Hence the “ripped off” part.

The tricky business is defining effectiveness (and the target population). This drug was not effective at the specified clinical end-point for one set of patients. But it did show promise for other end-points (production of a normal dystrophin transcript).

For complex diseases with a range of severities, failing the specified clinical endpoint is not the same as selling dyed water.

Is production of a normal dystrophin transcript a real clinical endpoint, or just a biomarker that's supposed to correlate for one? It's not immediately obvious how normalizing production of a protein involved in muscle function is beneficial, if it doesn't actually improve muscle function.

Absolutely. But DMD has a spectrum of severities, and it seems possible that for some patients, producing some normal transcript would make a real difference, so that until more people are treated, we cannot know when more normal transcripts make a difference.

Ensuring people have options that aren't certain death is exactly why we care about effectiveness.

Opening up a market for "certain death with extra steps" doesn't address this.

What about the obvious middle position, where the FDA continues to do everything it does and labels drugs as safe and effective, but then theres also non-FDA approved stuff that won't be labeled as FDA approved and you can do it if you want.

The middle of the road solution: let quacks scam desperate people suffering from incurable diseases, as long as the quacks don't put the wrong kind of label on their snake oil bottle.

That’s already established.

It’s called alternative medicine/homeopathy/etc.

That's also deplorable. Herbal supplements too.

If drugs are failing clinical trials, why should they be allowed to be made and consumed at all?

>theres also non-FDA approved stuff that won't be labeled as FDA approved and you can do it if you want.

I assume (even if you didn't realize it) that you mean the $100 Billion plus/year dietary supplements market[0]? That's already (and has been for centuries) in place.

[0] https://www.mordorintelligence.com/industry-reports/dietary-...

> The FDA, like other regulatory agencies, exists for a reason: to help prevent people from being ripped off, or worse, by snake oil salesmen.

This is obviously false given the existing supplements business. The idea that we have a way to prevent people from being ripped off is naive. But even so, the "reason" for the FDA doesn't change its incentive structure: allowing a drug that kills a few people will reflect badly on it, while disallowing a drug that would have saved millions of lives likely would have little consequence for the decision makers.

The carve out for supplements was created by Congress in 1994 during the Clinton administration, long after FDA was established, so I don’t think it is a false statement.

https://en.wikipedia.org/wiki/Dietary_Supplement_Health_and_...

IMO, the FDA's authority should be limited to making sure that the snake oil does indeed contain genuine oil from genuine snakes.

They could put a label on it to the effect of "We don't think this stuff works, and it might even be harmful", but they should not be allowed to ban it outright.

The current situation is one-sided:

FDA approves something harmful -> people are harmed and their friends and family start calling for the FDA's heads.

FDA doesn't approve something helpful -> people are also harmed, but most of them don't even know they were harmed. There's little chance of an angry mob showing up at the FDA's door.

The FDA is biased in favor of rejection, not approval.

There is a reasonable argument for a regulatory agency to make sure that the peddlers of medication are not selling you something that needlessly will harm you.

There is a weaker but still defensible argument that they should stop others from selling you flu medication that isn't proven to work. But one could imagine a less restrictive reality where such drugs simply must be labeled clearly and you make your own decisions. In fact, there's already a weird carve-out like that for "natural" substances, so you can for example buy artemisinin as a "supplement" if you want to...

But what's the humane argument for "protecting" people with terminal or otherwise devastating diseases from trying drugs that can plausibly work, and were created by people acting in good faith, and that had some clinical trials done, but the trials weren't as thorough as a committee wanted them to?

"Yeah, he died, but at least we stopped him from potentially wasting some money."

I’m going to assume the clinical trial bar exists for a good reason unless proven otherwise. The current system is battle tested at this point and is a significant improvement over the situation that predated the current regulations in terms of safety and efficacy.

And, yes, protecting people - both from being injured and from being ripped off - is a feature of modern society, not a bug.

"I’m going to assume the clinical trial bar exists for a good reason unless proven otherwise."

You cannot, nevertheless, assume that its implementation is absolutely optimal.

There already exists a "Right to Try" exemption for terminally ill patients - precisely what the GP was talking about. https://www.fda.gov/patients/learn-about-expanded-access-and...

It was only introduced in 2018 (federally), so it is a relatively recent development, mostly due to pressure from terminally ill patients and their relatives.

Another thing that is being discussed is that the FDA should allow use of drugs that were approved in other developed countries, without requiring separate clinical trials in the US. American patients aren't that different from British or French patients, after all.

I actually agree with the last paragraph. It does make some sense to have some sort of reciprocity with other trusted nation-states. However, there is obviously going to be some forum shopping as a result, and the country with the lowest bar (as opposed to the highest standards) is going to become the one that bears the lion’s share of the evaluation burden.

If we're going to do this, the nations involved should have a rotation, so that 1/you can't predict which nation is going to get a particular evaluation job and 2/to eliminate the "free rider" problem (which exists today in other contexts, such as unfairly burdening the USA with the majority of Western defense spending).

My city has extensive education and occupational licensing requirements if you want to work at a nail care salon. The assumption that bureaucracies left to their own devices always reach an optimum state and then stop expanding is pretty hard to support.

The FDA had 7,500 employees in the 1990s and 18,000 now. Has the world of food and drug gotten 2.5x more perilous? Or is it possible that, just like in tech, every departmental fiefdom wants more resources and more authority with no special regard for what the trade-offs are?

Another plausible (and less sinister) explanation is that pharmaceutical invention and discovery has accelerated since the 1990s and more applications are being submitted to FDA every year that requires more staff to process them in a timely fashion.

Reply on news.ycombinator.com