Comment by bena | Hacker News Reader

Comment by bena | Hacker News Reader

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This is a complicated subject.

Because those rules are in place for reasons. And some of those reasons are to prevent drug companies from turning the poor into lab rats with no regard to their safety. And I guarantee you, you let "terminal" patients skirt rules, there will be a hell of a lot more "terminal" patients.

And I'm sure there are some non-regulation reasons to limit various therapies. They are trying to see if thing X can help. And if thing X only helps when combined with thing Y, you don't exactly get that information when focusing on thing X. Or the worse scenarios of thing Y making thing X ineffective or harmful.

This was written from a very emotional place, and understandably so. But that state means they are not exactly in a position to consider all the reasons. And it must be frustrating as hell to have tried 40 things that didn't work to only be denied the 41st because you tried too many other things. Especially if that 41st thing turns out to be something that works.

But I don't think the answer is let terminal patients take whatever they feel like.

As someone that works in drug discovery as an academic and has patented drugs, I can tell you that the current process is biased way too far towards safety for optimal life saving outcomes if you look at it in a cold utilitarian way. A lot of lives would be saved by fast-tracking the approval process, despite the fact that there would also be an increase in negative outcomes.

However, it is probably not socially or politically tenable to kill or harm people with experimental drugs even if it saves a greater number of people. Realistically, I don't see things changing much.

I don't think its fair to dismiss this perspective as "written from an emotional place." As Alex Tabarrok wrote above, both Jake and his wife (a medical doctor) were involved with this issue before his diagnosis.

> But I don't think the answer is let terminal patients take whatever they feel like.

I don't think anyone has the moral authority to tell anyone else what they can take, especially terminal patients.

I do, however think governments have a responsibility to regulate how drug companies conduct trials so as to minimize harm to patients. This probably has the same outcome in practice, but I find the moral distinction important.

I don't think it's just that. Imagine the kind of money the more unscrupulous could make selling sugar pills for $100 each saying that it's the cure for whatever is killing you.

Desperation can cloud even the most rational of minds.

People selling stuff are in the same category as the drug companies; I have no objection to regulating them, and imprisoning them for fraud, with an enhanced penalty for preying on particularly vulnerable people in the case you described.

How exactly are you going to prove fraud without, you know, the clinical trial data that you've just allowed them not to produce in the first place?

Fraud is one risk -- the much bigger one is well-intentioned people trying to save lives seeing positive outcomes where there aren't any.

You could require them to disclose that they have no clinical data proving efficacy while also allowing them to sell the drug.

You mean like supplements, which exist today?

Experimental drugs cannot be given freely like supplements.

Of course they can. You take any molecule, put it in a pill bottle, disclose there's no clinical evidence of its efficacy and you can put it on store shelves. There are thousands of such products on the market today. Stores will often put these in a section called "Supplements" so that people don't mistake them for medications which have proven their efficacy.

These molecules generally don't do anything of substantial value because it's incredibly difficult and expensive to produce a molecule that does anything of value. If you're going to undertake that billion dollar effort, then you're going to want consumers to trust it, pharmacies to carry it (near the medications, not the unproven supplements), and most critically: insurers to pay for it.

You do not have to seek FDA clearance to sell your molecule to consumers. To achieve marketing objectives necessary to recoup the development costs of a working molecule, you choose to seek FDA clearance.

What exactly do you think distinguishes an "experimental drug" that's not going to be put through trials from the thousands of other unproven molecules typically sold on aisles labeled "Supplements" or behind the counter at gas stations? Your hope, belief, or presumption that it actually works?

If the manufacturer creates the substance with the intention of treating a disease, then the substance falls under FDA restrictions, irrespective of whether they make explicit claims about its medical benefits.

"Sugar Pills"

Yeah it happens a lot more than you think - the entire everything - about USA pharma is absolute evil.

I've pissed off a lot of people in my statements about how chemists are a very unscrupulous profession, and many are downright evil. (you need to really learn about the history of Sandoz, Bayer, Novartis, Du Pont, J&J, Monsanto, and all the others.... <--- LONG history of chemical weapons, chemical poisons, super-sites, deformed babies. The lack of regulation and oversight in the chemical industry has enabled these scandals to occur.

Watch the Devil We Know, for example about Teflon

https://i.imgur.com/vGIcL0d.png

--- [0] https://www.forbes.com/sites/conormurray/2023/09/12/heres-wh...

If I recall correctly, that is why it is illegal for clinical trials to charge for experimental and unapproved medication. The patient's "payment" is in taking the risk, and the 'pay-off' towards the experimenter is that it helps get their drug approved to a saleable state, if it works. That part sounds like a good ethical system design to avoid perverse incentives - the drug maker doesn't gain anything unless it works and even then it is indirectly.

Is it illegal? Or does it just not make any sense to ask someone taking an experimental drug to pay you for it? It's ridiculously hard to get people to participate in a trial even when pharma is paying them (granted though, also under the same ethics umbrella, such payments are not supposed to incentivize a decision to participate, only to remove the disincentives to participation, like having to pay for Ubers to/from the trial site).

Actually the way that we prevent pharma companies from using trials to commit fraud of this type is by tightly (very tightly) controlling the language they use to describe drugs that are still under evaluation. Basically every sentence that a researcher makes to a trial participant needs to pass an ethics review board to make sure it's not overselling the promise or underselling the risk.

> I don't think anyone has the moral authority to tell anyone else what they can take, especially terminal patients

Yet euthanasia is a very fraught subject in the land of the free. The country may be coming less religious, but the puritanical values remain; every life is precious, even one that's in unbearable, irreversible agony, and those who suffer probably deserve it.

That's really the perspective I'm coming from. When I say the answer isn't to let terminal patients take whatever they feel like, it's to say that they shouldn't be the one to make the decision that a developing drug is safe enough for them to trial.

Just because one is terminal, it does not make one an expert in medicine or pharmaceuticals. So it shouldn't be used an exception to the processes in place.

I don't understand this. Society at large supports assisted suicide and a host of other personal choices that unquestionably harm the health of the person making them. Why draw a line at potential treatments for illnesses? Why can't someone choose to be a guinea pig for the sake of advancing the science?

My guess is that consumer safety is being used as an excuse by those who want to control the market via regulatory gatekeepers, to reduce competition. But regardless of what's motivating it, it's illiberal.

Killing someone who is trying to live is a bit at odds with compassion.

Desperation can make us short-sighted and reckless. It’s why most people who are prevented from committing suicide often don’t try again. It’s an act of desperation. We shouldn’t allow drug companies to exploit desperate people.

Assisted suicide has several hurdles you have to jump through. You have to be completely sure from a sound state of mind.

They're going to die anyway. This might give them a non-zero chance at survival, and at the very least let them contribute to medical science by being a test case for an experimental treatment.

Yep individual rights and autonomy over our bodies are fundamental

Some who are terminally ill want to be lab rats. You get one last shot at surviving and, perhaps more importantly, you also get to leave the world a little better by helping advance drug science. I don't think "lab rat" conveys the courage it takes to participate in a clinical trial and the gratitude we should have for them.

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