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Comment by somerandomqaguy | Hacker News Reader

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.

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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.

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.

"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...

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