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Comment by jasonhansel | Hacker News Reader

You do know that these new psychedelic-like drugs are going to be patented and probably quite expensive, right?

That's not even hypothetical either. Ketamine was proven to have great anti-depressant effects so Johnson &Johnson came out with their own patentable formulation of it called Spravato.

Not exactly.

Ketamine is well known to have great anti-depressant effects, but since it's long out of patent, no one has the incentive to spend $1B to get the FDA approval for it.

So J&J invented the chiral twin molecule (the mirrored version), got it approved, and it's now sold as Spravato.

To me this is 100% a regulation bug rather than some misfeature of capitalism or corporate greed.

I don't think it's a regulation bug to require a study to approve a drug for a certain use.

The bug is that we don't incentivize funding expensive studies to discover unpatentable (i.e. cheap) treatments.

The minimum "patch" would be that the governments of the major drug markets decide that effort and discovery of applications count as a basis for patents. Then a drug maker could fund their studies based on which drug candidate is the most promising, not which is the most promising but also novel and thus patentable.

Much better, would be to have the governments presiding over the major drug markets get together and create a proportional fund to cover studies for the public's benefit. The economics of that would be similar to private companies, but at least the profits would go towards further research.

> I don't think it's a regulation bug to require a study to approve a drug for a certain use.

That's actually not how it works.

When a drug is FDA approved for a certain use, doctors are free to prescribe it for anything the think it's useful for. This is called "off label" use, and is ~20% of prescriptions in the US. This "loophole" cures a lot of people!

And there are some clinics who do use regular Ketamine for depression. The main problem for them is that insurance will not cover this usage.

> The bug is that we don't incentivize funding expensive studies to discover unpatentable (i.e. cheap) treatments.

This I agree with. Though I'd expect some philanthropic billionaire to get to that long before any governments would.

Normal ketamine is a mix of both antiomers. Spravato is only s-ketamine in an inhaler.

Also, while some see the trip as the point of this, I woke up at knife point due to psychosis caused by that. Yet it also really does basically cure depression, if not accompanying anxiety, and it is known to cause new psychosis.

So I hope this works out and can be used on people who really need to avoid the psychosis caused by ketamine.

tbh never heard of ketamine psychosis

It can apparently trigger them in susceptible people. I got to see it first hand.

$1B? Is that an exaggeration? I can't seem to find anything close to that number anywhere. Perhaps you're mistaking the low-end cost of developing a new drug (around a billion, but it can be three times that) with the cost of FDA approval.

It's probably the full cost of getting an approved drug, including a lot more than the approval itself.

So that number was probably 10x off. That doesn't change the conclusion though.

I learned all this from Scott Alexander. All details here: https://slatestarcodex.com/2019/03/11/ketamine-now-by-prescr...

J&J didn't invent esketamine, they patented the use and formulations of esketamine for certain conditions.

They didn't invent anything, they just made a specific enantiomer

Alright we can call the FDA-regulations-on-top-of-capitalism thing Americaism, and say there's something wrong with that then. Because whatever part you want to blame it on, regulation bug or capitalism or corporate greed, something has gone wrong. Here's a medical technology that improves people's lives, but it's being held back from dying patients (an estimated 7% of men with depression go on to commit suicide) because they couldn't make enough money from it. I guess the real question is how could you structure regulations so as to incentivize getting FDA approval for unpatenable life-saving medicine?

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