Related, one of my all time favorite articles: https://www.propublica.org/article/revlimid-price-cancer-cel...
The Price of Remission - https://news.ycombinator.com/item?id=43925396 - May 2025 (93 comments)
Hospitals and universities repurposing drugs at lower cost
51–60 of 189 posts
Re: Hospitals and universities repurposing drugs at lower cost
#52Earlier quoted context omitted.
There tens of millions of people being treated off-label.
The doctors are assuming liability or let the patient sign waivers, which I guess is fine. But the lack of a pathway prevents a lot of commercial possibilities. For instance it is almost impossible to build a business around supporting off-label use cases (for instance selling necessary accessories).
That's not my experience at all, my doctor's have prescribed plenty of things off label. No special waivers.
Re: Hospitals and universities repurposing drugs at lower cost
#53Earlier quoted context omitted.
There tens of millions of people being treated off-label.
The doctors are assuming liability or let the patient sign waivers, which I guess is fine. But the lack of a pathway prevents a lot of commercial possibilities. For instance it is almost impossible to build a business around supporting off-label use cases (for instance selling necessary accessories).
> For instance it is almost impossible to build a business around supporting off-label use cases (for instance selling necessary accessories).
There is no need for a business. Off label use is hacking around the existing commercial and regulatory system. The innovation to be had is fixing said commercial and regulatory system, not another business. Make cheap drugs or medical supplies, distribute them to those in need with as little margin and risk to the patient as possible. This is a utility system masquerading as a market. More duct tape by way of new businesses is suboptimal.
Re: Hospitals and universities repurposing drugs at lower cost
#54Such studies are great but there is no regulatory pathway to extend the use of existing drugs for new indications of use without the consent of the manufacturer (or becoming a manufacturer yourself). This means such studies can give more clarity on which off-label use is beneficial but it can't be an officially allowed usage.
This is all untrue so far as I understand.
A research group can file for a new drug application (or abbreviated new drug application) for an existing drug. There is no mandate that an NDA sponsor be a manufacturer or the existing manufacturer.
Only the entity holding an approved NDA can file a supplemental NDA but that’s not the only path.
The real reason no one files for off label use is that there’s high cost and little to no practical benefit to doing so.
Re: Hospitals and universities repurposing drugs at lower cost
#55Earlier quoted context omitted.
To get a drug approved you have to go through regulatory approval for a particular use. If the fuck-fuck game is you can just off-label for whatever but only if first approved by the FDA to solve some other problem, why not just bypass the bullshit and get straight to the point of approving the drug without any approved use? Oh yes, because that assures the barriers to entry are arbitrarily higher, and Pfizer and oth…
Like a lot of the systems we have today, it grew from good intentions. We need to figure out a way to refresh our systems without throwing them away. The current system does provide new drugs and benefit. The question is is it limiting, and are the tradeoff of those limits worth while. In other words it takes hard work, with politically risky outcomes and an upside that becomes invisible as far as political careers g…
If we're just letting doctors yolo* off-label, i have no problem with that, but that functionally relegates FDA protections to testing risk profile at some particular dose regimen, with a bunch of extra bullshit tacked on that is highly inefficient process for off-label use even if partially applicable.
It's pretty clear if you're allowing off-label use you can just gate dose-risk profile at one gate and then just add additional gates for on-label uses if you want to approve one.
Of course the issue is the FDA regulator gets the hammer and damned if anything goes wrong but nothing good happens to them if they approve something. So they have no real incentive to approve anything except ideological satisfaction to whatever extent it lives within their mind, plus whatever revolving door benefits industry is offering them.
Probably best to reward the FDA employees for approving good drugs so that the prisoners' dilemma doesn't always fall back to erring on the side of denials, and being easier on them for taking some risk that approves bad drugs to the point they're willing to take some risk to let potentially good drugs through. The regulator doesn't get to see all the bad they cause by not approving drugs because that's invisible, and that's the unintended consequence of their activities and something they're not really held to account for.
* --------- re: below due to throttling -------
>Doctors aren't yoloing it.
If you take offense, call it whatever the hell you want, I was using it in the context of using a drug for a non-approved off-label use. You're making no legal distinction, it's not an FDA approved use and telling the FDA you have some evidence elsewhere but you won't be going through the process to approve it doesn't mean dick to the approval process anymore than my disapproved use of the world "yolo" to refer to same does. If the best my counterparties have is disapproving of "yolo" I rest my case.
Re: Hospitals and universities repurposing drugs at lower cost
#56Earlier quoted context omitted.
I'm in the US, and there are a couple of wrinkles to this: insurance typically won't cover off label use, so patients end up paying the full cost of the medication, and if there is a big enough market, I believe companies can patent the new use even if the patents for the original use have run out. Doctors here are allowed to prescribe them though.
> insurance typically won't cover off label use I’m in the US. This is not true. Insurance will have prior authorization rules for certain drugs that are expensive that require the doctor to submit documentation of the condition, but in most cases the common medication is simply covered if prescribed. The insurance company does not receive documentation of every condition for every prescription to determine if the pr…
So much weirdly confident misinformation here. When LLMs do this we can it hallucination.
Re: Hospitals and universities repurposing drugs at lower cost
#57Earlier quoted context omitted.
I have some difficult-to-treat medical issues and about 1/3 of the handful of pills I take every day are off-label. I think when you get into less common medical concerns off-label use becomes much, much more frequent. E.g. gabapentin is an anti-seizure medication that has been found to reduce neuropathic pain as well. It has shot up to the 5th most prescribed medication in the last decade as it has replaced long-ter…
> I’ve never been asked to sign a waiver That presumably has to do with the risk profile of the medications you've taken. If there was a high risk of devastating side effects and it was off label presumably the prescriber wouldn't be willing to take on the liability.
Do you know that for a fact or are you just guessing?
Re: Hospitals and universities repurposing drugs at lower cost
#58Earlier quoted context omitted.
> I’ve never been asked to sign a waiver That presumably has to do with the risk profile of the medications you've taken. If there was a high risk of devastating side effects and it was off label presumably the prescriber wouldn't be willing to take on the liability.
Do you know that for a fact or are you just guessing?
I would wager if those waivers actually did anything they'd boilerplate a generic version of it in the legal mumbo jumbo you have to sign even if you come in to have the doctor look at a stubbed toe.
Re: Hospitals and universities repurposing drugs at lower cost
#59Earlier quoted context omitted.
Look at the development of price and quality of something that is outside the regulated medical system, like eg Lasik, and everything within that system. Its like night and day. If we had proper competition and price discovery, things would be much better.
On the other hand, dental work, especially anything above basic filings, are prohibitively expensive. I'd say Lasik is the exception, not the rule.
Dentists are only slightly more honest as a profession than Chiropractors. More than half of the one's you meet are outright fraudsters/charlatans/scammers. Most who work in that business will reincarnate as cockroaches or durian fruits.
Re: Hospitals and universities repurposing drugs at lower cost
#60The prices of drugs in the USA are especially high. This is interesting because the USA claims to pursue a maximum capitalistic society - but if this were the case, you'd have competition in a free market. But you don't have that. You have a cartel (or rather more than one). A pure capitalistic society works on assumptions that are not real. People are often cheaters. This would have to be taken into account. But whe…
> This is interesting because the USA claims to pursue a maximum capitalistic society No it doesn't. This is silly. Drug prices in the US are high for non-generic drugs because patent law gives the patent holder an artificial government-granted monopoly, which is blatantly not "pure" or "maximum capitalistic". Generic drugs - where the free market does apply - in the US are as cheap or cheaper than in other countries…
The maximum libertarian alternative to patents isn't free-for-all copying, it's trade secret formulas - e.g. Coca Cola. Drug patents actually exist as a compromise given the clear need for the state to force companies to publish their drug formulas for research. Allowing companies to just keep their drugs secret would be even more capitalistic, and would increase drug prices even more.