[oezi]

Such 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.

[intrasight]

There tens of millions of people being treated off-label.

[oezi]

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).

[jnovek]

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-term opioid use for new chronic neuropathic pain patients. This is 100% off-label and is prescribed by everyone from NPs all the way up to neurosurgeons for this purpose.

I’ve never been asked to sign a waiver and I can’t imagine that for-profit hospitals would allow their doctors to prescribe off-label medications willy-nilly if they represented big liability. (I don’t know this for sure, this is just what my experience implies.)

[Aurornis]

Off label prescribing is extremely common.

This isn’t a new or novel concept. Doctors manage patients with off-label prescriptions all day long.

[forgetfreeman]

The business is already built given the drug in question is already being manufactured and available on the market.

[uberex]

Can confirm. LDN user here.

[cjbgkagh]

Also a LDN user, that drug saved my life. I bought it from a shady dude online, the initial effect was so strong that I thought they shipped me meth instead - that wore off after a week but the lifting of the brain fog persisted.

[jnovek]

It didn’t have that sort of immediate, intense effect for me (though yours isn’t the only account like this that I’ve seen) but I’m still happy with the outcome; it dropped my average 1-to-10 pain score by about two points at three months.

[vidarh]

The article points out that it is typically after patent expiry that the universities and hospitals start looking at repurposing.

[oezi]

The patents aren't hindering off-label use. The hinder commercial exploitation by others.

[vidarh]

Yes, but that isn't relevant to what happens after the type of trials described in the article, which tends to happen when the patents are no longer relevant. As the article points out, while the drugs are patented, the manufacturers themselves are generally very interested in repurposing because it broadens their market. The article is discussing trials that mostly happens once the patents have expired.

[ktallett]

This isn't completely true at least in the UK. It is simply that the manufacturer is no longer responsible legally. The GMC allow prescibing of unlicensed meds. However the change needs to be made to the pathway. So many issues in the NHS has been due to pathway problems.

[boxed]

That seems wild. Do you have a citation to back that up? And in what country/countries?

[amanaplanacanal]

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.

[Aurornis]

> 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 prescription is on label or off label.

Insurance companies can and do also support some off label treatments that are commonly used under their prior auth requirements.

I don’t know why there are so many comments in this thread making confident assertions that off label prescribing or insurance or so uncommon. This happens all day long at doctors offices and pharmacies.

[bonsai_spool]

> I believe companies can patent the new use even if the patents for the original use have run out.

This is not true

> insurance typically won't cover off label use

Generally not true but it can be the case, especially for expensive medications

[amanaplanacanal]

Yes new uses of existing drugs can be patented:

https://www.drugpatentwatch.com/blog/patenting-new-uses-for-...