[tootie]

I'm pretty sure the FDA has never denied a drug use application because it's not patentable and that's just a conspiracy theory used by people pushing bogus treatments. If there's peer-reviewed research that it works, it would be prescribed without doctor shopping.

[Enginerrrd]

>I'm pretty sure the FDA has never denied a drug use application because it's not patentable and that's just a conspiracy theory used by people pushing bogus treatments.

No, that's not it, that's a very uncharitable interpretation and is unnecessarily dismissive . The real issue is that no one wants to pay for studies to turn off-label uses to on-label uses if there isn't money in it because the process is expensive, and so won't be done when there are better returns on investment.

[tootie]

Apologies for the wrong interpretation, but I'm still skeptical. The generic drug market is huge, this drug in particular is already approved and in wide use for fertility treatment meaning that it's already passed safety trials. Getting approval for a secondary usage would be less costly than starting from scratch and there would likely be a huge market for this. There is absolutely money to be made from anyone who wants to get in this market.

[fnordpiglet]

Unfortunately I’ve been unable to dig up the details and citations but there have been companies that have tried. It isn’t as straight forward as it seems. See my other comment in this thread about one that tried. I even owned their stock for a while hoping it’ll work out but in the end the FDA didn’t want to encourage safer TRT’s. I was floored when I read their justification and my stock went to zero, and it looks like the company is dead now. I wish I could dig it up, the FDA memo on their decision changed my view of medicine forever.

[fnordpiglet]

That’s not my point. It’s not patentable so it’s not commercially viable to go through the clinical trials process for something that’s basically free to produce.

There is plenty of peer reviewed research, but not all doctors are aware of all research and testosterone replacement is widely marketed with very lucrative contracts to urologists.

Feel free to read the research yourself

https://www.ncbi.nlm.nih.gov/pmc/?term=Clomiphene+testostero...

[mattkrause]

That's not entirely true.

The FDA has a "new clinical investigation" program that is supposed to reward people running clinical trials. If you collect data showing efficacy of a new use of a previously-approved drug, you can "earn" the exclusive right to market it for that condition. Of course, someone has to actually do it...and the numbers don't always pan out.

[fnordpiglet]

I think a part of this is also the FDA has been really reluctant to touch testosterone producing substances - there was a company trying to get approval for a patented isomer of clomiphene and they took it through phase 3 and the fda indicated they wouldn’t approve it because they viewed the primary benefit of not being castrating as not compelling enough for a new treatment for low T. Their reasoning to my memory was mostly elderly men suffer from low T and they wanted to discourage what they viewed as a growing trend of lifestyle testosterone treatment. As a clomid user I bought the companies stock and followed it closely through the process and was terribly discouraged about the FDAs processes as a result (and my wallet too!). I’ve been trying to dig that stuff up but it appears the company died as a result and googles not finding the FDA communications. This was like almost 10 years ago.

[zemptime]

If the cost of providing this research is high, who would fund this peer-reviewed research which wouldn't make them any money?

For example, who would fund more studies on ginger? https://nutritionfacts.org/video/ginger-for-migraines/