4 ms·
Interesting article, but the lack of mention of 'patent' or 'intellectual property' sort of stands out. There may be many out-of-patent drugs that are effectiv
by photochemsyn 4y ago
Interesting article, but the lack of mention of 'patent' or 'intellectual property' sort of stands out. There may be many out-of-patent drugs that are effective treatments for various conditions, but typically clinical trials for alternative uses of out-of-patent drugs are not pursued as anyone could then manufacture and sell them.
This is not new - it dates back to the origins of the modern for-profit pharmaceutical industry, such as with Bayer's discovery of the anti-bacterial action of sulfanilimide (patented 1909) in the early 1930s (by which time patent had expired). Bayer made a derivative of sulfanilimide, i.e. Prontosil (patented in 1932) and tried to convince the world that this was the more effective product. In reality, it just broke down to sulfanilimide once ingested, that being the active species.
As far as clinical trials in the USA, there have been numerous scandals regarding lack of consent, failure to halt trials immediately on indication of severe side effects, etc. Major stories about this came out in 2005, 2008, etc. Then there's the world of unregulated third-world clincal trial testing, and actual falsification of clinical trial data by contractors hired to run trials for various Big Pharma outfits, such as this from 2022.
https://endpts.com/clinical-trial-coordinators-sentenced-to-prison-after-data-falsification-scheme/ https://endpts.com/clinical-trial-coordinators-sentenced-to-...
> "Tellus, which has worked with big-name pharma sponsors in the past like Pfizer, Gilead, Takeda, Boehringer Ingelheim and Eli Lilly, initially came under scrutiny for two trials related to opioid dependency, two for irritable bowel syndrome, and one for diabetes."
That's just organized crime 101: hire a contractor to do the dirty work, keep your own hands clean, claim ignorance, act shocked, promise reforms, etc.
Best solution I've heard of is a move to open-source (patent-free) drug discovery with federally financed clinical trials. Since almost all new drugs are discovered at universities with federal funds (see remdecivir, mRNA vaccines, etc.), before being exclusively licensed to private interests, the quickest way to that is to revoke Bayh-Dole and state that universities must non-exclusively license their discoveries to any parties for a flat fee.
- refurb 4y agoThe FDA will still give you regulatory exclusivity if you get an off patent drug approved in a new indication. https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a https://www.fda.gov/drugs/development-approval-process-drugs... Orphan drug exclusivity is 7 years. The FDA will not approve a generic version of that drug for the same indication for 7 years after your approval. Of course the challenge is that doctors are free to prescribe whatever they want, including compounded versions of your drugs. There are ways around it (formulation), but it's not like there is no option at all if you don't have a patent.