4 ms·

> Economists say the cost to Medicare of giving new drugs for obesity to just a fraction of this aging generation would be staggering—$13.6 billion a year, acco

> Economists say the cost to Medicare of giving new drugs for obesity to just a fraction of this aging generation would be staggering—$13.6 billion a year, according to an estimate published in The New England Journal of Medicine last March. Man, drive the prices of these drugs down already. Can an LLM tell me how to synthesize semaglutide? Can a YouTuber take a stab at producing liraglutide in the home lab? Maybe an underground railroad of sorts between neighboring countries where the drug is sold for less....

Sakos 2y ago
1) Drugs in medicare need to be cheaper, absolutely, but that's regulatory/legal issue, not something that can be solved by tech. 2) $13.6 billion sounds like a lot. But what is it costing the entire economy by not "curing" obesity with these drugs? How much is spent on health care, how much lost utility and lost quality of life is there for older Americans who are obese?
andrewla 2y ago
2031 is when it becomes entirely (in the US) unencumbered by patents for its use in weight loss according to Wikipedia. The initial patents seem to date to ~2008 which means that as of 2028 the synthesis will be free of patents, but you won't be able to market a generic for weight loss until the non-exclusivity period ends. [1] There are already "compounding" pharmacies in the US that sell it cheaper; I can't seem to find a straight answer on what the hell this means though. [1] https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity https://www.fda.gov/drugs/development-approval-process-drugs... if you're interested in the FDA's summary -- I found this to be almost entirely useless though.
- simoncion 2y ago
  > ...I can't seem to find a straight answer on what the hell this means though. This may help to explain it: <https://www.astralcodexten.com/p/the-compounding-loophole https://www.astralcodexten.com/p/the-compounding-loophole>.
  - andrewla 2y ago
    In the end this comes down to a Reddit post from Henry's, one of the online compounding pharmacies: > There are now around ~20 FDA licensed facilities that have a DMF for the active pharmaceutical ingredient (API) Semaglutide including: Bachem AG (Switzerland), Ambiopharm (South Carolina, USA), etc. > Novo Nordisk does not sell bulk Semaglutide API to compounding pharmacies, and while they are 100% the only licensed source for Ozempic & Wegovy, there are other licensed API manufacturers that work on the active ingredients and excipients used by compounding pharmacies. > Any API used in sterile compounding is required to come from an FDA licensed manufacturer. I confess that I'm more confused than when I started -- why can these companies get away with selling it to any party other than Novo Nordisk? And if they are doing it extrajurisdictionally, how on earth is it getting back into the US and sold to customers without the FDA police knocking down doors? I've talked to survivalists who get their tubs of antibiotics by buying fish azithromycin in bulk from veterinarian suppliers -- are we going to be buying horse Ozempic next?
    - vundercind 2y ago
      > I confess that I'm more confused than when I started -- why can these companies get away with selling it to any party other than Novo Nordisk I don’t think (many? Most? All?) of the drugs in this class are patent-encumbered. They’ve been around for a while. … application as a weight loss drug is patented. That’s new. You can’t package and sell them to fill a weight loss prescription if you’re not allowed to by the patent holder. So it stands to reason that the factories that make the chemical can sell it to whoever they want, as long as the buyer is permitted to receive drugs and such in the first place. The drugs themselves, the actual chemical, isn’t what’s covered by the patent. The compounding’s legality is covered by the Codex post: compounding pharmacies are allowed to package and sell drugs that are on the FDA’s shortage list, regardless of patents that would ordinarily prevent selling them. These drugs (various glp-1 agonists) are on the shortage list. So, that part’s fine too.
      - andrewla 2y ago
        The initial patent for semaglutide specifically was issued in 2008 and is under protection for 20 years -- while liraglutide has been around for much longer, semaglutide is relatively new in patent terms. So presumably the licensed DMF facilities are operating under a license from Novo Nordisk, because otherwise they'd be shut down. But why do the terms of the license allow them to sell to anyone else? You are correct that the use specifically for weight loss is newer and the FDA's labyrinthine procedures give Novo Nordisk exclusivity for a significant amount of time after that.

Sakos 2y ago

1) Drugs in medicare need to be cheaper, absolutely, but that's regulatory/legal issue, not something that can be solved by tech. 2) $13.6 billion sounds like a lot. But what is it costing the entire economy by not "curing" obesity with these drugs? How much is spent on health care, how much lost utility and lost quality of life is there for older Americans who are obese?

andrewla 2y ago

2031 is when it becomes entirely (in the US) unencumbered by patents for its use in weight loss according to Wikipedia. The initial patents seem to date to ~2008 which means that as of 2028 the synthesis will be free of patents, but you won't be able to market a generic for weight loss until the non-exclusivity period ends. [1] There are already "compounding" pharmacies in the US that sell it cheaper; I can't seem to find a straight answer on what the hell this means though. [1] https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity https://www.fda.gov/drugs/development-approval-process-drugs... if you're interested in the FDA's summary -- I found this to be almost entirely useless though.

simoncion 2y ago
> ...I can't seem to find a straight answer on what the hell this means though. This may help to explain it: <https://www.astralcodexten.com/p/the-compounding-loophole https://www.astralcodexten.com/p/the-compounding-loophole>.
- andrewla 2y ago
  In the end this comes down to a Reddit post from Henry's, one of the online compounding pharmacies: > There are now around ~20 FDA licensed facilities that have a DMF for the active pharmaceutical ingredient (API) Semaglutide including: Bachem AG (Switzerland), Ambiopharm (South Carolina, USA), etc. > Novo Nordisk does not sell bulk Semaglutide API to compounding pharmacies, and while they are 100% the only licensed source for Ozempic & Wegovy, there are other licensed API manufacturers that work on the active ingredients and excipients used by compounding pharmacies. > Any API used in sterile compounding is required to come from an FDA licensed manufacturer. I confess that I'm more confused than when I started -- why can these companies get away with selling it to any party other than Novo Nordisk? And if they are doing it extrajurisdictionally, how on earth is it getting back into the US and sold to customers without the FDA police knocking down doors? I've talked to survivalists who get their tubs of antibiotics by buying fish azithromycin in bulk from veterinarian suppliers -- are we going to be buying horse Ozempic next?
  - vundercind 2y ago
    > I confess that I'm more confused than when I started -- why can these companies get away with selling it to any party other than Novo Nordisk I don’t think (many? Most? All?) of the drugs in this class are patent-encumbered. They’ve been around for a while. … application as a weight loss drug is patented. That’s new. You can’t package and sell them to fill a weight loss prescription if you’re not allowed to by the patent holder. So it stands to reason that the factories that make the chemical can sell it to whoever they want, as long as the buyer is permitted to receive drugs and such in the first place. The drugs themselves, the actual chemical, isn’t what’s covered by the patent. The compounding’s legality is covered by the Codex post: compounding pharmacies are allowed to package and sell drugs that are on the FDA’s shortage list, regardless of patents that would ordinarily prevent selling them. These drugs (various glp-1 agonists) are on the shortage list. So, that part’s fine too.
    - andrewla 2y ago
      The initial patent for semaglutide specifically was issued in 2008 and is under protection for 20 years -- while liraglutide has been around for much longer, semaglutide is relatively new in patent terms. So presumably the licensed DMF facilities are operating under a license from Novo Nordisk, because otherwise they'd be shut down. But why do the terms of the license allow them to sell to anyone else? You are correct that the use specifically for weight loss is newer and the FDA's labyrinthine procedures give Novo Nordisk exclusivity for a significant amount of time after that.