News: 0175236917

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The Crackdown on Compounded GLP-1 Meds Has Begun (wired.com)

(Saturday October 12, 2024 @03:00AM (msmash) from the incumbent-speaks dept.)


Eli Lilly and Novo Nordisk are leading efforts to [1]curb the sale of compounded GLP-1 medications . Lilly has issued hundreds of cease-and-desist letters to entities selling compounded tirzepatide, following the end of its FDA-declared shortage. Novo Nordisk, whose semaglutide drugs remain in shortage, is taking a different approach. The company [2]published a peer-reviewed study in Pharmaceutical Research, highlighting quality concerns in compounded semaglutide samples, including lower-than-claimed strength and banned ingredients. These actions signal a broader industry pushback against compounders who entered the market during drug shortages. Wired adds:

> With mounting evidence that GLP-1s like tirzepatide are [3]an effective treatment for other ailments beyond obesity and diabetes -- including addiction and Parkinson's disease -- demand is only expected to increase. It remains to be seen whether the pharmaceutical companies will be able to keep pace with the demand or if the meds will go back into shortage and compounders will be able to bound back into the market.



[1] https://www.wired.com/story/crackdown-compounded-glp-1-lilly-mounjaro-zepbound/

[2] https://link.springer.com/epdf/10.1007/s11095-024-03771-6

[3] https://www.wired.com/story/the-benefits-of-ozempic-are-multiplying/



GLP = Ozempic (Score:3, Informative)

by iAmWaySmarterThanYou ( 10095012 )

Since the summary couldn't bother to say so, glp is the primary active ingredient in the ozempic family of drugs being used off label for super fast weight loss.

Re: (Score:2)

by sosume ( 680416 )

Rather these - GLP - than take GPL-1 medication. Although that kind of medication probably won't get a patent.

Re: (Score:2)

by backslashdot ( 95548 )

Oops so much for pedantism .. I wrote blocks it should be mimics .. not blocks.

Re: (Score:2)

by backslashdot ( 95548 )

Because the article itself is inaccurate, what you meant to say is "correct enough" but what you say isn't accurate for pedantic people like me. Ozempic is semaglutide, which is a molecule that is similar to, but not the same as, a natural hormone called GLP-1. Semaglutide attaches to and thereby blocks cell GLP-1 receptors (we call semaglutide a GLP-1 receptor agonist).

Re: (Score:2)

by backslashdot ( 95548 )

Oops so much for pedantism .. I wrote blocks it should be mimics .. not blocks!

None of this would even be a thing (Score:2)

by Rosco P. Coltrane ( 209368 )

If medical research was publicly funded.

Fuck Big Pharma.

Re: (Score:3)

by Strider- ( 39683 )

The crazy thing is that it *is* publicly funded, even in the USA. Much of the R&D is done by universities and similar institutions using public money through various grants and institutes.

But as soon as something looks promising, it gets snapped up by the private sector.

It's the whole "Socialize the losses, privatize the profits" writ large.

Re: (Score:2)

by ShanghaiBill ( 739463 )

The expensive part isn't the development but the clinical trials.

Those are privately funded.

Re: (Score:2)

by Rosco P. Coltrane ( 209368 )

Well then, I say let's pay for 100% of the whole expensive process once in our taxes then get medications at cost instead of letting a for-profit bear the cost then charge us for it repeatedly a hundred times more - either paid for by people individually or by health insurance, which is also our taxes.

I know some idiots will scream "communism" but think about it: wouldn't you rather pay something only once than be surcharged for it many many times over? It makes good economic sense.

Re: (Score:2)

by sinkskinkshrieks ( 6952954 )

Any medication or medical technology that greatly reduces harm and increases life quality preventatively should be heavily subsidized, if not taken over in a "defense production act" manner. No awkward doubletalking, pharma bro CEO should be able to extract $100's of billions from the populace in order to survive the deathcare industry or the over-processed foods industry.

Re: (Score:2)

by wickerprints ( 1094741 )

That might seem to make sense in theory, but in practice, there are some problems doing this on a large scale.

First, not all investigational compounds that make it to the clinical stage will lead to an approved product. Some drugs fail. In fact, a lot of them do, and that's something that drugmakers have worked really hard to minimize, especially at Phase III, because that's typically when the number of enrolled subjects jumps from dozens to hundreds or even thousands. The costs of Phase III trials is ex

Re: (Score:3)

by sinkskinkshrieks ( 6952954 )

Yep. The problem is that profits and incentives due to the excessive privatization of big pharma, big insurance, and big hospital are out-of-control in the USA while the rest of the world benefits off the backs of Americans. America needs to throw away Medicaid, Medicare, and private health insurance, and transistion to a single-payer universal healthcare system with prescription, optical, dental, mental, and long-term care coverage like the rest of the civilized world.

Re: (Score:2)

by gweihir ( 88907 )

So essentially, these people are not only complete assholes, they are _thieves_. Figures.

Re: (Score:2)

by gweihir ( 88907 )

Indeed. Some industries must never be weakly (or not) regulated private enterprises or everything goes to hell. I wonder why this crap does not happen in Europe though. Is curbing industrial greed in situations where people need that products really this broken in the US?

Go back to (Score:2)

by Barny ( 103770 )

I got news for you. "go back to" isn't really valid right now. There is still a shortage on the stuff. I have 1 week left and my chemist can't give me an ETA for more.

Already happened in Australia (Score:3)

by jonwil ( 467024 )

The Australian government recently banned compounding pharmacies from producing these drugs.

Re: (Score:1)

by sinkskinkshrieks ( 6952954 )

AU govt is currently in control by neoliberal and neocon corporatists who don't want regular people to amass any amount of generational wealth, and promote the extraction of money from consumers at every opportunity and forcing them into bankruptcy with a major health event or when requiring ongoing care.

Re: (Score:2)

by gweihir ( 88907 )

I wonder how much bribe money that sabotage of the market took.

Incidentally, the reason why Novo Nordisk takes a different approach is pretty clear: In Europe, pharmacies are allowed to make anything as long as they can assure quality and, if required, there is a prescription for it. Given the qualifications (an "Apothecary" is a person with a PhD in pharmacy in at least some European countries), these claims by Novo Nordisk are quite likely bogus or they had to look really hard to find these bad samples. I

Can still buy IRL compounded semaglutide (Score:3)

by sinkskinkshrieks ( 6952954 )

Instead of $1406 USD (+ no sales tax) for 4 Wegovy autoinjectors, I get 4 compounded manual syringes of semaglutide from a licensed pharmacy for ~$200. It fucking sucks that prescriptions to reduce weight gain side-effects of other medications aren't covered. The for-profit prescription drug and healthcare racket is total horseshit.

Greedy scum will be greedy scum (Score:2)

by gweihir ( 88907 )

No matter how many people that kills. And a society that does not keep these people under does not have a good future.

Re: (Score:2)

by backslashdot ( 95548 )

They must be less greedy than you, because you didn't bother to develop semaglutide but did whatever else it is that you did instead.

Re: (Score:2)

by gweihir ( 88907 )

And, obviously some moron must come in with an invalid AdHominem. Do you even realize how utterly stupid you sound? Probably not.

It must be remembered that there is nothing more difficult to plan, more
doubtful of success, nor more dangerous to manage, than the creation of
a new system. For the initiator has the enmity of all who would profit
by the preservation of the old institutions and merely lukewarm defenders
in those who would gain by the new ones.
-- Niccolo Machiavelli, 1513