The Crackdown on Compounded GLP-1 Meds Has Begun (wired.com) 46
Eli Lilly and Novo Nordisk are leading efforts to 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 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 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.
GLP = Ozempic (Score:3, Informative)
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.
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Rather these - GLP - than take GPL-1 medication. Although that kind of medication probably won't get a patent.
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Oops so much for pedantism .. I wrote blocks it should be mimics .. not blocks.
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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).
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Oops so much for pedantism .. I wrote blocks it should be mimics .. not blocks!
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Something that binds to a receptor, but does not activate it, is a receptor antagonist. https://en.wikipedia.org/wiki/... [wikipedia.org]
If it binds to and activates, that's an agonist (what you said). Which could be classified as full agonist, partial agonist, or if it does the opposite, inverse agonist.
Re: GLP = Ozempic (Score:2)
As usual you're the dumbest motherfucker in the room and wrong.
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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.
And pancreatitis. I've seen people with that - works for weight loss better than Ozempic or WeGoVy.
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My wife has a few buddies at the gym on Ozempic who *very* quickly lost LOTS of weight. Like very noticeable difference in only 2 weeks, getting "Ozempic face". We had a whole discussion about it during which I looked up side effects. Pancreatitis is one of the possible side effects of Ozempic so these gym women could get an Ozempic/pancreatitis two-fer weight loss "plan" if they're unlucky.
None of this would even be a thing (Score:1)
If medical research was publicly funded.
Fuck Big Pharma.
Re:None of this would even be a thing (Score:4, Informative)
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.
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The expensive part isn't the development but the clinical trials.
Those are privately funded.
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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.
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The unique and extraordinary microorganism that produces the avermectins (from which ivermectin is derived) was discovered by mura in 1973 (Figure 1). It was sent to Merck laboratories to be run through a specialized screen for anthelmintics in 1974 and the avermectins were found and named in 1975. The safer and more effective derivative, ivermectin, was subsequently commercialized, entering the veterinary, agricultural and aquaculture markets in 1981. The drug’s potential in human health was confirmed a few years later and it was registered in 1987 and immediately provided free of charge (branded as Mectizan)—‘as much as needed for as long as needed’—with the goal of helping to control Onchocerciasis (also known as River Blindness) among poverty-stricken populations throughout the tropics. Uses of donated ivermectin to tackle other so-called ‘neglected tropical diseases’ soon followed, while commercially available products were introduced for the treatment of other human diseases.
Many excellent, eloquent and comprehensive reviews covering the discovery, advent, development, manufacture and distribution of ivermectin have been published by those intimately involved with the various stages.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 It would be folly to replicate those here. Instead, it is the current status, beneficial global health impact and exciting future potential that ivermectin has to offer to human health worldwide that will be the focus of attention.
Today, ivermectin remains a relatively unknown drug, although few, if any, other drugs can rival ivermectin for its beneficial impact on human health and welfare. Ivermectin is a broad-spectrum anti-parasitic agent, primarily deployed to combat parasitic worms in veterinary and human medicine. This unprecedented compound has mainly been used in humans as an oral medication for treating filarial diseases but is also effective against other worm-related infections and diseases, plus several parasite-induced epidermal parasitic skin diseases, as well as insect infestations
https://www.nature.com/article... [nature.com]
Problem is, there's not much profit in commodity drugs. Ivermectin shows promise as a PAK-1 degrader, possibly being an anti cancer treatment. Many other drugs may be able to be repurposed and go on to greatly reduce harm and increase quality of life. Dr Robert Malone said in an interview that he faced a lot of pushback. It seems as though the industry does not want to repurpose generic drugs. They want to push their own concoctions due to profit.
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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.
I'm not so certain that HollyWood's latest craze is something that is health providing. The drugs our prdeominately "white" celebraties take to look "beautiful" have some side effects that might have them looking beautiful from a hospital bed.
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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
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Im sure a balance needs to be struck. Ive been told its not the r&d thats the most expensive part. Its the trials. If we single-payer the whole system there has to be a way to do trials without a huge backlog of drugs awaiting approval because the system is overrun with unqualified idiots looking for an easy job with retirement benefits. A lot of government jobs include a sort of tenure where you cannot get fired for any reason short of a criminal arrest. Remove the tenure system and make them as nervou
Re: None of this would even be a thing (Score:1)
Please quantify the profit margins of the drug companies. Most are at 2%, Pfizer is currently at 0.31%. People like to say certain drugs have such high margins which is true if you just look at the successes. You can see the effects fixed drug prices had on insulin - all but 2 companies left the market, shortages and the prices for those that werenâ(TM)t on a government plan skyrocketed as they had to subsidize them.
Trust the science or follow the money? (Score:2)
Drug studies sponsored by drug manufacturers tend to report higher drug efficacy than studies not sponsored by the drug company, a new report published in the Journal of Political Economy on Oct. 7 finds.
She said that the difference in results between sponsored and unsponsored trials may be that “manufacturers are running multiple trials and selectively publishing those that are more favorable towards their drug.”
“Removing the sponsorship effect would reduce the difference in efficacy ... by about 50%,” Tamar Oostrom, an assistant professor of economics at Ohio State University, said in her paper.
“If some of the results from a clinical trial are biased, patients may be taking a less effective drug for them, or they may be taking a drug when alternate treatment might be more beneficial,” Oostrom said.
“Trials in which the manufacturer’s drug appears more effective are more likely to be published,” Oostrom said.
These published trials can be used in marketing to physicians. Prescriptions also tend to increase in response to favorable clinical trials.
Oostrom cited a 2023 study that found that when a clinical trial significantly favors a drug, “there is a large and immediate increase in demand.”
The trials Oostrom reviewed included an average of 100 participants, with a mean age of 42. Sex distribution was nearly equal, with 51 percent of participants being female. Case Study: Effexor Versus Prozac
As an example of bias, Oostrom presented the case of Effexor, an antidepressant introduced by Wyeth Pharmaceuticals in 1993. Over the following 15 years, Wyeth funded 14 randomized controlled trials comparing Effexor’s effectiveness to its rival, Prozac. In 12 of these trials, funded solely by Wyeth, Effexor was found to be more effective.
However, when Effexor and Prozac were compared with alternative funding, only one out of three trials found Effexor to be more effective.
“Each of these trials is a double-blind RCT comparing the exact same two molecules and examining the same standard outcomes,” Oostrom wrote in her paper.
The study confirms that the funding of studies greatly influences their design and results, Dr. Chad Savage, an internal medicine specialist and founder of YourChoice Direct Care, told The Epoch Times.
“Multiple attempts have been made over the years to counter this effect, such as requiring financial disclosures from authors, but none have succeeded in fully eradicating the bias that can exist,” Savage said.
This bias often stems from the “self-preservation instincts of researchers, who are in a constant quest for funding” or possibly facing unemployment, he added.
https://www.journals.uchicago.... [uchicago.edu]
https://www.theepochtimes.com/... [theepochtimes.com]
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So essentially, these people are not only complete assholes, they are _thieves_. Figures.
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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?
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Go back to (Score:2)
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:4, Insightful)
The Australian government recently banned compounding pharmacies from producing these drugs.
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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
Re:Already happened in Australia (Score:4, Insightful)
I wonder how much bribe money that sabotage of the market took.
I bet you none. Compounding drugs is incredibly common in Australia. They are only banned for specific compounding using certain subset of compounds deemed risky and in that list is semaglutide which is used (among other things) in the compounding here. The issue is purely one of risk. Literally an TGA certified lab (that's like the FDA for you Americans) can produce the medication, the production isn't banned. The goal here is just to stop a bunch of pharmacists mixing certain drugs together which historically has not gone well for any drug suffering a shortage.
Re:Already happened in Australia (Score:4, Insightful)
This. Absolutely this. They had clear instances of pharmacies making questionable batches of the drugs (all in a rush to "cash in" on the shortages) and the government said "ok, we are going to stop all the little guys making these drugs but proper labs that know what they are doing and can do it properly are still allowed to do it".
Can still buy IRL compounded semaglutide (Score:4, Interesting)
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Re: Can still buy IRL compounded semaglutide (Score:2)
I've heard that emigrating to North Korea can do wonders for your waistline.
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https://www.venasolutions.com/... [venasolutions.com].
Does pharma make profits? Yes. Their profit margin is somewhat above the average. But it's hardly at the top. Pharma isn't exactly rolling around in money like scrooge mcduck and lighting their cuban cigars using flaming hundred dollar bills.
Here are some hard truths: Everything about modern medicine is technical and expensive. Producing pharmeceutical-grade chemicals is highly technical and expensive, and high-quality technical workers cos
Greedy scum will be greedy scum (Score:3)
No matter how many people that kills. And a society that does not keep these people under does not have a good future.
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And, obviously some moron must come in with an invalid AdHominem. Do you even realize how utterly stupid you sound? Probably not.
Ozempic is the new opiod crisis (Score:2)
Can't put the toothpaste back into the tube (Score:2)
The demand is so high for this class of compounds that, huff and puff the lawyers and judges may do as they will, it will just be widely pirated anyway. Underground manufacture will flood the market, as for fentanyl, and the pharma monopoly will soon be gone forever.
Info (Score:2)