FDA regulates the marketing of drugs and medical devices. This is a case of Hims and Hers (and other compounding pharmacies) marketing drugs without having been granted approval.
There is an abbreviated application for new drug approval (ANDA) pathway meant for generics, but it does not seem like H&H has gone this route. It does require you to open your supply chain up to inspections and to provide evidence that your generic version basically works the same as the brand name.
In my opinion there two things going on here that I strongly feel are true.
1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.
2. Hims and Hers are also in the wrong. The rules and laws are there for a good reason. It is not just for us to arbitrarily pick and choose when to enforce them.
I think the real surprise is that hims was able to sell the drug without approval in the first place. I do not support gatekeeping drugs from generic makers but their supply chain should be inspected just like any body else. The fact that they were able to sell a drug for so long without approval shows that something is really broken in the process.
I was under the impression that they were initially allowed to produce the drugs since they were on FDA drug shortage lists. As expected, the compounders scaled up their pipelines to meet demand and now that the drugs have been taken off the shortage list the compounders are incentivized to figure out how to keep things legal. (Of course, they should have had clean supply chains this whole time.)
I'm curious if one of these outfits got bought out to end the supply shortage.
I don’t think this is about inspecting supply chains, or keeping anybody safe. It’s about somebody’s profits. Other times it’s about the FDA’s incredibly overconservative approach, which keeps many meds you can buy OTC everywhere else, Rx only here, and keeps other drugs available elsewhere illegal here. Even for people facing terminal illness.
if it helps people facing terminal illness it doesn't mean it should be OTC. "facing terminal illness" probably needs strong stuff. something required for that can harm the normal guy. it's not like Vit D supplement.
No, what I mean is it takes pulling teeth to get someone who would die anyway, the ability to try experimental drugs even with a doctor’s prescription.
It’s a separate dysfunction than their obsession with making things Rx-only, such as for example, an albuterol inhaler. In Mexico you can just grab one at a drugstore.
> No, what I mean is it takes pulling teeth to get someone who would die anyway, the ability to try experimental drugs even with a doctor’s prescription.
This topic came up in another online community (which I'm intentionally not mentioning) a lot a few years ago. I left a comment about why giving experimental drugs to terminally ill patients is not a simple or obvious idea like many would assume. I got some very long, very intense replies from someone who was dying of a type of cancer who believed he had a good shot at recovery if he could get his hands on an experimental drug. He had all of the links and papers to prove it.
I remember trying to take it all in and reconsider my position.
A few years later, there was a post from his wife that he had died. It was a very sad situation. I clicked some of her links and found that he had a blog where he had written a lot. He actually did go through with the process of requesting the experimental drug and his request was granted. However, the drug not only didn't work, it had caused some irreversible damage to his body that made his final months a lot more painful and difficult than they had to be.
Apparently the "compassionate use" exemptions are not as hard to get as the anti-FDA writers have led us to believe. The harder part is often getting the companies to provide the drugs, because they know the risk profiles and uncertainties better than anyone and aren't always interested in letting terminally ill patients experiment on themselves outside of the process.
experimantal, not fully proven drugs available to help terminally ill patients (which should be true) needs first to make sure the patient is terminally ill. it is not about making them available OTC to anyone who asks. because what happens then is free for all, scams and corporate experimentation on live population.
What specifically do you think is problematic about this, and how do you propose that we mitigate companies from preying on desperate patients while making it easier for patients in need?
Any idea why they'd change their mind about point 4?
The regulatory agencies were understaffed for the work load even before recent layoffs. Why focus on this, of all the things they could put their effort into?
They didn't change their minds. The enforcement was consistent. It's the companies who scaled up their production to mass market levels who prompted the action.
There have been several examples in the past 5-6 years of the FDA loosening regulations to benefit patients and companies rushing in to abuse the opportunity at scale.
Another one that comes to mind is when the FDA loosened restrictions on telehealth prescribing of controlled substances during COVID. Several companies saw this as an opportunity to set up digital pill mills, advertising on TikTok and offering Adderall prescriptions as a service. Nurse practitioners were paid up to $60,000 per month to write prescriptions as fast as they could without interacting with patients.
The companies who bet several billions of dollars in literal decades of research on this stuff should absolutely be swimming in cash until the end of their days. Hims & Hers should be sued into oblivion for stealing the rewards of other companies' ingenuity, risk-taking, and dedication toward helping patients.
I am highly sympathetic to the argument that the government should just buy these patents and mass manufacture to increase availability, or just buy guarantee order vast amounts to scale up manufacturing and distribute cheaply, but the idea that a different private company ought to be able to profit in the way Hims & Hers has is absolutely flatly fucking insane.
So millions of Americans should deal with years of obesity because Novo is a disaster, insurance coverage is ridiculous (any insurer accurately charging for the purpose of risk mitigation should be paying people to take GLP-1s, when instead they are out of coverage for most plans), and there exists no government body to do what you’ve said?
While I'm sympathetic to this argument, I should point out patent time to expiration for medicine in the US is pretty inoffensive (relative to how bad it could be, like software patents), and we already have plenty of drugs for excreting excess. We get a big basket of drugs into public domain each year, and government would be wise to publicly celebrate this, I think; would help with the general sense of impending doom citizens feel.
Semaglutide molecule patent will expire in 2031 here (many caveats to this). For the most part, you can get any pill ~15+ years old for ~nothing without insurance, but associated devices like auto-injectors can extend this due to goofy rules; I expect execs thoughtfully considered medical patent law when deciding to initially trial and release GLP-1s as an injection.
Because “this” is about the biggest in-your-face blatant disregard for FDA rules that has quite literally ever existed in history. The scale is unprecedented.
If there was a single thing an understaffed FDA would go after it would be the compounding pharmacies and that whole ecosystem blatantly thumbing their nose at it all.
Not that I agree with the rules - but if this is allowed it’s essentially an end-around the entire prescription drug regime as we know it.
Hims is mostly marketing. They are using compounding pharmacies to fulfill orders. Compounders are a shady industry in general, and most the GLP places are using Florida pharmacies, which are notoriously extra shady, as Floridas regulatory function is deliberately incompetent.
Compounders are primarily regulated at the state level, and regulatory effectiveness varies. The more legit ones are mostly buying Rybelsus (the pill version of Ozempic for Type 2 diabetes) at wholesale and crushing it. The shadier ones are using precursors, sourcing from questionable & unregulated suppliers or watering down does and adding stuff like vitamin B-12.
The FDA has more limited jurisdiction, and they have been busy firing people.
The federal attention probably has more to do with whatever grift POTUS has going with Eli Lily and Novo Nordisk. Both companies are about to scale up their daily tablet versions of Wegovy and Zepbound at lower price points, and that availability will push the cost of compounded injectables way down.
They are adding B12 as a way to say that it’s tailored to individuals and not available.
I’ve used mainly compounded medicine over the last five years and find the fervent dislike that people have for compounders bizarre.
If you look into generic regulation in the US, the standards are already through the floor. I’d rather work with someone who has a more direct financial incentive to not fuck up.
that reminds me, as in Canada the semaglutide patent expired, Sandoz said they will put a generic on the market in Canada, could that be imported into the US and be sold?
The fact that they could sell in the first place I think implies some corruption occurred at some point in the past that permitted them to do so (not necessarily by them, but someone must have lobbied for "compounding" since that afaik doesn't exist in other proper countries). Then they failed to pay the necessary bribe to be allowed to continue. To be fair, the bribe would have been very large given the GLP-1 manufacturers' position in the pension savings of ordinary Americans.
Compounding pharmacies are in many ways just a continuation of the original apothecaries and pharmacies, and the US is hardly the only country with the legal framework that allows this.
Australia was basically a carbon copy of the US in this regard until 2024, but they have specifically started targeting a lot of the "wellness" compounding that includes peptides, GLP-1s, etc. since then.
Germany has two classes of pharmacy that are nearly the exact same as 503A and 503B compounders in the US
Canada is similar but stricter about the big pharmacies turning into de facto manufacturers, pumping out huge quantities for downstream compounders and clinics, which is what happened in the US.
Lots of other countries that you might not consider "proper countries" (whatever that means) follow a very similar system to the US, and lots of countries that allow some form of compounding, like the UK through their "specials" program, but it's much more centralized - basically cutting out the 503A compounders in the US.
Fundamentally compounding pharmacies offer pretty important services - there are people out there that would literally not be able to take the most effective medication for their condition without the compounding pharmacies making formulation changes that the larger manufacturers might not have incentive to make. Their existence quite literally saves lives. So it becomes a matter of not making that so restrictive that you wind up killing people due to restricted access vs. letting it get abused in situations like we're seeing today with tirzepatide and semaglutide.
> The US is the only country, aside from New Zealand, that allows direct-to-consumer marketing of prescription only medicines.
What interesting here is that Hims & Hers are able to skirt the pharmaceutical marketing regulations. They are able to blanket the world in their ads whereas pharma companies have to abide by strict safety information requirements in their commercials. Him/Hers give literally zero safety and side effect info.
The other weird thing is that the companies like Hims/Hers are basically dial a script. You call them and get whatever you want. They probably deny no one and don't turn anyone away. Unethical and lacks physician oversight.
GLP-1 drugs don’t require marketing. There are tons of people who have been prescribed them and aren’t being covered by insurance. Both Novo and Eli Lily are now selling them direct to consumers with prescriptions that don’t have insurance coverage.
They market the service that gives you the drugs with the smallest oversight possible. These services are becoming popular among people who shouldn't be taking GLP-1s (eating disorders, body dysmorphia, people who are too thin but want to lose more weight) because most of their providers are just trying to write prescriptions as fast as possible to collect their payments.
Also the elderly and poor who cannot afford the prescriptions.
GLP-1 drugs range from $100-$200 a month from mail order compounding pharmacies, or $500 a month on "discount" plans from the drug makers.
This change to FDA enforcement is going to prevent a lot of people from getting help.
The positive impact of GLP-1 drugs is huge, but the price is out of reach for most people. The people who most benefit, elderly obese people at high risk of injury due to falls, who have a low quality of life from morbid obesity, are least able to afford access to the drugs.
These compounding pharmacies were improving a lot of lives.
Anthony Kiedis isn't headlining an event that's being put on by an expressly christian organization. He also is not closely tied to someone who's mentioned more in the Epstein Files than Harry Potter is mentioned in the Harry Potter books.
Kid Rock has some pretty infamous, explicit lyrics I won’t be pasting here. Just look it up, there are dozens of articles about this right now. It’s not rumors or something ambiguous, he is a disgusting person with some pretty awful things to say. Given TP’s christian mission/focus and constant moral panic stance, coupled with the MAGA movement’s alleged concern for minors, “he is not appropriate” is an understatement.
Unfortunately he stays somewhat relevant because he drapes himself in an American flag.
In the UK there's a lot of TV advertising for "weight loss medication" that never refers to any drug by name. But if you look at the small print, it refers to "Orlistat", which is technically available without a prescription. Of course, nobody (or few) actually want Orlistat or end up being prescribed it after the consultation.
The law prohibits ads from simultaneously naming a prescription drug and its therapeutic use. So you might see an ad pushing a specific drug, but it will never say what it's used for. Or you might see an ad where people talk about treatments for a condition but never mention the drug, just saying talk to your doctor.
Sometimes they get around this subtly. In one ad a number of overweight actors discuss how much they love a specific drug, but it's never mentioned what it's for but is implied.
And of course when US channels are simulcast in Canada, US ads just run as is.
This is a vacuous statement because in much of the world (ie most of the developing world), there's no such thing as "prescription only" medicine, people can buy whatever they want over the counter.
To be fair, most medication in the US is overpriced due to patents and what not. The "cost" is hardly the real, legitimate cost and generally inflated 1000%+ compared to other countries.
This is not really the correct way to think about this.
Pharma is ultra R&D heavy so yes, medications are deeply profitable on a per-pill cost to manufacture basis. However, drug companies by and large are not extremely profitable. This is because to produce a single drug (which is high-margin from point of production), they have to sink billions of dollars into literally thousands of other drug candidates to figure out which ones are viable.
This is all "real, legitimate cost," as is reflected in their rather abysmal overall profitability.
As for the disparity between US and foreign markets, it's a basic tenet of commercialization to sell to every buyer at the highest price they'll accept, so long as that price is above your price to produce. All sorts of companies engage in "price discrimination" to achieve this. For example, cereal manufacturers will sell their own brand at $4/box, and sell the exact same product in a store brand box for $3.25/box. A lot of products in your local retail stores do this.
Overall, no one is really hurt by this per se. Every consumer is making a transaction they're willing to make, and the company is making the most money it can in aggregate, which actually gives it room to push the price at every price point lower than it would be able to if it could only sell to a single segment.
This is actually extremely important in the drug context due to the aforementioned abysmal profitability.
Let's take Trump's attempt to force a Most Favored Nation (MFN) clause onto drug manufacturers which guarantees US consumers pay the same price as the lowest price internationally. The intended effect is for US prices to come down to the level paid elsewhere.
But here's Pfizer CEO: "When [we] do the math, shall we reduce the US price to France’s level or stop supplying France? We [will] stop supplying France. So they will stay without new medicines. The system will force us not to be able to accept the lower prices.”
Not only does this obviously not result in lower US prices, but it very possibly results in higher US prices (since now there is less net revenue from lower priced consumers) and, more troubling in the pharma case, there is now even less net revenue coming in to justify new drug development.
It's hard to overstate how asinine this entire endeavor is. US consumers certainly pay too-high prices for drugs, but this intervention does very little to actually address that problem. The much more proximal issue is the incredible degree of intermediation in the US market between payers, providers, PBMs, GPOs, and more.
> Not only does this obviously not result in lower US prices, but it very possibly results in higher US prices
Here's the thing: yes, you may "very possibly" be right, but that means you may also "very possibly" be wrong. The truth is, we don't know, and we can't really trust the CEO of any business to openly admit that they could tolerate a policy disadvantageous to them. So how would you suggest testing the case where you're wrong?
There is no world in which an MFN clause does anything other than reduce the overall revenues to the pharma companies.
There is no world in which lower overall revenues does not reduce R&D spend.
There is no world in which lower R&D spend does not reduce the number and quality of new drugs.
This doesn't require trusting anyone about anything other than trusting that pharma companies are generally profit-seeking and therefore an MFN clause imposed by USG will create less optimal pricing (for the pharma companies' own incentives) than currently exists.
The exact price changes that happen in different localities that net out to "less revenue → less R&D → fewer drugs" is hard to predict, but the fact that it will be lower and it nets out to "less revenue → less R&D → fewer drugs" is absolutely predictable.
Please suggest an alternative outcome, if you can think of one.
> Not only does this obviously not result in lower US prices
Maybe in Pfizer’s portfolio this is true. However, I just watched the Amazon Pharmacy pricing for GLP-1s drop substantially immediately following this. I think you may be being too black and white on claiming this categorically does not work.
Businesses will adapt pricing models, obviously this hurts Pfizer in some way, but Lilly and Novo found the new system was worth negotiating into. Like most things - when people say “always” or “never” - it’s reducing the spectrum of possibilities
GLP-1s are already under immense pricing pressure due to competition, direct to consumer sales outside of the insurance system (to the point of forging entire new markets for drug companies never possible before - what other drugs have millions of customers paying $300-400/mo for prescription medications?), compounding pharmacies end-arouding patent law like this article is about, and outright black market sales that dwarf any other prescription medication classes outside of opioids and benzodiazepines.
It has nearly nothing to do with government action. These will be the most profitable medications ever invented once the dust settles and it’s a game of price optimization right now.
GLP-1 prices are ultra-competitive and in an honest-to-god price war.
Not only are there multiple current-generation GLP-1s on the market (Novo's and Lilly's), but there are at least 2 or 3 more generations approaching the market.
> But here's Pfizer CEO: "When [we] do the math, shall we reduce the US price to France’s level or stop supplying France? We [will] stop supplying France. So they will stay without new medicines. The system will force us not to be able to accept the lower prices.”
This person is a less than neutral source in an industry that's already infamous for lying through its teeth to grind out every red cent from its customers. I would lend precisely zero credence to what he says when he's trying to justify why his poor billion dollar company wouldn't be able to lighten up on its wholesale fleecing of American customers.
"Poor billion dollar company" cannot possibly be a slur in an industry that requires $2 billion in investment (and rising!) to make each subsequent product. Maybe if the product were a luxury good that the world could do without, but it's not, and we cannot.
You don't need to trust anything except that left to their own devices, those greedy pharma companies will price as efficiently as possible in order to maximize revenues. Despite this revenue maximization, the industry as a whole is nearly uninvestable.
Any deviation from the optimal pricing will reduce their overall revenues, which will obviously make the industry even less investable.
In an R&D heavy sector means they will no longer make new products, i.e. no new breakthrough medications that you or I or our parents or children may need.
Sure, I doubt Pfizer et al will just outright stop selling medications to France. Far more likely they will both reduce US prices and raise EU+ prices, but this still ultimately results in fewer drugs for fewer people today, and definitely much slower innovation toward new drugs by virtue of having less cash on hand and much worse expected ROI.
You do not need "trust" whatsoever, this is just basic logic.
> Sure, I doubt Pfizer et al will just outright stop selling medications to France. Far more likely they will both reduce US prices and raise EU+ prices
This is my point – quoting the man on what he says will happen is pointless because he's just using scary hypotheticals to make the best case to keep the cash hose turned on. He's not some altruistic saint bestowing new formulations upon the world if only he had more money, he's a slimeball pharma CEO trying to balance that R&D with reaping maximum profits.
Would lowering prices for Americans mean the world has less R&D bankrolled by American consumers? Probably. But the current situation is untenable.
Americans are willing to pay higher prices because direct to consumer advertising is allowed, making people more willing to pay a higher price because an ad convinced them it will be worth it. If people wouldn't pay, then pharma companies would lower the prices.
Fix the demand side and the supply side will adjust.
I would suggest it's the reverse. Americans accept higher prices because they have many many layers of intermediation.
Americans pick their employer. Their employer picks their health plan. Their health plan picks which drugs are covered and which doctors and pharmacies they can use.
With the "innovation" of vertical integration between insurers, healthcare providers, and PBMs, there is effectively zero incentive for health insurers to manage costs, because those costs show up as revenue for their own subsidiaries. This is actually hugely advantageous for insurers because they are required by law to spend a certain percentage (~80%) of their members' premiums on healthcare goods and services, not profit or business development.
Well... if you own the pharmacies, the PBMs, the GPOs, and especially the healthcare providers... you can arbitrarily siphon money at any % rate you want while increasing the gross dollar intake by simply raising prices at your subsidiary companies!
All of this is well documented. Here are a few places to start:
I just started taking Wegovy. Went the regulated route through my doctor, getting a prescription. She’s been monitoring loads of patients and noted that some of her patients going the ‘compound’ route had, in fact, had allergic reactions to their shots, or experienced their shots being less effective, after months of no problems. Nothing life threatening. But the fact is there is no oversight to what the GLP-1 is compounded with.
People report this with HPLC tested stuff that is proven to be of the same purity/concentration too, "feels" reports are notoriously unreliable in medicine.
Yes, they can 'prove' what is in something to the limits of the physics.
However, the human in the loop is quite frail for most operators. In that, these very fancy and very expensive instruments are mostly run by high school grads and serviced by field engineers with a huge backlog.
For a first time one off test of something's composition, I'd go for at least 3 companies and preferably you have a history with them. This stuff is terribly complicated and misinterpretation is shockingly common. If the tech hasn't used the standards before then your at the mercy of fate.
Like, we have 5 (!) places on the home screen that do the exact same function of ending a run because when we try to consolidate it to just 1, our customers freak out and can't find where the button went to. Granted they pay $100k+ per instrument plus service plan, so we add it back in no question ( and this is life critical equipment in many cases), but I hope that shows how embedded to routine these operators get.
Janoshik is the primary company people use here, and their business is basically entirely peptides and anabolic steroids, and the GLP-1 stuff exploded their business from gym bros to soccer moms everywhere. https://janoshik.com/
But they basically test the same 12ish compounds day in and day out, with another couple of dozen making up the remainder. They don't have most of the worries that you are referring to - first time for a tech running a specific set of standards, limited experience interpreting them, etc., and when people head to head their results against different labs, they are consistent.
What she presented to me was that more than one of her patients taking unregulated GLP-1s simply stopped losing weight, and in an unexpected way. I have no idea how many patients this was. My doctor is rad and very much pro-GLP-1s and pro-preventative-care. This is ultimately an anecdote.
There's a well known plateau effect with GLP-1s where the body adjusts to the changes in caloric intake and the medication itself so that weight loss levels off and stops after a period of time. It could be that but it's hard to tell with 2nd hand info.
Personally I feel the hims etc of this world need to go away. They give a false sense of security and they mask an incredibly shady industry.
I also think people should be able to source from the grey market if they can figure it out. This means they understand the risks and likely take measures like ensuring their compounds are properly tested before injecting them.
I’d feel differently if I didn’t understand how the average medspa gets their product and the corners they cut. I honestly trust some outright black market dealers better than most of those shops. They actually do testing on their product before shipping it. Likely sourced from exactly the same manufacturer as the guy in the locker room buys from.
So long as the choices are informed I agree. The issue is hims/hers puts a fancy veneer of “sanctioned medical system” on top of what amounts to a black market. They are laundering and obscuring the risk and many patients simply do not understand this fact.
It’s the difference between buying Xanax from a legit pharmacy vs a street dealer. The street dealer transaction you understand the risks involved and are making an informed decision. If you thought you were buying from a legit pharmaceutical company but they ended up just rebranding the same shit the street dealer is selling from his wholesaler - that is not informed consent even a little bit.
There is something in the middle here but some HLPC testing I’ve seen of supposed legit compounding pharmacies hasn’t been great for these drugs.
Can you quote from the five sentences I wrote where I said anything about telling people what to do? I simply noted that my medical provider has first-hand experience with people getting questionable results from unregulated GLP-1s.
This is precisely why we have clinical studies. We want to measure the efficiency and the innocuousness of drugs. You seem to imply we should just go ahead and try those directly on the general population.
Has anybody ever been forced anyone else to take any drug? The problem is not about being forced, it is about making an informed decision. When you don't have enough safety data you are effectively gambling with your health.
The individually compounded versions have a higher risk because there's a person involved who can make mistakes, as opposed to a carefully controlled and tested manufacturing line.
Compounded drugs have higher rates of bacterial problems, doses being too high or low, and other issues.
Someone I know worked for a company that took over a poorly run compounding pharmacy and cleaned up their process. Some of the stories I've heard have made me want to avoid compounded medications wherever possible.
Yes. Drugs are too damn expensive and innovation is too damn slow. Better to allow higher risk options. And if you don't like it, you are always free not to use them.
"If you don't like it don't take it" ignores all of human history. A huge majority of substances can be fatal if ingested. Are you sure you want to live in a world where Elon can speed run figuring out what won't kill "most" people?
I'm on death row. So are you. The only thing that has a chance of giving me a stay of execution is rapid technological advancement so I'm willing to accept a lot of risk here. It's a matter of self preservation.
You are misrepresenting the FDA post. They focus on the fact that the API was not approved for use, which means removing the marketing authorisation is something perfectly fine to do. All API sources need FDA inspections proving the GMP practices are respected and compliant.
ANDA is for drugs that have gotten off patent. Semaglutide has not gone off patent in the US. It won’t until 2032 at the earliest.
And ANDA absolutely does require supply chain inspections, first at approval then random inspections there after.
Whats Hims and Hers was doing was compounding (turning the chemical into a formulation patients can take) under an exception due to limited supply. Supply issues are over, so they can not longer compound.
I do t think anything is wrong with the US system here. These patients got access under a temporary exception, they have the option to obtain a supply through other channels going forward. If affordability is an issue, the manufacturers have several programs that make these drugs affordablez
Are they? This example seems to be a clear contradiction of your first point. Stuff like this weakens the authority and credibility of the FDA, allowing legitimacy to people like RFK.
If the description in the first comment isn't missing anything important, and this could be fixed with some paperwork and inspections, then I don't think taking action makes the FDA look bad.
The particular complaint of "cannot state compounded drugs use the same active ingredient" is weird but if it only applies to marketing then sure crack down on that too.
Eli Lilly will categorically state it is impossible for the compounders to be using the same API as they are due to being the sole source of manufacturing for it on the planet.
From what I can tell they are technically correct. The FDA approved method of manufacturing the peptide chain is different than the Chinese sources these compounders are sourcing from. It may not make an actual biological difference (and hefty evidence of millions of people on it show there is unlikely to be a material difference) but it’s not the same as a generic medication being approved.
This is about as Wild West as most of us have lived through for the U.S. drug market.
> This is about as Wild West as most of us have lived through for the U.S. drug market.
I don't know about that. I'm old enough to remember The Vaping Panic of 2019, where (medical and/or recreational) cannabis vape liquid was adulterated with Vitamin E acetate in industrial quantities, which caused widespread injury and death. The real cause was called out very quickly (thanks in part to investigative reporting by...WeedMaps[1]), but health departments flailed and spent months blaming it on Juul and teen e-cigarettes. The panic evaporated because right as the public health community realized what was happening, Covid broke out.
To this day, afaik no testing of vapes is required to ensure they don't contain this toxic ingredient.
> To this day, afaik no testing of vapes is required to ensure they don't contain this toxic ingredient.
This is a pretty good example of how "testing requirements" tend to be reactionary and effectively useless.
Vapes contained Vitamin E because the sellers were cutting the product with it, the same way drug dealers cut drugs with starch or sugar or something worse. It wasn't a manufacturing mistake, they were adding it on purpose to rip off the customer. It makes sense for that to be a crime -- it's fraud and negligence -- so the argument comes that we should require testing for it.
But if you add a test for something like that, they either cut it with something else that the test won't show (which might be even worse) or they add the cutting agent to the distribution pipeline somewhere after the point where the testing requirement is imposed. Testing for something works against mistakes, not purposeful behavior.
Meanwhile the people doing it were probably idiots who didn't know it would cause physiological harmful and thought they were just ripping people off, so then the argument comes that we should be testing to make sure they're not doing that. Except there is no generic test for every possible problem, so at the point they first started adding it, the government would have had no reason to test for that in particular, and by the time it becomes generally known that adding that substance is harmful, they'd have stopped adding it because they don't want to be sued or arrested when their customers have those symptoms and then permanently testing everything for something everybody has already independently stopped doing is a waste of resources.
The problem is people want the generic test that could catch every possible problem and that isn't a real thing, and there is no point in doing the specific test for something that has already stopped happening.
I wouldn’t put vapes in the same category as patented pharmaceuticals.
They are already an unhealthy vice for one thing. They do not require a prescription and are sold over the counter to anyone who presents an ID showing they are of age.
Those vapes were also largely made by relatively fly-by-night manufacturers selling into mostly shady retail shops. Additionally there was (still is? Haven’t kept up on it) no real consensus that vitamin E acetate was a dangerous chemical unfit for purpose.
This is the first time in my lifetime that I can recall of major companies blatantly end-arounding the entire pharmaceutical approval process for a prescription drug. Full on advertising their disregard for the rules on public airwaves and everything.
FDA being slow to react to a public health concern due to an adulterated over the counter product imo is not the same category. This is literally telling the FDA and major pharma “come at me bro” and expecting the delay to be profitable enough to offset any future penalties.
That specific medicine is about a molecule that was insufficiently vetted.
It does not seem as egregious as the risk of getting medication made in other countries. As far as I know, all the patented medicine comes from barely audited factories in places like India anyway.
Yes yes, it's super beneficial to destroy the incentive for anyone to risk billions of dollars and decades of research to develop new breakthrough medications for people
The interesting systems-level question here is whether the FDA approval pipeline was designed for a world where a single drug class can generate this much demand this fast.
Traditional pharma economics assumes the patent holder can supply the market. GLP-1s broke that assumption — Novo Nordisk and Lilly literally could not manufacture enough to meet demand, which created the shortage that let compounders in legally.
Now the shortage is declared over, so compounders lose their legal basis. But "shortage over" is doing a lot of work in that sentence. It means the brand manufacturers say they can supply, not that the drug is accessible to most people who would benefit from it at a price they can afford.
The deeper tension: FDA's framework is binary (approved or not) but the actual risk landscape is continuous. A compounded semaglutide from an inspected 503A pharmacy with proper testing is a very different risk profile than something mixed in someone's garage. Treating them identically under enforcement seems like it optimizes for regulatory clarity over public health outcomes.
"Demand" is not a good metric for proper medical or safety review. There is constant demand for products that promise amazing things, but they should not be approved more rapidly because of their claims until they have gone through the proper process and reviews to show both that they do what they claim and that they do not have other serious side effects or consequences.
We're talking about allowing an "essentially" generic version of an existing FDA approved drug made by licensed compounding pharmacies that has been legally distributed for years due to the shortage. If it's safe enough for people to take in a shortage then it's probably safe enough for people to take in a not shortage.
You’re putting more things I. The FDA’s regulatory basket than the law intends.
Whether or not “people who could benefit have access” is not relevant to the FDA’s mandate. The intent of the FDA is to regulate the safety and efficacy of medicines - not access, not price.
Once supply was addressed, the FDA’s regulatory objectives were complete
I don’t understand how it’s not legally required to be covered by all insurance in the US given all the health problems downstream of being overweight.
Because then the companies that have been given legal license to monopolize this technology (through the legal technology known as "patents") could charge whatever price they wanted and insurance companies would have to pay for it? The ability for an insurance company to say no is literally their only negotiation leverage.
Every country arranges their payment mechanism slightly differently- the US is worse than pretty much all of them but they are all slightly different- but every form of insurance has to be able to walk away in the negotiations, or else the monopoly producer will hike the price up.
I imagine if you forced insurance to cover but also removed patent protection and allowed generics immediately... drug companies would be even more unhappy than the insurance companies would if you forced them to cover GLP-1's.
> Because then the companies that have been given legal license to monopolize this technology (through the legal technology known as "patents") could charge whatever price they wanted and insurance companies would have to pay for it? The ability for an insurance company to say no is literally their only negotiation leverage.
Insurance companies have to pay $100k+ per month for medicine for anemic people, and many other much higher cost medicines. Why is a couple hundred dollars to fix THE single biggest cause of future healthcare expenses (diabetes, high blood pressure, and cholesterol) not covered?
Insurers routinely pay for $1M+ NICU babies, $100k+ heart surgeries, yada yada, but the US government draws the line at medicine that costs $200 per month that prevents hundreds of thousands of dollars in future spend?
I can’t make it make sense, unless the junk food/alcohol/restaurant/sugar caffeine drink lobby has their tentacles deep in the government.
>Do we really need insurance to cover $100/mo meds?
For people making how much? Low income people are jumping through the hoops to get SNAP. $100 for them is a lot, and which they might just not have. And for insurance it would be cheaper long-run than dealing with diabetes, etc.
Anyway, why a such "submarine" attack on the $100 GLP-1 sources and why now? Well, one way of thinking would be that Trump RX just went online and there, thanks to the well known Trump's care about people's needs, the GLP-1 is $350, so one has to remove the $100 competitors.
It’s not a submarine attack at all. If anything I bet you these compounders are surprised they haven’t been shut down already for blatantly violating the law.
It’s a case of trying to get so many consumers buying that regulators are scared to touch you due to blowback. Much like Uber did.
Well, 67% of Americans are overweight and the mandatory drug costs $1k. So premiums must be $670 per person or higher to cover nothing but this drug. The drug manufacturers will know that the insurers must provide it so they’ll use the highest price they used at scale: $1k.
That means that every healthy person is also paying $670 per month just so that the 2/3 of the country can get this drug. But current medical loss ratios are at least 85% and if we did nothing but pay $670 we’d be at 100% loss ratio and the drug paid for.
Boy the economics for the average person look pretty bad, considering they can just get it off the internet for a fraction. I have 240 mg of retatrutide in my fridge for about a dollar a mg in comparison.
I like the way you're thinking about it, but worth mentioning that the net prices paid are likely in the $200-500 range, similar to the cash pay. List price doesn't mean much
This calculation is incorrect because the medicines cost significantly less than $1k per month, and there there would be cost savings from people being less overweight needing less healthcare.
For decades now, every single healthcare study seems to say overconsumption is the root cause, and now that there is a way to combat it, the government is saying the fix to overconsumption at a few hundred dollars per month is not worth it?
Yes, plans have pretty wide latitude on what they cover. ACA limited quite a lot by not only in plan design, but also what therapeutics must be covered. And you are correct, obesity is not one of them.
Medicare Part D (outpatient drugs) has wide latitude on what medicines they cover - it's actually smart for patients to shop their Part D plans if they are taking an expensive, chronic medication.
The only classes of drugs that Part D plans must included are:
Part D sponsor formularies must include all or substantially all drugs in the immunosuppressant (for prophylaxis of organ transplant rejection), antidepressant, antipsychotic, anticonvulsant, antiretroviral, and antineoplastic classes. (Page 28)
After the first big crackdown on compound pharmacies, I have seen a lot of people go to gray market. Especially now that it has become pretty clear that the remaining compound pharmacies defying the FDA are getting their API from the same sources that we can buy it from directly, and their testing is way more suspect. On the gray market the batches of peptides are routinely subject to a battery of tests run by groups of volunteers, which is a lot more than what you can get from your chosen compound pharmacy (most will give you a COA, but that's already table stakes if you buy from a "research" vendor.)
I have noticed that the "research" vendors have started to tighten up their operations, especially the ones based in the US. A lot of people have seen the writing on the wall and expect it to become somewhat harder to get the peptides, and are stocking up. It's a running joke how many years worth of tirzepatide or retatrutide people have in the freezer. Once you've had the miracle drug, you won't risk being without it.
I would silly things to hold onto a steady supply of pentadeca arginate. It has completely eliminated lingering effects of joint and ligament injury and has enabled me to exercise like a normal person. If you have the money it is very easy to acquire a year or twos worth from multiple sources.
Just posting for general awareness - people search this stuff up and then find nothing but research chem sites singing the benefits and providing no info on the risks.
I've had great success with BPC-157 and tendon issues, but I try to use it sparingly - no history of cancer, but everyone has no history of cancer until they do - and try to rehab any injuries with slow heavy eccentrics, etc., and only go for the BPC when that isn't making any improvement.
What makes you say that compounding pharmacies' testing is way more suspect? Curious because I know people who are still using compounding pharmacies (specifically mom-and-pop joints that might be able to evade crackdowns for a while longer) but have considered going grey market... maybe this is the sign to switch?
It's opaque, and limited. They buy the raws from China just like everyone else, then reconstitute them, fill vials, and drop them in the mail. They'll only provide a COA if you ask them to, and it will just be one basic mass/purity test most often.
In the gray market, there are multiple mass/purity tests for a batch (to look for variation in fill, mostly), as well as tests for endotoxins, sterility, heavy metals, and fentanyl. Rarely (maybe never; I have certainly never seen it) will a compounder do these additional tests and provide the results.
I think in general the well-known compounding pharmacies (e.g. Hallandale, BPI, couple others) are probably reputable enough to feel okay with. The mom & pop ones (or med spas) I'd be a lot more nervous about. Often ends up being someone who's just reconstituting vials in their living room, and maybe not with the quality controls you'd like to see.
Novo and Lilly spent billions making Semaglutide, Tirzepatide, and future formulations/modalities.
They are going to monetize this heavily while they have IP coverage. There is no world they will let HIMS or any compounding pharmacy of scale undercut them.
On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.
Fortunately, the prices are coming down. Amazon pharmacy has Wegovy in an auto-injector starting at $199 without insurance. And that’s delivered to your door in under 24 hrs in most major cities.
I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now. Historically, we subsidized R&D globally by allowing pharma to make most profits on Americans then have cheaper prices abroad. That is changing and hopefully that’s a net positive.
> I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now.
Brief research indicates otherwise unless you're talking about a handful of Brand name Rx. For generics, CostPlus and other options are still better pricing.
> I highly recommend checking out the terms of trumprx.gov
The website is very good marketing for people who don't typically follow drug pricing. Here is more about why the only folks who will benefit are those without insurance—but those people will find better prices in several places, sometimes significantly better prices [1]. Further, it's likely that they're already finding those prices, since the website prices are no better than what you can get today outside fertility medication; and fertility medications are neither new, nor the most expensive part of that process.
This site has nothing to do with the effective subsidies that Americans provide to the world, and it will change nothing about that. The major thing that would help all Americans, negotiating for drug prices, has been neutered by the current administration. In fact, an executive order has specifically lengthened the amount of time that new drugs will be able to charge higher prices to Americans [2].
We should all be very careful in parsing news items that are not in our field of expertise.
Drug companies produce drugs to make money. There is a huge investment. They maximize revenue by price discrimination to recover the cost of the good drug and all the drugs that didn't work. The US is a rich country. People in other countries can't pay as much for the drug. To maximize revenue the drug company sells the drug at a lower price to those people.
More generally, price controls lead to less supply. Drug price controls will result in fewer new drugs. Minimum wage laws result in no workers doing work that is worth less than minimum wage. Anti- price gouging laws result in less bottled water and fewer generators after a hurricane. The principle is universal despite promises of delightful state run grocery stores.
I think 'MFN' is almost propaganda (not a term that existed before 2016-2020 administration) so let's leave that aside.
Are you claiming that the new website is offering lower prices than patients are paying after their co-pay? That is not the case outside the example I presented; moreover, the way the website is organized, there will be no pressure for prices to remain competitive after the initial media attention dies away.
I agree that a hypothetical case where we were paying lower prices would be better for us—but this remains an unrealized hypothetical. One way for us to pay lower prices would be to allow our government to negotiate prices for Medicare/Medicaid recipients, and that is exactly the thing that has been hampered.
Not arguing on broken internal pricing dynamics that are skewed by all sorts of gov programs and payors.
It’s about external, global pricing dynamics. The site clearly isn’t going to be able to give clean payor/pbm/gov subsidized pricing tables - that is almost an impossible exercise in our system.
What the agreement does accomplish is saying Americans will not pay $1150/mo while EU pays $400/mo while Argentina pays $120/mo.
It guarantees drugs will be greater than or equal to US pricing abroad which effectively forces pharma to find deeper profits outside of the US, or lower prices for all countries to acquire demand.
That is extremely effective. Now it’s up to a really complex group of people to figure out what that means inside our weird system of pharma/pbm/rebates/insurance/medicare.
But that’s not what trumprx is aiming to solve for right?
> But that’s not what trumprx is aiming to solve for right?
Correct
> What the agreement does [...]
This is hypothetical and does not exist. It also is not going to happen, politically, because drug companies are currently expecting to charge US prices in the US, while charging lower, non-US prices outside the US.
> That is extremely effective
This is hypothetical—and, as I've said, the attempt that the Inflation Reduction Act made toward this was watered down by an executive order. To be fair, the negotiation mechanism is still in place, and its existence must be influencing drug pricing already.
The most effective use of public funds would be to simply buy out the patent and give it out for free. It will save so much in future medical costs it's a no-brainer.
It’s a no brainer for reasonable people, but a very substantial portion of US voters would rather shoot themselves in the foot so long as there was a chance some shrapnel grazed a liberal.
It can't possibly be a net positive. The first pill costs $1B and subsequent ones costs 50 cents. Yes, the U.S. pays more, but the result can only be some combination of 1) other countries also paying more and 2) fewer new drugs.
And 3) US consumers pay less for pharmaceuticals. Together this might be a net positive for US consumers (even if they get fewer new drugs out of the bargain).
Well that's the choice. Allow drug companies to price discriminate so that poorer people can also buy the drugs or don't allow it and get more new drugs. It's not clear that drug companies are even going to retain low prices in other countries if it means that the US consumers will pay less.
Which drugs that haven't been invented yet do you think we should forego?
Why are you so sure that isn't a net positive? Maybe we're spending too much money on inventing drugs that would be better spent on building houses or feeding the poor.
> On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.
It's often up to the employer whether these meds are covered - many insurers just offer it as an option to check or not check.
That said, even at 3-6k/year, it wouldn't surprise me if these drugs were net savings to cover for a lot of patients due to their extremely positive effects as preventative care.
Yeah, my employer changed insurance a few months ago from UHC to Cigna.
Cigna is terrible, even worse than UHC, I'm not happy that we have them but that's a whole separate rant I don't care to get into right now, but one thing I was really annoyed by was that UHC covered Zepbound, but then Cigna didn't. They actually wouldn't cover any GLP-1s unless you are already diabetic, so my wife had to stop.
I initially blamed Cigna for this, but eventually I found out that my employer deliberately opted out of it, so now I'm mad at my employer and Cigna.
We've had to use a compounding pharmacy for my wife to continue her terzepazide, which has worked fine and at least thus far hasn't been an issue, but I knew that these things were on borrowed time due to their kind of gray legality.
>On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes.
I'm not understanding this part. If these drugs have solved obesity and the whole host of associated diseases, including the number one killer; heart disease, shouldn't the insurance companies be clambering over each other to cover these drugs and heavily encouraging their use considering the cost reduction on the overall health system.
And if the incentives are misaligned with insurance companies why are governments not handing out GLP-1s to anyone who asks?
For chronic diseases that tend to be caused by obesity, the expensive bits tend to be towards retirement aged people - or are so disabling that people drop out of the workforce early.
In either case the vast majority of those costs will be incurred by either Medicare or Medicaid. Or at least the next insurer in line as the typical worker doesn’t spend an entire career at the same firm with the same insurance provider.
By the time any cost savings benefits have been realized (call it a decade later), chances are that insured patient is long gone and all they were was an additional expense.
By the time government gets involved you have someone who has been obese all their life and the damage is largely already done. Even if you paid for the meds now, the savings are limited.
Given the market already though - these drugs will be affordable to the average working person within a few years
Your employer (large employers usually dictate what is covered by their insurance benefit offerings) may not care much about whether you end up with obesity-related diseases in your 60s and above.
The major Indian generics manufacturers have all signed branding and IP agreements with Lilly and Novo as well, so the only people that are hurt are consumers I guess.
India wins (because Indian pharma gets IP and branding transfers). The Trump admin wins (the right strategic lobbying was done). The GOP wins (strategic tariffs on Iowa, North Dakota, and Montana lentil and soybean oil exports were about to kick off in India after they were hit by similar tariffs from China). The American consumer (who voted for Trump) loses.
Was my glucose under control without glp-1's? Yeah I could manage an a1c of 5.4-5.6 with metformin but I was still hovering near 300 lbs.
With glp-1's I'm down over 50 lbs, my a1c is a much more manageable around 4.0-4.5 and it makes it much easier to exercise and portion control is a huge benefit. Not to mention a buncha other things like triglicerides and blood pressure have come down due to exercise and eating better. it sucks i have to take it forever, but at the same time i feel a ton better physically, and if i loose 50 more lbs, and labs continue to show improvement, i can reduce the cocktail of other meds I'm on my doc says.
Cigna denied me at first until my doc appealed twice. Cigna wouldnt cover because i wasnt a full diabetic so wasnt on insulin. I would've had to pay close to $1k a month to take it otherwise. Thank goodness for a tenacious doctor!
> I would've had to pay close to $1k a month to take it otherwise.
If your frame of reference for GLP-1 prices is in like, 2024 or earlier, check prices again. They've come down a lot. You can get tirzepatide from Lilly without insurance coverage for under $500/mo (a little less for the smaller doses): https://investor.lilly.com/news-releases/news-release-detail...
I've been taking metformin off-label for weight loss, and it's been working well. I'm a little annoyed that I have to resort to off label stuff because I too have Cigna and I have not been successful at getting them to cover it.
I think it's more my employer's fault than anything else; fortunately metformin actually seems to be doing the job. They won't cover that either but even without insurance it's so cheap that it's not worth complaining about.
It was infuriating trying to get Wegovy via insurance. My doctor made three appeals, all denied. Out of pocket it wouldve been $1600/mo. Ive been getting semaglutide from compounding pharmacies for the last year and half for $149-$200. I have lost 97lbs, come back to running 30 miles a week after several major knee injuries made even a mile jog a multiday recovery effort. I absolutely get the regulatory stance but the name brands are absolutely unaffordable.
They’re down to hundreds a month, now, with a coupon.
I can’t say I disagree with insurance not being willing to pay those costs (apart from diabetes patients etc.). I bet a large part of the reason you can get the name brands cheaper now is because they did the math they’d make more that way than they could squeeze out of insurance companies.
Also, on a personal level it rubs me the wrong way to have my insurance premiums go towards something that people could just do themselves, from something they did to themselves. I know many will disagree, of course, and there are other examples (say, lung cancer treatments) that are similar.
A fairly large portion of lung cancer patients didn't "do it to themselves" (about 20% and rising).
It remains to be seen how vaping impacts lung cancer,
I don't like the idea of finding reasons to penalize people for predicable life decisions that lead to treatment needs. Insurance companies have a lot of resources to make those predictions and if unshackled they aren't afraid of using them. Making construction workers, miners, or truck drivers pay more (or be denied outright) for insurance because their job has negative health effects would be bad for society.
I personally think that overeating is an addiction, not a moral failing, and is often the side effect of other mental illnesses.
I don't do this as much as others, but as someone who has suffered from Major Depressive Disorder [1], it can be really easy to eat your feelings away. When I've had really bad depressive episodes, I don't want to cook, I don't want a fucking salad, I mostly just want to feel bad about myself and I end up getting a huge meal at Taco Bell and sadly eating that. Doing that one day isn't that bad. Even doing that two days isn't that bad, but when you have a long extended depressive episode, it can easily become a pattern of weeks where you're getting unhealthy fast food every day.
I know a lot of people act like depression is a moral failing as well [2], but I personally don't think that, and it feels like obesity can be a symptom of major depression. If you ever watch "My 600lb Life", you'll see that a lot of the people on there are really going through serious mental disorders and/or dealing from PTSD from sexual abuse, and the overeating can come as a result from that.
I guess I just feel like it's reductive to say "they did this to themselves". The human brain and human psychology are complicated and irritating.
[1] Fortunately my current set of meds has really helped...medical science is pretty cool sometimes!
If losing the weight is good for them, isn’t it possible that it’s not just the humanitarian thing (which I know is a useless argument to make to the soulless ghouls who run insurance companies anyway) but also the economically right choice for them, to avoid paying for their worse health problems later?
> Also, on a personal level it rubs me the wrong way to have my insurance premiums go towards something that people could just do themselves, from something they did to themselves. I know many will disagree, of course, and there are other examples (say, lung cancer treatments) that are similar.
> Also, on a personal level it rubs me the wrong way to have my insurance premiums go towards something that people could just do themselves, from something they did to themselves.
The usual note for this is your insurance premiums were already going towards that, just indirectly by way of paying for heart disease treatments, diabetes management and other secondary effect of obesity.
But I'd also like to propose that "could just do themselves" is carrying a lot of assumptions that may not hold for any individual. A few years back now I started a medication with the side effect of appetite suppression, and I learned something about myself. To the best of my ability to recall, I had never before starting that medication not been hungry. "Full" to me was a physical sensation of being unable to fit more food physically in my stomach, but even when I was "full" I was hungry. Luckily for myself as a teen and young adult I had an incredibly high metabolism. I could eat 3 meals a day, 3-4 bowls of cereal and milk as an "afternoon snack" after school and some late evening snacks while watching TV and I still was in the "almost underweight" category. It was in this context, a time when I could go to a fast food restaurant and order two meals just for myself and stay well inside a healthy weight range that I learned to eat as an adult. Eventually though, the metabolism slowed down, and I started packing on weight but the hunger never subsided. Oh sure, as I got older the idea of and ability to eat an entire pizza by myself slowly went away, but hungry was always there, so I was still always eating and always eating more than I should have.
And I did manage to lose weight on my own many times. Through extremely strict self control and portion control, multiple times I managed to lose 25, 30 even 50lbs, one painstaking week at a time. Every day was strict tracking and weighing of everything I ate, and many days were hard battles of "I know I'm hungry, but I've already hit my limit for the day, so I can't eat more", and going to bed extremely hungry with the hope that when I woke the next morning that feeling would have subsided a little. And it worked each time, until inevitably something happened to disrupt the routines and habits built over the months. Maybe it was a set of family emergencies that had me eating on the run, unable to properly monitor everything and adding some "stress eating" on top of it. Maybe it was running into "the holidays" where calories are cheap and abundant even if you are still keeping track. And sometimes it was just being unable to sustain the high degree of willpower it required to keep myself on the schedule. And what takes month of carefully losing 1lb a week to do only takes a month or two to almost completely undo.
Hunger is probably the closest thing I've ever experienced to an addiction. I've thankfully never had to battle an addiction for anything else, but when it comes to hunger that eternal gnawing was ever present and the more weight I lost by sheer force of will, ever distracting. If the idea popped into my head after lunch that "I'd like a snack", it was an idea that would not leave my head until either I'd given in and gotten a snack or forced myself to not give in and waited until dinner. But that forcing meant dedicating ever larger parts of my mental energy away from my work and tasks at hand to just convincing myself to not go get the snack. And worse, when the time for dinner finally came, I was already feeling "hungry" on top of my normal hunger state, so often not eating the snack just meant delaying the excess consumption to dinner or having to continue that fight at dinner. If it sounds exhausting, in a lot of ways it was. But of course, like you said I can "just do" this. It's simple CI < CO math. And yet it never stuck, in part because unlike a lot of other unhealthy habits you can pick up in your life, you cant just not eat. Yes you can eat different things, or eat healthier, both of which can help with weight problems, but you can't stop eating. You have to eat, the hunger is always there and the same thing the hunger wants is the same thing you NEED to literally survive.
But that medication with its appetite suppressant effect was a game changer for me. For the first time in over 30 years, I actually felt full. Not physically stuffed, but "done eating". I could eat a small lunch and think to myself "that was good, and I feel satisfied". For the first time, when the idea of an afternoon snack popped into my head, I could remind myself that dinner was in 2 hours and I needed to make sure I had room to eat that so the snack could wait, and that would be the end of it, no fight necessary because the hunger wasn't gnawing at me the whole time. When I first started, I was concerned that the medication was giving me anxiety attacks because about 6PM every day, I'd start getting this feeling of my stomach tying itself in knots, and this sensation of "needing something". And after a week or so it occurred to me that what I was feeling for the first time in my life was the feeling of transitioning from having been full and satiated to being hungry again. I'd never not been hungry before. And I know that sounds insane, because it sounded insane to me then. Before taking the medication if you'd asked me if I know what it felt like to be full or to not be hungry I would tell you that I did. But apparently I didn't, and I didn't know that until I started that medication. And for the first time since the weight started coming on, the weight I've lost is staying lost.
So yes, you can "just" eat better and less and control your portions and not eat so much. But from personal experience, it's a hell of a lot easier to have that will power when your body is giving you the right signals and isn't constantly pushing you over the limits.
At the end of 2023 and the beginning of 2024, I lost about 60lbs, and it was a basic calorie counting thing. For me, it wasn't too hard; I was able to get used to the hunger and after about a month the feeling of wanting to eat all the time was somewhat tolerable.
In May of 2024, I started taking Pristiq, and one of the side effects is a huge increase in appetite. Like you said, I would feel "full" in the sense that my stomach wouldn't fit anymore matter, but I was always hungry and pretty much perpetually craving sweets. I would get a whole large pizza for lunch, a large meal at Popeyes for dinner, and chase it down with snack cakes, and I would still be "hungry" the entire time.
I managed to undo all the progress I had made with my dieting and a bit extra, and it was kind of weird. It's not really "hard" to know what to do. Obviously everyone knows to eat less processed food, focus more on protein and fiber, etc, but despite me "knowing" this, it was strangely hard to actually do it.
I'm very thankful that I found out about Metformin. I'm not diabetic and never have been, but it's prescribed off-label for weight loss, and according to my doctor it can be useful in the particular case of "canceling out the appetite-increase from medication", and to my surprise it worked shockingly well. I'm still not quite down to my diet weight yet, but I'm down about 30lbs in the four months I've been taking it, and I don't really feel hungry all the time. I still enjoy eating unhealthy food, but food is considerably more transactional now: I eat food because I need energy to survive. I budget about 200 calories lower than what my smartwatch says I burn during the day. It's much easier to treat food as a more utilitarian necessity.
If anyone here is in the unfortunately situation of not having their insurance covering GLP-1 medication, I highly recommend seeing if you can get your doctor to prescribe metformin. It's been out of patent for decades and cost on the order of ~$5 a month [2] and there are very few side effects [2], so it's a relatively low-risk experiment.
I was receiving compounded Semaglutide (Wegovy generic) from Victory Pharmacy, a brick & mortar compounding pharmacy, in Austin for $150/mo, then $200/mo, and finally I stopped when it reached $250/mo. I have SSDI and Medicare but it wasn't covered and it's still not covered for pharmacologically-induced obesity or weight gain. If I developed diabetes, then it would be covered as Ozempic (lower dose). I'm having to go without because of bureaucratic gatekeeping and discrimination and because of opportunists cash grabs by pharmaceutical companies' price gouging.
Why is obesity not considered a necessitating condition? It often carries the comorbidities you just mentioned. Should not exclude people just because they haven’t had these specific health problems (yet) but will eventually have them.
While I tend to agree, insurance companies don't see it that way. They need a doctor to indicate a necessity to treat a condition, as opposed to it being the easiest way to treat it.
For example, I have to take digestive enzymes to digest my food (pancreatic insufficiency). For someone with an unusually high metabolism, they would also give them a leg up on gaining weight, even though there are other approaches to gaining that weight. However in many cases, the insurance company wouldn't cover their prescription when they will mine.
As always it’s insurance nonsense. If incentives were aligned insurance companies would be lining up out the door to give this to obese people because they (the insurance companies) would eventually be on the hook for paying for the care of the conditions you just mentioned. It is very well demonstrated in literature that obese people have a much higher occurrence of these conditions than non obese people.
But the system is not set up with aligned incentives
The problem is that if it's just about obesity, you have to prove that cheaper treatments such as diet and exercise didn't work. That's not impossible to do, but it's hard and annoying even for people who really were trying. My doctor told me that you basically have to keep a detailed journal of your weight loss efforts for months on end.
Are GLP-1s so much more effective that we should make an exception to the general principle, maximizing healthcare resources by providing the cheapest effective treatment? I kinda think so, but I have a conflict of interest, and I can understand why others might think that money is better spent elsewhere.
I think you would be hard-pressed to find any human who has been 100 pounds overweight for any amount of time that doesn't have an obesity-related comorbidity.
Hypertension, sleep apnea, high cholesterol, etc are all common in the general population and exacerbated or even caused by the physical and lifestyle conditions that beget obesity.
I was 347lbs at the time. Wasnt a diabetic (nor pre-diabetic) no heart disease, blood pressure or really anything other than my weight. Prior to then Id had two massive bouts of weight loss at 50-100lbs so I know what it takes. Id tried but this last time without meds was extremely hard. You cant do much in the way of productive exercise when both your shoulders need replacement at 30 and between two knees have an ACL tear and two MCL tears. To top it off I had wildly out of whack hormones.
Why is this a bad thing? The quickest way to fix the medical/insurance/bureaucracy complex is to just allow people to sell direct to consumer.
The best (worst) example of this is CPAP. Ideally you'd just be able to go and buy one for $300, but instead there is a complex around "necessity" and "prescription", which creates an effective monopoly where the exact same hardware can be sold at different price points with software locked features.
If even a "simple" mechanical device like this which violates no patents and can't materially harm a person in any way can be restricted on grounds of paternalistic "safety", then one would be right to remain skeptical of the claim that the FDA is restricting action against unauthorized semaglutide knockoffs to
>safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.
Going to Japan felt like living in the future. I could walk into any glasses store, and for $50 or less buy a pair of frames and lenses. If I didn't know my prescription, included in the price was an automated eye exam machine which'd figure it out in 2 or 3 minutes.
You can do the same in the US, zennioptical.com. You need to measure your PD which is very easy (Most optometry shops are hesitant to tell you your PD. And it's normally measured when you go to order the glasses, not as part of the initial eye exam.)
As for needing a prescription <1 year old, if your vision hasn't changed, just edit the date in the PDF. Same for contact lens prescriptions.
As part of the regular eye exam, they generally use an autorefractor machine on your current glasses and/or eyes to get a baseline before they manually fine tune with the 1/2 on the eye chart test. But yeah, you can't just get the quick prescription from the autorefractor like you talked about in Japan.
While we are in the minority, Zenni and many online optical shops recently decided they will not make you glasses if your prescription is over a certain power. In 2025 I broke $800 on frames+lenses and contacts.
...violates no patents and can't materially harm a person in any way can be restricted on grounds of paternalistic "safety", then one would be right to remain skeptical of the claim that the FDA is restricting action against unauthorized semaglutide knockoffs to...
Well actually, there are lawsuits in the works because the Philips CPAP machine had toxic foam which would break down and increase the risk of cancer.
But I think that proves my point, the supposedly "rigorous" FDA review didn't flag concerns about foam in the airpath of something you breathe through, so what exactly is the approval process buying you? Philips issued a voluntary recall but resmed uses foam in their units too, and while they claim it's a different type of foam it seems there are better ways to engineer sound reduction than putting foam in the air channel and potentially breathing in microplastics.
Well you either remove all the bureaucracy around drug testing and approval and make it cheap to develop a new drug, or you prevent drug makers from making money if they are successful at developing a new molecule. But if you do both, all you will get is zero research. Right now it takes 10s of billions in R&D budget to bring new molecules to the market, which is insane.
Or you pay them directly. Most countries have research funding. Since there's no way to know what you'll find or how long it will take, research doesn't fit well in the capitalist model. Makes much more sense to apply a fixed effort and accept whatever results come out, but only the government can do that — or a rich monopoly like Bell.
That's nice. The rest of the world has price caps on what these companies can charge for drugs.
It's one or the other. You can have your ''patents'' and ''intellectual property'' respected...but that requires you not charge an outrageously higher price in certain markets, like the US.
The rest of the world isn't free riding - the USA has just setup a market where there is very little bargaining power for consumers because of how the US medical market and insurance works.
Novo and Eli are still making plenty of money in Europe where these drugs cost a fraction of the price, and where there aren't other significant suppliers for GLP-1's like is being implied.
No, they're free-riding. If drug companies can't charge higher prices in the US, they will do less drug development. Everyone involved in the business/investing side of pharma knows this; it's not even an argument.
That's why I pay Apple extra money to develop the next big thing. If I only pay the sticker price of the iPhone, there won't be any more innovative products. But if we all get together and pay double the sticker price, we'll get some true innovation!
Nobody is suggesting paying Novo up front, they footed that bill, we are talking about paying a premium after product lunch, which people certainly did for the iPhone.
In a free-market approach to drug development, if the expected loss of attempting to develop as drug is negative, and the cost isn't too high, then there is an incentive to develop that.
The best public policy outcome in such an approach would be for losses to be only slightly negative. Positive or zero expected losses mean no drug development, and highly negative expected losses mean the drug is more expensive than necessary and reduces the accessibility of the drug.
However, current patent law allows companies to minimise their expected loss, with no controls to prevent highly negative expected losses.
There are alternative models - such as state funding of drug development. This model has benefit that it is possible to optimise more directly for measures like QALY Saved (Quality Adjusted Life Years Saved) - which drug sale revenue is an imperfect proxy for due to some diseases being more prevalent amongst affluent people, and because one-time cures can be high QALY Saved but lower revenue.
The complexity of state funding is it still has the free-rider problem at a international level (some states invest less per capita in funding). This is a problem which can be solved to an extent with treaties, and which doesn't need to be solved perfectly to do a lot of good.
The US has zero credibility w.r.t making international treaties these days. And generally is completely set up for a few peoples maximum “expected negative loss”. Sure things could theoretically be structured differently, but for the foreseeable future they aren’t.
Excessive profits from patented drugs are controlled by development of competing drugs. These competitors arise until profits are driven down to the point further development of competitors is inhibited.
Nah modern mega corps are free riding on all our backs. They use the power of the state and frivolous mechanisms like the broken patent system to create monopolistic situations for themselves.
That would require those same companies from not abusing our political process to obtain illegal political outcomes - outcomes that are unconstitutional - like Citizens United, which led to PHrMA dumping unimaginable money into bad faith political advertising/lobbying.
Until or unless they stop being bad actors, everyone should pirate their stuff. Free Luigi.
No because you literally have no idea what the citizen united ruling was based on what you wrote. Those 99.9% of people use “Citizen United” the way you used it. As a catch all for “corporate political contributions” except it wasn’t that impactful of a ruling regarding that.
If you actually know what it was then answer how does limiting non-electioneering advertisements from PACs for 30 days out of the year changes anything?
What percentage of global rich, obese people live in the US? This is the main market and the product would not exist if it could not command a high profit here. Besides that, I think the US prices are so high due to the insane medical insurance structure, not because the drug companies really make much more than in other countries.
The main reason drug development is so enormously expensive because the FDA makes it that way with their paranoid risk averse regulatory process and insanely restrictive requirements on what requires a doctor prescription.
> because the FDA makes it that way with their paranoid risk averse regulatory process
FDA is constrained by Congress here. Its function (safety and efficacy in advance of marketing) is required by legislation dating to the 60s. Feel free to advocate for Congress to change the law, but it isn't obvious it would be popular with Americans.
> insanely restrictive requirements on what requires a doctor prescription.
I don't think OTC vs Rx rules have much if any impact on drug development expenses.
As always, depends on the law. This is a bright line example of companies breaking the law to the direct tangible benefit of not only their customers but the population at large. Letting Novo Nordisk jack the price back up and deprive the vast majority of Americans access to the greatest good to public health in a century meanwhile is… maybe not the example you should be holding as the law working.
Yes, bootleggers can undercut legit competitors, providing a boon for consumers.
In this case, Novo developed the drug. In your view, why does Hims get credit for "the greatest good to public health in a century" and not the company that sank over $10B into developing Ozempic?
Of course, Novo faces competition from Lilly and every other pharma company in the world and continues to lower prices in the face of this competition.
And they provide a valuable service to their customers, I have a very positive association with various drug dealers I've had over the years. Say what you want but they're literally out on the streets serving their local community. For a more HN example, people in the real world are extremely pro piracy and view the people cracking DRM as doing a public good.
I fully expect the state to take action against the, to me, very obvious will of the people who are actively seeking out and purchasing these products. Clearly folks don't respect the legitimacy of IP rights in the same way they respect property rights since nobody blinks when buying compounded GLP but at the same time wouldn't shoplift at their local BestBuy.
So yeah the government's response isn't surprising but you won't see me cheering them on, and I don't think you should either. You literally stand to lose from it.
Yep in other countries CPAPs are over the counter. In America you need to go to a sleep lab for a wasteful overnight sleep study (sometimes two!) that costs thousands. And then have appointments with a “doctor” who provides no useful help but is necessary for the prescription. All for the machine to figure out its own optimal settings anyways. Total racket and regulatory capture.
Right I used CPAP as an example because it bypasses all arguments about "novel technology", "drug development" cost, or "need for safety". Even an ASV algorithm could probably be implemented as a ~graduate project since it seems to be a rather basic control algorithm (today with ML you could probably do even fancier things). It's basically a piece of pure technology that could be commoditized, manufactured and sold to people for < $300 in the way smartphones are. If something as "basic" as this can't be accomplished due to the regulatory environment then it's sort of pointless talking about anything more complex like pharma drugs.
As long as the company that did the research and the medical professional gets paid the same amount. I’m completely OK with cutting out the insurance and the bureaucracy and other non-value add middleman, but the value add partners need to get paid for this to be sustainable.
Patent laws exist for a reason. It’s so people that come up with paradigm changing ideas and inventions can get rich off of it. This is something we want to maintain.
And maybe in this case they are functioning as intended.
Unfortunately, they are also leveraged to provide a moat and profits in situations where no innovation has occurred. (Eg, patents on one click shopping.)
Can you please explain (TFA doesn't mention patent laws, just unregulated drugs)? For example, my understanding is that semaglutide is protected by patent in the US - I had assumed HIMS was including semaglutide in some of their formulations under an agreement with the patent holder, but I guess that's not correct?
Side note, I'm all for the true innovators being able to patent drugs (like semaglutide) that they put a lot of research dollars into, but seriously fuck all these additional "method of delivery" and "formulation" patents that are bullshit that just get added on later by the patent holder solely as a way to try to restrict the entry of generics into the market after the original patent expires.
Everyone can make their own compounding drug in their basements, thanks to Telegram and other hidden platforms: source sema/tirz, get bac water, mix them.
China tries to steal IP, but otherwise has a functioning IP system including for drugs Chinese companies make.
And China’s growth is about 5% in 2025, which isn’t close in the least to the fastest (Vietnam at 17%).
And China has medications because of other countries with IP (mostly Europe and US). So if the US gets rid of IP, the. A very large part of new drugs won’t happen.
I don't care about the numbers, I care about the growth. They went from zero to high speed trains linking all major cities in a decade. They went from manufacturing cheap slop knockoffs of American products to top–of–the–line locally–designed products in about the same time. They make their own semiconductors now.
As an aside, I wonder why this wasn't discussed during the recent Greenland dispute. The US government basically legally pirate the drug, and it'd make a fairly large dent in Denmark's economy. It'd be a politically popular move too.
There is zero need to “pirate” ozempic (semaglutide) as there are already US alternatives on the market (Tirzepatide) and about to be more (Retatrutide) that outperform all other medications in the class.
Just have insurers stop insuring ozempic/wegovy but have them insure mounjaro/zepbound and it’s a done deal. No need to even ban it.
Lol, a military showdown where a few hundred people are killed might be horrible.
Leave the US with an island it doesn't recognize as its own (because Congress wouldn't) and that isn't recognized as US by most of the rest of the world.
Would economic ties between the US and Europe be broken as a result? Probably, but maybe everybody else decides that this will be resolved peacefully in the UN. And the can is kicked down the road, until Trump kicks the can.
Because ending economic ties between Europe and the US would mean a massive depression on both sides. Massive assets lost and written off. Goodbye pension.
Economic meltdown might be worse than a military showdown in the Arctic. Casualties from an economic conflict would be worse.
Two can play at the game, and the EU was probably closer to starting it.
The EU trade bazooka measure (Anti-Coercion Instrument) allows the EU to legally suspend patents, copyright, etc. if a member state is threatened, for example using tarifs. Which the US was a actively doing.
At the end of day, it doesn't matter the Danish government cannot surrender. Following WW2 it was made illegal for the government to do so. And voters would never support, not would Trump have the patience for Danish constitutional changes.
I'm quite convinced that:
(A) An invasion would have been a shooting matter. Even if the shooting would eventually come to an end.
(B) Denmark and most of EU and large parts of the world would never recognize an annexation.
(C) Congress in the US wouldn't recognize the annexation.
(D) EU and US would be both have entirely unnecessary and massive depression as massive assets would be seized or written off.
(E) Russia and China would be thrilled.
It was an allround shit show.
Trying to go further would have upended economic ties across the Atlantic. Causing massive economic depression on both sides.
But at the specific measures of parents: HUGE parts of US economy is Intellectual Property -- how dumb would the US have to be to declare IP laws invalid?
It is wild that it took until 2026 for this to happen.
In the late 1990s, when my friends wanted mushrooms or 5MEO-DMT, they'd order from "Poisonous Non-Consumables" catalogs. Today, people are literally doing that (same words, even!), but for the next iteration of GLP1 drugs not yet on the wider market. Compounding pharmacies are selling "research chemicals", like in Bitcoin Mining Profit Calculator: Gaiden.
Compounding pharmacies are selling compound, not "for research only" peptides. That's a different thing, even if they probably get the API (drug itself) from the same sources.
I think this is compounding pharmacies selling legit semaglutide (or tirzepatide?), but doing the packaging (dilution in water) themselves. No? I don't think Hims is selling RCs. They're violating Novo's (or Lilly's) patents.
It is wild to me that compounding pharmacies continued to sell these in violation of patents even after the expiration of the FDA supply shortfall status last year -- but I suppose there's so much money in it they don't want to give it up.
Compounding pharmacies are getting the raw API from China. Some of them are getting it from FDA registered facilities in China. Some are not.
It should be more or less the same thing as the legit stuff, but it is made with a different process, with different excipients, etc. For those going the more legit route, FDA registered still does not mean FDA inspected or that the FDA has signed off on them as being a reputable manufacturer.
There has also been cases of compounding pharmacies offering reta and other unapproved peptides, resulting in the FDA sending lots of angry letters to state pharmacy certification boards.
There is no way for a compounder to acquire “legit” semaglutide or Tirzepatide as novo and Lilly are the sole manufacturers of it using the FDA approved process.
Every other source is acquiring the APIs from China and effectively buying from the same sources that the random sites selling a vial of lypholized “research chemical” powder are getting it from.
The huge compounding companies might skip the lypholization step and mix it directly due to cost savings at scale, but it’s effectively the same sources you could buy direct from China from if you spent a bit of time researching.
and the end result of this action will be every neighborhood having a guy who orders the peptides from overseas and mixes it into a liquid with a net reduction in safety for millions
Hard to regulate. A lot of the retatrutide sold today is marketed on Discord & Telegram groups and paid for with crypto. It is infeasible for customs to open every last package entering the US, so this avenue will continue to work. The only gov't that could realistically stop it (for a while at least) is the Chinese. And they do, occasionally, shut down a manufacturer for a while. Though not because they are shipping GLP1s to the states.
The regulation is pretty clear? We just don't choose to blackhole shady foreign (in this case, Chinese) companies from the American internet as a matter of policy. And cannot effectively screen all imports.
It’s regulated quite tightly. But if you can’t shut down the illicit street drug market you aren’t going to be able to shut down the illicit make-your-life-better black market either.
I think what’s happening now is about right. FDA approval process for the vast majority of people, and make those who want to play drug astronaut biohacker find it via underground methods. No reason to crack down super hard on such folks since the societal impact is likely net positive - unlike fentanyl or what have you.
Perhaps there could be better enforcement for the folks being totally blatant about it as it risks going “mainstream” and hitting people who don’t have informed consent, but I imagine that’s coming as law enforcement catches up.
The real question is will there be any ban on ads from gray/underground suppliers that openly advertise on Instagram? Or will Meta simply allow that to go on, exposing a lot of people to potentially harmful concoctions?
this was bound to happen with the number of compounding pharmacies getting into the glp-1 game. from a risk side, it’s a total mess it’s basically impossible for insurers to model long-term liability when the supply chain for these drugs is a black box. fda had to drop the hammer before the claims started flying.
The compound pharmacies are the leeches I have the least amount of sympathy for. While Lilly may gouge on the price, at least they can claim to have invented the drug. Some compound pharmacy buying $20 worth of API from China and selling it reconstituted for at least 10x that is just raking in huge profit, and they did none of the R&D.
What the FDA will probably have trouble cracking down on are the vendors selling lyophilized peptides direct to the public. And the number of people going that route goes up dramatically over time.
The Atlantic did a write-up in December [0] about retatrutide availability and they named at least one well known vendor (who also sells tirzepatide, semaglutide, and all the other usual peptides). Not the cheapest vendor, but well known, does the batch lyophilization in the US, still takes credit cards, and gets pretty solid group test participation due to their popularity. And if you know how their pre-sales work, the price premium isn't too terrible, worth it for the test participation IMO.
If you want to know who else to avoid, join the Discord the vendor links to from their web page and ask around in the general discussion topics, people will share.
Nexaph does not lyophilize in the US despite Cain's claims - if you're buying from Nexaph, do so because they're popular and well tested by 3rd parties, but not off of anything they're saying about themselves. Hell, just go to the About page and you can find an artifact from back when Cain was lying about Nexaph being a chinese pharma company that had mRNA vaccine production experience.
That's also why the "presale" periods are cheaper - just letting them know how many vials to put in an order for.
I agree such claims should be viewed skeptically. The aspect of SNP that appeals to me is the excellent test participation. It’s basically just a big, reliable group buy. I shop other places too, but I’ve been burned a couple times.
I thought the pill form was actually pretty high tech to get the peptides through the digestive system. I don’t see how a compounding pharmacy would be able to produce it. Anyone know?
Is there a cash price for getting the government to shake down your competitors, the way there is for pardons ? Or is this type of service only available in exchange for equity stakes?
There's a reason the major Indian generics manufacturers like Cipla have partnered with Ely Lilly [0] and Novo Nordisk [1] for exclusivity deals for GLP branding and IP even though it isn't required outside the US.
Keep screeching about H1Bs and offshoring while sweetheart deals are signed with the Trump admin [2] by lobbyng with the right leverage points [3][4][5][6] and threatening the right GOP ruled states with tariffs [7][8].
Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back.
> Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back.
Given how transactional this administration is, you can be confident that one set of companies donated to the administration or enriched the Trump family somehow, and the other set is facing regulatory attacks.
HIMS has known this was coming for a very long time. How much has the CEO cashed out with ? I think i saw 133 million. Sounds criminal. Where is the Occupy Wall Street movement when shit like this happens?
FDA regulates the marketing of drugs and medical devices. This is a case of Hims and Hers (and other compounding pharmacies) marketing drugs without having been granted approval.
There is an abbreviated application for new drug approval (ANDA) pathway meant for generics, but it does not seem like H&H has gone this route. It does require you to open your supply chain up to inspections and to provide evidence that your generic version basically works the same as the brand name.
In my opinion there two things going on here that I strongly feel are true.
1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.
2. Hims and Hers are also in the wrong. The rules and laws are there for a good reason. It is not just for us to arbitrarily pick and choose when to enforce them.
I think the real surprise is that hims was able to sell the drug without approval in the first place. I do not support gatekeeping drugs from generic makers but their supply chain should be inspected just like any body else. The fact that they were able to sell a drug for so long without approval shows that something is really broken in the process.
I was under the impression that they were initially allowed to produce the drugs since they were on FDA drug shortage lists. As expected, the compounders scaled up their pipelines to meet demand and now that the drugs have been taken off the shortage list the compounders are incentivized to figure out how to keep things legal. (Of course, they should have had clean supply chains this whole time.)
I'm curious if one of these outfits got bought out to end the supply shortage.
Related: https://www.fda.gov/drugs/drug-safety-and-availability/fda-c...
I don’t think this is about inspecting supply chains, or keeping anybody safe. It’s about somebody’s profits. Other times it’s about the FDA’s incredibly overconservative approach, which keeps many meds you can buy OTC everywhere else, Rx only here, and keeps other drugs available elsewhere illegal here. Even for people facing terminal illness.
if it helps people facing terminal illness it doesn't mean it should be OTC. "facing terminal illness" probably needs strong stuff. something required for that can harm the normal guy. it's not like Vit D supplement.
No, what I mean is it takes pulling teeth to get someone who would die anyway, the ability to try experimental drugs even with a doctor’s prescription.
It’s a separate dysfunction than their obsession with making things Rx-only, such as for example, an albuterol inhaler. In Mexico you can just grab one at a drugstore.
> No, what I mean is it takes pulling teeth to get someone who would die anyway, the ability to try experimental drugs even with a doctor’s prescription.
This topic came up in another online community (which I'm intentionally not mentioning) a lot a few years ago. I left a comment about why giving experimental drugs to terminally ill patients is not a simple or obvious idea like many would assume. I got some very long, very intense replies from someone who was dying of a type of cancer who believed he had a good shot at recovery if he could get his hands on an experimental drug. He had all of the links and papers to prove it.
I remember trying to take it all in and reconsider my position.
A few years later, there was a post from his wife that he had died. It was a very sad situation. I clicked some of her links and found that he had a blog where he had written a lot. He actually did go through with the process of requesting the experimental drug and his request was granted. However, the drug not only didn't work, it had caused some irreversible damage to his body that made his final months a lot more painful and difficult than they had to be.
Apparently the "compassionate use" exemptions are not as hard to get as the anti-FDA writers have led us to believe. The harder part is often getting the companies to provide the drugs, because they know the risk profiles and uncertainties better than anyone and aren't always interested in letting terminally ill patients experiment on themselves outside of the process.
Sounds like you might be talking about Jake Seliger, and indeed, his and Bess' fight to get treatments was rather eye-opening for me too.
Jake's blog where he posted throughout his entire illness: https://jakeseliger.com/
Bess' blog: https://bessstillman.substack.com/
It was a heartbreaking story to follow, and one that hit me a lot harder than I thought it would when Jake died.
experimantal, not fully proven drugs available to help terminally ill patients (which should be true) needs first to make sure the patient is terminally ill. it is not about making them available OTC to anyone who asks. because what happens then is free for all, scams and corporate experimentation on live population.
Anyone can read about the requirements for Expanded Access/"compassionate use" here: https://www.fda.gov/news-events/expanded-access/expanded-acc...
IMO this all seems very reasonable.
What specifically do you think is problematic about this, and how do you propose that we mitigate companies from preying on desperate patients while making it easier for patients in need?
It's basically a regulatory arbitrage, see here:
https://old.reddit.com/r/FamilyMedicine/comments/1nz5xkd/how...
> they get away with it because:
> In-house prescription
> legally registered 503A compounding pharmacy that is not selling bulk (individual prescription quantities)
> They can argue clinically distrinct compounding
> FDA does limited enforcement unless its unsafe or mass bulk production
Point 4 seems not to be holding anymore.
Any idea why they'd change their mind about point 4?
The regulatory agencies were understaffed for the work load even before recent layoffs. Why focus on this, of all the things they could put their effort into?
They didn't change their minds. The enforcement was consistent. It's the companies who scaled up their production to mass market levels who prompted the action.
There have been several examples in the past 5-6 years of the FDA loosening regulations to benefit patients and companies rushing in to abuse the opportunity at scale.
Another one that comes to mind is when the FDA loosened restrictions on telehealth prescribing of controlled substances during COVID. Several companies saw this as an opportunity to set up digital pill mills, advertising on TikTok and offering Adderall prescriptions as a service. Nurse practitioners were paid up to $60,000 per month to write prescriptions as fast as they could without interacting with patients.
Whoever isn’t making their profits when people buy them this way is directing the FDA to act. You can bet on it.
As they should.
The companies who bet several billions of dollars in literal decades of research on this stuff should absolutely be swimming in cash until the end of their days. Hims & Hers should be sued into oblivion for stealing the rewards of other companies' ingenuity, risk-taking, and dedication toward helping patients.
I am highly sympathetic to the argument that the government should just buy these patents and mass manufacture to increase availability, or just buy guarantee order vast amounts to scale up manufacturing and distribute cheaply, but the idea that a different private company ought to be able to profit in the way Hims & Hers has is absolutely flatly fucking insane.
So millions of Americans should deal with years of obesity because Novo is a disaster, insurance coverage is ridiculous (any insurer accurately charging for the purpose of risk mitigation should be paying people to take GLP-1s, when instead they are out of coverage for most plans), and there exists no government body to do what you’ve said?
While I'm sympathetic to this argument, I should point out patent time to expiration for medicine in the US is pretty inoffensive (relative to how bad it could be, like software patents), and we already have plenty of drugs for excreting excess. We get a big basket of drugs into public domain each year, and government would be wise to publicly celebrate this, I think; would help with the general sense of impending doom citizens feel.
Semaglutide molecule patent will expire in 2031 here (many caveats to this). For the most part, you can get any pill ~15+ years old for ~nothing without insurance, but associated devices like auto-injectors can extend this due to goofy rules; I expect execs thoughtfully considered medical patent law when deciding to initially trial and release GLP-1s as an injection.
What do you mean "there exists no government body to do what you've said?"
HHS could do it tomorrow.
Because “this” is about the biggest in-your-face blatant disregard for FDA rules that has quite literally ever existed in history. The scale is unprecedented.
If there was a single thing an understaffed FDA would go after it would be the compounding pharmacies and that whole ecosystem blatantly thumbing their nose at it all.
Not that I agree with the rules - but if this is allowed it’s essentially an end-around the entire prescription drug regime as we know it.
There was a good Planet Money episode which went into what was behind all of this.
https://www.npr.org/2025/08/22/nx-s1-5511707/ozempic-zepboun...
Hims is mostly marketing. They are using compounding pharmacies to fulfill orders. Compounders are a shady industry in general, and most the GLP places are using Florida pharmacies, which are notoriously extra shady, as Floridas regulatory function is deliberately incompetent.
Compounders are primarily regulated at the state level, and regulatory effectiveness varies. The more legit ones are mostly buying Rybelsus (the pill version of Ozempic for Type 2 diabetes) at wholesale and crushing it. The shadier ones are using precursors, sourcing from questionable & unregulated suppliers or watering down does and adding stuff like vitamin B-12.
The FDA has more limited jurisdiction, and they have been busy firing people.
The federal attention probably has more to do with whatever grift POTUS has going with Eli Lily and Novo Nordisk. Both companies are about to scale up their daily tablet versions of Wegovy and Zepbound at lower price points, and that availability will push the cost of compounded injectables way down.
They are adding B12 as a way to say that it’s tailored to individuals and not available.
I’ve used mainly compounded medicine over the last five years and find the fervent dislike that people have for compounders bizarre.
If you look into generic regulation in the US, the standards are already through the floor. I’d rather work with someone who has a more direct financial incentive to not fuck up.
that reminds me, as in Canada the semaglutide patent expired, Sandoz said they will put a generic on the market in Canada, could that be imported into the US and be sold?
You can do anything you want when you get a bunch of “noctor” NPs on your payroll to rubber stamp drugs for “patients” nonstop.
The fact that they could sell in the first place I think implies some corruption occurred at some point in the past that permitted them to do so (not necessarily by them, but someone must have lobbied for "compounding" since that afaik doesn't exist in other proper countries). Then they failed to pay the necessary bribe to be allowed to continue. To be fair, the bribe would have been very large given the GLP-1 manufacturers' position in the pension savings of ordinary Americans.
Compounding pharmacies are in many ways just a continuation of the original apothecaries and pharmacies, and the US is hardly the only country with the legal framework that allows this.
Australia was basically a carbon copy of the US in this regard until 2024, but they have specifically started targeting a lot of the "wellness" compounding that includes peptides, GLP-1s, etc. since then.
Germany has two classes of pharmacy that are nearly the exact same as 503A and 503B compounders in the US
Canada is similar but stricter about the big pharmacies turning into de facto manufacturers, pumping out huge quantities for downstream compounders and clinics, which is what happened in the US.
Lots of other countries that you might not consider "proper countries" (whatever that means) follow a very similar system to the US, and lots of countries that allow some form of compounding, like the UK through their "specials" program, but it's much more centralized - basically cutting out the 503A compounders in the US.
Fundamentally compounding pharmacies offer pretty important services - there are people out there that would literally not be able to take the most effective medication for their condition without the compounding pharmacies making formulation changes that the larger manufacturers might not have incentive to make. Their existence quite literally saves lives. So it becomes a matter of not making that so restrictive that you wind up killing people due to restricted access vs. letting it get abused in situations like we're seeing today with tirzepatide and semaglutide.
> 1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.
The US is the only country, aside from New Zealand, that allows direct-to-consumer marketing of prescription only medicines.
> The US is the only country, aside from New Zealand, that allows direct-to-consumer marketing of prescription only medicines.
What interesting here is that Hims & Hers are able to skirt the pharmaceutical marketing regulations. They are able to blanket the world in their ads whereas pharma companies have to abide by strict safety information requirements in their commercials. Him/Hers give literally zero safety and side effect info.
The other weird thing is that the companies like Hims/Hers are basically dial a script. You call them and get whatever you want. They probably deny no one and don't turn anyone away. Unethical and lacks physician oversight.
GLP-1 drugs don’t require marketing. There are tons of people who have been prescribed them and aren’t being covered by insurance. Both Novo and Eli Lily are now selling them direct to consumers with prescriptions that don’t have insurance coverage.
The marketing isn't for the drugs.
They market the service that gives you the drugs with the smallest oversight possible. These services are becoming popular among people who shouldn't be taking GLP-1s (eating disorders, body dysmorphia, people who are too thin but want to lose more weight) because most of their providers are just trying to write prescriptions as fast as possible to collect their payments.
Also the elderly and poor who cannot afford the prescriptions.
GLP-1 drugs range from $100-$200 a month from mail order compounding pharmacies, or $500 a month on "discount" plans from the drug makers.
This change to FDA enforcement is going to prevent a lot of people from getting help.
The positive impact of GLP-1 drugs is huge, but the price is out of reach for most people. The people who most benefit, elderly obese people at high risk of injury due to falls, who have a low quality of life from morbid obesity, are least able to afford access to the drugs.
These compounding pharmacies were improving a lot of lives.
I'm obese. The drugs are approved. But without another condition they aren't covered by my HMO so I have to go outside.
But they still market regardless. They probably constitute 50% of the medical ads I see now
Make sure to tune into the superbowl tomorrow.
> a Hims & Hers Health (HIMS.N) (Super Bowl) commercial features a voiceover by rapper Common with the tag line "Rich People Live Longer"
At least I know kid rock won’t be there
Thankfully we have options - Kid Rock will be performing an alternative half-time show and it's available on X and Youtube @ 8PM.
Is there a Kalshi bet going about whether he'll perform his song about preferring underage girls?
Isn’t this a common rock star trope? Anthony Kiedis talks about a 14 yo who he slept with on tour.
Anthony Kiedis isn't headlining an event that's being put on by an expressly christian organization. He also is not closely tied to someone who's mentioned more in the Epstein Files than Harry Potter is mentioned in the Harry Potter books.
It is if you baseline is Ian Watkins, but we tend to look at these people with disgust for their blatant displays of depravity.
Kid Rock has some pretty infamous, explicit lyrics I won’t be pasting here. Just look it up, there are dozens of articles about this right now. It’s not rumors or something ambiguous, he is a disgusting person with some pretty awful things to say. Given TP’s christian mission/focus and constant moral panic stance, coupled with the MAGA movement’s alleged concern for minors, “he is not appropriate” is an understatement.
Unfortunately he stays somewhat relevant because he drapes himself in an American flag.
Doesn’t really narrow it down
Yes. That is why I know he won’t be on for the Super Bowl. It’s also why I find the Super Bowl so appealing tomorrow night.
I thought this was true, but I got direct marketing for prescription medicine in Canada a few weeks ago. I don't think this claim is accurate anymore.
It is still not legal in Canada. Someone must have been flouting the law.
>> The US is the only country, aside from New Zealand
And canada. I have seen many commercials on hotel televisions for prescription drugs there.
In the UK there's a lot of TV advertising for "weight loss medication" that never refers to any drug by name. But if you look at the small print, it refers to "Orlistat", which is technically available without a prescription. Of course, nobody (or few) actually want Orlistat or end up being prescribed it after the consultation.
Canada's laws around this are...odd.
The law prohibits ads from simultaneously naming a prescription drug and its therapeutic use. So you might see an ad pushing a specific drug, but it will never say what it's used for. Or you might see an ad where people talk about treatments for a condition but never mention the drug, just saying talk to your doctor.
Sometimes they get around this subtly. In one ad a number of overweight actors discuss how much they love a specific drug, but it's never mentioned what it's for but is implied.
And of course when US channels are simulcast in Canada, US ads just run as is.
I like the one where they're in a coffee shop or whatever and everytime they talk about the indications, there's a noisy machine running.
Much better than the one where everybody is like I asked my doctor about Flugeltrophen.
I like it.
I'm on one medication I wouldn't have know could help me without seeing ads. It's improved my life.
This is a vacuous statement because in much of the world (ie most of the developing world), there's no such thing as "prescription only" medicine, people can buy whatever they want over the counter.
No… The rest of the first world countries as a counter example.
?
> Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.
Are we cutting off people's access to meds or do they just not want to pay what they cost?
To be fair, most medication in the US is overpriced due to patents and what not. The "cost" is hardly the real, legitimate cost and generally inflated 1000%+ compared to other countries.
This is not really the correct way to think about this.
Pharma is ultra R&D heavy so yes, medications are deeply profitable on a per-pill cost to manufacture basis. However, drug companies by and large are not extremely profitable. This is because to produce a single drug (which is high-margin from point of production), they have to sink billions of dollars into literally thousands of other drug candidates to figure out which ones are viable.
This is all "real, legitimate cost," as is reflected in their rather abysmal overall profitability.
As for the disparity between US and foreign markets, it's a basic tenet of commercialization to sell to every buyer at the highest price they'll accept, so long as that price is above your price to produce. All sorts of companies engage in "price discrimination" to achieve this. For example, cereal manufacturers will sell their own brand at $4/box, and sell the exact same product in a store brand box for $3.25/box. A lot of products in your local retail stores do this.
Overall, no one is really hurt by this per se. Every consumer is making a transaction they're willing to make, and the company is making the most money it can in aggregate, which actually gives it room to push the price at every price point lower than it would be able to if it could only sell to a single segment.
This is actually extremely important in the drug context due to the aforementioned abysmal profitability.
Let's take Trump's attempt to force a Most Favored Nation (MFN) clause onto drug manufacturers which guarantees US consumers pay the same price as the lowest price internationally. The intended effect is for US prices to come down to the level paid elsewhere.
But here's Pfizer CEO: "When [we] do the math, shall we reduce the US price to France’s level or stop supplying France? We [will] stop supplying France. So they will stay without new medicines. The system will force us not to be able to accept the lower prices.”
Not only does this obviously not result in lower US prices, but it very possibly results in higher US prices (since now there is less net revenue from lower priced consumers) and, more troubling in the pharma case, there is now even less net revenue coming in to justify new drug development.
It's hard to overstate how asinine this entire endeavor is. US consumers certainly pay too-high prices for drugs, but this intervention does very little to actually address that problem. The much more proximal issue is the incredible degree of intermediation in the US market between payers, providers, PBMs, GPOs, and more.
> Not only does this obviously not result in lower US prices, but it very possibly results in higher US prices
Here's the thing: yes, you may "very possibly" be right, but that means you may also "very possibly" be wrong. The truth is, we don't know, and we can't really trust the CEO of any business to openly admit that they could tolerate a policy disadvantageous to them. So how would you suggest testing the case where you're wrong?
There is no world in which an MFN clause does anything other than reduce the overall revenues to the pharma companies.
There is no world in which lower overall revenues does not reduce R&D spend.
There is no world in which lower R&D spend does not reduce the number and quality of new drugs.
This doesn't require trusting anyone about anything other than trusting that pharma companies are generally profit-seeking and therefore an MFN clause imposed by USG will create less optimal pricing (for the pharma companies' own incentives) than currently exists.
The exact price changes that happen in different localities that net out to "less revenue → less R&D → fewer drugs" is hard to predict, but the fact that it will be lower and it nets out to "less revenue → less R&D → fewer drugs" is absolutely predictable.
Please suggest an alternative outcome, if you can think of one.
> Not only does this obviously not result in lower US prices
Maybe in Pfizer’s portfolio this is true. However, I just watched the Amazon Pharmacy pricing for GLP-1s drop substantially immediately following this. I think you may be being too black and white on claiming this categorically does not work.
Businesses will adapt pricing models, obviously this hurts Pfizer in some way, but Lilly and Novo found the new system was worth negotiating into. Like most things - when people say “always” or “never” - it’s reducing the spectrum of possibilities
GLP-1s are already under immense pricing pressure due to competition, direct to consumer sales outside of the insurance system (to the point of forging entire new markets for drug companies never possible before - what other drugs have millions of customers paying $300-400/mo for prescription medications?), compounding pharmacies end-arouding patent law like this article is about, and outright black market sales that dwarf any other prescription medication classes outside of opioids and benzodiazepines.
It has nearly nothing to do with government action. These will be the most profitable medications ever invented once the dust settles and it’s a game of price optimization right now.
GLP-1 prices are ultra-competitive and in an honest-to-god price war.
Not only are there multiple current-generation GLP-1s on the market (Novo's and Lilly's), but there are at least 2 or 3 more generations approaching the market.
> But here's Pfizer CEO: "When [we] do the math, shall we reduce the US price to France’s level or stop supplying France? We [will] stop supplying France. So they will stay without new medicines. The system will force us not to be able to accept the lower prices.”
This person is a less than neutral source in an industry that's already infamous for lying through its teeth to grind out every red cent from its customers. I would lend precisely zero credence to what he says when he's trying to justify why his poor billion dollar company wouldn't be able to lighten up on its wholesale fleecing of American customers.
"Poor billion dollar company" cannot possibly be a slur in an industry that requires $2 billion in investment (and rising!) to make each subsequent product. Maybe if the product were a luxury good that the world could do without, but it's not, and we cannot.
You don't need to trust anything except that left to their own devices, those greedy pharma companies will price as efficiently as possible in order to maximize revenues. Despite this revenue maximization, the industry as a whole is nearly uninvestable.
Any deviation from the optimal pricing will reduce their overall revenues, which will obviously make the industry even less investable.
In an R&D heavy sector means they will no longer make new products, i.e. no new breakthrough medications that you or I or our parents or children may need.
Sure, I doubt Pfizer et al will just outright stop selling medications to France. Far more likely they will both reduce US prices and raise EU+ prices, but this still ultimately results in fewer drugs for fewer people today, and definitely much slower innovation toward new drugs by virtue of having less cash on hand and much worse expected ROI.
You do not need "trust" whatsoever, this is just basic logic.
If you want to understand how Americans should actually reduce drug prices, you can start to get an idea here: https://news.ycombinator.com/item?id=46933520
> Sure, I doubt Pfizer et al will just outright stop selling medications to France. Far more likely they will both reduce US prices and raise EU+ prices
This is my point – quoting the man on what he says will happen is pointless because he's just using scary hypotheticals to make the best case to keep the cash hose turned on. He's not some altruistic saint bestowing new formulations upon the world if only he had more money, he's a slimeball pharma CEO trying to balance that R&D with reaping maximum profits.
Would lowering prices for Americans mean the world has less R&D bankrolled by American consumers? Probably. But the current situation is untenable.
Please engage with the substance of the argument put in front of you.
The thrust of the comment above is that you do not need to trust him.
Americans are willing to pay higher prices because direct to consumer advertising is allowed, making people more willing to pay a higher price because an ad convinced them it will be worth it. If people wouldn't pay, then pharma companies would lower the prices.
Fix the demand side and the supply side will adjust.
I would suggest it's the reverse. Americans accept higher prices because they have many many layers of intermediation.
Americans pick their employer. Their employer picks their health plan. Their health plan picks which drugs are covered and which doctors and pharmacies they can use.
With the "innovation" of vertical integration between insurers, healthcare providers, and PBMs, there is effectively zero incentive for health insurers to manage costs, because those costs show up as revenue for their own subsidiaries. This is actually hugely advantageous for insurers because they are required by law to spend a certain percentage (~80%) of their members' premiums on healthcare goods and services, not profit or business development.
Well... if you own the pharmacies, the PBMs, the GPOs, and especially the healthcare providers... you can arbitrarily siphon money at any % rate you want while increasing the gross dollar intake by simply raising prices at your subsidiary companies!
All of this is well documented. Here are a few places to start:
https://www.statnews.com/unitedhealth-group-investigation-he...
https://hntrbrk.com/pbmgpo/
https://www.wsj.com/health/healthcare/unitedhealth-medicare-...
Do you have some information on the relationship between advertising and the willingness to pay higher prices for the advertised product?
A distinction without a difference...
Were people not previously paying what they cost? It sounds like that's the concept we're getting rid of here.
Where is the evidence that anyone has been harmed by these unapproved GLP1s? Until I see that I will assume the government is 100% in the wrong.
I just started taking Wegovy. Went the regulated route through my doctor, getting a prescription. She’s been monitoring loads of patients and noted that some of her patients going the ‘compound’ route had, in fact, had allergic reactions to their shots, or experienced their shots being less effective, after months of no problems. Nothing life threatening. But the fact is there is no oversight to what the GLP-1 is compounded with.
> experienced their shots being less effective
People report this with HPLC tested stuff that is proven to be of the same purity/concentration too, "feels" reports are notoriously unreliable in medicine.
My company makes HPLCs.
Yes, they can 'prove' what is in something to the limits of the physics.
However, the human in the loop is quite frail for most operators. In that, these very fancy and very expensive instruments are mostly run by high school grads and serviced by field engineers with a huge backlog.
For a first time one off test of something's composition, I'd go for at least 3 companies and preferably you have a history with them. This stuff is terribly complicated and misinterpretation is shockingly common. If the tech hasn't used the standards before then your at the mercy of fate.
Like, we have 5 (!) places on the home screen that do the exact same function of ending a run because when we try to consolidate it to just 1, our customers freak out and can't find where the button went to. Granted they pay $100k+ per instrument plus service plan, so we add it back in no question ( and this is life critical equipment in many cases), but I hope that shows how embedded to routine these operators get.
Janoshik is the primary company people use here, and their business is basically entirely peptides and anabolic steroids, and the GLP-1 stuff exploded their business from gym bros to soccer moms everywhere. https://janoshik.com/
But they basically test the same 12ish compounds day in and day out, with another couple of dozen making up the remainder. They don't have most of the worries that you are referring to - first time for a tech running a specific set of standards, limited experience interpreting them, etc., and when people head to head their results against different labs, they are consistent.
What she presented to me was that more than one of her patients taking unregulated GLP-1s simply stopped losing weight, and in an unexpected way. I have no idea how many patients this was. My doctor is rad and very much pro-GLP-1s and pro-preventative-care. This is ultimately an anecdote.
There's a well known plateau effect with GLP-1s where the body adjusts to the changes in caloric intake and the medication itself so that weight loss levels off and stops after a period of time. It could be that but it's hard to tell with 2nd hand info.
You had the choice to go the expensive route and you took it. Don't tell other people they can't make their own choices too.
Personally I feel the hims etc of this world need to go away. They give a false sense of security and they mask an incredibly shady industry.
I also think people should be able to source from the grey market if they can figure it out. This means they understand the risks and likely take measures like ensuring their compounds are properly tested before injecting them.
I’d feel differently if I didn’t understand how the average medspa gets their product and the corners they cut. I honestly trust some outright black market dealers better than most of those shops. They actually do testing on their product before shipping it. Likely sourced from exactly the same manufacturer as the guy in the locker room buys from.
So long as the choices are informed I agree. The issue is hims/hers puts a fancy veneer of “sanctioned medical system” on top of what amounts to a black market. They are laundering and obscuring the risk and many patients simply do not understand this fact.
It’s the difference between buying Xanax from a legit pharmacy vs a street dealer. The street dealer transaction you understand the risks involved and are making an informed decision. If you thought you were buying from a legit pharmaceutical company but they ended up just rebranding the same shit the street dealer is selling from his wholesaler - that is not informed consent even a little bit.
There is something in the middle here but some HLPC testing I’ve seen of supposed legit compounding pharmacies hasn’t been great for these drugs.
Can you quote from the five sentences I wrote where I said anything about telling people what to do? I simply noted that my medical provider has first-hand experience with people getting questionable results from unregulated GLP-1s.
This is precisely why we have clinical studies. We want to measure the efficiency and the innocuousness of drugs. You seem to imply we should just go ahead and try those directly on the general population.
What do you mean "try them on the general population?" Who is forcing anyone to take any of this?
Has anybody ever been forced anyone else to take any drug? The problem is not about being forced, it is about making an informed decision. When you don't have enough safety data you are effectively gambling with your health.
The individually compounded versions have a higher risk because there's a person involved who can make mistakes, as opposed to a carefully controlled and tested manufacturing line.
Compounded drugs have higher rates of bacterial problems, doses being too high or low, and other issues.
Someone I know worked for a company that took over a poorly run compounding pharmacy and cleaned up their process. Some of the stories I've heard have made me want to avoid compounded medications wherever possible.
So you think it's better to wait until people are harmed than for companies to go through the proper approval process for these drugs?
I'd argue more harm is done by any delays in approval
Yes. Drugs are too damn expensive and innovation is too damn slow. Better to allow higher risk options. And if you don't like it, you are always free not to use them.
"If you don't like it don't take it" ignores all of human history. A huge majority of substances can be fatal if ingested. Are you sure you want to live in a world where Elon can speed run figuring out what won't kill "most" people?
I'm on death row. So are you. The only thing that has a chance of giving me a stay of execution is rapid technological advancement so I'm willing to accept a lot of risk here. It's a matter of self preservation.
> Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.
The US is a funny thing: no issue cutting access to Healthcare in general, education, healthy food etc.
But it is all the rage when a pill can undo people's bad habits.
> The rules and laws are there for a good reason.
"To be circumvented. Regards, Uber, Microsoft, Meta, Google, Antropic, OpenAI, AirBnB and others"
You are misrepresenting the FDA post. They focus on the fact that the API was not approved for use, which means removing the marketing authorisation is something perfectly fine to do. All API sources need FDA inspections proving the GMP practices are respected and compliant.
ANDA is for drugs that have gotten off patent. Semaglutide has not gone off patent in the US. It won’t until 2032 at the earliest.
And ANDA absolutely does require supply chain inspections, first at approval then random inspections there after.
Whats Hims and Hers was doing was compounding (turning the chemical into a formulation patients can take) under an exception due to limited supply. Supply issues are over, so they can not longer compound.
I do t think anything is wrong with the US system here. These patients got access under a temporary exception, they have the option to obtain a supply through other channels going forward. If affordability is an issue, the manufacturers have several programs that make these drugs affordablez
> The rules and laws are there for a good reason
Are they? This example seems to be a clear contradiction of your first point. Stuff like this weakens the authority and credibility of the FDA, allowing legitimacy to people like RFK.
If the description in the first comment isn't missing anything important, and this could be fixed with some paperwork and inspections, then I don't think taking action makes the FDA look bad.
The particular complaint of "cannot state compounded drugs use the same active ingredient" is weird but if it only applies to marketing then sure crack down on that too.
Eli Lilly will categorically state it is impossible for the compounders to be using the same API as they are due to being the sole source of manufacturing for it on the planet.
From what I can tell they are technically correct. The FDA approved method of manufacturing the peptide chain is different than the Chinese sources these compounders are sourcing from. It may not make an actual biological difference (and hefty evidence of millions of people on it show there is unlikely to be a material difference) but it’s not the same as a generic medication being approved.
This is about as Wild West as most of us have lived through for the U.S. drug market.
> This is about as Wild West as most of us have lived through for the U.S. drug market.
I don't know about that. I'm old enough to remember The Vaping Panic of 2019, where (medical and/or recreational) cannabis vape liquid was adulterated with Vitamin E acetate in industrial quantities, which caused widespread injury and death. The real cause was called out very quickly (thanks in part to investigative reporting by...WeedMaps[1]), but health departments flailed and spent months blaming it on Juul and teen e-cigarettes. The panic evaporated because right as the public health community realized what was happening, Covid broke out.
To this day, afaik no testing of vapes is required to ensure they don't contain this toxic ingredient.
[1] https://weedmaps.com/news/2019/10/why-vitamin-e-acetate-and-...
> To this day, afaik no testing of vapes is required to ensure they don't contain this toxic ingredient.
This is a pretty good example of how "testing requirements" tend to be reactionary and effectively useless.
Vapes contained Vitamin E because the sellers were cutting the product with it, the same way drug dealers cut drugs with starch or sugar or something worse. It wasn't a manufacturing mistake, they were adding it on purpose to rip off the customer. It makes sense for that to be a crime -- it's fraud and negligence -- so the argument comes that we should require testing for it.
But if you add a test for something like that, they either cut it with something else that the test won't show (which might be even worse) or they add the cutting agent to the distribution pipeline somewhere after the point where the testing requirement is imposed. Testing for something works against mistakes, not purposeful behavior.
Meanwhile the people doing it were probably idiots who didn't know it would cause physiological harmful and thought they were just ripping people off, so then the argument comes that we should be testing to make sure they're not doing that. Except there is no generic test for every possible problem, so at the point they first started adding it, the government would have had no reason to test for that in particular, and by the time it becomes generally known that adding that substance is harmful, they'd have stopped adding it because they don't want to be sued or arrested when their customers have those symptoms and then permanently testing everything for something everybody has already independently stopped doing is a waste of resources.
The problem is people want the generic test that could catch every possible problem and that isn't a real thing, and there is no point in doing the specific test for something that has already stopped happening.
I wouldn’t put vapes in the same category as patented pharmaceuticals.
They are already an unhealthy vice for one thing. They do not require a prescription and are sold over the counter to anyone who presents an ID showing they are of age.
Those vapes were also largely made by relatively fly-by-night manufacturers selling into mostly shady retail shops. Additionally there was (still is? Haven’t kept up on it) no real consensus that vitamin E acetate was a dangerous chemical unfit for purpose.
This is the first time in my lifetime that I can recall of major companies blatantly end-arounding the entire pharmaceutical approval process for a prescription drug. Full on advertising their disregard for the rules on public airwaves and everything.
FDA being slow to react to a public health concern due to an adulterated over the counter product imo is not the same category. This is literally telling the FDA and major pharma “come at me bro” and expecting the delay to be profitable enough to offset any future penalties.
In that case I want to see more wild west because this is working fine for me.
https://en.wikipedia.org/wiki/Thalidomide_scandal
That specific medicine is about a molecule that was insufficiently vetted.
It does not seem as egregious as the risk of getting medication made in other countries. As far as I know, all the patented medicine comes from barely audited factories in places like India anyway.
Me too. This particular Wild West scenario clearly benefits the public
Yes yes, it's super beneficial to destroy the incentive for anyone to risk billions of dollars and decades of research to develop new breakthrough medications for people
I don't think this is about paperwork. They are presumably violating patents by not buying these drugs from the patent owners.
The interesting systems-level question here is whether the FDA approval pipeline was designed for a world where a single drug class can generate this much demand this fast.
Traditional pharma economics assumes the patent holder can supply the market. GLP-1s broke that assumption — Novo Nordisk and Lilly literally could not manufacture enough to meet demand, which created the shortage that let compounders in legally.
Now the shortage is declared over, so compounders lose their legal basis. But "shortage over" is doing a lot of work in that sentence. It means the brand manufacturers say they can supply, not that the drug is accessible to most people who would benefit from it at a price they can afford.
The deeper tension: FDA's framework is binary (approved or not) but the actual risk landscape is continuous. A compounded semaglutide from an inspected 503A pharmacy with proper testing is a very different risk profile than something mixed in someone's garage. Treating them identically under enforcement seems like it optimizes for regulatory clarity over public health outcomes.
"Demand" is not a good metric for proper medical or safety review. There is constant demand for products that promise amazing things, but they should not be approved more rapidly because of their claims until they have gone through the proper process and reviews to show both that they do what they claim and that they do not have other serious side effects or consequences.
We're talking about allowing an "essentially" generic version of an existing FDA approved drug made by licensed compounding pharmacies that has been legally distributed for years due to the shortage. If it's safe enough for people to take in a shortage then it's probably safe enough for people to take in a not shortage.
You’re putting more things I. The FDA’s regulatory basket than the law intends.
Whether or not “people who could benefit have access” is not relevant to the FDA’s mandate. The intent of the FDA is to regulate the safety and efficacy of medicines - not access, not price.
Once supply was addressed, the FDA’s regulatory objectives were complete
I don’t understand how it’s not legally required to be covered by all insurance in the US given all the health problems downstream of being overweight.
Because then the companies that have been given legal license to monopolize this technology (through the legal technology known as "patents") could charge whatever price they wanted and insurance companies would have to pay for it? The ability for an insurance company to say no is literally their only negotiation leverage.
Every country arranges their payment mechanism slightly differently- the US is worse than pretty much all of them but they are all slightly different- but every form of insurance has to be able to walk away in the negotiations, or else the monopoly producer will hike the price up.
I imagine if you forced insurance to cover but also removed patent protection and allowed generics immediately... drug companies would be even more unhappy than the insurance companies would if you forced them to cover GLP-1's.
> Because then the companies that have been given legal license to monopolize this technology (through the legal technology known as "patents") could charge whatever price they wanted and insurance companies would have to pay for it? The ability for an insurance company to say no is literally their only negotiation leverage.
Insurance companies have to pay $100k+ per month for medicine for anemic people, and many other much higher cost medicines. Why is a couple hundred dollars to fix THE single biggest cause of future healthcare expenses (diabetes, high blood pressure, and cholesterol) not covered?
https://www.desmoinesregister.com/story/news/health/2017/05/...
Insurers routinely pay for $1M+ NICU babies, $100k+ heart surgeries, yada yada, but the US government draws the line at medicine that costs $200 per month that prevents hundreds of thousands of dollars in future spend?
I can’t make it make sense, unless the junk food/alcohol/restaurant/sugar caffeine drink lobby has their tentacles deep in the government.
Because it is $1K/month, it would raise premiums too much. When it is $100/month like in most other countries, then let's talk.
PS - And, yes, compound versions are $100/month, but insurance doesn't cover those.
Where is it $1k/month??? I just started Wegovy and it is $199/month from Costco with insurance not covering it. I picked up my four shots on Thursday…
Do we really need insurance to cover $100/mo meds? Insurance already doesn’t cover OTC vitamins, right?
>Do we really need insurance to cover $100/mo meds?
For people making how much? Low income people are jumping through the hoops to get SNAP. $100 for them is a lot, and which they might just not have. And for insurance it would be cheaper long-run than dealing with diabetes, etc.
Anyway, why a such "submarine" attack on the $100 GLP-1 sources and why now? Well, one way of thinking would be that Trump RX just went online and there, thanks to the well known Trump's care about people's needs, the GLP-1 is $350, so one has to remove the $100 competitors.
It’s not a submarine attack at all. If anything I bet you these compounders are surprised they haven’t been shut down already for blatantly violating the law.
It’s a case of trying to get so many consumers buying that regulators are scared to touch you due to blowback. Much like Uber did.
Well, 67% of Americans are overweight and the mandatory drug costs $1k. So premiums must be $670 per person or higher to cover nothing but this drug. The drug manufacturers will know that the insurers must provide it so they’ll use the highest price they used at scale: $1k.
That means that every healthy person is also paying $670 per month just so that the 2/3 of the country can get this drug. But current medical loss ratios are at least 85% and if we did nothing but pay $670 we’d be at 100% loss ratio and the drug paid for.
Boy the economics for the average person look pretty bad, considering they can just get it off the internet for a fraction. I have 240 mg of retatrutide in my fridge for about a dollar a mg in comparison.
I like the way you're thinking about it, but worth mentioning that the net prices paid are likely in the $200-500 range, similar to the cash pay. List price doesn't mean much
This calculation is incorrect because the medicines cost significantly less than $1k per month, and there there would be cost savings from people being less overweight needing less healthcare.
For decades now, every single healthcare study seems to say overconsumption is the root cause, and now that there is a way to combat it, the government is saying the fix to overconsumption at a few hundred dollars per month is not worth it?
Because not all overweight individuals have the same risk profile thus don’t get the same benefit.
Insurance companies are allowed to limit access to more expensive therapies unless cheaper therapies have been tried and have failed.
Insurance plans are currently allowed to have complete exclusions of all obesity medications, even cheaper therapies
Yes, plans have pretty wide latitude on what they cover. ACA limited quite a lot by not only in plan design, but also what therapeutics must be covered. And you are correct, obesity is not one of them.
Medicare Part D (outpatient drugs) has wide latitude on what medicines they cover - it's actually smart for patients to shop their Part D plans if they are taking an expensive, chronic medication.
The only classes of drugs that Part D plans must included are:
Part D sponsor formularies must include all or substantially all drugs in the immunosuppressant (for prophylaxis of organ transplant rejection), antidepressant, antipsychotic, anticonvulsant, antiretroviral, and antineoplastic classes. (Page 28)
https://www.cms.gov/medicare/prescription-drug-coverage/pres...
After the first big crackdown on compound pharmacies, I have seen a lot of people go to gray market. Especially now that it has become pretty clear that the remaining compound pharmacies defying the FDA are getting their API from the same sources that we can buy it from directly, and their testing is way more suspect. On the gray market the batches of peptides are routinely subject to a battery of tests run by groups of volunteers, which is a lot more than what you can get from your chosen compound pharmacy (most will give you a COA, but that's already table stakes if you buy from a "research" vendor.)
I have noticed that the "research" vendors have started to tighten up their operations, especially the ones based in the US. A lot of people have seen the writing on the wall and expect it to become somewhat harder to get the peptides, and are stocking up. It's a running joke how many years worth of tirzepatide or retatrutide people have in the freezer. Once you've had the miracle drug, you won't risk being without it.
I would silly things to hold onto a steady supply of pentadeca arginate. It has completely eliminated lingering effects of joint and ligament injury and has enabled me to exercise like a normal person. If you have the money it is very easy to acquire a year or twos worth from multiple sources.
Dangerous to use if you have any cancerous or pre-cancerous growths in your body, though. We know they love VEGF, and BPC-157/PDA majorly amp it up.
Im aware from the BPC research from the last few years. No history of cancer.
Just posting for general awareness - people search this stuff up and then find nothing but research chem sites singing the benefits and providing no info on the risks.
I've had great success with BPC-157 and tendon issues, but I try to use it sparingly - no history of cancer, but everyone has no history of cancer until they do - and try to rehab any injuries with slow heavy eccentrics, etc., and only go for the BPC when that isn't making any improvement.
Are you using it for a specific injury or generally for anti-aging like people often do? What dose?
Several ligament tears and general wear from sports. A very low dose taken daily.
What makes you say that compounding pharmacies' testing is way more suspect? Curious because I know people who are still using compounding pharmacies (specifically mom-and-pop joints that might be able to evade crackdowns for a while longer) but have considered going grey market... maybe this is the sign to switch?
It's opaque, and limited. They buy the raws from China just like everyone else, then reconstitute them, fill vials, and drop them in the mail. They'll only provide a COA if you ask them to, and it will just be one basic mass/purity test most often.
In the gray market, there are multiple mass/purity tests for a batch (to look for variation in fill, mostly), as well as tests for endotoxins, sterility, heavy metals, and fentanyl. Rarely (maybe never; I have certainly never seen it) will a compounder do these additional tests and provide the results.
I think in general the well-known compounding pharmacies (e.g. Hallandale, BPI, couple others) are probably reputable enough to feel okay with. The mom & pop ones (or med spas) I'd be a lot more nervous about. Often ends up being someone who's just reconstituting vials in their living room, and maybe not with the quality controls you'd like to see.
Good to know, and thanks for the info!
The situation is basically this -
Novo and Lilly spent billions making Semaglutide, Tirzepatide, and future formulations/modalities.
They are going to monetize this heavily while they have IP coverage. There is no world they will let HIMS or any compounding pharmacy of scale undercut them.
On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.
Fortunately, the prices are coming down. Amazon pharmacy has Wegovy in an auto-injector starting at $199 without insurance. And that’s delivered to your door in under 24 hrs in most major cities.
I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now. Historically, we subsidized R&D globally by allowing pharma to make most profits on Americans then have cheaper prices abroad. That is changing and hopefully that’s a net positive.
> I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now.
Brief research indicates otherwise unless you're talking about a handful of Brand name Rx. For generics, CostPlus and other options are still better pricing.
https://www.healthcompiler.com/cost-plus-drugs-vs-trumprx-ho...
> I highly recommend checking out the terms of trumprx.gov
The website is very good marketing for people who don't typically follow drug pricing. Here is more about why the only folks who will benefit are those without insurance—but those people will find better prices in several places, sometimes significantly better prices [1]. Further, it's likely that they're already finding those prices, since the website prices are no better than what you can get today outside fertility medication; and fertility medications are neither new, nor the most expensive part of that process.
This site has nothing to do with the effective subsidies that Americans provide to the world, and it will change nothing about that. The major thing that would help all Americans, negotiating for drug prices, has been neutered by the current administration. In fact, an executive order has specifically lengthened the amount of time that new drugs will be able to charge higher prices to Americans [2].
We should all be very careful in parsing news items that are not in our field of expertise.
1. https://www.nytimes.com/2026/02/05/health/trumprx-online-dru...
2. https://www.kff.org/medicare/the-effect-of-delaying-the-sele...
Can you explain from first principles how the US market gaining MFN pricing does not benefit Americans? Open to changing my mind
Drug companies produce drugs to make money. There is a huge investment. They maximize revenue by price discrimination to recover the cost of the good drug and all the drugs that didn't work. The US is a rich country. People in other countries can't pay as much for the drug. To maximize revenue the drug company sells the drug at a lower price to those people.
More generally, price controls lead to less supply. Drug price controls will result in fewer new drugs. Minimum wage laws result in no workers doing work that is worth less than minimum wage. Anti- price gouging laws result in less bottled water and fewer generators after a hurricane. The principle is universal despite promises of delightful state run grocery stores.
Praise for price-gouging: https://www.grumpy-economist.com/p/praise-for-price-gouging
I think 'MFN' is almost propaganda (not a term that existed before 2016-2020 administration) so let's leave that aside.
Are you claiming that the new website is offering lower prices than patients are paying after their co-pay? That is not the case outside the example I presented; moreover, the way the website is organized, there will be no pressure for prices to remain competitive after the initial media attention dies away.
I agree that a hypothetical case where we were paying lower prices would be better for us—but this remains an unrealized hypothetical. One way for us to pay lower prices would be to allow our government to negotiate prices for Medicare/Medicaid recipients, and that is exactly the thing that has been hampered.
Not arguing on broken internal pricing dynamics that are skewed by all sorts of gov programs and payors.
It’s about external, global pricing dynamics. The site clearly isn’t going to be able to give clean payor/pbm/gov subsidized pricing tables - that is almost an impossible exercise in our system.
What the agreement does accomplish is saying Americans will not pay $1150/mo while EU pays $400/mo while Argentina pays $120/mo.
It guarantees drugs will be greater than or equal to US pricing abroad which effectively forces pharma to find deeper profits outside of the US, or lower prices for all countries to acquire demand.
That is extremely effective. Now it’s up to a really complex group of people to figure out what that means inside our weird system of pharma/pbm/rebates/insurance/medicare.
But that’s not what trumprx is aiming to solve for right?
> But that’s not what trumprx is aiming to solve for right?
Correct
> What the agreement does [...]
This is hypothetical and does not exist. It also is not going to happen, politically, because drug companies are currently expecting to charge US prices in the US, while charging lower, non-US prices outside the US.
> That is extremely effective
This is hypothetical—and, as I've said, the attempt that the Inflation Reduction Act made toward this was watered down by an executive order. To be fair, the negotiation mechanism is still in place, and its existence must be influencing drug pricing already.
> unless you are at serious risk of diabetes
The US obesity rate is in the 40% range.
The most effective use of public funds would be to simply buy out the patent and give it out for free. It will save so much in future medical costs it's a no-brainer.
It’s a no brainer for reasonable people, but a very substantial portion of US voters would rather shoot themselves in the foot so long as there was a chance some shrapnel grazed a liberal.
> hopefully that’s a net positive
It can't possibly be a net positive. The first pill costs $1B and subsequent ones costs 50 cents. Yes, the U.S. pays more, but the result can only be some combination of 1) other countries also paying more and 2) fewer new drugs.
And 3) US consumers pay less for pharmaceuticals. Together this might be a net positive for US consumers (even if they get fewer new drugs out of the bargain).
Well that's the choice. Allow drug companies to price discriminate so that poorer people can also buy the drugs or don't allow it and get more new drugs. It's not clear that drug companies are even going to retain low prices in other countries if it means that the US consumers will pay less.
Which drugs that haven't been invented yet do you think we should forego?
I'm not taking a side here.
Why are you so sure that isn't a net positive? Maybe we're spending too much money on inventing drugs that would be better spent on building houses or feeding the poor.
Anyone who's buying GLP-1 drugs can choose to give that money to the poor instead. What particular drug do you think shouldn't have been invented?
> On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.
It's often up to the employer whether these meds are covered - many insurers just offer it as an option to check or not check.
That said, even at 3-6k/year, it wouldn't surprise me if these drugs were net savings to cover for a lot of patients due to their extremely positive effects as preventative care.
Yeah, my employer changed insurance a few months ago from UHC to Cigna.
Cigna is terrible, even worse than UHC, I'm not happy that we have them but that's a whole separate rant I don't care to get into right now, but one thing I was really annoyed by was that UHC covered Zepbound, but then Cigna didn't. They actually wouldn't cover any GLP-1s unless you are already diabetic, so my wife had to stop.
I initially blamed Cigna for this, but eventually I found out that my employer deliberately opted out of it, so now I'm mad at my employer and Cigna.
We've had to use a compounding pharmacy for my wife to continue her terzepazide, which has worked fine and at least thus far hasn't been an issue, but I knew that these things were on borrowed time due to their kind of gray legality.
Good. Now we just need to cut out the doctors. No reason this medications shouldn't be over the counter.
Novo will also sell you the auto-injector Wegovy directly starting at $199/month. And the pill starting at $149/month.
>On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes.
I'm not understanding this part. If these drugs have solved obesity and the whole host of associated diseases, including the number one killer; heart disease, shouldn't the insurance companies be clambering over each other to cover these drugs and heavily encouraging their use considering the cost reduction on the overall health system.
And if the incentives are misaligned with insurance companies why are governments not handing out GLP-1s to anyone who asks?
For chronic diseases that tend to be caused by obesity, the expensive bits tend to be towards retirement aged people - or are so disabling that people drop out of the workforce early.
In either case the vast majority of those costs will be incurred by either Medicare or Medicaid. Or at least the next insurer in line as the typical worker doesn’t spend an entire career at the same firm with the same insurance provider.
By the time any cost savings benefits have been realized (call it a decade later), chances are that insured patient is long gone and all they were was an additional expense.
By the time government gets involved you have someone who has been obese all their life and the damage is largely already done. Even if you paid for the meds now, the savings are limited.
Given the market already though - these drugs will be affordable to the average working person within a few years
Your employer (large employers usually dictate what is covered by their insurance benefit offerings) may not care much about whether you end up with obesity-related diseases in your 60s and above.
>why are governments not handing out GLP-1s to anyone who asks?
Governments require consensus, which makes them slow. It took decades to phase out leaded gasoline.
The major Indian generics manufacturers have all signed branding and IP agreements with Lilly and Novo as well, so the only people that are hurt are consumers I guess.
India wins (because Indian pharma gets IP and branding transfers). The Trump admin wins (the right strategic lobbying was done). The GOP wins (strategic tariffs on Iowa, North Dakota, and Montana lentil and soybean oil exports were about to kick off in India after they were hit by similar tariffs from China). The American consumer (who voted for Trump) loses.
Welcome to a trade war.
It’s unfortunate that shutting these companies down will result in less people gaining access to the drug.
GLP-1’s might be the best thing to happen to medicine this decade - I personally want everyone who would benefit from it to have access.
Was my glucose under control without glp-1's? Yeah I could manage an a1c of 5.4-5.6 with metformin but I was still hovering near 300 lbs.
With glp-1's I'm down over 50 lbs, my a1c is a much more manageable around 4.0-4.5 and it makes it much easier to exercise and portion control is a huge benefit. Not to mention a buncha other things like triglicerides and blood pressure have come down due to exercise and eating better. it sucks i have to take it forever, but at the same time i feel a ton better physically, and if i loose 50 more lbs, and labs continue to show improvement, i can reduce the cocktail of other meds I'm on my doc says.
Cigna denied me at first until my doc appealed twice. Cigna wouldnt cover because i wasnt a full diabetic so wasnt on insulin. I would've had to pay close to $1k a month to take it otherwise. Thank goodness for a tenacious doctor!
> I would've had to pay close to $1k a month to take it otherwise.
If your frame of reference for GLP-1 prices is in like, 2024 or earlier, check prices again. They've come down a lot. You can get tirzepatide from Lilly without insurance coverage for under $500/mo (a little less for the smaller doses): https://investor.lilly.com/news-releases/news-release-detail...
I've been taking metformin off-label for weight loss, and it's been working well. I'm a little annoyed that I have to resort to off label stuff because I too have Cigna and I have not been successful at getting them to cover it.
I think it's more my employer's fault than anything else; fortunately metformin actually seems to be doing the job. They won't cover that either but even without insurance it's so cheap that it's not worth complaining about.
It was infuriating trying to get Wegovy via insurance. My doctor made three appeals, all denied. Out of pocket it wouldve been $1600/mo. Ive been getting semaglutide from compounding pharmacies for the last year and half for $149-$200. I have lost 97lbs, come back to running 30 miles a week after several major knee injuries made even a mile jog a multiday recovery effort. I absolutely get the regulatory stance but the name brands are absolutely unaffordable.
They’re down to hundreds a month, now, with a coupon.
I can’t say I disagree with insurance not being willing to pay those costs (apart from diabetes patients etc.). I bet a large part of the reason you can get the name brands cheaper now is because they did the math they’d make more that way than they could squeeze out of insurance companies.
Also, on a personal level it rubs me the wrong way to have my insurance premiums go towards something that people could just do themselves, from something they did to themselves. I know many will disagree, of course, and there are other examples (say, lung cancer treatments) that are similar.
> lung cancer treatments
A fairly large portion of lung cancer patients didn't "do it to themselves" (about 20% and rising).
It remains to be seen how vaping impacts lung cancer,
I don't like the idea of finding reasons to penalize people for predicable life decisions that lead to treatment needs. Insurance companies have a lot of resources to make those predictions and if unshackled they aren't afraid of using them. Making construction workers, miners, or truck drivers pay more (or be denied outright) for insurance because their job has negative health effects would be bad for society.
They need to be in a separate risk pool. It isn’t a penalty.
I personally think that overeating is an addiction, not a moral failing, and is often the side effect of other mental illnesses.
I don't do this as much as others, but as someone who has suffered from Major Depressive Disorder [1], it can be really easy to eat your feelings away. When I've had really bad depressive episodes, I don't want to cook, I don't want a fucking salad, I mostly just want to feel bad about myself and I end up getting a huge meal at Taco Bell and sadly eating that. Doing that one day isn't that bad. Even doing that two days isn't that bad, but when you have a long extended depressive episode, it can easily become a pattern of weeks where you're getting unhealthy fast food every day.
I know a lot of people act like depression is a moral failing as well [2], but I personally don't think that, and it feels like obesity can be a symptom of major depression. If you ever watch "My 600lb Life", you'll see that a lot of the people on there are really going through serious mental disorders and/or dealing from PTSD from sexual abuse, and the overeating can come as a result from that.
I guess I just feel like it's reductive to say "they did this to themselves". The human brain and human psychology are complicated and irritating.
[1] Fortunately my current set of meds has really helped...medical science is pretty cool sometimes!
[2] Not saying that you said that, to be clear.
If losing the weight is good for them, isn’t it possible that it’s not just the humanitarian thing (which I know is a useless argument to make to the soulless ghouls who run insurance companies anyway) but also the economically right choice for them, to avoid paying for their worse health problems later?
> Also, on a personal level it rubs me the wrong way to have my insurance premiums go towards something that people could just do themselves, from something they did to themselves. I know many will disagree, of course, and there are other examples (say, lung cancer treatments) that are similar.
Our Obsession With Personal Responsibility Is Making Us Sick - https://jacobin.com/2026/02/health-inequality-individual-res... - February 6th, 2026
People with high blood pressure could just try harder to relax, too.
> Also, on a personal level it rubs me the wrong way to have my insurance premiums go towards something that people could just do themselves, from something they did to themselves.
The usual note for this is your insurance premiums were already going towards that, just indirectly by way of paying for heart disease treatments, diabetes management and other secondary effect of obesity.
But I'd also like to propose that "could just do themselves" is carrying a lot of assumptions that may not hold for any individual. A few years back now I started a medication with the side effect of appetite suppression, and I learned something about myself. To the best of my ability to recall, I had never before starting that medication not been hungry. "Full" to me was a physical sensation of being unable to fit more food physically in my stomach, but even when I was "full" I was hungry. Luckily for myself as a teen and young adult I had an incredibly high metabolism. I could eat 3 meals a day, 3-4 bowls of cereal and milk as an "afternoon snack" after school and some late evening snacks while watching TV and I still was in the "almost underweight" category. It was in this context, a time when I could go to a fast food restaurant and order two meals just for myself and stay well inside a healthy weight range that I learned to eat as an adult. Eventually though, the metabolism slowed down, and I started packing on weight but the hunger never subsided. Oh sure, as I got older the idea of and ability to eat an entire pizza by myself slowly went away, but hungry was always there, so I was still always eating and always eating more than I should have.
And I did manage to lose weight on my own many times. Through extremely strict self control and portion control, multiple times I managed to lose 25, 30 even 50lbs, one painstaking week at a time. Every day was strict tracking and weighing of everything I ate, and many days were hard battles of "I know I'm hungry, but I've already hit my limit for the day, so I can't eat more", and going to bed extremely hungry with the hope that when I woke the next morning that feeling would have subsided a little. And it worked each time, until inevitably something happened to disrupt the routines and habits built over the months. Maybe it was a set of family emergencies that had me eating on the run, unable to properly monitor everything and adding some "stress eating" on top of it. Maybe it was running into "the holidays" where calories are cheap and abundant even if you are still keeping track. And sometimes it was just being unable to sustain the high degree of willpower it required to keep myself on the schedule. And what takes month of carefully losing 1lb a week to do only takes a month or two to almost completely undo.
Hunger is probably the closest thing I've ever experienced to an addiction. I've thankfully never had to battle an addiction for anything else, but when it comes to hunger that eternal gnawing was ever present and the more weight I lost by sheer force of will, ever distracting. If the idea popped into my head after lunch that "I'd like a snack", it was an idea that would not leave my head until either I'd given in and gotten a snack or forced myself to not give in and waited until dinner. But that forcing meant dedicating ever larger parts of my mental energy away from my work and tasks at hand to just convincing myself to not go get the snack. And worse, when the time for dinner finally came, I was already feeling "hungry" on top of my normal hunger state, so often not eating the snack just meant delaying the excess consumption to dinner or having to continue that fight at dinner. If it sounds exhausting, in a lot of ways it was. But of course, like you said I can "just do" this. It's simple CI < CO math. And yet it never stuck, in part because unlike a lot of other unhealthy habits you can pick up in your life, you cant just not eat. Yes you can eat different things, or eat healthier, both of which can help with weight problems, but you can't stop eating. You have to eat, the hunger is always there and the same thing the hunger wants is the same thing you NEED to literally survive.
But that medication with its appetite suppressant effect was a game changer for me. For the first time in over 30 years, I actually felt full. Not physically stuffed, but "done eating". I could eat a small lunch and think to myself "that was good, and I feel satisfied". For the first time, when the idea of an afternoon snack popped into my head, I could remind myself that dinner was in 2 hours and I needed to make sure I had room to eat that so the snack could wait, and that would be the end of it, no fight necessary because the hunger wasn't gnawing at me the whole time. When I first started, I was concerned that the medication was giving me anxiety attacks because about 6PM every day, I'd start getting this feeling of my stomach tying itself in knots, and this sensation of "needing something". And after a week or so it occurred to me that what I was feeling for the first time in my life was the feeling of transitioning from having been full and satiated to being hungry again. I'd never not been hungry before. And I know that sounds insane, because it sounded insane to me then. Before taking the medication if you'd asked me if I know what it felt like to be full or to not be hungry I would tell you that I did. But apparently I didn't, and I didn't know that until I started that medication. And for the first time since the weight started coming on, the weight I've lost is staying lost.
So yes, you can "just" eat better and less and control your portions and not eat so much. But from personal experience, it's a hell of a lot easier to have that will power when your body is giving you the right signals and isn't constantly pushing you over the limits.
I think I know this feeling well.
At the end of 2023 and the beginning of 2024, I lost about 60lbs, and it was a basic calorie counting thing. For me, it wasn't too hard; I was able to get used to the hunger and after about a month the feeling of wanting to eat all the time was somewhat tolerable.
In May of 2024, I started taking Pristiq, and one of the side effects is a huge increase in appetite. Like you said, I would feel "full" in the sense that my stomach wouldn't fit anymore matter, but I was always hungry and pretty much perpetually craving sweets. I would get a whole large pizza for lunch, a large meal at Popeyes for dinner, and chase it down with snack cakes, and I would still be "hungry" the entire time.
I managed to undo all the progress I had made with my dieting and a bit extra, and it was kind of weird. It's not really "hard" to know what to do. Obviously everyone knows to eat less processed food, focus more on protein and fiber, etc, but despite me "knowing" this, it was strangely hard to actually do it.
I'm very thankful that I found out about Metformin. I'm not diabetic and never have been, but it's prescribed off-label for weight loss, and according to my doctor it can be useful in the particular case of "canceling out the appetite-increase from medication", and to my surprise it worked shockingly well. I'm still not quite down to my diet weight yet, but I'm down about 30lbs in the four months I've been taking it, and I don't really feel hungry all the time. I still enjoy eating unhealthy food, but food is considerably more transactional now: I eat food because I need energy to survive. I budget about 200 calories lower than what my smartwatch says I burn during the day. It's much easier to treat food as a more utilitarian necessity.
If anyone here is in the unfortunately situation of not having their insurance covering GLP-1 medication, I highly recommend seeing if you can get your doctor to prescribe metformin. It's been out of patent for decades and cost on the order of ~$5 a month [2] and there are very few side effects [2], so it's a relatively low-risk experiment.
[1] Not a referral link https://pharmacy.amazon.com/Metformin-Generic-Glucophage-Ext...
[2] And potential benefits apparently! https://www.health.harvard.edu/blog/is-metformin-a-wonder-dr...
I was receiving compounded Semaglutide (Wegovy generic) from Victory Pharmacy, a brick & mortar compounding pharmacy, in Austin for $150/mo, then $200/mo, and finally I stopped when it reached $250/mo. I have SSDI and Medicare but it wasn't covered and it's still not covered for pharmacologically-induced obesity or weight gain. If I developed diabetes, then it would be covered as Ozempic (lower dose). I'm having to go without because of bureaucratic gatekeeping and discrimination and because of opportunists cash grabs by pharmaceutical companies' price gouging.
Do you have diabetes, heart disease, or another condition necessitating a GLP-1?
Why is obesity not considered a necessitating condition? It often carries the comorbidities you just mentioned. Should not exclude people just because they haven’t had these specific health problems (yet) but will eventually have them.
While I tend to agree, insurance companies don't see it that way. They need a doctor to indicate a necessity to treat a condition, as opposed to it being the easiest way to treat it.
For example, I have to take digestive enzymes to digest my food (pancreatic insufficiency). For someone with an unusually high metabolism, they would also give them a leg up on gaining weight, even though there are other approaches to gaining that weight. However in many cases, the insurance company wouldn't cover their prescription when they will mine.
As always it’s insurance nonsense. If incentives were aligned insurance companies would be lining up out the door to give this to obese people because they (the insurance companies) would eventually be on the hook for paying for the care of the conditions you just mentioned. It is very well demonstrated in literature that obese people have a much higher occurrence of these conditions than non obese people.
But the system is not set up with aligned incentives
The problem is that if it's just about obesity, you have to prove that cheaper treatments such as diet and exercise didn't work. That's not impossible to do, but it's hard and annoying even for people who really were trying. My doctor told me that you basically have to keep a detailed journal of your weight loss efforts for months on end.
Are GLP-1s so much more effective that we should make an exception to the general principle, maximizing healthcare resources by providing the cheapest effective treatment? I kinda think so, but I have a conflict of interest, and I can understand why others might think that money is better spent elsewhere.
I think you would be hard-pressed to find any human who has been 100 pounds overweight for any amount of time that doesn't have an obesity-related comorbidity.
Hypertension, sleep apnea, high cholesterol, etc are all common in the general population and exacerbated or even caused by the physical and lifestyle conditions that beget obesity.
I was 347lbs at the time. Wasnt a diabetic (nor pre-diabetic) no heart disease, blood pressure or really anything other than my weight. Prior to then Id had two massive bouts of weight loss at 50-100lbs so I know what it takes. Id tried but this last time without meds was extremely hard. You cant do much in the way of productive exercise when both your shoulders need replacement at 30 and between two knees have an ACL tear and two MCL tears. To top it off I had wildly out of whack hormones.
Yeah...so in India, the GLP patent owners went to court. however, it was deemed as patent expired in March 2026.
In anycase, India generally doesnt honor product patents for pharma. Right now, Indian pharma cos are court empowered to churn out GLP-1.
Everyone knows that we are gonna have 10$ GLP-1 before 2027 coming out of India.
This is big. HIMS and HERS and other companies are blantatly skirting patent laws under the guise of compounding.
>blantatly skirting patent laws
Why is this a bad thing? The quickest way to fix the medical/insurance/bureaucracy complex is to just allow people to sell direct to consumer.
The best (worst) example of this is CPAP. Ideally you'd just be able to go and buy one for $300, but instead there is a complex around "necessity" and "prescription", which creates an effective monopoly where the exact same hardware can be sold at different price points with software locked features.
If even a "simple" mechanical device like this which violates no patents and can't materially harm a person in any way can be restricted on grounds of paternalistic "safety", then one would be right to remain skeptical of the claim that the FDA is restricting action against unauthorized semaglutide knockoffs to
>safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.
In Italy, you can walk into a shop and buy as many contacts as you like.
In the US, if you haven't paid your annual tithing to get a hall pass from an optometrist, the FDA won't let you.
Going to Japan felt like living in the future. I could walk into any glasses store, and for $50 or less buy a pair of frames and lenses. If I didn't know my prescription, included in the price was an automated eye exam machine which'd figure it out in 2 or 3 minutes.
In the US I'm paying $200 just for the exam.
You can do the same in the US, zennioptical.com. You need to measure your PD which is very easy (Most optometry shops are hesitant to tell you your PD. And it's normally measured when you go to order the glasses, not as part of the initial eye exam.)
As for needing a prescription <1 year old, if your vision hasn't changed, just edit the date in the PDF. Same for contact lens prescriptions.
As part of the regular eye exam, they generally use an autorefractor machine on your current glasses and/or eyes to get a baseline before they manually fine tune with the 1/2 on the eye chart test. But yeah, you can't just get the quick prescription from the autorefractor like you talked about in Japan.
While we are in the minority, Zenni and many online optical shops recently decided they will not make you glasses if your prescription is over a certain power. In 2025 I broke $800 on frames+lenses and contacts.
European Respiratory society disagrees on the cancer risk fwiw https://www.ersnet.org/wp-content/uploads/2022/02/Update-on-... but yeah obviously degraded foam isn't good. The foam isn't actually a required part, it's just for sound reduction.
But I think that proves my point, the supposedly "rigorous" FDA review didn't flag concerns about foam in the airpath of something you breathe through, so what exactly is the approval process buying you? Philips issued a voluntary recall but resmed uses foam in their units too, and while they claim it's a different type of foam it seems there are better ways to engineer sound reduction than putting foam in the air channel and potentially breathing in microplastics.
Well you either remove all the bureaucracy around drug testing and approval and make it cheap to develop a new drug, or you prevent drug makers from making money if they are successful at developing a new molecule. But if you do both, all you will get is zero research. Right now it takes 10s of billions in R&D budget to bring new molecules to the market, which is insane.
Or you pay them directly. Most countries have research funding. Since there's no way to know what you'll find or how long it will take, research doesn't fit well in the capitalist model. Makes much more sense to apply a fixed effort and accept whatever results come out, but only the government can do that — or a rich monopoly like Bell.
Why is it bad when companies break the law? We have patent laws for a reason (to incentivize enormously expensive drug development).
Novo and Lilly already sell direct to the consumer! Yes, you need a prescription, but once you have one you can buy straight from the manufacturer.
That's nice. The rest of the world has price caps on what these companies can charge for drugs.
It's one or the other. You can have your ''patents'' and ''intellectual property'' respected...but that requires you not charge an outrageously higher price in certain markets, like the US.
The rest of the world is free riding.
The solution is a law preventing drug firms from pricing in the US higher than (some small multiple of) what it charges anyone else in the world.
> The rest of the world is free riding.
The rest of the world isn't free riding - the USA has just setup a market where there is very little bargaining power for consumers because of how the US medical market and insurance works.
Novo and Eli are still making plenty of money in Europe where these drugs cost a fraction of the price, and where there aren't other significant suppliers for GLP-1's like is being implied.
No, they're free-riding. If drug companies can't charge higher prices in the US, they will do less drug development. Everyone involved in the business/investing side of pharma knows this; it's not even an argument.
Somebody has to pay for the drugs development, the poor can't pay, if the rich (US) won't pay, there simply won't be any drug.
That's why I pay Apple extra money to develop the next big thing. If I only pay the sticker price of the iPhone, there won't be any more innovative products. But if we all get together and pay double the sticker price, we'll get some true innovation!
Nobody is suggesting paying Novo up front, they footed that bill, we are talking about paying a premium after product lunch, which people certainly did for the iPhone.
In a free-market approach to drug development, if the expected loss of attempting to develop as drug is negative, and the cost isn't too high, then there is an incentive to develop that.
The best public policy outcome in such an approach would be for losses to be only slightly negative. Positive or zero expected losses mean no drug development, and highly negative expected losses mean the drug is more expensive than necessary and reduces the accessibility of the drug.
However, current patent law allows companies to minimise their expected loss, with no controls to prevent highly negative expected losses.
There are alternative models - such as state funding of drug development. This model has benefit that it is possible to optimise more directly for measures like QALY Saved (Quality Adjusted Life Years Saved) - which drug sale revenue is an imperfect proxy for due to some diseases being more prevalent amongst affluent people, and because one-time cures can be high QALY Saved but lower revenue.
The complexity of state funding is it still has the free-rider problem at a international level (some states invest less per capita in funding). This is a problem which can be solved to an extent with treaties, and which doesn't need to be solved perfectly to do a lot of good.
The US has zero credibility w.r.t making international treaties these days. And generally is completely set up for a few peoples maximum “expected negative loss”. Sure things could theoretically be structured differently, but for the foreseeable future they aren’t.
Excessive profits from patented drugs are controlled by development of competing drugs. These competitors arise until profits are driven down to the point further development of competitors is inhibited.
The poor can pay for the drug development quite well. It takes a rich country to pay for all the regulatory capture.
Nicely put :)
Remind me from whenceforth come Bayer, Novo Nordisk, Moderna?
These are international companies that depend heavily on profits from the American market. Their C suite knows this; their investors know this.
Remind me from whenceforth comes the money that they depend on to make a profit?
The European Central Bank system prints it
Nah modern mega corps are free riding on all our backs. They use the power of the state and frivolous mechanisms like the broken patent system to create monopolistic situations for themselves.
Nope.
That would require those same companies from not abusing our political process to obtain illegal political outcomes - outcomes that are unconstitutional - like Citizens United, which led to PHrMA dumping unimaginable money into bad faith political advertising/lobbying.
Until or unless they stop being bad actors, everyone should pirate their stuff. Free Luigi.
Holy non sequitur, batman.
Whenever someone cites Citizens United, I'm 99.9% sure they have no idea what that ruling was about.
In other words: you are a reactionary who thinks little of others. Noted.
No because you literally have no idea what the citizen united ruling was based on what you wrote. Those 99.9% of people use “Citizen United” the way you used it. As a catch all for “corporate political contributions” except it wasn’t that impactful of a ruling regarding that.
If you actually know what it was then answer how does limiting non-electioneering advertisements from PACs for 30 days out of the year changes anything?
What percentage of global rich, obese people live in the US? This is the main market and the product would not exist if it could not command a high profit here. Besides that, I think the US prices are so high due to the insane medical insurance structure, not because the drug companies really make much more than in other countries.
The main reason drug development is so enormously expensive because the FDA makes it that way with their paranoid risk averse regulatory process and insanely restrictive requirements on what requires a doctor prescription.
> because the FDA makes it that way with their paranoid risk averse regulatory process
FDA is constrained by Congress here. Its function (safety and efficacy in advance of marketing) is required by legislation dating to the 60s. Feel free to advocate for Congress to change the law, but it isn't obvious it would be popular with Americans.
> insanely restrictive requirements on what requires a doctor prescription.
I don't think OTC vs Rx rules have much if any impact on drug development expenses.
OTC vs Rx has massive impact on sales volume which has a massive effect on pricing.
As always, depends on the law. This is a bright line example of companies breaking the law to the direct tangible benefit of not only their customers but the population at large. Letting Novo Nordisk jack the price back up and deprive the vast majority of Americans access to the greatest good to public health in a century meanwhile is… maybe not the example you should be holding as the law working.
Yes, bootleggers can undercut legit competitors, providing a boon for consumers.
In this case, Novo developed the drug. In your view, why does Hims get credit for "the greatest good to public health in a century" and not the company that sank over $10B into developing Ozempic?
Of course, Novo faces competition from Lilly and every other pharma company in the world and continues to lower prices in the face of this competition.
And they provide a valuable service to their customers, I have a very positive association with various drug dealers I've had over the years. Say what you want but they're literally out on the streets serving their local community. For a more HN example, people in the real world are extremely pro piracy and view the people cracking DRM as doing a public good.
I fully expect the state to take action against the, to me, very obvious will of the people who are actively seeking out and purchasing these products. Clearly folks don't respect the legitimacy of IP rights in the same way they respect property rights since nobody blinks when buying compounded GLP but at the same time wouldn't shoplift at their local BestBuy.
So yeah the government's response isn't surprising but you won't see me cheering them on, and I don't think you should either. You literally stand to lose from it.
Yep in other countries CPAPs are over the counter. In America you need to go to a sleep lab for a wasteful overnight sleep study (sometimes two!) that costs thousands. And then have appointments with a “doctor” who provides no useful help but is necessary for the prescription. All for the machine to figure out its own optimal settings anyways. Total racket and regulatory capture.
Right I used CPAP as an example because it bypasses all arguments about "novel technology", "drug development" cost, or "need for safety". Even an ASV algorithm could probably be implemented as a ~graduate project since it seems to be a rather basic control algorithm (today with ML you could probably do even fancier things). It's basically a piece of pure technology that could be commoditized, manufactured and sold to people for < $300 in the way smartphones are. If something as "basic" as this can't be accomplished due to the regulatory environment then it's sort of pointless talking about anything more complex like pharma drugs.
As long as the company that did the research and the medical professional gets paid the same amount. I’m completely OK with cutting out the insurance and the bureaucracy and other non-value add middleman, but the value add partners need to get paid for this to be sustainable.
Patent laws exist for a reason. It’s so people that come up with paradigm changing ideas and inventions can get rich off of it. This is something we want to maintain.
My grandfather was one of the originators of the technology that became CPAP. He did not get rich from it.
The company he worked for probably did.
> Patent laws exist for a reason
And maybe in this case they are functioning as intended.
Unfortunately, they are also leveraged to provide a moat and profits in situations where no innovation has occurred. (Eg, patents on one click shopping.)
> blantatly skirting patent laws
Can you please explain (TFA doesn't mention patent laws, just unregulated drugs)? For example, my understanding is that semaglutide is protected by patent in the US - I had assumed HIMS was including semaglutide in some of their formulations under an agreement with the patent holder, but I guess that's not correct?
Side note, I'm all for the true innovators being able to patent drugs (like semaglutide) that they put a lot of research dollars into, but seriously fuck all these additional "method of delivery" and "formulation" patents that are bullshit that just get added on later by the patent holder solely as a way to try to restrict the entry of generics into the market after the original patent expires.
Everyone can make their own compounding drug in their basements, thanks to Telegram and other hidden platforms: source sema/tirz, get bac water, mix them.
> blantatly skirting patent laws
Implied but not explicitly stated in the FDA announcement: the compounders’ real crime is not paying their protection money.
I’m generally happy to see IP disrespected.
Then you’ll eventually be generally unhappy to see no new medications come out.
China disrespects IP and has the fastest growth of anywhere, and has medications
China tries to steal IP, but otherwise has a functioning IP system including for drugs Chinese companies make.
And China’s growth is about 5% in 2025, which isn’t close in the least to the fastest (Vietnam at 17%).
And China has medications because of other countries with IP (mostly Europe and US). So if the US gets rid of IP, the. A very large part of new drugs won’t happen.
I don't care about the numbers, I care about the growth. They went from zero to high speed trains linking all major cities in a decade. They went from manufacturing cheap slop knockoffs of American products to top–of–the–line locally–designed products in about the same time. They make their own semiconductors now.
A significant change to IP doesn't necessarily mean the world stops working on things. It just pivots us to a new set of problems.
There seems to be an explosion of drugs for fat loss. No signs of slowing down.
Mochi health too
As an aside, I wonder why this wasn't discussed during the recent Greenland dispute. The US government basically legally pirate the drug, and it'd make a fairly large dent in Denmark's economy. It'd be a politically popular move too.
https://en.wikipedia.org/wiki/Government_patent_use_(United_...
There is zero need to “pirate” ozempic (semaglutide) as there are already US alternatives on the market (Tirzepatide) and about to be more (Retatrutide) that outperform all other medications in the class.
Just have insurers stop insuring ozempic/wegovy but have them insure mounjaro/zepbound and it’s a done deal. No need to even ban it.
The responds of Denmark and or worse the EU invalidating US patents in retaliation is rather dangerous.
Dangerous? It'd be awesome. Think of the cheap products and services.
I hope they abolish DMCA anticircumvention law.
Sure, but not as dangerous as a literal military showdown which was also on the table.
Lol, a military showdown where a few hundred people are killed might be horrible.
Leave the US with an island it doesn't recognize as its own (because Congress wouldn't) and that isn't recognized as US by most of the rest of the world.
Would economic ties between the US and Europe be broken as a result? Probably, but maybe everybody else decides that this will be resolved peacefully in the UN. And the can is kicked down the road, until Trump kicks the can.
Because ending economic ties between Europe and the US would mean a massive depression on both sides. Massive assets lost and written off. Goodbye pension.
Economic meltdown might be worse than a military showdown in the Arctic. Casualties from an economic conflict would be worse.
Two can play at the game, and the EU was probably closer to starting it.
The EU trade bazooka measure (Anti-Coercion Instrument) allows the EU to legally suspend patents, copyright, etc. if a member state is threatened, for example using tarifs. Which the US was a actively doing.
At the end of day, it doesn't matter the Danish government cannot surrender. Following WW2 it was made illegal for the government to do so. And voters would never support, not would Trump have the patience for Danish constitutional changes.
I'm quite convinced that:
(A) An invasion would have been a shooting matter. Even if the shooting would eventually come to an end.
(B) Denmark and most of EU and large parts of the world would never recognize an annexation.
(C) Congress in the US wouldn't recognize the annexation.
(D) EU and US would be both have entirely unnecessary and massive depression as massive assets would be seized or written off.
(E) Russia and China would be thrilled.
It was an allround shit show.
Trying to go further would have upended economic ties across the Atlantic. Causing massive economic depression on both sides.
But at the specific measures of parents: HUGE parts of US economy is Intellectual Property -- how dumb would the US have to be to declare IP laws invalid?
For comedic relief on the GLP-1 issues, highly recommend "South Park: The End of Obesity" special.
https://en.wikipedia.org/wiki/South_Park:_The_End_of_Obesity
Ozempic lost its patent in Canada and a generic might be approved there soon.
It is wild that it took until 2026 for this to happen.
In the late 1990s, when my friends wanted mushrooms or 5MEO-DMT, they'd order from "Poisonous Non-Consumables" catalogs. Today, people are literally doing that (same words, even!), but for the next iteration of GLP1 drugs not yet on the wider market. Compounding pharmacies are selling "research chemicals", like in Bitcoin Mining Profit Calculator: Gaiden.
Compounding pharmacies are selling compound, not "for research only" peptides. That's a different thing, even if they probably get the API (drug itself) from the same sources.
I think this is compounding pharmacies selling legit semaglutide (or tirzepatide?), but doing the packaging (dilution in water) themselves. No? I don't think Hims is selling RCs. They're violating Novo's (or Lilly's) patents.
It is wild to me that compounding pharmacies continued to sell these in violation of patents even after the expiration of the FDA supply shortfall status last year -- but I suppose there's so much money in it they don't want to give it up.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-c...
Compounding pharmacies are getting the raw API from China. Some of them are getting it from FDA registered facilities in China. Some are not.
It should be more or less the same thing as the legit stuff, but it is made with a different process, with different excipients, etc. For those going the more legit route, FDA registered still does not mean FDA inspected or that the FDA has signed off on them as being a reputable manufacturer.
There has also been cases of compounding pharmacies offering reta and other unapproved peptides, resulting in the FDA sending lots of angry letters to state pharmacy certification boards.
> There has also been cases of compounding pharmacies offering reta and other unapproved peptides
Can you elaborate more on this? I hadn't heard about it.
https://lengealaw.com/fda-warns-companies-over-compounded-re...
There is no way for a compounder to acquire “legit” semaglutide or Tirzepatide as novo and Lilly are the sole manufacturers of it using the FDA approved process.
Every other source is acquiring the APIs from China and effectively buying from the same sources that the random sites selling a vial of lypholized “research chemical” powder are getting it from.
The huge compounding companies might skip the lypholization step and mix it directly due to cost savings at scale, but it’s effectively the same sources you could buy direct from China from if you spent a bit of time researching.
and the end result of this action will be every neighborhood having a guy who orders the peptides from overseas and mixes it into a liquid with a net reduction in safety for millions
People are getting retatrutide from random websites (not what’s being shut down here) not from compounding pharmacies.
Totally fair point. I'm just surprised how poorly regulated this stuff is.
Hard to regulate. A lot of the retatrutide sold today is marketed on Discord & Telegram groups and paid for with crypto. It is infeasible for customs to open every last package entering the US, so this avenue will continue to work. The only gov't that could realistically stop it (for a while at least) is the Chinese. And they do, occasionally, shut down a manufacturer for a while. Though not because they are shipping GLP1s to the states.
The regulation is pretty clear? We just don't choose to blackhole shady foreign (in this case, Chinese) companies from the American internet as a matter of policy. And cannot effectively screen all imports.
It’s regulated quite tightly. But if you can’t shut down the illicit street drug market you aren’t going to be able to shut down the illicit make-your-life-better black market either.
I think what’s happening now is about right. FDA approval process for the vast majority of people, and make those who want to play drug astronaut biohacker find it via underground methods. No reason to crack down super hard on such folks since the societal impact is likely net positive - unlike fentanyl or what have you.
Perhaps there could be better enforcement for the folks being totally blatant about it as it risks going “mainstream” and hitting people who don’t have informed consent, but I imagine that’s coming as law enforcement catches up.
The real question is will there be any ban on ads from gray/underground suppliers that openly advertise on Instagram? Or will Meta simply allow that to go on, exposing a lot of people to potentially harmful concoctions?
this was bound to happen with the number of compounding pharmacies getting into the glp-1 game. from a risk side, it’s a total mess it’s basically impossible for insurers to model long-term liability when the supply chain for these drugs is a black box. fda had to drop the hammer before the claims started flying.
The compound pharmacies are the leeches I have the least amount of sympathy for. While Lilly may gouge on the price, at least they can claim to have invented the drug. Some compound pharmacy buying $20 worth of API from China and selling it reconstituted for at least 10x that is just raking in huge profit, and they did none of the R&D.
What the FDA will probably have trouble cracking down on are the vendors selling lyophilized peptides direct to the public. And the number of people going that route goes up dramatically over time.
Who are these unscrupulous vendors selling direct to the public? Please name them so I can avoid them for my own personal safety.
The Atlantic did a write-up in December [0] about retatrutide availability and they named at least one well known vendor (who also sells tirzepatide, semaglutide, and all the other usual peptides). Not the cheapest vendor, but well known, does the batch lyophilization in the US, still takes credit cards, and gets pretty solid group test participation due to their popularity. And if you know how their pre-sales work, the price premium isn't too terrible, worth it for the test participation IMO.
If you want to know who else to avoid, join the Discord the vendor links to from their web page and ask around in the general discussion topics, people will share.
[0] https://archive.ph/n0daP
> does the batch lyophilization in the U
Nexaph does not lyophilize in the US despite Cain's claims - if you're buying from Nexaph, do so because they're popular and well tested by 3rd parties, but not off of anything they're saying about themselves. Hell, just go to the About page and you can find an artifact from back when Cain was lying about Nexaph being a chinese pharma company that had mRNA vaccine production experience.
That's also why the "presale" periods are cheaper - just letting them know how many vials to put in an order for.
I agree such claims should be viewed skeptically. The aspect of SNP that appeals to me is the excellent test participation. It’s basically just a big, reliable group buy. I shop other places too, but I’ve been burned a couple times.
We've been hearing these claims for a long time that they're going to crack down soon.
I thought the pill form was actually pretty high tech to get the peptides through the digestive system. I don’t see how a compounding pharmacy would be able to produce it. Anyone know?
That’s part of the FDA scrutiny, it’s likely the Hims/Hers pills wouldn’t have much bioavailability, yet marketed as “same active ingredient”.
Oh no next you're going to tell me they're coming after the gas station dick pills.
Is there a cash price for getting the government to shake down your competitors, the way there is for pardons ? Or is this type of service only available in exchange for equity stakes?
And India wins again!
There's a reason the major Indian generics manufacturers like Cipla have partnered with Ely Lilly [0] and Novo Nordisk [1] for exclusivity deals for GLP branding and IP even though it isn't required outside the US.
Keep screeching about H1Bs and offshoring while sweetheart deals are signed with the Trump admin [2] by lobbyng with the right leverage points [3][4][5][6] and threatening the right GOP ruled states with tariffs [7][8].
Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back.
[0] - https://www.reuters.com/business/healthcare-pharmaceuticals/...
[1] - https://www.reuters.com/business/healthcare-pharmaceuticals/...
[2] - https://www.whitehouse.gov/briefings-statements/2026/02/unit...
[3] - https://www.trump.com/residential-real-estate-portfolio/trum...
[4] - https://www.trump.com/residential-real-estate-portfolio/trum...
[5] - https://www.trump.com/residential-real-estate-portfolio/trum...
[6] - https://www.trump.com/residential-real-estate-portfolio/trum...
[7] - https://www.daines.senate.gov/2026/01/20/daines-travels-to-i...
[8] - https://governor.iowa.gov/press-release/2025-09-16/gov-reyno...
[9] - https://www.bloomberg.com/news/articles/2025-12-11/india-dra...
[10] - https://www.wsj.com/business/energy-oil/big-oil-is-offshorin...
[11] - https://www.bloomberg.com/news/features/2025-11-11/trump-s-h...
> Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back.
“This is not the flex you think it is.”
But thanks for keeping us informed.
You're welcome!
If you don't value IP and knowhow that's on you. Every piece of knowledge is valuable no matter what.
China did something similar 15 years ago when it was where India is today.
We also know how little it costs to lobby the US. Maybe the Chinese were a bit right - it's a bit like the late Qing period.
Given how transactional this administration is, you can be confident that one set of companies donated to the administration or enriched the Trump family somehow, and the other set is facing regulatory attacks.
;) - https://www.reuters.com/business/healthcare-pharmaceuticals/...
What culminated these past 2 weeks will be a great FT Big Read to participate in later. Years of work.
HIMS has known this was coming for a very long time. How much has the CEO cashed out with ? I think i saw 133 million. Sounds criminal. Where is the Occupy Wall Street movement when shit like this happens?