This is very easy to explain. Anthropic outlines some limitations in their terms of service. Palantir accepted those terms. The DoD did not.
OpenAI claims their terms of service for DoD contain the same limitations as Anthropics proposed service agreement. Anthropic claims that this is untrue.
Now given that (a) the DoD terminated their deal with Anthropic, (b) stated that they terminated because Anthropic refused modify their terms of service, and (c) then signed a deal with openAI; I am inclined to believe that there is in fact a substantial difference between the terms of service offered by Anthropic and OpenAI.
Yeah, it never made sense when Sam immediately said that they had the same constraints yet de DoW immediately agreed with that.
From what I can see, OpenAI’s terms basically say “need to comply with the law”, which provides them with plenty of wiggle room with executive orders and whatnot.
Are you sure about that? Every information I’ve seen suggests that the DoD has been using Anthropic’s models through Palantir.
My understanding is that Anthropic requested visibility and a say into how their models were being used for classified tasks, while the DoD wanted to expand the scope of those tasks into areas that Anthropic found objectionable. Both of those proposals were unacceptable for the other side.
Wasn’t the trigger for all this what happened with Maduro earlier this year? From what I understood, Anthropic wasn’t very happy how their systems were being used by the DoW through Palentir which caused this whole feud.
“We’ve actually held our red lines with integrity rather than colluding with them to produce ‘safety theater’ for the benefit of employees (which, I absolutely swear to you, is what literally everyone at [the Pentagon], Palantir, our political consultants, etc, assumed was the problem we were trying to solve),” Amodei reportedly wrote.
“The real reasons [the Pentagon] and the Trump admin do not like us is that we haven’t donated to Trump (while OpenAI/Greg have donated a lot),” he wrote, referring to Greg Brockman, OpenAI’s president, who gave a Pac supporting Trump $25m in conjunction with his wife.
I can see how being able to bring your chats with you would be appealing. But the truth is that context rot is real, context management is everything, and more often than not stating from a blank slate yields the best results.
That being said, if you have a library of images or some other collection artifacts / assets indexed on their servers that is a different story.
I have multiple years of extremely dense, technical design and planning conversations locked in the ChatGPT web interface.
Hearing that starting from a blank slate yields the best outcomes is sort of like hearing extremely wealthy people talk about how money doesn't make you happier.
Why not use Claude Code from the cli and follow along in your IDE? I did not quite believe when people were telling me or understand what I was missing until I tried it, but after trying that set up I am convinced that it is superior. I don’t have any hard data to back it up, but it feels much more capable that way.
AFAIK the claude vs code plugin uses claude code under the hood.
I recent switched from vs code copilot to open code and I kinda miss it. Just selecting text and directly asking the chat. Or seeing the generated code in the ide to accept it reject it. It's neat.
Looks like the statistical geneticists have jumped the shark with this one. This big problem here is that their endpoint (chills) is poorly defined, reported by subjects (and thus highly subjective), and not measured using any type of validated instrument. So I question whether they might be fitting a model to noise here.
In the land of drug development patient reported outcomes, even when captured with meticulously designed instruments in prospectively designed clinical trails, are notorious for being noisy and confounded by the placebo effect.
I had a similar experience in my genetics class in grad school- the professor explained that children of musicians were more likely to have perfect pitch, hence it was a genetic trait. Some folks suggested that perhaps it was possible that children of musicians were subjected to lots of labelled and unlabelled training data (musical notes) making it "environment" rather than genetic.
I pretty much figure from the title it's self reported and yep: "We gather self-reports from a genotyped sample of thousands of partly related individuals from the Netherland".
And the author summary goes on to state: "Many people experience chills when listening to music, reading poetry, or viewing art. Yet not everyone feels these reactions in the same way.". So the subjects aren't even self reporting the same thing.
Fine, but this is the land of genome-wide association studies. I am unaware of any overlap, considering that such 'GWAS' studies require tens or hundreds of thousands of participants to get any definitive signal... Such work is the nature of statistical genetics.
> So I question whether they might be fitting a model to noise here.
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?
What about drugs that were initially prescribed, but have to be taken for a long time?
A long time ago I had a Lexapro prescription. This is a very, very common drug and is on the list of the WHO's essentials for bootstrapping a healthcare system.
Then I quit my job and spent a few months unemployed. I was no longer seeing the psych who prescribed them and I was not covered by health insurance.
The last few refills my prescription had? Walgreens bumped the price to $200 a bottle, and unless I paid another doctor there was no way to keep taking the medication I'd been on for two years.
Mind you, this drug is old and generics are CHEAP. I've also got all the knowledge I need to take it safely because I have been.
Instead of doing that, I made the decision to quit rather than deal with the doctor mafia. We let people buy industrial chemicals on the Internet and trust they're not gonna kill themselves with it, but somehow my situation was an unacceptable risk?
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.
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.
When dealing with depression I suffered ED. So I looked at Hims.
They have a fairly cavalier attitude to medication administration at best - the goal is sell, sell, sell.
I filled out the questionnaire on symptoms prior to my virtual physician interview...
"Based on your answers to questions 3, 4 and 8, this would not meet the criteria for prescription. You would need to answer differently. Would you like a minute or two to review your answers for accuracy?"
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.
Sure, and Novo spent 2M last quarter on lobbying. Nobody in this industry comes out looking wonderful. But the compounders who are meeting demand are not Hims & Hers.
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 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.
Not quite, the physicians or NPs or whomever will actively coach you on how to correctly answer their (very simplistic) questionnaires to get the drug you want. And if you fill it out incorrectly, they'll tell you what to correct and offer you a chance to "review your answers for accuracy".
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.
In Germany, I cannot buy ibuprofen, paracetamol (acetamenophen), or ASS (Aspirin - TM Bayer) at a grocery or "Drogerie" (place to buy cosmetics and other health & beauty items). I have to go to a pharmacy and ask for it at the counter - truly "OTC", and they're expensive compared to their US retail equivalents. That said, most common prescription drugs are significantly cheaper in Germany than in the US, even without insurance.
Antibiotics are definitely prescription-only, as are birth control and morning after ("Plan B") pills. I was once able to talk an airport pharmacy into selling me an albuterol inhaler without a script in hand, but only when I promised that I'd had it before and explained how to use it, and that I was about to get on a flight.
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.
Their industry is only shady because lots of fairly harmless drugs require a prescription. Viagra, the GLPs, and minoxidi+finasteride come to mind.
For a long time in this country, a flesh-eating bacteria infection required an amputation. In Russia and Eastern Europe, it was easily treatable with bacteriophages and people normally kept their limbs. There's still no process for approving a bacteriophage treatment in this country for general use.
Our system is ossified to protect big pharma and doctors. Liberalization is needed; hims and their like need to be regulated, but with a lighter touch than the current requirements.
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.
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
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.
> 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.
> 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.
> Please engage with the substance of the argument put in front of you.
Back at you bub. My original comment was addressing why a quote from the guy who would be most affected by drug prices changing is hog wash, and you skillfully dodged my whole point to talk about R&D, investments and revenue. I didn't write my comment to dive into those things, I wrote it to point out that Pfizer's CEO would say anything if it means his company will get more money.
Your point being that you don't trust the words of a pharma CEO?
Fine! Why is that relevant to me?
Just because you're starting from the prior of "pharma CEOs are liars" doesn't mean everyone else is. Some people find it quite helpful to hear from the most powerful and most informed people on issues they want to learn about, even if you have to discount them due to conflicted interests (spoiler alert: nearly everyone who's well-informed on an issue will have some type of conflict to be discounted).
Evidently you are fine writing the words of Pfizer's CEO down to zero value, which is fine!
That's why I provided an alternative path by which applying your own critical thinking skills would get you to the same conclusion.
"Applying basic logic gets me to a similar conclusion as Pfizer's CEO, but Pfizer's CEO is a liar and conflicted and can't be trusted, therefore... [ ??? ]"
Edit in response to your edit: Don't act as if I introduced revenue/investment/R&D/etc after you raised the issue about Bourla's quote. That was the entire basis of the conversation from the start. Profoundly low-quality contribution to just chime in with "pharma CEO is conflicted." Yeah, everyone is aware of that. That's why there's an entire comment around the quote.
Literally you yourself said a few comments above that you "doubt Pfizer et al will just outright stop selling medications to France." It sounds like you don't trust his words either, so why are you going to bat for this guy?
> That's why I provided an alternative path by which applying your own critical thinking skills would get you to the same conclusion.
To be clear, the only thing I've taken issue with here is his own words and how you've quoted him. I don't believe I've said anything regarding your overall position on drug prices and pharma profits, so it's weird that you're attacking me like I've specifically taken a position against it.
Lmao imagine thinking that separately deriving the same conclusion using such sophisticated economic knowledge as “how prices work” was equivalent to “taking someone’s word at face value.”
You can derive the same conclusion yourself! As stated over and over, much to your chagrin and denial, because “pharma bad.”
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:
At some point when the compounding was ramping up it was difficult to get the drugs even with a prescription and being willing to pay the full no-insurance price. Nowadays you can mostly get it, but insurance coverage is spotty. Because of weird incentives, the no-insurance prices of drugs are highly inflated so the amount that they cost isn't a realistic price for most people to afford. The manufacturers offer coupons but the conditions on them, and the fact that they still leave you with a pretty inflated price tag means that the compounded versions like what HIMS sell are the most cost effective option for a lot of people - it's still highly marked up, but to a level that is manageable for way more people.
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
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.
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
As stated elsewhere, the competition in pharmaceuticals does not live (nor should it) in cost of production. It's in R&D. So no, pharma companies cannot systematically dump billions of dollars into developing new medical breakthroughs and then race to the bottom on production efficiency with unregulated pill mills from every backwater on the planet with an Internet connection and a parcel service.
At least, not if you want science to move forward in your lifetime. As a person who has used, currently uses, and will in the future use medicines, I really prefer that we don't eliminate the financial viability of efforts to continue making better ones.
Oh boy, are you going to be in for a rude awakening. Might I ask what is your exposure? Because this does not line up with what I am witnessing day to day at all.
This type of commentary reminds me of the people during the dot com boom who were adamant that e-commerce was all film flam and would never take off.
Consider that it is possible that both (1) we are in an investment bubble and (2) we are underestimating the long term impact of LLMs and perhaps mispredicting where they will land.
In what way is the long term impact of LLMs being underestimated? If anything, it seems that it has been overestimated in the past years and that something other than LLMs will be needed to reach the original scaled LLM hope of AGI.
Back when the Internet was America online and some CGI bin perl scripts, there were a lot of very lofty things said about the potential of the Internet in the future. I don’t remember any of them predicting the power of the tech would have over business, politics, media, and hours of every single day for billions of people. Even without AGI, it’s quite possible that were still underestimating. The effects of predictive, probabilistic computing 20 or 50 years from now.
The internet alone didnt change sh!t. Without smartphones, unified app stores, cellular network innovation et al internet traffic would not be so high.
Funny how people leave this stuff out. Yawn. Basic simpleton analysis and takes.
The Internet created the backbone that allowed for rapid experimentation in communications technologies, and created the ability for anyone to create and share technologies and reach a huge audience very quickly.
Without the Internet, most consumer electronics would have been far more expensive to build, and would have been strictly controlled walled gardens, but the Internet in general and the Web in particular allowed so many inventors to flourish. Ever since that Genie was let out of the bottle, corporate and government interests have been trying to put it back in, and most companies are trying to build and reinforce walled gardens under the banner of unified app stores that extract insane rents.
That is such a bummer. At the time, it was annoying and I groused and grumbled about it; but in hindsight my reviewers pointed me toward some good articles, and I am better for having read them.
Hotels are not platforms. No network effects at play. The idea of ban is to push teen DAUs below the critical mass necessary for self sustaining retention and growth.
Sure teens will still figure out a way to access when they really want to, but they won’t be be the same level of peer pressure.
I feel like this is the strongest argument in favor of the bans. I am not sure it will be effective or is the most effective way to go about it. I am curious to see the data that comes out of Australia in a few years.
I don’t know what this comment is, but it is totally missing and underselling Chinese capability in biotech. They are not coming to push TCM. They are coming to dominate high end drug discovery and development. Perhaps they are looking to dominate both the high end and the low end bro science segments of the health market…
I didn’t claim that Chinese biotech isn’t great. I am sure that like most Chinese research, engineering etc it is world class.
But there is evidence from all around the world that the Chinese government is actively pushing TCM, that they push it with the WHO, and that they are actively trying to open up markets for TCM “pharmaceuticals” and practice in African and other nations.
I put links in some of the sibling comments showing this.
Hi, would there be a a way to contact you? I have an email in my profile. Would love to exchange some thought on that.
China is not only a strong player in biotech. Their capability in chemical R&D and market transfer is very strong, too both in small and industrial scale. And let’s not speak about electronics …
OpenAI claims their terms of service for DoD contain the same limitations as Anthropics proposed service agreement. Anthropic claims that this is untrue.
Now given that (a) the DoD terminated their deal with Anthropic, (b) stated that they terminated because Anthropic refused modify their terms of service, and (c) then signed a deal with openAI; I am inclined to believe that there is in fact a substantial difference between the terms of service offered by Anthropic and OpenAI.
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