Lowe has a point, but the FDA has painted itself into a corner by (a) forcing up the costs and the various bureaucratic demands associated with clinical trials, (b) allowing drug advertising , but then forcing those comical "may cause death" disclaimers, both of which have become totally ubiquitous, and (c) inconsistently following its own rules, and in some cases flouting its own rules.
At this point, broscience is considered no less valid than actual clinical trials, and the FDA should blame itself for this. Not "human nature being what it is in this fallen world" in a sort of general or abstract sense.
Another point I could raise is that telemedicine has turned the entire prescription system into nothing more than a parasitic middleman/gatekeeper.
FDA reform is very badly necessary. That ought to come before harsher enforcement, and I think that much of the populace already intuitively understands this.
People want GLP-1 drugs. They can't get them without a prescription. They pay $$$ to a "telemedicine" "doctor", recite a list of well-known symptoms, and buy the prescription.
The system is that you can't buy these drugs without the piece of paper, and the piece of paper is basically something that anybody can buy regardless of whether or not they actually need the drug. Wanting it is usually enough.
I think access is a good thing. The issue isn't with telemedicine but the fact that there's a prescription wall for helpful meds like GLP-1 in a country where we've failed people by creating one of the worst food environments.
Also, most doctor's visits aren't any different from getting it if you want it except it's gated on the mood/attitude of the doctor, maybe your ability to sell some sob story. And then you book a different doctor until you get it. Telemedicine just makes the process easier an arbitrary system.
GLP-1 prescriptions are easy to get in the US. It's filling the prescription that is the problem, because insurance rarely covers it and it is beyond the disposable income of most Americans.
The prescription hurdle is absolutely necessary -- these are not drugs that anyone can safely take without guidance. It's the price that needs to be fixed.
I actually think "informed" is almost definitely defined already. Doctors already need to provide informed consent, so I think it would borrow from that. As for "egregious", I also suspect that this is understood already in a similar vein, but perhaps not - I'd suggest that this is effectively "would near definitively cause imminent harm".
FWIW I do not think that most people agree with this.
There's a lot of definitions for both of those words.
I can tell you that the conversations I've had with people who take these drugs from telehealths or from med spas -- they generally don't understand how these drugs work, what the risk profiles, are or how dosing should be managed. There's a lot of misinformation going around about all these drugs.
"immiment" is a different word than "egregious" isn't it? Malnutrition, cancer, and death are pretty egregious as well, even if they occur maybe months or years in the future, aren't they?
Literally, enough people are fucking this stuff up that we have pop culture references to it: "ozempic face". Losing weight this rapidly is unsafe. Sure, a lot of people might consent to the idea of rapidly losing weight, but there's nothing "informed" about it.
> There's a lot of definitions for both of those words.
Sure. I don't think that that implies we have the right system currently or that we can't come up with good definitions. And again, "informed" is almost definitely already an understood term in medicine since "informed consent" is already understood.
> they generally don't understand how these drugs work, what the risk profiles, are or how dosing should be managed.
That's fine. I don't think they have to understand how they work. They have to have the risks conveyed appropriately to them. They might make a call that's ultimately harmful. Adults can do that, they should be allowed to do that.
> "immiment" is a different word than "egregious" isn't it?
Well, yes. If I had defined "egregious" as the same word, that wouldn't be very helpful.
> Malnutrition, cancer, and death are pretty egregious as well, even if they occur maybe months or years in the future, aren't they?
Not really. Things that take years to happen are a lot less serious, especially as they can be monitored for. But again, this can all be explained to the patient. I'd say the bar for "egregious" should be very, very high. When in doubt, give patients the power to choose.
> Literally, enough people are fucking this stuff up that we have pop culture references to it: "ozempic face". Losing weight this rapidly is unsafe.
That isn't compelling. How many of those people are getting ozempic from a nurse practitioner at one of these compound pharmacies? If anything, I'd bet that doctors taking the time to ensure patients are informed would lead to a reduction here.
I know a lot of people on GLP-1 meds and even took a dose myself out of curiosity.
You take a dose every two weeks. And if you accidentally double dose because you misread 1U to mean 1 dose, it just gives you some nausea.
Are we going to pretend it's hard to take this drug now too? Or that the doctor has some magical insight into your getting-on? Remember to eat. That's it. I guess a few people might need the doctor to go "you're eating, right?" but I don't believe in infantilizing everyone over that.
Weekly, if you are following guidelines correctly. The half-life of most GLP1 peptides is 5-6 days.
I otherwise agree with your point entirely. Though anecdotally, I may have given my brother-in-law a single small vial of tirzepatide at his request so that he could experience it, and the results were ... not good. Turns out he's an idiot, thought that 'more is better', 'drinking enough water is for weenies', and 'I am not an alcoholic even though I get plowed most evenings.' All against my very specific advice on how to give it a try. Whoops.
My fault, yes, I should have realized he was too stupid to do it without adult supervision. He made himself so sick he almost went to the ER. Nothing really dangerous, of course, tirzepatide is pretty safe stuff, but overdosing on it can make you feel very shitty for a few days until the blood concentration drops.
> Or that the doctor has some magical insight into your getting-on beyond a couple questions they ask you in your visit? Remember to eat. That's it.
Apparently we have forgotten people who died from eating disorders (previously called anorexia nervosa)?
There is a VAST difference between someone who weighs 300lbs asking for GLP-1 to combat morbidity and someone who is barely 100lbs asking for a GLP-1 to take off weight for bikini season. That's what needing to ask a doctor for a prescription is for.
One dose is one thing -- but there are other risks that can lead to complication or death here if taken improperly for a long period of time. Musculoskeletal issues, cardiac issues, thyroid issues, etc.
Additionally, getting the correct dose is not straightforward for a layperson as it is for other OTC drugs with standard doses.
There are similar risks, and probably more likely, to all sorts of consumables that aren't regulated at all. It is reasonable to ask whether the prescription regime for GLP-1s makes sense. It isn't the only substance posing that conundrum! Ondansetron is OTC in a lot of countries, but not in the US, Canada, or UK. But ondansetron is arguably less dangerous and more helpful than pseudoephedrine.
Pseudoephedrine, of course, isn't BTC because it's dangerous to take or complicated to dose. It's there because of the war on drugs. But I do agree that not all drugs are regulated appropriately. Marijuana also comes to mind.
I do think GLP-1s are just about right. It is appropriate to take them under personalized professional guidance.
Right, and I actually see the logic of that (unlike virtually everyone else on HN, and let's not rekindle that debate; the search bar avails). The point is you don't need a prescription to get it. People might be better off if GLP1s were also BTC. Hard to say!
Certainly you can abuse a GLP1 and get yourself very sick, or not abuse it and still end up with pancreatitis. But smoking and alcohol presumably cause way more cases of pancreatitis, and you don't need a script for a handle of Popov.
There used to be prescriptions for alcohol products and cigarettes have been sold as medical products -- the reason we accept them in society today is not because we think they have relative less risk to other things, but that their acceptance as recreational vices outweighs the harm that we know they cause.
> smoking and alcohol presumably cause way more cases of pancreatitis
Indeed. In fact, I think just recently there were updated studies for at least one of the popular GLP1s that disclaimed entirely a link to pancreatitis.
To be clear I don't think it's actually reasonable to suggest GLP1s should be OTC in 2026. Were that to happen it would be part of a regime change in drug regulation that I'd categorically oppose. The timeline on GLP1s (unlike Zofran) doesn't support it. There are arguments for why your doctors would want to know that you're taking it, and on what schedule. But it should be extremely easy to get.
Agree, it does feel like a class of medication that deserves more control than OTC would provide. I do think it should be largely voluntary, however, with doctors expected to provide it unless there is a specific contraindication that would make it harmful.
It's that your health care system the doctor is in builds a few extra hurdles. I've talked to my (non-tele) doctor about GLP-1. I've tried losing weight before, with her, there's a long history.
To get approval, between the hospital my doc is in and the insurance, I need to:
1) Have a BMI of >30. Since it's only 29.5, I get to stuff my face if I want to lose weight.
2) Have six sessions with a nutritionist. Which are massively useless, their advice is roughly equivalent to reading Cosmopolitan. I know because I had prior conversations, and they're documented. But still, gotta do it again.
3) Do six months on Weight Watchers. Which is one massive scam leading you right to disordered eating. Also, I've tried for years to lose weight via diet changes, documented and talked through with my doc.
4) Before I can get tirzepatide, I have to get semaglutide for three months to see if it works. Never mind there's study over study over study showing it's slightly less effective and has massively more side effects.
Or I can just cough up the cash directly and buy from Eli Lilly, if somebody signs that receipt.
I'm fortunate enough I could afford that, so I did. (After a second consultation with my family's doctor back home - both they and my doctor agreed it was appropriate, so it's not just a case of "wanting is enough")
And after six months, my weight was in a much better region, lipid panels were much improved, other related biomarkers looked better as well - exactly as numerous studies and my doctors said one could expect.
So, as long as I cough up enough money, sure, I can bypass all the hoops. My health didn't enter the equation, just screw the poors (whose treatment for worse outcomes because they couldn't get access will cost a whole lot more than GLP-1 would've cost).
So, fuck the "prescription hurdle" and the medical system in the US with a hot white glowing iron rod right up the ass.
As for "these are not drugs that anyone can safely take without guidance", that's not really true either.
They're neither hard to take - "inject one vial once a week into the flabby part" isn't rocket science - nor does it cause massive health risks by itself. (And the hazard ratios for diabetes 2 and cardio events are so spectacularly low that they dwarf the other risks)
Yes, talking to a doc is a good idea. No, the current gatekeeping is in no way necessary.
Those are coverage requirements from your insurance company. Consider yourself lucky to even have any path to get these covered under insurance -- most insurance plans do not cover weight loss drugs under any circumstances.
The diagnostic criteria is simply (BMI > 30) OR (BMI > 27 + a weight related comorbidity like high blood pressure or high cholesterol)
> They're neither hard to take - "inject one vial once a week into the flabby part" isn't rocket science
It's not that they're difficult to administer, it's that dosage needs to be managed appropriately.
You're totally missing the point thought. The prescription hurdle effectively does not exist. It's just a paywall.
You pay your $100, get a 3 minute call with a NP/PA/whomever, and basically the robot writes you a prescription for whatever you want. The point is you pay and you get the prescription. Patient safety has nothing to do with anything.
It's cheaper for most people to get the prescription written at a PCP.
The advantage to a telehealth is not getting the prescription written -- it's that they'll fill it for cheap through a tiny compounding pharmacy that is making it, technically illegally, but are small enough to be off the FDAs enforcement radar for the moment.
I have used both my PCP and telehealth for prescription writing, never once have I used a compounding pharmacy.
It's slightly cheaper for me to use telehealth vs. billing through my insurance. The downside is it doesn't go towards my deductible of course.
The stuff you are describing are entire supply chains of a sort where you want a GLP-1 or perhaps a few other things like TRT. Those you are signing up for the drug itself, which happens to include the prescription part with it.
Telehealth can be used for any old medication you want. It removes the permission slip part of the process and replaces it with a payment gateway. If you have $75-150 you can just click some buttons and have a prescription for nearly anything you want at most a day later. This includes antibiotics, ADHD meds (getting harder on these), certain benzos, etc.
HIMS/HERS/etc. and their smaller ilk are super popular, but they are the tip of the iceberg.
Telehealth providers can certainly work with compounding pharmacies but not necessarily. If you are looking to get a prescription for Diazapam you are going to be getting that sent to your local Walgreens or whatnot.
> It's slightly cheaper for me to use telehealth vs. billing through my insurance.
How? Usually PCP visit are cheap and everyone gets one for free.
> HIMS/HERS/etc. and their smaller ilk are super popular, but they are the tip of the iceberg.
> Telehealth providers can certainly work with compounding pharmacies but not necessarily.
Yeah I’m aware there are a whole host of services telehealths provide but the primary reason people use them for GLP1s is to avoid the name brand cost.
The "perscription system" used to be that you'd have to go see a doctor, the doctor knew who you were, and would make decisions on what prescriptions/medications you should be given.
Due to drug advertising rules, the prescription system has been turned on its head, and the patient now goes to their doctor asking for a specific prescription.
Telemedicine took advantage of this and has effectively removed the middleman (the doctor) in many cases and you just sign-up look at a person on a camera, and get your drugs sent to you.
> Telemedicine took advantage of this and has effectively removed the middleman (the doctor) in many cases and you just sign-up look at a person on a camera, and get your drugs sent to you.
This is only true for a handful of drugs that are basically OTC already (or that have OTC formulations). Additionally, telemedicine didn’t take advantage of drug advertising- that’s an odd assertion.
The system changed from the doctor deciding what drugs you should take to the patient asking for the drug by name from the doctor.
I think this enabled telemedicine to work in the way it does not. The patient says "I want wegovy" and the telemedicine platform says "ok, here you go".
Would telehealth pill-pushers exist without this mentality?
Go to doctor, get prescription for restricted medicine, pick up prescription.
If you can call up a teledoc and they give you a prescription based on your description why could you not just go buy the meds yourself without a prescription. You have essentially diagnosed yourself and just asked the doctor for permission to buy the drug you want.
That’s… not how actual telemedicine works. That’s how jackasses “disrupt” healthcare for very specific drugs. Mostly birth control, ED meds, and various hair regrowth meds.
It’s really clear that some of you are really mad about something you don’t understand.
I take certain medications--nothing interesting, nothing controlled, nothing abusable. I have to deal with a whole thing just to get refills, because my PCP forces me to come in every time--and even that is now just a telehealth call that is annoying.
In Mexico, for meds like mine, you can just buy them at the pharmacy. There's no reason for all this nonsense.
(Edit: same PCP refused to prescribe GLP-1s early, without any scientific or medical reason not to. Delayed my weightloss by months until I found a place that would.)
> I’m curious what you mean by this. I’m not sure what you mean by “prescription system” specifically.
They basically operate as a "pay for a prescription" service.
Figure out what drug you want, google the drug name and telehealth. You will be marketed in a wink wink sort of manner over how easy it is to get them, just hours away! Then if you are not a total idiot, you answer certain questions in the right manner on the intake form, the doctor (usually NP/PA or similar for most things) will quickly run through that and expect you to answer correctly - perhaps guide you a bit if you don't.
5 minutes later you have a prescription in the web portal and it's sent to your pharmacy of choice.
It really shows how the whole "permission slip" program is BS. I've used these services a couple times vs. my normal doctor just to save time and expense of an office visit. If I can click some buttons, have a call 30 minutes later, and be on my way to the pharmacy for $50 it's sometimes the path I take now vs. traditional route.
Someone used to the traditional doctor/patient relationship thing and prescriptions being "holy" would be shocked at how easy and gamed it all is.
Well that's a problem with the profit driven US health system (although admittedly other countries have similar problems to varying degrees) not prescriptions in general though? In particular the take home from this should be to make it more difficult to get the prescriptions not to do away with prescriptions.
So you are stating that there has been no change in how clinical trials are required to be run, and the associated costs, since the changes immediately following the thalidomide catastrophe?
Medicine doesn't really ignore nutrition, but the problem is:
1. Most people don't believe it anyway. People want to hear they can eat hamburgers and milkshakes and be healthy. Telling them "we know that gives you heart disease and cancer" does nothing.
2. Nutrition is complicated and different for every person, because everyone has different things they can tolerate. The "perfect" diet is actually worthless because it has a 0% success rate. Really, we have to optimize for how miserable people are willing to be.
3. Most people are unhealthy enough that nutrition is the least of their concerns. That sounds crazy, I know, but if you're obese (which most people are!), then priority is being not obese. Not your nutrition. I know those sound related but they're way less related than you think.
> hamburgers and milkshakes don’t give you heart disease and cancer
They absolutely do, particularly if you're getting most of your calories from them. If evidence-based medicine doesn't convince you, uh, hamburgers and supermarket milk tends to be processed.
They absolutely do not, unless you’re getting too many calories.
Individual foods are—with some exceptions—neither bad for you nor good for you. A healthy diet can occasionally include doughnuts, and milkshakes. Your overall diet is what matters.
Most green vegetables you can eat unlimited amount and stay healthy. They are absolutely "good" food. (Please don't reply with something trite like "oh, but what about the pesticide residues?") The same can be said for high fiber (soluable and insoluable) fruits like apples, oranges, and bananas. As long as eaten whole (minus skin for oranges and bananas), it is almost impossible to overeat these and they are absolutely "good" foods.
Sure, they are not mercury-level toxic. However, these recommendations are for people who consume way too much of these dishes, and it's a safe assumption that this is the case for a significant part of the population.
Sure. We’re saying roughly the same thing. For most Americans, hamburgers cause heart disease because we don’t exercise enough or eat enough plants. If you’re backpacking twenty miles a day, sure, eat whatever, you won’t suffer inflammation or obesity from it. (Though you may run nutritional deficiencies. And you’re building bad habits for when your activity necessarily tapers off.)
Hamburgers are not causing heart disease and diabetes for most Americans. Bad diets loaded with too many calories, too many saturated fats, and too many simple carbs are.
Messaging matters. When you tell people hamburgers and bacon and everything they love are bad, they stop listening, give up, or just eat some other junk that wasn’t prohibited. When you tell them some foods are good, they start buying into superfood marketing.
Diet is the only thing that matters. Lots of veggies are extremely useful because they add bulk without adding calories, and along with fresh fruits are great sources of fiber. Cheeseburgers can only come so often because they’re extremely calorie dense and send enormous reward signals to your brain.
Give people the tools they need to thrive, not just “don’t eat these specific bad foods, eat these specific good foods”.
Agreed (remember where I said overeating). Non-homogenized gently pasteurized milk/cream with minimally processed honey or maple syrup, and fresh ground hamburger, all of which which you can definitely get at supermarkets by the way, are much better for you than Big Macs and McFlurries. Ask yourself why? It’s obviously not “because they aren’t hamburgers and milkshakes”
I agree 100% with your follow-up. In the last 30 years of medical research, I do not recall anything but negative health results from eating red meat (beef). The real culprit is saturated fat. It is the cigarettes of food. There is almost no healthy level to consume, so keep it to 20g per day or less.
Reading this chain of responses from the original is making my internal bullshit alarm (Brandolini's law) go "wee woo wee woo".
> The real culprit is saturated fat. It is the cigarettes of food. There is almost no healthy level to consume
Not at all an expert, but from what I understood saturated fat isn't particularly good but it's not “no healthy level to consume” either (fortunately because you practically cannot avoid them).
I think you're confusing them with trans-insaturated fat (which I don't think are as bad as cigarettes either, but are still bad).
Everything is a carcinogen. Even water. Dose matters, and most of the "omg zomg causes cancer if you eat it!" dietary nonsense purposefully omits absolute amounts or base rates, lest you realize it's actually as likely to give you cancer as smiling at people.
I don't know what else to tell you. Except maybe that if one gets this single concept, that quantities matter, it becomes immediately apparent why most of the "healthy eating" / fitness fads is just pure bullshit.
Depends on the nutrients that comprise them to the extent they contain a lot of omega-6 or not. Not heart disease so much but the other killer - might as well mention in this context. 'A high omega-3, low omega-6 diet with FO for 1 year resulted in a significant reduction in Ki-67 index, a biomarker for prostate cancer'. https://doi.org/10.1200/JCO.24.00608.
Also Prostate Cancer and Prostatic Diseases (2024) 27:700 – 708 'Our preclinical findings provide rationale for clinical trials evaluating ω-3 fatty acids as a potential therapy for prostate cancer'.
Seed oils are not as bad as painted but some caution is needed given for instance the industrial processes used to bring them to market sometimes. Plus the way the oils are cooked when they create free radicals. This is not nonsense.
You don’t have to wonder. It’s public record that 45% of the FDA’s budget incomes from user fees that companies pay when they apply for approval of a medical device or drug.
In the drug division specifically, the number is about 75%.
Naive question: What is wrong with this? Lots of gov't agencies in highly developed countries operate similarly. User fees account for a non-trivial portion of department budgets. A more simple example: Should the Dept of Motor Vehicles (DMV) charge zero, low, medium, high, or infinity money to get a driver's license?
In principle there is nothing wrong with it, as long as the FDA or other testing body retains an appropriate impartiality or lack of bias (perceived or real). The issue, however, would be a lax system that allows revolving door access between the approval body and the industry that is seeking approval. Ironically, the common refrain becomes that their industry specific knowledge means they "must" be the only possible candidates for the role, which just so conveniently starts the revolving door swinging between leadership in industry and upper roles in regulatory bodies.
All but one I have had did not, and his suggestion to eat something other than cheeseburgers every day was less than revolutionary.
When I brought it up with other physicians the answer was always that I probably get all the nutrients I need from regular food. Whatever that may be.
Dietary changes have helped me feel better and healthier and perform better, and a few vitamin and other supplements as well.
I’m not selling a lifestyle. I’m criticizing the foolishness of a food and drug industry based in the idea that preventing death or lifelong disability is sufficient.
Nutrition is run on fads - see whole fitness and healthy food bullshit. Nutrition supplements ended up being a loophole that allows pharmacies and pharma companies to sell all kinds of random stuff that they can't or don't want to, show is safe, or doing anything at all.
> Nutrition is run on fads - see whole fitness and healthy food bullshit.
You raise an interesting point. I watched a YouTube video recently of someone walking around a large US supermarket pointing out all of the processed foods that now claimed to be high protein. It is nuts!
I wonder what will come after the protein boom? My guess: Fiber is back because you need to "fibermaxx" when taking GLP-1 antagonists. I can remember some of the funny adverts in the 1980s of old people taking fiber supplements to "stay regular". (See SNL comedy skit "Colon Blow" for a good laugh.)
Medicine doesn't ignore nutrition, you just don't like the answers.
And it shows on the research: e.g. does creatine help muscle building? No.[1] But cue some anecdote from someone where they also changed a dozen other things at the same time but are sure it was that.
Creatine is probably the most well-studied nutritional supplement we have, and one of the most efficacious. You are presenting a single study to counter that. Not even a meta-analysis, but a single study of just 54 participants who did not exercise at all previously (from the study; "Apparently healthy individuals, with a body mass index of ≤30 kg/m2 and not meeting current physical activity guidelines of at least 150 min of moderate-intensity exercise were included. Individuals who undertook [resistance training] within the previous 12 months were excluded"). The general consensus is that it is absolutely helpful in muscle-building. See, for example [0] and [1]. Beware the man of one study. https://slatestarcodex.com/2014/12/12/beware-the-man-of-one-...
[1]: https://www.mdpi.com/2072-6643/17/17/2748 - "A total of 69 studies with 1937 participants were included for analysis. Creatine plus resistance training produced small but statistically significant improvements... when compared to the placebo."
But there's a core problem with this, in many states doctors are legally forbidden to give nutrition advice. The academy of nutrition and dietetics has worked very hard to make it so that only dietitians can provide nutrition advice. Take Ohio for example, a medical doctor in Ohio is legally forbidden and actually in jeopardy of losing their license and going to jail if they were to provide nutrition advice without a dietetics license. Dietitians are not doctors, but the academy of nutrition and dietetics wants you to think they are.
Doctors in the US receive an average of under 20 hours of training in nutrition over four years of medical school. What little they do receive is often focused on nutrient deficiencies rather than on meal planning for health and chronic disease prevention. Less than 15% of residency programs include anything on nutrition.
To become a registered dietician requires at least a Master's degree in dietetics or nutrition or a related field, and at least 1000 hours of supervised internships.
PS: before any Europeans hold this up as an example of the poor US health care system, doctors in Europe average 24 hours of nutrition training.
Aren't doctors actually exempted specifically from such regulations in almost all states? AFAIK they can actually give nutritional advice legally in nearly every jurisdiction in the US.
To your first point, if you know where to look, you can get tens of vials of GLP-1s that have much higher dosing per vial for cheaper than you can get a third of the amount on the grey market. A lot of these sites even have purity testing to soothe consumers worries that they're getting garbage. For your third point, you have the FDA limiting HGH, yet you can buy the growth horomone releasing factor peptides (tesamorelin, sermorelin, ipamorelin) after doing a simple Google search.
As for broscience, moving into peptides was a logical next step after exhausting anabolic steroid "research". In fact, I'd say that biohackers are actually behind the bros when it comes to trying various peptides out and documenting experiences.
At this point, broscience is considered no less valid than actual clinical trials, and the FDA should blame itself for this. Not "human nature being what it is in this fallen world" in a sort of general or abstract sense.
Another point I could raise is that telemedicine has turned the entire prescription system into nothing more than a parasitic middleman/gatekeeper.
FDA reform is very badly necessary. That ought to come before harsher enforcement, and I think that much of the populace already intuitively understands this.