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Comment by Sanzig | Hacker News Reader

> FDA confirmed through laboratory analyses that the “MANNERS Energy Boost,” “Round 2,” “Genergy,” and “X Max Triple Shot Energy Honey” products, purchased on www.amazon.com, contained the active pharmaceutical ingredient (API) tadalafil; and the “WeFun,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” products, also purchased on www.amazon.com, contained the API sildenafil. These ingredients are not declared on the products’ labeling. Sildenafil and tadalafil are phosphodiesterase type-5 (PDE-5) inhibitors and the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction (ED).

So Amazon was literally selling Viagra and Cialis disguised as a supplement. Wow.

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Not just Amazon, every time these "ED supplements" are tested, most of them turn out to have actual pharmaceuticals in them.

Here's a similar article from 5 years ago: https://www.wired.com/story/dietary-supplements-can-contain-...

They are practically OTC everywhere in the world. A huge pain in the add to get in the US where the MD cartel engages in rent seeking by claiming every pharmaceutical is dangerous and they need $200 every quarter to let you buy the meds at hyper inflated prices.

Well, sure, but the solution to that is to make it OTC or added to the list of medications that pharmacists are allowed to prescribe by themselves. That way the medication dispensed is still coming from an authorized and inspected facility with adequate quality control. Mixing it with dodgy supplements is not the solution.

Can we have an honest conversation about whether there's any good reason for Viagra to require a prescription?

The barrier right now is that you have to waste 2 hours and $100 to tell a doctor that you have ED. What's the point? It's not stopping anyone except people too poor or busy to jump through the hoops.

A middle ground is to let a pharmacist dispense it after going over side effects, instructions, interactions and existing conditions (without a Rx).

Yeah, I think this is the most reasonable approach. ED medication can have some nasty side effects and interactions, so a medical professional should be in the loop - but that professional could easily be a pharmacist who already has a copy of all the other Rx drugs the patient is taking.

Feels a little silly to be forced to have a chat with the lady at the grocery store pharmacy about dick pills whenever I might need them. I can just order it on Amazon apparently.

That would work. Viagra is a blood-pressure lowering drug (that was its original purpose). If you take it with other BP-lowering drugs like nitroglycerin etc, you could pass out or even die.

So some degree of oversight by a medical professional is warranted.

The pharmacist probably doesn't have a medical history. You could have a copy sent to them from your doc.

At that point we're approaching the same level of hassle as just getting a prescription, though.

My proposal would be to create a new type of rx: a "standing rx". Some form of probably-digital rx that your doctor gives you that allows you to buy unlimited quantities of the named drug until the doctor revokes it, and it's easily transfer-able between pharmacies. Digital mostly to provide a means of revoking it that doesn't involve calling the doctor every time you try to buy it, though I'm open to counter-arguments about being vulnerable to hacking.

Then you only have to go through the hassle once, and it's honestly probably easier to have your doctor check the interactions than it is to do yourself. They have nifty tools to do that kind of stuff.

I do still wonder whether it should just be OTC, though. On one hand, the interactions are easy to understand. On the other hand, I routinely see people not read or intentionally ignore the instructions on stuff like tylenol (oh it says 2? I'll take 4, because my headache is bad). The common "do we give adults agency or try to protect them from themselves?" issue.

The reason is to check for preexisting conditions and negative interactions with other medicines. Also, the barrier is even lower than what you say with companies like blue chew, hims, etc.

If we’re going to have an honest conversation, Sildenafil does have some serious potential side effects and contraindications. Googling “why does viagra require a prescription?” I get an answer attributed to Healthline: “due to these severe (but rare) side-effects, Viagra requires a prescription”. At least acknowledge that, it is a good reason.

A doc visit does take time but it neither takes 2 hours nor costs $100 for me, co-pay is still $20 I think (or maybe covered 100% once a year), and the visit might be 45 minutes when the clinic is pretty busy. There is plenty that’s messed up and wrong with our health care system and insurance, but maybe the minor hurdle of having to require a doc to check on the potential for side-effects really is justified?

Another decent reason, I speculate, is that the drug is relatively new and we don’t know the long term effects of overuse, nor all of the contraindications. If it’s available over the counter and many men use it when they don’t really need it, just because it’s available and easy, there could be dramatic unforeseen consequences. Like a lot of drugs, Viagra might be something that people look to as an easier alternative to changing habits or doing preventative work.

> maybe the minor hurdle of having to require a doc to check on the potential for side-effects really is justified?

Viagra is trivially available on the black market because many people don’t want to put up with that B.S. Antibiotics have a public interest in being gatekept; they harm everyone if abused. A similar argument can be made for addictive substances.

Merely-harmful drugs, on the other hand, can be disclaimed and, where the clinical and fatal doses are close, diluted. Beyond that, we’re manufacturing busywork.

Everything is available on the black market, that doesn’t mean regulations are BS, it means people are willing to risk breaking the law to avoid being tracked. The demand for Viagra might have more to do with being embarassed about ED or other fears than with concern about the difficulty of getting it legally. (As another commenter pointed out, the bar is extremely low when using online remote clinics.)

What does “merely-harmful” mean? What do you mean it can be disclaimed? If it were over the counter, how will people know when and how to avoid fatal doses? Why do you assume it might be either effective or safe if diluted?

> What does “merely-harmful” mean?

Drugs that really only harm the person who takes them if abused. Alternatively, drugs which are unproblematically sold over the counter the world over.

> Everything is available on the black market

Available versus commonly procured.

> that doesn’t mean regulations are BS, it means people are willing to risk breaking the law to avoid being tracked

It means they’re willing to break regulations to get it. We can’t impute motivation.

> how will people know when and how to avoid fatal doses

Same way they do for e.g. Tylenol.

> Why do you assume it might be either effective or safe if diluted?

I don’t. Dilution is a common (and obvious) pharmaceutical tool for increasing the distance between the therapeutic and harmful dose.

> What does “merely-harmful” mean? Drugs that really only harm the person who takes them if abused. Alternatively, drugs which are unproblematically sold over the counter the world over.

In the extreme case where someone ends up being injured or dead, friends and family are most definitely affected. There are few people this would not apply to.

Aside from that, the healthcare system takes a hit, employers do too and a thousand other little ripples spread out.

Some drugs are over-regulated and this is why I’m a fan of the middle line where some are sold at a pharmacy with no script needed and they can partially control the purchasing.

> We can’t impute motivation.

Correct, you’re right, I was speculating on alternative reasons people might avoid the doctor. We also don’t have evidence that the cost or time of a doctors visit is the reason for the existence of the black market demand, contrary to your claim above.

Of course, a huge risk for black market purchases is that they turn out to be fake and/or have unlisted harmful ingredients. It’s already happening with black market Viagra. You get what you pay for, which is people who are breaking the law, are secretive and unaccountable, and putting anything they want in those pills. Good luck with that. A co-pay and a quick Zoom call with a doc seems like a safer choice to me…

> co-pay and a quick Zoom call with a doc seems like a better choice to me

Nobody is arguing it isn’t. The point is the forced choice is flawed. There wouldn’t be a market for the adultered stuff if the medicine were OTC.

> The point is the forced choice is flawed. There wouldn’t be a market for the adulterated stuff if the medicine were OTC.

You haven’t convinced me that there’s anything wrong with the regulation. There might be, but again, the existence of a black market is not a valid reason to relax the regulation. The black market exists for guns and heroine and antibiotics and certain types of illegal porn too, not to mention crazier things like bazookas. You wouldn’t argue any of those should be less regulated just because you can buy them on the black market right? What actual reasons justify deregulating Sildenafil?

> wouldn’t argue any of those should be less regulated just because you can buy them on the black market

I’d use that as evidence there is demand. Then I’d consider the harm of looser controls. The harm balance for Viagra seems minimal, particularly given so many people take it without bothering with a prescription. If you think Viagra is in the same harm bucket as guns and heroin, then yes, it makes sense to regulate it.

Demand is not a valid reason to deregulate, that’s exactly the same argument as the existence of a black market argument. And it doesn’t have to be in a severe harm bucket as heroine to deserve deregulation, it has to be relatively safe, and not have big contraindications with others commonly used medications.

Better reasons to deregulate would be that it’s shown as safe or safer than existing OTC products, that many other countries offer it OTC, or that Viagra provides a compelling health benefit when used safely. The benefit is there for some specific cases, but quite questionable broadly speaking, given that it often gets used casually and to help men who don’t truly need it, to party when they’re drunk or whatever. The safety has been reviewed and deemed worthy of a prescription gate, and it’s not a hard gate to get through at all, the top comment exaggerated it. Maybe it’ll change and get deregulated, but I guess I don’t really even see why deregulating Viagra would be a net positive for anything other than Pfizer’s pocketbook.

How, in your view, does dilution change the therapeutic index of a chemical? If a drug is effective at 20 milligrams, but at 60 milligrams has a steep rise in the incidence of hypotension, how does taking that same 60 milligrams in a larger volume of filler (e.g. water, or spread across more physical pills) change the fact that you've just taken 60 milligrams?

> how does taking that same 60 milligrams in a larger volume of filler (e.g. water, or spread across more physical pills) change the fact that you've just taken 60 milligrams?

It increases tolerance to mismeasurement and mistake. Same reason many pharmaceuticals require multiple pills for minimum dosing despite a concentrated form existing. A child eating a single pill, or you missing that you popped an extra pill into your hand, causes less damage.

That doesn't change the difference between effective and toxic doses, it changes the potential scale of off-by-one user error. If 20 milligrams is delivered in 1 tablet, then 3 tablets is the toxic dose. If 20 milligrams is delivered in 5 tablets, then 15 is the toxic dose. A single daily tablet is far superior to multiple daily tablets in terms of patient adherence and hence disease management.

Can you name specific examples where the number of pills/capsules/tablets has been increased to improve drug safety? Increased pill counts historically reduces patient adherence, which worses disease management. This is just the first example I found which measured it: https://pubmed.ncbi.nlm.nih.gov/31298592/ This review explicitly states it in the abstract even: https://pubmed.ncbi.nlm.nih.gov/30561486/

Idk what to say, this is established medicine [1]. When you have a small TI you dilute to make measurement tolerances wider in absolute terms. This is a motivating factor behind prescription-strength medicine.

> Increased pill counts historically reduces patient adherence

Of course. There are tradeoffs. You want to know what also increases burden? Requiring a prescription.

[1] https://en.m.wikipedia.org/wiki/Therapeutic_index

I don't see dilution anywhere on that page, and increasing volume of administration at a lower concentration to achieve the same effective dose does not alter the dose itself. You are not interpreting TI correctly.

Edit: further, to your comment about "prescription strength" nomenclature, look at section 14 of the Cialis/tadalafil prescribing information, IIRC, table of clinical studies, where they have the second two outcomes of the clinical studies broken down by dose. Efficacy increases pretty directly with increasing dose, and these are where the observed side effects show up. It seems like patients may well self-escalate. Maybe the OTC countries have public data on this?

NTI drugs, a/k/a critical dose drugs, can avoid titration requirements through dilution. It’s harder to fuck up a 500 mL difference than a 1 mL difference. Again, this is why most OTC versions of prescription drugs are different in only one way: concentration.

Aspirin has "severe (but rare) side effects", too. Many of the OTC pharmaceuticals we take have potentially nasty side effects. The only 100% safe stuff is homeopathic, and that's because it's not actually chemically active. I'd be a lot more convinced by the argument if it weren't widely OTC in most of the rest of the world.

Interestingly, there do seem to be long-term side effects of sildenafil/tadalafil - though they seem to be positive. There is a possible link between long-term usage of ED drugs and cognitive protections in old age:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6705107/

https://content.iospress.com/articles/journal-of-alzheimers-...

As for that "100% safe" homeopathic stuff... https://www.fda.gov/news-events/press-announcements/fda-conf...

That first paper is not showing a positive long-term effect for healthy men, it’s showing some cognitive return to normal for people who have a cognitive impairment, possibly associated with their ED. It’s wrong to jump to the unsupported conclusion that it might help old people in general. On top of that, 17% of the very small sample had to bail out of the study due to excessive side-effects.

It’s not useful to say other things have side effects without actually comparing magnitudes or dosage. Everything can kill you if you ingest too much. The call the FDA made is about the relative severity and danger level, and they allow lots of things OTC that have side effects. Why do you not believe that Viagra is more dangerous than Aspirin, why are you armchair second guessing that call? I’m pretty sure Aspirin is far safer than Viagra when used as directed, and that people sometimes take a lot of it because it’s a pain killer and believed to be quite safe. Two thirds of Aspirin deaths are attributed to taking high doses, where Viagra is rarely if ever taken with higher than prescribed dose because everyone knows that’s pretty dangerous.

This is how it is in the UK now, it's an OTC drug, so you can simply buy it in pharmacy or online.

But then you cut off the career path of an FDA lackey in becoming a big pharma exec after they've served big pharma so well. Curious if they went after supplements that don't step on big pharma products, but are actually harmful to the public they supposedly serve.

Reminds me of the X-Ray glasses and aphrodisiac ads from old magazines and comics when I was a kid.

Cosmetics get away with anti-aging and beautification claims, but I believe they are not regulated by the FDA for thise claims, because a lot if it is hogwash.

Tadalafil (Cialis) is available as a generic in the United States. If you think "big pharma" is served by drugs going off-patent, you may want to re-evaluate your perspective.

If you want to get more reasonably unhappy with market exclusivity, look at Celgene's grip on thalidomide/lenalidomide/pomalidomide for the treatment of multiple myeloma.

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