Comment by krackers
16 days ago
>blantatly skirting patent laws
Why is this a bad thing? The quickest way to fix the medical/insurance/bureaucracy complex is to just allow people to sell direct to consumer.
The best (worst) example of this is CPAP. Ideally you'd just be able to go and buy one for $300, but instead there is a complex around "necessity" and "prescription", which creates an effective monopoly where the exact same hardware can be sold at different price points with software locked features.
If even a "simple" mechanical device like this which violates no patents and can't materially harm a person in any way can be restricted on grounds of paternalistic "safety", then one would be right to remain skeptical of the claim that the FDA is restricting action against unauthorized semaglutide knockoffs to
>safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.
In Italy, you can walk into a shop and buy as many contacts as you like.
In the US, if you haven't paid your annual tithing to get a hall pass from an optometrist, the FDA won't let you.
Going to Japan felt like living in the future. I could walk into any glasses store, and for $50 or less buy a pair of frames and lenses. If I didn't know my prescription, included in the price was an automated eye exam machine which'd figure it out in 2 or 3 minutes.
In the US I'm paying $200 just for the exam.
You can do the same in the US, zennioptical.com. You need to measure your PD which is very easy (Most optometry shops are hesitant to tell you your PD. And it's normally measured when you go to order the glasses, not as part of the initial eye exam.)
As for needing a prescription <1 year old, if your vision hasn't changed, just edit the date in the PDF. Same for contact lens prescriptions.
As part of the regular eye exam, they generally use an autorefractor machine on your current glasses and/or eyes to get a baseline before they manually fine tune with the 1/2 on the eye chart test. But yeah, you can't just get the quick prescription from the autorefractor like you talked about in Japan.
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Well actually, there are lawsuits in the works because the Philips CPAP machine had toxic foam which would break down and increase the risk of cancer.
European Respiratory society disagrees on the cancer risk fwiw https://www.ersnet.org/wp-content/uploads/2022/02/Update-on-... but yeah obviously degraded foam isn't good. The foam isn't actually a required part, it's just for sound reduction.
But I think that proves my point, the supposedly "rigorous" FDA review didn't flag concerns about foam in the airpath of something you breathe through, so what exactly is the approval process buying you? Philips issued a voluntary recall but resmed uses foam in their units too, and while they claim it's a different type of foam it seems there are better ways to engineer sound reduction than putting foam in the air channel and potentially breathing in microplastics.
Never heard the follow-up, so good to hear that it was potentially less hazardous than the initial reporting.
However, I am still mixed on the interpretation. I do not think the FDA is as good as say the NTSB, but I do think they will take lessons learned from a bad outcome. New medical products are likely to undergo additional scrutiny on any kinds of foams/solvents/whatever that are directly in the airway path. It is only because it is such a heavily regulated product that the entire product chain had to be stamped, certified, and traced so that such an investigation was possible. In a theoretical fly-by-night product offering, SKUs might be changing daily as the vendor can shave pennies off of the development price.
Yep in other countries CPAPs are over the counter. In America you need to go to a sleep lab for a wasteful overnight sleep study (sometimes two!) that costs thousands. And then have appointments with a “doctor” who provides no useful help but is necessary for the prescription. All for the machine to figure out its own optimal settings anyways. Total racket and regulatory capture.
Right I used CPAP as an example because it bypasses all arguments about "novel technology", "drug development" cost, or "need for safety". Even an ASV algorithm could probably be implemented as a ~graduate project since it seems to be a rather basic control algorithm (today with ML you could probably do even fancier things). It's basically a piece of pure technology that could be commoditized, manufactured and sold to people for < $300 in the way smartphones are. If something as "basic" as this can't be accomplished due to the regulatory environment then it's sort of pointless talking about anything more complex like pharma drugs.
Not to sound like a broken record, but they're also prescription-required in Germany, as are the accessories. My otherwise very by-the-books husband ended up buying grey-market masks in order to be able to try several styles before finding one that worked well for him.
Well you either remove all the bureaucracy around drug testing and approval and make it cheap to develop a new drug, or you prevent drug makers from making money if they are successful at developing a new molecule. But if you do both, all you will get is zero research. Right now it takes 10s of billions in R&D budget to bring new molecules to the market, which is insane.
Or you pay them directly. Most countries have research funding. Since there's no way to know what you'll find or how long it will take, research doesn't fit well in the capitalist model. Makes much more sense to apply a fixed effort and accept whatever results come out, but only the government can do that — or a rich monopoly like Bell.
As long as the company that did the research and the medical professional gets paid the same amount. I’m completely OK with cutting out the insurance and the bureaucracy and other non-value add middleman, but the value add partners need to get paid for this to be sustainable.
Patent laws exist for a reason. It’s so people that come up with paradigm changing ideas and inventions can get rich off of it. This is something we want to maintain.
> Patent laws exist for a reason
And maybe in this case they are functioning as intended.
Unfortunately, they are also leveraged to provide a moat and profits in situations where no innovation has occurred. (Eg, patents on one click shopping.)
My grandfather was one of the originators of the technology that became CPAP. He did not get rich from it.
The company he worked for probably did.
Why is it bad when companies break the law? We have patent laws for a reason (to incentivize enormously expensive drug development).
Novo and Lilly already sell direct to the consumer! Yes, you need a prescription, but once you have one you can buy straight from the manufacturer.
That's nice. The rest of the world has price caps on what these companies can charge for drugs.
It's one or the other. You can have your ''patents'' and ''intellectual property'' respected...but that requires you not charge an outrageously higher price in certain markets, like the US.
The rest of the world is free riding.
The solution is a law preventing drug firms from pricing in the US higher than (some small multiple of) what it charges anyone else in the world.
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What percentage of global rich, obese people live in the US? This is the main market and the product would not exist if it could not command a high profit here. Besides that, I think the US prices are so high due to the insane medical insurance structure, not because the drug companies really make much more than in other countries.
The main reason drug development is so enormously expensive because the FDA makes it that way with their paranoid risk averse regulatory process and insanely restrictive requirements on what requires a doctor prescription.
> because the FDA makes it that way with their paranoid risk averse regulatory process
FDA is constrained by Congress here. Its function (safety and efficacy in advance of marketing) is required by legislation dating to the 60s. Feel free to advocate for Congress to change the law, but it isn't obvious it would be popular with Americans.
> insanely restrictive requirements on what requires a doctor prescription.
I don't think OTC vs Rx rules have much if any impact on drug development expenses.
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As always, depends on the law. This is a bright line example of companies breaking the law to the direct tangible benefit of not only their customers but the population at large. Letting Novo Nordisk jack the price back up and deprive the vast majority of Americans access to the greatest good to public health in a century meanwhile is… maybe not the example you should be holding as the law working.
Yes, bootleggers can undercut legit competitors, providing a boon for consumers.
In this case, Novo developed the drug. In your view, why does Hims get credit for "the greatest good to public health in a century" and not the company that sank over $10B into developing Ozempic?
Of course, Novo faces competition from Lilly and every other pharma company in the world and continues to lower prices in the face of this competition.
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