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Drug Goes from $13.50 a Tablet to $750, Overnight

nytimes.com

201–210 of 461 posts

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#201

Earlier quoted context omitted.

It seems to me that the overall result would be other companies start manufacturing the generic and sell the drug for maybe 20% less than Martin and over time the price drops back down towards where it once started. In the meantime, this company either goes bankrupt or is sold off. Or the government passes a law capping how much you can raise the price of a generic drug over so many years.

That's exactly what would happen, but the generics companies can't procure sufficient samples due to the changes in how Daraprim is distributed. So long as Shkreli is able to control distribution tightly enough, there's no worry about a generic coming onto the market.

Why would they need samples when the chemical structure is so widely known[1]? It's not like it's a biologic where sequence and other formulation details are critically important. Can you explain?

[1] https://en.wikipedia.org/wiki/Pyrimethamine

Edit: I noticed that paulmd, further down, explained why this is important. I didn't realize the rules were this stupid. The FDA should be able to force companies to make their product available for comparison testing. It's insane that it isn't the case.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#202
post #181

Earlier quoted context omitted.

They should just allow importing drugs from other markets that have good enough quality standards - like the EU or Canada I guess. Problem solved.

But who provides the quality standards oversight? The drug is apparently produced in India. What if pills were shipped to the US and it was found after the fact that many batches contained unacceptable levels of iron? Who to blame? I'm sure Canada has decent oversight, but who wants to say that the solution is no direct US agency oversight, and that we want a "Pharmaceuticals-NAFTA"? It seems funding oversight with a…

> Pharmaceuticals-NAFTA

I'm not a libertarian and I'm in favor regulations when needed, but in this case I think that recognizing drug testing and quality controls between countries that have similar standards would be a great help at curbing costs. "FDA approval" in this case should mean that the FDA could recognize that if agency X from Country Y says that a generic pharmaceutical is safe, you don't need to do the same tests again.

Of course this should work both ways - I'm from the EU, and I'd like to be able to get drugs manufactured in the US when they're cheaper and just as safe.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#203
post #157

This is insane. But then again; the whole pharmaceuticals business is insane. Why again do we have a problem with antibiotics resistant bacteria? Because we stopped researching antibiotics in the 1970, because antibiotics weren't profitable anymore. (That, and the practice to feed antibiotics to our livestock to enhance growth, I guess.) Research and trials shouldn't be done by the companies. Instead it should be don…

Again, the end result is a decrease in the number of drug therapies available to doctors. Instead of multiple options, where one can be selected that best fits an individual patient, you'd have one. If that therapy works for the patient, fine. If it doesn't, if that patient fits outside the bell curve or stops responding to it (as is very, very common across a wide number of therapies), then that patient is screwed. And often, dead.

Just look at antidepressants, where doctors have to slog through a huge number of different options (not just different classes, like SSRIs or SNRIs, but often radically different drugs within those classes) to find the right drug therapy that works for each individual patient. Choosing the right medication, and the right dose (which can have a huge effect on how the drug functions) can mean the difference between someone living a healthy, productive life and suicide.

Drug R&D is an entirely different ballgame than basic science. And there's already countless examples of how basic science funding, from appropriations to attempts by politicians to interfere with the grants process, can be screwed up. Hell, just the amount of funding necessary to replace private drug R&D would be a significant political expenditure. And here's a fun consequence: how long will it be until some arrogant politician comes along and complains about how drugs developed with American taxpayer dollars are being provided to foreign countries? I can see it now, and it's terrifying: some bullshit slogan like "American drugs for Americans" should terrify you, too.

Even under the best case scenario, public funding would mean tradeoffs: research option A or option B, but not both if there's any overlap. And that's before politicians start playing games and before budget cuts start impacting research. Maybe the solution is to have manufacturer bids be sufficient to cover those R&D costs? Congratulations, you're right back where you started, with drug costs either the same or negligibly less. And where does the money go? If it goes into the state's general funds, politicians will use that money for their own special interests and pet projects. If it goes into an earmarked fund, politicians will cut back taxpayer funding by an equal or greater amount. You can see textbook examples of each with federal infrastructure funds and education funding in states that host lotteries "for the children."

Simple idea in theory, horrible in practice. Unintended consequences are still consequences.

As for antibiotics, that's a bit of a different case. There are a lot more arguments for public funding in these sorts of circumstances, where pharmaceutical companies can't research and bring a drug to specific, niche markets. Antibiotics are a classic example, especially when you consider the broader public health risks associated with the rise in antibiotic-resistant strains.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#204
post #190
post #42

Earlier quoted context omitted.

At least in the US, that actually sounds like it's already illegal from general business regulation. As in, no new laws needed, get the ones we have enforced. Wouldn't be surprised you can already pierce the corporate veil without new laws too. This is not specifically in reply to the parent, but the point fits here: I'd observe that calling for more regulation or even outright nationalization to fix this, when it's…

> undersell until they're the only supplier left I don't think this is illegal unless they're selling the drug below cost (dumping).

IANAL, but I do know 2/3rds of the company existed entirely to push the papers that kept the place running above the boards, along with yearly inspections by the FDA, etc. Whether this is a problem of regulation or enforcement can't be discerned by me, but my simplistic understanding of it was

( cost of entry to market + stringent packaging requirements for these particular drugs ) / market = nobody else bothers to get in the game

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#206
post #48

The surprise voiced in this article is suprising. Now that the NY Times has told me about it, this idea of buying the one company that makes a particular generic drug and then raising the price ridiculously high makes a lot of sense. I wonder if they thought they'd lower the price as sales dropped and were themselves surprised when this didn't happen. I gotta agree with jug5: "Breaking News: America doesn't understan…

Oh, I see you have an infection that will kill you. How much you gonna pay? Why not bring back smallpox while we are at it? Just imagine the profits! There is a special place in hell for people like Martin Shkreli.

Just in case hell doesn't exist, it would only be right that the guy will contract a painful and slowly degenerating disease that has no cure.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#207

Drug creation needs to be nationalized, 100% tax funded all the way from researcher to trials to manufacture, and the drugs sold at cost thereafter. And the pharmaceuticals industry needs to just go away.

It's really shocking to such an anti-technological development comment on site about technological development. If the federal government had locked down all IT development in the 1980s as you proposing they do for pharmaceuticals, we wouldn't have this forum to comment on, much less the industry it is built around.

I'd be happy if Big Pharma had to play on the same field as us. But as it is now, they reap huge amounts of cash from NIH and other public entities for research. Of course, the profits are all privatized.

For 20+ years, they've been moving more and more of their R&D and manufacturing overseas to save on labor costs. They then get Congress to approve of anti-competitive laws that disallow citizens from importing cheaper drugs from overseas for both use and resale. Big Pharma should have to compete on the same level as labor.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#208
post #188
post #149

Earlier quoted context omitted.

It's way down there in the article, but Turing's distributor (Impax) is tampering with the generic approval process. They use a controlled distribution strategy where you need to buy it directly from them, and they won't sell it to anyone who uses it for approval testing. Without the namebrand drug, there's no way to prove that your generic is equally efficacious, and thus no generic approvals and no competition.

Why can't you just go to a doctor or hospital and pay them a couple grand per pill and use that? Nobody has to know where you got it from...

Because then you don't have an audit trail to use in your study documentation.

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#209
post #96

Earlier quoted context omitted.

That's the loophole though, the quantities are so small that realistically, no pharmaceutical company has the incentive to make their version of the drug, even at $750 per dose. There are still costs to making a drug that's off-patent, and sometimes the number of patients being treated is only in the double digits. Additionally, a competing drug released at say, $500 per dose would still be considered predatory anywa…

They should just allow importing drugs from other markets that have good enough quality standards - like the EU or Canada I guess. Problem solved.

I'm sure he'd be happy to let that go unprotested ... "Skrelicame to attention after his attempts to have the FDA not approve drugs being produced by companies whose stocks he was shorting".

Who needs morality in the free market, right?

Re: Drug Goes from $13.50 a Tablet to $750, Overnight

#210

Earlier quoted context omitted.

That's exactly what would happen, but the generics companies can't procure sufficient samples due to the changes in how Daraprim is distributed. So long as Shkreli is able to control distribution tightly enough, there's no worry about a generic coming onto the market.

Why would they need samples when the chemical structure is so widely known[1]? It's not like it's a biologic where sequence and other formulation details are critically important. Can you explain? [1] https://en.wikipedia.org/wiki/Pyrimethamine Edit: I noticed that paulmd, further down, explained why this is important. I didn't realize the rules were this stupid. The FDA should be able to force companies to make thei…

Formulating the generics isn't the hard part (well, beyond the chemistry but that's straightforward enough - once you know something can be done, it's just a matter of time and effort). Once a generics company does that, they have to perform bioequivalence testing. It makes a lot of sense, because generics can have different inactive ingredients (fillers, etc.) that can still affect the patient.

But in order to perform that testing, they need examples of the brand-name drug to test against. If a manufacturer can prevent them from gaining access to those examples, then the generic is never coming to market. They can't get a doctor to just write up a prescription for somebody, so they have to go through established distribution channels. There are a lot of other, equally nasty ways manufacturers can use to try and forestall generic versions of their drugs. It's not easy to do, because the laws are written to incentivize generic competition, but if a company thinks it's profitable enough to try (and certain factors are in their favor, like with Daraprim), they can.

The FTC has a really interesting document available on their ongoing efforts to fight anti-competitive pharmaceutical practices if you're interested:

https://www.ftc.gov/system/files/attachments/us-submissions-...

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