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Thread: Rent-seeking in the modern pharmaceutical market

  1. #1

    Default Rent-seeking in the modern pharmaceutical market

    I'm sure most of you have read about the recent 5000% price-hike on Daraprim, a drug used to treat a potentially lethal parasite infection in eg. people with AIDS. Much of the media attention has been directed towards the character-flaws of sleazeball CEO Martin Shkreli, perhaps because he's a scummy kinda guy. The following blog post however looks at some other curious aspects of the situation:

    http://blogs.sciencemag.org/pipeline...-its-a-bad-one

    Martin Shkreli Has One Idea, And It’s a Bad One

    By Derek LoweSeptember 21, 2015

    Martin Shkreli may finally have overstepped, and it will be a good thing if he has.

    Let me back up both those statements. Shkreli, you may recall, was the founder of Retrophin, a company whose business model was to buy up obscure orphan generic drugs (such as Thiola) and immediately raise their price by, say, twenty-fold. They had analyzed the market, and what insurance companies might be able to put up with, and determined that this could be gotten away with, so why not? After writing about this here, I got involved in a Shkreli skirmish on Reddit (he’s famously active on social media, rather unusually so for someone in his position). But not long after that encounter, he was fired by Retrophin’s board, and the lawsuits are flying.

    Shkreli wasted no time forming another company, Turing Pharmaceuticals, and Alan Turing should be sitting up in his grave any day now, at the rate things are going. In my Reddit exchanges with Shkreli, he’d talked about the drugs he’d “discovered”, and Turing made claims about how if you work for them and discover a drug, you’d get a share of the profits (see that last link for more). But so far, they don’t seem to be as interested in discovering drugs as in discovering opportunities to use other people’s drugs as a means to stick it to patients and payers. The company has bought up rights to yet another obscure medicine, Daraprim (pyramethimine), and immediately hiked the price fifty-fold, from $13 to $750 per dose.

    So here’s the conflict: companies do (and should) have the right to charge what they think their market will bear. But ordinarily, you’d think that most markets wouldn’t have enough slack in them for a price increase like that one. What we’re seeing is a peculiar part of a generally peculiar market, though. Drug companies are granted a temporary monopoly by the patent system, in recognition of the value of new therapies. Arguing about this tradeoff does not cease, but overall, I think it’s a reasonable system (although one can imagine others, which would involve tradeoffs of their own). But one feature of the existing order is that patents expire (and you’d be surprised how many loud anti-pharma activists don’t seem to realize that). And once they expire, the price comes down as the generic manufacturers get into the market.

    That’s how it’s supposed to work, anyway. But in recent years, another strategy has emerged, and Retrophin/Turing are just the most dramatic examples of it. Entire companies have sprung up to take advantage of this sort of leverage – not by discovering their own drugs (too expensive, too risky!) but by buying up existing ones. And the most egregious examples have come in the generic sector. By various means, old generic compounds have ended up as protected species, and several companies have made it their business to take advantage of these situations to the maximum extent possible. The FDA grants market exclusivity to companies that are willing to take “grandfathered” compounds into compliance with their current regulatory framework, and that’s led to some ridiculous situations with drugs like colchicine and progesterone. (Perhaps the worst example is a company that’s using this technique to get ahold of a drug that’s currently being provided at no charge whatsoever). There are also loopholes that companies are trying to exploit when competitors try to prove generic equivalence: whatever it takes to keep competition away and get unlimited pricing power.

    But as I discussed in one of those links above, that pricing power is a mighty weapon, and should be handed out sparingly. A company that takes on the substantial risk of new drug discovery deserves it much more than one that is merely rent-seeking. And that’s exactly the economic term for what Retrophin, Turing, Catalyst, Makena and other such companies are engaging in: a chance to put the squeeze on. Here’s the situation with Daraprim:

    Daraprim, which is also used to treat malaria, was approved by the FDA in 1953 and has long been made by GlaxoSmithKline. Glaxo sold US marketing rights in 2010 to CorePharma. Last year, Impax Laboratories agreed to buy Core and affiliated companies for $700 million. In August, Impax sold Daraprim to Turing for $55 million, a deal announced the same day Turing said it had raised $90 million from Shkreli and other investors in its first round of financing.

    Daraprim cost only about $1 per tablet several years ago, but it went up sharply after CorePharma acquired it. According to IMS Health, which tracks prescriptions, sales of the drug jumped to $6.3 million in 2011 from $667,000 in 2010, even as prescriptions held steady at about 12,700. In 2014, after further price increases, sales were $9.9 million, as the number of prescriptions shrank to 8,821. The figures do not include inpatient use in hospitals.

    So there’s already been one round of price-jacking with this old drug, and now Turing is here to take it to unheard-of levels. In any functioning market, someone else would jump in and offer this compound for less – but Turing’s business plan includes “closed distribution”, that loophole mentioned above to try to keep any other generic companies from getting enough of the drug to run a clinic trial proving equivalence. (What to do about this will be the subject of the next post, going up immediately after this one).

    Shkreli himself is saying that Turing needs this price increase to do research on better drugs than Daraprim, but this is a need that up until now no one seems to have thought worth filling. And if it’s worth filling, then surely there are other ways to go about raising the money than via a 50x price hike. He’s also dealing with criticism in his usual diplomatic way, calling John Carroll of FierceBiotech a “moron” on Twitter for questioning this strategy. In that case, put me down as a moron, too, because I think it’s a terrible idea. See the next post for more. . .
    So, is this something the FDA should be blamed for?
    "One day, we shall die. All the other days, we shall live."

  2. #2
    in b4 hargle bargle the free market
    When the sky above us fell
    We descended into hell
    Into kingdom come

  3. #3
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    The same pills cost €0.40 in The Netherlands, €0,60 in the UK and €0.10 in India. Free market doesn't seem to be the problem. Govermnent regulation shielding a single producer in the USA from competition makes this type of price gauging possible.
    Congratulations America

  4. #4
    It certainly seems like an FDA-created problem, Minx.
    Last night as I lay in bed, looking up at the stars, I thought, “Where the hell is my ceiling?"

  5. #5
    Quote Originally Posted by Steely Glint View Post
    in b4 hargle bargle the free market
    The problem is a broken market not a free market. This is a 62 year old drug that should be long since out of patent and any other generic competitor ought to be able to create this and sell it for cents per tablet as it is elsewhere.

    This is a company exploiting a government created loophole, most likely it seems to be the FDA that is at fault. The answer is to close the loopholes and open up the market.
    Quote Originally Posted by Ominous Gamer View Post
    ℬeing upset is understandable, but be upset at yourself for poor planning, not at the world by acting like a spoiled bitch during an interview.

  6. #6
    Cause god forbid the entity being the asshole share any of the blame.
    "In a field where an overlooked bug could cost millions, you want people who will speak their minds, even if they’re sometimes obnoxious about it."

  7. #7
    People are going to be assholes. That's a given. People are also going to seek to maximize their profits. That's also a given and the general intent is to help them do it, to the extent that's possible without hurting others. The point of regulatory schemes is preventing that kind of thing from actually hurting people. Instead of preventing the behavior, they're making it easier AND maximizing the rewards the assholes can receive by it.

    But you're more interested in castigating the stuff you don't like than actually looking to prevent it. So yeah, for you it's more important to yell at the asshole than look for how they were able to act that way in the first place.
    Last night as I lay in bed, looking up at the stars, I thought, “Where the hell is my ceiling?"

  8. #8
    You think this kind of exploitative behavior wouldn't occur if the government regulated less?
    When the sky above us fell
    We descended into hell
    Into kingdom come

  9. #9
    Quote Originally Posted by Ominous Gamer View Post
    Cause god forbid the entity being the asshole share any of the blame.
    If you let people be assholes someone will try to be an asshole. If there's a problem then yes you can b***h and moan about it on Twitter calling the asshole mean names that he'll laugh off all the way to the bank.

    Or you could try and fix the problem and ensure that he and his ilk can't get away with this.

    The situation is flawed and should be fixed.
    Quote Originally Posted by Steely Glint View Post
    You think this kind of exploitative behavior wouldn't occur if the government regulated less?
    There should be smart regulations.

    Nobody is proposing complete anarchy (if there was then this behaviour wouldn't be permissible as there'd be no copyright law). But broken regulations allowing out of copyright drugs to be essentially recopyrighted and exploited should be addressed.

    IIRC copyright applies for 20 years after a drug gets approval, that is a reasonable. This was approved in 1953, it ought to be generic now.
    Quote Originally Posted by Ominous Gamer View Post
    ℬeing upset is understandable, but be upset at yourself for poor planning, not at the world by acting like a spoiled bitch during an interview.

  10. #10
    Quote Originally Posted by Steely Glint View Post
    You think this kind of exploitative behavior wouldn't occur if the government regulated less?
    I made no assertion about more regulation, less regulation, or the efficacy of regulation in general. Not everything is pure ideological argument. In fact, very few things I post are pure ideological argument. I care far more for robust function than I do about any ideology. I think this particular kind of exploitative behavior would not be possible if the FDA was not using this particular set of regulations in this particular way. Whether that fix is just changing them, removing them, adding new ones, etc. is far beyond my power to determine but it looks like the fix, like the problem, has to come from the FDA. A bit less prejudice if you don't mind, Steely.
    Last night as I lay in bed, looking up at the stars, I thought, “Where the hell is my ceiling?"

  11. #11
    Much of what you say is self-evident; that the this particular kind of exploitative behaviour would not be possible without this particular set of regulation and that the FDA are the only ones who should or even can fix this specific problem. It also seems self-evident that the guy in the article is a nob-end.

    It also seems self-evident that people are going to attempt to game the rules, no matter what. It is also self-evident that in a domain as complex as health-care, writing a game-proof set of rules and regulations is a tall order.

    It seems to me, therefore, that the only question actually worth discussing, is whether or not the free market actually belongs in healthcare at all; is this an area of human endeavor where we should be seeking to extract value or is it actually something we should be putting value into; does it add something to the process that compensates for the inevitable exploitative behaviour and the subsequent game of thwack-a-mole the regulation has to play to keep the system somewhat functional.
    When the sky above us fell
    We descended into hell
    Into kingdom come

  12. #12
    Quote Originally Posted by LittleFuzzy View Post
    But you're more interested in castigating the stuff you don't like than actually looking to prevent it. So yeah, for you it's more important to yell at the asshole than look for how they were able to act that way in the first place.
    No I think that people being assholes should be called assholes. I made no assertion concerning the regulatory aspect. People don't all have to act like assholes.


    Your givens are far from givens.
    "In a field where an overlooked bug could cost millions, you want people who will speak their minds, even if they’re sometimes obnoxious about it."

  13. #13
    Shkreli was a hedge fund 'investor' who found a way to exploit pharmaceutical patents for profit.

    More than one system is broken here, so it's stupid to place the blame on just one thing...or claim that "freeee market capitalism" would have avoided the mess.

    This is a battle between patent/trademark law, contract law, the financial industry, and regulators. It just so happens that this debate about "monetizing intellectual property" falls in the pharmaceutical sector....a subset of the healthcare sector....but it's common in other vital sectors, too. It just doesn't get the same press (or moral outrage on social media) when it involves other necessities of life (like water, food, or shelter).

    And this only got attention because the price increase was so fast, unlike the same exorbitant rises in housing or education that took a few years before anyone noticed.



    edit: does anyone else remember the thread about Monsanto and their hybrid seed "patent" lawsuits?
    Last edited by GGT; 09-25-2015 at 12:22 AM.

  14. #14
    Quote Originally Posted by Ominous Gamer View Post
    No I think that people being assholes should be called assholes. I made no assertion concerning the regulatory aspect. People don't all have to act like assholes.


    Your givens are far from givens.
    No, you did not make an assertion concerning the regulatory aspect. You just put down some rhetorical disbelief aimed at us, for responding to the question Minx posed, which WAS about the regulatory aspect. And people don't all have to act like assholes, but some will. That's as inevitable as some people acting with compassion and charity. So you can stop pretending you're on any sort of moral high horse.
    Last night as I lay in bed, looking up at the stars, I thought, “Where the hell is my ceiling?"

  15. #15
    Quote Originally Posted by Steely Glint View Post
    Much of what you say is self-evident; that the this particular kind of exploitative behaviour would not be possible without this particular set of regulation and that the FDA are the only ones who should or even can fix this specific problem. It also seems self-evident that the guy in the article is a nob-end.

    It also seems self-evident that people are going to attempt to game the rules, no matter what. It is also self-evident that in a domain as complex as health-care, writing a game-proof set of rules and regulations is a tall order.

    It seems to me, therefore, that the only question actually worth discussing, is whether or not the free market actually belongs in healthcare at all; is this an area of human endeavor where we should be seeking to extract value or is it actually something we should be putting value into; does it add something to the process that compensates for the inevitable exploitative behaviour and the subsequent game of thwack-a-mole the regulation has to play to keep the system somewhat functional.
    If free markets can put better drugs on the market at the cost of unequal access to the drugs are you OK with that? This is an assumption that the free market will provide better drugs faster than some government agency but go with it for now.

  16. #16
    Using terms like "free markets" without context isn't gonna help this debate much.

    The FDA has power as a regulatory agency, but less power than a legislative body like Congress. The FTC and SEC has power over pharmaceutical companies trading on market exchanges too, but only with congressional approval/oversight first. For that matter, congress controls the purse strings to publicly funded R & D, from NASA to NIH to state university funding.

    Congress isn't working like it's meant to, and this kind of 'pharmaceutical profiteering' is a problem.....because our political system is broken and dysfunctional.

  17. #17
    Quote Originally Posted by Lewkowski View Post
    If free markets can put better drugs on the market at the cost of unequal access to the drugs are you OK with that? This is an assumption that the free market will provide better drugs faster than some government agency but go with it for now.
    Let's add some context to that, and turn the question around: IF a new drug claims to be 'better' than an old drug, or provides benefits no previous drug did.....how do you know their claims are true? Obviously studies were involved, but who did them, and were they done correctly? How much weight would you give to previous studies done by governmental agencies (and tax payer dollars) for comparison? Would you trust a manufacturer or distributor with a financial incentive and profit motive to cite their "own" studies?

    Moving onto pricing: IF a "new" drug is just and old drug with a new name, does it warrant a 5000% price hike just because its corporate owner changed names? And regarding access: IF cheap, older, generic drug formulas (like Aspirin) could be "bought" by big pharmaceutical corporations, making them more expensive (with unequal access) would you be okay with that?

  18. #18
    My question is about what matters more to the liberals. In-equal access to care but more advances in medicine or equal access to care?

  19. #19
    Quote Originally Posted by Lewkowski View Post
    My question is about what matters more to the liberals. In-equal access to care but more advances in medicine or equal access to care?
    Is this what you mean when you say liberals?

    http://www.studentnewsdaily.com/cons...beral-beliefs/
    Faith is Hope (see Loki's sig for details)
    If hindsight is 20-20, why is it so often ignored?

  20. #20
    Assigning blame and finger pointing over such topics is largely redundant what is more important is there any will to change what is clearly broken or corrupt and if there is how to go about it.

    There are thousands of little things like this everywhere. This is what happens when corporations are citizens and have the monetary clout and influence to rewrite or put into law a lot of things that if the public was even remotely interested in or concerned about they'd not allow in the first place. However the public does not give a shit till something stupid or bad happens so, we have the system we deserve, especially when you consider how easy/gullible the public is in terms of being emotionally manipulated into accepting more shit for even noticing something isn't right in most cases.

    It is not interesting just sad and predictable.

  21. #21
    None, you remind me of my kids, the millennial generation's struggles. They don't care to register to vote, let alone vote! They see the system as rigged, with no way out or moving forward. They don't feel like "public policy" or "corporate policy" will do them any good, even if they're fully employed, earning poverty wages, or are getting a college degree. They either hate or resent their parents' generation for fucking things up on such a massive scale, with good reason. Some of them will take that as an opportunity, and become innovators or entrepreneurs....without throwing granny's heart medication under the bus for their own "profit margin".

  22. #22
    Quote Originally Posted by None View Post
    Assigning blame and finger pointing over such topics is largely redundant what is more important is there any will to change what is clearly broken or corrupt and if there is how to go about it.

    There are thousands of little things like this everywhere. This is what happens when corporations are citizens and have the monetary clout and influence to rewrite or put into law a lot of things that if the public was even remotely interested in or concerned about they'd not allow in the first place. However the public does not give a shit till something stupid or bad happens so, we have the system we deserve, especially when you consider how easy/gullible the public is in terms of being emotionally manipulated into accepting more shit for even noticing something isn't right in most cases.

    It is not interesting just sad and predictable.
    There are much larger corporations that are desperate to get the US Food and Drug Administration (FDA) to modernize and improve their drug approval process. This is a regulatory failure more than anything else.

    The Yurps might be in a better place on this issue policy-wise, but R&D is depressed due to socialism. The US has a unique combination of a slightly real drug market, coupled with regulations that are simultaneously ultra-conservative and nonsensical at the same time.

  23. #23
    Quote Originally Posted by GGT View Post
    None, you remind me of my kids, the millennial generation's struggles. They don't care to register to vote, let alone vote! They see the system as rigged, with no way out or moving forward. They don't feel like "public policy" or "corporate policy" will do them any good, even if they're fully employed, earning poverty wages, or are getting a college degree. They either hate or resent their parents' generation for fucking things up on such a massive scale, with good reason. Some of them will take that as an opportunity, and become innovators or entrepreneurs....without throwing granny's heart medication under the bus for their own "profit margin".
    So they're fools?
    Quote Originally Posted by Ominous Gamer View Post
    ℬeing upset is understandable, but be upset at yourself for poor planning, not at the world by acting like a spoiled bitch during an interview.

  24. #24
    Quote Originally Posted by Dreadnaught View Post
    There are much larger corporations that are desperate to get the US Food and Drug Administration (FDA) to modernize and improve their drug approval process. This is a regulatory failure more than anything else.
    And that "regulatory failure" sits in our legislators' laps! Congress has the power to regulate and coordinate between governmental agencies....but none of that will happen if our political process remains so polarized and dysfunctional.

    The Yurps might be in a better place on this issue policy-wise, but R&D is depressed due to socialism. The US has a unique combination of a slightly real drug market, coupled with regulations that are simultaneously ultra-conservative and nonsensical at the same time.
    "The Yurps" have invested in SSSocialist programs that lead to great things for the rest of the world, beginning with public education, that leads to the next generations of scientists. That doesn't mean R & D is "depressed" in places like Germany or Sweden, does it?

    Yeah, the US has a "unique" system, with a weird way of looking at things like public education, public funding, and the common good....that favors Freee Market Capitalism as a political ideal, even though it's divorced from reality.




    Quote Originally Posted by RandBlade View Post
    So they're fools?
    No, they're definitely not fools. They probably "know" more than their elders did, thanks to technology and the internet. They just might be the first generation fully aware that making policy for future generations includes "unintended consequences", and "analytical risks" models.

    edit: that kind of policy didn't matter much, until the POTUS (Kennedy) declared NASA a national imperative.
    Last edited by GGT; 10-15-2015 at 11:08 PM.

  25. #25
    Martin Shkreli did a reddit IamA in a marathon session that lasted several hours through the middle of the night and several hours in the morning.

    He answered hundreds of questions, including some of my own. Thinking about it in its totality, what he did isn't really that nefarious, especially as he claims to want to advance research in the area of toxoplasmosis. As a trader and a biotech investor he knew that he would definitely need a huge cushion to pay for research and having the only FDA-approved generic (an NDA) for the drug does that, and is synergistic (at least, in terms of marketing) with development of a new/better drug.

  26. #26
    Quote Originally Posted by agamemnus View Post
    especially as he claims to want to advance research in the area of toxoplasmosis.
    https://np.reddit.com/r/IAmA/comment...7zsa?context=3

    Do love this one description I found about the CEO in that AMA:

    The CEO sounds like an obnoxious teenager who just finished reading Ayn Rand. I don't think he's self-aware to say the least.
    "In a field where an overlooked bug could cost millions, you want people who will speak their minds, even if they’re sometimes obnoxious about it."

  27. #27
    The CEO sounds like an obnoxious teenager who just finished reading Ayn Rand. I don't think he's self-aware to say the least.
    I don't really agree...

    There's a massive hate-on for him though, especially from internet trolls, and a lot of inaccurate or outright false reporting. For example, there was a USA Today video piece that said the drug he is selling is an AIDS drug. It is not an AIDS drug.

    Anyway, I saw that comment too. I don't know anything really about the research but it sounds like this does bear some examination.
    Last edited by agamemnus; 10-26-2015 at 06:14 PM.

  28. #28
    It is not an HIV drug but it IS an AIDS drug, Aga, because Toxo is really only an infection that needs medicating in the the immuno-compromised.
    Last night as I lay in bed, looking up at the stars, I thought, “Where the hell is my ceiling?"

  29. #29
    That's just entirely incorrect. If you are immuno-compromised, a lot of diseases and infections affect you more than most others.

    https://en.wikipedia.org/wiki/Toxoplasmosis

    Also, having AIDS is far away from being the only way to be immuno-compromised. Taking remicade, for example, causes one to be immuno-compromised.

  30. #30
    So?

    Aga, may I ask what is you think an "AIDS drug" is?
    Last night as I lay in bed, looking up at the stars, I thought, “Where the hell is my ceiling?"

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