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posted by martyb on Tuesday August 23 2016, @07:34AM   Printer-friendly
from the staying-alive-is-getting-more-expensive dept.

EpiPen's price has ballooned about 400% since 2008, rising from about a $100 list price to $500 today. The EpiPen is one of the most important life-saving medical innovations for people with severe food allergies—which affect as many as 15 million Americans and 1 in 13 children in the United States. But its price has exploded over the last decade despite few upgrades to the product itself. The product's lack of competitors is likely a significant driver of the costs. [...] [The] EpiPen enjoys a near-monopoly on the market with annual sales of more than $1.3 billion and nearly 90% U.S. market share.

At Fortune, NYT, The Hill.


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  • (Score: 2) by Kilo110 on Tuesday August 23 2016, @12:44PM

    by Kilo110 (2853) Subscriber Badge on Tuesday August 23 2016, @12:44PM (#392086)

    Why would any company invest in R&D if their product can be reverse engineered and replicated before they can recoup their costs?

    Also in theory other private organizations could review and test for safety, but in practice it doesn't really happen. See the lack of regular open source code auditing and the too few replication studies done in academia.

    Starting Score:    1  point
    Karma-Bonus Modifier   +1  

    Total Score:   2  
  • (Score: 0) by Anonymous Coward on Tuesday August 23 2016, @01:31PM

    by Anonymous Coward on Tuesday August 23 2016, @01:31PM (#392107)

    first mover advantage. reputation, quality control.
    there are many ways to make it profitable.
    or at the very least compromise to limit patent to only 1 year monopoly.
    patents are out of control and are the largest money suck in our healthcare system.

    Capitalism and free markets are good,
    monopolies/bailouts and cronyism supported but liberals and statists are evil.

    • (Score: 2) by HiThere on Tuesday August 23 2016, @03:09PM

      by HiThere (866) Subscriber Badge on Tuesday August 23 2016, @03:09PM (#392161) Journal

      I think a 5 year monopoly is generally justifiable. 10 years if there is a large amount of required initial investment...but you should need to really prove the requirement. And patents should be unenforceable against individuals whose income is less than half of yours...without allowing either party exemptions. Perhaps also companies should not be able to enforce patents against other companies whose income was less than half of theirs, but I'm less certain.

      --
      Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
    • (Score: 0) by Anonymous Coward on Tuesday August 23 2016, @04:09PM

      by Anonymous Coward on Tuesday August 23 2016, @04:09PM (#392193)

      That would not be enough to even cover the costs of a Phase I clinical trial. It would maybe be enough for the pre-clinical work.

  • (Score: 4, Insightful) by jelizondo on Tuesday August 23 2016, @02:46PM

    by jelizondo (653) Subscriber Badge on Tuesday August 23 2016, @02:46PM (#392147) Journal

    Children, children... read history instead of playing Pokémon...

    In an interview [nytimes.com], after the Ann Arbor conference, Murrow asked Salk, "Who owns the patent on this vaccine?" Salk magnanimously replied: "Well, the people, I would say. There is no patent. Could you patent the sun?"

    Not everything should be about profit, particularly not when dealing with human health and life.

    No profit on saving lifes? I guess that makes a communist...

    • (Score: 0) by Anonymous Coward on Tuesday August 23 2016, @04:16PM

      by Anonymous Coward on Tuesday August 23 2016, @04:16PM (#392197)

      To be fair, the Salk vaccine was just inactivated virus. Could you patent the virus or the formalin-inactivation of the virus?

      I'm all for universal healthcare, but patents are useful for drugs with high development costs while we have a for-profit system.

    • (Score: 2) by Kilo110 on Tuesday August 23 2016, @07:58PM

      by Kilo110 (2853) Subscriber Badge on Tuesday August 23 2016, @07:58PM (#392262)

      Modern drug development is high risk and high cost. A pharma company may go through dozens of possible drugs until they land one that works and is safe. This means considerable cost to bring a single drug to market. If there's no assurance of at least breaking even (forget about profit for now) no one would take that risk.

      It's all well and good to pooh-pooh the evil capitalists and their greed for profit. But the labs need to be furnished. Lights and water kept running. Researchers need to be paid. Studies to be run on the safety and efficacy of drugs. If all of that work and investment can be cancelled out by some generics drug manufacturer on a shoe-string budget a quarter or two after launch, it'll be for nothing. And development costs will only increase as new complex and powerful technologies are introduced. Stem cells, dna editing, who knows what else.

      Lastly. There's no need to be condescending by calling everyone children. Can we all act as adults here?

      • (Score: 0) by Anonymous Coward on Tuesday August 23 2016, @08:36PM

        by Anonymous Coward on Tuesday August 23 2016, @08:36PM (#392286)

        Also, without patents companies would rely on drugs being a black box that are protected trade secrets or have increasingly complex formulations to prevent reverse engineering.

      • (Score: 2) by turgid on Tuesday August 23 2016, @08:42PM

        by turgid (4318) Subscriber Badge on Tuesday August 23 2016, @08:42PM (#392288) Journal

        There is a powerful argument for state-owned, public-funded medical research. Let the bread heads do the easy less-risky stuff and the rest of us can pull together and look after ourselves.

        • (Score: 1) by khallow on Tuesday August 23 2016, @10:42PM

          by khallow (3766) Subscriber Badge on Tuesday August 23 2016, @10:42PM (#392354) Journal

          There is a powerful argument for state-owned, public-funded medical research.

          And that powerful argument is?

          Let the bread heads do the easy less-risky stuff and the rest of us can pull together and look after ourselves.

          There is nothing too risky for the private world. There are purely private markets that have risk that makes the medical industry look tame (such as the sea salvage industry or oil well fire fighters). They do just fine without government funding.

          I think the real powerful argument here is that government is notorious for coming up with rules and spending that don't reduce risk or make us safer, including the medical industry and medical research, but make everything cost a lot more.

          • (Score: 3, Insightful) by jelizondo on Tuesday August 23 2016, @11:55PM

            by jelizondo (653) Subscriber Badge on Tuesday August 23 2016, @11:55PM (#392378) Journal

            Oh, my god.

            You mean as long as it is profitable it is free enterprise and we hate the government; as soon as large loses loom, flip-flop, we love the government and please bail us out.

            Please stop watching Fox News, their universe is completely different from the one you and I live in.

            • (Score: 0, Troll) by khallow on Wednesday August 24 2016, @12:20AM

              by khallow (3766) Subscriber Badge on Wednesday August 24 2016, @12:20AM (#392382) Journal

              You mean as long as it is profitable it is free enterprise and we hate the government; as soon as large loses loom, flip-flop, we love the government and please bail us out.

              You know, you could think. So let's try that. What is the research that is so expensive and so risky, yet still has a huge return on investment to justify public funding rather than private? Sorry, it doesn't exist. Even stuff like space stations or large particle colliders are within the grasp of the private world. Instead, we see the usual squandering of public funds on scientific white elephants, and people with a remarkable willful ignorance of economics.

        • (Score: 2, Insightful) by Anonymous Coward on Tuesday August 23 2016, @10:53PM

          by Anonymous Coward on Tuesday August 23 2016, @10:53PM (#392357)

          state-owned, public-funded medical research

          This, together with GP's on-target use of "Communist", gets top marks from me.

          ...and isn't most fundamental biological research already being done in public universities?
          Biologists and physicians, am I wrong?

          ...and for those who aren't aware, USA's healthcare costs are the highest[1] on the planet and the results are far from the best.

          [1] USAians spend ~3x what Britons do and Cuba (with its minimal monetary resources) bests USA in several ways in quality of outcome--largely through easy access and early intervention.

          -- OriginalOwner_ [soylentnews.org]

      • (Score: 2) by jelizondo on Tuesday August 23 2016, @11:47PM

        by jelizondo (653) Subscriber Badge on Tuesday August 23 2016, @11:47PM (#392372) Journal

        Sorry if I caused you offense.

        The effect intended was sarcasm together with the fact that I'm usually the oldest person around fora like this. (At Soylent I suspect only Runaway1956 is in my league, maybe a couple of others who might have encountered 80-column cards used in real-life.)

        The sarcasm part is due to younger people believing that the “correct” way is the modern may, even if other ways might be possible and even desirable. And even if the results are less than desirable, such as big pharma milking consumers, kids insist on there being only the market as a solution.

        When I was young, no thinking bro would defend the status quo and in return we got civil rights, a presidential resignation and good music. Now, it seems to be the opposite, if you are right thinking, then you must defend the Establishment.

        Now, I figure I’m ready for disposal, in my previous post I forgot to add: Get off my lawn! :-)

      • (Score: 1, Informative) by Anonymous Coward on Wednesday August 24 2016, @02:00AM

        by Anonymous Coward on Wednesday August 24 2016, @02:00AM (#392409)

        The largest cost for a new drug is marketing, none of that boring research stuff.

        Also if you don't pay to send doctors on junkets, who is going to trick all your customers into buying your 'medicine'?

  • (Score: 5, Insightful) by CirclesInSand on Tuesday August 23 2016, @03:50PM

    by CirclesInSand (2899) on Tuesday August 23 2016, @03:50PM (#392181)

    Why would any company invest in R&D if their product can be reverse engineered and replicated before they can recoup their costs?

    The idea that humans won't research new products unless the government grants market monopoly is so bizarre that it makes a person wonder how anyone with any exposure to humans could believe it. Creating new awesome things is what humans do, it's an evolutionarily defining characteristic of humanity.

    Just because the government forcefully involves itself in human activity doesn't mean they are helping. An analogy I heard once was a random man jumping in front of a parade and pretending to be leading it.

    Have you ever actually met an engineer before? I don't mean some kid trying to get a college degree to make money, I mean the kind of person who has half disassembled appliances all over their house, and more tools than clothes. Try stopping that person from inventing new things; it cannot be done.

    But since you did ask for a business motivated example reason, here is one among many: a small company would research a new product to make a name for themselves so they can overtake the larger company. And when the larger company tries to copy the smaller company's product, the smaller company has already researched something new again. You can't play catchup forever and you also can't reverse engineer good customer service and a good reputation. Investors will be able to distinguish between an old bloated inflexible copycat company and a new company with new ideas.

    The reason this new research doesn't happen is because of patents. Why bother doing new research if some large company with a huge patent portfolio is just going to sue you? Patents don't promote research, they destroy it.

    And I think that if you consider it even briefly, the reason why "open source" and "academia" are not counter examples to business auditing should be obvious. The keyword is "business". A counter example would have to be an area where a business should be audited, the government hasn't done it, and the markets haven't moved to do it either. You can literally find private reviews of the temperature gauges in outdoor grills.

    • (Score: 1, Informative) by Anonymous Coward on Tuesday August 23 2016, @04:27PM

      by Anonymous Coward on Tuesday August 23 2016, @04:27PM (#392200)

      Have you ever actually met an engineer before?

      Have you met a pre-clinical biologist, toxicologist, medicinal chemist, analytical chemist, clinical trial director, lawyer, and doctor all rolled-up into someone rich enough to actually be able to "tinker" with drug development?

      Medical science costs a lot of money and, currently, the public does not want to pay for academics or the government to do all the steps. There are also many laws that are in place to protect patients, lab animals, neighbors, and the environment from the products and waste from the drug development process.

      • (Score: 4, Informative) by CirclesInSand on Tuesday August 23 2016, @06:34PM

        by CirclesInSand (2899) on Tuesday August 23 2016, @06:34PM (#392233)

        Again, the position that researchers will never work together to develop new products unless the government gives them market monopoly. It's absolutely bizarre that anyone takes this seriously.

        There's a ton of voluntary public funding for research, and for all the costs you mentioned, they are nothing compared to the cost of having your research be illegal because of patent infringement.

        Furthermore, development in medicine isn't (usually) made in enormous leaps, it is made in small steps. Small steps depend on previous small steps being available to improve upon. Patent infringement prevents this. We can only imagine how many medicines haven't been developed at all because researchers weren't allowed to work on illegalized-by-patents life saving research.

        • (Score: 0) by Anonymous Coward on Tuesday August 23 2016, @08:31PM

          by Anonymous Coward on Tuesday August 23 2016, @08:31PM (#392282)

          estimates of drug development costs are around US$1.3 billion to US$1.7 billion.

          Researchers would love to work together, but it is a question of resources. I would be happy if the US government or a non-profit would dump that kind of money into developing drugs without patents.

          I'm also not convinced that fear of patent infringement is what is holding any of this back. If you mean incremental changes on small molecule drugs, then that already happens in pre-clinical development otherwise the abysmally low clinical trial success rate would be even lower. If you mean patents are interfering with academic research, then you are way off.

          http://m.ctj.sagepub.com/content/early/2016/02/06/1740774515625964.full [sagepub.com]

    • (Score: 2) by Kilo110 on Tuesday August 23 2016, @09:24PM

      by Kilo110 (2853) Subscriber Badge on Tuesday August 23 2016, @09:24PM (#392312)

      The idea that humans won't research new products unless the government grants market monopoly is so bizarre that it makes a person wonder how anyone with any exposure to humans could believe it. Creating new awesome things is what humans do, it's an evolutionarily defining characteristic of humanity.
      Just because the government forcefully involves itself in human activity doesn't mean they are helping. An analogy I heard once was a random man jumping in front of a parade and pretending to be leading it.
      Have you ever actually met an engineer before? I don't mean some kid trying to get a college degree to make money, I mean the kind of person who has half disassembled appliances all over their house, and more tools than clothes. Try stopping that person from inventing new things; it cannot be done.

      I agree but you’re not factoring in barrier to entry. Drug development is highly technical and very expensive and risky. A basement tinkering who likes to disassemble appliances can NEVER by himself develop a drug.

      But since you did ask for a business motivated example reason, here is one among many: a small company would research a new product to make a name for themselves so they can overtake the larger company. And when the larger company tries to copy the smaller company's product, the smaller company has already researched something new again. You can't play catchup forever and you also can't reverse engineer good customer service and a good reputation. Investors will be able to distinguish between an old bloated inflexible copycat company and a new company with new ideas.

      This is just fantasy. Modern drug development is incredibly complex and incredibly risky. Pharma houses simultaneously research dozens of drugs in hopes that a handful actually work and are safe. They fully expect most of their work is wasted but they still research it because you don’t know which avenues will bear fruit until you researched it. There’s no way a small startup can out-research a big company. By the time the startup has finished one research project. Big pharma has completed 6.

      The reason this new research doesn't happen is because of patents. Why bother doing new research if some large company with a huge patent portfolio is just going to sue you? Patents don't promote research, they destroy it.

      No No! Just the opposite. Remember how most of their research will fail? The revenue from the sales of the successful drugs pays for all the failed research. And companies are OK with failing because they know they’ll be able to still fund development due to patents on the successes. Killing off patents entirely will KILL research into all but a handful of possibilities. This is NOT good as many drugs will be left undiscovered if never researched. We can discuss the appropriate length of a patent, but killing it off entirely will have the opposite effect.

      And I think that if you consider it even briefly, the reason why "open source" and "academia" are not counter examples to business auditing should be obvious. The keyword is "business". A counter example would have to be an area where a business should be audited, the government hasn't done it, and the markets haven't moved to do it either. You can literally find private reviews of the temperature gauges in outdoor grills.

      I referenced those examples since you said the pharma market would govern itself on safety. Those are both real life systems that use peer auditing as quality control. Open source requires others programmers to volunteer their time to vet the code. Academia requires other scientists to run replication studies to vet their findings. Yet neither of those really happens to the degree as needed. Your proposed system also requires companies/individuals to volunteer their time and effort to proof others companies work. If it doesn’t work in open source development or academia, why would it work in pharmaceuticals? You vaguely mention “business” and gas grill thermostats. But the qualifications and cost to review a gas grill thermostat are significantly lower than to analyze a new drug molecule and review their research. Furthermore, the effects of an incorrect review are significantly different as drug efficacy and safety studies are a literal matter of life and death.

    • (Score: 0) by Anonymous Coward on Wednesday August 24 2016, @02:11AM

      by Anonymous Coward on Wednesday August 24 2016, @02:11AM (#392416)

      Consumers care for none of that. They want it cheaper. Why else all the fuss over Chinese imports killing American jobs.

      Investors also wouldn't care. If a group of investors have enough money they can produce more of your product, faster than you can. Economies of scale and cheap land, labour, regulations, will eat your lunch. You make something new, I'll copy that too, thanks.

  • (Score: 2) by edIII on Tuesday August 23 2016, @08:35PM

    by edIII (791) on Tuesday August 23 2016, @08:35PM (#392285)

    Recouping costs is one thing. That is NOT what is happening here.

    This is AVARICE. Watch Michael Moore's "Sicko" and you can see people getting meds for nickel for the same stuff that costs over $100 in the U.S. It's the same reason why there are huge buses of senior citizens going to Canada to get drugs.

    All of the executives deserve to burn in hell. While they're still here before they get there, we should dox every one of those fuckers. Why?

    So when they go into a restaurant they're ice tea is $49.50. They're side of fruit $93.75. The full meal is $432.68.

    When they complain to the rest of us, we can ask them back why the fuck is a life-saving EpiPen all of the sudden $500? When they respond tongue-in-cheek about RoI and we, the unwashed masses, are simply too ignorant about business and Capitalism, we can respond right back, "No, we learned quite well. That's why your meal is $432.68 and only cost us $8.00 to make in the kitchen. We know you will be back, because like life saving drugs, you have choice but to eat, or die".

    --
    Technically, lunchtime is at any moment. It's just a wave function.
    • (Score: 0) by Anonymous Coward on Thursday August 25 2016, @09:23AM

      by Anonymous Coward on Thursday August 25 2016, @09:23AM (#392929)

      We know you will be back, because like life saving drugs, you have choice but to eat, or die".

      Let me remind you its illegal to prepare your own meal from stuff you can get. We have "Worked With Congress" to have Law passed. You are not a certified chef and cannot prepare food. Even your own.

      Thank you, Congress, and let me Shake Your Hand, for passing legislation for my business model and taxing the people to support armed enforcement personnel if needed to protect my business model!