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Agreed. Any little price accountability will be lost when they convince that the federal government will need to pay for it.[1] I have to unfortunately be very

Agreed. Any little price accountability will be lost when they convince that the federal government will need to pay for it.[1] I have to unfortunately be very vague because I don't remember the actual reference, but I remember a similar problem where the lobbyists didn't get what they wanted , and discreetly added it into some kind of unrelated bill in the midst of some fine print.[2] An excellent use for using something like natural language processing is to find outlier items which simply do not belong in a law which is being passed. [1] I am also told that from the perspective of the R&D labs which spend a ton of money up front to produce the drug that this is the only way to recoup costs. And the costs for the R&D labs are usually blamed on excess regulation, so that is apparently a sort of justification for these subsidy requests (which still doesn't make sense). Edit: [2] I bring this up because the article mentions the following and I think the euphemism has at least one possible explanation: "But a review of Mylan’s lobbying history makes clear that the company has an exceptional track record at influencing government policies, both in Washington and in state capitals. Heather Bresch, Mylan’s chief executive, called the effort “our unconventional approach to growing this franchise” in remarks to Wall Street analysts last year."

criddell 10y ago
Maybe they should fold the R&D department into the marketing department. That's where all the drug company money is spent.
- rayiner 10y ago
  The fact that companies often spend more on marketing than R&D is irrelevant. The fact is that they spend billions on R&D. They have to recoup that. Presumably they don't spend money on marketing for shits and giggles--they spend how much they need to maximize revenue.
  - FireBeyond 10y ago
    Ask yourself, why is the United States the only country in the world where advertising prescription medicine to consumers is allowed? Why is it even needed? I know some people say "education", but that's backward. You have a problem. You go to your physician. He works out a treatment plan for you. For drugs advertised for specific conditions? To enlighten you to alternatives? You can oftentimes assume that alternatives exist, for most common complaints. For those that don't? Those ads are such a dragnet of wide ranging and vague conditions that oftentimes, the majority of the population would qualify ("Are you feeling run down? Do you have trouble getting to sleep? Ask your doctor about trying XXX". No. Ask your doctor about your conditions. Let them decide whether to try XXX. Or YYY. Or just to get more sleep). There's no justifiable need that I can see that prescription medication need be advertised to anyone other than physicians and practitioners. Oh, and it's not "often" that they spend "more". There is not one of the top ten pharma companies that spends more on R&D than marketing. Every one outspends on marketing. And by "more", the smallest gap is "four times more" leading up to "seventeen times more". And we wonder why healthcare is so expensive here...
    - GordonS 10y ago
      > why is the United States the only country in the world where advertising prescription medicine to consumers is allowed? I believe it's also allowed in New Zealand. But I totally agree with you, it's a ridiculous practise
      - FireBeyond 10y ago
        I knew it had been and appears to still be, but I believe it's been already decided to end, if not already.
    - SilasX 10y ago
      >Why is it even needed? Because, contrary to popular belief, doctors aren't gods, and have about the same fraction of slackers as any other occupation. Unless we're ready to have a really aggressive program for revoking licenses of doctors who don't keep up with modern advances, they can and do miss available treatments. "Hm, I could eagerly search all the latest treatments that might be relevant to my patents, or I could write them up something based on gut feel and what I learned in med school 30 years ago. Both pay the same."
      - mikeyouse 10y ago
        Doctors / nurses / pharmacists are required to submit dozens of hours of continuing medical education every year to maintain their licenses. There is an approximately 0% chance that a patient with no background in medicine will learn something useful from a TV Commercial that everyone in the treatment plan doesn't already know.
        SilasX 10y ago
        You're seriously claiming that no doctor has ever modified a treatment plan due to research provided by a patient?
        mikeyouse 10y ago
  - criddell 10y ago
    It's very relevant. With the incentives in place now, the most profitable thing a drug company can do is alter an existing drug enough to extend patent protection for as long as possible. It's sleazy. Are you not bothered at all about the EpiPen situation? Martin Shkreli doesn't make you angry? A pharmacologist friend once told me that the best way for a drug company to get a customer for life is to make sure they don't cure or kill them. She was joking, but I think it's true.
    - rayiner 10y ago
      They can't "extend patent protection" for the drug. Only the improvement. The existing drug loses patent protection. And no, the Epipen thing doesn't bother me. It's narrow minded to think about issues one crisis at a time. The only question is: how do you create a system with the proper incentives? At the end of the day, Mylan runs a very capital intensive business and has a profit margin about half what Google or Apple do. I think it creates perverse and absurd incentives for it to be more profitable to be in the advertising business than to be in the business of saving lives. That's the bottom line.
      - criddell 10y ago
        > They can't "extend patent protection" for the drug Yes they can. The Hatch-Waxman Act was written specifically for this. Also see: http://www.citizen.org/congress/article_redirect.cfm?ID=6435 http://www.citizen.org/congress/article_redirect.cfm?ID=6435 You never said whether or not Martin Shkreli makes you angry. Should investors be encouraged to find undervalued drugs, buy the IP, then raise the price through the roof? That would be good for society? Part of the reason the advertising business is so profitable is due to companies spending so much money on ads. We banned many kinds of cigarette ads because of public health concerns and I would argue that there are legitimate reasons to ban many types of drug ads as well.
        rayiner 10y ago
        You're confusing different things. Hatch Waxman does not extend the patent term for orphan drugs. It allows the patent term at the time of FDA approval to be extended to account for unusual approval delays, but only up to the point there is 14 years left post-approval. That has nothing to do with extending the patent term for modifications to the drug, as you state above. As to orphan drugs, Hatch Waxman does not extend patent protection. It provides a period of FDA exclusivity by preventing the filing of a new ANDA application. That provision has nothing to do with Epipen. As for Shkreli--he's an asshole, but it makes no sense to focus narrowly on isolated abuses. Does FDA exclusivity for orphan drugs make up a non-negligible percent of healthcare spending (I think the answer is no)? If not than its just rage-bait, not something that we should base policy judgments on. The big problem here is that manufacturers of generics have almost zero ability to invest in even minimal R&D. So they won't take an out-of-patent drug and use it to treat a long-tail disease. The orphan drug program is limited to diseases affecting less than 200,000 Americans. In the decade before Hatch-Waxmen, only 10 such drugs came to market. Since then, 400 have. So is it reasonable to judge the whole program by the Shkreli example?

criddell 10y ago

Maybe they should fold the R&D department into the marketing department. That's where all the drug company money is spent.

rayiner 10y ago
The fact that companies often spend more on marketing than R&D is irrelevant. The fact is that they spend billions on R&D. They have to recoup that. Presumably they don't spend money on marketing for shits and giggles--they spend how much they need to maximize revenue.
- FireBeyond 10y ago
  Ask yourself, why is the United States the only country in the world where advertising prescription medicine to consumers is allowed? Why is it even needed? I know some people say "education", but that's backward. You have a problem. You go to your physician. He works out a treatment plan for you. For drugs advertised for specific conditions? To enlighten you to alternatives? You can oftentimes assume that alternatives exist, for most common complaints. For those that don't? Those ads are such a dragnet of wide ranging and vague conditions that oftentimes, the majority of the population would qualify ("Are you feeling run down? Do you have trouble getting to sleep? Ask your doctor about trying XXX". No. Ask your doctor about your conditions. Let them decide whether to try XXX. Or YYY. Or just to get more sleep). There's no justifiable need that I can see that prescription medication need be advertised to anyone other than physicians and practitioners. Oh, and it's not "often" that they spend "more". There is not one of the top ten pharma companies that spends more on R&D than marketing. Every one outspends on marketing. And by "more", the smallest gap is "four times more" leading up to "seventeen times more". And we wonder why healthcare is so expensive here...
  - GordonS 10y ago
    > why is the United States the only country in the world where advertising prescription medicine to consumers is allowed? I believe it's also allowed in New Zealand. But I totally agree with you, it's a ridiculous practise
    - FireBeyond 10y ago
      I knew it had been and appears to still be, but I believe it's been already decided to end, if not already.
  - SilasX 10y ago
    >Why is it even needed? Because, contrary to popular belief, doctors aren't gods, and have about the same fraction of slackers as any other occupation. Unless we're ready to have a really aggressive program for revoking licenses of doctors who don't keep up with modern advances, they can and do miss available treatments. "Hm, I could eagerly search all the latest treatments that might be relevant to my patents, or I could write them up something based on gut feel and what I learned in med school 30 years ago. Both pay the same."
    - mikeyouse 10y ago
      Doctors / nurses / pharmacists are required to submit dozens of hours of continuing medical education every year to maintain their licenses. There is an approximately 0% chance that a patient with no background in medicine will learn something useful from a TV Commercial that everyone in the treatment plan doesn't already know.
      - SilasX 10y ago
        You're seriously claiming that no doctor has ever modified a treatment plan due to research provided by a patient?
        mikeyouse 10y ago
- criddell 10y ago
  It's very relevant. With the incentives in place now, the most profitable thing a drug company can do is alter an existing drug enough to extend patent protection for as long as possible. It's sleazy. Are you not bothered at all about the EpiPen situation? Martin Shkreli doesn't make you angry? A pharmacologist friend once told me that the best way for a drug company to get a customer for life is to make sure they don't cure or kill them. She was joking, but I think it's true.
  - rayiner 10y ago
    They can't "extend patent protection" for the drug. Only the improvement. The existing drug loses patent protection. And no, the Epipen thing doesn't bother me. It's narrow minded to think about issues one crisis at a time. The only question is: how do you create a system with the proper incentives? At the end of the day, Mylan runs a very capital intensive business and has a profit margin about half what Google or Apple do. I think it creates perverse and absurd incentives for it to be more profitable to be in the advertising business than to be in the business of saving lives. That's the bottom line.
    - criddell 10y ago
      > They can't "extend patent protection" for the drug Yes they can. The Hatch-Waxman Act was written specifically for this. Also see: http://www.citizen.org/congress/article_redirect.cfm?ID=6435 http://www.citizen.org/congress/article_redirect.cfm?ID=6435 You never said whether or not Martin Shkreli makes you angry. Should investors be encouraged to find undervalued drugs, buy the IP, then raise the price through the roof? That would be good for society? Part of the reason the advertising business is so profitable is due to companies spending so much money on ads. We banned many kinds of cigarette ads because of public health concerns and I would argue that there are legitimate reasons to ban many types of drug ads as well.
      - rayiner 10y ago
        You're confusing different things. Hatch Waxman does not extend the patent term for orphan drugs. It allows the patent term at the time of FDA approval to be extended to account for unusual approval delays, but only up to the point there is 14 years left post-approval. That has nothing to do with extending the patent term for modifications to the drug, as you state above. As to orphan drugs, Hatch Waxman does not extend patent protection. It provides a period of FDA exclusivity by preventing the filing of a new ANDA application. That provision has nothing to do with Epipen. As for Shkreli--he's an asshole, but it makes no sense to focus narrowly on isolated abuses. Does FDA exclusivity for orphan drugs make up a non-negligible percent of healthcare spending (I think the answer is no)? If not than its just rage-bait, not something that we should base policy judgments on. The big problem here is that manufacturers of generics have almost zero ability to invest in even minimal R&D. So they won't take an out-of-patent drug and use it to treat a long-tail disease. The orphan drug program is limited to diseases affecting less than 200,000 Americans. In the decade before Hatch-Waxmen, only 10 such drugs came to market. Since then, 400 have. So is it reasonable to judge the whole program by the Shkreli example?