Stories
Slash Boxes
Comments

SoylentNews is people

posted by on Sunday February 12 2017, @06:39AM   Printer-friendly
from the patent-trolls-by-another-name dept.

Dr. Derek Lowe, from In the Pipeline, writes:

So since drug pricing and FDA regulations are so much in the news, it would seem like the perfect time for a small company to game the system for big profits, right? That's apparently what Marathon Pharmaceuticals believes. They just got approval for deflazacort, a steroid, as a treatment for Duchenne Muscular Dystrophy.

[...] So what's not to like? Well, this drug has been around since the early 1990s. Marathon most certainly did not invent it. Nor did they think of applying it to DMD patients – the biggest clinical trial of the drug for that indication was done over twenty years ago, by someone else. DMD patients in the US were already taking the (unapproved) drug by importing it from Canada. Marathon just dug through the data again and ran a trial in 29 patients themselves, from what I can see. I should note that this is not any sort of cure, nor does it address the underlying pathology of the disease. The steroid treatment makes muscle strength in DMD patients stronger – barely. But even for that benefit, US patients will now have to get it from Marathon at something like 50 to 100 times the former price.

[...] So while I defend the FDA's function of making it tough on new drugs (making them prove safety and efficacy), I cannot stand how loose they are with old generic compounds. The agency hands out extremely valuable rewards like lollipops in these cases – a priority review voucher can be sold for hundreds of millions of dollars

[...] And they're also allowing the likes of Marathon to make the rest of the drug industry look like greedy sociopaths. Marathon, Catalyst, T*ring and all the rest of the people who are pulling these tricks have the word "Pharmaceuticals" in their name, but they are not drug companies. They discover nothing. They do no research. They take virtually no risks. They exist only to play legal games and watch the money roll in.

[...] As for the FDA, the agency probably can't change this on its own, though, even if it wants to – Congress has to act to give them the authority to deny market exclusivity or priority review vouchers under some conditions. Either that, or we should rethink these incentives entirely, because they are (clearly) too easy to exploit for fast bucks.

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

Also at ArsTechnica.


Original Submission

 
This discussion has been archived. No new comments can be posted.
Display Options Threshold/Breakthrough Mark All as Read Mark All as Unread
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
  • (Score: 3, Informative) by migz on Sunday February 12 2017, @09:57AM

    by migz (1807) on Sunday February 12 2017, @09:57AM (#466078)

    I cannot understand why companies are always painted as the culprits, when the problem is one that has been created by government. In this case the FDA should not be involved at all in regulating anything except fraud.

    If company A invents a drug, then that is great. Some would argue that as a result of those costs, companies should be granted a monopoly to license that drug. I don't think that is a good idea. A large chunk of those costs are invented by the incumbent in conspiracy with the regulators to keep competition out. This is the modern equivalent of a guild system. Anybody should be allowed to produce anything in their basement, and the FDA should only be there to prevent fraud.

    If someone sells chalk pills as aspirin, then they can get involved. They can even have a little FDA approved logo to show that they "have been tough". Heck if would probably be a good thing if there were private competitors to the FDA that had their own "safety marks". If I want to buy cut price acetylsalicylic acid from the cafe, nobody should stop me. If Beyer pharmaceutical's want's to put an Asprin(R) on theirs and charge more, then they should be allowed to. Nobody else should be allowed to as long as they control the trademark, since that would be fraud. The FDA should however leave everybody else alone.

    • (Score: 2, Informative) by Anonymous Coward on Sunday February 12 2017, @04:06PM

      by Anonymous Coward on Sunday February 12 2017, @04:06PM (#466179)

      In this case the FDA should not be involved at all in regulating anything except fraud.
      ...
      If someone sells chalk pills as aspirin, then they can get involved.

      You are hopelessly naive. The FDA wasn't created out of nowhere. It exists because people were being killed. [wikipedia.org]
      No amount of after the fact action can undo death or serious injury.
      The FDA is imperfect because it is a creation of imperfect humans, but your 'solution' is a recipe for far worse results.
      We've already been down that path.

      • (Score: 2) by migz on Sunday February 12 2017, @05:08PM

        by migz (1807) on Sunday February 12 2017, @05:08PM (#466208)

        > You are hopelessly naive.
        Ad hominum
        > The FDA wasn't created out of nowhere.
        I never claimed that it was.
        >It exists because people were being killed.
        Yep, that's fraud.
        > No amount of after the fact action can undo death or serious injury.
        Yep.
        >The FDA is imperfect because it is a creation of imperfect humans,
        Yep.
        >but your 'solution' is a recipe for far worse results.
        Nope. You have not refuted a single word, nor have you presented anything in support of your contention.
        > We've already been down that path.?
        Really? There was a time that the FDA only acted as a vetting agency, and had competition? When was this?

        • (Score: 0) by Anonymous Coward on Sunday February 12 2017, @05:48PM

          by Anonymous Coward on Sunday February 12 2017, @05:48PM (#466220)

          > Ad hominum

          Nope. For your future reference:

          Ad hominem: "You are wrong because you are stupid."
          Not ad hominem: "You are stupid because you are wrong."

        • (Score: 1) by Roger Murdock on Monday February 13 2017, @12:43AM

          by Roger Murdock (4897) on Monday February 13 2017, @12:43AM (#466383)

          >>It exists because people were being killed.
          >Yep, that's fraud.

          It's not fraud if the deaths were from compounds that were accurately listed.

          > nor have you presented anything in support of your contention

          Neither have you really, just a bunch of opinions and something about an FDA conspiracy. How is any research going to be funded if the final product will just be copied as soon as it hits the market? Or do you think R&D costs are actually so low (if it weren't for the FDA) that being (marginally) first to market would make up for it?

      • (Score: 2) by sjames on Sunday February 12 2017, @05:46PM

        by sjames (2882) on Sunday February 12 2017, @05:46PM (#466219) Journal

        There is justification for regulating novel drugs and inactive ingredients in drugs, but fundamentally, the FDA is just as much after the fact as anyone else. They do not have anything in place that could actually prevent a bad actor from including a toxic substance into a remedy except the knowledge that the after-the-fact consequences would be ruinous.

        It's fine that we have the FDA provide a means by which a novel substance can become approved for human consumption. But once it is, the FDA should butt out other than periodic checking that the drug contains what it says it does in the amount it claims (or perhaps the FTC should do that, they seem to manage it without quadrupling the price).

    • (Score: 0) by Anonymous Coward on Sunday February 12 2017, @04:12PM

      by Anonymous Coward on Sunday February 12 2017, @04:12PM (#466181)

      Some would argue that as a result of those costs, companies should be granted a monopoly to license that drug. I don't think that is a good idea.

      Do you have a better idea?
      Doing research, developing drugs, and running clinical trials all cost money. That money has to come from somewhere and many people are not happy with tax money even paying for the first part.

      • (Score: 2) by migz on Sunday February 12 2017, @05:12PM

        by migz (1807) on Sunday February 12 2017, @05:12PM (#466211)

        > Do you have a better idea?
        Sure. Don't grant monopolies.
        > Doing research, developing drugs, and running clinical trials all cost money.
        Sure. None of those should be required to manufacture and distribute substances.
        > That money has to come from somewhere
        No it does not. You only need the money if the FDA forces you to do it. Otherwise people can find other ways to fund research, trials, and drugs.
        > ... any people are not happy with tax money even paying for the first part.
        I'm not happy with tax money paying for ANY part of this WHATSOEVER. The FDA should be self funding.

        • (Score: 0) by Anonymous Coward on Sunday February 12 2017, @10:43PM

          by Anonymous Coward on Sunday February 12 2017, @10:43PM (#466334)

          Otherwise people can find other ways to fund research, trials, and drugs.

          Like what?

          Without patent protection, how would pharmaceutical companies fund the research necessary to develop new drugs? Should they try to rely on trade secrets, enter into exclusive contracts with healthcare providers, or should they just stop making new drugs?

    • (Score: 2) by sjames on Sunday February 12 2017, @10:09PM

      by sjames (2882) on Sunday February 12 2017, @10:09PM (#466317) Journal

      The FDA is a serious enabler but Marathon and their ilk play it for all it's worth. You may leave your backpack on the bench at the park, but I'm still a thief if I take it away, remove your ID, and treat it as my own.

  • (Score: 2) by Justin Case on Sunday February 12 2017, @11:39AM

    by Justin Case (4239) on Sunday February 12 2017, @11:39AM (#466096) Journal

    This is not a case of too little regulation but too much.

    The only thing the FDA should control is whether a product gets a sticker or logo saying "approved by FDA". Then, if you're the sort of person who wants to wait for the results of 10 years of tests, you don't try anything that might help you until 10 years have gone by and billions of dollars have been spent. However, if you don't have ten years, maybe you can risk an experiment. Or get something from Canada without making yourself a felon and risking spending those last six months of your deteriorating life in jail.

  • (Score: 3, Insightful) by Rosco P. Coltrane on Sunday February 12 2017, @11:52AM

    by Rosco P. Coltrane (4757) on Sunday February 12 2017, @11:52AM (#466099)

    And they're also allowing the likes of Marathon to make the rest of the drug industry look like greedy sociopaths

    Because it isn't?

    The whole pharma industry is an unending lithany of profiteering on the back of sick people, price fixing and corruption. When was the last time you saw any of these companies putting out a truly useful molecule at a reasonable price for the good of the people?

    • (Score: 2) by Justin Case on Sunday February 12 2017, @12:02PM

      by Justin Case (4239) on Sunday February 12 2017, @12:02PM (#466105) Journal

      Since you don't need or want money, perhaps you could do the good deed you seem to expect others to do, and start a pharma company that is unprofitable. I mean, no one's stopping you.

      No one but those pesky regulators, that is.

      • (Score: 3, Interesting) by Rosco P. Coltrane on Sunday February 12 2017, @12:09PM

        by Rosco P. Coltrane (4757) on Sunday February 12 2017, @12:09PM (#466108)

        Can't you understand the difference between a new, useful molecule at, say, 5x profit margin and an old, tired one at 100x?

        I'm all for pharma companies making profit - especially considering how much R&D and red tape they have to deal - but I'm totally against obscene profits that benefit no-one. Most pharma companies don't do real R&D to solve real health problems anymore: they just do variants of old shit they can patent and profit on. Incidentally, part of the reason why they behave like that is the system the very regulators you seem to value so much set in place - the others being, they're greedy bastards.

        • (Score: 2) by Justin Case on Sunday February 12 2017, @12:47PM

          by Justin Case (4239) on Sunday February 12 2017, @12:47PM (#466119) Journal

          Yes, I understand the difference, and since you do too, buy the rights to the old tired one and sell at 2x.

          the very regulators you seem to value so much

          Uh, no, that would be someone else. I'm strongly deregulate when it comes to the FDA. You should have a choice whether or not to buy and use FDA approved substances.

          they're greedy bastards.

          In other words, they're a group of people who want or need money. Since you don't want or need money (great to be you I guess) get off your high horse and do something good for the world instead of mumbling around your Cheetos about what others should do. Start an unprofitable pharma company. Round up investors who, like you, don't want or need money but just want to Do Good Things For The World. Promise your investors a negative rate of return as you spend all their money developing or buying your product line. Sell at a loss and go to sleep every night knowing you're not a bastard.

          What are you waiting for?

          • (Score: 2) by sjames on Sunday February 12 2017, @05:17PM

            by sjames (2882) on Sunday February 12 2017, @05:17PM (#466212) Journal

            You claim to know the difference, but you demonstrate that you don't.

            If the FDA were stripped of the power to grant exclusivity in exchange for ass kissing and we then enforced existing laws against such practices as paying potential competitors to stay out of the market AND we force the FDA to treat generics as generic rather than treating them as a brand new product, we might actually see companies willing to produce generic drugs in exchange for a reasonable profit (that is, not at a loss but not for hundreds of times the cost).

  • (Score: 0) by Anonymous Coward on Sunday February 12 2017, @02:22PM

    by Anonymous Coward on Sunday February 12 2017, @02:22PM (#466150)

    Step 1: allow imports from other reasonable countries.
    Step 2: give the FDA the ability to call out sham differences where two drugs are different enough to get different rules but essentially the same
    Step 3: perhaps include price versus benefit into the mix of things considered during patent and drug approval proceedings
    Step 4: tell Marathon that under the new rules, their 'invention' does not add to the availability of treatments and so no longer qualifies for a monopoly
    Step 5: (For extra credit) consider penalties for those gaming the system

    If you believe in a fundamental right to medical care, the pharma is not just another industry.
    It, and the medical profession in general, have a responsibility to help folks.
    This doesn't mean they can't make a good living.
    Just not a crazy one with contrived scarcity, non-productive efforts, and a general attitude of anything for a buck.

    These special rules are there to support bringing new treatment options where it helps the patient.
    They are not there to cause windfall profits.