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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.


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  • (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.

    Starting Score:    1  point
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    Total Score:   2  
  • (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).