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posted by martyb on Monday September 12 2016, @10:02AM   Printer-friendly
from the better-mousetrap-trapped-in-limbo dept.

AlterNet reports

The [EpiPen], which millions of Americans depend on, was invented in the 1970s by engineer Sheldon Kaplan[PDF], who died seven years ago in modest surroundings amid obscurity. But Kaplan's patent made its way into [the] Netherlands-based drug maker Mylan, which, since 2007, has jacked up the price of the spring-loaded injector from $57 a shot to $300.

[...] The high price [...] caught the attention of Dr. Douglas McMahon. The 38-year-old allergy specialist in St. Paul, Minnesota, has been thinking about how to improve on the EpiPen and to do so in a way that's affordable.

[...] McMahon saw that the EpiPen device was not only overpriced for what it does but also was too big to be easily carried in a pocket. For the past couple of years, he has been tinkering with injection-device components in his lab. And the result of his work is AllergyStop [1], an injection prototype that's small enough to fit on a key chain. McMahon claimed his device is as effective as the EpiPen and can be marketed and sold for about $50.

But, even though McMahon's device has been production-ready for the past two months, the steps he must take to get the device approved will cost him about $2 million and it will potentially take him years to go through all the hurdles required by the U.S. Food and Drug Administration for possible approval of his invention.

[1] All content is behind scripts. archive.li will run those for you.

Previously:
EpiPen's Price Increased 400% since 2008


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  • (Score: 5, Insightful) by esperto123 on Monday September 12 2016, @11:36AM

    by esperto123 (4303) on Monday September 12 2016, @11:36AM (#400631)

    The article kind of paints the FDA as a bad guy here, but the process that he (and everyone else, for that matter) has to go through is in place for good reason.
    He says that his device is ready, but we cannot be sure unless independent test is done and following a strict protocol to guarantee that it will behave as it should, in this case inject some epinephrine into the body, be effective, work reliably and not cause accidents, over dosage or other problems.

    Regarding the money to do that, if he holds the patent for the device I think it would probably be very easy to get a loan or associate with some medical device manufacturer (preferably not Mylan), if he wants to keep this open and free, he could try the federal government, NGOs, thrusts or other parties that I'm sure would love to help with this issue.

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  • (Score: 4, Insightful) by Arik on Monday September 12 2016, @12:11PM

    by Arik (4543) on Monday September 12 2016, @12:11PM (#400649) Journal
    It's not about safety. If it was about safety, he could get a third party to test and certify it for much less.

    It's about control, and barriers to entry in particular. The more barriers that can be raised to entry into a market (in this case, for pharmaceuticals and related items) the more protected the incumbents are and the higher the prices they can sell their goods for. This is the purpose the FDA serves, the purpose it was designed for, the purpose it has always served. 'Safety' is just a fig leaf.

    --
    If laughter is the best medicine, who are the best doctors?
    • (Score: 5, Informative) by fadrian on Monday September 12 2016, @01:05PM

      by fadrian (3194) on Monday September 12 2016, @01:05PM (#400673) Homepage

      Yes, third parties like bond rating agencies that were supposed to watch the ratings of all those AAA mortgage bonds for those banks in the late 2000's. I think that Libertarians have too simple minds - they can't see obvious failure modes.

      --
      That is all.
      • (Score: 0) by Anonymous Coward on Monday September 12 2016, @02:44PM

        by Anonymous Coward on Monday September 12 2016, @02:44PM (#400732)

        Yes, third parties like bond rating agencies that were supposed to watch the ratings of all those AAA mortgage bonds for those banks in the late 2000's.

        To be clear those bond rating agencies were paid by the banks who offered the bonds. The conflict of interest was so glaring that it is amazing it didn't fall apart far sooner. Arik's simple-minded solution has the exact same conflict of interest.

      • (Score: 2) by Arik on Monday September 12 2016, @03:45PM

        by Arik (4543) on Monday September 12 2016, @03:45PM (#400764) Journal
        You look directly at a failure mode of state capitalism and ascribe it to libertarianism. That's just perverse.

        Those bond rating agencies, and the banks, and the bonds themselves were all part of a heavily regulated walled garden. The conflict of interest was, as another poster noted, obvious on its face. Only the state can get away with such a con game and have no fear of arrest.
        --
        If laughter is the best medicine, who are the best doctors?
  • (Score: 3, Informative) by Fnord666 on Monday September 12 2016, @12:21PM

    by Fnord666 (652) on Monday September 12 2016, @12:21PM (#400658) Homepage

    The article kind of paints the FDA as a bad guy here, but the process that he (and everyone else, for that matter) has to go through is in place for good reason.
    He says that his device is ready, but we cannot be sure unless independent test is done and following a strict protocol to guarantee that it will behave as it should, in this case inject some epinephrine into the body, be effective, work reliably and not cause accidents, over dosage or other problems.

    Looking at his site, he isn't just changing the form factor for the injector. He is also changing the dosing and the way that it is determined. I highly suspect that this sort of change requires significantly more testing than a simple change to the injector would require.

    • (Score: 3, Informative) by Zinho on Monday September 12 2016, @01:54PM

      by Zinho (759) on Monday September 12 2016, @01:54PM (#400701)

      He is also changing the dosing and the way that it is determined. I highly suspect that this sort of change requires significantly more testing than a simple change to the injector would require.

      I disagree; AllergyStop appears to be simply providing greater granularity in the dose than what's available through the EpiPen. The inventor isn't innovating on recommended dosage, he's simply providing the accurate dosage for the individual patient; doing so involves a doctor's examination to pick the correct amount (people lie about their weight) and length of needle to penetrate all the way to the muscle (people lie about their weight). As long as he's still following the FDA recommended dosage of 0.01mg serum/kg body weight I don't think that constitutes an innovation on dosage that the FDA would insist on testing.

      It appears from the video that he may also be offering standard size doses (i.e. same as EpiPen), for which he'd accept an EpiPen prescription. So if you want the same sloppy dosage you're already used to then it's available as well, likely at lower cost to the manufacturer.

      --
      "Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin
      • (Score: 2) by Fnord666 on Monday September 12 2016, @04:46PM

        by Fnord666 (652) on Monday September 12 2016, @04:46PM (#400801) Homepage

        I disagree; AllergyStop appears to be simply providing greater granularity in the dose than what's available through the EpiPen. The inventor isn't innovating on recommended dosage, he's simply providing the accurate dosage for the individual patient; doing so involves a doctor's examination to pick the correct amount (people lie about their weight) and length of needle to penetrate all the way to the muscle (people lie about their weight). As long as he's still following the FDA recommended dosage of 0.01mg serum/kg body weight I don't think that constitutes an innovation on dosage that the FDA would insist on testing.

        It seemed to me that introducing BMI into the dosing equation would deviate from the prescribed dosing. I'm not saying that it's a bad thing, just that it is different. Only the FDA can say whether it's different enough I guess. I'm not in the medical research field though, so take this as nothing more than an opinion.

        It appears from the video that he may also be offering standard size doses (i.e. same as EpiPen), for which he'd accept an EpiPen prescription. So if you want the same sloppy dosage you're already used to then it's available as well, likely at lower cost to the manufacturer.

        That makes sense since it would allow schools, etc. to immediately switch if the substitution is acceptable.

  • (Score: 2, Informative) by fubari on Monday September 12 2016, @01:57PM

    by fubari (4551) on Monday September 12 2016, @01:57PM (#400704)

    Picture of what it looks like here in an interview w/inventor, actually explains the device: a-conversation-with-the-doctor-who-invented-it/ [salon.com], and interesting read.

    Summary: the new device is keyring size (see link for neat picture). Advantage: while epi-pens aren't huge, many people don't carry them on-person all the time). And no, not auto-inject but still plenty fast: pre-dosed, quick assembly, easy to administer. Seems like a good size/complexity trade off, might actually be more field-usable than epi-pens.

    • (Score: 2) by bob_super on Monday September 12 2016, @05:30PM

      by bob_super (1357) on Monday September 12 2016, @05:30PM (#400828)

      I've seen a few human beings before, and deducted that if something is so tiny that they don't have to think about it when carrying it, and designed for rare emergencies, I would not trust it to properly deliver a safe product by the time they need it.
      The epipen being big might cost lives, but it also forces people to remember they are carrying life-saving IM medication, not just a toy.

  • (Score: 1) by khallow on Monday September 12 2016, @02:06PM

    by khallow (3766) Subscriber Badge on Monday September 12 2016, @02:06PM (#400708) Journal

    The article kind of paints the FDA as a bad guy here, but the process that he (and everyone else, for that matter) has to go through is in place for good reason.

    $300 per EpiPen of good reason. It's not just some shady inventor getting blocked.