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Medicine Businesses The Almighty Buck Science

Hackers Offer a DIY Alternative To The $600 EpiPen (ieee.org) 327

After the pharmaceutical company Mylan raised the price of a 2-pen set of EpiPens by nearly $500 over the course of 9 years, Michael Laufer and his "pharma-hacking confederates at the Four Thieves Vinegar Collective," decided to make their own budget-friendly EpiPens. IEEE Spectrum reports: Today they released a video and instructions showing DIYers how to make a generic EpiPen using materials that can be bought online for about $30. They call it the EpiPencil. "It functions just as well as an EpiPen," Laufer says in the video, after demonstrating the assembly and showing that it works. "With no special training, anybody can use it." An EpiPen is just a spring-loaded syringe filled with the pharmaceutical epinephrine. Laufer's video shows how to assemble the "open source medical device" and provides links for where to buy the components online. He stops short of telling viewers how to get their hands on the drug, noting that you need a prescription for it. But Laufer tells IEEE Spectrum in an interview that it's easy to buy epinephrine online from a chemical supplier, and he hopes viewers will do just that. "There's a small but hopefully growing subculture of people who are buying the active ingredients of drugs," he says. "It's encouraging to see people take control of their own health."
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Hackers Offer a DIY Alternative To The $600 EpiPen

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  • by DatbeDank ( 4580343 ) on Tuesday September 20, 2016 @06:11AM (#52922475)

    The issue here isn't the materials cost of the epipen. You don't even need an epipen to deliver the medicine, just a syringe and an epinephrine vial. Any school nurse worth her salt will know how to use a needle. If school districts wanted to give a fat middle finger to the pharma industry on this they could go and purchase them.

    The issue here is that Mylan (the makers of the pen) lobbied the FDA and government to require its purchase be done by school districts and then jacking the price up to gouge the taxpayer (ie you and me). Now school districts have to purchase the pen instead of going the route I outlined above.

    The only way to hack the regulatory process is to donate a retarded sum of money to "charity" of a specific presidential candidate and various other lobbying groups. Though that isn't really hacking. Just, "business as usual" in the fairy tale land known around that stretch of highway known as the beltway.

    • by tburkhol ( 121842 ) on Tuesday September 20, 2016 @06:30AM (#52922499)

      There's an additional constraint, which is that the autoinjector is intended to be used by untrained people. It has to be, literally, idiot proof. The reason the competing producer got pulled from the market is failure of idiot-proofness - that it would sometimes deliver the wrong dose.

      Proving that your device is idiot proof is expensive, putting a high barrier to entry of new market participants. The liability cost of failing idiot-proofness is outrageous. The result is, even with a 95% profit margin, no commercial entity (in the US) wants to start up and compete with the entrenched monopoly on price. Seems rational to me.

      The DIY publishers have done a nice job of demonstrating the regulatory walls that protect the US pharmaceutical industry, but the first time someone tries to use an epi-pencil and delivers a wrong dose, gets a venous injection, or an infection, they're going to be targets of civil lawsuits from whomever managed to build or use the device wrong. We need reform of the laws that facilitate monopoly-like entrenchment and reform of the culture that looks at misfortune as a lottery ticket.

      • by Daemonik ( 171801 ) on Tuesday September 20, 2016 @07:15AM (#52922639) Homepage

        We need reform of the laws that facilitate monopoly-like entrenchment and reform of the culture that looks at misfortune as a lottery ticket.

        I don't think any amount of regulation will help with this, because it comes down to greed. If it weren't for the monopoly, they would just collude with the other manufacturers to keep prices high. Greed will find a way.

        What we need is mandatory price regulation of the pharmaceutical industry. Will there be less R&D? Possibly, but the majority of new drugs produced now are just new formulations of old compounds that are no longer covered by patents.

        • by sjbe ( 173966 ) on Tuesday September 20, 2016 @07:51AM (#52922751)

          I don't think any amount of regulation will help with this, because it comes down to greed.

          Untrue. In most countries the government is in charge of health care and they have a VERY easy way to regulate price gouging such as this. In any single payer system the national health service basically sets the price they are willing to pay and that's what it costs. End of story. We only run into this problem because we have a portion of our population who breaks out in hives anytime they hear the words "socialized medicine".

          What we need is mandatory price regulation of the pharmaceutical industry. Will there be less R&D?

          The only way to do that is to go to a single payer health care system. Has worked well for a lot of countries so it's not a bad idea.

          Possibly, but the majority of new drugs produced now are just new formulations of old compounds that are no longer covered by patents.

          That is easily disproven. Yes there are some shenanigans like what you describe but it does not constitute the "majority of new drugs".

          • The epipen costs $120 in Canada, so there is still PLENTY of profit on that. Just not as obscene.
          • I live in Canada, and although we have single payer healthcare, that doesn't mean that everything is covered. Most notable among things that aren't covered are prescription drugs. EpiPens are priced a bit more affordably here, but many other drugs are not very affordable, most notably things like cancer drugs. Although socalized/single payer health care would go a long way to helping the health care situation in the United States, it would definitely not solve all problems, especially depending on exactly

          • by guises ( 2423402 )

            The only way to do that is to go to a single payer health care system. Has worked well for a lot of countries so it's not a bad idea.

            This isn't the only way, it can be done through collective bargaining - in principle, this is part of what health insurance companies is for. This came up back in the early 2000s when there was a big $200 billion pharmaceutical bill intended (originally) to alleviate some of the high cost of drugs. The problem is that certain legislators got an amendment passed which explicitly prevented medicare from doing any kind of bargaining, which meant that the drug companies just raised their prices by exactly the s

          • Re: (Score:2, Insightful)

            by Major Blud ( 789630 )

            There's only one company making the EpiPen (Mylan).....they can charge what they want, even with a single payer system. The single payer (the goverment) can either not pay for it at that price, or Mylan can choose not to sell it.

            The only way this works in single payer systems currently is that Mylan is able to make up the loss by charging higher prices in non-single payer markets. If every single country in the world was single-payer, EpiPens wouldn't exist because every country would want to pay $1 per p

            • by sjames ( 1099 )

              The single payer systems DO have to be reasonable about it (nobody will sell at a loss). However, the same greed that makes Mylan charge $600 instead of $100 will cause them to agree to make $500 million on the thing rather than zero.

          • by hey! ( 33014 )

            Technically what you are describing isn't socialized medicine; it's socialized health insurance.

          • by moeinvt ( 851793 ) on Tuesday September 20, 2016 @10:18AM (#52923421)

            The U.S. federal government makes it illegal to import, or even RE-import prescription drugs. That's right. Thanks to government, you can't even buy the same exact product in the manufacturer's original packaging after it has been exported.

            Then, you have Medicare and Medicaid which dictate prices for products and services. The medical service providers then jack up prices on everyone else to offset the below-market prices from the government programs. That's why people go bankrupt due to medical bills. The uninsured have no negotiating power, and get charged 10x, 50x or more for the same exact services. If everyone paid the Medicare/Medicaid prices, providers would go bankrupt. If Medicare/Medicaid paid fair market prices, those programs would go bankrupt.
            The USA federal government has been involved in healthcare for over 50 years. Their intervention has been an absolute disaster. Skyrocketing prices, millions unable to afford even basic services, substandard quality of outcomes.

            And these are the people you want to put in charge of the entire USA healthcare system? Fuck "socialized medicine" and fuck the U.S. federal government. They're the problem, not the solution.

            • by dirk ( 87083 )

              The thing is, there is no "fair market pricing" for a lot of health care. If you are in a car accident, you don't have the benefit of shopping around to different emergency rooms to find the best deal. Many times, you have no option and have to take what is there because you don;t have a week to research all your different options.

              As for Medicare, they actually pay a reasonable cost. There is a group of physicians who actually figure out what it costs to perform certain functions and this is what the paymen

          • That is the reason people break out in hives about socialized medicine. Everywhere that has socialized medicine has to deal with health care rationing. Regardless if the frogs have been slowly boiled to the point where they "don't care" about having to wait endlessly for medical care so that they die before they need expensive treatments, no one wants it.

            Oh, and no one wants to pay for people who don't think their health is sufficiently important to pay for themselves, either.

            • Everywhere that has socialized medicine has to deal with health care rationing.

              All health care is rationed as it's not an infinite resource. It's just that in non-socialized settings, those with more money/ power/ influence get to go the head of the line regardless of actual need or urgency. People don't like waiting in line and many only care about "fair" when it affects them.

          • by Jahta ( 1141213 )

            I don't think any amount of regulation will help with this, because it comes down to greed.

            Untrue. In most countries the government is in charge of health care and they have a VERY easy way to regulate price gouging such as this. In any single payer system the national health service basically sets the price they are willing to pay and that's what it costs. End of story. We only run into this problem because we have a portion of our population who breaks out in hives anytime they hear the words "socialized medicine".

            If there was a score above 5 on /. then your comment should get it. America has the most expensive medical system on the planet. I've had first-hand experience of a family member falling ill on a US holiday and the insurance company chartered a plane to fly them home because it cost less than paying US hospital bills. And the sad part is that the medical outcomes are no better in the US than they are in Europe where we have national public health systems ("socialized medicine" as you neatly put it).

            As you

            • I hope the flight wasn't for cancer, heart disease, or a stroke, because then your country's insurance cheaped out on what would have almost certainly been the superior US treatment.

              There's a reason the rich often come to the US when the shit hits the fan.

            • Nope. From your description you don't have any experience with the US health care system. You opted to leave the US rather than make use of it.

          • In any single payer system the national health service basically sets the price they are willing to pay and that's what it costs. End of story. We only run into this problem because we have a portion of our population who breaks out in hives anytime they hear the words "socialized medicine".

            You do realize that really means the U.S. is subsidizing the cost of the drug for those other countries, right? Free riders do not a free lunch make.

        • by raymorris ( 2726007 ) on Tuesday September 20, 2016 @10:43AM (#52923605) Journal

          Greed! Monopoly! Regulation! These are fun words to say.

          The weird thing is, pharmaceutical companies don't make money consistently more than car companies, food companies, electronics companies, software companies, or any other kind of company. They simply aren't making the ton of money we'd like to complain about. This makes sense, because if drug research, development, and production DID make more money than doing something else, then Apple, Google, Bill Gates, Larry Ellison and Jeff Bezos would invest their money into new pharmaceutical companies, so that they would make a ton more money. Those new companies would be competition for the old, tending to reduce prices.

          In fact, when you think about who has a billion dollars to invest, who makes a ton of money, the big names that make crazy money are Apple, Google, Bill Gates, Larry Ellison and Jeff Bezos - it's the computer technology people making crazy money. *We* are the greedy bastards. :â'O

          * Like some technology companies, drug companies have bad years, when they spend $2 billion on R&D and nothing gets approved, and good years when they have a hit. Over time, their total returns are similar to other industries with similar volatility, and risk-adjusted returns are inline with the overall economy.

      • by Dunbal ( 464142 ) * on Tuesday September 20, 2016 @07:50AM (#52922749)

        the autoinjector is intended to be used by untrained people.

        The "training" in this case takes literally 5 minutes if you are a slow reader. I refuse to have that used as an excuse for a $600 (or even a $50) "auto-injector". Blah blah blah you're not qualified to say this what are you a doctor? Yes. Yes I am a medical doctor.

        • by cdrudge ( 68377 )

          You have a lot of faith that people can read in our schools.

        • Repurposed insulin pen- one-time cost of $100, should last a lifetime. Epinephrine - dirt cheap. Disposable pen-tips - less than 2 for a buck. Used insulin cartridges - free.

          I don't see why people haven't been taking insulin pens that take cartridges, emptying the cartridge, and filling it with epinephrine. Simple, cheap, easy to use, and you just replace the epinephrine every 6 months to a year, which is a couple of bucks. The pens last pretty much forever with 3-4x daily use, so one pen should last a lifetime. Using the longest pen tip needle will mean being able to hit the muscle instead of subcutaneous injection, unless you're more than a little obese.

          Advantages: Device already approved for injecting drugs. Dial a dose (more accurate than a syringe), stick it in you, push the button with your thumb.. Easily replaceable needle. Available over-the-counter at most pharmacies.

          The cartridges you can get free almost empty from anyone who uses them (they were goig to dispose of them at that point anyway), you can use a syringe to inject air into the narrow end of the cartridge until the rubber stopper pops out, rinse VERY well (don't want any traces of insulin), add the epinephrine, stick the rubber stopper back in, you're all set for the next year (no, epinephrine doesn't "go bad" after 6 months. Studies show that at that point it's still at 90% potency or better. Just look for a color change).

          The pen is under $100, the cartridges are free, the pentip needles are less than half a buck apiece so if you ask someone with type 1 diabetes they'll probably just give you one, along with the near-empty cartridge they were going to toss, so once you buy the pen, your annual cost will be what - $5.00?

          As for ease of use, kids already use them.

          • <quote><p> <b>Repurposed insulin pen</b>- one-time cost of $100, should last a lifetime. Epinephrine - dirt cheap. Disposable pen-tips - less than 2 for a buck. Used insulin cartridges - free.
            </p><p>I don't see why people haven't been taking insulin pens that take cartridges, emptying the cartridge, and filling it with epinephrine. Simple, cheap, easy to use, and you just replace the epinephrine every 6 months to a year, which is a couple of bucks. The pens last pretty mu
            • 1) Experimental trial already done - The cartridge is easily completely cleaned out. I tried it before posting, because this whole thing is stupid greed gone stupidly far. Replacing the insulin with a normal saline solution and injecting it doesn't affect insulin levels. The only area that requires a bit of care is the rubber stopper. It takes longer to clean, unlike the glass. You'll be able to tell when you're good because it won't smell of insulin any more (yes, insulin has a particular odor).

              2) Manufac

        • the autoinjector is intended to be used by untrained people.

          The "training" in this case takes literally 5 minutes if you are a slow reader. I refuse to have that used as an excuse for a $600 (or even a $50) "auto-injector". Blah blah blah you're not qualified to say this what are you a doctor? Yes. Yes I am a medical doctor.

          First, thank you for saying this.

          Second, the EpiPen is NOT "idiot-proof"! Studies have shown that only about 16% of patients use epinephrine autoinjectors correctly [seattletimes.com]. (Here's [annallergy.org] the original 2015 study.)

          Yes, this study only tracked 102 patients with epinephrine, but it's a large enough group to see the problem. (Also, other earlier studies are cited in the one above showing correct use to be around 22%.) The most common error was failing to hold the device on the thigh for at least 10 seconds (required to

      • Proving that your device is idiot proof is expensive, putting a high barrier to entry of new market participants. The liability cost of failing idiot-proofness is outrageous. The result is, even with a 95% profit margin, no commercial entity (in the US) wants to start up and compete with the entrenched monopoly on price. Seems rational to me.

        Let's try and understand this "barrier" to entry a bit more, in financial terms that would attract a few more investors than your 95% number.

        The cost of the materials is around $30, according to information here. Charging merely double for the product would be a 100% markup. Charging what they currently charge ($600+) represents a 2000% markup. Those kinds of numbers are enough to justify mining precious metals out of the earth, so I fail to see how someone would fail to reverse-engineer what is essentia

      • by Lumpy ( 12016 )

        bullshit.

        The epi pen design has NOT CHANGED in 20 years. sorry but they dont deserve to "make up the development costs" 20 years later for a product they did not even design but instead bought.

        come on back when you actually know about thew product being talked about.

      • It's an Intramuscular Injection (IM). Anyone can do that.
      • Why do you hate the American dream? How do you think people could get rich if they can't sue for ridiculous sums? By hard work and wise investment?

      • There's an additional constraint, which is that the autoinjector is intended to be used by untrained people. It has to be, literally, idiot proof.

        I don't see where that "constraint" comes from. Commercially prefilled syringes eliminate the risk of overdose and ensure sterility, and are very easy to use. Certainly, any public school employee could administer them with minimal instruction. And I suspect even entirely untrained people would likely find it no harder to inject a prefilled syringe compared to an

    • You don't even need an epipen to deliver the medicine, just a syringe and an epinephrine vial. Any school nurse worth her salt will know how to use a needle.

      I coach school sports teams so I've been on staff at a number of schools. Most school nurses I've ever met are prohibited from administering any injectable medications and I've met more than a few who were not trained nurses at all. School nurses are not on the school grounds at all times either, particularly after school hours. Schools are certainly not about to start storing syringes and vials of medications. The whole point of something like an epipen is that it can be administered by someone with no

      • So get another kid to do it. There's got to be at least one kid around who's on insulin.And "training"? - it's simple as sh*t. Literally so easy that a kid can do it. "Specially trained professionals?" Give me a break. Kids with diabetes are sticking themselves all the time. Give them an insulin pen and a cartridge that's got epinephrine instead of insulin, and pretty much anyone can get it right first time in less than 30 seconds.
        • So get another kid to do it. There's got to be at least one kid around who's on insulin.

          You might want to look up some actual data [jamanetwork.com] before spouting off something so stupid and easily disproven. The prevalence among children is somewhere around 1 to 2 per 1000.

          And "training"? - it's simple as sh*t. Literally so easy that a kid can do it.

          Missing the point. Unless you are going to provide training to basically everyone on injecting drugs then it isn't "easy as shit". Furthermore training the general public on how to administer drugs? The same general public with a HUGE drug problem? Oh yeah, no predictable side effects of that...

          Seriously you think public health offici

          • There's no more "training" than using an epipen. Hand the kid the pen with a new tip, dial the dose, and give it to the kid. They stick it in the thigh, and push the button on the end of the pen. Bonus points because they don't have to remember "Orange to the thigh, blue to the sky" or other crap. So no more instructions than an epipen, so what's your beef?

            As for dosing, unlike syringes, you just dial the dose, and this has been proven to be more accurate than syringes.

            Kids receive a lot of coaching - but

        • by NotAPK ( 4529127 )

          Only challenge is choosing the dose, but a safety margin can be built into it by making the vials limited to a sub-lethal dose for children of a certain size/age range.

          • Or just limiting the maximum dose that can be selected on the dial. This way, you don't have to change cartridges after every use, and some people require more than 1 injection sometimes, so you're ready for that eventuality as well.
      • Oh God. I'm fascinated. What on earth makes one qualified to be a school nurse in the US if not a valid nursing qualification?
      • Schools are certainly not about to start storing syringes and vials of medications.

        There are very few medications that need emergency treatment like epinephrine. We're talking about one special case here. And syringes can be pre-filled to correct dosage (and put in a special case/kit), so no need for "vials of medications."

        The whole point of something like an epipen is that it can be administered by someone with no medical training whatsoever because there is a very high chance that whoever administers the epipen will not be a trained medical professional.

        I already posted on this above [slashdot.org], so i won't repeat myself. Actual studies show a very high chance that "someone with no medical training" will misuse an EpiPen. More than a syringe? I don't know, because no such studies are available.

        That's a minor part of this problem. Most buyers of epipens are not schools but individuals. School districts might be getting ripped off but that's small potatoes compared with individuals getting ripped off.

        Actually, no it's not just a "mi

    • to give a fat middle finger to the pharma industry on this they could go and purchase them.

      You are absolutely correct identifying government regulation as the primary expense. And yet, you blame pharma industry?

      lobbied the FDA and government to require its purchase

      That a maker of something — anything — would try to sell as much for as much as possible, is perfectly normal. That their lobbying efforts were successful — that's wrong.

      The only way to hack the regulatory process is to donate a

    • by tlhIngan ( 30335 )

      The issue here isn't the materials cost of the epipen. You don't even need an epipen to deliver the medicine, just a syringe and an epinephrine vial. Any school nurse worth her salt will know how to use a needle. If school districts wanted to give a fat middle finger to the pharma industry on this they could go and purchase them.

      The issue here is that Mylan (the makers of the pen) lobbied the FDA and government to require its purchase be done by school districts and then jacking the price up to gouge the ta

  • It's my non-expert understanding that epinephrine has a short shelf life, and that the dose is fairly critical so using expired vials/doses is not really an option... the recommendation is that Epipens be replaced after 12-18 months but apparently the vials/normal syringes only last about two months. I can only imagine that in a system like this, the exposure to oxygen would shorten it even more.

    So you'd probably need to replace the syringe and dose daily, or every other day, for both dose freshness and ste

    • by Lumpy ( 12016 )

      yet my canadian epi pends have a 5 year shelf life....

      Dont believe the bullshit printed on american pharmacuticals. It's all about profits and not about reality.

      • So you'd have no problems citing a source for that, then? A photo of an epipen showing an expiry date of 2021 or something?

        Epinephrine degrades steadily with time [nih.gov] and expired doses are not as effective as fresh ones. I've not been able to find anything to suggest a 5-year shelf life for an epipen anywhere, so if you'd be so kind...
        =Smidge=

  • by Daemonik ( 171801 ) on Tuesday September 20, 2016 @07:06AM (#52922607) Homepage

    "There's a small but hopefully growing subculture of people who are buying the active ingredients of drugs," he says. "It's encouraging to see people take control of their own health."

    There used to be a time when you could walk to your corner pharmacy and get a bottle of laudanum, or some cocaine. This did not work out well. There are far too many stupid or murderous people to allow this. I'm sure these guys have the best of intentions but when the idiots start rolling up with lawsuits because they didn't assemble their pen correctly or overdosed or used old medicine or got an air bubble into their veins or the cheap needle they used broke off into their leg or any of the infinite number of horrible things that will happen, they will be wiped out.

    There are very good reasons we don't allow Doctor Mom to build her own x-ray machine to save a buck. Just because this medical device is simple doesn't mean it isn't a medical grade device that should be constructed in your Maker lab.

    • As someone who researches my own drugs, assesses my own risks, and has in fact obtained my own stuff, I'd have to agree. I've used Phenylpiracetam as an amphetamine-like stimulant because the toxicity is *far* lower than amphetamine; and I've seen people talking about how they chug down their full month's supply of Adderall in 5 days, and then use 600mg Phenylpiracetam 4-6 times per day--these people are fucking insane. There's a huge array of stuff I won't touch without medical guidance because, even th

    • by eth1 ( 94901 )

      There are very good reasons we don't allow Doctor Mom to build her own x-ray machine to save a buck. Just because this medical device is simple doesn't mean it isn't a medical grade device that should be constructed in your Maker lab.

      Except that if you're highly allergic to something, you risk a good chance of death by NOT having an EpiPen or similar around. If you simply don't have the obscene amount of money they're asking for them, your choices are:
      1. Risk death by not having an EpiPen(cil)
      2. Risk death (but probably much less so) by constructing your own.

      Which would you pick?

      Unfortunately, with our idiotic healthcare system here in the US, that logic applies to more than just epinephrine.

    • by hey! ( 33014 )

      There used to be a time when you could walk to your corner pharmacy and get a bottle of laudanum, or some cocaine. This did not work out well.

      We've returned to that state, with one proviso: it can't be something that's been shown to work. I can get all the herbal nostrum and "supplements" I want, and they can (with a few ineffective limitations) promise me they work as well for cancer or impotence as laudanum does for pain.

    • by houghi ( 78078 )

      but when the idiots start rolling up with lawsuits because they didn't assemble their pen correctly or overdosed or used old medicine or got an air bubble into their veins or the cheap needle they used broke off into their leg or any of the infinite number of horrible things that will happen, they will be wiped out.

      And you think that this never happens with an Epi-Pen?

      And all this bullshit about "but it costs money to develop". Sure. How much? 1 million? 10 million? Even 100 million? Then why the need to ma

  • The article doesn't say how much (in mg) needs to be loaded in to the pen, but here is one source at USP grade from a highly respected supplier [sigmaaldrich.com], 200mg for $326.50 in the US. A quick google search suggests .3mg per injection [google.com] so that 200mg should last quite a while.
    • by PPH ( 736903 )

      200mg should last quite a while

      Shelf life of an EpiPen (the epenephrine inside it) is something like one year. Refrigerated, that 200mg might last longer. But unless you are dosing yourself once or twice a day, you might want to buy it in smaller quantities. But yeah; the drug itself is pretty cheap.

  • If you go making your own auto-injector syringe, you better have a way to be absolutely damn sure there's no air in the hypo before you let it go.

    • by pz ( 113803 ) on Tuesday September 20, 2016 @08:54AM (#52922965) Journal

      A few small air bubbles, while not ideal, are not as bad as you might think. An important reason that you use the Hollywood-style flick-flick-flick to get air bubbles to the top of a syringe and then press them out is to make sure that you've filled the syringe with the appropriate amount of drug. Whereas 0.2 cc of air probably won't do much to you if injected (and that's a pretty big bubble in a syringe), if you're injecting 1 cc of drug, that 20% difference with versus without bubble can make a big difference in the mount of drug that actually gets delivered.

  • It's sad to see that we're now reduced to making our own medical devices.
    • I disagree.

      When companies screw over the public, especially those with certain medical needs, that makes me sad. But when those same people who need medicine find a way to cut out the greedy drug companies by doing an end-run around their product, I find that HILARIOUS!
  • by sjbe ( 173966 ) on Tuesday September 20, 2016 @08:00AM (#52922769)

    So many problems with this:

    1) Dosing is a big issue. Huge. Not just determining the correct dose but mechanically and reliably administering the correct dose. This is NOT a trivial concern. Both under and overdosing with epinephrine can be a very serious matter.

    2) Quality control in a device like this is essentially nonexistent. It might work but you can virtually guarantee that it won't always work. If it doesn't then that will very likely result in serious injury or possibly death. I work in a company that makes components for medical devices. The quality control standards are VERY stringent for very good reasons.

    3) Sourcing the medication. Sure you might be able to buy it but there are VERY good reasons why we have a controlled supply chain in the pharmaceutical industry. You are seriously rolling the dice if you buy outside the normal supply chain.

    4) The person who administers the injection is quite likely to not be the person who built the device. This raises a whole host of problems.

    • by moeinvt ( 851793 ) on Tuesday September 20, 2016 @08:42AM (#52922905)

      As sad as it seems, more than 100 million people in the USA have a BIG problem with a $500 investment:

        Nearly half of Americans would have trouble finding $400 to pay for an emergency. [theatlantic.com]

      If they can't scrape up $400 for an emergency, they probably can't afford a $500 investment for an epi-pen they might not need. A visit to the ER not only introduces a time delay which puts the person's health at greater risk, and it might also mean bankruptcy.

      The risk associated with use of a $30 device is probably acceptable to people who would otherwise risk death or bankruptcy. Having options is a good thing, even if they come with risk.

      • As sad as it seems, more than 100 million people in the USA have a BIG problem with a $500 investment:

        Which is why the correct solution to the problem is to ensure that epipens or properly manufactured equivalents are available for reasonable amounts of money. This is a regulatory problem, not a technological one. If someone really is in a tough spot financially then of course they should do what they need to do and I have no problem with that at all. But that's not the solution to this problem in the long run.

      • Meanwhile, the average American spends $775 dollars a year for Cable TV.
        http://www.fool.com/investing/... [fool.com]

        If you gave them a choice between an $600 EpiPen that they may not need (but may save their life) and missing out on Keeping up with the Kardashians or Monday Night football, I'm sure the later would win out.

    • If you start with a small syringe - say 0.5cc - it's practically impossible to (dangerously) overdose except in a very small child. Of course, and IMHO, everyone should know how to successfully administer an IM injection. It's one of those common sense, walking around things we seem to have forgotten about.

    • I don't think any of the problems you state are legitimate.

      The autoinjector he uses is a medically approved device used by many diabetics that can't bring themselves to casual stick a needle into their body and then inject the insulin.

      1) Dosing is a big issue. Huge. Not just determining the correct dose but mechanically and reliably administering the correct dose. This is NOT a trivial concern. Both under and overdosing with epinephrine can be a very serious matter.

      For dosing, it cannot administer more than was loaded into the syringe. Those with severe allergies can get approval and training from their physician to use a regular syringe and ampule to administer epinephrine to themselves (or a parent to a child). If dosing isn't a conc

    • If there was a 0.1% chance of killing yourself on an insulin injection and you were diabetic, that would be a serious issue, because you would take that risk every day. But your chances of going into anaphylactic shock and dying are rather low, even if you have serious allergies (only about ~200 people per year actually do wind up dying), and a 0.1% chance of dying in a 1/100000 scenario puts it in the category of daily hazards most of us regard as non-concerns. So unless those factors you mention are VER

  • by nomadic ( 141991 ) <nomadicworld&gmail,com> on Tuesday September 20, 2016 @08:51AM (#52922947) Homepage
    If you can't afford a $600 EpiPen, buy a $144 Adrenaclick. [goodrx.com] Only if you can't afford that do you go for the homebrew.
  • Why bother? (Score:2, Insightful)

    by Anonymous Coward

    Just tell your doctor to re-write your prescription from "EpiPen" to "Automatic Epinephrine Injector". There's plenty of generic alternatives that are reasonably priced. It's just that doctors are lazy or unaware.

  • The Epipen fiasco would have been completely avoided if the FDA didn't have the position that it alone, among all regulatory agencies, is qualified to evaluate generic drugs and devices. The sensible thing, which is not being done because the FDA is protecting its turf, is to recognize generic drug approvals from other advanced countries such as the European countries and Canada. The Epipen has a de-facto monopoly due to FDA foot-dragging. The FDA, ad nauseam, trots out the Thalidomide tragedy to prove t
  • I hated them, the spring sometimes wouldn't trigger unless you hit the button just right....sometimes really scaring the bejesus out of you because it would catch you off guard. Sometimes they wouldn't fire at all.

    It got to the point to where I would ask for the old school plastic "insulin" syringes, which were getting pretty hard to come by. I get that they are supposed to be idiot proof, but they really do suck.

  • by geekmux ( 1040042 ) on Tuesday September 20, 2016 @10:06AM (#52923325)

    Title of my post says it all.

    The 2000% markup the current monopoly is charging for this should be a wake-up call to anyone thinking otherwise.

    And I'm talking about actual competition, not some bullshit "alliance" of like businesses colluding to create a "standard" price.

  • by NotARealUser ( 4083383 ) on Tuesday September 20, 2016 @11:27AM (#52923945)

    People have become so risk averse in the western world that we would rather watch someone die a slow suffocating death from an allergy than actually help the person because, "only experts can do that." We have this phobia of doing anything outside of our specialization. A phobia that is largely propagated by the "experts" of various fields to ensure their own job security and their elite status. Several of the commentators on this article need to stop whimpering in the corner, worried about the new, and instead do what it takes to help those around you. Sometimes that means working on changing the laws and changing the way we do things.

    As others mentioned, the real key is that the EpiPen is fairly foolproof. However, for the cost, it seems like an extreme hurdle to cross. It is at the point where some facilities, and some families, do not keep one on hand, even when they know there are those that have severe allergies, simply because of the cost.

    I would propose that most institutions, and families with allergy sufferers, could bring a lay person to a level of understanding and skill such that they could administer an injection of epinephrine via syringe if needed. This is not rocket science. You could have classes on this administered by the Red Cross (much like some of the CPR and first aid classes). For the $50 to $100 that it would take to take the class, it would more than make up for the savings for the EpiPen, even if you had to renew yearly. Also, you could always scholarship in those that could not afford the class cost. For schools and summer camps, this would be a no brainer as I imagine the policy is that only the trained nurse administers the EpiPen anyway.

    This is one of those situations where regulations kill. Because we have private companies steering government policy to keep the competition out, and because these governments and businesses engage in a symbiotic relationship to maintain each other's power (also known as fascism), we run into extremely high costs where literally only the rich and well connected can afford to be ready for a bee sting or other reaction.

  • But remember, folks: the black market for anything is the real market.

  • by Computershack ( 1143409 ) on Tuesday September 20, 2016 @02:37PM (#52925613)
    Don't need to DIY them, just need to sort out the ridiculous situation in the USA. The Epipen I have here in the UK which comes from a company called Meda cost me £8.40 on prescription. Obviously the NHS don't pay that little but a quick cursory search shows that here and in France it costs $85 for two.

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