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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


Original Submission

Related Stories

EpiPen's Price Increased 400% since 2008 97 comments

EpiPen's price has ballooned about 400% since 2008, rising from about a $100 list price to $500 today. The EpiPen is one of the most important life-saving medical innovations for people with severe food allergies—which affect as many as 15 million Americans and 1 in 13 children in the United States. But its price has exploded over the last decade despite few upgrades to the product itself. The product's lack of competitors is likely a significant driver of the costs. [...] [The] EpiPen enjoys a near-monopoly on the market with annual sales of more than $1.3 billion and nearly 90% U.S. market share.

At Fortune, NYT, The Hill.


Original Submission

Mylan Overcharged U.S. Government on EpiPens 19 comments

If you're going to overcharge the U.S. government, you don't want to get caught:

Mylan NV for years overcharged the U.S. Medicaid health program to buy its EpiPen shot, the government said Wednesday, despite being told that it needed to give bigger discounts under the law. From 2011 to 2015, the joint state-federal program for the poor spent about $797 million on EpiPens, the Centers for Medicare and Medicaid Services, or CMS, said in a letter Wednesday. That included rebates of about 13 percent, but the U.S. should have been getting a larger discount of at least 23.1 percent.

While the agency didn't say exactly how much Mylan had overcharged, the amount could be substantial. Under law, companies are required to give [Medicaid] back any price increases they take on brand drugs above the rate of inflation, in addition to the 23.1 percent discount. Mylan, after acquiring the drug in 2007, has raised the price of EpiPen by about sixfold, to over $600 for a package of two. The government has in the past "expressly told Mylan that the product is incorrectly classified," CMS said in the letter, which came in response to an inquiry by Congress. "This incorrect classification has financial consequences for the amount that federal and state governments spend because it reduces the amount of quarterly rebates Mylan owes for EpiPen."

Previously:
EpiPen's Price Increased 400% since 2008
AllergyStop: $50 EpiPen is Production-Ready but...


Original Submission

NIH Reverses Allergy Guidelines, Recommends Feeding Peanuts to Infants 18 comments

In a press release Thursday, the National Institutes of Health reported an addendum to its official guidelines for Diagnosis and Management of Food Allergy. The specific change is intended to address the precipitous rise in peanut allergies which has occurred recently. For many years, parents have been strictly advised to avoid exposing babies to peanuts, eggs, and other potential allergen foods, on the hypothesis that early exposure could be dangerous and exacerbate problems in those children likely to develop allergies.

The new guidelines are a complete reversal in that the NIH now recommends earliest exposure (4 to 6 months) for children at most risk of developing allergies, such as those with severe eczema and/or known egg allergies. Other children should also have peanuts -- though not whole ones, which can be a choking hazard -- introduced into diets freely along with solid foods. The new guidelines are based on results from the landmark Learning Early About Peanut Allergy (LEAP) study. From the NIH press release:

"The LEAP study clearly showed that introduction of peanut early in life significantly lowered the risk of developing peanut allergy by age 5. The magnitude of the benefit and the scientific strength of the study raised the need to operationalize these findings by developing clinical recommendations focused on peanut allergy prevention," said Daniel Rotrosen, M.D., director of NIAID's Division of Allergy, Immunology and Transplantation.

CNN reports on the history of the LEAP study, noting that there was an earlier practice in Israel to expose children to peanuts as early as possible. Anecdotally, these children had a much lower frequently of allergies than Israeli children raised in the UK. The LEAP study thus assigned over 600 children randomly to a group with early exposure or a group which avoided peanuts completely for the first 5 years of life. The results were striking:

All the children participating in the study were at high risk of peanut allergy due to family history or having eczema or egg allergy themselves, said Nepom [one of the developers of the LEAP study]. At age 5, the children in both groups were given peanuts and observed, Nepom said: Eighteen percent of the children who had been avoiding peanuts had a peanut allergy at age 5, compared with only 1% of the children who had been introduced to peanut butter or Bamba early in life. "This showed that early introduction of peanut flour had over 80% prevention effect," Nepom said.

The study and the new NIH guidelines represent one of the most scientifically rigorous rationales to reconsider allergy guidelines in general. Proponents of early exposure to problematic foods, along with the hygiene hypothesis, claim that the obsession with avoiding exposure to potential allergens in early life has actually caused the current epidemic of allergies. Approximately 1 in 13 children in the U.S. has a food allergy; over 2% alone have peanut allergies. While death from anaphylaxis after exposure is relatively rare, various studies indicate that peanuts are likely the most common trigger in children and frequently result in hospital visits. The NIH policy change is also quite relevant, following the extended national debate on cost of anaphylaxis medication, particularly the outrageous prices for EpiPens (see SoylentNews coverage here, here, and here).


Original Submission

CVS Partners With Impax to Sell Low-Cost Generic Epipen Alternative 17 comments

Just months after an outcry about a price hike for the life-saving "Epipen", CVS pharmacies will begin carrying a new generic injector at a cutthroat price:

Pharmaceutical giant CVS announced Thursday that it has partnered with Impax Laboratories to sell a generic epinephrine auto-injector for $109.99 for a two-pack—a dramatic cut from Mylan's Epipen two-pack prices, which list for more than $600 as a brand name and $300 as a generic.

The lower-cost auto-injector, a generic form of Adrenaclick, is available starting today nationwide in the company's more than 9,600 pharmacies. Its price resembles that of EpiPen's before Mylan bought the rights to the life-saving devices back in 2007 and raised the price repeatedly, sparking outcry. [...] The price of $109.99 for the alternative applies to those with and without insurance, CVS noted. And Impax is also offering a coupon to reduce the cost to just $9.99 for qualifying patients. [...] Meanwhile, backlash to Mylan's price hikes continue. This week, Cigna, a top health insurance company, said that it will no longer cover Mylan's brand name EpiPen—it will only cover the generic, which was rolled out in December.

Previously: AllergyStop: $50 EpiPen is Production-Ready but...
Mylan Overcharged U.S. Government on EpiPens


Original Submission

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  • (Score: 0) by Anonymous Coward on Monday September 12 2016, @10:13AM

    by Anonymous Coward on Monday September 12 2016, @10:13AM (#400615)

    to get the device approved will cost him about $2 million

    So? There are

    millions of Americans

    who

    depend on

    EpiPen.

    Ask each of them to contribute $1 toward this worthy cause, see how they refuse, and then give up in disgust, because the people do not deserve to be helped.

    • (Score: 5, Informative) by Zinho on Monday September 12 2016, @11:38AM

      by Zinho (759) on Monday September 12 2016, @11:38AM (#400632)

      RTFA. [allergystopnow.com] I know, that's an odd request around here.

      The website is a frontend to the inventor's Indiegogo campaign, [indiegogo.com] where he's asking for donations of $50 to get a T-shirt reward or $250 for an injector capsule following FDA approval; as a result, the practical cost of one of these is currently $250 + a bunch of other people making donations to complete the campaign.

      There are a few of head-scratchers for me on this:
      * number of backers listed on the allergystop website is greater than those listed on Indiegogo; it appears that the inventor is running two parallel campaigns, one on his own website, and another on Indiegogo
      * Numbers on the campaign are pretty low; 16 on the website, 8 on Indiegogo. The Indiegogo campaign appears to be running for at least 25 days now, and has ~ a month left. Needs more publicity, I guess.
      * Average donations seem low, too. $75 on the website, $34 on Indiegogo. Most contributors are not committing to the "give me an injector" level.
      * The Indiegogo campaign has a "flexible goal" of $200k, which is less than 1/5 the cited financial need. I'd guess that he has other funding sources lined up, but he doesn't mention them.
      * This is presented as a replacement for Epipen, but isn't an autoinjector; it appears to be manual. At a guess, this gets them around the patents on autoinjectors to keep the price down.

      All in all, I wish the campaign luck. I'm all for life-saving medicine being affordable and available when needed. I just hope that the price point doesn't rise too high from the need to pay advertisers to get the word out.

      --
      "Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin
      • (Score: 0) by Anonymous Coward on Monday September 12 2016, @11:52AM

        by Anonymous Coward on Monday September 12 2016, @11:52AM (#400640)

        Numbers on the campaign are pretty low; 16 on the website, 8 on Indiegogo.

        Millions, right? Is it millions?

        You're just proving the assertion: people don't deserve a replacement for Epipen.

  • (Score: 5, Interesting) by mth on Monday September 12 2016, @11:10AM

    by mth (2848) on Monday September 12 2016, @11:10AM (#400626) Homepage

    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.

    Since I live in the Netherlands, I wondered why I had never heard of the company. It turns out it's a US company that is registered in the Netherlands, possibly for tax reasons.

    As the original invention is from the 70's, I don't think the patents from the original invention are relevant anymore today. Wikipedia lists several patent lawsuits [wikipedia.org], so there are patent issues, but I guess those would be about changes made to the device over the years.

    • (Score: 0) by Anonymous Coward on Monday September 12 2016, @12:00PM

      by Anonymous Coward on Monday September 12 2016, @12:00PM (#400643)

      its mainly the injector. Its not so trivial to make a device with a needle that is safe to carry around yet can be used to inject yourself rapidly and easily.

      • (Score: 2) by art guerrilla on Monday September 12 2016, @07:02PM

        by art guerrilla (3082) on Monday September 12 2016, @07:02PM (#400876)

        i dont know, apparently hundreds of thousands of heroin/etc addicts apparently manage to do so, even in prison... because of bee sting allergy, used to carry epipen in glove compartment, came in a little red plastic case that was semi durable, semi crushproof...

    • (Score: 3, Informative) by Thexalon on Monday September 12 2016, @12:27PM

      by Thexalon (636) on Monday September 12 2016, @12:27PM (#400661)

      It turns out it's a US company that is registered in the Netherlands, possibly for tax reasons.

      There's no "possibly" about it: There has been a strong trend towards what's called "inversion", where a US-based company will create a subsidiary in another country and then reshuffle the paperwork so that the subsidiary is the one responsible for the taxes. And it just so happens that the taxes in that country are much lower than the taxes in the US.

      This works because the tariffs are lower than the tax rates. And that's why Apple is theoretically an Irish company, not a US company based in Cupertino.

      --
      The only thing that stops a bad guy with a compiler is a good guy with a compiler.
  • (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.

    • (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.

  • (Score: 1) by noneof_theabove on Monday September 12 2016, @11:39AM

    by noneof_theabove (6189) on Monday September 12 2016, @11:39AM (#400633)

    and Patent Office is highly needed....NOW!
    If the FDA took 1000 pens and made sure they did not fail injecting a liquid with a viscosity of EpiPen liquid, yes-it is harder to push thick stuff out a small needle and conversely a large needle and thin liquid may go faster than can be utilized causing leaking and blowout.

    So, if 999 devices pass that is a 0.1% failure, which the one should be sent back for "failure analysis" and correction.

    Now explain again why years and millions are need since the drug is not being tested....only the mechanical device.

    BTW...you can declare something GRAS [General Recoginized As Safe] and boom! Instant FDA approval.

    Welcome to the United Corporations and Churches of America - the best government any currency can buy.

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

    by Dunbal (3515) on Monday September 12 2016, @12:01PM (#400644)

    Vial of epinephrene, syringe. If diabetics can be taught to do it, atopic people can be taught to do it.

    • (Score: 5, Informative) by Rivenaleem on Monday September 12 2016, @12:14PM

      by Rivenaleem (3400) on Monday September 12 2016, @12:14PM (#400652)

      Unfortunately, the times you urgently need a shot of epinephrine, are also the times when it is incredibly difficult to measure out an accurate amount of it from a vial and syringe it into yourself (or someone else). The point of the pen is that the dose is pre-measured and auto-injected for those in anaphylactic shock to self administer.

      • (Score: 5, Insightful) by Dunbal on Monday September 12 2016, @01:17PM

        by Dunbal (3515) on Monday September 12 2016, @01:17PM (#400676)

        the times you urgently need a shot of epinephrine,

        Friend, I am a doctor. It's never THAT urgent unless you are clueless or actually trying to kill yourself by anaphylaxis. Even if you mess up and you (or a stranger) loads your syringe with 1cc (the full ampule) instead of 0.1cc or 0.3cc or however much you were told to use, it ain't going to kill you. You're going to feel like crap and the injection site is going to hurt like hell, that's all. Yes, a pencil case is a little harder to carry around than a "pen". If you feel you absolutely must have an auto-injector, then pay $600 and support the thieves.

        • (Score: 2) by Rivenaleem on Monday September 12 2016, @01:39PM

          by Rivenaleem (3400) on Monday September 12 2016, @01:39PM (#400688)

          I don't disagree with you on the $600 injector. It doesn't need to cost that much. The reality is that in other countries, it doesn't cost that much. Don't confuse, however, the advantage of having a device that you can keep in reserve for the time you do urgently need it, with diabetics who are on regular doses. You might as well argue that a shoe-horn is a useless idea, and that everyone should only buy shoes that don't need one. Remember, we live in a world where you can buy 100$ selfie-sticks, with bluetooth.

          • (Score: 2) by Dunbal on Monday September 12 2016, @02:24PM

            by Dunbal (3515) on Monday September 12 2016, @02:24PM (#400719)

            It is daylight robbery that it costs that much. I merely mention my "low tech" solution because I practice in the developing world and only the richest can afford Epi-Pens, which they have to buy overseas because they're simply not sold here. While it's less than ideal, it's no worse than the Epi-pen you forgot in the glove compartment of your car. Like I said it's hard to kill yourself with one ampule of 1:1000 epinephrine especially when you're not putting it directly in your veins but rather im/sc. And it is cheap as heck - box of 25 ampules can cost you $10 or so and the syringe is negligible. There ARE alternatives and the fact that the government and/or others seem to be scratching their heads at this patented "stumbling block" is ridiculous. It's as if someone didn't know how to get to the other side of town anymore if cars stopped working. Look down. See those things? Yeah - they're called feet and they work.

        • (Score: 3, Interesting) by Thexalon on Monday September 12 2016, @01:47PM

          by Thexalon (636) on Monday September 12 2016, @01:47PM (#400695)

          The system I remember from a backcountry first aid kit I was trained to use over a decade ago was also pretty simple: It came in a pre-filled syringe, and the plunger required you to give it a quarter-turn before pushing 0.1cc out. So it basically was "put needle in, turn plunger, push until it stops, pull out needle". If you need to do it again, it's the exact same series of steps, and you have about 5 doses in it, which would be enough to get somebody transported before you ran out even if you were a ways away from a road.

          Those kinds of things apparently go for about $10.

          Those pens sure are convenient though: 2 weeks ago I watched someone save a life with that one (patient had severe bee sting allergies and took a sting right under her chin).

          --
          The only thing that stops a bad guy with a compiler is a good guy with a compiler.
        • (Score: 2) by Zinho on Monday September 12 2016, @02:23PM

          by Zinho (759) on Monday September 12 2016, @02:23PM (#400718)

          Dunbal, can you comment on this a bit more?

          From what little there is on the website, it sounds like a bunch of the money is going to verification of sterility; sounds like the FDA is worried that the process of filling the syringes would introduce pathogens.

          How viable would it be for a consumer to DIY something like this by purchasing the syringes, ampoules, and carrying case on the open market and pre-fill their own syringe to carry around? I'm asking specifically about the sterility issue. Usually a diabetic patient is injecting immediately after measuring, here there would be a delay and some risk of contamination during storage.

          I imagine that this inventor feels about the same as you do on this topic; comparisons to the injection of insulin to treat diabetes seem justified, and given that context the costs/requirements on sterile delivery must seem burdensome.

          --
          "Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin
          • (Score: 3, Informative) by Dunbal on Monday September 12 2016, @02:36PM

            by Dunbal (3515) on Monday September 12 2016, @02:36PM (#400728)

            Dunbal, can you comment on this a bit more?

            The questions you are asking are the questions that would interest lawyers. So a company like Epi-pen will invest a lot of money in making sure they can't be sued if anyone gets infected by their product because "oh we have this process, and that system, and such and such, and these studies..." - which is understandable but 100% MARKETING. Pay attention to this further comment:

            ALL MEDICAL PROCEDURES INVOLVE RISK. ALL OF THEM. NO EXCEPTIONS. INCLUDING INJECTING YOURSELF WITH AN EPI-PEN.

            You can infect yourself with the DIY system. You can infect yourself with an Epi-Pen. You might have an increased chance of infection if you do it yourself with a plain old needle. The chance of any wound being infected normally is around 7%. If the most cautious anti-septic and aseptic procedures are followed, it drops to around 1%.

            A course of antibiotics and a walk in clinic doctors' visit is still cheaper than a $600 epi-pen. Of course you could be the unlucky one that not only got infected but got infected by a resistant strain, got complications, and died. It happens. It's not likely. Heck heroin addicts inject themselves far more often, with far dirtier things (both the needles and the tainted, "cut" drugs they shoot themselves with) and not all of them drop dead on the spot from infection.

            And at the end of the day - you did it to yourself with a needle you loaded yourself. Who are you going to sue? You were explained how to do it properly, and you were made aware of the risk. But Epi-pen, well of course they have to cover their backsides. They are a magnet for lawyers.

            • (Score: 2) by Zinho on Monday September 12 2016, @03:02PM

              by Zinho (759) on Monday September 12 2016, @03:02PM (#400739)

              The questions you are asking are the questions that would interest lawyers. So a company like Epi-pen will invest a lot of money in making sure they can't be sued if anyone gets infected by their product because "oh we have this process, and that system, and such and such, and these studies..." - which is understandable but 100% MARKETING. . .

              And at the end of the day - you did it to yourself with a needle you loaded yourself. Who are you going to sue? You were explained how to do it properly, and you were made aware of the risk. But Epi-pen, well of course they have to cover their backsides. They are a magnet for lawyers.

              Yeah, that's what I suspected. The regulatory hoops AllergyStop is jumping through sound exactly like lawyerproofing instead of actual treatment requirements. Unfortunate, and a side-effect of the "shift responsibility to someone else" culture we've developed.

              --
              "Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin
              • (Score: 3, Insightful) by Dunbal on Tuesday September 13 2016, @01:22AM

                by Dunbal (3515) on Tuesday September 13 2016, @01:22AM (#401047)

                Unfortunate, and a side-effect of the "shift responsibility to someone else" culture we've developed.

                You hit the nail on the head. Of course this culture exists for a reason, and that is financial gain. The lawyer will advise you to sue because he and his profession have a vested interest. They get paid. And they let you have a cut, too. So it becomes a game of find the most vulnerable target as opposed to actually caring about medicine and patient welfare. Of course the lawyer will deny this, and will tell you about how punitive damages provide a service to health-care by offering consequences for the unethical. But that's not the whole truth. At the end of the day, they will go wherever the money is.

                I get US TV stations where I live, and I am constantly seeing ambulance chasing advertisements from law firms for things like Mesothelioma. It's all they seem to talk about. Is mesothelioma a serious problem? It's cancer, but not really. There are far worse and far more aggressive types of cancer. Is it a common illness? No, it's extremely rare. Then why the disproportionate advertising - you'd think everyone in the US was dying of mesothelioma. Ahhh - because it is one of the most EASILY MISSED diagnoses. A lawyer with a mesothelioma patient can go through the file and be pretty much guaranteed to find some sort of evidence, IN HINDSIGHT, that points to a missed early diagnosis. It's pretty much a guaranteed payout - and a BIG payout, after all, you get to go in front of a jury and tell them you are dying of CANCER because of Dr. So and so. But does the lawyer actually care about the patient? No. Does it improve the prognosis of mesothelioma? No. Does it cause doctors all over the country to order inappropriate tests to defensively rule out mesothelioma just to lawyer-proof the patient file, wasting time, money and resources? Yes. But such is the world we live in now.

                • (Score: 1) by segwonk on Tuesday September 13 2016, @05:31AM

                  by segwonk (3259) <jwinnNO@SPAMearthlink.net> on Tuesday September 13 2016, @05:31AM (#401142) Homepage

                  "Then why the disproportionate advertising....Ahhh - because it is one of the most EASILY MISSED diagnoses."

                  I haven't looked into this very much, but I was under the impression that Mesothelioma is sought after by ambulance chasers because of the disease's link to asbestos. And I also have this dim memory that there is a fund set aside by some chemical companies as a result of some class action settlement for Mesothelioma.

                  But I could be wrong. Anyone know?

                  --
                  .......go til ya know.
          • (Score: 3, Interesting) by sjames on Monday September 12 2016, @07:57PM

            by sjames (2882) on Monday September 12 2016, @07:57PM (#400902) Journal

            It seems to me that sterility goes out the window when you inject someone through their pants leg.

        • (Score: 2) by MichaelDavidCrawford on Monday September 12 2016, @11:42PM

          by MichaelDavidCrawford (2339) Subscriber Badge <mdcrawford@gmail.com> on Monday September 12 2016, @11:42PM (#401017) Homepage Journal

          From time to time I get quite a severe sharp pain on the sole just behind the big toe.

          Thanks!

          --
          Yes I Have No Bananas. [gofundme.com]
  • (Score: 3, Insightful) by jdavidb on Monday September 12 2016, @03:31PM

    by jdavidb (5690) on Monday September 12 2016, @03:31PM (#400754) Homepage Journal

    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.

    Another horrendous example of how granting monopoly privileges hurts and kills people. The solution to this is to not pass intellectual property laws and to not enforce them when they exist. Disobeying this law is every bit as moral as disobeying Jim Crow laws. More so, in fact.

    --
    ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
  • (Score: 2) by MichaelDavidCrawford on Monday September 12 2016, @11:37PM

    by MichaelDavidCrawford (2339) Subscriber Badge <mdcrawford@gmail.com> on Monday September 12 2016, @11:37PM (#401015) Homepage Journal

    The word "EpiPen" in the title is incorrect, as EpiPen is the trademark for the $300 epinephrine self injector.

    --
    Yes I Have No Bananas. [gofundme.com]