6 ms·
One of the early on-line responses was "maybe we can figure out how to 3D print these cases". It turns out that an Epi-pen is just a plastic safety housing arou
by gmisra 10y ago
One of the early on-line responses was "maybe we can figure out how to 3D print these cases". It turns out that an Epi-pen is just a plastic safety housing around a normal syringe.
Some discussions:
https://www.reddit.com/r/news/comments/4y5481/cost_of_epipen_continues_to_rise_putting_burden/d6lao38 https://www.reddit.com/r/news/comments/4y5481/cost_of_epipen...
https://www.reddit.com/r/3Dprinting/comments/4y7f26/epipen_fork_of_the_enable_project/d6lmoaf https://www.reddit.com/r/3Dprinting/comments/4y7f26/epipen_f...
- Cyph0n 10y agoThat second discussion got heated quite fast. I agree with the downvoters though. 3D printing a medical device is not something to take lightly. Edit: Here's why I agree. You download this design from the internet, and 3D print the parts. You then assemble it. Awesome! Some time later, you get an allergic reaction. You use the pen, but it fails to work correctly. Who's responsible? The designer? You (if you're alive)? The printer manufacturer? Your friend who emailed you the design? etc. There's a reason why even getting such a simple design considered for FDA approval and certified for use on live humans is such a long and complex process. It's easy to make something that works some of the time, but it's extremely hard to make it work essentially every time, especially in life-or-death scenarios. Of course, the price hike is terrible and the company behind it deserves punishment, but that doesn't make it OK to endanger the lives of people.
- toomuchtodo 10y agoScarcity demands innovation. I don't think its being taken lightly; more like, "a private company is gouging medical users and the government won't step in". Not left with many options when your life depends on it. EDIT: Alternatively, a "better" temporary solution would be to arrange for the import of these from Canada, where the price is fixed by the government.
- bobdole1234 10y agoNot so much fixed as "Canada doesn't insist that everyone make separate deals so everyone can get fucked harder". It turns out when you have millions of people dealing together as a block, they have much more bargaining power.
- toomuchtodo 10y agoI agree. My hack is safer than 3D printing medical devices, as its simply a geographical arbitrage. Thank you Canada.
- refurb 10y agoThat's not why Canada gets better prices. United Healthcare has 42M members which is bigger than the entire population of Canada.
- dlitz 10y agoYes, apparently Canada has something called the Patented Medicine Prices Review Board: http://pmprb-cepmb.gc.ca/about-us/frequently-asked-questions http://pmprb-cepmb.gc.ca/about-us/frequently-asked-questions
- dredmorbius 10y agoIt's not merely size. It's size-relative-to-market. Canada negotiates with drugs suppliers. Supplier says "take a hike". Canada says, "OK, you're out of the market", turns to next drug supplier. Canada here has right-of-refusal, and can negotiate, as a single block entity, with ability to restrict market, to each. The drugs company which finds those terms acceptable has a market. A bloc of 42 million in the US is only about 12% of the total market. The discussion there still leaves another 290M possible customers for a drugs vendor. Hence the strength is with the vendors. If US Medicare had rights to exclusively negotiate drugs deals (it doesn't), this would change tremendously. Similarly for single payor. Which is precisely why the entire medical services industry is so mortally opposed to it. They'd lose absolutely all market leverage. They know this.
- niels_olson 10y agoSurely design files can be signed...
- greenknight 10y agoSure... but then there is the problem of the end user. Is there 3D printer correctly calibrated? will miscalibration effect its end use? how can you test to make sure the printed design is working as intended? Can the printed plastic withstand direct sunlight for days on end? Some printed plastics become brittle over time in sunlight (PLA for instance).
- rangibaby 10y agoWhen the difference is $1 vs $600, I think a lot of people would be willing to take that risk, especially for something that is basically an unexpected expense; I doubt any allergic people are getting stung by bees on purpose. Most people I know couldn't handle a sudden $600 expense like a car repair without help from someone like their parents (I'm mid-20s living in JP).
- cjbprime 10y ago> When the difference is $1 vs $600, I think a lot of people would be willing to take that risk, especially for something that is basically an unexpected expense; I doubt any allergic people are getting stung by bees on purpose. What probabilities are you assigning to needing the printed epipen to survive, and to it functioning correctly, such that it's worth that risk?
- rangibaby 10y agoI get where you're coming from. I guess my point was that to most people $600 might as well be $6,000 or $6,000,000, since that's not something they can afford on their own. At that point, the dollar version is (hopefully) better than nothing.
- infinite8s 10y agoWell the cheaper and more effective solution would be to carry around a syringe and a small bottle of epinephrine.
- imglorp 10y agoThe autoinjector provides value for people that don't do IM administration every day. It's rugged, sterile, can be used right through clothing if necessary, and provides the right amount of force to go through to the muscle. The kit might also include a practice injector for training the user. Oh and it's probably a little hard to handle a bottle and syringe on yourself while you're suffocating.
- icantdrive55 10y agoThat makes too much sence for the FDA, AMA lobby, big pharma, and very entity/persons that makes a killing off health care. As to the simplicity the EpiPen, I once used it, and under stress didn't do it right. When I was younger I was very interested in medicine. In college finished all pre-med courses. Interned at a Coroner's office, etc. Even spent some time in med school. Very familiar with giving a subdermal injection. Now my father had a bad asthma attack years ago. I knew he was in poor health, so my stress level was high. He blurted out where the EpiPen was kept. I got the device, didn't have time to read the instructions, and just stuck it in his thigh. I apparently pulled it out too quick--just wasn't thinking, and nervous. I pulled it out so quick, because I was scared, felt the device was foolproof, and felt weird hurting my father. We luckey had enother one around, and injected him longer this time. If I was forced to use a syringe, their would be no assuming. "I need to get the drug into the syring. I then need to empty the syring into his thigh. Done?" Well it didn't work, and he ended up in the emergency room. He survived. I drove home feeling guilty, and still do today. I always felt a kit with a single dosed bottles of epinephrine, and a syringe would make intuitive sence to a lot of people? I know I would have felt more comfortable that night. I honestly think the powers at be underestimate the abilities of the average person, especially a person who's had an previous asthma attack. If a doctor/nurse spent a minute showing a patient how to injection themselfs with epinephrine; I don't think most would ever forget. Plus--we have all watched injections given on the boob tube? "But the average person would probally jab the syringe in the Carotid artery, or pull a Pulp fiction." They could jam it into a carotid, even with a EpiPen--with enough effort/stupidity? I hope in the future we have over the counter life saving medications over the counter, including naloxone. Demand passing a basic test if worried about consumers hurting themselfs? Something like a CPR certification? If the patient can pass, they can buy cheap medications over the counter? They don't need fancy propriatiatry drug delivery gadgets in so many cases. I really think the only way to bring down medicine costs will be to make many drugs OTC, and demand basic competency exams if worried about ineptitude? There will always be people out there that will find a way to abuse/overdose/screw up dosesages on medication. Let's just try it for a year? Especially with certain life saving drugs. How many diabetics die each year because they don't have a prescription for insulin, and couldn't get to a hospital? I used to have so much respect for any sector of the health care; now I look at most of them with utter discontent.
- mikeash 10y agoDying because you can't afford a device you need is also not something to take lightly. It may not be a good idea, but blame should lie with the manufacturer for raising the price to such ridiculous levels.
- hkmurakami 10y agoNot condoning this behavior at all, but don't we see this with the lack of equal access to drugs all the time? :(
- cortesoft 10y agoYes; this is why using the free market to set prices in health care is always such a troubling thing. People don't like the idea of putting a price on their health.
- gwright 10y agoPlease don't blame the free market for these high prices. This is a highly regulated medical device market with patent protections and insurance market complications. The price hikes would immediately attract lower-cost competitors if this were truly a free market.
- Ironchefpython 10y ago> The price hikes would immediately attract lower-cost competitors if this were truly a free market. Any participants in a free market for a product with inelastic demand (e.g. something you need to stay alive) and non-trivial entry costs immediately implements price fixing in the absence of regulation. When life-saving devices that require a significant supply chain to manufacture capture the bulk of consumer surplus from the majority of potential customers (and the poorest are left to die), the free market is working as intended, efficiently allocating resources to maximize profits.
- gwright 10y ago
- dfsegoat 10y agoThanks for this summary comment. This is backed in the literature by people who are systems / usability engineers: tldr: Reliable design is HUGELY important. You can't just put these things together haphazardly. "The fact that less than 50% of participants across all devices could follow the labeled instructions without committing a single error provides confirmation that the need for training on the use of epinephrine autoinjectors is still important...The user-centered device design may have a significant impact on correct epinephrine autoinjector use and patient preference." http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2892620/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2892620/
- helloworld 10y agoIn the study below, moms of kids with severe allergies were trained to use the EpiPen. Six weeks later in a simulated test, only about two out of five were able to successfully deliver a lifesaving dose of adrenaline. Shouldn't the FDA require that manufacturers provide evidence that consumer medical devices can be used reliably for their intended purpose? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4654245/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4654245/ Patients’ ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial. Allergy. 2015 Jul; 70(7): 855–863.
- refurb 10y agoShouldn't the FDA require that manufacturers provide evidence that consumer medical devices can be used reliably for their intended purpose? What makes you think the FDA doesn't require this?
- helloworld 10y agoThe fact that three out of five people trained to use this lifesaving product weren't able to.
- refurb 10y agoThat doesn't mean the FDA doesn't ask for data. I have a friend who works in the industry and it's his job to run usability trials for medical devices. The FDA won't approve a device without it.
- shanacarp 10y agoSemi-yes, semi-no. The epi-pen case is specially made to try and get people to shoot it into themselves/other people correctly. They are super color coded and once triggered can't be untriggered Other than that, they could be 3-d printed or whatever is cheapest by many providers
- hackuser 10y agoConsider also reliability: What if some 3D-printed part breaks? What if it sticks when it gets hot or cold, or after a few hot/cold cycles, or after some flexing in a pocket? The first 90% of quality is easy ... Think of the difference between the quality needed for a mobile game app and the software that flies airplanes.
- incongruity 10y agoIf they're significantly cheaper, carry 2 or 3. If you're at a 90% level, you will be almost assured of cheaply having one work, assuming the error/failures are random. Yes, this is sub-optimal in a life or death situation, but it's a reasonable counter to unreasonably high EpiPen pricing. Moreover, if this becomes common practice or if it's even feared as plausible, it could help reduce EpiPen pricing.
- hackuser 10y ago> this is sub-optimal in a life or death situation I think that rules it out. Imagine a family member, or anyone, dying because of your sub-optimal solution.
- incongruity 10y agoI am allergic to bee stings, myself and, to be honest, I don't agree with you. The best solution is the one you can actually carry with you – if you can't afford the EpiPen, this system would be far, far better than nothing. Further, while anaphylaxis is a life threatening situation, it isn't a situation where, if recognized in a timely manner, 10 seconds more to pull out the second or even 3rd home-brew auto-injector would kill the patient. Next, the widespread existence and feasibility of a home-brew option would itself exert significant pricing pressure on the original EpiPen thereby making it more affordable for everyone and thus less likely that I would even need to actually make one. Lastly, I would, in fact, use the above hypothesized home-brew option for my kids or wife (if they were alergic), if we couldn't afford an EpiPen or as a way of making sure we always had one available. As I argued, having multiple devices cheaply on hand makes failure of one an okay thing. If they have a 10% failure rate (which itself is a high failure rate even for this scenario), having 3 on hand would mean you'd have one-tenth of one percent odds of all three failing. Add a 4th and you get down to 0.01% – get the individual reliability down to 5% failure rate and 3 devices would give you 0.0125% odds of failure. Those are actually pretty good odds. Moreover, I'm not sure what the traditional EpiPen's reliability is, but I'd bet it's not that much better than a 0.000125 failure rate.
- tw04 10y agoWell, if I can print 3 of them for 1/100th the price of a single one from said manufacturer, if the design is even adequate I'm probably still better off.
- curiousgeorgio 10y agoConsider this: every time you get into a car, you are putting yourself into life-or-death scenarios that greatly depend on the class and quality of car you've chosen. The government enforces some minimum safety standards for any registered car on the road, but above that, you pay for safety - quite literally. Does the government prevent the sale of cheaper, inferior cars just because higher-priced cars are substantially safer? Why should medical devices be any different? If the barriers to entry (e.g., costs associated with FDA approval) were lower, then we'd absolutely have some inferior EpiPens on the market. But we'd also have a lot more options, and all of them (even the best) would be ridiculously cheap compared to what we're seeing now. Wouldn't that be better overall for people who might not be able to afford one at all in the current system?
- ceejayoz 10y ago> Does the government ban us from purchasing cheaper, inferior cars just because higher-priced cars are substantially safer? Yes?
- foota 10y agoBut also no, I can be a used car with lower safety features than mandated for new cars I believe
- Cyph0n 10y agoIn that case, there is no ambiguity when it comes to determining who's responsible, unless the DMV or whoever allowed you to drive it.
- ceejayoz 10y agoYes, and you can use an expired or recalled medication. I'm not sure how that's relevant. The used car will also need to pass an annual safety inspection here in NY, at least, as it's required to meet some minimum safety standards.
- derekp7 10y agoEven though there are cars with a 5-star safety rating, you can still get ones with a 4-star or even 3-star ratings. So I would say the answer to the original question "Does the government prevent you from buying less safe cars" is "No".
- tibbon 10y agoI rather dislike the (frequently American) immediate viewpoint of assigning blame/responsibility in the case of a failure, and thus who can someone sue. This isn't an uncommon viewpoint at all, rather it seems to be the first that many go to.
- wodencafe 10y agoResponsibility (blame) is not the same thing as "who can I sue?" For one thing, finding the source of the problem, or whatever warped thought process resulted in it, is a good place to start fixing things.
- redpola 10y agoWhat doesn't seem to be represented in the discussion is that if you source and build your own epi pen, you might not have that initial discussion with your doctor and you certainly don't get any medical guidance leaflet with it. Using an epi pen is a dangerous business and can cause considerable complications. It is absolutely not to be taken lightly and is literally for life-or-death situations. I fear that those making their own (or heaven forbid somebody else's) pen will not know this. Source: my doctor when I bought my first epi pen (beekeeper).
- chaostheory 10y agoSounds like an opportunity for a startup...
- jstanley 10y ago> You use the pen, but it fails to work correctly. Who's responsible? You are responsible for making decisions for yourself. If you think a 3D printed pen is not safe, buy the more expensive one. Don't hedge every decision you make against who you'd be able to sue if it goes wrong.
- wodencafe 10y agoI was going to reply and say this, but you said it first :)
- incongruity 10y agoOn the other hand, it doesn't have to work 100% of the time to be viewed as a threat, economically. Make it widespread, make it reasonably effective and you will likely succeed in driving the price of the certified EpiPen.
- JoeAltmaier 10y agoLiability isn't (shouldn't be) the first concern in health discussions. Presuming an individual cannot afford the $600 version, surely the chance that a printed version might work is purely an improvement in their situation.
- limeyx 10y agoI think it's patented so yeah but no...?