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Hackers Offer a DIY Alternative To The $600 EpiPen (ieee.org)
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."
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.
"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.
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 medical training whatsoever because there is a very high chance that whoever administers the epipen will not be a trained medical professional.
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.
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.
Apparently in a lab study epipens that were used 2-3 years past date still contained 90% of epinephrine; 5-7 years had 70%.
https://www.verywell.com/expir...
"Stratigraphically the origin of agriculture and thermonuclear destruction will appear essentially simultaneous" -- Lee
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".
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.
First of all, the EpiPen is certainly covered by some sort of patent, so Mylan is going to sue them into the middle ages for infringing on their patents.
Mylan does have a patent, which covers their design until 2025. However, after watching the video, I really don't see how they could sue for patent infringement.
Basically, the video shows you how to take an auto-injector for diabetics and replace the needle of the syringe with the larger one required to deliver the epinephrine. I was actually surprised how simple it really is to make, I think most people could actually do this fairly easily. In fact, the solution is so cheap, and the only part that needs to be replaced is the needle itself, that you could afford to try dozens of times to get it right before you would come close to the cost of even one EpiPen.
In fact, if Mylan actually tried to sue for infringement, they might open themselves up to invalidating their own patent, because it wouldn't pass the test of non-obviousness. Specifically, in the US, the criteria for determining obviousness is (source):
1. Combining prior art elements according to known methods to yield predictable results;
2. Simple substitution of one known element for another to obtain predictable results;
3. Use of known technique to improve similar devices (methods, or products) in the same way;
4. Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
5. "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
6. Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
7. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
I think the EpiPencil hits every one of these points. So if Mylan wants to say that the EpiPencil violates their patent on the EpiPen, then they are basically saying that the design of the EpiPen is obvious, and thus their patent is invalid. In a weird way it almost makes me hope they do sue for infringement.
Only crack the nuts that crack. You don't put the ones that don't crack in the sack.
We only run into this problem because we have a portion of our population who will sue anyone over anything bad that happens.
You will have either regulation through government or regulation through legal action. You cannot opt out of having one or the other. You don't get both and you don't get neither. Having neither would be a TERRIBLE idea because that's how you get quacks. Without having regulations or tort action you have no means for people to get redress when they are injured. And make no mistake that there are plenty of people who would sacrifice your life to make a few extra bucks.
If you can't afford a $600 EpiPen, buy a $144 Adrenaclick. Only if you can't afford that do you go for the homebrew.
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.
Put my fist through my alarm clock with its ding-dong death inside my ear. - The Blackjacks.
"The company that makes epipens has been given free reign to set the price however they want"
You do realize that the line right there was made possible by government, right? There are competitors who make them and sell them for much cheaper on the international market, but the government, the one you're saying would make everything better, has banned them from being allowed to be sold in this country.
And if you think the government has no profit motive, you're a naive fool. How do you think lobbying groups work? They just say "pretty please with a cherry on top"? No, they dump lots of money at the government to get their way.
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.
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.
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.
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.
It's worse than that. Most of the quacks actually think they're right and that they're helping people. It's hard to do trials that really prove efficacy (or prove that something is ineffective), and people who are sick are desperate so they'll believe just about anything, and on top of all that the Placebo Effect is a real thing, so we end up with stuff like Homeopathy and Chiropractic. The vast majority of these "practitioners" IMO are not sacrificing your life to make a few extra bucks, they do it because they genuinely believe in their snake oil.
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.
It must have been something you assimilated. . . .
Now let's figure out what we'd like to cut from Government. Defense? That's part of the constitutionally limited responsibilities (CLR). That's roughly half of discretionary spending (about $600 billion).
Of course, not all of that is for proper "Defense". Do we actually need aircraft carriers to defend the US? No, we need them to protect our foreign interests and commitments. I imagine the Defense Budget could be trimmed quite a bit if we limited it to actual Defense.
It must have been something you assimilated. . . .
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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