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."

Comments

Epipen cost: $30, regulatory costs: $30 mil+

[DatbeDank]

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.

Re:Epipen cost: $30, regulatory costs: $30 mil+

[tburkhol]

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.

Re:Epipen cost: $30, regulatory costs: $30 mil+

[BarbaraHudson]

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.

Just an onion on my belt!

[Daemonik]

"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.

Single payer system would avoid this problem

[sjbe]

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".

Re:Single payer system would avoid this problem

[dywolf]

works fine everywhere else.
the us isn't such a special snowflake that it cant work here too.

Re:Single payer system would avoid this problem

[moeinvt]

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.

Re:Better be careful, people

[pz]

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.

Why competition is mandatory, not optional.

[geekmux]

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.

Sounds great, except they don't make more money

[raymorris]

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.