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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.
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.
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.
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 that everyone else in the world is incompetent, but the world has changed since 1957, and people can and have learned from their mistakes. Now it's the FDA that's incompetent, introducing needless delays in approving drugs that have already been fully vetted elsewhere.
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.