Outraged by the recent news that Mylan Pharmaceuticals had gradually hiked the price of life-saving epinephrine auto-injector EpiPen for a one-year two-pack supply from a little over $100 to $600, pharma hackers collective — Four Thieves Vinegar — has developed EpiPencil, a $30 DIY version of EpiPen.
Dr. Michael Laufer, one of the founders of Four Thieves Vinegar, says:
“We’ve gotten many requests to do something about the EpiPen, so we have. We developed the EpiPencil, which is an epinephrine auto-injector built entirely from off-the-shelf parts, which can be assembled in a matter of minutes for just over $30. The idea is that someone can do what we’ve done — that they can get the pieces and put it together and get the medicines they need if they’re disenfranchised from access.”
In the instructional video, Laufer shares links from where people can buy the parts needed to assemble an auto-injector at home. Although epinephrine will still need to be acquired with a prescription, Laufer and his team are trying to figure out other ways to obtain the unpatented adrenaline drug. He told IEEE Spectrum:
“It’s easy to buy epinephrine online from a chemical supplier, and I hope viewers will do just that. There’s a small but hopefully growing subculture of people who are buying the active ingredients of drugs. It’s encouraging to see people take control of their own health.”
Earlier this month, two industry insiders claimed that EpiPen was costing Mylan Pharmaceuticals not more than $30. Kevin Deane — head of medical technologies for PA Consulting Group, a global technology and design firm that sold a drug delivery technology company to Pfizer in 2004 — said the base components for each EpiPen, including the plastic cap, tube, and needle, cost between $2 to $4 to purchase. The epinephrine inside the EpiPen costs less than $1.
Vermont Senator Bernie Sanders told NBC News:
“There’s no reason an EpiPen, which costs Mylan no more than $30 to make, should cost families more than $600. The only explanation for Mylan’s outrageous price increase is that the company values profits more than the lives of millions of Americans.”
Should you go out and make your own EpiPen since it is not advisable to hack your own EpiPen? The United States Food and Drug Administration (FDA) spokesperson, Theresa Eisenman, told in-Pharma Technologist such DIY medical devices put patients at risk:
“It’s essential to remember that epinephrine auto-injectors are life-saving products, and it is critical that they are made to a high standard of quality so patients can rely on them to work safely and effectively. Using unapproved prescription drugs for personal use is a potentially dangerous practice. Neither FDA nor the American public has any assurance that unapproved products are effective, safe or produced under Current Good Manufacturing Practices (CGMP). Unapproved drugs may be contaminated, sub-potent, super-potent or counterfeit.”
The EpiPencil requires users to measure the correct dose of epinephrine before administering it on self or to save the life of someone who is going into anaphylactic shock. Thus, Dr. Schuman Tam, a San Francisco-based allergist, warns:
“An overdose can cause edema, heart palpitation, or possibly even death. If you don’t draw up the epinephrine carefully into the syringe, there will be a problem with contamination. The risks of an epinephrine overdose could be catastrophic.“
While Four Thieves Vinegar’s stated aim of “free medicine for everyone” is commendable, experts believe people with allergies must steer clear of EpiPencil. Yvette d’Entremont, a former chemist who debunks science myths on her blog SciBabe, told The Daily Beast:
“I look at this and go, there are so many things that could go wrong in constructing it. It seems like such a bad idea. It’s all fun and games until your product gets contaminated and you get a giant abscess in your muscle. You either don’t start breathing again or you stop your heart.
“What’s going on with the EpiPen is a tragedy. It’s devastating people who don’t have the money to pay for it. I’m horrified for the person who’s desperate and looks at this like the only chance of keeping their child alive.”
Nevertheless, Four Thieves Vinegar seems unfazed and undeterred. Laufer eventually hopes to offer other instructional videos featuring medical hacks. His team is working on developing alternatives to medicines like Solvadi (which treats hepatitis C) that costs $80,000 for a course of treatment. The hackers are also looking to hack into Mifepristone and Misoprostol pills, which are used in chemical abortions.
According to U.S. News, Four Thieves Vinegar is also looking into developing an alternative drug for GlaxoSmithKline’s Cabotegravir, which treats HIV infections; as well as Naloxone, the drug used to counter the effects of heroin, fentanyl or prescription painkiller overdose.
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