EpiPen Alternative? Meet the $30, DIY EpiPencil | US News – U.S. News & World Report

September 23, 2016 Facebook Twitter LinkedIn Google+ Uncategorized

A how-to video for constructing a do-it-yourself version of lifesaving EpiPen has surfaced on YouTube, raising regulatory issues and questions about how far people will go when they are priced out of medicines they need to save their lives.

The “EpiPencil,” as its creator, Michael Laufer calls it, can be assembled in a matter of minutes and for a little more than $30 – a fraction of the price of a set of EpiPens, which have skyrocketed from about $100 for a pair in 2007 to $608 today. The costly auto-injector is pre-loaded with epinephrine and used to counter severe allergic reactions.

In the instructional video, Laufer provides links for people to buy the parts needed to assemble an auto-injector at home. He suggests people get a prescription for epinephrine, but says he plans to explain other ways to obtain it, once he and his team figure it out. The video has been viewed more than 115,000 times.

“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,” he says.

The 37-year-old mathematics lecturer at Menlo College in California, who often goes by the spelling “Mixael” online, says he’s deeply troubled by the way people are being priced out of lifesaving medications. He has created a group called the Four Thieves Vinegar collaborative, comprised of roughly 18 specialists like chemists and doctors, as well as hardware and web specialists.

“If people don’t have access their lives are in danger,” he says. “That’s wrong.”

But Dr. Lawrence Gostin, faculty director for the O’Neill Institute for National and Global Health Law at Georgetown University, says that he is concerned about the possibility of people making their own medications.

“The cost and the lack of access is a legitimate problem,” he says. “That’s just not the solution.”

He cited examples from other countries, where people purchase counterfeit medications on the street, and the plethora of websites that offer drugs with fake ingredients. A person can overdose, he points out, or get an infection. The drug also may not work and people could die.

“This DIY is done without quality control, without uniformity, without Food and Drug Administration supervision and without physician guidance,” he says. “It’s a recipe for disaster.”

Asked how he would feel if someone were to try to make their own EpiPen and was harmed or died as a result, Laufer says he thinks that outcome would be “extraordinarily unlikely.”

“I think it would take a lot of things that would have to be done incorrectly in a lot of really severe ways for something even minor to go awry,” he says.

Laufer says the feedback he has received on the video has been positive, but he believes backlash is inevitable.

In an email, the FDA, which approves drugs for safety and efficacy, said it was “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,” wrote Theresa Eisenman, FDA spokeswoman, noting Americans have no way of knowing whether unapproved products were safe or effective.‎ “Unapproved drugs may be contaminated, sub-potent, super-potent or counterfeit.”

It’s unclear what the government could do about people posting DIY medication videos online. Gostin says the authority may fall under the FDA or the Federal Trade Commission, which oversees the safety of consumer products. Still, he explains, there would need to be instances of harm or fraud.

Laufer says he hasn’t received any warning letters from federal agencies, and after consulting with lawyers he doesn’t think he will because he is distributing information, not actual medical products. He believes he will be protected under the First Amendment’s freedom of speech provisions.

He is concerned about a possible civil suit, however, or that a drug company could bring a case against his group.

Mylan, the company that sells the EpiPen, said in an email that its product is designed to administer epinephrine “quickly and properly in an emergency situation.” The company did not say whether it could or would seek legal action; Mylan itself is currently facing scrutiny over the extreme hike in EpiPen prices.

“All epinephrine auto-injectors are available by prescription only after review and approval by FDA to ensure the highest level of patient safety and product effectiveness,” a Mylan spokesperson said in the email. “We encourage all patients and caregivers to receive training on proper administration of their prescribed epinephrine auto-injector in a physician’s office and practice between doctor office visits.”

Laufer eventually hopes to offer other instructional videos featuring medical hacks. His team would like to work on mifepristone and misoprostol pills, which are used in chemical abortions; he’s also looking into Sovaldi’s blockbuster drug that cures hepatitis C (priced at $84,000 for a round of treatment); a developmental drug GlaxoSmithKline is working on that treats an HIV infection, called cabotegravir; as well as naloxone, the drug used to counter the effects of a heroin, fentanyl or prescription painkiller overdose.

At a hacker conference in July, Laufer presented how he used the “Apothecary Microlab,” a machine he created, to make Daraprim, the HIV treatment that Turing Pharmaceuticals, led by then-CEO Martin Shkreli, raised the price of by 5,000 percent.

Laufer’s group is mostly unfunded, receiving only a handful of anonymous donations so far.

Laufer wouldn’t specify the amount, saying only that donations were “very small” and “enough for a few plane tickets.”

The Four Thieves Vinegar collaborative’s name comes from a story about the plague in Europe, in which a group of brothers shared the recipe for an herbal vinegar infusion that they used to protect themselves from infection, saving others from the plague.

Critics, Laufer says, come from a different set of values.

“Is it more heartbreaking that the technology exists to save someone’s life and they can’t get it, or is it more important to maintain a system of control where we don’t trust people to take care of themselves and as a result people die?” he asks. “Theoretically, in protecting people from themselves we deny them access to certain medications.”

But Georgetown University’s Gostin maintains the do-it-yourself approach is dangerous, noting that it is the result of a system in the U.S. in which the government cannot negotiate drug prices and has not provided better access to medications.

“This has created a market of poor people that are losing hope,” Gostin says. “This is the worst recipe for exploitation and harm.”