Was the EpiPen Hack Ethical?

Update  June 5, 2017  

From The New  York Times Sunday: Charles Duhigg  writes that last year's outrage over Mylan ratcheting up the price of the EpiPen, so that patients out-of-pocket costs increased by over 500 percent in a few years, has not resulted in the company lowering the price of the product. Duhigg writes:

Mylan has been called out again and again over the years — by the company’s own employees, regulators, patients, politicians and the press — and hasn’t changed, even as revenue has skyrocketed, hitting $11 billion last year. The firm is a case study in the limits of what consumer and employee activism, as well as government oversight, can achieve.

Meanwhile last week, Iowa Republican Sen. Charles Grassley announced that the government has estimated Mylan may have overcharged Medicaid by as much as $1.27 billion for the EpiPen under the agency's drug rebate program.

Original post from Jan. 23, 2017

Should we be free, as individuals, to make and take our own medicine at home? Who’s responsible if we get hurt or die? Do we have to right to do what we wish with our bodies in the interests of survival, healing and self-care? For years, such questions have been at the heart of public health debates over euthanasia – the right to die – and even drug addiction.

They also lie at the center of the infamous Mylan EpiPen pricing scandal. Last fall, Mylan CEO Heather Bresch appeared before the House Oversight Committee to explain the company’s 548 percent price hike for a simple device that injects a lifesaving anti-allergy hormone, FDA-approved epinephrine.

The cost drove desperate allergy patients to seek alternatives, including the dangerous practice of shooting epinephrine straight from a vial into a muscle.

Enter a new challenger: the pharmaceutical hacking collective Four Thieves Vinegar. The group is led by Michael Laufer, a math professor by day at Menlo College in Atherton, California, who shot to internet fame overnight last August when he uploaded a DIY instructional video that went viral, showcasing his homemade version of a copycat EpiPen he called the EpiPencil. His device costs around $35 to construct– a fraction of Mylan’s $600 brand name dual-pack EpiPen. Anyone can make it at home for personal use, he claims.

Laufer isn’t a medical doctor and doesn’t pretend to be. But he’s a numbers guy, well versed in computer science, and has dipped into biology and chemistry. It took him two weeks to research and assemble the plastic components of the EpiPen, an auto injector created by a NASA researcher and marketed in 1980 for $20. Mylan later picked up the patent and has benefited from a monopoly.

Four Thieves Vinegar is named after a folk remedy made from vinegar and spices to ward off bubonic plague. The collective is part of the fast-growing DIY Biology movement, a subculture in which tech meets pharma--a Maker Faire for bio-geeks. In the video, Laufer carefully demonstrates how anyone can do what he did: combine a cheap off-the-shelf needle injector made for diabetics that is easy to buy on the internet, and combine it with a syringe that can be preloaded with a $1 dose of epinephrine.

Under fire, Mylan soon released a $300 generic of its EpiPen, but that did little to quiet critics. Georgia Congressman Buddy Carter accused the company of failing to disclose the truth about its profiteering. “There is no transparency, that's the problem here," he declared.

Leaders also criticized the FDA for its slow-paced approval of generic rivals. Teva Pharmaceutical Industries failed to get approval for its generic EpiPen in late 2016, but expects approval by 2018. Meanwhile, CVS Pharmacy has just released a $109.99 generic two-pack EpiPen called Adrenaclick. At $55 a pen, it’s close to Laufer’s DIY price -- and provides consumers with a safe, FDA-approved product.

That’s exactly what Laufer hoped might happen. As he sees it, his EpiPencil hack was a classic example of The Emperor Has No Clothes: It revealed the actual cost of the plastic auto injector – and showed others how they could make such a device cheaply.

It’s a mixed victory, though. The media spotlight gained supporters for Laufer's collective, but also opened him up to criticism. “I get a lot more fan mail then hate mail,” he says, including from parents. But others sharply condemn his actions, and his hacking group’s broader mission: making medicine at home.

Home Pharma Hacks Raise Safety Questions

Shortly after Laufer’s hack, the FDA issued a strongly worded warning against its use: “Using unapproved prescription drugs for personal use is a potentially dangerous practice,” an FDA spokesperson told the website in-PharmaTechnologist. “Unapproved drugs may be contaminated, sub-potent, super-potent or counterfeit.”

Critics agree. Yvette d’Entremont, known as SciBabe, is a former chemist-cum-blogger who quickly labeled the EpiPen hack a potential major fail if misused. “It seems like such a bad idea,” she told the Daily Beast. “It’s all fun and games until your product gets contaminated and you get a giant abscess in your muscle.”

Contamination and improper dosing can happen with approved drugs too. Epinephrine is a serious drug, used to shock the heart. Laufer defends his device as safe. “In most ways it is equivalent” to Mylan’s EpiPen, he argues, pointing out that it features a safety cap like approved EpiPens, and only carries a single dose.

But it’s still untested. And as the father of toxicology himself, Paracelsus, famously warned: all medicine is poison at a certain dose.

Oncologist Ezekiel Emanuel,  a bioethicist and senior fellow at the Center for American Progress, adds to the chorus of concern, cautioning strongly against using the device.

“We have the FDA for a reason. We want to protect the American public from dangerous drugs, which they have no ability to evaluate independently,” he says. “So now we’re going to have some guy who’s going to make a drug and a drug delivery device, put it out there -- no testing, no evaluation of whether it’s safe or effective -- and who the hell knows how many people are going to be hurt -- or not.”

Adds Emanuel: “In this case he may turn out to be lucky and no one’s hurt. But we don’t want that regime.”

He said the solution to high pharmaceutical prices was "not this cockamamie 'let people throw drugs out there untested,'" but to reduce the market power that drug companies rely on to set prices.

"We give drug companies monopolies through the patent law, and marketing exclusivity," he said. "No other country gives a monopoly and then expects good behavior on pricing.

"So what we’ve done is say, 'Oh we’re giving drug companies monopoly pricing power and then we’re like shocked, shocked they're raising prices."

Margaret McLean, director of bioethics at the Markkula Center for Applied Ethics in Santa Clara, also agrees using Laufer's device could be dangerous. She herself, carries an EpiPen. It carries a higher copay than her other medicines, so she sympathizes with parents who can’t afford even generic versions. But the safety risks remain serious.

“There is always user error,” says McLean, citing incorrect dosing as a concern. “That is true with FDA-approved drugs too. But the error is less if I don’t have to draw up the right amount of epinephrine myself. I’m grateful for the standardization and check on the injector itself, and that the dose in there is appropriate for me.” She doesn’t want to worry about bubbles in the syringe, which are very dangerous. “There are a lot of steps here,” she says of Laufer’s DIY epinephrine device, “where sitting at home in your kitchen, never having done this before, it puts you in a higher risk category then buying it from the pharmacy.”

Still, she understands the urgent unmet need for affordable EpiPens. “The FDA is not able to move things through in an expeditious way, so people rightly get antsy.”

Perhaps surprisingly, Laufer agrees about the warnings on safety. “Chemistry is science. So, yes, it’s a concern. You have to think immediately, ‘What if it’s misused?’ But that’s a first-order reaction,” he says. “Ideologically, I believe that more access to more information is inherently better for everyone.” He supports FDA safety reviews and clinical trial tests for new drugs and devices that are marketed to consumers. But he stresses, he’s not marketing anything.

Where Laufer draws a hard line – and marks his battleground -- is the domain of the private individual. “What I’m saying is, here is something you can think about... If you decide you’d like to adopt it, then that’s the whole ethic: Here is an idea, play with it, if you like -- no strings attached.”

More Drug Hacks On the Horizon

In his cramped faculty office, Laufer greets visitors with a warm smile, eager to share his mission and rebut critics who, he feels, have misperceptions about the true goals and the impact of his hacking action. Online, he looks like a steampunk rebel hero in a metal-studded leather jacket, rimless glasses shoved high on his forehead. Offline, he’s natty in a dark suit, purple tie and tie pin, and fancy abacus-shaped cuff links befitting a math geek.

“I believe in empowering people, in sharing information,” Laufer says, citing his hacker creed. “We need to talk about alternatives to expensive medication regimens.” He compares the need for a cheap drug delivery device like his EpiPencil to IKEA furniture: something that should be easy to make, with simple instructions for the average consumer.

What people do with that information is not his business, he declares. “I don’t know if anyone has built it besides me,” he says of the EpiPencil. “I don’t want to know. I believe in giving people information they can use to make important decisions about their self-care. That’s what I can offer.”

Anyone who copies a patented device risks running afoul of patent law. It's a form of civil disobedience with life-or-death stakes. That make it easy to justify, according to Laufer's group, whose website asks, "If the choices presented to you are to die, because you cannot afford medication, or violate a copyright, which would you choose?"

Four Thieves Vinegar is presently focused on “small batch” chemistry--medicines that are easy to make with at-home equipment. Laufer’s first successful hack was pyrimethamine (brand name Daraprim), a decades-old drug used to treat toxoplasmosis in AIDS, cancer and malaria patients. Turing Pharmaceuticals purchased the patent in August 2015 and, a month later, hiked the price for a single Daraprim pill overnight by 5,000 percent, from $13.50 to $750. Turing CEO Martin Shkreli became a Big Pharma pariah. In response, Laufer made a batch of DIY Daraprim for $2 a pill. So did a group of Australian high school students.

Laufer has now set his sights on several drugs he feels urgently merit greater public access, including the abortion drugs RU-486 (Mifepristone) and Misoprostol; Solvadi, a hepatitis C drug; and Glaxo’s HIV prevention pill, GSK-744. He’s keenly aware his choices remain controversial and politically charged.

Looking ahead, Laufer foresees a future of medicine more like Socrates, less like Big Pharma: “Maybe in not too long, the idea of doing chemistry on a personal and individual level and applying it to medicine will be more commonplace. I like dreaming about that.”