FDA WARNING ABOUT EPIPEN MALFUNCTIONSIn March 2020, the Food and Drug Administration (FDA) released a
safety alertto warn the public that epinephrine auto-injectors (EpiPen, EpiPen Jr, and generic forms) may malfunction. This could prevent you from receiving potentially lifesaving treatment during an emergency. If you’re prescribed an epinephrine auto-injector, see recommendations from the manufacturer hereand talk with your healthcare provider about safe usage.
Imagine a world in which you produce the prescription medicine you need right inside your home.
With the push of a button, a machine synthesizes your blood pressure medication, without a trip to the pharmacy.
In addition, the cost is minimal.
The concept of “open-source” medicine, where drug formulas are shared openly online to use and modify, is a somewhat utopian vision of the future of healthcare.
The idea exploded in September 2016 when a pharmaceutical hacking group called the Four Thieves Vinegar Collective created a do-it-yourself epinephrine injector dubbed the “EpiPencil” for $30 — a fraction of the cost of injectors on the market.
In a YouTube video, Michael Laufer, a math professor at Menlo College in California and spokesperson for the hacking group, instructs viewers on the steps to create the device.
Mylan, the patent-holder of EpiPen, increased the price of their product to more than $600 in 2014, seven years after they obtained the rights to it in 2007.
Researchers found that consumer out-of-pocket spending for the drug soared 535 percent between 2007 and 2014.
Meanwhile, prescriptions for it nearly tripled.
Since then, Mylan has released a $300 generic EpiPen, and CVS stores offer their own generic for $110.
EpiPen contains a potentially life-saving dose of epinephrine that treats anaphylactic shock, a condition that can cause airways to close and blood pressure to drop rapidly, resulting in death.
Attention and caution
In response to the EpiPencil, the Four Thieves Vinegar Collective received a flurry of attention from the media and even the U.S. Food and Drug Administration (FDA).
The device took on a symbolic quality: the greed of the pharmaceutical industry stymied by a cheap product that could be assembled using parts bought on Amazon.
While many praised the device on this level, actual support for the device as a real-world tool was scant.
In fact, The Daily Beast published a story titled, “Please Do Not Hack Your Own EpiPen.”
“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,” Ezekiel Emanuel, a bioethicist, told KQED.
“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,” he said.
The FDA also released their own response and, despite not explicitly naming the group or the EpiPencil, the statement was concurrent with the product’s media buzz.
A representative from the FDA provided Healthline with the following comment:
“Using unapproved prescription drugs for personal use is a potentially dangerous practice. Neither FDA nor the American public have any assurance that unapproved products are effective, safe or produced under current good manufacturing practices (CGMPs). Unapproved drugs may be contaminated, sub-potent, super-potent or counterfeit.”
Spreading the word
However, Laufer says his group is about spreading information that can save lives.
Whether individuals choose to use that information is their own decision.
“We don’t ever want to be seen as pushing people to use it, saying this is what you should be doing. That’s a personal decision,” Laufer told Healthline.
Laufer does believe in his work as a real tool to be used by those in need and not just a symbolic gesture.
When it comes to qualms about the safety of such a device, he is even more straightforward:
“If you want to talk about danger. What exactly is the danger? People are already dying and they aren’t getting treated, and the treatment is on the shelf. That’s danger. That’s tragedy that we are already looking it,” he said.
Despite the criticism, the group has continued to forge ahead in the year since they were thrust into the spotlight.
Currently, the Four Thieves Vinegar Collective is working on a handful of drug formulas that they hope to make available through the internet.
They include GSK744 (Cabotegravir), an HIV treatment, as well as abortion drugs mifepristone and misoprostol, and Sovaldi, a hepatitis C drug.
Hepatitis C drugs remain some of the most expensive treatments in the United States.
“When you are looking at life-saving medications, looking at things that have the biggest barriers in terms of price or legality or infrastructure, [these] are the ones that are most in the political limelight,” says Laufer.
“Global health is at the front of human rights and women’s reproductive health is at the forefront of global health, so there is a natural choice to look at abortion drugs,” Laufer said.
He adds that the group was previously looking at naloxone, the “anti-overdose” drug used to treat opioid overdose, but Laufer says that access in most states has increased dramatically enough that it is no longer a priority.
The next step for the group is releasing an updated version of their Apothecary Micro Lab, the machine central to synthesizing and producing drugs at home.
They hope to have that available near the beginning of the year.
The plans for building the lab will be available on the collective’s website, as are their other formulas.
“There’s a list of things that you need to buy, where you can get them the cheapest. There’s code that you upload to the microcomputer and then there are separate programs for each thing that you want to synthesize,” said Laufer.
Readers should be aware that there are both potential legal and safety implications of using the device and any of the formulas provided.
Laufer reiterates that if people choose to use the information provided, it is “their own business.”
Despite the hazy ethical grounds on which the open-source medicine concept exists today, Laufer believes that there is a path forward in which it operates alongside established healthcare infrastructure, but doesn’t replace it.
“I don’t think that the systems of insurance and traditional healthcare are ever going to go away, but I think that there is a great potential for those to be augmented,” he said. “It could get to that stage where perhaps small communities have some specialist who knows enough that they are able to manufacture medications for their community.”
Laufer also believes there is potential for such a decentralized system of drug manufacturing to also include federal oversight.
What is clear, he insists, is that in a world of soaring drug costs, there will be a breaking point.
What the Four Thieves Vinegar Collective is doing, says Laufer, is “a small footnote or a short chapter in a much larger story.”
“It’s one of a crisis between economics and morality. We’ve seen a number of times throughout history where those two things have come to a head,” he said.