The crescendo of outrage at the health care system lately has some arguably valid complaints. Take insulin for example. Affordable insulin is so hard to come by in the U.S. that people turn to underground networks of shared medicines, ration their own supply to cut costs, or sometimes cross the border to Mexico or Canada to get the medication they need.
Pharmaceutical companies recently introduced price caps on insulin after coming under scrutiny for charging hundreds of dollars per vial, which could be purchased in Canada for roughly one-tenth the price. About 8 million people in the U.S. with diabetes rely on insulin, and its high prices have become emblematic of what many see as a broken health care system.
“Among diabetics, there is quite a lot of desperation, and there’s quite a lot of people facing really serious health consequences and often even death because of the fairly arbitrary and often deeply flawed ways that the system that provides us with the medicine we need to survive fails,” said Anthony Di Franco, a Type 1 diabetic and computer scientist.
Insulin is one of many inaccessible medications in this system, with Americans paying three-fold the price for drugs as comparable countries in 2022. Desperate for relief, people with conditions like long COVID also turn to online drug markets because clinical trials testing therapies to treat it have been slow. People with rare diseases often don’t have access to therapies that could help because there is little financial incentive for pharmaceutical companies to invest in trials to test them. And some patients with fatal conditions who do have treatments approved still can’t access them through insurance because of complications in the current regulatory structure.
Fed up with the U.S. health care system, many so-called biohackers are trying to increase access to therapies by providing people with DIY instructions to make them from the comfort of their own home. Biohacking covers a range of activities, from performing gene-editing in garages to synthesizing the ingredients of certain medicines or technologies and publishing DIY instructions on how to make them at home to reverse engineering vaccines.
The emergence of biohacking in itself shows that there are unmet needs within the current system, said Ishaan Kumar, medical student at University of Chicago, who has written about the movement.
“This is, fundamentally, a response to a system that is perceived to be not working and arguably doesn’t work in a lot of cases, like with super rare genetic diseases that affect something like two to three new patients a year,” Kumar told Salon in a phone interview. “That’s not enough to run trials, let alone return a profit, so the regulatory and economic incentives that we have in our pharmaceutical system just do not account for those patients.”
One through-line in many of these initiatives is that they are counter-institutional in nature. In a 2010 conference, computer scientist Meredith Patterson delivered a “Biopunk Manifesto” and described her stance on biohacking: “We reject the popular perception that science is only done in million-dollar university, government or corporate labs; we assert that the right of freedom of inquiry, to do research and pursue understanding under one’s own direction, is as fundamental a right as that of free speech or freedom of religion.”
In 2015, Di Franco founded The Open Insulin Project, a community based organization run by volunteers, with the intention to “biohack” publicly available research on how insulin is made and provide those directions in an open-source format. Under the project’s model, the cost of insulin could be as low as $7. The project is still in the development stages but Di Franco says one day it might partner with local medical institutions to scale a production model. (If that is the case, it will have to meet the regulatory requirements of the Food and Drug Administration.)
“There are reasons to be skeptical that everyone is going to have insulin factories on their countertop,” Di Franco told Salon in a video call. “But there are also reasons to be skeptical about the currently dominant way of doing things, which has its own very serious issues.”
Critics are concerned that DIY initiatives forgo some of the rigor of testing the safety and effectiveness of treatments regulated in the current regulatory system. Without the checks and balances, and resources, of a larger system, many are concerned that the DIY approach could lead to someone getting hurt.
“Making insulin is something that should be doable,” said Hank Greely, who directs the Center for Law and Biosciences at Stanford University. “But whether it’s doable in a safe, effective, reliable and non-contaminated manner is a different question.”
Making medicines can be complex and often requires specific equipment as well. While some things may be feasible to make at home, other medications require machines like a liquid chromatography-mass spectrometry (LC-MS) that can cost hundreds of thousands of dollars, said Derek Lowe, a long-time drug discovery researcher, who has criticized some biohacking initiatives.
"Organic synthesis is widely varied," Lowe told Salon in a phone interview. "There are so many compounds, so many reactions, and so many ways to run every reaction, that keeping up with all the things that can go wrong is literally a full-time job."
Others see biohacking as a way to restore autonomy to patients and provide an option that cuts costs for them. Nevertheless, the concern is that some individuals could appropriate the biohacking space with bad intentions, said Lisa Rasmussen, a philosophy professor at University of North Carolina, Charlotte who is writing a book about DIY science.
“When people write about citizen science or DIY bio, it's often an enthusiast about it who says, ‘Look at all the amazing things we'll be able to do!’ But then you can imagine someone else coming along and saying, ‘Oh, well, this is a good way to avoid all the expensive FDA regulations, I'm just going to do this,” Rasmussen told Salon in a phone interview. “We are trying to think about the ethics in the sense not of preventing helpful innovation, but rather preventing potentially harmful misuse.”
In 1980, the Bayh-Dole Act was passed to allow institutions to benefit financially from government-funded research. Today, regulatory institutions are often influenced by financial investors, said Jean Peccoud, a professor at Colorado State University who has studied DIY insulin.
“You could have something that is slightly, you know, not quite as bulletproof, but would be infinitely cheaper and affordable,” Peccoud told Salon in a phone interview. “But that conversation is not taking place because the only people who are invited are the people who are making the patents.”
The current system is certainly not bulletproof. In addition to the people who cannot afford or access medications, there are plenty of historical examples in the traditional scientific framework to point to, like when researchers withheld treatment to Black patients in the Tuskegee syphilis study or used genetic material from the Havasupai tribe without consent.
Mixael Laufer founded the Four Thieves Vinegar Collective — self-described as an “anarchist collective” — to provide free instructions on how to make drugs like the EpiPen, the abortion medication misoprostol, and the opioid-overdose reversal medication naloxone, among others. Everyone in the collective is a volunteer, which is also not-for-profit. The price of a full course of Sovaldi, a treatment for hepatitis C, using the collective’s instructions costs around $300, Laufer said, whereas its market price can run up to $84,000.
“We are not trying to present ourselves as a better alternative to the existing medical infrastructure, we just want there to be an alternative,” Laufer told Salon in a phone interview. “The goal is that people make up their own mind.”
The collective has not been contacted by the FDA directly for providing these services, Laufer said. However, the FDA did issue a statement warning against a “$30 DIY alternative” to an EpiPen shortly after Four Thieves released instructions for making their device. A few months afterward, the FDA revisited the EpiPen conversation to accuse Pfizer of failing to properly investigate malfunctioning EpiPens, leading to patient deaths.
Kumar, at the University of Chicago, said an important question to consider is who would be responsible for something like this if it happened with a DIY EpiPen. Patricia J. Zettler, a former FDA attorney, has argued that what the collective is doing is legal because they are only providing information and not actual pharmaceuticals.
“From an ethical and moral perspective that is a very difficult question in terms of responsibility … but it feels wrong to me, at least in an intuitive sense, to say it would be the parents’ fault because they couldn’t afford an EpiPen,” Kumar said. “Again, we come back to the question of: Where is the failing? And I think the failing, arguably, is the system.”
