The Rogue Experimenters
Community labs want to make everything from insulin to prostheses. Will traditional scientists accept their efforts?
By Margaret Talbot
May 18, 2020
One evening in February, I went to hear a lecture at the Baltimore Underground Science Space, a community lab in a former bottle-top factory. Like several dozen other "biospaces" around the country, bugss, as the lab is known, is animated by a spirit of subversive amateurism. Anybody can go there to learn about, and then do, the kind of cutting-edge bench science—gene editing, synthetic biology—that is generally confined to well-funded academic institutions and private corporations. Inside, a chalkboard with cartoon drawings of a microbe and a double helix welcomes newcomers, but the lab areas are seriously kitted out. bugss has a real-time PCR machine, the gadget that allows scientists to make millions of copies of a particular strand of DNA, in order to study and manipulate it. "We don't have a lot else that's super fancy," Lisa Scheifele, the lab's executive director, told me, though that might depend on how fancy you consider such items as a laminar-flow hood ("for working with cells and cultures that you really don't want contaminated," according to the lab's Web site), an Alpha Innotech gel imager, or a negative-seventy–degree storage freezer. "We have what we need," Scheifele said. "You can do most genetics here. You can do microbiology."
That night, two dozen people had filed in to hear Yann Huon de Kermadec—a low-key thirty-three-year-old with a Ph.D. in protein biochemistry from the University of Grenoble—talk about the Open Insulin Project, for which he hoped to recruit local volunteers. The project, which originated in 2015, at the biospace Counter Culture Labs, in Oakland, proposes a "biohack" for a stark failing in the American health-care system: the rising cost of insulin, the synthetic form of the hormone that 7.5 million diabetics must inject daily in order to live. Its goal is to replicate the insulin that is manufactured and sold in this country by three pharmaceutical companies—Eli Lilly, Novo Nordisk, and Sanofi—and to publish a protocol for safely producing it. The three U.S. manufacturers have lately been charging upward of three hundred dollars a vial. Eventually, the project hopes to launch a network of patient-and-worker-owned coöperatives that will produce small batches of insulin and offer vials to diabetics for about seven dollars each. At the very least, Open Insulin wants to show that such pharmaceutical code-breaking can be done, in the hope that it will demystify the drug-production process.
The Baltimore lecture took place a few weeks before the covid-19 crisis necessitated social distancing, so we sat in tight semicircles. Pepperidge Farm cookies and mixed nuts were set out on a table, near a book for sale called "Zero to Genetic Engineering Hero: The Beginner's Guide to Programming Bacteria at Home, School & in the Makerspace." A flyer advertised an event, BioPrinting Breakout, which promised to introduce "3D tissue engineering to new audiences and applications." In the crowd, there were some hip-looking young couples, a middle-aged African-American man in a parka, and a sixty-one-year-old regular who works in computer security and loves the community-lab scene because, he told me, you can talk science as much as you want, whereas in "normal social situations people start running away."
Huon de Kermadec, who wore Clark Kent glasses, jeans, and a gray hoodie, introduced himself as "a French guy having my Ph.D. who followed my wife when she found a position." (He is married to Louise Lassalle, who also works with Open Insulin, and came to the U.S. to do a postdoc in biochemistry at the Lawrence Berkeley National Laboratory.) Huon de Kermadec was originally attracted to Open Insulin because he thought the lab work would be fun—he loves the craft of biology but is annoyed by the academic pressure to publish. He noted to the audience that nearly half of American adults have diabetes or high blood-sugar levels, yet there are currently no generic forms of insulin available in the U.S., nor are there any mechanisms in place for controlling the price, as there are in Canada and in Europe. "If one of the three big companies increases the price, they all increase the price," he said. "Because they can." He showed a slide of a chart depicting an exponential curve for insulin prices. In 1996, Eli Lilly introduced Humalog, its synthetic version of the hormone, at twenty-one dollars for a ten-millilitre vial; during the next two decades, the retail price increased tenfold. Sanofi's Lantus and Novo Nordisk's Novolog have similarly soared in cost. (Eli Lilly recently announced that, during the covid-19 epidemic, it would lower the monthly out-of-pocket cost of insulin to thirty-five dollars, but the drug is a crucial source of revenue for the company, and the price will likely rebound.) Patients with Type 1 diabetes typically require two to three vials of insulin a month. Even if they have insurance, it doesn't necessarily cover the entire expense. A 2018 study conducted by researchers at the Yale School of Medicine found that one in four diabetes patients scrimped on insulin usage—not filling prescriptions regularly, using less than prescribed—risking kidney failure, blindness, and death.
Jean Peccoud, a professor of chemical and biological engineering at Colorado State University and the founder of the journal Synthetic Biology, told me, "The price of insulin is something for which there is no technical justification, no justification other than greed. It's simple to make, with a large market. It should be as cheap as Tylenol."
The scientist who discovered that injections of insulin could save diabetics from a painful death wanted to see the drug affordable and widely available. In 1921, Frederick Banting, a Canadian orthopedist, derived insulin from the pancreases of dogs; he sold the patent to the University of Toronto for one dollar, clearing the way for it to be mass-produced. "Insulin does not belong to me," he declared. "It belongs to the world."
Open Insulin plans to use protocols laid out in published papers to perform genetic engineering on two organisms—yeast and E. coli—causing them to produce insulin. This is how pharmaceutical factories generally make the drug. Last spring, the group announced that preliminary results indicated the successful insertion of a target gene into E. coli cells, and the subsequent production of a protein that converts into insulin. The next step was to assess the samples, using mass spectrometry and other technologies.
When Huon de Kermadec mentioned this development, a guy with a close-shaved head and a Russian accent interjected to say that he ran a drug-testing lab, and wouldn't mind vetting some of Open Insulin's samples. The project was a "fascinating testament to the prospect of citizens doing science," the man said. Still, he noted, maybe it would be simpler for people who needed expensive medications to get hold of them on the black market, or in other countries.
Huon de Kermadec sighed. "You could find a way with a black market," he said. "But who will have access to that? You don't change the system." Pacing the front of the room, he went on, "What we aim for is more changing the way this is produced. It doesn't have to be a situation where Big Pharma exploits people's misery. We can design a better system."
Open Insulin has its critics, and not only lobbyists for the pharmaceutical industry. Gregg Gonsalves, a professor of epidemiology at the Yale School of Public Health, is a former member of act up, which took a confrontational, anti-institutionalist stance to drug development during the aids crisis. Yet Gonsalves told me that D.I.Y. medicine is "like GoFundMe campaigns for basic health care—a sign of a broken system." The D.I.Y. movement, he continued, "is going down a dead end of desperation, when all that energy and anger might be better focussed on dealing with politicians" and fighting for universal access to health care.
Yet, given the profound flaws of the American health-care system, there is something hopeful about Open Insulin's approach. The group is considering teaming up with local hospitals and pharmacies, which would help integrate its methods with those of mainstream institutions. Kelly Hills, a bioethicist at a consulting firm called Rogue Bioethics, appreciates Open Insulin's efforts, a feeling that has only deepened during the coronavirus crisis. She told me that the decentralized production of standard drugs in small community labs might be a way of insuring that we don't run into shortages when traditional supply lines are disrupted. Drug shortages occur fairly often, even when we're not dealing with a pandemic, and they are "very scary if you are life-dependent on a medication," Hills said. "But, if you have a community lab, you're skipping manufacturing delays and pauses at borders. It would be a huge stress relief if you knew you could go to a community lab and fill your insulin prescription for a month for a few bucks." The big question, she said, is whether Open Insulin can meet the exacting safety requirements mandated by the Food and Drug Administration.
John Wilbanks, a health technologist at the research nonprofit Sage Bionetworks, told me that D.I.Y. medicine, for all its radical aspects, can be viewed as a quintessentially American project. "We have this whole culture of hustle and grind, in which you're supposed to find your own individual solutions," he pointed out. "Well, that's what they're doing."
The D.I.Y.-bio movement, which emerged in the early two-thousands, seems almost evolutionarily adapted to its historical moment. It echoes aspects of startup culture, especially the early days of personal computing, with its garage-based origin stories. First came the hardware, then the software; now even the wetware of life can be created in people's homes. D.I.Y. bio reflects popular skepticism about professional authority and gatekeeping, but it is not skeptical about learning or expertise. igem, a synthetic-biology competition for undergraduates which started at M.I.T. in 2004, has expanded to include people working in community labs and other extra-institutional scientists. The D.I.Y.-bio movement also feeds off the notion of the side hustle and the rise of Maker Faire events, which have lent hobbyists a cool new legitimacy. To some budding scientists who want to make a difference in the world, the challenges of climate change and pandemic disease have made biology more compelling than, say, computer science.
In recent years, it has become relatively easy for people to acquire sophisticated lab instruments such as PCR machines, atomic-force microscopes, and environmental sensors. For example, when new biotech companies fail, they tend to sell off their equipment for a discount, and community labs and biohackers scoop it up. Wilbanks told me, "D.I.Y. bio is very similar to the home-brew, hacker-club culture of the late seventies in Silicon Valley. If you've not gone on eBay to shop for a DNA sequencer that they can ship to you in twenty-four hours, check it out—there's a massive secondary market."
The D.I.Y.-bio ecosystem includes a lot of do-gooders, and many of them have been galvanized by the covid-19 crisis. Ellen Jorgensen is a molecular biologist and a founder of GenSpace, the country's first community lab, which opened in Brooklyn in 2010. She is now a biotech executive, but she continues to believe in the possibilities of D.I.Y. bio. Under the auspices of Just One Giant Lab, a collaborative network founded in Paris, Jorgensen is leading research on a diagnostic covid-19 test that would eliminate the need for PCR machines, which, as commonplace as they have become in the U.S., are hard to come by in poorer parts of the world. Jorgensen's team is developing a covid-19 testing protocol based on loop-mediated isothermal amplification, a low-cost method of replicating a virus's genetic material, initially developed by researchers in Japan; according to Just One Giant Lab's Web page, the process "can be done in a cup of hot water."
Another veteran of GenSpace, Will Canine, co-founded a company that makes open-source robots. The machines allow labs to automate a tedious task required in a lot of modern biological research: dispensing precise amounts of liquids, over and over again. When the coronavirus emerged, a hundred and seventy of Canine's machines were repurposed by a public-private partnership, the Covichain Robots Initiative, and shipped, at no cost, to hospitals in Spain. The robots can make testing for covid-19 speedier and cheaper, and help eliminate humans from labs at a time when social distancing is crucial. Canine told me that D.I.Y. bio has a lot to teach our pandemic world. The movement has learned to use accessible language without dumbing down science, and it has also learned what not to do: "speculate about scientifically invalid and dangerous things in public forums"; "hoard protocols, data, equipment, reagents, or anything else that could be broadly useful to others." Canine added that "D.I.Y. bio should not be concerned with doing the most bleeding-edge experiments but, rather, with making the most relevant scientific knowledge and tools available to those otherwise excluded from them."
The D.I.Y.-bio spectrum includes anarcho-libertarians. To the frustration of people like Jorgensen and Canine, this bro-ish element tends to attract media attention, because of a predilection for live-streaming stunts. In 2018, at a conference in Austin, the twenty-eight-year-old biohacker Aaron Traywick live-streamed his self-injection of a D.I.Y. treatment for genital herpes. (It's unclear if it worked; Traywick died later that year, in Washington, D.C., while using a sensory-deprivation tank.) This part of the movement includes gonzo self-experimenters, transhumanists seeking to extend their life spans, and people eager to become cyborgs—by, say, implanting microchips in their arms which contain their medical records. One person I spoke to called this cohort the "You did what?" crowd. Another said that such people followed a credo of "because it's cool, and because we can."
Perhaps the best known of these edgier types is Josiah Zayner, a biohacking entrepreneur with a Ph.D. in biophysics from the University of Chicago, a cheeky public persona, and a slyly contentious relationship with regulatory authorities. In 2017, Zayner live-streamed his self-injection of crispr gene-editing technology, which was an attempt to enhance his muscles. (It didn't work.) He also documented a self-experiment in which he transplanted matter from a friend's donated stool into his gut, thus altering his microbiome. He now has a company, the Odin, which sells mail-order kits that allow you to try your hand at crispr, make glow-in-the-dark yeast, and genetically engineer tree frogs. Zayner seems to embrace the idea that the only interesting scientist is a mad one.
Last August, at a conference in Las Vegas called Biohack the Planet, Zayner gave a speech in which he noted that, in such nearby countries as the Dominican Republic, there were many desperate patients who'd be willing to try any kind of experimental gene therapy, even if there was a good chance that it would kill them. D.I.Y. radicals, he suggested, should perform tests on this population. "Why fight against the U.S. government when you can just, you know, fly a couple hours, and you don't have to fight against any government?" he said.
Big Pharma makes a tempting target for some biohacking provocateurs. At the Biohack the Planet conference, a man named Gabriel Licina sat on the edge of the stage and gave a pugnacious talk about a project that he and two friends—Andreas Stürmer, a biotechnologist in Austria, and David Ishee, an oil worker, self-taught biologist, and dog breeder in Mississippi—had embarked on. They had, he announced, reverse engineered the gene-therapy drug Glybera, which treats a rare disease, called lipoprotein-lipase deficiency, that results in a dangerous buildup of triglycerides in the blood.
Licina is famous in the biohacking community for a self-experiment he undertook in 2015, with eye drops of his own devising, to create "night vision." (The drops contained Chlorin e6, a light-sensitive substance similar to one found in sea creatures.) If you Google his name, you'll discover photographs of him with his pupils dilated, his eyelids swollen, and his head shaved, looking like an extraterrestrial. He says that he saw farther at night for a few hours and suffered no lasting damage.
When the Dutch firm UniQure introduced Glybera, in 2015, it was the most expensive medication in the world, at about a million dollars a dose. Two years later, UniQure pulled Glybera from the market, because only one insurer, in Germany, would cover it—for one patient. (Approximately one in a million people have lipoprotein-lipase deficiency.) In Las Vegas, Licina said that he and his colleagues had identified the relevant DNA, sent their findings to an outside genetics lab, and engineered E. coli to produce the protein that is missing in people who suffer from the disease. (The process is similar to how insulin is made.) Licina announced that he had brought forty vials of the modified bacteria to the conference, and he periodically waved one above his head, chuckling. He invited scientists to culture, purify, and test his creation. But, knowing his audience's penchant for self-experimentation, he said, "Do not inject yourself with this thing. For the love of God, stop stabbing yourselves."
In February, I spoke to Licina on the phone. He was in South Bend, Indiana, where he runs a community lab, Scihouse, out of his home. "This is going to sound so flippant," he said. "But my friends and I decided to do the Glybera thing because we thought it would be funny. I mean, this was a million-dollar drug." Yet even its secrets were unlocked with relative ease, he claimed. (UniQure, which retains a patent on the drug, said that it was blindsided by Licina's "knockoff" but has not sued.) Licina said that he doesn't want anyone to use his creation therapeutically. He just wanted biohackers like him to stop making glow-in-the-dark beer—yes, that's a thing—and focus their thrill-seeking minds on more substantive projects. He was pleased when two Stanford undergraduates, Alec Luiz Lourenco and Cooper Veit, volunteered to test his version of Glybera at a university lab. Lourenco and Veit are part of biome, a student group that takes inspiration from the D.I.Y. movement and pursues what Lourenco calls "independent-type" biological research. (The biome project is pending, having been delayed by the pandemic shutdown.)
In many ways, the earnest, democratizing amateurism of community labs feels nothing like the snarky, performative energy projected by biohackers. The people I spoke with at Open Insulin are modest, serious, and, in some cases, steeped in social-justice activism. Still, there is overlap between members of the two factions—they know one another, attend some of the same conferences, and share a belief that real science can be conducted outside institutional settings. And they are similarly committed to making their protocols and findings transparent. One of Open Insulin's founders, Anthony Di Franco—a computer scientist who lives in Berkeley and is himself a Type 1 diabetic—told me that, though he thinks of Open Insulin as belonging to the "lineage of mutual-aid societies," he also sees the group as "definitely part of the biohacking community."
The D.I.Y.-bio movement first emerged in places where biotech was booming, like Cambridge, Massachusetts, and the Bay Area. Some people who lacked the funding or the credentials required to work on biological research at the academic and corporate labs where it was being done began to equip themselves. Others wanted to demonstrate that high-level medical information and techniques could be shared. In 2008, Kay Aull had just graduated from M.I.T. with a degree in biological engineering when she decided that, before moving on to grad school, she would spend five hundred dollars setting up a lab in a closet in her apartment, and see what she could do with it. Among other things, she created a genetic test that could be taken at home for a disease that afflicts her father, hemochromatosis—excess iron in the blood. She told me that, for her, it was an important way of "demystifying the science" and "showing it wasn't magic."
Community labs were launched in a similar spirit, bringing in members of the public to learn how to perform the latest in synthetic biology: DNA sequencing, protein engineering, crispr techniques. The pioneering GenSpace, in Brooklyn, was followed by BioCurious, in Santa Clara, California; Counter Culture Labs, in Oakland; and bugss, in Baltimore. In 2010, at a conference in Los Angeles, Meredith Patterson, a thirty-two-year-old computer scientist and science-fiction writer, gave a rousing speech that was later circulated as "A Biopunk Manifesto." She declared, "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. We have no quarrel with Big Science; we merely recall that small science has always been just as critical to the development of the body of human knowledge. . . . A thirteen-year-old kid in South Central Los Angeles has just as much of a right to investigate the world as does a university professor. If thermocyclers"—PCR machines—"are too expensive to give one to every interested person, then we'll design cheaper ones and teach people how to build them."
In a 2017 book, "Synthetic," Sophia Roosth, a historian of science at Harvard, differentiates D.I.Y. bio from citizen science, the wholesome enterprise in which volunteers do such things as count migratory butterflies or identify celestial bodies, then hand over their data to professionals. "Though democratic, D.I.Y. bio is notably antagonistic, roguish, and mischievous in tone," Roosth writes. She also distinguishes it from pseudoscience: biohackers rarely put forward " 'crackpot' theories." Their aim "is for amateurs or nonprofessionals to make not new theories, but new things." The credo of D.I.Y. bio might be that of the physicist Richard Feynman, who, shortly before his death, in 1988, wrote on a chalkboard at Caltech, "What I cannot create, I do not understand."
Community labs such as bugss take pains to avoid looking jerry-built. They maintain safety standards and codes of ethics modelled on those of academic labs, and add extra precautions, on the ground that some participants aren't steeped in such practices. (At bugss, the rules include no use of infectious agents—phew!—and no work with human or other mammalian cells.) Christi Guerrini, a legal scholar and a professor at Baylor College of Medicine, who is conducting a research project about biohackers, told me that many community labs go well beyond "check-the-box compliance," adding, "There was one individual I interviewed who really struck me in his thoughtfulness around to what extent organisms can experience pain—he was very conflicted about it. The organisms he was considering working with were jellyfish."
Guerrini feels that D.I.Y. biologists often have a greater commitment than their professional counterparts do to making their work open to scrutiny—and available for free on the Internet. Their research might not be paradigm-shifting, but you or I could access it without having an institutional affiliation or an expensive journal subscription. (We'd have less confidence, of course, that the research was legit.) Among professionals, Guerrini said, "you have the phenomenon of scientists wanting to hold onto their data and sort of dribble it out, because they are responding to incentives around promotion and tenure and intellectual property."
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If transparency is a core tenet of biohacker culture, it's also a defensive strategy. D.I.Y. bio arose soon after 9/11, and its practitioners sometimes attracted the attention of law-enforcement officials, who equated biohacking with bioterrorism. In a notorious 2004 case, Steven Kurtz, a suny Buffalo art professor who worked with bacterial cultures, had his home raided by federal agents. (Kurtz was eventually cleared of all charges.) Todd Kuiken, a researcher at N.C. State who has studied the D.I.Y.-bio community for years, told me, "At first, there was this fear that biohackers in the basement were going to release pandemics. These were really myths."
In recent years, biohackers have largely figured out how to avoid intervention by the law. In 2016, Mixæl Laufer, a math professor in California who oversees an anarchist biohacking collective called Four Thieves Vinegar, devised instructions for building an EpiPen, the device that opens the airway of someone suffering an allergic reaction. He called his version an EpiPencil, and said that making it would cost about thirty dollars. At the time, Mylan, the manufacturer of the EpiPen, was charging as much as three hundred dollars for one. The EpiPencil was made by combining off-the-shelf parts: an auto-injector designed for diabetics which could be purchased online; epinephrine, which could be prescribed by coöperative doctors; a syringe and a needle. Four Thieves Vinegar, which is named after a medieval legend about a home-brewed antidote for the bubonic plague, shared the directions for the EpiPencil on its Web site and on YouTube. Because the group was not manufacturing or distributing the product, it technically did not violate F.D.A. rules. (YouTube removed the video, claiming that it promoted "acts that have an inherent risk of serious physical harm or death.")
Since then, Four Thieves has started disseminating other work-around protocols, including a recipe for making a version of the overdose-reversal drug naloxone out of oxycodone, and instructions for concocting a homemade version of the abortion pill out of misoprostol. (Veterinary suppliers, Laufer points out, dispense a form of the drug, without a prescription, for treating ulcers in horses.) In February, I spoke by Skype with Laufer, who was in Singapore, where his wife recently took a job. He told me that he does not interact with patients who make something using Four Thieves instructions: "A lot of people ask about the relationships we have with people who use our protocols and technologies. But we don't really have them, very intentionally, because we don't want to be pushing what we're creating."
In early March, I spent an afternoon with Sebastian Cocioba, a twenty-nine-year-old self-taught plant biologist who has built a remarkable lab in his parents' Long Island City apartment by making clever use of items purchased on eBay and what he calls "a little bit of electronics know-how." In a small spare bedroom, Cocioba has a PCR machine ("one of the schmanciest, with an actual freakin' touch screen!"); a gene gun, for injecting DNA or RNA into cells; a laminar-flow hood; a centrifuge; a vortex shaker, for mixing fluids; and shelves lined with bottles of chemicals and proteins. He put together this suite of equipment at a cost of about seven thousand dollars. (For fun, he's affixed googly eyes to some of the machines.) Cocioba works on plant-tissue cultures and genetic engineering, and has expertise in designing and producing flowers with new colors and patterns. In his parents' kitchen, the white cabinets are covered in notes, scrawled in Sharpie, from a meeting that Cocioba had several months ago with a Japanese businessman and an N.Y.U. biologist, who were hoping to create a specially patterned morning glory as a symbol for the Tokyo 2020 Olympics. Cocioba's mom, who sometimes doubles as his lab manager, likes how the marked-up cabinets look. On the refrigerator was a list describing the steps involved in engineering a blue rose.
I watched Cocioba lead a synthetic-biology workshop for students at the Parsons School of Design, in New York, and it was clear how much he enjoys sharing his techniques. He made the students laugh with stories about how, as a teen-ager, he'd first funded his lab by "flipping orchids": he'd take home plants that Home Depot had thrown away because they weren't flowering, expose them to blue light until they bloomed, then sell them back to the store. Cocioba, who studied for a few years at Stony Brook University but left for financial and family reasons, is now getting outside research contracts—one is from a private donor interested in genetically engineering plants to produce pharmaceuticals. (In 2017, a British research center announced that it had conducted an experiment that used genetically engineered plants to produce polio vaccines.)
Cocioba has shoulder-length hair, which he sometimes wears in a samurai-style bun; he favors shorts and T-shirts, and has a genial manner. He welcomes collaborations with academics and thinks it important that they not "ostracize the D.I.Y.-bio community," because "science is science." "Amateur scientist" is a label that he embraces, pointing out that the word "amateur" doesn't mean a novice. He likes to cite the example of Félix d'Hérelle, a French microbiologist who, with only a high-school education, "basically founded bacterial phage research in the early twentieth century." (Phages are viruses that infect bacteria but don't harm humans.)
When Cocioba has genetic-engineering clients, he "sets up an open lab notebook for them" online, so that "they see every day what is happening, as opposed to what my competitors—universities, mostly—do, which is just give them the plant at the end." When a student at Parsons asked him if he worried about being scooped, Cocioba said, "I'd rather be totally open and give these tools away for free. Because nothing is more inspirational than being able to build something yourself."
So far, D.I.Y. medicine's biggest successes have been less in making pharmaceuticals than in manufacturing tests and medical hardware. In 1994, Sharon Terry, a former college chaplain turned stay-at-home mom in the Boston area, learned that her two young children, Elizabeth and Ian, had a rare genetic disorder, pseudoxanthoma elasticum (PXE), which causes premature aging and other problems. After the children's diagnoses, two teams of researchers from separate academic institutions came around to collect blood samples. Terry didn't want her kids to get poked with needles repeatedly, and asked the researchers why they didn't just share the samples. That wasn't how academic research worked, she was told: the teams were competing to see which could publish findings first.
Terry and her then husband, Pat, a construction manager, read all the articles they could find about PXE. The literature was daunting, but eventually they began to see patterns. They decided that it would be helpful to create a DNA repository for studying the disease, so they collected tissue and blood samples from PXE patients and their families and began conducting research on the samples at night, in a space that they borrowed from a Harvard lab. In time, they became part of a team that identified the gene for PXE and patented it—not for profit but to try to insure that the discovery would be shared for research. Terry went on to co-author a hundred and forty peer-reviewed articles, published in such journals as Nature and Science. She now heads an organization called the Genetic Alliance, and a research consortium on PXE that is conducting clinical trials on a cocktail of possible treatments for the disease. (Her children are now in their thirties.)
In 2013, Dana Lewis, a twenty-five-year-old with Type 1 diabetes who had no engineering or medical background, was trying to figure out how to make the alarms louder on the glucose monitor she used at night, so that she wouldn't sleep through them. Lewis, who worked in public relations and lived in Seattle, started collaborating with a software engineer she was dating, Scott Leibrand, and they developed an algorithm that predicted when her glucose levels would fall dangerously low at night. Eventually, they came up with a more ambitious device that precluded the need to get up out of bed and inject insulin. They called it an Open Artificial Pancreas System and posted instructions for making one online. The device linked up glucose sensors, open-source software that could run on a smartphone, and an insulin pump, allowing patients to automatically calibrate dosing through the night. Though the Open Artificial Pancreas System is not an approved medical device, and no company manufactures one commercially, more than seventeen hundred people have assembled their own. Initial review studies, in The Lancet and other journals, have shown it to be effective.
e-nable, an international collective of thirty thousand volunteers, designs and 3-D-prints prosthetic hands and arms, then gives them to people at no cost—more than ten thousand so far. (Most operating expenses are absorbed by the volunteers.) In the U.S., many recipients are children. Kids sometimes stop using medical-grade prosthetic devices because they are quite heavy and aren't supposed to get wet or dirty. Children also quickly outgrow prostheses, and not all families can afford to keep buying new ones, especially if insurance doesn't cover enough of the cost, which ranges between three thousand and ten thousand dollars. And no company produces a prosthesis for kids with a rare congenital condition in which they have a palm but no fingers. Jen Owen, one of the founders of e-nable, told me that, for many children, the primary benefit of a 3-D-printed prosthesis is "psychosocial"—you can go from being the kid with a weird hand to the kid with a superhero hand that peers are curious about in a good way. e-nable volunteers make plastic hands in colors of their clients' choosing—sometimes eye-catching blue or purple. Peregrine Hawthorn, who was born without fingers on one hand, got his first e-nable prosthesis as a teen-ager, and then started designing new models with his father. Hawthorn, in an article he co-wrote in 2017, "Cyborg Pride: Self-Design in e-nable," said that making his own prostheses had helped him fight off depression. He recalled how excited he'd been to show off his first design, which was "glossy black with bright-blue actuation cables."
In other parts of the world, recipients are often people who can't afford any kind of prosthesis. Jon Schull, an e-nable co-founder who was formerly an Internet entrepreneur and a professor at the Rochester Institute of Technology, told me that he recently met two young men in Honduras who had lost their hands in electrical accidents, and had been out of work until they got e-nable hands. One now ran a houseplant business, and the other sold sandals. They told Schull that they could finally hold a child's hand on a walk, or gesticulate freely when telling a story, or fist-bump their friends. "Hands are social tools even more than manipulative ones," Schull said. Seen in this light, it doesn't matter that e-nable hands aren't state-of-the-art. The job of professional prostheses-makers, he said, is "to produce something really good, and if it's merely better than nothing it's not good enough"—but, in some circumstances, something is better than nothing.
Schull told me that, although he wasn't paid for his time at e-nable, it was the most satisfying work he'd ever done. Not only was there the "visual and emotional appeal of giving prosthetics to people"; he was fascinated by how a highly decentralized group of humanitarians had been "able to circumvent the medical-industrial-academic complex and address needs that complex has proved incapable of solving."
In part because e-nable doesn't pay designers or charge recipients, it has not been subject to F.D.A. oversight of medical devices. And, though some prosthesis manufacturers resent its incursion into their market, the volunteers have been able to work largely unimpeded.
e-nable has a whimsical origin story. Jen Owen was married to a man named Ivan Owen, a nerdy, mild-mannered artist and designer in Seattle who sometimes worked on monster suits for low-budget horror films. He and Jen were into cosplay, and, in 2011, for a steampunk convention, he made an outsized metal hand with moving fingers that made a sound like a thief rustling in a silverware drawer. The cosplay crowd loved it—it reminded them, depending on their temperaments, of Freddy Krueger or Edward Scissorhands. A carpenter in South Africa named Richard Van As spotted a video that Ivan had posted and saw a bigger purpose for such craft. Van As had recently lost four fingers on his right hand and couldn't afford professional prostheses. The two men began a long-distance collaboration by e-mail and Skype. Eventually, the Owens and Van As posted videos about that project, and started receiving requests for prostheses from people around the world.
In 2012, they hit on the idea of using 3-D printers to make hands. At the time, such devices cost thousands of dollars. (Now you can get a good one for about three hundred.) Owen asked a company called MakerBot if it would consider sending him a few printers for free. To his surprise, the answer was yes. Instead of patenting their designs, the Owens, Van As, and other collaborators released their files into the public domain, allowing anyone who wanted to make—or modify—prosthetic limbs based on their models to do so. (To become a certified e-nable maker, you must record a video of yourself printing a hand, so that experienced volunteers can evaluate your process and your final product.)
Volunteers submit proposals for new designs and projects, and the community votes whether or not to fund them with grant money. Nate Munro, of Littleton, Colorado, recently got a grant to design an arm that he called the niop, for No-Insurance-Optimized-Prosthetic. In 2015, Munro had been fixing up a little pink bike for a friend's daughter, and when he tested it out—"riding it like a clown"—he popped the front wheel over a crack in the cement, fell, and broke his arm in several places. At the time, Munro, an independent contractor, had no health insurance and little savings, so he never got proper care for his arm. An infection developed and, in 2017, the arm was amputated just below the elbow. He told the e-nable newsletter, "I was living in a first-world country for people with insurance but a developing country for those without insurance." Munro eventually got a professional prosthesis, but the year he spent waiting for it—"when every destination you go to is packed with people that make you feel like a freak"—stuck with him. When he heard about e-nable, he joined and started making arms for others, including one for a fourteen-year-old boy in Aleppo, Syria, who had lost an arm up to the shoulder.
One afternoon, I went to see Eric Bubar, an e-nable volunteer who teaches physics at Marymount University, in Arlington, Virginia. He showed me the 3-D printer that he and his students use to make hands, and the spaghetti-like plastic filaments that are fed into it. It takes fifteen to twenty hours to print all the parts of a hand, and about half an hour for Bubar to assemble them. I spoke with him as the printer hummed, squeezing out purple plastic in tight rotations, like a miniature Zamboni machine. After it stopped, he handed me a child-size plastic thumb. I put it in my coat pocket, as a keepsake.
One good thing about being a leaderless "do-ocracy"—the word e-nable volunteers use to describe their movement—is that priorities can shift quickly. When covid-19 went global, e-nable volunteers began producing face shields. Eric Bubar had three 3-D printers running at all times, filling dozens of requests a day for up to a hundred shields—from hospitals, assisted-living facilities, dentists' offices. Bubar, like other e-nable volunteers, solicited feedback from the recipients and then adapted his designs in response. When doctors told him that they would prefer a shield made with the kind of plastic used in overhead transparencies—it was lighter and easier to clean—he began offering that. The e-nable Web site posted one photograph after another of medical workers wearing the group's face shields and giving thumbs-ups. Collectively, e-nable has distributed more than fifty thousand face shields in more than twenty-five countries.
e-nable wasn't alone in its efforts. After it became clear that a shortage of flexible plastic nasal swabs was one of the bottlenecks slowing down covid-19 testing, other D.I.Y. groups started 3-D-printing them. As impressive as this outpouring of altruism was, there was understandable concern that some products might not be safe or effective. Fortunately, efforts to review and test D.I.Y. products for fighting covid-19 have emerged almost as fast as the products themselves. For a forthcoming special issue of the journal HardwareX, which is published by Elsevier, Joshua Pearce, an engineering professor at Michigan Technological University, put out a call for articles on low-cost, open-source covid-19 medical equipment. Publication in the journal would mean that a design had been tested and validated; given the urgency of the situation, the peer review would be done quickly, and the articles would be open access. It wasn't the same as F.D.A. approval, but it was a serious attempt to impose rigor on the movement. Pearce told me, "With medical hardware, it's not good enough to say, 'I did something.' You need proof that it's good enough if you're going to risk somebody's life using it."
Since the covid-19 crisis began, lab work at Open Insulin has been on hold, but project members have stayed busy working on the legal and social aspects of their mission. Even if Open Insulin begins producing a consistent product, it will have to overcome all kinds of regulatory obstacles to demonstrate safety and purity before taking it to market. Manufacturers of pharmacy-grade medications must provide the F.D.A. with reams of evidence that they can produce the substances with complete consistency, in sterile environments. Proving this level of proficiency can cost millions of dollars.
Open Insulin's task may be made a little easier by a new F.D.A. rule that spells out conditions for making "biosimilars" to therapeutics such as insulin. Kelly Hills, the bioethicist, told me, "If Open Insulin can show that what they're doing is biosimilar to something already on the market, they might be able to go through the approval path faster and wouldn't have to go through the entire clinical-trial process, which is where much of the money is required."
Open Insulin members have been getting legal advice on how they could structure their production network. In addition to partnering with hospitals and pharmacies, one model being considered is that of California's cannabis coöperatives—which are regulated by the state, not by the federal government.
The covid-19 testing shortage has made some Open Insulin members think that their vision of a network of small production facilities could be applied to the larger medical-supply chain. Pharmaceutical plants are optimized for producing on a mass scale, and, as Open Insulin points out on its Web site, "it is a very slow and costly procedure to add capacity or change to making a different product." A system of numerous small plants, each producing medicine for local clients, would be far more flexible.
Like so many people these days, the group's volunteers are finding inspiration in stories of people who weathered past public-health crises, and they've found a good one to tell about insulin. In 1940, a nineteen-year-old Czech Jew named Eva Saxl fled Nazi-occupied Prague with her husband, Viktor. They made it to Shanghai, where Eva, an English teacher, was given a diagnosis of Type 1 diabetes. The city was under a Japanese blockade, and medicine was hard to come by. Eva acquired a textbook that described the pioneering experiments treating diabetics and began studying it intensively. She traded stockings that she had knit for a steady supply of water-buffalo pancreases; soon, she was producing purified insulin. The Saxls tested the product in rabbits, after which Eva injected it in herself. They shared their insulin with four hundred others.
Not long ago, Jean Peccoud, the synthetic biologist at Colorado State, co-authored a paper about Open Insulin. He told me that he found the project's approach "refreshing," but had concluded that it was not best applied to a drug as widely used as insulin. He thought that Open Insulin's ideas could be most helpful for "orphan drugs with a very small market, where it might be difficult for a company to justify producing a commercial drug." In such a scenario, "there could be small-scale manufacturing with no commercial transaction between drug company and patient, and thus no liability exposure. That could be the right environment for patients to produce their drugs in conditions that may not be quite as safe as what they could be getting from a drug company but much safer than not getting the drug at all."
Ultimately, the pandemic may help the D.I.Y.-bio movement gain legitimacy. In an e-mail, Will Canine, the creator of the liquid-dispensing robots, said, "While the President seems to be doing D.I.Y. bio all wrong, professional scientists are behaving a lot more like D.I.Y. biologists now than they were a few months ago. . . . Experimental data and protocols are being published and maintained openly—secrecy and hoarding are being shamed rather than justified."
Ellen Jorgensen, the GenSpace co-founder, sees the pandemic as an occasion for the kind of openness and coöperation in science that the D.I.Y.-bio movement has championed. A professional system that has always rewarded scientists on the basis of publishing, patents, and competition is adapting fast: disseminating papers before they have gone through a formal peer review, sharing materials, making designs for medical equipment open source. This is "evidence in favor of more open science," she said, adding, "That's the hope that a lot of us have—that there will be some permanent good that will result from this terrible tragedy of the pandemic. And part of that might be the institutions of science breaking down barriers and having more open scientific communication, which leads to an acceleration of scientific progress—and the betterment of humankind." ♦
An earlier version of this article misstated the name of the university with which Christi Guerrini is affiliated.
