A Million Patients Have Innovated Their Own Medical Solutions, And Doctors Are Terrified
Diabetes patient advocate Renza Scibilia with her continuous glucose monitor, used in innovative DIY health technology.
In the fall of 2017, patient advocate Renza Scibilia told a conference of endocrinologists in Australia about new, patient-developed artificial pancreas technology that helped her manage her Type 1 diabetes.
"Because it's not a regulated product, some [doctors] were worried and said 'What if it goes wrong?'"
"They were in equal measure really interested and really scared," recalled Scibilia. "Because it's not a regulated product, some were worried and said 'What if it goes wrong? What is my liability going to be?'"
That was two years ago. Asked if physicians have been more receptive to the same "looping" technology now that its benefits have been supported by considerable data (as Leapsmag pointed out in May), Scibilia said, "No. Clinicians are still really insecure. They're always going to be reluctant to accept consumer-driven technology."
This exemplifies a major challenge to the growing Do-It-Yourself (DIY) biohealth movement: physicians are unnerved and worried about innovations developed by patients and other consumers that haven't been tested in elaborate clinical trials or sanctioned by regulatory authorities.
"It's difficult for patients who develop new health technology to demonstrate the advantage in a way that physicians would accept." said Howard DeMonaco, visiting scientist at MIT's Sloan School of Management. "New approaches to the treatment of diseases are by definition suspect to clinicians. Most are risk averse unless there is a substantial advantage to the new approach and the risks in doing so appear to be minimized."
Nevertheless, the DIY biohealth movement is booming. About a million people reported that they created medical innovations to address their own medical needs in surveys conducted from 2010-2015 in the U.S., U.K., Finland, Canada and South Korea.
Add in other DIY health innovations created in homes, community biolabs and "Maker" health fairs, and it's clear that health care providers are increasingly confronted with medical devices, information technology, and even medications that were developed in unconventional settings and lack the blessing of regulatory authorities.
Researchers in Portugal have tried to spread the word about many of these solutions on the Patent Innovations website, which has more than 500 examples, ranging from a 3-D printed arm and hand to a sensor device that warns someone when an osteomy bag is full.
When Reddit asked medical professionals, "What is the craziest DIY health treatment you've seen a patient attempt?" thousands shared horror stories.
But even in this era of patient empowerment, more widespread use of DIY health solutions still depends upon the approval and cooperation of physicians, nurses and other caregivers. And health care providers still lack awareness of promising patient-developed innovations, according to Dr. Joyce Lee, a pediatric endocrinologist at the University of Michigan who advocates involving patients in the design of healthcare technology. "Most physicians are scared of what they don't know," she said.
They're also understandably worried about patients who don't know what they're doing and make irresponsible decisions. When Reddit asked medical professionals, "What is the craziest DIY health treatment you've seen a patient attempt?" thousands shared horror stories, including a man who poked a hole in his belly button with a knitting needle to relieve gas.
Yet DeMonaco and Lee think it's possible to start bridging the gaps between responsible patient innovators and skeptical doctors as well as unprepared regulatory systems.
One obstacle to consumer-driven health innovations is that clinical trials to prove their safety and effectiveness are expensive and time-consuming, as De Monaco points out in a recent article. He and his colleagues suggested that low-cost clinical trials by and for patients could help address this challenge. They urged patients to publish their own research and detail the impact of innovations on their own health, and create databases that incorporate the findings of other patients.
For example, Adam Brown, who has Type 1 diabetes, compared the effects of low and high carbohydrate diets on his blood sugar management, and conveyed the results in an online journal. "Sharing the information allowed others to copy the experiment," the article noted, suggesting that this could be a model to create multi-patient trials that could be "analyzed by expert patients and/or by professionals."
Asked how to convince health care providers to consider such research, DeMonaco cited the example of doctors prescribing "off label" drugs for purposes that aren't approved by the FDA. "The secret to off label use, like any other user innovation, is dissemination," he said. Sharing case reports and other low-cost research serves to disseminate the information "in a way that is comfortable for physicians," he said, and urged patient innovators to take the same approach.
The FDA regulates commercial products and has no authority if consumers want to use medical devices, medications, or information systems that they find on their own.
Physicians should also be encouraged to engage in patient-driven research, said Dr. Lee. She suggests forming "maker spaces in which patients and physicians are involved in designing personalized technology for chronic diseases. In my vision, patient peers would build, iterate, and learn from each other and the doctor would be part of the team, constantly assessing and evaluating the technology and facilitating the process."
Some kind of regulatory oversight of DIY health technology is also necessary, said Todd Kuiken, senior research scholar at NC State and former principal investigator at the Woodrow Wilson Center's Synthetic Biology Project.
The FDA regulates commercial products and has no authority if consumers want to use medical devices, medications, or information systems that they find on their own. But that doesn't stop regulators from worrying about patients who use them. For example, the FDA issued a warning about diabetes looping technology earlier this year after one diabetic was hospitalized with hypoglycemia.
Kuiken, for one, believes that citizen-driven innovation requires oversight "to move forward." He suggested that Internal Review Boards, with experts on medical technology, safety and ethics, could play a helpful role in validating the work of patient innovators and others engaged in DIY health research. "As people are developing health products, there would be experts available to take a look and check in," he said.
Kuiken pointed out that in native American territories, tribally based IRBs working with the national Indian Health Services help to oversee new health science research. The model could be applied more broadly.
He also offered hope to those who want to integrate the current health regulatory structure into the ecosystem of DIY health innovations. "I didn't expect people from the FDA or NIH to show up" he said about a workshop on citizen-driven biomedical research that he helped organize at the Wilson Center last year. But senior officials from both agencies attended.
He indicated they "were open to new ideas." While he wouldn't disclose contributions made by individual participants in the workshop, he said the government staffers were "very interested in figuring out how to engage with citizen health innovators, to build bridges with the DIY community."
"Why should we wait for regulatory bodies? Why wait for trials that take too long?"
Time will tell whether those bridges will be built quickly enough to increase the comfort of physicians with health innovations developed by patients and other consumers. In the meantime, DIY health innovators like patient advocate Scibilia are undeterred.
"Why should we wait for regulatory bodies?" she asked. "Why wait for trials that take too long? There are plenty of data out there indicating the [diabetes looping] technology works. So we're just going to do it. We're not waiting."
Chicken that is grown entirely in a laboratory, without harming a single bird, could be sold in supermarkets in the coming months. But critics say the doubts about lab-grown meat have not been appropriately explored.
Last November, when the U.S. Food and Drug Administration disclosed that chicken from a California firm called UPSIDE Foods did not raise safety concerns, it drily upended how humans have obtained animal protein for thousands of generations.
“The FDA is ready to work with additional firms developing cultured animal cell food and production processes to ensure their food is safe and lawful,” the agency said in a statement at the time.
Assuming UPSIDE obtains clearances from the U.S. Department of Agriculture, its chicken – grown entirely in a laboratory without harming a single bird – could be sold in supermarkets in the coming months.
“Ultimately, we want our products to be available everywhere meat is sold, including retail and food service channels,” a company spokesperson said. The upscale French restaurant Atelier Crenn in San Francisco will have UPSIDE chicken on its menu once it is approved, she added.
Known as lab-grown or cultured meat, a product such as UPSIDE’s is created using stem cells and other tissue obtained from a chicken, cow or other livestock. Those cells are then multiplied in a nutrient-dense environment, usually in conjunction with a “scaffold” of plant-based materials or gelatin to give them a familiar form, such as a chicken breast or a ribeye steak. A Dutch company called Mosa Meat claims it can produce 80,000 hamburgers derived from a cluster of tissue the size of a sesame seed.
Critics say the doubts about lab-grown meat and the possibility it could merge “Brave New World” with “The Jungle” and “Soylent Green” have not been appropriately explored.
That’s a far cry from when it took months of work to create the first lab-grown hamburger a decade ago. That minuscule patty – which did not contain any fat and was literally plucked from a Petri dish to go into a frying pan – cost about $325,000 to produce.
Just a decade later, an Israeli company called Future Meat said it can produce lab-grown meat for about $1.70 per pound. It plans to open a production facility in the U.S. sometime in 2023 and distribute its products under the brand name “Believer.”
Costs for production have sunk so low that researchers at Carnegie Mellon University in Pittsburgh expect sometime in early 2024 to produce lab-grown Wagyu steak to showcase the viability of growing high-end cuts of beef cheaply. The Carnegie Mellon team is producing its Wagyu using a consumer 3-D printer bought secondhand on eBay and modified to print the highly marbled flesh using a method developed by the university. The device costs $200 – about the same as a pound of Wagyu in the U.S. The initiative’s modest five-figure budget was successfully crowdfunded last year.
“The big cost is going to be the cells (which are being extracted by a cow somewhere in Pennsylvania), but otherwise printing doesn’t add much to the process,” said Rosalyn Abbott, a Carnegie Mellon assistant professor of bioengineering who is co-leader on the project. “But it adds value, unlike doing this with ground meat.”
Lab-Grown Meat’s Promise
Proponents of lab-grown meat say it will cut down on traditional agriculture, which has been a leading contributor to deforestation, water shortages and contaminated waterways from animal waste, as well as climate change.
An Oxford University study from 2011 concludes lab-grown meat could have greenhouse emissions 96 percent lower compared to traditionally raised livestock. Moreover, proponents of lab-grown meat claim that the suffering of animals would decline dramatically, as they would no longer need to be warehoused and slaughtered. A recently opened 26-story high-rise in China dedicated to the raising and slaughtering of pigs illustrates the current plight of livestock in stark terms.
Scientists may even learn how to tweak lab-grown meat to make it more nutritious. Natural red meat is high in saturated fat and, if it’s eaten too often, can lead to chronic diseases. In lab versions, the saturated fat could be swapped for healthier, omega-3 fatty acids.
But critics say the doubts about lab-grown meat and the possibility it could merge “Brave New World” with “The Jungle” and “Soylent Green” have not been appropriately explored.
A Slippery Slope?
Some academics who have studied the moral and ethical issues surrounding lab-grown meat believe it will have a tough path ahead gaining acceptance by consumers. Should it actually succeed in gaining acceptance, many ethical questions must be answered.
“People might be interested” in lab-grown meat, perhaps as a curiosity, said Carlos Alvaro, an associate professor of philosophy at the New York City College of Technology, part of the City University of New York. But the allure of traditionally sourced meat has been baked – or perhaps grilled – into people’s minds for so long that they may not want to make the switch. Plant-based meat provides a recent example of the uphill battle involved in changing old food habits, with Beyond Meat’s stock prices dipping nearly 80 percent in 2022.
"There are many studies showing that people don’t really care about the environment (to that extent)," Alvaro said. "So I don’t know how you would convince people to do this because of the environment.”
“From my research, I understand that the taste (of lab-grown meat) is not quite there,” Alvaro said, noting that the amino acids, sugars and other nutrients required to grow cultivated meat do not mimic what livestock are fed. He also observed that the multiplication of cells as part of the process “really mimic cancer cells” in the way they grow, another off-putting thought for would-be consumers of the product.
Alvaro is also convinced the public will not buy into any argument that lab-grown meat is more environmentally friendly.
“If people care about the environment, they either try and consume considerably less meat and other animal products, or they go vegan or vegetarian,” he said. “But there are many studies showing that people don’t really care about the environment (to that extent). So I don’t know how you would convince people to do this because of the environment.”
Ben Bramble, a professor at Australian National University who previously held posts at Princeton and Trinity College in Ireland, takes a slightly different tack. He noted that “if lab-grown meat becomes cheaper, healthier, or tastier than regular meat, there will be a large market for it. If it becomes all of these things, it will dominate the market.”
However, Bramble has misgivings about that occurring. He believes a smooth transition from traditionally sourced meat to a lab-grown version would allow humans to elide over the decades of animal cruelty perpetrated by large-scale agriculture, without fully reckoning with and learning from this injustice.
“My fear is that if we all switch over to lab-grown meat because it has become cheaper, healthier, or tastier than regular meat, we might never come to realize what we have done, and the terrible things we are capable of,” he said. “This would be a catastrophe.”
Bramble’s writings about cultured meat also raise some serious moral conundrums. If, for example, animal meat may be cultivated without killing animals, why not create products from human protein?
Actually, that’s already happened.
It occurred in 2019, when Orkan Telhan, a professor of fine arts at the University of Pennsylvania, collaborated with two scientists to create an art exhibit at the Philadelphia Museum of Art on the future of foodstuffs.
Although the exhibit included bioengineered bread and genetically modified salmon, it was an installation called “Ouroboros Steak” that drew the most attention. That was comprised of pieces of human flesh grown in a lab from cultivated cells and expired blood products obtained from online sources.
The exhibit was presented as four tiny morsels of red meat – shaped in patterns suggesting an ouroboros, a dragon eating its own tail. They were placed in tiny individual saucers atop a larger plate and placemat with a calico pattern, suggesting an item to order in a diner. The artwork drew international headlines – as well as condemnation for Telhan’s vision.
Telhan’s artwork is intended to critique the overarching assumption that lab-grown meat will eventually replace more traditional production methods, as well as the lack of transparency surrounding many processed foodstuffs. “They think that this problem (from industrial-scale agriculture) is going be solved by this new technology,” Telhan said. “I am critical (of) that perspective.”
Unlike Bramble, Telhan is not against lab-grown meat, so long as its producers are transparent about the sourcing of materials and its cultivation. But he believes that large-scale agricultural meat production – which dates back centuries – is not going to be replaced so quickly.
“We see this again and again with different industries, like algae-based fuels. A lot of companies were excited about this, and promoted it,” Telhan said. “And years later, we know these fuels work. But to be able to displace the oil industry means building the infrastructure to scale takes billions of dollars, and nobody has the patience or money to do it.”
Alvaro concurred on this point, which he believes is already weakened because a large swath of consumers aren’t concerned about environmental degradation.
“They’re going to have to sell this big, but in order to convince people to do so, they have to convince them to eat this product instead of regular meat,” Alvaro said.
Hidden Tweaks?
Moreover, if lab-based meat does obtain a significant market share, Telhan suggested companies may do things to the product – such as to genetically modify it to become more profitable – and never notify consumers. That is a particular concern in the U.S., where regulations regarding such modifications are vastly more relaxed than in the European Union.
“I think that they have really good objectives, and they aspire to good objectives,” Telhan said. “But the system itself doesn't really allow for that much transparency.”
No matter what the future holds, sometime next year Carnegie Mellon is expected to hold a press conference announcing it has produced a cut of the world’s most expensive beef with the help of a modified piece of consumer electronics. It will likely take place at around the same time UPSIDE chicken will be available for purchase in supermarkets and restaurants, pending the USDA’s approvals.
Abbott, the Carnegie Mellon professor, suggested the future event will be both informative and celebratory.
“I think Carnegie Mellon would have someone potentially cook it for us,” she said. “Like have a really good chef in New York City do it.”
In this week's Friday Five, breathing this way may cut down on anxiety, a fasting regimen that could make you sick, this type of job makes men more virile, 3D printed hearts could save your life, and the role of metformin in preventing dementia.
The Friday Five covers five stories in research that you may have missed this week. There are plenty of controversies and troubling ethical issues in science – and we get into many of them in our online magazine – but this news roundup focuses on scientific creativity and progress to give you a therapeutic dose of inspiration headed into the weekend.
Here are the promising studies covered in this week's Friday Five, featuring interviews with Dr. David Spiegel, associate chair of psychiatry and behavioral sciences at Stanford, and Dr. Filip Swirski, professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai.
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Here are the promising studies covered in this week's Friday Five, featuring interviews with Dr. David Spiegel, associate chair of psychiatry and behavioral sciences at Stanford, and Dr. Filip Swirski, professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai.
- Breathing this way cuts down on anxiety*
- Could your fasting regimen make you sick?
- This type of job makes men more virile
- 3D printed hearts could save your life
- Yet another potential benefit of metformin
* This video with Dr. Andrew Huberman of Stanford shows exactly how to do the breathing practice.