A Million Patients Have Innovated Their Own Medical Solutions, And Doctors Are Terrified
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."
New implants let paraplegics surf the web and play computer games
When I greeted Rodney Gorham, age 63, in an online chat session, he replied within seconds: “My pleasure.”
“Are you moving parts of your body as you type?” I asked.
This time, his response came about five minutes later: “I position the cursor with the eye tracking and select the same with moving my ankles.” Gorham, a former sales representative from Melbourne, Australia, living with amyotrophic lateral sclerosis, or ALS, a rare form of Lou Gehrig’s disease that impairs the brain’s nerve cells and the spinal cord, limiting the ability to move. ALS essentially “locks” a person inside their own body. Gorham is conversing with me by typing with his mind only–no fingers in between his brain and his computer.
The brain-computer interface enabling this feat is called the Stentrode. It's the brainchild of Synchron, a company backed by Amazon’s Jeff Bezos and Microsoft cofounder Bill Gates. After Gorham’s neurologist recommended that he try it, he became one of the first volunteers to have an 8mm stent, laced with small electrodes, implanted into his jugular vein and guided by a surgeon into a blood vessel near the part of his brain that controls movement.
After arriving at their destination, these tiny sensors can detect neural activity. They relay these messages through a small receiver implanted under the skin to a computer, which then translates the information into words. This minimally invasive surgery takes a day and is painless, according to Gorham. Recovery time is typically short, about two days.
When a paralyzed patient thinks about trying to move their arms or legs, the motor cortex will fire patterns that are specific to the patient’s thoughts.
When a paralyzed patient such as Gorham thinks about trying to move their arms or legs, the motor cortex will fire patterns that are specific to the patient’s thoughts. This pattern is detected by the Stentrode and relayed to a computer that learns to associate this pattern with the patient’s physical movements. The computer recognizes thoughts about kicking, making a fist and other movements as signals for clicking a mouse or pushing certain letters on a keyboard. An additional eye-tracking device controls the movement of the computer cursor.
The process works on a letter by letter basis. That’s why longer and more nuanced responses often involve some trial and error. “I have been using this for about two years, and I enjoy the sessions,” Gorham typed during our chat session. Zafar Faraz, field clinical engineer at Synchron, sat next to Gorham, providing help when required. Gorham had suffered without internet access, but now he looks forward to surfing the web and playing video games.
Gorham, age 63, has been enjoying Stentrode sessions for about two years.
Rodeny Dekker
The BCI revolution
In the summer of 2021, Synchron became the first company to receive the FDA’s Investigational Device Exemption, which allows research trials on the Stentrode in human patients. This past summer, the company, together with scientists from Icahn School of Medicine at Mount Sinai and the Neurology and Neurosurgery Department at Utrecht University, published a paper offering a framework for how to develop BCIs for patients with severe paralysis – those who can't use their upper limbs to type or use digital devices.
Three months ago, Synchron announced the enrollment of six patients in a study called COMMAND based in the U.S. The company will seek approval next year from the FDA to make the Stentrode available for sale commercially. Meanwhile, other companies are making progress in the field of BCIs. In August, Neuralink announced a $280 million financing round, the biggest fundraiser yet in the field. Last December, Synchron announced a $75 million financing round. “One thing I can promise you, in five years from now, we’re not going to be where we are today. We're going to be in a very different place,” says Elad I. Levy, professor of neurosurgery and radiology at State University of New York in Buffalo.
The risk of hacking exists, always. Cybercriminals, for example, might steal sensitive personal data for financial reasons, blackmailing, or to spread malware to other connected devices while extremist groups could potentially hack BCIs to manipulate individuals into supporting their causes or carrying out actions on their behalf.
“The prospect of bestowing individuals with paralysis a renewed avenue for communication and motor functionality is a step forward in neurotech,” says Hayley Nelson, a neuroscientist and founder of The Academy of Cognitive and Behavioral Neuroscience. “It is an exciting breakthrough in a world of devastating, scary diseases,” says Neil McArthur, a professor of philosophy and director of the Centre for Professional and Applied Ethics at the University of Manitoba. “To connect with the world when you are trapped inside your body is incredible.”
While the benefits for the paraplegic community are promising, the Stentrode’s long-term effectiveness and overall impact needs more research on safety. “Potential risks like inflammation, damage to neural tissue, or unexpected shifts in synaptic transmission due to the implant warrant thorough exploration,” Nelson says.
There are also concens about data privacy concerns and the policies of companies to safeguard information processed through BCIs. “Often, Big Tech is ahead of the regulators because the latter didn’t envisage such a turn of events...and companies take advantage of the lack of legal framework to push forward,” McArthur says. Hacking is another risk. Cybercriminals could steal sensitive personal data for financial reasons, blackmailing, or to spread malware to other connected devices. Extremist groups could potentially hack BCIs to manipulate individuals into supporting their causes or carrying out actions on their behalf.
“We have to protect patient identity, patient safety and patient integrity,” Levy says. “In the same way that we protect our phones or computers from hackers, we have to stay ahead with anti-hacking software.” Even so, Levy thinks the anticipated benefits for the quadriplegic community outweigh the potential risks. “We are on the precipice of an amazing technology. In the future, we would be able to connect patients to peripheral devices that enhance their quality of life.”
In the near future, the Stentrode could enable patients to use the Stentrode to activate their wheelchairs, iPods or voice modulators. Synchron's focus is on using its BCI to help patients with significant mobility restrictions—not to enhance the lives of healthy people without any illnesses. Levy says we are not prepared for the implications of endowing people with superpowers.
I wondered what Gorham thought about that. “Pardon my question, but do you feel like you have sort of transcended human nature, being the first in a big line of cybernetic people doing marvelous things with their mind only?” was my last question to Gorham.
A slight smile formed on his lips. In less than a minute, he typed: “I do a little.”
Leading XPRIZE Healthspan and Beating Negativity with Dr. Peter Diamandis
A new competition by the XPRIZE Foundation is offering $101 million to researchers who discover therapies that give a boost to people aged 65-80 so their bodies perform more like when they were middle-aged.
For today’s podcast episode, I talked with Dr. Peter Diamandis, XPRIZE’s founder and executive chairman. Under Peter’s leadership, XPRIZE has launched 27 previous competitions with over $300 million in prize purses. The latest contest aims to enhance healthspan, or the period of life when older people can play with their grandkids without any restriction, disability or disease. Such breakthroughs could help prevent chronic diseases that are closely linked to aging. These illnesses are costly to manage and threaten to overwhelm the healthcare system, as the number of Americans over age 65 is rising fast.
In this competition, called XPRIZE Healthspan, multiple awards are available, depending on what’s achieved, with support from the nonprofit Hevolution Foundation and Chip Wilson, the founder of Lululemon and nonprofit SOLVE FSHD. The biggest prize, $81 million, is for improvements in cognition, muscle and immunity by 20 years. An improvement of 15 years will net $71 million, and 10 years will net $61 million.
In our conversation for this episode, Peter talks about his plans for XPRIZE Healthspan and why exponential technologies make the current era - even with all of its challenges - the most exciting time in human history. We discuss the best mental outlook that supports a person in becoming truly innovative, as well as the downsides of too much risk aversion. We talk about how to overcome the negativity bias in ourselves and in mainstream media, how Peter has shifted his own mindset to become more positive over the years, how to inspire a culture of innovation, Peter’s personal recommendations for lifestyle strategies to live longer and healthier, the innovations we can expect in various fields by 2030, the future of education and the importance of democratizing tech and innovation.
In addition to Peter’s pioneering leadership of XPRIZE, he is also the Executive Founder of Singularity University. In 2014, he was named by Fortune as one of the “World’s 50 Greatest Leaders.” As an entrepreneur, he’s started over 25 companies in the areas of health-tech, space, venture capital and education. He’s Co-founder and Vice-Chairman of two public companies, Celularity and Vaxxinity, plus being Co-founder & Chairman of Fountain Life, a fully-integrated platform delivering predictive, preventative, personalized and data-driven health. He also serves as Co-founder of BOLD Capital Partners, a venture fund with a half-billion dollars under management being invested in exponential technologies and longevity companies. Peter is a New York Times Bestselling author of four books, noted during our conversation and in the show notes of this episode. He has degrees in molecular genetics and aerospace engineering from MIT and holds an M.D. from Harvard Medical School.
Show links
- Peter Diamandis bio
- New XPRIZE Healthspan
- Peter Diamandis books
- 27 XPRIZE competitions and counting
- Life Force by Peter Diamandis and Tony Robbins
- Peter Diamandis Twitter
- Longevity Insider newsletter – AI identifies the news
- Peter Diamandis Longevity Handbook
- Hevolution funding for longevity
XPRIZE Founder Peter Diamandis speaks with Mehmoud Khan, CEO of Hevolution Foundation, at the launch of XPRIZE Healthspan.
Hevolution Foundation