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."
Time to visit your TikTok doc? The good and bad of doctors on social media
Rakhi Patel has carved a hobby out of reviewing pizza — her favorite food — on Instagram. In a nod to her preferred topping, she calls herself thepepperoniqueen. Photos and videos show her savoring slices from scores of pizzerias. In some of them, she’s wearing scrubs — her attire as an inpatient neurology physician associate at Tufts Medical Center in Boston.
“Depending on how you dress your pizza, it can be more nutritious,” said Patel, who suggests a thin crust, sugarless tomato sauce and vegetables galore as healthier alternatives. “There are no boundaries for a health care professional to enjoy pizza.”
Beyond that, “pizza fuels my mental health and makes me happy, especially when loaded with pepperoni,” she said. “If I’m going to be a pizza connoisseur, then I also need to take care of my physical health by ensuring that I get at least three days of exercise per week and eat nutritiously when I’m not eating pizza.”
She’s among an increasing number of health care professionals, including doctors and nurses, who maintain an active persona on social media, according to bioethics researchers. They share their hobbies and interests with people inside and outside the world of medicine, helping patients and the public become acquainted with the humans behind the scrubs or white coats. Other health care experts limit their posts to medical topics, while some opt for a combination of personal and professional commentaries. Depending on the posts, ethical issues may come into play.
“Health care professionals are quite prevalent on social media,” said Mercer Gary, a postdoctoral researcher at The Hastings Center, an independent bioethics research institute in Garrison, New York. “They’ve been posting on #medTwitter for many years, mainly to communicate with one another, but, of course, anyone can see the threads. Most recently, doctors and nurses have become a presence on TikTok.”
On social media, many health care providers perceive themselves to be “humanizing” their profession by coming across as more approachable — “reminding patients that providers are people and workers, as well as repositories of medical expertise,” Gary said. As a result, she noted that patients who are often intimidated by clinicians may feel comfortable enough to overcome barriers to scheduling health care appointments. The use of TikTok in particular may help doctors and nurses connect with younger followers.
When health care providers post on social media, they must bear in mind that they have legal and ethical duties to their patients, profession and society, said Elizabeth Levy, founder and director of Physicians for Justice.
While enduring three years of pandemic conditions, many health care professionals have struggled with burnout, exhaustion and moral distress. “Much health care provider content on social media seeks to expose the difficulties of the work,” Gary added. “TikTok and Instagram reels have shown health care providers crying after losing a patient or exhausted after a night shift in the emergency department.”
A study conducted in Beijing, China and published last year found that TikTok is the world’s most rapidly growing video application, amassing 1.6 billion users in 2021. “More and more patients are searching for information on genitourinary cancers via TikTok,” the study’s authors wrote in Frontiers in Oncology, referring to cancers of the urinary tracts and male reproductive organs. Among the 61 sample videos examined by the researchers, health care practitioners contributed the content in 29, or 47 percent, of them. Yet, 22 posts, 36 percent, were misinformative, mostly due to outdated information.
More than half of the videos offered good content on disease symptoms and examinations. The authors concluded that “most videos on genitourinary cancers on TikTok are of poor to medium quality and reliability. However, videos posted by media agencies enjoyed great public attention and interaction. Medical practitioners could improve the video quality by cooperating with media agencies and avoiding unexplained terminologies.”
When health care providers post on social media, they must bear in mind that they have legal and ethical duties to their patients, profession and society, said Elizabeth Levy, founder and director of Physicians for Justice in Irvine, Calif., a nonprofit network of volunteer physicians partnering with public interest lawyers to address the social determinants of health.
“Providers are also responsible for understanding the mechanics of their posts,” such as who can see these messages and how long they stay up, Levy said. As a starting point for figuring what’s acceptable, providers could look at social media guidelines put out by their professional associations. Even beyond that, though, they must exercise prudent judgment. “As social media continues to evolve, providers will also need to stay updated with the changing risks and benefits of participation.”
Patients often research their providers online, so finding them on social media can help inform about values and approaches to care, said M. Sara Rosenthal, a professor and founding director of the program for bioethics and chair of the hospital ethics committee at the University of Kentucky College of Medicine.
Health care providers’ posts on social media also could promote patient education. They can advance informed consent and help patients navigate the risks and benefits of various treatments or preventive options. However, providers could violate ethical principles if they espouse “harmful, risky or questionable therapies or medical advice that is contrary to clinical practice guidelines or accepted standards of care,” Rosenthal said.
Inappropriate self-disclosure also can affect a provider’s reputation, said Kelly Michelson, a professor of pediatrics and director of the Center for Bioethics and Medical Humanities at Northwestern University’s Feinberg School of Medicine. A clinician’s obligations to professionalism extend beyond those moments when they are directly taking care of their patients, she said. “Many experts recommend against clinicians ‘friending’ patients or the families on social media because it blurs the patient-clinician boundary.”
Meanwhile, clinicians need to adhere closely to confidentiality. In sharing a patient’s case online for educational purposes, safeguarding identity becomes paramount. Removing names and changing minor details is insufficient, Michelson said.
“The patient-clinician relationship is sacred, and it can only be effective if patients have 100 percent confidence that all that happens with their clinician is kept in the strictest of confidence,” she said, adding that health care providers also should avoid obtaining information about their patients from social media because it can lead to bias and risk jeopardizing objectivity.
Academic clinicians can use social media as a recruitment tool to expand the pool of research participants for their studies, Michelson said. Because the majority of clinical research is conducted at academic medical centers, large segments of the population are excluded. “This affects the quality of the data and knowledge we gain from research,” she said.
Don S. Dizon, a professor of medicine and surgery at the Warren Alpert Medical School of Brown University in Providence, Rhode Island, uses LinkedIn and Doximity, as well as Twitter, Instagram, TikTok, Facebook, and most recently, YouTube and Post. He’s on Twitter nearly every day, where he interacts with the oncology community and his medical colleagues.
Also, he said, “I really like Instagram. It’s where you will see a hybrid of who I am professionally and personally. I’ve become comfortable sharing both up to a limit, but where else can I combine my appreciation of clothes with my professional life?” On that site, he’s seen sporting shirts with polka dots or stripes and an occasional bow-tie. He also posts photos of his cats.
Don S. Dizon, a professor of medicine and surgery at Brown, started using TikTok several years ago, telling medical stories in short-form videos.
Don S. Dizon
Dizon started using TikTok several years ago, telling medical stories in short-form videos. He may talk about an inspirational patient, his views on end-of-life care and death, or memories of people who have passed. But he is careful not to divulge any details that would identify anyone.
Recently, some people have become his patients after viewing his content on social media or on the Internet in general, which he clearly states isn’t a forum for medical advice. “In both situations, they are so much more relaxed when we meet, because it’s as if they have a sense of who I am as a person,” Dizon said. “I think that has helped so much in talking through a cancer diagnosis and a treatment plan, and yes, even discussions about prognosis.”
He also posts about equity and diversity. “I have found myself more likely to repost or react to issues that are inherently political, including racism, homophobia, transphobia and lack-of-access issues, because medicine is not isolated from society, and I truly believe that medicine is a social justice issue,” said Dizon, who is vice chair of diversity, equity, inclusion and professional integrity at the SWOG Cancer Research Network.
Through it all, Dizon likes “to break through the notion of doctor as infallible and all-knowing, the doctor as deity,” he said. “Humanizing what I do, especially in oncology, is something that challenges me on social media, and I appreciate the opportunities to do it on TikTok.”
Could this habit related to eating slow down rates of aging?
Last Thursday, scientists at Columbia University published a new study finding that cutting down on calories could lead to longer, healthier lives. In the phase 2 trial, 220 healthy people without obesity dropped their calories significantly and, at least according to one test, their rate of biological aging slowed by 2 to 3 percent in over a couple of years. Small though that may seem, the researchers estimate that it would translate into a decline of about 10 percent in the risk of death as people get older. That's basically the same as quitting smoking.
Previous research has shown that restricting calories results in longer lives for mice, worms and flies. This research is unique because it applies those findings to people. It was published in Nature Aging.
But what did the researchers actually show? Why did two other tests indicate that the biological age of the research participants didn't budge? Does the new paper point to anything people should be doing for more years of healthy living? Spoiler alert: Maybe, but don't try anything before talking with a medical expert about it. I had the chance to chat with someone with inside knowledge of the research -- Dr. Evan Hadley, director of the National Institute of Aging's Division of Geriatrics and Clinical Gerontology, which funded the study. Dr. Hadley describes how the research participants went about reducing their calories, as well as the risks and benefits involved. He also explains the "aging clock" used to measure the benefits.
Evan Hadley, Director of the Division of Geriatrics and Clinical Gerontology at the National Institute of Aging
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