Ordinary people are living better with chronic conditions thanks to a recent explosion of developments in medical implants.
Beware, cyborgs walk among us. They’re mostly indistinguishable from regular humans and are infiltrating every nook and cranny of society. For full disclosure, I’m one myself. No, we’re not deadly intergalactic conquerors like the Borg race of Star Trek fame, just ordinary people living better with chronic conditions thanks to medical implants.
In recent years there has been an explosion of developments in implantable devices that merge multiple technologies into gadgets that work in concert with human physiology for the treatment of serious diseases. Pacemakers for the heart are the best-known implants, as well as other cardiac devices like LVADs (left-ventricular assist devices) and implanted defibrillators. Next-generation devices address an array of organ failures, and many are intended as permanent. The driving need behind this technology: a critical, persistent shortage of implantable biological organs.
The demand for transplantable organs dwarfs their availability. There are currently over 100,000 people on the transplant waiting list in the U.S., compared to 40,000 transplants completed in 2021. But even this doesn’t reflect the number of people in dire straits who don’t qualify for a transplant because of things like frailty, smoking status and their low odds of surviving the surgery.
My journey to becoming a cyborg came about because of a lifelong medical condition characterized by pathologically low motility of the digestive system, called gastroparesis. Ever since I was in my teens, I’ve had chronic problems with severe nausea. Flareups can be totally incapacitating and last anywhere from hours to months, interspersed with periods of relief. The cycle is totally unpredictable, and for decades my condition went both un- and misdiagnosed by doctors who were not even aware that the condition existed. Over the years I was labeled with whatever fashionable but totally inappropriate medical label existed at the time, and not infrequently, hypochondria.
Living with the gastric pacer is easy. In fact, most of the time, I don’t even know it’s there.
One of the biggest turning points in my life came when a surgeon at the George Washington University Hospital, Dr. Frederick Brody, ordered a gastric emptying test that revealed gastroparesis. This was in 2009, and an implantable device, called a gastric pacer, had been approved by the FDA for compassionate use, meaning that no other treatments were available. The small device is like a pacemaker that’s implanted beneath the skin of the abdomen and is attached to the stomach through electrodes that carry electrical pulses that stimulate the stomach, making it contract as it’s supposed to.
Dr. Brody implanted the electrical wires and the device, and, once my stomach started to respond to the pulses, I got the most significant nausea relief I’d had in decades of futile treatments. It sounds cliché to say that my debt to Dr. Brody is immeasurable, but the pacer has given me more years of relative normalcy than I previously could have dreamed of.
I should emphasize that the pacer is not a cure. I still take a lot of medicine and have to maintain a soft, primarily vegetarian diet, and the condition has progressed with age. I have ups and downs, and can still have periods of severe illness, but there’s no doubt I would be far worse off without the electrical stimulation provided by the pacer.
Living with the gastric pacer is easy. In fact, most of the time, I don’t even know it’s there. It entails periodic visits with a surgeon who can adjust the strength of the electrical pulses using a wireless device, so when symptoms are worse, he or she can amp up the juice. If the pulses are too strong, they can cause annoying contractions in the abdominal muscles, but this is easily fixed with a simple wireless adjustment. The battery runs down after a few years, and when this happens the whole device has to be replaced in what is considered minor surgery.
Such devices could fill gaps in treating other organ failures. By far most of the people on transplant waiting lists are waiting for kidneys. Despite the fact that live donations are possible, there’s still a dire shortage of organs. A bright spot on the horizon is The Kidney Project, a program spearheaded by bioengineer Shuvo Roy at the University of California, San Francisco, which is developing a fully implantable artificial kidney. The device combines living cells with artificial materials and relies not on a battery, but on the patient’s own blood pressure to keep it functioning.
Several years into this project, a prototype of the kidney, about the size of a smart phone, has been successfully tested in pigs. The device seems to provide many of the functions of a biological kidney (unlike dialysis, which replaces only one main function) and reliably produces urine. One of its most critical components is a special artificial membrane, called a hemofilter, that filters out toxins and waste products from the blood without leaking important molecules like albumin. Since it allows for total mobility, the artificial kidney will provide patients with a higher quality of life than those on dialysis, and is in some important ways, even better than a biological transplant.
The beauty of the device is that, even though it contains kidney cells sourced, as of now, from cadavers or pigs, the cells are treated so that they can’t be rejected and the device doesn’t require the highly problematic immunosuppressant drugs a biological organ requires. “Anti-rejection drugs,” says Roy, “make you susceptible to all kinds of infections and damage the transplanted organ, causing steady deterioration. Eventually they kill the kidney. A biological transplant has about a 10-year limit,” after which the kidney fails and the body rejects it.
Eventually, says Roy, the cells used in the artificial kidney will be sourced from the patient himself, the ultimate genetic match. The patient’s adult stem cells can be used to produce some or all of the 25 to 30 specialized cells of a biological kidney that provide all the functions of a natural organ. People formerly on dialysis could drastically improve their functionality and quality of life without being tethered to a machine for hours at a time, three days a week.
As exciting as this project is, it suffers from a common theme in early biomedical research—keeping a steady stream of funding that will move the project from the lab, into human clinical trials and eventually to the bedside. “It’s the issue,” says Roy. “Potential investors want to see more data indicating that it works, but you need funding to create data. It’s a Catch-22 that puts you in a kind of no-man’s land of funding.” The constant pursuit of funding introduces a variable that makes it hard to predict when the kidney will make it to market, despite the enormous need for such a technology.
Another critical variable is if and when insurance companies will decide to cover transplants with the artificial kidney, so that it becomes affordable for the average person. But Roy thinks that this hurdle, too, will be crossed. Insurance companies stand to save a great deal of money compared to what they ordinarily spend on transplant patients. The cost of yearly maintenance will be a fraction of that associated with the tens of thousands of dollars for immunosuppressant drugs and the attendant complications associated with a biological transplant.
One estimate that the multidisciplinary team of researchers involved with The Kidney Project are still trying to establish is how long the artificial kidney will last once transplanted into the body. Animal trials so far have been looking at how the kidney works for 30 days, and will soon extend that study to 90 days. Additional studies will extend much farther into the future, but first the kidneys have to be implanted into people who can be followed over many years to answer this question. But unlike the gastric pacer and other implants, there won’t be a need for periodic surgeries to replace a depleted battery, and the stark improvements in quality of life compared to dialysis add a special dimension to the value of whatever time the kidney lasts.
Another life-saving implant could address a major scourge of the modern world—heart disease. Despite significant advances in recent decades, including the cardiac implants mentioned above, cardiovascular disease still causes one in three deaths across the world. One of the most promising developments in recent years is the Total Artificial Heart, a pneumatically driven device that can be used in patients with biventricular heart failure, affecting both sides of the heart, when a biological organ is not available.
The TAH is implanted in the chest cavity and has two tubes that snake down the body, come out through the abdomen and attach to a 13.5-pound external driver that the patient carries around in a backpack. It was first developed as a bridge to transplant, a temporary alternative while the patient waited for a biological heart to replace it. However, SynCardia Systems, LLC, the Tucson-based company that makes it, is now investigating whether the heart can be used on a long-term basis.
There’s good reason to think that this will be the case. I spoke with Daniel Teo, one of the board members of SynCardia, who said that so far, one patient lived with the TAH for six years and nine months, before he died of other causes. Another patient, still alive, has lived with the device for over five years and another one has lived with it for over four years. About 2,000 of these transplants have been done in patients waiting for biological hearts so far, and most have lived mobile, even active lives. One TAH recipient hiked for 600 miles, and another ran the 4.2-mile Pat Tillman Run, both while on the artificial heart. This is a far cry from their activities before surgery, while living with advanced heart failure.
Randy Shepard, a recipient of the Total Artificial Heart, teaches archery to his son.
Randy Shepard
If removing and replacing one’s biological heart with a synthetic device sounds scary, it is. But then so is replacing one’s heart with biological one. “The TAH is very emotionally loaded for most people,” says Teo. “People sometimes hold back because of philosophical, existential questions and other nonmedical reasons.” He also cites cultural reasons why some people could be hesitant to accept an artificial heart, saying that some religions could frown upon it, just as they forbid other medical interventions.
The first TAHs that were approved were 70 cubic centimeters in size and fit into the chest cavities of men and larger women, but there’s now a smaller, 50 cc size meant for women and adolescents. The FDA first cleared the 70 cc heart as a bridge to transplant in 2004, and the 50 cc model received approval in 2014. SynCardia’s focus now is on seeking FDA approval to use the heart on a long-term basis. There are other improvements in the works.
One issue being refined deals with the external driver that holds the pneumatic device for moving the blood through a patient’s body. The two tubes connecting the driver to the heart entail openings in the skin that could get infected, and carrying the backpack is less than ideal. The driver also makes an audible sound that some people find disturbing. The next generation TAH will be quieter and involve wearing a smaller, lighter device on a belt rather than carrying the backpack. SynCardia is also working toward a fully implantable heart that wouldn’t require any external components and would contain an energy source that can be recharged wirelessly.
Teo says the jury is out as to whether artificial hearts will ever obviate the need for biological organs, but the world’s number one killer isn’t going away any time soon. “The heart is one of the strongest organs,” he says, “but it’s not made to last forever. If you live long enough, the heart will eventually fail, and heart failure leads to the failure of other organs like the kidney, the lungs and the liver.” As long as this remains the case and as long as the current direction of research continues, artificial organs are likely to play an ever larger part of our everyday lives.
Oh, wait. Maybe we cyborgs will take over the world after all.
Doctors used new eye drops to treat a rare genetic disorder.
The gene therapy: In May 2023, the FDA approved Vyjuvek, the first gene therapy to treat DEB.
Vyjuvek uses an inactivated herpes simplex virus to deliver working copies of the gene for collagen 7 to the body’s cells. In small trials, 65 percent of DEB-caused wounds sprinkled with it healed completely, compared to just 26 percent of wounds treated with a placebo.
“It was like looking through thick fog.” -- Antonio Vento Carvajal.
The patient: Antonio Vento Carvajal, a 14 year old living in Florida, was one of the trial participants to benefit from Vyjuvek, which was developed by Pittsburgh-based pharmaceutical company Krystal Biotech.
While the topical gene therapy could help his skin, though, it couldn’t do anything to address the severe vision loss Antonio experienced due to his DEB. He’d undergone multiple surgeries to have scar tissue removed from his eyes, but due to his condition, the blisters keep coming back.
“It was like looking through thick fog,” said Antonio, noting how his impaired vision made it hard for him to play his favorite video games. “I had to stand up from my chair, walk over, and get closer to the screen to be able to see.”
The idea: Encouraged by how Antonio’s skin wounds were responding to the gene therapy, Alfonso Sabater, his doctor at the Bascom Palmer Eye Institute, reached out to Krystal Biotech to see if they thought an alternative formula could potentially help treat his patient’s eyes.
The company was eager to help, according to Sabater, and after about two years of safety and efficacy testing, he had permission, under the FDA’s compassionate use protocol, to treat Antonio’s eyes with a version of the topical gene therapy delivered as eye drops.
The results: In August 2022, Sabater once again removed scar tissue from Antonio’s right eye, but this time, he followed up the surgery by immediately applying eye drops containing the gene therapy.
“I would send this message to other families in similar situations, whether it’s DEB or another condition that can benefit from genetic therapy. Don’t be afraid.” -- Yunielkys “Yuni” Carvajal.
The vision in Antonio’s eye steadily improved. By about eight months after the treatment, it was just slightly below average (20/25) and stayed that way. In March 2023, Sabater performed the same procedure on his young patient’s other eye, and the vision in it has also steadily improved.
“I’ve seen the transformation in Antonio’s life,” said Sabater. “He’s always been a happy kid. Now he’s very happy. He can function pretty much normally. He can read, he can study, he can play video games.”
Looking ahead: The topical gene therapy isn’t a permanent fix — it doesn’t alter Antonio’s own genes, so he has to have the eye drops reapplied every month. Still, that’s far less invasive than having to undergo repeated surgeries.
Sabater is now working with Krystal Biotech to launch trials of the eye drops in other patients, and not just those with DEB. By changing the gene delivered by the therapy, he believes it could be used to treat other eye disorders that are far more common — Fuchs’ dystrophy, for example, affects the vision of an estimated 300 million people over the age of 30.
Antonio’s mother, Yunielkys “Yuni” Carvajal, meanwhile, has said that having her son be the first to receive the eye drops was “very scary,” but she’s hopeful others will take a chance on new gene therapies if given the opportunity.
“I would send this message to other families in similar situations, whether it’s DEB or another condition that can benefit from genetic therapy,” she said. “Don’t be afraid.”
This article originally appeared on Freethink, home of the brightest minds and biggest ideas of all time.
A chatbot from the nonprofit National Eating Disorders Association aimed to provide 24/7 guidance on eating disorders. Several drawbacks point to the importance of therapist-tech collaboration in multiple areas of health.
Then everything went off the rails. Tessa told Maxwell an unequivocal yes, and that “it’s important to approach weight loss with a balanced and realistic mindset,” and recommended eating whole foods and lean proteins to create a 500-1000 calorie per day deficit that would lead to a loss of 1-2 pounds per week. To most people, the advice sounds anodyne, but alarm bells sounded in Maxwell’s head.
“This is actively going to feed eating disorders,” Maxwell says. “Having a chatbot be the direct response to someone reaching out for support for an eating disorder instead of the helpline seems careless.”
“The scripts that are being fed into the chatbot are only going to be as good as the person who’s feeding them.” -- Alexis Conason.
According to several decades of research, deliberate weight loss in the form of dieting is a serious risk for people with eating disorders. Maxwell says that following medical advice like what Tessa prescribed was what triggered her eating disorder as a child. And Maxwell wasn’t the only one who got such advice from the bot. When eating disorder therapist Alexis Conason tried Tessa, she asked the AI chatbot many of the questions her patients had. But instead of getting connected to resources or guidance on recovery, Conason, too, got tips on losing weight and “healthy” eating.
“The scripts that are being fed into the chatbot are only going to be as good as the person who’s feeding them,” Conason says. “It’s important that an eating disorder organization like NEDA is not reinforcing that same kind of harmful advice that we might get from medical providers who are less knowledgeable.”
Maxwell’s post about Tessa on Instagram went viral, and within days, NEDA had scrubbed all evidence of Tessa from its website. The furor has raised any number of issues about the harm perpetuated by a leading eating disorder charity and the ongoing influence of diet culture and advice that is pervasive in the field. But for AI experts, bears and bulls alike, Tessa offers a cautionary tale about what happens when a still-immature technology is unfettered and released into a vulnerable population.
Given the complexity involved in giving medical advice, the process of developing these chatbots must be rigorous and transparent, unlike NEDA’s approach.
“We don’t have a full understanding of what’s going on in these models. They’re a black box,” says Stephen Schueller, a clinical psychologist at the University of California, Irvine.
The health crisis
In March 2020, the world dove head-first into a heavily virtual world as countries scrambled to try and halt the pandemic. Even with lockdowns, hospitals were overwhelmed by the virus. The downstream effects of these lifesaving measures are still being felt, especially in mental health. Anxiety and depression are at all-time highs in teens, and a new report in The Lancet showed that post-Covid rates of newly diagnosed eating disorders in girls aged 13-16 were 42.4 percent higher than previous years.
And the crisis isn’t just in mental health.
“People are so desperate for health care advice that they'll actually go online and post pictures of [their intimate areas] and ask what kind of STD they have on public social media,” says John Ayers, an epidemiologist at the University of California, San Diego.
For many people, the choice isn’t chatbot vs. well-trained physician, but chatbot vs. nothing at all.
I know a bit about that desperation. Like Maxwell, I have struggled with a multi-decade eating disorder. I spent my 20s and 30s bouncing from crisis to crisis. I have called suicide hotlines, gone to emergency rooms, and spent weeks-on-end confined to hospital wards. Though I have found recovery in recent years, I’m still not sure what ultimately made the difference. A relapse isn't improbably, given my history. Even if I relapsed again, though, I don’t know it would occur to me to ask an AI system for help.
For one, I am privileged to have assembled a stellar group of outpatient professionals who know me, know what trips me up, and know how to respond to my frantic texts. Ditto for my close friends. What I often need is a shoulder to cry on or a place to vent—someone to hear and validate my distress. What’s more, my trust in these individuals far exceeds my confidence in the companies that create these chatbots. The Internet is full of health advice, much of it bad. Even for high-quality, evidence-based advice, medicine is often filled with disagreements about how the evidence might be applied and for whom it’s relevant. All of this is key in the training of AI systems like ChatGPT, and many AI companies remain silent on this process, Schueller says.
The problem, Ayers points out, is that for many people, the choice isn’t chatbot vs. well-trained physician, but chatbot vs. nothing at all. Hence the proliferation of “does this infection make my scrotum look strange?” questions. Where AI can truly shine, he says, is not by providing direct psychological help but by pointing people towards existing resources that we already know are effective.
“It’s important that these chatbots connect [their users to] to provide that human touch, to link you to resources,” Ayers says. “That’s where AI can actually save a life.”
Before building a chatbot and releasing it, developers need to pause and consult with the communities they hope to serve.
Unfortunately, many systems don’t do this. In a study published last month in the Journal of the American Medical Association, Ayers and colleagues found that although the chatbots did well at providing evidence-based answers, they often didn’t provide referrals to existing resources. Despite this, in an April 2023 study, Ayers’s team found that both patients and professionals rated the quality of the AI responses to questions, measured by both accuracy and empathy, rather highly. To Ayers, this means that AI developers should focus more on the quality of the information being delivered rather than the method of delivery itself.
Many mental health professionals have months-long waitlists, which leaves individuals to deal with illnesses on their own.
Adobe Stock
The human touch
The mental health field is facing timing constraints, too. Even before the pandemic, the U.S. suffered from a shortage of mental health providers. Since then, the rates of anxiety, depression, and eating disorders have spiked even higher, and many mental health professionals report waiting lists that are months long. Without support, individuals are left to try and cope on their own, which often means their condition deteriorates even further.
Nor do mental health crises happen during office hours. I struggled the most late at night, long after everyone else had gone to bed. I needed support during those times when I was most liable to hurt myself, not in the mornings and afternoons when I was at work.
In this sense, a 24/7 chatbot makes lots of sense. “I don't think we should stifle innovation in this space,” Schueller says. “Because if there was any system that needs to be innovated, it's mental health services, because they are sadly insufficient. They’re terrible.”
But before building a chatbot and releasing it, Tina Hernandez-Boussard, a data scientist at Stanford Medicine, says that developers need to pause and consult with the communities they hope to serve. It requires a deep understanding of what their needs are, the language they use to describe their concerns, existing resources, and what kinds of topics and suggestions aren’t helpful. Even asking a simple question at the beginning of a conversation such as “Do you want to talk to an AI or a human?” could allow those individuals to pick the type of interaction that suits their needs, Hernandez-Boussard says.
NEDA did none of these things before deploying Tessa. The researchers who developed the online body positivity self-help program upon which Tessa was initially based created a set of online question-and-answer exercises to improve body image. It didn’t involve generative AI that could write its own answers. The bot deployed by NEDA did use generative AI, something that no one in the eating disorder community was aware of before Tessa was brought online. Consulting those with lived experience would have flagged Tessa’s weight loss and “healthy eating” recommendations, Conason says.
The question for healthcare isn’t whether to use AI, but how.
NEDA did not comment on initial Tessa’s development and deployment, but a spokesperson told Leaps.org that “Tessa will be back online once we are confident that the program will be run with the rule-based approach as it was designed.”
The tech and therapist collaboration
The question for healthcare isn’t whether to use AI, but how. Already, AI can spot anomalies on medical images with greater precision than human eyes and can flag specific areas of an image for a radiologist to review in greater detail. Similarly, in mental health, AI should be an add-on for therapy, not a counselor-in-a-box, says Aniket Bera, an expert on AI and mental health at Purdue University.
“If [AIs] are going to be good helpers, then we need to understand humans better,” Bera says. That means understanding what patients and therapists alike need help with and respond to.
One of the biggest challenges of struggling with chronic illness is the dehumanization that happens. You become a patient number, a set of laboratory values and test scores. Treatment is often dictated by invisible algorithms and rules that you have no control over or access to. It’s frightening and maddening. But this doesn’t mean chatbots don’t have any place in medicine and mental health. An AI system could help provide appointment reminders and answer procedural questions about parking and whether someone should fast before a test or a procedure. They can help manage billing and even provide support between outpatient sessions by offering suggestions for what coping skills to use, the best ways to manage anxiety, and point to local resources. As the bots get better, they may eventually shoulder more and more of the burden of providing mental health care. But as Maxwell learned with Tessa, it’s still no replacement for human interaction.
“I'm not suggesting we should go in and start replacing therapists with technologies,” Schueller says. Instead, he advocates for a therapist-tech collaboration. “The technology side and the human component—these things need to come together.”