What’s the Right Way to Regulate Gene-Edited Crops?
In the next few decades, humanity faces its biggest food crisis since the invention of the plow. The planet's population, currently 7.6 billion, is expected to reach 10 billion by 2050; to avoid mass famine, according to the World Resource Institute, we'll need to produce 70 percent more calories than we do today.
Imagine that a cheap, easy-to-use, and rapidly deployable technology could make crops more fertile and strengthen their resistance to threats.
Meanwhile, climate change will bring intensifying assaults by heat, drought, storms, pests, and weeds, depressing farm yields around the globe. Epidemics of plant disease—already laying waste to wheat, citrus, bananas, coffee, and cacao in many regions—will spread ever further through the vectors of modern trade and transportation.
So here's a thought experiment: Imagine that a cheap, easy-to-use, and rapidly deployable technology could make crops more fertile and strengthen their resistance to these looming threats. Imagine that it could also render them more nutritious and tastier, with longer shelf lives and less vulnerability to damage in shipping—adding enhancements to human health and enjoyment, as well as reduced food waste, to the possible benefits.
Finally, imagine that crops bred with the aid of this tool might carry dangers. Some could contain unsuspected allergens or toxins. Others might disrupt ecosystems, affecting the behavior or very survival of other species, or infecting wild relatives with their altered DNA.
Now ask yourself: If such a technology existed, should policymakers encourage its adoption, or ban it due to the risks? And if you chose the former alternative, how should crops developed by this method be regulated?
In fact, this technology does exist, though its use remains mostly experimental. It's called gene editing, and in the past five years it has emerged as a potentially revolutionary force in many areas—among them, treating cancer and genetic disorders; growing transplantable human organs in pigs; controlling malaria-spreading mosquitoes; and, yes, transforming agriculture. Several versions are currently available, the newest and nimblest of which goes by the acronym CRISPR.
Gene editing is far simpler and more efficient than older methods used to produce genetically modified organisms (GMOs). Unlike those methods, moreover, it can be used in ways that leave no foreign genes in the target organism—an advantage that proponents argue should comfort anyone leery of consuming so-called "Frankenfoods." But debate persists over what precautions must be taken before these crops come to market.
Recently, two of the world's most powerful regulatory bodies offered very different answers to that question. The United States Department of Agriculture (USDA) declared in March 2018 that it "does not currently regulate, or have any plans to regulate" plants that are developed through most existing methods of gene editing. The Court of Justice of the European Union (ECJ), by contrast, ruled in July that such crops should be governed by the same stringent regulations as conventional GMOs.
Some experts suggest that the broadly permissive American approach and the broadly restrictive EU policy are equally flawed.
Each announcement drew protests, for opposite reasons. Anti-GMO activists assailed the USDA's statement, arguing that all gene-edited crops should be tested and approved before marketing. "You don't know what those mutations or rearrangements might do in a plant," warned Michael Hansen, a senior scientist with the advocacy group Consumers Union. Biotech boosters griped that the ECJ's decision would stifle innovation and investment. "By any sensible standard, this judgment is illogical and absurd," wrote the British newspaper The Observer.
Yet some experts suggest that the broadly permissive American approach and the broadly restrictive EU policy are equally flawed. "What's behind these regulatory decisions is not science," says Jennifer Kuzma, co-director of the Genetic Engineering and Society Center at North Carolina State University, a former advisor to the World Economic Forum, who has researched and written extensively on governance issues in biotechnology. "It's politics, economics, and culture."
The U.S. Welcomes Gene-Edited Food
Humans have been modifying the genomes of plants and animals for 10,000 years, using selective breeding—a hit-or-miss method that can take decades or more to deliver rewards. In the mid-20th century, we learned to speed up the process by exposing organisms to radiation or mutagenic chemicals. But it wasn't until the 1980s that scientists began modifying plants by altering specific stretches of their DNA.
Today, about 90 percent of the corn, cotton and soybeans planted in the U.S. are GMOs; such crops cover nearly 4 million square miles (10 million square kilometers) of land in 29 countries. Most of these plants are transgenic, meaning they contain genes from an unrelated species—often as biologically alien as a virus or a fish. Their modifications are designed primarily to boost profit margins for mechanized agribusiness: allowing crops to withstand herbicides so that weeds can be controlled by mass spraying, for example, or to produce their own pesticides to lessen the need for chemical inputs.
In the early days, the majority of GM crops were created by extracting the gene for a desired trait from a donor organism, multiplying it, and attaching it to other snippets of DNA—usually from a microbe called an agrobacterium—that could help it infiltrate the cells of the target plant. Biotechnologists injected these particles into the target, hoping at least one would land in a place where it would perform its intended function; if not, they kept trying. The process was quicker than conventional breeding, but still complex, scattershot, and costly.
Because agrobacteria can cause plant tumors, Kuzma explains, policymakers in the U.S. decided to regulate GMO crops under an existing law, the Plant Pest Act of 1957, which addressed dangers like imported trees infested with invasive bugs. Every GMO containing the DNA of agrobacterium or another plant pest had to be tested to see whether it behaved like a pest, and undergo a lengthy approval process. By 2010, however, new methods had been developed for creating GMOs without agrobacteria; such plants could typically be marketed without pre-approval.
Soon after that, the first gene-edited crops began appearing. If old-school genetic engineering was a shotgun, techniques like TALEN and CRISPR were a scalpel—or the search-and-replace function on a computer program. With CRISPR/Cas9, for example, an enzyme that bacteria use to recognize and chop up hostile viruses is reprogrammed to find and snip out a desired bit of a plant or other organism's DNA. The enzyme can also be used to insert a substitute gene. If a DNA sequence is simply removed, or the new gene comes from a similar species, the changes in the target plant's genotype and phenotype (its general characteristics) may be no different from those that could be produced through selective breeding. If a foreign gene is added, the plant becomes a transgenic GMO.
Companies are already teeing up gene-edited products for the U.S. market, like a cooking oil and waxy corn.
This development, along with the emergence of non-agrobacterium GMOs, eventually prompted the USDA to propose a tiered regulatory system for all genetically engineered crops, beginning with an initial screening for potentially hazardous metaboloids or ecological impacts. (The screening was intended, in part, to guard against the "off-target effects"—stray mutations—that occasionally appear in gene-edited organisms.) If no red flags appeared, the crop would be approved; otherwise, it would be subject to further review, and possible regulation.
The plan was unveiled in January 2017, during the last week of the Obama presidency. Then, under the Trump administration, it was shelved. Although the USDA continues to promise a new set of regulations, the only hint of what they might contain has been Secretary of Agriculture Sonny Perdue's statement last March that gene-edited plants would remain unregulated if they "could otherwise have been developed through traditional breeding techniques, as long as they are not plant pests or developed using plant pests."
Because transgenic plants could not be "developed through traditional breeding techniques," this statement could be taken to mean that gene editing in which foreign DNA is introduced might actually be regulated. But because the USDA regulates conventional transgenic GMOs only if they trigger the plant-pest stipulation, experts assume gene-edited crops will face similarly limited oversight.
Meanwhile, companies are already teeing up gene-edited products for the U.S. market. An herbicide-resistant oilseed rape, developed using a proprietary technique, has been available since 2016. A cooking oil made from TALEN-tweaked soybeans, designed to have a healthier fatty-acid profile, is slated for release within the next few months. A CRISPR-edited "waxy" corn, designed with a starch profile ideal for processed foods, should be ready by 2021.
In all likelihood, none of these products will have to be tested for safety.
In the E.U., Stricter Rules Apply
Now let's look at the European Union. Since the late 1990s, explains Gregory Jaffe, director of the Project on Biotechnology at the Center for Science in the Public Interest, the EU has had a "process-based trigger" for genetically engineered products: "If you use recombinant DNA, you are going to be regulated." All foods and animal feeds must be approved and labeled if they consist of or contain more than 0.9 percent GM ingredients. (In the U.S., "disclosure" of GM ingredients is mandatory, if someone asks, but labeling is not required.) The only GM crop that can be commercially grown in EU member nations is a type of insect-resistant corn, though some countries allow imports.
European scientists helped develop gene editing, and they—along with the continent's biotech entrepreneurs—have been busy developing applications for crops. But European farmers seem more divided over the technology than their American counterparts. The main French agricultural trades union, for example, supports research into non-transgenic gene editing and its exemption from GMO regulation. But it was the country's small-farmers' union, the Confédération Paysanne, along with several allied groups, that in 2015 submitted a complaint to the ECJ, asking that all plants produced via mutagenesis—including gene-editing—be regulated as GMOs.
At this point, it should be mentioned that in the past 30 years, large population studies have found no sign that consuming GM foods is harmful to human health. GMO critics can, however, point to evidence that herbicide-resistant crops have encouraged overuse of herbicides, giving rise to poison-proof "superweeds," polluting the environment with suspected carcinogens, and inadvertently killing beneficial plants. Those allegations were key to the French plaintiffs' argument that gene-edited crops might similarly do unexpected harm. (Disclosure: Leapsmag's parent company, Bayer, recently acquired Monsanto, a maker of herbicides and herbicide-resistant seeds. Also, Leaps by Bayer, an innovation initiative of Bayer and Leapsmag's direct founder, has funded a biotech startup called JoynBio that aims to reduce the amount of nitrogen fertilizer required to grow crops.)
The ruling was "scientifically nonsensical. It's because of things like this that I'll never go back to Europe."
In the end, the EU court found in the Confédération's favor on gene editing—though the court maintained the regulatory exemption for mutagenesis induced by chemicals or radiation, citing the 'long safety record' of those methods.
The ruling was "scientifically nonsensical," fumes Rodolphe Barrangou, a French food scientist who pioneered CRISPR while working for DuPont in Wisconsin and is now a professor at NC State. "It's because of things like this that I'll never go back to Europe."
Nonetheless, the decision was consistent with longstanding EU policy on crops made with recombinant DNA. Given the difficulty and expense of getting such products through the continent's regulatory system, many other European researchers may wind up following Barrangou to America.
Getting to the Root of the Cultural Divide
What explains the divergence between the American and European approaches to GMOs—and, by extension, gene-edited crops? In part, Jennifer Kuzma speculates, it's that Europeans have a different attitude toward eating. "They're generally more tied to where their food comes from, where it's produced," she notes. They may also share a mistrust of government assurances on food safety, borne of the region's Mad Cow scandals of the 1980s and '90s. In Catholic countries, consumers may have misgivings about tinkering with the machinery of life.
But the principal factor, Kuzma argues, is that European and American agriculture are structured differently. "GM's benefits have mostly been designed for large-scale industrial farming and commodity crops," she says. That kind of farming is dominant in the U.S., but not in Europe, leading to a different balance of political power. In the EU, there was less pressure on decisionmakers to approve GMOs or exempt gene-edited crops from regulation—and more pressure to adopt a GM-resistant stance.
Such dynamics may be operating in other regions as well. In China, for example, the government has long encouraged research in GMOs; a state-owned company recently acquired Syngenta, a Swiss-based multinational corporation that is a leading developer of GM and gene-edited crops. GM animal feed and cooking oil can be freely imported. Yet commercial cultivation of most GM plants remains forbidden, out of deference to popular suspicions of genetically altered food. "As a new item, society has debates and doubts on GMO techniques, which is normal," President Xi Jinping remarked in 2014. "We must be bold in studying it, [but] be cautious promoting it."
The proper balance between boldness and caution is still being worked out all over the world. Europe's process-based approach may prevent researchers from developing crops that, with a single DNA snip, could rescue millions from starvation. EU regulations will also make it harder for small entrepreneurs to challenge Big Ag with a technology that, as Barrangou puts it, "can be used affordably, quickly, scalably, by anyone, without even a graduate degree in genetics." America's product-based approach, conversely, may let crops with hidden genetic dangers escape detection. And by refusing to investigate such risks, regulators may wind up exacerbating consumers' doubts about GM and gene-edited products, rather than allaying them.
"Science...can't tell you what to regulate. That's a values-based decision."
Perhaps the solution lies in combining both approaches, and adding some flexibility and nuance to the mix. "I don't believe in regulation by the product or the process," says CSPI's Jaffe. "I think you need both." Deleting a DNA base pair to silence a gene, for example, might be less risky than inserting a foreign gene into a plant—unless the deletion enables the production of an allergen, and the transgene comes from spinach.
Kuzma calls for the creation of "cooperative governance networks" to oversee crop genome editing, similar to bodies that already help develop and enforce industry standards in fisheries, electronics, industrial cleaning products, and (not incidentally) organic agriculture. Such a network could include farmers, scientists, advocacy groups, private companies, and governmental agencies. "Safety isn't an all-or-nothing concept," Kuzma says. "Science can tell you what some of the issues are in terms of risk and benefit, but it can't tell you what to regulate. That's a values-based decision."
By drawing together a wide range of stakeholders to make such decisions, she adds, "we're more likely to anticipate future consequences, and to develop a robust approach—one that not only seems more legitimate to people, but is actually just plain old better."
Starting this summer, the public buses in the Oberhaching suburb of Munich, Germany, won’t have to be plugged in to charge overnight anymore. Stefan Schelle, the mayor of Oberhaching, is taking advantage of the fact that an innovative startup has its offices in his community: Magment, short for “magnetizing cement,” will install its underground charging pad in the coming months. As soon as that happens, the buses will charge while they wait at the city’s main station or while stored at their overnight quarters.
In his light-filled office, Magment’s co-founder and CEO, Mauricio Esguerra, demonstrates how the new technology works: The lights on his black model car only flash when he puts the miniature Porsche directly atop the induction plate. “This works just like when you charge your iPhone on its charging pad or heat a pot on an induction range. People don’t have to be afraid of magnetic fields or anything like that,” says the 60-year-old Colombia-born entrepreneur. “The induction only gets activated when the storage battery is placed directly on top.
Patented by Esguerra, the “magnetizing concrete” is able to target the charge quite precisely. The batteries will be mounted in a box underneath the vehicles such as the retrofitted public buses. “Look, here’s one passing by,” says Esguerra, pointing out the window as a blue city bus rides past his office.
An invention finds its purpose
Esguerra grew up in Bogotá, studied physics at the Technical University Munich where he fell in love with a German woman, and started a family in her home country. For 15 years, he developed magnetic products, including the magnetizing cement, for Siemens, Europe’s largest industrial manufacturing company. The patent belonged to Siemens, of course. “But there were hardly any electric vehicles yet,” Esguerra says, “and Siemens didn’t quite know what to do with this invention.”
Esguerra changed companies a few times but, in 2015, he got an offer from Siemens. The patent for the magnetizing cement was expiring and Siemens wasn’t interested in keeping it. Would he, as the inventor, want it back? “I did not hesitate a second,” Esguerra remembers with a smile. “I’m a magnetician at heart.” That same year, he founded Magment to finally make use of the technology he created 20 years ago.
To demonstrate how his cement is made, he opens the lid of a plastic bucket filled with cement powder. Mixed in are fingernail-sized black pieces, so-called ferrites, mainly consisting of three ceramic oxides: iron, nickel and zinc. Conventionally, they are used in electronics such as cell phones, computers and cables. Molded in concrete, ferrites create a magnetic field that can transport charge to a vehicle, potentially eliminating range anxiety for EV drivers.
Molded in concrete, ferrites create a magnetic field that can transport charge to a vehicle, potentially eliminating range anxiety for EV drivers.
Magment
“Ferrites have extremely high rejection rates,” Esguerra adds. “It’s comparable to other ceramics: As soon as there is a small tear or crack, the material is rejected. We are talking about a rejection pile of 500,000 tons per year worldwide. There are mountains of unused materials.”
Exactly this fact was the starting point of his research at Siemens: “What can we do with this energy-intensive material? Back then, it was crushed up and mixed into the cement for building streets, without adding any function.” Today, too, the Magment material can simply be mixed with the conventional material and equipment of the cement industry. “We take advantage of the fact that we don’t have to build factories and don’t have high transportation costs."
In addition to saving resources, recycled ferrite also makes concrete more durable.
No plugs, no charging breaks
A young intern in the office next door winds cables around a new coil. These coils will later be lowered underground in a box, connected to the grid and encased in magnetizing concrete. The recipient box looks similar; it’s another coil but smaller, and it will be mounted underneath the carriage of the vehicle. For a car, the battery box would be 25 by 25 centimeters (about 10 inches), for a scooter five by five centimeters (about two inches).
Esguerra pushes an electric scooter into a cemented scooter rack next to his office. The charging pad is invisible. A faint beep is the only sign that it has started charging. “Childs play!” Esguerra says. “Even when someone puts in the scooter a little crooked, the charge still works. Our efficiency rate is up to 96 percent.” From this summer on, hotel chains in Munich will try out this system with their rental scooters, at a price of about 500 Euros per charging station.
Compared to plug-in charging, Magment’s benefits include smaller batteries that charge slower and, therefore, gentler, so they may last longer. Nobody needs to plug in the vehicles manually anymore. “Personally, I’ve had an EV for six years,” Esguerra says, “and how often does it happen that I forgot to plug it in overnight and then start out with a low charge in the morning? Once people get used to the invisible charging system, it will become the norm.“
There are also downsides: Most car companies aren’t ready for the new technology. Hyundai is the first carmaker that announced plans to equip some new models with inductive charging capability. “How many cars are electrified worldwide?” Esguerra asks and gives the answer himself: “One percent. And how many forklifts are electrified? More than 70 percent!” Therefore, Magment focuses on charging forklifts, e-scooters and buses.
Magment has focused most of its efforts on charging forklifts and other vehicle types that are entirely or predominantly electric, unlike cars.
Magment
On the morning of my visit to Esguerra’s office, a developer of the world’s third-biggest forklift manufacturer is there to inspect how the technology works on the ground. In the basement, a Magment engineer drives an electric forklift over a testbed with invisible charging coils, turning on the green charging light. Esguerra opens the interior of the forklift and points out the two batteries. “With our system, the forklift will only need one battery.” The savings, about 7,000 Euro per forklift, will pay for the installation of Magment’s charging system in warehouses, Esguerra calculates. “Less personnel and no unnecessary wait times for charging will lead to further savings,” he says.
To implement the new technology as efficiently as possible, Magment engineers began recording the transport routes of forklifts in warehouses. “It looks like spaghetti diagrams,” Esguerra explains. “Soon you get the areas where the forklifts pass or wait most frequently. This is where you install the chargers underground.” The forklifts will charge while in use, without having to pause for charging breaks. The method could also work for robots, for instance, in warehouses and distribution centers.
Roads of the future could be electric
Potential disadvantages might become apparent once the technology is more broadly in use. Therefore investors were initially reluctant, Esguerra admits. “Some are eager to be the first but most prefer to wait until the technology has been extensively used in real life.”
A clear hurdle today is that electrifying entire freeways with induction coils would cost at least 1 to 1.5 million Euros per kilometer. The German Department for Transportation even calculates overall costs of 14 to 47 million Euros per kilometer. So, the technology may only make sense for areas where vehicles pass or dwell the longest, like the Oberhaching train station or a busy interstate toll booth.
And yet, Magment is ramping up to compete with other companies that build larger inductive charging pads. The company just finished the first 20 meters of a testbed in Indiana, in partnership with the Purdue University and the Indiana Department of Transportation. Magment is poised to build “the world’s first contactless wireless-charging concrete pavement highway segment,” Purdue University announced.
The project, part of Purdue’s ASPIRE (Advancing Sustainability through Powered Infrastructure for Roadway Electrification) program, is financed by the National Science Foundation. “Indiana is known as the Crossroads of America, and we’re committed to fortifying our position as a transportation leader by innovating to support the emerging vehicle technology,” Governor Eric J. Holcomb said. If testing is successful, including the concrete’s capacity to charge heavy trucks operating at higher power (200 kilowatts and above), Indiana plans to identify a highway segment to install Magment’s charging pads. The earliest would be 2023 at best.
In the meantime, buses in the Californian Antelope Valley, trams at Hollywood's Universal Studios and transit buses in Tampa, Florida, are already charging with inductive technology developed by Wave, a company spun out of Utah State University. In Michigan, Governor Gretchen Whitmer announced plans to build a test route for vehicles to charge while driving, in collaboration with the Israel-based company Electreon, and this year contracted to build the first road-based charging system in the U.S. The state is providing support through an innovative grant program.
Costs remain one of the biggest obstacles, but Esguerra’s vision includes the potential that toll roads could charge a premium for inductive charging capabilities. “And in reverse, a driver who has too much energy could feed his surplus into the grid while driving,” Esguerra dreams.
Meanwhile, Wave’s upcoming big projects are moving trucks along a route in Southern California and running a UPS route between Seattle and Portland. Wave CTO Michael Masquelier describes the inductive power transfer his company champions as “similar to a tuning fork. By vibrating that fork, you sent energy through the air and it is received by another tuning fork across the room. So it’s similar to that, but it’s magnetic energy versus sound energy.”
He hopes to partner with Magment, saying that “the magnetizing cement makes installation easier and improves the energy efficiency.” More research is needed to evaluate which company’s technology will prove to be the most efficient, practical, and cost-effective.
Esguerra’s vision includes the potential that toll roads could charge a premium for inductive charging capabilities. “And in reverse, a driver who has too much energy could feed his surplus into the grid while driving,” Esguerra dreams.
The future will soon arrive in the idyllic town of Bad Staffelstein, a quaint tourist destination in the Upper Franconia region of Germany. Visitors will be taken to and from the main station and the popular thermal bath by driverless shuttles. Together with the University of Wuppertal, the regional government of Upper Franconia wants to turn its district into “the center of autonomous driving.” Magment is about to install inductive charging pads at the shuttle stations and the thermal bath, eliminating the need for the shuttles to stop for charging times. No more drivers, no cable, no range anxiety. Masquelier believes that “wireless and autonomous driving go hand in hand.” Science fiction? It will become science reality in spring 2023.
CORRECTION: An earlier version of the story erroneously mentioned that Electreon required overhead cables.
Smartwatches can track COVID-19 symptoms, study finds
If a COVID-19 infection develops, a wearable device may eventually be able to clue you in. A study at the University of Michigan found that a smartwatch can monitor how symptoms progress.
The study evaluated the effects of COVID-19 with various factors derived from heart-rate data. This method also could be employed to detect other diseases, such as influenza and the common cold, at home or when medical resources are limited, such as during a pandemic or in developing countries.
Tracking students and medical interns across the country, the University of Michigan researchers found that new signals embedded in heart rate indicated when individuals were infected with COVID-19 and how ill they became.
For instance, they discovered that individuals with COVID-19 experienced an increase in heart rate per step after the onset of their symptoms. Meanwhile, people who reported a cough as one of their COVID-19 symptoms had a much more elevated heart rate per step than those without a cough.
“We previously developed a variety of algorithms to analyze data from wearable devices. So, when the COVID-19 pandemic hit, it was only natural to apply some of these algorithms to see if we can get a better understanding of disease progression,” says Caleb Mayer, a doctoral student in mathematics at the University of Michigan and a co-first author of the study.
People may not internally sense COVID-19’s direct impact on the heart, but “heart rate is a vital sign that gives a picture of overall health," says Daniel Forger, a University of Michigan professor.
Millions of people are tracking their heart rate through wearable devices. This information is already generating a tremendous amount of data for researchers to analyze, says co-author Daniel Forger, professor of mathematics and research professor of computational medicine and bioinformatics at the University of Michigan.
“Heart rate is affected by many different physiological signals,” Forger explains. “For instance, if your lungs aren’t functioning properly, your heart may need to beat faster to meet metabolic demands. Your heart rate has a natural daily rhythm governed by internal biological clocks.” While people may not internally sense COVID-19’s direct impact on the heart, he adds that “heart rate is a vital sign that gives a picture of overall health.”
Among the total of 2,164 participants who enrolled in the student study, 72 undergraduate and graduate students contracted COVID-19, providing wearable data from 50 days before symptom onset to 14 days after. The researchers also analyzed this type of data for 43 medical interns from the Intern Health Study by the Michigan Neuroscience Institute and 29 individuals (who are not affiliated with the university) from the publicly available dataset.
Participants could wear the device on either wrist. They also documented their COVID-19 symptoms, such as fever, shortness of breath, cough, runny nose, vomiting, diarrhea, body aches, loss of taste, loss of smell, and sore throat.
Experts not involved in the study found the research to be productive. “This work is pioneering and reveals exciting new insights into the many important ways that we can derive clinically significant information about disease progression from consumer-grade wearable devices,” says Lisa A. Marsch, director of the Center for Technology and Behavioral Health and a professor in the Geisel School of Medicine at Dartmouth College. “Heart-rate data are among the highest-quality data that can be obtained via wearables.”
Beyond the heart, she adds, “Wearable devices are providing novel insights into individuals’ physiology and behavior in many health domains.” In particular, “this study beautifully illustrates how digital-health methodologies can markedly enhance our understanding of differences in individuals’ experience with disease and health.”
Previous studies had demonstrated that COVID-19 affects cardiovascular functions. Capitalizing on this knowledge, the University of Michigan endeavor took “a giant step forward,” says Gisele Oda, a researcher at the Institute of Biosciences at the University of Sao Paulo in Brazil and an expert in chronobiology—the science of biological rhythms. She commends the researchers for developing a complex algorithm that “could extract useful information beyond the established knowledge that heart rate increases and becomes more irregular in COVID patients.”
Wearable devices open the possibility of obtaining large-scale, long, continuous, and real-time heart-rate data on people performing everyday activities or while sleeping. “Importantly, the conceptual basis of this algorithm put circadian rhythms at the center stage,” Oda says, referring to the physical, mental, and behavioral changes that follow a 24-hour cycle. “What we knew before was often based on short-time heart rate measured at any time of day,” she adds, while noting that heart rate varies between day and night and also changes with activity.
However, without comparison to a control group of people having the common flu, it is difficult to determine if the heart-rate signals are unique to COVID-19 or also occur with other illnesses, says John Torous, an assistant professor of psychiatry at Harvard Medical School who has researched wearable devices. In addition, he points to recent data showing that many wearables, which work by beaming light through the skin, may be less accurate in people with darker skin due to variations in light absorption.
While the results sound interesting, they lack the level of conclusive evidence that would be needed to transform how physicians care for patients. “But it is a good step in learning more about what these wearables can tell us,” says Torous, who is also director of digital psychiatry at Beth Israel Deaconess Medical Center, a Harvard affiliate, in Boston. A follow-up step would entail replicating the results in a different pool of people to “help us realize the full value of this work.”
It is important to note that this research was conducted in university settings during the early phases of the pandemic, with remote learning in full swing amid strict isolation and quarantine mandates in effect. The findings demonstrate that physiological monitoring can be performed using consumer-grade wearable sensors, allowing research to continue without in-person contact, says Sung Won Choi, a professor of pediatrics at the University of Michigan who is principal investigator of the student study.
“The worldwide COVID-19 pandemic interrupted a lot of activities that relied on face-to-face interactions, including clinical research,” Choi says. “Mobile technology proved to be tremendously beneficial during that time, because it allowed us to collect detailed physiological data from research participants remotely over an entire semester.” In fact, the researchers did not have any in-person contact with the students involved in the study. “Everything was done virtually," Choi explains. "Importantly, their willingness to participate in research and share data during this historical time, combined with the capacity of secure cloud storage and novel mathematical analytics, enabled our research teams to identify unique patterns in heart-rate data associated with COVID-19.”