Will COVID-19 Pave the Way For Home-Based Precision Medicine?
n artist rendering of a "smart toilet" that gathers biometric data to monitor a person's health in real time.
It looks like an ordinary toilet but it is anything but. The "smart toilet" is the diagnostic tool of the future, equipped with cameras that take snapshots of the users and their waste, motion sensors to analyze what's inside the urine and stool samples, and software that automatically sends data to a secure, cloud-based system that can be easily accessed by your family doctor.
"It's a way of doing community surveillance. If there is a second wave of infections in the future, we'll know right away."
Using urine "dipstick tests" similar to the home pregnancy strips, the smart toilet can detect certain proteins, immune system biomarkers and blood cells that indicate the presence of such diseases as infections, bladder cancer, and kidney failure.
The rationale behind this invention is that some of the best ways of detecting what's going on in our bodies is by analyzing the substances we excrete every day, our sweat, urine, saliva and yes, our feces. Instead of getting sporadic snapshots from doctor's visits once or twice a year, the smart toilet provides continuous monitoring of our health 24/7, so we can catch the tell-tale molecular signature of illnesses at their earliest and most treatable stages. A brainchild of Stanford University researchers, they're now working to add a COVID-19 detection component to their suite of technologies—corona virus particles can be spotted in stool samples—and hope to have the system available within the year.
"We can connect the toilet system to cell phones so we'll know the results within 30 minutes," says Seung-min Park, a lead investigator on the research team that devised this technology and a senior research scientist at the Stanford University School of Medicine. "The beauty of this technology is that it can continuously monitor even after this pandemic is over. It's a way of doing community surveillance. If there is a second wave of infections in the future, we'll know right away."
Experts believe that the COVID-19 pandemic will accelerate the widespread acceptance of in-home diagnostic tools such as this. "Shock events" like pandemics can be catalysts for sweeping changes in society, history shows us. The Black Death marked the end of feudalism and ushered in the Renaissance while the aftershocks of the Great Depression and two world wars in the 20th century led to the social safety net of the New Deal and NATO and the European Union. COVID-19 could fundamentally alter the way we deliver healthcare, abandoning the outdated 20th century brick and mortar fee-for-service model in favor of digital medicine. At-home diagnostics may be the leading edge of this seismic shift and the pandemic could accelerate the product innovations that allow for home-based medical screening.
"That's the silver lining to this devastation," says Dr. Leslie Saxon, executive director of the USC Center for Body Computing at the Keck School of Medicine in Los Angeles. As an interventional cardiologist, Saxon has spent her career devising and refining the implantable and wearable wireless devices that are used to treat and diagnose heart conditions and prevent sudden death. "This will open up innovation—research has been stymied by a lack of imagination and marriage to an antiquated model," she adds. "There are already signs this is happening—relaxing state laws about licensure, allowing physicians to deliver health care in non-traditional ways. That's a real sea change and will completely democratize medical information and diagnostic testing."
Ironically, diagnostics have long been a step-child of modern medicine, even though accurate and timely diagnostics play a crucial role in disease prevention, detection and management. "The delivery of health care has proceeded for decades with a blind spot: diagnostic errors—inaccurate or delayed diagnoses—persist throughout all settings of care and continue to harm an unacceptable number of patients," according to a 2015 National Academy of Medicine report. That same report found as many as one out of five adverse events in the hospital result from these errors and they contribute to 10 percent of all patient deaths.
The pandemic should alter the diagnostic landscape. We already have a wealth of wearable and implantable devices, like glucose sensors to monitor blood sugar levels for diabetics, Apple's smart watch, electrocardiogram devices that can detect heart arrythmias, and heart pacemakers.
The Food and Drug Administration is working closely with in-home test developers to make accurate COVID-19 diagnostic tools readily available and has so far greenlighted three at-home collection test kits. Two, LabCorp's and Everlywell's, use nasal swabs to take samples. The third one is a spit test, using saliva samples, that was devised by a Rutgers University laboratory in partnership with Spectrum Solutions and Accurate Diagnostic Labs.
The only way to safely reopen is through large scale testing, but hospitals and doctors' offices are no longer the safest places.
In fact, DIY diagnostic company Everlywell, an Austin, Texas- based digital health company, already offers more than 30 at-home kits for everything from fertility to food sensitivity tests. Typically, consumers collect a saliva or finger-prick blood sample, dispatch it in a pre-paid shipping envelope to a laboratory, and a physician will review the results and send a report to consumers' smartphones.
Thanks to advances in technology, samples taken at home can now be preserved long enough to arrive intact at diagnostic laboratories. The key is showing the agency "transport and shipping don't change or interfere with the integrity of the samples," says Dr. Frank Ong, Everlywell's chief medical and scientific officer.
Ong is keenly aware of the importance of saturation testing because of the lessons learned by colleagues fighting the SARS pandemic in his family's native Taiwan in 2003. "In the beginning, doctors didn't know what they were dealing with and didn't protect themselves adequately," he says. "But over two years, they learned the hard way that there needs to be enough testing, contact tracing of those who have been exposed, and isolation of people who test positive. The value of at-home testing is that it can be done on the kind of broad basis that needs to happen for our country to get back to work."
Because of the pandemic, new policies have removed some of the barriers that impeded the widespread adoption of home-based diagnostics and telemedicine. Physicians can now practice across state lines, get reimbursed for telemedicine visits and use FaceTime to communicate with their patients, which had long been considered taboo because of privacy issues. Doctors and patients are becoming more comfortable and realizing the convenience and benefits of being able to do these things virtually.
Added to this, the only way to safely reopen for business without triggering a second and perhaps even more deadly wave of sickness is through large-scale testing, but hospitals and doctors' offices are no longer the safest places. "We don't want people sitting in a waiting room who later find out they're positive, and potentially infected everyone, including doctors and nurses," says Dr. Kavita Patel, a physician in Washington, DC who served as a policy director in the Obama White House.
In-home testing avoids the risks of direct exposure to the virus for both patients and health care professionals, who can dispense with cumbersome protective gear to take samples, and also enables people without reliable transportation or child-care to learn their status. "At home testing can be a critical component of our country's overall testing strategy," says Dr. Shantanu Nundy, chief medical officer at Accolade Health and on the faculty of the Milken Institute School of Public Health at George Washington University. "Once we're back at work, we need to be much more targeted, and have much more access to data and controlling those outbreaks as tightly as possible. The best way to do that is by leapfrogging clinics and being able to deliver tests at home for people who are disenfranchised by the current system."
In the not-too-distant future, in-home diagnostics could be a key component of precision medicine, which is customized care tailored specifically to each patient's individual needs. Like Stanford's smart toilet prototype, these ongoing surveillance tools will gather health data, ranging from exposures to toxins and pollutions in the environment to biochemical activity, like rising blood pressure, signs of inflammation, failing kidneys or tiny cancerous tumors, and provide continuous real-time information.
"These can be deeply personalized and enabled by smart phones, sensors and artificial intelligence," says USC's Leslie Saxon. "We'll be seeing the floodgates opening to patients accessing medical services through the same devices that they access other things, and leveraging these tools for our health and to fine tune disease management in a model of care that is digitally enabled."
[Editor's Note: This article was originally published on June 8th, 2020 as part of a standalone magazine called GOOD10: The Pandemic Issue. Produced as a partnership among LeapsMag, The Aspen Institute, and GOOD, the magazine is available for free online.]
Are the gains from gain-of-function research worth the risks?
Gain-of-function research can make pathogens more infectious and deadly. It also enables scientists to prepare remedies in advance.
Scientists have long argued that gain-of-function research, which can make viruses and other infectious agents more contagious or more deadly, was necessary to develop therapies and vaccines to counter the pathogens in case they were used for biological warfare. As the SARS-CoV-2 origins are being investigated, one prominent theory suggests it had leaked from a biolab that conducted gain-of-function research, causing a global pandemic that claimed nearly 6.9 million lives. Now some question the wisdom of engaging in this type of research, stating that the risks may far outweigh the benefits.
“Gain-of-function research means genetically changing a genome in a way that might enhance the biological function of its genes, such as its transmissibility or the range of hosts it can infect,” says George Church, professor of genetics at Harvard Medical School. This can occur through direct genetic manipulation as well as by encouraging mutations while growing successive generations of micro-organism in culture. “Some of these changes may impact pathogenesis in a way that is hard to anticipate in advance,” Church says.
In the wake of the global pandemic, the pros and cons of gain-of-function research are being fiercely debated. Some scientists say this type of research is vital for preventing future pandemics or for preparing for bioweapon attacks. Others consider it another disaster waiting to happen. The Government Accounting Office issued a report charging that a framework developed by the U.S. Department of Health & Human Services (HHS) provided inadequate oversight of this potentially deadly research. There’s a movement to stop it altogether. In January, the Viral Gain-of-Function Research Moratorium Act (S. 81) was introduced into the Senate to cease awarding federal research funding to institutions doing gain-of-function studies.
While testifying before the House COVID Origins Select Committee on March 8th, Robert Redfield, former director of the U.S. Centers for Disease Control and Prevention, said that COVID-19 may have resulted from an accidental lab leak involving gain-of-function research. Redfield said his conclusion is based upon the “rapid and high infectivity for human-to-human transmission, which then predicts the rapid evolution of new variants.”
“It is a very, very, very small subset of life science research that could potentially generate a potential pandemic pathogen,” said Gerald Parker, associate dean for Global One Health at Texas A&M University.
“In my opinion,” Redfield continues, “the COVID-19 pandemic presents a case study on the potential dangers of such research. While many believe that gain-of-function research is critical to get ahead of viruses by developing vaccines, in this case, I believe that was the exact opposite.” Consequently, Redfield called for a moratorium on gain-of-function research until there is consensus about the value of such risky science.
What constitutes risky?
The Federal Select Agent Program lists 68 specific infectious agents as risky because they are either very contagious or very deadly. In order to work with these 68 agents, scientists must register with the federal government. Meanwhile, research on deadly pathogens that aren’t easily transmitted, or pathogens that are quite contagious but not deadly, can be conducted without such oversight. “If you’re not working with select agents, you’re not required to register the research with the federal government,” says Gerald Parker, associate dean for Global One Health at Texas A&M University. But the 68-item list may not have everything that could possibly become dangerous or be engineered to be dangerous, thus escaping the government’s scrutiny—an issue that new regulations aim to address.
In January 2017, the White House Office of Science and Technology Policy (OSTP) issued additional guidance. It required federal departments and agencies to follow a series of steps when reviewing proposed research that could create, transfer, or use potential pandemic pathogens resulting from the enhancement of a pathogen’s transmissibility or virulence in humans.
In defining risky pathogens, OSTP included viruses that were likely to be highly transmissible and highly virulent, and thus very deadly. The Proposed Biosecurity Oversight Framework for the Future of Science, outlined in 2023, broadened the scope to require federal review of research “that is reasonably anticipated to enhance the transmissibility and/or virulence of any pathogen” likely to pose a threat to public health, health systems or national security. Those types of experiments also include the pathogens’ ability to evade vaccines or therapeutics, or diagnostic detection.
However, Parker says that dangers of generating a pandemic-level germ are tiny. “It is a very, very, very small subset of life science research that could potentially generate a potential pandemic pathogen.” Since gain-of-function guidelines were first issued in 2017, only three such research projects have met those requirements for HHS review. They aimed to study influenza and bird flu. Only two of those projects were funded, according to the NIH Office of Science Policy. For context, NIH funded approximately 11,000 of the 54,000 grant applications it received in 2022.
Guidelines governing gain-of-function research are being strengthened, but Church points out they aren’t ideal yet. “They need to be much clearer about penalties and avoiding positive uses before they would be enforceable.”
What do we gain from gain-of-function research?
The most commonly cited reason to conduct gain-of-function research is for biodefense—the government’s ability to deal with organisms that may pose threats to public health.
In the era of mRNA vaccines, the advance preparedness argument may be even less relevant.
“The need to work with potentially dangerous viruses is central to our preparedness,” Parker says. “It’s essential that we know and understand the basic biology, microbiology, etc. of some of these dangerous pathogens.” That includes increasing our knowledge of the molecular mechanisms by which a virus could become a sustained threat to humans. “Knowing that could help us detect [risks] earlier,” Parker says—and could make it possible to have medical countermeasures, like vaccines and therapeutics, ready.
Most vaccines, however, aren’t affected by this type of research. Essentially, scientists hope they will never need to use it. Moreover, Paul Mango, HSS former deputy chief of staff for policy, and author of the 2022 book Warp Speed, says he believes that in the era of mRNA vaccines, the advance preparedness argument may be even less relevant. “That’s because these vaccines can be developed and produced in less than 12 months, unlike traditional vaccines that require years of development,” he says.
Can better oversight guarantee safety?
Another situation, which Parker calls unnecessarily dangerous, is when regulatory bodies cannot verify that the appropriate biosafety and biosecurity controls are in place.
Gain-of-function studies, Parker points out, are conducted at the basic research level, and they’re performed in high-containment labs. “As long as all the processes, procedures and protocols are followed and there’s appropriate oversight at the institutional and scientific level, it can be conducted safely.”
Globally, there are 69 Biosafety Level 4 (BSL4) labs operating, under construction or being planned, according to recent research from King’s College London and George Mason University for Global BioLabs. Eleven of these 18 high-containment facilities that are planned or under construction are in Asia. Overall, three-quarters of the BSL4 labs are in cities, increasing public health risks if leaks occur.
Researchers say they are confident in the oversight system for BSL4 labs within the U.S. They are less confident in international labs. Global BioLabs’ report concurs. It gives the highest scores for biosafety to industrialized nations, led by France, Australia, Canada, the U.S. and Japan, and the lowest scores to Saudi Arabia, India and some developing African nations. Scores for biosecurity followed similar patterns.
“There are no harmonized international biosafety and biosecurity standards,” Parker notes. That issue has been discussed for at least a decade. Now, in the wake of SARS and the COVID-19 pandemic, scientists and regulators are likely to push for unified oversight standards. “It’s time we got serious about international harmonization of biosafety and biosecurity standards and guidelines,” Parker says. New guidelines are being worked on. The National Science Advisory Board for Biosecurity (NSABB) outlined its proposed recommendations in the document titled Proposed Biosecurity Oversight Framework for the Future of Science.
The debates about whether gain-of-function research is useful or poses unnecessary risks to humanity are likely to rage on for a while. The public too has a voice in this debate and should weigh in by communicating with their representatives in government, or by partaking in educational forums or initiatives offered by universities and other institutions. In the meantime, scientists should focus on improving the research regulations, Parker notes. “We need to continue to look for lessons learned and for gaps in our oversight system,” he says. “That’s what we need to do right now.”
The rise of remote work is a win-win for people with disabilities and employers
Disability advocates see remote work as a silver lining of the pandemic, a win-win for adults with disabilities and the business world alike.
Any corporate leader would jump at the opportunity to increase their talent pool of potential employees by 15 percent, with all these new hires belonging to an underrepresented minority. That’s especially true given tight labor markets and CEO desires to increase headcount. Yet, too few leaders realize that people with disabilities are the largest minority group in this country, numbering 50 million.
Some executives may dread the extra investments in accommodating people’s disabilities. Yet, providing full-time remote work could suffice, according to a new study by the Economic Innovation Group think tank. The authors found that the employment rate for people with disabilities did not simply reach the pre-pandemic level by mid-2022, but far surpassed it, to the highest rate in over a decade. “Remote work and a strong labor market are helping [individuals with disabilities] find work,” said Adam Ozimek, who led the research and is chief economist at the Economic Innovation Group.
Disability advocates see this development as a silver lining of the pandemic, a win-win for adults with disabilities and the business world alike. For decades before the pandemic, employers had refused requests from workers with disabilities to work remotely, according to Thomas Foley, executive director of the National Disability Institute. During the pandemic, "we all realized that...many of us could work remotely,” Foley says. “[T]hat was disproportionately positive for people with disabilities."
Charles-Edouard Catherine, director of corporate and government relations for the National Organization on Disability, said that remote-work options had been advocated for many years to accommodate disabilities. “It’s a little frustrating that for decades corporate America was saying it’s too complicated, we’ll lose productivity, and now suddenly it’s like, sure, let’s do it.”
The pandemic opened doors for people with disabilities
Early in the pandemic, employment rates dropped for everyone, including people with disabilities, according to Ozimek’s research. However, these rates recovered quickly. In the second quarter of 2022, people with disabilities aged 25 to 54, the prime working age, are 3.5 percent more likely to be employed, compared to before the pandemic.
What about people without disabilites? They are still 1.1 percent less likely to be employed.
These numbers suggest that remote work has enabled a substantial number of people with disabilities to find and retain employment.
“We have a last-in, first-out labor market, and [people with disabilities] are often among the last in and the first out,” Ozimek says. However, this dynamic has changed, with adults with disabilities seeing employment rates recover much faster. Now, the question is whether the new trend will endure, Ozimek adds. “And my conclusion is that not only is it a permanent thing, but it’s going to improve.”
Gene Boes, president and chief executive of the Northwest Center, a Seattle organization that helps people with disabilities become more independent, confirms this finding. “The new world we live in has opened the door a little bit more…because there’s just more demand for labor.”
Long COVID disabilities put a premium on remote work
Remote work can help mitigate the impact of long COVID. The U.S. Centers for Disease Control and Prevention reports that about 19 percent of those who had COVID developed long COVID. Recent Census Bureau data indicates that 16 million working age Americans suffer from it, with economic costs estimated at $3.7 trillion.
Certainly, many of these so-called long-haulers experience relatively mild symptoms - such as loss of smell - which, while troublesome, are not disabling. But other symptoms are serious enough to be disabilities.
According to a recent study from the Federal Reserve Bank of Minneapolis, about a quarter of those with long COVID changed their employment status or working hours. That means long COVID was serious enough to interfere with work for 4 million people. For many, the issue was serious enough to qualify them as disabled.
Indeed, the Federal Reserve Bank of New York found in a just-released study that the number of individuals with disabilities in the U.S. grew by 1.7 million. That growth stemmed mainly from long COVID conditions such as fatigue and brain fog, meaning difficulties with concentration or memory, with 1.3 million people reporting an increase in brain fog since mid-2020.
Many had to drop out of the labor force due to long COVID. Yet, about 900,000 people who are newly disabled have managed to continue working. Without remote work, they might have lost these jobs.
For example, a software engineer at one of my client companies has struggled with brain fog related to long COVID. With remote work, this employee can work during the hours when she feels most mentally alert and focused, even if that means short bursts of productivity throughout the day. With flexible scheduling, she can take rests, meditate, or engage in activities that help her regain focus and energy. Without the need to commute to the office, she can save energy and time and reduce stress, which is crucial when dealing with brain fog.
In fact, the author of the Federal Reserve Bank of New York study notes that long COVID can be considered a disability under the Americans with Disability Act, depending on the specifics of the condition. That means the law can require private employers with fifteen or more staff, as well as government agencies, to make reasonable accommodations for those with long COVID. Richard Deitz, the author of this study, writes in the paper that “telework and flexible scheduling are two accommodations that can be particularly beneficial for workers dealing with fatigue and brain fog.”
The current drive to return to the office, led by many C-suite executives, may need to be reconsidered in light of legal and HR considerations. Arlene S. Kanter, director of the disability law and policy program at the Syracuse University College of Law, said that the question should depend on whether people with disabilities can perform their work well at home, as they did during Covid outbreaks. “[T]hen people with disabilities, as a matter of accommodation, shouldn’t be denied that right,” Kanter said.
Diversity benefits
But companies shouldn’t need to worry about legal regulations. It simply makes dollars and sense to expand their talent pool by 15% of an underrepresented minority. After all, extensive research shows that improving diversity boosts both decision-making and financial performance.
Companies that are offering more flexible work options have already gained significant benefits in terms of diverse hires. In its efforts to adapt to the post-pandemic environment, Meta, the owner of Facebook and Instagram, decided to offer permanent fully remote work options to its entire workforce. And according to Meta chief diversity officer Maxine Williams, the candidates who accepted job offers for remote positions were “substantially more likely” to come from diverse communities: people with disabilities, Black, Hispanic, Alaskan Native, Native American, veterans, and women. The numbers bear out these claims: people with disabilities increased from 4.7 to 6.2 percent of Meta’s employees.
Having consulted for 21 companies to help them transition to hybrid work arrangements, I can confirm that Meta’s numbers aren’t a fluke. The more my clients proved willing to offer remote work, the more staff with disabilities they recruited - and retained. That includes employees with mobility challenges. But it also includes employees with less visible disabilities, such as people with long COVID and immunocompromised people who feel reluctant to put themselves at risk of getting COVID by coming into the office.
Unfortunately, many leaders fail to see the benefits of remote work for underrepresented groups, such as those with disabilities. Some even say the opposite is true, with JP Morgan CEO Jamie Dimon claiming that returning to the office will aid diversity.
What explains this poor executive decision making? Part of the answer comes from a mental blindspot called the in-group bias. Our minds tend to favor and pay attention to the concerns of those in the group of people who seem to look and think like us. Dimon and other executives without disabilities don’t perceive people with disabilities to be part of their in-group. They thus are blind to the concerns of those with disabilities, which leads to misperceptions such as Dimon’s that returning to the office will aid diversity.
In-group bias is one of many dangerous judgment errors known as cognitive biases. They impact decision making in all life areas, ranging from the future of work to relationships.
Another relevant cognitive bias is the empathy gap. This term refers to our difficulty empathizing with those outside of our in-group. The lack of empathy combines with the blindness from the in-group bias, causing executives to ignore the feelings of employees with disabilities and prospective hires.
Omission bias also plays a role. This dangerous judgment error causes us to perceive failure to act as less problematic than acting. Consequently, executives perceive a failure to support the needs of those with disabilities as a minor matter.
Conclusion
The failure to empower people with disabilities through remote work options will prove costly to the bottom lines of companies. Not only are limiting their talent pool by 15 percent, they’re harming their ability to recruit and retain diverse candidates. And as their lawyers and HR departments will tell them, by violating the ADA, they are putting themselves in legal jeopardy.
By contrast, companies like Meta - and my clients - that offer remote work opportunities are seizing a competitive advantage by recruiting these underrepresented candidates. They’re lowering costs of labor while increasing diversity. The future belongs to the savvy companies that offer the flexibility that people with disabilities need.