Overall, AI's implementation in everyday clinical care is less common than hype over the technology would suggest. Yet the coronavirus crisis has inspired some hospital systems to accelerate promising applications.
This article was first published on Friday, May 22, 2020 in Kaiser Health News.
Dr. Albert Hsiao and his colleagues at the University of California-San Diego health system had been working for 18 months on an artificial intelligence program designed to help doctors identify pneumonia on a chest X-ray. When the coronavirus hit the United States, they decided to see what it could do.
The researchers quickly deployed the application, which dots X-ray images with spots of color where there may be lung damage or other signs of pneumonia. It has now been applied to more than 6,000 chest X-rays, and it’s providing some value in diagnosis, said Hsiao, the director of UCSD’s augmented imaging and artificial intelligence data analytics laboratory.
His team is one of several around the country that has pushed AI programs developed in a calmer time into the COVID-19 crisis to perform tasks like deciding which patients face the greatest risk of complications and which can be safely channeled into lower-intensity care.
The machine-learning programs scroll through millions of pieces of data to detect patterns that may be hard for clinicians to discern. Yet few of the algorithms have been rigorously tested against standard procedures. So while they often appear helpful, rolling out the programs in the midst of a pandemic could be confusing to doctors or even dangerous for patients, some AI experts warn.
“AI is being used for things that are questionable right now,” said Dr. Eric Topol, director of the Scripps Research Translational Institute and author of several books on health IT.
Topol singled out a system created by Epic, a major vendor of electronic health records software, that predicts which coronavirus patients may become critically ill. Using the tool before it has been validated is “pandemic exceptionalism,” he said.
Epic said the company’s model had been validated with data from more 16,000 hospitalized COVID-19 patients in 21 health care organizations. No research on the tool has been published, but, in any case, it was “developed to help clinicians make treatment decisions and is not a substitute for their judgment,” said James Hickman, a software developer on Epic’s cognitive computing team.
Others see the COVID-19 crisis as an opportunity to learn about the value of AI tools.
“My intuition is it’s a little bit of the good, bad and ugly,” said Eric Perakslis, a data science fellow at Duke University and former chief information officer at the Food and Drug Administration. “Research in this setting is important.”
Nearly $2 billion poured into companies touting advancements in health care AI in 2019. Investments in the first quarter of 2020 totaled $635 million, up from $155 million in the first quarter of 2019, according to digital health technology funder Rock Health.
At least three health care AI technology companies have made funding deals specific to the COVID-19 crisis, including Vida Diagnostics, an AI-powered lung-imaging analysis company, according to Rock Health.
Overall, AI’s implementation in everyday clinical care is less common than hype over the technology would suggest. Yet the coronavirus crisis has inspired some hospital systems to accelerate promising applications.
UCSD sped up its AI imaging project, rolling it out in only two weeks.
Hsiao’s project, with research funding from Amazon Web Services, the University of California and the National Science Foundation, runs every chest X-ray taken at its hospital through an AI algorithm. While no data on the implementation has been published yet, doctors report that the tool influences their clinical decision-making about a third of the time, said Dr. Christopher Longhurst, UC San Diego Health’s chief information officer.
“The results to date are very encouraging, and we’re not seeing any unintended consequences,” he said. “Anecdotally, we’re feeling like it’s helpful, not hurtful.”
AI has advanced further in imaging than other areas of clinical medicine because radiological images have tons of data for algorithms to process, and more data makes the programs more effective, said Longhurst.
But while AI specialists have tried to get AI to do things like predict sepsis and acute respiratory distress — researchers at Johns Hopkins University recently won a National Science Foundation grant to use it to predict heart damage in COVID-19 patients — it has been easier to plug it into less risky areas such as hospital logistics.
In New York City, two major hospital systems are using AI-enabled algorithms to help them decide when and how patients should move into another phase of care or be sent home.
At Mount Sinai Health System, an artificial intelligence algorithm pinpoints which patients might be ready to be discharged from the hospital within 72 hours, said Robbie Freeman, vice president of clinical innovation at Mount Sinai.
Freeman described the AI’s suggestion as a “conversation starter,” meant to help assist clinicians working on patient cases decide what to do. AI isn’t making the decisions.
NYU Langone Health has developed a similar AI model. It predicts whether a COVID-19 patient entering the hospital will suffer adverse events within the next four days, said Dr. Yindalon Aphinyanaphongs, who leads NYU Langone’s predictive analytics team.
The model will be run in a four- to six-week trial with patients randomized into two groups: one whose doctors will receive the alerts, and another whose doctors will not. The algorithm should help doctors generate a list of things that may predict whether patients are at risk for complications after they’re admitted to the hospital, Aphinyanaphongs said.
Some health systems are leery of rolling out a technology that requires clinical validation in the middle of a pandemic. Others say they didn’t need AI to deal with the coronavirus.
Stanford Health Care is not using AI to manage hospitalized patients with COVID-19, said Ron Li, the center’s medical informatics director for AI clinical integration. The San Francisco Bay Area hasn’t seen the expected surge of patients who would have provided the mass of data needed to make sure AI works on a population, he said.
Outside the hospital, AI-enabled risk factor modeling is being used to help health systems track patients who aren’t infected with the coronavirus but might be susceptible to complications if they contract COVID-19.
At Scripps Health in San Diego, clinicians are stratifying patients to assess their risk of getting COVID-19 and experiencing severe symptoms using a risk-scoring model that considers factors like age, chronic conditions and recent hospital visits. When a patient scores 7 or higher, a triage nurse reaches out with information about the coronavirus and may schedule an appointment.
Though emergencies provide unique opportunities to try out advanced tools, it’s essential for health systems to ensure doctors are comfortable with them, and to use the tools cautiously, with extensive testing and validation, Topol said.
“When people are in the heat of battle and overstretched, it would be great to have an algorithm to support them,” he said. “We just have to make sure the algorithm and the AI tool isn’t misleading, because lives are at stake here.”
Vanderbilt University Medical Center conducted much of the COVID-19 testing in Tennessee during the early days through several designated outpatient clinics in Davidson and Williamson Counties, sometimes testing as many as 750 people a day.
This article was first published on Friday, May 22, 2020 in Kaiser Health News.
Hospitals around the country are afraid to send out hundreds of thousands of bills related to COVID-19 testing. That’s because Congress mandated there would be no copays and no out-of-pocket costs for patients. But many employers with self-funded health plans seem to believe they’re exempt from the rules.
When testing kits were still scarce, Vanderbilt University Medical Center in Nashville, Tennessee, fired up its clinical labs. It almost single-handedly took over testing in much of Tennessee. Other health systems didn’t even try to compete, although the tests were supposed to be covered by insurance.
In late March, Congress passed two laws, the Families First Coronavirus Response Act and the CARES Act, that essentially stated that not only does testing have to be covered, but patients shouldn’t have to pay a dime. Yet VUMC has found that’s frequently not the case.
“As many as half of those patients potentially have some out-of-pocket [cost], either for the tests or for companion services with the test,” VUMC Chief Financial Officer Cecelia Moore said.
VUMC is holding back bills for these patients, Moore said, rather than face a backlash of anger at surprise billing during the pandemic.
The issue comes down to an interpretation of whether the new federal legislation applies to health plans offered by larger employers. Those companies, which usually have at least a few hundred employees, often use their own money to pay claims as a way to drive down costs. A survey by the Kaiser Family Foundation finds a majority of Americans with health coverage are in this type of plan. (Kaiser Health News is an editorially independent program of the foundation.)
So BlueCross BlueShield of Tennessee may be on an employee’s insurance card, but the insurer is just managing the payments. The employer’s money pays the claims; these plans are often called self-funded or self-insured, and it may not be clear to employees that they are in such a plan.
According to multiple sources, many of the companies with those plans are operating as if they’re exempt from the new federal rules.
“In this case, it appears that the law may have left self-insured employers out of certain elements,” said Mike Thompson, CEO of the National Alliance of Healthcare Purchaser Coalitions.
The National Alliance represents employers with self-funded health plans. He said some are not waiving copays and other bills. Most are, he said, though sometimes only bills for the COVID-19 test itself and not for the doctor’s visit or the test to rule out the flu.
“Many of them have opted to cover on a first-dollar basis, but in different ways. They may or may not have included the related treatment elements,” Thompson said. He acknowledges the distinction would be lost on patients. “I get why it’s causing confusion.”
Other associations representing employer-funded health plans, including the Business Group on Health, said their members are generally following the spirit of the law.
Health policy experts don’t see any room for interpretation.
“It doesn’t matter if it’s a self-funded plan or a fully insured plan, if you get it from a small employer or a large employer, if you buy it on your own in the marketplace,” said Karen Pollitz, a senior fellow with KFF. “All private insurance has to cover 100% of the cost of COVID-19 testing.”
Pollitz said she is miffed that employers are trying to argue otherwise.
Still, it’s happening, and not only in Tennessee.
Duke Health in North Carolina confirms it’s not billing claims related to COVID testing or treatment, citing a lack of clarity in what the patient is responsible for paying. In California, UCSF Medical Center is also holding off on billing, and UCLA Medical Center is pressing health plans to pay their part.
“UCLA Health does not bill COVID-19 patients for testing even if their health plan erroneously does not pay,” spokesperson Enrique Rivero said in a written statement. “Our practice is to notify insurers of their error and request that they reprocess claims consistent with CARES Act guidelines.”
NYU Langone Health and Cleveland Clinic said they won’t bill patients any cost sharing for testing, even if that means they have to bear the cost.
The issue extends beyond academic medical centers. Envision Health, a Nashville-based firm that staffs and operates hundreds of emergency rooms around the country, is holding back 200,000 bills related to COVID-19 testing because of confusion about coverage of cost sharing.
So, many would-be surprise medical bills are still waiting to be sent out. At Vanderbilt alone, the medical center has held back more than $6 million in billing since mid-March.
“I know I’m supposed to be shaking everybody down, but we’re not right now,” said Heather Dunn, VUMC’s vice president of revenue cycle services.
Given the growing disdain for surprise medical bills, she expects a backlash from vulnerable patients.
“My greatest fear is [for] patients who are already suffering from the COVID virus or issues after or have lost their job. I’m hesitant to also say, ‘Your insurance company has passed along this $50 copay,’” she said.
Sometimes, the patient is also left with a large deductible to pay, in the hundreds of dollars.
Dunn said that she can’t delay billing forever and that just because the tests are supposed to be free to patients doesn’t mean they have no cost.
This story is part of a partnership that includes WPLN, NPR and Kaiser Health News.
Dr. Albert Hsiao and his colleagues at the University of California-San Diego health system had been working for 18 months on an artificial intelligence program designed to help doctors identify pneumonia on a chest X-ray. When the coronavirus hit the United States, they decided to see what it could do.
The researchers quickly deployed the application, which dots X-ray images with spots of color where there may be lung damage or other signs of pneumonia. It has now been applied to more than 6,000 chest X-rays, and it's providing some value in diagnosis, said Hsiao, the director of UCSD's augmented imaging and artificial intelligence data analytics laboratory.
His team is one of several around the country that has pushed AI programs developed in a calmer time into the COVID-19 crisis to perform tasks like deciding which patients face the greatest risk of complications and which can be safely channeled into lower-intensity care.
The machine-learning programs scroll through millions of pieces of data to detect patterns that may be hard for clinicians to discern. Yet few of the algorithms have been rigorously tested against standard procedures. So while they often appear helpful, rolling out the programs in the midst of a pandemic could be confusing to doctors or even dangerous for patients, some AI experts warn.
"AI is being used for things that are questionable right now," said Dr. Eric Topol, director of the Scripps Research Translational Institute and author of several books on health IT.
Topol singled out a system created by Epic, a major vendor of electronic health records software, that predicts which coronavirus patients may become critically ill. Using the tool before it has been validated is "pandemic exceptionalism," he said.
Epic said the company's model had been validated with data from more 16,000 hospitalized COVID-19 patients in 21 health care organizations. No research on the tool has been published, but, in any case, it was "developed to help clinicians make treatment decisions and is not a substitute for their judgment," said James Hickman, a software developer on Epic's cognitive computing team.
Others see the COVID-19 crisis as an opportunity to learn about the value of AI tools.
"My intuition is it's a little bit of the good, bad and ugly," said Eric Perakslis, a data science fellow at Duke University and former chief information officer at the Food and Drug Administration. "Research in this setting is important."
Nearly $2 billion poured into companies touting advancements in health care AI in 2019. Investments in the first quarter of 2020 totaled $635 million, up from $155 million in the first quarter of 2019, according to digital health technology funder Rock Health.
At least three health care AI technology companies have made funding deals specific to the COVID-19 crisis, including Vida Diagnostics, an AI-powered lung-imaging analysis company, according to Rock Health.
Overall, AI's implementation in everyday clinical care is less common than hype over the technology would suggest. Yet the coronavirus crisis has inspired some hospital systems to accelerate promising applications.
UCSD sped up its AI imaging project, rolling it out in only two weeks.
Hsiao's project, with research funding from Amazon Web Services, the University of California and the National Science Foundation, runs every chest X-ray taken at its hospital through an AI algorithm. While no data on the implementation has been published yet, doctors report that the tool influences their clinical decision-making about a third of the time, said Dr. Christopher Longhurst, UC San Diego Health's chief information officer.
"The results to date are very encouraging, and we're not seeing any unintended consequences," he said. "Anecdotally, we're feeling like it's helpful, not hurtful."
AI has advanced further in imaging than other areas of clinical medicine because radiological images have tons of data for algorithms to process, and more data makes the programs more effective, said Longhurst.
But while AI specialists have tried to get AI to do things like predict sepsis and acute respiratory distress — researchers at Johns Hopkins University recently won a National Science Foundation grantto use it to predict heart damage in COVID-19 patients — it has been easier to plug it into less risky areas such as hospital logistics.
In New York City, two major hospital systems are using AI-enabled algorithms to help them decide when and how patients should move into another phase of care or be sent home.
At Mount Sinai Health System, an artificial intelligence algorithm pinpoints which patients might be ready to be discharged from the hospital within 72 hours, said Robbie Freeman, vice president of clinical innovation at Mount Sinai.
Freeman described the AI's suggestion as a "conversation starter," meant to help assist clinicians working on patient cases decide what to do. AI isn't making the decisions.
NYU Langone Health has developed a similar AI model. It predicts whether a COVID-19 patient entering the hospital will suffer adverse events within the next four days, said Dr. Yindalon Aphinyanaphongs, who leads NYU Langone's predictive analytics team.
The model will be run in a four- to six-week trial with patients randomized into two groups: one whose doctors will receive the alerts, and another whose doctors will not. The algorithm should help doctors generate a list of things that may predict whether patients are at risk for complications after they're admitted to the hospital, Aphinyanaphongs said.
Some health systems are leery of rolling out a technology that requires clinical validation in the middle of a pandemic. Others say they didn't need AI to deal with the coronavirus.
Stanford Health Care is not using AI to manage hospitalized patients with COVID-19, said Ron Li, the center's medical informatics director for AI clinical integration. The San Francisco Bay Area hasn't seen the expected surge of patients who would have provided the mass of data needed to make sure AI works on a population, he said.
Outside the hospital, AI-enabled risk factor modeling is being used to help health systems track patients who aren't infected with the coronavirus but might be susceptible to complications if they contract COVID-19.
At Scripps Health in San Diego, clinicians are stratifying patients to assess their risk of getting COVID-19 and experiencing severe symptoms using a risk-scoring model that considers factors like age, chronic conditions and recent hospital visits. When a patient scores 7 or higher, a triage nurse reaches out with information about the coronavirus and may schedule an appointment.
Though emergencies provide unique opportunities to try out advanced tools, it's essential for health systems to ensure doctors are comfortable with them, and to use the tools cautiously, with extensive testing and validation, Topol said.
"When people are in the heat of battle and overstretched, it would be great to have an algorithm to support them," he said. "We just have to make sure the algorithm and the AI tool isn't misleading, because lives are at stake here."
If there is a silver lining to the flawed U.S. response to the coronavirus pandemic, it is this: The relatively high number of new cases being diagnosed daily — upward of 20,000 — will make it easier to test new vaccines.
To determine whether a vaccine prevents disease, the study's subjects need to be exposed to the pathogen as it circulates in the population. Reopening the economy will likely result in the faster spread of the coronavirus and therefore more opportunities to test a vaccine's efficacy in trial subjects.
Under a proposal under discussion by a committee set up by the National Institutes of Health, each of four or five experimental vaccines would be tested on about 20,000 trial participants with a placebo group of 10,000 for each vaccine. Some 50 U.S. medical centers — and perhaps an equal number overseas — would participate in these trials.
On Monday, Moderna, the biotech company, reported promising results in the first eight of 45 people enrolled in an initial test of the safety and immune responses to its vaccine. Analysts attributed a 900-point jump in the Dow that day at least partly to this very preliminary data, so eager are investors for any signs of progress in efforts to control the pandemic.
Moderna is running animal and human studies simultaneously and plans to invest hundreds of millions of dollars to build laboratories where the vaccine will be produced even before it's approved. The Food and Drug Administration on May 12 promised an accelerated review of Moderna's vaccine, which works by injecting pieces of synthetic viral RNA into the body to stimulate an immune response to the virus.
The speed in developing vaccines for widespread testing this summer is impressive, certainly compared with the nation's inadequate, delayed response to providing coronavirus testing and personal protective equipment to health care providers.
Still, many scientists have expressed skepticism at the breakneck timetable put forward by some Trump administration officials, who say that 100 million doses of a vaccine could be available by November. Even the normally sober Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, tolda Senate committee on May 12 that a vaccine could have proven safety and efficacy by then.
Running a trial of the size and speed contemplated by the NIH will be an immense undertaking. Just setting up trial locations and getting common consent and data-entry forms into shape usually take months. Enrolling 30,000 people for a single vaccine trial is a big challenge.
In addition, defining success in a vaccine against COVID-19 will be no simple matter. As scientists design vaccine trials, they first have to set the "endpoints" that determine success or failure. Death? Length of illness? Hospitalization? Number of days in which a subject is infectious?
If there is little virus circulating where a trial is being run, even a vast study won't prove anything. On the other hand, if a vaccine trial had started in early April in New York City, where roughly 10,000 cases a day were reported for weeks, 30,000 participants would have been plenty to show whether the vaccine protected against the disease.
In all likelihood, the big NIH trials will focus on rates of infection as well as clinical symptoms such as fever and cough. To discover whether the vaccine prevents severe disease, which is relatively rare, is harder. COVID-19, according to one account, kills about 0.6% of those it infects, while perhaps six times that many require hospitalization.
People who take part in a trial will be given clear instructions to protect themselves against infection through social distancing, face masks, frequent hand-washing and so on. That will lower the number of people infected during the study.
"You'd have to ask all the people enrolled in a trial to practice good hygiene," said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia. "You don't want them to get infected — but you do."
When Jonas Salk announced the successful trial of his polio vaccine in 1955, the nation celebrated a vaccine that could virtually eliminate a deadly infectious disease overnight. A new coronavirus vaccine may not provide that kind of overnight success. Instead, it may be more akin to the flu vaccine, which reduces the risk or severity of the illness but requires a new shot each year.
Vaccinating 20,000 people in a trial can reveal whether a vaccine is clearly dangerous to a general population. But when 200 million receive the same vaccine, less common side effects could still affect thousands. Botched batches of polio vaccines released after Salk's trial permanently paralyzed 200 people and killed 10. Early vaccines against measles caused tens of thousands of cases of grave illness in the 1960s.
Maurice Hilleman, the vaccine pioneer who developed successful vaccines against measles, mumps, hepatitis A and B and other diseases, once said he never breathed a sigh of relief "until the first 3 million doses" had been delivered.
Unexpected problems naturally bedevil quick rollouts, as this one will almost certainly be as the nation searches for a way to check a pandemic that is killing tens of thousands of Americans and paralyzing the economy. But as Gregory Poland, the leader of Mayo Clinic's vaccine research, told me, "There is an irresolvable tension of speed versus safety."
Allen is the San Francisco editor for California Healthline, produced by Kaiser Health News, and the author of "Vaccine: The Controversial Story of Medicine's Greatest Lifesaver."
To reopen businesses and public spaces safely, experts say, states need to be testing and contact tracing on a massive scale. But only a handful of states are doing enough testing to stay on top of potential outbreaks, according to a state-by-state analysis published by NPR.
Among those, Tennessee stands out for its aggressive approach to testing. In Tennessee, anyone who wants a test can get one, and the state will pick up the tab. The guidance has evolved to "when in doubt, get a test," and the state started paying for it in April.
It's still rare for a community to encourage such broad symptom-free testing.
"In most places, you still need to show you have the signs and symptoms of COVID-19 to get a test," research professor Sabrina Corlette of Georgetown University said. "It's really patchwork."
Ample testing, preferably including people who are not symptomatic, can help contain future outbreaks of COVID-19 by giving health officials the knowledge to act quickly to suppress any new cluster of cases.
Because of testing shortages, many states still have limitations on who can get a test. Some states, such as Alabama, are inviting people without symptoms to be tested, but only if they qualify as high-risk. A few counties in Nevada have started asymptomatic testing, and Rite Aid in a dozen states has opened up its walk-in testing, but it's still for people who preregister.
Tennessee's commitment to testing so broadly has helped it pull ahead of most other states in its rate of testing. According to NPR's analysis, Tennessee is doing more than double the minimum number of tests needed to control its outbreak.
Tennessee Department of Health Commissioner Lisa Piercey gave credit for much of the state's testing success to private, commercial labs.
"We've called on almost all of them to say, 'We need you to ramp up, because you're about to get a flood of tests,' and that's exactly what we've given them," Piercey said at a daily briefing in late April.
In one weekend, it was more than 11,000 tests.
But private labs are shouldering the testing load in most states. What's novel in Tennessee is that the state guaranteed payment to those companies upfront.
So, rather than making them bill various health insurance plans — which are required to cover coronavirus testing but still create paperwork — the state is picking up the tab. And the typical rate set by the federal government just doubled to $100 a swab.
Memphis-based American Esoteric Laboratories has been processing the bulk of the state-collected swabs. The company declined to comment for this story.
Nashville-based Aegis Sciences Corp. jumped in more recently and is already doubling its capacity to 7,000 tests a day. CEO Frank Basile said the guaranteed payment was a big motivator.
"Clearly, it's beneficial for the lab companies like us to receive the assurance of payment," Basile said. "That's definitely a positive. And it gives us the confidence to put the effort and the capital in to make this happen."
And coronavirus testing requires more investment right now because the swabs and chemicals necessary to do it are in such high demand.
The tax dollars are well spent, said Dr. Ashish Jha, faculty director of the Harvard Global Health Institute, which has been tracking testing capacity by state. He said Tennessee's investment could more than pay for itself since ample capacity is seen as a necessity to reopen businesses. Jha said he's been recommending this approach to government officials across the country.
"If the state says they'll just pay everybody 100 bucks every time you do a test, that strikes me as very smart policy," he said.
Tennessee officials said they're banking on being reimbursed by the federal government at some point.
The Tennessee Department of Health doesn't yet know exactly how much it's on the hook for. But the tab grows by millions of dollars a week. Aside from weekend drive-thru events, the state is also paying to process the weekday testing being done by local health departments in 95 counties.
On a recent Sunday, more than 800 people were tested at a site in Hendersonville. Christine Garner was willing to wait in her minivan as she slowly moved through the parking lot of a local high school. "I said, 'I know there will be a long line, but we'll just sit and wait.' We charged our tablets, and I'm doing sight words with the kids," she said.
Garner closes refinanced mortgages for a living, which puts her in close contact with multiple families a day — often in their homes. Still, she had no symptoms. And her closest contact to someone with COVID-19 was secondhand.
"I'm just hypersensitive to any change in my body at all. I think a lot of people are," she said.
All this testing access is generally a good thing, said Dr. Kelly Moore, a pandemic consultant, formerly of the state health department. She refers to the test takers as primarily "the worried well" since nearly 99% of them have tested negative at some testing events.
"If these highly motivated, worried well people coming out for free tests are not taking up scarce resources we need for someone else, then it's definitely not a problem to test them," Moore said.
But there's a potential downside. All those negative test results improve a state's closely watched positivity rate — that is the percentage of cases coming back positive. A low rate of positives is seen as a sign that a community is doing enough testing. But it's possible to miss pockets of infection among people who might not have the awareness or resources to get tested.
"We can't draw conclusions about what's going on in the whole community based on this self-selected group of people who are so motivated they come out to get tested," Moore said.
From March 8 to April 11, the number of organ donors who died in traffic collisions was down 23% nationwide, while donors who died in all other types of accidents were down 21%.
This article was first published on Tuesday, May 19, 2020 in Kaiser Health News.
On Day Two of the San Francisco Bay Area's stay-at-home orders in March, Nohemi Jimenez got into her car in San Pablo, California, waved goodbye to her 3-year-old son and drove to her regular Wednesday dialysis appointment.
The roads were deserted. No traffic. Jimenez, 30, said it is hard to admit what she thought next: No traffic meant no car accidents. And that meant she'd be on the waiting list for a kidney transplant even longer.
"I don't want to be mean, but I was like, 'Oh, my God. Nobody's going to die,'" she said. "I'm not going to get my transplant."
Jimenez was 20 and pregnant with her first child when doctors discovered she had been born with only one kidney, and that lone kidney was failing. By age 29, doctors told her she needed a new one. It was strange and scary, she said, waiting for someone to die so she could live.
"You're just thinking about it," she said. "It's sitting in your mind. It just can never leave you alone."
Deaths from accidents are the biggest source of organs for transplant, accounting for 33% of donations, according to the United Network for Organ Sharing, UNOS, which manages the nation's organ transplant system.
But since the coronavirus forced Californians indoors, accidents have declined. Traffic collisions and fatalities in the state dropped by half in the first three weeks of sheltering in place, according to a study by the University of California-Davis. Drowning deaths dropped 80% in California, according to data compiled by the nonprofit Stop Drowning Now.
In April organ procurement organizations typically see a surge in donations related to outdoor, spring break-related activities and travel, but not this year.
From March 8 to April 11, the number of organ donors who died in traffic collisions was down 23% nationwide compared with the same period last year, while donors who died in all other types of accidents were down 21%, according to data from UNOS.
"Spring break accidents are almost nonexistent because there's no spring break — beach accidents, motorcycle accidents, hunting accidents," said Janice Whaley, CEO of Donor Network West, which manages organ donations for Northern California and Nevada.
Doctors said they've also noticed a decline in emergency room visits overall, not just for accidents, and this may also be limiting the supply of donor organs.
"Where are all the people with heart attacks? Where are all the people with strokes?" said George Rutherford, a professor and infectious disease physician at the University of California-San Francisco. "Are those patients staying away from the ERs for fear of COVID? Clearly, the census is way down in ERs."
Strokes and heart attacks are the second and third most common sources of organ donations, accounting for 27% and 20% of organs, respectively, according to UNOS.
When people die from a stroke or heart attack at home instead of a hospital, their organs cannot be used for transplant because of lost blood flow. Most organ donations occur after a person suffers a near-fatal event and lifesaving measures do not work. For organs to be viable, people must die or be declared brain-dead while on a ventilator, so blood keeps pumping to the heart, lungs, liver and kidneys.
COVID Preparations Slow Transplant Pipeline
A range of other logistical complications have made transplants difficult during the coronavirus pandemic. Hospitals have had to scale back surgeries of all kinds to preserve scarce supplies of personal protective equipment and ventilators. And many haven't had the bandwidth to manage the delicate timing and complexity of organ donation, recovery, transportation and transplantation.
Transplant surgeries across the country plummeted 52% from March 8 to April 11, according to UNOS data.
"There's a lot of things that have to happen perfectly, and now we're in an imperfect situation where we're trying to deal with so many other things," Whaley said.
As medical centers braced for a wave of COVID-19 patients, they wanted to free up as many ventilators as possible. In addition to donors needing to die on ventilators to keep their organs viable, doctors often keep them on ventilators for two or three days while transplant teams and recipients are lined up. Then the recipients need to be on ventilators during surgery.
"People were very antsy about having non-COVID-19 patients on ventilators, taking up space," Whaley said. "They wanted to make sure they were ready for that next patient."
Many COVID patients who died offered their organs for donation, but those were declined out of concern that recipients could become infected, she said.
And a shortage of coronavirus testing supplies made it difficult for transplant centers to test potential donors who later died of other causes to make sure they were not infected with the virus.
"So there may have been some organ turndowns that we normally wouldn't have seen," said Dr. Chris Freise, a professor and transplant surgeon at UCSF.
As a matter of policy, hospitals canceled virtually all organ transplants from living donors, where a family member or someone else donates a kidney or section of their liver.
"That involves bringing two patients into the hospital — the donor and the recipient — and we certainly didn't want to put donors at any significant extra risk," Freise said. "Living-donor kidney transplant ground down to almost a complete halt in most programs across the country."
Some hospitals began doing living donations again in early May, while donations from deceased donors started to increase slowly in mid-April.
That's when Jimenez got her call from Freise's team at UCSF. A condition related to Jimenez's three pregnancies made finding a donor match for her very difficult, Freise said, "like a needle in a haystack." That also put her at the top of the waiting list in case a match was found.
Jimenez's phone rang at 2 a.m. on April 17. A transplant staffer told her to get to the hospital right away.
"I was excited," Jimenez said. "But then my mind hit me: Somebody died."
All she knows is that the donor was 19 and died in an accident in Los Angeles. Jimenez wrote a letter to the donor's family.
"I told them that I will forever be thinking of them," she said. "I will have him or her in my body for the rest of my life, and I will live for both of us."
Jimenez has six months of recovery ahead of her. She said she's looking forward to going back to work and having more energy to play with her kids.
This story is part of a reporting partnership that includes KQED, NPR and Kaiser Health News.
Children have largely escaped the ravages of COVID-19, but children's hospitals have not eluded the financial pain the pandemic has wrought on health care providers.
Pediatric hospitals offered themselves as backups to their adult counterparts in case of a surge of coronavirus patients. They suspended nonemergency surgeries and stockpiled protective gear and virus test kits, according to hospital executives and financial analysts.
But, in many regions, the surge was smaller than anticipated – or hasn't materialized. And children's hospitals that have offered to take sick kids off the hands of adult hospitals, or extend the age of people they admit, have not seen an influx of patients to fill the beds they emptied. As a result, numerous pediatric facilities, like many of the adult ones, face sharply declining revenues and extra expenses.
"We turned off a significant volume of our activity for a surge that isn't going to occur. And since we've had continuing expenses, it's been pretty devastating," said Paul A. King, CEO of Stanford Children's Health, which runs Lucile Packard Children's Hospital in Palo Alto, California.
King said he expected annual net revenue for the hospital and its affiliated clinics to drop about 10%. Lucile Packard's net revenue in 2019 was about $1.7 billion, according to data from California's Office of Statewide Health Planning and Development.
Other children's hospitals have given similarly downbeat assessments.
Many of them — including Lucile Packard and UCSF Benioff Children's Hospital — have furloughed staff members, required them to use paid vacation time, or cut hours or pay.
Robin Leffert, a registered nurse at UCSF Benioff's hospital in Oakland, California, said she's seen a "huge drop-off" in patients. Many staffers have been temporarily cut, requiring the nurses who are still working to perform extra tasks. "The physical environment feels different," she said. "There's an eerie, empty quality to it. But that doesn't decrease the tension we are feeling."
Stay-at-home orders have reduced car accidents, injuries and illnesses that would normally bring kids to the ERs of children's hospitals, while parents' fear of exposing their families to the COVID-19 virus has exacerbated the trend.
In early February, Jennifer Griffin, a 44-year-old mother of two boys, decided against taking her 9-year-old for adenoid removal surgery at Renown Children's Hospital in Reno, Nevada, where they live.
"We were not comfortable with what was going on with COVID and didn't know what the exposure was going to be like," Griffin said.
Renown, like many other children's hospitals, has begun to resume some of the nonemergency surgeries it halted as the COVID pandemic spread. Griffin is still not convinced it's safe to bring in her son, however.
"If people continue to not abide by the distancing guidelines and isolation guidelines, I might wait," she said.
Nicholas Holmes, chief operating officer of Rady Children's Hospital in San Diego, said his facility faces similar parent concerns and is making a push — via social media and in collaboration with local pediatricians — to "make sure families know it is safe to come to the campus."
For all their current problems, however, pediatric hospitals were generally in a stronger financial position than adult facilities before the pandemic, so many of them "are absolutely well positioned to weather the storm," said Kevin Holloran, a senior director at Fitch Ratings.
A 2019 Fitch report based on 2018 hospital audits showed the aggregate operating profit margin of a representative sample of not-for-profit children's hospitals was nearly triple that of nonprofit adult hospitals. The pediatric facilities had enough cash on hand to last 1.6 times longer than the adult hospitals.
In California, the average operating profit margin of children's hospitals was almost three times that of non-children's facilities last year — though individual results ranged widely, from an extremely profitable 25.38% for Rady to operating losses for UCSF Benioff's Oakland hospital (-0.78%) and Lucile Packard (-2.53%), according to the Office of Statewide Health Planning and Development.
Holloran and others say children's hospitals typically benefit from strong philanthropic and public support, and their specialization in complex acute cases results in higher prices while often affording them a commanding pediatric market share.
In 2018, California voters approved $1.5 billion in state bonds to help children's hospitals with capital expenses including equipment, construction and seismic retrofitting. That means they can save some of the dollars they would have spent on such projects.
So far, however, just 9% of that money — $142.1 million — has been distributed, and to only three hospitals, according to Frank Moore, executive director of the California Health Facilities Financing Authority.
Children's hospitals across the U.S. have reported declines in surgery and outpatient procedures of 60% to 80%, with inpatient admissions cut by nearly half as of the end of April, said Amy Knight, chief operating officer of the Children's Hospital Association in Washington, D.C.
At Children's Hospital New Orleans, ER visits plummeted from 4,000 in February to 1,700 in April, said Matt Schaefer, the chief operating officer. Outpatient visits dropped from 1,100 to about 400 over the same period. The hospital, like others around the country, has managed to offset some of the loss in outpatient volume with telehealth.
When COVID-19 was wreaking havoc in southeastern Louisiana, the children's hospital offered to take pediatric patients from adult hospitals and admit patients up to age 30, said George Bisset, the chief medical officer. "But we didn't get a lot of takers."
Children's facilities received virtually none of the first $30 billion in federal relief money intended for hospitals and other providers, though they have received some of a subsequent $20 billion tranche.
Children's hospitals that are part of larger health systems may also benefit from the aid received by affiliated adult hospitals. And belonging to a hospital chain can allow for greater operational flexibility, industry executives say.
Cohen Children's Medical Center in Queens, New York, part of the $13.5 billion, 23-hospital Northwell Health system, redeployed numerous staff members to the adult hospitals that were struggling to cope with an onslaught of COVID-19 cases, said Dr. Charles Schleien, Cohen's vice president for pediatric services.
Cohen also turned over more than half its beds to Long Island Jewish Medical Center, an adult hospital connected to Cohen by a hallway, and converted virtually every available space to more adult beds, Schleien said.
But filling beds with COVID patients doesn't offset the lost revenue from suspending profitable elective surgeries anyway, Schleien said. "The economics of it are brutal, because when you lose elective surgeries, that's where your margin is."
Even though children's hospitals have begun to resume nonemergency surgeries, they will likely continue to face financial challenges.
"If we enter into a recession, and particularly if it is prolonged, that will have an effect on hospitals, including children's hospitals, because people won't have jobs and may be uninsured, or more may be on Medicaid, which doesn't pay as well," said Lisa Martin, a senior vice president on the not-for-profit health care ratings team at Moody's Investors Service.
In California, nearly 60% of children's hospital charges are tied to Medicaid, more than double the proportion for adult hospitals, according to OSHPD data. At some pediatric facilities in the U.S., that figure is well above 70%.
After spending staggering sums to mitigate the consequences of the pandemic, Congress will be looking for programs to prune, said Knight, of the Children's Hospital Association. "One with a target on its back is Medicaid."
Jordan Rau, a senior correspondent for Kaiser Health News, contributed to this report.
Casa de Salud, a nonprofit clinic in Albuquerque, New Mexico, provides primary medical care, opioid addiction services and non-Western therapies, including acupuncture and reiki, to a largely low-income population.
And, like so many other health care providers that serve as a safety net, its revenue — and its future — are threatened by the COVID-19 epidemic.
"I've been working for the past six weeks to figure out how to keep the doors open," said the clinic's executive director, Dr. Anjali Taneja. "We've seen probably an 80% drop in patient care, which has completely impacted our bottom line."
In March, Congress authorized $100 billion for health care providers, both to compensate them for the extra costs associated with caring for patients with COVID-19 and for the revenue that's not coming in from regular care. They have been required to stop providing most nonemergency services, and many patients are afraid to visit health care facilities.
But more than half that money has been allocated by the Department of Health and Human Services, and the majority of it so far has gone to hospitals, doctors and other facilities that serve Medicare patients. Officials said at the time that was an efficient way to get the money beginning to move to many providers. That, however, leaves out a large swath of the health system infrastructure that serves the low-income Medicaid population and children. Casa de Salud, for example, accepts Medicaid but not Medicare.
State Medicaid directors say that without immediate funding, many of the health facilities that serve Medicaid patients could close permanently. More than a month ago, bipartisan Medicaid chiefs wrote the federal government asking for immediate authority to make "retainer" payments — not related to specific care for patients — to keep their health providers in business.
"If we wait, core components of the Medicaid delivery system could fail during, or soon after, this pandemic," wrote the National Association of Medicaid Directors.
So far, the Trump administration has not responded, although in early April it said it was "working rapidly on additional targeted distributions" for other providers, including those who predominately serve Medicaid patients.
In an email, the Centers for Medicare & Medicaid Services said officials there will "continue to work with states as they seek to ensure continued access to care for Medicaid beneficiaries through and beyond the public health emergency."
CMS noted that states have several ways of boosting payments for Medicaid providers, but did not directly answer the question about the retainer payments that states are seeking the authority to make. Nor did it say when the funds would start to flow to Medicaid providers who do not also get funding from Medicare.
The delay is frustrating Medicaid advocates.
"This needs to be addressed urgently," said Joan Alker, executive director of Georgetown University's Center for Children and Families in Washington, D.C. "We are concerned about the infrastructure and how quickly it could evaporate."
In the administration's explanation of how it is distributing the relief funds, Medicaid providers are included in a catchall category at the very bottom of the list, under the heading "additional allocations."
"To not see anything substantive coming from the federal level just adds insult to injury," said Todd Goodwin.
He runs the John F. Murphy Homes in Auburn, Maine, which provides residential and day services to hundreds of children and adults with developmental and intellectual disabilities. He said his organization — which has already furloughed almost 300 workers and spent more than $200,000 on COVID-related expenses including purchases of essential equipment such as masks and protective equipment that will not be reimbursable — has not been eligible for any of the various aid programs passed by Congress. It gets most of its funding from Medicaid and public school systems.
The organization has tapped a line of credit to stay afloat. "But if we're not here providing these services, there's no Plan B," he said.
Even providers who largely serve privately insured patients are facing financial distress. Dr. Sandy Chung is CEO of Trusted Doctors, which has about 50 physicians in 13 offices in the Northern Virginia suburbs around Washington, D.C. She said about 15% of its funding comes from Medicaid, but the drop off in private and Medicaid patients has left the group "really struggling."
"We've had to furlough staff, had to curtail hours, and we may have to close some locations," she said.
Of special concern are children because Medicaid covers nearly 40% of them across the county. Chung, who also heads the Virginia chapter of the American Academy of Pediatrics, said that vaccination rates are off 30% for infants and 75% for adolescents, putting them and others at risk for preventable illnesses.
The biggest rub, she added, is that with the economy in free fall, more people will qualify for Medicaid coverage in the coming weeks and months.
"But if you don't have providers around anymore, then you will have a significant mismatch," she said.
Back in Albuquerque, Taneja is working to find whatever sources of funding she can to keep the clinic open. She secured a federal loan to help cover her payroll for a couple of months, but worries what will happen after that. "It would kill me if we've survived 15 years in this health care system, just to not make it through COVID," she said.
KHN senior correspondent Phil Galewitz contributed to this story.
Coronavirus patients and their families who believe a doctor, nurse, hospital or other provider made serious mistakes during their care may face a new hurdle if they try to file medical malpractice lawsuits.
This story was first published on Friday, May 15, 2020 in Kaiser Health News.
Coronavirus patients and their families who believe a doctor, nurse, hospital or other provider made serious mistakes during their care may face a new hurdle if they try to file medical malpractice lawsuits.
Under pressure from health provider organizations, governors in Connecticut, Maryland, Illinois and several other states have ordered that most providers be shielded from civil ― and, in some cases, criminal — lawsuits over medical treatment during the COVID-19 health emergency. In New York and New Jersey, immunity is now part of state law. In California, six hospital, physician and long-term care provider groups are pressing Gov. Gavin Newsom to also issue an order assuring immunity.
The efforts are attracting congressional attention as well and threatening to derail the next federal coronavirus stimulus package on Capitol Hill. Senate Majority Leader Mitch McConnell is demanding that Congress include liability protections against COVID-related suits for businesses and health care providers. The contentious issue of legal liability claims in health care has divided congressional Republicans and Democrats for years.
“We are not going to let health care heroes emerge from this crisis facing a tidal wave of medical malpractice lawsuits so that trial lawyers can line their pockets,” the Kentucky Republican said in the Senate on Tuesday. “This will give our doctors, nurses and other health care providers a lot more security as they clock in every day and risk themselves to care for strangers.”
Some legal experts and seniors’ advocates worry that the state immunity guarantees go too far, leaving patients with no way to hold providers accountable. Supporters argue that health care providers and facilities deserve protection from lawsuits as they battle a deadly virus during an unprecedented public health emergency.
Pennsylvania Gov. Tom Wolf, a Democrat, joined the movement last week, acknowledging that the COVID-19 epidemic has “required our health care providers to broaden their professional responsibilities and experiences like never before.” Like other governors, Wolf included in his order exceptions for the most egregious lapses in care involving intentional misconduct or extreme negligence.
“When you are asking nurses to work around-the-clock and the ICU has 2½ times as many people than it was engineered for, well, my goodness, doesn’t this make common sense?” said Kenneth Raske, president and chief executive officer of the Greater New York Hospital Association, which represents more than 160 hospitals and health systems in New York, New Jersey, Connecticut and Rhode Island.
The group helped draft New York’s immunity measure, said Raske. Supporters also include the American Medical Association, which urged the National Governors Association to use the New York law as a model for other states.
Immunity for providers during the COVID-19 emergency “is good for patients” because it encourages providers to work in extraordinarily tough conditions, said James Hodge, an Arizona State University law professor and regional director at the Network for Public Health Law.
It is an extension of the usual protection for a “good Samaritan” — the doctor or nurse who sees a car accident, for example, and stops to help the injured. The well-intentioned doctor doesn’t have the equipment and support of a hospital and shouldn’t be held to the same standards.
Similarly, some well-intentioned medical providers treating COVID-19 patients work with scarce supplies and overburdened staff and face other conditions often beyond their control.
Since some states offer no virus-related liability protection for long-term care providers — such as skilled nursing facilities, assisted living communities and continuing care retirement communities — during the current crisis, their trade associations are looking to the federal government instead.
“Long-term care workers and centers are on the front line of this pandemic response,” said Cristina Crawford, a spokesperson for the American Health Care Association, “and it is critical that states and the federal government provide the necessary liability protection.”
But Mairead Painter, director of Connecticut’s State Long Term Care Ombudsman Program, said the immunity guarantee could discourage nursing home residents and their families from filing complaints about abuse or neglect, or challenging their transfer to other homes as administrators try to separate residents who have the coronavirus from those without it.
“So they might sort of just let it fall to the wayside, and we don’t want them to do that,” she said.
As infection rates slowly decrease, providers should be expected to follow the usual standard of care, said Barry Furrow, director of Drexel University law school’s health law program in Philadelphia, who has studied hospital corporate negligence.
“These immunity statutes do too much, because now we’re settling back to a more normalized health care situation where we have a new disease vector, which we’re beginning to understand,” he said.
The immunity guarantee covers the duration of the COVID-19 emergency, which could continue for several more months, if not longer, Furrow said, so states are letting providers “off the hook.”
Despite the state immunity guarantees, the Centers for Medicare & Medicaid Services ordered state health inspectors to crack down on nursing homes that don’t follow infection-control requirements, and, starting May 8, required facilities to inform residents or their families by 5 p.m. the day after a new case of COVID-19 is confirmed. And officials in some parts of the country have begun criminal investigations of nursing homes suspected of endangering residents.
The mixed messages are most evident in New York, the coronavirus epicenter in the U.S., which has one of the nation’s most comprehensive COVID-19 shields against medical liability. It protects individual medical professionals as well as health care facilities from both civil and criminal lawsuits involving any patients, regardless of whether they had the virus. There’s an exception for egregious conduct, which Furrow said is a high bar and up to a jury to define.
“This sends a message to the nursing home inspectors to step back,” said Richard Mollot, executive director of the Long Term Care Community Coalition in New York City. “This is an insidious quieting of accountability just when it is needed the most.”
But Dani Lever, a spokesperson for Gov. Andrew Cuomo, said the immunity law “imposes no limitations on the ability of the state to investigate nursing homes.”
About 20% of the 27,450 confirmed and presumed coronavirus deaths in the state by Wednesday have occurred in nursing homes, prompting an investigation by Cuomo and Attorney General Letitia James. When Cuomo described the investigation, he was both sympathetic and critical of nursing homes.
“This is a crisis situation for nursing homes … through no fault of their own,” he said. “Mother Nature brought a virus and the virus attacks old people.” Nonetheless, he added, they must “do their job by the rules and regulations.”
Although scientists and stock markets have celebrated the approval for emergency use of remdesivir to treat COVID-19, a cure for the disease that has killed nearly 260,000 people remains a long way off — and might never arrive.
Hundreds of drugs are being studied around the world, but "I don't see a lot of home runs right now," said Dr. Carlos del Rio, a professor of infectious diseases at the Emory University Rollins School of Public Health. "I see a lot of strikeouts."
Researchers have launched more than 1,250 studies of COVID-19. Pharmaceutical companies are investing billions to develop effective drugs and vaccinesto help end the pandemic.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, was cautious when announcing the results of a clinical trial of remdesivir last week, noting it isn't a "knockout." Although remdesivir helped hospitalized COVID-19 patients recover more quickly, it hasn't been proved to save lives.
"This [drug] is opening the door," Fauci said. "As more companies and investors get involved, it's going to get better and better."
Researchers have already announced that they will combine remdesivir with an anti-inflammatory drug, baricitinib — now used to treat rheumatoid arthritis — in the hope of improving results.
But COVID-19 is an elusive enemy.
Doctors treating COVID patients say they're fighting a war on multiple fronts, battling a virus that batters organs throughout the body, causes killer blood clots and prompts an immune system overreaction called a "cytokine storm."
With so many parts of the body under siege at once, scientists say, improving survival rates will require multiple routes of attack — and more than one drug. While some of the experimental medications target the virus, others aim to prevent the immune system from inflicting collateral damage.
"There are so many pieces of this, and they will all require different therapies," said Dr. Lewis Kaplan, president of the Society of Critical Care Medicine, whose doctors provide intensive care.
Scientists are also taking a fresh look at existing medications that might be repurposed to fight COVID-19. These include antivirals for influenza, arthritis drugs, estrogen patches and even antacids. If repurposed drugs are successful, they could reach patients relatively quickly, because doctors are already familiar with their side effects and safety concerns.
Some doctors are skeptical that drugs for heartburn or hot flashes have any chance of treating a killer like COVID-19.
Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, said he fears that hype over unproven products will harm patients, even if it temporarily boosts company stock prices. Patients who demand antacids or antimalarial drugs being studied in COVID-19 could be harmed by side effects, for example. Those who hoard drugs — on the hope of protecting themselves from COVID-19 — could deprive other patients of medications they need to stay healthy. Some people may refuse to participate in clinical trials because they fear being given a placebo.
"This rush to get every imaginable treatment into a study, it's not prudent," Nissen said. "It's not good medicine. It's an act of desperation."
Other experts say scientists should cast a wide net.
"I don't think we want to rule anything out because it sounds out of the ordinary," said Dr. Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
Antivirals In The Spotlight
Antivirals such as remdesivir aim to prevent viruses from replicating, said Dr. Peter Hotez, a professor at Baylor College of Medicine in Houston.
That doesn't always work. A small Chinese study of remdesivir, published last month in The Lancet, found no benefit to severely ill COVID-19 patients. Remdesivir had previously failed when tested against Ebola.
Antivirals tend to be most helpful in the early stages of infection, when most of the harm to the patient is caused by the virus itself, rather than the immune system, Hotez said.
Remdesivir is just one of many antivirals being tested against COVID-19.
International researchers are studying the antiviral favipiravir, developed to fight the flu.
A study in the New England Journal of Medicine likewise found no benefit in giving two antivirals used to treat HIV ―a combination of lopinavir and ritonavir, sold as Kaletra— in adults hospitalized with severe COVID-19.
Harnessing The Immune System
One of the therapies generating excitement is also one of the oldest: antibody-rich blood from COVID survivors.
The immune system produces antibodies in response to invaders such as viruses and bacteria, allowing the body to recognize and neutralizethem. Antibodies also recognize and neutralize the virus the next time that person is exposed.
Doctors hope that patients who develop antibodies against the novel coronavirus will become immune, at least for a few years, although this hasn't been proved.
Scientists developing this "convalescent plasma" are studying whether COVID-19 survivors can share this immunity with others by donating their plasma, the liquid part of blood that contains antibodies, said Dr. Shmuel Shoham, an associate professor of medicine at the Johns Hopkins University School of Medicine.
In addition to treating people who are already sick, donated plasma could potentially prevent people exposed to the virus — such as health care workers — from developing symptoms.
Donated antibodies ― and any immunity they might provide — don't last forever, said Dr. William Schaffner, a professor at the Vanderbilt University Medical Center. The body destroys aging antibodies as part of its routine maintenance, he said. In general, half of donated antibodies are eliminated in about three weeks.
The use of convalescent plasma goes back more than a century. It was used during the 1918 flu pandemic and was shown to improve survival during the 2009-10 H1N1 pandemic.
Doctors don't know yet whether convalescent plasma will benefit people with COVID-19.
In general, convalescent plasma is expected to be more effective in preventing illness than in treating it. It may be less likely to help someone in intensive care, Shoham said.
Researchers are also studying the use of prepackaged plasma, called intravenous immunoglobulin, in COVID patients. This product, known as IVIG, is taken from healthy donors in the general population and has long been used to help patients with weakened immune systems fight off infections. Hospitals keep it in stock and some are already using it to treat COVID patients.
Although the antibodies in prepackaged IVIG don't specifically target the coronavirus, researchers hope they will tamp down the immune response.
In a third form of immune therapy, researchers are trying to identify the specific antibodies that are most important for neutralizing the coronavirus, then reproduce them as drugs called monoclonal antibodies. Monoclonal antibodies are already used to treat a variety of conditions, from cancer to rheumatoid arthritis and migraines.
"When we give people an antibody, they are immediately at least partially immune to that specific virus," said Dr. James Crowe, director of the Vanderbilt Vaccine Center, who hopes to have antibodies ready for a clinical trial in a few months. "We're moving the immune system from one person to another."
Ideally, doctors would develop a very potent monoclonal antibody or a cocktail of antibodies for COVID-19 patients, to ensure the best chance of success, Crowe said. But manufacturing these drugs can be complicated, expensive and time-consuming.
"Making two antibodies would be at least twice as complicated as making one," Crowe said. "A cocktail might be preferred, but cocktails are harder to move quickly."
Calming The Immune System
In most cases of COVID-19, the immune system neutralizes the coronavirus and patients recover without going to the hospital.
For reasons that doctors don't totally understand, the immune system of some COVID-19 patients becomes hyperactive, attacking not just the virus but the patient's own cells. A "cytokine storm," in which the immune system floods the body with inflammatory chemicals, can do more damage than the virus itself.
In an effort to calm the immune system, researchers are testing immune-suppressing drugs, including monoclonal antibodies already used to treat autoimmune diseases such as rheumatoid arthritis, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.
Health care giant Roche is conducting large clinical trials of its drug, Actemra, in the hope of preventing cytokine storms, which can cause organ failure and a life-threatening condition called sepsis. Actemra is designed to lower levels of an inflammatory chemical, interleukin-6, which has been found to be elevated in some COVID-19 patients.
Another immune suppressant from Regeneron and Sanofi, called Kevzara, has had disappointing results in clinical trials. The manufacturers plan to continue studying the drug to see if it can help certain types of patients.
Dr. Anar Yukhayev, a New York OB-GYN who was hospitalized with COVID-19 on March 16, agreed to join a clinical trial of Kevzara.
"I was having so much trouble breathing that I was desperate for anything to help," said Yukhayev, 31, who was treated at Long Island Jewish Medical Center.
About 36 hours after receiving an infusion, as Yukhayev was being treated in intensive care, his symptoms began to improve. He was able to avoid being put on a ventilator. Doctors didn't tell him if he received Kevzara or a placebo, but his liver enzymes also began to rise, suggesting the organ was under stress. Elevated liver enzymes are a known side effect of Kevzara.
Yukhayev made a full recovery and went back to work full time April 13. He donated his plasma to researchers.
Until vaccines and other preventive medicines are developed, the best way to prevent coronavirus infections is to maintain social distancing, Adalja said.
"Social distancing is a blunt tool," he said, "but it's all that we have."