In early December, Miguel Fernandez lay unconscious in the intensive care unit at a Los Angeles area hospital. A mechanical ventilator pumped oxygen into his lungs, which had been ravaged by COVID-19. The 53-year-old was dying.
The best, and likely only, chance of Miguel surviving was a therapy called extracorporeal membrane oxygenation, better known as ECMO. It would allow his lungs to rest while a machine infused his blood with the oxygen he needed. But PIH Health Whittier Hospital, where he had been admitted, didn't have any ECMO machines or the highly trained staff needed to run them. Only a handful of hospitals in southern California did, and they were overrun with COVID-19 cases.
Since the beginning of the pandemic, public health experts had been warning about the need to "bend the curve" — to prevent the number of COVID-19 cases from spiking so hospitals wouldn't get overwhelmed.
But starting in early November, the daily number of COVID-19 hospitalizations surged in Los Angeles County, rising eightfold between then and the wave's crest, which arrived just after New Year's Day. Within weeks, overflowing hospitals faced exactly the types of care-rationing decisions experts had feared. Hospitals set up tents to increase capacity, and ambulances circled for hours as they waited for beds to open. By early January, Los Angeles County emergency medical personnel were directed to conserve supplemental oxygen by only administering it to the neediest patients, and to stop transporting to hospitals cardiac arrest patients who couldn't be revived in the field. State officials dispatched refrigerated trucks and thousands of body bags to the region.
Inside the hospitals, for patients like Miguel, a dire situation unfolded out of public view. Critically ill patients who might survive with ECMO could not get the treatment. Doctors had to choose who received the therapy based on who they thought had the best chance to survive. Some were approved, but had to be put on a waitlist. Many patients died waiting.
"I don't think we ever thought we'd get to this point, not in California," said Dr. Jack Sun, who oversees the program that includes ECMO at UCI Health in Orange County, 30 miles southeast of Los Angeles. "You know if you don't have a bed for somebody, they are going to die."
In some parts of the country, doctors can tap into centralized systems to quickly find any available bed for ECMO at any hospital in the region. That's not the case in Los Angeles. Miguel's caregivers and family would have to hack through red tape and navigate an opaque, disconnected and sometimes unfair system to try to save his life.
Miguel, the oldest of seven siblings in a family of Mexican immigrants, was always the one who fixed things. If someone needed a job, he would help them find work. If a car broke down, he would repair it. His sister, Margarita Rodriguez, described him as a "big cuddly bear" who gave her hugs and always made her smile. Just before he was hospitalized, he had stopped by to patch a leak in her roof.
Now the family had to find a way to fix Miguel.
They scoured the internet with searches like "What do you do when a ventilator fails?" One night, Margarita found a success story from San Diego about the use of ECMO. An ECMO machine takes over the work of a patient's lungs. It extracts blood from the body and circulates it through an artificial lung that removes carbon dioxide and adds oxygen before returning the blood to the body. One study of patients at 68 U.S. hospitals found that critically ill COVID-19 patients like Miguel "had a considerably lower risk of death" if they received ECMO during their first seven days in an ICU.
Miguel was relatively healthy other than having COVID-19. He didn't smoke or have any preexisting illnesses like diabetes. He was overweight, but below weight cutoffs used by ECMO centers to determine eligibility. Across the country, patients like Miguel who had been near death on a ventilator one day were alive and leaving a hospital weeks later after undergoing ECMO.
Miguel's oldest son, Miguel Jr., knew from his conversations with doctors that his dad wasn't going to get better by staying on the ventilator. "ECMO was his last hope, his best chance to survive," Miguel Jr. said. "It was ECMO or death."
A Desperate Search
Miguel and his family had tried to protect themselves from the virus. Three of his four adult children live in his home, and when they got infected in the fall, the family isolated as much as possible. Miguel stayed distanced on some nights by sleeping in an old RV he had in the backyard.
The pandemic had forced the extended Fernandez clan to cut back on family gatherings. Before COVID-19, Miguel had often organized get-togethers at his home on the southeastern side of Los Angeles, for birthdays or graduations, or to watch football or grill. After his only daughter, Jeannette, was accepted by UCLA last year, he proudly walked around her send-off bash in a "UCLA Dad" T-shirt.
But Miguel had to keep working. He and two of his brothers owned a construction business that bought and renovated homes. They had flipped hundreds of properties, starting 12 years ago with an $80,000 fixer-upper in Compton and more recently a $2.5 million project in Pasadena. Two of Miguel's three sons worked with him. Even after COVID-19 struck his family, Miguel still had to pick up supplies and go to job sites.
In early November, Miguel started to feel sick and went to a coronavirus testing site at a local recreation center. Two days later he received an email telling him what he already suspected: He had COVID-19. By Nov. 15, he had a fever and night sweats and was having trouble breathing.
Even though he was getting sicker, Miguel didn't want to go to the hospital. He knew people like him were dying. Latino Angelenos have suffered the highest COVID-19 death rate in Los Angeles County — almost twice the rate of Blacks and about three times the rate for whites.
But by Nov. 17, Miguel struggled to breathe as he walked from the bathroom to the couch. The family had purchased an oximeter, a device that measures oxygen levels in the blood when clipped onto a finger. His oxygen level had dropped to 77%, dangerously below the 95% considered at the low range of what's normal.
"We realized this was a real emergency," said Jeannette, his 21-year-old daughter. Just before midnight, two of Miguel's sons helped him into the passenger seat of the family's Ford Explorer. Jeannette took the wheel and Miguel's wife, Alejandrina, got in the back seat.
Jeannette headed to PIH Health Whittier Hospital, a 523-bed facility near their home. Outside the emergency room, the staff helped the 275-pound Miguel into a wheelchair and put an oxygen monitor on his finger. It sounded an alarm. His wife and daughter could see fear in his eyes; he didn't say a word as he was rushed into the hospital. Jeannette and Alejandrina didn't even get to say goodbye.
PIH Health declined to make caregivers available for interviews or answer questions about Miguel's care. "PIH Health will not be able to provide a statement for this story," a hospital spokesperson said in an email.
Hospital records show that Miguel was given high-flow oxygen through a face mask and put in a bed that allowed hospital staff to flip him on his belly, boosting his oxygen level to 93%. He was treated with steroids and an antiviral drug. Two days after admission, things were looking up.
Jeannette began providing updates through a group text message labeled "Familia." It included Miguel's brothers, many cousins, nieces and nephews, parents and his four children. Miguel was "doing good," she reported. Miguel spent his days reading messages on his phone, even when lying on his stomach. He sent his family photos of his food, and made special requests of the hospital staff, asking for buttered sourdough toast and prune juice with breakfast.
The family hoped Miguel would be home for Thanksgiving. But the course of COVID-19 is unpredictable.
At 11 p.m. on Nov. 22, Miguel texted his family, letting them know he expected to have a long night. He wrote in a text: "if I want to make it to thanksgiving have stay awake and restore my oxygen levels."
When Thanksgiving arrived four days later, a scan of Miguel's lungs revealed inflammation and scar tissue. Doctors started him on a 10-day course of anti-inflammation medication. "Be out by Christmas," Miguel texted.
The family responded with encouragement. "Hang in there we are all with you," wrote his sister Margarita. "Ten days go by really fast."
But eight days later, on Dec. 4, Miguel's oxygen levels plummeted. The doctors put him on a ventilator.
Miguel was now fighting for his life.
Unable to visit him, the family prayed for his recovery. Every night Miguel was in the hospital, his extended family gathered on Zoom at 7:30 p.m. Miguel's 71-year-old mother, Martha, and 73-year-old father, Salvador, would lead an hour-long prayer session while clutching rosary beads.
The separation was especially difficult for Alejandrina, who had been married to Miguel since 1991. Miguel liked to tease her when she watched her Mexican telenovelas: Why do you watch those shows when you have me? On Mother's Day earlier in the year, Miguel had surprised her by buying a pair of rings, getting down on one knee and proposing again. The couple made plans to renew their vows on their 30th wedding anniversary this summer. When he became sick with COVID-19, Miguel assured Alejandrina he would get better so they could get married again. She promised she would wait for him.
After Miguel was intubated, his family gathered in the parking lot outside the building where ICU patients are treated, to be as close to him as possible. Miguel's mother knelt on the pavement for 40 minutes, her hands clasped in prayer. She told her grandchildren that praying needed to be sacrificial. It had to hurt to be effective.
It was hard for Miguel's family to reach the doctors to discuss treatment options, in part because family members couldn't visit. It was impossible to build a relationship at the bedside or buttonhole doctors on their rounds, the way they could have in non-pandemic times. They called multiple times a day, but it was difficult to get clear information.
When a doctor did call with an update, Miguel's daughter Jeannette would patch in her brother, Miguel Jr., and Miguel's niece, Jhaimy Fernandez, a fourth-year medical student at the University of Vermont's Larner College of Medicine.
Miguel's family members said they were the ones to bring up ECMO, shortly after he was intubated. The ICU doctor treating Miguel told them ECMO was not an option, they recalled. Jhaimy requested a consultation with the palliative care team, which specializes in helping critically ill patients and their families make treatment decisions. The palliative care team, however, agreed with the ICU doctor, she said.
"They just thought it was outrageous for us to even think about ECMO," Jhaimy said of the hospital's doctors.
Miguel Jr. said it seemed as if the doctors were not familiar with his father's medical history. They asked if he had diabetes, Miguel Jr. said, which he didn't. He didn't have any preexisting conditions that typically make patients unsuitable for ECMO. Although some ECMO centers use age cutoffs, Miguel, at 53, was young enough to be considered appropriate for the therapy.
Carlos Fernandez, Miguel's younger brother and business partner, said it was frustrating that the family had to bring the ECMO option to the caregiving team.
"They just kind of wrote him off," he said, adding that it's possible the treatment team was just overwhelmed. "He's an older, Latino, overweight man. That is the demographic the coronavirus is looking for."
In a discussion with Miguel's daughter in the early afternoon of Dec. 7, a doctor called his prognosis "very poor," according to notes in his hospital record.
That update, however, was followed by more hopeful news. The family's insistence had paid off. His doctors had now decided he was, in fact, a candidate for ECMO. The family doesn't know what changed their minds, and the medical records do not describe how the doctors arrived at that decision. The medical team told the family Miguel would be transferred soon to a site where he could receive the new treatment.
A Tangled System
That afternoon, a hospital patient case manager began the effort to find Miguel an ECMO bed.
There is no central database that hospital staff can tap into to quickly figure out where in the greater Los Angeles area an empty ECMO bed might exist. Case managers typically have to call hospitals one by one, navigating each facility's particular bureaucracy and coordinating it all with Miguel's insurer.
"It is a nonsensical, haphazard collection of stakeholders, and the pandemic has found the fault lines in it," said Dr. Douglas White, a physician who directs the program on ethics and decision making in critical illness at the University of Pittsburgh School of Medicine.
A key reason ECMO is being rationed in the U.S. is a lack of regional coorination, White said. "If one hospital has no ECMO [units], but another 50 miles away has one, there needs to be a system in place to connect them," he said. "That's how you prevent the need to ration."
In Arizona, the state health department created the Arizona Surge Line early in the pandemic to coordinate care statewide for critically ill patients, said White. More than 4,000 patients, including many from hard-hit Native American reservations, have been transferred through this clearinghouse, according to White. The system is focused on capacity for all critically ill patients, so it's broader than just ECMO treatment. But it's an example of how to connect patients to the resources they need in real time, he said.
In Washington and Oregon, ECMO program directors can log in to a document that displays the availability of ECMO beds throughout the region.
In 2016, the directors of Minnesota's six ECMO centers created a consortium to help with pandemic and emergency operations, said Dr. Matthew Prekker, a pulmonologist and critical care specialist at Hennepin County Medical Center in Minneapolis. The consortium established uniform eligibility guidelines to make sure all critically sick patients get a fair chance at the therapy.
If half the state's medical centers reach capacity, it triggers an emergency conference call between the ECMO center directors, who steer patients to open beds. "We are well organized," said Prekker. "We don't work in silos."
Los Angeles has vast academic medical centers, but no real-time coordination on finding ECMO beds. Before COVID-19 there had not been a need to coordinate such a high volume of patients, said Dr. Peyman Benharash, director of the adult ECMO program at UCLA Health. He said when COVID-19 hit, ECMO doctors created an informal group chat so they could coordinate patients and resources, but it's not something case managers can access. Benharash said his center does not use a waiting list, because he wants case managers to continue searching for any hospitals that might have a bed available. If UCLA is full, it tells case managers to call back in 12 hours.
The lack of a centralized system in Los Angeles can result in a scramble for case managers and doctors as patients' lives hang in the balance.
On the afternoon of Dec. 7, Miguel's medical records show, the PIH Whittier case manager called Miguel's insurance company. There was no guarantee the insurer would agree to a therapy that can easily run into the six figures. Insurance company rejections of ECMO are not uncommon, according to ECMO directors. But in Miguel's case that didn't seem to be an obstacle. The insurer told PIH that the University of Southern California's Keck Hospital, the Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center might be options. The case manager left a message at USC and provided UCLA with Miguel's information. Cedars-Sinai came back with a no, saying Miguel didn't meet its criteria for ECMO therapy.
The case manager, after talking to Miguel's insurer, tried two more hospitals. One, UCI Health in Orange County, didn't have any ECMO beds available. A second, Providence Saint John's Health Center in Santa Monica, said it would review Miguel's records.
During the COVID-19 surge, ECMO centers were screening the growing number of patients to prioritize those with the best chances of survival. At 5:08 p.m., after three hours of working the phones, the case manager turned over the search to a colleague. Soon after, UCLA called to say it wouldn't take Miguel because he had a hematoma and blood clotting.
A Prayer Answered
As the case managers searched for an ECMO bed, Miguel's mother was back in the hospital parking lot holding a vigil for her son. This time, she hid a prayer card and string of rosary beads underneath the green leaves of a day lily to protect Miguel when she was not there.
The search for an ECMO bed did not make progress for most of the day on Dec. 8. The longer Miguel depended on a ventilator, the greater the chance he would either die or suffer complications that could disqualify him for ECMO. Even without complications, extended ventilator time could rule out ECMO. By now, he had been intubated for four days. Some programs will not take a patient who has been intubated more than a week.
"When it comes to somebody needing ECMO, they can fail very quickly," said Sun.
The next day, on Dec. 8, the palliative care team offered a grim prognosis in a telephone call with Miguel's family: "We told them that Mr. Fernandez was not likely to recover at this point," according to hospital records. The family said it still wanted the hospital to make every effort to save Miguel if his heart stopped.
Throughout the day on Dec. 8, a staffer at the Saint John's transfer center was trying to reach someone at PIH to discuss Miguel's case. At 8:33 that evening, a case worker at PIH wrote that she had received a call from Saint John's. The transfer contact said he had "been trying to get in contact with [case manager] all day and left VMs but no one called back."
The next day, a PIH case worker noted in the records that she had missed messages from Saint John's because it was her day off.
Saint John's had been calling PIH with good news: The hospital had accepted Miguel for its ECMO program and would admit him as soon as a bed became available. Over the next few hours, paperwork was faxed back and forth between the hospitals, and the insurance company was contacted for approval.
"Great news!!!" Jeannette announced in a message to the family group chat, adding a heart emoji. "My dad got accepted to St. John's hospital in Santa Monica!!"
The plan, she informed the group, was for Miguel to be moved later that day.
A Life-Saving Therapy
At Saint John's, Dr. Terese Hammond was receiving up to three requests a day to use ECMO to treat patients like Miguel. Hammond had been instrumental in starting the hospital's ECMO program after she was recruited in 2018 to oversee critical care. She had worked with the therapy at USC, where she headed up the pulmonary critical care fellowship.
Community hospitals like Saint John's don't typically have the budget or specialized staff for an ECMO program. Even in the United States — which spends about twice as much per person on healthcare as other developed nations — more than 90% of hospitals do not offer ECMO. In Los Angeles, the established programs are located at big academic medical centers like USC, UCLA and Cedars-Sinai.
At Saint John's, private donors came up with the money to buy a dozen ECMO units, which can cost up to $85,000 each, Hammond said. The hospital can care for as many as eight ECMO patients at once, depending on staffing.
Hammond was an early believer in using ECMO to help COVID-19 patients whose lungs were failing. Nearly every one of the COVID-19 patients treated with ECMO at Saint John's transferred in, some from more than an hour away.
"We have to validate there is benefit, and we have been able to do that," she said. "I have people alive today because of ECMO."
Miguel's family didn't have to look hard for those success stories. Los Angeles Police Department detective Michael Chang was an early ECMO patient at Saint John's whose near-death experience was featured in local news reports.
Chang had been assigned to robbery and gang investigations but was shifted early in the pandemic to working in uniform at COVID-19 testing sites, food giveaways and supermarkets. On March 30, he was admitted to a small Orange County hospital near his home with COVID-19. Six days later, he was intubated and placed on a ventilator.
As soon as Chang was intubated, his wife, Dana Chang, tapped into a network of police contacts in search of more advanced care. A captain put her in touch with an LAPD reservist who is also a surgeon, she said. That doctor told her about Saint John's and its ECMO program. He called Hammond, and a transfer was arranged.
"He was going downhill fast," Dana said of her husband. "If I left him there, he would have died."
Chang arrived by ambulance at Saint John's on April 7 and was immediately hooked up to an ECMO machine. On the evening of April 12, he was removed from the machine. He left the hospital five days later.
Michael Chang sometimes still experiences shortness of breath and bouts of a dry cough, but he credits ECMO with saving his life. "Prior to me getting it, I had never heard of ECMO," he said. "I had no idea what this thing is. The world needs to know about this."
Of the 39 COVID-19 patients placed on ECMO at Saint John's since the start of the pandemic, 15 are alive today. Hammond said most of them almost certainly would have died without ECMO.
Hammond is the first to caution that ECMO is not a miracle cure. About half the COVID-19 patients undergoing ECMO die in the hospital, according to a registry of more than 3,400 COVID-19 patients worldwide, though some centers have reported survival rates of as high as two-thirds.
Miguel's family said they knew ECMO wasn't a guarantee, just a chance, something the doctors at PIH were telling them he didn't have there. If it didn't work, they said, they would take comfort in knowing everything possible had been done to help him.
The Waiting List
The news of Miguel's pending transfer to Saint John's quickly gave way to a larger reality: There were lots of patients like Miguel in Los Angeles.
COVID-19 was surging. The number of COVID-19 patients in intensive care units had doubled in the three weeks since Miguel was hospitalized. At PIH Whittier, two weeks before he was admitted, 17 patients had COVID-19. The week Miguel arrived, that number swelled to 47. By the time he was intubated, there were 76. By Dec. 7, when the ECMO search began, there were 93.
At Saint John's, the ICU was full and unable to take in any new patients. While Hammond had approved the transfer of Miguel and had an ECMO machine to treat him, there were no beds available.
The waiting list was not something the family could see or monitor. There was no way to know who was ahead of Miguel, or why, or how fast people were moving up the list. At least at the deli counter or DMV, they could see numbers on a board, monitor their progress and make sure no one jumped the line. With Miguel's life in the balance, his family was completely in the dark.
"My dad didn't have anybody that would call to make him a priority," said Miguel Jr. "There was no way for us to hold anyone accountable for what they were saying. We just had to take them at their word."
Hammond said the waiting list is not influenced by a patient's wealth or social status, only whether they are medically qualified and "likely to survive this therapy." In the case of Miguel, she had approved him for ECMO when other hospitals said either they had no room or he didn't meet their criteria.
On Dec. 10, Miguel Jr. shared the bad news on the family chat that his father's transfer had not taken place the night before as hoped. "We have been calling my dads transfer case manager at the hospital and we even called saint johns and spoke to one of their case managers to try to speed up the transfer process but there is not much we can do but wait for a bed to open," he texted to the Familia group.
The next two days brought more waiting. "Call to Providence St Johns to follow up on ECMO spoke w/ Rachel, still no bed. no movement yet, same status," Miguel's caseworker at PIH wrote in her notes for Dec. 11.
By now Miguel had not been breathing on his own for a week and was becoming "more and more difficult to ventilate," according to hospital records.
The family didn't understand what it meant when hospitals said they had "no beds" in their intensive care units. Jeannette and Miguel Jr. called Saint John's to ask if they could buy a bed for their father. They did research to find out if donations were allowed to fund additional beds at the hospital, but were told it doesn't work that way.
Jeannette imagined ways to get inside the hospital and see with her own eyes that every one of its 266 beds was occupied. She looked into becoming a volunteer at Saint John's and found an application online.
Hammond said the phrase "not having a bed" was a euphemism for lacking enough nurses, respiratory therapists, perfusionists and doctors to care for patients who need intensive care. Saint John's expanded its ICU capacity from the normal 23 beds to 40, but adding beyond that meant stretching the staff too far.
On the morning of Dec. 12, nearly five days after the search for an ECMO bed began, the case manager told Miguel's family that he was in "the top 3" of those waiting for an ICU bed at Saint John's, according to the medical records. 12, saying that Miguel was third on a list of people waiting for an ICU bed at Providence Saint John's Health Center in Santa Monica. Credit: Courtesy of the Fernandez family
Less than an hour later, a team of doctors and nurses hurried to Miguel's room at PIH. The hospital had called a Code Blue. Miguel's heart had stopped. The team started chest compressions and administered drugs to restart his heart. It worked, but Miguel had suffered damage to his kidneys and other organs.
The next day around noon, someone from the Saint John's transfer center called a nurse at PIH Whittier to say that once again no beds were available. The PIH case manager told Saint John's that Miguel was in multi-organ failure, and might not survive the ambulance ride to the other hospital. Two hours later, Saint John's informed PIH it would no longer take Miguel as a patient "due to change in condition."
At 5:23 p.m., another Code Blue alert was sounded. This time, Miguel did not survive. In his room, a hospital worker gathered items left behind after his 26-day stay: an Apple laptop, an iPhone and a pair of cracked black-rimmed glasses.
"People Are Dying Waiting"
Miguel's wife, Alejandrina, at his funeral on Dec. 30, 2020. Credit: James Carbone for ProPublica
The story of Miguel's death and his family's scramble to get him potentially life-saving care has become a familiar one for Hammond.
She said she has had as many as seven people on her waiting list at one time, all in similarly desperate situations.
"Part of the PTSD I have, the nightmares I have, are as much having to say no and having people die on a waiting list," she said. "Those are all things that represent a lot of moral injury for physicians. We know the limitations the surge placed on our ability to do the best we can. People are dying waiting."
The rationing is not limited to Los Angeles. It is playing out across the country.
In Dallas, the ECMO unit at Baylor University Medical Center receives daily requests from across Texas and neighboring states on behalf of desperately sick COVID-19 patients. Their last chance at survival could come down to whether Baylor has a bed. "A few days ago I had five patients on my waitlist," Dr. Gary Schwartz, a lung transplant surgeon who leads the ECMO program at Baylor, said in an interview. "Two passed away while waiting. It is absolutely terrible."
Schwartz said his center, one of the busiest in the country, averaged about 120 ECMO patients a year before COVID-19. In 2020, that number grew to 158, and the number would have been higher if he had had additional capacity. "Quite honestly, there was an additional 50 to 100 who were appropriate but there were no resources for them," he said.
National guidelines created by the Extracorporeal Life Support Organization, a consortium of hundreds of ECMO centers, essentially call for rationing as the demand for ECMO spikes in regions saturated with COVID-19 cases. As surge levels escalate, "we recommend that selection criteria become more stringent to use this resource for those most likely to benefit," according to the guidelines.
Some centers have moved to implement an age cutoff for ECMO, or lower the age in existing guidelines. At Baylor, the maximum age of those considered appropriate for ECMO was dropped to 60 from 75 before COVID-19, Schwartz said. He said another center in the region reduced its age range to 50 or younger because it was overwhelmed with requests. "Many of the patients in the beginning were elderly, and we were afraid that if we had lots of those people that the younger people, 30 to 40, wouldn't have that available," he said. Schwartz said he has colleagues in Europe who think an age restriction is unethical. "In a perfect world, we would be using [ECMO] for the people most likely to survive," he said.
Schwartz and the directors of other ECMO centers in Dallas created an ad hoc group chat on WhatsApp to try to keep track of where beds were available as hospitals filled to capacity. "The real question is do we learn from this and change in the future to some kind of centralized process?" Schwartz said.
Hammond said the ECMO directors in Los Angeles have a similar arrangement where they text each other to find empty beds. The surge in Los Angeles is waning, and cases throughout the country are also going down. But new variants of COVID-19 are emerging, posing a threat of fresh surges. Hammond hopes the experience with COVID-19 will prompt the creation of a formal, permanent network to coordinate the care and movement of critically ill patients in Southern California.
Miguel's niece, Jhaimy, will become a doctor in five months and has been interviewing to do her family medicine residency training in Los Angeles. She's always been aware of healthcare disparities, and went to medical school to find ways to improve the system.
"It just pains me to see how typical a case my uncle was," she said. "He was Hispanic, mid-50s, an essential worker, not trusting of the healthcare system. He fit all the checks."
On Dec. 30, Jhaimy was one of dozens of family members who gathered to bury Miguel in a sprawling cemetery near his home.
A family friend organized a fundraiser to help defray the cost of the funeral. Miguel was his family's primary source of income, and since his death, bills have mounted.
A blue and white floral arrangement spelling out "PAPA" was placed on a stand near his grave. Underneath it was a photograph of a younger Miguel, wearing a white button-down shirt and a leather jacket.
The specter of COVID-19 hung over the graveside service. Everyone wore a mask. Miguel's mother slumped over his casket, gripping it with hands covered in clear medical gloves. She wore a face shield and a cloth mask.
Miguel's sister, left, and mother, at his casket. Credit: James Carbone for ProPublica
The burial did not bring Miguel's family members much closure. Jhaimy said she has wondered what would have happened if her uncle had not been so afraid to go to the hospital. Would he have survived if he had been treated sooner?
Miguel Jr. and Jeannette are troubled that Miguel's doctors didn't present ECMO as an option, and then resisted the idea when the family suggested it.
The family still thinks about what would have happened if an ECMO bed opened up in time.
"I believe with ECMO he would still be here today," Miguel Jr. said. "He never got the chance to fight."
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Prioritizing by age might seem like an obvious choice, given the disproportionate impact of the disease on the elderly. Setting the initial threshold at 75, however, ignores the fact that a smaller share of Black people reach that age than white people.
This article was published on Friday, February 12, 2021 in ProPublica.
MEMPHIS, Tenn. — Rosalyn Campbell and her husband, Calvin, are waiting for what may be the most in-demand item on the planet: the COVID-19 vaccine. They both caught the virus in November; Calvin Campbell tested positive just days after he’d been released from the hospital following open heart surgery.
After a weeklong stint in the hospital, he returned to his job as a buildings and grounds engineer, where he’s on light duty. But Rosalyn Campbell, who also has a heart condition, remains anxious.
“I’ve got to have it. … I want this behind me,” said Campbell, who retired from FedEx in 2013.
But it may be March before the couple, who are both Black and 65, are eligible to get the vaccine, based on the state’s age-based vaccination plan. Tennessee, like most states, gave first priority to those 75 and over, following the advice of the Centers for Disease Control and Prevention. As the virus’s death toll climbs to more than 465,000 nationwide, policymakers around the country are struggling to inject equity into vaccination policies.
Prioritizing by age might seem like an obvious choice, given the disproportionate impact of the disease on the elderly. Setting the initial threshold at 75, however, ignores the fact that a smaller share of Black people reach that age than white people. It also fails to account for research, released by the nonprofit Brookings Institution in June, showing that Black people who die of COVID-19 are, on average, about 10 years younger than white victims of the disease. (Data for Shelby County, Tennessee, where Memphis is located, bears this out as well.)
“If you [allocate the vaccine] strictly by age, you’re going to vaccinate white people who have lower risks before you vaccinate Black people with higher risks,” said Sarah Reber, co-author of the Brookings research and associate public policy professor at the UCLA Luskin School of Public Affairs.
“If you’re trying to avert deaths, you would want to vaccinate Blacks who are about 10 years younger than whites.”
The pandemic is expected to lower life expectancies nationwide, which will only exacerbate the Black-white life-expectancy gap. Before the pandemic, Black residents of Shelby County, on average, were expected to live to be 73 years and four months old, compared to 78 years and one month for white residents. What that means is that while 54% of the county’s residents are Black, Black people account for only 39% of residents 75 and up.
In Shelby County, the poverty rate is 25% higher than the statewide rate, and the residents who live below the poverty line are concentrated inside Memphis city limits.
Data from around the country — and from cities such as Washington, D.C., and Chicago — reveal vast disparities between where COVID-19 is hitting hardest and where shots are making it into arms. The latest national government data shows that when the race of the person getting the vaccine is known, Black residents are underrepresented; just over 5% of vaccine recipients were Black, compared to just over 60% who were white. By contrast, about 12% of the U.S. population is Black and 60% is white.
The population of Shelby County is 54% Black and 35% white. As of Feb. 6, 22% of Shelby County vaccine recipients are Black, compared to 43% who are white. (Around 16% are categorized as “Other/Multiracial/Asian,” while the remaining 18% or so are unknown).
Experts attribute the vaccination disparity to a number of factors, including poor internet access, lack of transportation and distrust of the medical system caused by racist practices such as the federal government’s Tuskegee syphilis study. The distrust becomes visible in a recent Kaiser Family Foundation survey in which a much higher share of Black people than white say they prefer to wait and see how the vaccine works before receiving it. (An equal share of white and Black respondents — 14% — say they definitely won’t get vaccinated.)
But these disparities aside, strict age cutoffs also play a role. Calculating the impact of those cutoffs is difficult because the age criteria are shifting downward as the rollout plan advances. Last week, the Shelby County Health Department announced that people over 70 are now eligible to be vaccinated. But that is unlikely to fully address the inequity built into the age-based system.
According to the state’s health disparities dashboard, Black residents of Shelby County have higher rates of infections, hospitalizations and mortality than white residents. Among residents between 65 and 74 whose race is known, Black people are notably overrepresented in COVID-19 fatalities, according to the SCHD, making up 67% of deaths in that age range, compared to 28% for white residents, as of Jan. 31.
Even before the vaccine rollout, some experts warned about the racial implications of prioritizing by age. Before the CDC issued its recommendations, a Chicago health disparities researcher and bioethicist raised her concerns about a “one-size-fits-all” age threshold during the public comments at a December CDC committee meeting.
“The burden of COVID mortality that we’re seeing in minority communities has shifted to much younger populations than what we are seeing in the non-minority populations,” said Dr. Monica Peek, an associate professor and physician at the University of Chicago.
The Tricky Balance of Efficiency and Equity
From the start of the pandemic, it has been clear how much harder communities of color have been hit. Late last month, two senators and a congresswoman from Massachusetts, all Democrats, sent a letter to the U.S. Department of Health and Human Services. “It is critical that the federal government’s vaccine deployment campaign does not fail the communities that have been forced to shoulder the greatest burden,” it read.
But reddressing that disparity in a vaccination rollout plan proved difficult. Reporting by MLK50 and ProPublica opens a window on those debates. The Advisory Committee on Immunization Practices, a CDC group of vaccinologists and medical and public health experts, was responsible for developing a national framework for vaccine approval and distribution. An ACIP work group decided in November to ground their work in four ethical principles: Maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.
Questions about how to handle race and ethnicity surfaced at the group’s June meeting. “How should racial and ethnic groups at high risk for severe COVID-19 be prioritized? Should race and ethnicity be a criterion for vaccine prioritization?” read the June meeting summary.
Four months later, ACIP answered its own questions. “It is critical for ACIP to address equity and disproportionate impact on disadvantaged populations,” reads the October meeting summary. But, the notes continue, “approaching this from a race/ethnicity standpoint is probably not the best approach.”
Prioritizing one group over another inevitably pushes others to the back of the line, experts say, and it’s not clear whether governments could legally specify different age cutoffs by race, or whether it would be feasible politically or possible logistically.
“In general our country is very reluctant to encode racial categories into law,” said Elizabeth Wrigley-Field, assistant professor of sociology at the University of Minnesota. Wrigley-Field, who is not on the ACIP committee, recently published research on racial inequality and life expectancy that suggests racism may be as deadly as the pandemic.
In some communities that have tried more race-specific solutions for vaccine distribution, the blowback has been swift. After early data showed residents in affluent and predominantly white neighborhoods were the primary vaccine recipients, the Dallas, Texas, County Commission decided in mid-January to target the most vulnerable ZIP codes. The very next day, Texas health officials announced that the state would shrink Dallas County’s vaccine allocation unless it abandoned the plan, which the county did.
Tennessee’s vaccination plan states that “equity remains a crosscutting consideration,” and sets aside 5% of its weekly vaccine allocation for counties, including Shelby, that rank high on the CDC’s social vulnerability index, which includes race as one of 15 factors.
“This allows those counties to vaccinate more people more quickly and move ahead in the phases,” said Tennessee Department of Health spokesperson Bill Christian in an email. He didn’t answer questions about how many doses Shelby County receives or if the doses are distributed based on population; to date, those numbers have not been made public.
Although ACIP and the CDC recommended the social vulnerability index as a proxy for race, that was a mistake, said Dr. Uché Blackstock, an emergency physician and CEO and founder of Advancing Health Equity, a national group that works with health care institutions to address health inequities. “That was an opportunity for the federal advisory committee to really make a statement about how racism has essentially created environments and limited opportunities,” she said. “Racism so explicitly harms Black people, but then in terms of addressing that and mitigating the impact of racism, we cannot use race explicitly.”
The Shelby County Divide
While COVID-19 is expected to lower the country’s life expectancy by more than a year, for Black residents, it will drop by more than five years, wiping away reductions in the Black-white gap made over the last 15 years, according to research from the University of Southern California and Princeton.
On a census tract level, the life expectancy disparities in Shelby County become even more stark. Even pre-COVID-19, the gap between a virtually all-white suburban census tract and a virtually all-Black one in Memphis stood at more than 19 years.
The county’s census tract with the highest life expectancy, 84.6 years, is in the suburban town of Collierville, in a neighborhood where some street names — Scarlett’s Way, Rhett’s Way and Taraview — are inspired by “Gone With The Wind.” Here the population is 96% white, the poverty rate is less than 1%, and the median household income of nearly $108,000 is twice that of the county.
More than 20 miles west is the neighborhood with the lowest life expectancy — 65.3 years. It sits in South Memphis, where a boulevard bears the name of a wealthy developer. The census tract is 96% Black, with a 42% poverty rate and a median household income of less than $20,000, less than half of the county’s.
Campbell and her husband live about 6 miles away, in a predominantly Black part of Memphis called Whitehaven. In her neighborhood, the life expectancy is 74.5 years, just shy of the 75 and older age bracket that was first to get the vaccine.
Both Campbell and her oldest sister, retired educator Linda Williams, live in almost all-Black census tracts where the poverty rate is higher than the county’s and household income is lower. The life expectancy in Williams’ neighborhood is even shorter, at 71.7 years. Williams, 69, recalls fondly her pre-pandemic life. In the before times, she kept busy with water Zumba and water aerobics. Now, she exercises on a stationary bike that sits near a window so she can look outside. “Can’t go to church, can’t go anywhere,” she said. Late last year, she lost a friend of 30 years to the virus, and she’s eager for the vaccine. “You see the numbers on the screen, but ... it hits you different when you actually know the person,” she said.
Struggling With Equitable Distribution and Access
Of course, being eligible to receive the vaccine isn’t the same as being able to access it. And the vaccination rollout in Shelby County, as in other communities, has been troubled in ways that worsen racial inequities.
As of Feb. 1, 24 states, including Tennessee, were publicly reporting COVID-19 vaccination figures by race and ethnicity, according to the Kaiser Family Foundation. As of Feb. 10, less than 7% of the state’s vaccine recipients were Black, compared to about 17% of the state's population.
As of Feb. 6, Shelby County’s vaccination rates have been highest along the Poplar Avenue corridor, a predominantly white swath of town that starts at the Mississippi River and runs southeast toward the county’s more affluent suburbs. Rates are far lower in the largely Black and less-affluent ZIP codes north and south of the Poplar corridor.
Other problems have plagued the rollout. In January, the SCHD made more than 10,000 appointments available online two and a half days before the phone lines opened. By then, all the appointments had been claimed, largely boxing out those without internet access, who tend to be disproportionately Black, elderly and low-income.
After a particularly troubled day in late January, in which people with appointments were turned away after waiting for hours, SCHD Director Alisa Haushalter apologized. “We recognize it was not what we want to deliver for the public and we’ll make adjustments to continue to improve,” she said during a press conference.
As community leaders’ demands for equity have grown louder, the SCHD opened a drive-through vaccination site in the predominantly black neighborhood of Whitehaven. The Tennessee health department also partnered with Walmart pharmacies in an effort to expand to “rural and underserved areas,” but only four of the county’s 11 Walmarts are in what can be considered underserved areas.
In an effort to address growing community complaints about equity, late last month the SCHD made the vaccine available at a Memphis commodity center in the city’s core. Through a federal program, the center distributes healthy food to elderly residents with household incomes around $22,500 for a family of two. In Memphis, that population is overwhelmingly Black. Two residents told MLK50 and ProPublica that several of their white, affluent friends got vaccinated at the center.
Campbell knows of people who have skipped the line, and other residents have told MLK50 and ProPublica that they've seen ineligible residents subvert the SCHD’s eligibility systems. Local news outlets have reported similar circumstances.
No one wants to waste doses, said Dr. Grace Lee, an ACIP member, but equity has to be as important as efficiency.
“We want to protect as much of the population as quickly as possible,” said Lee, who is also a professor of pediatrics at Stanford University School of Medicine. “But if you take a look at that alone, without also considering measures of equity, then what you focus on is potentially losing that balance.”
Without stronger federal involvement, “the problem is just going to get worse,” said Rachael DeCruz, chief of staff for Race Forward, a national organization that works to infuse equity into public policy.
Last month, a coalition of civil rights groups asked the Biden administration to create a White House office of racial equity and inclusion, which could assist with equitable vaccine distribution.
On a grassroots level, DeCruz also encourages people to organize and “not [let] up the pressure until we see some actual change.”
“If that started happening in Memphis and in places across the country in a really unified way, I think it could have a huge impact.”
The governor finally released data on nursing home cases after lawsuits and demands from lawmakers, but hundreds of presumed COVID-19 deaths have yet to be included in the state's official total.
This article was published on Friday, February 12, 2021 in ProPublica.
Hundreds of COVID-19 deaths among New York state’s nursing home residents still have not been formally acknowledged by the administration of Gov. Andrew Cuomo, according to the Empire Center, a public policy think tank in Albany.
Bill Hammond, an analyst with the Empire Center, said recent state disclosures of all deaths of nursing home residents, whether they perished in their facilities or at local hospitals, to date failed to include more than 650 deaths of people presumed to have died of COVID-19.
Hammond said the state referenced the deaths in a footnote to its public data release, saying that it is still seeking to verify the official cause of death in those cases.
In Columbia County, for instance, at a nursing home that local health officials said had seen 18 residents die of COVID-19 in local hospitals, the state’s public tally today still just lists nine such deaths.
After months of requests from state lawmakers, subpoenas from Congress and a lawsuit by the Empire Center, the Cuomo administration in recent weeks had finally begun to concede that thousands more nursing home residents had died of COVID-19 than previously made public. When the administration last month announced totals of those nursing home residents who had died in hospitals, the number of overall deaths swelled by 50%, from some 8,000 to more than 12,000.
Today, as the virus continues to ravage New York, slightly more than 15,000 residents of nursing homes and other adult care facilities have died of COVID-19, more than in any other state. Roughly 13,000 of those were nursing home residents, close to 13% of the state’s nursing home population.
A Cuomo administration spokesman declined to respond to questions about the hundreds of still uncounted nursing home residents.
The true toll of nursing home deaths has been a controversy for the administration from the outset of the pandemic. For more than six months it has been criticized for failing to publicly count the deaths that occurred in hospitals. The administration’s policy allowing patients who had tested possible to be sent from hospitals to nursing homes already struggling to prevent the spread of the disease provoked outrage. The state’s largest union for nurses sued the Health Department for policies it said endangered front-line health care workers.
On Thursday, Melissa DeRosa, Cuomo’s most senior adviser on the pandemic response, apologized to lawmakers for the delays in making basic death data available, saying the administration was worried the death tolls would arm Republicans in Washington in what it regarded as a political vendetta against the governor. The admission shocked lawmakers, who said it was no excuse for withholding information vital to the public’s understanding of the pandemic’s true toll.
Ron Kim, the Democratic chairman of the State Assembly’s Committee on Aging, said he and others almost didn’t believe what they had heard.
“They should not be apologizing to us,” Kim said, “they should be apologizing to the people of New York.”
DeRosa’s remarks, made in an online meeting with lawmakers and administration officials and reported first by the New York Post, set off calls for resignations and a criminal inquiry.
Peter Ajemian, an administration spokesman, suggested DeRosa’s remarks should not be taken out of context. He argued that the administration had made clear to lawmakers last summer that the data on hospital deaths was difficult to verify and pull together, and that releasing unconfirmed deaths in a partisan political moment was fraught. He suggested the state had intended to get the work done on hospital deaths by the fall, but the second wave of infections had made that impractical.
A wide range of lawmakers and health experts have long derided the administration’s claims that counting COVID-19 deaths at hospitals was complicated, and they note that the administration had been doing just that in the early days of the pandemic.
“They could have disclosed the raw data on hospital deaths of nursing home residents with the caution that work needed to be done to verify official totals,” Kim said.
“They could have done that at any time, at the start, in the early months, well before Republicans were calling for them to,” he added. “But they wanted to hide bad news. They wanted to control or change the narrative of the state’s performance.”
In an interview, Hammond described months of legal combat with the administration to make the hospital deaths public. In the end, a state judge ordered the administration to answer Hammond’s freedom of information requests.
“I still don’t think this is everything,” he said of the administration data releases to date.
For instance, Hammond said the state has still not released the dates and facility names of close to 1,000 COVID-19 deaths involving residents of adult care facilities other than nursing homes. The numbers of those residents known to have died of COVID-19 jumped from 219 to close to 1,800 when the state released its data on hospital deaths.
Hammond said the failure to make public the dates and locations of the deaths handicapped efforts to better understand how the pandemic’s toll unfolded over time and across the state.
For this to happen by the start of the next school year, trials need to prove the vaccine is safe and effective in children. Experts say manufacturers aren't moving quickly enough, and that this is important for achieving herd immunity and stopping the spread of variants.
This article was published on Thursday, February 11, 2021 in ProPublica.
Children as young as first graders may be able to get the coronavirus vaccine by the time school starts in September, presuming trials are successful in those age groups, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview with ProPublica.
"We're in the process of starting clinical trials in what we call age de-escalation, where you do a clinical trial with people 16 to 12, then 12 to 9, then 9 to 6," Fauci said. When asked what was the youngest age group that might be authorized for the vaccine by September, he said, "I would think by the time we get to school opening, we likely will be able to get people who come into the first grade."
As optimistic as Fauci is, several pediatricians and infectious disease experts said they wish the pediatric trials would move more quickly. In addition to restoring stability to the education system and parents' work schedules and keeping kids and those around them safe, vaccinating children is essential to helping the country, as a whole, reach herd immunity and decrease the threat of new variants.
Otherwise, "we're going to have tens of millions of individuals in our communities that are able to maintain the virus. And when that happens, what that allows is for these unusual variants to emerge that may have the ability to evade our immunity," said Dr. Buddy Creech, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program.
Despite the need, Pfizer is the only manufacturer whose pediatric vaccine trials are far enough along to potentially have data on elementary-school age children by the end of the summer.
Pfizer has finished enrolling participants in its study of 12- to 15-year-olds and anticipates having data in "the early part of 2021," according to a spokeswoman. "From there, we will plan to finalize our study in 5-11 year olds," she added. As Pfizer completes its trials in adolescents, then 5- to 11-year-olds, it'll need to submit the data to the U.S. Food and Drug Administration for review and get authorization for the vaccine's use in those age groups before it's available; currently in the U.S., the vaccine is indicated only for those ages 16 and up.
Moderna is still enrolling participants in its trial for adolescents ages 12 to 18, and it is "on track to provide updated data around mid-year 2021," the company said in an emailed statement. Stéphane Bancel, Moderna's chief executive officer, has said that the company's goal is to have data from the adolescent study in advance of the 2021 school year. Moderna said it'll begin an age de-escalation study in children ages 11 years to 6 months this year, but Bancel has said that the company doesn't expect clinical data until 2022.
Johnson and Johnson hasn't started any pediatric studies yet. "We are in discussions with regulators and partners regarding the inclusion of pediatric populations in our development plan," a spokesman said. Novavax, similarly, hasn't begun any trials in children, and a company spokeswoman said it couldn't share any details at this time. The University of Oxford, which partnered with AstraZeneca in developing a vaccine, will begin tests in 12- to 18-year-olds next month, according to Bloomberg News.
The American Academy of Pediatrics has been "really advocating to try and make these trials happen with the same urgency that they happen for adults," said Dr. Sean O'Leary, who is vice chair of its committee on infectious diseases.
The manufacturers will need to prove vaccines are safe and effective in younger bodies. The adult trials paved much of the way, but researchers still need to study how kids' immune systems react and to confirm the optimal dosage. And even if the shots are authorized by September, there will need to be enough supply on hand in order to get school children immunized before school doors open.
It's essential to act expeditiously, O'Leary said. "I would love to see a vaccine available for all children in time for the next school year."
Why It's Important to Vaccinate Kids Against COVID-19
Early on in the pandemic, some thought that children might be entirely immune. That's clearly been disproven. Out of more than 20 million U.S. cases where age information is available, about 2.2 million, or 11%, have been in children under 18. Some get very ill, though this is rare. As of Feb. 8, the Centers for Disease Control and Prevention has tracked more than 2,000 cases of what's known as multisystem inflammatory syndrome in children (MIS-C), a serious condition associated with COVID-19 that can result in cardiac dysfunction and kidney injury; 37% of the cases recorded were in Latino children and 32% in Black children.
It's also become evident that children are capable of transmitting the virus to some extent. On one hand, kids aren't superspreaders: COVID-19 is clearly dissimilar to influenza or the common cold virus, Vanderbilt's Creech pointed out. "You put one of those in a classroom, then in a few days, it's overrun," he said. "That's not what we see with COVID." But exactly how infectious children are remains somewhat unclear, in part because schools have not been fully open, making it hard to gather data, said Dr. Yvonne Maldonado, a pediatrician and professor of global health and infectious diseases at Stanford University. Studies from other countries, while informative, may not always extrapolate well to the U.S., she added.
So while the "preponderance of data" points to children being less likely to infect people when compared with adults, "they certainly do," said O'Leary, who is also a professor of pediatrics at the University of Colorado School of Medicine. "So, if you've got vulnerable people in the household and your 7-year-old comes home with COVID, it's not to say they can't give it to anybody else. They absolutely can. It's just a bit less likely."
It's important to note that the vaccines have only been proven — so far — to prevent disease and not infection (data on that is harder to gather and takes longer to prove), which means it's not guaranteed yet that vaccinated individuals can't spread the coronavirus.
But there are some inklings of hope that vaccination can at least reduce onward transmission. So if this bears out, the more people who are vaccinated in a community, including children, the more likely transmission will drop overall.
"Our current chaos about children not being in schools is just terrible for children, and I think a lot of the concern would be assuaged if children were immunized," said Dr. Sarah Long, professor of pediatrics at the Drexel University College of Medicine. "That doesn't mean to me that they can't get the infection or transmit it every once in a while, but it would reduce those possibilities tremendously."
Long is also a member of the CDC's Advisory Committee on Immunization Practices, where she has been reviewing the trial data and helping to make recommendations on how the vaccines should be used. She continued: "There are real virus control reasons, there are real societal reasons and there are economic reasons, because if children can't go to school, people can't work."
O'Leary said children as young as 6 months, which is the youngest age that Moderna plans to test, can get vaccinated so long as trial data shows the vaccines to be safe and effective. Infants under 6 months are likely to be protected by antibodies transferred through the placenta if the pregnant mother is vaccinated, he added.
How the Vaccine Will Be Studied in Kids
The pediatric vaccine trials will not be as large as the final stage adult trials, which enrolled 30,000 or more participants, giving a placebo to half and the vaccine to half. Pfizer's 12- to 15-year-old study has enrolled 2,259 participants and Moderna's adolescent trial is a similar size, aiming for about 3,000 participants. In both trials, some teens will receive a placebo.
That's enough to prove safety and benefit, experts said, in part, because the adult trials have already paved the way. To show the vaccine is safe, among the many things that Pfizer is tracking includes the percentage of participants reporting "local" reactions such as pain at the injection site, redness and swelling, as well as the percentage of participants reporting systemic reactions such as fever, headache, chills, vomiting, diarrhea, muscle pain and joint pain.
After the trials are completed, tracking for any safety issues will continue in the real world as physicians and patients will be encouraged to report to the FDA and CDC any side effects they think may be due to the vaccine.
Doctors said they'd want to make sure that there are no signs that the vaccine overinflames the immune system or causes any allergic or autoimmune responses. "I think most people that are developing these vaccines feel like the vaccine is not going to trigger MIS-C, but it's something that will be monitored for very closely both in the trials and more importantly, post-licensure," added O'Leary, from the University of Colorado. Maldonado said she'll also be on the lookout for any cases of Guillain-Barré syndrome, which is often a concern when it comes to vaccines, but she noted that no significant increases in cases were seen in any of the adult trials.
When it comes to proving benefit, the pediatric trials will focus on a different metric than the adult trials. The adult trials' primary efficacy measure was to compare how many vaccinated people wound up sick with COVID-19 symptoms compared with those who received the placebo and whether the vaccine impacted the severity of illness. Since children rarely are hospitalized due to COVID-19, the vaccine's ability to reduce severe cases would be hard to measure unless the trials enrolled an enormous number of children.
Instead, Pfizer's and Moderna's adolescent trials will focus on evaluating participants' immune response by measuring antibodies, according to Pfizer's spokeswoman and Moderna's clinical trial website.
Scientists haven't yet identified an "immune correlate of protection," which is usually defined to be the level of antibodies in the blood at which they can feel confident that a person is going to be protected from infection. Some vaccines that have been approved, like the one for measles, have an immune correlate of protection identified, while others don't.
In the absence of a definitive immune correlate of protection, the trials would compare antibody levels in children with those found in adults and extrapolate that the efficacy should then be similar. The FDA and advisory groups like the CDC's Advisory Committee on Immunization Practices would then need to discuss whether the evidence is compelling. If scientists are able to identify an immune correlate of protection, however, "and you can demonstrate that kids get that with the vaccine, that's even more satisfying," O'Leary said.
One final difference in pediatric studies is the potential for lower doses. Moderna has said that it will run its studies of children under 12 testing lower doses first.
"As we go down in age, we give the smallest possible dose of vaccine that we think is reasonable, and then we steadily increase until that point when we get that magic 'Goldilocks' level at which it works great and the side effects are tolerable," Vanderbilt's Creech explained. "I don't think one dose fits all."
A Call to Speed Pediatric Trials
Some pediatricians and infectious disease experts said they were eager for pediatric studies to move faster.
"My understanding is that the entity formerly known as Operation Warp Speed had a lot of involvement with those adult trials, but with pediatric clinical trials, they're not having the same degree of involvement," O'Leary said. "So it's more up to the manufacturers, and from my perspective, these manufacturers don't have the financial incentive to conduct these trials with the same urgency that they did with the adult trials."
Stanford's Maldonado added that she's concerned that there's not as much pressure on the manufacturers to recruit children of diverse backgrounds as there was for the adult trials."I think it's important to get those kids in to understand factors around the actual vaccine and also to get buy-in of those communities where we're seeing more hesitancy. We want to make sure they are feeling comfortable about being represented," she said.
While O'Leary is not as confident as Fauci that we'll see Pfizer's data on younger kids by September, he feels very optimistic about the availability of a vaccine in the coming months for kids as young as 12, who tend to get sicker than the younger age group.
"I think that's a really big deal," he said.
Caroline Chen covers healthcare for ProPublica. She is currently reporting on the coronavirus pandemic.
Governors continue to open indoor dining and other activities before vaccinations become widespread. Experts warn this could create superspreading playgrounds for dangerous variants and squander our best shot at getting the pandemic under control.
This article was published on Saturday, February 6, 2021 in ProPublica.
On Jan. 29, New York Gov. Andrew Cuomo was promoting “marital bliss” at a coronavirus news conference.
Announcing that indoor dining would reopen at 25% capacity in New York City on Valentine’s Day, and wedding receptions could also resume with up to 150 people a month after, Cuomo suggested: “You propose on Valentine’s Day and then you can have the wedding ceremony March 15, up to 150 people. People will actually come to your wedding because you can tell them, with the testing, it will be safe. … No pressure, but it’s just an idea.”
Cuomo isn’t alone in taking measures to loosen pandemic-related restrictions. Michigan Gov. Gretchen Whitmer allowed indoor dining to resume at 25% capacity starting Feb. 1. Idaho Gov. Brad Little increased limits on indoor gatherings from 10 to 50 people. Massachusetts Gov. Charlie Baker is raising business capacity from 25% to 40%, including at restaurants and gyms. California Gov. Gavin Newsom lifted stay-at-home orders on Jan. 25.
To justify their reopening decisions, governors point to falling case counts. “We make decisions based on facts,” Cuomo said. “New York City numbers are down.”
But epidemiologists and public health experts say a crucial factor is missing from these calculations: the threat of new viral variants. One coronavirus variant, which originated in the United Kingdom and is now spreading in the U.S., is believed to be 50% more transmissible. The more cases there are, the faster new variants can spread. Because the baseline of case counts in the U.S. is already so high — we’re still averaging about 130,000 new cases a day — and because the spread of the virus grows exponentially, cases could easily climb past the 300,000-per-day peak we reached in early January if we underestimate the variants, experts said.
Furthermore, study after study has identified indoor spaces — particularly restaurants, where consistent masking is not possible — as some of the highest-risk locations for transmission to occur. Even with distanced tables, case studies have shown that droplets can travel long distances within dining establishments, sometimes helped along by air conditioning.
We’re just in the opening stage of the new variants’ arrival in the United States. Experts say we could speed viruses’ spread by providing them with superspreading playgrounds or slow them down by starving them of opportunities to replicate.
“We’re standing at an inflection point,” said Sam Scarpino, assistant professor at Northeastern University and director of the school’s Emergent Epidemics Lab. Thanks to the arrival of vaccines, he said, “we finally have the chance right now to bring this back under control, but if we ease up now, we may end up wasting all the effort we put in.”
Dr. Luciana Borio, an infectious disease physician who was a member of the Biden-Harris transition team’s COVID-19 advisory board, put it more bluntly at a congressional hearing on Feb. 3. “Our worst days could be ahead of us,” she said.
I interviewed 10 scientists for this story and was surprised by the vehemence of some of their language. “Are you sure it could be that bad?” I asked, over and over.
They unanimously said they expected B.1.1.7, the variant first discovered in the U.K., to eventually become the dominant version of coronavirus in the U.S. The Centers for Disease Control and Prevention has estimated that B.1.1.7 will become dominant in March, using a model that presumes it’s 50% more transmissible than the original “wildtype” coronavirus. The model’s transmission rate was based on experience in the U.K., which first detected B.1.1.7 in September and saw an increase in cases that became apparent in December, straining hospitals despite stringent closures and stay-at-home orders. So while our country appears relatively B.1.1.7-free right now, the situation could look drastically different in a matter of months.
Experts are particularly concerned because we don’t have a handle on exactly how far B.1.1.7 has spread. Our current surveillance system sequences less than 1% of cases to see whether they are a variant.
Throwing an even more troubling wrench into the mix is that B.1.1.7 is continuing to morph. Just this week, scientists discovered that some B.1.1.7 coronaviruses in Britain had picked up a key change, known as the E484K mutation. That mutation had previously been found in the B.1.351 variant, which was first discovered in South Africa. Scientists have hypothesized that it’s the E484K mutation that has reduced the efficacy of some vaccines in South African trials, so this is incredibly worrying news.
“It’s really hard to thread this needle without sounding like a prophet of doom,” said Angela Rasmussen, a virologist at Georgetown University’s Center for Global Health Science and Security. While vaccines bring hope, she said, governors who are moving to expand indoor dining are “completely reckless”; if they don’t course correct, “I don’t think it’s hyperbolic to say the worst could be yet to come.”
The choices that our federal and state leaders make right at this moment will determine if we can bend the curve once and for all and start ending the pandemic, or if we ride the rollercoaster into yet another surge, this one fueled by a viral enemy harder to fight than ever before.
All of us have agency in deciding this narrative, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, stressed. “Certainly you need to be prepared for the possibility that things might get worse in the light of the variants, but that is not inevitable because there are things that we can do to mitigate against it,” he said in an interview. “We're not helpless observers of our own fate."
Fauci urged states to “double down on your public health measures … to have virtually everybody wear masks, to have everyone maintain social distance, to have everybody avoid congregate settings, and to have everybody wash their hands very frequently.”
And don’t wait until it’s too late, warned Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
“We are so good at pumping the brakes after we’ve wrapped the car around the tree,” he said. The new variants aren’t being complacent. “There’s still a lot of human wood out there for this coronavirus to burn.”
To understand the epidemiologists’ warnings, it helps to understand what variants are, how they have been behaving and our limitations in knowing exactly how far they have spread.
People have a bad habit of anthropomorphizing the coronavirus: ascribing human-like intentions to it, as if a microbe can discern that we finally have a vaccine and try to evade it. But viruses don’t really have any schemes; they just reproduce. “Coronaviruses are a single strand of RNA in a sac of fat,” epidemiologist Larry Brilliant reminded me. “They’re preprogrammed to replicate and continue replicating. That’s their job.”
Once in a while, when a virus replicates, a mistake occurs, and a letter in the strand of RNA is copied inaccurately. That’s called a mutation. Many times, those mutations are neutral. Sometimes they are detrimental to the virus, and that lineage will quickly die off. Other times, they’re beneficial to the virus in some way, such as by making it more transmissible. When a version of the virus becomes functionally different, that’s when scientists consider it a variant.
As of Feb. 4, according to the CDC, the U.S. has found 611 cases of B.1.1.7, the variant first discovered in the United Kingdom, five cases of B.1.351, first identified in South Africa, and two cases of P.1., first identified in Brazil. But that’s almost certainly an undercount.
Part of the reason why epidemiologists are advocating for us to stay hunkered down is because the U.S. doesn’t know exactly where all the variant cases are.
The term that public health uses is “surveillance.” I like to think of it as having eyes on the virus. In order to have good eyes on where coronavirus infections are in general, all you need is the regular swab tests that we’re all familiar with. But in order to tell whether a positive case is the wildtype coronavirus or one of the more nasty variants, an additional step is needed: genomic sequencing. For that, the sample needs to be sent on to a lab that has specialized machinery capable of conducting sequencing.
Until recently, sequencing in the U.S. was a patchwork effort, conducted by a mix of academic and public health agency labs keen to track the evolution of the coronavirus. Though the CDC hosted a weekly call where those scientists already conducting sequencing could compare notes, there was no dedicated federal funding or coordination to ensure that samples were routinely gathered from across the country.
Today, the U.S. sequences less than 1% of its total cases. This is a pittance compared to the U.K., which sequences around 8-10% of its positive test results. But volume alone isn’t the only thing that matters. Representation, meaning where the samples come from, is another crucial factor. Since most of the sequencing so far has come from voluntary efforts, the U.S. has suffered from uneven visibility, with a whole bunch of eyeballs in parts of the country that are biotechnology and academic hubs, like Boston, San Francisco and San Diego, and less in “surveillance deserts” like North and South Dakota. There, barely any samples have been sequenced at all, even when those states had explosions of COVID-19 cases.
Dr. Phil Febbo is chief medical officer at Illumina, one of the world’s biggest sequencing technology companies. Like so many parts of the coronavirus response, keeping a lookout for variants has suffered from a lack of federal leadership, Febbo said. As early as March of last year, Illumina representatives began meeting with federal agencies, advocating for a national genomic surveillance system.
“We talked to any three-lettered agency we could,” Febbo said. “Those conversations were cordial: They said they heard what we were saying, but then they’d say, ‘But we need more tests, but can you do it in five minutes, can it be point-of-care?’” It wasn’t until Dec. 18, when B.1.1.7 was taking off in the United Kingdom, that Illumina finally got a call from the CDC offering to sign a contract with the company. (Since December, CDC has engaged Illumina to do surveillance work by signing twocontracts potentially worth up to $4.6 million.)
Today, Illumina sequences positive samples that are passed on from a diagnostic testing company, Helix. Each RNA strand of the SARS-CoV-2 virus has about 30,000 nucleotides, each represented by one of four letters. Illumina’s sequencers read through each sample’s code and compare each letter to a reference sequence, looking for significant changes. The data gets passed back to the CDC, which uses location data stripped of personal identifiers to map the spread of any variants that Illumina has picked up.
The CDC said it has contracted with several large commercial companies with the goal of sequencing up to 6,000 samples a week by mid-February. Through another program, called the National SARS-CoV-2 Strain Surveillance System, state public health labs are supposed to send a total of 1,500 samples to the agency every other week. This program went into effect on Jan. 25 and is still ramping up, according to a CDC spokesperson.
Febbo says more can be done to increase surveillance. He notes that the Biden administration, while clearly more invested in variant surveillance than the Trump administration, hasn’t set a public target in the same way it has for vaccinations with its “100 million shots” campaign. Illumina estimates that sequencing 5% of all samples would allow us to be confident that we are catching all variants of concern, and he would like the Biden administration to make that a public goal. It can be done, Febbo says: “It hasn’t been the lack of capacity, it’s been the lack of will.”
Having clearer information about where variants are would give governors and local officials actual information with which to make decisions. Then they could say with confidence, “We can open indoor dining because we know that the variants aren’t circulating in our community.” Absent that information, the only thing we can do is act like the variants are here.
The good news is that so far, the vaccines that have been made available to the public appear to be reasonably effective against the coronavirus variants. They may be slightly less effective against B.1.351, the variant discovered in South Africa, but none of the variants are total “escapes,” so a vaccine should offer you at least partial protection against any form of the coronavirus you encounter.
All of the available shots give your immune system some familiarity with the virus, allowing it to be more prepared to meet the bug in the wild, whether it’s the original strain or a variant. Having a savvier immune system, in turn, means that even if you do get infected, you’re less likely to need to be hospitalized, and less likely to die.
“Regardless of what’s happening with this variant, we’re much better with [people’s immune systems] seeing SARS-CoV-2 after seeing the vaccine than not,” said Derek Cummings, a biology professor at the University of Florida’s Emerging Pathogens Institute.
However, we’re not very far along with vaccinations yet. As of Feb. 4, only 2.1% of the U.S. population had been reported to have received both doses of the vaccine; 8.5% had received one dose. That means we’re in a precarious moment right now where the vast majority of the U.S. hasn’t had a chance to get protected, and the variants have a window to multiply. (Of course, those who have already gotten sick with COVID-19 have natural immunity, but some scientists are concerned that those who develop only mild symptoms may not gain as much innate immunity as those who receive a vaccine.)
Of the scientists I talked to, Caitlin Rivers, a computational epidemiologist at Johns Hopkins Center for Health Security, was the most optimistic about a potential variant-fueled surge. “I do think that B.1.1.7 has the possibility to precipitate a wave, but it probably won’t be as bad as the last wave, because we have a lot of preexisting immunity and we are rolling out the vaccines,” she said. Thanks to the vaccines, the U.S. will have more population immunity by March, when the CDC predicts B.1.1.7 will become dominant, than the U.K. did when the variant hit there late last year. “It’s a low likelihood that we will have a gigantic fourth wave, but not impossible,” she said.
Still, Rivers said, “now is not the time to relax.” She, too, was critical of state policies to loosen restrictions. “When you create the same conditions that allowed the last surge, you should expect the same results,” she said. “Our main move should be to reduce transmission as much as possible while we vaccinate as much as possible.”
Time is not on our side, as the morphing B.1.1.7 variant showed us when it picked up the E484K mutation. While we are lucky that our vaccines still work against the current variants, we have to keep in mind that in this race between vaccines and variants, the variants aren’t staying static.
The big fear is that eventually, a variant will come along that provides the virus with a complete immune escape, preventing our vaccines from working against it. Even though we can update our vaccines, that would take time. The only way to guarantee that the virus won’t mutate into a variant that our current vaccines don’t cover is to lower transmission significantly, said genomic epidemiologist Alli Black: “The virus will continue to mutate as it continues to spread. We’re not going to stop that biological fact unless transmission stops.” And vaccinating everyone quickly is one key way to make it harder for the coronavirus to get from person to person in the first place.
“We need to start responding like the variants are going to take over and they are one of the biggest threats,” said Cummings, “or we won’t have vaccinated enough people when this rolls through.”
Throughout this pandemic, the U.S. has often been in the fortunate position of not being first when it comes to novel viral encounters. We weren’t the country where SARS-CoV-2 originated. We weren’t the place where B.1.1.7 was spawned. We’ve had the opportunity to look to other countries and learn from them, if only we’d choose to.
Epidemiologist after epidemiologist pointed out that the U.K., Denmark and Portugal required drastic measures — the dreaded L word, “lockdown” — to get B.1.1.7 under control. “We’ve seen that multiple different countries in Europe have had to close schools after making it a policy that schools would be the last to close,” Rivers, from Johns Hopkins, noted.
If we don’t want the same fate to befall the U.S., now is the time to act, the scientists urged.
Improving surveillance can help. Utah Public Health Laboratory has a robust state sequencing program, analyzing a random sample of cases sent by the state’s two largest hospital groups. Kelly Oakeson, its chief scientist for next generation sequencing and bioinformatics, has set a goal of sequencing 10% of all cases in the state; his lab is currently doing about 3%. They could do more, he said. The only problem is that they don’t have enough pipette tips due to a national shortage. Oakeson said he’s hoping that the Biden administration will leverage the Defense Production Act to produce more pipette tips so he can increase his state’s surveillance capabilities.
“We can’t get transmission down through vaccination alone,” said Rasmussen, the Georgetown virologist. “We need to be encouraging leadership, both at the state and federal levels, to protect people, to have paid sick leave for people if they become symptomatic.”
A restaurant server in New York City, who was laid off early in the pandemic from a high-end steakhouse, told me he understood what the epidemiologists were saying from a scientific point of view. But, he asked, “if you want to shut everything down, who’s going to pay the bills?”
He continued, “In order to do what the epidemiologists want to get done, you can only do that with policies to support the people and make it worth their while to do it.” He’s job hunting, and he said that if he was offered a position that put him indoors on Valentine’s Day, “I would have to take it.” He’d put on a double mask and go to work.
Whenever we have options, though, individual decisions can make a difference. Black, the genomic epidemiologist, encouraged everyone to limit travel as much as possible: “It just really facilitates introductions of these circulating variants.”
Hang in there, urged Scarpino, the Northeastern professor, painting a hopeful picture: “Cases are coming down, vaccines are going up. Let’s pretend that politicians wake up and don’t reopen restaurants and we avoid a big wave in March. Then we’re running downhill on the vaccines because the pipeline gets better and better. Then we can get our lives back.”
That sounded so tantalizing. Dream-worthy. Just a matter of good science-based public policy and collective compliance driving down the case counts until those little mindless RNA-filled fat sacs have nowhere to go, no one to infect, no way to replicate, no chances to mutate. I imagine them bumping around, lost without crowded indoor spaces to breed in, thwarted by vaccine-boosted immune cells, unable to find a host, dwindling, going, gone.
Private equity firm Leonard Green and other investors extracted $645 million from Prospect Medical before announcing a deal to sell it and leave it with $1.3 billion in financial obligations. Four states approved it — but Rhode Island is holding out.
This article was published on Thursday, February 4, 2021 in ProPublica.
In a David-and-Goliath battle, a group of Rhode Island officials and a union for hospital workers have so far stymied a multi-billion-dollar private equity fund's attempt to unload its controlling stake in a national for-profit hospital chain.
Investors led by the private equity firm, Leonard Green & Partners, previously extracted $645 million in dividends from the investment, and the firm now seeks to leave behind another $1.3 billion in financial obligations at the chain.
In the face of more than a year of often-vehement public opposition in Rhode Island, the hospital chain suddenly agreed in the final days of December to pay $27.25 million to resolve a group of lawsuits they had previously refused to settle. But a Jan. 29 deadline for the state to approve the deal has been extended indefinitely and other obstacles remain.
Leonard Green and the hospital chain, Prospect Medical Holdings, were the subject of a ProPublica investigation in September that explored Prospect's history of patient-care violations — including some that posed "immediate jeopardy" to patients, according to multiple government findings — along with complaints about deteriorating facilities, broken financial commitments and allegations of Medicare fraud surrounding the company. These problems surfaced over the past decade, after the private equity firm purchased the company in 2010. Prospect has defended its quality of care and denied any improprieties.
Leonard Green, which owns about 60% of the hospital chain, announced plans in October 2019 to sell its stake to Prospect CEO Sam Lee and his longtime business partner for $12 million plus the assumption of $1.3 billion in lease obligations. The $12 million is to be paid by the company, not the two executives. As Prospect previously told ProPublica, "In effect, the company's money is their money." At the time the deal was announced, Prospect said it expected the sale to close by the spring of 2020.
The transaction breezed past regulators in four states where Prospect owns a total of 15 hospitals. But not so in Rhode Island, where Prospect owns its other two hospitals. The sale of the two Rhode Island hospitals — and thus the entire deal — requires approval from the state's health department and attorney general, which first must conduct a review process to assure the transaction meets nine statutory criteria.
The Rhode Island officials have subjected the transaction to a high level of scrutiny. There have been multiple rounds of public hearings and questions to both Prospect and Leonard Green, generating thousands of pages of submissions in response. The state has sought details on topics such as COVID-19's impact on the company's finances and has requested interviews with multiple company officials, including the CEO.
As criticism of Prospect grew during 2020, Rhode Island officials first delayed their decision on the sale to November, citing missing documents and unanswered questions, then extended it again to the end of January 2021. On Jan. 18, the health department and attorney general wrote to Prospect confirming that the Jan. 29, 2021 deadline would be "extended," and advised the company, "as of this date, we do not have a new deadline for completing the review."
Proposed legislation in Rhode Island threatens to further stall the deal. The bill comes from state senate president Dominick Ruggerio, a Democrat, who previously wrote a letter urging regulators to subject the Prospect sale to "the utmost scrutiny" and warning that approval posed "a probability of serious harm to the health and welfare of all Rhode Islanders." On Jan. 12, Ruggerio introduced a bill, citing Prospect's two Rhode Island hospitals, that would impose a one-year moratorium on all hospital ownership transfers "involving a for-profit corporation as acquiree or acquiror." The bill has nine co-sponsors.
Prospect and Leonard Green declined to comment on the bill. Responding to questions through an outside spokesman, they said they have no intention of abandoning their plans for the company's sale. "Based on our communications with RI regulators," they stated, "we expect to complete the transaction in the coming months."
Prospect has managed to silence one prominent group of Rhode Island critics by reversing course and, on Dec. 30, agreeing to settle multiple fraud lawsuits with a $27.25-million payment. The money is part of a broader settlement with the court-appointed receiver for the employee retirement plan at Our Lady of Fatima hospital, one of Prospect's two facilities in the state. The plan was declared insolvent and placed in receivership in 2017. The receiver then sued the company, asserting that Prospect had misled the public and 2,700 current and past hospital employees about the pension fund's financial health. The receiver demanded that Prospect help make the fund whole. The company denied the claims, pointing out that its 2014 purchase of the hospitals included contract language absolving it of any future liability for the retirement plan.
The settlement, subject to multiple court approvals that will take several months, will end the receiver's public opposition to Prospect's pending sale. As late as Dec. 10, the receiver's special counsel told a public hearing that Lee and his partner were "predators," using the hospitals "as their private piggy banks." A financial consultant for the receiver also warned in a report that Prospect's financial statements through fiscal year 2019 (even preceding the financial stress caused by the COVID-19 pandemic) revealed a worsening "state of insolvency" and "imminent" bankruptcy, absent a big capital infusion. (A Prospect spokesman disputed the claim, insisting that the company had "ample liquidity." The company's 2020 financial results have not been made public yet.)
The settlement agreement explicitly requires the receiver to notify state regulators that his objections to the sale are withdrawn. It also bars "any statements to media which would reasonably be expected to cause the reader or hearer thereof to question the solvency or honesty of, or the quality of care or other services provided by" Prospect.
Other Prospect critics remain undeterred. They include United Nurses & Allied Professionals, the union for hospital workers at Our Lady of Fatima; elected officials, including five Democratic members of the U.S. Congress, Rhode Island's state treasurer and its senate majority leader; and the Private Equity Stakeholder Project, a union-backed research group that has produced critical reports about Leonard Green's conduct and lobbied the firm's public pension fund investors.
Prospect has conducted a public relations counter-offensive. After the retirement plan settlement was announced, the company took out a large ad in The Providence Journal, stating that by making the $27 million payment, it was "helping our retirees and employees," and doing so "because we are fully committed to Rhode Island." A second ad solicited support for the company's sale: "Today, Prospect seeks state approval to allow its founders to buy out the outside investors in Prospect. With all that Prospect has done for Rhode Island, and will continue to do, we hope the state will recognize the benefits and approve this request." The company issued a press release noting that an outside monitor for the state had found that Prospect had met the commitments it had made for capital spending at the two hospitals.
The union is responding to Prospect's claims with a postcard that is being mailed this week to 4,000 state opinion-makers. It warns: "RHODE ISLANDERS BEWARE! PROSPECT MEDICAL HOLDINGS IS A WOLF IN SHEEP'S CLOTHING." The mailer urges recipients to press state officials to reject the proposed sale.
Chris Callaci, general counsel for the Fatima hospital union, said his group is also considering running a radio ad to boost public opposition to the sale. The union, which initially welcomed Prospect's acquisition of the two hospitals in 2014, has waged a series of battles with company management in the years since.
Callaci told ProPublica that attorneys representing Prospect approached him to explore what it would take to get the union to drop its opposition, but that the discussions went nowhere. "We can't find anything that will make us feel comfortable they'll be good stewards of these safety-net hospitals in Rhode Island," he said. "As far as the union's concerned, they're not welcome in Rhode Island."
At least part of the delay in approving the sale in Rhode Island appears to be self-inflicted by Prospect. In late October, the company — which has a lengthy history of litigation — threatened to sue an accounting firm hired by Rhode Island to assess the deal because a former accountant at the firm made critical comments to ProPublica about a company that Prospect CEO Lee had been involved with more than a decade ago. In response, Rhode Island terminated the accounting firm's contract to avoid any "perception of impropriety, motivation, and influence." The state informed Prospect that the termination would delay the review process as Rhode Island needed to hire a new accounting firm. That in turn led Prospect to retract its threat of legal action and say, in effect, never mind.
It was too late. Prospect's about-face, a Rhode Island official responded, couldn't remove "the initial taint of the original receipt of threatened litigation." (Prospect declined to comment on this matter.)
Peter Elkind is a senior reporter covering the Trump administration.
A key House subcommittee cited reports by ProPublica and other news outlets in launching an investigation into how the country's meatpacking companies handled the pandemic, which has killed hundreds of workers to date.
This article was published on Thursday, February 4, 2021 in ProPublica
By Bernice Yeung and Michael Grabell A key congressional panel launched an investigation this week into the wave of COVID-19 infections that killed hundreds of workers at meatpacking plants nationwide last year and highlighted longstanding hazards in the industry.
Since the start of the pandemic, the meat industry has struggled to contain the virus in its facilities, and plants in Iowa, South Dakota and Kansas have endured some of the biggest workplace outbreaks in the country.
The meat companies' employees, many of them immigrants and refugees, slice pig bellies or cut up chicken carcasses in close quarters. Many of them don't speak English and aren't granted paid sick leave. To date, more than 50,000 meatpacking workers have been infected and at least 250 have died, according to a ProPublica tally.
The congressional investigation, opened by the House Select Subcommittee on the Coronavirus Crisis, will examine the role of JBS, Smithfield Foods and Tyson Foods, three of the nation's largest meat companies, which, the subcommittee said, had "refused to take basic precautions to protect their workers" and had "shown a callous disregard for workers' health."
The subcommittee is chaired by Rep. James E. Clyburn of South Carolina, the No. 3 Democrat in the House.
In response to the subcommittee's announcement, officials for JBS and Tyson said that the companies had spent hundreds of millions of dollars to implement coronavirus protections and to temporarily increase pay and benefits, and they looked forward to discussing their pandemic safety efforts with the panel. Smithfield said in a statement that it had also taken "extraordinary measures" to protect employees from the virus, spending more than $700 million on workplace modifications, testing and equipment.
The House subcommittee noted that reports from a variety of news organizations had illuminated problems with how the meatpacking companies handled the pandemic, and with the Occupational Safety and Health Administration's enforcement efforts. The subcommittee cited ProPublica's reporting on how meat companies blindsided local public health departments, and on Nebraska Gov. Pete Ricketts' efforts to intervene when local health officials tried to temporarily shutter a JBS plant amid an outbreak.
ProPublica has also documented how meat companies ignored years of warnings from the federal government about how a pandemic could tear through a food processing facility, and chronicled the role that meatpacking plants like a Tyson pork facility in Waterloo, Iowa, have played in spreading the virus to the surrounding community.
The subcommittee's inquiry will also scrutinize the federal government's shortcomings in protecting meatpacking workers. "Public reports indicate that under the Trump Administration, the Occupational Safety and Health Administration (OSHA) failed to adequately carry out its responsibility for enforcing worker safety laws at meatpacking plants across the country, resulting in preventable infections and deaths," according to the subcommittee's letter to OSHA.
The subcommittee also said that the agency had issued only a "few meager fines" and "failed to show urgency in addressing safety hazards at the meatpacking facilities it inspected." The letter noted that OSHA had received complaints about JBS and Smithfield plants months before the agency conducted inspections.
The council has announced a package of bills to reshape the NYPD and improve officer accountability. A City Council member cited a "direct line" from ProPublica's coverage to the proposals.
David Seligman, a lawyer who helped meatpacking workers in Pennsylvania file a lawsuit against OSHA during the pandemic, said he hopes the subcommittee's efforts are "just one of the initial steps" to holding companies accountable and ensuring workers are safe. "The harm inflicted on meat-processing workers during this pandemic, in service of the profits of corporate meat-packing companies and under a government that seemed happy to turn a blind eye, is a grave scandal," Seligman wrote in an email.
In a statement, a Department of Labor spokesperson said that the subcommittee's inquiry is "focused on the Trump administration's actions surrounding the protection of workers from COVID-19 related risks," and the agency is committed to protecting workers, and that new guidance on coronavirus enforcement that was issued in late January will serve as a "first step."
In its Feb. 1 letters to OSHA, JBS, Tyson and Smithfield, the subcommittee has requested documents related to government inspections at meatpacking plants and COVID-19 complaints lodged with the companies. OSHA was asked to brief the subcommittee by Feb. 15.
Michael Grabell writes about economic issues, labor, immigration and trade. In 2019, he was part of a team that was a finalist for the Pulitzer Prize for public service.
The VA and FEMA agreed to pay a first-time vendor in a desperate search for protective equipment. Now Robert Stewart admits he defrauded three federal agencies and lied about being in the Marine Corps.
This article was published on Thursday, February 4, 2021 in ProPublica
An amateur mask broker who was awarded more than $38 million in federal contracts to provide N95 masks has pleaded guilty to defrauding three different federal agencies as part of a scheme to profit from the COVID-19 pandemic.
Robert Stewart Jr., 35, pleaded guilty to three counts of making false statements, wire fraud and theft of government funds Wednesday in U.S. District Court in the Eastern District of Virginia, including charges that he lied to the Department of Veterans Affairs in April in order to win a $34.5 million no-bid deal to supply personal protective equipment to nurses and doctors in a sprawling health system serving 9 million veterans. He similarly acknowledged lying to the Federal Emergency Management Agency when he stated he had masks "stored securely in our climate control warehouse located in VA and PA," according to his plea agreement.
Stewart was a key figure in a ProPublica investigation published in May in which he invited a reporter to tag along on a doomed mask deal, which produced zero masks for the VA and revealed that Stewart had none and had no plan for finding them or financing a purchase. Stewart's hapless journey provided the first details of a shadowy network of brokers and investors who were pursuing billions in loosely monitored contracts from government agencies desperately trying to deal with the virus.
"Mr. Stewart made intentionally false statements to the VA and to FEMA in order to be awarded lucrative contracts," U.S. Attorney William Fitzpatrick, head of the district's Financial Crimes and Public Corruption Unit, told the court Wednesday.
"At the time, Mr. Stewart made these representations, he well knew he didn't possess the masks."
Stewart and his Arlington, Virginia-based business, Federal Government Experts LLC, were not ultimately paid by the VA for masks because none were delivered.
Federal agencies have hired contractors with no experience to find respirators and masks, fueling a black market filled with price gouging and multiple layers of profiteering brokers. One contractor called them "buccaneers and pirates."
But Stewart did collect a huge payday from another government program responding to the pandemic, the Paycheck Protection Program, or PPP. Stewart pleaded guilty to wire fraud and a scheme to defraud the Small Business Administration, which guaranteed $350 billion in loans to help struggling businesses stay afloat, many of which could be forgiven.
Federal prosecutors alleged that Stewart, trying to collect federally backed bank loans, provided false tax forms showing his business employed 37 people for a total quarterly payroll of $960,000, when his business actually employed nine people. Celtic Bank approved Federal Government Experts' PPP loan of $805,000, most of which Stewart has repaid to the bank, according to court filings.
Stewart also pleaded guilty to collecting about $261,000 on false pretenses from another small business loan program, the Economic Injury Disaster Loan Program, which provides low-interest financing to struggling small businesses during disasters.
The prosecutor told the judge that Stewart gave about $60,000 of that cash to himself as wages and also spent lavishly, including renting a private jet to hunt down masks, which ProPublica reported last spring.
"There was definitely some extravagant spending," the prosecutor said.
Stewart, who declined comment in the courtroom Wednesday, is an Air Force veteran, a designation which gave him an edge when seeking federal contracts, especially from the VA. But prosecutors said that in a separate scheme, he claimed to be a decorated veteran of the Marine Corps, which was untrue.
From September 2013 to October 2020, Stewart collected nearly $74,000 in medical and educational benefits from the VA by falsely claiming he had been honorably discharged at the rank of Marine corporal. Stewart also pleaded guilty to that charge, which carries a maximum penalty of 10 years in prison and a fine of $250,000.
Last year, when ProPublica asked Stewart to explain what designated his business as owned by a disabled veteran, which gives an edge in contract competition, he declined to provide a specific disability.
As Stewart entered his plea, Judge Rossie Alston Jr. at one point turned to him and said, "I was inclined after reading what you did to lock you up."
But prosecutors did not object to Stewart's request that he remain free under court supervision while his lawyer negotiates terms for him to aid in a separate congressional investigation into the failed federal coronavirus response.
Stewart's sentencing is scheduled for June. He faces a maximum penalty of 35 years in prison.
An audit found that the time it takes the Louisiana Department of Environmental Quality to issue penalties to polluters has doubled. Some companies that have been known to violate air quality rules were able to keep at it for years, or even decades.
This article was published on Friday, January 29, 2021 in ProPublica.
By Mark Schleifstein
The Louisiana Department of Environmental Quality needs to do a better job of identifying industrial polluters that don't properly report emission violations, and it should enforce those violations more aggressively, according to a new management audit by the Louisiana Legislative Auditor’s office.
Many of the audit's findings tracked those of a 2019 investigation by The Times-Picayune, The Advocate and ProPublica.
The newsrooms showed how emissions of cancer-causing chemicals from clusters of large industrial facilities in seven parishes along the lower Mississippi River combine to increase overall air toxicity for nearby residents. Overall, the analysis found that a crush of new industrial plants will increase the levels of cancer-causing chemicals in the air of predominantly Black and poor communities.
The auditor’s report found that the time it took for the LDEQ to issue enforcement actions after a known violation more than doubled between fiscal year 2015 and 2019, from nearly 10 months to nearly 20 months.
Auditors also found it could take as long as nine years from the time a company was cited for violating emission standards before it was ordered to pay a fine or was required by a settlement to pay for a mitigation project.
“Overall, we found DEQ could strengthen its monitoring and enforcement processes by identifying violations and issuing enforcement actions in a timelier manner,” Legislative Auditor Daryl Purpera said in a cover letter to the report.
“As a result, there is a risk that facilities may have violations that remain uncorrected for years,” an audit summary said. “Best practices state that effective enforcement includes swift and predictable responses to violations.”
The DEQ also needs to do a better job identifying facilities that fail to submit self-monitoring reports on emissions, and to speed its review of the reports for violations, the audit said. The auditors also found the agency doesn’t adequately track the penalties it has assessed or whether the penalties were paid.
Part of the agency’s enforcement problems can be traced to DEQ’s reduced number of employees, employees’ high workloads, frequent staff turnover “and ineffective data systems,” the audit said.
“Louisiana has the highest toxic air emissions per square mile of any state,” the report said, based on data gathered by the U.S. Environmental Protection Agency's 2018 Toxics Release Inventory, a self-reported measurement of toxic chemicals released into the air, land or water by individual facilities.
Based on TRI data, the audit said, in 2018, Louisiana had an average of 1,239 pounds of toxic air releases per square mile. Ohio, the state with the second-highest air emissions rate, averaged 899 pounds per square mile.
The audit also pointed to the EPA’s most recent National Air Toxics Assessment, from 2014, which identified a number of Louisiana locations where emissions from nearby manufacturing facilities are linked to a high potential for cancer risks or high respiratory illness hazards.
But the audit also pointed out that its criticisms come amid better news about some forms of air pollution in Louisiana. It pointed out that the EPA’s AirNow website’s daily reports of air pollution issues — mostly ground-level ozone and particulate matter — indicated that “good air quality” days in Louisiana had increased by 21% between 2008 and 2018, and the number of “unhealthy days for sensitive groups” had decreased by 71%.
The audit noted that several areas of the state “are highly industrialized and have high concentrations of air pollution” involving chemicals not measured by AirNow. The EPA does not regularly monitor cancer-causing chemicals such as chlorine and ethylene oxide, which the 2019 investigation by ProPublica, The Times-Picayune and The Advocate highlighted as being elevated in certain parts of Louisiana’s industrial river corridor.
The report included 11 major recommendations. A response included in the report from DEQ Secretary Chuck Carr Brown said the agency generally agreed with 10 of them.
The only one they’re at odds over is a recommendation that DEQ inspectors take photographs or gather other hard evidence that will show inspections actually take place. Brown pointed out that inspectors fill out a field interview form during the inspection that is left at the facility, and that copies are signed by both the inspectors and facility employees.
But the audit report pointed out that the DEQ had to notify both the state legislative auditor and the EPA’s inspector general that a former employee had falsified at least three compliance investigations.
The facilities involved were not named in the report.
A spokesman for the DEQ said the skipped inspections were the fault of an employee who left the agency before they were discovered.
In his response included in the audit, Brown said DEQ is developing its own software to allow the staff to better track violations. When complete, it should also issue notices to staffers if reports aren’t submitted on time or if a new violation shows up in a company’s records. Brown did not say when the software would be ready.
Other findings of the audit include:
The DEQ should vary when it inspects facilities so the inspections are less predictable. DEQ agreed.
DEQ should develop goals for how long it should take to issue enforcement actions and track their progress. Again, DEQ agreed.
DEQ should establish a process requiring facilities to submit settlement offers within a certain time frame, such as six months, and draft a penalty amount for those who do not comply. This recommendation is aimed at shortening the time between when a company is notified of a penalty and when the agency issues a final penalty decision, a span that now often lasts several years. DEQ mostly agreed, but it pointed out that compliance orders and notices of potential penalty are subject to appeal, which can delay the process.
DEQ management should determine whether staffing levels are sufficient and, if not, should request funding for additional staff. DEQ agreed to consider moving staff within its divisions, but said requesting more money was likely to be a problem.
The Legislative Auditor’s office has produced a podcast explaining the highlights of its report for members of the Legislature.
A report by New York Attorney General Letitia James says that a survey of dozens of nursing homes suggests the number of residents who died of COVID-19 could be a huge undercount.
This article was published on Thursday, January 28, 2021 in ProPublica.
Thousands more New York state nursing home residents may have died of COVID-19 than Gov. Andrew Cuomo’s administration has publicly acknowledged, according to a report issued Thursday by the state’s attorney general.
The report by Attorney General Letitia James said a survey of dozens of nursing homes conducted by her staff suggested the state’s failure to include in its official counts residents who died in hospitals after being sickened by COVID-19 in facilities had led to an undercount of as much as 50%. To date, the state Health Department says some 8,400 nursing home residents in New York have died of COVID-19.
The Cuomo administration’s failure to make public deaths of nursing home residents who perished in hospitals has for almost a year enraged local and national lawmakers who have accused the administration of hiding the true death toll to avoid accountability. New York state Health Commissioner Howard Zucker testified before lawmakers last summer that his department was actively working to accurately tabulate the loss of life, but five months later, the department has remained silent.
The attorney general’s report said the office had contacted 62 nursing homes, about a tenth of the state’s total, to better understand how many residents had truly been lost to COVID-19. At a single home last spring, 29 more residents had died of COVID-19 when deaths at hospitals were included than were reflected in the state’s count. At another, the undercount was 25 deaths.
In a statement, the Health Department did not dispute the finding that thousands of nursing home residents died of COVID-19 after being taken to the hospital, and that those totals were not reflected in the state’s public tally of nursing home deaths. It offered no explanation for why it chose not to include the hospital deaths and once more claimed it was still trying to accurately count exactly how many residents had died of the virus in hospitals.
“DOH has consistently made clear that our numbers are reported based on the place of death,” the statement said. “DOH does not disagree that the number of people transferred from a nursing home to a hospital is an important data point, and is in the midst of auditing this data from nursing homes.”
When ProPublica in October had asked the Health Department why the count of hospital deaths was taking so long to be made public, Jonah Bruno, a department spokesman, said, “We are carefully reviewing all previous data, as the commissioner committed to, and we’re also requiring confirmatory and post mortem testing for anybody who may have had COVID-19 or flu symptoms, or exposure to someone who did, to ensure data integrity.”
The claim was widely ridiculed by lawmakers and health officials, who said counting hospital deaths of nursing home residents was not a complicated undertaking.
“Attorney General Tish James validates the cover-up of nursing home deaths, and the only question remains is why this administration chose to lie to the public for months,” said Ron Kim, a state legislator from Queens whose district’s nursing homes were battered by the pandemic.
The attorney general’s report cited a wide array of failings as accounting for the extraordinary death toll, nearly 9% of the state’s entire population of nursing home residents. Nursing homes had inadequate protective equipment, failed to implement effective infection control procedures and communicated poorly with the families of residents, many of whom feared for their loved ones and were unable to visit in person to check on their welfare.
The report also said another Cuomo administration policy requiring nursing homes to take in patients from hospitals who had COVID-19 and were stable enough to be discharged had likely contributed to the loss of life. The administration, which reversed the policy last May after six weeks, has said homes that could not safely handle patients with COVID-19 were not required to admit them.
Late last year, ProPublica noted that the true death toll among nursing home residents was not mentioned in Cuomo’s much-publicized memoir on his leadership successes handling the pandemic.
The attorney general’s investigation also turned up evidence that the state had undercounted some number of nursing home deaths that had taken place inside the facilities and that the state Health Department had made public.
Bill Hammond, a health care policy analyst at the Empire Center, an Albany think tank, said those findings raise “new questions about the accuracy of the limited numbers the department has released.” He said there was much to still learn about the true dimensions of the human loss in New York during the pandemic, and he criticized the administration for not releasing additional data even when subpoenaed by Congress.
“It’s shocking that the Cuomo administration continues to withhold basic information about a major public health crisis that New Yorkers urgently want to know and clearly have a right to know,” Hammond said.
