by Duaa Eldeib

]

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By the time Cheryl Cosey learned she had COVID-19, she had gone three days without dialysis — a day and a half more than she usually waited between appointments. She worried how much longer she could wait before going without her life-saving treatments would kill her.

The 58-year-old Cosey was a dialysis technician for years before she herself was diagnosed with end-stage renal disease. After that, she usually took a medical transport van to a dialysis facility three days a week. There, she sat with other patients for hours in the same kind of cushioned chairs where she’d prepped her own patients, connected to machines that drew out their blood, filtered it for toxins, then pumped it back into their fatigued bodies.

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Her COVID-19 diagnosis in the pandemic’s first weeks, after she’d been turned away from a dialysis facility because of a fever, meant Cosey was battling two potentially fatal diseases. But even she didn’t know how dangerous the novel coronavirus was to her weakened immune system.

Had she realized the risks, she would have had her daughter Shardae Lovelady move in. Just the two of them in Cosey’s red brick home on Chicago’s West Side, looking out at the world through the sliding glass door in the living room, leaving only for her dialysis.

Cheryl Cosey (Courtesy of Shardae Lovelady)

After Cosey’s positive test in April 2020, Lovelady had to take her mother to a facility that treated patients with suspected or confirmed COVID-19. The facility fit her in for one of its last appointments the next day.

At that point, Cosey had gone more than four days without dialysis.

Four hours later, after Cosey completed her treatment, Lovelady returned to the nearly deserted building to bring her mother home, the sun having long disappeared from the sky. Cosey, dressed in a sweater and a green spring jacket, was disoriented, her breathing sporadic.

Alone with her mother on the sidewalk, Lovelady ran inside to ask workers for help getting Cosey out of her wheelchair and into her car.

“They offered no assistance,” Lovelady said. “They treated her as though she was an infection.”

(A spokesperson for the facility said employees aren’t allowed to help patients once they leave, for safety reasons.)

As Lovelady waited for paramedics to arrive, she grabbed a blanket from her car to wrap around her mother.

“My mother has COVID. I know she has COVID, but I didn’t care,” Lovelady said. “I hugged her and just held on until the ambulance came.”

Then she followed the flashing lights to the hospital.

In the three decades before the pandemic, the number of Americans with end-stage renal disease had more than quadrupled, from about 180,000 in 1990 to about 810,000 in 2019, according to the United States Renal Data System, a national data registry. About 70% of these patients relied on dialysis in 2019; the other 30% received kidney transplants.

The Midwest stood out as the region with the highest rate of patients with the disease, and Illinois had the nation’s third highest prevalence after Washington, D.C., and South Dakota, according to the Centers for Disease Control and Prevention.

A rare bright spot was the downturn in the death rate. Although diagnoses have been going up, death rates for patients who are on dialysis have declined since the early 2000s.

Then COVID-19 struck. Nearly 18,000 more dialysis patients died in 2020 than would have been expected based on previous years. That staggering toll represents an increase of nearly 20% from 2019, when more than 96,000 patients on dialysis died, according to federal data released this month.

The loss led to an unprecedented outcome: The nation’s dialysis population shrank, the first decline since the U.S. began keeping detailed numbers nearly a half century ago.

They were COVID-19’s perfect victims.

“It can’t help but feel like a massive failure when we have such a catastrophic loss of patients,” said Dr. Michael Heung, a clinical professor of nephrology at the University of Michigan. “It speaks to just how bad this pandemic has been and how bad this disease is.”

Before most patients reach advanced kidney failure, they are diagnosed with diabetes, hypertension or a host of other underlying conditions. Their immune systems are severely compromised, meaning they are essentially powerless to survive the most dangerous infections.

Many are old and poor. They also are disproportionately Black, as was Cosey. A 2017 study called end-stage renal disease “one of the starkest examples of racial/ethnic disparities in health.” Those inequities carried through to the pandemic. Dialysis patients who were Black or Latino, according to federal data, suffered higher rates of COVID-19 by every metric: infection, hospitalization, death.

Their deaths went largely unnoticed.

To get their treatments, the majority of dialysis patients in the U.S. must leave the relative safety of their homes and travel to a facility, often with strangers on public or medical transportation. Once at the dialysis center, they typically gather together in a large room for three to four hours.

The fear of contracting the virus was enough to keep many from venturing out for medical care, including those already on dialysis and those set to get the treatment for the first time. Exactly how long patients can go without dialysis depends on a number of factors, but doctors generally begin to worry if they miss two of their thrice-weekly sessions.

Dr. Kirsten Johansen, director of the United States Renal Data System, said the rates of people starting dialysis had been relatively stable until the pandemic. “Then the floor fell out,” she said in an interview.

COVID-19’s collateral damage played out in other ways as well. It meant that people delayed going to the hospital for everything from heart disease to cancer. For dialysis patients, whose life expectancy in some cases is three decades shorter than the general population, the results were calamitous. Hospitalizations of dialysis patients for reasons unrelated to COVID-19 dropped 33% between late March and April of 2020, federal data shows.

Dr. Delphine Tuot, a nephrologist and associate professor at University of California San Francisco and Zuckerberg San Francisco General Hospital and Trauma Center who focuses on vulnerable populations, found herself pleading with some of her patients to come in for their regular dialysis appointments.

One of them was a 60-year-old man whose shortness of breath landed him in the hospital in February. Doctors scheduled dialysis three times a week, and though he was initially resistant, Tuot said, he came around once he realized he would die without it.

Still, he missed appointments. When Tuot followed up, he told her he was afraid to leave the house because he was caring for his wife who had cancer, and he didn’t want to contract COVID and bring it home to her. Soon a cycle began. He skipped treatments, fluid built up in his body and an ambulance rushed him to the hospital because he couldn’t breathe. He got dialysis, was sent home and got back on track.

When cases surged and the delta variant took hold this summer, the cycle restarted — until he skipped dialysis for three weeks in a row, so long that his heart couldn’t recover, according to Tuot. He died last month.

Despite early efforts to mask and isolate patients at dialysis facilities, one study found the rate of COVID-19 hospitalizations of dialysis patients from March to April 2020 was 40 times higher than the general population.

Even with skyrocketing hospitalizations, it took three months after vaccines were approved before federal officials provided vaccinations to dialysis clinics, despite advocacy groups urging that this high-risk population be prioritized.

Although dialysis centers were swift to implement safety protocols in the pandemic’s early days, some facilities didn’t follow their own infection control policies, including washing hands properly, keeping workers home when sick or disinfecting equipment, federal inspection records show.

And home dialysis, which has been shown to be safer for patients during the pandemic, is out of reach for many, especially Black and Latino patients. Nephrologists had pushed for greater access to home dialysis before the pandemic; that need is more apparent now than ever, Tuot said.

“The fact that individuals had to go to a center with other individuals who are equally immunocompromised and had to get to that center, whether that was by public transportation or by van transportation, it’s clearly additional risks,” Tuot said. “Bottom line, they are very vulnerable. They’re very sick.”

The ambulance took Cosey to Chicago’s Rush University Medical Center. Lovelady filled in the staff on her mother’s medical history of end-stage renal disease, high blood pressure and asthma. The next day, Cosey called her daughter from her hospital bed. Lovelady noticed marked improvement from the night before.

“She sounded like herself,” Lovelady said. “We joked around a little bit. I asked her what kind of medicine she was on. She said they started her on dialysis.”

One by one, Lovelady added her sister, cousin and brother to the call. They told Cosey she had scared them, but now that she was doing better, they teased that they needed her to come home to bake her famous cheesecake. Her grandchildren hadn’t stopped asking about her either. They missed movie nights at Cosey’s house, when she made them popcorn and covered the floor with blankets.

Cosey’s boisterous laugh reassured them.

When Lovelady sensed her mother tiring, she told her she’d call her back the next day.

“Go ahead and get some rest,” she said.

Dialysis Patient Deaths Spiked in Early 2020 (Source: The United States Renal Data System)

While the arrival of the pandemic rocked the health care system as a whole, the effect on dialysis facilities has received little attention.

The Centers for Medicare & Medicaid Services typically monitor the facilities through routine inspections and surprise visits to investigate specific complaints. But federal officials are two years overdue on more than 5,000 inspections at dialysis facilities across the country, Medicare data shows, and three years behind on more than 3,000 of them. Since the start of 2020, the number of inspections to dialysis facilities by government officials fell by more than 30% from the previous two years, ProPublica found. Complaints made up a larger portion of investigations. In 2019, 35% of total visits were in response to complaints. Last year, it jumped to 51%.

A spokesperson for the Centers for Medicare & Medicaid Services said in a statement that the pandemic forced the agency to temporarily suspend or delay inspections for non-urgent complaints and routine inspections to focus on infection control and critical concerns that placed patients in immediate jeopardy. The agency is working with states, which act on behalf of federal officials, to address the resulting backlog, the spokesperson said, but “nearly all state agencies report insufficient resources to complete the required, ongoing federal workload.”

The spokesperson said “the COVID-19 pandemic has presented a unique challenge unlike any other in history and has impacted our routine oversight work,” adding that “complaint investigations remain our first priority to ensure we address the immediate needs of patients receiving care in dialysis facilities.”

Insufficient funding has compounded those challenges. The budget for inspections has “been flatlined” since fiscal year 2015, while the number of dialysis facilities has increased by 21% to nearly 8,000 today, according to the agency. After several years of requesting more money, the centers were approved to receive an increase for fiscal year 2022.

When investigators did inspect dialysis facilities, they found some violations specific to COVID-19 and others that involved general safety lapses, according to federal records from March 2020 to July 2021.

A dialysis patient who started treatment just before the pandemic died after a nurse at a Kentucky facility failed to properly dilute an antibiotic, according to inspection reports. Minutes after the medicine began dripping through an IV, the patient said: “My body is on fire! It’s going through my whole body,” records show.

At a New York facility, another patient died after losing more than 1 1/2 pints of blood when their catheter became disconnected, according to federal records. That same facility underreported its number of deaths in the first 11 months of the pandemic by 16 people.

Federal officials issued their most serious citation to an Indiana facility for refusing to provide dialysis to a patient suspected of having COVID-19. The patient’s previous dialysis had also been cut short because their assisted living facility did not provide them transportation after 9:15 p.m. So they did not receive a complete treatment.

An estimated 5% to 10% of end-stage renal patients live in congregate settings, such as nursing homes or assisted living facilities. The same factors that led to nursing home populations being decimated — age, health, difficulty isolating — applied to those dialysis patients. In the first months of the pandemic, they contracted the virus at a rate more than 17 times higher than those who lived independently, according to one study.

Workers at those facilities weren’t immune either. Oluwayemisi Ogunnubi, 59, worked as a nurse administering dialysis to patients inside a nursing home on Chicago’s South Side. A Nigerian immigrant, she had sent money home to pay for her children’s schooling until she was able to bring them to the U.S. Her smile and supportive nature made her popular among her coworkers, according to an official at Concerto Renal Services, the dialysis company where she worked.

On April 21, 2020, Ogunnubi’s body began to ache, and she was sent home early from work. She was later taken to a hospital, where she tested positive for COVID-19. She died three days later, federal and county records show.

Occupational Safety and Health Administration officials cited Concerto, and levied a penalty of $12,145. The company provided employees who performed dialysis on patients with N95 respirators, but investigators found that Concerto’s written procedures weren’t complete and that the company had failed to provide medical evaluations that ensured employees knew how to use the respirators.

Two other Concerto employees, including one who fell ill the same day as Ogunnubi, contracted COVID-19 at the time but survived. Within two weeks of Ogunnubi’s death, 10 residents at the nursing home died of complications related to COVID-19, according to Cook County Medical Examiner records. Half had kidney failure.

Kyle Stone, Concerto’s executive vice president and general counsel, said the first and only COVID-related death of an employee shook the company. Stone said Concerto “made a difficult choice” to use respirator masks without providing medical evaluations to employees, but it “was clearly the correct choice under the circumstances.”

If Concerto had been required to fulfill every aspect of OSHA requirements for a written policy that early in the pandemic, he said, the company would not have been able to provide the respirator masks, “almost certainly resulting in greater risk of harm and death.”

OSHA’s failure to “see and appreciate” the trying circumstances at the time, Stone said, “was “baffling and disappointing.” Concerto eventually settled with OSHA, which downgraded the violation and reduced the penalty to $9,000.

“We are quite proud of our work in 2020 during the eye of the COVID storm,” Stone said.

As devastating as the pandemic has been, many experts say it could have been worse. Dr. Alan Kliger, a clinical professor of medicine at Yale School of Medicine, co-chaired the American Society of Nephrology COVID-19 Response Team that held weekly calls with chief medical officers from 30 or so dialysis companies, including the largest two, DaVita and Fresenius. The facilities, Kliger said, implemented universal masking and patient screenings before the CDC recommended them. They also treated COVID-19 patients in separate shifts or at specifically designated isolation clinics.

“There’s been a tremendous amount of collaboration and sharing of information and uptake of best practices in this group of competitive companies,” Kliger said. “They really rallied together to protect patients.”

Epidemiologist Eric Weinhandl said that there’s another battle on the horizon with the omicron variant spreading rapidly, which he finds especially worrisome given how federal officials failed by not distributing vaccines to dialysis facilities in December 2020.

“It’s heartbreaking because you look at this, and much like nursing home residents, these patients are completely vulnerable. But they still have to go to a dialysis facility three times a week,” Weinhandl said. “Why wouldn’t you prioritize this population?”

The CDC said in a statement that “demand exceeded supply” when vaccines were first authorized and “as supply increased and states adopted CDC’s recommendations, older adults and those with underlying health conditions began being prioritized.”

It wasn’t until March 25 that the Biden administration announced it was partnering with dialysis facilities to send vaccines to patients at the centers.

Now, Weinhandl wonders if dialysis patients will be a priority if the federal government approves a second round of boosters for high-risk patients.

“Is there a plan? Because I think that there should be,” he said. “I think this is getting pretty predictable. Every time COVID surges, you see the dialysis population’s excess mortality surge with it.”

Sometimes the frailty of dialysis patients is no match for COVID-19’s brutality.

Oscar and Donna Perez were the kind of siblings who loved each other without judgment or condition. After Oscar began dialysis in 2018, Donna picked him up from his appointments three nights a week. She cut his toenails when his feet were too swollen for him to reach and massaged them when the pain woke him up at night.

He was her son’s godfather, her best friend who shared his love of music with her — especially the 1960s R&B singer Billy Stewart — and annoyed her in the way only brothers can, swatting her feet off chairs just as she got comfortable and pestering her with questions when she was deep into Instagram.

Oscar Perez and his daughter Jasmin (Courtesy of Donna Perez)

But Oscar Perez was sick. In addition to his failing kidneys, the 38-year-old Latino father struggled with hypertension, diabetes and congestive heart failure. In early January, doctors performed coronary bypass surgery. He was not yet eligible for the vaccine, but the hospital tested him for COVID-19 when he was admitted. He was negative.

He went home on Jan. 18, the same day as the wake for his uncle, who, his family said, died after he missed too many dialysis appointments. But the next day, Oscar collapsed at home, confused and mumbling in pain, with signs that the coronavirus was flourishing in his lungs. He was rushed back to the hospital. A doctor called to tell Donna Perez that her brother had tested positive and needed to be intubated.

On Jan. 31, doctors called Donna again and told her that her brother’s condition was declining fast. She picked up her parents, another brother and his girlfriend, and headed to the hospital to visit Oscar from outside the glass door of his room. They told doctors to try to resuscitate him if his heart stopped.

That night, after they returned home, Donna Perez’s phone rang one more time. Oscar’s doctor said he probably wasn’t going to make it through the night. This time, they could visit him in his hospital room in PPE.

Seeing her brother up close, swollen and helpless, she leaned in, hugged him, and said, “I can tell you’re tired. You can go.” Donna promised to take care of his daughter.

Her family pushed back and said she had to tell him to be strong.

Donna told them they needed to let Oscar go. He died a few hours later.

“This disaster is one that befalls dialysis patients, with diabetes especially, regularly,” Dr. David Goldfarb, clinical director of the nephrology division at NYU Langone Health in New York City, who reviewed Oscar Perez’s medical records for ProPublica.

“Of course, it’s possible to do better,” he continued. “Given his age, it’s really tragic.”

The advent of technology to filter a patient’s blood revolutionized kidney care in the 1950s, and people lined up to get access to the limited number of machines. In 1960, one hospital created its own admissions panel, later nicknamed the “God committee,” to review cases to decide who would receive the groundbreaking treatment.

Twelve years later, Congress approved legislation that created the Medicare End Stage Renal Disease program, which guaranteed coverage of medical care, including dialysis and kidney transplants. It remains the only disease-specific Medicare entitlement program, credited by some as possibly saving more lives than any other federal government program. Generally, Medicare only covers those over age 65 and the disabled, but this program is available to people of all ages with end-stage renal disease.

Total Medicare-related spending in 2019 on end-stage renal disease patients topped $50 billion. Even with that budget, the agency hasn’t been able to fix persistent health disparities. That year, Black patients were more than four times more likely than their white counterparts to have the disease.

Black patients also progressed from chronic kidney disease to end-stage renal disease three times as often as white patients. Yet they are less likely to start off their dialysis treatments on a waiting list for a transplant — or eventually receive one from a living donor — than white patients.

In a statement, Medicare said it is working to address the disparities and said it is “committed to ensuring the health and safety” of all its dialysis patients.

Another area of concern is home dialysis, which research has shown is cheaper than in-center dialysis and offers similar or better survival rates, enhanced quality of life and greater flexibility. Barriers to home dialysis affect all patients, but the percentages of Black and Hispanic patients receiving home dialysis in 2019 were 10% and 11% respectively, compared with white and Asian patients at 17% each.

The push for closing that gap has gained traction, bolstered by federal data that found COVID-19 hospitalizations rates of patients who underwent home dialysis from late March to June 2020 were between one-quarter and one-third those of patients traveling to dialysis facilities.

“We do have to figure out a way to do better because we’re really, in essence, causing harm, when we’re not able to divert proper resources to patients who most require them,” said Dr. Kirk Campbell, a nephrology professor and vice chair of medicine for diversity, equity and inclusion at the Icahn School of Medicine at Mount Sinai in New York City.

Some patients don’t have the space to store the supplies needed for home dialysis. Others are overwhelmed by the prospect of having to keep the area around the catheter clean to prevent infection. But, Campbell said, that’s where patient education comes in. The most common type of home dialysis, called peritoneal dialysis, often is done at night while the patient is sleeping and does not involve blood flowing outside the body.

While home dialysis isn’t possible for all patients, some doctors are hesitant to recommend it at all, in part because the clinicians lack the training, experience or a certain comfort level with it. That’s especially true, Campbell said, for patients of color and those from disadvantaged backgrounds. There’s often an unconscious bias that those patients won’t be able to handle it, he said.

Campbell and others said it’s critical that clinicians receive additional training in home dialysis. He leads one of the few nephrology fellowship programs in the country where doctors can spend an extra year specializing in home dialysis. The results have been so promising, he said, that they hope to expand.

In July 2019, the Trump administration issued an executive order aimed at revamping kidney care in the United States through the Department of Health and Human Services’ Advancing American Kidney Health initiative. The goals of the initiative were lofty — some say unrealistic — and included having 80% of new end-stage renal disease patients in the U.S. receive in-home dialysis or transplants by 2025. In 1972, the year the Medicare program passed, 40% of patients were on home dialysis. Currently, about 13% of patients are receiving dialysis at home.

Starting January, the Centers for Medicare & Medicaid Services will offer facilities greater reimbursement for improving their home dialysis rates for low-income patients.

Some observers say the change doesn’t go far enough. In September, U.S. Rep. Bobby Rush, an Illinois Democrat, and Rep. Jason Smith, a Republican from Missouri, proposed legislation that would require Medicare to pay for workers to assist patients who need additional help with home dialysis. The measure, which was introduced without much fanfare, also calls for greater patient education around the treatment and a federal study analyzing racial disparities.

Hong Kong, where about three in four patients are on peritoneal dialysis, is a global leader in home treatment. Patients there receive peritoneal dialysis first unless there is a medical reason that would preclude it.

Dr. Isaac Teitelbaum, a nephrologist who has been the medical director of the home dialysis unit at the University of Colorado School of Medicine since 1986, said expanded training for clinicians and incentives for patients, including a reduced co-pay or a tax credit, could encourage more patients to dialyze at home.

“You don’t live just so you can do dialysis. You do dialysis so that you can enjoy life,” he said. “You do dialysis so that you can watch your children and grandchildren grow up and so that you can participate in family events and go on vacations.”

Cheryl Cosey was not offered home dialysis, her family said. Shardae Lovelady said it might have made all the difference for her mother.

Cosey’s health deteriorated quickly after the call from her hospital bed. Doctors transferred Cosey to the intensive care unit, put her on a ventilator and gave her medication to push the oxygen from her lungs into her bloodstream, according to hospital records.

The family braced themselves. Lovelady drove to Minnesota to pick up her sister. She gathered everyone for a big dinner the way her mother used to do.

Lovelady and her sister stayed up late talking, finally dozing off when the house quieted.

When the phone rang at three in the morning, Lovelady recognized the hospital’s 312 area code.

Everything she had done to prepare for that moment suddenly vanished, and she allowed herself to hope.

The call was short. She never even flipped on the bedroom light. She turned to her sister, who was asleep next to her, and nudged her awake.

“Mama gone.”

We Want to Talk to People Working, Living and Grieving on the Front Lines of the Coronavirus. Help Us Report.

This post was originally published on Articles and Investigations – ProPublica.

by Lydia DePillis

]

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When COVID-19 started sweeping across America in the spring of 2020, Irene Bosch knew she was in a unique position to help.

The Harvard-trained scientist had just developed quick, inexpensive tests for several tropical diseases, and her method could be adapted for the novel coronavirus. So Bosch and the company she had co-founded two years earlier seemed well-suited to address an enormous testing shortage.

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E25Bio — named after the massive red brick building at MIT that houses the lab where Bosch worked — already had support from the National Institutes of Health, along with a consortium of investors led by MIT.

Within a few weeks, Bosch and her colleagues had a test that would detect coronavirus in 15 minutes and produce a red line on a little chemical strip. The factory where they were planning to make tests for dengue fever could quickly retool to produce at least 100,000 COVID-19 tests per week, she said, priced at less than $10 apiece, or cheaper at a higher scale.

Bosch’s prototype attracted a top Silicon Valley venture capital firm, which pitched in $2 million.

“We are excited about what E25Bio is capable of shipping in a short amount of time: a test that is significantly cheaper, more affordable, and available at-home,” said firm founder Vinod Khosla. (Disclosure: Khosla’s daughter Anu Khosla is on ProPublica’s board.)

On March 21 — when the U.S. had recorded only a few hundred COVID-19 deaths — Bosch submitted the test for emergency authorization, a process the Food and Drug Administration uses to expedite tests and treatments.

A green light from the FDA could have made a big difference for the many Americans who were then frantically trying to find doctors to swab their noses, with results, if they were lucky, coming back only days later.

But the go-ahead never came.

In the months that followed, Bosch responded to repeated requests from FDA reviewers for data and studies. When the agency finally put out guidance that summer about the performance over-the-counter home tests needed to meet, officials required that such tests be nearly as sensitive as the lab tests used to definitively determine whether a patient has COVID-19.

That standard proved difficult to meet. Rapid tests are usually sensitive enough to detect viral antigens when someone has enough of them to be able to spread the disease. Such tests are not as good at picking up cases in either earlier or later stages of infection, when viral loads are lower.

Bosch’s tests missed the FDA’s high bar. It wasn’t until the spring of 2021 that much larger companies were able to design similar tests — relatively inexpensive, over-the-counter rapid tests — that the agency found acceptable.

“You could have antigen tests saving lives since the beginning of the pandemic,” said Bosch, sitting in her lab at MIT. “That’s the sad story.”

As ProPublica recently detailed, many companies with at-home tests have been stymied by an FDA review process that has flummoxed experts and even caused one agency reviewer to quit in frustration.

While E25Bio’s test didn’t catch quite as many cases as those now on the market, it could have been used to catch superspreaders, with warnings that a negative result wouldn’t rule out infection. Experts told us that the test could have been a vital public health tool had it been produced in the millions in 2020 just as COVID-19 was racing across the country undetected.

“Since we didn’t have other options, it would have been a very good test,” said Michael Mina, an epidemiologist who followed E25Bio’s early progress. “If we were going to war, and somebody was invading us, and we had a bunch of revolver pistols, and we didn’t yet have the shipment of machine guns, hell yeah, you’re going to pick up the revolver pistol. You do what you can when you need to in an emergency.”

Three other experts reviewed Bosch’s submissions at ProPublica’s request and agreed that her test approached what is now considered acceptable for over-the-counter tests.

Mina and others have been calling for an embrace of rapid testing since the pandemic’s early days, saying that tests should be ubiquitous and cheap enough that people could stock them in their medicine cabinet, like aspirin or Band-Aids. Although not a panacea, rapid tests can slow the spread of COVID-19 when used repeatedly and when the infected follow instructions to isolate, many studies suggest.

After not showing urgency on the issue for much of the past year, the Biden administration has moved recently to boost production and lower prices. Facing a huge new wave of cases and an increasing outcry about shortages of tests, Biden announced Tuesday that 500 million more at-home tests would be distributed by mail, starting in January.

David Paltiel, a professor at the Yale School of Public Health, said a significant part of the problem is that the FDA created a detailed roadmap for tests that give patients a close-to-definitive answer on whether they have COVID-19, but never created a separate framework for rapid tests that serve a different purpose: helping people get frequent, fast evidence of whether they may be contagious.

“The former are tests of infection; the latter are tests of infectiousness,” Paltiel said. “They both share the same regulatory pathway — a pathway that was designed with diagnostic testing in mind and is littered with requirements that make no sense for the purpose they serve.”

He added, “It’s an outrage that rapid tests aren’t dirt cheap and plentiful on grocery store shelves.”

The FDA declined to comment on individual test submissions, but said in a statement that it has worked to authorize “accurate and reliable” home tests since the beginning of the pandemic.

“Unfortunately, many submissions the FDA has received for home tests include incomplete or poor data, and it is the FDA’s responsibility to protect the public health by declining to authorize poorly performing tests or those without complete data,” the agency said. “We have also worked interactively with many developers to resolve concerns when data was incomplete or unclear, or to find solutions to issues that arose during review. If the FDA received a home test that the data and science supported in early-to-mid 2020, we would have quickly authorized it.”

Bosch has since moved on to start a new venture focused on helping other test developers conduct trials that meet the FDA’s standards. This winter, she’s working with the housing authority in the high-poverty Boston suburb of Chelsea to conduct a trial using several tests that have been authorized in other countries, but not America. The goal: to demonstrate that such tests can be effective when deployed for free, in conjunction with education and outreach.

“The next thing is frequent testing for communities that need it,” Bosch said. “How do we flood the market with a $2 test that is as good as a $20? We’re doing it in Chelsea. We should be an example for the whole country.”

American medical device regulators have never been enthusiastic about letting people test themselves.

In the 1980s, the FDA banned home tests for HIV on the grounds that people who tested positive might do harm to themselves if they did not receive simultaneous counseling. In the 2010s, the agency cracked down on home genetic testing kits, concerned that people might make rash medical decisions as a result.

But the FDA wasn’t an obstacle to Bosch’s work on tropical diseases, since the tests were mostly needed in places like the Brazilian Amazon, where infected mosquitoes are hard to escape. The National Institutes of Health thought Bosch’s tests had enough potential to give E25Bio $1.8 million for the project.

So when the pandemic struck, the small company decided to use its expertise for the new threat. Within a few weeks, Bosch and her colleagues developed antibodies that could detect the presence of proteins attached to the new coronavirus.

In her previous work, Bosch had found that tests of this type could be validated in the lab, so she ordered up some samples of the SARS-CoV-2 virus and ran two different types of antigen tests on them. She found that both worked fairly well, and packaged up all her evidence and sent it to the FDA, with little guidance on what would pass muster.

Shortly after, an FDA reviewer told her she’d need to conduct a clinical trial, which would take months. “My first huge surprise was when they said, ‘Nope, none of your validations are going to pass for an EUA,’” Bosch said.

The next challenge was that the accuracy of antigen tests would be measured by how they compared to a different type of diagnostic: the polymerase chain reaction, or PCR, test, which is considered the “gold standard” for finding coronaviruses. Many see that as an unproductive comparison, given the fact that PCR detects remnants of the virus, which may persist for many days after the infection ceases to be a threat.

“When you’re PCR testing, you’re testing for the presence of the virus itself,” said Hannah Mamuszka, the CEO of Alva10, a company that helps diagnostics manufacturers prove their value for insurers. “When you’re antigen testing you’re testing for presence of a protein on the surface of the virus, indicative of an immune response. Those are obviously not the same thing. So it’s really confounding that the FDA has had such a hard time communicating what they need, and defining what a test would need to look like to be used at home.”

Nevertheless, by April 2020, E25Bio had lined up a trial with three hospitals in Florida. They found the test identified 80% of the swabs that a PCR test had shown to be positive (known as sensitivity) and 94% of the negatives (known as specificity).

The FDA wanted to see fewer false positives, even though people who test positive on an antigen test are usually advised to confirm it with a PCR. And while the overall sensitivity of E25Bio’s test was lower than other tests would later demonstrate, it measured 100% for people with higher viral loads — those most likely to be infectious.

Bosch was in frequent contact with her assigned reviewer at the FDA, and even talked to Tim Stenzel, the head of the agency’s office that vets diagnostic tests. The Bill & Melinda Gates Foundation gave E25Bio another $500,000 to continue research and development.

But at the end of July 2020, the FDA came out with a template that laid out the expectation that tests available for home use without a prescription would reach 90% overall sensitivity — that is, antigen tests would pick up nine out of ten positive tests that a PCR identified. Bosch knew her tests couldn’t meet that standard. And without an EUA for home use, they wouldn’t be able to serve their intended function.

Already, plenty of models had illustrated the importance of frequent testing, including one co-authored last year by Yale’s Paltiel with Rochelle Walensky, now head of the Centers for Disease Control and Prevention. In September 2020, as chief of infectious diseases at Massachusetts General Hospital, Walensky argued that antigen tests were actually most useful for pinpointing people at their most infectious.

In fact, the utility of that approach was being tested at Bosch’s own former workplace. Beginning in the late summer of 2020, a coworking lab space in Cambridge where E25Bio had launched started a trial with 257 of its users who agreed to take both the antigen rapid test at home and a PCR test twice a week. (This was also closer to a home use scenario than the Florida hospitals study, in which COVID-19 was more prevalent and tests were administered by medical professionals.)

An E25Bio trial (Lindsey Crockett/LabCentral)

A peer-reviewed paper based on the results showed overall sensitivity of 79%, and that the rapid test picked up nearly all of the positives later detected by a PCR in the first few days after symptoms appeared, allowing infected people to stay out of the office as soon as they knew.

But the FDA does not consider test performance data broken out by how much virus the subjects have in their systems, saying the typical method for measuring it is inconsistent. Nor did the agency initially authorize tests on the condition that they be sold in packs of more than one, with instructions to use them sequentially to catch any fast-moving infections.

Bosch wasn’t the only one to be tripped up by the new standard. In mid-September 2020, Stenzel said on his weekly town hall call with test developers that his office had received zero applications for home use tests, a month and a half after putting out the template, despite his insistence that the agency was willing to be “flexible.”

Meanwhile, a $666 million NIH program to accelerate the approval and production of new COVID-19 tests funded mostly PCR tests in 2020.

The antigen tests that did make it into the NIH program in the first three funding rounds — including one made by Quidel, a public company that multiplied its profits by tenfold in 2020 over the previous year — generally had to be processed in labs or required expensive analyzers.

One of few simple antigen tests to win government support, made by Maxim Biomedical, still hasn’t submitted an EUA application, according to chief operating officer Jonathan Maa. Another grantee, Ellume, was authorized for nonprescription home use in December 2020. But it took months to go into widespread production, and still costs $39, if you can find it.

Toward the end of October 2020, Bosch received a 48-hour ultimatum from the FDA for a response to a request for additional data. She had answers to the agency’s questions, but didn’t quite make that deadline.

By the time she replied, the FDA had already closed her application. “You call and they say, ‘Oh sorry, the clock started and we can’t stop it,’” she said.

Soon after, the company’s leadership asked her to resign. The company continues to operate, but hasn’t obtained FDA authorization for any tests. “As we commercialize our COVID-19 rapid tests internationally, we are also focused on developing the next generation of rapid tests for consumer diagnostics,” an E25Bio spokesperson said, while declining to comment on Bosch’s departure or its current product pipeline.

“All our life, day in and day out, went to make antigen tests,” Bosch said. “It was tragic, because it was all because the FDA decided to be so harsh in their responses that investors said, ‘Oh, there’s no way she will pull it out.’”

E25Bio’s travails with the FDA didn’t stop Bosch from putting her expertise to use.

In early 2021, she started talking to the city of Chelsea about running a trial that could show how rapid antigen testing — even with the types of tests that the FDA had rejected — could be rolled out in a high-risk community. In the spring, when infection rates in Chelsea were among the highest in the nation, many residents had had a difficult time accessing PCR tests, because the places administering them often dissuaded immigrants by requiring identification.

Chelsea officials agreed, and Bosch secured donations of tests from five manufacturers that had been authorized in Britain, Germany, India or Korea, but none yet in the U.S. (They can still be used here for research purposes.) She said she has validated them in her lab and found them to be about as accurate as BinaxNOW, the FDA-authorized home test made by medical device giant Abbott Laboratories.

“If they have a budget for next year to do frequent testing, this will be an accomplishment,” Bosch said. “I wanted to show to the world that an experimental device is just as good as any other already-approved FDA test.”

Left: A study participant looks on as Bosch, right, and another evaluator go over the project consent form. Right: A Chelsea resident self-administers a rapid COVID-19 test while members of the project guide her through the process. (Kayana Szymczak for ProPublica)

So for the past few months, Bosch has canvassed three buildings owned by the local housing authority. Bosch, who is from Venezuela, puts on salsa music and explains in Spanish how the program will work.

The trial began in earnest last week, with study administrators walking newly enrolled subjects through using the tests. In a building reserved for elderly and disabled people, residents entered with walkers and in flip-flops to learn how to swab their noses, put the swabs in a vial of solution, squeeze a few drops onto a pad and wait anxiously for the single line to appear that would indicate a negative result.

A Chelsea resident is guided through entering his test information. (Kayana Szymczak for ProPublica)

Most were able to take a picture of the results with their phones and upload them using a special app, which they’ll continue to do in their homes each week.

The FDA frowns upon this kind of instruction in trials for at-home tests — users are supposed to be able to execute the test without training. But in reality, many need support.

For the nonprofit that helped launch the effort, the Center of Complex Interventions, the important part is demonstrating that rapid tests can work when used as part of a coordinated testing regime to address specific situations: right before people gather indoors or after an exposure to an infected person, for anyone in a high-risk job, for people in crowded living situations, or for those who have health risk factors. People in all of those situations are concentrated in Chelsea’s housing authority buildings.

“It’s a lot different than saying, ‘Let’s roll it out to everybody,’” said Karthik Dinakar, who is leading the project. “It all has to be connected in a way that makes people feel like they’re participating. The goal for us is to make the community safer, and also shift the mindset to a new equilibrium.”

Amelia Valesquez and other Buckley Apartment housing project residents self-administer COVID-19 tests. Valesquez checks on her results. (Kayana Szymczak for ProPublica)

Joshua Sharfstein, a vice dean at Johns Hopkins University’s Bloomberg School of Public Health who used to be principal deputy commissioner of the FDA, said that rapid tests could have been authorized earlier with these kinds of protocols in mind.

“There was no testing strategy,” Sharfstein said, outlining the opportunity that America missed to use a variety of tests for the purposes to which they were best suited. “What they could have done is to say, ‘Here are the six uses of tests. You’re sick, you’re exposed, you’re trying to maintain people on a campus. What’s the performance of test that you would need?’“Just think how amazingly helpful that would be,” he finished, wistfully.

Meanwhile, the CDC and NIH have been studying similar programs in a handful of communities using Quidel’s at-home test. Governors have been catching on to the utility of rapid tests too. Last week, the state of Massachusetts bought millions of rapid test kits made by iHealth laboratories. The company’s chief operating officer, Jack Feng, told National Public Radio that the price was higher in the U.S. because of the expense of clinical trials that aren’t required elsewhere.

And since rejecting Bosch’s submissions, the FDA has been coming around to her way of thinking. In March, the agency published a template for tests that would be used serially and sold in packages of two or more, allowing the kind of frequent testing she had advocated for. And last month, it published a new template that lowered the sensitivity standard for over-the-counter tests to 80%.

Bosch had tests a year and a half ago that missed that bar by 1%.

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If you have tips about America’s pandemic response, or anything else, reach Lydia DePIllis via email at lydia.depillis@propublica.org or Signal at 202-913-3717.

This post was originally published on Articles and Investigations – ProPublica.

by Neil Bedi and Maryam Jameel

]

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For the roughly 2,000 Americans who rely on it to keep their hearts going, the implanted pump is impossible to ignore.

They feel it pressing inside their ribs when they lean over. Or they ache from the weight of its controller strapped to their shoulders. Some can even hear the device’s whirring hum deep inside their chests.

Most of all, they now live with the stress of knowing the HeartWare Ventricular Assist Device has such serious issues — a higher rate of deaths and strokes than an alternative pump and a history of unexplained malfunctions — that the Food and Drug Administration and the device’s maker agreed this summer it should be taken off the market.

Those who already have the heart pump, also known as the HVAD, can’t simply get it removed or replaced. The required surgery is typically considered more dangerous than leaving it in.

They are now stuck in a medical dilemma that could have been prevented.

Buffy Shaw, left, an HVAD patient, with her daughter, who found the recall online. (Rachel Bujalski for ProPublica)

As we detailed in August, the FDA and HVAD maker Medtronic allowed the device to be implanted into thousands of people for years, even as federal inspectors found serious manufacturing problems, the company issued many high-risk safety alerts and people died after their implants malfunctioned. The FDA and Medtronic said they believed the benefits outweighed the risks for HVAD patients with severe heart failure, until this year when data was published showing a higher frequency of deaths and strokes compared to patients with a competing device.

The company has pledged to do everything it can to support the remaining HVAD users. Medtronic said it would provide patients with educational materials, financial assistance and technical support. “The wellbeing and experiences of patients are vitally important to us, which is why we’ve set up patient support programs, services, and feedback mechanisms,” a company spokesperson said in a written statement.

The FDA said it would “actively provide oversight of Medtronic to monitor their recall of the device and ensure that patient care remains a top priority.”

But when we spoke to people across the country who are living with HVADs, they said they’d experienced little of the promised support and had encountered financial and emotional hardships.

Here, in their own words, is what they told us.

(These interviews below have been edited for clarity.)

The purse where Shaw carries her HVAD equipment (Rachel Bujalski for ProPublica)

I haven’t gotten a letter to this day from anybody saying anything about that recall.

—Alicia Warren, a 44-year-old from Madison, Georgia, raised her two daughters alone while having heart failure. She has had the device since April 2018.

Alicia Warren started experiencing symptoms of heart failure at age 22, shortly after giving birth to her first daughter. “They said it came from the stress on my heart from pregnancy,” she said. “I went to the hospital one night telling them, ‘I’m not feeling good, something’s wrong.’ The emergency room doctor told me, ‘Your heart rate is racing, have you smoked crack or anything like that?’ You’ve got to be kidding me. My daughter was 1 month old.

“I did pretty well at keeping my health up and everything until around October of 2017. I was in end-stage heart failure and didn’t even know it. My kidneys were failing and my digestive system was shutting down. I’ll never say again in my life that I’m tired. Because I really know what tired is. My brothers were calling me and texting me asking what was going on, and I didn’t even have the strength to lift my finger to text back.

“The doctor acted like he was just gonna let me die. He was like, ‘I think we’ve reached the end of your life.’ I was 40 at the time. He told my kids that and everything.” Warren’s family had her moved to another hospital. Doctors there told her she only had about a month to live unless she got a left ventricular assist device, or LVAD.

LVAD is the general name for these heart pumps. Before June, there were two companies that sold LVADs in the United States, Medtronic with the HVAD and Abbott Laboratories with the HeartMate. The FDA found serious problems at the HVAD’s manufacturing plant in 2014 and labeled the device “adulterated.” But it continued to be implanted in patients for seven more years, even though dangerous issues persisted. In response, Medtronic said this month: “In 2014, the benefits of using the HVAD System for these patients significantly outweighed the known risks. Lives were saved and others extended.”

Warren and 13 other HVAD users said they weren’t told about those problems. Warren and many of the others also said they weren’t given a choice between the two devices. Sometimes that was because they had had an emergency implant with little time to research the options, or, as with Warren, their doctors only offered one device.

“I just think they should’ve went about it a different way, told the truth, and if people still want to get it, then fine. But don’t hold back the truth. Because people have died,” Warren said. “I was not informed about the issues, deaths or even the recall of the pump.”

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Three years after she received the HVAD, Warren was surprised to find out it had been suddenly removed from the market. “Someone in the LVAD friends group posted a link, and I went and read it. And then I was like, ‘What?’ I’m sure if this was true, my doctors would’ve told me. They should’ve been straightforward with us about what was going on.

“I haven’t gotten a letter to this day from anybody saying anything about that recall.

“Now here I am with this thing in me, and there’s nothing I can do. It’s in me now. The only thing I can do is pray and hope I never have any issues with this thing until they get it out of me. I’m mad, but I’m still alive.”

Five other people who still have the HeartWare pump told us they first found out about the device discontinuation from social media or news reports. Some only received a letter from Medtronic after they contacted their doctors or after we reached out to the company.

The FDA said that Medtronic is required to inform every patient in writing and that the federal agency published a public notice of this. Medtronic wrote in December, “We sent letters to patients and set up a patient website and hotline. We’ve confirmed 90 percent of patients in the United States received our letter and we will continue to work with clinician offices to reach the remaining 10 percent who either declined delivery or for whom we had outdated contact information.”

Pretty much everything they said could go wrong with it has gone wrong with it, except for the death part.

—Kelly Sanchez, 54, is a former meat cutter from Beulah, Michigan, who was forced to retire early because of his heart condition. He’s been an HVAD patient since August 2016. Kelly Sanchez outside his home in Beulah, Michigan (Brittany Greeson, special to ProPublica)

When Kelly Sanchez first got the letter announcing Medtronic’s discontinuation of the HVAD, he assumed it was nothing serious. “I thought they were sending me another card in the mail for carrying in my wallet,” he said. Then he read closer. “I was in shock. And then, of course, I’m worried. Because how much are they telling me? And how much are they not telling? Yeah, they sent me this letter. But if they’re doing all this, there’s got to be more to it.

“Pretty much everything they said could go wrong with it has gone wrong with it, except for the death part. Neurological issues, the strokes, the clotting. The pump exchange.”

A pump exchange is a surgery to replace the implanted heart pump with a new one if it stops working properly and the benefits of the operation now outweigh the risks. Sanchez had the operation after a clot got stuck in the device in 2017. “It sounded like a cement mixer,” he said.

Then, in July 2019, he went golfing with his stepson Tyler Schmidt. He never got past the first hole. “I teed off, I turned around, took a step and then all of a sudden I got, they called it, stacked double vision. I was seeing a head on top of a head. Tyler rushed me up with the car and we took off to the hospital.”

Sanchez plays pool with his HVAD external controller in a backpack. The cable connects the controller to the internal pump through a small incision in his waist. (Brittany Greeson, special to ProPublica)

Sanchez was taken in for brain scans and doctors found that not only did he have a stroke, but he had also had four or five earlier undiagnosed ones based on the damage in his brain. Much of the damage was in the optical center. “My cardiologist flat-out told me, if you have a major stroke you can lose your vision permanently,” he recalled.

When Medtronic discontinued the HVAD in June, the company said: “A growing body of observational clinical comparisons demonstrate a higher frequency of neurological adverse events and mortality.”

A study published in July found that HVAD patients experienced strokes and other neurological injuries more than twice as often as those with the competing HeartMate device. Medtronic said, “This study re-confirms our reasons for stopping sales and distribution of the HVAD device.” The company also noted the study compared the HVAD to the HeartMate 3, a newer version of the competing device. That device was approved by the FDA in 2017.

“I’m not gonna lie, we’ve been through so much stress after that first letter,” Sanchez said. “I love playing pool. I play pool three nights a week in leagues. It used to be a stress reliever. But it’s everywhere now. I mean, I can’t get away from it. With me, there’s no stress relief right now at all.”

Kelly Sanchez’s wife, Kim, points to a sheet listing his medications and their costs. (Brittany Greeson, special to ProPublica) Kelly Sanchez shows a bucket list of places he wants to visit with his family after he receives a heart transplant. (Brittany Greeson, special to ProPublica)

“I have diabetes and I can’t get my sugar under control because of the stress,” his wife, Kim Sanchez, said. “Every day, that thing is in his chest. And I’m always waiting. I always have my phone, right by me. When my phone rings, and it’s his number, I’m scared to death that something else has happened.”

Sanchez’s cardiologist said they needed to get him a heart transplant as soon as possible, Kim Sanchez said. Patients no longer need HVADs once they receive heart transplants, but they need to be eligible and wait for a donor heart to become available. People who aren’t transplant candidates could have the HVAD for the rest of their lives.

“Right now, my entire thought process is to get this thing out of my chest as quick as I can,” Kelly Sanchez said. In June, he underwent bariatric surgery to lose weight to meet transplant requirements. He lost 56 pounds by November and thought he was finally below the BMI limits. Then he learned the medical staff measured his height an inch shorter than before, pushing his BMI higher.

“I’m frustrated, I’m angry and I’m scared because I still have this thing in my chest,” he said. “As long as I’ve lost 8 pounds by the 23rd of December, they’ll go back to the board. Now our hope is, I lose the 8 pounds, I get down to 225. And hopefully by the new year I’ll be on the list. That’s all we got right now.”

Sanchez and his wife with their grandson Cassius at their home (Brittany Greeson, special to ProPublica)

Those costs all add up. If we did have to pay mortgage or rent, I wouldn’t make it with my disability payments.

—Dennis Partner, 65, is a former sales representative and truck driver from Lafayette, Indiana. He’s had his device since November 2017. He and his wife rely on disability insurance for income.

Dennis Partner had his first heart attack at 32, while playing softball. He’d go on to have about five more, each further damaging his heart. His doctor eventually recommended the HVAD, saying it could extend his life and give him more energy.

“I really thought the LVAD would bring back more and more movement. It never has,” he said. “I walk half a block and have to sit down and lean against something and rest. My legs just give out.”

After the HVAD was discontinued in June, doctors increased the frequency of his checkups. The additional attention also meant additional medical costs. Partner has to drive 125 miles round-trip to get to and from his doctors’ office, and each visit requires a co-pay. “Those costs all add up,” he said. Partner is thankful that his family downsized their home and paid off their purchase. “If we did have to pay mortgage or rent, I wouldn’t make it with my disability payments.”

Dennis Partner at his home in Lafayette, Indiana (Taylor Glascock for ProPublica)

Then, Partner’s device controller displayed a critical alert.

Before June, users were able to swap out their external device controllers at home if there was ever an issue. Patients told us that, after the recall, these controller exchanges are now done in hospitals. “They need to have a surgical suite and surgeon on call in case the pump wouldn’t start, to try to save me,” Partner said.

“It was a pretty nerve-wracking drive up there. I spent the night every five minutes having to quiet my alarm. My coordinator and her helper or trainee came into the hospital room and said, ‘You ready to change it out?’ And five minutes later it was done. Luckily mine started up just fine.”

When Medtronic discontinued the device, the company admitted there has been an issue since 2009 with the pump failing to start up. Medtronic said there had been 106 complaints related to the problem. Fourteen cases led to patients dying, and 13 others required emergency surgery to remove the devices. Medtronic said in June it still hadn’t been able to figure out the root cause of the malfunctions. The company said it was a rare problem, affecting only a small portion of devices based on the complaints submitted.

Linda Partner, Dennis’ wife, changes the bandage on the incision that connects his HVAD pump to its external controller. (Taylor Glascock for ProPublica)

Partner received a bill for about $47,000 for the two days he spent in the hospital for the exchange. Medicare negotiated the bill down to $29,000 and covered most of the cost, but Partner still has to pay $2,556 — a significant amount for his family, which relies on disability income.

“I never even thought there was going to be a bill. I’m still having a hard time — I can’t get an explanation of why they installed this model when they knew there were tons of problems with it. I just don’t feel that’s my responsibility.”

After we recently told Medtronic about patients who are struggling with new medical costs, a company spokesperson said in an email, “We anticipated patients might have concerns about medical costs, so we expanded the HVAD System warranty and are encouraging patients to contact us (1-800-635-3930) for potential coverage of non-reimbursed medical costs.”

The expanded financial support is news to patients. The people we spoke to said they weren’t informed of it. When asked, Medtronic didn’t provide evidence that it had told patients about the expanded assistance. Days later, the company updated its patient support website, which now says it can help patients with newly incurred medical expenses.

Medtronic told us last week it had heard from four patients in total and covered costs for two of them since June.

Partner said he contacted the company more than two months ago to see if it could help with his medical bills. A representative said they would “see what they could do,” he said.

The company finally reached back out to him last week, asking for more information.

Lottery tickets pile up at Partner’s home. (Taylor Glascock for ProPublica)

You guys messed up. You need to do something to correct this. We don’t really have a voice.

—Buffy Shaw, 47, has had the device since 2019. She’s from Oroville, California, but spends much of her time traveling around the world as an international flight nanny for American Bully dogs.

“It’s a nonstop lifestyle,” Buffy Shaw said about her job as an in-flight nanny for American Bully dogs. “I’ve built a bunch of clientele all over the world. It’s like I don’t ever stop.” So, when she learned she needed an LVAD, it was devastating.

“The first six weeks were extremely difficult. Very emotional. Very everything. Just learning how to do everything again. I couldn’t walk from the chair to the front door. I’d literally go to pass out. I couldn’t hold anything down as far as food. I got sick from everything. I couldn’t take a shower by myself. I couldn’t do anything by myself.”

Batteries for Shaw’s HVAD controller in a charger at her daughter’s home (Rachel Bujalski for ProPublica)

Shaw said it took almost six months to adapt to having the device. She began carrying the external controller in a purse to avoid questions and was able to continue taking dogs around the world.

Then, her daughter found the recall online. “Once I started learning exactly what it entailed, it was very depressing,” Shaw said. “I feel like they’ve used us as guinea pigs.”

Shaw said she feels powerless as only one person — or even one of 2,000 people — up against Medtronic, a multibillion-dollar company, and the federal government. “You guys messed up,” she said. “You need to do something to correct this. We don’t really have a voice. That’s what I feel like. We don’t have a voice to make something happen. There are people that have died because of this machine.”

Another HVAD patient, who Shaw met on Facebook, started having problems with his device in October. He needed emergency surgery to replace the pump, but he never fully recovered. He died three weeks ago. “Death. Literally all you can think about is death,” she said.

Shaw looks at photos from her travels for work. (Rachel Bujalski for ProPublica)

“I don’t sleep a lot as it is, which is a side effect of having heart failure, you know, sleep issues. So now it’s just stress about the recall and them not really offering any solutions to it. There’s certain things you can do, certain things you can’t do. It’s a lot of stress, like, extreme stress.

“They should have offered something for that as far as counseling. I feel like right now, we have zero resources. My doctors always say that I’m a high functioning patient as far as this goes. I’m just super high functioning because I don’t feel like I ever want to — I’m not going to — sit home and die. I’m not going to be one of those people that just sits online and reads about people dying and all the stuff that goes on and I just have to get out of that space.”

Shaw has visited Hawaii, France and Ireland for her job since September. “To me, that’s ideal in my situation, because I literally could drop dead tomorrow,” she said. “Right now I’m just thankful that I am able to do what I’m doing. Until I get to where I can’t anymore. It’s a very fine line. That’s for sure. It’s a very fine line.”

Shaw with her granddaughter at her daughter’s home (Rachel Bujalski for ProPublica)

Tell Us About Your Experience With Life-Sustaining Medical Devices

Maya Miller contributed reporting.

This post was originally published on Articles and Investigations – ProPublica.