Essential Worker Shoulders $1,840 Pandemic Debt Due To COVID Cost Loophole

Carmen Quintero works an early shift as a supervisor at a 3M distribution warehouse that ships N95 masks to a nation under siege from the coronavirus. On March 23, she had developed a severe cough, and her voice, usually quick and enthusiastic, was barely a whisper.

A human resources staff member told Quintero she needed to go home.

“They told me I couldn’t come back until I was tested,” said Quintero, who was also told that she would need to document that she didn’t have the virus.

Her primary care doctor directed her to the nearest emergency room for testing because the practice had no coronavirus tests.

The Corona Regional Medical Center is just around the corner from her house in Corona, California, and there a nurse tested her breathing and gave her a chest X-ray. But the hospital didn’t have any tests either, and the nurse told her to go to Riverside County’s public health department. There, a public health worker gave her an 800 number to call to schedule a test. The earliest the county could test her was April 7, more than two weeks later.

At the hospital, Quintero got a doctor’s note saying she should stay home from work for a week, and she was told to behave as if she had COVID-19, isolating herself from vulnerable household members. That was difficult — Quintero lives with her grandmother and her girlfriend’s parents — but she managed. No one else in her home got sick, and by the time April 7 came, she felt better and decided not to get the coronavirus test.

Then the bill came.

The Patient: Carmen Quintero, 35, a supervisor at a 3M distribution warehouse who lives in Corona, California. She has an Anthem Blue Cross health insurance plan through her job with a $3,500 annual deductible.

Total Bill: Corona Regional Medical Center billed Quintero $1,010, and Corona Regional Emergency Medical Associates billed an additional $830 for physician services. She also paid $50 at Walgreens to fill a prescription for an inhaler.

Service Provider: Corona Regional Medical Center, a for-profit hospital owned by Universal Health Services, a company based in King of Prussia, Pennsylvania, which is one of the largest health care management companies in the nation. The hospital contracts with Corona Regional Emergency Medical Associates, part of Emergent Medical Associates.

Medical Service: Quintero was evaluated in the emergency room for symptoms consistent with COVID-19: a wracking cough and difficulty breathing. She had a chest X-ray and a breathing treatment and was prescribed an inhaler.

What Gives: On that day in late March when her body shook from coughing, Quintero’s immediate worry was infecting her family, especially her girlfriend’s parents, both over 65, and her 84-year-old grandmother.

“If something was to happen to them, I don’t know if I would have been able to live with it,” said Quintero.

Quintero wanted to isolate in a hotel, but she could hardly afford to for the week that she stayed home. She had only three paid sick days and was forced to take vacation time until her symptoms subsided and she was allowed back at work. At the time, few places provided publicly funded hotel rooms for sick people to isolate, and Quintero was not offered any help.

For her medical care, Quintero knew she had a high-deductible plan yet felt she had no choice but to follow her doctor’s advice and go to the nearest emergency room to get tested. She assumed she would get the test and not have to pay. Congress had passed the CARES Act just the week before, with its headlines saying coronavirus testing would be free.

That legislation turned out to be riddled with loopholes, especially for people like Quintero who needed and wanted a coronavirus test but couldn’t get one early in the pandemic.

“I just didn’t think it was fair because I went in there to get tested,” she said.

Carmen Quintero (right) still tries to keep a safe distance from her grandmother, Teresa Carapia, and two other family members over 65. Quintero says she worried about them as she tried to self-isolate with COVID-like symptoms.(Heidi de Marco/KHN)

Some insurance companies are voluntarily reducing copayments for COVID-related emergency room visits. Quintero said her insurer, Anthem Blue Cross, would not reduce her bill. Anthem would not discuss the case until Quintero signed its own privacy waiver; it would not accept a signed standard waiver KHN uses. The hospital would not discuss the bill with a reporter unless Quintero could also be on the phone, something that has yet to be arranged around Quintero’s workday, which begins at 4 a.m. and ends at 3:30 p.m.

Three states have gone further than Congress to waive cost-sharing for testing and diagnosis of pneumonia and influenza, given these illnesses are often mistaken for COVID-19. California is not one of them, and because Quintero’s employer is self-insured — the company pays for health services directly from its own funds — it is exempt from state directives anyway. The U.S. Department of Labor regulates all self-funded insurance plans. In 2019, nearly 2 in 3 covered workers were in these types of plans.

Resolution: As lockdown restrictions, ease and coronavirus cases rise around the country, public health officials say quickly isolating sick people before the virus spreads through families is essential.

But isolation efforts have gotten little attention in the U.S. Nearly all local health departments, including Riverside County, where Quintero lives, now have these programs, according to the National Association of County and City Health Officials. Many were designed to shelter people experiencing homelessness but can be used to isolate others.

Raymond Niaura, interim chairman of the Department of Epidemiology at New York University, said these programs are used inconsistently and have been poorly promoted to the public.

“No one has done this before and a lot of what’s happening is that people are making it up as they go along,” said Niaura. “We’ve just never been in a circumstance like this.”

Quintero still worries about bringing the virus home to her family and fears being in the same room with her grandmother. Quintero returns from work every day now, puts her clothes in a separate hamper and diligently washes her hands before she interacts with anyone.

The bills have been another constant worry. Quintero called the hospital and her insurance company and complained that she should not have to pay since she was seeking a test on her doctor’s orders. Neither budged, and the bills labeled “payment reminders” soon became “final notices.” She reluctantly agreed to pay $100 a month toward her balance — $50 to the hospital and $50 to the doctors.

“None of them wanted to work with me,” Quintero said. “I just have to give the first payment on each bill so they wouldn’t send me to collections.”

The Takeaway: If you suspect you have COVID-19 and need to isolate to protect vulnerable members of your household, call your local public health department. Most counties have isolation and quarantine programs, but these resources are not well known. You may be placed in a hotel, recreational vehicle or other type of housing while you wait out the infection period. You do not need to have a positive COVID test to qualify for these programs and can use these programs while you await your test result. But this is an area in which public health officials repeatedly offer clear guidance — 14 days of isolation — which most people find impossible to follow.

At this point in the pandemic, tests are more widely available and federal law is very clearly on your side: You should not be charged any cost sharing for a coronavirus test.

Be wary, though, if your doctor directs you to the emergency room for a COVID test, because any additional care you get there could come at a high price. Ask if there are any other testing sites available.

If you do find yourself with a big bill related to suspected COVID, push beyond a telephone call with your insurance company and file a formal appeal. If you feel comfortable, ask your employer’s human resources staff to argue on your behalf. Then, call the help line for your state insurance commissioner and file a separate appeal. Press insurers — and big companies that offer self-insured plans — to follow the spirit of the law, even if the letter of the law seems to let them off the hook.

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California Prisons Are COVID Hotbeds Despite Billions Spent On Inmate Health

From Corcoran and Avenal state prisons in the arid Central Valley to historical San Quentin on the San Francisco Bay, California prisons have emerged as raging COVID-19 hot spots, even as the state annually spends more on inmate health care than other big states spend on their entire prison systems.

The new state budget taking effect July 1 authorizes $13.1 billion for California’s 34 prisons, housing 114,000 inmates, more than three times what any other state spends. That sum includes $3.6 billion for medical and dental services and mental health care — roughly what Texas spends to run its entire 140,000-inmate prison system.

And, yet, despite the extraordinary dedication of resources, California prison officials are struggling to contain the COVID outbreaks, let alone prevent them. On March 25, there was just one confirmed COVID-19 case among California’s inmates. Three months later, more than 4,600 inmates have contracted the disease, an infection rate of about 40 per 1,000 inmates and rising — more than seven times higher than the infection rate for the state’s population as a whole. Twenty-one inmates have died. More than 730 staffers have tested positive, and two have died.

Prison systems in several other states are seeing worse outbreaks. In Ohio, at least 84 inmates have died. In Michigan prisons, 68 inmates have died. In Texas, at least 79. But given what it spends on prison health care, and its history, California might have seen the scourge coming.

Prisoner rights attorneys in California for years have waged high-profile court challenges alleging inadequate health care delivery behind bars. As a result of their efforts, federal judges in San Francisco and Sacramento oversee the state’s prison health care system. A special office, known as the California Correctional Health Care Services, has a staff of 57 to monitor the delivery of care.

“Every year, there is a major outbreak,” said San Francisco attorney Michael Bien, who for 30 years has wrangled with the state over conditions for inmates diagnosed with varying levels of mental illness. Hepatitis, HIV and other communicable diseases are common in prisons. “Prisons are like nursing homes,” Bien said. “They’re very dangerous for infectious diseases.”

In 2011, the U.S. Supreme Court concluded that California’s prisons were so crowded and the physical and mental health care so deficient that conditions amounted to cruel and unusual punishment. In response, California cut its prison population and now houses 114,000 inmates, down from a peak of 173,000 in 2006. Many health experts believe the prison system is still too crowded to keep the novel coronavirus from spreading.

The California Institution for Men in Chino, in the suburbs east of Los Angeles, was the first California lockup struck. It reports more than 890 cases involving inmates and 16 deaths. In an effort to contain the virus at the Chino prison, the California Department of Corrections and Rehabilitation (CDCR) on May 30 transferred 121 inmates considered especially vulnerable to infection 444 miles north to California’s oldest prison, San Quentin, just north of San Francisco.

Assembly member Marc Levine, a Democrat whose Marin County district includes San Quentin, said some Chino prisoners initially were housed on the upper tier of a San Quentin cellblock, called the Badger Unit. That allowed their droplets to descend on inmates below.

“Everything was preventable. Everything,” Levine said.

In a statement, CDCR spokesperson Dana Simas said inmates from Chino who had tested positive upon arrival at San Quentin “were not exposed to the general population” of the prison.

However the virus arrived, more than 830 San Quentin inmates since have tested positive. Chino inmates also were transferred to Corcoran State Prison, south of Fresno. Now, 155 Corcoran prisoners have the virus. In Lassen County, officials are blaming the transfer of prisoners from San Quentin to the California Correctional Center in Susanville for an outbreak that has infected 211 inmates in the past two weeks.

Corrections officials say they now routinely distribute cloth masks to inmates and workers throughout the prison system, providing hand sanitizer in common areas, and have increased attention to disinfecting surfaces. Prisons are screening and taking the temperatures of staffers who enter the prisons.

“We have taken unprecedented steps to address the COVID-19 pandemic in all state prisons, including the cessation of visiting, volunteers, and group programs; developing comprehensive prevention and treatment protocols,” Simas said in a statement.

California’s prisons were built to contain felons, not the coronavirus. Each of the state’s 34 prisons house 2,000 to 5,000 inmates. Many live in dorms, sleeping in double bunks and sharing showers and dining halls. Others live two to a 60- to 80-square-foot cell.

Earlier this year, to create more space, the state sped the release of 3,500 inmates who had less than six months to serve on their sentences. Starting July 1, the state once more will start speeding the release of prisoners who have six months or less left on their sentences, with caveats: They cannot have been convicted of violent or serious felonies, domestic violence or sex crimes.

They also must have plans for housing. That’s important for officials grappling with California’s other epidemic: homelessness.

It’s not clear whether COVID-related releases from state prisons have amplified the state’s homeless crisis. But El Dorado County District Attorney Vern Pierson, vice president of the California District Attorneys Association, predicts it’s a matter of time.

“We’re going to exacerbate an already bad situation,” Pierson said. “The numbers that will become homeless will be high. The supervision will be less and less. The likelihood of reoffending will likely go up.”

In Sacramento, Mayor Darrell Steinberg, co-chair of Newsom’s homelessness task force, said that since the start of the pandemic the capital city has moved 800 people from the streets into hotels, a hopeful sign.

But that gain has been more than offset because fewer people are in county jails. To limit the spread of the coronavirus in county lockups, jailers statewide have reduced the number of total inmates from 72,000 to 51,000, the California Board of State and Community Corrections reports.

In part because of those releases, homeless encampments along the Sacramento River have “grown and grown in a very significant way,” Steinberg said. Similar spikes in homelessness are occurring across the state.

Releasing people, “if they do not present a real risk,” is not the problem, Steinberg said. “The problem is releasing them without any connection with housing and the support necessary for them to be successful.”

CDCR’s response to the pandemic will come under scrutiny in a July 1 oversight hearing to be convened by state Sen. Nancy Skinner, a Berkeley Democrat who chairs the Senate Committee on Public Safety.

“What are the biggest congregate facilities in the state? Prisons,” Skinner said. “They are exactly the type of facility no one wants to be in a pandemic.”

California’s efforts to stem the outbreaks matter beyond the prison gates, several experts noted. Prison workers go home at the end of their shifts. Inmates too sick to be cared for in prison infirmaries are sent to community hospitals. Ultimately, prison health and public health are inextricably intertwined.
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Seniors In Low-Income Housing Live In Fear Of COVID Infection

Davetta Brooks, 75, who has heart failure, a fractured hip and macular degeneration, is afraid. Conditions in her low-income senior building on Chicago’s Near West Side — the Congressman George W. Collins Apartments — are “deplorable,” she said.

Residents are not wearing masks or gloves to guard against the coronavirus, she said: “They’re touching everything on the elevator, in the laundry room. And anybody and everybody’s relatives and friends are coming in and out with no scrutiny.”

No one is checking on residents to see if they need help, Brooks said. And no one seems to know whether residents have tested positive for COVID-19 or died, though ambulances have screeched up to the entrance several times.

“This building is not safe,” she said in mid-June. “With all the things happening in the U.S., this is what ‘seniors lives don’t matter’ looks like.”

Nationwide, more than 1.6 million older adults live in low-income housing subsidized by the Department of Housing and Urban Development — most in apartment buildings with shared common spaces, elevators, staircases, mailrooms, hallways and laundry rooms where the coronavirus might lurk.

Most of these seniors have endured a life of disadvantage, have chronic illnesses such as diabetes and heart disease, and lack financial reserves to draw upon.

Yet in the midst of the pandemic, this population — the age group deemed most at risk of becoming critically ill and dying — has largely been overlooked.

“This is a moment when we really should be pushing assistance and guidance toward these senior communities, but we’re not,” said Linda Couch, vice president of housing for LeadingAge, an association that represents nonprofit senior housing and long-term care providers. “No one is watching over what’s happening.”

Nationally there is no data on COVID-19’s spread in low-income housing. The Centers for Disease Control and Prevention is not collecting it or requiring states to do so. The same is true of HUD and state and local housing agencies: This is “independent living,” and operators are not expected to monitor the health of residents.

Low-income housing operators find out about COVID cases only when residents or family members volunteer the information. For the most part, systematic testing is not done. A rare exception: Gov. Andrew Cuomo in mid-May announced plans to bring coronavirus testing to 40 public housing developments in New York.

“Without testing, there’s no way of knowing how many people have the virus,” said Michael Kane, executive director of the National Alliance of HUD Tenants. “Our concern is that there could be a transmission danger similar to what’s going on in nursing homes or assisted living.”

“People are dying all over in these buildings, and we don’t know what they’re dying from,” said Geraldine Collins, president of the National Alliance of HUD Tenants.

The situation in Chicago highlights how difficult it is to gauge the extent to which people in these settings are at risk. Although the Chicago health department requires “congregate living facilities,” including senior housing complexes, to report two or more confirmed COVID cases that occur within 14 days, it has not made that data publicly available. So there is no way of tracking where the virus is spreading.

The Chicago Housing Authority, which operates 55 buildings with 9,500 senior residents, “is not required to track or verify cases and, due to privacy issues, we do not inquire about the health status of residents,” the agency said in a statement.

At the federal level, HUD’s emergency preparedness plans did not incorporate infectious disease control and its guidance to housing operators was spotty in the pandemic’s early stages. Building managers were not required to notify residents of a COVID case.

Recently, HUD has come out more strongly on the side of transparency. On May 21, HUD said that multifamily housing management should, “in coordination with local health officials, communicate the possible COVID-19 exposure to all residents and workers, volunteers and visitors.”

On health concerns, HUD has deferred to the Centers for Disease Control and Prevention, which in March issued recommendations for preventing the spread of COVID-19 in retirement communities and independent living facilities.

Those include cancelling group activities; informing residents, workers and visitors about COVID-19; stepping up cleaning and disinfecting; screening people coming into buildings; and limiting visitors.

Very little of that was happening in Chicago buildings for low-income seniors, according to Lori Clark, executive director of the Jane Addams Senior Caucus, which has close to 700 members.

When the organization called members in mid-March, “we started to hear awful stories,” Clark said. Residents reported getting no information about how to stay safe. No one was checking who was going in and out. Buildings were understaffed as workers stayed home.

At the Elizabeth Woods Apartments, a senior building operated by the Chicago Housing Authority, “we felt abandoned,” said Carmen Betances, 68. “They did no cleaning, and they did not prepare the property for the invisible enemy that has now taken over. They gave us no information about what to do.”

“I am a target for coronavirus: I am a senior. I’m asthmatic. I have a compromised immune system,” Betances said. “Every breath I take, I take with fear, worrying that I could die from this invisible monster.”

At the end of March, Betances and other residents began using their own cleaning supplies to disinfect the handles of every door in the six-story apartment building twice a day. They wiped down water fountains, counters in the lobby, chairs and tables in the community room as well as vending and laundry machines.

Older adults like Davetta Brooks are at high risk of becoming critically ill from the coronavirus, according to federal guidelines. Davetta lives at the Congressman George W. Collins Apartments, a low-income building for seniors on Chicago’s Near West Side, where she says health conditions are “deplorable.” (Nolis Anderson for KHN)

On May 20, the housing authority said in a statement it is making more than 3,000 calls daily to check in on older residents, requiring property management firms to clean and disinfect common areas three times a day, and distributing information about Chicago’s six new coronavirus testing sites.

The complex where Brooks lives is privately operated. Its operations were taken over April 1 by WinnResidential, the nation’s largest manager of affordable housing.

“The immediate priority during this transition has been to protect the health and safety of the residents,” wrote Ed Cafasso, senior vice president of WinnCompanies, which owns WinnResidential. He said the complex was now being cleaned several times a day.

Cafasso said the company has helped tens of thousands of older residents at 520 properties obtain meals, groceries, household supplies and masks; renew prescriptions; and access telehealth.

Food assistance is a pressing need because people cannot get hot meals at community centres and many are afraid to go to grocery stores.

Also needed: help using technology, and better internet connections so seniors can participate in telehealth and virtual interactions with friends and family, easing their loneliness as stay-at-home orders remain in place. Most federally subsidized senior housing lacks building-wide Wi-Fi.

Going into the pandemic, some housing operators were better equipped to respond. In and around New York City, Selfhelp Community Services runs 11 low-income senior buildings with 1,400 residents. Social workers have identified vulnerable residents at the buildings and have stayed in contact with them, said Mohini Mishra, a managing director.

“If someone is coming home from the hospital, we try to check in with family members,” Mishra said. “Will they need home care? Do they understand what self-quarantine means?”

Across seven of Selfhelp’s buildings, there had been 20 confirmed cases of COVID-19 among residents and 12 people had died as of June 10.

At the Paul G. Stewart Center apartments in Chicago, officials called in the police after the first resident found to have COVID-19 in mid-March refused to stay in their apartment.

“We reiterated the guidelines of the CDC and the Chicago and Illinois health department[s],” said Shawn Person, chief operations officer of the South Side campus, which houses about 1,300 residents. “But this person refused to listen. We had to do something.” As of June 10, she said, 10 residents had tested positive and two had passed away.

The complex is participating in a federal pilot project that brings nurses into senior housing to help evaluate residents’ needs.

But there’s only so much they can do. “There’s a store in this building, and nobody practices true social distancing there,” said Shirley Moore, 71, who lives in an apartment tower on the campus, has COVID-19 and is not sure how she became infected.

Her 72-year-old husband has a much worse case of COVID-19 than she does, she said. He had been in intensive care for three weeks as of June 10, including eight days on a ventilator, she said, and early on doctors told her they did not think he would survive.

“You go up in the elevators, you’re bringing garbage to the garbage chute, you’re grabbing a guardrail in the hall,” she said. “Even if there’s been cleaning, people still will be touching all these places in between.”

As for what she would like to see happen, Moore said, “I think they should be testing. I’m sure if you tested everyone in this building, you’d come up with a lot of COVID-19.”
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Fearing The Deadly Combo Of COVID-19 And Cancer

Three Tuesdays each month, Katherine O’Brien straps on her face mask and journeys about half an hour by Metra rail to Northwestern University’s Lurie Cancer Center.

What were once packed train cars rolling into Chicago are now eerily empty, as those usually commuting to towering skyscrapers weather the pandemic from home. But for O’Brien, the excursion is mandatory. She’s one of the millions of Americans battling cancer and depends on chemotherapy to treat the breast cancer that has spread to her bones and liver.

“I was nervous at first about having to go downtown for my treatment,” said O’Brien, who lives in a suburb, La Grange, and worries about contracting the coronavirus. “Family and friends have offered to drive me, but I want to minimize everyone’s exposure.”

While her treatment hasn’t changed since the novel coronavirus spread across the United States, the 54-year-old is at high risk of severe complications should she become infected. Those risks haven’t declined significantly for her despite the Illinois governor’s loosening of COVID-related restrictions.

She’s not alone in fearing the deadly combination of COVID-19 and cancer. One study, which reviewed records of more than 1,000 adult cancer patients who had tested positive for COVID-19, found that 13% had died. That’s compared with the overall U.S. mortality rate of 5.9%, according to Johns Hopkins.

Beyond the concern of cancer patients — with their already depleted immune systems — catching the virus, many doctors worry about people delaying their scans and checkups and missing time-sensitive diagnoses. A KFF poll found that nearly half of Americans had skipped or postponed medical care because of the outbreak. Cancer patients seeking care face an array of obstacles as states reopen, such as heavily restricted in-hospital appointments and new clinical trials on hold. (KHN is an editorially independent program of KFF, the Kaiser Family Foundation.)

“Cancer doesn’t care that there’s a coronavirus pandemic taking place,” said Dr. Robert Figlin, chair in hematology-oncology at Cedars-Sinai in Los Angeles. “We don’t want people who have abnormalities to delay having them evaluated.”

While tending to her own breast cancer, Megan-Claire Chase takes her mother to regular treatments for blood cancer at Northside Hospital Forsyth in Cumming, Georgia. As the caregiver, Chase is given a green wristband and cleared to go in.(Courtesy of Megan-Claire Chase)

In late March, Megan-Claire Chase, 43, of Dunwoody, Georgia, got laid off from her job as a project manager for a staffing company, losing the health care benefits that came with it. Her chief concern was paying for a diagnostic mammogram and MRI, still on the calendar for two days before her benefits were to end. Currently, in remission from stage 2A breast cancer, Chase schedules scan for every six months well in advance at Breast Care Specialists in Atlanta.

“When I got there, it was really unsettling. You almost feel like a leper,” said Chase, noting the socially distanced waiting room and heavily sanitized clipboards. Already hyper-careful since her days of chemotherapy, Chase carries her own pens in her purse, along with gloves and extra masks.

Cancer centers across the country are taking extra precautions. At Northwestern, patients are funneled through a single entryway, where masks are required and are met by a security guard and a temperature check before signing in with receptionists seated behind plastic shields, O’Brien said. No visitors or accompanying family members are allowed inside the building, and the cafeteria and waiting rooms are devoid of unnecessary germ-spreading agents — no magazines or coffee machine in sight. The cubicle where she receives infusions of Abraxane used to seat four patients; now, only two sit in the space.

Dr. Mark Lewis, director of gastrointestinal oncology for Intermountain Healthcare, explains pancreatic cancer to a telehealth patient.(Courtesy of Dr. Mark Lewis)

Where they can, many doctors are turning to telemedicine to limit cancer patients’ trips to the hospital. In Salt Lake City, Dr. Mark Lewis, director of gastrointestinal oncology for Intermountain Healthcare, a 23-hospital system serving Utah and surrounding states, says about half his patient visits are now virtual. He’s also making some patients’ treatments less intense and less frequent. As at Northwestern, patients must arrive at the hospital solo for appointments unless assistance is physically necessary. It’s a significant shift for Lewis, who’s had up to 30 family members in his office for appointments alongside his patients for mental support.

“We are writing the rules as we go, trying to keep patients’ immune systems up and cancer at bay,” said Lewis. Still, he’s concerned about a later spike in cancer mortality due to the coronavirus pandemic. The coronavirus aside, the National Cancer Institute estimates over 600,000 Americans will die of cancer this year.

New clinical trials have also largely ground to a halt in this new era when traveling long distances for treatment is less of an option. Linnea Olson, who lives in Amesbury, Massachusetts, and has stage 4 lung cancer, worries there may be far fewer treatment options for her, as trials have been her “lifeline.”

Linnea Olson stands in front of a photo of herself on the “wall of hope” at Massachusetts General Hospital in Boston.(Courtesy of Linnea Olson)

About four months ago, Olson, 60, enrolled in her fourth phase 1 clinical trial at Massachusetts General Hospital’s Termeer Center for Targeted Therapies. The treatment has been accompanied by intense side effects, such as a sore mouth and throat from mucositis, also a sign of COVID-19. Before a recent infusion, nurses with plastic shields ferried Olson up a back entryway for a COVID test. It was negative.

The intensity of her treatment, coupled with the extreme social distancing measures, has left Olson, who lives alone, feeling depressed and unsure if she should continue the trial.

“It’s too much all at once — the isolation and the difficult side effects,” Olson said.

Rudy Fischmann goes on a daily walk around his Knoxville, Tennessee, neighborhood past a colorful home decorated in chalk.(Courtesy of Rudy Fischmann)

The strolls are critical for working on his balance issues stemming from brain cancer. (Courtesy of Rudy Fischmann)

Rudy Fischmann, a brain cancer patient and former true crime TV producer, battles balance issues that started after his first set of surgeries two years ago. Daily walks and physical therapy are part of his treatment regimen. Yet strolls around his Knoxville, Tennessee, neighborhood are already becoming more stressful as the state begins to open up.

“It’s getting harder and harder, with more and more people outside every day,” said Fischmann, 48. “I don’t enjoy walking laps around my kitchen, so I’m finding myself having to change my routes almost daily.”

A father of two young children who are now home round-the-clock, Fischmann finds all the family time-draining his limited energy. He also fears what germs they will bring back from school come fall.

“The thought of, if I were to contract the virus, would I get a different standard of care?” he said. “I’m used to staying home and not doing that much, but it’s more nerve-wracking now.”
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Is A Second Wave Of Coronavirus Coming?

As Americans continue to grapple with the novel coronavirus, one question is on a lot of people’s minds: Are we already seeing, or will we eventually see, a second wave of the virus?

On June 16, Vice President Mike Pence penned an op-ed in The Wall Street Journal headlined, “There Isn’t a Coronavirus ‘Second Wave,’” where he said the country was better off than media reports suggested.

Yet the same day, in an interview with the same newspaper, Dr. Anthony Fauci, the top federal infectious disease expert, threw cold water on Pence’s assertion by warning of a possible resurgence. “People keep talking about a second wave,” he said. “We’re still in a first wave.”

Defining a coronavirus “wave” is somewhat more art than science, but other scientists looking at the number of new daily infections echo Fauci’s caution.

The number of new daily infections (as seen in this chart) declined by only about one-third between its peak in early March and its most recent low point in early June. And since early June, the data shows an upward spike, approaching where it stood at that peak.

We checked with experts to better understand what wave we’re currently in, what the outlook is for a possible new wave, and what, if anything, we can learn from the history of the 1918 influenza pandemic, which was the last major pandemic in the United States. Here’s what we found.

Are We Out Of The First Wave Yet?

There’s no official definition of when a “wave” begins or ends but, generally speaking, it requires a peak in infections followed by a substantial reduction. A new rise and peak would signal the start of another wave.

“It is probably not realistic for the number of new cases to drop to zero, but ideally one would like to see sustained decreases in the number of new cases over time or stability in the number of new cases over time,” said Nicole Gatto, an associate professor in the School of Community and Global Health at Claremont Graduate University in California.

The chart above, showing the national picture, suggests there was an easing in the number of new cases, but not a large drop prior to the current spike, scientists say.
And certain states have not come close to finishing their first wave.

“Some places, such as New York and Boston, have what appears to be a clear first peak or wave,” said Brooke Nichols, an assistant professor at Boston University’s School of Public Health. “Some places are still in the first wave.”

The following chart shows states that have experienced a first wave and substantially brought down their new infections.

Meanwhile, other states haven’t yet turned the corner on the first wave:

If you’re in a state that is still seeing an increase in cases, “it would not be accurate to talk about a second wave,” Gatto said. “What causes those peaks, and whether or not there will be more than one peak, as opposed to one continuous wave, will be human behavior and how humans react to what is going on around them.”

Were There Multiple Waves During The 1918 Influenza Epidemic?

There were at least three distinct waves of influenza in 1918 and 1919, which killed an estimated 50 million people worldwide. The pandemic was simultaneous with World War I, and the war is believed to have spread the virus around the globe more quickly than it otherwise would have.

The first wave began in March 1918 and eased by the summer. The second wave came in the fall, followed by a third wave during the winter and spring of 1919. Here’s a rough graphic from an academic paper showing the waves in deaths:

The first wave “was not very deadly,” said J. Alexander Navarro, assistant director of the Center for the History of Medicine at the University of Michigan. “It was about as bad as ordinary strains of seasonal influenza that had been circulating up until that point.”

The second wave was the deadliest, and that may have been due to mutations that increased the virus’s lethality, although scientists say this is speculative and that such mutations more typically take much longer to develop and spread.

The second wave “slowed towards the end of November, in part because more stringent social distancing measures were put in place,” said Kenneth Davis, author of “More Deadly Than War: The Hidden History of the Spanish Flu and the First World War.” “When those were relaxed, a third wave commenced in the winter and spring of 1919.”

The third wave lasted into early March, and some suggest there was a fourth wave during the winter of 1920. Each was less deadly than the one before it, Navarro said, although there were regional differences in severity.

The decline in lethality after the second wave was probably shaped in part by the declining number of people who hadn’t already been infected, Navarro said. When infections in a population become sufficiently widespread, that can slow the further spread due to “herd immunity.”

How Much Can The 1918 Pandemic Tell Us About What To Expect Now?

While both pandemics involved an easily transmissible respiratory disease, there are some important differences that make the 1918 pandemic less helpful in predicting the course of the novel coronavirus.

One is that the 1918 outbreak involved influenza, which is caused by a different family of viruses than the coronavirus. This brings both good and bad news.

On the positive side, the coronavirus appears to be much more stable than the influenza virus, and thus less likely to mutate into a more deadly variant, said Ravina Kullar, an infectious disease specialist and adjunct faculty member at UCLA. The coronavirus’s “spike protein,” which enables it to attach to human cells and attack them, appears to be especially resistant to mutation.

On the downside, the coronavirus doesn’t seem to have a significant seasonal aspect. Influenza worsens as the weather gets colder but eases up during the warmer months. While we may have seen a reduction in coronavirus infections in recent weeks because more human interactions are moving outdoors, scientists don’t expect the same scale of seasonal drop-off for the coronavirus.

“What we’re seeing right now is that it’s not impacted by the climate,” Kullar said. “Warm and humid places like Mumbai and Indonesia have struggled with the virus, and in the United States, cases are rising in hot states like Arizona and Florida.”

The patterns in mutations and seasonality suggest that the coronavirus may not follow the wave patterns of the 1918 flu. Instead, the spread of the coronavirus may follow something more like a plateau, with spikes possible if social distancing isn’t adhered to fully.

There are other differences between now and 1918.

On the upside, we now know much more about viruses and public health, and science is able to devise targeted treatments and vaccines.

On the other hand, the world’s population is bigger and more densely packed. In 1918, the world’s population was smaller than 2 billion, while today it’s about 7.6 billion. Today, we also have commercial aviation, which can carry infected people around the world far faster than trains and ships could in 1918.

A bigger, denser, more mobile population means a greater chance for a virus to continue spreading.

In 1918, some cities saw an easing of the pandemic once they neared herd immunity, but that’s not going to be as helpful with the coronavirus. Because the coronavirus is more infectious than the 1918 virus, the percentage of the population needed to reach herd immunity has to be about 65% today, compared with about 35% in 1918.

“In 1918, they could get through the pandemic more quickly because of that, and even so, they did it with a staggering death toll,” Navarro said. “Today, the coronavirus will be with us for a lot longer.”

What Factors Could Cause A New Wave?

The biggest risk, scientists say, is a loosening of social distancing measures.
A much larger portion of the economy today is engaged in consumer-driven commerce such as the restaurant and entertainment sector. This heightens the economic pressure to relax social distancing standards. But doing so could worsen the pandemic.

“In 1918, once measures were lifted, the population very quickly went back to life as normal, flocking to movies, shops and stores, dance halls and saloons,” Navarro said. “That led to another spike of cases in many cities.”

Nichols said a community’s past experience with the virus can make a difference.
In Boston, where Nichols is based, “the first wave was relatively severe, and many people know someone who was personally affected by COVID or had a COVID-related death in the family,” she said. “That affects people’s behavior. In areas where epidemic growth has been slow, the urgency of changing one’s behavior is less.”

Nichols added that experiencing the summer, when people have the freedom to interact outdoors, could make it harder to practice social distancing in the colder months.

“I fear that people will continue their summer socializing patterns into the fall and winter, turning very low-risk interactions into relatively high-risk interactions,” she said.
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The Hidden Deaths Of The COVID Pandemic

BROOMFIELD, Colo. — Sara Wittner had seemingly gotten her life back under control. After a December relapse in her battle with drug addiction, the 32-year-old completed a 30-day detox program and started taking a monthly injection to block her cravings for opioids. She was engaged to be married, working for a local health association and counseling others about drug addiction.

Then the COVID-19 pandemic hit.

The virus knocked down all the supports she had carefully built around her: no more in-person Narcotics Anonymous meetings, no talks over coffee with a trusted friend or her addiction recovery sponsor. As the virus stressed hospitals and clinics, her appointment to get the next monthly shot of medication was moved back from 30 days to 45 days.

As best her family could reconstruct from the messages on her phone, Wittner started using again on April 12, Easter Sunday, more than a week after her originally scheduled appointment, when she should have gotten her next injection. She couldn’t stave off the cravings any longer as she waited for her appointment that coming Friday. She used again that Tuesday and Wednesday.

“We kind of know her thought process was that ‘I can make it. I’ll go get my shot tomorrow,’” said her father, Leon Wittner. “‘I’ve just got to get through this one more day and then I’ll be OK.’”

But on Thursday morning, the day before her appointment, her sister Grace Sekera found her curled up in bed at her parents’ home in this Denver suburb, blood pooling on the right side of her body, foam on her lips, still clutching a syringe. Her father suspects she died of a fentanyl overdose.

However, he said, what really killed her was the coronavirus.

“Anybody that is struggling with a substance abuse disorder, anybody that has an alcohol issue and anybody with mental health issues, all of a sudden, whatever safety nets they had for the most part are gone,” he said. “And those are people that are living right on the edge of that razor.”

Sara Wittner’s death is just one example of how complicated it is to track the full impact of the coronavirus pandemic — and even what should be counted. Some people who get COVID-19 die of COVID-19. Some people who have COVID die of something else. And then there are people who die because of disruptions created by the pandemic.

While public health officials are trying to gather data on how many people test positive for the coronavirus and how many people die from the infection, the pandemic has left an untold number dying in the shadows, not directly because of the virus but still because of it. They are unaccounted for in the official tally, which, as of June 21, has topped 119,000 in the U.S.

But the lack of immediate clarity on the numbers of people actually dying from COVID-19 has some onlookers, ranging from conspiracy theorists on Twitter all the way to President Donald Trump, claiming the tallies are exaggerated — even before they include deaths like Wittner’s. That has undermined confidence in the accuracy of the death toll and made it harder for public health officials to implement infection prevention measures.

Yet experts are certain that a lack of widespread testing, variations in how the cause of death is recorded, and the economic and social disruption the virus has caused are hiding the full extent of its death toll.

How To Count

In the U.S., COVID-19 is a “notifiable disease” — doctors, coroners, hospitals and nursing homes must report when encountering someone who tests positive for the infection, and when a person who is known to have the virus dies. That provides a nearly real-time surveillance system for health officials to gauge where and to what extent outbreaks are happening. But it’s a system designed for speed over accuracy; it will invariably include deaths not caused by the virus as well as miss deaths that were.

For example, a person diagnosed with COVID-19 who dies in a car accident could be included in the data. But someone who dies of COVID-19 at home might be missed if they were never tested. Nonetheless, the numbers are close enough to serve as an early-warning system.

“They’re really meant to be simple,” Colorado state epidemiologist Dr. Rachel Herlihy said. “They apply these black-and-white criteria to often gray situations. But they are a way for us to systematically collect this data in a simple and rapid fashion.”

Before the COVID-19 pandemic hit, Sara Wittner completed a 30-day detox program and started taking a monthly injection to block her addiction cravings. Yet the virus destroyed the support system she had built, including stopping her in-person Narcotics Anonymous meetings and delaying that monthly shot of medication. Wittner died in April, and her death is just one example of how complicated it is to track the full impact of the coronavirus pandemic.(Courtesy of Leon Wittner)

For that reason, she said, the numbers don’t always align with death certificate data, which takes much more time to review and classify. And even those can be subjective. Death certificates are usually completed by a doctor who was treating that person at the time of death or by medical examiners or coroners when patients die outside of a health care facility. Centers for Disease Control and Prevention guidelines allow for doctors to attribute a death to a “presumed” or “probable” COVID infection in the absence of a positive test if the patient’s symptoms or circumstances warrant it. Those completing the forms apply their individual medical judgment, though, which can lead to variations from state to state or even county to county in whether a death is attributed to COVID-19.

Furthermore, it can take weeks, if not months, for the death certificate data to move up the ladder from county to state to federal agencies, with reviews for accuracy at each level, creating a lag in those more official numbers. And they may still miss many COVID-19 deaths of people who were never tested.

That’s why the two methods of counting deaths can yield different tallies, leading some to conclude that officials are fouling up the numbers. And neither approach would capture the number of people who died because they didn’t seek care — and certainly will miss indirect deaths like Wittner’s where care was disrupted by the pandemic.

“All those things, unfortunately, are not going to be determined by the death record,” says Oscar Alleyne, chief of programs and services for the National Association of City and County Health Officials.

Using Historical Data To Understand Today’s Toll

That’s why researchers track what are known as “excess” deaths. The public health system has been cataloging all deaths on a county-by-county basis for more than a century, providing a good sense of how many deaths can be expected every year. The number of deaths above that baseline in 2020 could tell the extent of the pandemic.

For example, from March 11 to May 2, New York City recorded 32,107 deaths. Laboratories confirmed 13,831 of those were COVID-19 deaths and doctors categorized another 5,048 of them as probable COVID-19 cases. That’s far more deaths than what historically occurred in the city. From 2014 through 2019, the city averaged just 7,935 deaths during that time of year. Yet when taking into account the historical deaths to assume what might occur normally, plus the COVID cases, that still leaves 5,293 deaths not explained in this year’s death toll. Experts believe that most of those deaths could be either directly or indirectly caused by the pandemic.

City health officials reported about 200 at-home deaths per day during the height of the pandemic, compared with a daily average 35 between 2013 and 2017. Again, experts believe that excess is presumably caused either directly or indirectly by the pandemic.

And nationally, a recent analysis of obituaries by the Health Care Cost Institute found that, for April, the number of deaths in the U.S. was running about 12% higher than the average from 2014 through 2019.

“The excess mortality tells the story,” said Dr. Jeremy Faust, an emergency medicine physician at Brigham and Women’s Hospital in Boston. “We can see that COVID is having a historic effect on the number of deaths in our community.”

These multiple approaches, however, have many skeptics crying foul, accusing health officials of cooking the books to make the pandemic seem worse than it is. In Montana, for example, a Flathead County health board member cast doubt over official COVID-19 death tolls, and Fox News pundit Tucker Carlson questioned the death rate during an April broadcast. That has sowed seeds of doubt. Some social media posts claim that a family member or friend died at home of a heart attack but that the cause of death was inaccurately listed as COVID-19, leading some to question the need for lockdowns or other precautions.

“For every one of those cases that might be as that person said, there must be dozens of cases where the death was caused by coronavirus and the person wouldn’t have died of that heart attack — or wouldn’t have died until years later,” Faust said. “At the moment, those anecdotes are the exceptions, not the rule.”

At the same time, the excess deaths tally would also capture cases like Wittner’s, where the usual access to health care was disrupted.

A recent analysis from Well Being Trust, a national public health foundation, predicted as many as 75,000 people might die from suicide, overdose or alcohol abuse, triggered by the uncertainty and unemployment caused by the pandemic.

“People lose their jobs and they lose their sense of purpose and become despondent, and you sometimes see them lose their lives,” said Benjamin Miller, Well Being’s chief strategy officer, citing a 2017 study that found that for every percentage point increase in unemployment, opioid overdose deaths increased 3.6%.

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Source: Health Care Cost Institute

Meanwhile, hospitals across the nation have seen a drop-off in non-COVID patients, including those with symptoms of heart attacks or strokes, suggesting many people aren’t seeking care for life-threatening conditions and may be dying at home. Denver cardiologist Dr. Payal Kohli calls that phenomenon “coronaphobia.”

Kohli expects a new wave of deaths over the next year from all the chronic illnesses that aren’t being treated during the pandemic.

“You’re not necessarily going to see the direct effect of poor diabetes management now, but when you start having kidney dysfunction and other problems in 12 to 18 months, that’s the direct result of the pandemic,” Kohli said. “As we’re flattening the curve of the pandemic, we’re actually steepening all these other curves.”

Lessons From Hurricane Maria’s Shifting Death Toll

That’s what happened when Hurricane Maria pummeled Puerto Rico in 2017, disrupting normal life and undermining the island’s health system. Initially, the death toll from the storm was set at 64 people. But more than a year later, the official toll was updated to 2,975, based on an analysis from George Washington University that factored in the indirect deaths caused by the storm’s disruptions. Even so, a Harvard study calculated the excess deaths caused by the hurricane were likely far higher, topping 4,600.

The numbers became a political hot potato, as critics blasted the Trump administration over its response to the hurricane. That prompted the Federal Emergency Management Agency to ask the National Academy of Sciences to study how best to calculate the full death toll from a natural disaster. That report is due in July, and those who wrote it are now considering how their recommendations apply to the current pandemic — and how to avoid the same politicization that befell the Hurricane Maria death toll.

Leon Wittner with his daughter Sara as a child. “We kind of know her thought process was that ‘I can make it. I’ll go get my shot tomorrow. I’ve just got to get through this one more day and then I’ll be OK,’” Leon Wittner says of his 32-year-old daughter’s struggle to beat her addiction after COVID-19 began impacting her sobriety supports. Sara Wittner died in April, and Leon Wittner suspects it was from a fentanyl overdose. But he also blames the coronavirus pandemic.(Courtesy of Leon Wittner)

“You have some stakeholders who want to downplay things and make it sound like we’ve had a wonderful response, it all worked beautifully,” said Dr. Matthew Wynia, director of the University of Colorado Center for Bioethics and Humanities and a member of the study committee. “And you’ve got others who say, ‘No, no, no. Look at all the people who were harmed.’”

Calculations for the ongoing pandemic will be even more complicated than for a point-in-time event like a hurricane or wildfire. The indirect impact of COVID-19 might last for months, if not years, after the virus stops spreading and the economy improves.

But Wittner’s family knows they already want her death to be counted.

Throughout her high school years, Sekera dreaded entering the house before her parents came home for fear of finding her sister dead. When the pandemic forced them all indoors together, that fear turned to reality.

“No little sister should have to go through that. No parent should have to go through that,” she said. “There should be ample resources, especially at a time like this when they’re cut off from the world.”
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As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

The agency at that point had received 15 “adverse event reports” about Abbott’s ID NOW rapid COVID test suggesting that infected patients were wrongly told they did not have the coronavirus, which had led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher “false negative” rates from the Abbott device, including one from New York University researchers who found it missed close to half of the positive samples detected by a rival company’s test.

But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be considered useful in fighting the pandemic even if they miss 1 in 5 positive cases — a worrisome failure rate.

The FDA has now received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an agency spokesperson said.

In a statement, Abbott Laboratories said the NYU research was “flawed” and “an outlier,” citing studies with higher accuracy rates.

Though the Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has featured the product in the White House Rose Garden and the Health and Human Services Department’s preparedness and response division has issued more than $205 million worth of contracts to buy the test, according to federal contract records.

“Everybody was raving about it,” a former administration official said, speaking on the condition of anonymity to discuss internal deliberations. “It’s an amazing test, but it has limitations which are now being better understood.”

In its own COVID-19 testing policy for labs and commercial manufacturers, the FDA says a diagnostic test should correctly identify at least 95% of positive samples.

But medical professionals are split over the lower 80% threshold for the Abbott and other point-of-care tests’ “sensitivity” — a metric showing how often a test correctly generates a positive result. They are debating whether it’s sufficient, given the risks that an infected person unwittingly spreads COVID-19 after receiving a negative result.

False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis. Evaluations of the Abbott test have been among the most mixed, with some researchers finding that the test has bigger accuracy problems, but others saying it isn’t likely to miss sicker patients.

“There’s no way I would be comfortable missing 2 out of 10 patients,” said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center. Whittier and co-authors found that the Abbott test correctly identified 74% of positive samples compared with a rival test from Roche, another diagnostics giant. A point-of-care test from Cepheid, a rival company, correctly identified 99% of positives.

An FDA official cited the 80% accuracy minimum for point-of-care tests in late May even after two White House aides tested positive for the virus. The Executive Office of the President has spent roughly $140,000 on Abbott test kits, according to contract records.

In a statement, Abbott said when its test is used as intended it “is delivering reliable results and is helping to reduce the spread of infection in society by detecting more positive results than would otherwise be found.” Studies from University Hospitals Cleveland Medical Center and OhioHealth found that its test detected at least 91% of positives.

In March, HHS officials announced that Cepheid would receive approximately $3.7 million through its Biomedical Advanced Research and Development Authority for coronavirus diagnostic development work; the Strategic National Stockpile also made a one-time $2.3 million purchase of Cepheid’s point-of-care tests, according to an agency spokesperson.

“Knowing the true performance of such a point-of-care test and knowing that it may be less sensitive than a central lab molecular test is important, but also can play a role in triaging patients who are suspected of having COVID-19,” Dr. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the call when discussing the Abbott warning. “If we are able to determine that sensitivity of the assay in controlled trial circumstances is at least 80%, we feel like that test has a valuable place going forward in this pandemic.”

Until the FDA can complete post-market studies to verify performance, he said, negative results with the Abbott rapid test will be treated as “presumptive” negatives.

Despite that note of caution, governors were also told during a June 3 call with Vice President Mike Pence that the fast Abbott test should be used to test residents and staff in long-term care settings, according to two sources with knowledge of the discussions. As of May 31, more than 95,000 people in nursing homes have tested positive for COVID-19 and nearly 32,000 have died, according to the Centers for Medicare & Medicaid Services. If 20% of tests are false negatives, personnel with COVID-19 could be going about their normal activities, spreading the virus.

Spokespeople for Pence did not respond to requests for comment.

No test is perfect, whether it’s for a common illness like the flu or for COVID-19, which has killed nearly 120,000 Americans. Federal officials contend that the trade-off with point-of-care tests — especially ones as fast as Abbott’s, which can turn around a positive result in as little as five minutes and a negative one in 13 minutes — is that the tests can be used in spots where traditional lab tests aren’t as accessible. There’s also a greater risk of operator error when administering the test in the real world given the way patient specimens are collected and handled.

An FDA spokesperson said officials’ “general expectation” is that companies’ test validation data indicate a sensitivity of at least 95%; however, “based on the available information, FDA has issued EUAs [emergency use authorizations] to some tests that presented data indicating a sensitivity below 95%.”

“Rapid and reliable detection of positive patients can be important for public health,” the spokesperson said.

Cepheid would not comment on FDA’s 80% standard but pointed to a Northwell Health Laboratories study finding its test was 98% accurate in detecting positives. The company has shipped approximately 6 million tests since getting FDA authorization in March.

“Experience has shown that in COVID testing, pre-analytical variables such as the site of sample collection (nasal, nasopharyngeal, throat, saliva) and the quality of the sample collected can have a large impact on test performance,” Dr. David Persing, Cepheid’s chief medical and technology officer, said in a statement. “Tests with higher sensitivity have a natural advantage in this setting.”

As far as Abbott’s test, “there are certainly some elements of it that could be improved, but I think it’s a great assay,” said Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, who said the NYU study was “flawed” in part because of the number of patients researchers included with such low viral loads that they wouldn’t be infectious. An NYU spokesperson has defended the research.

Mina and others also took issue with the FDA’s threshold.

“For them to just say 80%, it lets people game the system,” he said. Companies presented with a single figure for sensitivity could manipulate which patients they test to exceed the minimum — for example, by including only very sick patients, which most tests would have an easier time detecting as a positive.

“They really need to fix this issue,” Mina said.

Abbott has already made several revisions to its materials for how its test should be performed. It removed prior language in its instructions saying swabs could be placed in a type of liquid — known as viral transport medium — before the test is run because doing so caused patient specimens to be too diluted. Now, the company says only direct swabs from patients should be inserted into the machine. It also revised its instructions for handling patient specimens following a KHN story in which lab professionals voiced safety concerns.

Christopher Polage, the medical director of Duke University Health System’s clinical microbiology lab, said experts have known for years that point-of-care tests are not as good at identifying known positives, but there are still legitimate situations in which they are used clinically.

“The difference now,” he said, “is that people are so fearful and tolerance for false negatives is just zero.”

Abbott’s rapid COVID-19 test isn’t the only point-of-care test to receive FDA authorization during the pandemic, but Trump has touted it the most by far, hailing the speed at which results can be given. To date, Abbott has delivered more than 3.6 million of the rapid tests to customers in all 50 states, including urgent care clinics, physicians’ offices, the federal government and hospital emergency departments.

In Washington, D.C., the city government has distributed 11 Abbott testing instruments across homeless shelters, jails, long-term care facilities, a clinic that largely serves lower-income Latinos and two public hospitals in the district’s poorest neighborhoods. Mobile testing units were also equipped with five Abbott machines, using them to test 40 to 50 people per site mostly at long-term care facilities, according to city officials.

The district has not found that the Abbott test has a higher rate of false negatives compared to other tests, said Dr. Jenifer Smith, director of the city’s Department of Forensic Services, which oversees the city’s public health lab.

“We test every test before we put it online,” she said. “We didn’t find the successively high rate of false negatives. In fact, we found we were getting the same results.”

But several labs have found the test with the presidential seal of approval to be less accurate than some of its competitors in detecting known positives.

“Without confirmation of negatives, I wouldn’t want to use it in hospitals,” said Gregory Berry, director of molecular diagnostics at Northwell Health Laboratories in New York. Berry co-authored the analysis finding that the Abbott ID Now test detected nearly 88% of positive samples compared with 98% from Cepheid, whose point-of-care test takes 45 minutes. Abbott contested the findings of the Northwell and Columbia papers because it said the tests were run in a way that diluted the specimens.

Berry and other lab personnel also said that a key metric Abbott reported as part of the process for receiving FDA authorization — known as the limit of detection, which specifies how little of the virus is needed for the test to reliably detect it — doesn’t match up with their own findings, and, in at least one instance, by a huge margin. A higher limit of detection means more viral material is needed for the test to detect the coronavirus. And a higher limit of detection increases the risk of false-negative results if a patient’s viral burden isn’t high.

Berry’s analysis determined that the lowest quantity of the virus needed to identify 100% of positive cases was 20,000 copies per milliliter. Abbott’s self-reported standard is a fraction of a percent of that.

Abbott said the limit of detection it provided to the FDA is accurate.

Of Abbott’s stated limit, Polage said: “I’m not sure what they were thinking.”
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Reuters report is another classic case study in how NOT to cover COVID-19 news

The statement that COVID-19 “has become much less lethal” and that “the virus clinically no longer exists in Italy” caused an uproar in the global scientific community.Four days ago, Reuters reported from Rome, “New coronavirus losing potency, top Italian doctor says.”

But it was Reuters that gave the scientist an international megaphone.

Journalist Roxanne Khamsi was one of the first I saw to react to the Reuters story on Twitter:

Indeed, it was a train wreck Reuters story.  A rushed 348-word brief, the first two-thirds of which were nothing but stenography of the scientist’s opinion, with no clear evidence to back it up.

We often hear that science is self-correcting. In this case, journalism employed some self-correcting steps on social media and in this story from the Washington Post, “Experts dispute reports that coronavirus is becoming less lethal.” The Post story calmly explained:

The consensus among other experts interviewed Monday is that the clinical findings in Italy likely do not reflect any change in the virus itself.

(The Italian scientist’s) clinical observations are more likely a reflection of the fact that with the peak of the outbreak long past, there is less virus in circulation, and people may be less likely to be exposed to high doses of it. In addition, only severely sick people were likely to be tested early on, compared with the situation now when even those with mild symptoms are more likely to get swabbed, experts said.

And a “What You Need To Know” piece in Forbes stated:

“As most horror movies have probably taught you, don’t make any assumptions that a threat has subsided until you are really, positively, absolutely sure that it has.”

Reuters itself published another story one day later, explaining:

World Health Organization experts and a range of other scientists said on Monday there was no evidence to support an assertion by a high-profile Italian doctor that the coronavirus causing the COVID-19 pandemic has been losing potency. …

“The suggestion by the Italian doctor is potentially dangerous as it gives false reassurance based on no evidence,” said Leana Wen, an emergency physician and public health professor at George Washington University. “There is no scientific evidence for there having been a change in the coronavirus. It’s a highly transmittable and highly contagious disease. We need to be as on guard as ever.”

Why weren’t those calls made to WHO and a range of other scientists before publishing the sensational Sunday story? What in the world justifies rushing a 348-word story to publication on a Sunday without doing extra research and reporting? Just because a scientist said it? COVID-19 journalism that devolves to that level of dreck is dangerous.

Reuters must examine its editorial decision-making. News spreads like a virus – globally – and causes harm when reported the way Reuters reported this story.

At the very end of the Reuters story is a link to Our Standards: The Thomson Reuters Trust Principles. One of them is this:

That no effort shall be spared to expand, develop, and adapt the news and other services and products of Thomson Reuters so as to maintain its leading position in the international news and information business.

It’s pretty clear that effort was spared in this example.
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Pharma PR appears as unvetted COVID-19 vaccine news in STAT newsletter

I’ve written about STAT’s Morning Rounds newsletter in the past, and criticized how STAT accepts pharma sponsorship of the newsletter.

In the last two weeks, for example, the newsletter has featured sponsored content from:

  • drug company AstraZeneca;
  • the Biotechnology Innovation Organization – whose biggest sponsors include drug companies Lilly, Merck, Amgen, Johnson & Johnson;
  • biotech company Genentech;
  • Blue Cross Blue Shield Association;
  • drug company Bristol Myers Squibb.

I believe that an ethical news organization that covers pharma and biotech full-time should not accept sponsorship from pharma and biotech.

In Monday’s STAT Morning Rounds newsletter this week, there was this news item:

AstraZeneca announced over the weekend that it had struck a deal to provide up to 400 million doses of its experimental Covid-19 vaccine to countries in the European Union. The company plans to begin delivering the vaccine to European countries by the end of this year under an agreement with the Inclusive Vaccine Alliance, which was formed by France, Germany, Italy, and the Netherlands. Other EU countries will also have a chance to partake in the deal.

I clicked on the link.  It didn’t take me to a news story or to any independently-vetted piece of journalism.  Instead, the link went directly to an AstraZeneca PR news release.

That’s a nice piece of free news attention – if you can get it.

I looked for data in the AstraZeneca PR to which STAT had linked me.  There was none.  But there was this – presumably to satisfy the lawyers:

AstraZeneca recognises that the vaccine may not work but is committed to progressing the clinical programme with speed and scaling up manufacturing at risk.

That doesn’t satisfy me – and it shouldn’t satisfy STAT’s readers.

The news item – and the link – weren’t sponsored content and weren’t associated with an advertisement.  We expect a leading news organization that specializes in health care news to offer news, not PR, with its links.

I recall how a leading health care journalist wrote to me about STAT’s coverage of the Gilead drug remdesivir on April 29.  The journalist wrote:

I know that STAT’s business model is implicitly pro-pharma but even given that, this story is a press release.

In this latest case, there could be no doubt that the story was nothing about a press release.

So it’s double bonanza time for some drug companies and biotech firms on STAT.  Pay for your sponsored content to be placed right in the middle of the morning news.  And, if you’re lucky, get your PR news releases posted for free.  Straight from the company’s keyboard to your eyes. I think we can and should do better in covering coronavirus vaccine news.
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The Costs Of Safely Reopening A High-End Restaurant

Like countless other restaurateurs across California and the nation, Alex and Charity Prestifilippo have been caught in a precarious health-and-safety limbo.

Beginning in March, the COVID-19 pandemic shuttered their popular Gourmet Italia restaurant in Temecula, a wine-growing community of 115,000 southeast of Los Angeles. Dozens of employees were laid off; food stocks quickly became outdated.

They began bleeding cash — about $20,000 every day in lost business, rent and sundry other payments on Gourmet Italia and their other properties, a winery and the pizzeria Spuntino.

While desperate to reopen, the couple also realized the perils involved in serving food to the public with a dangerous pathogen on the loose. The Centers for Disease Control and Prevention’s guidelines were confusing enough for the general public. For restaurants trying to keep loyal patrons safe, the lack of clarity was maddening.

What precisely did social distancing mean inside their restaurant, the Prestifilippos wondered. Did customers expect servers, chefs and busboys to wear masks? How vigilantly did they have to sanitize counters and tables? How often should employees wash their hands?

“It was stressful,” said Charity. “While we understood the government itself was trying to figure all of this out, nobody could give us any hard answers. And we couldn’t devise a plan of attack without permanent information.”

After being advised he could seat his restaurant at only 50% capacity, Alex said, he was later informed there was no capacity limit, as long as tables were spaced 6 feet apart.

“Government health officials were giving owners a moving target. Even restaurant associations were having a hard time getting a handle on the right process,” said Phil Mott, a Colorado-based restaurant consultant. “Owners faced retraining all their employees, but they weren’t even sure what that training entailed.”

The Prestifilippos recently reopened Gourmet Italia and Spuntino, but not without much anguish and deliberation, and many tough decisions.

Beginning in April, Charity joined a weekly virtual meeting with dozens of other restaurant owners in the tightknit tourist community, dotted with privately owned wineries and mom and pop eateries. Many feared they would be forced to close for good if they didn’t reopen soon. Some wanted to “go rogue,” opening collectively and gambling that heath officials would not close them all down.

In the end, the group of Temecula restaurant owners decided to wait, using the time to develop a list of preferred practices for the future, precautions that ranged from providing hand sanitizer and wipes to replacing traditional salt and pepper shakers with disposable packets.

They agreed to document bathroom cleaning schedules and open the parking lot to outdoor tables so customers could keep their distance. Cafes with counter service considered installing plexiglass barriers between diners.

“The idea was to do more than you would probably need — so customers could see that you were doing your best to create a safe place,” said Charity. “But there were also business considerations. Could you be as quick and efficient with your service if you have to take all these precautions? How was all this going to work?”

After emigrating from Sicily, Alex, 51, learned English and opened his first restaurant in 1999. He eventually developed a 7,000-square-foot space with high-end Italian cuisine and white linen tablecloths that Tripadvisor described as a romantic dining spot.

Charity, 47, was one who found romance there. She came in first as a customer, then met Alex, and they fell in love.

The Prestifilippos received about $300,000 in economic assistance through Small Business Administration loans. Still, it felt as if they were leaking hard-earned money. And the projected costs of implementing all these health precautions — between $500 and $1,000 a day — brought sticker shock.

“I showed Alex the figures and he said, ‘Are you kidding me?’” Charity recalled.

Not only were supply prices escalating with increased demand, but also there were long waits for items such as specialized thermometers that could be applied to the foreheads of employees, and possibly customers, which cost $180 or more — if you could get them. They also needed gallons of sanitizer, masks, gloves and who knew what else?

“I just spent $2,800 on peroxide for the two restaurants and I have no idea how long that’s going to last,” Alex said. Masks cost $1.50 each, and the chefs, servers and busboys use several each shift, he said.

Alex and Charity Prestifilippo closed their restaurant in Temecula, California, in March, because of the pandemic. They reopened after receiving assistance through Small Business Administration loans. (Courtesy of Alex and Charity Prestifilippo)

Alex decided not to raise prices to cover the costs. That would not be fair to his customers, he said.

On May 30, after months of quarantine, customers formed a line outside for Gourmet Italia’s first lunch seating.

The diners encountered a coronavirus safety plan that had been months in the making. For starters, the owners kept the front doors open so customers didn’t have to touch the handles and installed hand-sanitizing devices at the entrance.

Servers and busboys wore masks, and the bar and kitchen staff donned gloves as well. Only after tables were seated were plates and wrapped silverware presented. Menus were sanitized after each use, and salt and pepper shakers were brought on demand — and quickly wiped down. Tables were moved into the bar area to create extra distance, and workers patrolled the restaurant to clean surfaces. All 35 workers returned from layoffs.

So far, business has been down. Alex handled 150 diners during the Saturday night of the reopening and brought in $10,000, down from 450 customers and $30,000 on a typical Saturday before the shutdown. Street protests against police violence in Temecula held down the opening-day crowd, he said.

Alex described the opening-night atmosphere as like a family reunion, with people constantly approaching to congratulate him. He had to duck inside his office to get any paperwork done. Alex said he’s sure no customer will get sick in his restaurant. “We have one employee whose only job all day is to sanitize menus, chairs, tables and door handles, and clean the bathroom every half-hour,” he said. “I feel safe.”

And though he hails from an Italian culture of embraces and social kisses, Alex has chosen to put safety over traditional social graces.

“I told myself, ‘I’m not gonna hug,’” he said. “It’s very important to respect the code. I let my employees know — elbow bumps only. No hugs. No hands.”

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