Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. 

Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights.

U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.

Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.

The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

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The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University.

Vir Biotechnology, Inc. (VIR) and Alnylam Pharmaceuticals, Inc. (ALNY) announced Monday that they have selected a development candidate (DC) for VIR-2703 (ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 (COVID-19) genome.

Junshi Biosciences, a China-based biopharmaceutical company, and Eli Lilly and Company (LLY) have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Junshi SARS-CoV-2 Antibodies, or JS016, is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain. It is jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science.

Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems.

The FDA has issued emergency use authorization for Gilead Science Inc's (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease.

Organicell Regenerative Medicine Inc. (BPSR.OB) has received FDA clearance to initiate a phase I/II multi-center clinical trial of Organicell Flow in patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection.

Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19.

Life sciences company LabCorp (LH) announced Tuesday that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 at-home test kit.

Today's Daily Dose brings you news about the acquisition of Portola by Alexion; encouraging results from TG Therapeutics' chronic lymphocytic leukemia trial; Akebia's INNO2VATE trial results; and Vapotherm's Q1 financial results.

Today's Daily Dose brings you news about aTyr Pharma joining the COVID-19 battle; Cara's pivotal KALM-2 trial; LabCorp's at-home collection kit for COVID-19 testing securing Emergency Use Authorization from the FDA, and Myovant's much-awaited clinical trial catalyst.

In the span of just a few short months, the ramifications and impact of COVID-19 have been vast. Virtually every aspect of public health has been affected by this pandemic, and the fight against antibiotic-resistant bacteria is no exception.

The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.

The coronavirus pandemic has infected more than 2.5 million people worldwide, with the United States accounting for nearly 1 million of those cases.

The Pew Charitable Trusts sent a letter May 4 to the leaders of the Senate and House of Representatives urging them to support improved patient matching in electronic health records to help combat the COVID-19 pandemic.

Reflecting the discussions of the Health Working Group which met at the First APEC Senior Officials Meeting, 7-8 February 2020, Putrajaya, Malaysia

Business leaders from the Asia-Pacific region called for APEC leadership and cooperation to combat the grave challenges to health and economies posed by the COVID-19 pandemic.

Regional cooperation key to containment and rebound

Trade Ministers agree to work together towards a healthy, resilient and inclusive Asia-Pacific community.

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

In response to the COVID-19 pandemic, authorities in Australia and the European Union have allowed drug producers to collaborate to ensure medicine production and supply.

The Alliance met (virtually) on April 15 with Dr. Caitlin Boon, FDA Associate Commissioner for Food Policy and Response and several of her colleagues. She described CFSAN’s and CVM’s role in responding to the current pandemic, as well as how the agency is assuring a continued safe food supply. About 50% of food spending in the […]

J&J agrees a manufacturing partnership with Emergent, as it looks to hit its target of one billion doses.

As the industry shifts gears to combat the novel coronavirus, a number of leadership changes have taken place.

The likelihood of an effective vaccine being developed and scaled up in less than 12 months is unrealistic, suggests GlobalData analyst.

Ajinomoto agrees partnership to manufacture leronlimab, which is currently undergoing clinical trials for the treatment of COVID-19.

Moderna announces it has partnered with Lonza with the aim of producing one billion doses annually.

CEO of Berkeley Lights talks about the companyâs work to identify antibodies against COVID-19 and what the long-term picture looks like.

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading →

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

On February 21 I published a piece on LinkedIn – Communications Considerations for Medical Manufacturers as the COVID-19 Epidemic Emerges – that provided an overview of some of the communications considerations for pharma, biotech and device manufacturers related to the … Continue reading →

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

Virtually everyone is going virtual. Even in February, which seems like a very long time ago, many organizers began either postponing or canceling major conferences and meetings. This has included major medical meetings and given that large gatherings will be … Continue reading →

As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the … Continue reading →

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading →

There have been many parallels drawn between this pandemic and the AIDS pandemic that began in 1981. And in fact while many obvious differences exist there are many valid comparisons. Moreover, there are some common threads that run through crises … Continue reading →

by Nina Martin and Bernice Yeung

When Alfredo Pabatao told his family that he had helped move a suspected coronavirus patient through the hospital where he’d worked as an orderly for nearly 20 years, he didn’t make a big deal out of it. “My parents are the type of parents who don’t like to make us worry,” his youngest daughter, Sheryl, recalled. But Sheryl was concerned that her father’s vulnerabilities weren’t being given more consideration as he toiled on the pandemic’s front lines in hard-hit northern New Jersey. “Why would they let a 68-year-old man with an underlying heart condition … transport a suspected COVID patient when there’s younger transporters in the hospital who could do it?”

Sheryl’s mother, Susana, was an assistant nurse in a long-term care facility where she often pulled double shifts, saving money for her annual trips back to the Philippines. At 64, she wasn’t much younger than the elderly patients she helped bathe and feed, and she had diabetes, which increased her risk of severe complications if she got sick. The nursing home wasn’t providing adequate personal protection equipment, Susana reported, so Sheryl brought home a stash of surgical masks for her mother to wear on the job. That didn’t go over well with Susana’s managers, Sheryl said: “They gave her a warning, saying she shouldn’t be wearing that. … She was really mad.”

Alfredo fell ill first, his symptoms flaring on March 17. Susana soon developed a fever. The couple had grown up on the same street in Manila and shared a romance that reminded their daughter of a telenovela; after 44 years of marriage and five children, they were all but inseparable. “Where mom goes, my dad goes. Where my dad goes, my mom goes. That’s the way they are,” Sheryl said. The day Alfredo was admitted to the ICU, his heart failing, Susana checked into the same hospital. They died four days apart.

Filipino American medical workers have suffered some of the most staggering losses in the coronavirus pandemic. In the New York-New Jersey region alone, ProPublica learned of at least 30 deaths of Filipino health care workers since the end of March and many more deaths in those peoples’ extended families. The virus has struck hardest where a huge concentration of the community lives and works. They are at “the epicenter of the epicenter,” said Bernadette Ellorin, a community organizer.

Some of the largest Filipino enclaves on the East Coast are in the New York City borough of Queens and northern New Jersey — the very places now being ravaged by COVID-19.

Filipinos are on the front lines there and across the country, four times more likely to be nurses than any other ethnic group in the U.S., experts say. In the New York-New Jersey region, nearly a quarter of adults with Filipino ancestry work in hospitals or other medical fields, a ProPublica analysis of 2017 U.S. census data found. The statistic bears repeating: Of every man and woman in the Filipino community there, one in four works in the health care industry.

“So many people can rattle off five, 10 relations that are working in the medical field,” said filmmaker Marissa Aroy, whose most recent documentary is about Filipino nurses. Her parents were registered nurses in California, and various relatives are in health care professions, including a cousin who works in a rehab center in the Bronx and recently recovered from COVID-19. “Think about all of those family members who are going to be affected,” Aroy said. “We’re talking about huge family structures here.”

The scale of the trauma and the way it is unfolding are “similar to times of war,” said Kevin Nadal, a professor of psychology at John Jay College of Criminal Justice and The Graduate Center of the City University of New York who has written extensively about Filipino American psychology and culture.

The majority of the reported deaths have involved nurses, including Susan Sisgundo and Ernesto “Audie” DeLeon, who worked at Bellevue Hospital in New York City, and Marlino Cagas, who spent 40 years as a pharmacy tech at Harlem Hospital before embarking on a nursing career at the age of 60. A handful, including Jessie Ariel Ferreras, a family practitioner in Bergen County, were doctors. Others worked in support roles, like Louis Torres, 47, the director of food services at a nursing home in Woodside, Queens, and his 73-year-old mother, Lolita, or Lely, a clerk at a nearby hospital. They lived together and fell sick around the same time, both developing pneumonia. Lolita died on April 7, her son, the following day.

Don Ryan Batayola, a 40-year-old occupational therapist, was from a big, tight-knit family and lived in Springfield Township, New Jersey. He is believed to have caught the virus from a patient and was rushed to the hospital on March 31. By April 4, he had improved enough to FaceTime with his wife, also an occupational therapist who was sick and self-isolating at home, their children sheltering with relatives. Then, an hour later, he went into cardiac arrest.

One of the most wrenching aspects of the epidemic is the sense of disconnection and helplessness in a community that stakes its economic well-being on providing care and comfort and cherishes its closeness. So many members of Batayola’s extended family are health care workers, “we could almost open our own hospital,” said his oldest sister Aimee Canton, an oncology nurse in Northern California. But to protect each other, they’ve had to remain apart, with no idea when they’ll be able to come together again. “It’s so sad when you’re a nurse,” Canton said, “and you can’t even help your own family.”

Almost all the deaths of Filipino American health care workers that ProPublica found involve people, like the Batayolas, who immigrated during the 1970s to 2000s, when critical shortages created opportunities for medical personnel with the right training.

But the story of Filipino nurses in the U.S. goes back much further, to the end of the Spanish-American War in 1898, when the Philippines became a U.S. territory, said Catherine Ceniza Choy, a professor of ethnic studies at the University of California, Berkeley, and author of “Empire of Care: Nursing and Migration in Filipino American History.” One legacy of the colonial era is a network of hundreds of Americanized nursing schools that eventually produced tens of thousands of caregivers a year, making the country “the leading exporter of nurses in the world,” Choy said.

Nursing offered an escape route from economic and political instability and a path to the middle class for those who had few other options. It also appealed to deeply held cultural values: “kapwa,” Tagalog for “a feeling of interconnectedness to all people, putting others before yourself and taking care of the community,” Nadal said, and “utang ng loob,” the idea that people owe a debt to each other and to those who came before.

Most nurses trained in the Philippines who sought work abroad hoped to end up in the U.S. (They also migrated in large numbers to the Middle East and the U.K.) American immigration policies ebbed and flowed depending on labor shortages and political expediency. In the first third of the 20th century, the numbers of Filipino nurses were small; most workers from the islands were sent to the fields of California and the plantations of Hawaii. Then, in the wake of the Great Depression, Filipino immigrants were capped at just 50 per year, rising to 100 after World War II.

After the war, U.S. nursing shortages grew acute. Even as the passage of Medicare and Medicaid made health care more accessible to the elderly and poor, the rise of the feminist movement, which opened up professional opportunities for American women, made caregiver work less appealing, Choy said. The Immigration Act of 1965 swept aside the long-standing system of country-based quotas, instead giving preference to immigrants with professional degrees. Tens of thousands of Filipino nurses answered the call.

Many ended up at inner-city and rural hospitals that had the greatest difficulty recruiting staff, often working the least desirable jobs and shifts, including, in the 1980s and ’90s, on the front lines of the AIDS epidemic. It was part of a historical pattern, said Nadal, of “immigrants doing a lot of the dirty work that people don’t want to do... being painted as heroes, when in reality they are only put in these positions because their lives are viewed as disposable.”

Yet it was a template for economic security that many of their American-born children and grandchildren embraced. “It’s like any kind of family dynamic,” Aroy said. “You see your parents do the job. And so then you know that that’s accessible to you. As a second- generation kid, I always knew that was a path for me if I wanted it.”

Today, people of Filipino ancestry comprise about 1% of the U.S. population but more than 7% of the hospital and health care workforce in the United States — nearly 500,000 workers, according to census data. They find themselves fighting not just a potentially lethal illness, but the scapegoating stoked by President Donald Trump and supporters who have taken to calling COVID-19 the “Chinese virus.” Since late March, civil rights organizations have received nearly 1,500 reports of anti-Asian hate incidents, mostly from California and New York, including against Filipino Americans.

“This anti-Asian racism that’s happening right now,” Aroy said, “what it makes me want to do is scream out: ‘How dare you treat us like the carriers? We are your caregivers.’”

A host of factors, from medical to cultural, have put large numbers of Filipinos in harm’s way and made them vulnerable to the types of severe complications that often turn deadly. They begin with the specific type of health care work they do.

A survey by the Philippine Nurses Association of America published in 2018 found that a large proportion of respondents were concentrated in bedside and critical care — “the opposite of social distancing,” said executive director Leo-Felix Jurado, who teaches nursing at William Paterson University in Wayne, New Jersey. Many of the organization’s members have contracted the virus, he said, including the current president, New Jersey-based registered nurse Madelyn Yu; she is recovering, but her husband died.

For Daisy Doronila, employed at the Hudson County Correctional Facility in northern New Jersey for more than two decades, the profession was almost a religious calling. “My mom had a very, very humble beginning,” said her only child, Denise Rendor. “She really wanted to take care of people that no one wanted to take care of.”

Doronila saw her responsibilities to her colleagues no less seriously. The single mother and devout Catholic “was always the most reliable person at the job,” Rendor said. “If there was a snowstorm, people called out, nope, not her: ‘I’ll be there.’” As a kid, Rendor sometimes resented the missed volleyball games and dance recitals. Looking back now, “I don’t think I would have the life that I had had my mom not worked so hard.”

It’s not clear how Doronila contracted the virus, though the Hudson County jail has had at least four deaths. Once she fell ill in mid-March, she was turned away for testing by clinics and doctors on three occasions because her symptoms didn’t meet the criteria at the time, Rendor said. On March 21, Doronila started feeling breathless and drove herself to urgent care, which sent her by ambulance to the hospital. She died on April 5 at the age of 60.

If she hadn’t gotten sick, Rendor is sure she would have been volunteering for extra shifts. “That’s just who my mother was. She was just always willing to help.”

That selflessness is common among Filipino immigrants, said Zenei Cortez, a registered nurse in the San Francisco Bay Area who is the president of the California Nurses Association/National Nurses United. “They have such a profound willingness to work that they would forget their own well-being,” she said. “They would think of their loved ones in the Philippines — if they don’t work, then they can’t send money back home.”

In 2019, Filipinos abroad sent $35 billion back to the Philippines, making it the fourth-largest recipient of overseas remittances in the world; many are also helping to support networks of relatives in the U.S. “That’s the economic factor that is on the minds of a lot of Filipino nurses,” Cortez said. “If we miss work, there will be no income.”

It’s a worry that keeps many Filipinos doing sometimes-grueling labor well into their 70s. Doronila’s colleague at the Hudson County jail, nurse Edwin Montanano, was 73 when he died in early April. Jesus Villaluz, a much-beloved patient transporter at Holy Name Medical Center in Teaneck, one of the worst-hit hospitals in northern New Jersey, was 75. “They cannot in their conscience walk away from patients who need them,” said Maria Castaneda, a registered nurse and the secretary-treasurer of 1199SEIU United Healthcare Workers East, who immigrated from the Philippines in 1984. “At the same time, they are there in solidarity with other co-workers. If they are not there, it adds to the burden of those who are working.”

COVID-19 risks are magnified in people who are older or suffer underlying chronic conditions. Filipinos have very high rates of Type II diabetes and cardiovascular disease, both of which render the virus more dangerous. “They’re doing amazing things and helping others to survive,” Nadal said. “But they’re putting themselves at risk because they have immuno-compromised traits that make them susceptible to severe sickness and death.”

And in many situations, they’ve been forced to do that work without proper PPE and other safeguards, said Ellorin, the Queens-based community organizer and executive director of the advocacy group Mission to End Modern-Day Slavery. They are “being infected and not being protected, and then their families, or whoever they live with, are getting infected.”

Sheryl Pabatao thinks of the many people she knows who are working in hospitals and other medical settings and feel unable to speak out. “Even though they don’t want to do things, they still do it because they don’t want to lose their jobs.”

When they first applied to immigrate to the U.S. in the 1980s, Alfredo Pabatao was in the car business; Susana was a former nursing student turned housewife and mother of two. By the time their petition was approved about 14 years later, their two eldest children were too old to qualify to come to the U.S. with their parents, so the Pabataos were forced to leave them behind, bringing only their youngest two daughters and son. “To this day, that was one of the hardest things — being separated from everyone,” Sheryl said.

They arrived in the U.S. a few weeks after 9/11. One of Alfredo’s sisters, a registered nurse, helped him get a job transporting patients at her hospital, now known as Hackensack Meridian Health Palisades Medical Center, in North Bergen, New Jersey. “My father grew up with wealth, and when he came here, he had to be modest and humble,” Sheryl said. Susana earned her assistant nursing certification while working as a grocery store cashier, then went to work at what is now called Bergen New Bridge Medical Center in Paramus, the largest hospital and licensed nursing home in the state. Taking care of elderly people helped ease the sadness and guilt at what she had left behind. “She was not able to take care of her own mother,” Sheryl said. “So when she does her job here, she cares for them like her own.”

America proved to be both generous and hard. The couple prospered enough to buy a house, then lost it in the Great Recession. They managed to rebuild their lives and gained their U.S. citizenship, the kids choosing careers in the pharmaceutical side of health care. After 18 years in the same job, Alfredo was waiting for Susana to retire so he could, too.

Then came the pandemic.

Sheryl had been following the news reports from China since early February and was concerned enough about her family to procure a small supply of masks before vendors ran out; “I’d put my parents in a bubble if I can,” she said. Her father was more easygoing: “He has survived so many things in his life. His attitude is: ‘If I get it, I get it. I’ll be OK with it.’”

Sheryl doesn’t know how the responsibility fell to him to transport a patient suspected of having COVID-19 during the second week in March. “But knowing my dad, he agrees to anything. He has that work ethic: ‘This is my job. If I can do it, l do it.’ Knowing him, if one of the other [orderlies] didn’t want to transfer the patient, they asked him and he said yes.”

When Susana found out her husband had been exposed to the virus that way, she was not happy, Sheryl said. Susana was having her own issues at the nursing home. In mid-March, she received an email from her bosses that warned in boldface, “Facemasks are to be used only by staff who have an authorized or clinical reason to use them. Do not wear non-hospital issued facemasks.” It was a policy Susana complained was being made by people who weren’t doing bedside care and didn’t understand the real risks. She was also told the masks would scare patients. She pretended to obey the directive when her managers were around, Sheryl said, “but my mom was stubborn, so when they left, she put [her mask] back on.”

Bergen New Bridge called Susana a “valued” employee who is “greatly missed.” The hospital denied that it has experienced any PPE shortages, but it noted that “guidance from federal and state health officials regarding the use of PPE has been evolving.” Early on, “it was recommended that masks were to be worn only by those individuals who were sick or those who were caring for COVID-19 patients.” Once the virus began spreading within the community, “we quickly moved to universal masking of all employees,” the hospital said. “Like all healthcare facilities, our Medical Center has stressed the importance of using hospital-issued PPE, as guided by the CDC.”

As of April 29, New Bridge’s long-term care facility had recorded 120 confirmed COVID-19 cases and 26 deaths. Hackensack Meridian Health didn’t respond to ProPublica’s requests for comment about Alfredo’s case.

It wasn’t just Alfredo and Susana who fell ill. Sheryl and her brother, both living at home, caught the virus, too. The weekend before Alfredo’s symptoms emerged, he and the rest of the family attended a gathering in honor of a relative who had died in January from cancer. Alfredo spent much of the party talking to his younger brother; later, the brother ended up with COVID-19 and on a ventilator for nearly three weeks. An aunt of Sheryl’s who is a housekeeper in the same hospital system as Alfredo wasn’t at the gathering but fell ill anyway and was out sick for two weeks. Her symptoms weren’t as severe as those of some of the others; she’s already back at work.

The spread of the virus has been unrelenting for Sheryl. When she returned to her own job as a pharmacy tech this past week, a month after her parents died, she learned that someone who worked at her company — who was also Filipino — had died during her absence. “You have no idea about the extent of this,” she said, “until it hits you.”

Sophie Chou contributed reporting.

Correction, May 5, 2020: This story originally misspelled the first name of the president of the California Nurses Association/National Nurses United. She is Zenei Cortez, not Zeine.

by Yeganeh Torbati

Democratic members of Congress are urging President Donald Trump to authorize FEMA to reimburse funeral expenses for victims of the coronavirus pandemic, citing ProPublica’s reporting about the administration’s policies.

“Just as with all previous disasters, we should not expect the families of those that died — or the hardest hit states — to pay for burials,” said the statement issued Friday from Rep. Bennie Thompson, chairman of the House Homeland Security Committee, and Rep. Peter DeFazio, chairman of the House Transportation and Infrastructure Committee. “President Trump needs to step up and approve this assistance so FEMA can pay for the funerals of our fellow Americans so they can be buried in dignity. It is the least he can do.”

ProPublica reported last week that Trump has yet to free up a pool of disaster funding specifically intended to help families cover burial costs, despite requests from approximately 30 states and territories. In lieu of federal help, grieving families are turning to religious institutions and online fundraisers to bury the dead.

Trump has sharply limited the kinds of assistance that FEMA can provide in responding to the coronavirus pandemic. In an April 28 memorandum, he authorized FEMA to provide crisis counseling services but said that authority “shall not be construed to encompass any authority to approve other forms of assistance.”

In a statement last week, a FEMA spokesperson said the approval of assistance programs “is made at the discretion of the President.” A spokeswoman for the White House’s Office of Management and Budget last week referred questions to FEMA, and she and two White House spokesmen did not respond to a request for comment on Monday.

The administration’s failure so far to pay for funeral costs does not appear to be because of a lack of funds. Congress gave FEMA’s disaster relief fund an extra boost of $45 billion in the Coronavirus Aid, Relief and Economic Security Act in March.

On Sunday, NJ Advance Media reported that as of April 25, FEMA had committed less than $6 billion in disaster relief for the coronavirus pandemic, and it has $80.5 billion in available disaster relief funds. The information was attributed to a FEMA spokesperson. FEMA did not respond to a request to confirm the figures.

Calls for FEMA aid are likely to spike in the coming months, as hurricane season approaches and wildfire activity hits an anticipated peak.

The amount FEMA reimburses for funeral expenses can vary, but a September 2019 report from the Government Accountability Office found that FEMA paid about $2.6 million in response to 976 applications for funeral costs of victims of three 2017 hurricanes, or an average of about $2,700 per approved application. If FEMA provided that amount for every one of the nearly 68,000 people in America reported to have died in the pandemic thus far, it would cost the government about $183 million.

Do you have access to information about the U.S. government response to the coronavirus that should be public? Email yeganeh.torbati@propublica.org. Here’s how to send tips and documents to ProPublica securely.

by Annie Waldman

Last September, over pancakes at a diner in central Massachusetts, Molly Baldwin told her husband, Jonathan, they were going to have a baby. He cried into his coffee mug, elated and a little surprised. They had only been trying for about a week, and they had yearned for a summer baby, ideally in June, which would enable their parents to spend more time with their first grandchild.

“We thought we had the best timing,” she said.

But as the novel coronavirus began to spread through the country this year, Baldwin realized in early March that it was only a matter of time before the virus hit her town, Fitchburg, and the nursing home where she’s a social worker. Her patients would be among the most vulnerable: Some had battled addiction, many had experienced homelessness and most were elderly. Flu seasons were always hard on her patients, and she dreaded the havoc a more lethal disease would wreak.

Baldwin also worried about her baby. She spent hours looking up the prenatal effects of COVID-19, and the lack of evidence-based research concerned her. She called her obstetrician, who cautioned that because of the unknowns, she should consider working from home to limit her exposure to the virus.

So Baldwin made a plan for when COVID-19 arrived at her nursing home: She would swap shifts with a colleague to work fewer hours and request to work from home, as many of her duties are paperwork or computer-based.

She would work from the comfort of her kitchen table. She would avoid catching the virus. She would keep visiting her doctor until it was time to deliver, her belly swelling with a baby girl she knew was healthy and safe.

None of it, not a single thing, would go according to plan.

Baldwin said her supervisor and the human resources representative from the facility verbally agreed in mid-March to let her work from home. (Baldwin spoke with ProPublica on the condition that her workplace not be named; ProPublica contacted her employers with questions for this story.)

Then, on April 16, one of the residents at her facility tested positive for the virus. Baldwin sought testing at a walk-in clinic, and the results came back negative. But when she called her obstetrician’s office, she got a warning: If she continued to work at the facility, potentially exposing herself to the virus, they would not allow her to enter their office for prenatal appointments unless she could prove with a test, before each visit, that she was negative for COVID-19.

She understood their caution; her job was beginning to feel at odds with her pregnancy. It was time for her work-from-home plan to go into action.

She called her employer and asked to start the accommodations she had requested the month before. But they told her that now the plan would not be feasible, she said. Other pregnant employees were continuing to work at the facilities, and she would have to as well, she said she was told.

“The services provided at a nursing home do not typically allow for remote working,” a company spokesperson told ProPublica. “However, we have made changes to accommodate our staff whenever possible, provided there is no impact on patient care.”

After finding out her request to work from home would not be granted, Baldwin panicked. “I’m not even a mom yet,” she said. “This is my first baby, and I already feel like I’m doing everything wrong.”

Baldwin is one of dozens of pregnant workers who ProPublica has heard from who are navigating the risks of COVID-19 while in the field of health care.

“There are plenty of pregnant women across the country who are trying to figure out what to do to protect themselves, given the uncertainty,” said Emily Martin, vice president for education and workplace justice at the National Women’s Law Center. “If you feel like you can’t do your job because there aren’t certain accommodations and you feel like you’re at risk, it’s difficult to see where to go next.”

About half of the states have laws that allow pregnant women to request reasonable accommodations, including Massachusetts, Martin said.

According to the Massachusetts Pregnant Workers Fairness Act, signed into state law in July 2017, employers must grant reasonable accommodations to their pregnant employees that allow them to continue to do their job, “unless doing so would impose an ’undue hardship’ on the employer.” An employer also “cannot make an employee accept a particular accommodation if another reasonable accommodation would allow the employee to perform the essential functions of the job.”

Both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists have stated that based on the data available, pregnant women do not face a higher risk of infection or severe morbidity related to COVID-19. That said, both the CDC and ACOG have suggested that health care facilities may want to consider reducing the exposure of pregnant health care workers to patients with confirmed or suspected COVID-19, if staffing permits.

“In the overwhelming majority of pregnancies, the person who is pregnant recovered well with mild illness,” said Dr. Neel Shah, an obstetrician and assistant professor at Harvard Medical School, echoing the current guidance. But, he cautioned, there is a lot we still don’t know about how the virus impacts bodies, let alone those that are pregnant. “We can’t say that it’s completely safe — we don’t know.”

Baldwin and her husband went through their options.

She couldn’t quit because they needed her paycheck. They had a mortgage, student loans and a new baby on the way. She also loved her job and cared deeply for her patients, whom she wanted to continue to serve. Her employer, trying to manage understaffing, had discouraged employees from taking time off, she said. She didn’t want to take any additional sick days, because she needed to save them for her maternity leave.

They decided that she would have to return to work.

Her employer told her to wear a mask and gloves, use hand sanitizer and remain in her small, boxy office, which has three desks for four people. Though she didn’t have contact with the residents, her office mates still did.

Even though she was scared, she tried to stay optimistic. “I was grateful for what I had because I have friends that are out of work right now,” she said. But she remained perplexed about why her requests had been denied. “I was sitting in my office doing work that would have easily been done from a laptop on my kitchen table.”

The company spokesperson did not respond to a question about whether it had originally given Baldwin verbal approval to work from home. When asked why she couldn’t have done the same work remotely, he said, “Based on your questions, our HR and Risk Management are anticipating action and would prefer to not comment at all.”

The next day, the Massachusetts National Guard delivered testing kits to the nursing home, and every resident was checked for the virus. When the results came back, at least 22 residents and 20 other staff members tested positive.

“We are conducting cleanings and infection control measures multiple times per day, with extra focus on high touch areas,” the company spokesperson said. “We screen and take the temperature of anyone entering our building, and we have increased monitoring of our residents.”

Public data shows the facility has more than 30 cases among residents and staff, the maximum number that the state reports publicly.

“I thought if I just keep working, stay in my office, use hand sanitizer, wear my mask, go home and shower right away, disinfect my clothes, then I will be fine, and I can keep my baby safe, and I can shed all this guilt,” she said.

Then on April 24, two of her office mates texted to tell her they had the virus.

And that morning, she’d felt a tickle in her throat.

“I know I’m positive,” she thought to herself, as she left work midday and drove to a CVS drugstore testing site an hour away that was offering free rapid tests for front-line and health care workers. Hundreds of cars were already lined up.

She waited alone in her Jeep Wrangler for three hours, wearing her mask as required, which muffled her nagging cough. She shifted around constantly, to keep blood from pooling in her swelling feet. At the front of the line, she received a 6-inch cotton swab, wedged it deep in her nasal cavity, and returned it to the technicians. They directed her into a side parking lot, and 30 minutes later, she got a phone call with her results.

“We’re sorry to tell you that you’re positive,” the voice on the line told her. Baldwin’s mind stalled, engulfed in a wave of anxiety, which gave way to seething frustration.

“This was so preventable,” she said. “Now here I am, 33 weeks pregnant and positive. My most important job is to keep the baby safe, and my actual job wasn’t making that happen.”

When she called her co-workers and supervisor to tell them she tested positive, she said they were “all very caring and compassionate.” They told her to stay home for at least a week, or until her symptoms subsided. The Families First Coronavirus Response Act requires most employers to provide their workers with two weeks of paid leave if the employee is quarantined or experiencing COVID-19 symptoms. Baldwin said she would have to exhaust her sick days first; she’d been saving them for her maternity leave. Her husband, who works as a correctional officer at a county jail, was allowed to take 14 days of paid leave to tend to his wife, without using his own sick days.

She could no longer go to her normal obstetrician for in-person appointments, and instead, she would have to rely on telemedicine. Her doctor connected her with an obstetrician specializing in COVID-19 cases, with whom she planned to meet this week.

Last Saturday, Baldwin’s mother had planned to throw her daughter a baby shower. She had invited 50 of their closest friends to celebrate at a new restaurant and had ordered dozens of pink favors from Etsy.

Because of the stay-at-home order, her shower morphed into a drive-by celebration, where her friends and family passed by her house, honking their horns and holding celebratory signs, balloons and streamers. They dropped gifts in front of her house, including first aid kits and a handsewn pink mask for an infant.

Her symptoms have, so far, been relatively mild, similar to a normal flu: headaches, a stuffy nose, a sore throat and muscle pains. She’s spent most of the past week resting in bed and taking baths to soothe her body aches. While taking care of Baldwin, her husband has also contracted the virus and is experiencing severe body aches as well.

In addition to her disappointment that the hypnobirthing and breastfeeding classes she had signed up for are canceled, her time in quarantine is now filled with anxious questions about how the disease may impact her baby.

Will the stress of this experience damage her baby neurologically? Will her baby be born early? Will she have to deliver by cesarean section to relieve pressure on her body and lungs, like so many stories she had read? Will she have to be secluded from her baby for days or weeks after birth? And what if her own symptoms worsen?

“This is our first baby, and it was so planned and wanted,” she said. “But had we known this awful thing would happen, would we have tried when we did?”

by Joaquin Sapien

New York Attorney General Letitia James is looking into allegations that a Queens adult care facility has failed to protect residents from the deadly coronavirus and misled families about its spread, according to two lawmakers who asked for the inquiry and a relative of a resident who spoke to an investigator with the attorney general’s office.

In a separate action Tuesday, three residents of the Queens Adult Care Center sued the facility in federal court over similar allegations.

Both developments were prompted largely by ProPublica’s recent coverage of the facility, which houses both frail elderly residents and those with mental health issues. On April 2, we reported that workers and residents at the home were becoming ill with the coronavirus as residents wandered in and out of the home without any personal protective equipment. Family members later told ProPublica the management said no residents were sick with the virus at the time.

On April 25, ProPublica published a story and a short film with the PBS series Frontline about the harrowing experience of Natasha Roland, who rescued her father in the middle of the night as he suffered coronavirus symptoms so severe he could barely breathe. Roland, in heart-wrenching detail, described how the management of the Queens Adult Care Center repeatedly assured her that her 82-year-old father, Willie Roland, was safe, even as the virus swept through the facility. She said workers were too scared to care for him, forcing his girlfriend, Annetta King-Simpson, to do so. King-Simpson later fell ill herself. Roland and King-Simpson are now suing the facility in federal court.

In an interview, Assemblywoman Catalina Cruz, whose district covers Corona, Elmhurst and Jackson Heights, said she was troubled by what ProPublica reported. She said she hoped the attorney general can determine whether the Queens Adult Care Center had broken any laws.

“It didn’t sit right with me. I thought something was off here. So I said let’s have the experts look at whether there was a crime or a civil violation,” she said. “Folks who live in this adult home deserve the same dignity as everyone else, and if their rights have been violated, someone needs to pay for that.”

Cruz said she had been suspicious of the facility for several years and had come across a community Facebook page where people posted complaints about treatment of residents at the center. When she saw the ProPublica stories, she said she decided to take action, along with City Council member Daniel Dromm, who had already written to the New York State Department of Health and the office of Gov. Andrew Cuomo about the spread of the coronavirus in the facility on several occasions.

“The plight of those living in adult care centers during this crisis was highlighted in a recent article published by ProPublica, which focused on the perils faced by the residents at the Queens Adult Day Care Center,” the lawmakers wrote in their April 27 letter to the attorney general and the governor’s office. “Failure to inform families about the health of loved ones, to lying and covering up deaths have become regular concerns we have received. We are aware that adult care centers are struggling to keep COVID-19 from affecting their residents and we also know that minorities have been disproportionately affected by the virus. It seems to us that management at this particular center have struggled to implement procedures and policies to protect the lives of its residents.”

Cruz said she received an update from the attorney general’s office on May 5, saying it was looking into the matter but would not provide specific details.

Days after the lawmakers sent the letter, Natasha Roland, 35, said she received a phone call from an investigator with the attorney general’s office. Roland said she recapped what she had previously told ProPublica: She began to worry about her father’s safety when nearby Elmhurst Hospital became a viral hot spot, but the management repeatedly told her there were no coronavirus cases in the facility. She said she only found out the truth weeks later when a worker she was friendly with advised her to come and pick up her father because the virus was raging through the facility and aides were becoming too scared to check on residents. In a subsequent interview, that worker denied telling Roland to pick up her dad.

A spokesperson for the attorney general would not confirm or deny a specific, active investigation into the Queens Adult Care Center, but said James has received hundreds of complaints related to COVID-19 inside nursing homes and adult care facilities across the state and is investigating many of them.

For its part, the Queens Adult Care Center has denied any wrongdoing and repeated its belief that Roland’s allegations are “baseless.”

“Sadly, select elected officials and ProPublica have been intentionally misled with baseless assertions and utter fabrications crafted by the daughter of one of our long-term residents,” said Hank Sheinkopf, a crisis communications spokesperson hired by the facility. “We have strong reason to believe that this individual is seeking to use her father and other select residents as pawns in an attempt to extort the facility. We are considering our legal options.”

He said the facility has “worked tirelessly” to protect its residents and is unaware of a “potential investigation,” but understood that “the AG’s office has contacted many nursing homes, adult care, and assisted living facilities seeking information. We are glad to be a resource to the AG’s office and have nothing to hide.”

Bruce Schoengood’s 61-year-old brother, Bryan, lives in the facility and shared a room with one of the first residents to become infected with COVID-19 and subsequently die of the disease. Bruce told ProPublica he only learned that his brother’s roommate had died by happenstance during a casual conversation with his brother, and that he has complained for more than a month about a lack of communication from the facility. He said he had not yet heard from anyone with the attorney general’s office but would welcome such a conversation.

In the meantime, Bryan Schoengood, Willie Roland and King-Simpson are suing the facility under the Americans with Disabilities Act. In a 59-page complaint, the group has asked a federal judge to appoint a special master to oversee the facility at the home’s expense to ensure that residents there are safe.

The lawsuit argues that residents have experienced a “gross failure to provide the most basic level of care to safeguard their health and safety in the context of a global health pandemic. People with disabilities are exposed to high risks of contracting the virus with no or few preventative measures in place. Residents who fall sick are left to languish in their room without proper access to medical care.”

The lawsuit claims that because the facility has failed to follow state and federal guidelines, “COVID-19 is rampant in the facility among residents and staff alike.”

Alan Fuchsberg is the Manhattan-based personal injury and civil rights attorney representing the three Queens Adult Care Center residents.

In an interview, he said that the facility may not have the resources to properly follow the guidelines, which is why a special master should be assigned to work with a team of outside experts to make sure it can.

“Right now the residents are in a tinderbox,” he said. “And if you drop a match in there, all hell breaks loose. It should be run right. We don’t need dozens of people dying in all our nursing homes and adult care facilities. Some are running better than others and QACC sounds like a place that is not run up to standards.”

He and Bruce Schoengood pointed out that they are not currently suing for damages, but rather to persuade a court to immediately intervene and offer support to the facility’s roughly 350 residents.

Schoengood said the goals of the lawsuit are twofold.

“I think it is both short term and long term,” he said. “Immediate intervention to put proper protocols in place to treat the sick and stop the spread of coronavirus and to communicate with family members. And in the long term I would like to see this facility much better prepared to handle another pandemic or a second wave.”

Responding to the charges in the lawsuit, Sheinkopf again said that “the allegations are baseless and utter fabrications. Queens Adult Care Center (QACC) continues to meet all state issued guidelines.”

by Duaa Eldeib, Adriana Gallardo, Akilah Johnson, Annie Waldman, Nina Martin, Talia Buford and Tony Briscoe

ProPublica Illinois is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.

Larry Arnold lived less than a mile from a hospital but, stepping out of his South Side apartment with a 103-degree fever, he told the Uber driver to take him to another 30 minutes away.

Charles Miles’ breathing was so labored when a friend called to check on him that the friend called an ambulance. Still, Miles, a retired respiratory therapist, was reluctant to leave his home.

Close family support had helped Rosa Lynn Franklin recover from a stroke several years ago, but when she was admitted to the hospital in late March, her daughter could do little more than pat her on the back and say goodbye.

All three were among the first people to die of COVID-19 in Chicago, and all three were African American. Their deaths reflect the stunning racial disparity in the initial toll of the virus. Of the city’s first 100 recorded victims, 70 were black.

As the pandemic has spread, that gap has narrowed, and Latinos now make up the largest portion of any reported demographic of confirmed cases across Illinois, state data shows. But the disparity in black deaths persists. As of early May, African Americans, who make up just 30% of Chicago’s population, are about half of its more than 1,000 coronavirus deaths.

It has been well established that African Americans are dying of COVID-19 at a disproportionate rate in cities across America. ProPublica sought to explore the problem by examining the first 100 recorded deaths in Chicago, a city with a rich and often troubled history on issues of race.

Using a database obtained from the Cook County Medical Examiner’s Office that listed the names, health and location information of all COVID-19-related deaths, reporters reached out to the families and friends of each person who died. Reporters ultimately spoke with those who knew 22 of the victims; gleaned details about the lives of many others from obituaries and social media posts; and interviewed experts, medical professionals and government officials to understand how and why those first 100 died.

The racial disparities in coronavirus deaths have largely been attributed to endemic and entrenched inequalities in Chicago — decades of disinvestment in the predominantly black neighborhoods on the South and West sides that have left residents with fewer jobs, poorer health and diminished opportunities. Those forces often are portrayed as intractable and, during a pandemic, nearly impossible to fix.

Chicago Mayor Lori Lightfoot acknowledged the challenge when she spoke publicly about the disparities last month and announced a plan to address them.

“We’re not going to reverse this in a moment, overnight, but we have to say it for what it is and move forward decisively as a city, and that’s what we will do,” she said. “This is about health care accessibility, life expectancy, joblessness and hunger.”

While all this is true, ProPublica’s reporting also revealed other patterns, factors that could — and should — have been addressed and which almost certainly exist in other communities experiencing similar disparities. Even though many of these victims had medical conditions that made them particularly susceptible to the virus, they didn’t always get clear or appropriate guidance about seeking treatment. They lived near hospitals that they didn’t trust and that weren’t adequately prepared to treat COVID-19 cases. And perhaps most poignantly, the social connections that gave their lives richness and meaning — and that played a vital role in helping them to navigate this segregated city that can at times feel hostile to black residents — made them more likely to be exposed to the virus before its deadly power became apparent.

Many of the first 100 recorded Chicago COVID-19 victims led lives threaded through with community and civic involvement, powerfully connected to their city, to friends and family. Some had led careers of service, like Patricia Frieson, a retired nurse, and Rhoda Hatch, a former teacher, and Carl Redd, a U.S. Army veteran. Their small businesses helped shape their corners of the city; Hardwell Smith, 85, arrived in Chicago as part of the Great Migration from the Jim Crow South and established gas stations and auto repair shops on the South Side. They were church deacons and musicians; doting uncles like 32-year-old Carl White and nurturing mothers like Juliet Davis, who, despite her limited means, fed the homeless who lived under a neighborhood viaduct.

Most of the first 100 lived in majority-black neighborhoods, according to an analysis of medical examiner data; hardest hit were South Shore, Auburn Gresham and Austin, where the median income for 40% or more of the residents in each community is less than $25,000.

Many were already sick, with underlying health conditions. Seventy-eight of them had hypertension and 53 had diabetes. Just 12 had one health condition, and only five people had no comorbidities. James Brooks, a 27-year-old black man, was the youngest to die.

“I’m not surprised because every natural disaster will peel back the day-to-day covers over society and reveal the social fault lines that decide in some ways who gets to live and who gets to die,” said Dr. David Ansell, senior vice president for community health equity at Rush University Medical Center. “And in the United States, those vulnerabilities are often at the intersection of race and health.”

Ansell, who wrote “The Death Gap: How Inequality Kills,” has spent decades documenting the life expectancy gap between black and white Chicagoans, which is the largest in the country. Structural racism, concentrated poverty, economic exploitation and chronic stress cause what’s known as biological weathering, Ansell said, where the body ages prematurely and results in earlier death.

Who dies first is different for each pandemic, said Dr. Howard Markel, director of the Center for the History of Medicine at the University of Michigan. The coronavirus’s earliest victims, he said, were the most vulnerable.

“They’re not quite forgotten, but we don’t pay close enough attention to the health and well-being of this segment of the population,” he said. “Then a microscopic organism comes and topples them over.”

They were vulnerable, but their deaths cannot be dismissed as inevitable.

One-Size-Fits-All Guidance

Phillip Thomas, 48, started to feel sick while working a day shift at the Walmart in Evergreen Park. A diabetic, he was cautious about his health, and he reached out to a doctor, who told him to stay home and self-quarantine in case he had the coronavirus.

About a week into his bedrest, Thomas told his sister Angela McMiller that he was having a hard time standing up and was vomiting, no longer able to keep anything down. She encouraged him to go to the emergency room, but he didn’t immediately go, citing the doctor’s advice to stay home.

Within a couple of days, he called an ambulance, which took him to Jackson Park Hospital, where he was intubated. Two days later, on March 29, he died, in the hospital where he was born.

When McMiller next saw her brother, it was at his funeral, which only 10 people could attend because of social distancing requirements. “It was devastating,” said McMiller. “My mother fell down, my brothers cried.”

McMiller is upset that her brother was told to stay home when he was sick, particularly considering the additional risks posed by his health history.

“It shocked me,” she said. “He was diabetic.”

Since the earliest days of the pandemic, the Centers for Disease Control and Prevention’s guidelines have emphasized staying home when symptoms are mild. “Most people with COVID-19 have mild illness and can recover at home without medical care,” the CDC says on its website. It recommends people call a doctor before going to get care in person, unless experiencing emergency signs like trouble breathing, blue lips or chest pain.

But experts told ProPublica that this one-size-fits-all advice does not account for the fact that African Americans are not only more likely to have preexisting conditions that increase their chances of bad outcomes, but also have a long-standing wariness of the health care system.

“There is this distrust between black communities and health care systems based on this fraught history of how health care systems have exploited and abused black people,” said Dr. Uché Blackstock, an emergency medicine physician in Brooklyn and the founder and CEO of Advancing Health Equity. “What happens as a result of that is that patients don’t want to interface with the health care system.”

In addition, doctors said patients may delay seeking care out of a fear of the medical bills, lack of insurance or transportation barriers — all of which underscores the need for targeted guidance. So instead of encouraging staying at home, these doctors want guidance to encourage African American patients to proactively seek care before symptoms get out of hand.

Dr. Mira Iliescu-Levine, a pulmonary critical care doctor at The Loretto Hospital on Chicago’s West Side, is concerned that African American and Latino patients are waiting to come to the hospital after their symptoms become too severe.

“You end up with an overwhelming clinical picture, almost like a tornado, that’s very hard to stop,” she said.

She said she wants patients, especially her African American patients with diabetes, obesity and other comorbidities, to seek care when they have “innocent symptoms” like a cough, runny nose, itchy eyes or low-grade fever.

Earlier treatment does not guarantee a better outcome, she said, but it can give the patient a fighting chance.

“Reach out,” she said. “Don’t wait.”

Asked whether the CDC would consider tailoring its recommendations to reflect the underlying health conditions and barriers to care in African American communities, a spokesperson said the “CDC is collecting data to monitor and track disparities among racial and ethnic groups … to help inform decisions on how to effectively address observed disparities. … We will continue to update our recommendations as we learn more.”

The CDC spokesperson said the agency has increased “engagement with organizations and other partners representing and serving racial and ethnic minority groups to identify gaps in the current response efforts,” and that people should “never avoid emergency rooms or wait to see a doctor if you feel your symptoms are serious.”

On the first day, Willie Flake, a 72-year-old mechanic, lost his ability to taste. Then, he lost his appetite. With each new coronavirus symptom he experienced, his sister Betty and her daughter Yolanda pushed him to go to the hospital.

But Flake, who had diabetes, stayed home because he thought his symptoms were not severe enough to go to the emergency room. He soon developed a fever. By the fourth day, he had trouble breathing.

Flake took an ambulance to Rush University Medical Center on March 27, where his condition appeared to stabilize before worsening again.

“They say, ‘Don’t come in until your fever is high and you can’t breathe,’” Yolanda Flake said. “That’s the part where I feel like they failed him. He waited until he couldn’t breathe and it was too late.”

In the early hours of April 1, his sister and niece put on masks and gloves and looked through the glass window of his hospital room. He had been like a father to Yolanda, attended every graduation, from kindergarten through college, and had recently accompanied her to buy a car for her daughter, his 23-year-old grandniece, LaSeanda.

Yolanda said she wished she could have been with him inside the room, regardless of the risks.

“I wanted to touch him,” she said. “I wanted to talk to him before he took his last breath. I couldn’t say it through the glass door.”

And then, his heart stopped.

“He waited at home,” Yolanda said, “and he was dying already.”

Struggling Hospitals

Larry Arnold also waited, not because he was instructed to, but because he didn’t trust his neighborhood hospitals.

Two — Jackson Park Hospital and South Shore Hospital — sit within five minutes of his home. Both are century-old nonprofit facilities that serve majority low-income and uninsured patients on the South Side. When Arnold started to feel sick in mid-March, he worried that if he called an ambulance, it would take him to one or the other. He didn’t want to go to either.

“What upsets me is that we don’t have adequate medical facilities where we can go to and feel like we’ll be cared for,” his niece Angelyn Vanderbilt said. “I’m sure they’re very good people … but the consensus in the community is that those hospitals are inadequate and they have been for years.”

After his fever didn’t subside for a few days, Arnold, who was 70 and had chronic obstructive pulmonary disease, or COPD, knew he couldn’t wait any longer, his family said. He got into an Uber with a temperature of 103 and told the driver to take him to Advocate Christ Medical Center in Oak Lawn, some 30 minutes away.

On March 31, 16 days after he was admitted, the nurse put the phone to Arnold’s ear one last time.

“We told him to be strong and to continue to fight,” Vanderbilt said.

He died about an hour later.

People who live on Chicago’s South and West sides are often at a geographic disadvantage during medical crises because the hospitals that are closest to them frequently are those with fewer resources.

Illinois Gov. J.B. Pritzker acknowledged the hardships at a press briefing last month. “The safety-net hospitals are challenged in our state, and the availability of health care in communities of color has been at a lower quality or lower availability than in other communities,” he said.

The city’s safety-net hospitals, facilities that serve a large portion of low-income and uninsured patients regardless of their ability to pay, don’t have the private-insurance patient base or the cash reserves to fall back on during a pandemic that many larger hospitals have, said Larry Singer, associate professor at the Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law. Some are millions of dollars in the red and housed in aging buildings. And while their mission is a valiant one, he said, they have not been able to respond to the coronavirus as quickly or with the same equipment and staffing.

“They’re trying to fight the same fight as everybody else with one arm tied behind their back,” Singer said. “They deserve the resources to do an even better job. I’m truly impressed by what they are trying to achieve during a time of crisis.”

Tim Caveney, president and CEO of South Shore Hospital, said that limited resources is one reason safety-net hospitals have struggled to earn the trust of the communities they serve. “Safety net [hospitals] have gotten a bad beat because we don’t have much money. It’s a funding issue,” he said, adding that the pandemic has aggravated South Shore’s financial issues. Not only have lucrative elective surgeries been postponed, but COVID-19 patients often require complex and lengthy care, which can be expensive.

Dr. Khalilah Gates, an African American pulmonary and critical care specialist at Northwestern Memorial Hospital who has family on the South Side, said she is painfully aware that some black patients may prefer to “wait it out” or travel to distant hospitals.

“Both of those are very common phenomenons,” she said. “Not all community hospitals, but many of the community hospitals in those communities lack the resources that offer security to the residents in those areas.”

ProPublica spoke with several families who said their loved ones either delayed care because they didn’t want to go to neighborhood hospitals or ultimately wound up in those hospitals as a last resort.

Miles, the retired respiratory therapist, had worked for about 40 years at Northwestern Memorial Hospital providing breathing treatments for patients there. When he started feeling sick in mid-March, he knew what resources he might need.

A friend called him on March 22 and heard his labored breathing. He told Miles that he was calling an ambulance, but Miles resisted, in part, because he didn’t want to be taken to Jackson Park, the nearest hospital.

“He should’ve been in there a week before that,” said his sister Roselle Jones. “But he was insistent on not going.”

The paramedics said that they had to take him to Jackson Park because it was the closest hospital. Miles’ family asked that he be transferred to another hospital, but once he tested positive for the coronavirus, a doctor told the family that Miles couldn’t be moved, Jones said.

By the end of the week, Miles had been sedated and placed on a ventilator. He died on April 3.

“We wanted him out of there. We wanted him somewhere he could get some good care,” Jones said. “The doors should be closed, and the building torn down.”

Philman Williams’ family also said they tried in vain to get him transferred out of Jackson Park after an ambulance took him there. Williams, 70, worked as a doorman at a luxury high-rise where residents dubbed him the “Mayor of Michigan Avenue” for his charm and good humor. Not only was his doctor at another hospital, but the family worried about the quality of care he would receive.

A day after he was admitted, their concerns were amplified by a news story detailing reports from employees that the hospital did not have enough personal protective equipment, prompting nurses to avoid entering patient rooms.

Nurses who were sick and those afraid to come to work because they had elderly relatives at home have led to staffing shortages, said Kindra Perkins, a representative with National Nurses United, the union that represents nurses at Jackson Park. One day, an ambulance couldn’t drop off a patient because there were only two nurses working in the emergency room, she said.

“The nurses deserve to have the resources that they need to provide the quality care in that community, and the people in that community are just as important as the folks on the North Side of Chicago,” Perkins said.

Margo Brooks-Pugh, a vice president of development at Jackson Park Hospital, did not answer specific questions, but she wrote in an email that the hospital takes patient and staff safety seriously.

“Jackson Park Hospital follows all guidelines and standards as related to patient care and safety,” she wrote.

Austin, on the West Side, is one of the city’s largest and most chronically underserved areas. It has become a hot spot for COVID-19 cases. The Loretto Hospital, a small nonprofit that has been an anchor in the community for more than 90 years, is the primary provider in the area. Like many of the safety-net hospitals in Chicago, it has struggled financially for years.

When Asberry Stoudemire Jr., a 54-year-old diabetic, got a runny nose, then felt his blood sugar levels begin to fall, his family knew he needed to get care quickly. He also had a history of congestive heart failure, which had forced the avid stepper and musician to retire early from his job as a certified nursing assistant. The Loretto Hospital wasn’t their first choice — or their second. But it was the closest. Within hours of arriving at Loretto, his condition deteriorated so rapidly that he was sedated and intubated.

His daughter Miranda Stoudemire said she had trouble getting a clear sense of what was going on in the 10 days her father spent in the hospital’s recently reopened 15-bed ICU. Loretto couldn’t afford to keep the unit up and running before the pandemic, a fate hospital administrators said they fear could be repeated without an infusion of cash as the pandemic continues.

“He was saying, ‘I know one thing, I’m not going to Loretto,’” she said. But he did, and she is resolute in her belief that her father would have lived longer had he been at a better resourced hospital. His family tried having him transferred but said they were told he was too critical to be moved.

“I feel like he didn’t even have a chance to fight,” she said.

He died March 29.

Mark A. Walker, spokesman for The Loretto Hospital, said that the hospital has the capacity to care for its patients and is doing its best to communicate with families.

“This hospital has gone through hard times,” he said. “We’re doing everything we can. We’re learning along with everybody else. But better resourced communities don’t have to fight for the same divvy of health care resources that we do.”

Although L.B. Perry was 78 and suffered from hypertension and diabetes, nothing usually kept him in bed. So when he didn’t wake at 6:30 for his morning oatmeal and coffee, his family began to worry.

As he grew weaker and needed help walking to the bathroom, his family urged him to go to the hospital. After a few days, he relented and went to Holy Cross Hospital in Chicago Lawn on the South Side, but he was sent home, his daughter Vernice Perry said.

“That’s why I’m so upset,” she said. “He was in the age bracket, and he has all these health conditions, and he had some of the symptoms.”

His condition worsened at home, and his daughter said she begged him to let her drive him to another hospital. Four days later, his wife called an ambulance in the early morning of March 30, and he returned to Holy Cross Hospital. He died on April 2.

Dan Regan, a spokesperson for Sinai Health System, did not answer questions about specific patients, citing privacy restrictions. He said that its hospitals, including Holy Cross, are “thoroughly prepared for handling the COVID-19 pandemic,” having created dedicated COVID-19 teams, using mobile triage trailers outside facilities to handle sick patients, and isolating COVID-19 patients in specialized rooms.

“It is worth noting though that the challenging nature of COVID-19 is that patients can look fine at one point and be discharged home with monitoring and follow-up, only to deteriorate and have to return to the hospital,” said Regan. “This has been seen in many cases nationwide.”

At least 110 patients from community hospitals, including Holy Cross, have been transferred to Rush University Medical Center, a large, well-equipped facility that has been touted as having been “built for a pandemic.”

“They’re really patients that otherwise, in all likelihood, would not survive at those hospitals,” said Dr. Paul Casey, Rush’s acting chief medical officer. “The resources just aren’t the same. Nor is the ability within critical care to provide a lot of the life-saving therapies.”

The City’s Response

On April 6, when Mayor Lightfoot publicly announced that the coronavirus was disproportionately affecting the city’s black residents, the virus had been in Chicago at least since January, and more than 100 people were dead. The majority were black.

“When we talk about equity and inclusion, they’re not just nice notions,” Lightfoot said at the time. “They are an imperative that we must embrace as a city. And we see this even more urgently when we look at these numbers and this disparity. It’s unacceptable. No one should think that this is OK.”

That day, the city announced the Racial Equity Rapid Response Team in partnership with West Side United, with a goal to “bring a hyper local public health strategy to targeted communities.” In the weeks since, the team has held tele-town halls, delivered thousands of door hangers and postcards with targeted information, and distributed 60,000 masks for residents in the predominantly black communities of Austin, Auburn Gresham and South Shore.

Dr. Allison Arwady, the city’s public health commissioner said in an interview that officials had worked behind the scenes to combat rumors that black people couldn’t contract the coronavirus, reaching out to community and faith leaders on the South and West sides in February and March to let them know the city was seeing cases across all races.

Arwady said the department at first hoped to contain the spread. It had tracked the cases for weeks as the virus crept through the city, and then exploded. By the end of March, more than 40 Chicagoans had died from the virus, according to the county medical examiner data, though the city said its tally of deaths was less than half of that.

For the most part, Lightfoot has received plaudits for her handling of the pandemic. Illinois was one of the first states in the country to release statistics on COVID-19 deaths by race. Lightfoot herself has even become something of a national political star, with viral videos and memes of her urging residents to stay home. She also gave several high-profile interviews discussing the disproportionate impact of COVID-19 on black communities and emphasizing the importance of tracking demographic data.

The city also encountered some challenges. Early on, it found that up to 30% of the testing data it collected didn’t list race. At the April 6 press conference, which came one day after a WBEZ news report detailed the death disparities, the city released a detailed race analysis. The city also issued a public health order mandating demographic data of COVID-19 cases be reported in hopes of being better able to track and assist individuals and communities falling victim to the coronavirus.

Still, to some in the community, the city appeared a step behind. Niketa Brar, co-founder and executive director at Chicago United for Equity, which advocates for racial equity in the city, said officials didn’t do enough to engage the communities they knew would be hardest hit. As soon as the virus entered Chicago, she said, the city should have used racial, health and economic data to predict where it would take hold and then begin working with residents in those communities on how best to protect and support them. The Racial Equity Rapid Response Team was dispatched much later, she said.

“We’ve seen enough maps to know what the next map is going to look like,” Brar said. “And yet we consistently fail to engage those who are closest to the harm time and time again.”

Lightfoot said in an interview Friday she believes the city responded robustly to the virus from the start.

“I feel pretty good about where we are,” she said. “Has it been perfect? Has any of this been perfect? No, because you’re not going to be able to undo literally 100-plus years of racial disparities across black and brown Chicago. But I’m going to be a champion for people in my city, and particularly people who look like me and who grew up in circumstances like mine.”

The Perils of Connection

It made sense that they were out on Election Day — Revall Burke, a 60-year-old city worker, who served as an election judge for the March 17 primary, and John J. Hill Jr., 53, who was campaigning for a friend outside of City Hall, handing out masks and shaking hands.

Their community connections had shaped their lives. Both grew up in public housing. Burke went on to help form a building committee to give back to the neighborhood, including organizing picnics where he would give away school supplies. Hill, who built a successful business and counted among his proudest moments catering a campaign event for Barack Obama, met his wife at the iconic Rock ‘N’ Roll McDonald’s where she worked as a teenager. He came in to buy ice cream nearly every day; when she was sick, he got her a “get well soon” card signed “the ice cream man,” sparking a 40-year romance and two sons.

For black residents in a city as segregated as Chicago, connections to family, church and community can be a vital resource. During the 1995 Chicago heat wave, connectedness sometimes meant the difference between life and death: Sociologists found that compared with more affluent neighborhoods, Auburn Gresham had fewer deaths, in part because residents knew their neighbors and checked on one another during the extreme temperatures, just as they did every day.

Yet those deep connections put black Chicagoans in harm’s way as the novel coronavirus spread largely undetected, said Jaime Slaughter-Acey, a social epidemiologist at the University of Minnesota who did her doctoral work in Chicago. “What we’re seeing in the time of COVID is that this virus has taken this really important, health-promoting resource [of social connectivity] that we’ve created and used it against communities of color.”

Both men died on April 1, two weeks after the election.

The Chicago Department of Public Health and the CDC mapped one cluster of 16 known or suspected infections — and three deaths — dramatically illustrating the path the virus tore through families and friends who attended an intimate dinner, a funeral, a birthday celebration or a church service. Jennifer Layden, the department’s deputy commissioner, said the case study shows how insidious the virus could be in social settings — even a gathering of just three loved ones could be deadly.

Eboney Harrell was aware of the risk and barred all visitors from stopping by after her daughter SaDariah brought home her newborn baby. A single mother, Harrell was an anchor for SaDariah, rarely leaving her side after she learned her daughter became pregnant. Harrell went to the doctors’ appointments and hosted a circus-themed baby shower with custom T-shirts; hers read “Grandma.” After her grandson was born at the University of Chicago Medical Center on March 19, she took every opportunity to hold him.

Her friends believe she may have gotten the virus at the hospital.

When it came time for Harrell to be the patient, nobody was allowed to be by her side. She died on April 4, alone.

A bedside advocate is important for anyone in the medical system but especially the seriously ill. Sociologists say that, though critical, barring visitors during the pandemic to contain the virus may inadvertently magnify its deadly impact.

Human connections had fueled Rosa Lynn Franklin’s recovery after she suffered a stroke several years ago. Though Franklin had to retire from her longtime career as a social worker in her native Alabama, she filled her days with family, friendships and prayer. She moved to Chicago last year to be near her only child, finding a new community in extended family and a church down the street.

As COVID-19 encroached, Franklin, 64, became homebound, worried about how the virus might affect her fragile health. Despite all her precautions, she got sick, and by March 24, she was having such difficulty breathing that her daughter took her to the emergency room at University of Illinois Hospital.

“Because of social distancing, you can’t really do a lot of touching,” her daughter Jimeria Williams said, “so I just kind of patted her on the back and said, ‘I love you, I’ll see you.’”

Franklin was intubated the day after she was admitted, and while Williams was able to talk with the doctors, she could not communicate with her mother, not even by phone. It was the opposite of what had happened after the stroke, when Williams was a constant presence at her mother’s bedside.

“I couldn’t be there to hold her hand. I know she knew that, even though she was unconscious,” she said. “I think that had a metaphysical impact on her health.”

In the early evening of April 3, the hospital was able to connect Williams with her mother through FaceTime. A few minutes after hearing her daughter’s voice, Franklin died.

I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.

Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.

I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.

The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.

In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.

While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands!

The COVID-19 pandemic has brought to the fore some issues of ad-promo for FDA-regulated products. I'm posting here to highlight some developments and correct some of the discussion.

Snake Oil & Enforcement

Off-Label Promotion & Outbreaks