California, like the rest of the nation, is seeing a dramatic rise in COVID infections and deaths — and Los Angeles County has some of the most dire statistics.
Health officials reported more than 7,500 new cases in the county on Tuesday, shattering the old record, set last week. Hospitalizations tripled in the past month, and on average 30 people are dying of COVID-19 in the county every day.
The most populous county in the country, Los Angeles leads all U.S. counties in raw numbers of both infections and deaths, according to statistics compiled by Johns Hopkins University.
On Monday, the county started a three-week stay-at-home order, and Gov. Gavin Newsom said a similar order for the whole state could prove necessary.
“If these trends continue, we’re going to have to take much more dramatic — arguably drastic — action,” Newsom said.
But even as the restrictions began in Los Angeles, leaders across California took heat for their do-as-I-say-not-as-I-do pandemic behavior.
Los Angeles County Supervisor Sheila Kuehl dined outdoors at a favorite restaurant shortly after she voted to ban outdoor dining, a local TV station reported.
San Jose Mayor Sam Liccardo apologized for spending Thanksgiving with eight people from five households in his extended family.
And the San Francisco Chronicle reported that San Francisco Mayor London Breed joined a party of seven to dine at the famed French Laundry restaurant the day after Newsom did, angering many.
The questionable behavior threatens to overshadow alarming news about pandemic trends. Tuesday, California reported 20,759 new cases, a few hundred less than the record number of the day before. The state is in its worst situation since the pandemic started. Yet despite the record case numbers, California is so populous that it’s far from the top of the list of states with the most new cases per capita. (That spot was held by Montana on Wednesday.)
Newsom said Monday that Southern California is forecast to run out of intensive care unit capacity by mid-December if trends continue. By Christmas Eve, ICU beds are forecast to be at 107% of capacity across the region. There’s no clear plan in place for what to do when hospital demand outstrips capacity.
All races and ethnicities are seeing increases in cases, but disparities are widening. In Los Angeles County, Hispanics’ infection rate is more than twice that of whites.
“Death rates among people in high rates of poverty are three times the death rate of people in more affluent areas,” county public health director Barbara Ferrer said Wednesday.
Health officials estimate that one in every 200 people in the county has the virus and is infectious.
The hope is that the new restrictions of the stay-at-home order in Los Angeles County will slow that spread.
The order is designed to keep people in their homes as much as possible. It prohibits gatherings with anyone outside of a household and reduces capacity at stores. K-12 schools will continue to operate but at 20% capacity. Outdoor areas like beaches, parks and trails will remain open, but people are not allowed to gather.
Officials say they are trying to find a sweet spot where they can keep people from gathering and spreading the virus, but still allow some stores to remain open. Thus far the rules are less stringent than those imposed in the spring, because businesses owners have pushed back hard against more restrictions. They are losing money and, unlike in the spring, have no federal aid to offset their losses.
This story is from a reporting partnership that includes KPCC, NPR and KHN.
With multiple COVID-19 vaccines rapidly heading toward approval, optometrists and dentists are pushing for the authority to immunize patients during routine eye exams and dental cleanings.
Across the country, these medical professionals say their help will be needed to distribute the vaccines to millions of Americans — and they already have the know-how.
"When you look at what dentists do, and how many injections they give day in and day out, I think they're more than qualified," said Jim Wood, a California state assembly member and dentist. "It's kind of a no-brainer."
In California, the professional organizations representing dentists and optometrists are in talks with state officials to expand their job descriptions to include administering vaccines. Oregon has already begun training and certifying dentists to give vaccines. And at least half the states have considered allowing dentists to administer COVID vaccines once they're available, according to the American Association of Dental Boards.
That list is likely to grow, because the U.S. Centers for Medicare & Medicaid Services recommended in October that states consider expanding their list of vaccine providers.
The dentists and optometrists seeking permission to vaccinate patients against COVID-19 and other diseases argue that their help will take some of the pressure off hospitals and doctors' offices. It could also bring some extra money into their practices.
"Everyone in our specialized healthcare system should also play a preventive role," said Dr. William Sage, a professor of law and medicine at the University of Texas-Austin. "Pandemic or not, being alert to preventive health in any setting is a good thing."
In November, Pfizer, Moderna and AstraZeneca announced that their COVID vaccine candidates delivered promising results in clinical trials, and that millions of doses could be ready before the end of the year. Pfizer's has to be stored at ultracoldtemperatures, while Moderna's and AstraZeneca's can be kept at standard refrigerator temperatures.
This wouldn't be the first time health professionals other than doctors administered vaccines during a pandemic. Nursing students, EMTs and midwives in a handful of states were granted temporary and limited authority to administer flu vaccines during the H1N1 swine flu pandemic of 2009-10. Dentists in Massachusetts, Illinois, New York and Minnesota also were temporarily deputized as vaccinators.
Since then, Minnesota and Illinois have adopted laws to allow dentists to give flu shots to adults. And last year, Oregon became the first state to allow dentists to give any vaccine to any patient, whether a child or an adult.
So far, more than 200 dentists and dental students in Oregon have completed the training course offered by the Oregon Health & Science University's School of Dentistry, with 60 others expected to finish by the end of December, said Mary Pat Califano, an instructor who helped develop the hands-on part of the training.
Students spend around 10 hours in online classes. They then undergo hands-on training during which they practice injections on a shoulder pad before practicing injecting a partner with saline. They're taught how to counsel patients about vaccines and avoid injuring patients' shoulders when giving the shots.
Once dentists pass an exam, they can register with the Oregon Health Authority and begin getting their staff trained to handle vaccines and procuring a fridge to store them.
The goal, Califano said, is not to replace family doctors or primary care physicians, but to supplement them. The federal Agency for Health Research and Quality found that, in 2017, 31.1 million Americans saw a dentist but not a physician.
"We just need as many people as possible to give flu shots and COVID-19 vaccines when they're available," Califano said. "If it happens that they're in a dental office, and that provider is educated and capable of giving a vaccine, why not?"
In California, the state dental association is exploring options for gaining vaccine authority, which would likely require the legislature to step in. This year, California passed a law allowing pharmacists to administer COVID vaccines approved by the U.S. Food and Drug Administration.
Wood, who carried that measure, hasn't yet committed to sponsoring a bill that would let dentists give vaccines, but says he supports the idea.
"We give injections in the mouth all day long, and these are very precise kinds of injections," Wood said. "I think the learning curve for a dentist would be small."
Dr. Bill Schaffner, a professor of preventive medicine and infectious disease at Vanderbilt University, said these proposals for expanding the vaccine workforce are promising. Flu vaccines, which are relatively low-risk and simple to administer, would be the perfect candidate to stock in dental and optometric fridges to start.
But Schaffner doesn't believe dentists and optometrists will play a major role in the COVID immunization effort. It would take too long to pass legislation to expand the scope of practice for every professional who wants it in every state, he said. And since some COVID vaccines have specific shipping and subzero storing requirements, they will probably be distributed only to specially trained personnel at a small number of locations, he said.
There's also the question of payment. It's hard — but not impossible — to make a profit administering vaccines, Schaffner said.
Providers have to decide each season how many doses to buy, and any that go bad or remain in the fridge at the end of their shelf life equal monetary losses.
"Unless you're very assiduous about moving the vaccine from the fridge into arms, you're not going to make money," Schaffner said. "People who do that can augment their income, but nobody is going to drive a Porsche because of vaccines."
Jeff McCombs, an associate professor of health economics at the University of Southern California School of Pharmacy, agreed it might not make business sense for most dentists to start vaccinating. He said it would be hard to keep a well-stocked vaccine fridge with enough variety to meet patients' needs without wasting doses. Generally, adults who choose not to get vaccinated do so because they're uneducated about vaccines or afraid, he said, not because they can't access them.
"I don't think it's going to harm people," McCombs said. "I just don't think they'll make any money at it."
While the California Department of Public Health said the state's current vaccine infrastructure is sufficient for flu shots and routine immunizations, it is "carefully considering the need to include additional types of immunizers" to get Californians vaccinated against COVID-19, according to a statement from the department.
The California Optometric Association said it is in talks with Gov. Gavin Newsom's vaccine task force about how to get optometrists into the mix, and is exploring legislative options as well.
"We can serve the dual role of assisting with vision needs and protecting from COVID," said David Ardaya, an optometrist in Whittier who chairs an association committee that is looking into the issue. "Our whole hope is to assist our nation in regaining its health and in returning to a sense of normal."
But three years after AB-443 was signed, the regulations implementing it have yet to be finalized.
That didn't stop Frank Giardina, an optometrist in Nipomo, from going through a certification program anyway.
The 20-hour course, which includes online lectures, hands-on lessons and an exam, is the same course pharmacists take when learning how to give all vaccines to people of all ages.
Giardina pointed to the shingles, or herpes zoster, virus as an example of why optometrists are well suited to give vaccines. The virus can infect the eyes, and even though he's allowed to treat shingles, he can't give a vaccine to prevent it.
For now, he's holding out hope he will get permission to administer vaccines, including for COVID-19. He envisions a world in which a patient comes in for contact lenses and he can offer them a flu or COVID vaccine while they're there.
"We're another member of the healthcare team. It's a waste of manpower not to," Giardina said. "If you're trying to vaccinate all these people, especially in rural areas, you need whoever you can find."
Federal officials are banking on pharmacists to undergo additional training and help reverse the slump in child immunization rates caused by the coronavirus pandemic.
This article was published on Thursday, December 3, 2020 in Kaiser Health News.
Torey Watson is trained as a pharmacist but aims to do more than simply fill prescriptions.
Pharmax Pharmacy — a small drugstore chain where Watson works as a clinical services coordinator, about an hour and 30 minutes southwest of St. Louis — will soon allow him to offer childhood vaccines to patients without a doctor's prescription. This change came after the federal government expanded pharmacists' ability to administer routine immunizations to children as young as 3.
As a father of two young boys, Watson, 30, understands how difficult it can be to give a child a shot. Many pharmacists are accustomed to administering vaccines to adults, he said. Doing the same for children requires extra skill.
"We're going to have parents asking questions," he said. His other thought: "Holy cow, I don't think I can give a shot to a 3-year-old."
Federal officials are banking on pharmacists like Watson to undergo additional training and help reverse the slump in child immunization rates caused by the coronavirus pandemic. Fears over COVID-19 have led parents to avoid the doctor's office and pediatricians to curtail in-person care. As a result, many children are missing routine vaccinations.
Children who fall behind on vaccinations usually don't pose a health risk if kids around them are immunized, said Dr. Sean O'Leary, vice chair of the American Academy of Pediatrics committee for infectious diseases. However, large groups of children are now behind, and highly contagious vaccine-preventable diseases circulating in other parts of the world are only a plane ride away, he said.
"That's a big deal," he said in an email.
In August, the Department of Health and Human Services took steps to override restrictions in many states that kept state-licensed pharmacists from immunizing children.
"Today's action means easier access to lifesaving vaccines for our children, as we seek to ensure immunization rates remain high during the COVID-19 pandemic," HHS Secretary Alex Azar said in announcing the policy change.
However, challenges remain in getting pharmacists fully integrated into the nation's framework of childhood vaccinations, immunization experts said.
A key issue is that few pharmacists participate in the Vaccines for Children program, a federal initiative that purchases vaccines for the nation's neediest kids. Half of children in the U.S. receive immunizations through the program, which purchases government-recommended vaccines for kids ages 0 to 18 who are low-income, uninsured or belong to an indigenous group. Compared with last year, VFC-funded orders for vaccines overall are down 9.6 million doses as of Nov. 9, said a spokesperson from the Centers for Disease Control and Prevention. Measles-containing vaccines are down an estimated 1.3 million doses.
Weekly orders of non-flu vaccines and measles-containing vaccines have begun to rebound to levels seen last year, though the volume could again be affected if current COVID surges have a chilling effect on doctors' visits.
Without solving the issues that keep pharmacists from participating in the Vaccines for Children program, said Claire Hannan, executive director of the Association of Immunization Managers, the steps to give parents more access to immunizations through drugstores may ultimately help only Americans wealthy enough to use it.
"Yes, we have a situation with the pandemic that has caused a drop in routine vaccinations," Hannan said. "But I don't want to see us go to a solution that is only serving those who can pay."
Drugstores serve as a convenient access point. Nearly 90% of Americans in 2018 lived within 5 miles of a community pharmacy. In contrast, about 5% of rural counties in 2019 had no family physicians, according to a report from researchers at the University of Washington. Thirty-five percent of rural counties had no pediatricians. Additionally, KFF found over 51% of children in 2017 did not have a medical home, meaning they do not have a primary care doctor that manages their care. (KHN is an editorially independent program of KFF.)
"We need our pharmacists to be vaccinators" in order to catch children up on their immunizations, said L.J Tan, chief strategy officer at the Immunization Action Coalition, a national organization of physicians and health experts focused on vaccine education.
Congress established the Vaccines for Children program to remedy the immunization disparities uncoveredby a measles epidemic in the early 1990s that killed hundreds of people. While doctors jumped on board, pharmacist engagement lags far behind.
This pattern continues. As of Oct. 6, out of nearly 38,000 participating providers, a CDC spokesperson said, about two-thirds work in private practices. Seventy-one are pharmacies.
Stephanie Wasserman, executive director of Immunize Colorado, an Aurora-based nonprofit organization, said boosting the number of pharmacists in VFC will be "a really critical piece" to the success of the federal authorization. However, "just because they can participate doesn't mean they necessarily will jump on it" unless pharmacists think the program is well-supported and will help their business, she said.
Enrollees must adhere to strict storage and handling requirements that involve expensive thermometers and refrigerators used only for products delivered under the government program. And if there isn't enough demand, said vaccine experts, the investment may not be worth it.
For rural pharmacies, said Michaela Newell, president of the Community Pharmacy Enhanced Services Network of Missouri, the cost of paying for the equipment and personnel needed to handle the administrative work may price them out before they apply.
"I guess it hasn't been worth the squeeze," said Hannan.
Added Newell: "I just think that the barriers right now are too high for the pharmacists to enter into it."
On the flip side, state administrators have trouble keeping up with the demands of the program, too. One study from 2019 showed limited success in getting Michigan pharmacies to administer the human papillomavirus vaccine through the Vaccines for Children program because the state's health department didn't have the personnel to conduct on-site inspections.
The strain on state resources has only grown worse during the pandemic, said Hannan.
"You can't call them out for not having the bandwidth," said Rebecca Snead, executive vice president and chief executive officer of the National Alliance of State Pharmacy Associations. "They've been compromised."
Payment also poses a challenge to recruit and maintain providers in the program, immunization experts said.
Medicaid, the government-sponsored health insurance program that offers health coverage for many of the children supported by the vaccine initiative, does not pay providers enough to cover expenses. Participating clinicians lose an average of $5 to $15 for every vaccine they administer through Vaccines for Children, according to a report from Immunize Colorado.
Pharmacists cannot deny a vaccine to eligible children if the family is unable to pay.
Some states run their Medicaid programs using a managed-care model, which may make it harder for pharmacists to get paid, the report said. Children enrolled in these programs are often required to obtain care from designated providers. If their local pharmacist is not on the list of approved providers, they may not get paid.
The possibility of little to no pay hasn't stopped pharmacist and drugstore owner Tim Mitchell from offering vaccines at his three pharmacies in Neosho, Missouri, about 30 minutes from the Oklahoma state line. He said he's been immunizing patients since the late 1990s after he realized children coming into his pharmacies were missing routine vaccinations.
"I saw it as a way to help my community," he said, "but I also saw it as a business opportunity."
Mitchell, 53, views offering vaccines as a way to stand out from his competitors and bring more customers to his pharmacies. He said he submitted the paperwork to enroll in Vaccines for Children.
Although he welcomes the federal authorization, he acknowledged that not all his peers can afford to offer the service.
People buying their own health insurance have even more to think about this year, particularly those post-COVID-19 patients with lingering health concerns, the "long haulers," who join the club of Americans with preexisting conditions.
What type of plan is best for someone with an unpredictable, ongoing medical concern? That question is popping up on online chat sites dedicated to long haulers and among people reaching out for assistance in selecting insurance coverage.
"We are hearing from a lot of people who have had COVID and want to be able to deal with the long-term effects they are still suffering," said Mark Van Arnam, director of the North Carolina Navigator Consortium, a group of organizations that offer free help to state residents enrolling in insurance.
The good news for those shopping for their own coverage is that the Affordable Care Act bars insurers from discriminating against people with medical conditions or charging them more than healthier policyholders. Former COVID patients could face a range of physical or mental effects, including lung damage, heart or neurological concerns, anxiety and depression. Although some of these issues will dissipate with time, others may turn out to be long-standing problems.
So sign up, said Van Arnam and others to whom KHN reached out for tips on what people with post-COVID-19 should consider when selecting coverage. There's no one-size-fits-all answer, but they all emphasized the need to consider a wide range of factors.
But don't delay. Open enrollment in ACA plans is ongoing until Dec. 15 in most states — longer in some of the 14 states and the District of Columbia that run their own marketplaces.
Here are tips if you are shopping for health insurance, especially if you are a COVID long hauler or have other health issues:
Make sure to select an ACA-qualified plan.
It may be tempting to consider other, often far less expensive types of coverage offered by insurers, brokers, organizations and private websites. But those non-ACA plans offer less comprehensive coverage — and are not eligible for federal subsidies to help people who qualify cover the cost of the premiums. These are key factors for patients experiencing medical problems after battling the coronavirus.
Short-term, limited-duration plans, for example, are cheaper, but the insurers offering them don't have to accept people with preexisting conditions — or, if they do enroll those people, the plans don't cover the members' medical conditions. Many short-term plans don't cover benefits such as prescription drugs or mental healthcare.
Another type of plan that doesn't meet ACA requirements are "sharing ministries," in which members agree to pay one another's medical bills. But such payments aren't guaranteed — and many don't cover anything considered preexisting.
Shop around to consider all the ACA plans available in your region.
This will help you meet your post-COVID medical needs while also getting the best buy.
Comparison-shopping also lets consumers adjust their income information, which may have changed from last year, especially after being sick, and could affect subsidy levels for those eligible for assistance in purchasing a plan.
Under the ACA, subsidies to offset premium costs are available on a sliding scale for people who earn between 100% and 400% of the federal poverty level. That range next year is $12,760 to $51,040 for an individual and $26,200 to $104,800 for a family of four.
Networks matter. Look for your doctor or hospital in the plan.
One of the first things to do once you've narrowed down your choices of plans is to dig deeper to see if the doctors, specialists and hospitals you use are included in those plans' networks. Also, check plan formularies to see if the prescription medications you take are covered.
Many insurance plans don't have out-of-network benefits, except for emergency care. That means if a doctor or hospital doesn't participate in the network, consumers must switch medical providers or risk huge bills by receiving out-of-network care. This should be a concern for long haulers.
This subset of COVID patients who report lingering health concerns may need to see a range of specialists, including pulmonologists, cardiologists, neurologists, rheumatologists and mental health professionals.
"So, you are already talking about five or six," said Erika Sward, assistant vice president for national advocacy at the American Lung Association.
To check the network status of medical providers, go to the healthcare.gov website, which will direct you to your state site if you are in one of the 14 states or the District of Columbia, which run their own. Enter a ZIP code and some other information to start looking for available plans.
Narrow the search using the "add your medical providers" button on healthcare.gov, or access each plan's "provider directory" under plan documents to see which specific doctors and hospitals are included. To be safe, Sward said, call each office to make sure they are participating with that insurer next year.
Don't just look at premium costs: Deductibles also matter.
Consumers must pay deductible amounts before the bulk of financial assistance kicks in. That can be a big hit, especially for those who need complex care all at once or very expensive prescription drugs. Long haulers, as well as others with chronic health conditions, often fall into this category.
Median deductibles — the mark at which half cost more and half cost less — vary across the different "tiers" of ACA plans, hitting $6,992 for bronze plans; $4,879 for silver plans and $1,533 for gold plans, according to an analysis by the Centers for Medicare & Medicaid Services.
Generally, plans with higher deductibles have lower monthly premiums. But getting past the deductible is a challenge for many.
What's best for those with ongoing health conditions depends on individual circumstances.
"Balancing the deductibles and premiums is a really important consideration for consumers," said Laurie Whitsel, vice president of policy research and translation at the American Heart Association.
Those with ongoing health conditions need to carefully weigh the expected annual out-of-pocket costs for various health plans, given that they may well be moderate to high users of health services. Healthcare.gov has a financial estimator tool that can help with the decision. Consumers can select whether they think they will have low, medium or high medical use next year to see the estimated total annual costs of each plan.
Frequent users of health services may discover that plans that initially seem least expensive, based solely on the premium or the deductible, may be costlier once all out-of-pocket factors are considered.
Finally, insurers in some markets are touting zero-deductible plans.
Instead of an annual deductible, such policies have higher copayment or coinsurance amounts each time a patient sees a doctor, gets a test or has surgery. Those can range from $50 to more than $1,000, depending on the visit, test or service provided. Still, for some costly services, those payments may amount to less than paying a deductible.
Broker John Dodd in Columbus, Ohio, said such plans appeal to some people who don't want to have to shell out thousands of dollars in deductible payments before their insurance picks up the bulk of medical costs.
Still, he cautioned that many of the zero-deductible plans do have what can be a sizable deductible — hundreds or even thousands of dollars — for brand-name prescription drugs.
Long haulers should weigh those factors carefully, as such zero-deductible plans may be more suited to those who don't expect to use a lot of medical care.
Read the fine print, because there are other costs.
While plans may tout similar premiums, their dissimilar structures could affect how much a consumer will shell out in flat-dollar copayments or percentage coinsurance to see a doctor, pick up a prescription, get a blood test or spend the night in the hospital. This is, again, something long haulers should focus on.
These details are spelled out in the plan's "summary of benefits," a required document under the ACA, which can be found on healthcare.gov or insurers' websites.
Still, ACA plans limit how much a consumer must pay out-of-pocket for the year. Next year, the maximum is $8,550 for an individual or $17,100 for a family plan.
Ask for help.
While services such as Van Arman's navigator program have seen stiff budget cuts during the past few years, consumers there and in many states still have access to online or phone help. Healthcare.gov has a "find local help" button that can refer people by ZIP code to navigators, assisters and brokers.
Finally, those affected by COVID who miss the open enrollment deadline can request an extension under rules that allow special enrollment for emergencies or disasters.
"It's not a guarantee and you have to telephone the call center and ask for it," said Karen Pollitz, a senior fellow at KFF.
Still, she said, it's best to sign up before Dec. 15.
No single municipality in the country suffered more in the first wave of the pandemic than New York City, which saw more than 24,000 deaths, mainly in the spring. Medical staff in New York know precisely how difficult and dangerous overwhelmed hospitals can be and are braced warily as infections begin to rise again.
Around the New York metropolitan area, public health leaders and healthcare workers say they're watching the trend lines, as intensive care units fill up in other parts of the United States and around the world. They say it gives them flashbacks to last spring, when ambulance sirens were omnipresent and the region was the country's coronavirus epicenter.
There is wide agreement that hospitals and care providers are in much better shape now than then, because there is much more knowledge about the disease and how to handle it; much larger stockpiles of personal protective equipment; and much, much more widespread testing.
But at the same time, many front-line workers are nervous about hospital preparedness, and many observers are less bullish about the effectiveness of the coronavirus testing and tracing infrastructure.
"I think there's a lot of anxiety about doing this a second time," said Dr. Laura Iavicoli, head of emergency preparedness for NYC Health + Hospitals, the country's largest municipal hospital system. Iavicoli is also an active emergency room physician at Elmhurst Hospital, in Queens, which came to be called "the epicenter of the epicenter" back in April. Still, she has enormous confidence in the staff of the municipal hospital system.
"They will rally, because I know them," she said. "I've worked with them for 20 years, and they're the most amazing people I can possibly speak of, but there's anxiety and there's COVID fatigue."
Iavicoli said some of the city's hospitals are at capacity, but she hastened to add that she's not talking about "COVID capacity" — meaning not all the beds and recently reconfigured spillover spaces for COVID patients are full. Rather, she said, two of the network's 11 hospitals have had to transfer ICU patients to others to make room for incoming patients.
"We are doing a little bit of redistributing around the system to give them COVID capacity, but it's very manageable within the system," Iavicoli said. "The increase is definitely typical in flu season, but knowing that we have just entered upon the second wave [of COVID-19] and predicting what is to come, we're a little even more cognizant than normal to make sure we leave capacity in all of our facilities."
Many nurses, however, say hospital administrators have not learned enough from the experience in March and April.
"We're scared because we're afraid we're going to have to go through this again," said Michelle Gonzalez, a critical care nurse at Montefiore Medical Center, in the Bronx, and a union representative for NYSNA, the New York State Nurses Association.
She said that in her unit nurses typically handle one or two intensive care unit patients at a time — but now have to handle three, with the number of COVID patients creeping up once again. Tending to four patients or more was common at the peak of the pandemic surge. Gonzalez said that's overwhelming. If one patient crashes, several nurses need to converge at once, leaving other patients unmonitored.
"When we start to get triples with the frequency we're seeing right now, we know it's because we're short-staffed, and they're not getting ICU nurses into the building," she said at a demonstration that featured a phalanx of nurses marching from Montefiore to a nearby cemetery, bearing floral wreaths for fallen comrades, while a band and bagpiper played "When the Saints Go Marching In" and "Amazing Grace."
A spokesperson for the union said Montefiore, by its own reckoning, has 476 vacant nursing positions — a number that has climbed by nearly 100 since 2019.
"Management is not living up to their promise to fill vacancies and hire nurses," said Kristi Barnes, from NYSNA. "As of last week, they have 188 full-time nursing jobs they have not even posted, so there is no way they can be filled."
The Montefiore administration disagrees.
"We have a contractual agreement with the union, and we meet the contractual obligations of that agreement," said Peter Semczuk, senior vice president of operations. "We tailor our staffing in such a flexible way to meet the needs of the patient."
Like many hospital systems, Montefiore relied heavily on temporary staffing agencies for "traveling nurses" from around the country earlier this year. Hospitals are preparing to do so again — but there is demand all over the country.
"They got us travelers in April, but that was four or six weeks in, and until that we were on our own," said Kathy Santoiemma, who's been a nurse at Montefiore New Rochelle for 43 years. "I don't even know where they're going to get travelers now — everyone around the whole country needs travelers."
Iavicoli said each of her network's facilities has submitted requests, so that NYC Health + Hospitals could place a preliminary order now.
Health planners are hoping New Yorkers won't flood into emergency rooms this time. They point to the modest climb in COVID hospitalizations over the past two months compared with other areas, including New Jersey andConnecticut. One thing they hope will keep the curve relatively flat is testing, which is more pervasive in New York than almost anywhere else in the country. About 200,000 people across New York state are getting tested each day, roughly one-third of them in New York City.
"It's the first step to actually interrupting further spread," said Dr. Dave Chokshi, the city health commissioner.
He said mass testing works on two levels — by highlighting which areas are hot zones, so health workers can target residents with "hyper-local" messages about COVID-19 spread, to get them to change their behavior, and also by allowing contact tracers to communicate individually with newly infected people.
"Once someone tests positive, we very quickly help them isolate," Chokshi said. "We do an interview with them to know who their close contacts are, and then we call those contacts and make sure they're quarantining as well."
However, the city's contact-tracing program has had a mixed record. The people it reaches say they're staying put — but fewer than half of them share names of people they might have exposed. Denis Nash, an epidemiologist who previously worked for the city's Department of Health and Mental Hygiene and the Centers for Disease Control and Prevention, said the city hasn't successfully drilled down into how the coronavirus actually spreads, because contact tracers aren't asking people enough questions about their behaviors and possible exposures.
"During the summer and early fall, when things were slowly ramping up, there were missed opportunities to use contact tracing to talk to 80 or 90% of all newly diagnosed people, to understand what their risk factors were and what kinds of things … were they exposed to that could have potentially resulted in them getting the virus," he said. "You can never know with 100% certainty [where they contracted the virus], but if you ask these questions, you could begin to understand what some likely patterns were — for example, of public transportation use, or working in office buildings that didn't have rigorous safety protocols, or indoor dining."
This knowledge, though imperfect, could lead to better informed public policy decisions, Nash said, about whether to close indoor restaurants, beauty salons or fitness centers. Without that data, leaders are just making guesses.
Others fault the city's testing and tracing program for not reaching out enough to poor communities of color — which suffered disproportionately during the first COVID wave. Chokshi, the health commissioner, said getting testing sites to these neighborhoods has been a priority — but a recent analysis suggested it's not working as well as the city intended.
"There's clearly a disparity in providing widespread testing across New York City," said Wil Lieberman-Cribbin, a graduate student and environmental health researcher at Columbia University.
He looked at how many people are getting tested, by neighborhood, and correlated those figures with race, income level and COVID positivity. In wealthier areas, people are getting many more tests and have much less illness. In poorer ones, people are getting many fewer tests and are much sicker. More testing in those areas would pick up cases sooner, before people develop symptoms.
"Testing is really, really needed, not only to protect the most vulnerable, but to collectively try and get a handle on COVID and reopen New York City," Lieberman-Cribbin said.
Personal protective equipment, or PPE, is also much more ample than it was last spring but, similarly, remains a source of contention.
New York state health authorities are requiring hospitals to stockpile a 90-day supply of PPE; for nursing homes, it's 60 days' worth. Many facilities have complied with September and October deadlines, but others have not.
Montefiore, NYC Health + Hospitals, and other large hospital networks say they have at least that much, if not more.
Nurses, though, say they should be able to get fresh N95 masks each time they see a new patient, to limit the risk of contamination. Many administrators counter that isn't feasible, given the precariousness of the supply chain. They note that CDC guidelines permit "extended use" of some PPE.
"[Nurses and other caregivers] change their gloves between every patient, but they might wear the same N95 mask for one shift and put a surgical mask over it just to preserve it and only switch it out if there's some integrity issue or it gets contaminated," said Iavicoli, of the city hospital system. "But definitely at the next shift, they're getting a new one."
Iavicoli acknowledged the challenges as the pandemic rolls on and said there are four kinds of days: "blue skies, or normal," "busier than normal," "a little stretched" and "extremely stretched."
"I think we're at the top end of 'busy normal' bordering on 'a little more than overstretched,'" said Iavicoli.
This story is from a reporting partnership that includes WNYC, NPR and KHN.
Hospitals in much of the country are trying to cope with unprecedented numbers of COVID-19 patients. As of Monday, 96,039 were hospitalized, an alarming record that far exceeds the two previous peaks in April and July of just under 60,000 inpatients.
But beds and space aren't the main concern. It's the workforce. Hospitals are worried staffing levels won't be able to keep up with demand as doctors, nurses and specialists such as respiratory therapists become exhausted or, worse, infected and sick themselves.
The typical workaround for staffing shortages — hiring clinicians from out of town — isn't the solution anymore, even though it helped ease the strain early in the pandemic, when the first surge of cases was concentrated in a handful of "hot spot" cities such as New York, Detroit, Seattle and New Orleans.
Recruiting those temporary reinforcements was also easier in the spring because hospitals outside of the initial hot spots were seeing fewer patients than normal, which led to mass layoffs. That meant many nurses were able — and excited — to catch a flight to another city and help with treatment on the front lines.
In many cases, hospitals competedfor traveling nurses, and the payment rates for temporary nurses spiked. In April, Vanderbilt University Medical Center in Nashville, Tennessee, had to increase the pay of some staff nurses, who were making less than newly arrived temporary nurses.
In the spring, nurses who answered the call from beleaguered "hot spot" hospitals weren't merely able to command higher pay. Some also spoke about how meaningful and gratifying the work felt, trying to save lives in a historic pandemic, or the importance of being present for family members who could not visit loved ones who were sick or dying.
"It was really a hot zone, and we were always in full PPE and everyone who was admitted was COVID-positive," said Laura Williams of Knoxville, Tennessee, who helped launch the Ryan Larkin Field Hospital in New York City.
"I was working six or seven days a week, but I felt very invigorated."
After two taxing months, Williams returned in June to her nursing job at the University of Tennessee Medical Center. For a while, the COVID front remained relatively quiet in Knoxville. Then the fall surge hit. There have been record hospitalizations in Tennessee nearly every day, increasing by 60% in the past month.
Health officials report that backup clinicians are becoming much harder to find.
Tennessee has built its own field hospitals to handle patient overflows — one is inside the old Commercial Appeal newspaper offices in Memphis, and another occupies two unused floors in Nashville General Hospital. But if they were needed right now, the state would have troublefinding the doctors and nurses to run them because hospitals are already struggling to staff the beds they have.
"Hospital capacity is almost exclusively about staffing," said Dr. Lisa Piercey, who heads the Tennessee Department of Health. "Physical space, physical beds, not the issue."
When it comes to staffing, the coronavirus creates a compounding challenge.
As patient caseloads reach new highs, record numbers of hospital employees are themselves out sick with COVID-19 or temporarily forced to stop working because they have to quarantine after a possible exposure.
"But here's the kicker," said Dr. Alex Jahangir, who chairs Nashville's coronavirus task force. "They're not getting infected in the hospitals. In fact, hospitals for the most part are fairly safe. They're getting infected in the community."
Some states, like North Dakota, have already decided to allow COVID-positive nurses to keep working as long as they feel OK, a move that has generated backlash. The nursing shortage is so acute there that some traveling nurse positions posted pay of $8,000 a week. Some retired nurses and doctors were askedto consider returning to the workforce early in the pandemic, and at least 338 who were 65 or older have died of COVID-19.
In Tennessee, Gov. Bill Lee issued an emergency order loosening some regulatory restrictions on who can do what within a hospital, giving them more staffing flexibility.
For months, staffing in much of the country had been a concern behind the scenes. But it's becoming palpable to any patient.
Dr. Jessica Rosen is an emergency physician at St. Thomas Health in Nashville, where having to divert patients to other hospitals has been rare over the past decade. She said it's a common occurrence now.
"We have been frequently on diversion, meaning we don't take transfers from other hospitals," she said. "We try to send ambulances to other hospitals because we have no beds available."
Even the region's largest hospitals are filling up. This week, Vanderbilt University Medical Center made space in its children's hospital for non-COVID patients. Its adult hospital has more than 700 beds. And like many other hospitals, it has had the challenge of staffing two intensive care units — one exclusively for COVID patients and another for everyone else.
And patients are coming from as far away as Arkansas and southwestern Virginia.
"The vast majority of our patients now in the intensive care unit are not coming in through our emergency department," said Dr. Matthew Semler, a pulmonary specialist at VUMC who works with COVID patients.
"They're being sent hours away to be at our hospital because all of the hospitals between here and where they present to the emergency department are on diversion."
Semler said his hospital would typically bring in nurses from out of town to help. But there is nowhere to pull them from right now.
National provider groups are still moving personnel around, though increasingly it means leaving somewhere else short-staffed. Dr. James Johnson with the Nashville-based physician services company Envision has deployed reinforcements to Lubbock and El Paso, Texas, this month.
He said the country hasn't hit it yet, but there's a limit to hospital capacity.
"I honestly don't know where that limit is," he said.
At this point, the limitation won't be ventilators or protective gear, he said. In most cases, it will be the medical workforce. People power.
Johnson, an Air Force veteran who treated wounded soldiers in Afghanistan, said he's more focused than ever on trying to boost doctors' morale and stave off burnout. He's generally optimistic, especially after serving four weeks in New York City early in the pandemic.
"What we experienced in New York and happened in every episode since is that humanity rises to the occasion," he said.
But Johnson said the sacrifices shouldn't come just from the country's healthcare workers. Everyone bears a responsibility, he said, to try to keep themselves and others from getting sick in the first place.
As Black people face an onslaught of grief, stress and isolation triggered by a devastating pandemic and repeated instances of racial injustice, churches play a crucial role in addressing the mental health of their members and the greater community.
This article was published on Tuesday, December 1, 2020 in Kaiser Health News.
Wilma Mayfield used to visit a senior center in Durham, North Carolina, four days a week and attend Lincoln Memorial Baptist Church on Sundays, a ritual she's maintained for nearly half a century. But over the past 10 months, she's seen only the inside of her home, the grocery store and the pharmacy. Most of her days are spent worrying about COVID-19 and watching TV.
It's isolating, but she doesn't talk about it much.
When Mayfield's church invited a psychologist to give a virtual presentation on mental health during the pandemic, she decided to tune in.
The hourlong discussion covered COVID's disproportionate toll on communities of color, rising rates of depression and anxiety, and the trauma caused by police killings of Black Americans. What stuck with Mayfield were the tools to improve her own mental health.
"They said to get up and get out," she said. "So I did."
The next morning, Mayfield, 67, got into her car and drove around town, listening to 103.9 gospel radio and noting new businesses that had opened and old ones that had closed. She felt so energized that she bought chicken, squash and greens, and began her Thanksgiving cooking early.
"It was wonderful," she said. "The stuff that lady talked about [in the presentation], it opened up doors for me."
As Black people face an onslaught of grief, stress and isolation triggered by a devastating pandemic and repeated instances of racial injustice, churches play a crucial role in addressing the mental health of their members and the greater community. Religious institutions have long been havens for emotional support. But faith leaders say the challenges of this year have catapulted mental health efforts to the forefront of their mission.
Some are preaching about mental health from the pulpit for the first time. Others are inviting mental health professionals to speak to their congregations, undergoing mental health training themselves or adding more therapists to the church staff.
"COVID undoubtedly has escalated this conversation in great ways," said Keon Gerow, senior pastor at Catalyst Church in West Philadelphia. "It has forced Black churches — some of which have been older, traditional and did not want to have this conversation — to actually now have this conversation in a very real way."
At Lincoln Memorial Baptist, leaders who organized the virtual presentation with the psychologist knew that people like Mayfield were struggling but might be reluctant to seek help. They thought members might be more open to sensitive discussions if they took place in a safe, comfortable setting like church.
It's a trend that psychologist Alfiee Breland-Noble, who gave the presentation, has noticed for years.
Through her nonprofit organization, the AAKOMA Project, Breland-Noble and her colleagues often speak to church groups about depression, recognizing it as one of the best ways to reach a diverse segment of the Black community and raise mental health awareness.
This year, the AAKOMA Project has received clergy requests that are increasingly urgent, asking to focus on coping skills and tools people can use immediately, Breland-Noble said.
"After George Floyd's death, it became: 'Please talk to us about exposure to racial trauma and how we can help congregations deal with this,'" she said. "'Because this is a lot.'"
Across the country, mental health needs are soaring. And Black Americans are experiencing significant strain: A studyfrom the Centers for Disease Control and Prevention this summer found 15% of non-Hispanic Black adults had seriously considered suicide in the past 30 days and 18% had started or increased their use of substances to cope with pandemic-related stress.
Yet national data shows Blacks are less likely to receive mental health treatment than the overall population. A memo released by the Substance Abuse and Mental Health Services Administration this spring lists engaging faith leaders as one way to close this gap.
The Potter's House in Dallas has been trying to do that for years. A megachurch with more than 30,000 members, it runs a counseling center with eight licensed clinicians, open to congregants and the local community to receive counseling at no cost, though donations are accepted.
Since the pandemic began, the center has seen a 30% increase in monthly appointments compared with previous years, said center director Natasha Stewart. During the summer, when protests over race and policing were at their height, more Black men came to therapy for the first time, she said.
Recently, there's been a surge in families seeking services. Staying home together has brought up conflicts previously ignored, Stewart said.
"Before, people had ways to escape," she said, referring to work or school. "With some of those escapes not available anymore, counseling has become a more viable option."
To meet the growing demand, Stewart is adding a new counselor position for the first time in eight years.
At smaller churches, where funding a counseling center is unrealistic, clergy are instead turning to members of the congregation to address growing mental health needs.
At Catalyst Church, a member with a background in crisis management has begun leading monthly COVID conversations online. A deacon has been sharing his own experience getting therapy to encourage others to do the same. And Gerow, the senior pastor, talks openly about mental health.
Recognizing his power as a pastor, Gerow hopes his words on Sunday morning and in one-on-one conversations will help congregants seek the help they need. Doing so could reduce substance use and gun violence in the community, he said. Perhaps it would even lower the number of mental health crises that lead to police involvement, like the October death of Walter Wallace Jr., whose family said he was struggling with mental health issues when Philadelphia police shot him.
"If folks had the proper tools, they'd be able to deal with their grief and stress in different ways," Gerow said. "Prayer alone is not always enough."
Laverne Williams recognized that back in the '90s. She believed prayer was powerful, but as an employee of the Mental Health Association in New Jersey, she knew there was a need for treatment too.
When she heard pastors tell people they could pray away mental illness or use blessed oil to cure what seemed like symptoms of schizophrenia, she worried. And she knew many people of color were not seeing professionals, often due to barriers of cost, transportation, stigma and distrust of the medical system.
To address this disconnect, Williams created a video and PowerPoint presentation and tried to educate faith leaders.
At first, many clergy turned her away. People thought seeking mental health treatment meant your faith wasn't strong enough, Williams said.
But over time, some members of the clergy have come to realize the two can coexist, said Williams, adding that being a deacon herself has helped her gain their trust. This year alone, she's trained 20 faith leaders in mental health topics.
A program run by the Behavioral Health Network of Greater St. Louis is taking a similar approach. The Bridges to Care and Recovery program trains faith leaders in "mental health first aid," suicide prevention, substance use and more, through a 20-hour course.
The training builds on the work faith leaders are already doing to support their communities, said senior program manager Rose Jackson-Beavers. In addition to the tools of faith and prayer, clergy can now offer resources, education and awareness, and refer people to professional therapists in the network.
Since 2015, the program has trained 261 people from 78 churches, Jackson-Beavers said.
Among them is Carl Lucas, pastor of God First Church in northern St. Louis County who graduated this July — just in time, by his account.
Since the start of the pandemic, he has encountered two congregants who expressed suicidal thoughts. In one case, church leaders referred the person to counseling and followed up to ensure they attended therapy sessions. In the other, the root concern was isolation, so the person was paired with church members who could touch base regularly, Lucas said.
"The pandemic has definitely put us in a place where we're looking for answers and looking for other avenues to help our members," he said. "It has opened our eyes to the reality of mental health needs."
Dr. Jacqueline Chu considered the man with a negative coronavirus test on the other end of the phone, and knew, her heart dropping, that the test result was not enough to clear him for work.
The man was a grocery store clerk — an essential worker — and the sole earner for his family. A 14-day isolation period would put him at risk of getting fired or not having enough money to make rent that month. But he had just developed classic COVID-19 symptoms, and many others around him in Chelsea, Massachusetts, had confirmed cases. Even with the negative test, his chances of having the disease were too high to dismiss.
For many Americans, including clinicians like Chu, who specializes in primary care and infectious disease at Massachusetts General Hospital, the pandemic has forced difficult conversations about the limits of medical tests. It has also revealed the catastrophic harms of failing to recognize those limits.
"People think a positive test equals disease and a negative test equals not disease," said Dr. Deborah Korenstein, who heads the general medicine division at Memorial Sloan Kettering Cancer Center in New York City. "We've seen the damage of that in so many ways with COVID."
National COVID test shortages have emphasized testing's critical role in containing and mitigating the pandemic, but these inconvenient truths remain: A test result is rarely a definitive answer, but instead a single clue at one point in time, to be appraised alongside other clues like symptoms and exposure to those with confirmed cases. The result itself may be falsely positive or negative, or may show an abnormality that doesn't matter. And even an accurate, meaningful test result is useless (or worse) unless it's acted on appropriately.
These lessons are not unique to COVID-19.
Last year, David Albanese logged in to the online patient portal for his primary care doctor's office and discovered that his routine screening test for the hepatitis C virus showed a positive result.
"I never considered myself somebody who's in a high-risk category," said the 34-year-old Boston-area college administrator and adjunct history professor. "But I just know that for a couple of days, I was really, really anxious about this test. I didn't know if I should be behaving differently based on it."
Within days, a confirmatory test showed Albanese did not actually have the potentially severe yet curable liver infection. Still, the memory of that false positive result gave him a new perspective on testing writ large. He had been skeptical of recommendations shifting breast cancer screening to older ages to reduce the psychological toll of false positives, but he said they made more sense after his own testing drama.
"'Isn't it better to do the screening regardless?'" he said he used to think. "Now I realize it is a little more complicated."
These false positives are especially common for screening tests like hepatitis C antibody tests and mammograms that look for medical problems in healthy people without symptoms. They are designed to cast a wide net that catches more people with the disease, known as the test's sensitivity, but also risks catching some without it, which lowers what is known as the test's specificity.
Though some degree of uncertainty is inherent in all medical decisions, clinicians often fail to share this with patients because it's complicated to explain and unsettling and leaves doctors vulnerable to seeming uninformed, said Korenstein. What's more, doctors are trained to seek definitive answers and can themselves struggle to think in probabilities.
"High-tech diagnostic testing has led to this mirage of certainty," said Korenstein. "Back in the day before there were MRIs and what not, I think, doctors were more cognizant of how often they were uncertain."
Enter COVID. Coupled with genuine uncertainty about an emerging disease and a political environment that has sown misinformation and rendered science partisan, the nuances of testing are too often lost at a time when they are particularly crucial to convey.
Dr. Jasmine Marcelin, who specializes in infectious disease at the University of Nebraska Medical Center, was concerned to see Nebraskans tested at statewide facilities get "inconsistent results without a lot of guidance or explanation about what these results might mean." When she offers COVID testing, she said, she approaches it as she does any other medical decision, starting with a simple question: "What do you want to learn from this test?"
To answer this, it helps to know something about how coronavirus tests work and how well they do their jobs.
Many of the available tests are meant to tell you if you're infected right now. For example, polymerase chain reaction tests like the one Chu's patient received detect small traces of genetic material from the virus. But by some estimates, those tests have a false negative rate of up to 30%, meaning 3 out of 10 people who truly have the infection will test negative. This rate also varies based on who collects the sample, from which part of the body and when in the course of a possible infection.
Antigen tests look for viral proteins and are faster to analyze than the PCR, but also less accurate.
To know if you've already had COVID-19, the closest you can get is the COVID antibody test. But the too-common interpretation is black and white: I had COVID, or I didn't. Here, again, the reality is more nuanced. The test checks your blood for antibodies — your immune system's soldiers in the fight against the coronavirus. A negative antibody test could mean you were never infected with SARS-CoV-2, or it could mean that you're currently infected but haven't yet built up that army, or that these defenses have already faded away.
A positive test, on the other hand, may have mistakenly detected antibodies to another, similar-looking virus. And even if the test correctly shows you had COVID-19, it's not yet clear if this means you're protected from reinfection.
Yet, these shades of gray are difficult to internalize. Roy Avellaneda, the 49-year-old president of the Chelsea City Council, got the antibody test out of curiosity and could not help but see his positive result as what he called an immunity pass. "I can act a little bit cavalier with it now," he said. "Yes, I'll continue to wear a mask and so forth, but the fear is gone."
Korenstein said that's a common though worrisome reaction. "It's really hard to expect the public to have a more nuanced understanding when even doctors don't," she said.
Some of the uncertainty around COVID testing has abated as researchers learn more about the new disease. Early in the pandemic, healthcare providers retested patients with confirmed cases, looking for a negative PCR test to prove they were no longer infectious. But soon, epidemiologists discovered that a COVID patient rarely infected others 10 or more days after first developing symptoms (or 20, in severe cases), even if the PCR test was picking up traces of the — presumably dead — virus weeks or even months after initial infection. So the Centers for Disease Control and Prevention and health systems adjusted their policies to clear patients on the basis of time rather than a negative test.
But while the desire for certainty in coronavirus testing is magnified by the rampant uncertainty in other facets of pandemic life, this is simply not something most medical tests can provide.
The Trump administration relied on an unusual maneuver that allowed executives to keep investments in drug companies that would benefit from the government's pandemic efforts.
April 16 was a big day for Moderna, a Massachusetts biotech company on the verge of becoming a front-runner in the U.S. government's race for a coronavirus vaccine. It had received roughly half a billion dollars in federal funding to develop a COVID shot that might be used on millions of Americans.
Thirteen days after the massive infusion of federal cash — which triggered a jump in the company's stock price — Moncef Slaoui, a Moderna board member and longtime drug industry executive, was awarded options to buy 18,270 shares in the company, according to Securities and Exchange Commission filings. The award added to 137,168 options he'd accumulated since 2018, the filings show.
It wouldn't be long before President Donald Trump announced Slaoui as the top scientific adviser for the government's $12 billion Operation Warp Speed program to rush COVID vaccines to market. In his Rose Garden speech on May 15, Trump lauded Slaoui as "one of the most respected men in the world" on vaccines.
The Trump administration relied on an unusual maneuver that allowed executives to keep investments in drug companies that would benefit from the government's pandemic efforts: They were brought on as contractors, doing an end run around federal conflict-of-interest regulations in place for employees. That has led to huge potential payouts — some already realized, according to a KHN analysis of SEC filings and other government documents.
Slaoui owned 137,168 Moderna stock options worth roughly $7 million on May 14, one day before Trump announced his senior role to help shepherd COVID vaccines. The day of his appointment, May 15, he resigned from Moderna's board. Three days later, on May 18, following the company's announcement of positive results from early-stage clinical trials, the options' value shot up to $9.1 million, the analysis found. The Department of Health and Human Services said Slaoui sold his holdings May 20, when they would have been worth about $8 million, and will donate certain profits to cancer research. Separately, Slaoui held nearly 500,000 shares in GlaxoSmithKline, where he worked for three decades, upon retiring in 2017, according to corporate filings.
Carlo de Notaristefani, an Operation Warp Speed adviser and former senior executive at Teva Pharmaceuticals, owned 665,799 shares of the drug company's stock as of March 10. While Teva is not a recipient of Warp Speed funding, Trump promoted its antimalarial drug hydroxychloroquine as a COVID treatment, even with scant evidence that it worked. The company donated millions of tablets to U.S. hospitals and the drug received emergency use authorization from the Food and Drug Administration in March. In the following weeks, its share price nearly doubled.
Two other Operation Warp Speed advisers working on therapeutics, Drs. William Erhardt and Rachel Harrigan, own financial stakes of unknown value in Pfizer, which in July announced a $1.95 billion contract with HHS for 100 million doses of its vaccine. Erhardt and Harrigan were previously Pfizer employees.
"With those kinds of conflicts of interest, we don't know if these vaccines are being developed based on merit," said Craig Holman, a lobbyist for Public Citizen, a liberal consumer advocacy group.
An HHS spokesperson said the advisers are in compliance with the relevant federal ethical standards for contractors.
These investments in the pharmaceutical industry are emblematic of a broader trend in which a small group with the specialized expertise needed to inform an effective government response to the pandemic have financial stakes in companies that stand to benefit from the government response.
Slaoui maintained he was not in discussions with the federal government about a role when his latest batch of Moderna stock options was awarded, telling KHN he met with HHS Secretary Alex Azar and was offered the position for the first time May 6. The stock options awarded in late April were canceled as a result of his departure from the Moderna board in May, he said. According to the KHN analysis of his holdings, the options would have been worth more than $330,000 on May 14.
HHS declined to confirm that timeline.
The fate of Operation Warp Speed after President-elect Joe Biden takes office is an open question. While Democrats in Congress have pursued investigations into Warp Speed advisers and the contracting process under which they were hired, Biden hasn't publicly spoken about the program or its senior leaders. Spokespeople for the transition didn't respond to a request for comment.
The four HHS advisers were brought on through a National Institutes of Health contract with consulting firm Advanced Decision Vectors, so far worth$1.4 million, to provide expertise on the development and production of vaccines, therapies and other COVID products, according to the federal government's contracts database.
Slaoui's appointment in particular has rankled Democrats and organizations like Public Citizen. They say he has too much authority to be classified as a consultant. "It is inevitable that the position he is put in as co-chair of Operation Warp Speed makes him a government employee," Holman said.
The incoming administration may have a window to change the terms under which Slaoui was hired before his contract ends in March. Yet making big changes to Operation Warp Speed could disrupt one of the largest vaccination efforts in history while the American public anxiously awaits deliverance from the pandemic, which is breaking daily records for new infections. Warp Speed has set out to buy and distribute 300 million doses of a COVID vaccine, the first ones by year's end.
"By the end of December we expect to have about 40 million doses of these two vaccines available for distribution," Azar said Nov. 18, referring to front-runner vaccines from Pfizer and Moderna.
Azar maintained that Warp Speed would continue seamlessly even with a "change in leadership." "In the event of a transition, there's really just total continuity that would occur," the secretary said.
Pfizer, which didn't receive federal funds for research but secured the multibillion-dollar contract under Warp Speed, on Nov. 20 sought emergency authorization from the FDA; Moderna announced on Monday it would do so. In total, Moderna received nearly $1 billion in federal funds for development and a $1.5 billion contract with HHS for 100 million doses.
While it's impossible to peg the precise value of Slaoui's Moderna holdings without records of the sale transactions, KHN estimated their worth by evaluating the company's share prices on the dates he received the options and the stock's price on several key dates — including May 14, the day before his Warp Speed position was announced, and May 20.
However, the timing of Slaoui's divestment of his Moderna shares — five days after he resigned from the company's board — meant he did not have to file disclosures with the SEC confirming the sale, even though he was privy to insider information when he received the stock options, experts in securities law said. That weakness in securities law, according to good-governance experts, deprives the public of an independent source of information about the sale of Slaoui's stake in the company.
"You would think there would be kind of a one-year continuing obligation [to disclose the sale] or something like that," said Douglas Chia, president of Soundboard Governance and an expert on corporate governance issues. "But there's not."
HHS declined to provide documentation confirming that Slaoui sold his Moderna holdings. His investments in London-based GlaxoSmithKline — which is developing a vaccine with French drugmaker Sanofi and received $2.1 billion from the U.S. government — will be used for his retirement, Slaoui has said.
"I have always held myself to the highest ethical standards, and that has not changed upon my assumption of this role," Slaoui said in a statement released by HHS. "HHS career ethics officers have determined my contractor status, divestures and resignations have put me in compliance with the department's robust ethical standards."
Moderna, in an earlier statement to CNBC, said Slaoui divested "all of his equity interest in Moderna so that there is no conflict of interest" in his new role. However, the conflict-of-interest standards for Slaoui and other Warp Speed advisers are less stringent than those for federal employees, who are required to give up investments that would pose a conflict of interest. For instance, if Slaoui had been brought on as an employee, his stake from a long career at GlaxoSmithKline would be targeted for divestment.
Instead, Slaoui has committed to donating certain GlaxoSmithKline financial gains to the National Institutes of Health.
Offering Warp Speed advisers contracts might have been the most expedient course in a crisis.
"As the universe of potential qualified candidates to advise the federal government's efforts to produce a COVID-19 vaccine is very small, it is virtually impossible to find experienced and qualified individuals who have no financial interests in corporations that produce vaccines, therapeutics, and other lifesaving goods and services," Sarah Arbes, HHS' assistant secretary for legislation and a Trump appointee, wrote in September to Rep. James Clyburn (D-S.C.), who leads a House oversight panel on the coronavirus response.
That includes multiple drug industry veterans working as HHS advisers, an academic who's overseeing the safety of multiple COVID vaccines in clinical trials and sits on the board of Gilead Sciences, and even former government officials who divested stocks while they were federal employees but have since joined drug company boards.
Dr. Scott Gottlieb and Dr. Mark McClellan, former FDA commissioners, have been visible figures informally advising the federal response. Each sits on the board of a COVID vaccine developer.
After leaving the FDA in 2019, Gottlieb joined Pfizer's board and has bought 4,000 of its shares, at the time worth more than $141,000, according to SEC filings. As of April, he had additional stock units worth nearly $352,000 that will be cashed out should he leave the board, according to corporate filings. As a board member, Gottlieb is required to own a certain number of Pfizer shares.
McClellan has been on Johnson & Johnson's board since 2013 and earned $1.2 million in shares under a deferred-compensation arrangement, corporate filings show.
The two also receive thousands of dollars in cash fees annually as board members. Gottlieb and McClellan frequently disclose their corporate affiliations, but not always. Their Sept. 13 Wall Street Journal op-ed on how the FDA could grant emergency authorization of a vaccine identified their FDA roles and said they were on the boards of companies developing COVID vaccines but failed to name Pfizer and Johnson & Johnson. Both companies would benefit financially from such a move by the FDA.
"It isn't a lower standard for FDA approval," they wrote in the piece. "It's a more tailored, flexible standard that helps protect those who need it most while developing the evidence needed to make the public confident about getting a Covid-19 vaccine."
About the inconsistency, Gottlieb wrote in an email to KHN: "My affiliation to Pfizer is widely, prominently, and specifically disclosed in dozens of articles and television appearances, on my Twitter profile, and in many other places. I mention it routinely when I discuss Covid vaccines and I am proud of my affiliation to the company."
A spokesperson for the Duke-Margolis Center for Health Policy, which McClellan founded, noted that other Wall Street Journal op-eds cited his Johnson & Johnson role and that his affiliations are mentioned elsewhere. "Mark has consistently informed the WSJ about his board service with Johnson & Johnson, as well as other organizations," Patricia Shea Green said.
Johnson & Johnson's vaccine is in phase 3 clinical trials and could be available in early 2021.
Still, while they worked for the FDA, Gottlieb and McClellan were subject to federal restrictions on investments and protections against conflicts of interest that aren't in place for Warp Speed advisers.
According to the financial disclosure statements they signed with HHS, the advisers are required to donate certain stock profits to the NIH — but can do so after the stockholder dies. They can keep investments in drug companies, and the restrictions don't apply to stock options, which give executives the right to buy company shares in the future.
"This is a poorly drafted agreement," said Jacob Frenkel, an attorney at Dickinson Wright and former SEC lawyer, referring to the conflict-of-interest statement included in the NIH contract with Advanced Decision Vectors, the Warp Speed advisers' employing consulting firm. He said documents could have been "tighter and clearer in many respects," including prohibiting the advisers from exercising their options to buy shares while they are contractors.
De Notaristefani stepped down as Teva's executive vice president of global operations in October 2019, but according to corporate filings he would remain with the company until the end of June 2020 in order to "ensure an orderly transition." He's been working with Warp Speed since at least May overseeing manufacturing, according to an HHS spokesperson.
When Erhardt left Pfizer in May, U.S. COVID infections were climbing and the company was beginning vaccine clinical trials. Erhardt and Harrigan, whose LinkedIn profile says she left Pfizer in 2010, have worked as drug industry consultants.
"Ultimately, conflicts of interest in ethics turn on the mindset behavior of the responsible persons," said Frenkel, the former SEC attorney. "The public wants to know that it can rely on the effectiveness of the therapeutic or diagnostic product without wondering if a recommendation or decision was motivated for even the slightest reason other than product effectiveness and public interest."
Workplace safety regulators have taken a lenient stance toward employers during the pandemic, giving them broad discretion to decide internally whether to report worker deaths.
This article was published on Monday, November 30, 2020 in Kaiser Health News.
As Walter Veal cared for residents at the Ludeman Developmental Center in suburban Chicago, he saw the potential future of his grandson, who has autism.
So he took it on himself not just to bathe and feed the residents, which was part of the job, but also to cut their hair, run to the store to buy their favorite body wash and barbecue for them on holidays.
"They were his second family," said his wife, Carlene Veal.
Even after COVID-19 struck in mid-March and cases began spreading through the government-run facility, which serves nearly 350 adults with developmental disabilities, Walter was determined to go to work, Carlene said.
Staff members were struggling to acquire masks and other personal protective equipment at the time, many asking family members for donations and wearing rain ponchos sent by professional baseball teams.
All Walter had was a pair of gloves, Carlene said.
By mid-May, rumors of some sick residents and staffers had turned into 274 confirmed positive COVID tests, according to the Illinois Department of Human Services COVID tracking site. On May 16, Walter, 53, died of the virus. Three of his colleagues had already passed, according to interviews with Ludeman workers, the deceased employees' families and union officials.
State and federal laws say facilities like Ludeman are required to alert Occupational Safety and Health Administration officials about work-related employee deaths within eight hours. But facility officials did not deem the first staff death on April 13 work-related, so they did not report it. They made the same decision about the second and third deaths. And Walter's.
It's a pattern that's emerged across the nation, according to a KHN review of hundreds of worker deaths detailed by family members, colleagues and local, state and federal records.
Workplace safety regulators have taken a lenient stance toward employers during the pandemic, giving them broad discretion to decide internally whether to report worker deaths. As a result, scores of deaths were not reported to occupational safety officials from the earliest days of the pandemic through late October.
KHN and The Guardian are tracking health care workers who died from COVID-19 and writing about their lives and what happened in their final days.
KHN examined more than 240 deaths of health care workers profiled for theLost on the Frontline project and found that employers did not report more than one-third of them to a state or federal OSHA office, many based on internal decisions that the deaths were not work-related — conclusions that were not independently reviewed.
Work-safety advocates say OSHA investigations into staff deaths can help officials pinpoint problems before they endanger other employees as well as patients or residents. Yet, throughout the pandemic, health care staff deaths have steadily climbed. Thorough reviews could have also prompted the Department of Labor, which oversees OSHA, to urge the White House to address chronic protective gear shortages or sharpen guidance to help keep workers safe.
Since no public agency releases the names of health care workers who die of COVID-19, a team of reporters building the Lost on the Frontline database has scoured local news stories, GoFundMe campaigns, and obituary and social media sites to identify nearly 1,400 possible cases. More than 260 fatalities have been vetted with families, employers and public records.
For this investigation, journalists examined worker deaths at more than 100 health care facilities where OSHA records showed no fatality investigation was underway.
At Ludeman, the circumstances surrounding the April 13 worker death might have shed light on the hazards facing Veal. But no state work safety officials showed up to inspect — because the Department of Human Services, which operates Ludeman and employs the staff, said it did not report any of the four deaths there to Illinois OSHA.
The department said "it could not determine the employees contracted COVID-19 at the workplace" — despite its being the site of one of the largest U.S. outbreaks. Since Veal's death in May, dozens more workers have tested positive for COVID-19, according to DHS' COVID tracking site.
OSHA inspectors monitor local news media and sometimes will open investigations even without an employer's fatality report. Through Nov. 5, federal OSHA offices issued 63 citations to facilities for failing to report a death. And when inspectors do show up, they often force improvements — requiring more protective equipment for workers and better training on how to use it, files reviewed by KHN show.
Still, many deaths receive little or no scrutiny from work-safety authorities. In California, public health officials have documented about 200 health care worker deaths. Yet the state's OSHA office received only 75 fatality reports at health care facilities through Oct. 26, Cal/OSHA records show.
Nursing homes, which are under strict Medicare requirements, reported more than 1,000 staff deaths through mid-October, but only about 350 deaths of long-term care facility workers appear to have been reported to OSHA, agency records show.
Workers whose deaths went unreported include some who took painstaking precautions to avoid getting sick and passing the virus to family members: One California lab technician stayed in a hotel during the workweek. An Arizona nursing home worker wore a mask for family movie nights. A Nevada nurse told his brother he didn't have adequate PPE. Nevada OSHA confirmed to KHN that his death was not reported to the agency and that officials would investigate.
KHN asked health care employers why they chose not to report fatalities. Some cited the lack of proof that a worker was exposed on-site, even in workplaces that reported a COVID outbreak. Others cited privacy concerns and gave no explanation. Still others ignored requests for comment or simply said they had followed government policies.
"It is so disrespectful of the agencies and the employers to shunt these cases aside and not do everything possible to investigate the exposures," said Peg Seminario, a retired union health and safety director who co-authored a study on OSHA oversight with scholars from Harvard's T.H. Chan School of Public Health.
A Department of Labor spokesperson said in a statement that an employer must report a fatality within eight hours of knowing the employee died and after determining the cause of death was a work-related case of COVID-19.
The department said employers also are bound to report a COVID death if it comes within 30 days of a workplace incident — meaning exposure to COVID-19.
Yet pinpointing exposure to an invisible virus can be difficult, with high rates of pre-symptomatic and asymptomatic transmission and spread of the virus just as prevalent inside a hospital COVID unit as out.
Those challenges, plus May guidance from OSHA, gave employers latitude to decide behind closed doors whether to report a case. So it's no surprise that cases are going unreported, said Eric Frumin, who has testified to Congress on worker safety and is health and safety director for Change to Win, a partnership of seven unions.
"Why would an employer report unless they feel for some reason they're socially responsible?" Frumin said. "Nobody's holding them to account."
Downside of Discretion
OSHA's guidance to employers offered pointers on how to decide whether a COVID death is work-related. It would be if a cluster of infections arose at one site where employees work closely together "and there is no alternative explanation." If a worker had close contact with someone outside of work infected with the virus, it might not have been work-related, the guidance says.
Ultimately, the memo says, if an employer can't determine that a worker "more likely than not" got sick on the job, "the employer does not need to record that."
In mid-March, the union that represented Paul Odighizuwa, a food service worker at Oregon Health & Science University, raised concerns with university management about the virus possibly spreading through the Food and Nutrition Services Department.
Workers there — those taking meal orders, preparing food, picking up trays for patient rooms and washing dishes — were unable to keep their distance from one another, said Michael Stewart, vice president of the American Federation of State, County and Municipal Employees Local 328, which represents about 7,000 workers at OHSU. Stewart said the union warned administrators they were endangering people's lives.
Soon the virus tore through the department, Stewart said. At least 11 workers in food service got the virus, the union said. Odighizuwa, 61, a pillar of the local Nigerian community, died on May 12.
OHSU did not report the death to the state's OSHA and defended the decision, saying it "was determined not to be work-related," according to a statement from Tamara Hargens-Bradley, OHSU's interim senior director of strategic communications.
She said the determination was made "[b]ased on the information gathered by OHSU's Occupational Health team," but she declined to provide details, citing privacy issues.
Stewart blasted OHSU's response. When there's an outbreak in a department, he said, it should be presumed that's where a worker caught the virus.
"We have to do better going forward," Stewart said. "We have to learn from this." Without an investigation from an outside regulator like OSHA, he doubts that will happen.
Stacy Daugherty heard that Oasis Pavilion Nursing and Rehabilitation Center in Casa Grande, Arizona, was taking strict precautions as COVID-19 surged in the facility and in Pinal County, almost halfway between Phoenix and Tucson.
Her father, a certified nursing assistant there, was also extra cautious: He believed that if he got the virus, "he wouldn't make it," Daugherty said.
Mark Daugherty, a father of five, confided in his youngest son when he fell ill in May that he believed he contracted the coronavirus at work, his daughter said in a message to KHN.
Early in June, the facility filed its first public report on COVID cases to Medicare authorities: Twenty-three residents and eight staff members had fallen ill. It was one of the largest outbreaks in the state. (Medicare requires nursing homes to report staff deaths each week in a process unrelated to OSHA.)
By then, Daugherty, 60, was fighting for his life, his absence felt by the residents who enjoyed his banjo, accordion and piano performances. But the country's occupational safety watchdog wasn't called in to figure out whether Daugherty, who died June 19, was exposed to the virus at work. His employer did not report his death to OSHA.
"We don't know where Mark might have contracted COVID 19 from, since the virus was widespread throughout the community at that time. Therefore there was no need to report to OSHA or any other regulatory agencies," Oasis Pavilion's administrator, Kenneth Opara, wrote in an email to KHN.
Since then, 15 additional staffers have tested positive and the facility suspects a dozen more have had the virus, according to Medicare records.
Gaps in the Law
If Oasis Pavilion needed another reason not to report Daugherty's death, it might have had one. OSHA requiresnotice of a death only within 30 days of a work-related incident. Daugherty, like many others, clung to life for weeks before he died.
That is one loophole — among others — in work-safety laws that experts say could use a second look in the time of COVID-19.
In addition, federal OSHA rules don't apply to about 8 million public employees. Only government workers in states with their own state OSHA agency are covered. In other words, in about half the country if a government employee dies on the job — such as a nurse at a public hospital in Florida, or a paramedic at a fire department in Texas — there's no requirement to report it and no one to look into it.
So there was little chance anyone from OSHA would investigate the deaths of two health workers early this year at Central State Hospital in Georgia — a state-run psychiatric facility in a state without its own worker-safety agency.
On March 24, a manager at the facility had warned staff they "must not wear articles of clothing, including Personal Protective Equipment" that violate the dress code, according to an email KHN obtained through a public records request.
Three days later, what had started as a low-grade illness for Mark DeLong, a licensed practical nurse at the facility, got serious. His cough was so severe late on March 27 that he called 911 — and handed the phone to his wife, Jan, because he could barely speak, she said.
She went to visit him in the hospital the next day, fully expecting a pleasant visit with her karaoke partner. "By the time I got there it was too late," she said. DeLong, 53 "had passed."
She learned after his death that he'd had COVID-19.
Back at the hospital, workers had been frustrated with the early directive that employees should not wear their own PPE.
Bruce Davis had asked his supervisors if he could wear his own mask but was told no because it wasn't part of the approved uniform, according to his wife, Gwendolyn Davis. "He told me 'They don't care,'" she said.
Two days after DeLong's death, the directive was walked back and employees and contractors were informed they could "continue and are authorized to wear Personal Protective Gear," according to a March 30 email from administrators. But Davis, a Pentecostal pastor and nursing assistant supervisor, was already sick. Davis worked at the hospital for 27 years and saw little distinction between the love he preached at the altar and his service to the patients he bathed, fed and cared for, his wife said.
Sick with the virus, Davis died April 11.
At the time, 24 of Central State's staffers had tested positive, according to the Georgia Department of Behavioral Health and Developmental Disabilities, which runs the facility. To date, nearly 100 staffers and 33 patients at Central State have gotten the virus, according to figuresfrom the state agency.
"I don't think they knew what was going on either," Jan DeLong said. "Somebody needs to check into it."
In response to questions from KHN, a spokesperson for the department provided a prepared statement: "There was never a ban on commercially available personal protective equipment, even if the situation did not call for its use according to guidelines issued by the Centers for Disease Control and Prevention and the Georgia Department of Public Health at the time."
KHN reviewed more than a dozen other health worker deaths at state or local government workplaces in states like Texas, Florida and Missouri that went unreported to OSHA for the same reason — the facilities were run by government agencies in a state without its own worker safety agency.
Inside Ludeman
In mid-March, staff members at the Ludeman Developmental Center were desperate for PPE. The facility was running low on everything from gloves and gowns to hand sanitizer, according to interviews with current and former workers, families of deceased workers, and union officials.
Due to a national shortage at the time, surgical masks went only to staffers working with known positive cases, said Anne Irving, regional director for AFSCME Council 31, the union that represents Ludeman employees.
Residents in the Village of Park Forest, Illinois, where the facility is located, tried to help by sewing masks or pivoting their businesses to produce face shields and hand sanitizer, said Mayor Jonathan Vanderbilt. But providing enough supplies for more than 900 Ludeman employees proved difficult.
Michelle Abernathy, 52, a newly appointed unit director, bought her own gloves at Costco. In late March, a resident on Abernathy's unit showed symptoms, said Torrence Jones, her fiancé who also works at the facility. Then Abernathy developed a fever.
When she died on April 13 — the first known Ludeman staff member lost to the pandemic — the Illinois Department of Human Services, which runs Ludeman, made no report to safety regulators. After seeing media reports, Illinois OSHA sent the agency questions about Abernathy's daily duties and working conditions. Based on DHS' responses and subsequent phone calls, state OSHA officials determined Abernathy's death was "not work-related."
Barbara Abernathy, Michelle's mom, doesn't buy it. "Michelle was basically a hermit," she said, going only from work to home. She couldn't have gotten the virus anywhere else, she said. In response to OSHA's inquiry for evidence that the exposure was not related to her workplace, her employer wrote "N/A," according to documents reviewed by KHN.
Two weeks after Abernathy's passing, two more employees died: Cephus Lee, 59, and Jose Veloz III, 52. Both worked in support services, boxing food and delivering it to the 40 buildings on campus. Their deaths were not reported to Illinois OSHA.
Veloz was meticulous at home, having groceries delivered and wiping down each item before bringing it inside, said his son, Joseph Ricketts.
But work was another story. Maintaining social distance in the food prep area was difficult, and there was little information on who had been infected or exposed to the virus, according to his son.
"No matter what my dad did, he was screwed," Ricketts said. Adding, he thought Ludeman did not do what it should have done to protect his dad on the job.
A March 27 complaint to Illinois OSHA said it took a week for staff to be notified about multiple employees who tested positive, according to documents obtained by the Documenting COVID-19 project at the Brown Institute for Media Innovation and shared with KHN. An early April complaint was more frank: "Lives are endangered," it said.
That's how Rose Banks felt when managers insisted she go to work, even though she was sick and awaiting a test result, she said. Her husband, also a Ludeman employee, had already tested positive a week earlier.
Banks said she was angry about coming in sick, worried she might infect co-workers and residents. After spending a full day at the facility, she said, she came home to a phone call saying her test was positive. She's currently on medical leave.
With some Ludeman staff assigned to different homes each shift, the virus quickly traveled across campus. By mid-May, 76 staff and 198 residents had tested positive, according to DHS' COVID tracking site.
Carlene Veal said her husband, Walter, was tested at the facility in late April. But by the time he got the results weeks later, she said, he was already dying.
Carlene can still picture the last time she saw Walter, her high school sweetheart and a man she called her "superhero" for 35 years of marriage and raising four kids together. He was lying on a gurney in their driveway with an oxygen mask on his face, she said. He pulled the mask down to say "I love you" one last time before the ambulance pulled away.
The Illinois Department of Human Services said that, since the beginning of the pandemic, it has implemented many new protocols to mitigate the outbreak at Ludeman, working as quickly as possible based on what was known about the virus at the time. It has created an emergency staffing plan, identified negative-airflow spaces to isolate sick individuals and made "extensive efforts" to procure more PPE, and it is testing all staffers and residents regularly.
"We were deeply saddened to lose four colleagues who worked at Ludeman Developmental Center and succumbed to the virus," the agency said in a statement. "We are committed to complying with and following all health and safety guidelines for COVID-19."
The number of new cases at Ludeman has remained low for several months now, according to DHS' COVID tracking site.
But that does little to console the families of those who have died.
When a Ludeman supervisor called Barbara Abernathy in June to express condolences and ask if there was anything they could do, Abernathy didn't know how to respond.
"There was nothing they could do for me now," she said. "They hadn't done what they needed to do before."
Shoshana Dubnow, Anna Sirianni, Melissa Bailey and Hannah Foote contributed to this report.