In Face of COVID Threat, More Dialysis Patients Bring Treatment Home

NIPOMO, Calif. — After Maria Duenas was diagnosed with Type 2 diabetes about a decade ago, she managed the disease with diet and medication.

But Duenas’ kidneys started to fail just as the novel coronavirus established its lethal foothold in the U.S.

On March 19, three days after Duenas, 60, was rushed to the emergency room with dangerously high blood pressure and blood sugar, Gov. Gavin Newsom implemented the nation’s first statewide stay-at-home order.

Less than one week later, Duenas was hooked up to a dialysis machine in the Century City neighborhood of Los Angeles, 160 miles from her Central Coast home, where tubes, pumps and tiny filters cleansed her blood of waste for 3½ hours, doing the work her kidneys could no longer do.

In the beginning, Duenas said she didn’t understand the severity of COVID-19, or her increased vulnerability to it. “It’s not going to happen to me,” she thought. “We’re in a small little town.”

But she was unable to find a spot in a dialysis clinic in, or near, Nipomo. So, with her husband, Jose, at her side, Duenas made long road trips to Century City for more than two months.

In May, Duenas’ doctor told her she was a good candidate for home dialysis, which would save her drive time and stress — and reduce her exposure to the virus.

Now, Duenas assiduously sterilizes herself and her surroundings five nights a week so she can administer dialysis to herself at home while she sleeps.

“There’s always a chance going in that somebody’s going to have COVID and still need dialysis” in a clinic, Duenas said. “I’m very grateful to have this option.”

The increase in home dialysis has accelerated recently, spurred by social-distancing requirements, increased use of telehealth and remote monitoring technologies — and fear of the virus.

While recent, comprehensive data is hard to come by, experts confirm the trend based on what they’re seeing in their own practices. Fresenius Medical Care North America, one of the country’s two dominant dialysis providers, said it conducted 25% more home dialysis training sessions in the first quarter of 2020 than in the same period last year, according to Renal & Urology News.

“People recognized it would be better if they did it at home,” said Dr. Susan Quaggin, president-elect of the American Society of Nephrology. “And certainly from a health provider’s perspective, we feel it’s a great option.”

Nearly half a million people in the United States are on dialysis, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Roughly 85% of them travel to a clinic for their treatments.

Dialysis patients are at higher risk of contracting COVID-19 and getting seriously ill with it, said Dr. Anjay Rastogi, director of the UCLA CORE Kidney Program, where Duenas is a patient.

In an analysis of more than 10,000 deaths in 15 states and New York City, the Centers for Disease Control and Prevention found about 40% of people killed by COVID-19 had diabetes. That percentage rose to half among people under 65.

But people on dialysis are also vulnerable to COVID-19 because they usually visit dialysis clinics two to three times a week for an average of four hours at a time, exposing themselves to other patients and, potentially, the virus, Rastogi said.

“Now even more so, we are strongly urging our patients to consider home dialysis,” he said.

There are two kinds of dialysis: hemodialysis and peritoneal dialysis. In hemodialysis, which is administered in a hospital or clinic, or sometimes at home, a dialysis machine pumps blood out of the body and through a special filter called a dialyzer, which clears waste and extra fluid from the blood before it is returned to the body.

Dialysis treatment centers that offer hemodialysis have intensified their infection-control procedures in response to COVID-19, said Dr. Kevin Stiles, a nephrologist at Kaiser Permanente in Bakersfield. Visitors are no longer allowed to accompany patients, and patients get temperature checks and must wear masks during treatment, he said. (KHN, which produces California Healthline, is not affiliated with Kaiser Permanente.)

In peritoneal dialysis, which is the more popular home option because it is less cumbersome and restrictive, the inside lining of the stomach acts as a natural filter. Dialysis solution cleanses waste from the body as it is washed into and out of the stomach through a catheter in the abdomen.

Not everyone is eligible for home dialysis, which comes with its own challenges.

Home dialysis requires patients or their caregivers to lift bags of dialysis solution that weigh 5 to 10 pounds, Stiles said. Good eyesight and hand dexterity are also critical because patients must be able to maintain sterile environments.

Home patients need dialysis equipment and regular deliveries of supplies such as dialysis fluid, drain bags, tubing, disinfectant and personal protective equipment. In response to COVID-19, some clinics have arranged courier services and contracted with labs to deliver supplies to patients.

The Trump administration has encouraged greater use of home dialysis and in July proposed increasing Medicare reimbursement rates for home dialysis machines, citing “the importance that this population stay at home during the public health emergency to reduce risk of exposure to the virus.”

Medicare covers almost all patients who receive dialysis treatment, including home dialysis, and patients typically pay 20% as coinsurance.

Medicare, which spends an average of $90,000 per hemodialysis patient annually, spent more than $35 billion on patients with end-stage renal disease in 2016.

Duenas is awaiting a kidney transplant. Until she finds a match, she’ll be administering her own peritoneal dialysis at home.

“To be honest, I didn’t want to do it,” she said of home dialysis. “It was scary having to think about taking care of my own treatment.”

Now, three months later, guided by training and the prompts on the dialysis machine, Duenas feels comfortable, capable and safe.

Looking back, she said, “it was a blessing in disguise.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Lack of Antigen Test Reporting Leaves Country ‘Blind to the Pandemic’

More than 20 states either don’t release or have incomplete data on the rapid antigen tests now considered key to containing the coronavirus, which has sickened more than 6 million Americans. The lapses leave officials and the public in the dark about the true scope of the pandemic as untold numbers of cases go uncounted.

The gap will only widen as tens of millions of antigen tests sweep the country. Federal officials are prioritizing the tests to quickly detect COVID-19’s spread over slower, but more accurate, PCR tests.

Relying on patchy data on COVID testing carries enormous consequences as officials decide whether to reopen schools and businesses: Go back to normal too quickly and risk even greater outbreaks of disease. Keep people at home too long and risk an even greater economic crisis.

“The absence of information is a very dangerous thing,” said Janet Hamilton, executive director of the Council for State and Territorial Epidemiologists, which represents public health officials. “We will be blind to the pandemic. It will be happening around us and we will have no data.”

The states that don’t report antigen test results or don’t count antigen positives as COVID cases are California, Colorado, Georgia, Illinois, Maryland, Minnesota, Missouri, Montana, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and Wyoming, as well as the District of Columbia.

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So far, most of the COVID tests given in the U.S. have been PCR tests, which are processed in medical labs and can take days to return results. By contrast, antigen tests offer results in minutes outside of labs, appealing to everyone from medical clinics to sports teams and universities.

Each relies on swabs to test patients. But unlike using tests run through labs, many providers who would use antigen tests don’t have an easy way to send data electronically to public health authorities.

Since July, though, the federal government has pushed roughly 5 million antigen tests into nearly 14,000 nursing homes to contain outbreaks among staff members and residents. The Department of Health and Human Services also awarded a $760 million contract to buy 150 million rapid antigen tests from Abbott, the Illinois-based diagnostics behemoth. It plans to send 750,000 of those to nursing homes starting this week, Brett Giroir, the HHS official heading the Trump administration’s testing efforts, told industry executives on Sept. 8. Federal officials have not elaborated on how many tests will be sent elsewhere but have suggested many will go to governors to distribute as schools reopen.

The rush of antigen tests, however, won’t be particularly useful to officials if the results are not publicly and uniformly reported.

KHN surveyed 50 states and the District of Columbia on their collection of antigen test results and what is reported publicly. Forty-eight responded between Sept. 3 and 10, revealing significant variation over whether people who test positive for COVID-19 with an antigen test are counted as cases and whether states even publicly report antigen data in their testing numbers:

  • 21 states and D.C. do not report all antigen test results.
  • 15 states and D.C. do not count positive results from antigen tests as COVID cases.
  • Two states do not require antigen test providers to report results, and five others require only positive results to be reported.
  • Nearly half of states believe their antigen test results are underreported.

Consequently, many state counts of infected people could be artificially low. For instance, the lack of reporting could imply infection rates are declining because the virus isn’t spreading as widely — when really more antigen tests are being used and not counted, public health officials and experts say.

“It’s going to look like your cases are coming down when they’re not,” said Jeffrey Morris, a biostatistics professor at the University of Pennsylvania.

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HHS recognizes that antigen tests are underreported but maintained that officials are not missing the full scale of the pandemic, an agency spokesperson said.

“There is sufficient testing to achieve all objectives outlined in the testing strategy, including identifying newly emergent outbreaks, supporting public health isolation and contact tracing, protecting the vulnerable, supporting safe reopening of schools and businesses, and enabling state testing plans,” spokesperson Mia Heck said.

Part of the problem on antigen test reporting stems from what counts as a COVID case. Guidance from the Centers for Disease Control and Prevention defines a “confirmed” COVID case as one that is determined from a PCR test. Positive results from antigen tests are considered “probable” cases because the tests can be less accurate.

Months after the first COVID antigen test received emergency authorization from the Food and Drug Administration, the CDC revised its COVID case definition in early August to allow a positive antigen test to count as a probable case without assessing whether a person had clinical symptoms or was in close contact with a confirmed infected person.

That prompted many states — including Arkansas, starting Sept. 2 — to adjust how they report cases.

“It’s easy for people to think since we use the word ‘probable’ that maybe it’s a case, maybe it isn’t. But that’s not how we think of it,” said Dr. Jennifer Dillaha, medical director for the Arkansas Department of Health. “It is a real case in the same way that a PCR is a real case.”

Dr. Karen Landers, an assistant state health officer for the Alabama Department of Public Health, said her biggest concern was the potential undercounting of antigen test results as they continue to grow in popularity. While the state has been trying to work with each urgent care or other medical provider, some struggle to submit the results.

“We can’t afford to miss a case,” she said.

The CARES Act, which Congress passed in March, requires a broad range of health care providers to report any COVID test result to state or local health departments. Nonetheless, two states — Montana and New Jersey — said they weren’t requiring antigen test providers to report results, positive or negative. Colorado, Maine, Mississippi, New Hampshire and Wyoming require only positive results to be reported, which can distort the positivity rate.

Sara Mendez, the support services manager for the Brazos County Health Department in Texas, said the department saw an increase of antigen tests being administered as Texas A&M University students returned. Even though the state health department was not including positive COVID cases from antigen tests in its public reports, the local health department felt obligated to do so.

“A lot of the college students will just go and get those done as opposed to the PCR tests,” Mendez said, “so we felt like we were missing out.”

Indiana University undertook a massive antigen testing operation for students living on campus in August, administering 14,870 antigen tests across four campuses through drive-thrus, according to Graham McKeen, an assistant university director for public health. The test results were delivered while students waited in cars for about 30 minutes, with 159 coming back positive. Each night, a university staff member would manually download the spreadsheet off each of the test machines and securely email it to the state health department.

But Indiana began reporting antigen testing only on Aug. 24, adding over 16,000 antigen tests into its public dashboard that day and saying in a news release that it plans to retroactively add in earlier antigen testing figures.

McKeen said that, even though the state is now reporting some antigen data, tests are still missed under the cumbersome reporting system. The state said some of the data is being sent by fax.

“It doesn’t give the community a good handle on the infection in the community,” McKeen said.

Heck, the HHS spokesperson, said that federal agencies are working to improve the reporting of results and that problems were likely to be eased in the future, citing that Abbott’s antigen test includes an electronic reader for automated reporting. By October, 48 million of those tests will be in circulation each month, she said.

Still, to date, “what this is exposing is the antiquated systems that public health agencies have had for years,” said Scott Becker, executive director of the Association of Public Health Laboratories. “So much of the data we’ve gotten is incomplete.”

That data barrier is playing out in nursing homes as well.

Victoria Crenshaw is holding off on using antigen tests to screen residents and staff members at Westminster Canterbury on Chesapeake Bay nursing home in Virginia Beach, Virginia. As senior director, she sees one major holdup: No technology platform is in place to easily send results to health officials. Instead, she and colleagues would need to resort to taping pieces of paper together to deliver details of who was tested, and hope local officials would accept it.

The Trump administration is pushing for nursing homes to use the tests for required screenings at least once a month and as often as twice a week. Under new federal regulations, nursing homes that don’t comply with regular testing and reporting requirements are subject to citations or fines.

“We have no technology today to submit this information,” Crenshaw said, “which leaves us in a vulnerable position.”

Black Women Turn to Midwives to Avoid COVID and ‘Feel Cared For’

From the moment she learned she was pregnant late last year, TaNefer Camara knew she didn’t want to have her baby in a hospital bed.

Already a mother of three and a part-time lactation consultant at Highland Hospital in Oakland, Camara knew a bit about childbirth. She wanted to deliver at home, surrounded by her family, into the hands of an experienced female birth worker, as her female ancestors once did. And she wanted a Black midwife.

It took the COVID-19 pandemic to get her husband on board. “Up until then, he was like, ‘You’re crazy. We’re going to the hospital,’” she said.

As the COVID-19 pandemic has laid bare health care inequities, more Black women are looking to home birth as a way not only to avoid the coronavirus but also to shun a health system that has contributed to African American women being three to four times more likely to die of childbirth-related causes than white women, regardless of income or education. Researchers argue that the roots of this disparity — one of the widest in women’s health care — lie in long-standing social inequities, from lack of safe housing and healthy food to inferior care provided at the hospitals where Black women tend to give birth.

“It feels like we are needed,” said midwife Kiki Jordan, who co-owns Birthland, a prenatal practice that opened early this year in a 400-square-foot storefront in Oakland’s Temescal neighborhood targeting low-income women of color.

Since the COVID-19 pandemic hit in March, she said, the practice’s clientele has more than tripled.

Images of hospitals inundated with coronavirus patients have sparked a flurry of new interest among women of all races in home births, which account for just over 1% of deliveries in the United States. Birth centers and midwives who attend home births say they’ve been swamped by new clients since the pandemic.

“Every midwife I’m talking to has seen their practice double or sometimes triple in the wake of COVID,” said Jamarah Amani, a Florida midwife and co-founder of the National Black Midwives Alliance.

Many Americans think of giving birth at home as backward and scary, or as a quixotic practice of privileged white women, akin to cloth diaper services and home-cooked baby food.

But the growing interest in home births in recent years has fueled a growing Black midwifery movement that harks back to a venerable, if long-forgotten, tradition in the United States.

Jordan’s practice is now 98% Black, “something I’ve never seen before,” she said. She provides pre- and postnatal care regardless of where women plan to deliver, though the majority of her clientele choose home births.

African American infants are more than twice as likely to die as white infants, and the risks extend across social class. Tennis superstar Serena Williams’ harrowing 2018 account of her own near-death postpartum experience with a blood clot in her lungs and a cascade of life-threatening complications was a sobering reminder that even wealth and fame are no protection from being dismissed or mistreated during one of the most vulnerable moments of a woman’s life.

At least three Black women have died in childbirth since March in New York City, which was hit hard early on by the coronavirus. One of the women, 26-year-old Amber Isaac, had reportedly tried to switch to a home or birth-center delivery after not getting an in-person appointment with her obstetrician as providers abruptly switched to telemedicine in the wake of the shutdown.

For Katrina Ayoola, 29, avoiding unnecessary medical interventions that researchers say can lead to dangerous maternal complications was a key reason for switching to a home birth. As the coronavirus hit last spring, when Ayoola was around five months pregnant with her first baby, she was already frustrated with her obstetricians in Martinez, California. She didn’t like their system of rotating providers, to whom she felt she constantly had to reexplain herself. The last straw was being told to go shopping for a home blood pressure monitor. They were sold out everywhere. “I ended up canceling what would have been an online appointment, and I haven’t heard from them since,” said Ayoola.

“I did not feel cared for,” she said.

On Aug. 1, Ayoola delivered her son, Oluwatayo, at home in Fairfield with her husband, Daré, and her mother at her side following a 29-hour labor supervised by Jordan and her partner, Anjali Sardeshmukh.

“At the hospital, I’d probably have had a C-section,” said Ayoola, who said her home birth was “an amazing, empowering experience,” worth every penny of the out-of-pocket $4,500 the couple paid for it — a discount, based on their insurance and income, from Birthland’s typical $6,500 fee.

Cost is a major barrier for poor people to access out-of-hospital births. Medicaid, the federal-state health insurance program that covers many low-income pregnant women, pays for home births in only a handful of states. Since 2015 these have included California, but reimbursement is low and bureaucratic requirements make it difficult for most midwives to accept Medi-Cal, California’s Medicaid program. A quarter of U.S. states do not even offer midwife licenses, making the practice of home birth effectively illegal.

Jordan led a free-standing birth center in San Rafael that was the first in the state to accept Medi-Cal when it opened in 2016. She and a handful of other Black midwives around the country are leading the effort to make out-of-hospital births more accessible to low-income women, a group that could particularly benefit from community-based midwifery, according to a 2018 study.

Many of these birth workers are struggling to break even, but that’s nothing new.

In past generations, Black midwives sometimes walked miles and stayed days with laboring women, massaging their feet, cooking and babysitting, and reading from the Bible in exchange for a few dollars or a chicken, according to historical accounts. Immigrants and African Americans dominated midwifery during much of this country’s history, and in the South, enslaved women passed from mother to daughter childbirth techniques and remedies brought from West Africa starting in the 1600s.

In certain rural pockets, Black midwives continued to deliver babies for poor Black and white families alike, even into the last century, as modern obstetrics regulated traditional birth attendants virtually out of existence. Midwives delivered half of the nation’s babies in 1900 and just over 10% by the 1930s, as physicians launched a campaign to promote hospital birth as safe and hygienic, while dismissing midwives as “relics of barbarism.”

But in recent years, with hospital birth as the norm, the United States has registered the poorest birth outcomes in the industrialized world. The numbers have worsened during the past 25 years even as they’ve improved in most of the world, largely because of the disproportionate toll on African Americans.

California has led the effort to reverse that trend, cutting its maternal death rate by 55% between 2006 and 2013, though the disparity for Black mothers has persisted.

Researchers have documented countless instances of pregnant African American women being ignored, drug-tested without permission, or sutured without pain medication.

There is a growing consensus among medical researchers and social scientists that discrimination can result in toxic stress that causes maternal complications or premature births. Respectful, holistic prenatal care can improve outcomes, said Jennie Joseph, a British-trained midwife. Her prenatal clinic in Florida serving mostly low-income women of color has had consistently low rates of maternal complications and premature and low-birth-weight babies.

Joseph believes it matters less where a woman gives birth than how she is treated during the previous nine months, and most of her clients deliver in hospitals.

Groups like Amani’s are encouraging more midwives of color to penetrate what she calls the profession’s “old girls’ network.” Just 2% of American midwives are Black, and research has shown that Black patients tend to do better with Black providers.

There is evidence that their numbers are growing with demand, however. California now has about half a dozen licensed Black midwifery practices, including three that have opened in the San Francisco Bay Area since 2017.

Camara said she wanted to support them: She’s had supportive, competent white birth attendants in the past, “but it wasn’t the same,” she said. “This is returning to what we did before.”

At around 6 on a Saturday morning in mid-August, as a heat wave gripped the Bay Area, she phoned Jordan to tell her she was having contractions. Barely two hours later, the midwives helped her give birth to her son, Esangu, 8 pounds, 6 ounces, on her hands and knees on her living room floor.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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COVID Vaccine Trials Move at Warp Speed, But Recruiting Black Volunteers Takes Time

Participation in clinical trials among Black people is low, according to Food and Drug Administration statistics. Still, including them in coronavirus vaccine trials has been a stated priority for the pharmaceutical companies involved, since African American communities, along with those of Latinos, have suffered disproportionately from the pandemic.

The ongoing trials are moving at a pace that is unprecedented for medical research, with the Trump administration’s vaccine acceleration effort dubbed “Operation Warp Speed.” Yet recruiting minority participants requires sensitivity to a mistrust borne of past and current medical mistreatment. Trust-building cannot be rushed.

So far, participation by minority volunteers in coronavirus trials has increased only slightly compared with typically low levels for other clinical trials — and targeted outreach efforts to recruit more minorities have been slow to launch.

Some of that outreach is taking place at historically black colleges and universities, which are trusted institutions for many Black Americans. At Meharry Medical College in Nashville, Tennessee, researchers have set up in-person meetings with patients they already know. Earlier this month, a half-dozen patients gathered in a cramped conference room on campus. They snacked on turkey sandwiches and potato chips and listened to the pitch from their physician, Dr. Vladimir Berthaud.

“What’s the best hope to get rid of this virus?” he asked them.

“Vaccination,” they replied.

Then Berthaud followed up: “So raise your hand if you would like to take the vaccine?”

Some hands shot up, but not all.

“I ain’t going to be the first one, now,” said Lanette Hayes.

Katrina Thompson said she does eventually want to get a shot for protection against the coronavirus. She explained she’s especially worried about all the residents of her apartment building who don’t seem to be doing the basics of covering their coughs.

“The word ‘vaccination’ don’t scare me,” she said. “The word ‘trial’ do.”

Black Americans have reason to be suspicious — stemming beyond the well-known Tuskegee experiments, in which Black men with syphilis were deceived and mistreated as part of an experiment that went on for decades. Many Black Americans report ongoing mistreatment by medical providers today.

Berthaud is recruiting patients for a clinical trial site he will oversee in Nashville, and he would like more than 300 people of color to enroll. Berthaud, who is Black and from Haiti, appeals to his patients’ sense of duty.

“If you don’t have enough people like you in those vaccine trials, you will not know if it works for you,” he told them. “You will not know.”

For most of the current coronavirus vaccine trials, recruitment mainly takes place online — which often results in mostly white people enrolling.

That’s why Meharry researchers are wooing Black patients with a personal invitation. But they’re not recruiting for the phase 3 trials underway. Meharry’s first trial, for a vaccine candidate by Novavax, doesn’t launch until October.

Other pharmaceutical companies are nearly done recruiting. Moderna said it chose nearly 100 trial sites for their “representative demography.”

The company did not respond to requests for comment but publicizes demographic statistics about the clinical volunteers every week. While somewhat more inclusive than the typical clinical trial, it still is not a good representation of the diversity of the U.S.

For the coronavirus vaccine in particular, the National Institutes of Health has suggested minorities should be overrepresented in testing — perhaps at rates that are double their percentage of the U.S. population.

“We say we want to have everybody included, but really the effort for the vaccinations — in a sense — [is] starting the same way they’ve always been,” said Dr. Dominic Mack, of Morehouse School of Medicine in Atlanta.

He’s working with the NIH to make sure people of color are included in COVID-19 research. Mack said there are no shortcuts if medical research is going to reflect the diversity of the U.S. It takes time to build trust and meaningful relationships with people who have endured a history of abuse or neglect by medical providers, and exclusion from biomedical research and decision-making.

“Now, that being said, the only thing we can do is what we’re doing,” he said — by which he means respectful, unrushed outreach and dialogue.

The primary effort, called the COVID-19 Prevention Network, taps into four existing clinical trial networks designed to advance HIV research. Those networks are based in Seattle, Atlanta, Los Angeles and Durham, North Carolina.

One project will be led by the Rev. Edwin Sanders II of the Metropolitan Interdenominational Church in Nashville. It will involve seven “faith ambassadors” and 30 “clergy consultants” in the African American community working to dispel myths and increase trust in the clinical trial process. But Sanders cautioned this is not about a hard sell. It’s not his job to preach trial participation from the pulpit, he said.

“We are not out beating the drum,” he said, acknowledging that congregants may have legitimate concerns. “I am not going to do anything more than make sure people are able to make an informed choice.”

The danger in lunging for big diversity goals is that it could spark a backlash, meaning minorities might be even less willing to participate, said associate professor Rachel Hardeman, who studies health equity at the University of Minnesota. It’s important that the doctors doing the asking look like the people they’re appealing to, she said.

“It’s racial concordance,” she explained. “It offers this feeling of, ‘You know who I am, you know where I come from, you have my best interests at heart.’”

Historically Black medical institutions in the U.S. are uniquely positioned to do this work. While they haven’t been on the leading edge of recruitment for vaccine trials, they intend to play an important part. The president of Nashville’s Meharry Medical College, Dr. James Hildreth, is an infectious disease researcher. But instead of overseeing the trial site being hosted on his campus, Hildreth has a more modest goal in mind: He plans to participate as a patient, and urge others to join him.

“I think my role is more important in advocating for people to be involved in vaccine studies than to be one of the leaders of the study,” he said.

So at Meharry, Berthaud is the principal investigator. As lunch wraps up in the crowded conference room, he has managed to win over some holdouts.

“Where is the line?” asked Robert Smith. “Where do we sign?”

Smith, with his young grandson in tow, didn’t raise his hand at first when asked if he’d take the vaccine. But after listening to Berthaud, Smith agreed to participate in the clinical trial — for no other reason than the trust he has in Berthaud, his longtime physician.

“He’s not only my doctor; he’s proven that he cares about me,” Smith said.

Persuading hundreds or thousands of Black Americans to sign up will be difficult. But researchers hope their outreach efforts will at least result in more minorities agreeing to take an approved vaccine when available.

This story is part of a partnership that includes Nashville Public Radio, NPR and KHN.


This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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COVID Exodus Fills Vacation Towns With New Medical Pressures

The staff at Stony Brook Southampton Hospital is accustomed to the number of patients tripling or even quadrupling each summer when wealthy Manhattanites flee the city for the Hamptons. But this year, the COVID pandemic has upended everything.

The 125-bed hospital on the southern coast of Long Island has seen a huge upswing in demand for obstetrics and delivery services. The pandemic has families who once planned to deliver babies in New York or other big cities migrating to the Hamptons for the near term.

From the shores of Long Island to the resorts of the Rocky Mountains, traditional vacation destinations have seen a major influx of affluent people relocating to wait out the pandemic. But now as summer vacation season has ended, many families realize that working from home and attending school online can be done anywhere they can tether to the internet, and those with means are increasingly waiting it out in the poshest destinations.

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Many of the medical facilities in these getaway spots are used to seeing summer visitors for bug bites or tetanus shots, hiring an army of temporary doctors to get through the summer swells. Now they face the possibility of needing to treat much more serious medical conditions into the fall months — and for the foreseeable future.

Such increase in demand could strain or even overwhelm the more remote towns’ hospitals and health care providers, threatening the availability of timely care for both the newcomers and the locals. The Southampton hospital has just seven intensive care unit beds, with the capacity to expand to as many as 30, but it wouldn’t take much for the hospital to be swamped by patients.

“For health care, the bottom line is: As our population grows, we have to have the infrastructure to support it,” said Tamara Pogue, CEO of Peak Health Alliance, a nonprofit community health insurance-purchasing cooperative in Colorado ski country.

And many communities do not.

Home Sales Soar

Sunny shores and mountain vistas are prompting people to relocate to second homes if they have them, or to purchase new homes in those areas if they don’t. Renters who used to come for a month are now staying for two or three, and summer renters are becoming buyers. Multimillion-dollar residences in the ski resort town of Aspen, Colorado, for example, that once sat on the market for nearly a year now move in weeks.

“Some of the most experienced and seasoned real estate brokers have never seen activity like what we have experienced in July and August,” said Tim Estin, a broker in Aspen, whose firm draws clients from COVID hot spots such as Dallas, Houston, New York, Miami, Los Angeles and Chicago.

Many destinations tried to discourage second-home owners from coming, particularly early in the pandemic after Colorado ski resorts became an epicenter of COVID cases. Gunnison County, Colorado, home to the Crested Butte ski resort, banned out-of-towners, prompting the Texas attorney general to take up the matter on behalf of Texans with homes in the area. In Lake Tahoe, along the California-Nevada border, second-home owners were told to go back to the Bay Area. And in New York vacation destinations, online messages targeted big-city transplants with classic New York aplomb.

The ski resort town of Vail, Colorado, on the other hand, welcomed them with open arms with its Welcome Home Neighbor campaign in May.

“We have long held the belief that in a resort community with so many second homes, that lights on are good, lights off are bad,” said Chris Romer, president and CEO of the Vail Valley Partnership, the region’s chamber of commerce.

Romer said the 56-bed Vail Health Hospital supported the campaign, particularly after visits to the town plummeted 90% in April once the ski lifts stopped running.

“We never would have launched the program if the hospital didn’t sign off on it,” Romer said.

Demand for Health Care

The influx of patients to these rural areas is helping hospitals and clinics rebound from the drop in typical patient visits during the pandemic, but there is concern that additional growth could overwhelm local resources. So far, though, enough people seem reluctant to seek care during the pandemic, unless it’s an emergency or COVID-related, that it hasn’t reached a tipping point. Others might be seeking care with their providers in the big city through telehealth or the occasional run back to their primary residence. But the mix of patients is different.

In Leadville, Colorado, a town nestled in the mountains at an altitude of 10,151 feet, summertime usually means an influx of mountain bikers and runners.

“Leadville has these crazy 100-mile races, where we have very elite athletes from all over the planet, and they have specific medical needs,” said Dr. Lisa Zwerdlinger, chief medical officer at the local St. Vincent Hospital. “But what we’re seeing now are these second-home owners, people who are coming from other places to spend extended periods of time in Leadville and who come with a whole host of other medical issues.”

Most of the races this summer were canceled. That meant fewer extreme athletes and more Texans; fewer broken bones and turned ankles, and more chronic conditions exacerbated by the high altitude. Nonetheless, August was the busiest month ever at Zwerdlinger’s family medicine practice.

Hospitals in vacation towns typically prepare for surges during holidays, said Jason Cleckler, CEO of Middle Park Health, with locations serving Colorado’s Winter Park and Granby Ranch ski resorts in Grand County. During Christmas week, the population of neighboring Summit County, which houses resorts like Breckenridge and Keystone, swells from 31,000 to 250,000. But Cleckler said the COVID surge in resort communities is drawn-out so hospitals may have to respond with more permanent increases in capacity.

In Big Sky, Montana, whose part-time residents include Bill Gates and Justin Timberlake, Big Sky Medical Center doubled its capacity to eight beds in anticipation of a surge in patients due to COVID-19. The center’s two primary care doctors are completely booked. With so many new people in town, the hospital has accelerated plans to shift a third full-time doctor into the clinic.

As the wily coronavirus works its way into all corners of America, though, patients may find that not all regions have the same capacity to deal with COVID or even other complex medical problems.

Visitors to the sole clinic in nearby West Yellowstone, a gateway to the namesake national park, expect to be able to get COVID tests even if they have no symptoms or a known connection to a case, said Community Health Partners spokesperson Buck Taylor.

“There seems to be a frustration that a rural Montana clinic doesn’t have the resources they expect at home,” Taylor said. “That’s nothing new. People come to Montana all the time and say, ‘But where can I get any good Thai food?’”

Planning for What’s Next

The year has been such an outlier for hospitals that it’s difficult for them to predict and plan for what will happen next. On Long Island, many locals typically leave the Hamptons for Florida during the winter. But it’s unclear whether those snowbirds will stay or go this year, given the high levels of COVID-19 in Florida now, said Robert Chaloner, CEO of Stony Brook Southampton. That could also change the demand for who needs medical care.

One indication that some visitors may be staying put? The jump in new students. The Big Sky school district expects a 20% increase in enrollment this fall. Leadville schools have at least 40 new students. Vail Mountain School’s waiting list is its longest ever.

Many have speculated that the pandemic lockdown might fundamentally change the way companies operate, allowing more people to work from distant locations for the foreseeable future.

“Every indicator that I see is pointing to the fact that this is a shift,” said Romer in Vail. “It has the potential to be permanent.”

Taylor Rose, Big Sky Medical Center’s director of operations and clinical services, said that, if that happens, the hospital will have to rebalance its services.

“I’d probably give it a year or two before I make any major changes,” Rose said. “People are going to start deciding, ‘This really isn’t for me. I’m not going to stay here and deal with 6 feet of snow in the winter.’”

New Dental Treatment Helps Fill Cavities and Insurance Gaps for Seniors

DENVER ― Dental hygienist Jennifer Geiselhofer often cleans the teeth of senior patients who can’t easily get to a dentist’s office. But until recently, if she found a cavity, there was little she could do.

“I can’t drill. I can’t pull teeth,” said Geiselhofer, whose mobile clinic is called Dental at Your Door. “I’d recommend they see a dentist, but that was often out of the question because of mobility challenges. So visit after visit, I would come back and there would be more decay.”

But now Geiselhofer has a weapon to obliterate a cavity with a few brushstrokes.

Silver diamine fluoride is a liquid that can be painted on teeth to stop decay. Fast, low-cost and pain-free, the treatment is rapidly gaining momentum nationwide as the cavity treatment of choice for patients who can’t easily get a filling, such as the very young or the very old.

“It has been life-changing for my patients,” said Geiselhofer, who has been using the treatment for about 18 months.

Geiselhofer has not been able to go into nursing homes during the COVID-19 pandemic, but she uses the liquid on the older adults she visits in private homes. She also uses it to treat the cavities of patients in homeless shelters, jails and Head Start programs ― now wearing greater protective gear, including gloves, a surgical mask, an N95 mask and a face shield.

The topical medication is an especially good option for seniors, dental industry experts say, because dental care has remained a major gap in health insurance coverage despite poor dental hygiene being linked to heart disease and other health problems like diabetes and pneumonia. Medicare doesn’t cover most dental care, and patients on a fixed income often can’t afford treatment. But because of the effectiveness and low cost of silver diamine fluoride, more state Medicaid programs now cover it — and older adults who pay out-of-pocket can afford it outright.

Silver diamine fluoride has been used in other countries for decades, and studies have proved it safe. Its biggest downside is that it permanently turns the decayed area black — a turnoff, in particular, for people with decay on a front tooth.

Dental providers say the black spots can be covered by tooth-colored material for an extra cost. For older adults, Geiselhofer said, a dark spot is a small price to pay for a treatment that stops cavities quickly, with no drilling, needle prick or trip to the dentist required.

Oral Care a Problem for Older Adults

Silver diamine fluoride was approved by the Food and Drug Administration in 2014 for reducing tooth sensitivity. But its off-label use to treat cavities was quickly adopted. It made headlines as a trauma-free treatment for tooth decay in children under age 5.

Pediatric dentists have embraced it as a solution for kids who can’t sit still for treatment and whose parents want to avoid general anesthesia. In 2018, the then-president of the American Academy of Pediatric Dentistry, James Nickman, said that, aside from fluoridated water, the topical cavity fighter “may be the single greatest innovation in pediatric dental health in the last century.”

But today, with more older Americans keeping their natural teeth than in decades past, the treatment is also serving as a boon for a different generation. Because of insurance gaps and the prohibitive cost of most dental treatments, many seniors miss out on preventive care to stave off dental decay, putting them at risk for dental disease that can trigger serious health problems. About 27% of Americans age 65 and older have untreated cavities, according to the Centers for Disease Control and Prevention.

Residents in long-term care facilities are at especially high risk, studies show. Medications cause their mouths to dry, promoting decay. They also may have cognitive issues that make it difficult to practice good oral care. And many are either too frail for traditional dental treatment or too weak to be transported.

Dental Hygienists Lead the Way

Take 87-year-old Ron Hanscom, for example. A patient of Geiselhofer’s, he has been in a Denver nursing home since he had a stroke six years ago, and needs a mechanical lift to get into and out of his wheelchair.

On a visit to Hanscom’s nursing home earlier this year, before the pandemic, Geiselhofer spotted a cavity under one of his crowns. After checking in with his dentist, she used a small brush to paint on the silver treatment.

“It’s a good thing she had the silver, because I couldn’t get to a dentist’s office — no way,” Hanscom said. “She did it right in my room.”

Across the country, dental hygienists provide much of the care to patients like Hanscom who otherwise might never see a dentist. They also see patients in homeless shelters, schools, jails and low-cost medical clinics. Since the pandemic hit, Geiselhofer said she has received a flood of requests for in-home care from seniors who are too nervous to go into a dentist’s office, but she has turned them down because she is too busy caring for underserved populations.

Many states allow hygienists to work directly with patients in public health settings without a dentist’s supervision, and Colorado is one of a few that allows them to set up a completely independent practice.

Because the silver treatment is relatively new in this country and can leave a stain, the Colorado state legislature passed a law in 2018 that says hygienists must have an agreement with a supervising dentist to apply it. The law also requires them to get special training on how to use the liquid, which at least 700 hygienists from across the state have completed.

Other states, including Maryland and Virginia, have no special requirements for applying the cavity treatment but require some supervision by a dentist, said Matt Crespin, president of the American Dental Hygienists’ Association. In those places, hygienists apply it under the same rules that govern the application of other fluoride products.

Preventing New Cavities, Too

Studies show silver diamine fluoride stops decay in 60% to 70% of cases with one application. A second application six months later boosts the treatment’s long-term effectiveness to more than 90%.

In addition to killing cavity-causing bacteria, the treatment hardens tooth structure, desensitizes the tooth and even stops new cavities from forming. Applying the liquid on the exposed root surfaces of older adults once a year is “a simple, inexpensive, and effective way” to prevent cavities, a 2018 study concluded.

One of the most important benefits of the application on older patients is that the liquid can reach decay that forms under existing dental work such as crowns and bridges, said dental hygienist Michelle Vacha, founder of Community Dental Health, which runs clinics in Colorado Springs and Pueblo, Colorado.

Previously, a dentist would have had to remove the crown, drill out the cavity and make a new crown — a traumatic, time-consuming procedure with a typical cost of $1,000 or more, Vacha said. Unable to afford the cost, many patients would instead have the tooth pulled.

The paint-on liquid is significantly cheaper than traditional treatment. Estimates vary, but a private dentist may charge $10 to $75 for one application, compared with $150 to $200 for a filling. Hygienists often have lower fees. At Vacha’s community clinics, the cost is $10 a tooth.

About half of state Medicaid programs now reimburse for the treatment, said Steve Pardue, scientific officer of Elevate Oral Care that distributes Advantage Arrest, the main brand of the topical medication used nationally. Reimbursement rates range from $5 to $75 per application.

More private insurers — about 20% to 30% of them — have also started covering it, Pardue said.

Coming Soon to a Dentist Near You?

A small but growing number of mainstream dentists have begun to offer the treatment to all patients, not just the youngest and oldest.

It’s a good option for those who have anxiety about dental work or concerns about cost, said Dr. Janet Yellowitz, director of geriatric and special care dentistry at the University of Maryland School of Dentistry.

A 2017 survey by the American Dental Association found that almost 8 in 10 dentists had never used the treatment. The ADA doesn’t have more recent statistics, but ADA spokesperson Matthew Messina said anecdotal reports indicate usage is increasing dramatically.

Yellowitz noted that dentists still have a financial incentive to drill and fill. She has made presentations highlighting the benefits of the silver solution at national conferences.

“We’re trying to get everyone to use it,” she said. “It’s a slow process because we’re asking dentists who have been trained for their whole careers to do things one way to completely change their mentality. It’s like asking them to go to another country and drive on the other side of the road.”


This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Tough to Tell COVID From Smoke Inhalation Symptoms — And Flu Season’s Coming

The patients walk into Dr. Melissa Marshall’s community clinics in Northern California with the telltale symptoms. They’re having trouble breathing. It may even hurt to inhale. They’ve got a cough, and the sore throat is definitely there.

A straight case of COVID-19? Not so fast. This is wildfire country.

Up and down the West Coast, hospitals and health facilities are reporting an influx of patients with problems most likely related to smoke inhalation. As fires rage largely uncontrolled amid dry heat and high winds, smoke and ash are billowing and settling on coastal areas like San Francisco and cities and towns hundreds of miles inland as well, turning the sky orange or gray and making even ordinary breathing difficult.

But that, Marshall said, is only part of the challenge. Facilities already strapped for testing supplies and personal protective equipment must first rule out COVID-19 in these patients, because many of the symptoms they present with are the same as those caused by the virus.

“Obviously, there’s overlap in the symptoms,” said Marshall, the CEO of CommuniCare, a collection of six clinics in Yolo County, near Sacramento, that treats mostly underinsured and uninsured patients. “Any time someone comes in with even some of those symptoms, we ask ourselves, ‘Is it COVID?’ At the end of the day, clinically speaking, I still want to rule out the virus.”

The protocol is to treat the symptoms, whatever their cause, while recommending that the patient quarantine until test results for the virus come back, she said.

It is a scene playing out in numerous hospitals. Administrators and physicians, finely attuned to COVID-19’s ability to spread quickly and wreak havoc, simply won’t take a chance when they recognize symptoms that could emanate from the virus.

“We’ve seen an increase in patients presenting to the emergency department with respiratory distress,” said Dr. Nanette Mickiewicz, president and CEO of Dominican Hospital in Santa Cruz. “As this can also be a symptom of COVID-19, we’re treating these patients as we would any person under investigation for coronavirus until we can rule them out through our screening process.” During the workup, symptoms that are more specific to COVID-19, like fever, would become apparent.

For the workers at Dominican, the issue moved to the top of the list quickly. Santa Cruz and San Mateo counties have borne the brunt of the CZU Lightning Complex fires, which as of Sept. 10 had burned more than 86,000 acres, destroying 1,100 structures and threatening more than 7,600 others. Nearly a month after they began, the fires were approximately 84% contained, but thousands of people remained evacuated.

Dominican, a Dignity Health hospital, is “open, safe and providing care,” Mickiewicz said. Multiple tents erected outside the building serve as an extension of its ER waiting room. They also are used to perform what has come to be understood as an essential role: separating those with symptoms of COVID-19 from those without.

At the two Solano County hospitals operated by NorthBay Healthcare, the path of some of the wildfires prompted officials to review their evacuation procedures, said spokesperson Steve Huddleston. They ultimately avoided the need to evacuate patients, and new ones arrived with COVID-like symptoms that may actually have been from smoke inhalation.

Huddleston said NorthBay’s intake process “calls for anyone with COVID characteristics to be handled as [a] patient under investigation for COVID, which means they’re separated, screened and managed by staff in special PPE.” At the two hospitals, which have handled nearly 200 COVID cases so far, the protocol is well established.

Hospitals in California, though not under siege in most cases, are dealing with multiple issues they might typically face only sporadically. In Napa County, Adventist Health St. Helena hospital evacuated 51 patients on a single August night as a fire approached, moving them to 10 other facilities according to their needs and bed space. After a 10-day closure, the hospital was allowed to reopen as evacuation orders were lifted, the fire having been contained some distance away.

The wildfires are also taking a personal toll on health care workers. CommuniCare’s Marshall lost her family’s home in rural Winters, along with 20 acres of olive trees and other plantings that surrounded it, in the Aug. 19 fires that swept through Solano County.

“They called it a ‘firenado,’” Marshall said. An apparent confluence of three fires raged out of control, demolishing thousands of acres. With her family safely accounted for and temporary housing arranged by a friend, she returned to work. “Our clinics interact with a very vulnerable population,” she said, “and this is a critical time for them.”

While she pondered how her family would rebuild, the CEO was faced with another immediate crisis: the clinic’s shortage of supplies. Last month, CommuniCare got down to 19 COVID test kits on hand, and ran so low on swabs “that we were literally turning to our veterinary friends for reinforcements,” the doctor said. The clinic’s COVID test results, meanwhile, were taking nearly two weeks to be returned from an overwhelmed outside lab, rendering contact tracing almost useless.

Those situations have been addressed, at least temporarily, Marshall said. But although the West Coast is in the most dangerous time of year for wildfires, generally September to December, another complication for health providers lies on the horizon: flu season.

The Southern Hemisphere, whose influenza trends during our summer months typically predict what’s to come for the U.S., has had very little of the disease this year, presumably because of restricted travel, social distancing and face masks. But it’s too early to be sure what the U.S. flu season will entail.

“You can start to see some cases of the flu in late October,” said Marshall, “and the reality is that it’s going to carry a number of characteristics that could also be symptomatic of COVID. And nothing changes: You have to rule it out, just to eliminate the risk.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Es difícil decir si es COVID, síntomas por inhalar humo… o la gripe que ya llega

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Los pacientes entran en las clínicas comunitarias de la doctora Melissa Marshall, en el norte de California, con síntomas reveladores. Tienen problemas para respirar, tos, y dolor de garganta.

¿Un caso claro de COVID-19? No tan rápido. Esta es una región de incendios forestales.

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A lo largo de la costa oeste, hospitales y centros de salud reportan pacientes con problemas relacionados con la inhalación de humo.

A medida que los incendios se propagan de forma descontrolada, por el calor seco y los fuertes vientos, el humo y las cenizas se expanden y se asientan en zonas costeras como San Francisco, y en ciudades y pueblos a cientos de kilómetros tierra adentro, haciendo que el cielo se vuelva naranja o gris y dificultando incluso la respiración normal.

Pero eso, dijo Marshall, es sólo una parte del desafío. Los centros, que ya están al límite de suministros para hacer pruebas y de equipos de protección personal (EPP), deben descartar primero la presencia de COVID-19 en estos pacientes, porque muchos de los síntomas que presentan son los mismos que los que causa el virus.

“Obviamente, existe una coincidencia en los síntomas”, señaló Marshall, que es CEO de CommuniCare, una red de seis clínicas en el condado de Yolo, cerca de Sacramento, que trata principalmente a pacientes con poca cobertura o sin seguro médico. “Cada vez que alguien llega con algunos de esos síntomas, nos preguntamos, ‘¿Es COVID?’ Clínicamente hablando, debo descartar el virus”.

El protocolo es tratar los síntomas, cualquiera que sea su causa, y recomendar que el paciente se ponga en cuarentena hasta que lleguen los resultados de las pruebas del virus, afirmó Marshall.

Es una escena que se repite en numerosos hospitales. Administradores y médicos, atentos a la rápida propagación de COVID-19, no se arriesgan cuando observan síntomas que podrían revelar al virus.

“Hemos visto un aumento en el número de pacientes que llegan a la sala de emergencias con problemas respiratorios”, expresó la doctora Nanette Mickiewicz, presidenta y CEO del Dominican Hospital en Santa Cruz.

“Al llegar con síntomas que podrían ser de COVID-19, tratamos a estos pacientes como lo haríamos con cualquier persona sospechosa de coronavirus hasta que podamos descartarlos con nuestro proceso de detección”. Durante el proceso, los síntomas más específicos de COVID-19, como la fiebre, se harían evidentes.

Para los trabajadores de Dominican, el tema pronto se vivió con urgencia. Los condados de Santa Cruz y San Mateo han sido los más afectados por los incendios del CZU Lightning Complex, que hasta el 10 de septiembre habían quemado más de 86,000 acres, destruyendo 1,100 edificios y amenazando a otros 7,600. Casi un mes después de que comenzaran, los incendios fueron contenidos en un 84%, pero miles de personas permanecían evacuadas.

Dominican, un hospital de Dignity Health, permanece “abierto, es seguro y proporciona atención médica”, aseguró Mickiewicz. Múltiples tiendas de campaña, levantadas en el exterior del centro, sirven como una extensión de la sala de espera para el servicio de Urgencias. También se utilizan para llevar a cabo lo que se considera una función esencial: separar a los que tienen síntomas de COVID-19 de los que no.

En los dos hospitales del condado de Solano, operados por NorthBay Healthcare, la trayectoria de algunos de los incendios forestales llevó a los funcionarios a revisar sus procedimientos de evacuación, explicó el vocero Steve Huddleston. Al final, no hubo necesidad de evacuar a los pacientes, y los nuevos llegaron con síntomas parecidos a los de COVID que, en realidad, podían deberse a la inhalación de humo.

Huddleston dijo que el proceso de admisión de NorthBay “requiere que cualquier persona con síntomas de COVID se considere sospechosa para el coronavirus, lo que significa que son separados, examinados y manejados por personal con EPP”.

En los dos hospitales, que hasta ahora han tratado casi 200 casos de COVID, el protocolo está bien establecido.

Los hospitales de California, aunque en su mayoría no están saturados, se enfrentan a múltiples problemas que normalmente sólo se presentan de forma esporádica.

En el condado de Napa, el hospital Adventist Health St. Helena evacuó a 51 pacientes en una sola noche de agosto ante la cercanía del fuego, trasladándolos a otros 10 centros según sus necesidades y la disponibilidad de camas. Tras un cierre de 10 días, se permitió la reapertura del hospital al finalizar las órdenes de evacuación, ya que el incendio se había contenido.

Los incendios forestales también afectan de manera personal a los trabajadores de salud. La doctora Marshall, de CommuniCare, perdió la casa de su familia en la zona rural de Winters, junto con 20 acres de olivos y otras plantaciones que la rodeaban, en los incendios del 19 de agosto que arrasaron el condado de Solano.

“Lo llamaron un ‘fogonazo’”, contó Marshall. Una confluencia de tres incendios que se desató fuera de control, arrasando miles de acres. Con su familia a salvo y una vivienda temporal proporcionada por un amigo, volvió al trabajo. “Nuestras clínicas interactúan con una población muy vulnerable”, dijo, “y este es un momento crítico para ellos”.

Mientras pensaba en cómo reconstruiría su hogar, la doctora debió enfrentarse a otra crisis: la escasez de suministros de la clínica. El mes pasado, CommuniCare sólo contaba con 19 kits para pruebas de COVID, y la escasez de hisopos era tal “que literalmente nos dirigimos a nuestros amigos veterinarios en busca de refuerzos”, explicó.

Mientras tanto, los resultados de las pruebas de COVID de la clínica tardaban casi dos semanas en llegar, desde un abrumado laboratorio exterior, haciendo que el rastreo de contactos fuera casi inútil.

Esas situaciones ya están controladas, al menos temporalmente, aseguró Marshall. Y aunque la Costa Oeste se encuentra en la época más peligrosa del año para los incendios forestales, generalmente de septiembre a diciembre, ahora surge otra complicación para los proveedores de salud: la temporada de gripe.

Las tendencias de la temporada de gripe en el hemisferio sur, que coincide con nuestros meses de verano, por lo general predicen lo que nos espera en los Estados Unidos. Pero este año, se ha visto muy poco de la enfermedad, presumiblemente debido a la restricción de los viajes, el distanciamiento social y el uso de máscaras. Y es demasiado pronto para saber lo que traerá la temporada de gripe a los Estados Unidos.

“Se pueden empezar a ver algunos casos de gripe a finales de octubre”, apuntó Marshall, “y la realidad es que van a llegar con una serie de características que también podrían ser sintomáticas de COVID. Y nada cambia: tienes que descartarlo, para eliminar el riesgo”.

NIH and FDA Examine Serious Side Effect That Surfaced in COVID Vaccine Trial

The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.

“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”

A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.

AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people,” said Nath. “We would like to see how we can help, but the lack of information makes it difficult to do so.”

Any decision about whether to continue the trial is complex because it’s difficult to assess the cause of a rare injury that occurs during a vaccine trial — and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic.

“So many factors go into these decisions,” Nath said. “I’m sure everything is on the table. The last thing you want to do is hurt healthy people.”

The NIH has yet to get tissue or blood samples from the British patient, and its investigation is “in the planning stages,” Nath said. U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue.

Such studies might take a month or two, he said. The FDA declined to comment on how long it would take before it decides whether to move forward.

Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported. Two other coronavirus vaccines are also in late-stage trials in the U.S.

If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.

A volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas.

Neurologists who study illnesses like transverse myelitis say they are rare — occurring at a rate of perhaps 1 in 250,000 people — and strike most often as a result of the body’s immune response to a virus. Less frequently, such episodes have also been linked to vaccines.

The precise cause of the disease is key to the decision by authorities whether to resume the trial. Sometimes an underlying medical condition is “unmasked” by a person’s immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial might be continued without fear, because the illness was not specific to the vaccine.

More worrisome is a phenomenon called “molecular mimicry.” In such cases, some small piece of the vaccine may be similar to tissue in the brain or spinal cord, resulting in an immune attack on that tissue in response to a vaccine component. Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. A second case would shut down the trial, he said.

In 1976, a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder, Guillain-Barré syndrome, in people who received the vaccine. At the time no one knew how common GBS was, so it was difficult to tell whether the episodes were related to the vaccine.

Eventually, scientists found that the vaccine increased the risk of the disorder by an additional one case among every 100,000 vaccinated patients. Typical seasonal flu vaccination raises the risk of GBS in about one additional case in every 1 million people.

“It’s very, very hard” to determine if one rare event was caused by a vaccine, Schaffner said. “How do you attribute an increased risk for something that occurs in one in a million people?”

Before allowing U.S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U.K. felt it was safe to continue, Goodman said. The AstraZeneca trial in the United States has a separate safety board.

FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.

It’s possible that the volunteer’s health problem was a coincidence unrelated to the vaccine, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies aren’t usually stopped over a single health problem, even if it’s serious.

Yet many health leaders have expressed frustration that AstraZeneca hasn’t released more information about the health problem that led it to halt its U.K. trial.

“There is just so little information about this that it’s impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured” that it was safe to continue, Goodman said.

AstraZeneca has said it’s unable to provide more information about the health problem, saying this would violate patient privacy, although it didn’t say how.

But there’s an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration’s handling of the COVID-19 response, leading scientists say.

“While I respect the critical need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? If there wasn’t a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be.”

The FDA will need to balance any possible risks from an experimental vaccine with the danger posed by COVID-19, which has killed nearly 200,000 Americans.

“There are also potential consequences if you stop a study,” Goodman said.

If the AstraZeneca vaccine fails, the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed. The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.

“This is part of the idea of not having just one vaccine candidate going forward,” he said. “It gives you a little more insurance.”

Schaffner said researchers need to remember that vaccine research is unpredictable.

“The investigators have inadvisedly been hyping their own vaccine,” Schaffner said. “The Oxford investigators were out there this summer saying, ‘We’re going to get there first.’ But this is exactly the sort of reason … Dr. [Anthony] Fauci and the rest of us have been saying, ‘You never know what will happen once you get into large-scale human trials.’”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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‘It Seems Systematic’: Doctors Cite 115 Cases of Head Injuries From Crowd Control Devices

At least 115 people were injured this summer when police shot them in the head or neck with so-called “less-lethal” projectiles at protests over racial injustice and police brutality, according to a report published Monday.

It’s the most comprehensive tally of such injuries to date, with about twice as many victims as KHN and USA Today cited in a July examination of how police across the U.S. wielded the weapons to control crowds.

But Physicians for Human Rights, the organization that compiled the incidents, believes even its figures are an undercount because its analysis is based on publicly available data and excluded some reports without adequate evidence.

The organization identified Austin, Texas; Portland, Oregon; and Los Angeles as hot spots during the period studied, May 26 to July 27.

Abigail Rodas, who was shot in the jaw with a rubber bullet on May 30, was one of the victims in Los Angeles, according to a lawsuit filed against the city and the police chief on behalf of Black Lives Matter Los Angeles, the Los Angeles Community Action Network and 14 people, including six who were struck with projectiles.

According to the suit, Rodas was leaving a protest when she “was struck in the face by a projectile and momentarily lost consciousness.”

A steel plate was used to repair her jawbone, the lawsuit says. She couldn’t talk for about 10 days and could drink only liquids for a week, it says.

“Nearly three weeks after the injury, she has screws in her gums and rubber bands to immobilize her jaw while the bones rejoin,” the suit says.

The city denied the allegations in a court filing, saying any use of force “was reasonable and necessary for self-defense.”

Protests Shine Light on Use of ‘Less-Lethal’ Weapons

The sheer number of incidents in those two months was shocking, said Dr. Rohini Haar, lead investigator for the analysis and an emergency physician in Oakland, California.

“It seems systematic,” Haar said. “It seems like there needs to be a reckoning with the use of force in protests.”

The projectiles in question are often called “rubber bullets,” but in law enforcement they’re known as “kinetic impact projectiles.”

They include plastic projectiles tipped with hard sponge or foam, “bean bag” rounds that consist of fabric socks containing metal shot, and “Sting-Balls” — grenades that spray hard rubber pellets. The report also cites incidents in which tear gas canisters were fired at people.

Though the weapons are referred to as “less lethal,” Haar said, there should be a shift to language that acknowledges how dangerous they can be. “Weapons are just as lethal as somebody wants them to be,” she said.

A study published in 2017 in the medical journal BMJ Open, which Haar co-authored, found that 3% of people hit by projectiles worldwide died. Fifteen percent of the 1,984 people studied were permanently injured.

In a letter to the editor of the New England Journal of Medicine, a group of Austin doctors said 19 patients were treated for bean bag-related wounds at the downtown hospital closest to the protests over two days in late May.

For its analysis, Physicians for Human Rights searched social media, news accounts, lawsuits and other publicly available sources. They counted incidents on social media only if they were documented by photos or videos, and included news reports without visual evidence only from major newspapers or local affiliates of major outlets.

Physicians for Human Rights identified by name most of the people who were struck.

Among the group’s recommendations are banning weapons that release scattershot or multiple projectiles from a single canister because they can hit people indiscriminately, Haar said. Metal projectiles are particularly dangerous, she said.

She called for more training and adherence to departments’ rules on the use of such weapons.

“One of the findings of our study is police do not even appear to be following their own protocols for how to use these weapons or when,” Haar said.

There are no national standards for police use of less-lethal projectiles and no comprehensive data on their use, USA Today found.

Demonstrators in Los Angeles, Minneapolis, San Jose, Denver and Dallas told USA Today they were shot with less-lethal projectiles even though those departments don’t allow the weapons to be used against nonviolent people. Some witnesses said police aimed at faces or fired at close range.

Police have said they fired the weapons to protect themselves and property in chaotic, dangerous situations.

‘Protesters Feel Like They’re Being Attacked’

Haar, who has been studying these projectiles since 2014, said they have no place in crowd control. “Even before you get to the use of weapons, there needs to be a change in how we engage with protesters in terms of communication,” she said.

For example, police can get the phone number of a protest leader, opening the lines of communication. Police have other options besides firing projectiles, Haar said, such as “arresting the person that is actually violent, not just dispersing the entire crowd, or changing what you decide is an illegal assembly.”

Haar said the use of these projectiles tends to escalate tensions, “where the protesters feel like they’re being attacked.” Those who aren’t struck, she said, “are often incited. It’s not until that full crowd is dispersed that the anger goes away. The volatility has a cumulative impact that can last weeks or months.”

At least seven major U.S. cities and a few states have enacted or proposed limits on the use of less-lethal projectiles.

However, similar efforts have stalled in the face of opposition from police agencies or other critics. And as the summer stretched on, local and federal law enforcement agencies continued to use less-lethal weapons when confronting protesters.

Haar said city councils have reached out to her recently, showing they are “really trying to reckon with what they want in their communities.”

“I see more hope now than I have in all of my years of research,” she said. “I think the attention now is remarkable, and we actually have a really good chance of getting some actual, meaningful change.”

USA Today’s Kevin McCoy contributed to this report.


This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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This story can be republished for free (details).