Obamacare Co-Ops Down From 23 to Final '3 Little Miracles'

KFF Health News, September 9, 2020

Today, co-ops cover about 128,000 people, just 1% of the 11 million Obamacare enrollees who get coverage through the exchanges.

By Phil Galewitz

New Mexico Health Connections' decision to close at year's end will leave just three of the 23 nonprofit health insurance co-ops that sprang from the Affordable Care Act.

One co-op serves customers in Maine, another in Wisconsin, and the third operates in Idaho and Montana and will move into Wyoming next year. All made money in 2019 after having survived several rocky years, according to data filed with the National Association of Insurance Commissioners.

They are also all in line to receive tens of millions of dollars from the federal government under an April Supreme Court ruling that said the government inappropriately withheld billions from insurers meant to help cushion losses from 2014 through 2016, the first three years of the ACA marketplaces. While those payments were intended to help any insurers losing money, it was vitally important to the co-ops because they had the least financial backing.

Lauded as a way to boost competition among insurers and hold down prices on the Obamacare exchanges, the co-ops had more than 1 million people enrolled in 26 states at their peak in 2015. Today, they cover about 128,000 people, just 1% of the 11 million Obamacare enrollees who get coverage through the exchanges.

The nonprofit organizations were a last-minute addition to the 2010 health law to satisfy Democratic lawmakers who had failed to secure a public option health plan — one set up and run by the government — on the marketplaces. Congress provided $2 billion in startup loans. But nearly all the co-ops struggled to compete with established carriers, which already had more money and recognized brands.

State insurance officials and health experts are hopeful the last three co-ops will survive.

"These are the three little miracles," said Sabrina Corlette, a research professor and co-director of the Center on Health Insurance Reforms at Georgetown University, in Washington, D.C.

Maine Aided in Supreme Court Victory

The Maine co-op, Community Health Options, helped bring competition to the state's market, which has had trouble at times attracting insurance carriers, said Eric Cioppa, who heads the state's bureau of insurance.

"The plan has added a level of stability and has been a positive for Maine," he said.

The co-op has about 28,000 members — down from about 75,000 in 2015 — and is building up its financial reserves, Cioppa said. Community Health Options is one of three insurers in the Obamacare marketplace in Maine, the minimum number experts say is needed to ensure vibrant competition.

Kevin Lewis, CEO of the plan, attributed its survival to several factors, including an initial profit in 2014, the year the ACA marketplaces opened, that put the plan on a secure footing before several years of losses. He also credited bringing most functions of the health plan in-house rather than contracting out, diversifying to sell plans to small and large employers, and securing lower rates from two health systems during a couple of difficult years.

Jay Gould, 60, a member who offers the plan to workers at his small grocery in Clinton, has been happy with the plan. "They have great customer service, and it's good to know when I am talking to someone that they are from Maine," he said.

Central Aroostook Association, a Presque Isle nonprofit that helps children with intellectual disabilities, switched to the co-op last year to save 20% on its health premiums, said administrator Tammi Easler. Having a Maine insurer means any issues can be dealt with quickly, she said. "They are readily available, and I never have to wait on hold for an hour."

The co-op, which made a $25 million profit each of the past two years, has proposed dropping its average premiums by about 14% in 2021, Lewis said.

Community Health was one of the lead plaintiffs in the case before the Supreme Court and expects to get $59 million in back payments from the settlement.

The federal decision to suspend those so-called risk corridor payments — designed to help health plans recover some of their losses — was one of the factors that caused many of the co-ops to fail, Corlette said. Republican critics of the ACA, however, blame poor management by the plans and lack of oversight by the Obama administration.

Insurers are in talks with the Trump administration about whether the $13 billion due the carriers must be added to their 2020 balance sheet or could be counted toward operations from prior years. This year, insurers are generally banking large profits since many people have delayed non-urgent care because of the COVID-19 pandemic. Since the ACA limits insurers' profit margins, adding that federal windfall to this year's ledger might mean many insurers would have to pay out most of the money to their consumers. If the money is applied to earlier years, the insurers could likely keep more of it to add to their reserves.

Too Much Competition in New Mexico

The Supreme Court ruling came too late for New Mexico Health Connections, which lost nearly $60 million from 2015 to 2017. The co-op would have received $43 million in overdue payments, but, in an effort to raise needed cash, it sold that debt to another insurer in 2017 for a much smaller amount.

Marlene Baca, CEO of the co-op, which made a $439,000 profit in 2019, said its goal of bringing competition into the market was achieved, since five other companies will be enrolling customers this fall for 2021. Yet, that competition eventually led to the plan's decision to end operations, announced last month.

With only 14,000 members, it made no sense to continue operating due to high fixed administrative costs, she said. Her plan was also hurt by the slumping economy this year, which pushed many state residents out of work and made more than 3,000 members eligible for Medicaid, the state-federal health program for the poor.

"We did our very best," Baca said, noting that her company is closing with enough money to pay its outstanding health claims. Many other co-ops that shuttered were closed out by their states and unable to meet all their debts to health providers, she said.

Montana's Co-Op Is Expanding

The Mountain Health Co-Op, with about 32,000 members, has just two competitors in its home state of Montana and four in Idaho.

A big factor behind its survival was that the plan received a $15 million loan in 2016 from St. Luke's Health System, Idaho's largest hospital provider, said CEO Richard Miltenberger. Although he wasn't working for the co-op at that time, Miltenberger said, it is his understanding that the hospital wanted to help maintain competition in that marketplace.

The co-op is expecting $57 million from the Supreme Court victory.

"We are in excellent shape," Miltenberger said. The plan, which paid back the St. Luke's loan and made a $15 million profit in 2019, added vision benefits this year and is offering a dental exam benefit for next year. It's also providing most insulin and medications for asthma and chronic obstructive pulmonary disease to members without any copayment to help ensure compliance.

The insurer is moving into Wyoming for 2021, which will end the Blue Cross plan monopoly in that state's Obamacare marketplace, he said.

Wisconsin's Mystery Donor

Wisconsin's Common Ground Healthcare Cooperative was on the verge of ending operations in 2016 when it received a lifesaving $30 million loan, said CEO Cathy Mahaffey. The insurer has refused to identify the benefactor other than to say it was not a person or company doing business with the plan.

In 2018, Common Ground was the only health plan in seven northeastern Wisconsin counties, she said. Today, the co-op has about 54,000 members and faces competition from two to five carriers in the 20 counties where it operates.

Common Ground, which recorded a $73 million profit last year, expects to receive about $95 million from the Supreme Court case victory.

Wisconsin's decision not to expand Medicaid under the health law has benefited the co-op because people with incomes from 100% to 138% of the federal poverty level ($12,760 to $17,609 for an individual) are ineligible for Medicaid and must stay with marketplace plans for coverage. In states that expanded Medicaid, everyone with incomes under 138% of the poverty level is eligible.

Another factor was its decision in 2016 to eliminate the broad provider network offering and sell a plan offering only a narrow network of doctors and hospitals, allowing it to benefit from lower rates from its providers, according to Mahaffey.

"We are very strong financially," she said.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

With Schools Starting Online, Vaccinations Head for Recess

KFF Health News, September 8, 2020

The COVID-19 pandemic has resulted in steep declines in vaccinations.

This article was published on Tuesday, September 8, 2020 in Kaiser Health News.

By Carmen Heredia Rodriguez

Dr. Chris Kjolhede is focused on the children of central New York.

As co-director of school-based health centers at Bassett Healthcare Network, the pediatrician oversees about 21 school-based health clinics across the region — a poor, rural area known for manufacturing and crippled by the opioid epidemic.

From ankles sprained during recess to birth control questions, the clinics serve as the primary care provider for many children both in and out of the classroom. High on the to-do list is making sure kids are up to date on required vaccinations, said Kjolhede.

But, in March, COVID upended the arrangement when it forced schools to close.

"It was like, holy smokes," he said, "what's going to happen now?"

Schools play a pivotal role in U.S. vaccination efforts. Laws require children to have certain immunizations to enroll and attend classes.

But this academic year, to prevent COVID-19 from spreading, many school districts have opted to start classes online. The decision takes away much of the back-to-school leverage pushing parents to stay current on their children's shots, said Dr. Nathaniel Beers, member of the Council on School Health for the American Academy of Pediatrics. If schooling is not happening in person, said Beers, who also led multiple roles in the District of Columbia Public Schools system, "it is harder to enforce."

Public health officials have relied on schools as a means to control vaccine-preventable diseases for over a century. Vaccination laws that require immunizations to enter school first emerged in the 1850s in Massachusetts as a means to control smallpox, as the Centers for Disease Control and Prevention has noted.

Every state requires children to receive certain vaccinations against illnesses like polio, mumps and measles before entering the classroom or a child care center, unless the child has a medical exemption. Some states allow people to opt children out of vaccinations for religious or philosophical reasons, although these exemptions have been associated with outbreaks of otherwise well-controlled diseases like measles.

"If they get behind or they don't get specific vaccines they need, kindergarten is a real catch point to get them up to speed and make sure they're up to date," said Claire Hannan, executive director of the Association of Immunization Managers.

At the local level, the responsibility of tracking whether students are compliant generally falls on the school nurse. If one is not present, a clerical worker or administrator does the job, said Linda Mendonca, president-elect of the National Association of School Nurses. Usually, school systems face a deadline for checking every child's record and reporting compliance to government health officials, she said.

How districts choose to hold noncompliant children accountable varies, Beers said. Some schools work with parents to set up appointments with a provider. Some isolate children in a classroom, he said, and some are so strict that "you can't even walk through the door unless you are appropriately immunized."

The COVID-19 pandemic has resulted in steep declines in vaccinations. In May, a report from the CDC showed a sharp drop in the number of orders submitted to the Vaccines For Children program, a federal initiative that purchases vaccines for half the children in the U.S. A second release revealed similar trends — vaccination coverage in Michigan declined among all milestone ages, with the exception of immunizations given at birth, which are generally done in a hospital.

Making Backup Plans

In Pennsylvania, for instance, the state health department in July suspended vaccine requirements for two months after the start of the school year. In addition to causing delays in doctors' offices, the state said, the pandemic may also prevent school and public health nurses from holding in-school "catch-up" vaccination clinics.

"The department cannot stress enough that as soon as children can be vaccinated, they should be," said Nate Wardle, press secretary for the state's health department, in a written statement. However, the lockdown order prompted by COVID meant "that there was a several month period in some parts of the state where well-child visits were not occurring."

Members of the American Academy of Pediatrics, the National Association of School Nurses and the Association of Immunization Managers said the grace periods are a prudent step to account for the pandemic's effect on pediatric care. The majority of children already have some protection from diseases from previous vaccines, they said.

Additionally, Beers acknowledged that closing schools — among other actions like restricting travel and shuttering large gathering spaces — make children less likely to contract or spread illnesses that typically incubate in classrooms. For example, according to CDC data, measles has essentially disappeared — 12 cases had been reported as of Aug. 19 this year, compared with 1,282 throughout 2019.

However, schooling will eventually resume in person, which will also bring back the risks of illnesses moving through classrooms, Beers said. And school systems may be less forgiving of children who enter the classroom without the needed vaccinations.

"What would be an immense shame is if schools reopen in person and children are back together and we start getting outbreaks of other diseases that are preventable based on immunizations," he said.

School-based health centers in New York are actively contacting parents about vaccinations. In Cooperstown, Kjolhede reached out to every superintendent soon after the lockdown in March to ask if the clinic could remain open. All but one said no.

The staff then set up telehealth appointments and phoned students who needed in-person care to arrange visits — including those who needed a vaccine before the start of this school year, he said. Luckily, the health center that remained open had a door that allowed patients to enter the clinic without walking through the school.

Several hours away, Dr. Lisa Handwerker is grappling with how to tackle the problem that hundreds of students across her six school-based health clinics in New York City have missed a required vaccine.

The city's health department gave her a list of students in her care who needed additional immunizations, she said. Over 400 children were missing the second dose to prevent meningococcal meningitis, generally given to teens and young adults ages 16 to 23. Because the department used data from the last academic year to compile the list, Handwerker has no information about new students. Some families left the city because of the lack of income and resources caused by the pandemic.

"We had difficulty with at least half of the kids on our vaccine list," Handwerker said. "Then when we reached families, they were reluctant to leave their houses."

A Shot at Normalcy

That wasn't the case for Tracey Wolf, a mother of two who visited the doctor recently to get her son Jordan vaccinated for measles, mumps, rubella and HPV before starting the seventh grade. He will be attending middle school in Dunedin, Florida, in person, said Wolf, 38.

It seemed nonsensical to keep Jordan, 13, from his classmates when he already plays baseball and hangs out with his friends, she said. His grades also slipped last spring when the COVID threat transformed his classroom into a computer.

She also took her 6-month-old Ethan for his immunizations. When asked whether she was afraid of going into her doctor's office, she replied, "Not more than going to the grocery store."

Regardless of whether a child starts school at home or in the classroom, immunization experts stressed the importance of vaccinating a child on time. The schedules factor in a child's stage of development to maximize the vaccine's effectiveness. That said, it is preferable that children get their vaccines from their regular doctor to prevent lost immunization records and additional shots, said Beers.

Yet on Aug. 19, the Department of Health and Human Services released a statement allowing pharmacists to provide childhood immunizations for children ages 3 to 18.

Carmen Heredia Rodriguez: CarmenH@kff.org, @ByCHRodriguez

Why Black Aging Matters, Too

KFF Health News, September 5, 2020

Older Black Americans have received little attention as protesters proclaim that Black Lives Matter and experts churn out studies about the coronavirus.

This article was published on Thursday, September 3, 2020 in Kaiser Health News.

By Judith Graham

Old. Chronically ill. Black.

People who fit this description are more likely to die from COVID-19 than any other group in the country.

They are perishing quietly, out of sight, in homes and apartment buildings, senior housing complexes, nursing homes and hospitals, disproportionately poor, frail and ill, after enduring a lifetime of racism and its attendant adverse health effects.

Yet, older Black Americans have received little attention as protesters proclaim that Black Lives Matter and experts churn out studies about the coronavirus.

“People are talking about the race disparity in COVID deaths, they’re talking about the age disparity, but they’re not talking about how race and age disparities interact: They’re not talking about older Black adults,” said Robert Joseph Taylor, director of the Program for Research on Black Americans at the University of Michigan’s Institute for Social Research.

A KHN analysis of data from the Centers for Disease Control and Prevention underscores the extent of their vulnerability. It found that African Americans ages 65 to 74 died of COVID-19 five times as often as whites. In the 75-to-84 group, the death rate for Blacks was 3½ times greater. Among those 85 and older, Blacks died twice as often. In all three age groups, death rates for Hispanics were higher than for whites but lower than for Blacks.

(The gap between Blacks and whites narrows over time because advanced age, itself, becomes an increasingly important, shared risk. Altogether, 80% of COVID-19 deaths are among people 65 and older.)

The data comes from the week that ended Feb. 1 through Aug. 8. Although breakdowns by race and age were not consistently reported, it is the best information available.

Mistrustful of Outsiders

Social and economic disadvantage, reinforced by racism, plays a significant part in unequal outcomes. Throughout their lives, Blacks have poorer access to health care and receive services of lower quality than does the general population. Starting in middle age, the toll becomes evident: more chronic medical conditions, which worsen over time, and earlier deaths.

Several conditions — diabetes, chronic kidney disease, obesity, heart failure and pulmonary hypertension, among others — put older Blacks at heightened risk of becoming seriously ill and dying from COVID-19.

Yet many vulnerable Black seniors are deeply distrustful of government and health care institutions, complicating efforts to mitigate the pandemic’s impact.

The infamous Tuskegee syphilis study — in which African American participants in Alabama were not treated for their disease — remains a shocking, indelible example of racist medical experimentation. Just as important, the lifelong experience of racism in health care settings — symptoms discounted, needed treatments not given — leaves psychic scars.

In Seattle, Catholic Community Services sponsors the African American Elders Program, which serves nearly 400 frail homebound seniors each year.

“A lot of Black elders in this area migrated from the South a long time ago and were victims of a lot of racist practices growing up,” said Margaret Boddie, 77, who directs the program. “With the pandemic, they’re fearful of outsiders coming in and trying to tell them how to think and how to be. They think they’re being targeted. There’s a lot of paranoia.”

“They won’t open the door to people they don’t know, even to talk,” complicating efforts to send in social workers or nurses to provide assistance, Boddie said.

In Los Angeles, Karen Lincoln directs Advocates for African American Elders and is an associate professor of social work at the University of Southern California.

“Health literacy is a big issue in the older African American population because of how people were educated when they were young,” she said. “My maternal grandmother, she had a third-grade education. My grandfather, he made it to the fifth grade. For many people, understanding the information that’s put out, especially when it changes so often and people don’t really understand why, is a challenge.”

What this population needs, Lincoln suggested, is “help from people who they can relate to” — ideally, a cadre of African American community health workers.

With suspicion running high, older Blacks are keeping to themselves and avoiding health care providers.

“Testing? I know only of maybe two people who’ve been tested,” said Mardell Reed, 80, who lives in Pasadena, California, and volunteers with Lincoln’s program. “Taking a vaccine [for the coronavirus]? That is just not going to happen with most of the people I know. They don’t trust it and I don’t trust it.”

Reed has high blood pressure, anemia, arthritis and thyroid and kidney disease, all fairly well controlled. She rarely goes outside because of COVID-19. “I’m just afraid of being around people,” she admitted.

Other factors contribute to the heightened risk for older Blacks during the pandemic. They have fewer financial resources to draw upon and fewer community assets (such as grocery stores, pharmacies, transportation, community organizations that provide aging services) to rely on in times of adversity. And housing circumstances can contribute to the risk of infection.

In Chicago, Gilbert James, 78, lives in a 27-floor senior housing building, with 10 apartments on each floor. But only two of the building’s three elevators are operational at any time. Despite a “two-person-per-elevator policy,” people crowd onto the elevators, making it difficult to maintain social distance.

“The building doesn’t keep us updated on how they’re keeping things clean or whether people have gotten sick or died” of COVID-19, James said. Nationally, there are no efforts to track COVID-19 in low-income senior housing and little guidance about necessary infection control.

Large numbers of older Blacks also live in intergenerational households, where other adults, many of them essential workers, come and go for work, risking exposure to the coronavirus. As children return to school, they, too, are potential vectors of infection.

‘Striving Yet Never Arriving’

In recent years, the American Psychological Association has called attention to the impact of racism-related stress in older African Americans — yet another source of vulnerability.

This toxic stress, revived each time racism becomes manifest, has deleterious consequences to physical and mental health. Even racist acts committed against others can be a significant stressor.

“This older generation went through the civil rights movement. Desegregation. Their kids went through busing. They grew up with a knee on their neck, as it were,” said Keith Whitfield, provost at Wayne State University and an expert on aging in African Americans. “For them, it was an ongoing battle, striving yet never arriving. But there’s also a lot of resilience that we shouldn’t underestimate.”

This year, for some elders, violence against Blacks and COVID-19’s heavy toll on African American communities have been painful triggers. “The level of stress has definitely increased,” Lincoln said.

During ordinary times, families and churches are essential supports, providing practical assistance and emotional nurturing. But during the pandemic, many older Blacks have been isolated.

In her capacity as a volunteer, Reed has been phoning Los Angeles seniors. “For some of them, I’m the first person they’ve talked to in two to three days. They talk about how they don’t have anyone. I never knew there were so many African American elders who never married and don’t have children,” she said.

Meanwhile, social networks that keep elders feeling connected to other people are weakening.

“What is especially difficult for elders is the disruption of extended support networks, such as neighbors or the people they see at church,” said Taylor, of the University of Michigan. “Those are the ‘Hey, how are you doing? How are your kids? Anything you need?’ interactions. That type of caring is very comforting and it’s now missing.”

In Brooklyn, New York, Barbara Apparicio, 77, has been having Bible discussions with a group of church friends on the phone each weekend. Apparicio is a breast cancer survivor who had a stroke in 2012 and walks with a cane. Her son and his family live in an upstairs apartment, but she does not see him much.

“The hardest part for me [during this pandemic] has been not being able to go out to do the things I like to do and see people I normally see,” she said.

In Atlanta, Celestine Bray Bottoms, 83, who lives on her own in an affordable senior housing community, is relying on her faith to pull her through what has been a very difficult time. Bottoms was hospitalized with chest pains this month — a problem that persists. She receives dialysis three times a week and has survived leukemia.

“I don’t like the way the world is going. Right now, it’s awful,” she said. “But every morning when I wake up, the first thing I do is thank the Lord for another day. I have a strong faith and I feel blessed because I’m still alive. And I’m doing everything I can not to get this virus because I want to be here a while longer.”

KHN data editor Elizabeth Lucas contributed to this story.

Will Labor Day Weekend Bring Another Holiday COVID Surge?

KFF Health News, September 4, 2020

In time for the tail end of summer, many local governments are lifting restrictions to resuscitate tourism activity and rescue small businesses.

This article was published on Friday, September 4, 2020 in Kaiser Health News.

By Blake Farmer, Nashville Public Radio

Hopefully, summer won’t end the way it began. Memorial Day celebrations helped set off a wave of coronavirus infections across much of the South and West. Gatherings around the Fourth of July seemed to keep those hot spots aflame.

And now Labor Day arrives as those regions are cooling off from COVID-19. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, warned Wednesday that Americans should be cautious to avoid another surge in infection rates. But travelers are also weary of staying home — and tourist destinations are starved for cash.

“Just getting away for an hour up the street and staying at a hotel is like a vacation, for real,” says Kimberly Michaels, who works for NASA in Huntsville, Alabama, and traveled to Nashville, Tennessee, with her boyfriend to celebrate his birthday last weekend.

Lifting Restrictions for Summer’s End

In time for the tail end of summer, many local governments are lifting restrictions to resuscitate tourism activity and rescue small businesses.

Nashville, for instance, gave the green light to pedal taverns this week, allowing the human-powered bars-on-wheels to take to the streets again. “They’re not Nashville’s favorite group, frankly. But fairness requires this protocol change to take place,” Mayor John Cooper said, noting the city’s dramatic reduction in new cases. This week, the city also raised the attendance cap on weddings, funerals and other ceremonies.

Elsewhere, Virginia Beach tried to get some leniency for its struggling restaurants over the holiday weekend. But Virginia Gov. Ralph Northam rejected pleas from the mayor, at the encouragement of Fauci. The country’s top health official has encouraged governors to keep restrictions in place to avoid another holiday-related surge.

“Sometimes, as we start to lift restrictions, the impression that people get is ‘Oh, that must mean it’s safe,’” says epidemiologist Melissa McPheeters of Vanderbilt University. “We want to make sure we don’t give that impression, because this disease has not gone anywhere.”

Some communities have gone the other direction and reimposed restrictions, especially for the three-day weekend. Santa Barbara, California, has banned sunbathing to avoid another surge in cases.

Schooling Screws Up COVID Circles

There’s also a new X-factor with summer’s last holiday weekend. In many states, schools have resumed in-person classes. So families and friends meeting up are now more likely to expose each other to the virus, even if they tried to keep a tight circle over the summer.

“If those bubbles now have kids that went back to school and are interacting with others or they’ve gone back to sports and the bubble has since expanded, that ability to be safely together in a gathering is probably less likely,” says epidemiologist Bertha Hidalgo of the University of Alabama-Birmingham.

And yet, getting together safely — preferably outdoors — is still worth a try, Hidalgo says. She says people’s mental health needs a boost to get through the next few months.

“If you can do the safe things now before winter hits and that cold weather hits, then you’ll be more resilient to get through any bad times that may come,” she says.

In drivable destinations like Nashville that have welcomed visitors throughout the pandemic, tourism has not bounced back entirely. But on some weekend nights, the neon-soaked tourist district can draw a crowd.

This week, Vaj Vemulapalli and his girlfriend, of Dallas, turned back to their hotel after feeling uncomfortable with how tightly people were packed together.

“We crave the social interaction, the going out to bars and everything,” he says. “But at the end of the day, our general stance is it’s not worth getting [COVID-19] just to get a drink.”

Those crowds have limits, though, as Kimberly Michaels and birthday boy Marcus Robinson discovered. They arrived in Nashville fashionably late, masked up and ready to responsibly party. But after they checked into their hotel, they discovered that everything has to shut down by 10:30.

“It’s crazy. It was like the twilight zone,” Robinson says. “We went in [to the hotel], the streets were full. Got dressed, come downstairs. Like, where did everybody go? Like, did something happen? But we didn’t know, because we’re not from here.”

Still, as time goes by, some travelers are willing to take more risks to get back to activities that feel normal.

Suzette Ourso lives outside New Orleans and flew to Nashville for her first out-of-town trip since the pandemic hit. She says she’s cautious, wearing her mask whenever near anyone else.

“I keep hand sanitizer in my purse now. That’s something I’ve never really done before,” she says. “But you can die tomorrow riding in your vehicle. So you can’t live your life in fear, either.”

Ourso has a trip to the beach planned for later in the month.

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

As Threat of Valley Fever Grows Beyond the Southwest, Push Is On for Vaccine

KFF Health News, September 4, 2020

In addition to Galgiani's research, the National Institutes for Health's National Institute for Allergy and Infectious Diseases is funding two other cocci vaccine research projects.

This article was published on Friday, September 4, 2020 in Kaiser Health News.

By Jim Robbins

One New Year’s Day, Rob Purdie woke up with a headache that wouldn’t quit. Vision problems, body aches and a slight fever followed. At the emergency room, the Bakersfield, California, resident was given antibiotics, which didn’t touch his symptoms. His headache turned into cluster headaches and the fatigue became worse.

“I was not really functional,” he said in a recent interview, recalling the beginning of his eight-year struggle with the mystery illness.

After five weeks, he ended up at Bakersfield’s Kern Medical, home to the Valley Fever Institute. A resident physician quickly realized the cause of the symptoms. A spinal fluid sample confirmed Purdie was suffering from valley fever, a fungal infection that occurs in the deserts of the Southwest, primarily Arizona and California. The infection had spread from his lungs into his brain, causing inflammation and headaches.

He was in and out of the hospital for a year with debilitating symptoms. There is no cure for valley fever; doctors use existing antifungal medications that often don’t relieve the symptoms. He tried three oral antifungal drugs and finally ended up with injections of amphotericin B — “salvage therapy,” meaning it is a drug of last resort — which he is still on, eight years later.

Purdie, 39, now works for the Valley Fever Institute, teaching others about the poorly understood disease. He still has no clue how he inhaled the spore that causes it. “I was probably out doing yardwork,” he said, “and took the wrong breath.”

Valley fever — coccidioidomycosis (“cocci” for short) is the scientific name — is an “orphan disease.” An orphan disease is defined in the U.S. as one affecting fewer than 200,000 people. Valley fever is diagnosed in the range of 10,000 to 15,000 cases a year in the U.S. with 160 fatalities, though both numbers are likely several times higher in reality because many cases are never identified. That’s why it’s often hard to attract attention to developing a vaccine.

In the 1980s, a promising vaccine candidate failed in clinical trials. There has been no other candidate for a vaccine until recently. Now, with mouse studies showing promise, there is a renewed push. Dr. John Galgiani, head of the University of Arizona’s Valley Fever Center for Excellence, is heading up vaccine research there and believes the vaccine shown to prevent valley fever in mice should be available for dogs, which also get infected in large numbers, as soon as next year. A veterinary vaccine company, Anivive, is developing it. “It’s very promising,” said Galgiani.

The same vaccine is in the early stage of development for humans, though it’s still years away.

In addition to Galgiani’s research, the National Institutes for Health’s National Institute for Allergy and Infectious Diseases is funding two other cocci vaccine research projects.

One drug, nikkomycin Z, has cured the disease in mice; experts believe it could do the same for humans. It’s being developed by the University of Arizona with funding from the National Institutes of Health, the Food and Drug Administration and other sources.

Valley fever is getting more attention for a few reasons. The number of cases has been increasing, and a study last year predicted it may spread north through the West as the climate warms. By 2095, five more states may be added to the list of 12 where the fungus now lives, growing its range in a swath across the West and into the Great Plains from Texas to Montana and North Dakota. The fungus is also found in Mexico and in Central and South America.

U.S. House Minority Leader Kevin McCarthy represents parts of California’s Central Valley, where cocci is prevalent. It’s a voting issue there and the Republican has made it a priority, bringing federal dollars to bear for research, surveillance and awareness.

The big problem with developing a vaccine is the relatively small market. The cost of studies to bring the drug to market, Galgiani estimated, is $50 million, while a federal study in 2000 pegged the cost of developing a vaccine at $360 million — though Galgiani believes it could be done for half that, still a hefty cost for a small group of patients.

“We don’t compete effectively against other investment opportunities,” he said.

Two types of the fungus Coccidioides cause valley fever. They dwell in desert soil between 2 inches and a foot deep and when disturbed become suspended in the air and are occasionally inhaled.

Cocci, sometimes called “desert rheumatism,” causes fever, cough, body aches, extreme exhaustion and difficulty breathing. There is no person-to-person spread.

Because the pneumonia-like symptoms are similar to those caused by the novel coronavirus, many cases of valley fever are likely being reported as COVID-19, Galgiani said, which means they are not getting treatment with antifungal medications that can temper symptoms if applied early on.

The infection can spur inflammation that “causes scarring and damage to parts of your nervous system,” Galgiani said. “Early diagnosis means less damage.”

Valley fever case numbers have grown substantially in the past five years, though they are down this year, perhaps because many doctors mistake the condition for COVID-19.

Most cases resolve on their own without treatment. Yet in 5% to 8% of diagnosed patients, the disease spreads to skin, bones and organs, and can be deadly. If it reaches the brain and spinal cord, as it did with Rob Purdie, it can cause meningitis, or swelling of the membranes. These patients, if they don’t die, may need antifungal treatments for life.

Blacks and Filipinos are four times more likely to have these serious effects than other demographic groups, according to Galgiani.

An epidemic devastated prisoners in the San Joaquin Valley, the southern section of California’s Central Valley, in the early and mid-2000s. Investigation showed the rate in two prisons — which had populations with higher numbers of minorities than the surrounding communities — was hundreds of times higher than in the surrounding area. Eventually, more than 30 prisoners died and many more had serious chronic infections.

The high season for infection is late summer and fall. Some 95% of the cases occur in the Central Valley and the Phoenix area. “They are in urban areas; you don’t have to be out on the desert to be infected,” Galgiani said.

Compounding the effects of valley fever is that it often goes undiagnosed. Even in Phoenix’s Maricopa County — where the fungus is endemic in the desert soil and 50% of the nation’s cases occur — it’s not on the radar screen of many doctors. Further complicating a diagnosis is that test results are often wrong and it may take two or three tests to identify the disease.

The lack of awareness of valley fever is one of the factors that led Purdie to take a job last year as outreach coordinator of the Valley Fever Institute. “There’s a lot of misinformation about it,” he said.

The vaccine that experts are banking on is called Delta CPS-1. It has proved very effective in mice in published studies and could be on the market as soon as next year for dogs. It’s estimated that 60,000 dogs contract valley fever every year in what’s known as the “Valley Fever Corridor” between Phoenix and Tucson, Arizona, and the numbers are probably similar for Bakersfield and other parts of the Central Valley. Symptoms in canines are similar to those in humans.

The same vaccine could one day prove effective in humans, though trials are years and many millions of dollars away. “It’s a great candidate for human immunization,” said Dr. Tom Monath, managing partner and chief scientific officer of Crozet BioPharma, which is working on the vaccine. “It’s hard to offer any promises, but it could take less than 10 years.”

HHS Plan to Improve Rural Health Focuses on Better Broadband, Telehealth Services

KFF Health News, September 4, 2020

This announcement comes in response to Trump's executive order last month calling for improved rural health and telehealth access.

This article was published on Friday, September 4, 2020 in Kaiser Health News.

By Sarah Jane Tribble

Knowing it may be met with some skepticism, the Trump administration Thursday announced a sweeping plan that officials say will transform health care in rural America.

Even before the coronavirus pandemic reached into the nation’s less-populated regions, rural Americans were sicker, poorer and older than the rest of the country. Hospitals are shuttering at record rates, and health care experts have long called for changes.

The new plan, released by Health and Human Services Secretary Alex Azar, acknowledges the gaps in health care and other problems facing rural America. It lists a litany of projects and directives, with many already underway or announced within federal agencies.

“We cannot just tinker around the edges of a rural healthcare system that has struggled for too long,” Azar said in a prepared statement.

Yet, that is exactly what experts say the administration continues to do.

“They tinker around the edges,” said Tommy Barnhart, former president of the National Rural Health Association. And, he added, “there’s a lot of political hype” that has happened under President Donald Trump, as well as previous presidents.

In the past few months, rural health care has increasingly become a focus for Trump, whose polling numbers are souring as COVID-19 kills hundreds of Americans every day, drives down restaurant demand for some farm products and spreads through meatpacking plants. Rural states including Iowa and the Dakotas are reporting the latest surges in cases.

This announcement comes in response to Trump’s executive order last month calling for improved rural health and telehealth access. Earlier this week, three federal agencies also announced they would team up to address gaps in rural broadband service — a key need as large portions of the plan seek to expand telehealth.

The plan is more than 70 pages long and the word “telehealth” appears more than 90 times, with a focus on projects across HHS, including the Health Resources and Services Administration and the Centers for Medicare & Medicaid Services.

Barnhart said CMS has passed some public health emergency waivers since the beginning of the pandemic that helped rural facilities get more funding, including one that specifically was designed to provide additional money for telehealth services. However, those waivers are set to expire when the coronavirus emergency ends. Officials have not yet set a date for when the federal emergency will end.

Andrew Jay Schwartzman, senior counselor to the Benton Institute for Broadband & Society, a private foundation that works to ensure greater internet access, said there are multiple challenges with implementing telehealth across the nation. Many initiatives for robust telehealth programs need fast bandwidth, yet getting the money and setting up the necessary infrastructure is very difficult, he said.

“It will be a long time before this kind of technology will be readily available to much of the country,” he said.

Ge Bai, associate professor of accounting and health policy at Johns Hopkins University in Baltimore, noted that telehealth was short on funding in the HHS initiative. However, she said, the focus on telehealth, as well as a proposed shift in payment for small rural hospitals and changing workforce licensing requirements, had good potential.

“We are so close to the election that this is probably more of a messaging issue to cater to rural residents,” Bai said. “But it doesn’t matter who will be president. This report will give the next administration useful guidance.”

The American Hospital Association, representing 5,000 hospitals nationwide, sent a letter to Trump last week recommending a host of steps the administration could take. As of late Thursday, AHA was still reviewing the HHS plan but said it was “encouraged by the increased attention on rural health care.”

Buried within the HHS announcement are technical initiatives, such as a contract to help clinics and hospitals integrate care, and detailed efforts to address gaps in care, including a proposal to increase funding for school-based mental health programs in the president’s 2021 budget.

A senior HHS official said that while some actions have been taken in recent months to improve rural health — such as the $11 billion provided to rural hospitals through coronavirus relief funding — more is needed.

“We’re putting our stake in the ground that the time for talk is over,” he said. “We’re going to move forward.”

In Legislative Shuffle, California Prioritizes Safety Gear and Sick Leave During Crisis

KFF Health News, September 4, 2020

Newsom has until Sept. 30 to sign the bills into law or veto them.

This article was published on Friday, September 4, 2020 in Kaiser Health News.

By Rachel Bluth and Angela Hart and Samantha Young

SACRAMENTO, Calif. — California lawmakers convened this year with big plans to tackle soaring health care costs, expand health insurance coverage and improve treatment for mental health and addiction.

But the pandemic abruptly reoriented their priorities, forcing them to grasp for legislative solutions to the virus ripping through the state.

Legislative deliberations this year were defined by quarantined lawmakers, emergency recesses and chaotic video voting — plus a late-night partisan dust-up that led to the death of dozens of bills by the time lawmakers gaveled out early Tuesday morning. Nonetheless, legislators managed to send Gov. Gavin Newsom nearly 430 bills, roughly 40% of the number they’d send in a typical year, according to Sacramento lobbyist Chris Micheli.

Among them were about two dozen COVID-related bills that addressed a range of challenges, including dire shortages of protective gear, sick leave for workers and the administration of a hoped-for COVID-19 vaccine. The measures broadly fit into three categories: dealing with the current crisis, protecting workers and consumers, and preparing for future pandemics.

Newsom has until Sept. 30 to sign the bills into law or veto them.

“In a year that couldn’t be business as usual, this session we were still able to get important business done for the people of California who are facing so many challenges,” said Senate President Pro Tem Toni Atkins. “This year’s session may be over, but this pandemic is not, and neither is our work.”

Just as important as the measures that made it to Newsom’s desk were the ones that didn’t. For instance, bills that would have limited the use of sensitive personal information in contact tracing investigations died, as did a proposal to help rebuild and fund public health infrastructure across California.

“It leaves us with the status quo,” said Michelle Gibbons, executive director of the County Health Executives Association of California, which lobbies on behalf of the state’s county health directors. “If we had sufficient staffing of public health all along, and stronger resources, it would have helped.”

Immediate Action

Narrowly focused bills that targeted real-time COVID-related problems — and avoided big price tags — were among those easily winning approval.

AB-685, by Assembly member Eloise Gómez Reyes (D-San Bernardino), would require employers to notify their workers of COVID-19 infections at work — and would mandate the reporting of infection data to state and local public health authorities.

A different measure, AB-2164, would require Medi-Cal, California’s Medicaid program, to cover more telehealth visits in underserved areas by eliminating an existing requirement for patients and providers to establish an in-person relationship first.

But this wouldn’t be a permanent change: If signed, the law would sunset 180 days after the official COVID-19 state of emergency is over. Rivas said he had to scale back the cost of the measure by applying it only to the pandemic to get it passed.

“Had we not done that, it was very likely this bill would have been held in the Senate Appropriations Committee,” said Assembly member Robert Rivas (D-Hollister), who introduced the bill.

Another bill written with near missile-guided precision is AB-1710, which would allow pharmacists to administer a COVID vaccine once one is approved by the Food and Drug Administration.

“We want to make sure we can gear up as quickly as possible,” said Assembly member Jim Wood (D-Santa Rosa), who authored the bill.

Wood also authored AB-2644, which would require nursing homes to have a full-time “infection preventionist,” and to report deaths from communicable diseases to the state during an emergency. Wood said the bill was written after he “watched with horror” as COVID-19 killed thousands of nursing home residents in the spring.

Consumer and Worker Protections

Lawmakers took on powerful business interests to boost protections for essential workers.

A bill introduced by Sen. Jerry Hill (D-San Mateo) would make it easier for some employees infected with COVID-19 to file a workers’ compensation insurance claim until January 2023.

Should Newsom sign SB-1159, for instance, state law would presume that certain front-line workers — from health care workers in hospitals to firefighters who go into people’s homes — were infected on the job unless their employers prove otherwise.

The California Chamber of Commerce, which opposed the measure, questioned whether an employee’s illness could be traced to their job when the virus is so widespread. By varying degrees, at least 14 states have extended workers’ compensation to include COVID-related scenarios, according to the National Conference of State Legislatures.

Frustrated with outbreaks at meatpacking plants, lawmakers also advanced legislation calling on food-processing companies with at least 500 workers to provide two weeks of paid sick leave to those exposed to COVID-19 or advised to quarantine.

The measure, AB-1867, spearheaded by Assembly member Phil Ting (D-San Francisco), also would close a loophole in the federal emergency paid sick leave benefit that Congress authorized this spring, which excluded health care workers and emergency responders. If Newsom signs the bill, they too would qualify for two weeks of paid sick time.

And in what would be the biggest expansion to the state’s family leave program since it began in 2004, lawmakers voted to extend job protections to more workers who wish to take time off to care for a new baby or a sick relative.

California’s family leave program currently exempts small-business workers from the job protections, leaving millions of workers without the benefit. For example, an employee who works for a company with 20 or fewer employees does not qualify for job protection to bond with an infant. Employers with 50 or fewer workers aren’t required to guarantee someone’s job if they leave to care for a sick parent or other family member.

In both cases, that would change to employers with five or more workers if the governor signs SB-1383, introduced by Sen. Hannah-Beth Jackson (D-Santa Barbara).

“In the time of COVID, we are relying on families, grandparents, children to take care of each other when they get sick,” Jackson said. “We should be able to protect ourselves, to take responsibility for ourselves, to be able to protect ourselves without fear of losing our jobs.”

Lessons Learned

Inadequate personal protective gear emerged early on as one of the biggest impediments to California’s coronavirus response — and measures advanced by the legislature could prepare the state for future threats.

“We can be more prepared to protect our state in the next health crisis,” said Assembly Speaker Anthony Rendon.

California lawmakers approved a pair of high-profile bills to address protective equipment shortages. The more ambitious proposal, authored by Assembly member Freddie Rodriguez (D-Pomona), would require hospitals to stockpile a three-month supply by April 2021.

“We’ve already lost far too many members to COVID-19,” said Stephanie Roberson, lead lobbyist for the California Nurses Association, which sponsored AB-2537.

“It’s something that could have been prevented,” Roberson said, adding that “it’s the responsibility of employers to protect their workers.”

Newsom also must decide whether the state government should maintain a supply of protective gear for essential workers. SB-275, from Sen. Richard Pan (D-Sacramento) and sponsored by the Service Employees International Union California, would mandate the California Department of Public Health within one year to establish a PPE stockpile for health and other essential workers to last 90 days during a pandemic.

It also would require major employers of health care workers — such as dialysis clinics, nursing homes and hospitals — to establish by 2023 or later an additional 45-day stockpile of PPE.

An August report from the University of California-Berkeley found that at least 20,860 California cases of COVID-19 among essential workers could have been avoided, as well as dozens of deaths, if the state had had a sufficient supply of protective gear.

The powerful California Hospital Association fought both measures, saying the goals are laudable yet unworkable. “We agree that bolstering the supply and reliability of PPE for health care and other essential workers is a top priority,” said spokesperson Jan Emerson-Shea.

“It is critically important to remember, however, that we are still in the midst of a pandemic and there are still significant challenges with the global supply chain of PPE.”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

LA County Authorities Cautious Despite Declining COVID Numbers

KFF Health News, September 3, 2020

The number of new cases in Los Angeles County, despite daily bounces up and down, has trended sharply lower in recent weeks — from peaks well above 4,000 in July to figures well under 2,000 by late August.

This article was published on Thursday, September 3, 2020 in Kaiser Health News.

By Bernard J. Wolfson

In Los Angeles County, California’s main COVID-19 hot spot since early in the pandemic, key indicators of the disease have taken an encouraging turn recently.

New cases, hospitalizations, deaths and the rate of positive test results have all been dropping.

But because of the surge of infections after the lifting of restrictions in May, followed by a spike after Memorial Day — and another one after July Fourth — health officials and other experts are wary of loosening restrictions too quickly this time. The approaching Labor Day holiday weekend, when people traditionally gather in groups, reinforces their caution.

The daily number of new cases in the county, despite bounces in each direction, has trended sharply lower in recent weeks — from peaks well above 4,000 in July to numbers well under 2,000 by late August.

The seven-day average of daily coronavirus deaths has dropped steadily, from 44 in late July to 19 as of Aug. 25. And the seven-day average rate of positive COVID tests, another widely watched measure, fell from over 9% in early July to about 5% as of Monday.

Barbara Ferrer, L.A. County’s top public health official, expressed guarded optimism but urged caution with regard to any further loosening of restrictions on business or recreation.

“Please, let’s not let down our guard,” she said at a news conference last week. “We did have a surge after each of the other large holidays, so it would not be a good idea to move with haste on reopening plans until we can make sure that we get through Labor Day with people acting appropriately.”

The recent data is “very encouraging,” said Dr. Ravi Kavasery, medical director of quality and population health at AltaMed, one of the nation’s largest community clinic chains. But “it is very clear we are making this progress because we have made these changes to our behavior, and it provides all the more reason for us to stay the course.”

Indeed, a new plan for reopening businesses and other activities, unveiled Friday by California Gov. Gavin Newsom, shows L.A. County has a long way to go before it is out of the woods.

The new plan replaces the state’s previous county “watchlist” with a four-tier, color-coded system that ranks counties by their risk, based on how prevalent the coronavirus is.

Counties with more than 7 new daily cases per 100,000 people, or positive COVID test rates of more than 8%, are defined as highest-risk, with the danger of infection deemed “widespread” (purple). Three lower tiers are defined as counties of “substantial” (red), “moderate” (orange) and “minimal” risk (yellow).

L.A. County is in the “widespread” tier, as are 38 of the 57 other California counties. The state blueprint prohibits many nonessential businesses from operating indoors in these counties, though hair salons and barbershops can open indoors, and retail — including shopping centers — can operate while limited to a maximum of 25% capacity.

Counties must remain in each tier for at least three weeks before advancing to a less risky one. If a county’s indicators worsen for two consecutive weeks, it will be moved to a more restrictive tier.

L.A. County got some welcome news last week when another widely monitored indicator, the 14-day average COVID case rate, dropped below 200 per 100,000 residents — the state’s threshold under which elementary schools can apply for waivers to reopen for in-person classes.

“We are grateful to see this number come down,” Ferrer said, noting that just a few weeks ago the county was at 400 cases per 100,000 residents.

On Wednesday, the county health department announced that K-12 schools can reopen in a limited way to provide services for “small cohorts” of students with special needs, such as individualized education plans and instruction in English as a second language. Schools won’t fully reopen yet for general instruction, the department said.

It’s not certain the county’s case rate will hold under 200, Ferrer said last week, and for all its progress “we are still considered one of the hot spots.”

Hence, her pre-Labor Day message to the public: “Whether you are traveling or staying at home, you need to be mindful of the fact that we all have to reduce our transmission, and the way to do that is to reduce our exposure to other people. So please, always wear that face covering, always keep your distance, always be washing your hands, and make sure you’re avoiding those crowded situations.”

Dozens of U.S. Hospitals Poised to Defy FDA's Directive on COVID Plasma

KFF Health News, September 3, 2020

As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center.

This article was published on Thursday, September 3, 2020 in Kaiser Health News.

By JoNel Aleccia

Dozens of major hospitals across the U.S. are grappling with whether to ignore a federal decision allowing broader emergency use of blood plasma from recovered COVID patients to treat the disease in favor of dedicating their resources to a gold-standard clinical trial that could help settle the science for good.

As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center, said principal investigator Dr. Todd Rice.

Officials at some hospitals said they are considering committing only to the clinical trial — and either avoiding or minimizing use of convalescent plasma through an emergency use authorization issued Aug. 23 by the federal Food and Drug Administration.

The response comes amid concerns that the Trump administration pressured the FDA into approving broader use of convalescent plasma, which already has been administered to more than 77,000 COVID patients in the U.S. President Donald Trump characterized the treatment as a "powerful therapy," even as government scientists called for more evidence that COVID plasma is beneficial.

A National Institutes of Health panel this week countered the FDA's decision, saying that the therapy "should not be considered the standard of care for the treatment of patients with COVID-19" and that well-designed trials are needed to determine whether the therapy is helpful. Data so far suggests the treatment could be beneficial, but it's not definitive.

"It's an important scientific question that we don't have the answer to yet," said Rice, an associate professor of medicine and director of VUMC's medical intensive care unit.

Convalescent plasma uses an antibody-rich blood product taken from people who have recovered from a viral infection and injects it into people still suffering in the hopes that the therapy will jump-start their immune systems, boosting their ability to fight the virus. The approach has been used on an experimental basis for more than a century to fight other virulent diseases, including the 1918 flu, measles, Ebola, SARS and H1N1 influenza.

Last month, NIH officials awarded $34 million to Rice's study, the Passive Immunity Trial of the Nation for COVID-19, dubbed PassItOnII, which has also received funding from country music superstar Dolly Parton. The trial, which aims to enroll 1,000 adult hospitalized patients, could meet its goals by the end of October. If it shows evidence of likely benefit to COVID patients, it could immediately change clinical practice, Rice said.

Half of the participants will receive convalescent plasma with high levels of disease-fighting antibodies from a stockpile of more than 150 units of the product already collected, Rice said. The other half will receive a placebo solution.

Though the trial launched in April, enrollment has been slow. The funding allows enlistment at more than 50 sites nationwide. That has spurred new conversations about joining the trial — and about not employing the controversial authorization issued by the FDA, said Dr. Claudia Cohn, director of the Blood Bank Laboratory at the University of Minnesota Medical School. She expected her institution to decide this week.

"I'd rather frame it as not rejecting the FDA, but simply taking the longer view," said Cohn, who is also medical director for the AABB, an international nonprofit focused on transfusion medicine and cellular therapies.

At the Ohio State University Wexner Medical Center, officials have opted to join the trial and are considering making it "the first option" for COVID patients who qualify, said Dr. Sonal Pannu, an assistant professor and pulmonologist.

"Many of the academic leaders believe we should do the trial, and we would be severely limiting" the emergency use authorization, or EUA, she said, noting that first patients could be enrolled soon. The plasma still could be used under the EUA to treat patients such as prisoners, who are unable to consent to join a clinical trial, she added.

That's the same stance adopted by the University of Washington, said Dr. Nicholas Johnson, an assistant professor of emergency medicine who's leading the trial at the Seattle site. "We're really interested in enrolling patients as the first option," he said.

The questions are similar to those raised with hydroxychloroquine, another treatment Trump touted for treating COVID-19. FDA officials issued an EUA for the drug in April, only to revoke it in June after data indicated the drug might be harmful.

"On a couple of occasions, we've allowed clinical practice to get ahead of the science," Johnson said. "We've learned that lesson a couple of times now."

FDA officials did not respond to requests for comment.

Top federal health leaders, including NIH Director Dr. Francis Collins and Dr. Anthony Fauci, the nation's leading infectious disease doctor, initially resisted the move to issue the EUA for convalescent plasma last month, telling The New York Times that the evidence for it was too weak.

Trump has criticized the FDA for moving too slowly to speed approval of treatments and vaccines for COVID-19. He announced the EUA on the eve of the Republican National Convention, calling it a "truly historic announcement."

Issuing the EUA puts the fate of clinical trials into "extreme jeopardy," said Arthur Caplan, a professor of bioethics at the New York University School of Medicine. With convalescent plasma in very short supply, it sets the stage for fights over access and makes sick patients less inclined to join a trial, where they might receive a placebo.

"If you have the EUA, it starts to damage the trials," Caplan said.

Still, given that the FDA has authorized convalescent plasma for patients ill with COVID-19, hospitals that hesitate or refuse to provide it outside a trial are sure to face questions from families.

That creates "a very interesting and delicate ethics problem," said Cohn.

"If you commit to the randomized controlled trial only, you're committing to a long-term dedication to science," she said. "The question is, is it ethically inappropriate not to provide a therapy that has been shown to be possibly beneficial?"

Johnson, at the University of Washington, said most patients have been willing — even eager — to participate in clinical trials once they understand the need for rigorous scientific results.

And Caplan, the bioethicist, applauded the decision of hospitals to minimize the EUA and focus on the trial, calling it "a pretty feisty action."

"It's sensible," he said. "It's likely to really generate an answer to the question of 'Does COVID convalescent plasma do anything?'"

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

Fauci Says COVID Vaccine Trials Could End Early If Results Are Overwhelming

KFF Health News, September 2, 2020

Prominent vaccine experts have said they fear Trump is pushing for an early vaccine approval to help win reelection.

This article was published on Tuesday, September 1, 2020 in Kaiser Health News.

By Liz Szabo

A COVID-19 vaccine could be available earlier than expected if ongoing clinical trials produce overwhelmingly positive results, said Dr. Anthony Fauci, the nation’s top infectious disease official, in an interview Tuesday with KHN.

Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.

The Data and Safety Monitoring Board could say, “‘The data is so good right now that you can say it’s safe and effective,’” Fauci said. In that case, researchers would have “a moral obligation” to end the trial early and make the active vaccine available to everyone in the study, including those who had been given placebos — and accelerate the process to give the vaccine to millions.

Fauci’s comments come at a time of growing concern about whether political pressure from the Trump administration could influence federal regulators and scientists overseeing the nation’s response to the novel coronavirus pandemic, and erode shaky public confidence in vaccines. Prominent vaccine experts have said they fear Trump is pushing for an early vaccine approval to help win reelection.

Fauci, director of the National Institute of Allergy and Infectious Diseases, said he trusts the independent members of the DSMB — who are not government employees — to hold vaccines to high standards without being politically influenced. Members of the board are typically experts in vaccine science and biostatistics who teach at major medical schools.

“If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective,” Fauci said. “I’m not concerned about political pressure.”

The safety board periodically looks at data from a clinical trial to determine if it’s ethical to continue enrolling volunteers, who are randomly assigned to receive either an experimental vaccine or a placebo shot. Neither the volunteers nor the health workers who vaccinate them know which shot they’re receiving.

Manufacturers are now testing three COVID vaccines in large-scale U.S. trials. The first two studies — one led by Moderna and the National Institutes of Health and the other led by Pfizer and BioNTech — began in late July. Each study was designed to enroll 30,000 participants. Company officials have said both trials have enrolled about half that total. AstraZeneca, which has been running large-scale clinical trials in Great Britain, Brazil and South Africa, launched another large-scale vaccine study this week in the U.S., involving 30,000 volunteers. Additional vaccine trials are expected to begin this month.

In trials of this size, researchers will know if a vaccine is effective after as few as 150 to 175 infections, said Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, in a call with reporters Friday.

“It may be surprising, but the number of events that need to occur is relatively small,” Redfield said.

Right now, only the safety board has access to the trial data, said Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services. As for when trial results will be available, “we cannot determine if it will be the middle of October or December.”

Safety boards set “stopping rules” at the beginning of a study, making their criteria for ending a trial very clear, said Dr. Eric Topol, executive vice president for research at Scripps Research in San Diego and an expert on the use of data in medical research.

Although the safety board can recommend stopping a trial, the ultimate decision to halt a study is made by the scientists running the trial, Topol said.

A vaccine manufacturer could then apply to the Food and Drug Administration for an emergency use authorization, which can be granted quickly, or continue through the regular drug approval process, which requires more time and evidence.

Safety monitors also can stop a trial because of safety concerns, “if it looks like it’s actually harming people in the vaccine arm, due to a lot of adverse events,” Fauci said.

Fauci said people can trust the process, because all the data that outside monitors used to make their decisions would be made public.

“All of that has to be transparent,” Fauci said. “The only time you get concerned is if there is any pressure to terminate the trial before you have enough data on safety and efficacy.”

Topol and other scientists have sharply criticized the FDA in recent weeks, accusing Commissioner Stephen Hahn of bowing to political pressure from the Trump administration, which has pushed the agency to approve COVID treatments faster.

Stopping trials early poses a number of risks, such as making a vaccine look more effective than it really is, Topol said.

“If you stop something early, you can get an exaggerated benefit that isn’t real,” because less positive evidence only emerges later, Topol said.

Stopping the studies early also could prevent researchers from recruiting more minority volunteers. So far, only about 1 in 5 trial participants are Black or Hispanic. Given that Blacks and Hispanics have been hit harder than other groups by the pandemic, Topol said, it’s important that they make up a larger part of vaccine trials.

Ending vaccine trials early also carries safety risks, said Dr. Paul Offit, a vaccine developer who serves on an NIH advisory panel on COVID vaccines and treatments.

A smaller, shorter trial could fail to detect important vaccine side effects, which could become apparent only after millions of people have been immunized, said Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Researchers will continue to follow vaccinated volunteers for a full year to look for long-term side effects, Redfield said.

And Fauci acknowledged that cutting a trial short could undermine public confidence in COVID vaccines. One American in three is unwilling to get a COVID vaccine, according to a recent Gallup Poll.

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