America's Obesity Epidemic Threatens Effectiveness of Any COVID Vaccine

KFF Health News, August 6, 2020

In the United States, the promise of a vaccine for the coronavirus is hampered by a vexing epidemic that long preceded COVID-19: obesity.

This article was published on Thursday, August 6, 2020 in Kaiser Health News.

By Sarah Varney

For a world crippled by the coronavirus, salvation hinges on a vaccine.

But in the United States, where at least 4.6 million people have been infected and nearly 155,000 have died, the promise of that vaccine is hampered by a vexing epidemic that long preceded COVID-19: obesity.

Scientists know that vaccines engineered to protect the public from influenza, hepatitis B, tetanus and rabies can be less effective in obese adults than in the general population, leaving them more vulnerable to infection and illness. There is little reason to believe, obesity researchers say, that COVID-19 vaccines will be any different.

"Will we have a COVID vaccine next year tailored to the obese? No way," said Raz Shaikh, an associate professor of nutrition at the University of North Carolina-Chapel Hill.

"Will it still work in the obese? Our prediction is no."

More than 107 million American adults are obese, and their ability to return safely to work, care for their families and resume daily life could be curtailed if the coronavirus vaccine delivers weak immunity for them.

In March, still early in the global pandemic, a little-noticed study from China found that heavier Chinese patients afflicted with COVID-19 were more likely to die than leaner ones, suggesting a perilous future awaited the U.S., whose population is among the heaviest in the world.

And then that future arrived.

As intensive care units in New York, New Jersey and elsewhere filled with patients, the federal Centers for Disease Control and Prevention warned that obese people with a body mass index of 40 or more — known as morbid obesity or about 100 pounds overweight — were among the groups at highest risk of becoming severely ill with COVID-19. About 9% of American adults are in that category.

As weeks passed and a clearer picture of who was being hospitalized came into focus, federal health officials expanded their warning to include people with a body mass index of 30 or more. That vastly expanded the ranks of those considered vulnerable to the most severe cases of infection, to 42.4% of American adults.

Obesity has long been known to be a significant risk factor for death from cardiovascular disease and cancer. But scientists in the emerging field of immunometabolism are finding obesity also interferes with the body's immune response, putting obese people at greater risk of infection from pathogens such as influenza and the novel coronavirus. In the case of influenza, obesity has emerged as a factor making it more difficult to vaccinate adults against infection. The question is whether that will hold true for COVID-19.

A healthy immune system turns inflammation on and off as needed, calling on white blood cells and sending out proteins to fight infection. Vaccines harness that inflammatory response. But blood tests show that obese people and people with related metabolic risk factors such as high blood pressure and elevated blood sugar levels experience a state of chronic mild inflammation; the inflammation turns on and stays on.

Adipose tissue — or fat — in the belly, the liver and other organs is not inert; it contains specialized cells that send out molecules, like the hormone leptin, that scientists suspect induces this chronic state of inflammation. While the exact biological mechanisms are still being investigated, chronic inflammation seems to interfere with the immune response to vaccines, possibly subjecting obese people to preventable illnesses even after vaccination.

An effective vaccine fuels a controlled burn inside the body, searing into cellular memory a mock invasion that never truly happened.

Evidence that obese people have a blunted response to common vaccines was first observed in 1985 when obese hospital employees who received the hepatitis B vaccine showed a significant decline in protection 11 months later that was not observed in non-obese employees. The finding was replicated in a follow-up study that used longer needles to ensure the vaccine was injected into muscle and not fat.

Researchers found similar problems with the hepatitis A vaccine, and other studies have found significant declines in the antibody protection induced by tetanus and rabies vaccines in obese people.

"Obesity is a serious global problem, and the suboptimal vaccine-induced immune responses observed in the obese population cannot be ignored," pleaded researchers from the Mayo Clinic's Vaccine Research Group in a 2015 study published in the journal Vaccine.

Vaccines also are known to be less effective in older adults, which is why those 65 and older receive a supercharged annual influenza vaccine that contains far more flu virus antigens to help juice up their immune response.

By contrast, the diminished protection of the obese population — both adults and children — has been largely ignored.

"I'm not entirely sure why vaccine efficacy in this population hasn't been more well reported," said Catherine Andersen, an assistant professor of biology at Fairfield University who studies obesity and metabolic diseases. "It's a missed opportunity for greater public health intervention."

In 2017, scientists at UNC-Chapel Hill provided a critical clue about the limitations of the influenza vaccine. In a paper published in the International Journal of Obesity, they showed for the first time that vaccinated obese adults were twice as likely as adults of a healthy weight to develop influenza or flu-like illness.

Curiously, they found that adults with obesity did produce a protective level of antibodies to the influenza vaccine, but they still responded poorly.

"That was the mystery," said Chad Petit, an influenza virologist at the University of Alabama.

One hypothesis, Petit said, is that obesity may trigger a metabolic dysregulation of T cells, white blood cells critical to the immune response. "It's not insurmountable," said Petit, who is researching COVID-19 in obese patients. "We can design better vaccines that might overcome this discrepancy."

Historically, people with high BMIs often have been excluded from drug trials because they frequently have related chronic conditions that might mask the results. The clinical trials underway to test the safety and efficacy of a coronavirus vaccine do not have a BMI exclusion and will include people with obesity, said Dr. Larry Corey, of the Fred Hutchinson Cancer Research Center, who is overseeing the phase 3 trials sponsored by the National Institutes of Health.

Although trial coordinators are not specifically focused on obesity as a potential complication, Corey said, participants' BMI will be documented and results evaluated.

Dr. Timothy Garvey, an endocrinologist and director of diabetes research at the University of Alabama, was among those who stressed that, despite the lingering questions, it is still safer for obese people to get vaccinated than not.

"The influenza vaccine still works in patients with obesity, but just not as well," Garvey said. "We still want them to get vaccinated."

Sarah Varney: svarney@kff.org, @SarahVarney4

Could Labs That Test Livestock Ease COVID Testing Backlog for People? Well … Maybe.

KFF Health News, August 5, 2020

Can labs that test animals run tests on humans? And, if so, what role are they playing in the national pandemic, and how much is it helping?

This article was published on Wednesday, August 5, 2020 in Kaiser Health News.

By Julie Appleby

Adm. Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services, during an appearance on CNN's "State of the Union" with Jake Tapper, July 26, 2020

In a heated exchange late last month on CNN's State of the Union, host Jake Tapper pressed Adm. Brett Giroir, the Health and Human Services assistant secretary who oversees COVID testing efforts for the Trump administration, on why the government isn't requiring commercial labs to increase testing capacity in order to speed turnaround time.

Giroir's response described a series of steps — some unusual — being taken by the federal government. One focus was on the role veterinary labs, including those with special certification, could play in helping to build capacity. "Five veterinary labs have their CLIA certification to officially test human patients," he said. "There are a lot of labs who are doing surveillance testing that don't need the CLIA certification."

He was referring to certification under the Clinical Laboratory Improvement Amendments of 1988, a federal law that sets the standard for labs that test human specimens.

So that got us wondering: Can labs that test cattle, chickens or your pet Fido run tests on humans? And, if so, what role are they playing in the national pandemic, and how much is it helping?

After all, the issue of expanding lab capacity will likely come up repeatedly as demand for testing increases with mounting case counts. Turnaround times at some labs have grown, with results now taking days to more than a week in some areas, frustrating consumers and public health officials. Delays for test results mean delays for contact tracing and quarantining. The administration's pandemic response, including testing issues, is also proving to be a hot topic on the campaign trail.

We reached out to HHS for more information about Giroir's statement.

An HHS spokesperson emailed a list of nine veterinary labs that have received the required certification to do patient-specific human testing, saying Giroir had been mistakenly briefed before the interview that there were only five. A U.S. Department of Agriculture spokesperson said there are 15 National Animal Health Laboratory Network facilities nationwide that have CLIA certification to test human samples. Clearly, there are vet labs in the U.S. with the necessary credentials, but the exact number is a matter of confusion.

As for the surveillance efforts, the HHS spokesperson did not provide specific examples of veterinary labs doing such work but provided a Centers for Medicare & Medicaid Services FAQ saying labs that don't have CLIA certification can do some types of surveillance if results are not given to specific patients.

Similar Science, Same Machines

Our experts all quickly noted that veterinary labs — especially those that focus on food animals, including cows, pigs and chickens, have long tested for diseases, including many kinds of coronaviruses.

They're on the lookout for microbes that can affect food safety, such as salmonella or E. coli, or diseases that can devastate the animals themselves, including avian influenza, hoof and mouth disease or African swine fever.

Hence, a lot of testing goes on in the 63 food-animal testing labs in 33 states and four Canadian provinces accredited by the American Association of Veterinary Laboratory Diagnosticians, said its executive director, David Zeman.

"In some states, we have more capacity in the vet labs than in the public health labs," he added.

Those vet labs, often affiliated with universities or government agencies, use highly sophisticated equipment, including polymerase chain reaction (PCR) techniques, as do labs focusing on human testing. Many of the COVID tests being done are PCR, which can detect the virus's genetic material.

"It's the same machines, the same science," said Zeman.

However, these are large, full-service labs that deal mainly with farm animals, different from the smaller labs generally found at your neighborhood vet. So, sorry, Fido.

A Different Regulatory Chain of Command

Earlier this year, researchers at Iowa State University found that the testing process for the new coronavirus is similar to that used to test pigs for porcine epidemic diarrhea (PED) virus, a disease that killed thousands of piglets in 2013. Because a lot of labs had updated their equipment and processes so they could check for PED, they were in a good position to help with COVID-19 testing.

Except, of course, it's never that simple.

While the science and technology are the same, the administrative requirements are not.

Veterinary labs must meet standards for accreditation by such groups as the American Association of Veterinary Laboratory Diagnosticians and are overseen by federal and state agricultural agencies.

Human labs also must meet strict standards, including CLIA, and fall under the auspices of other agencies, including the Centers for Medicare & Medicaid Services, the Food and Drug Administration and the Centers for Disease Control and Prevention.

One requirement is that the CLIA lab must have a director who is a medical doctor with specialized experience. Most animal labs are run by, not surprisingly, veterinarians, often ones with Ph.D.s. Some vet labs have formed partnerships with CLIA-certified labs to clear this hurdle. Still, it's a process that can take weeks, so it's not an overnight fix, said Zeman.

Running the Numbers

Sources

CNN's "State of the Union With Jake Tapper" transcript of interview with Adm. Brett Giroir, U.S. assistant secretary for Health and Human Services, July 26

Telephone interview with Mark Ackermann, director of the Oregon Veterinary Diagnostic Laboratory, July 28, 2020

Email correspondence with Michelle Forman, manager, Media Association of Public Health Laboratories, July 28, 2020

Email correspondence with Mia Heck, spokesperson for Department of Health and Human Services, July 28 and 29, 2020

Telephone interview with Gigi Gronvall, a senior scholar at Johns Hopkins Center for Health Security, July 28, 2020

Telephone interview with David Zeman, executive director of the American Association of Veterinary Laboratory Diagnosticians, July 28, 2020

Telephone interview with Thomas Sparkman, senior vice president, government affairs and policy, American Clinical Laboratory Association, July 28, 2020

Email correspondence with Lyndsay Cole, assistant director for public affairs, USDA Animal and Plant Health Inspection Service, July 30, 2020

American Veterinary Medical Association, "Veterinary Labs Continue to Support COVID-19 Testing," July 1, 2020

The Washington Post, "This Veterinary Lab Is the Linchpin in One State's Coronavirus Testing Approach," May 12, 2020

American Association of Veterinary Laboratory Diagnosticians, "Requirements for an Accredited Veterinary Medical Diagnostic Laboratory," accessed July 29, 2020

Neoteryx, "How Veterinary Diagnostic Labs are Supporting Human COVID-19 Testing," July 13, 2020

Centers for Disease Control and Prevention, "Clinical Laboratory Improvement Amendments," Aug. 6, 2018

Johns Hopkins University Coronavirus Resource Center, accessed July 29, 2020

The Atlantic, "US Historical Data," The COVID Tracking Project, accessed July 29, 2020

Centers for Medicare & Medicaid Services, "Frequently Asked Questions: SARS-CoV-2 Surveillance Testing," June 19, 2020

But can these labs really make a difference in the testing backlog?

A June article on the American Veterinary Medicine Association website quoted an official in May saying that the then-seven CLIA-certified vet labs had the capacity to process 12,000 PCR samples with a 24-hour turnaround.

Zeman said he sent out a survey in July to his 63 members in response to an HHS inquiry and found that, on average, each lab — if CLIA-certified — could process 500 to 1,000 COVID samples a day on top of what it needs to do to monitor animals.

"Multiply that by 60 some labs and you have a rough idea of what they could do," he said. The math adds up to at least 31,500 tests a day.

Currently, more than 700,000 samples are taken daily and sent to all types of labs — mainly large commercial and hospital-based facilities, according to tracking by Johns Hopkins University. The Atlantic's COVID Tracking Project notes similar testing numbers at the end of July.

More vet labs participating "could ease the burden on these labs, but it doesn't sound like a game changer in terms of wait times," said Gigi Gronvall, a senior scholar at Johns Hopkins Center for Health Security.

Some vet labs are working with public health labs to "test a specific segment of the population (university students, routine screening of government workers, etc.)," said Michelle Forman, media manager for the Association of Public Health Laboratories in an email. "So it's not so much taking existing burden off of the public health labs and commercial labs but it is preventing additional burden from being put on them."

Giroir said "lots" of labs that are non-CLIA certified labs are helping by doing research or  surveillance, but Zeman was not aware of such efforts by such labs in his organization.

Perhaps Giroir was talking about "pooled testing," in which a number of specimens are tested in a batch, speculated Mark Ackermann, director of the Oregon Veterinary Diagnostic Laboratory in Corvallis, Oregon. Under that method, if any batch tests positive, individual specimens from the batch are then each tested to see who is positive.

Ackermann, whose lab has CLIA certification, pointed to another way vet labs might be helping: Many are making the liquid needed for the vials that hold the swabs taken from patients' nasal passages.

Our Ruling

Giroir was correct in saying there are some veterinary labs helping out with COVID testing.

But even if all 63 accredited food-animal vet labs in the U.S. and Canada were pressed into processing human COVID tests, an industry survey estimates it would increase capacity by between 31,500 to 63,000 samples per day. While helpful, that would still be only a small portion of the more than 700,000 daily tests being conducted, which some experts say falls short of what is needed.

Additionally, while vet labs are helping in some ways, Giroir provided little evidence to back up his assertion that "lots" of labs that lack CLIA certification are assisting in surveillance efforts.

We rate this statement Mostly True.

Julie Appleby: jappleby@kff.org, @Julie_Appleby

Covered California Announces Record-Low Rate Hike for 2021

KFF Health News, August 5, 2020

Some industry observers had called for rate cuts, given the windfall health plans have reaped so far this year from lower spending on care.

This article was published on Tuesday, August 4, 2020 in Kaiser Health News.

By Bernard J. Wolfson

Premiums for health plans sold through Covered California, the state's Affordable Care Act insurance exchange, will rise an average of 0.6% next year — the smallest hike since it started providing coverage in 2014, the agency announced Tuesday.

The modest increase follows an average statewide increase of 0.8% on coverage that started in January of this year, which was the previous record low.

The rate changes will vary across regions, ranging from an average increase of 5.6% in Santa Clara County to reductions of 2.1% in southwestern Los Angeles County and 2.6% in Mono, Inyo and Imperial counties.

Before the announcement, some industry observers had called for rate cuts, given the windfall health plans have reaped so far this year from lower spending on care. The COVID-19 pandemic shut down elective surgeries in the spring and has continued to sharply reduce patient visits to doctors, emergency rooms and outpatient clinics.

But Peter Lee, Covered California's executive director, told California Healthline that lower spending by insurers due to the pandemic had "very, very little" impact on 2021 premiums.

Covered California's insurance carriers "are seeing their healthcare costs rebound and are projecting that for the balance of the year they will catch up on the health expenses they thought they were going to spend for 2020," Lee said. Health plans in the exchange projected increases in non-COVID medical costs of 4% to 8% next year and did not think they needed to budget extra for the pandemic, he said.

The rate increase was modest mainly because of a surge of new, "healthier" enrollees both during the regular enrollment period for 2020 coverage and the current "special" enrollment period — recently extended to Aug. 31 — for people whose coverage has been affected by the pandemic, Lee said. Covered California said an analysis of the medical risk and demographics of these newcomers showed "they are healthier on average than the equivalent cohorts from 2019."

But Kaiser Permanente said in a regulatory filing that it saw no change in the overall health of enrollees, and Anthem Blue Cross expected a less healthy patient mix, pushing costs up about 2.2%,

Covered California said that other factors keeping the average rate hike low include the repeal of a federal tax on health plans, which reduced 2021 premiums by an average of 1.7%, and a cut next year in the "participation" fee health plans pay Covered California, from 3.5% of premiums to 3.25%.

The exchange provides coverage for about 1.5 million Californians who buy their own insurance. About 90% of them receive financial assistance from the federal or state government, or both, to help them pay for their premiums. Another 800,000 Californians buy coverage in the open market, where financial assistance is not available. About 600,000 of that group are in plans that mirror the ones available on the exchange and will see the same rate increase.

Glenn Melnick, a professor of public finance at the University of Southern California's Sol Price School of Public Policy, differed with Lee's view of the medical spending trend, saying health plans will likely continue to benefit from depressed patient volume next year, which will more than offset their assumed 4% to 8% increase in non-Covid costs.

Emergency room visits are lagging pre-pandemic levels by about 20% and outpatient volume is about 5% to 10% down, Melnick said. "I don't see those people coming back unless there's a vaccine – and when there's a spike, more people will stay home."

Michael Johnson, a health insurance industry observer and critic who worked as an executive at Blue Shield of California from 2003 to 2015, said next year's premiums should be lower. "Preliminary indications are that rates for 2020 are way too high, so for 2021 they should be going down, not up," he said.

The average statewide increase among Covered California carriers is smaller than what's been proposed in many other states.

A KFF analysis last month of proposed 2021 rates in the exchanges of 10 states and the District of Columbia showed a median increase of 2.4%, with changes ranging from a hike of 31.8% by a health plan in New Mexico to a cut of 12% by one in Maryland. (Kaiser Health News, which produces California Healthline, is an editorially independent program of KFF.)

This year's rate announcements come as the Affordable Care Act remains under threat from a federal lawsuit by Republican officials in 18 states, joined by the Trump administration, who want to repeal it. If they prevail, more than 20 million people could lose their health coverage and popular consumer protections afforded by the ACA, including the ban on health plan discrimination against people with preexisting medical conditions, could be eliminated.

The Supreme Court plans to hear the case in the fall.

All 11 insurance companies operating in Covered California this year will remain in 2021, and no new ones will enter the marketplace. But Anthem Blue Cross and Oscar Health Insurance will expand their offerings geographically, the exchange said. Anthem will enter Inyo, Kern, Mono and Orange counties. Oscar will join the competition in San Mateo County. Many of the Covered California health plans are available only in certain regions of the state.

Kaiser Permanente is the largest carrier in the exchange, with about 526,000 enrollees this year, more than one-third of the total. Kaiser is followed by Blue Shield of California, with 392,000, and Health Net, with 232,000.

Kaiser is seeking an average increase of 0.9% in its individual market plans, including those sold in the exchange and outside of it, according to a filing with the state's Department of Managed Healthcare. Last year, Kaiser raised its rates by an average of 0.7%.

Blue Shield of California plans to cut rates by an average of 2.4% statewide, following a hike of 3.6% this year, according to its regulatory filings. One of the main factors in next year's rate cut, it said, is that it set current premiums with a projection of medical costs that was too high.

Rates differ not only from carrier to carrier and region to region, but also by the covered person's age. Premiums also differ by benefit level, from the cheaper "bronze" coverage tier up to the highest, known as "platinum." The lower the premium, the higher the deductibles and coinsurance payments for care.

The individual deductible for the bronze tier in 2021 is set at $6,300, unchanged from this year. For the silver tier, the second-cheapest level of coverage, the full individual deductible in 2021 will be $4,000, also unchanged from this year. But many silver enrollees are in plans that offer financial aid to reduce their share of medical costs, and that can push the 2021 silver deductible as low as $75.

Moreover, numerous medical services are not subject to the deductible in silver plans, including primary care and specialist visits, lab tests, X-rays and other imaging. In bronze plans, the first three primary care visits are not subject to the deductible.

Covered California said that, on average, exchange enrollees who plan to renew for 2021 can save 7.3% on premiums by switching to the least expensive plan in the same tier of coverage.

The 2021 rates are subject to final review by the Department of Managed Healthcare and the Department of Insurance, but significant changes are unlikely.
The enrollment period for 2021 coverage starts Nov. 1 and runs through Jan. 31.

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

When Green Means Stop: How Safety Messages Got So Muddled

KFF Health News, August 4, 2020

As businesses started to reopen, mixed messages on every level of government have made what's permissible and safe feel like a matter of interpretation.

This article was published on Tuesday, August 4, 2020 in Kaiser Health News.

By Nina Feldman, WHYY

When Marquita Burnett heard Philadelphia was moving to the "green" phase of reopening, she was confused. She was pretty sure the city had already earned a green designation from Pennsylvania's governor (it had). The next thing she knew, the city was scaling back some of the businesses it had planned to reopen (namely, indoor dining and gyms). But it was still calling this phase "restricted green."

"I feel like it's been back and forth — the mayor says one thing, the governor says another. So who do you really listen to?" asked Burnett, a 32-year-old teacher's assistant.

Looking for something to do with her 6-year-old son at the end of June, she saw the mayor announce that libraries could open in the new, modified green phase. But people who worked at the library were posting on Twitter that they were not open.

"The lines are very blurred," said Burnett. "Are we completely in the green, or not?"

When the coronavirus shutdown was ordered in March, the message was straightforward and simple: Stay at home; don't leave the house except to perform essential work or shop at essential businesses. However hard those restrictions were to stomach, they were clear.

Skip ahead four months. As businesses started to reopen, mixed messages on every level of government have made what's permissible and safe feel like a matter of interpretation.

Absent any overarching or consistent national messaging, elected officials are left to come up with localized rules, which at times contradict one another, presenting a false choice between personal freedoms and protecting one's health. That forces individuals to make decisions about their actions that carry heavy moral weight.

Color-Coded Confusion

Pennsylvania's phased reopening, coded according to the colors of a traffic light, factors in two indicators: the amount of virus circulating in the community, and the degree to which the economy is open.

"In the beginning, we had a plan where there was pretty tight linkage between level of viral transmission and reopening activities," said Dr. Susan Coffin, a pediatric infectious disease specialist working on Children's Hospital of Philadelphia's response to the pandemic. Over time, she said, though the color-coding system remained a good indicator for which businesses were opening up, it stopped reflecting the viral risk as closely as the number of new cases ebbed and flowed. And that, she said, has resulted in confusion.

Philadelphia in late July is officially in "modified, restricted green," and gyms have been allowed to reopen. Indoor dining remains off-limits.

"Now, we are seeing what might sound like a contradictory message: Yes, we are reopening, but, no, we don't want you to stop behaving as though there is virus in our community."

In neighboring New Jersey, by contrast, the phased reopening is incremental. There is no overall color-coding; instead, each phase offers a broad sense of what will change, and, industry-by-industry, individual restrictions are loosened one at a time.

For his part, Philadelphia Health Commissioner Thomas Farley said he wished people could have ignored Pennsylvania's color-coding altogether.

"The governor came up with this high-level plan with these three different colors, but clearly Philadelphia is unique," Farley told reporters at a June 30 press conference at which he announced the city would pause before entering the full green phase. "So we're calling it green, but I would rather have people focus less on the color and more on what activities are allowed and not allowed."

Part of the issue is that the science is evolving and information about the novel coronavirus changes rapidly. Masks, for example, were initially explicitly discouraged because of short supply. Once they became more available, and research emerged supporting their use, masks were back in full force.

Though health departments do their best to keep up with the research as it emerges — and to explain why their recommendations change, when they do — it can be hard to keep track of. And it doesn't help when politicians contradict the science-backed recommendations.

"We can't be out there as the secretary of health telling you to wear a mask and your local elected official is telling you, 'Don't wear a mask. You'll be fine,'" said April Hutcheson, communications director for the Pennsylvania Department of Health. "It makes the job more challenging."

But there is some messaging health departments can control. Pennsylvania laid out what many interpreted as specific metrics for testing capacity, contact tracing, nursing home outbreaks and the number of new cases that counties would have to hit to move to less restrictive phases by a certain date. Many counties in the southeastern part of the state didn't meet those benchmarks but transitioned anyway. The governor later said the metrics were not hard marks but would be considered in concert with other factors to determine overall risk.

Setting aside whether Pennsylvania's transition from red to yellow led to an increase in coronavirus cases, the mixed messaging was likely to contribute to distrust in government, said Ellen Peters, who runs the Center for Science Communication Research at the University of Oregon.

"It gives people inconsistent information, so you're being told, 'Eh, that didn't happen, but we're going to go ahead and do it anyway,'" said Peters, whose Oregon county similarly failed to meet its benchmarks but moved into a new phase anyway. "And so people are left with, 'Well, the guidelines don't matter then. If they don't matter, what else can I not trust that this city or state entity is telling me?'"

Research has shown that when people are stuck at an impasse, they are more likely to just opt for doing what they want to do in the first place.

How Safe Is Safe?

The health departments at the city and state level point to their regular news briefings, where they advise not just which activities are safe, but also how to do them safely. Asking people to constantly evaluate what they consider safe is a tall order.

"What does it mean to be careful right now? I don't think that's actually a meaningful instruction," said Tess Wilkinson-Ryan, a professor of law and psychology at the University of Pennsylvania.

"The level of care we are asking of individuals is really high — we would never ask this in normal life."

At the start of the pandemic, what it meant to be safe was easier to grasp, said Wilkinson-Ryan. Memes like "flattening the curve" gave people new language they needed to understand the broader reasoning behind shutting down the economy. They felt like they were doing something by doing nothing — it created a norm. In the partial reopening, that norm is gone, but it is not clear what replaces it as people make decisions about how to keep themselves and others safe.

Wilkinson-Ryan confronted her own dilemma on safety. About six weeks into strict lockdown in Philadelphia, her husband was out walking the dog when the leash got tangled around his ankle, and he fell back and hit his head. He told her what had happened and she asked him who the president was, half-joking, to test for signs of a concussion. "He said, deadpan, 'George Bush.' And he wasn't joking."

Wilkinson-Ryan spent the next few hours trying to determine how severe her husband's concussion might be, and if it was bad, whether they should go to an emergency room that might be overwhelmed with contagious coronavirus patients.

Luckily, she was able to reach a pediatrician friend who advised her to take him to the hospital, where he was triaged into a non-COVID wing. He's now doing fine.

Wilkinson-Ryan is grateful she had a friend with expertise to call upon, but she longed for a set of clear-cut rules to guide her in that stressful moment.

Making Their Own Decisions

Without those clear rules, Wilkinson-Ryan, Marquita Burnett and others have been left to make their own decisions based on a combination of the emerging science around the virus, whom they trust and what's most important to them.

Burnett, for instance, had been taking her son to get his hair cut on his barber's front porch. The barber always wore a mask and took the virus seriously, so when the barbershop reopened, she felt comfortable taking her son there.

But she's not comfortable with any of her typical summer activities, like going to the zoo, amusement parks or outdoor restaurants. If she can't predict the way a crowd of strangers will act, she's not taking the risk.

Despite her sound reasoning, it's easy to imagine someone else, confronted with the same choices, making the exact opposite decisions: skipping the barbershop because it's indoors; hitting the zoo because it's outside.

"It's sort of like asking everyone to decide their own speed limit based on, like, the make and model of their car," said Wilkinson-Ryan. "'Think about who you're gonna drive with. Think about the importance of your destination. Good luck!'"

Because one person's idea of 'careful' in a pandemic is different from another's, she said, the most helpful instructions are those that are clear and specific: maximum capacities in public spaces; marks on the ground to denote 6 feet of distance; specific instructions for people on how often they should go to the grocery store.

Otherwise, people are likely to come to different conclusions based on the same information, which in turn, leads to public shaming. And that has its own risks.

"When someone gets angry, they shut down to new information. They react and simply do what they want to do," said Peters of the University of Oregon. "I could see where you could get much worse health behaviors from shaming other people."

She cited pictures of people on beaches as a flashpoint, where some felt justified shaming others. The perspective of some photos, though, may have made beaches look more crowded than they were. "Maybe in reality, people are pretty far apart and they're outdoors," she said.

Wilkinson-Ryan said the shaming is a natural result of a lack of clear norms in a new and changing environment. Overburdened with decisions, it's also a cognitive shortcut.

"It's easy and salient to think about what people in my neighborhood are doing wrong," said Wilkinson-Ryan. "They're sitting at the park, they're playing, they're touching each other. That's an availability bias: It comes easily to mind because it's part of my everyday life. You tend to place blame on the causes that come to mind quickly and easily."

She sees people blaming neighbors who make different decisions rather than holding state legislatures and Congress accountable.

In other countries, coordinated federal responses skirted this issue to some degree. National messaging meant there was no need to deputize hundreds of local health officials to project hyperlocal and often conflicting messages.

"It really is kind of ridiculous, that idea of asking all of these people to come up with their own experts and their own way of guiding behavior in the states or cities, rather than having the experts in the country come together and decide what is the best guidance for all of us and having the politicians stick with that," said Peters.

To streamline her own decision-making, Peters said she adopted a "What Would Anthony Fauci Do?" approach. But when everyone is guided by a different North Star, people are bound to crash into one another.

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

What Seniors Can Expect as Their New Normal in a Post-Vaccine World

KFF Health News, August 3, 2020

Experts say that in the aftermath of the pandemic, everything will change, from the way older folks receive healthcare to how they travel and shop.

This article was published on Monday, August 3, 2020 in Kaiser Health News.

By Bruce Horovitz

Imagine this scenario, perhaps a year or two in the future: An effective COVID-19 vaccine is routinely available and the world is moving forward. Life, however, will likely never be the same — particularly for people over 60.

That is the conclusion of geriatric medical doctors, aging experts, futurists and industry specialists. Experts say that in the aftermath of the pandemic, everything will change, from the way older folks receive healthcare to how they travel and shop. Also overturned: their work life and relationships with one another.

"In the past few months, the entire world has had a near-death experience," said Ken Dychtwald, CEO of Age Wave, a think tank on aging around the world. "We've been forced to stop and think: I could die or someone I love could die. When those events happen, people think about what matters and what they will do differently."

Older adults are uniquely vulnerable because their immune systems tend to deteriorate with age, making it so much harder for them to battle not just COVID-19 but all infectious diseases. They are also more likely to suffer other health conditions, like heart and respiratory diseases, that make it tougher to fight or recover from illness. So it's no surprise that even in the future, when a COVID-19 vaccine is widely available — and widely used — most seniors will be taking additional precautions.

"Before COVID-19, baby boomers" — those born after 1945 but before 1965 — "felt reassured that with all the benefits of modern medicine, they could live for years and years," said Dr. Mehrdad Ayati, who teaches geriatric medicine at Stanford University School of Medicine and advises the U.S. Senate Special Committee on Aging. "What we never calculated was that a pandemic could totally change the dialogue."

It has. Here's a preview of post-vaccine life for older Americans:

Medical Care

  • Time to learn telemed. Only 62% of people over 75 use the internet — and fewer than 28% are comfortable with social media, according to data from the Pew Research Center. "That's lethal in the modern age of healthcare," Dychtwald said, so there will be a drumbeat to make them fluent users of online healthcare.
  • 1 in 3 visits will be telemed. Dr. Ronan Factora, a geriatrician at Cleveland Clinic, said he saw no patients age 60 and up via telemedicine before the pandemic. He predicted that by the time a COVID-19 vaccine is available, at least a third of those visits will be virtual. "It will become a significant part of my practice," he said. Older patients likely will see their doctors more often than once a year for a checkup and benefit from improved overall healthcare, he said.
  • Many doctors instead of just one. More regular remote care will be bolstered by a team of doctors, said Greg Poland, professor of medicine and infectious diseases at the Mayo Clinic. The team model "allows me to see more patients more efficiently," he said. "If everyone has to come to the office and wait for the nurse to bring them in from the waiting room, well, that's an inherent drag on my productivity."
  • Drugstores will do more vaccinations. To avoid the germs in doctors' offices, older patients will prefer to go to drugstores for regular vaccinations such as flu shots, Factora said.
  • Your plumbing will be your doctor. In the not-too-distant future — perhaps just a few years from now — older Americans will have special devices at home to regularly analyze urine and fecal samples, Dychtwald said, letting them avoid the doctor's office.

Travel

  • Punch up the Google Maps. Many trips of 800 miles or less will likely become road trips instead of flights, said Ed Perkins, a syndicated travel columnist for the Chicago Tribune. Perkins, who is 90, said that's certainly what he plans to do — even after there's a vaccine.
  • Regional and local travel will replace foreign travel. Dychtwald, who is 70, said he will be much less inclined to travel abroad. For example, he said, onetime plans with his wife to visit India are now unlikely, even if a good vaccine is available, because they want to avoid large concentrations of people. That said, each year only 25% of people 65 and up travel outside the U.S. annually, vs. 45% of the general population, according to a survey by Visa. The most popular trip for seniors: visiting grandchildren.
  • Demand for business class will grow. When older travelers (who are financially able) choose to fly, they will more frequently book roomy business-class seats because they won't want to sit too close to other passengers, Factora said.
  • Buying three seats for two. Older couples who fly together — and have the money — will pay for all three seats so no one is between them, Perkins said.
  • Hotels will market medical care. Medical capability will be built into more travel options, Dychtwald said. For example, some hotels will advertise a doctor on-site — or one close by. "The era is over of being removed from healthcare and feeling comfortable," he said.
  • Disinfecting will be a sales pitch. Expect a rich combination of health and safety "theater" — particularly on cruises that host many older travelers, Perkins said: "Employees will be wandering around with disinfecting fogs and wiping everything 10 times."
  • Cruises will require proof of vaccination. Passengers — as well as cruise employees — will likely have to prove they've been vaccinated before traveling, Factora said.

Eating/Shopping

  • Local eateries will gain trust. Neighborhood and small-market restaurants will draw loyal customers — mainly because they know and trust the owners, said Christopher Muller, a hospitality professor at Boston University.
  • Safety will be a bragging point. To appeal to older diners in particular, restaurants will prominently display safety-inspection signage and visibly signal their cleanliness standards, Muller said. They will even hire employees exclusively to wipe down tables, chairs and all high-touch points — and these employees will be easy to identify and very visible.

Home Life

  • The homecoming. Because of so many COVID-19 deaths in nursing homes, more seniors will leave assisted living facilities and nursing homes to move in with their families, Factora said. "Families will generally move closer together," he said.
  • The fortress. Home delivery of almost everything will become the norm for older Americans, and in-person shopping will become much less common, Factora said.
  • Older workers will stay home. The 60-and-up workforce increasingly will be reluctant to work anywhere but from home and will be very slow to re-embrace grocery shopping. "Instacart delivery will become the new normal for them," Dychtwald said.

Gatherings

  • Forced social distancing. Whenever or wherever large families gather, people exhibiting COVID-like symptoms may not be welcomed under any circumstances, Ayati said.
  • Older folks will disengage, at a cost. Depression will skyrocket among older people who isolate from family get-togethers and large gatherings, Ayati said. "As the older population pulls back from engaging in society, this is a very bad thing."
  • Public restrooms will be revamped. For germ avoidance, they'll increasingly get no-touch toilets, urinals, sinks and entrances/exits. "One of the most disastrous places you can go into is a public restroom," Poland said. "That's about the riskiest place."

Bruce Horovitz: brucehorovitz@gmail.com

Fauci Unfazed as Scientists Rely on Unproven Methods to Create COVID Vaccines

KFF Health News, August 3, 2020

The country's top infectious disease expert said he's "cautiously optimistic" that researchers will develop a COVID-19 vaccine.

This article was published on Monday, August 3, 2020 in Kaiser Health News.

By Liz Szabo

With millions of lives on the line, researchers have been working at an unprecedented pace to develop a COVID-19 vaccine.

But that speed — and some widely touted breakthroughs — belie the enormous complexity and potential risks involved. Researchers have an incomplete understanding of the coronavirus and are using technology that's largely unproven.

Among many worries: A handful of studies on COVID-19 survivors suggest that antibodies — key immune system proteins that fight infection — begin to disappear within months. That's led scientists to worry that the protection provided by vaccines could fade quickly as well. Some even question whether vaccines will really end the pandemic. If vaccines produce limited protection against infection, experts note, people will need to continue wearing masks and social distancing even after vaccines roll out.

Yet in an interview with KHN, the country's top infectious disease expert, Dr. Anthony Fauci, said he's "cautiously optimistic" that researchers will overcome such obstacles.

"We know the body can make an adequate response against this virus" after two shots of a vaccine being tested, Fauci said. "There's no reason to believe that we won't be able to develop a vaccine against it."

Because early-stage trials began just a few months ago, doctors don't know how long antibodies in vaccinated people will last, he said.

Scientists will get answers to some of their questions from the country's first large-scale COVID-19 vaccine trial, launched last week by the National Institutes of Health and Moderna at 89 locations around the country.

"Once we get a protective response, we will see how long it lasts," Fauci said.

"If we don't get as long a response as we want, we can always give a booster shot."

The leading vaccine candidates are based on new approaches that have never resulted in a licensed vaccine. Moderna, a relatively young company, has yet to produce any approved vaccines.

"Even more so than usual, as we create vaccines, we're sailing in uncharted water," said Dr. William Schaffner, a professor at the Vanderbilt University School of Medicine.

If approved, a COVID vaccine created by researchers at Oxford University and drugmaker AstraZeneca would be the first licensed vaccine to use a virus that causes colds in chimpanzees but doesn't sicken people. Scientists use the cold virus to deliver key elements of the vaccine into a patient's body. In this case, the virus delivers the gene that instructs the cell to make the spike protein, which helps the novel coronavirus enter cells.

Early studies show that the Oxford vaccine stimulates the immune system as intended. If the vaccine is successful, these antibodies and other immune cells will recognize and neutralize the spike protein if they encounter it again, protecting people from disease.

Two other candidates — a vaccine from Moderna and another from Pfizer and BioNTech, a German company — were also developed with novel methods. They use genetic material from the coronavirus called messenger RNA, or mRNA.

Unlike traditional vaccines, which expose the body to a viral protein to stimulate the immune system, mRNA acts as an instruction kit, telling the body how to construct the proteins itself. The immune system then responds to the viral protein by making antibodies.

Moderna officials have said they were able to produce the COVID-19 vaccine so rapidly because they had developed experimental vaccines against two other lethal coronaviruses — those that cause SARS and MERS — which are closely related to the COVID-19 virus.

When the pandemic emerged, Moderna tweaked those vaccines to target COVID-19, Fauci told KHN. Fauci's team contacted the company the day after China made the virus's genome public.

Two months later, Moderna's vaccine was ready for a trial because "98% of the scientific work had been done," Schaffner said. "They went back to these scientific methods and adapted them very quickly. That saves years of work."

But there is a potential risk in relying so heavily on unproven techniques: New technology can sometimes cause unforeseen problems or side effects, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

For all their differences, most of the vaccines in development target the spike protein, Adalja said. That is likely a winning strategy, considering successful veterinary coronavirus vaccines also target the spike protein.

But some scientists say this uniform approach could also leave us vulnerable.

Ideally, scientists should diversify the portfolio of vaccines, in case targeting the spike protein doesn't work as well as researchers hope, Adalja said. Developing a vaccine that targets other key proteins might help scientists to hedge their bets.

Researchers around the world are working on more than 165 vaccines; more than two dozen are already being tested in people. Early human studies focus on safety and finding the best dose. Later clinical trials are larger and measure a vaccine's effectiveness by comparing the outcomes of volunteers who receive the vaccine with those of people given a placebo.

Fauci said he's reassured by early studies that showed the Moderna vaccine to be safe. Although some volunteers developed fevers and headaches after vaccination, these side effects were no worse than those caused by other licensed vaccines.

"That's not a showstopper at all," he said.

A Perplexing Pathogen

Some of COVID-19's most important mysteries involve the immune system, said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.

Offit said he's mystified by the fact that a small fraction of people with COVID-19 don't make any antibodies against the virus. He knows of no other virus that does this.

"We're only seven months into this and we've had a lot of surprises," said Offit, a member of a National Institutes of Health effort to develop vaccines and drugs to treat COVID-19. "This virus does things that no other virus does."

This is not like preventing measles. "It's easier to create a vaccine for diseases that confer long-term immunity," Offit said. People never catch measles more than once. The two-dose measles vaccine stimulates immunity, protecting 97% of people for life, Offit said.

It's also not like strep throat or gonorrhea, which people can catch multiple times because the bacteria that cause them don't ignite lasting immunity. "That's why we don't have a vaccine for them," he said.

Some coronaviruses cause more serious symptoms than others. Coronaviruses that cause the common cold don't stimulate lasting antibodies, which is one reason people can catch colds repeatedly, Schaffner said.

Studies show that antibodies against more lethal coronaviruses last a bit longer. Antibodies against the severe acute respiratory syndrome virus, which caused a pandemic in 2003, and the Middle East respiratory syndrome virus, which appeared in 2011, appear to last two to three years.

People with severe symptoms from COVID-19 tend to have higher antibody levels than those with milder cases.

Some people fail to generate antibodies because they have compromised immune systems, said Mark Sangster, a research professor at the University of Rochester Medical Center.

Even when people do generate antibodies against the novel coronavirus, studies suggest the antibodies may not last long.

In a recent New England Journal of Medicine report on COVID-19 survivors, antibody levels dropped rapidly over three months, at a rate that could leave them without any antibodies within one year. Those findings echo the results of a June report in Nature Medicine that found antibody levels began to fall two to three months after infection.

Such reports have worried some scientists, who fear that antibodies will decline just as rapidly among people vaccinated against COVID-19.

"One wants a vaccine that lasts longer than two months," Schaffner said.

Other antibody research has been more encouraging.

A July paper found that COVID-19 infection "induces robust, neutralizing antibody responses that are stable for at least three months." Antibodies typically rise during an infection, then fall again as the immune system returns to normal, said Florian Krammer, co-author of the study, which was published online before undergoing peer review.

"What we found looks like a normal antibody response to a viral infection," said Krammer, a professor of microbiology at the Icahn School of Medicine at Mount Sinai in New York.

Early studies of the Moderna vaccine suggest people mount a strong immune response after two doses, Fauci said. But because the earliest trials began just a few months ago, doctors don't yet know how long antibodies in vaccinated people will last.

The United States has invested nearly $6 billion in potential COVID-19 vaccines.

Conflicting evidence on antibodies "shouldn't interfere with efforts to develop a safe and effective vaccine," added Fauci, noting he's encouraged by the results of early clinical trials. "The durability of the vaccine may be quite good."

Dr. Michael Watson, who is developing Moderna's COVID-19 vaccine, said he hopes vaccinated people will have a stronger immune response than those sickened by the coronavirus. He said it's possible the virus not only infects cells, but also dampens the immune system, suppressing antibody response.

A vaccine that contains only one part of the novel coronavirus — a protein that allows it to enter cells — might be able to stimulate antibody production without suppressing the immune response, Watson said. Only large clinical studies will show whether this is the case.

Memories That Don't Fade

Yet there's more to the immune system than antibodies.

The body is also protected by memory T-cells, which can recognize viral threats to stimulate the production of antibodies even after many years, said Dr. Jeffrey Klausner, professor of infectious diseases at UCLA. Memory T-cells can stimulate B-cells to make antibodies, while instructing other immune system players to fight the virus in different ways.

"The T-cells are like the conductors of a symphony," Klausner said. "These multiple, complex arms of the immune system work together like a symphony to control infection."

Even if antibodies dwindle over time, memory cells can often replenish the supply, preventing infected patients from developing dangerous symptoms, Sangster said.

New studies suggest people who survive COVID-19 develop both memory T-cells and B-cells. One paper even documented memory T-cells —which can instruct other cells to make antibodies — in survivors of the 2003 SARS pandemic.

Fauci said it's too early to know what sort of role T-cells will play in defending against the novel coronavirus.

Researchers will get more definitive answers about vaccine-induced immunity to COVID-19 in coming months, after they complete large, rigorous trials of tens of thousands of volunteers, Offit said. Vaccine makers have said they plan to study their products' safety and effectiveness even after approval, to measure long-term efficacy as well to detect rare side effects that don't appear in smaller, shorter studies.

In addition to Moderna's trial, AstraZeneca said results from an ongoing study of 50,000 volunteers should be available this fall.

With so many vaccines in development, Adalja said, it's difficult to know which one will prove the safest and most effective.

"The first vaccines may not be the ultimate vaccine that everybody uses," he said.

And some vaccines may work better in certain populations than others, Offit said. For example, studies may find that one shot works particularly well in children, while another better protects older adults. "There is definitely a lot to learn," he said.

Ideally, doctors would like all vaccines to be as successful as the measles shot, Offit said. But a COVID-19 vaccine could more closely resemble flu shots and rotavirus vaccines, which don't prevent all infections but dramatically reduce the risks of hospitalization and death. Although some people who receive a flu shot still get influenza, their infections tend to be much milder than those of people who aren't vaccinated.

"You'd like to have a vaccine that protects against severe disease, and it likely will," Offit said. "But people might still get mild infections and still shed the virus and still spread it" even after being vaccinated.

If that happens, Offit said, the vaccine may not slow the spread of the pandemic as much as people have hoped. "You'd still need masks and social distancing" to reduce the spread of the virus, Offit said. "It's going to take both — a vaccine and these hygienic measures — to defeat the virus."

KHN editor Arthur Allen contributed to this story.

Liz Szabo: lszabo@kff.org, @LizSzabo

Hospital Merger in Washington State Stokes Fears About Catholic Limits on Care

KFF Health News, August 3, 2020

It is unclear whether secular hospitals can continue to offer services forbidden by church doctrine, including abortion, birth control, gender confirmation surgery and physician aid in dying.

This article was published on Monday, August 3, 2020 in Kaiser Health News.

By Harris Meyer

The proposed merger of a well-regarded secular hospital system and a larger Roman Catholic system in Washington state has triggered new alarms about religious restrictions on patients' access to care.

Virginia Mason Health System and CHI Franciscan announced plans in mid-July to form a joint operating company including 12 hospitals and more than 250 other treatment sites in the Puget Sound region and the Yakima area in central Washington. They touted the deal as a way to improve care.

But the plan was unclear on whether the secular hospitals could continue to offer services forbidden by church doctrine, including abortion, birth control, gender confirmation surgery and physician aid in dying, which is legal in Washington.

These questions keep arising across the country because Catholic conglomerates are some of the largest hospital systems in the U.S. — with four Catholic systems ranked in the top seven — and they frequently gobble up smaller, non-Catholic medical centers.

The issue is particularly urgent in Washington, where Swedish Medical Center — the largest nonprofit health care system in the Puget Sound area — merged with Providence Health & Services in 2012 and stopped providing emergency services to end pregnancies at the hospital. Bellingham and other Washington cities saw similar service cessations following Catholic takeovers of secular hospitals.

Already, 1 in 6 U.S. hospital beds are in Catholic facilities. The figure is 41% in Washington, according to a new report on religious-based hospital systems to be released in September by MergerWatch. If the Virginia Mason merger goes through, four cities in the state — Bellingham, Centralia, Walla Walla and Yakima — will have only a Catholic hospital.

Seattle-based Virginia Mason said that, as part of the deal, it would work with CHI Franciscan to comply with the directives governing Catholic health care institutions.

But it declined to offer specifics on what services the system would stop offering or make an executive available for an interview. Tacoma-based CHI Franciscan is part of the 137-hospital Catholic giant CommonSpirit Health, the second-largest hospital system in the U.S.

The U.S. Conference of Catholic Bishops' Ethical and Religious Directives forbid services such as abortion, contraception, tubal ligation and physician aid in dying for terminally ill patients. Catholic providers differ over whether gender transition care is permitted, but Virginia Mason said its service offerings for LGBTQ patients would not change.

In a July 21 letter, 12 organizations — including the ACLU of Washington, NARAL Pro-Choice Washington, End of Life Washington and the state chapter of the American Academy of Obstetricians and Gynecologists — warned the proposed merger would jeopardize access to needed services. The ACLU and Planned Parenthood have set up meetings for early this month with Virginia Mason's CEO, Dr. Gary Kaplan, to discuss ways to maintain those services.

"We're actively working with community groups to address their questions," Virginia Mason and CHI Franciscan said in a joint written statement.

It's the latest conflict to arise as more Catholic and non-Catholic hospital systems around the country consider merging, driven by the long-running consolidation in the health care industry and now by the economic collapse caused by the COVID-19 pandemic. Some of these efforts have been derailed by objections from regulators and advocacy groups to Catholic care restrictions.

The Washington attorney general's office said it will review the proposed merger to ensure it doesn't lessen competition or harm state residents. But advocacy groups don't expect the state to block the deal.

Research shows that most Catholic facilities do not explicitly inform patients about their religious care restrictions and that physicians, particularly OB-GYNs, often struggle to arrange workarounds to get patients care they need, such as birth control devices. Doctors say they are discouraged from even informing patients about medical options forbidden by Catholic rules.

Washington advocacy groups are particularly worried the merger will reduce access to services in Yakima, a geographically isolated city of 94,000 east of the Cascade Mountains, where Virginia Mason Memorial is the only hospital.

"The people of Washington have voted many times for access to abortion and Death with Dignity, and it's really frustrating that hospitals won't be delivering those services," said state Rep. Eileen Cody (D-Seattle), who chairs the House health committee.

Women's health groups are particularly worried that Virginia Mason's facilities in Seattle and Yakima will stop providing services to terminate a pregnancy or remove fetal tissue in emergencies such as ectopic pregnancies and miscarriages or allow tubal ligations. Many Catholic-controlled hospitals don't offer those procedures.

"In secular hospitals, when a woman is miscarrying, she'll be given the option to wait and see if the bleeding passes, or to immediately terminate the nonviable pregnancy," said Linda McCarthy, CEO of Mt. Baker Planned Parenthood in Bellingham. "In Catholic hospitals they don't get that option."

Planned Parenthood may ask Virginia Mason to set up a model similar to one it established with Swedish Health Services in Seattle after that system affiliated with Providence, said Christine Charbonneau, CEO of Planned Parenthood of the Great Northwest and the Hawaiian Islands. Swedish funded a new Planned Parenthood clinic near its campus for procedures that violate Catholic doctrine.

Similarly, End of Life Washington wants Virginia Mason to agree to let its physicians individually choose whether to provide patients with aid in dying, as Swedish did after its merger, said Dr. Robert Wood, the group's medical adviser.

"But we've heard CHI Franciscan is a more conservative group than Providence, and we're not optimistic that VM can negotiate that deal," Wood said.

Virginia Mason has said its physicians would inform patients about all their treatment options and would provide information about other providers if patients seek services it doesn't offer.

Another barrier is that the Catholic bishops revised their religious care rules in 2018 to toughen church scrutiny of workaround deals in which non-Catholic merger partners seek to preserve access to Catholic-prohibited services.

Harris Meyer: @Meyer_HM

Don't Fall for This Video: Hydroxychloroquine Is Not a COVID-19 Cure

KFF Health News, July 31, 2020

Members of a new group called America's Frontline Doctors touch on several unproven conspiracy theories about the coronavirus pandemic.

This article was published on Friday, July 31, 2020 in Kaiser Health News.

Millions of people, including the president of the United States, have seen or shared a video in which a doctor falsely claims there is a cure for the coronavirus, and it's a medley starring hydroxychloroquine.

The video shows several doctors in white coats giving a press conference outside the Supreme Court in Washington, D.C. It persists on social media despite bans from Facebook, Twitter and YouTube, and it was published by Breitbart, a conservative news site.

The July 27 event was organized by Tea Party Patriots, a conservative group backed by Republican donors, and attended by U.S. Rep. Ralph Norman, R-S.C.

In the video, members of a new group called America's Frontline Doctors touch on several unproven conspiracy theories about the coronavirus pandemic. One of the most inaccurate claims comes from Dr. Stella Immanuel, a Houston primary care physician and minister with a track record of making bizarre medical claims, such as that DNA from space aliens is being used in medical treatments.

"This virus has a cure. It is called hydroxychloroquine, zinc, and Zithromax," Immanuel said. "I know you people want to talk about a mask. Hello? You don't need [a] mask. There is a cure."

As of July 27, nearly 150,000 Americans had died because of the coronavirus. Could those deaths have been prevented by a drug that's used to treat lupus and arthritis?

No. Immanuel's statement is wrong on several points.

'This Virus Has a Cure'

There is no known cure for COVID-19.

According to the Centers for Disease Control and Prevention, there is no specific antiviral treatment for the virus. Supportive care, such as rest, fluids and fever relievers, can assuage symptoms.

"There is currently no licensed medication to cure COVID-19," according to the World Health Organization.

The Cure Is 'Hydroxychloroquine, Zinc and Zithromax'

Sources

Centers for Disease Control and Prevention, "About Cloth Face Coverings," accessed July 28, 2020

Centers for Disease Control and Prevention, "Food and Coronavirus Disease 2019 (COVID-19)," accessed July 28, 2020

Centers for Disease Control and Prevention, "What to Do If You Are Sick," accessed July 28, 2020

ClinicalTrials.gov, "Coronavirus 2019 (COVID-19) — Using Ascorbic Acid and Zinc Supplementation (COVIDAtoZ)"

CNN, "Social Media Giants Remove Viral Video With False Coronavirus Claims That Trump Retweeted," July 28, 2020

The Daily Beast, "Trump's New Favorite COVID Doctor Believes in Alien DNA, Demon Sperm, and Hydroxychloroquine," July 28, 2020

Facebook video, July 27, 2020

Food and Drug Administration, "FDA Cautions Against Use of Hydroxychloroquine or Chloroquine for COVID-19 Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems," accessed July 28, 2020

Food and Drug Administration, letter revoking EUA for chloroquine phosphate and hydroxychloroquine sulfate, June 15, 2020

GoodRx, "Can Hydroxychloroquine and Chloroquine Be Used to Treat Coronavirus (COVID-19)?" July 23, 2020

National Institutes of Health, "NIH Halts Clinical Trial of Hydroxychloroquine," June 20, 2020

PolitiFact, "Don't Fall for Conspiracy About Dr. Anthony Fauci, Hydroxychloroquine," May 6, 2020

PolitiFact, "Hydroxychloroquine and Coronavirus: What You Need to Know," April 8, 2020

PolitiFact, "Hydroxychloroquine Is Not Proven to Treat COVID-19 or Radiation Sickness," May 19, 2020

Retweet from Donald Trump, July 27, 2020

Rev, America's Frontline Doctors SCOTUS Press Conference Transcript

The Washington Post, "Twitter Penalizes Donald Trump Jr. for Posting Hydroxychloroquine Misinformation Amid Coronavirus Pandemic," July 28, 2020

World Health Organization, "Coronavirus Disease (COVID-19) Advice for the Public: Mythbusters," accessed July 28, 2020

World Health Organization, "Q&A: Hydroxychloroquine and COVID-19," June 19, 2020

In spite of Immanuel's anecdotal evidence, hydroxychloroquine alone or in combination with other drugs is not a proven treatment (or cure) for COVID-19.

The Food and Drug Administration has not approved hydroxychloroquine for the prevention or treatment of COVID-19. In mid-June, the FDA revoked its emergency authorization for the use of hydroxychloroquine and the related drug chloroquine in treating hospitalized COVID-19 patients.

"It is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks," FDA Chief Scientist Denise M. Hinton wrote.

The WHO and the National Institutes of Health have also stopped their hydroxychloroquine studies. Among the safety issues associated with treating COVID-19 patients with hydroxychloroquine include heart rhythm problems, kidney injuries and liver problems.

While some studies have found that the drug could help alleviate symptoms associated with COVID-19, the research is not conclusive. Few studies have been accepted into peer-reviewed journals. And large, randomized trials — the gold standard for clinical trials — are still needed to confirm the findings of studies conducted since the pandemic began.

In the video, Immanuel cited a 2005 study that found chloroquine — not hydroxychloroquine — was "effective in inhibiting the infection and spread of SARS CoV," the official name for severe acute respiratory syndrome. But the drug was not tested on humans, the authors wrote that more research was needed to make any conclusions, and SARS is different from COVID-19.

'You Don't Need a Mask'

Health officials advise everyone to wear a mask in public.

The reason has to do with how the coronavirus spreads. When an infected person coughs or sneezes, they expel respiratory droplets containing the virus. Those droplets can then land in the mouths or noses of people nearby.

Since some people infected with the coronavirus may exhibit no symptoms, public health officials say everyone should cover their face in public — even if they don't feel sick.

"The spread of COVID-19 can be reduced when cloth face coverings are used along with other preventive measures, including social distancing, frequent handwashing, and cleaning and disinfecting frequently touched surfaces," according to the CDC.

Our Ruling

In a viral video, Immanuel said there is a cure for COVID-19, hydroxychloroquine can treat it, and people don't need to wear masks to prevent the spread of the virus.

All of those claims are inaccurate. There is no known cure for COVID-19, hydroxychloroquine is not a proven treatment, and public health officials advise everyone to wear a face mask in public.

Immanuel's statement is False.

Daniel Funke, PolitiFact: dfunke@poynter.org, @dpfunke

Avoiding Care During the Pandemic Could Mean Life or Death

KFF Health News, July 31, 2020

The coronavirus has so diminished trust in the U.S. medical system that even people with serious illnesses are staying out of the ED, with potentially mortal consequences.

This article was published on Friday, July 31, 2020 in Kaiser Health News.

By John M. Glionna

These days, Los Angeles acting teacher Deryn Warren balances her pain with her fear. She's a bladder cancer patient who broke her wrist in November. She still needs physical therapy for her wrist, and she's months late for a cancer follow-up.

But Warren won't go near a hospital, even though she says her wrist hurts every day.

"If I go back to the hospital, I'll get COVID. Hospitals are full of COVID people," says Warren, a former film director and author of the book "How to Make Your Audience Fall in Love With You."

"Doctors say, 'Come back for therapy,' and my answer is, 'No, thank you.'"Bottom of Form

Many, many patients like Warren are shunning hospitals and clinics. The coronavirus has so diminished trust in the U.S. medical system that even people with obstructed bowels, chest pain and stroke symptoms are ignoring danger signs and staying out of the emergency room, with potentially mortal consequences.

A study by the Centers for Disease Control and Prevention found that emergency room visits nationwide fell 42% in April, from a mean of 2.1 million a week to 1.2 million, compared with the same period in 2019.

A Harris poll on behalf of the American Heart Association found roughly 1 in 4 adults experiencing a heart attack or stroke would rather stay at home than risk getting infected with the coronavirus at the hospital. These concerns are higher in Black (33%) and Hispanic (41%) populations, said Dr. Mitchell Elkind, president of the American Heart Association and a professor of neurology and epidemiology at Columbia University.

Perhaps even more worrisome is the drastic falloff of routine screening, especially in regions hit hard by the virus. Models created by the medical research company IQVIA predict delayed diagnoses of an estimated 36,000 breast cancers and 19,000 colorectal cancers due to COVID-19's scrambling of medical care.

At Hoag Memorial Hospital Presbyterian in Newport Beach, California, mammograms have dropped as much as 90% during the pandemic. "When you see only 10% of possible patients, you're not going to spot that woman with early-stage breast cancer who needs a follow-up biopsy," said Dr. Burton Eisenberg, executive medical director of the Hoag Family Cancer Institute.

Before the epidemic, Eisenberg saw five melanoma patients a week. He hasn't seen any in the past month. "There's going to be a lag time before we see the results of all this missed care," he said. "In two or three years, we're going to see a spike in breast cancer in Orange County, and we'll know why," he said.

Dr. Farzad Mostashari, former national coordinator for health information technology at the U.S. Department of Health and Human Services, agreed. "There will be consequences for deferring chronic disease management," he said.

"Patients with untreated high blood pressure, heart and lung and kidney diseases are all likely to experience a slow deterioration. Missed mammograms, people keeping up with blood pressure control — there's no question this will all cause problems."

In addition to fear? Changes in the healthcare system have prevented some from getting needed care.

Many medical offices have remained closed during the pandemic, delaying timely patient testing and treatment. Other sick patients lost their company-sponsored health insurance during virus-related job layoffs and are reluctant to seek care, according to a study by the Urban Institute.

A study by the American Cancer Society's Cancer Action Network found that 79% of cancer patients in treatment had experienced delays in care, including 17% who saw delays in chemotherapy or radiation therapy.

"Many screening facilities were shuttered, while people were afraid to go to the ones that were open for fear of contracting COVID," said Dr. William Cance, chief medical and scientific officer for the American Cancer Society.

And then there are patients who have fallen through the cracks because of the medical system's fixation on COVID-19.

Dimitri Timm, a 43-year-old loan officer from Watsonville, California, began feeling stomach pain in mid-June. He called his doctor, who suspected the coronavirus and directed Timm to an urgent care facility that handled suspected COVID patients.

But that office was closed for the day. When he was finally examined the following afternoon, Timm learned his appendix had burst. "If my burst appendix had become septic, I could have died," he said.

The degree to which non-COVID patients are falling through the cracks may vary by region. Doctors in Northern California, whose hospitals haven't yet seen an overwhelming surge of COVID-19 cases, have continued to see other patients, said Dr. Robert Harrington, chairman of the Stanford University Department of Medicine and outgoing president of the American Heart Association. Non-COVID issues were more likely to have been missed in, say, New York during the April wave, he said.

The American College of Cardiology and American Heart Association have launched campaigns to get patients to seek urgent care and continue routine appointments.

The impact of delayed care might be felt this winter if a renewed crush of COVID-19 cases collides with flu season, overwhelming the system in what CDC Director Robert Redfield has predicted will be "one of the most difficult times that we've experienced in American public health."

The healthcare system's ability to handle it all is "going to be tested," said Anthony Wright, executive director of Health Access California, an advocacy group.

But some patients who stay at home may actually be avoiding doctors because they don't need care. Yale University cardiologist and researcher Dr. Harlan Krumholz believes the pandemic could be reducing stress for some heart patients, thus reducing heart attacks and strokes.

"After the nation shut down, the air was cleaner, the roads were less trafficked. And so, paradoxically, people say they were experiencing less stress in the pandemic, not more," said Krumholz, who wrote an April op-ed in The New York Times headlined "Where Have All the Heart Attacks Gone?" "While sheltering in place, they were eating healthier, changing lifestyles and bad behaviors," he said.

At least some medical experts agree.

"The shutdown may have provided a sabbatical for our bad habits," said Dr. Jeremy Faust, a physician in the division of health policy and public health at Boston's Brigham and Women's Hospital. "We're making so many changes to our lives, and that includes heart patients. If you go to a restaurant three times a week or more, do you realize how much butter you're eating?"

While some patients may be benefiting from a COVID-19 change of regimen, many people have urgent and undeniable medical needs. And some are pressing through their fear of the virus to seek care, after balancing the risks and benefits.

In March, when the virus took hold, Kate Stuhr-Mack was undergoing a clinical trial at Hoag for her stage 4 ovarian cancer, which had recurred after a nine-month relapse.

Members of her online support group considered staying away from the facility, afraid of contracting the virus. But Stuhr-Mack, 69, a child psychologist, had no choice: To stay in the trial, she had to keep her regular outpatient chemotherapy appointments.

"We all make choices, so you have to be philosophical," she said. "And I thought it was far more risky not to get my cancer treatment than face the off-chance I'd contract COVID on some elevator."

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

Don't Count on Lower Premiums Despite Pandemic-Driven Boon for Insurers

KFF Health News, July 31, 2020

Numerous insurers across the country have announced plans to hike rates next year, though some have proposed cuts.

This article was published on Friday, July 31, 2020 in Kaiser Health News.

By Bernard J. Wolfson

When COVID-19 smacked the United States in March and April, health plans feared medical costs could skyrocket, jacking up premiums drastically in 2021, when millions of the newly unemployed might still be out of work.

But something else happened: Non-COVID care collapsed as hospitals emptied beds and shut down operating rooms to prepare for an expected onslaught of patients sickened by the coronavirus, while fear of contracting it kept people away from ERs, doctors' offices and outpatient clinics. In many regions of the country, the onslaught did not come, and the billions of dollars lost by hospitals and physicians constituted huge savings for health plans, fattening their bottom lines.

But that doesn't mean consumers will see lower premiums next year.

Numerous insurers across the country have announced plans to hike rates next year, though some have proposed cuts.

Peter Lee, executive director of Covered California, appeared skeptical about premium reductions in the state's Affordable Care Act exchange, which is likely to announce 2021 health plan rates next week.

"Would we like zero increases? Absolutely. Would we like them negative? Yeah — but not if that means you're going to increase premiums in a year by 20%," Lee said in an interview with California Healthline this week. "We've been leaning on them to do what we always lean on them to do, and this is to have the lowest possible rates where you won't be on a rate roller coaster. We want health plans to price right — not to price artificially low or artificially high."

Covered California provides coverage for about 1.5 million residents who buy their own insurance.

If the insurance exchanges in other states offer any guidance for Covered California, it is in the direction of moderate premium increases for 2021, though there is wide variation.

A KFF analysis last week of proposed 2021 rates in the exchanges of 10 states and the District of Columbia showed a median increase of 2.4%, with changes ranging from a hike of 31.8% by a health plan in New Mexico to a cut of 12% in Maryland. (Kaiser Health News, which produces California Healthline, is an editorially independent program of KFF.)

Among the roughly one-third of filings that stated how much COVID-19 added to premiums, the median was 2%, with estimates ranging from minus 1.2% at a plan in Maine to 8.6% at one in Michigan.

The proposed premiums for ACA marketplace plans do not affect job-based coverage, but they may indicate how the pandemic is affecting premiums generally.

The consensus among industry experts is that COVID-19 has generated little pressure for rate rises, and health plans should err on the side of moderation. But some fear that many insurers will hold onto the reserves they've built up, citing the possibility of widespread vaccinations and concerns that the care forgone in 2020 could rebound with a vengeance next year.

"The tendency of health plans, when they are faced with any degree of uncertainty, is to be very conservative and price for the worst-case scenario," said Michael Johnson, an industry observer and critic who worked as an executive at Blue Shield of California from 2003 to 2015. "Actuaries are less likely to get fired if the plan prices too high than if the plan prices too low. But I think regulators really need to push back hard on that."

Lee said all 11 insurers participating in the exchange this year will remain in 2021, and no new ones will be added to the mix, though some of the current carriers will extend their coverage geographically. Ninety percent of consumers who buy their own health insurance get subsidies from the federal government or the state to help pay their premiums.

In January, California became the first state to offer subsidies to middle-income people who make too much money to qualify for federal subsidies. The lion's share of the state subsidies is earmarked for those who earn between 400% and 600% of the federal poverty level, or $51,040 to $76,560 a year for an individual and $104,800 to $157,200 for a family of four.

The rate proposals expected to be unveiled next week will be subject to scrutiny by state regulators before they are finalized. Sign-ups for the plans start Nov. 1 and run through Jan. 31. This year, the average Covered California rate increase statewide was 0.8%, the lowest since the exchange started providing coverage in 2014.

The benefits reaped by health plans so far in the pandemic can be seen in strong second-quarter earnings and reduced spending on care. UnitedHealth Group, the nation's largest health insurer, announced earlier this month that its net profit in the April-June quarter nearly doubled from the same period a year earlier. Its medical spending plummeted from 83.1% of premium revenue to 70.2% over that period.

Anthem, the parent company of Blue Cross of California, reported Wednesday that its net profit in the second quarter doubled from the same period in 2019, also on the back of plunging medical expenses.

Anthem said it offered one-month premium credits ranging from 10% to 50% to enrollees in individual, employer and group dental policies — including its Blue Cross plans in California.

UnitedHealth said it has provided $1.5 billion worth of financial support to consumers so far, including premium credits and cost-sharing waivers, and expects to pay out $1 billion in rebates.

But UnitedHealth, which does not participate in Covered California, is seeking a rate increase of 13.8% in the New York exchange. Anthem, which covers about 80,000 people in Covered California, is planning rate hikes of 16.6% in Kentucky and 9.9% in Connecticut.

On the other hand, Kaiser Permanente, which covers more than one-third of Covered California enrollees, plans rate cuts in other states, ranging from 1% in Hawaii to 11% in Maryland. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)

Lee downplayed the notion of a financial boon for California health plans, saying that, partly because of the use of telehealth, primary care has rebounded and the plans are paying for it. "So we don't see this as being at this point a bonanza year for health plans," he said. "Rather, it's a year in which there are lessons learned for how we can deliver care in a pandemic."

Still, the health plans are in a far stronger position than they had feared earlier this year.

In March, Covered California released a study showing that COVID-19's impact on 2021 premiums for individuals and employers could range from an increase of 4% to more than 40%. But less than three months later, projections commissioned by the industry's national advocacy group, America's Health Insurance Plans, showed that even in the worst-case scenario of a 60% COVID infection rate — far above where it stands now — the pandemic would increase medical costs in 2020 and 2021 by 6% at most, and could even decrease them.

That moderate effect is largely attributable to what Katherine Hempstead, a senior policy adviser at the Robert Wood Johnson Foundation, called "a kind of yin and yang: If you have a lot of COVID, you don't have a lot of other healthcare spending."

Independent of the course the pandemic takes, emergency room and outpatient visits still lag behind pre-COVID levels and will probably continue to do so next year, to the continued benefit of insurers, predicted Glenn Melnick, a professor of healthcare finance at the University of Southern California's Sol Price School of Public Policy. That could be good news for consumers, he said, potentially leading to lower premium increases or even reductions next year.

On the other hand, hospitals and doctors have lost money, and the ones whose contracts with health plans are up for renewal will be looking to make up those losses, Melnick said.

"Providers could be asking for 20-25% increases next year," he said, "and if they've got market power, they can make it stick."

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

Bernard J. Wolfson: bwolfson@kff.org, @bjwolfson

 

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