If clinical trials for COVID-19 vaccines aren't expanded soon to include children, it's unlikely that even kids in their teens will be vaccinated in time for the next school year.
The hurdle is that COVID vaccine makers are only in the early stages of testing their products on children. The Pfizer vaccine authorized for use by the Food and Drug Administration on Friday was greenlighted only for people ages 16 and up. Moderna just started trials for 12- to 17-year-olds for its vaccine, likely to be authorized later this month.
It will take months to approve use of the vaccines for middle- and high school-aged kids, and months more to test them in younger children. But some pediatricians say that concerns about the safety of the front-runner vaccines make the wait worthwhile.
Although most pediatricians believe the eventual vaccination of children will be crucial to subduing the COVID virus, they're split on how fast to move toward that, says Dr. James Campbell, professor of pediatrics at the University of Maryland School of Medicine's Center for Vaccine Development and Global Health. Campbell and colleagues say it's a matter of urgency to get the vaccines tested in kids, while others want to hold off on those trials until millions of adults have been safely vaccinated.
Much of the debate centers on two issues: the degree of harm COVID-19 causes children, and the extent to which children are spreading the virus to their friends, teachers, parents and grandparents.
COVID-19's impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it would qualify as a pretty serious childhood disease, having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among people 19 and younger in the United States. Those numbers rank it as worse than a typical year of influenza, and worse than diseases like mumps or hepatitis B in children before the vaccination era.
Studies thus far show that 1%-2% of children infected with the virus end up requiring intensive care, Dr. Stanley Plotkin, professor emeritus of pediatrics at the University of Pennsylvania, told a federal panel. That's in line with the percentage who become gravely ill as result of infections like Haemophilus influenza type B, or Hib, for which doctors have vaccinated children since the 1980s, he pointed out.
Campbell, who with colleagues has developed a plan for how to run pediatric COVID vaccine trials, points out that "in a universe where COVID mainly affected children the way it's affecting them now, and we had potential vaccines, people would be clamoring for them."
The evidence that teens can transmit the disease is pretty clear, and transmission has been documented in children as young as 8. Fear of spread by children has been enough to close schools, and led the American Academy of Pediatrics to demandthat children be quickly included in vaccine testing.
"The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission," said Dr. Yvonne Maldonado, a professor of pediatrics at Stanford University who chairs the AAP's infectious disease committee. "If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren't a risk."
Other pediatricians worry that early pediatric trials could backfire. Dr. Cody Meissner, chief of pediatric infectious diseases at Tufts Medical Center and a member of the FDA's advisory committee on vaccines, is worried that whatever causes Multisystem Inflammatory Syndrome in Children, a rare but frightening COVID-related disorder, might also be triggered, however rarely, by vaccination.
Meissner abstained from the committee's vote Thursday that supported, by a 17-4 vote, an emergency authorization of the Pfizer vaccine for people 16 and older.
"I have trouble justifying it for children so unlikely to get the disease," he said during debate on the measure.
But panel member Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children's Hospital, said the 16-and-up authorization would speed the vaccine's testing in and approval for younger children. That is vital for the world's protection from COVID-19, he said, since in the United States and most places "most vaccines are delivered early in life."
While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Dr. Emily Erbelding, director of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases.
Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late last month, Pfizer had vaccinated approximately 100 children 12-15 years of age, said spokesperson Jerica Pitts.
Moderna has started enrolling 3,000 children 12 and over in another clinical trial, and other companies have similar plans. Assuming the trials show the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.
Similar stepdown approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.
Vaccine trials geared to tweens or younger children may involve testing half-doses, which, if protective, would require less vaccine and might cause fewer incidents of sore arms and fevers that afflicted many who've received the Pfizer and Moderna vaccines, Campbell said.
But unless additional studies begin quickly, the window for having an FDA-authorized vaccine available before the next school year "will be closed even for our oldest children," said Dr. Evan Anderson, a pediatrics professor at Emory University. "Our younger children are almost certainly going into next school year without a vaccine option available for them."
In the meantime, teachers are likely to be high on the priority list for vaccination. Protecting school staff could allow more schools to reopen even if most children can't be vaccinated, Erbelding said.
Eventually, if the SARS-CoV-2 virus remains in circulation, governments may want to mandate childhood vaccination against the virus to protect them as they grow up and protect society as a whole, Plotkin said.
In the 1960s, Plotkin invented the rubella vaccine that has been given to hundreds of millions of children since. Like COVID-19, rubella, or German measles, is not usually a serious illness for children. But congenital rubella syndrome afflicted babies in the womb with blindness, deafness, developmental delays and autism. Immunizing toddlers, which, in turn, protects their pregnant mothers, has indirectly prevented hundreds of thousands of such cases.
"We don't want to use children to protect everyone in the community," said Campbell. "But when you can protect both children and their community, that's important."
And while a coronavirus infection may not be bad for most children, missed school, absent friends and distanced families have caused them immense suffering, he said.
"It's a huge burden on a child to have their entire world flipped around," Campbell said. "If vaccinating could help to flip it back, we should begin testing to see if that's possible."
In the final weeks before the Nov. 3 election, supporters of a down-in-the-weeds effort to overturn a tax law in Colorado received a cascade of big checks, for a grand total of more than $2 million.
All came from Kent Thiry, the former CEO of DaVita, one of the largest kidney care companies in the country. This was not the first time he donated big to a ballot initiative aimed at tweaking the nitty-gritty details of how Colorado functions. Nor will it be the last.
Thiry hasgiven at least $5.9 million to Colorado ballot measures since 2011 — and all of them won, according to a KHN review of Colorado campaign finance data. According to data from the National Institute on Money in Politics, Thiry's donations to ballot measures in that state are second only to those of billionaire Pat Stryker, an heiress whose grandfather founded a medical technology company. Campaign finance records show that before that, he gave to ballot issue committees in California, where he used to live, dating to at least 2007.
It's the same playbook his former company has successfully used in California. As KHN has reported, in 2018 DaVita was among several companies to break an industry record in campaign spending for a ballot measure by any one side in California. This year, the industry came close to breaking that record to defeat a measure that would have further regulated dialysis clinics and that DaVita said would have limited access to care.
"Wealthy individuals have been pouring money into ballot measures, even seemingly unrelated to their industry, for over a century," Daniel Smith, a political scientist studying direct democracy at the University of Florida, wrote in an email to KHN.
Given that healthcare is a $3.6 trillion industry, its top executives are among the ranks of those who can have an enormous impact in ballot measure politics. This year, Kent Thiry and Mike Fernandez, chairman and CEO of private equity firm MBF Healthcare Partners, were among the 19 individuals or couples who spent $1 million or more on ballot issue campaigns this year, according to Bloomberg. In previous elections, medical equipment company owner Loren Parks has also given big money to ballot initiatives.
Overall, those in the health industry have spent more on ballot measures in Colorado than in any other state except Missouri and California, according to data from the National Institute on Money in Politics, and that's largely due to Thiry.
"He really has become the 800-pound gorilla of the ballot initiative process in Colorado," said Josh Penry, a Republican campaign strategist in Denver who has worked with Thiry, including on a ballot measure campaign Thiry helped fund. "He wields more power in an informal way than virtually all the elected officials, if you look at the impact he's had."
Even though Thiry and his wife, Denise O'Leary, a former venture capitalist on the board of directors of medical device company Medtronic, have madehefty earnings from healthcare, Thiry's ballot initiative donations as an individual have nothing to do with the industry.
"I prefer things that have systemic impact," said Thiry. Measures he has bankrolled have eliminated the caucus system for presidential primaries, brought unaffiliated voters into the primaries and created a system intended to eliminate gerrymandering.
"Democracy is not a spectator sport," he said.
Thiry previously donated to ballot measure committees in California, to prevent changes to term limits and to create a system for redistricting led jointly by Democrats, Republicans and citizens unaffiliated with a political party.
After moving his company's headquarters from Los Angeles to Denver in 2010, he began backing ballot measures in his new state, too, with equal success and bigger sums, jumping from the tens of thousands to the millions. He spent more than $2 million backing a pair of measures to allow unaffiliated voters to participate in primaries.
In 2018, while his company was helping break an election spending record to defeat a California measure that would have cappedthe industry's profits, Thiry was putting more than $1.2 million toward redistricting efforts in Colorado very similar to the one he backed in his previous home state to help reduce gerrymandering.
His latest donations went to a measure that successfully overturned a tax law from the 1980s that may have helped Colorado homeowners, but which critics saidleft public services like education and fire districts underfunded in some rural areas.
Thiry doesn't just shell out cash. As the online newspaper The Colorado Independent has pointed out, Thiry's offices played a large role in bringing two warring groups with different ideas about redistricting to the same table. His efforts tend to revolve around raising the power of unaffiliated voters, who make up about 40% of Colorado's active voters, according to state data.
Fernandez, the private equity billionaire, said he has similar motivations. He donated $7.3 million to a Florida initiative to change how primaries work in that state and bring unaffiliated voters like himself into the fold.
"I've never spent so much money [on] something that I have no business reason to be in at all," he said.
The effort was, he said, nearly "a one-man show" in terms of financing. But it still failed, garnering 57% of votes when it needed 60% to pass. Fernandez said he'll try again in 2022.
"I come from a country where you can see that control of a government by a single party is deadly," said Fernandez, who was born in Cuba. "Florida has been controlled by the Republican Party for the last three decades. And when I was a Republican, that was great."
But, he said, it quickly became clear that bringing the issue to legislators was a dead end. That's expected, according to John Matsusaka, executive director of the Initiative and Referendum Institute at the University of Southern California. Ballot initiatives are a natural route to tweak electoral machinery, he said, because legislators have a conflict of interest on issues like gerrymandering and term limits.
"I don't look at ballot propositions as a way to drive a progressive agenda or conservative agenda or any sort of agenda," he said. "I view it as a way to put the people in control. And they can go where they want to go."
Even if that means eroding their own power a little. One of the first initiatives Thiry donated to in Colorado is something Matsusaka considers "anti-democracy" — an effort called Raise the Bar, a ballot initiative about ballot initiatives. Itrequired petitioners to get signatures from every corner of the state to put an initiative on the ballot. Some view this as problematic.
"You have to now collect signatures in every senate district of Colorado," said Corrine Rivera Fowler, director of policy and legal advocacy with the Ballot Initiative Strategy Center, a national organization that supports progressive ballot initiatives. "That's a tremendous undertaking for grassroots communities."
Thiry, meanwhile, intends to take what he's learned in Colorado and apply it elsewhere. He said he's getting more involved in several national democracy reform groups, including Unite America, an effort to break what's been called the "doom loop" of partisanship. Thiry said he hopes to help create "a tidal tsunami of political momentum."
"One of my goals is to have this democracy reform energy in places like Colorado — or elsewhere — move from being an ad hoc collection of activist projects to a true movement," he said. "Kind of like the civil rights movement, kind of like the gay marriage movement, and like the #MeToo movement or Black Lives Matter."
He no longer works for DaVita, after stepping down as executive chairman earlier this year.
"I have no title anymore. Just 'citizen.' It's a title I wear with great pride and energy," he said.
As for the next measure Thiry will back, he's open to recommendations.
[Update: This article was revised at 10:15 a.m. ET on Dec. 14, 2020, to provide more context on billionaire Pat Stryker.]
If there's such a thing as a date with destiny, it's marked on Dr. Taison Bell's calendar.
At noon Tuesday, Bell, a critical care physician, is scheduled to be one of the first healthcare workers at the University of Virginia Health System to roll up his sleeve for a shot to ward off the coronavirus.
"This is a long time coming," said Bell, 37, who signed up via hospital email last week. "The story of this crisis is that each week feels like a year. This is really the first time that there's genuine hope that we can turn the corner on this."
For now, that hope is limited to a chosen few. Bell provides direct care to some of the sickest COVID-19 patients at the UVA Health hospital in Charlottesville, Virginia. But he is among some 12,000 "patient-facing" workers at his hospital who could be eligible for about 3,000 early doses of vaccine, said Dr. Costi Sifri, director of hospital epidemiology.
"We're trying to come up with the highest-risk categories, those who really spend a significant amount of time taking care of patients," Sifri said. "It doesn't account for everybody."
Even as the federal Food and Drug Administration engaged in intense deliberations ahead of Friday's authorization of the Pfizer and BioNTech COVID vaccine, and days before the initial 6.4 million doses were to be released, hospitals across the country have been grappling with how to distribute the first scarce shots.
An advisory committee of the Centers for Disease Control and Prevention has recommended that top priority go to long-term care facilities and front-line healthcare workers, but the early allocation was always expected to fall far short of the need and require selective screening even among critical hospital workers.
Hospitals in general are advised to target the members of their workforce at highest risk, but the institutions are left on their own to decide exactly who that will be, Colin Milligan, a spokesperson for the American Hospital Association, said in an email.
"It is clear that the hospitals will not receive enough in the first weeks to vaccinate everyone on their staff, so decisions had to be made," Milligan wrote.
At Intermountain Healthcare in Salt Lake City, the first shots will go to staff members "with the highest risk of contact with COVID-positive patients or their waste," said Dr. Kristin Dascomb, medical director of infection prevention and employee health. Within that group, managers will determine which caregivers are first in line.
At UW Medicine in Seattle, which includes Harborview Medical Center, one early plan called for high-risk staff to be selected randomly to receive first doses, said Dr. Shireesha Dhanireddy, medical director of the infectious disease clinic. But the University of Washington hospital system expects to receive enough doses to vaccinate everyone in that high-risk tier within two weeks, so randomization isn't necessary — for now.
"We are allowing people to schedule themselves," Dhanireddy said, and encouraging staffers to be vaccinated near the end of their workweeks in case they have reactions to the new vaccine.
Trial results have shown the shots frequently produce side effects that, while not debilitating, could cause symptoms such as fever, muscle aches or fatigue that might keep someone home for a day or two.
"We want to make sure that not everybody has the vaccine on the same day so that if there are some side effects, we don't end up being short-staffed," said Sifri, of UVA Health, noting that guidelines call for no more than 25% of any unit to be vaccinated at once.
At UVA Health, once the initial 3,000 doses are distributed, the hospital plans to rely on what Sifri described as "a very strong honor code" to allow staff members to decide where they should be in line. They've been asked to consider professional factors, like the type of work they do, as well as personal risks, such as age or underlying conditions like diabetes.
"We're going to ask team members, using the honor code, to determine what their risk is for COVID and to determine whether they need to have an early vaccine sign-up time or a later vaccine sign-up time," he said.
That plan was chosen after healthcare staff members soundly rejected other options. For instance, few favored a proposal to allocate dosages via a lottery, like the chaotic birthday-based system depicted in the 2011 pandemic horror film "Contagion." "That was the biggest loser," he said.
Hospital officials also stressed they are trying to devise distribution plans that ensure vaccines are allocated equitably among healthcare workers, including the social, racial and ethnic groups that have been disproportionately harmed by COVID-19 infections. That requires thinking beyond front-line doctors and nurses.
At UVA Health, for example, one of the first groups invited to get shots will be 17 workers whose job is to clean rooms in the special pathogens unit where severe COVID cases are treated.
"We acknowledge that everybody is at risk for COVID, everybody is deserving of a vaccine," Sifri said.
In many cases, it will be clear who should go first. For instance, although Dhanireddy is an infectious disease doctor who consults on COVID cases, she is happy to wait to be vaccinated. "I wouldn't put myself in the first group at all," she said. "I think that we need to protect our staff that are really right there with them most of the day — and that's not me."
But hospitals must remain vigilant about relying on workers to prioritize their own access, Dhanireddy cautioned. "Sometimes, self-selection works more for self-advocacy," she said. "It's great that some individuals say they would defer to others, but sometimes that's not actually the case."
For some healthcare workers, not being first in line for vaccination is fine. Because the vaccine initially has been authorized only for emergency use, hospitals won't require employees to be inoculated as part of this first round. Between 70% and 75% of healthcare staff at UVA Health and Intermountain Health would accept a COVID vaccine, internal surveys showed. The rest are unsure — or unwilling.
"There are some that will be immediate acceptors and some who will want to watch and wait," Dascomb said.
Still, hospital officials say they're confident that those who want the vaccine won't have to wait long. Enough doses for roughly 21 million healthcare personnel should be available by early January, according to CDC officials.
Bell, the critical care doctor, said he's grateful to be among the first to receive the vaccine, especially after his parents, who live in Boston, both contracted COVID-19. He has posted about his upcoming appointment on Twitter and said he and other healthcare workers who are among the first in line should be public about the process.
"We'll serve as an example that this is a safe and effective vaccine," he said. "We're letting it go into our bodies. You should let it go into yours, too."
Public health officials are bracing for an additional surge in cases resulting from the millions who, despite CDC advice, traveled home for Thanksgiving.
This article was published on Thursday, December 11, 2020 in Kaiser Health News.
Vivek Kaliraman, who lives in Los Angeles, has celebrated every Christmas since 2002 with his best friend, who lives in Houston. But, this year, instead of boarding an airplane, which felt too risky during the COVID pandemic, he took a car and plans to stay with his friend for several weeks.
The trip — a 24-hour drive — was too much for one day, though, so Kaliraman called seven hotels in Las Cruces, New Mexico — which is about halfway — to ask how many rooms they were filling and what their cleaning and food-delivery protocols were.
“I would call at nighttime and talk to one front desk person and then call again at daytime,” said Kaliraman, 51, a digital health entrepreneur. “I would make sure the two different front desk people I talked to gave the same answer.”
Once he arrived at the hotel he’d chosen, he asked for a room that had been unoccupied the night before. And even though it got cold that night, he left the window open.
Scary Statistics Trigger Strict Precautions
Many Americans, like Kaliraman, who did ultimately make it to Houston, are still planning to travel for the December holidays, despite the nation’s worsening coronavirus numbers.
Last week, the Centers for Disease Control and Prevention reported that the weekly COVID hospitalization rate was at its highest point since the beginning of the pandemic. More than 283,000 Americans have died of COVID-19. Public health officials are bracing for an additional surge in cases resulting from the millions who, despite CDC advice, traveled home for Thanksgiving, including the 9 million who passed through airports Nov. 20-29. Hospital wards are quickly reaching capacity. In light of all this, health experts are again urging Americans to stay home for the holidays.
For many, though, travel comes down to a risk-benefit analysis.
According to David Ropeik, author of the book “How Risky Is It, Really?” and an expert in risk perception psychology, it’s important to remember that what’s at stake in this type of situation cannot be exactly quantified.
Our brains perceive risk by looking at the facts of the threat — in this case, contracting or transmitting COVID-19 — and then at the context of our own lives, which often involves emotions, he said. If you personally know someone who died of COVID-19, that’s an added emotional context. If you want to attend a wedding of loved family members, that’s another kind of context.
“Think about it like a seesaw. On one side are all the facts about COVID-19, like the number of deaths,” said Ropeik. “And then on the other side are all the emotional factors. Holidays are a huge weight on the emotional side of that seesaw.”
The people we interviewed for this story said they understand the risk involved. And their reasons for going home differed. Kaliraman likened his journey to see his friend as an important ritual — he hasn’t missed this visit in 19 years.
What’s clear is that many aren’t making the decision to travel lightly.
For Annette Olson, 56, the risk of flying from Washington, D.C., to Tyler, Texas, felt worth it because she needed to help take care of her elderly parents over the holidays.
“In my calculations, I would be less of a risk to them than for them to get a rotating nurse that comes to the house, who has probably worked somewhere else as well and is repeatedly coming and going,” said Olson. “Once I’m here, I’m quarantined.”
Now that she’s with her parents, she’s wearing a mask in common areas of the house until she gets her COVID test results back.
Others plan on quarantining for several weeks before seeing family members — even if, as in Chelsea Toledo’s situation, the family she hopes to see is only an hour’s drive away.
Toledo, 35, lives in Clarkston, Georgia, and works from home. She pulled her 6-year-old daughter out of her in-person learning program after Thanksgiving, in hopes of seeing her mom and stepdad over Christmas. They plan to quarantine for several weeks and get groceries delivered so they won’t be exposed to others before the trip. But whether Toledo goes through with it is still up in the air, and may change based on COVID case rates in their area.
“We’re taking things week by week, or really day by day,” said Toledo. “There is not a plan to see my mom; there is a hope to see my mom.”
And for young adults without families of their own, seeing parents at the holidays feels like a needed mood booster after a difficult year. Rebecca, a 27-year-old who lives in Washington, D.C., drove up with a roommate to New York City to see her parents and grandfather for Hanukkah. (Rebecca asked KHN not to publish her last name because she feared that publicity could negatively affect her job, which is in public health.)
“I’m doing fine, but I think having something to look forward to is really useful. I didn’t want to cancel my trip completely,” said Rebecca. “I’m the only child and grandchild who doesn’t have children. I can control my actions and exposures more than anyone else can.”
She and her two roommates quarantined for two weeks before the drive and also got tested for COVID-19 twice during that time. Now that Rebecca is in New York, she’s also quarantining alone for 10 days and getting tested again before she sees her family.
“I think, based on what I’ve done, it does feel safe,” said Rebecca. “I know the safest thing to do is not to see them, so I do feel a little bit nervous about that.”
But the best-laid plan can still go awry. Tests can return false-negative results and relatives may overlook possible exposure or not buy into the seriousness of the situation. To better understand the potential consequences of the risk you’re taking, Ropeik advises coming up with “personal, visceral” thoughts of the worst thing that could happen.
“Envision Grandma getting sick and dying” or “Grandma in bed and in the hospital and not being able to visit her,” said Ropeik. That will balance the positive emotional pull of the holidays and help you to make a more grounded decision.
Harm Reduction?
All of those interviewed for this story acknowledged that many of the precautions they’re taking are possible only because they enjoy certain privileges, including the ability to work from home, isolate or get groceries delivered — options that may not be available to many, including essential workers and those with low incomes.
Still, Americans are bound to travel over the December holidays. And much like teaching safe-sex practices in schools rather than an abstinence-only approach, it’s important to give out risk mitigation strategies so that “if you’re going to do it, you think about how to do it safely,” said Dr. Iahn Gonsenhauser, chief quality and patient safety officer at the Ohio State University Wexner Medical Center.
First, Gonsenhauser advises that you look at the COVID case numbers in your area, consider whether you are traveling from a higher-risk community to a lower-risk community, and talk to family members about the risks. Also, check whether the state you’re traveling to has quarantine or testing requirements you need to adhere to when you arrive.
Also, make sure you quarantine before your trip — recommendations range from seven to 14 days.
Another thing to remember, Gonsenhauser said, is that a negative COVID test before traveling is not a free pass, and it works only if done in combination with the quarantine period.
Finally, once you’ve arrived at your destination, prepare for what might be the most difficult part: to continue physical distancing, wearing masks and washing your hands. “It’s easy to let our guard down during the holidays, but you need to stay vigilant,” said Gonsenhauser.
On tap is an initial stockpile of vaccines made during the approval process, with federal officials hoping to distribute at least 20 million doses by year’s end.
This article was published on Thursday, December 11, 2020 in Kaiser Health News.
High stakes and big challenges await as the U.S. prepares to roll out vaccines against COVID-19, with front-line health care workers and vulnerable nursing home residents recommended as the top priority.
Doses could be on their way very soon. An independent advisory committee to the Food and Drug Administration on Thursday gave a green light to the first vaccine candidate, made by Pfizer in conjunction with the German company BioNTech — a recommendation expected to be approved by the agency within days. The committee is scheduled to consider a second candidate, made by Moderna, Dec. 17.
On tap is an initial stockpile of vaccines made during the approval process, with federal officials hoping to distribute at least 20 million doses by year’s end.
While that will go a long way toward reaching the top-priority groups — the nation’s 21 million health care workers and 3 million long-term care residents — there won’t be enough to inoculate everyone on Day One, or even the first week.
In Ohio, for example, the governor expects an initial delivery of 98,000 doses, with the state allocating 88,000 of those to long-term care facilities, said Pete Van Runkle, executive director of the Ohio Health Care Association, which represents long-term care facilities.
“It’s more than a drop in the bucket, but it’s not all that’s needed,” said Van Runkle, who estimated there are between 150,000 and 175,000 residents and staff members in long-term care centers in the state.
Consequently, the doses will be distributed in waves, with the centers and hospitals not chosen for the first wave getting them in the coming weeks, he said.
Facilities will have to divvy up the supplies to best address the needs of patients and employees.
For hospitals, first up are likely to be “workers with the greatest exposure” to the virus, said Anna Legreid Dopp, a senior director at the American Society of Health-System Pharmacists, a trade group representing more than 55,000 pharmacists who work for hospitals and health systems.
Then who? Perhaps those with personal medical conditions putting them at higher risk. And there may be other considerations specific to individual hospitals. What if, for example, only two people are trained to run a specialized treatment system in the ICU needed to care for patients seriously ill with COVID-19?
“Are they at the top of the list?” asked Dopp.
Nursing homes have a slightly different calculation because they have fewer employees than hospitals, said Van Runkle.
“It’s more a question of choosing which facilities” will get the initial doses, he said. “Once those are chosen, they’ll vaccinate everyone there [who consents], not pick and choose among people.”
Even so, there may be some selectivity because most nursing home employees are women and many are of child-bearing age. Because the vaccines have not yet been tested on pregnant women, those who are pregnant or breastfeeding may not be eligible in the initial rollout.
Which long-term care facilities get the vaccine first may come down to where they are located in relation to two large pharmacy chains: CVS and Walgreens.
In October, the federal government signed an agreement with CVS and Walgreens to store and administer the vaccines. Most long-term care facilities opted to join the partnership.
Under the agreement, the pharmacist teams will make at least three trips to each nursing home over a couple of months to administer the vaccines, which must be given in two doses, set several weeks apart.
One big hurdle in distributing the two vaccines seeking FDA approval is keeping them cold. The Pfizer vaccine is stored at around 94 degrees below zero, while the Moderna option is kept at minus 4 degrees. CVS expects to keep the vaccine at 1,100 locations around the country that have the required refrigeration technology, said Mike DeAngelis, senior director of corporate communications at CVS Health. From those hubs, teams of pharmacists and pharmacy technicians will take thawed doses of the vaccines to the long-term care facilities and administer them to staff and residents. About 30,000 homes have signed on with CVS for the clinics.
Walgreens expects to administer the vaccinations in more than 23,000 long-term care locations, according to a written statement.
While there’s no charge to the nursing homes or residents, Medicare will pay an administrative fee to CVS and Walgreens of $16.94 for the first shot and $28.39 for the second.
Yet there’s a flip side to the supply equation: What if no one wants to go first?
“That’s what keeps me up at night,” said Dr. Michael Wasserman, the immediate past president of the California Association of Long Term Care Medicine, a group of physicians, nurses, social workers and others who provide care to seniors.
That’s key because a good portion of America must be vaccinated to get to the much-sought-after “herd immunity,” in which most people are protected and the virus finds it difficult to spread.
“What if government and pharmacies do a great job in getting vaccine to the front door, then no one takes it?” Wasserman worries.
Nursing home residents are particularly vulnerable to COVID-19 and account for 40% of all reported deaths.
With COVID-positive test results on the rise in almost every state, vaccinating nursing home workers is crucial to protecting not only themselves, but also their patients.
That reality meets a reluctance among many front-line nursing home workers to take the vaccine, said Lori Porter, co-founder and CEO of the National Association of Health Care Assistants, which represents certified nursing assistants who work in long-term care.
Their distrust stems from many things, she said, including politicization around the vaccines, fueled by misinformation on social media.
Educational campaigns and personal endorsements from trusted organizations could help counter the falsehoods, she said. A nationwide event planned for next week by her organization will allow certified nursing assistants to ask questions directly of physician experts and hear from a panel of their peers.
“I’m asked 100 times a day if I’m going to be taking it,” said Porter, who definitely will, hoping to do so in a live webcast, to further convince her members it’s safe.
Despite the need to vaccinate staff to protect residents, Wasserman, a former regulator and nursing home executive, does not think mandates are appropriate for workers, many of whom are low-paid and people of color. “As a society, are we prepared to force this group of folks to get a brand-new vaccine?” he asked.
A better approach, he said, is the type of educational programs that Porter mentioned, so that workers can weigh the evidence and decide whether they want to get vaccinated.
Although employers may have the authority to mandate vaccination, many experts don’t think that policy will be widespread in the nursing home industry, given a shortage of workers and a fear of losing staffers who choose not to comply.
“I can tell you our members are not going to do that,” said Van Runkle, with the Ohio trade group. “If they were to try a mandate, some number of workers would say, ‘Sorry, this is the last straw. I’m leaving.’”
Instead of a mandate, Porter said, a few nursing homes are offering prizes or financial incentives — with at least one talking about offering a drawing for a new car among those who participate. Others, however, may take the opposite approach: ending supplemental hazard pay for workers who refuse.
As for residents, there is no debate. They will not get the vaccine unless they agree, often in writing, said Van Runkle.
For those with dementia or other health problems that prevent making such a decision, family members or others with legal authority must sign, which could slow down the vaccination process considerably.
“During a pandemic, it may be difficult to get hold of them or get their handwritten signature on a document,” said Van Runkle. “We’ve got to sort all this out in the next couple of weeks.”
After nearly four years of battling President Donald Trump and federal policies they view as unfriendly, Gov. Gavin Newsom and other Democratic leaders welcome a strong ally who could help make California a laboratory for progressive ideas.
This article was published on Thursday, December 10, 2020 in Kaiser Health News.
SACRAMENTO — President-elect Joe Biden didn’t back “Medicare for All” during his campaign.
Yet his choice of California Attorney General Xavier Becerra to serve in the nation’s top health care post is fueling California lawmakers’ most progressive health care dreams, including pursuing a government-run single-payer system at the state level.
“Now it’s much more real, and it energizes me in terms of pushing for single-payer now,” said state Assembly member Ash Kalra (D-San Jose), who is considering spearheading a new single-payer campaign next year — a move he argues is more plausible under the Biden-Harris administration, with Becerra at the helm of the U.S. Department of Health and Human Services.
“It’s not good enough to just say that we believe health care is a human right. We’re now obligated to act,” Kalra said.
Across California, Democrats are changing their political calculus for what could be possible if Becerra, 62, is confirmed to the powerful position. After nearly four years of battling President Donald Trump and federal policies they view as unfriendly, Gov. Gavin Newsom and other Democratic leaders welcome a strong ally who could help make California a laboratory for progressive ideas. He would set the agenda for key federal health care agencies, which have broad authority to steer more money to states and approve their ambitious health care proposals.
Becerra, whose mother emigrated from Mexico, would be the first Latino to serve in the position. He would lead a massive $1.3 trillion federal health care apparatus that oversees agencies responsible for Medicare, Medicaid, vaccines, prescription drug approval and the U.S. public health response to the coronavirus pandemic.
“It’s a game changer for us — the stale era of normalcy versus the fresh era of progress,” Newsom said Monday. “We’re going to take advantage of this moment and these relationships — not unfairly.”
A native Californian with 30 years of political experience, 24 of them in Congress, Becerra has long backed a progressive health care agenda, including single-payer, environmental justice and protecting immigrants’ access to safety-net care. He has fiercely defended the Affordable Care Act and fought to preserve reproductive rights. He has gone after deep-pocketed pharmaceutical companies, and successfully sued a large health system in California for anti-competitive practices.
Newsom said he’s already spoken to Becerra about California’s health care priorities and is “accelerating” a dramatic transformation of the state’s Medicaid program to better serve the chronically sick and those suffering from untreated mental illness.
Immigrant advocates, who are deploying a new strategy to expand the state’s Medicaid program to all income-eligible unauthorized immigrants, plan to lobby Becerra and the Biden administration for additional federal money that could help fast-track it. They also want Becerra to agree to allow young unauthorized immigrants known as “Dreamers” to purchase insurance through Covered California, the state exchange. And California Senate President Pro Tem Toni Atkins said she’s “excited” to seek renewed approval to use federal Medicaid dollars for nontraditional uses, such as combating homelessness and providing emergency housing assistance.
“We’ve had a lot less money to bank on under Trump, but Becerra at HHS bodes well for us,” said Cathy Senderling-McDonald, incoming executive director for the County Welfare Directors Association of California. “We can rethink and possibly open up more federal funding.”
Democrats are also seizing on Becerra’s past support for single-payer, which dates back to his early congressional career in the 1990s. He has described himself as a lifelong single-payer advocate, and when a reporter asked him last year whether the idea is too costly and “pie in the sky,” Becerra responded, “I love pie.”
A young XAVIER BECERRA, Biden’s pick to run HHS, lays out his health care principles as a congressman in 1994.
“We must have universal coverage. We must have portability. We must have choice of provider,” Becerra says, endorsing single-payer. pic.twitter.com/fkJVNV0DYQ
But it’s unclear whether Becerra as HHS secretary would embrace progressive — and expensive — health care ideas like single-payer. In his first public remarks on his nomination Tuesday, he touted his work helping to pass the Affordable Care Act and said on Twitter he would “build on our progress to ensure every American has access to quality, affordable health care.”
Some congressional Republicans are raising red flagsabout Becerra’s nomination, which must be confirmed by the U.S. Senate. They cite his anti-Trump stance and opposition to some federal policies, such as a Trump-era Obamacare rule that allows private employers with religious objections to deny workers contraceptive coverage. Becerra has sued the Trump administration 107 times, including 13 times on health care.
Although Becerra has no direct health care experience, “the court has become the arbiter of health policy, and he certainly got experience there,” said Trish Riley, executive director of the National Academy for State Health Policy.
In announcing Becerra as his Cabinet pick Tuesday, Biden described him as someone who is unafraid to take on special interests and has spent his career working to expand health care access and reduce racial health disparities. California, under Becerra’s leadership, led the defense of the federal health care law before the U.S. Supreme Court last month.
“No matter what happens in the Supreme Court, he’ll lead our efforts to build on the Affordable Care Act, to work to dramatically expand coverage and take bold steps to lower health care prescription drug costs,” Biden said at the news briefing.
In Congress, I helped pass the Affordable Care Act. As California's Attorney General, I defended it. As Secretary of Health and Human Services, I will build on our progress and ensure every American has access to quality, affordable health care—through this pandemic and beyond.
At the outset, however, Becerra would be consumed by managing the U.S. response to the coronavirus pandemic. In his new role, he would oversee the Centers for Disease Control and Prevention and the National Institutes of Health.
“The No. 1 task he’s going to be completely absorbed with is getting this pandemic under control. We need a consistent message,” said Bruce Pomer, a public health expert and chief lobbyist for the California Association of Public Health Laboratory Directors. “It’s going to be critical for the Biden administration to show people that it can be effective at keeping the American people safe.”
Becerra’s public comments Tuesday indicated the pandemic would be his top priority. “The COVID pandemic has never been as vital or as urgent as it is today,” Becerra said, adding that the economic fallout has “thrust families into crisis. Too many Americans are sick or have lost loved ones, too many have lost their jobs.”
But liberal California lawmakers and advocates say the pandemic has made their ambitious health care goals all the more urgent. And should Becerra back a progressive health agenda in California, similar proposals could follow from other states, said Mark Peterson, a professor of public policy, political science and law at UCLA.
“California has pushed the envelope on health care beyond where other states are,” he said. “And that gives more capacity for California sensibilities and ideas to get into the mix in Washington.”
Most of the money the industry spent from Jan. 1, 2017, through Nov. 30, 2020, funded the defeat of two union-backed ballot measures that would have regulated dialysis clinics — and eaten into their profits.
This article was published on Thursday, December 10, 2020 in Kaiser Health News.
SACRAMENTO — The nation's dialysis industry has poured $233 million into California campaigns over the past four years, establishing its leading companies as a formidable political force eager to protect their bottom line and influence state policy.
Most of the money the industry spent from Jan. 1, 2017, through Nov. 30, 2020, funded the defeat of two union-backed ballot measures that would have regulated dialysis clinics — and eaten into their profits. But the companies and their trade association also stepped up their offense, dedicating about $16.4 million to lobbying and political contributions during the same period, a California Healthline analysis of state campaign finance records shows.
Nearly every member of the legislature, Democratic Gov. Gavin Newsom and his predecessor, former Gov. Jerry Brown, the Democratic and Republican parties, and dozens of political campaigns — including some local school board and city council races — received a contribution from a dialysis company.
"These are very large, very profitable companies," said Mark Stephens, founder of Prima Health Analytics, a health economics research and consulting firm. "They have a lot to lose. The fear would be that if some of this stuff passed in California, the union would certainly try to get similar measures on the ballot or in the legislatures in other states. The stakes are higher than just California for them."
Staking Ground in Sacramento
California has about 600 dialysis clinics, which are visited by an estimated 80,000 patients each month, typically three times a week. At the clinics, patients are hooked up to machines that filter toxins and remove excess fluid from their blood because their kidneys can no longer do the job.
Medicare, which covers most dialysis patients, pays a base rate of $239.33 for each dialysis treatment.
DaVita and Fresenius Medical Care North America are the largest dialysis providers in the state and country, operating roughly 80% of clinics nationwide. Last year, DaVita reported $811 million in net income, on revenue of $11.4 billion. Fresenius posted $2 billion in operating income on revenue of $13.6 billion.
DaVita was responsible for about $143 million — or more than three-fifths — of the political spending in the past four years, and Fresenius gave about $68 million.
Until four years ago, the dialysis industry's political spending was relatively modest compared with that of the hospital, physician and other health care associations so well known in Sacramento. In those days, dialysis lobbyists focused on regulatory issues and health care reimbursement rates, and companies gave minimal campaign contributions.
The industry's transformation into one of the biggest spenders in California politics began in 2017, the first of four years in which it faced ballot or legislative threats. In 2017, a Democratic lawmaker introduced a bill that would have set strict staff ratios at dialysis clinics. The bill, SB-349, which failed, had faced opposition from the California Hospital Association, the California Chamber of Commerce and the dialysis industry.
The SEIU-United Healthcare Workers West union (SEIU-UHW) followed the next year with Proposition 8, a ballot initiative that would have capped industry profits.
DaVita and Fresenius were forced to defend their huge profits and allegations of subpar patient care, turning the competitors into allies — at least in politics.
The industry spent $111 million to successfully defeat the measure, breaking the record for spending by one side on an initiative.
"I think it's very natural for these private chains to spend millions to make billions of profits," said Ryan McDevitt, associate professor of economics at Duke University. "They're lobbying to protect their profits."
Last year, the industry fought AB-290, a billthat aimed to stop a billing practice dialysis companies use to get higher insurance reimbursements for some low-income patients. But the legislature wasn't swayed, and Newsom signed the bill into law, which is now tied up in federal court.
And this year, the industry spent $105 million to block Proposition 23, which would have required every clinic have a physician on site and institute other patient safety protocols.
Kent Thiry, the former chairman and CEO of DaVita, said the industry had no choice but to spend heavily to defeat the ballot measures, which he said would have increased costs and harmed patient care.
"When someone does that, you have to use some of your money to defend yourself, your patients and your teammates," Thiry said in an interview with KHN, which publishes California Healthline. "It forces companies to allocate precious resources to do something that never should have been brought up to start with."
In an emailed statement, DaVita said it would continue to work to "educate lawmakers and defend against policy measures that are harmful to our patients." Fresenius also defended its advocacy, saying the company needs to protect itself against special interests intent on abusing the political system. The company will "continue to support legislation that improves access to quality care and improves patient outcomes," said Brad Puffer, a company spokesperson.
By comparison, SEIU-UHW, which sponsored the ballot measures, spent about $25 million to advocate for the initiatives, and $7.8 million on lobbying and political contributions. The union lobbies lawmakers on a wide array of health care issues
"They've got tons of money. We understand that," said Dave Regan, the union's president. "We've seen them spend a quarter of a billion dollars in a very short period of time. I hope they're prepared to spend another quarter of a billion dollars, because we're not going to go away until there's legitimate commonsense reforms to this industry."
From Defense to Offense
While most of dialysis companies' political spending in California has been used to defeat ballot measures, several of the largest companies also dedicated about $16.4 million to lobbying and political contributions over the past four years.
The companies and their trade association, the California Dialysis Council, put almost three-fourths of that — nearly $12 million — into hiring veteran lobbyists to advocate for dialysis companies when lawmakers consider legislation that could affect the industry.
For instance, when Newsom took office in 2019, both DaVita and Fresenius added Axiom Advisors to their lobbying teams, paying it $737,500 since then. One of the firm's partners is Newsom's longtime friend Jason Kinney, whose close relationship with the governor was highlighted by the recent French Laundry dinner fiasco. Newsom came under intense criticism for attending the early November dinner at the exclusive restaurant, held to celebrate Kinney's birthday, because he and his administration were asking Californians not to gather.
The industry has also given at least $4.6 million in contributions to political candidates and committees, both directly and to entities on behalf of a lawmaker or candidate.
All but five state senators and Assembly members who served during the 2019-20 legislative session received a direct contribution from at least one of the companies or the California Dialysis Council.
Most of the donations to individuals went to state lawmakers, but DaVita dipped into local races, too. For instance, it contributed $10,000 to a Glendale city council candidate in February, $7,700 to an El Monte school board candidate in October and $3,500 to a Signal Hill city council candidate last year.
Dialysis companies also gave to the state Democratic and Republican parties.
"They're spreading it out. They're doing the full gambit," said Bob Stern, former general counsel for the California Fair Political Practices Commission, which enforces state political campaign and lobbying laws.
Legal Loopholes
State law limits how much a company or person can give to a political candidate in an election, but there are legal loopholes that allow individuals and corporate interests to give more. The dialysis industry has taken advantage of them.
Under state campaign finance rules, lawmakers can accept only $4,700 from any one person or company per election.
But some lawmakers operate "ballot measure committees" so they can accept unlimited contributions. These committees are supposed to advocate for a ballot measure, but lawmakers often use them to pay for political consultants and marketing, and to contribute to state and local initiatives they support. Candidates can also get unlimited help from donors who independently pay for campaign costs, such as mailings and digital campaign ads.
For instance, DaVita chipped in $93,505 to help pay for a direct mail campaign on behalf of state Sen. Steve Glazer (D-Orinda) in this year's primary election. Glazer also received $55,600 from DaVita, Fresenius and the California Dialysis Council in contributions to himself and his ballot committee, Citizens for a Better California.
In some cases, lawmakers such as Glazer who netted some of the biggest contributions from dialysis companies voted with the industry. That was the case last year when the legislature approved AB-290, the bill limiting the dialysis billing practice.
Glazer voted no, as did Assembly member Adam Gray (D-Merced), whose Valley Solutions ballot measure committee had received $112,500 from DaVita and Fresenius since 2017. Gray also received $36,900 in direct contributions from Fresenius, DaVita and U.S. Renal Care.
Gray issued a statement saying campaign contributions play "zero role" in how he represents his district. Glazer did not respond to a request for comment.
Targeting Legislative Adversaries
Assembly member Reggie Jones-Sawyer's 84-year-old mother is on dialysis. The Los Angeles Democrat and SEIU-UHW member has called for improved staffing ratios at dialysis clinics and has voted repeatedly to regulate them.
DaVita wrote a $249,000 check in October to a political committee supporting Jones-Sawyer's opponent, Efren Martinez, another Democrat, but one the industry considered more friendly. DaVita followed up with a $15,000 check the week before the election.
Jones-Sawyer, who won the race, said he's frustrated dialysis companies aren't willing to make changes to improve patient safety on their own, saying it would cost them far less than the nearly quarter-billion dollars they have spent on political contributions. So for now, he said, he will continue to push to improve conditions at dialysis clinics from the Capitol, despite the industry's growing political clout.
"I think dialysis is saying, 'Look, we can be the 800-pound gorilla now,'" Sawyer said. "It's not just influence for a day; it's longevity."
Rae Ellen Bichell and Elizabeth Lucas of KHN contributed to this report.
Methodology
How California Healthline compiled data about dialysis companies' political spending
Among the ways dialysis companies exert influence on the political process is by contributing money to campaigns; hiring lobbyists; and paying for advertising and marketing on behalf of candidates.
Opposition to ballot measures: Using the California secretary of state's website, California Healthline downloaded the contributions made by DaVita, Fresenius Medical Care North America, U.S. Renal Care, Satellite Healthcare, Dialysis Clinic Inc. and American Renal Management to the campaign committees formed to defeat Propositions 8 and 23. This includes some non-monetary contributions.
Lobbying: We created a spreadsheet of expenses reported on lobbying disclosure forms, also available on the secretary of state's website, by DaVita, Fresenius, U.S. Renal Care, Satellite Healthcare and the California Dialysis Council. We found details about how much the industry paid lobbying firms, what agencies it lobbied and which bills it tracked.
Political contributions: DaVita, Fresenius, U.S. Renal Care and the California Dialysis Council made direct contributions to more than 100 candidates, which we compiled from the secretary of state's website. DaVita and Fresenius made other contributions, often large, to Democratic and Republican committees, and ballot measure committees led by lawmakers. The two companies also made contributions known as "independent expenditures" that benefited candidates' campaigns and "behested payments," which are donations to nonprofit organizations and charities in lawmakers' names. Behested payments are disclosed on the California Fair Political Practices Commission website.
The SEIU-United Health Care West union uses two political committees for its giving. ItsPAC contributes mostly to lawmakers and county and state Democratic parties while its Issues Committee gives to local hospital ballot measures. We did not tally spending for local hospital ballot measures for this story, but we did include contributions made by the Issues Committee to the California Democratic Party, which helps state lawmakers.
After nine months, the staff at Harborview Medical Center, the large public hospital run by the University of Washington, has the benefit of experience.
This article was published on Thursday, December 10, 2020 in Kaiser Health News.
As hospitals across the country weather a surge of COVID-19 patients, in Seattle — an early epicenter of the outbreak — nurses, respiratory therapists and physicians are staring down a startling resurgence of the coronavirus that's expected to test even one of the best-prepared hospitals on the pandemic's front lines.
After nine months, the staff at Harborview Medical Center, the large public hospital run by the University of Washington, has the benefit of experience.
In March, the Harborview staff was already encountering the realities of COVID-19 that are now familiar to so many communities: patients dying alone, fears of getting infected at work and upheaval inside the hospital.
This forced the hospital to adapt quickly to the pressures of the coronavirus and how to manage a surge, but all these months later it has left staff members exhausted.
"This is a crisis that's been going on for almost a year — that's not the way humans are built to work," said Dr. John Lynch, an associate medical director at Harborview and associate professor of medicine at the University of Washington.
"Our health workers are definitely feeling that strain in a way that we've never experienced before," he said.
Until the late fall, the Seattle area had mostly kept the virus in check. But now cases are rising faster than ever, and Washington Gov. Jay Inslee has warneda "catastrophic loss of medical care" could be on the horizon.
"This is the very beginning, to be honest, so thinking about what that looks like in December and January has got me very concerned," Lynch said.
Lessons Learned From Spring Surge
When the outbreak first swept through western Washington, hospitals were in the dark on many fronts. It was unclear how contagious the virus was, how widely it had spread and how many intensive care beds would be needed.
Intensive care unit nurse Whisty Taylor remembers the moment she learned one of her colleagues — a young, active nurse — was hospitalized on their floor and intubated.
"That's really when it hit — that could be any of us," Taylor said.
Concerns over infection control and conserving personal protective equipment meant nurses were delegated all sorts of unusual tasks.
"The nurses were the phlebotomists and physical therapists," said nurse Stacy Van Essen. "We mopped the floors and we took the laundry out and made the beds, plus taking care of people who are extremely, extremely sick."
A lot has changed since those early days.
Staff members besides just nurses are now trained to go into COVID rooms and be near patients, and the hospital has ironed out the thorny logistics of caring for these highly contagious patients, said Vanessa Makarewicz, Harborview's manager of infection control and prevention.
How to clean the rooms? Who's going to draw the blood? What's the safest way to move people around?
"We've grown our entire operation around it," Makarewicz said.
The physical layout of the hospital has changed to accommodate COVID patients, too.
"It's still busy and chaotic, but it's a lot more controlled," said Roseate Scott, a respiratory therapist in the ICU.
Harborview has also learned how to stretch its supplies of PPE safely. And as cases started to rise significantly last month, the hospital quickly reimposed visitor restrictions.
"In the past, we've had visitors who then call us two days later and say, 'Oh, my gosh, I just came up positive,'" said nurse Mindy Boyle.
Boyle said months of caring for COVID patients — and all the steps the hospital has taken, including having health care workers observed as they don and doff their PPE — has tamped down the fears of catching the virus at work.
"It still scares me somewhat, but I do feel safe, and I would rather be here than out in the community, where we don't know what's going on," said Boyle.
'We're All Tired of This'
Preparation can go only so far, though. The hospital still runs the risk of running low on PPE and staff, just like so much of the country.
During the spring, the hospital cleared out beds and recruited nurses from all over the nation, but that is unlikely to happen this time, with so many hospitals under pressure at once.
"All things point to what could be an onslaught of patients on top of a very tired workforce and less staff to go around," said Nate Rozeboom, a nurse manager on one of the COVID units. "We're all tired of this, tired of taking care of COVID patients, tired of the uncertainty."
Already, COVID's footprint at Harborview is expanding and bringing the hospital close to where it was at its previous peak.
"The fear I have personally is overwhelming the resources, using up all the staff — and the numbers are still going to go up," said Scott.
And she said the realities of caring for these desperately ill patients have not changed.
"When they're on their belly, laying down with all the tubes and drains and all these extra lines hanging off of them, it takes about four to five people to manually flip them over," Scott said. "It feels intense every time. It doesn't matter how many times you've done it."
Hospitalized patients are faring better than in the spring, but there are still no major breakthroughs, said Dr. Randall Curtis, an attending physician in the COVID ICU and a professor of medicine at the University of Washington.
"The biggest difference is that we have a better sense of what to expect," Curtis said.
The few treatments that have shown promise, including the steroid dexamethasone and the antiviral remdesivir, have "important but marginal effects," he said.
"They're not magic bullets. … People are not jumping out of bed and saying, 'I feel great. I'd like to go home now,'" Curtis said.
Taylor said nursing has never quite felt the same since she started in the COVID ICU.
"These people are in the rooms for months. Their families can only see them through Zoom. The only interaction they have is with us through our mask, eyewear, plastic," Taylor said. "We're just giving their body a runaround trying to keep them alive."
This story is from a reporting partnership that includes NPR and KHN.
The move has met a fierce backlash from health providers and consumer advocates who fear it would hamstring federal health officials while they seek to control the COVID-19 pandemic.
This article was published on Thursday, December 10, 2020 in Kaiser Health News.
The Trump administration wants to require the Department of Health and Human Services to review most of its regulations by 2023 — and automatically void those not assessed in time.
Aproposed rule would require HHS to analyze within 24 months about 2,400 regulations — rules that affect tens of millions of Americans on everything from Medicare benefits to prescription drug approvals.
The move has met a fierce backlash from health providers and consumer advocates who fear it would hamstring federal health officials while they seek to control the COVID-19 pandemic, which has killed more than 250,000 Americans.
The HHS proposal appears designed to tie up the incoming Biden administration, say critics. They note the timing of the proposal, which was issued Nov. 4 — the day after Election Day, when it appeared President Donald Trump would likely lose his bid for a second term.
"The cynical part of me thinks this is a perfectly designed way to bring the department to a standstill in the next administration," said Mary Nelle Trefz, health policy associate at Common Good Iowa, a consumer advocacy group.
She said HHS does not have the bandwidth to review all these regulations during the next two years while running its many programs, including Medicaid and Medicare.
If the proposal is finalized before Jan. 20, it is likely to be undone by the incoming Biden administration. But the chore would add to duties of HHS officials trying to attack the pandemic, she said.
HHS officials deny their proposal was aimed at the Biden administration. Brian Harrison, chief of staff at the department, said he first sought legal review of the proposal in April. "Our lawyers moved as fast as they could," he said, and the rule was written with the expectation it would be implemented during Trump's second term.
"The outcome of the election had nothing to do with it," he said.
Democrats and Republicans for the past 40 years have failed to review existing regulations, leaving unnecessary and irrelevant rules on the books, Harrison said.
But Andy Schneider, a research professor at the Center for Children and Families at Georgetown University who has written about the proposal, said he fears the sunset provision will be one of many actions the Trump team will take to distract the incoming administration.
"It speaks volumes that they waited until the end of the fourth year of the administration to decide that the regulatory process needs to be improved," he said.
Incoming administrations have typically frozen new rules that were pending but have not taken effect before Inauguration Day. That gives new administrations time to unwind them.
Efforts to enact reviews of funding bills and other legislation, known as sunset clauses, have been popular among conservatives for years. The federal government has occasionally used sunset provisions in legislation, such as the tax cuts enacted during the George W. Bush administration, but it is rare to make department regulations subject to these types of mandatory deadlines.
The option is more popular among states, which have adopted varying procedures for measures passed by the legislatures or regulatory boards. Those efforts run the gamut from requiring most initiatives to be reviewed to identifying specific agencies or legislation that must be reconsidered on a regular timetable.
HHS accepted public comments on the proposal though Dec. 4, except on part of the rule affecting Medicare regulations, which has a Jan. 4 deadline. A final rule is expected before Biden becomes president on Jan. 20.
HHS officials don't point to any specific regulations they say are outdated. However, in their supporting material for the proposal, they note in part:
"An artificial-intelligence-driven data analysis of HHS regulations found that 85 percent of department regulations created before 1990 have not been edited; the Department has nearly 300 broken citation references in the Code of Federal Regulations, meaning CFR sections that reference other CFR sections that no longer exist."
Harrison said the scarcity of reviews is due to "inertia" and "lack of an incentive mechanism."
"Many presidents have formally ordered their agencies to review existing regulations, and it has been existing law for 40 years, so simply asking the divisions to review these regulations has been tried for decades and proven to be ineffective," Harrison said.
"We need to incentivize their behaviors," he said.
With more than 80,000 employees, the department should be able to complete the review of 2,400 rules in 24 months, he added.
Harrison said the proposal is authorized by a law signed by President Jimmy Carter in the late 1970s requiring federal agencies to review existing rules. But that law has no provision that calls for cutting regulations that are not reviewed within a certain time frame, Schneider said.
The proposal says the HHS secretary would have flexibility to stop some regulations from being eliminated "on a case by case basis."
HHS estimates the reviews would cost up to $19 million over two years. Regulations would have to be reviewed every 10 years under the proposal.
When he took office in 2017, Trump vowed that for every regulation his administration issued, it would remove two. In July, he said his administration had more than exceeded that goal.
"For every one new regulation added, nearly eight federal regulations have been terminated," he said in a Rose Garden speech. The Washington Post Fact Checker said that claim was based on "dubious math and values each regulation as having equal weight."
One of the few groups to endorse the HHS proposal is the National Federation of Independent Business. The group said the proposal would alleviate regulatory burdens on small businesses.
But other groups, such as the American Academy of Neurology, suggest the proposed rule would limit input from interest groups on changes to existing regulations, because it would not follow the usual process of seeking public comments when altering rules. "The AAN is highly supportive of the current process to modify and rescind regulations through the notice and comment period, as it affords stakeholders the necessary opportunity to provide feedback on proposed regulations prior to changes being implemented," the group told HHS.
The Medicaid and CHIP Payment and Access Commission, which advises Congress, opposes the proposal. "MACPAC questions the need for a proposed rule that creates a duplicative and administratively burdensome new process that is likely to create confusion for beneficiaries, states, providers, and managed care plans," the group said in a letter to HHS. "The new requirements will create additional unnecessary work that will distract the department and CMS from the critical roles they play in our health care system, Medicaid and CHIP amid the pandemic and its resulting economic challenges."
It's unclear how the proposed rule would affect long-standing regulations for product safety and standards, said Betsy Booren, senior vice president of the food lobbying group Consumer Brands Association. "The idea that these regulations would be sunset because a regulations timer went too long is not acceptable," she wrote in comments on the proposed rule.
Mister Rogers-type nice isn't working in many parts of the country. It's time to make people scared and uncomfortable. It's time for some sharp, focused, terrifying realism.
This story was published on Wednesday, December 9, 2020 in Kaiser Health News.
I still remember exactly where I was sitting decades ago, during the short film shown in class: For a few painful minutes, we watched a woman talking mechanically, raspily through a hole in her throat, pausing occasionally to gasp for air.
The public service message: This is what can happen if you smoke.
I had nightmares about that ad, which today would most likely be tagged with a trigger warning or deemed unsuitable for children. But it was supremely effective: I never started smoking and doubt that few if any of my horrified classmates did either.
When the government required television and radio stations to give $75 million in free airtime for antismoking ads between 1967 and 1970 — many of them terrifyingly graphic — smoking rates plummeted. Since then, numerous smoking "scare" campaigns have proved successful. Some even featured celebrities, like Yul Brynner's posthumous offering with a warning after he died from lung cancer: "Now that I'm gone, don't smoke, whatever you do, just don't smoke."
As the United States faces out-of-control spikes from COVID-19, with people refusing to take recommended, often even mandated, precautions, our public health announcements from governments, medical groups and health care companies feel lame compared with the urgency of the moment. A mix of clever catchphrases, scientific information and calls to civic duty, they are virtuous and profoundly dull.
The Centers for Disease Control and Prevention urges people to wear masks in videosthat feature scientists and doctors talking about wanting to send kids safely to school or protecting freedom.
Quest Diagnostics made a video featuring people washing their hands, talking on the phone, playing checkers. The message: "Come together by spending time apart."
As cases were mounting in September, the Michigan government produced videos with the exhortation, "Spread Hope, Not Covid," urging Michiganders to put on a mask "for your community and country."
Forget that. Mister Rogers-type nice isn't working in many parts of the country. It's time to make people scared and uncomfortable. It's time for some sharp, focused, terrifying realism.
"Fear appeals can be very effective," said Jay Van Bavel, associate professor of psychology at New York University, who co-authored a paper in Nature about howsocial science could support COVID response efforts. (They may not be needed as much in places like New York, he noted, where people experienced the constant sirens and the makeshift hospitals.)
I'm not talking fear-mongering, but showing in a straightforward and graphic way what can happen with the virus.
From what I could find, the state of California came close to showing the urgency: a soft-focus videoof a person on a ventilator, featuring the sound of a breathing machine, but not a face. It exhorted people to wear a mask for their friends, moms and grandpas.
But maybe we need a PSA featuring someone actually on a ventilator in the hospital. You might see that person "bucking the vent" — bodies naturally rebel against the machine forcing pressurized oxygen into the lungs, which is why patients are typically sedated.
(Because I had witnessed this suffering as a practicing doctor, I was always upfront about the trauma with loved ones of terminally ill patients when they were trying to decide whether to consent to a relative being put on a ventilator. It sounds as easy as hooking someone to an IV. It's not.)
Another message could feature a patient lying in an ICU bed, immobile, tubes in the groin, with a mask delivering 100% oxygen over the mouth and nose — eyes wide with fear, watching the saturation numbers rise and dip on the monitor over the bed.
Maybe some PSAs should feature a so-called COVID long hauler, the 5% to 10% of people for whom recovery takes months. Perhaps a professional athlete like the National Football League's Ryquell Armstead, 24, who has been in and out of the hospital with serious lung issues and missed the season.
These PSAs might sound harsh, but they might overcome our natural denial. "One consistent research finding is that even when people see and understand risks, they underestimate the risks to themselves," Van Bavel said. Graphs, statistics and reasonable explanations don't do it. They haven't done it.
Only after Chris Christie, an adviser to President Donald Trump, experienced COVID, did he start preachingabout mask-wearing: "When you have seven days in isolation in an ICU, though, you have time to do a lot of thinking," Christie said, suggesting that people, "follow CDC guidelines in public no matter where you are and wear a mask to protect yourself and others."
We hear from many who resist taking precautions. They say, "I know someone who had it and it's not so bad." Or, "It's just like the flu."
Sure, most longtime smokers don't end up with lung cancer — or tethered to an oxygen tank — either. (That, in fact, was the justification of smokers like my father, whose two-pack-a-day habit contributed to his death at 47 of a heart attack.)
These new ads will seem hard to watch. "We live in a Pixar era," Van Bavel reflected, with traditional fairy tales now stripped of their gore and violence.
But studies have shown that emotional ads featuring personal stories about the effects of smoking were the most effective at persuading folks to quit. And quitting smoking is much harder than maintaining physical distance and mask-wearing.
Once a vaccine has proved successful and enough people are vaccinated, the pandemic may well be in the rearview mirror. In the meantime, the creators of public health messaging should stop favoring the cute, warm and dull. And — at least sometimes — scare you.