Early in the pandemic, some mountain towns and counties shut out visitors. These days, they're welcoming tourists with open arms — and, in some cases, a shot in the arm.
This article was published on Wednesday, March 31, 2021 in Kaiser Health News.
Bartenders were pouring Old-Fashioneds at a bar with a bullet hole straight through the wood. Servers in corsets and fishnet stockings roamed the room, passing an old piano that, twice a week, fills the building with ragtime tunes.
It was a Friday evening at the Diamond Belle Saloon on the main drag in Durango, Colorado. Outside, a man in boots, a cowboy hat and a button-down vest adorned with a U.S. marshal badge patrolled the block, eyes scanning the streets for trouble. If trouble were to appear, it would likely take the form of errant Texans.
“You can’t throw a stone around here without hitting a Texan,” recalled Scott Perez, the man in the marshal get-up.
This was the Wild West, after all: spring break 2021. And leaders of this city of about 19,000 are eager to hold covid-19 at bay with a bit of old-time law and order on mask mandates — and even a little modern vaccine science.
Perez is very familiar with this block, having staged his death several times outside the saloon during summertime gunfight performances. The former cowboy and current actor, stuntman and history buff also pretended to rob the steam train that takes tourists to the former mining town of Silverton. Now, a consortium that includes local businesses and the tourism office has hired him and a few other actors for a very specific task: to get people to obey the city’s mandate to wear their dang masks.
Early in the pandemic, some mountain towns and counties shut out visitors. These days, they’re welcoming tourists with open arms — and, in some cases, a shot in the arm.
The health department that serves Durango’s La Plata County is among those offering covid vaccines to outsiders. In neighboring San Juan County, where the sheriff was threatening to fine and tow cars with out-of-county license plates a year ago, officials are now telling visitors, “If you’re here and with us now, let’s get you vaccinated if you’re eligible,” county spokesperson DeAnne Gallegos said. Andrew Sandstrom, a spokesperson for the Gunnison County covid response, said his county is doing the same but officials are just asking that visitors receive both doses in the same place.
Liane Jollon, executive director of the health department that spans La Plata and Archuleta counties, said more than 30% of residents have gotten at least one vaccine dose, putting the counties ahead of the curve. They aren’t advertising their vaccine supply as a lure for tourists, but as long as visitors fit Colorado’s vaccine eligibility criteria, Jollon said, they aren’t turning anyone away.
The state told vaccine providers not to ask for IDs or proof of residency, to avoid creating barriers for immigrants or homeless people, said Brian Spencer, with the Colorado State Joint Information Center. By extension, though, that means spring break tourists or second-home visitors also can partake.
“While it can feel like a difficult burden to vaccinate more individuals in your jurisdiction, it also helps keep our entire community safe,” Jollon said. “We’ve had people drive up for the day from New Mexico to get a vaccine.”
Typically this time of year, visitors come in spring break waves from Texas, Oklahoma, New Mexico and Arizona. Oklahoma’s governor has refused to impose a statewide mask mandate, and the governor of Texas lifted that state’s mandate and fully reopened businesses shortly before spring break tourists began arriving in Colorado.
In La Plata County, cellphone data analyzed by the health department shows that, from the first week of March to the third, mobile devices belonging to nonresidents shot from 15% of the total to 40%, with most coming from Texas and Oklahoma.
Some of the influx started even earlier. Gunnison County, which banned visitors during last year’s spring break, has seen tourism more than rebound in the past few months. It had a jump of at least 30% in tax revenue from short-term lodging in December and January compared with the same months before the pandemic.
Coloradans fear what the visitors may leave behind.
“In many of our mountain towns, we’re starting to see a new uptick,” said Jollon. “We’re really concerned that after spring break we could see an uptick that would hurt our schools’ ability to continue to offer in-person learning options.”
Around this time 102 years ago, Durango was closing its schools and opening an emergency hospital — again — to deal with a resurgence of the 1918 flu pandemic. People were fumigating their houses with formaldehyde, and kids were jumping rope to the song “I had a little bird. Its name was Enza. I opened the window, and in-flu-Enza.”
“It was definitely bad here,” said Perez. “They had bodies stacked up, particularly the ones that died in the winter because they couldn’t dig to bury them. They couldn’t find the mortician. He was laying amongst the bodies because he died. … A lot of the ladies of the evening became nurses.”
So this time, the community wants to prevent a resurgence, but also keep the tourism dollars flowing.
Durango, which usually attracts an estimated 1.5 million visitors each year with its brick buildings, steam train and bluffs crumbling into the Animas River, initially planned to hire a private security firm to persuade out-of-towners to don masks. That’s what the town of Breckenridge did. But then Rachel Brown, executive director of Visit Durango, jokingly proposed Old West actors instead.
“I have been told that the fun and theatrical approach of the Mask Marshal program is being very well received,” Brown said. “We are glad that we chose this option over private security.”
The need for mask police puzzles Perez. “I can’t figure it out at all,” he said. “I mean, there’s so much evidence about how this helps and yet somehow it became political.”
His right-hand woman in mask compliance is Cathy Roberts, a fellow reenactor, plus an animal advocate and military veteran. She wears a red-and-black cancan dress and goes by “Miss Kitty,” after the saloon owner in the TV and radio series “Gunsmoke.”
“She can disarm anybody with charm,” said Perez. “The goal is that I disarm them with some humor.” But he’s also clear they have a second option if things go sour: a direct line to the Durango Police Department.
“And the third option is not pretty,” said Perez. To be clear, the only heat he’s packing is two rounds of Pfizer.
As the pair entered the saloon Friday night, Roberts recounted, a waitress gave her what she calls “the look.”
“That’s all they gotta do,” said Roberts, who quickly spotted the problem by the door: four people who clearly were not familiar with Durango’s mask rules. People are required to wear masks indoors, even in a bar or restaurant, unless they’re seated and eating or drinking. The women had on masks, but their noses weren’t covered. The men didn’t have masks at all.
Roberts walked up cheerfully in her red dress, greeted them, welcomed them to Durango, and offered masks that said “I [heart] Durango.” One man accepted it, she said, and put it on. The other sulked, zipping his coat up over his mouth. “I’m like, ‘Sorry, sir, it’s not over your nose,’ and he pulled it up even higher,” she recalled.
Perez hung back behind her, silent beneath his bandanna and white mustache. Technically speaking, all noses had been covered, so the pair moved on.
“Mask compliance actually is really, really high,” said Perez. “There’s a lot of people wearing masks even out on the sidewalks, where they don’t have to.”
The past few weekends, he’s mostly found himself greeting people, welcoming them to Durango, chatting about local history and then slipping in the rules about masks.
“And 99.9% of the time, that’s well received,” he said, even among the Texans, who may also go home vaccinated.
As of Monday, nearly 49% of seniors in the U.S. had been fully vaccinated, while nearly 73% had received one dose of the Moderna or Pfizer-BioNTech vaccine.
This article was published on Wednesday, March 31, 2021 in Kaiser Health News.
With a mix of relief and caution, older adults fully vaccinated against COVID-19 are moving out into the world and resuming activities put on hold during the pandemic.
Many are making plans to see adult children and hug grandchildren they haven't visited for months — or longer. Others are getting together with friends indoors, for the first time in a long time.
People are scheduling medical appointments that had been delayed and putting trips to destinations near and far on calendars. Simple things that felt unsafe pre-vaccination now feel possible: petting a neighbor's dog, going for a walk in the park, stopping at a local hangout for a cup of coffee.
"I feel I can breathe again," said Barry Dym, 78, of Lexington, Massachusetts, expressing a widely shared sense of freedom.
The rapid rollout of COVID vaccines to people 65 and older makes this possible. As of Monday, nearly 49% of seniors in the U.S. had been fully vaccinated, while nearly 73% had received one dose of the Moderna or Pfizer-BioNTech vaccine. (A third vaccine, from Johnson & Johnson, became available earlier this month and requires just one dose.)
Recent guidance from the Centers for Disease Control and Prevention recognizes the protection that vaccines offer. According to the CDC, people who are fully vaccinated can meet indoors without masks, without incurring significant risk. Also, they can visit relatively safely with people who haven't been vaccinated, so long as those individuals are healthy and gatherings remain small.
Still, with coronavirus variants circulating and 55,000 new infections reported daily, the CDC continues to recommend precautions elsewhere, such as wearing masks, staying physically distant in public and refraining from air travel.
How are older adults who've been fully vaccinated — a privileged group, to be sure, given the millions of seniors who've yet to get shots — balancing a desire to shed isolation with a need to stay safe amid a pandemic that's not yet over? I asked several people I've spoken with previously about their plans and their reflections on the difficult year we've been through.
Mardell Reed, 80, of Pasadena, California, told me she wasn't sure she'd get the vaccine originally, because "I was concerned about the process going so fast and drug companies maybe producing something that wasn't up to par." But she changed her mind "once we all started hearing from actual scientists rather than politicians."
Now, Reed tries to educate people she knows who remain reluctant to get the shots. One of them is her 83-year-old stepsister. "No one had explained anything about the vaccines to her," Reed told me. "I talked about all the things that would be possible — seeing her daughter, who lives up north, seeing more of her grandkids, and I think that convinced her."
Reed used to walk in her neighborhood regularly before the pandemic but stopped when she became afraid of being around other people. Reviving that habit is a goal.
Among Reed's other priorities in the months ahead: visiting with her daughter, grandchildren and great-grandchildren, and seeing her primary care physician, a dentist, a neurologist who's treating nerve damage and an eye doctor. "I didn't want to go to places where people might be sick this last year; now, it's time for me to catch up on all that," she said.
Harry Hutson, 73, and his wife, Mikey, 70, invited two couples to their house in Baltimore, on separate nights, after getting their second Moderna shots in February and waiting two weeks. "We're going right into having safe dinners with people who've been vaccinated," Hutson told me.
He feels a touch of lingering uncertainty, however. "While we're 95% sure this is the right thing to do, we're a little tentative. For a whole year, we've had 'COVID is death' engrained in us. After that, you can't just go back to normal, just like that," he said.
Hutson has continued working as an executive coach during the pandemic and has recently been giving talks on hope to business groups, nonprofit organizations and churches. "What I tell people is 'You'll help yourself by helping others.' We're all emerging from trauma and healing has to be a collective, not an individual, endeavor."
On a personal note, Hutson is going through an attic full of yearbooks, letters and photos, "curating my family's history." He hopes to make an across-the-country road trip with his wife later this year visiting his son's family in Madison, Wisconsin, his daughter's family in Portland, Oregon, and his brother in Eugene, Oregon, as well as several friends.
Marian Hollingsworth, 67, of La Mesa, California, spent last spring and summer sequestered at home with her husband, Ed, 72, who had stomach cancer, focused on keeping Ed safe from the coronavirus. But his illness progressed and, in early October, Ed died at home, where the couple's four adult children had gathered to say goodbye.
Since then, Hollingsworth's son Morgan, 27, who lives in New York City, has stayed with his mom, keeping her company. But grief struck hard: Hollingsworth lost weight and couldn't sleep at night despite profound fatigue. "It was like getting hit by the biggest Mack truck you could find," she told me.
The pandemic's resurgence in the fall and winter made adjusting to Ed's loss "even more of a challenge," Hollingsworth said, since she couldn't get together with friends or get hugs — a form of contact she longed for. To this day, his clothes hang in the closet because the places she'd like to send them aren't accepting donations.
When Hollingsworth became fully vaccinated in early March, she said, she felt for the first time that "my head was coming up above water." Although she's not sure, yet, how much she wants to go out and see people, she's looking forward to simple pleasures: petting the neighbor's dog and going on "distanced walks" with a few friends. "I'm going to be cautious until there's more clarity about what's really safe," she told me.
Wilma Jenkins, 82, who lives in South Fulton, Georgia, has struggled with depression off and on for years — a challenge she's spoken about publicly in talks to older adults. This fall and winter, isolated at home, "it's been rough for me — it's just been so sad," she admitted.
Even though Jenkins describes herself as an "introvert," she made sure she had regular social contact before the pandemic. Most days, she'd take herself out to lunch at local restaurants, chatting with the wait staff and other regular customers.
One of Jenkins' great loves is music — the blues and jazz. A few days after we spoke, she was planning to return to her favorite nightclub, St. James Live in Atlanta, to catch a show — her first such outing since becoming fully vaccinated in mid-February.
"I'm not afraid to move back into the world, but I will continue to be masked and socially distanced and wash my hands," she told me.
Jenkins plans to start walking outside again; go to restaurants, so long as they're not too crowded; and resume visits with her two daughters, both physicians, who live in Atlanta and Washington, D.C. Her most ambitious goal: flying out to San Diego in late July for a celebration marking her grandson Jamal's retirement from the Navy.
Barry Dym is haunted by an image that's recurred often during the past year: He's on a moving sidewalk, unable to get off, being hurried to a destination he doesn't want to reach: old age. The image is associated with the pandemic and knee pain that has worsened, painfully, over the past six months, making walking harder.
This past year was a time of adjustment for Dym, who retired four years ago from his work as a consultant to nonprofit organizations. "One of the lessons of COVID for me was I still need to feel useful and I love helping people. I realized maybe I'd pulled back too far."
So, Dym expanded his coaching and mentoring practice — an activity he plans to continue. "Whatever I can do to help make this world better, I'm not going to stop trying," he said.
Outside of travel plans with his wife, Franny — to the Florida Keys this spring, to the Berkshires in western Massachusetts in the summer, and perhaps to Israel in the fall — Dym said he finds himself "more curious than anything" about what lies ahead. "I really don't know what my life will be like. I'll have to find out."
U.S. flu deaths this season will be measured in the hundreds instead of thousands. In 2018-19, a moderate flu season, an estimated 34,200 Americans died.
This article was published on Wednesday, March 31, 2021 in Kaiser Health News.
Masks and physical distancing are proving to have major fringe benefits, keeping people from getting all kinds of illnesses — not just COVID-19. But it's unclear whether the protocols will be worth the pain in the long run.
The teachers at New Hope Academy in Franklin, Tennessee, were chatting the other day. The private Christian school has met in person throughout much of the pandemic — requiring masks and trying to keep kids apart, to the degree it is possible with young children. And Nicole Grayson, who teaches fourth grade, said they realized something peculiar.
"We don't know anybody that has gotten the flu," she said. "I don't know of a student that has gotten strep throat."
It's not just an anecdote.
A study released this month in the Journal of Hospital Medicine, led by researchers from Vanderbilt University Medical Center, found that across 44 children's hospitals the number of pediatric patients hospitalized for respiratory illnesses is down 62%. The number of kids in the U.S. who have died of the flu this season remains in the single digits. Deaths have dropped dramatically, too, compared with the past 10 years: The number of flu deaths among children is usually between 100 and 200 per year, but so far only one child has died from the disease in the U.S. during the 2020-21 flu season.
Adults aren't getting sick either. U.S. flu deaths this season will be measured in the hundreds instead of thousands. In 2018-19, a moderate flu season, an estimated 34,200 Americans died.
Effective Combo
It's not just the masks and physical distancing that are tamping down communicable disease, said Dr. Amy Vehec, a pediatrician at Mercy Community Healthcare, a Tennessee clinic that gets federal funding. It's become a serious societal faux pas to go anywhere with a fever — so parents don't send their ailing kids to school, she said.
"They are doing a better job of staying home when they're sick," Vehec said. That includes adults who may feel ill.
Isolating when feeling bad could be kept up after the pandemic. But the isolation, the distance and the masks are not working for many kids, Vehec said.
Children with speech trouble aren't seeing their teacher's mouth to learn how to speak correctly, for instance.
"I think it has been a necessary evil because of the pandemic, and I have completely supported it, but it has had prices. It's had consequences," she said. "Kids' education is suffering, among other things."
And with COVID vaccines unavailable to children for a while yet, it may be another year of masks in schools.
Some experts, like researchers trying to improve masks, argue that more societies should embrace masking — as some Asian countries have. But even infectious-disease experts like Dr. Ricardo Franco of the University of Alabama-Birmingham doubt that's practical.
"I'm a little skeptical that this crisis will be enough for a widespread culture change, given how difficult it's been to achieve a reasonable culture shift in the previous months," Franco said.
The most realistic setting for lasting change may be within healthcare itself.
Doctors and nurses didn't usually wear masks before COVID. Dr. Duane Harrison, who directs an emergency department for an HCA hospital outside Nashville, mentioned a physician colleague who has worn a mask since he got out of medical school.
"We used to joke and clown with him about this," Harrison said. "Until this."
Now that everyone wears masks, Harrison's department has found the same thing many other workplaces have: Employees aren't calling out sick, unless it's COVID.
"When COVID's done, this is a practice that most of us will probably continue," Harrison said. "Because we won't be worried about runny-nose kids and elderly people who don't know they're sneezing in your face."
Some hospital systems, including Nebraska Medicine, have started to relax universal masking requirements for their staffs. But even vaccinated staffers still have to wear a mask when seeing patients. Intermountain Healthcare in Utah has signaled masks will continue to be required when a statewide mandate lifts in April.
'Is Everyone Going to Need a Break?'
But even believers in the effectiveness of masks have their doubts about the medical community keeping it up.
"The larger question is: Is everyone going to need a break?" asked Dr. Joshua Barocas, who studies infectious diseases at Boston University.
Whatever the future holds, public health officials say, the time has not yet come to drop mask requirements as the U.S. waits for more people to get a COVID vaccine. But eventually, even doctors and nurses are ready to see smiling faces again.
"I know I'm going to need to retire my masks at some point in the future," Barocas said, "for a little bit."
But 13% of respondents overall said they will "definitely not" be vaccinated, signaling that significant hurdles remain in the nation's vaccination campaign.
This article was published on Tuesday, March 30, 2021 in Kaiser Health News.
A new poll of attitudes toward COVID vaccinations shows Americans are growing more enthusiastic about being vaccinated, with the most positive change in the past month occurring among Black Americans.
About 55% of Black adults said they had been vaccinated or plan to be soon, up 14 percentage points from February, according to a poll released Tuesday by KFF. The rate now approaches that of Hispanics, at 61%, and whites at 64%. (Asian Americans were not polled in sufficient numbers to compare their responses with other racial and ethnic groups.)
But the poll found that 13% of respondents overall said they will "definitely not" be vaccinated, signaling that significant hurdles remain in the nation's vaccination campaign. (KHN is the editorially independent newsroom of KFF, an endowed nonprofit organization providing national information on health issues.)
Among all groups, Republicans and white evangelical Christians were the most likely to say they will not get vaccinated, with almost 30% of each group saying they will "definitely not" get a shot.
And while the poll indicated that some arguments are effective at persuading hesitant people — such as sharing that the vaccines are nearly 100% effective at preventing hospitalization and death — those messages do almost nothing to change the minds of people who have decided not to be vaccinated.
Last week, President Joe Biden announced that the United States has administered more than 100 million vaccine doses and doubled his goal, to 200 million doses, by early May. According to KFF's poll, 32% said they had already received at least one dose, and 30% said they planned to get it as soon as possible.
The poll also showed fewer people waiting to see how others respond to the vaccines before deciding to get vaccinated themselves, with 17% saying they fall into that "wait and see" group this month — a drop from 22% in February and 31% in January.
Young adults, ages 18-29, and Black adults were most likely to be in this "wait and see" group, at 25% and 24%, respectively.
Twenty-seven percent of Republicans and 35% of white evangelical Christians said they had already received at least one dose, the poll showed. Forty-two percent of Democrats said they have been vaccinated.
But Republicans and white evangelical Christians, along with 21% of essential workers in non-health fields and 20% of rural residents, were the most likely to say they will "definitely not" get vaccinated. One in 5 Republicans said they would be more likely to get vaccinated if former President Donald Trump strongly urged them to do so.
People who said they would "definitely not" receive a vaccine were asked to identify the main reason for their decision. The most common reason, at 17%, was that the vaccines are too new and not enough information is known about their long-term effects.
But informing people in the "definitely not" camp that scientists have been working on the technology used in the vaccines for about 20 years, among other arguments, did little to change their minds. Only about 6% said hearing that argument made them more likely to get the vaccine.
The poll found that some arguments were persuasive to those who had yet to make up their minds, though. Forty-one percent said they were more likely to get the vaccine after hearing that the vaccines are nearly 100% effective at preventing hospitalization and death from COVID — the most effective message KFF tested.
Some indicated they would be more likely to get vaccinated if it were easier to do while going about their daily lives — or made going about their daily lives easier.
Of those in the "wait and see" group, half said they would be more likely to get vaccinated if it were offered to them during a routine medical appointment. And 37% said they would be more likely if their employer arranged for on-site vaccinations at their workplace. Thirty-eight percent said they would be more likely if their employer offered to pay them an extra $200 to be vaccinated.
Of those who were not already vaccinated or planning to be soon, the poll showed travel restrictions could prove persuasive. About 3 in 10 said they would be more likely to get vaccinated if airlines required passengers to be vaccinated, or if the Centers for Disease Control and Prevention said vaccinated people could travel freely and, in most cases, would not need to wear masks.
Still, 7% of those who said they would "definitely not" be vaccinated said they would be more likely to do so if airlines and the CDC were to make those policy changes.
The poll also showed that, for the first time, most of those who had not been vaccinated said they have enough information to know where and when to get a vaccine. However, problems remain: About 3 in 10 said they did not know whether they were eligible in their state. Most likely to respond that way were Hispanic adults and those under age 30, making less than $40,000 annually or who do not have a college degree.
The survey was conducted March 15-22 among 1,862 adults and has a margin of error of +/-3 percentage points.
The research underpinning these vaccines isn't that new at all. Some of it is decades old. This foundation, combined with technical expertise, urgency and financial resources, enabled scientists to pull off the medical marvel.
This article was published on Tuesday, March 30, 2021 in Kaiser Health News.
The development of the first COVID vaccines may have seemed to occur at a dizzying pace. After all, scientists identified a new virus and created vaccines to protect against its most severe effects within a year.
But the research underpinning these vaccines isn't that new at all, vaccine experts say. Some of it is decades old. This foundation, combined with technical expertise, urgency and financial resources, enabled scientists to pull off the medical marvel.
"The reason it was so fast is money and work," said Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia.
Leveraging mRNA: A Technique as Old as Millennials
COVID mRNA vaccines use the human body's natural immune response to its advantage. The shot contains the recipe for making the molecule known as the spike protein, which the COVID virus uses to bind to cells. Once the cell receives these instructions, it creates the protein and displays it on its surface. The immune system then spots the unknown protein and makes antibodies to fight it.
The vaccines made by the companies Pfizer-BioNTech and Moderna use this technology, which stems from research that began in the early '90s, said Dr. Drew Weissman, a professor of medicine at the University of Pennsylvania. It has been tested against other viruses like influenza. Scientists learned from previous clinical trials and have since worked to perfect the use of mRNA, he said. Previous work on related coronaviruses like SARS helped speed the process.
Weissman and his colleague Katalin Karikó, a senior vice president of BioNTech, are credited with the breakthrough discovery that enabled these vaccines to be safe and highly effective.
"This isn't new technology," Weissman said.
Viral Vector Vaccines: A Health Emergency Veteran
The third vaccine being distributed in the United States to protect against severe COVID-19 uses viral vector technology to generate an immune response. It contains a weakened form of a different virus that carries instructions for cells to make the spike protein found on SARS-CoV-2, the virus that causes COVID. The protein appears on the cell's surface, and the immune system creates antibodies against it.
Like the mRNA vaccines, this technology carries the code for making the spike protein to the cell, said Dr. Ruth Karron, director of the Center for Immunization Research at Johns Hopkins University.
"The truck is different," she said, "but what's being delivered is very similar."
Viral vector technology has been studied since the 1970s. These vaccines have been approved for use around the world to immunize people against Japanese encephalitis. Johnson & Johnson, which uses this platform for its COVID shot, also created a viral vector vaccine for Ebola after a massive outbreak of the disease in 2019 in the Democratic Republic of the Congo.
Are They Safe?
In addition to existing research, generous resources were allocated to quickly create the COVID vaccines, experts said. As of Dec. 2020, the federal government spent $12.4 billion alone on Operation Warp Speed to hasten vaccine development. Drug companies partnered with the National Institutes of Health to tap into its expertise and quickly enroll trial participants.
Perhaps most important, the final clinical trials for the COVID vaccines enrolled between 30,000 and nearly 45,000 participants.
"These studies are so much bigger than the studies we do for many licensed vaccines," Karron said. Some trials for previously approved vaccines have included as few as 3,000 participants, she added.
Dr. Scott Ratzan, who runs a COVID-19 vaccine communications initiative called CONVINCE USA at the City University of New York, said pushing certain information has helped assuage fears among the vaccine hesitant. These include highlighting the reality of the virus, comparing the shot's side effects to other vaccines and showing the vaccines' effectiveness in millions of people.
Waiting for others to get the shot first was "a fair thing" when they first rolled out, Offit said. However, after nearly 90 million people in the United States have received at least one vaccine dose with no sign of safety issues, he said, the skepticism should be fading away.
"You have your proof in terms of efficacy and safety," Offit said. If you are still refusing, "then that's because you're not a skeptic anymore. You're a cynic."
Linda Heim knew her dad didn't plan to wait for the cancer to kill him. For decades, he'd lived in Montana, which they'd thought was one of the few places where terminally ill people could get a prescription to end their life.
After two years of being sick, Heim's dad got the diagnosis in 2019: stage 4 kidney cancer. His physician offered treatments that might extend his life by months. Instead, the 81-year-old asked the doctor for help dying. Heim said her parents left the appointment in their hometown of Billings with two takeaways: The legality of medically assisted death was questionable in Montana, and her father's physician didn't seem willing to risk his career to put that question to the test.
"My parents knew when they left there that was the end of that conversation," said Heim, now 54. "My dad was upset and mad."
The day after the appointment, Heim's mother went grocery shopping. While she was gone, Heim's dad went to the backyard and fatally shot himself. (Heim asked that her father's name not be published due to the lingering stigma of suicide.)
About a decade earlier, in 2009, the Montana Supreme Court had, in theory, cracked open the door to sanctioned medically assisted death. The court ruled physicians could use a dying patient's consent as a defense if charged with homicide for prescribing life-ending medication.
However, the ruling sidestepped whether terminally ill patients have a constitutional right to that aid. Whether that case made aid in dying legal in Montana has been debated ever since. "There is just no right to medical aid in dying in Montana, at least no right a patient can rely on, like in the other states," said former state Supreme Court Justice Jim Nelson. "Every time a physician does it, the physician rolls the dice."
Every session of the biennial Montana state legislature since then, a lawmaker has proposed a bill to formally criminalize physician-assisted death. Those who back the bills say the aid is morally wrong while opponents say criminalizing the practice would be a backstep for patients' rights. But so far, lawmakers haven't gained enough support to pass any legislation on the issue, though it has been close. The latest effort stalled on March 1, on a split vote.
Even the terminology to describe the practice is disputed. Some say it's "suicide" anytime someone intentionally ends their life. Others say it's "death with dignity" when choosing to expedite a painful end. Such debates have gone on for decades. But Montana remains the sole state stuck in a legal gray zone, even if the practice can still seem taboo in many states with clear laws. Such continued uncertainty makes it especially hard for Montana patients like Heim's dad and their doctors to navigate what's allowed.
"Doctors are risk-averse," said Dr. David Orentlicher, director of the health law program at the University of Nevada-Las Vegas, who helped write clinical aid-in-dying guidelines published in the Journal of Palliative Medicine in 2016. "The fear of being sued or prosecuted is still there."
Despite that, access to medical aid in dying is gaining momentum across the U.S. Outside Montana, eight states and the District of Columbia allow the life-ending aid — six of them since 2014. So far in 2021, legislators in at least 19 states have pushed aid-in-dying bills, most seeking to legalize the practice and some seeking to drop barriers to existing aid such as expanding which medical professionals can offer it. Many are repeat legalization efforts with some, like in New York, dating as far back as 1995. Only the Montana bill this year specifically sought to criminalize it.
North Dakota considered legislation to legalize medically assisted death for the first time. Rep. Pamela Anderson, a Democrat from Fargo who proposed the measure after hearing from a cancer patient, said she wasn't surprised when the bill failed in February in a 9-85 vote. The state's medical association said it was "incompatible with the physician's role as healer." Angry voters called Anderson asking why she wanted to kill people.
"But I heard from just as many people that this was a good bill," Anderson said. "There is momentum to not let this concept go away."
Back in Montana, now retired state Supreme Court Justice Nelson said he has always regretted joining the majority in the case that allowed the practice because the narrow ruling focused on physicians' legal defense, not patients' rights. Having watched a friend die slowly from disease, Nelson, 77, wants the choice himself if ever needed.
Despite — or because of — the court decision, some Montana doctors do today feel that they can accommodate such patient decisions. For example, Dr. Colette Kirchhoff, a hospice and palliative care physician, said until she retired from private practice last year she considered patients' requests for life-ending drugs.
Physicians who help in such cases follow well-established guidelines set by other states, Kirchhoff said. A patient must have six months or less to live — a fact corroborated by a second physician; can't be clinically depressed; needs to ask for the aid; and be an adult capable of making healthcare decisions, which is determined by the attending physician. They must also administer the life-ending medication themselves.
"You're obviously not going to do a case that is vague or nebulous or has family discord," Kirchhoff said. "The doctors who are prescribing have felt comfortable and that they're doing the right thing for their patient, alleviating their suffering." Of her few patients who qualified for a prescription, she said, none actually took the drugs. Kirchhoff noted that, in some cases, getting the prescription seemed to provide comfort to her patients — it was enough knowing they had the option if their illness became unbearable.
For the past six legislative sessions — dating to 2011 — a Montana lawmaker has proposed a bill to clarify that state law doesn't allow physician-assisted death. Republican Sen. Carl Glimm picked up that effort the past two sessions. Glimm said the current status, based on the more than decade-old court decision, sends a mixed message in a state that the Centers for Disease Control and Prevention ranks as having among the nation's highest suicide rates. Glimm said allowing someone to end their life because of pain from a terminal illness could normalize suicide for people living with depression, which is also a form of pain.
"It's really hard because I do sympathize with them," Glimm said. "What it boils down to is, if you're going to take your own life, then that's suicide."
Kim Callinan, president and CEO of national nonprofit Compassion & Choices, said the comparison to suicide is frustrating. "People who are seeking medical aid in dying want to live, but they are stricken with a life-ending illness," she said.
Glimm and his bill's supporters say that some patients could be pressured into it by family members with something to gain, and doctors could prescribe it more often than they should.
But Callinan, whose group advocates for aid in dying, said that since Oregon first legalized it in 1997, no data has shown any merit to the warnings about abuse and coercion. One study showed no evidence of heightened risk of abuse within the practice for vulnerable populations such as the elderly. But critics have said states aren't doing enough to track the issue.
By now, Leslie Mutchler, 60, knows most of the people on all sides of the debate after years of testifying in support of protecting aid in dying. Her dad, Bob Baxter, was a plaintiff in the case that eventually led to the 2009 Montana Supreme Court decision on medically assisted death. After leukemia whittled his body for years, he died in 2008 without the option, the same day a lower court ruled in his favor.
Mutchler said she didn't understand how complicated the Supreme Court's ultimate ruling was until her son TJ was diagnosed with terminal metastatic pancreatic cancer in 2016.
He was 36 and lived in Billings, Montana. By then, the 6-foot-5 man had lost 125 pounds off what had been a 240-pound frame. He couldn't keep food down and needed a feeding tube for medicine and water. TJ Mutchler wanted to have the choice his grandfather never got. But when he went to his physician and asked for aid in dying, the response was it wasn't legal. Eventually, Mutchler found a doctor to evaluate her son and write the prescriptions for phenobarbital and amitriptyline. TJ took the drugs more than two months later and died.
"People contact me asking how to find someone and it's difficult," Mutchler said. "That's why people end up taking matters into their own hands." Research into terminally ill populations is limited, but one national study published in 2019 found the risk of someone with cancer taking their own life is four times higher than the general population.
For Roberta King, another one of Baxter's daughters, the ongoing fight over aid in dying in Montana means she knows every other winter she'll make the more than 200-mile round trip from her Missoula home to the state capital. King, 58, has testified against all six bills that sought to ban aid in dying following her dad's case. She memorized a speech about how her dad became so thin after his medicine stopped working that it hurt for him to sit.
"It's still terrible, you still have to get up there in front of everybody and they know what you're going to say because it's the same people doing the same thing," King said. But skipping a hearing doesn't feel like an option. "If something were to happen to this and I didn't try, I would never forgive myself," she said.
It's true that the leaders of the recall petition are connected to Republican donors, right-wing extremists and QAnon, and that many conservatives have signed the recall petitions. But Democratic and independent voters say they've lost trust in the once-rising star of the Democratic Party.
This article was published on Monday, March 29, 2021 in Kaiser Health News.
SACRAMENTO — California Gov. Gavin Newsom is framing the burgeoning effort to remove him from office as a fringe Republican movement backed by right-wing extremists, Trump supporters and QAnon conspiracy theorists.
But Newsom isn’t telling the whole story about who supports his recall.
Democrats and independent voters — who together dominate the state’s electorate — have also signed the recall petition, motivated by frustration with Newsom’s response to the covid-19 pandemic. Even Californians who helped elect Newsom to his first term in 2018 are angry over prolonged school closures, the whipsaw of business closings and openings and closings, vaccination chaos and turmoil at the state’s unemployment agency — which has been plagued with fraud, website failures and devastating backlogs that have left legions of residents without benefits.
“I’m not anti-mask, I’m not anti-science,” said Hastin Zylstra, 34, a Santa Ana Democrat who owns a laundromat and voted for Newsom in 2018. He signed the recall petition earlier this year, in part because he feels Newsom hasn’t done enough to help struggling small businesses.
“It sucks to be lumped into a group of white supremacists and anti-mask Republicans when a few months ago I was text-banking for Joe Biden and helping in the Georgia runoffs,” he added. “It feels a little bit like a knife in the back.”
Zylstra and other Newsom voters are chafing at the governor’s escalating attempts, in campaign advertising and on national television, to cast the recall drive as a partisan power grab. He told CNN on March 16 that his leadership during the covid-19 pandemic “saved thousands and thousands of lives,” and the same day on “The View,” Newsom dismissed recall supporters as extremists who don’t believe in science.
“It’s the anti-maskers and anti-vaxxers, not just the mega Trump donors,” Newsom said on the ABC daytime talk show. It’s also “the conspiracy theorists and militia members that are behind this recall.”
It’s true that the leaders of the recall petition are connected to Republican donors, right-wing extremists and QAnon, and that many conservatives have signed the recall petitions. But Democratic and independent voters say they’ve lost trust in the once-rising star of the Democratic Party.
A recent Emerson College poll found that 58% of Democrats and 55% of independent voters — those registered under no-party preference — would be open to dumping Newsom in favor of another Democratic candidate. And back-to-back polls this year by the University of California-Berkeley Institute of Governmental Studies and the Public Policy Institute of California showed Newsom’s poll numbers dropping, although they are higher than those of former Gov. Gray Davis before his recall in 2003.
“I would vote for another Democrat over Gavin, of course I would,” said Mara Kolesas, 51, a Berkeley mother of two who also voted for Newsom but believes he has failed students. “He had an opportunity to lead, but he’s putting politics and labor unions above kids.”
The Republican recall organizers have seized on unpopular decisions Newsom has made since last March, when he issued the nation’s first statewide stay-at-home order, shuttering businesses, churches and schools across California. His mask mandate further fired up recall backers, but Newsom’s attendance at a birthday dinner with lobbyists last November at the high-end French Laundry restaurant in Napa Valley marked a turning point that gave recall supporters momentum.
More than 2.1 million Californians have signed the petition to recall Newsom, according to campaign organizers. They need 1.5 million to place the question before voters, and the secretary of state’s office has so far validated nearly 1.2 million. Local election officials have until April 29 to certify the remaining signatures.
“The governor’s pandemic response is clearly driving voter attitudes, and concerns about his performance are not limited to Republicans,” said Darry Sragow, a Democratic strategist and publisher of the nonpartisan California Target Book, which predicts the recall will take place in November. “And people who never signed a recall petition are going to be asked to pass judgment on how the governor has been doing.”
Nathan Click, Newsom’s campaign spokesperson, argues that controversy surrounding the governor’s pandemic decisions will not result in his ouster, with powerful Democrats still backing Newsom. Newsom’s allies have characterized the movement as a waste of money and a distraction from ending the pandemic.
“Gov. Newsom followed science and moved aggressively to keep Californians safe during the pandemic. His actions saved countless lives,” Click said. “What we are seeing up and down the state is Democrats uniting around the governor to stand up against this Republican recall.”
He always has the right things to say, but I feel he will do things that are expedient for him and not necessarily the public he’s serving.
Debbie Blake
Now, as California’s massive economy begins to reopen quickly — the state is allowing restaurants, gyms and theaters to open for indoor patrons — some public health experts warn that the state is once again prematurely loosening restrictions. While cases and deaths have declined since the winter peak, they say, the drop is leveling off and case rates nationwide are beginning to rise, presenting worrisome signs for California. Most concerning is the spread of new, more infectious and deadly variants.
“I’m afraid we’re doing the same thing we did in May and June and October — opening too soon,” said Dr. John Swartzberg, a UC-Berkeley expert on infectious diseases. “Nobody can predict the future, but I think it’s likely we’re heading for a swell in new cases.”
The quick pace of reopening is angering some Democrats.
Butte County resident Debbie Blake strongly supported Newsom’s decision last March to order a statewide lockdown but said now she’s disappointed with his quick pace of reopening, vaccination chaos and inadequate testing early on. She said she wants to vote for another Democrat should a viable candidate emerge.
“He had us. Then he lost us,” said Blake, 64, a lifelong Democrat and retired school administrator who voted for Newsom in 2018.
“I felt like by opening up so fast, he succumbed to business pressures. And once you open up, it’s really hard to shut back down,” she added. “He always has the right things to say, but I feel he will do things that are expedient for him and not necessarily the public he’s serving.”
And as schools in the rest of the country have begun to reopen, the frustration among many California parents has boiled over.
Parents accuse Newsom of caving to the powerful California Teachers Association union — one of his largest political contributors — which rebuffed his calls for educators to return to campuses without strict health and safety measures in place, rather than requiring them to come back sooner to teach in person.
Jen Tarbox, a Folsom mom of two high schoolers, said Newsom went too far and didn’t consider the social-emotional impact on kids left at home, sitting in front of screens, disconnected from their friends, teachers and coaches.
“He messed with our children,” said Tarbox, 40, who led a protest at the state Capitol in February. “Any parent — Republican, Democrat, I don’t care what political belief — is going to fight for their child.”
And when Newsom lamented earlier this month in his State of the State speech about his four children’s experience with distance learning and “Zoom school,” Tarbox said he was not being honest. His kids attend private school and started to return in person in October.
“He called himself a Zoom parent,” said Tarbox, who signed the recall petition. “Absolutely laughable.”
That Sen. Rand Paul of Kentucky often disagrees with infectious-disease expert Dr. Anthony Fauci is well known.
Recently, the pair clashed at a Senate hearing when Paul, a Republican, argued against mask recommendations for people who have had COVID-19 or have been vaccinated against it.
At the hearing, Fauci, President Joe Biden's chief medical adviser, pushed back against Paul's characterization of wearing masks as "theater." Continued caution is advised, Fauci said, as scientists study the new variants now circulating in the U.S. and other countries.
Paul, an eye doctor by training, continued the squabble a few days later, calling out Fauci in a tweet, pointing to a study that he said "shows vaccines and naturally acquired immunity DO effectively neutralize COVID variants."
The tweet linked to a study published online at the JAMA Network, a family of specialty medical journals.
We reached out to Paul's office for additional sources for his tweet but did not receive a reply.
So, we asked the experts: Are COVID variants effectively neutralized by vaccines or natural immunity conferred on people who recover from the illness?
In short, the research cited by Paul does show good blood levels of neutralizing antibodies against at least some of the current variants following infection or vaccination. But they're not the whole story.
Mehul S. Suthar, an author of the study Paul cited, said the results are encouraging but should not be seen as all-encompassing: "Our interpretation is that our study looks at one aspect of immune response, antibodies."
Small Samples. Big Questions.
Neutralizing antibodies are important because they can block the ability of a virus like the one that causes COVID to infect cells. But the body also has other defenses. T cells, for example, can be spurred by infection or vaccination, Suthar said, although the study was not designed to look at those.
For the study, researchers gathered blood samples from 40 people who were in the hospital with COVID or had recovered from it. From the National Institutes of Health, they also received blood samples drawn from 14 people who had gotten both doses of the Moderna vaccine, said Suthar, an assistant professor at Emory University's vaccine center.
Then they ran tests on those samples against the original SARS-CoV-2 virus and three variants, including the one dubbed B.1.1.7, which first appeared in the United Kingdom and is now circulating widely in the U.S.
They wanted to know: Did antibodies produced by being infected or vaccinated neutralize B.1.1.7?
"We are lucky with B.1.1.7 that our antibodies appear to work well against this virus," Suthar said.
However, as with any study, there are caveats. For one thing, the results were based on a small number of samples. And the analysis did not include other variants of concern, such as the ones that emerged in South Africa and Brazil, which limits the ability to draw broad conclusions.
Finally, antibodies are just one measure of potential protection against disease. Laboratory research measuring antibodies indicates that some immunity is created by both illness and vaccination, but the strength and longevity of that protection — the effectiveness in the real world — is a separate question. That's partly because the ideal level of neutralizing antibodies needed for protection is not known and other immune protections, such as T cells, aren't measured.
Also, in the real world, other factors — such as the variant a person is exposed to, and the presence of other mitigating factors, including masks and good ventilation — can make a difference.
"Part of the reason that real-world data are so important is looking at the whole picture of immunity," said Gigi Gronvall, a senior scholar at Johns Hopkins Bloomberg School of Public Health. "Also, with the level of community transmissions of disease, I would be concerned that there will be more variants that emerge."
Nuance Matters
Paul's tweet — taking aim at what he sees as an overcautious approach by public health experts — doesn't capture that type of nuance, nor does it reference studies on the other emerging variants.
"Blanket assertions made by non-scientific experts are not going to help," said Gronvall.
Dr. Jesse Goodman, professor of medicine and a specialist in infectious diseases at Georgetown University, agreed.
"It's wrong to declare victory and say there's no problem with variants and that everyone previously infected will be fine," said Goodman, who served as chief scientist of the Food and Drug Administration under the Obama administration.
Viruses naturally mutate as they replicate. So it's not surprising that the coronavirus has done so. Several variants have emerged, including home-grown ones from California and New York.
Lab tests on blood samples from vaccine trial participants in South Africa showed lower levels of neutralizing antibody production, possibly related to the variant circulating there.
How big a difference the lower levels measured in those samples make isn't yet known.
Levels are still high and could "effectively neutralize the virus," Fauci wrote in an editorial published Feb. 11 in JAMA.
Even so, clinical trials used to test COVID vaccines before they were approved for emergency use showed lower efficacy when tested in areas where the South African variant was circulating.
"We expect vaccines and prior infection to offer significant protection against variants that are closely related," said Goodman. "But as they become more genetically different — like the South African one — that protection could go down."
The main goal of the vaccines is to prevent hospitalization and death, and all the vaccines in use in the U.S. appear to substantially reduce the risk of hospitalization and death from COVID, according to research.
"Even if the current vaccines may not be perfect, they do appear to prevent more severe outcomes," Goodman said.
Don't assume, as Paul's tweet implies, that recovering from COVID or getting vaccinated means zero risk of infection.
For one thing, reinfection is rare but can occur.
Goodman pointed to a recent study conducted in Denmark showing that a small percentage (0.65%) of people who tested positive for COVID in the spring fell ill again.
"People should not presume that even if they had the vaccine or were previously infected that there's no future risk," Goodman said.
Even though no vaccine is 100% effective, Gronvall at Hopkins said not to use that as an excuse to avoid inoculation.
"The vaccines appear to be great," she said. "Get one when you can."
Our Ruling
Paul is correct that the JAMA study showed vaccination or previous infection appeared, based on a small sample of people, to help neutralize the virus. However, he left out important details that make his position an oversimplification of a complicated issue.
The study considered only one variant — the one that emerged in the U.K. — and did not include an analysis of other types now circulating, or the potential for additional variants that could emerge. Also, the type of antibody studied is just one factor in protecting against disease, and just what those levels of neutralizing antibodies measured in a laboratory experiment may mean in the real world is not known.
So, for those reasons, we rate the senator's statement Half True.
Source List:
Telephone interview with Mehul S. Suthar, assistant professor at the Emory Vaccine Center, March 22, 2021
Telephone interview with Gigi Gronvall, senior scholar at Johns Hopkins Center for Health Security and associate professor in the environmental health and engineering department at Johns Hopkins Bloomberg School of Public Health, March 23, 2021
Telephone interview with Jesse Goodman, professor of medicine at Georgetown University and former chief scientist of the Food and Drug Administration, March 24, 2021
Here's one big takeaway from our country's disastrous 2020 COVID response: For 20 years, we've lavished attention and money on fighting human terrorism and forgot that the terrorism of nature is equally deadly, deserving equal preparation.
Today, with more than 545,000 U.S. COVID deaths, I hope we've learned the huge cost of allowing our public health structure to wither as we single-mindedly pursued the decades-long war on terror. Slowly, with no one much paying attention, here's how it happened.
After the horror of 9/11 and the anthrax powder attacks that followed, the United States rapidly created a massive infrastructure to ferret out and combat terrorism, focusing mostly on threats from international actors. Within weeks, Congress passed the Patriot Act. It created the Department of Homeland Security and the Transportation Safety Authority, which alone has an annual budget of nearly $8 billion for, among other things, intensive screening at airports.
Even relatively remote counties were supplied with military-like equipment. As a reporter covering the 2004 election, I remember being shocked to see Humvees and soldiers in body armor at county fairs in the Midwest, though they seemed an unlikely terrorist target. In the years that followed, terrorists carrying explosives in shoes and underwear on flights resulted in more screening and attention.
Sadly, a good part of that focus and investment came at the expense of public health. "There's only so much money, and so if you buy more of one thing, you have to buy less of another," former FDA Commissioner Dr. Tom Frieden noted in explaining one reason the federal government had an enormous stockpile of anthrax vaccine, but not enough ventilators when COVID-19 hit.
As our defenses against international and bioterrorism hardened, our defenses against infectious diseases shrank.
Though many public health experts fretted about possible pandemics, it was hard to capture lawmakers' attention. After all, by the late 1990s, there were drugs to combat HIV/AIDS. Flu? There were vaccines. Infectious diseases? Perceived as conquered.
That's partly why two large sources of money established after 9/11 — the Public Health Emergency Preparedness program and the Hospital Preparedness Program — were gradually chipped away.
Federal funds for state, local and tribal public health preparedness declined from $940 million in 2002 to $675 million in 2019, according to a report by the Trust for America's Health, a nonpartisan research group. When the 2008 recession throttled government budgets, money was diverted again from public health programs to support other services.
The Affordable Care Act established the Prevention and Public Health Fund, with promised investment reaching about $2 billion annually by 2015. But that pot was reduced by half by the Obama administration and Congress to pay for other priorities.
By the time a deadly virus arrived on our shores last year, nearly two-thirds of Americans were living in counties that spend more than twice as much on policing as they spend on nonhospital healthcare, which includes public health, according to an investigation by KHN and The Associated Press.
Since 2010, spending on local health departments has dropped by 18% and at least 38,000 state and local public health jobs have disappeared since the 2008 recession. When COVID hit, about 75% of counties had no epidemiologist on staff to track disease.
Countries like South Korea and Taiwan orchestrated a rapid, aggressive public health response as soon as the pandemic began. Testing, contact tracing and quarantines helped control spread and death — as did good national systems for electronic health records. In South Korea, a nation of 51 million, about 1,600 people have died. In Taiwan, population 26 million, the cumulative death toll is 10. Ten.
Contact tracing and quarantining takes people — lots of them. Tracking local spread takes epidemiologists and software. Many health departments in the U.S. had been limping by for years, with a skeleton staff, relying on fax machines. And remember, those local departments often also inspect restaurants, test water and give childhood vaccines.
Yes, President Donald Trump made the U.S. response far worse with lies and denial and sidelining the government's top medical experts. But the lack of adequate public health agencies and sufficient personnel in most of the country made targeted and rapid response most likely impossible.
The Centers for Disease Control and Prevention, the national public health agency, has been regarded as a bastion of international scientific expertise, but that doesn't always translate into good on-the-ground public health work. (Polio was eliminated by a vaccination campaign largely organized by charitable foundations.)
The human costs exacted by the pandemic are incalculable. And it will take years to tally the full financial costs of job losses, business closures, the more than $5 trillion approved in federal aid to contain the catastrophe, money that might have been spent on longer-term investments on education and the environment.
The tragedy is that a good part of this pain could have been avoided had there been a robust and functioning public health infrastructure in early 2020. That investment would have been a bargain, compared with what has been spent in the past year alone — not to mention the financial burden well into the future.
Some experts have estimated that the nation has a deficit of 250,000 public health workers. That's about the number of people who work at DHS, now the third-largest Cabinet-level agency. But the deficits go well beyond staffing numbers.
The CDC and local public health departments need to be equipped with the same level of sophisticated tools provided to, say, airport screeners. Even though the federal government spent $36 billion to digitize medical records, we still don't have a uniform national digital database that can track who is getting the vaccine.
Through Operation Warp Speed and private purchases, the U.S. helped make possible amazing new vaccines, paving a path out of the pandemic. By last December the government had spent $12.4 billion on shots, and the Biden administration has purchased several hundred million more doses, hoping to vaccinate most Americans by summer.
That's a great accomplishment. But would we be so desperate if some of that money had been spent over the past decades on public health? The pandemic is a reminder that the terrorism of nature can't be ignored, and our public health system needs to be rebuilt and expanded.
Could a decades-old antidepressant be a secret weapon against COVID? A few scientists think so, after two small studies showed that fluvoxamine, typically prescribed for obsessive-compulsive disorder, prevented serious illness in all participants who took the pills soon after developing symptoms.
It's an exciting notion: A $10, two-week course of this drug could reduce death and hospitalizations. The drug could be used to fight ongoing outbreaks in the United States and would be a particular godsend for lower-income countries that may have to wait years for vaccines against the virus. But fluvoxamine, as well as other old drugs showing potential against COVID, face hurdles to full evaluations.
Drug companies have no incentive to spend millions to test new uses for cheap, off-patent drugs. Chances are slim that any drug, even one showing promise in early trials, would provide a major benefit. And early enthusiasm for COVID treatments that later flopped has "made people gun-shy," said Dr. Jeffrey Klausner, a professor of preventive medicine at the University of Southern California.
In particular, former President Donald Trump's premature promotion of hydroxychloroquine likely stymied efforts to find other generic cures. The Food and Drug Administration granted emergency use of the malaria drug in March, then revoked the authorization less than three months later after evidence showed it was more likely to harm than help patients.
"We doctors who want to use evidence-based medicine feel somewhat burned by the hydroxychloroquine experience and really want to see good studies before we actually jump on the bandwagon," said Dr. Paul Sax, clinical director of the division of infectious diseases at Brigham and Women's Hospital in Boston.
And that poses a Catch-22. Until recently, the National Institutes of Health, the world's largest public funder of biomedical research, has shown little interest in studies of repurposed drugs. Without big money, it's hard to do the research needed to show whether existing treatments could work against COVID.
As a result, efforts to repurpose drugs have fallen to philanthropists, some in the Bay Area. "We're missing out on public health benefits of the drugs we already have because we're relying almost entirely on capitalism and private industry to make advances," said Elaine Lissner, founder of the San Francisco-based Parsemus Foundation, which is supporting COVID research on fluvoxamine and other low-cost oral drugs.
Repurposing is a long shot, yet compared to creating drugs and vaccines, the approach has clear advantages during a fast-moving pandemic. "If it works and it's on the shelf, you don't have any development time," said Dr. Lisa Danzig, a specialist in infectious diseases who consults with companies, investors, government and philanthropies. One of the best treatments in the COVID arsenal — the common steroid dexamethasone — is a repurposed drug. But it is recommended only for hospitalized patients who are seriously ill.
Danzig was "very excited" last April by news that a team led by University of California-San Francisco researchers had identified 69 possible drugs that, when used early on, could counteract infections with SARS-CoV-2, the virus that causes COVID. "I'm thinking, if we can rapidly test some of these in clinical trials, we can have answers by October."
Yet these studies struggled to get off the ground. Solid COVID trials of early treatments are particularly hard to pull off. Patients often must enroll within days of noticing symptoms. And without a national research infrastructure, "it's hard to get anyone's attention to participate in a trial or refer to it," said Dr. Eric Lenze, a psychiatrist at Washington University in St. Louis who teamed with his colleague Dr. Angela Reiersen last year to conduct a trial of fluvoxamine in newly infected COVID patients with mild symptoms.
Participants in that early study logged symptoms on a website while taking fluvoxamine or placebo tablets that were mailed to their homes. Fluvoxamine, sold under the brand name Luvox, is one of the oldest drugs in the selective serotonin reuptake inhibitor (SSRI) class. It is prescribed for major depression in many countries and was approved by the FDA in 1994 to treat OCD.
The results of the trial, published in November in the Journal of the American Medical Association, showed that none of the 80 fluvoxamine-treated patients became seriously ill, while six of 72 patients who took placebo pills worsened and required hospitalization.
Last month, another journal published results of a real-world study that echoed the JAMA results: Among 113 horse racetrack workers who were offered fluvoxamine after contracting COVID during a Bay Area outbreak, none of the 65 patients who chose to take the drug got sicker, whereas six of 48 people who declined the drug wound up hospitalized, and one died.
The evidence for fluvoxamine — which includes cell and animal data showing that the drug blocks harmful inflammation through a molecular pathway different from the way it treats depression or OCD — puts it "among the more promising non-proven therapies," Sax said. He is waiting for more definitive results from an ongoing national trial being conducted by the Washington University team. "Based on years of watching therapeutic trials in infectious disease," Sax said, "a lot of these things turn out to be busts."
Smaller studies are more likely to overestimate a drug's effects, said Elizabeth Ogburn, a biostatistician at Johns Hopkins Bloomberg School of Public Health.
Experiences with several experimental treatments illustrate this word of caution. Earlier in the pandemic, some doctors jumped on early lab data and started treating people with convalescent plasma — blood donated by recovered patients. Enthusiasm for plasma, however, has waned somewhat as the pandemic eased and larger studies suggested it did not improve survival in hospitalized patients.
Research on the gout drug colchicine caused similar whiplash. A news release in January claimed the drug reduced COVID deaths by 44%, but once the full data was released, enthusiasm cooled, said Dr. David Boulware, a physician-scientist at the University of Minnesota Medical School who led several hydroxychloroquine trials that helped disprove that drug's value in fighting COVID.
"It's tough to weed through what's real and what's not," he said.
With NIH showing little interest in generics, private funders have seized an opportunity. Silicon Valley tech entrepreneur Steve Kirsch launched the COVID-19 Early Treatment Fund last spring to support research on promising outpatient drugs.
Kirsch's fund helped finance the published fluvoxamine trial and coordinated fundraising for most of the $2 million needed for the current nationwide study. But his zeal gave some the impression that Kirsch was hyping the drug. Newspapers have rejected his op-eds, Facebook took down his posts, and Medium removed Kirsch's story titled "The Fast, Easy, Safe, Simple, Low-Cost Solution to COVID That Works 100% of the Time That Nobody Wants to Talk About," and closed his account.
Claims about a drug's efficacy and safety can be made only after authorization of the product by the FDA for its intended use, said Danzig, who serves as a volunteer medical adviser for Kirsch's fund. These rules "are not widely known to people in the tech world."
Agency-level guidelines are slow to change, and for good reason, Boulware said. "If something's a guideline, and you're not doing it, that starts to become medical malpractice."
In the case of fluvoxamine, though, Boulware finds the data promising and hopes the larger trial can be completed quickly. "If this was the first drug that came along and there wasn't the hydroxychloroquine experience, people would view it very differently," he said.
"I think we're going to get some answers," said Dr. Vikas Sukhatme, dean of the Emory School of Medicine. "It just would have been nice to get them sooner."