The Shock and Reality of Catching COVID After Being Vaccinated

KFF Health News, April 16, 2021

As more Americans every day are inoculated, a tiny but growing number are contending with the disturbing experience of getting COVID despite having had one shot, or even two.

This article was published on Friday, April 16, 2021 in Kaiser Health News.

By Steven Findlay

Robin Hauser, a pediatrician in Tampa, Florida, got COVID in February. What separates her from the vast majority of the tens of millions of other Americans who have come down with the virus is this: She got sick seven weeks after her second dose of the Pfizer-BioNTech vaccine.

"I was shocked," said Hauser. "I thought: 'What the heck? How did that happen?' I now tell everyone, including my colleagues, not to let their guard down after the vaccine."

As more Americans every day are inoculated, a tiny but growing number are contending with the disturbing experience of getting COVID despite having had one shot, or even two.

In data released Thursday, the Centers for Disease Control and Prevention reported that at least 5,800 people had fallen ill or tested positive for the coronavirus two weeks or more after they completed both doses of the Pfizer-BioNTech or Moderna vaccine.

A total of about 78 million Americans are now fully vaccinated.

These so-called breakthrough infections occurred among people of all ages. Just over 40% were in people age 60 or older, and 65% occurred in women. Twenty-nine percent of infected people reported no symptoms, but 7% were hospitalized and just over 1%, 74 people, died, according to the CDC.

Public health officials have said breakthrough infections were expected, since manufacturers have warned loudly and often that the vaccines are not 100% protective. The Pfizer and Moderna versions have consistently been shown to be above 90% effective, most recently for at least six months. Studies have also shown they are nearly 100% effective at ensuring that the small fraction of vaccinated patients who do contract the virus will not get severe cases or require hospitalization.

Still, people are usually shocked and befuddled when they become the rare breakthrough victim. After months of fear and taking precautions to avoid contracting COVID, they felt safe once they got their shots.

Hauser, 52, had stayed home from work to care for her kids, ages 21 and 16, both of whom had contracted the virus. She was confident she was protected. She was also taking care of her father, who has cancer.

"It's a minor miracle that I didn't infect him before I realized I, too, was sick," Hauser said. In keeping with the virus's fickle behavior, Hauser's husband, Brian, who had not yet been vaccinated, also never got infected.

Masha Gessen, a staff writer for The New Yorker, completed the two-shot process in mid-February. A month later, Gessen fell ill and tested positive after both Gessen's son and partner, Julia Loktev, had weathered bouts of COVID. The experience was "unsettling, even a bit traumatic," Gessen said. Loktev's illness occurred six days after her first dose.

"The psychological effect of getting the virus after a year of being very, very careful and getting vaccinated got to me," Gessen, 54, said in an interview with KHN. "It took me about three weeks to feel back to normal." Gessen wrote about the experience this month in The New Yorker.

Dr. Kami Kim, director of the infectious disease and international medicine division at the University of South Florida in Tampa, said physicians are equally disturbed when these cases crop up.

"All this, while anticipated, is definitely confusing and frustrating for people, both doctors and patients. We are all learning on the go and making judgments about what's best for our patients — and ourselves," Kim said.

Vaccine manufacturers said the number of breakthrough cases reported by the CDC was not surprising.

Moderna's latest analysis of its vaccine clinical trial data shows 900 people got COVID after being vaccinated, consistent with 90% or more efficacy for the vaccine, company spokesperson Colleen Hussey said.

Pfizer spokesperson Jerica Pitts said the company would monitor trial participants for two years after their second dose to learn more about the Pfizer vaccine's protection against COVID.

In their reporting, the CDC is defining a breakthrough case strictly as illness or a positive test two weeks or more after full vaccination. But tens of thousands of people who have had a first shot or are short of two weeks after their second shot are also getting infected.

Pfizer and Moderna report data showing up to 80% protection from infection two weeks or so after the first shot. But most experts believe protection ranges widely, from 50% to 80%, depending on the length of time after the shot and the individual variation that exists with any vaccine.

The second shot boosts immunity further but not for a few days, at minimum, and then builds over two weeks. And again, this could vary from person to person.

Leslie Fratkin, 60, a freelance photographer in New York City, got her second Pfizer dose March 12. So she was surprised when clear symptoms of COVID showed up March 24 and she was quite sick at home for three days.

"You can't print the words I uttered at the time," she said.

The CDC advises people who get COVID after a first shot to get the second dose soon after recovery, with no minimum wait time specified. That's a change from prevalent advice back in December and January, when some state health departments advised people to wait 90 days after a bout of COVID to get a first or second shot, and especially a second shot.

Driving this important change is mounting evidence from studies and experience indicating that immunity to infection conferred by the vaccines is stronger and possibly more "stable" over time than immunity derived from COVID infection.

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota in Minneapolis, said further research and better public health guidance are urgently needed. For example, is a second dose even needed for people who get COVID after the first dose, or does the infection itself serve as enough of an immune system booster? And if a second shot is recommended, what's the optimal waiting period before getting it?

"These are important practical questions that need to be prioritized," Osterholm said. "We are sort of flying blind now."

Other countries have handled the second dose rollout differently.

In the U.K., health authorities delayed it up to 12 weeks, to stretch vaccine supply and prioritize getting at least one shot into more people's arms more quickly. In Canada, a government vaccine advisory committee recommended April 7 that second doses be delayed up to four months.

At two press briefings this month, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a COVID adviser to President Joe Biden, said that the number of breakthrough cases in the U.S. so far is not cause for alarm and that the administration will continue to monitor these instances closely.

One important line of investigation is how big a role variants or mutated versions of the initial coronavirus play in these breakthrough cases. Research suggests the current vaccines may be somewhat less effective against some new variants.

Martha Sharan, a CDC spokesperson, said the agency is now urging states to use genetic sequencing to test virus specimens from patients with breakthrough cases to identify variants. In Washington state, for instance, eight variants were detected in the genetic sequencing of nine breakout cases reported through April 3.

Today the Biden administration announced $1.7 billion in spending would be directed from the COVID relief bill to help the CDC, states and other jurisdictions more effectively detect and track variants by scaling genomic sequencing efforts.

The CDC also has launched a national COVID vaccine breakthrough database in which state health departments can store and manage data.

"We are behind on sequencing samples," said Osterholm. "That will give us valuable information."

KHN senior correspondent JoNel Aleccia contributed to this story.

Steven Findlay, a KHN contributing reporter, came down with COVID 30 days after his first dose and 24 hours after his second dose.

Ask KHN-PolitiFact: I've Recovered From COVID. Why Do I Still Have to Mask Up?

KFF Health News, April 16, 2021

Important questions remain unanswered about the level of post-infection immunity that make it advisable to continue wearing a mask.

By Carmen Heredia Rodriguez

More than 120 million Americans have joined arguably the most sought-after club on Earth: those immunized against the coronavirus.

Fully vaccinated people were given the green light in March by the Centers for Disease Control and Prevention to gather with other fully vaccinated people or with low-risk unvaccinated people from one other household without a mask and, earlier this month, to travel without quarantining afterward. (As reports of state and local case surges mount, the CDC is increasingly urging caution.)

But what about all the people — a number impossible to count, though estimated to be in the millions — who now possess some degree of immunity because they recovered from COVID-19?

The agency recommends that everyone — vaccinated, recovered or otherwise — wear a mask in public.

There is no mention of whether people who have recovered can congregate without face coverings like those who are fully vaccinated.

And, through it all, the need for masks continues to be a contentious issue. As the federal government doubles down on their importance, some states have thrown caution — and face coverings — to the wind. We decided to dig into the science and motives behind the masking recommendation.

I Beat COVID! Isn't This Behind Me?

People who recover from the virus enjoy some immunity. The CDC says the protection lasts at least 90 days after testing positive for the virus. During that time, they do not need to quarantine or retest if they're exposed again.

Cases of reinfection are rare. While those infected can continue shedding the virus for months after they recover, the CDC said, the amount is low enough that it is unlikely to infect others.

Given that, some have questioned whether people who have recovered still need to abide by mask mandates. Linsey Marr, an engineering professor at Virginia Tech University who studies airborne transmission, told us there's no strong scientific rationale for face coverings among people who have had the virus.Bottom of Form

However, important questions remain unanswered about the level of post-infection immunity that make it advisable to continue wearing a mask, experts said. For instance, scientists have yet to determine whether people who experienced mild or no symptoms generated enough of an immune response to meaningfully shield them from getting the virus again.

Additionally, no one knows how long immunity lasts. A person could get reinfected and start spreading the virus without knowing it, said A. Oveta Fuller, associate professor of microbiology and immunology at University of Michigan Medical School.

"You don't want to be putting virus into the environment," she said.

What Makes Vaccines More Protective?

The COVID vaccines available in the United States provide a high degree of protection from illness, hospitalization and death.

The Moderna and Pfizer-BioNTech vaccines are over 94% effective after two doses. The percentage is lower for the Johnson & Johnson vaccine — 72% in the U.S. These vaccines can't be compared exactly for a variety of reasons. (Tuesday, the FDA recommended a pause in use of the J&J vaccine as reports of a rare side effect are investigated.)

So far, studies suggest the Moderna and Pfizer-BioNTech injections shield people for at least six months, but research is ongoing. This data is not yet available for the J&J shot.

Scientific evidence also appears to show vaccine-induced immunity is stronger than what the body generates after an infection, Fuller said. And vaccines appear to offer some protection against the variant discovered in the United Kingdom, now widely circulating in the U.S. Whether natural immunity can combat this strain or other variants is unknown, CDC spokesperson Jade Fulce said.

What could account for these differences? Visualize the virus as a hand, Fuller said. A natural infection triggers the body to attack any part of the pathogen, including dispensable bits like the tip of a fingernail. But the vaccines are engineered to create fighters that react to the virus's "thumb," the spike protein that binds it to the human cell.

"We know the thumb is critical for infection," Fuller said, "so any immunity you make against that will be more protective against infection than immunity from natural infection."

Emerging evidence suggests the vaccines could also prevent or limit how much the virus replicates in the respiratory system, an effect that could further cut down transmission.

That said, vaccine-induced immunity comes with its share of unknowns. Vaccines have a high efficacy rate, but they are still not 100% protective against the virus. Scientists are still figuring out whether immunity from vaccines or an infection will fade over time.

Depending on how this protection dissipates, people with vaccine-induced immunity could become vulnerable to the virus again and get infected without knowing it, said Fuller. Infected people can start shedding the virus up to two days before they show symptoms, and an estimated 30% never show signs of illness.

"We've learned a lot" in the year since COVID emerged, Fuller said. "But there's so, so much more to know."

A Mask Protects You, Your Neighbor and the World

When a person infected with SARS-COV-2 breathes out, they release droplets into the air that contain moisture, saliva and possibly bits of virus.

Masks work by blocking those droplets from landing in or on another person. Tightly woven fabrics can trap smaller droplets than those made with looser weaves, said Richard Sachleben, a retired chemist. Some versions also help the wearer inhale less virus.

Droplets of different sizes come with different risks, said Sachleben. Larger ones are pulled to the ground by gravity, he said, but they're more dangerous because they carry more virus than smaller ones that linger in the air. Luckily, they're also easier to block with a face covering.

"That's why a crappy mask is better than no mask," Sachleben said.

Face coverings also help stop more variants from forming, he continued, because the fewer particles are in the air, the fewer opportunities the virus has to mutate into a form that's more resilient against humanity's defenses.

That said, not even the best masks are 100% effective at catching and blocking every piece of virus, said Dr. Donald Milton, professor of environmental health at the University of Maryland School of Public Health. But, when combined with other public health measures, they can meaningfully reduce viral spread.

"If you combine a mask that does a little bit on me with a mask that does a little bit on you with being outside or having good ventilation inside," he said, "these things then add up."

Wearing a mask also sends a message about what people need to do "to break the back of this pandemic," said Fuller. Because face coverings protect the public from the wearer's germs, it also communicates that the wearer cares about the community, said Sachleben.

"When you wear a mask, that means you care," said Sachleben. "When I wear a mask, that means I care about you."

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

Pandemic Highlights Need for Urgent Care Clinics for Women

KFF Health News, April 16, 2021

For years, many women with common but urgent conditions like painful urinary tract infections or excessive bleeding in the aftermath of a miscarriage have faced a grim choice between waiting weeks for an appointment with their regular OB-GYN or braving hours in an ER waiting room.

This article was published on Friday, April 16, 2021 in Kaiser Health News.

By Rachel Scheier

SAN JOSE — Last spring, only weeks into the pandemic, Christina Garcia was spending her days struggling to help her two young sons adjust to online schooling when she got such a heavy, painful period she could barely stand. After a few days, her vision began to blur and she found herself too weak to open a jar.

Garcia's regular OB/GYN — like most medical offices at the time — was closed, and she was terrified by the prospect of spending hours waiting in an emergency room shoulder to shoulder with people who might have COVID.

By the time she stumbled into the newly opened Bascom OB-GYN urgent care clinic at the Santa Clara Valley Medical Center, clutching a pillow to her belly, Garcia was pale and dehydrated from blood loss and certain she was dying.

"If I didn't get to the clinic when I did, I think, things could have ended up very different," said Garcia, 34, who underwent an emergency hysterectomy for uterine fibroids.

Her story illustrates a long-standing gap in women's healthcare. For years, many women with common but urgent conditions like painful urinary tract infections or excessive bleeding in the aftermath of a miscarriage have faced a grim choice between waiting weeks for an appointment with their regular OB-GYN or braving hours in an ER waiting room.

Urgent care OB-GYN clinics have begun popping up around the country in recent years, and the COVID pandemic has increased demand. While no data is available on the number of urgent care clinics for women, they are part of a surge of interest in urgent care clinics in general and other alternative models like retail clinics and so-called digital-first healthcare startups. One of these, the New York-based women's health startup Tia ("aunt" in Spanish), won $24 million in venture capital funding last spring and is opening physical clinics nationwide.

"It's clear that access and convenience are increasingly more important to consumers than seeing a specific provider," said Rob Rohatsch, chief medical officer at Solv, an app that books urgent care appointments.

The Urgent Care Association has reported steadily increasing visits by people who use its members' walk-in clinics as an alternative to hospital emergency departments. Traffic to these clinics has surged during the past year, according to Solv.

The Bascom clinic had been a nearly decadelong dream of Drs. Cheryl Pan and Anita Sit, two obstetrician-gynecologists at the Santa Clara Valley Medical Center, a sprawling public hospital that serves as the regional trauma center, treating critical cases like car accident and gunshot victims and relegating people suffering less life-threatening problems to long waits.

"Women — perhaps pregnant or bleeding — could be sitting there 12 to 14 hours, depending on the time of day," Pan said.

After the onset of the pandemic, doctors worried that women with serious or even deadly issues like Garcia's might avoid seeking treatment for fear of contracting COVID. ER visits plummeted an unprecedented 42% in the early months of the pandemic, according to the Centers for Disease Control and Prevention. A June CDC report noted that, while the number of ER visits for heart attacks had increased, visits for nonspecific chest pain had decreased, suggesting that people might be risking their lives by avoiding the ER.

"You can imagine that a woman with three kids at home might be even more scared," Sit said. "We just couldn't keep sending women having miscarriages to wait hours in the COVID tent."

Instead, women can now be triaged over the phone and seen within a day or two at the Bascom OB-GYN urgent care clinic — much the way they would at their local Planned Parenthood branch for contraceptives or a sexually transmitted disease screening. Bascom is equipped to treat conditions from severe morning sickness to ectopic pregnancies that require emergency surgery. In its first year, the clinic has treated some 1,300 women and served as a backup to local clinics that provide basic reproductive health services in counties hundreds of miles away.

It's still in its pilot phase, however, operating weekdays from 8:30 a.m. to 5 p.m., which "leaves a big chunk of off-hours that we cannot serve women," Sit acknowledges.

A handful of other clinics have taken the concept of urgent care for women a step further. Dr. Miriam Mackovic runs Complete Women Care, a chain of four clinics in the Los Angeles area that also has an emergency care center in Long Beach, which is staffed 24/7 with a nurse practitioner and equipped with a lab and a pharmacy. Women who walk in are typically seen within 30 minutes, according to Mackovic, and every patient receives a follow-up call the next day.

One woman who turned up at a Complete Women Care clinic said that, after desperately seeking treatment at an ER one Saturday night for a nasty yeast infection, she got a bill in the mail for $1,500.

"In the middle of the night, urgent care centers are closed. OB-GYN offices are definitely closed. So, what is her option except the ER?" asked Mackovic, an obstetrician-gynecologist who also has an MBA.

Mackovic ticked off cautionary tales of patients who've arrived at her clinics from as far away as Arizona and Nevada after suffering for weeks while trying to schedule routine operations for uterine cysts or twisted ovaries.

"The medical advances are here. Most emergencies can be resolved on an outpatient basis — a woman can have a hysterectomy with just a fine incision and be home the same day," Mackovic said. "But a woman who has a miscarriage calls her OB, who says there's no openings for weeks, so she goes to the ER, and the physician says: Are you dying? No? Then follow up with your OB-GYN."

Fees for the uninsured — around 20% of Mackovic's clientele — run from $100 to around $600, she said.

Women in the United States have for years lagged behind those in other rich countries in both their access to healthcare and their health status. America has the highest maternal mortality rate among developed nations.

Some women see a doctor only in an emergency.

"We have diagnosed so many cancers in the last few years because women walked in for another reason," said Dr. Adeeti Gupta, founder and CEO of a chain of open-daily clinics in New York City called Walk In Gyn Care that provides comprehensive care without appointments.

Gupta's three clinics have grown steadily since she opened them seven years ago, largely out of frustration with the months-long wait for an appointment at her own Queens OB-GYN practice. But after the coronavirus hit the city hard, she has seen an uptick in patients — 40% in one location.

The country needs more accessible, comprehensive women's healthcare to treat everything from the menstrual pains of adolescents to the hot flashes of postmenopausal grannies, Gupta said.

"The thing about women," she said, "is their problems never stop."

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Healthcare Foundation.

Rachel Scheier: @rachelscheier

Mysterious Ailment, Mysterious Relief: Vaccines Help Some COVID Long Haulers

KFF Health News, April 16, 2021

As the U.S. pushes to get people vaccinated, a curious benefit is emerging for those with this post-illness syndrome: Their symptoms are easing and, in some cases, fully resolving after vaccination.

This article was published on Friday, April 16, 2021 in Kaiser Health News.

By Will Stone

An estimated 10% to 30% of people who get COVID-19 suffer from lingering symptoms of the disease, or what's known as "long COVID."

Judy Dodd, who lives in New York City, is one of them. She spent nearly a year plagued by headaches, shortness of breath, extreme fatigue and problems with her sense of smell, among other symptoms.

She said she worried that this "slog through life" was going to be her new normal.

Everything changed after she got her COVID vaccine.

"I was like a new person. It was the craziest thing ever," said Dodd, referring to how many of her health problems subsided significantly after her second shot.

As the U.S. pushes to get people vaccinated, a curious benefit is emerging for those with this post-illness syndrome: Their symptoms are easing and, in some cases, fully resolving after vaccination.

It's the latest clue in the immunological puzzle of long COVID, a still poorly understood condition that leaves some who get infected with wide-ranging symptoms months after the initial illness.

The notion that a vaccine aimed at preventing the disease may also treat it has sparked optimism among patients, and scientists who study the post-illness syndrome are taking a close look at these stories.

"I didn't expect the vaccine to make people feel better," said Akiko Iwasaki, an immunologist at the Yale School of Medicine who's researching long COVID.

"More and more, I started hearing from people with long COVID having their symptoms reduced or completely recovering, and that's when I started to get excited because this might be a potential cure for some people."

While promising, it's still too early to know just how many people with long COVID feel better as a result of being vaccinated and whether that amounts to a statistically meaningful difference.

In the meantime, Iwasaki and other researchers are beginning to incorporate this question into ongoing studies of long haulers by monitoring their symptoms pre- and post-vaccination and collecting blood samples to study their immune response.

There are several leading theories for why vaccines could alleviate the symptoms of long COVID: It's possible the vaccines clear up leftover virus or fragments, interrupt a damaging autoimmune response or in some other way "reset" the immune system.

"It's all biologically plausible and, importantly, should be easy to test," said Dr. Steven Deeks of the University of California-San Francisco, who is also studying the long-term impacts of the coronavirus on patients.

Patient Stories Offer Hope

Before getting the vaccine, Dodd, who's in her early 50s, said she felt as if she had aged 20 years.

She had trouble returning to work, and even simple tasks left her with a crushing headache and exhaustion.

"I'd climb the subway stairs and I'd have to stop at the top, take my mask off just to get air," Dodd said.

After she got her first dose of the Pfizer vaccine in January, many of Dodd's symptoms flared up, so much so that she almost didn't get her second dose.

But she did — and a few days later, she noticed her energy was back, breathing was easier and soon even her problems with smell were resolving.

"It was like the sky had opened up. The sun was out," she said. "It's the closest I've felt to pre-COVID."

In the absence of large studies, researchers are culling what information they can from patient stories, informal surveys and clinicians' experiences. For instance, about 40% of the 577 long-COVID patients contacted by the group Survivor Corps said they felt better after getting vaccinated.

Among the patients of Dr. Daniel Griffin at Columbia University Medical Center in New York, "brain fog" and gastrointestinal problems are two of the most common symptoms that seem to resolve post-vaccination.

Griffin, who is running a long-term study of post-COVID illness, initially estimated that about 30% to 40% of his patients felt better. Now, he believes the number may be higher, as more patients receive their second dose and see further improvements.

"We've been sort of chipping away at this [long COVID] by treating each symptom," he said. "If it's really true that at least 40% of people have significant recovery with a therapeutic vaccination, then, to date, this is the most effective intervention we have for long COVID."

A small U.K. study, not yet peer-reviewed, found about 23% of long-COVID patients had an "increase in symptom resolution" post-vaccination, compared with about 15% of those who were unvaccinated.

But not all clinicians are seeing the same level of improvement.

Clinicians at post-COVID clinics at the University of Washington in Seattle, Oregon Health & Science University in Portland, National Jewish Health in Denver and the University of Pittsburgh Medical Center told NPR and KHN that, so far, a small number of patients — or none at all — have reported feeling better after vaccination, but it wasn't a widespread phenomenon.

"I've heard anecdotes of people feeling worse, and you can scientifically come up with an explanation for it going in either direction," said UCSF's Deeks.

Why Are Patients Feeling Better?

There are several theories for why vaccines could help some patients — each relying on different physiological understandings of long COVID, which manifests in a variety of ways.

"The clear story is that long COVID isn't just one issue," said Dr. Eric Topol, director of the Scripps Research Translational Institute, which is also studying long COVID and the possible therapeutic effects of vaccination.

Some people have fast resting heart rates and can't tolerate exercise. Others suffer primarily from cognitive problems, or some combination of symptoms like exhaustion, trouble sleeping and issues with smell and taste, he said.

As a result, it's likely that different therapies will work better for some versions of long COVID than others, said Deeks.

One theory is that people who are infected never fully clear the coronavirus, and a viral "reservoir," or fragments of the virus, persist in parts of the body and cause inflammation and long-term symptoms, said Iwasaki, the Yale immunologist.

According to that explanation, the vaccine might induce an immune response that gives the body extra firepower to beat back the residual infection.

"That would actually be the most straightforward way of getting rid of the disease, because you're getting rid of the source of inflammation," Iwasaki said.

Griffin at Columbia Medical Center said this "viral persistence" idea is supported by what he's seeing in his patients and hearing from other researchers and clinicians. He said patients seem to be improving after receiving any of the COVID vaccines, generally about "two weeks later, when it looks like they're having what would be an effective, protective response."

Another possible reason that some patients improve comes from the understanding of long COVID as an autoimmune condition, in which the body's immune cells end up damaging its own tissues.

A vaccine could hypothetically kick into gear the "innate immune system" and "dampen the symptoms," but only temporarily, said Iwasaki, who has studied the role of harmful proteins, called autoantibodies, in COVID.

This self-destructive immune response happens in a subset of COVID patients while they are ill, and the autoantibodies produced can circulate for months later. But it's not yet clear how that may contribute to long COVID, said John Wherry, director of the Institute for Immunology at the University of Pennsylvania.

Another theory is that the infection has "miswired" the immune system in some other way and caused chronic inflammation, perhaps like chronic fatigue syndrome, Wherry said. In that scenario, the vaccination might somehow "reset" the immune system.

With more than 77 million people fully vaccinated in the U.S., teasing apart how many of those with long COVID would have improved even without any intervention is difficult.

"Right now, we have anecdotes; we'd love it to be true. Let's wait for some real data," said Wherry.

This story is part of a partnership that includes NPR and KHN.

Airports Step Up Mental Health Assistance as Passenger Anxiety Soars

KFF Health News, April 15, 2021

Airport chaplains have become close witnesses to people's worsening mental condition.

This article was published on Thursday, April 15, 2021 in Kaiser Health News.

By Katja Ridderbusch

ATLANTA — Robin Hancock gently worked her steel tongue drum with a pair of mallets, producing a set of soothing, mystical tones. They blended with the soft sound of chirping birds and bubbling creeks pouring from a Bluetooth speaker. Her warm voice invited the two visitors in the dimly lit room to slip into a nature setting of their choosing.

The 20-minute guided meditation took place at an unlikely location: Atlanta's Hartsfield-Jackson International Airport, which until 2020 was the world's busiest passenger hub. The airport interfaith chapel's executive director, Blair Walker, introduced the meditation sessions last fall in the midst of the COVID-19 pandemic.

People were noticeably more stressed during the past year, Walker said as he stepped out of his office onto the second-floor gallery, which overlooks the airport's main atrium. Walker is an ordained minister who previously worked in higher education and public health. He said people have been quicker to lose their temper, lose their patience or lose it altogether.

"There was a tightness that I've never seen before," he said.

That's why he brought on board Hancock, a nature meditation guide, to join his team of 40 volunteer airport chaplains. She said her goal is to provide people with "a piece of calm in whatever storm is going on at that moment" and leave them with a tool to use the next time they're feeling overwhelmed.

"Traveling is tough," said Jordan Cattie, a clinical psychologist and assistant professor at Atlanta's Emory University School of Medicine. Airports, in particular, trigger panic and anxiety because of the frenetic pace, noise and glaring screens, she said, but COVID amplifies travel anxiety.

Airport chaplains have become close witnesses to people's worsening mental condition. "No doubt, the pandemic has accelerated the need for our services to a new level," said the Rev. Greg McBrayer.

McBrayer, an Anglican priest, is the corporate chaplain for American Airlines and director of the interfaith chapel at Dallas/Fort Worth International Airport, the world's largest airport chapel. During the pandemic, he said, he has seen depression, anxiety and addiction increase among the travelers and workers served by him and his staff of 20 chaplains.

"We have encountered a tremendous amount of grief and fear," McBrayer said, especially among airport employees. In the past year, he logged over 300 counseling sessions via Zoom and more in person.

Many struggled not only with economic woes, health concerns and COVID deaths, but also with feelings of guilt for being well and employed when some of their former colleagues weren't. "We've seen a lot of workers come up to the chapel because they need a quiet space to sit, chill and maybe cry," said Walker.

In the early months of the pandemic, Hartsfield-Jackson also became a refuge for up to 300 homeless people per night, many with mental health conditions such as addiction and schizophrenia. They were redirected to hotels rented by the city. But now, with a $400,000 grant from the Transportation Research Board, the airport is working with researchers to study homelessness at airports around the world, including how to stage mental health interventions.

"We will put together best practices of what airports can do to assist these vulnerable populations," said Steve Mayers, the airport's director of customer experience.

Chaplains typically encounter people in distress as they walk the concourses in what they call "the ministry of presence." Walker and McBrayer said they've seen more breakdowns and panic attacks during the pandemic. Many of these events are triggered by the contentious issue of wearing masks, said Walker. A few weeks ago, a gate agent called when a passenger furiously refused to wear a face covering and then broke down as the airline took her off the flight.

"It was obvious there was much more going on than just the mask issue," Walker said.

The guided mediation at Hartsfield-Jackson is designed to "help people breathe, recenter, step away," said Hancock, who inherited a love of flying from her pilot father and volunteers at the airport once a week. On a busy day, each session has up to five participants to accommodate physical-distancing guidelines.

"I can read people pretty well," she said. "Many of them carry a lot of vulnerability and angst right now."

Most people are quiet when they come in, and their bodies are tense. Hancock remembers an older couple who were on their way to Texas for a family emergency. After the meditation, the couple became more talkative. "They were fearful about what to expect. They were fearful about traveling," Hancock said. "They were fearful just being among people."

Cattie, the clinical psychologist, said practices such as mindfulness, meditation, yoga and controlled breathing can be very effective at thwarting anxiety triggers that are inherent in air travel.

Mental health and well-being were on the radar of airport administrators long before COVID, but some services were paused because of the pandemic. Now, though, they're making a comeback. Several airports have yoga, stretching and silent meditation areas. Live music and therapy pet programs are also intended to calm stressed-out travelers.

As more people get vaccinated, passenger volumes continue to rise and more trips are for vacations and other joyous occasions. Still, Cattie expects the pandemic's mental health fallout to last a while longer. "COVID has seeped into every crack and every foundation and created so much loss and change and fear," she said. "There will be a huge echo."

In her clinical practice, she's seen many patients who are anxious about rejoining life, with its crowded places and people on the move. "This past year, many of us have been living in a safety bubble," she said. For most people, traveling is a social muscle that hasn't been exercised in a while. "It's OK to be scared," she said. "It's normal to feel uncomfortable."

The FDA Seeks a New Way to Review Old Drugs Without Causing Prices to Soar

KFF Health News, April 15, 2021

The departing Trump administration unexpectedly ended the FDA program that led to a price spike for colchicine and other older drugs, saying it drove up drug costs and in some cases caused shortages.

This article was published on Thursday, April 15, 2021 in Kaiser Health News.

By Harris Meyer

Chuck Peterson of Omaha, Nebraska, recently experienced a swollen, painful knuckle caused by arthritis. He got a prescription for colchicine.

Doctors have used the drug for treating gout and other rheumatic conditions for well over two centuries.

When Peterson went to the pharmacy, he was shocked to discover that a two-month supply of 120 pills, distributed by Par Pharmaceutical, would cost him $225 out-of-pocket on his Medicare Part D drug plan. Taking it for an additional three months, as his rheumatologist wanted him to do, would cost him nearly $600 under his drug plan.

A dozen years ago, the drug cost about a dime per pill.

"My reaction was 'goodness gracious,' or maybe something I couldn't say in polite company," he said.

The startling price hike was precipitated by a well-intentioned federal government program, called the Unapproved Drugs Initiative, that created unforeseen consequences. It was supposed to protect the public by ensuring that older drugs went through a Food and Drug Administration approval process to determine their safety and efficacy and that older versions were taken off the market.

In November, the departing Trump administration unexpectedly ended the FDA program that led to a price spike for colchicine and other older drugs, saying it drove up drug costs and in some cases caused shortages. Now the FDA is considering whether and how to replace it, while advancing the Biden administration's goal of reducing prescription drug prices overall. An announcement is expected soon.

But healthcare policy analysts and executives fear drugmakers still will find ways to maintain high prices for drugs already approved through the program, and to jack up prices for remaining unapproved drugs on the market, estimated to number at least 1,500. They note that the manufacturers of drugs that were granted FDA approval and market exclusivity through the UDI program, including colchicine, have aggressively used the courts to block other drug companies from marketing cheaper generic alternatives, often for many years.

Colchicine was one of many drugs that were sold before the FDA was created in 1938. No manufacturer ever took it through the agency's approval process for determining safety and efficacy, but its approval for wide use was effectively grandfathered in.

Then the FDA, under the UDI program it launched in 2006, approved a branded version of colchicine in 2009, gave the manufacturer seven years of exclusivity and ordered previous versions off the market. With no competition, the price soared to about $4.50 a pill. That has since dipped to less than $2 a pill since generic competitors were approved by the FDA and entered the market in the past few years. However, the price is still much higher than before.

Price increases of drugs approved through UDI have boosted U.S. health spending by $3.2 billion so far, and will increase costs by tens of billions more in coming years, according to a study last year by Vizient, a purchasing firm serving hospitals.

Drug policy experts would like to see the Biden administration develop alternatives to UDI for reviewing the safety and efficacy of unapproved drugs that don't lead to big price hikes. One way, especially for common drugs that physicians and hospitals have used safely for decades, is having the FDA work with healthcare providers to collect and analyze data on their own through patient registries.

"If other entities collect the data, thus minimizing the research expense, it would perhaps be more appropriate for the manufacturers not to take enormous price increases," said Steven Lucio, a vice president  at Vizient.

Other older drugs whose prices skyrocketed after drugmakers won exclusive rights to sell branded versions include selenium, a common mineral supplement used in patients who need feeding through a stomach tube. It soared 1,190% after American Regent gained FDA approval for branded "Selenious Acid" in 2019.

Belcher Pharmaceuticals hiked the price of branded "Dehydrated Alcohol 99%," used to treat severe heart disease, 668% after it won FDA approval in 2018.

Hospital executives are particularly vexed about the price hike for Vasostrict — formerly known as vasopressin and first developed in 1928 — because that drug, used to increase a patient's blood pressure, has been widely used in intensive care units to treat COVID-19 patients. From 2019 to 2020, hospital spending for the drug rose 56%, to nearly $600 million, according to the American Society of Health-System Pharmacists.

The price of the drug increased 1,644% after Par Pharmaceutical won FDA approval in 2014, according to Vizient. It received market exclusivity through 2035. And Par Pharmaceutical has hiked the price 7% to 10% each year, said Eric Tichy, vice chair of supply chain management at the Mayo Clinic.

"I don't mind paying a lot for innovative drugs, but vasopressin has been around much longer than I've been alive," he said. "Par has made a windfall from COVID. That's just gaming the system. It's outrageous."

Two other drugmakers have sought, unsuccessfully so far, to develop and market a generic alternative to Vasostrict. A German drug company, Fresenius Kabi, sued Par in a New Jersey federal court for alleged antitrust violations in blocking its access to information about the drug's active ingredients. Par sued Sandoz for patent infringement to block that drugmaker from marketing a generic version of vasopressin. Par recently reached confidential settlements with both companies, Tichy said.

None of the three companies would comment on the settlements.

Heather Zoumas-Lubeski, vice president of corporate affairs for Endo International, which owns Par, justified Vasostrict's price by saying the company "invested significant time and resources in the formulation, approval, and manufacturing" and "continues to invest in efforts that benefit patients."

Drug manufacturers, including makers of generics, opposed the elimination of the UDI program and have urged the FDA to continue to grant approvals and market exclusivity to branded versions of previously unapproved older drugs.

They particularly oppose the Trump administration's proposal to let the FDA determine that some older, non-patented drugs are "generally recognized as safe and effective," known as having GRASE status, and don't need to go through a new drug approval process.

Broadly granting GRASE status would "allow potentially unsafe, ineffective, or poor-quality drugs to enter the U.S. market, and put patients at risk," the Pharmaceutical Research and Manufacturers of America warned in December in response to the Trump administration's request for comments on what should replace the UDI program. The trade group stressed that the FDA is not allowed under law to consider drug prices in making approval decisions.

But drug policy researchers say drugmakers generally have done little or no original research to improve the safety and efficacy of old unapproved drugs or expand clinical uses for these products. They also say there's no justification for the much higher prices of the FDA-approved branded versions.

One exception they cite is L-cysteine, an amino acid used in intravenous nutrition for preterm infants, which Exela Pharma Sciences improved by removing potentially harmful metals. The company won FDA approval for its new branded version, Elcys, in 2019. Its wholesale price is $8.24 per milliliter, compared with $0.24 per milliliter for the previous generic product.

"That company did a lot of work to bring a new and improved formulation to market," said Soumi Saha, vice president of advocacy for Premier, which does group purchasing for healthcare providers. "That's different than taking the same recipe, slapping a different label on it and seeking market exclusivity."

This isn't just an abstract policy issue. The higher prices resulting from the branding of cheap old drugs can significantly affect patient care.

Colchicine's higher price prompted Dr. Marcus Snow, a rheumatologist in Omaha, to switch some of his gout patients to more affordable anti-inflammatory drugs. But those drugs can elevate blood sugar and affect kidney function, so he has to be vigilant.

The drug's price also could become a bigger issue as its use expands. Recent studies have shown that colchicine is effective in preventing complications after heart attacks, and that it may be effective in reducing heart problems in COVID patients. If demand soars for these new uses, Par and other colchicine distributors might seek further price hikes for this ancient drug.

"I would love to see colchicine drop to the old days of pennies per pill through generic availability," said Snow, who heads the American College of Rheumatology's Committee on Rheumatic Care. "But I'm not expecting that."

Harris Meyer: @Meyer_HM

Biden Moves to Overturn Trump Birth Control Rules

KFF Health News, April 15, 2021

HHS says the Trump policy 'has been devastating to the hundreds of thousands of Title X clients who have lost access to critical family planning and related preventive health services.'

This article was published on Thursday, April 15, 2021 in Kaiser Health News.

By Julie Rovner

The Biden administration Wednesday formally proposed the repeal of Trump-era regulations barring abortion referrals and making other changes intended to evict Planned Parenthood and other abortion providers from the federal family planning program, Title X. The 2019 rules dramatically limited access to these family planning services for many low-income people.

In promising to return to the pre-Trump rules for the program, the new regulations by the Department of Health and Human Services note that the Trump policy "has been devastating to the hundreds of thousands of Title X clients who have lost access to critical family planning and related preventive health services." Since the Trump rules took effect, Planned Parenthood and many city and state health departments have dropped out of the program, resulting in six states with no Title X providers and six more with dramatically reduced services.

Rules for the program, which provides contraceptive services, tests and treatment for sexually transmitted infections, cancer screenings and other basic healthcare, have been the subject of debate since the 1980s. Even though Title X has not, since its inception in 1971, allowed its funding to be used for abortion, Planned Parenthood has for decades been the dominant recipient of the funds. Not all Planned Parenthood affiliates perform abortions, but many do, and abortion opponents have complained for years that the federal funding was indirectly subsidizing the abortion industry.

In 1991, the Supreme Court upheld Reagan administration rules that would have barred medical providers in Title X-funded clinics from referring pregnant patients to abortion providers or even mentioning abortion as an option. That policy was dubbed a "gag rule" by opponents. The Reagan rules also would have required facilities that perform abortions to be physically and financially separate from those that receive Title X funding. Those rules, however, never took effect, and were repealed by President Bill Clinton when he took office in 1993.

The Trump administration rules, which took effect in July 2019, did not go as far as the Reagan rules. They did forbid recipients of federal family planning funds to make abortion referrals, however, and reinstated the requirement that facilities that perform abortions be physically and financially separate from those that get federal assistance.

In a statement, Planned Parenthood President and CEO Alexis McGill Johnson said the organization's affiliates stand ready to rejoin the program when the new rules are made final. "As the nation's only federal program dedicated to providing affordable birth control and other reproductive healthcare to people with low incomes, Title X is a critical piece of our social safety net that can, and should, help ensure equitable access to essential healthcare," she said.

Abortion opponents who had pushed for the Trump rules were not pleased. "Abortion is not 'family planning' and Biden-Harris Democrats pursue this extreme, unpopular agenda at their political peril," said a statement from Marjorie Dannenfelser, president of the Susan B. Anthony List, an anti-abortion group.

The proposed rollback of the family planning rules represented the second win of the week for abortion rights supporters. Monday night, the Food and Drug Administration agreed to waive the "in person" requirements for women seeking the abortion pill mifepristone for the duration of the pandemic. Under the drug's labeling rules, the pill must be delivered directly by a doctor to the woman, although she may take it at home.

In July, a federal district court judge said the requirement should be temporarily suspended, because requiring women to go to a clinic in person during a pandemic threatened their health. But the Trump administration appealed that ruling, and in January the Supreme Court sided with the Trump FDA, again making the pills unavailable except during in-person visits.

Acting FDA Commissioner Janet Woodcock, however, said in a statement that studies conducted recently, including during those months when women were able to get the pills remotely, "do not appear to show increases in serious safety concerns … occurring with medical abortion as a result of modifying the in-person dispensing requirement during the COVID-19 pandemic."

The decision was praised by, among others, the American College of Obstetricians and Gynecologists, which brought the original lawsuit seeking to eliminate the in-person requirement. "Requiring the medicine to be dispensed in person, then taken elsewhere at the patients' discretion, is arbitrary and does nothing to bolster the safety of an already-safe medicine," said a statement from the group.

Anti-abortion forces, however, decried the move. A statement from the group Students for Life said that "what is tragic is that more lives will be lost because the Biden Administration wanted to make it easier to deliver death by mail."

Julie Rovner: jrovner@kff.org, @jrovner

Analysis: I Was a Teenage Rifle Owner, Then an ER Doctor. Assault Weapons Shouldn't Count as 'Guns.'

KFF Health News, April 14, 2021

When I entered high school in the 1970s, I joined the riflery team and often slung my cased gun over my shoulder on my mile-long walk to school for practice.

This article was published on Wednesday, April 14, 2021 in Kaiser Health News. This story also ran on The Washington Post.

By Elisabeth Rosenthal

Many who know me might be shocked by this: I shot my first pistol when I was 8 or 9, taught by my father, a physician, aiming at targets in our basement. At summer camp, I loved riflery the way some kids loved art. Staring through the sight, down the barrel, I proved an excellent shot, gathering ever more advanced medals from the National Rifle Association. As a reward, for my 13th birthday, my uncle gave me a .22 Remington rifle.

I did not grow up on a farm or in a dangerous place where we needed protection. I grew up in the well-off, leafy suburb of Scarsdale, N.Y.

When I entered high school in the 1970s, I joined the riflery team and often slung my cased gun over my shoulder on my mile-long walk to school for practice. It didn’t seem dissonant that, on other mornings, I went to the train station to join protests against the Vietnam War.

Since then, the United States has undergone a cultural, definitional, practical shift on guns and what they are for.

Once mostly associated in the public mind with sport, guns in the United States are now widely regarded more as weapons to maim or kill — or to protect from the same. Guns used to be on a continuum with bows and arrows; now they seem better lumped in with grenades, mortars and bombs.

In the 1990s, by which time I was an emergency room doctor at a Level 1 trauma center in New York City, I became acquainted with the damage that small-caliber handguns could cause. When I started treating gunshot victims, I marveled at how subtle and clean the wounds often were, externally at least. Much cleaner than stabbings or car wreck injuries.

We searched for a tiny entrance wound and the larger exit wound; they were often subtle and hard to locate. If you couldn’t find the latter, you would often see the tiny metal bullet, or fragments, lodged somewhere internally on an X-ray — often not worth retrieving because it was doing no damage.

These were people shot in muggings or in drug deals gone wrong. Most of these patients had exploratory surgery, but so long as the bullet had not hit a vital organ or major vessel, people survived.

No one was blown apart.

An assault-style weapon was allegedly used last month to kill 10 people in a Boulder, Colo., supermarket, just as one has been used in more than a dozen mass-casualty shootings, leaving four or more people dead, since 2017.

Guns and the devastating injuries they cause have evolved into things I don’t recognize anymore. My Remington .22 has about as much in common with an assault-style weapon as an amoeba has with a human life. The injuries they produce don’t belong under one umbrella of “gun violence.” Though both crimes are heinous, the guy who shoots someone with an old pistol in a mugging is a different kind of perpetrator from the person who, dressed in body armor, carries a semiautomatic weapon into a theater, house of worship or school and commences a slaughter.

Certainly many American gun owners — maybe a majority of them — are still interested in skill and the ability to hit the bull’s-eye of a target (or a duck or deer, if you’re of the hunting persuasion). But the adrenaline in today’s gun culture clearly lies in paramilitary posturing, signaling to the world the ability to bring mayhem and destruction. Add a twisted mind with the urge to actually bring mayhem and destruction, and tragedy awaits.

Before Congress passed an assault weapons ban in 1994, Americans owned about 400,000 AR-15s, the most popular of these military-style weapons. Today, 17 years after Congress failed to reauthorize the ban, Americans own about 20 million AR-15-style rifles or similar weapons.

Why this change in the nature of gun ownership? Was it because 9/11 made the world a much scarier place? Was it NRA scaremongering about the Second Amendment? The advent of violent video games?

Now, not just emergency rooms but also schools and offices stage active-shooter drills. When I was an ER doctor, we, too, practiced disaster drills. A bunch of surrogate patients would be wheeled in, daubed with fake blood. Those drills seem naive in 2021 — we never envisioned the kinds of mass-shooting disasters that have now become commonplace.

And, frankly, no disaster drill really prepares an emergency room for a situation in which multiple people are shot with today’s semiautomatic weapons. You might save a few people with careful triage and preparation. Most just die.

I gave up riflery as a teenager when other options — boys, movies, travel — came along. Maybe I’ll take it up again someday, if assault-style weaponry is banned and the word “gun” again brings to mind sport and not a spinoff of war.

Syphilis Cases in California Drive a Record-Setting Year for STDs Nationwide

KFF Health News, April 14, 2021

From 2015 to 2019 alone, cases rose 74%. There were nearly 130,000 cases nationwide in 2019.

This article was published on Wednesday, April 14, 2021 in Kaiser Health News.

By April Dembosky, KQED

In certain circles of San Francisco, a case of syphilis can be as common and casual as the flu, to the point where Billy Lemon can't even remember how many times he's had it.

"Three or four? Five times in my life?" he struggles to recall. "It does not seem like a big deal."

At the time, about a decade ago, Lemon went on frequent methamphetamine binges, kicking his libido into overdrive and silencing the voice in his head that said condoms would be a wise choice at a raging sex party.

"It lowers your inhibitions, and also your decision-making abilities are skewed," said Lemon, who is 50.

He's sober now and runs the Castro Country Club in San Francisco — which is not a resort, but a place where gay men come to get help with addiction, especially meth. Lemon said syphilis comes with the territory.

"In the 12-step community, if meth was your thing, everybody had syphilis," he said.

In 2000, syphilis rates were so low that public health officials believed eradication was on the horizon. But the rates started creeping up in 2001. From 2015 to 2019 alone, cases rose 74%. There were nearly 130,000 cases nationwide in 2019, according to data released Tuesday by the Centers for Disease Control and Prevention.

In California and the U.S., about half of syphilis cases are in men who have sex with men. More than a third of women in the West who have syphilis also use meth, which has surged in recent years. These are just some of the trends causing overall national cases of sexually transmitted diseases to hit an all-time high for the last six years in a row, reaching 2.5 million. And the consequences are now trickling down to babies, who are contracting syphilis from their mothers: Congenital syphilis rates nearly quadrupled between 2012 and 2019.

This was all before the coronavirus pandemic took hold in the U.S., and with contact tracers and testing supplies diverted from STDs to COVID-19, the CDC is predicting 2020 numbers will be no better.

"We are quite worried about this and have seen this trend over time," said Dr. Erica Pan, California's state epidemiologist. "Unfortunately, with years of not having enough funding and infrastructure in public health, and then in this past year, of course, both at the local and state level, a lot of personnel who had been focusing on STDs and syphilis follow-up have really been redirected to the pandemic."

There's No Single Cause

Many factors have contributed to the rise of STDs, and syphilis in particular.

In San Francisco's gay community, for example, the rise of mobile dating apps like Grindr and Tinder made finding a date "faster than getting pizza delivered to your home," said Dan Wohlfeiler, an STD prevention specialist and co-founder of Building Healthy Online Communities, which uses these apps to improve gay men's health.

When the dating apps first came on the scene around 2009, they made it harder for disease investigators to track the spread of STDs and notify people who may have been infected, because men don't always know the names of the men they hook up with.

"They sometimes only know their online handle," said Dr. Ina Park, associate professor at the medical school of the University of California-San Francisco and author of "Strange Bedfellows," about the history of STDs. "And if the sex didn't go well, then sometimes they will block the person from their app and they don't even know how to reach that person again."

Online dating began back in the late 1990s, around the same time effective medications to prevent the transmission of HIV became available: first, antiretrovirals that suppress the virus in those who are HIV-positive, and then later, in 2012, pre-exposure prophylaxis, or PrEP, which prevents new infections in people who are HIV-negative but considered at risk for contracting the virus.

With the risk of contracting a deadly disease falling to almost zero, condoms fell even more out of favor than they already were, said Park.

"If one man is taking PrEP and the other one is virally suppressed, there's no HIV risk at all," she said. "So why use condoms if you don't mind having a touch of syphilis?"

Diagnosing Syphilis Is Tricky

While syphilis is not benign – it can cause blindness, deafness or brain damage — it is easy to treat. Typically, a shot of penicillin in the butt will cure it.

But diagnosing syphilis can be tricky, said Park, who treats patients with STDs at the San Francisco City Clinic. She often finds herself crouched low in the exam room, "lifting up their scrotum and lifting up their penis," craning her head to get a look from all angles.

She does these gymnastics to find rashes associated with syphilis. Some are obvious, others subtle. She said doctors in regular family medicine clinics often aren't trained on where to look, or when.

"The patient came in saying, 'I'm tired,'" Park said, referring to a common symptom of syphilis. "How many people are going to say, 'Take off your pants and lift up your scrotum. I want to look'? We only do that at the STD clinic because that's what we do."

But specialized public STD clinics, like the one where Park works, have been shutting down nationwide. One reason is persistent underfunding of public health programs, a trend laid bare during the pandemic. Another reason is the Affordable Care Act. In a strange way, the 2010 law, intended to expand access to healthcare, actually contributed to the closure of STD clinics.

"Honestly, I think everyone thought they weren't going to be necessary," Dr. Karen Smith said in 2019, when she was the director of the California Department of Public Health. She said that, once Obamacare was in place, the thought was that STD testing would happen in primary care clinics.

"We sort of all assumed that if you've got health insurance and you've got access to a doctor, that's all that you need," she said. "It turns out that that's not really all that you need."

People still had affairs they didn't want to talk about with their family doctor. And some family doctors didn't want to probe into patients' sex lives. Young people, in particular, prefer clinics geared to them, out of their parents' purview.

"That loss of anonymous care really was a problem," Smith said.

The Syphilis Epidemic Reaches Babies, Too

When Christian Faulkenberry-Miranda decided to become a pediatrician, she never thought she'd become an expert in syphilis.

In 2010, shortly after finishing her medical training and starting work at Community Regional Medical Center in Fresno, California, she began seeing babies with a rash on their tummies that looked like a blueberry muffin. She thought it was a common viral infection, until these babies tested positive for syphilis.

In those early days, Dr. Faulkenberry-Miranda saw perhaps a few instances of congenital syphilis each year. Now she sees two cases every week. It's important to start the 10-day antibiotic treatment right away, to avoid complications, but she still follows her patients through their first year of life, and often through childhood, to watch for vision and hearing problems, developmental delays, attention deficits and learning disabilities, all of which can result from congenital syphilis infections. In 2019, 128 cases resulted in stillbirth or neonatal death.

"The disappointing thing is that syphilis is very treatable," she said. "This is something that's completely preventable, with proper screening and treatment of these moms during pregnancy."

Congenital syphilis cases hit a troubling milestone in 2019, reaching a high of 1,870 cases, an increase of 279% in five years. That is higher than the number of mother-to-child HIV cases at their peak in 1991.

"How could this be happening? Testing is cheap and widely available. The same treatment we've been using since the '40s still works," said Park, who has also seen an increase in congenital syphilis cases in San Francisco. "And yet we have this completely out-of-control epidemic among the most vulnerable babies in our society."

Many of the women who give birth to babies with syphilis have had no prenatal care. They often use drugs — mainly methamphetamine — and are often homeless, said Smith, the former California public health director. This makes them more likely to trade sex for housing, food or drugs. Drug use, in particular, makes women less likely to recognize they're pregnant at all, and less likely to seek healthcare if they do.

"They're very concerned about what's going to happen when they're found to be pregnant and using drugs," said Smith. "They're concerned that their drug use will be reported and then … their children will be taken away."

The complications of these women's lives also make disease investigation and contact tracing very challenging. Veteran contact tracer Romni Neiman remembers the difficulty she has had tracking down pregnant women in her career. Neiman works for the CDC, and before she was redirected to COVID last year, she worked on preventing STDs, including congenital syphilis, in California.

She remembers looking for one woman in the late '80s in Chicago. The pregnant woman used drugs and had been exposed to syphilis. Her housing was so unstable that Neiman went to three places before finding her. The woman had no car, so Neiman offered to drive her to the clinic to get tested. The woman had no safe place to leave her toddler, because a man in the place she was staying was abusive, so Neiman took care of the child while the woman saw the doctor.

"She was just trying to do the best that she can, and she was really afraid," Neiman recalled. "Sometimes it's really taxing and really sad. And you come home at the end of the day and you're like, 'Wow. Wow.'"

Challenges like those, combined with persistent underfunding for public health, are what led to the initial spike in congenital syphilis in Fresno County in the 2010s, said Park. Local contact tracers couldn't keep up, and the state had to step in with reinforcements.

The state is taking new measures to address the rates, said Pan, the state epidemiologist, like requiring women to be screened for syphilis twice during pregnancy instead of once. And, rather than wait for women to come in for prenatal care, the state is doing more outreach and screening pregnant women in the emergency room and in prisons and jails.

Pan believes the COVID pandemic has created an opportunity to invest in a nimbler response to emerging and reemerging public health issues like syphilis.

"It's been a really long, hard year responding to this pandemic, but people have really acknowledged and realized the impact of divesting in public health infrastructure," she said. "I hope that a lot of the resources that we hope to bring to bear in the longer term after this pandemic will benefit STDs as well."

This story is part of a partnership that includes KQED, NPR and KHN.

April Dembosky, KQED: @adembosky

A Year Into Pandemic, Federal Officials Design New Mask Guidelines to Better Protect More Workers

KFF Health News, April 14, 2021

The changes come as U.S. mask-makers say the demand from hospitals is so sluggish that they've laid off 2,000 workers and fear some new protective gear companies could collapse.

This article was published on Wednesday, April 14, 2021 in Kaiser Health News.

By Christina Jewett

Federal officials announced new measures to help get fresh, new N95 masks to healthcare workers and expand their use in other industries after scientists argued that the highly protective masks are essential to keep workers safe from COVID-19.

The changes come as U.S. mask-makers say the demand from hospitals is so sluggish that they've laid off 2,000 workers and fear some new protective gear companies could collapse. Yet in a letter to lawmakers, hospitals cite ongoing concerns about scarce supplies, saying limits on which workers should get N95s must stay in place.

Among the new moves: The Food and Drug Administration plans to eventually revoke its approval of the widespread crisis-era practice of decontaminating N95 respirators and returning them to front-line workers to use again.

A Centers for Disease Control and Prevention official also announced a tweak to its guidelines, which used to say the protective N95 respirators were reserved for health workers. Now they are "prioritized" for those workers but will be OK for bulk sales to other employers — a step that should boost overall demand.

A group of prominent scientists had written to the White House in February, saying a broader swath of U.S. workers need more protection from the airborne virus. And on March 1, U.S. mask-makers wrote to President Joe Biden decrying a glut of nearly 300 million N95 or equivalent respirators that were made in this country and sitting unused in warehouses.

KHN also reported that in January federal officials approved the export of U.S. N95s amid mounting unsold inventory, a move a nurses union leader called "unconscionable."

Lloyd Armbrust, president of the American Mask Manufacturers Association, took a career U-turn to launch Armbrust American and start making masks near Austin, Texas, last year, troubled by "cheap, flimsy" personal protective equipment coming in from overseas: "We … decided to take matters into our own hands." He said that he was gratified to see federal officials respond to U.S. mask-makers' concerns and that he expects to see sales rise in coming months.

But he said it's been a shock for the upstart industry to try and fail over many months to break into the U.S. healthcare market — dominated by large group purchasing organizations — where the preference to buy from China is ingrained.

"Who knows how many healthcare workers are getting infected, maybe dying, because of a logistics problem that doesn't exist," he said. "That was very frustrating. As a human, that was hard for me to understand."

Armbrust said about 50 U.S. mask-makers the association represents reported in a survey that they've collectively laid off about 2,000 workers in recent months amid sluggish demand. They expect some companies to fail.

Mike Bowen, vice president of Prestige Ameritech, another Texas-based N95 maker, said he has reduced production because he has 11 million masks on hand. "I am waiting to see if [the] FDA announcement will make hospitals buy more N95s," he said by email. "If they do, we'll make what they need. We have a lot of N95 manufacturing capacity."

Yet even through last month, the American Hospital Association cited supply chain concerns in a letter to lawmakers and endorsed existing CDC guidelines that allow health workers to use a surgical mask unless performing an aerosol-generating procedure. (Although some experts now say a cough produces more aerosols than such procedures.)

Another change by the CDC would allow major retailers like Amazon to sell N95s in bulk to businesses outside the healthcare sector, said Maryann D'Alessandro, director of the CDC's National Institute for Occupational Safety and Health lab for personal protective technology.

Researchers and journalists have noted elevated workplace risk to bus drivers, meatpacking employees, and those in manufacturing and food processing who labor in crowded conditions.

D'Alessandro said the agency also approved several models of durable "elastomeric" respirators that are meant to be reused, including one by 3M, and signed a contract to add 375,000 to the Strategic National Stockpile.

That move might serve to protect more healthcare workers in the case of a variant surge or new pandemic. Healthcare workers were two to five times more likely than the average person to get COVID, studies have shown.

KHN and The Guardian counted more than 3,600 healthcare workers who died over the past 12 months, many of them people of color and most working outside of hospitals. In interviews with families and colleagues, dozens raised concerns about inadequate protective gear.

Throughout the pandemic, workers who used N95 respirators were routinely asked to put them in a brown paper sack so they could be disinfected by gas, UV light or other means and then returned to them to wear again. Nurses have complained that the respirators, which are designed to be used once, come back misshapen or with a chemical odor.

The FDA on Friday sent a letter to healthcare providers urging them to "transition away from crisis capacity conservation strategies," including the disinfection and reuse of disposable N95s.

The letter is one step toward revoking the "emergency use authorizations" that allowed companies to disinfect and reuse N95s, said Suzanne Schwartz, director of the FDA's Office of Strategic Partnerships and Technology Innovation.

"That was never intended to be anything other than a crisis measure," Schwartz said in an interview. "We want to be sure healthcare facilities are getting themselves in a situation where they have respirators or reusables in stock."

Surveys by National Nurses United from November and February show that about 80% of nurses reported using reprocessed respirators.

The changes are "tiny steps" in the right direction but fall short of what's needed to fully protect nurses, said Jane Thomason, lead industrial hygienist for National Nurses United.

She said about half of more than 9,000 nurses surveyed report working in hospitals where patients are not universally screened for COVID, presenting the potential for pre- or asymptomatic patients to infect staffers.

The CDC guidance updated in February advising health workers to use N95s or well-fitted masks to care for COVID patients remains nonbinding, she said, allowing employers to outfit nurses and other health workers in surgical masks instead of more protective N95s.

The practice has been controversial even after the initial supply chain collapse. Doctors on Twitter reacted strongly to a recent debate held by the University of Calgary where two academics pointed to evidence that COVID is airborne — meriting N95 protection for front-line health workers. 

Another doctor argued that the coronavirus is primarily spread by droplets — a position held by many U.S. hospital leaders. 

Nurses called early in the pandemic for a high level of protection against an airborne virus, but in many places have had to stage protests to get it or go without.

Since last summer, mounting evidence has shown that healthcare workers in surgical masks were more likely than those in respirators to catch the coronavirus. Harvard researchers and those in Israel pinpointed specific instances when a patient or visitor in a surgical mask infected healthcare workers who also wore a surgical mask. 

Christina Jewett: ChristinaJ@kff.org, @by_cjewett

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