President Joe Biden's failure to name someone to lead the Food and Drug Administration, more than 10 months after the election, has flummoxed public health experts who say it's baffling for the agency to be without a permanent leader during a national health crisis.
The pandemic has taxed the FDA, an 18,000-person agency whose chiefs have traditionally received bipartisan backing during the Senate confirmation process. Many leaders in public health, industry and consumer groups agree that Biden's foot-dragging on finding a new director has demoralized the staff and sent the wrong message about the agency's importance, even as the toll of COVID-19 mounts, with an average of 130,000 new cases and 1,500 deaths daily, according to the Centers for Disease Control and Prevention.
It's a tough job in normal times, observers say, and at the moment may be the worst top job in Washington. At the heart of the tension is finding a nominee who balances the agency's dual responsibilities of protecting public health while also working with the drug, medical device and other industries to approve products and treatments for market. Meanwhile, the agency has been mired in controversies related to drug approvals and COVID vaccines, and discord over decisions has spilled into public view.
FDA commissioner is a "particularly rough job in wartime," said Steven Grossman, executive director of the Alliance for a Stronger FDA, an outside organization consisting of industry, research and other groups, which pushes for Congress to increase agency funding. "It is a much more difficult post to fill than it appears to the eye."
Dr. Janet Woodcock, an agency veteran of three decades, has for months led as acting commissioner. She commands broad respect. But her perceived closeness to the drug industry, particularly with respect to the agency's role in the opioid crisis, led some Senate Democrats to come out against her official assumption of the role. Biden would need all Democrats on board or some Republican senators to back his choice to get the votes for confirmation.
In December, Biden announced other top health appointees who would helm his pandemic response, including Health and Human Services Secretary Xavier Becerra, Surgeon General Vivek Murthy and CDC Director Rochelle Walensky. HHS oversees the FDA — as it does the office of the Surgeon General, the CDC and the National Institutes of Health.
But still no sign of an FDA nomination. Biden officials reportedly considered multiple potential candidates throughout the spring, including Woodcock; former top FDA official and Maryland health secretary Joshua Sharfstein; former FDA official Michelle McMurry-Heath; and Scripps Research Translational Institute director Dr. Eric Topol (who confirmed to KHN he wasn't interested). Then the process seemed to deadlock.
"People are just flabbergasted," said Dr. John Whyte, chief medical officer of WebMD and former FDA official. "We don't even have rumors of viable candidates."
Many of the agency's other critical responsibilities require sustained leadership even as the FDA urgently vets COVID treatments, tests and vaccines, according to people in public health, the healthcare industry and consumer groups. The FDA oversees much of the nation's food supply and the regulation of tobacco products, and reviews everything from stents and catheters to cancer drugs.
Long-term decisions on tobacco regulation can't wait, said Matthew Myers, president of the Campaign for Tobacco-Free Kids, which has pushed the FDA to move quickly to implement a ban on menthol cigarettes — something it announced in April — and decide which e-cigarettes can stay on the market. This month the agency punted on whether it would ban the sale of e-cigarettes from several major companies, including Juul, the largest maker of such products.
"What the FDA does over the next weeks or months with regard to e-cigarettes will determine whether we have a decades-long youth e-cigarette epidemic or whether we reverse it now," Myers said. "Waiting for a new commissioner is not an option."
He and others conceded that, regardless of qualifications, an acting commissioner's ability to set priorities is diminished. That adds to anxiety about a leadership vacuum, even though few doubt Woodcock's expertise.
"One significant disadvantage to being 'acting' is there is no time frame of how long that individual will be in that position," said Dr. Andrew von Eschenbach, FDA commissioner in the George W. Bush administration. As important work is executed, "there is no certainty" how long an acting leader is "going to be there" to see it through, he said. "That's an instability that is very, very difficult to deal with."
For agency staffers, it stings to see other physicians in the Biden administration speak publicly on issues squarely in the agency's purview, said Stacy Cline Amin, a partner at law firm Morrison & Foerster and former chief counsel of the agency.
"It's been a morale hit for FDA," she said.
Under federal law, Woodcock can serve as acting commissioner until mid-November unless Biden nominates a permanent commissioner, in which case she can remain until that person is confirmed by the Senate.
"People are anxious," said Ellen Sigal, founder of the influential nonprofit Friends of Cancer Research, which receives funding from the pharmaceutical industry and supported Woodcock for the job. "Is it going to be someone that knows the agency? Is it going to be someone that people really respect and really want to work with?"
The FDA is overwhelmingly run by career scientists whose jobs don't depend on who wins the White House. Any Senate-confirmed leader largely defers to the scientists who run FDA divisions to make decisions on products, according to former officials and experts with knowledge of the agency's inner workings. For example, an FDA spokesperson said Woodcock was not involved in the controversial decision to approve Aduhelm, a costly Alzheimer's drug manufactured by Biogen that went to market even though experts say there's little evidence it works. But in July, the lingering controversy led Woodcock to ask the HHS Office of Inspector General to "conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm."
A leader appointed by the president and confirmed by the Senate has clout in setting priorities, hiring staff and making long-term decisions.
"The commissioner has obviously tremendous influence … not on a product-by-product basis but what the philosophy is," related to the regulatory process, said Scott Whitaker, president and CEO of AdvaMed, which lobbies for the medical device industry. The expressed paradigm "can impact how you think about developing products."
Others said Biden's speed in announcing a nominee is less important than selecting the right one, a calculation that's especially fraught given the agency's recent controversies.
Chief among them was the criticism from several scientists after the Biden administration announced a plan for widespread COVID "booster" shots beginning Sept. 20, well before agency scientists had finished necessary reviews. Woodcock had signed onto an HHS statement announcing the plan, but some experts said the proposal came too far ahead of the science and unfairly jammed her staff. Two veteran FDA officials who have announced their retirements were part of an international group of scientists that published an essay in The Lancet questioning whether the general public needed additional vaccine doses at this time.
The FDA was expected to authorize booster shots for high-risk patients and those 65 and older, following the recommendation Friday of an advisory panel that overwhelmingly rejected the administration's initial plan to offer extra shots for the general population, citing a need for additional research.
The White House didn't respond to questions about why Biden hasn't nominated someone as FDA commissioner or set a timeline for doing so.
"If it takes a little longer to get the right person who's going to be more aligned in protecting public health and represent interests of the public, as opposed to the interest of industry, which is what the case has been for many years under Dr. Woodcock, then it may be worth the wait," said Dr. Michael Carome, director of the health research group at Public Citizen, a liberal advocacy group that opposed Woodcock's nomination. The FDA referred a request for comment to the White House, which didn't respond.
Sigal sees it differently.
"FDA approves drugs, and they have to work with industry," she said. "The fact that you work with industry on drug development or on diagnostics with developers, or you work with people that are manufacturing food, with manufacturers or whatever — it's what the agency does."
BILLINGS, Mont. — Nurses fill the hospital room to turn a patient from his stomach to his back. The ventilator forcing air into him is most effective when he's on his stomach, so he is in that position most hours of the day, sedated and paralyzed by drugs.
Lying on his stomach all those hours has produced sores on his face, and one nurse dabs at the wounds. The dark lesions are insignificant given his current state, but she continues just the same, gently, soothingly, appearing to whisper to him as she works.
The man has been a patient at Billings Clinic for nearly a month, most of that time in the hospital's intensive care unit. He is among other patients, room after room of them, with the same grim tubes inserted down their throats. They have COVID-19 — the vast majority unvaccinated against the virus, the hospital says. Visitors generally aren't permitted in these rooms, but the man's mother comes most days to gaze through a glass window for the allowed 15 minutes.
This all happened Friday. He was dead, at age 24, by Sunday morning.
The hospital's morgue cart arrived at the ICU — as it frequently has these days — then the room was sterilized, another patient took the man's place, and the cycle began again. In the past week, 14 people have died of COVID here, the state's largest hospital.
"I do feel a little hopeless," said Christy Baxter, the hospital's director of critical care.
The situation has played out in hospitals around the nation since 2020. But now Montana is a national hot spot for COVID infections, recording the highest percentage increase in new cases over the past seven days. The state announced 1,209 new cases on Friday, and Yellowstone County, home to Billings Clinic, is seeing the worst of it. Last week, the county had 2,329 active cases, more than the next two counties combined.
What's different from the early scenes of the pandemic is the public's response. Not so long ago, the cheers of community support could be heard from the hospital parking lot. Now, tensions are so strained that Billings Clinic is printing signs for its hallways, asking that the staff members not be mistreated.
The ICU here has space for 28 patients but last Friday was operating at 160% capacity, Baxter said. To handle the overflow, nurses elsewhere provide care beyond their training as COVID patients fill other parts of the hospital. In the lobby of the emergency department, rooms roughly 6 feet by 6 feet have been fashioned with makeshift plastic walls. Ten members of the Montana Army National Guard arrived last week to help however they can. Hospital staffers volunteer to sit with dying patients. Beds line hallways.
"The problem is," said Brad Von Bergen, the hospital's ER manager, "we are running out of hallways."
The hospital announced it may soon implement "crisis standards of care," which basically means it will ration its equipment, staff and medicine, giving preference to those it can most likely save, regardless of vaccination status. It's an ugly system, abhorred by those who will wield it, with tiebreakers in place to decide who potentially lives and dies. Other hospitals in Montana have taken similar steps.
An overcrowded hospital also means that a person ― say, one injured in a car crash in rural eastern Montana and needing advanced hospitalization ― won't be able to get that care at Billings Clinic.
"We are at the point where we are not confident going forward that we can continue to meet all patients' needs," said Dr. Nathan Allen, the medical ethicist for Billings Clinic and its department chair for emergency medicine. "And that's heartbreaking."
"Nobody wants to be in a position where we may have to ration healthcare and potentially remove a ventilator from one patient who would likely die and give it to another," said Dr. Scott Ellner, the hospital's CEO. "Are we there? I would say we are very close."
To some extent, that rationing is already happening. A patient still hospitalized here with COVID might have benefited from a machine, known as an ECMO machine, needed to keep his heart and lungs functioning. Operating that machine, though, requires at least one nurse, 24 hours a day, usually for two to three weeks. Typically, it would be a last-ditch effort for the most critical of patients. Even with that care, the prognosis for the middle-aged man would be poor. Without it, Baxter said, he will assuredly die.
"The reality is I can't staff that," Baxter said. "Do you give that optimal care to one patient or do you give great care to five?"
Billings Clinic would hire more than 100 additional nurses if it could. The staffing shortage is not unique to this hospital; it's nationwide, meaning the needed help isn't arriving anytime soon. Baxter tells the story of a young nurse who quit, saying he had grown tired of lying to patients he knew would die.
"The patients look at you with that fear in their eyes and say, 'Am I going to make it?'" Baxter said. "You want to encourage them to not give up hope, but you also know the chances of survival are going to be slim."
Recently, a patient's dying wish was to have their preschool-age child come and sit with them, to see them one last time. That typically wouldn't be allowed, but an exception was made, with staffers at the hospital draping the child in oversized protective clothing, goggles and an N95 mask. Afterward, the nurse and doctor sobbed with the patient.
"The moral distress of working in healthcare is for many, many people extremely high right now," said Allen.
Intensifying that, he said, are patients or their loved ones mistreating doctors and nurses. Threats have on occasion required a police response. Screaming, profanity-laden insults are a daily occurrence. One patient threw his own feces at a doctor. Some, even in the face of an intubation tube, question the need to be vaccinated or the effectiveness of the medicine being prescribed.
Dr. Sara Nyquist, an emergency medicine physician, said she has been asked by a patient if she is a Republican or a Democrat.
"I said, 'I am your doctor,'" she recalled. "You do wonder how we got here."
Ellner, the clinic's CEO, said he doesn't understand what happened to civility. "There is a part of the society that wants to pretend that the COVID surge isn't really happening," he said. "But this is our reality every single day."
Jennifer Tafelmeyer, a nurse in the hospital's cardiovascular unit, said the best part of her job before the pandemic was helping patients improve, walking them down hallways, talking about diet and exercise, and eventually escorting them to the front door. That hasn't happened in a long time.
"We just don't get the wins," she said.
As she told the story, she stopped to wipe a tear. Moments before, she had learned that one of the patients on this floor was not expected to survive the night.
Allen predicted Billings Clinic hasn't yet seen the worst of the recent surge in infections.
"We are still seeing growing numbers in community cases," he said. "And we know hospitalizations lag behind new diagnoses. Unfortunately, it can absolutely get worse than where it is at."
In the meantime, he said, he expects the doctors and nurses here will rally as they have, taking comfort from words of thanks from many patients and gestures like a father bringing pizza to the emergency department as a show of appreciation for the care given his child.
"The most difficult things have been the big things," Allen said, "and the most inspiring things have been the little things."
In 2004, 24-year-old Manny Lanza urgently needed surgery for a life-threatening brain condition. But he didn't have insurance, so his hospital refused to schedule the treatment — until it was too late. Manny died waiting.
In the months that followed, Manny's parents, Reynaldo Prieto and Levia Lanza, fought to make their son's story known — and to make sure it didn't happen again. They came up empty … until a reporter from the New York Post took their call. Then, things changed fast.
What Manny's parents didn't know: The fight had already begun years before Manny's illness. Folks like Elizabeth Benjamin, then a Legal Aid attorney, and Dr. Rosemarie Guercia, a retired Long Island, New York, physician, had spent those years campaigning for laws that would require hospitals to extend financial aid to uninsured patients. And with Manny's story in the news, it was finally their time.
Poor care coordination is one of the many shortcomings of Medi-Cal, which covers over a third of the state's population and nearly 40% of children under 18.
This article was published on Tuesday, September 21, 2021 in Kaiser Health News.
When Denise Williams' baby boy was 2 months old, she became alarmed by a rattling sound in his lungs and took him to the emergency room. While undergoing treatment, he spiraled into a disabling neurological disorder.
Now 2 years old, Markeano is attached to breathing and feeding tubes. He can't walk or move his arms.
"If I want him to sit up, I have to sit him up. If I want him to play with a car, I've got to put his hand on the car and move it back and forth," said Williams, 38, who lives with Markeano, her four other children and her husband, Marcus, in Adelanto, California, a small city in the High Desert region of San Bernardino County.
Markeano is enrolled in the Inland Empire Health Plan, a county-run managed-care insurer that provides coverage under Medi-Cal, California's version of the federal Medicaid program for people with low incomes or disabilities. He also receives care through California Children's Services, which covers kids with serious conditions.
But Williams still finds it difficult to get her son the specialized care he needs. What's worse, neither his insurers nor his doctors take responsibility for managing his care, she said. "No one coordinates the care except for me."
Poor care coordination is one of the many shortcomings of Medi-Cal, which covers over a third of the state's population and nearly 40% of children under 18. Advocates, patients and even the state auditor say Medi-Cal has failed to hold accountable the managed-care health plans that cover almost 12 million of its nearly 14 million enrollees.
To remedy these failings, the state has begun an ambitious contracting process that aims to commit the health plans to better service. The state's exact strategy is unclear. But it is expected to result in new rules for Medi-Cal managed care. The nine commercial insurers, including giants Health Net, Anthem Blue Cross, and Blue Shield of California, will have to bid for new contracts intended to set more rigorous care standards. While their members account for fewer than one-third of managed-care enrollees, the companies have made nearly $3 billion from Medi-Cal since 2014.
Non-commercial plans like the Inland Empire Health Plan, which are established by county authorities, won't have to submit bids, but they will be required to sign the new contracts.
"The state has had a lot of difficulty — because of skill and will — in managing and enforcing the terms of its existing contracts," said Alex Briscoe, head of the California Children's Trust and former director of Alameda County's Healthcare Services Agency. "This represents an opportunity not only to redesign the contracts but also to reimagine the state's role in enforcing them."
It's also an opportunity for the state to make a statement in selecting plans.
"Some are doing worse than others, and that should be taken into account in terms of decisions as the plans bid," said Edwin Park, a California-based research professor at the Georgetown University Center for Children and Families.
Jacey Cooper, California's Medicaid director, said the state's focus will be assuring that plans provide access to care and are committed to improving the outcomes of Medi-Cal beneficiaries.
The recontracting process is intertwined with an ambitious $6 billion experiment to move Medi-Cal beyond medicine into the realm of social services.
'Deficient Oversight'
Data shows that Medi-Cal plans are failing enrollees in many ways. Patients often have long waits or travel times for medical appointments, and get fragmented services and poor information about their care. Some communities of color, as well as rural residents, receive lower-quality service than others.
Faulty treatment hits the 4.6 million kids in managed-care Medi-Cal particularly hard because children need a lot of routine care, and many are not getting it. In July, close to 500 advocacy and provider groups sent a letter to the Department of Healthcare Services, which runs Medi-Cal, urging it to make the managed-care plans improve pediatric care. "The deficiencies in the Medi-Cal managed care program contribute to health disparities for children across the state that can last a lifetime," they wrote. The new contracts, the letter said, should require health plans to fix the problem.
Federal law provides significant protection for all children in Medi-Cal and other state Medicaid programs. It requires coverage for regular checkups, immunizations, and other preventive and diagnostic care.
But state data shows that Medi-Cal managed-care plans often fail to meet these requirements. Only about one-quarter of infants and toddlers in Medi-Cal get the recommended number of well-child visits and screenings for developmental delays. The plans fall short on immunizations as well.
A 2019 report by the California State Auditor ranked California 40th among state Medicaid programs in use of preventive services by children.
The report blamed the state's poor performance on "deficient oversight of the managed care plans" and an insufficient number of healthcare providers willing to accept Medi-Cal's low payment rates.
"I don't see how we can have a high-performing Medi-Cal system that doesn't do well on those basic services for kids," said Mike Odeh, health policy director at Children Now, an Oakland-based advocacy group.
To be fair, Medi-Cal has had its share of successes, too, including early and robust expansion of enrollment under the Affordable Care Act, extension of coverage to large numbers of immigrants without legal documents, and pioneering programs that address not only medical and mental health but also the social and environmental circumstances of enrollees.
Nonetheless, Medi-Cal managed-care plans often earn poor to mediocre marks for the quality of their care. Meanwhile, the largest commercial plans have profited handsomely from the program, especially since the expansion of Medicaid in 2014. That helps explain why the rebidding process is such a sensitive matter for them. Health Net, Anthem Blue Cross, Molina Healthcare and Blue Shield of California all declined to discuss their bidding strategies with KHN.
Collectively, the commercial plans have generated $2.9 billion in net profits from Medi-Cal since fiscal year 2014, according to data provided by the state. Health Net, the state's largest commercial Medi-Cal insurer, with around 2 million enrollees, accounted for $2.1 billion of that amount. Anthem Blue Cross, the second-largest commercial Medi-Cal plan, with 1.3 million enrollees, accounted for $873 million.
An Anthem Blue Cross spokesperson noted that Medi-Cal managed-care plans are required by law to spend at least 85 cents of every dollar on medical care or efforts to improve care. That, along with other factors, limits the health plans' profits, he said.
Kaiser Permanente, which is at or near the top of Medi-Cal quality scores, has lost money in the program every year since 2014 — and before that, too.
Health Net and Anthem Blue Cross get poor to mediocre marks on key pediatric services in many counties, according to state data. Health Net Medi-Cal plans in Sacramento, Kern, Stanislaus and San Diego counties, for example, were at or near the bottom of the pack in timeliness of pediatric appointments.
A Health Net spokesperson said the company has improved over the past two years and now outperforms its competitors on state quality indicators in nine of the 13 counties where it operates.
The 2019 state audit, citing earlier concerns about incomplete and inaccurate reporting, noted that the integrity of the state's quality data can be hard to assess.
And non-commercial plans often have low scores, too. "Quality is stubbornly low across all plans in Medi-Cal. Nobody gets a pass here," said Cary Sanders, senior policy director at the California Pan-Ethnic Health Network.
The state rarely holds any of the plans fully to account, advocates and Medi-Cal experts say. The Department of Healthcare Services started imposing financial penalties for poor quality only in 2017, and since then it has levied only two such fines: one against Health Net for $335,000 and one against the publicly run Health Plan of San Joaquin for $135,000.
The department does require subpar performers to devise so-called corrective action plans, but critics say they rarely produce significant improvement.
Even if enforcement were effective, the standards for Medi-Cal plans are too low, advocates say. Until 2019, insurers needed to be only in the 25th percentile of Medicaid plans nationally to avoid corrective action. The department raised the bar to the 50th percentile in 2019 but has not enforced it so far because of the COVID-19 pandemic.
The department next year will begin penalizing any health plan that "fails to exceed, rather than just meet" the minimum performance level on any measure, said Cooper, the state's Medicaid chief. It will do so every year, rather than target only persistently poor performers, she said.
Pay for Performance
In June, the Department of Healthcare Services released preliminary details on the bidding process, outlining some of the new requirements. It expects to issue more details by year's end but won't announce plan selections until the end of 2022. The new contracts are slated to take effect Jan. 1, 2024.
But will the state lean hard enough on the plans? Based on the documents released so far, this could be a "potential missed opportunity," said Sanders. "There aren't enough teeth here to improve health plan accountability."
Other advocates cite what they say has been a cozy relationship between health plans and the state. "I just think the whole delivery system has historically been filled with a lot of politics, favoritism, good old boys," said Isabel Becerra, CEO of the Coalition of Orange County Community Health Centers, whose members provide Medi-Cal services in the county.
Some advocates and analysts say the best way for the state to hold the managed-care plans' feet to the fire is to tie the fixed monthly rates it pays them to their performance on a number of measures, including preventive services and health equity.
"If you want to change how they work, you have to change the incentives that drive them," said Briscoe, of the California Children's Trust.
Medicaid chief Cooper said her staff is working to link payment to quality and health equity.
Some advocates say the state should withhold payments from poorly performing plans. The plans, however, would prefer being rewarded for exceeding expectations to being dinged for failing to meet them.
A Communication Breakdown
The rebidding process is expected to reduce the number of insurance companies participating in Medi-Cal — and some experts say that's a good thing.
"The idea of competition is you're supposed to be competing on the basis of quality, but if there are too many choices beneficiaries aren't able to discern the differences," said Georgetown University's Park.
In some regions, the Medi-Cal health plans that contract directly with the state outsource care and administrative tasks to other plans or physician groups. L.A. Care, for example, farms out enrollees to subcontractors such as Kaiser Permanente, Anthem Blue Cross and Blue Shield of California. The Department of Healthcare Services says that in evaluating the bids it will look favorably on health plans that commit to keeping closer tabs on their subcontractors.
The state reports quality scores only for plans with which it contracts directly, and their data can be skewed by wide variation in the performance of the subcontractors.
Moreover, the divided responsibility between health plans and their subcontractors can confuse beneficiaries.
"The subcontractor says, 'No, call the plan' — and the plan says, 'Call the subcontractor,' and there's really no accountability," said Abigail Coursolle, a senior attorney at the National Health Law Program in Los Angeles.
Denise Williams faces a similar problem. She said the Inland Empire Health Plan does not communicate effectively — or at all — with California Children's Services or Markeano's doctors. As a result, she is saddled with hours of legwork to find care for her son, whether speech, swallowing and cognitive therapy or extra oxygen tanks to make sure he doesn't run out during long car trips to see his doctors.
"They tell me, 'Your pediatrician or neurologist should be doing this.' Then when I talk to the pediatrician and the neurologist, they say, 'Talk to your insurance,'" Williams said. "So it's like, 'I already talked to you guys. Can't you guys talk to each other — or can we get on a three-way? Because this is draining. I've got a kid that I need to take care of.'"
Inland Empire Health acknowledged the gaps in coordination among managed-care plans, California Children's Services and providers, saying it was "eager to embrace the care coordination improvements" that the state says it will require. The new contracts also will require plans to address some of the nonmedical problems that can compromise health, such as inadequate housing, unclean air and water, and food insecurity.
In addition to being predominantly poor, over two-thirds of Medi-Cal enrollees are from non-white communities that have historically been socially and economically marginalized — which is why the state says it will put a high priority on reducing healthcare inequities.
Denise Williams, who is Black, wonders if her travails are related to long-standing inequities.
"Sometimes I don't know if it's because of my color or what," she said. "I try to remain calm at all times, so that way it's not a stereotype of an angry Black lady or whatever. But at the same time, I'm my kid's only advocate, so if I never say nothing, my kid would just be lying in the bed all day."
California Healthline correspondent Angela Hart contributed to this report.
The test results that hot day in early August shouldn't have surprised me — all the symptoms were there. A few days earlier, fatigue had enveloped me like a weighted blanket. I chalked it up to my weekend of travel. Next, a headache clamped down on the back of my skull. Then my eyeballs started to ache. And soon enough, everything tasted like nothing.
As a reporter who's covered the coronavirus since the first confirmed U.S. case landed in Seattle, where I live, I should have known what was coming, but there was some part of me that couldn't quite believe it. I had a breakthrough case of COVID-19 — despite my two shots of the Pfizer-BioNTech vaccine, the second one in April.
I was just one more example of our country's tug and pull between fantasies of a post-COVID summer and the realities of our still-raging pandemic, in which even the vaccinated can get sick.
Not only was I sick, but I'd exposed my 67-year-old father and extended family during my first trip back to the East Coast since the start of the pandemic. It was just the scenario I had tried to avoid for a year and a half.
Where did I get it? Who knows. Like so many Americans, I had loosened up on wearing masks all the time and physical distancing after getting fully vaccinated. We had flown across the country, seen friends, stayed at a hotel, eaten indoors and, yes, even gone to a long-delayed wedding with other vaccinated people.
I ended up in quarantine at my father's house. Two rapid antigen tests (taken a day apart) came back negative, but I could tell I was starting to feel sick. After my second negative test, the nurse leveled with me. "Don't hang your hat on this," she said of the results. Sure enough, a few days later the results of a PCR test for the coronavirus (this one sent to a lab) confirmed what had become obvious by then.
It was a miserable five days. My legs and arms ached, my fever crept up to 103 and every few hours of sleep would leave my sheets drenched in sweat. I'd drop into bed exhausted after a quick trip to the kitchen. To sum it up, I'd put my breakthrough case of COVID right up there with my worst bouts of flu. Even after my fever broke, I spent the next few weeks feeling low.
Of course, I am very lucky. I didn't go up against the virus with a naive immune system, like millions of Americans did before vaccines were widely available. And, in much of the world, vaccines are still a distant promise.
"You probably would have gotten much sicker if you had not been vaccinated," Dr. Francesca Torriani, an infectious-disease physician at the University of California-San Diego, explained to me recently.
As I shuffled around my room checking my fever, it was also reassuring to know that my chances of ending up in the hospital were slim, even with the delta variant. And now, about a month later, I've made a full recovery.
The reality is breakthrough cases are becoming more common. Here's what I wish I'd known when those first symptoms laid me low.
1. Is it time for a reality check about what the vaccines can — and can't do?
The vaccines aren't a force field that wards off all things COVID. They were given the green light because they greatly lower your chance of getting seriously ill or dying.
But it was easy for me — and I'm not the only one — to grab onto the idea that, after so many months of trying not to get COVID, the vaccine was, more or less, the finish line. And that made getting sick from the virus unnerving.
After all, there were reassuring findings earlier this year that the vaccine was remarkably good at stopping any infection, even mild ones.
"There was so much initial euphoria about how well these vaccines work," said Dr. Jeff Duchin, an infectious-disease physician and the public health officer for Seattle and King County. "I think we — in the public health community, in the medical community — facilitated the impression that these vaccines are bulletproof."
It's hard to keep adjusting your risk calculations. So if you'd hoped to avoid getting sick at all, even slightly, it may be time for a "reset," Duchin said. This isn't to be alarmist but a reminder to clear away expectations that COVID is out of your life, and stay vigilant about commonsense precautions.
2. How high are my chances of getting a breakthrough case these days?
It used to be quite rare, but the rise of delta has changed the odds.
"It's a totally different ballgame with this delta phase," said Dr. Eric Topol, a professor of molecular medicine and director of the Scripps Research Translational Institute in San Diego. "I think the chance of having a symptomatic infection has gone up substantially."
But "quantifying that in the U.S. is very challenging" because our "data is so shoddy," he said.
The vaccinated still have a considerably lower chance of getting infected than those who aren't protected that way. Los Angeles County collected data over the summer as the delta variant started to surge: Unvaccinated people were five times more likely to test positive than those who were vaccinated.
3. How careful do I need to be if I want to avoid a breakthrough?
Looking back, I wish I'd taken more precautions.
And my advice to friends and family now is: Wear masks, stay away from big gatherings with unvaccinated people and cut down on travel, at least until things calm down.
The U.S. is averaging more than 150,000 coronavirus infections a day (about twice what it was when I fell sick), hospitals are overwhelmed, and the White House has proposed booster shots. Scientists are still making sense of what's happening with breakthrough cases.
In many parts of the U.S., we're all more likely to run into the virus than we were in the spring. "Your risk is going to be different if you are in a place that's very highly vaccinated, with very low level of community spread," said Dr. Preeti Malani, a specialist in infectious diseases at the University of Michigan. "The piece that's important is what's happening in your community."
4. What does a "mild" case of COVID feel like?
In my case, it was worse than I expected, but in the parlance of public health, it was "mild," meaning I didn't end up in the hospital or require oxygen.
This mild category is essentially a catchall, said Dr. Robert Wachter, who chairs the Department of Medicine at the University of California-San Francisco. "Mild" can range from "a day of feeling crummy to being completely laid up in bed for a week, all of your bones hurt and your brain isn't working well."
There's not great data on the details of these mild breakthrough infections, but so far it appears that "you do way better than those who are not vaccinated," said Dr. Sarang Yoon, an occupational medicine specialist at the University of Utah who was part of a nationwide study by the Centers for Disease Control and Prevention on breakthrough infections.
Yoon's study, published in June with data collected before the delta surge, found that the presence of fever was cut in half, and the days spent in bed reduced by 60% among people with breakthrough infections, compared with unvaccinated people who got sick.
If you're vaccinated, the risk of being hospitalized is 10 times lower than if you weren't vaccinated, according to the latest data from the CDC. Those who get severely and critically ill with a breakthrough case tend to be older — in one study done before delta, the median age was 80.5 — with underlying medical conditions such as cardiovascular disease.
5. Can I spread it to others, and do I need to isolate?
Unfortunately, you still have COVID and need to act like it.
Even though my first two tests were negative, I started wearing a mask at my house and keeping my distance from my vaccinated family members. I'm glad I did: No one else got sick.
"Even in fully vaccinated, asymptomatic individuals, they can have enough virus to transmit it," said Dr. Robert Darnell, a physician-scientist at The Rockefeller University.
The science isn't settled about just how likely vaccinated people are to spread the virus, and it does appear that the amount of virus in the nose decreases faster in people who are vaccinated.
Still, wearing masks and staying isolated from others if you test positive or have symptoms is absolutely critical, Darnell said.
6. Could I get long COVID after a breakthrough infection?
While there's not a lot of data yet, research does show that breakthrough infections can lead to the kind of persistent symptoms that characterize long COVID, including brain fog, fatigue and headaches. "Hopefully that number is low. Hopefully it doesn't last as long and it's not as severe, but it's just too early to know these things," Topol said.
Recent research from the United Kingdom suggests that vaccinated people are about 50% less likely to develop long COVID than those who are unvaccinated.
This story is from a reporting partnership that includes NPR and KHN.
Delta, currently the primary variant in the United States, is far more contagious than the original coronavirus, so the density of virus in the air is greater.
This article was published on Monday, September 20, 2021 in Kaiser Health News.
In recent months, some European airlines have banned the use of cloth face coverings to control the spread of the coronavirus during air travel, instead favoring surgical masks — sometimes referred to as medical or disposable — and N95 respirators.
It's another salvo in the debate over the effectiveness of the ubiquitous cloth mask, which sprang into fashion when surgical masks and N95s were harder to find in the pandemic's early days. The Centers for Disease Control and Prevention still promotes cloth face coverings in its guidance about masks.
And masks remain a critical mitigation tool because people primarily become infected with SARS-CoV-2, the virus that causes COVID-19, by inhaling small aerosol particles that linger in the air or large respiratory droplets produced in coughs and sneezes.
But the science is changing. Delta, currently the primary variant in the United States, is far more contagious than the original coronavirus, so the density of virus in the air is greater.
Some experts have adjusted their advice proportionally. "Given the delta variant that's out there, you probably need to upgrade your mask," Dr. Ashish Jha, a leading COVID expert and dean of the Brown University School of Public Health, said on "Fox News Sunday" earlier this month.
What Type of Mask Should You Wear?
Don't worry if you are confused. Mask guidance has been mixed since the dawn of the pandemic, and new research has altered conventional thinking. We decided to dig in and sort out the latest developments.
First, people were told masking wasn't necessary. Soon after, this recommendation changed, but the public was advised against purchasing surgical-style masks used by health professionals because of dire shortages of such protective gear. Americans instead were told to spring for cloth masks or make do-it-yourself versions. Shortages do not appear to be as big a problem now, though the CDC still advises against choosing N95 respirators.
As recently as late August, the nation's top infectious-disease doctor, Dr. Anthony Fauci, declined to recommend higher-quality masks. "Instead of worrying about what kind of mask, just wear a mask," he told "The Mehdi Hasan Show" on MSNBC.
So, what gives? Dr. Peter Chin-Hong, an expert on infectious diseases at the University of California-San Francisco, said Fauci was taking a harm-reduction approach. "It probably is more important to wear something that you feel comfortable with, and you can wear for long periods of time if you're going into a particular environment … rather than saying you need to wear the gold standard thing at all times," he said.
"A baseline should be a surgical mask," added Chin-Hong. "It's easier to implement. It's cheap, albeit not always environmentally friendly." Personally, he wears only N95s when wildfires are blazing. "Even in the hospital, I'm mainly wearing a surgical mask," he said.
While he thinks government and public health officials should emphasize wearing surgical masks, Chin-Hong said cloth masks can offer enough protection in certain circumstances. For example, a fully vaccinated person, he said, would likely get adequate protection by wearing a cloth face covering for brief periods indoors when the venue is not at capacity. A lot depends on the context, so he provided these questions to help the decision-making process: If you are going indoors, will the building be especially crowded? How long will you be inside? Will everyone most likely be masked? Are you and others around you fully vaccinated? Are you immunocompromised?
The riskier the situation, the more likely the higher-quality mask is the best option. "Nothing is zero risk, so it's just a matter of risk reduction," Chin-Hong said.
"So definitely, masks need to be stepped up to fight delta, but it does not mean those who cannot afford N95s have no options," said Raina MacIntyre, head of the biosecurity research program at the University of New South Wales in Sydney, Australia, who has conducted many studies on masks.
MacIntyre said it is "possible to design a high-performing cloth mask." An experimental lab study she co-authored found a layered cloth mask can effectively block droplets. The study, published in May in the journal ACS Biomaterials Science & Engineering, recommends using a minimum of three layers — a combination of cotton/linen and polyester/nylon — to resemble the droplet-blocking performance of surgical masks.
A large-scale, real-world study published this month found surgical masks especially effective at reducing symptomatic infections. These types of masks prevented 1 in 3 infections among people 60 and older.
Researchers from Yale, Stanford and the nonprofit GreenVoice monitored more than 340,000 adults in rural Bangladesh for at least eight weeks. Roughly half the Bangladeshis received interventions like free mask distribution and promotion. Villages that received interventions saw mask use jump from 13% to 42%. The same villages reported fewer confirmed COVID infections and a lower incidence of related symptoms.
Villages where cloth masks were given out reported an 8.5% reduction in symptoms, while villages that received surgical masks reported a 13.6% reduction. When a third of adults with symptoms commonly associated with COVID agreed to get their blood tested for the virus, researchers discovered an 11% reduction among those who wore surgical masks. Researchers observed a 5% reduction in infections among those who wore cloth masks. This study was conducted before the delta variant was circulating widely in the country. The study has not yet undergone peer review, but some experts have already heralded its methodology and results.
"When I saw those results, I threw away my cloth mask," said Stephen Luby, a co-author of the study and professor of infectious disease at Stanford University. "If delta is circulating and if you're going to wear a mask, why don't you wear one that the data tell you is good?"
"We find very strong evidence that surgical masks are effective," added Jason Abaluck, an economist at Yale who helped lead the study. "My read of that is that cloth masks are probably somewhat effective. They are probably better than nothing."
Abaluck suspects his study offers mixed evidence for cloth masks because only about a third of those who reported symptoms consented to blood testing for COVID. In other words, the sample size was too small to observe anything significant. "The most likely interpretation of this whole constellation of results is that [cloth masks] actually do help. They actually do make you less likely to get COVID. That's why we saw fewer symptoms," he said. A second possibility is that cloth masks prevent other respiratory diseases that have similar symptoms, he said.
Multiple observational studies and trend analyses found community masking, which includes the use of cloth masks, reduces the spread of COVID. The researchers of the Bangladesh study said those studies had drawbacks, which is why they conducted a randomized clinical trial. For example, some of those studies could not observe the independent effect of masks in real-world settings because they looked at the aftermath of mask mandates, which were often coupled with other COVID mitigation steps such as physical distancing. However, they agreed with those studies' overall assessment: People who wear masks are less likely to get infected than people who don't.
"This is the nature of science. Science evolves," Luby said. "We had evidence that we get some protection from cloth masks, and we now have newer evidence that we get better protection from surgical masks."
Nevada dentist David White has seen diseased and rotted teeth in the mouths of patients who routinely put off checkups and avoided minor procedures such as fillings. While dental phobia is a factor, White said, the overriding reason people avoid treatment is cost.
To help patients lacking dental insurance, White in 2019 started offering a membership plan that looks much like an insurance policy — except it's good only at his offices in Reno and Elko. Adults pay $29 a month — or $348 a year — and receive two free exams, two cleanings, X-rays and an emergency exam, services valued at $492. They also get a 20% discount on office procedures such as fillings and extractions.
About 250 of White's patients have signed up, and it's led many to visit more frequently for routine exams and get necessary treatment, he said. "It's pushing patients toward better oral health," White said.
He's among a quarter of dentists nationwide offering memberships, according to a 2021 survey of 70,000 dentists by the American Dental Association.
These in-office plans are largely targeted to the 65 million Americans who lack dental insurance and have to pay out-of-pocket for all their care. Dentists also like the plans better than handling insurance plans because they don't have to deal with insurers' heavily discounted reimbursement rates, waits to get preapprovals to provide services and delays in getting their claims paid.
Lack of dental coverage contributes to the delaying or forgoing of dental care by 1 in 4 adults, according to a KFF analysis of a 2019 national survey.
Kleer, a Wayne, Pennsylvania, company started in 2018, has helped more than 5,000 dentists set up the offerings. "Patients on membership plans act like insured patients and come in as much as insured patients, but they pay less for coverage while dentists get paid more," said CEO Dave Monahan. "All we are doing is cutting out the middleman," he said.
Monahan said business has soared during the COVID-19 pandemic as more dentists, confronted with higher costs for personal protective equipment and more patients without job-based coverage, saw the need for such plans.
Anthony Wright, executive director of consumer health advocacy group Access California, said he's skeptical about the value of individual dental insurance but said patients also should be cautious about a dental membership plan because they are generally not overseen by states. "People should be aware that this is a generally unregulated field, so it's buyer beware," he said.
Before joining a membership plan, consumers should ask what the dentist charges for procedures so they know not just the discount but their actual out-of-pocket cost. In some cases, the membership plans are a viable option.
"If you are going to an established practice and if the costs are reasonable and within your budget, it may make some sense" to enroll, he said.
Vanessa Bernal, office manager at Winter Garden Smiles in central Florida, said many patients who are self-employed or work for small businesses have joined the practice's membership plan.
"They don't have employer coverage, and if they went to buy it on their own they would face a waiting period, whereas our discounts start immediately," she said.
Winter Garden Smiles has enrolled more than 370 patients in its plan, which costs $245 a year for children and $285 for adults. The office has dropped out of three small insurance networks since starting its own plan.
Many of the plans being offered around the country look much like dental insurance. Patients pay the dental office typically $300 to $400 a year. In return, they receive certain preventive services at no charge and other procedures at a discount.
But the membership plans don't have the annual deductibles or waiting periods that can make individually purchased dental insurance unattractive. Another deterrent to traditional insurance plans is their maximum benefit limits, usually $1,200 to $1,500 a year. In comparison, patients with memberships can use the discounts for unlimited treatment.
About half of Americans get dental coverage through their workplace. Those policies are generally the best buy for those with the benefit. But Medicare doesn't offer dental coverage, and most state Medicaid programs don't cover dental treatment for adults.
But for patients without a job-based plan, purchasing an independent dental policy is expensive and, unlike buying health insurance, it's unclear whether the benefit outweighs the costs. That's because dental costs are not as financially catastrophic as hospital bills, which can run into tens of thousands of dollars.
Annual dental insurance premiums typically range from $400 to $700. Most plans cover all the cost of preventive services, like cleanings. For minor procedures, like fillings, the plans generally pay 70% to 80%. For major procedures, such as crowns, the plans often pay about 50% of the cost, which is still more than what the membership plans cover. The insurance plans, however, often have negotiated prices with dentists, so plan members' responsibility is reduced by that also.
Melissa Burroughs, who leads an oral-health-for-all campaign for the advocacy group Families USA, said the dental membership plans may help some people, but they don't solve the problems of high dental costs and insurers treating coverage for teeth differently than for the rest of the body. "I don't think these plans are the answer, and they definitely don't meet the standard to make care truly affordable for many people," she said.
Megan Lohman, CEO of Plan Forward, an Indianapolis company that helps set up membership plans, said many insurers haven't raised reimbursement rates in years, encouraging dentists to offer their own plans. "We do not see dental insurance going away, but patients and dentists just needed an alternative," she said.
Patients say they appreciate that services under the memberships are less expensive than when paying strictly out-of-pocket, and prepaying for services motivates them to seek preventive services.
"The membership plan keeps me on track, as it's almost like I have a down payment on my care," said Christina Campbell, 29, of Hamden, Connecticut. She had dental coverage under her mother's policy until she was 26 and then started shopping for her own coverage.
When her dentist, Kevin D'Andrea, mentioned his plan, she decided it looked too good to pass up. With the membership, she said, she is back to getting twice-annual checkups and cleanings, and she no longer hesitates when it's time for X-rays. Campbell, who manages a winery, pays $38 a month.
Holly Wyss, 59, of Greenwood, Indiana, found dental insurance too expensive, so she joined a $300-a-year membership plan through her dentist, David Wolf. The discounts saved her several hundred dollars on two crowns, she said. "For me, it's a no-brainer," said Wyss, a nurse practitioner. "It's been a godsend to me, since everything I pay is out-of-pocket."
Among the groups lacking dental insurance that have recently attracted attention are people covered by traditional Medicare. Many private Medicare Advantage plans, however, offer some dental benefits. These plans provide coverage only at certain dental offices, have a premium and often cover just a small portion of patients' costs. The average limit on coverage is $1,300, and more than half of enrollees are in plans with a $1,000 cap on benefits, according to a report from KFF.
President Joe Biden and congressional Democrats have proposed adding a dental benefit to Medicare, along with other healthcare initiatives, as part of a $3.5 trillion human infrastructure plan those lawmakers are seeking to push through this fall. The bill released by the House Ways and Means Committee this month would still leave beneficiaries paying 20% of costs for preventive services such as checkups and between 50% to 90% of costs for certain procedures. And the law, if passed, could take five years or more to implement.
The need among older Americans is great.
Nearly half of Medicare beneficiaries, or 24 million people, had no dental coverage in 2019, according to KFF. In 2018, almost half of all Medicare beneficiaries had not visited a dentist within the past year (47%), with higher rates among African Americans (68%) and Hispanics (61%).
D'Andrea, the Hamden, Connecticut, dentist, said the membership plan he started in 2020 builds patient loyalty. "Patients know upfront what their out-of-pocket expenses are, and they don't have to wait and see what their insurance will cover," he said. "It's like a game the insurers play, keeping us on hold for an hour to get preapprovals. We pull enough teeth in the office, and it's the same getting information out of them."
Until the delta variant laid siege this summer, nearly all children seemed to be spared from the worst ravages of COVID, for reasons scientists didn't totally understand.
This article was published on Friday, September 17, 2021 in Kaiser Health News.
Eighteen months into the COVID-19 pandemic, with the delta variant fueling a massive resurgence of disease, many hospitals are hitting a heartbreaking new low. They're now losing babies to the coronavirus.
"It's so hard to see kids suffer," said Dr. Paul Offit, an expert on infectious diseases at Children's Hospital of Philadelphia, which — like other pediatric hospitals around the country — has been inundated with COVID patients.
Until the delta variant laid siege this summer, nearly all children seemed to be spared from the worst ravages of COVID, for reasons scientists didn't totally understand.
Although there's no evidence the delta variant causes more severe disease, the virus is so infectious that children are being hospitalized in large numbers — mostly in states with low vaccination rates. Nearly 30% of COVID infections reported for the week that ended Sept. 9 were in children, according to the American Academy of Pediatrics.
Experts say it's a question of basic math. "If 10 times as many kids are infected with delta than previous variants, then, of course, we're going to see 10 times as many kids hospitalized," said Dr. Dimitri Christakis, director of the Center for Child Health, Behavior and Development at the Seattle Children's Research Institute.
But the latest surge gives new urgency to a question that has mystified scientists throughout the pandemic: What protects most children from becoming seriously ill? And why does that protection sometimes fail?
"This is an urgent and complex question," said Dr. Bill Kapogiannis, senior medical officer and infectious-disease expert at the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
"We are doing everything we can to address it, using all the tools we have available," Kapogiannis said. "Answers can't come soon enough."
Investigating Immune Systems
For much of the pandemic, doctors could only guess why children's immune systems were so much more successful at rebuffing the coronavirus.
Despite the alarming number of hospitalized children in the recent surge, young people are much less likely to become critically ill. Fewer than 1% of children diagnosed with COVID are hospitalized and about 0.01% die — rates that haven't changed in recent months, according to the American Academy of Pediatrics. Most children shrug off the virus with little more than a sniffle.
A growing body of evidence suggests that kids' innate immune systems usually nip the infection early on, preventing the virus from gaining a foothold and multiplying unchecked, said Dr. Lael Yonker, an assistant professor of pediatrics at Massachusetts General Hospital.
In a series of studies published in the past year, the husband-and-wife team of Drs. Betsy and Kevan Herold found that children have particularly strong mucosal immunity, so called because the key players in this system are not in the blood but in the mucous membranes that line the nose, throat and other parts of the body that frequently encounter germs.
These membranes act like the layered stone walls that protected medieval cities from invaders. They're made of epithelial cells — these also line many internal organs — which sit side by side with key soldiers in the immune system called dendritic cells and macrophages, said Betsy Herold, chief of the division of pediatric infectious diseases at the Albert Einstein College of Medicine.
Significantly, these cells are covered in proteins — called pattern recognition receptors — that act like sentries, continuously scanning the landscape for anything unusual. When the sentries notice something foreign — like a new virus — they alert cells to begin releasing proteins called interferons, which help coordinate the body's immune response.
In an August study in Nature Biotechnology, Roland Eils and his colleagues at Germany's Berlin Institute of Health found that kids' upper airways are "pre-activated" to fight the novel coronavirus. Their airways are teaming with these sentries, including ones that excel at recognizing the coronavirus.
That allows kids to immediately activate their innate immune system, releasing interferons that help shut down the virus before it can establish a foothold, Eils said.
In comparison, adults have far fewer sentinels on the lookout and take about two days to respond to the virus, Eils said. By that time, the virus may have multiplied exponentially, and the battle becomes much more difficult.
When innate immunity fails to control a virus, the body can fall back on the adaptive immune system, a second line of defense that adapts to each unique threat. The adaptive system creates antibodies, for example, tailored to each virus or bacterium the body encounters.
While antibodies are some of the easiest pieces of the immune response to measure, and therefore often cited as proxies for protection, kids don't seem to need as many to fight COVID, Betsy Herold said. In fact, the Herolds' research shows that children with COVID have fewer neutralizing antibodies than adults. (Both kids and adults usually make enough antibodies to thwart future coronavirus infections after natural infection or vaccination.)
While the adaptive immune system can be effective, it can sometimes cause more harm than good.
Like soldiers who kill their comrades with friendly fire, a hyperactive immune system can cause collateral damage, triggering an inflammatory cascade that tramples not just viruses, but also healthy cells throughout the body.
In some COVID patients, uncontrolled inflammation can lead to life-threatening blood clots and acute respiratory distress syndrome, which occurs when fluid builds up in the air sacs of the lung and makes it difficult to breathe, Betsy Herold said. Both are common causes of death in adult COVID patients.
Because kids typically clear the coronavirus so quickly, they usually avoid this sort of dangerous inflammation, she said.
Research shows that healthy children have large supplies of a type of peacekeeper cell, called innate lymphoid cells, that help calm an overactive immune system and repair damage to the lungs, said Dr. Jeremy Luban, a professor at the University of Massachusetts Medical School.
Kids are born with lots of these cells, but their numbers decline with age. And both children and adults who are sick with COVID tend to have fewer of these repair cells, Luban said.
Men also have fewer repair cells than women, which could help explain why males have a higher risk of dying from COVID than females.
Scientists have fewer clues about what goes wrong in certain children with COVID, said Kevan Herold, who teaches immunobiology at the Yale School of Medicine.
Research suggests that children have more robust innate immune systems than adults because they have experienced so many recent respiratory infections, within their first few years, which may prime their immune systems for subsequent attacks.
But not all children shrug off COVID so easily, Eils said. Newborns haven't been alive long enough to prime their immune systems for battle. Even toddlers may fail to mount a strong response, he said.
At Children's Hospital New Orleans, half of COVID patients are under 4, said Dr. Mark Kline, a specialist in infectious diseases and physician-in-chief.
"We've had babies as young as 7 weeks, 9 weeks old in the ICU on ventilators," Kline said. "We had a 3-month-old who required ECMO," or extracorporeal membrane oxygenation, in which the patient is connected to a machine similar to the heart-lung bypass machine used in open-heart surgery.
Even previously healthy children sometimes die from respiratory infections, from COVID to influenza or respiratory syncytial virus.
But studies have found that 30% to 70% of children hospitalized with COVID had underlying conditions that increase their risk, such as Down syndrome, obesity, lung disease, diabetes or immune deficiencies. Premature babies are also at higher risk, as are children who've undergone cancer treatment.
One thing hospitalized kids have in common is that almost none are vaccinated, said Dr. Mary Taylor, chair of pediatrics at the University of Mississippi Medical Center.
"There's really no way to know which child with COVID will get a cold and be just fine and which child will be critically ill," Taylor said. "It's just a very helpless sensation for families to feel like there is nothing they can do for their child."
Although scientists have identified genetic mutations associated with severe COVID, these variants are extremely rare.
Scientists have had more success illuminating why certain adults succumb to COVID.
Some cases of severe COVID in adults, for example, have been tied to misguided antibodies that target interferons, rather than the coronavirus. An August study in ScienceImmunology reported that such "autoantibodies" contribute to 20% of COVID deaths.
Autoantibodies are very rare in children and young adults, however, and unlikely to explain why some youngsters succumb to the disease, said study co-author Dr. Isabelle Meyts, a pediatric immunologist at the Catholic University of Leuven in Belgium.
Although hospitalizations are declining nationwide, some of the most serious consequences of infection are only now emerging.
Two months into the delta surge, hospitals throughout the South are seeing a second wave of children with a rare but life-threatening condition called multisystem inflammatory syndrome, or MIS-C.
Unlike kids who develop COVID pneumonia — the major cause of hospitalizations among children — those with MIS-C typically have mild or asymptomatic infections but become very ill about a month later, developing symptoms such as nausea, vomiting, a rash, fever and diarrhea. Some develop blood clots and dangerously low blood pressure. More than 4,661 children have been diagnosed with MIS-C and 41 have died, according to the Centers for Disease Control and Prevention.
Although scientists still don't know the exact cause of MIS-C, research by Yonker of Massachusetts General and others suggests that viral particles may leak from the gut into the bloodstream, causing a system reaction throughout the body.
It's too soon to tell whether children who survive MIS-C will suffer lasting health problems, said Dr. Leigh Howard, a specialist in pediatric infectious diseases at Vanderbilt University Medical Center.
Although an August study in The Lancet shows that delta doubles the risk of hospitalization in adults, scientists don't know whether that's true for kids, said Dr. Anthony Fauci, the country's top infectious-disease official.
"We certainly don't know at this point whether children have more severe disease, but we're keeping our eye on it," he said.
To protect children, Fauci urged parents to vaccinate themselves and children age 12 and up. As for children too young for COVID shots, "the best way to keep them safe is to surround them by people who are vaccinated."
OHSU hospital, Oregon's only public academic medical center, has had to postpone numerous surgeries and procedures in the wake of the delta surge of the pandemic.
This article was published on Friday, September 17, 2021 in Kaiser Health News.
It's a bad time to get sick in Oregon. That's the message from some doctors, as hospitals fill up with COVID-19 patients and other medical conditions go untreated.
Charlie Callagan looked perfectly healthy sitting outside recently on his deck in the smoky summer air in the small Rogue Valley town of Merlin, in southern Oregon. But Callagan, 72, has a condition called multiple myeloma, a blood cancer of the bone marrow.
"It affects the immune system; it affects the bones," he said. "I had a PET scan that described my bones as looking 'kind of Swiss cheese-like.'"
Callagan is a retired National Park Service ranger. Fifty years ago, he served in Vietnam. This spring, doctors identified his cancer as one of those linked to exposure to Agent Orange, the defoliant used during the war.
In recent years, Callagan has consulted maps showing hot spots where Agent Orange was sprayed in Vietnam.
"It turns out the airbase I was in was surrounded," he said. "They sprayed all over."
A few weeks ago, Callagan was driving the nearly four-hour trek to Oregon Health & Science University in Portland for a bone marrow transplant, a major procedure that would have required him to stay in the hospital for a week and remain in the Portland area for tests for an additional two weeks. On the way, he got a call from his doctor.
"They're like, 'We were told this morning that we have to cancel the surgeries we had planned,'" he said.
Callagan's surgery was canceled because the hospital was full. That's the story at many hospitals in Oregon and in other states where they've been flooded with COVID patients.
OHSU spokesperson Erik Robinson said the hospital, which is the state's only public academic medical center and serves patients from across the region, has had to postpone numerous surgeries and procedures in the wake of the delta surge of the pandemic. "Surgical postponements initially impacted patients who needed an overnight hospital stay, but more recently has impacted all outpatient surgeries and procedures," Robinson wrote.
Callagan said his bone marrow transplant has not yet been rescheduled.
Such delays can have consequences, according to Dr. Mujahid Rizvi, who leads the oncology clinic handling Callagan's care.
"With cancer treatment, sometimes there's a window of opportunity where you can go in and potentially cure the patient," Rizvi said. "If you wait too long, the cancer can spread. And that can affect prognosis and can make a potentially curable disease incurable."
Such high stakes for delaying treatment at hospitals right now extends beyond cancer care.
"I've seen patients get ready to have their open-heart surgery that day. I've seen patients have brain tumor with visual changes, or someone with lung cancer, and their procedures are canceled that day and they have to come back another day," said Dr. Kent Dauterman, a cardiologist and co-director of the regional cardiac center in Medford, Oregon. "You always hope they come back."
In early September, Dauterman said, the local hospital had 28 patients who were waiting for open-heart surgery, 24 who needed pacemakers, and 22 who were awaiting lung surgeries. During normal times, he said, there is no wait.
"I don't want to be dramatic — it's just there's plenty of other things killing Oregonians before this," Dauterman said.
Right now, the vast majority of patients in Oregon hospitals with COVID are unvaccinated, about five times as many as those who got the vaccine, according to the Oregon Health Authority. COVID infections are starting to decline from the peak of the delta wave. But even in non-pandemic times, there's not a lot of extra room in Oregon's healthcare system.
"If you look at the number of hospital beds per capita, Oregon has 1.7 hospital beds per thousand population. That's the lowest in the country," said Becky Hultberg, CEO of the Oregon Association of Hospitals and Health Systems.
A new study focused on curtailing nonemergency procedures looked back at how Veterans Health Administration hospitals did during the first pandemic wave. It found that the VA health system was able to reduce elective treatments by 91%.
It showed that stopping elective procedures was an effective tool to free up beds in intensive care units to care for COVID patients. But the study didn't look at the consequences for those patients who had to wait.
"We clearly, even in hindsight, made the right decision of curtailing elective surgery," said Dr. Brajesh Lal, a professor of surgery at the University of Maryland School of Medicine and the study's lead author. "But we as a society have not really emphatically asked the question 'At what price in the long term?'"
He said they won't know that without more long-term research.
At his home in southern Oregon, Charlie Callagan said he doesn't consider his bone-marrow transplant as urgent as what some people are facing right now.
"There's so many other people who are being affected," he said. "People are dying waiting for a hospital bed. That just angers me. It's hard to stay quiet now."
He said it's hard to be sympathetic for the COVID patients filling up hospitals, when a simple vaccine could have prevented most of those hospitalizations.
As executive director of Covered California, Peter Lee has worked closely with the administrations of Democratic presidents Barack Obama and Joe Biden to expand health coverage to millions of people.
This article was published on Friday, September 17, 2021 in Kaiser Health News.
Peter Lee, who has steered California's Affordable Care Act marketplace since late 2011 and helped mold it into a model of what the federal healthcare law could achieve, announced Thursday he will leave his post in March.
As executive director of Covered California, Lee has worked closely with the administrations of Democratic presidents Barack Obama and Joe Biden to expand health coverage to millions of people who don't get it through an employer or government program, most of them aided by income-based financial assistance from the state or federal government. Over 1.6 million people are now enrolled in plans through the exchange, which has covered 5.3 million Californians since it started selling health plans.
Lee lobbied fiercely to fight efforts by the Trump administration and Republicans to repeal the ACA, known popularly as Obamacare. Those efforts appear dead following the U.S. Supreme Court's decision in June to uphold the law for the third time.
"The really terrific thing, and you can't say this of every leader, is that Peter is leaving the organization in a position where it is still poised to have the success it has had recently," said Dr. Mark Ghaly, who chairs the Covered California board and is secretary of the California Health and Human Services Agency.
The board will launch a national search for Lee's successor. The long runway to his departure "gives us time to cast a wide net and find a leader who understands the history of this organization but also has the vision of where we can go," Ghaly said.
Lee said he was leaving largely for personal reasons, including the deaths of his mother, Sharon Girdner, and his uncle, Dr. Philip R. Lee. The latter was part of the original Medicare brain trust under President Lyndon Johnson, and the younger Lee described him as a health policy mentor. Lee's father and grandfather were also deeply involved in healthcare policy.
The past two years have prodded him to reflect, he said. "COVID reminds you that life's too short. It's a good time to say, 'What else do I want to do?'"
But, at 62, he has no intention of retiring. In his next job, Lee said, he wants to tackle what he believes are flaws in employer-based health insurance that leave many workers, especially low-wage earners, at financial risk if they get sick.
He said he has no idea whether he'll land in the private sector, a nonprofit or government. First, he plans to take time off to travel and think about his next move.
Covered California's enrollment is at its highest level since the exchange opened for business — credited partly to longer enrollment periods due to COVID and the expansion of federal premium assistance, at least through 2022, under the American Rescue Plan Act.
The expanded federal subsidies were based on California's first-in-the-nation state-funded financial aid, which — with Lee's ardent support and implementation — extended subsidized coverage well into the middle class.
The percentage of Californians who don't have insurance has dropped sharply, from 17% before the ACA began expanding coverage in 2014 to 7% now — mostly due to the expansion of Medicaid rather than the Covered California marketplace.
Those who have worked with Lee credit him for innovations that transcend the provisions of Obamacare and have either set California apart or served as templates for other states.
Covered California, unlike many state exchanges, has standardized health plan designs, so that plans within each coverage level offer the same services with the same deductibles and other out-of-pocket costs.
"Instead of insurers submitting and selling dozens and dozens of plans with differences that just cause consumer confusion, he established standardized benefit packages so you could make apples-to-apples comparisons," said Anthony Wright, executive director of Health Access California, a consumer advocacy group. Consumers need only compare provider networks and price, Wright said, "but you don't have to worry that, 'Oh, in this plan the deductible is $50 less but the copays are $30 more.' That stuff is crazy-making."
Paul Markovich, CEO of Blue Shield of California, Covered California's second-largest insurer, said the health plans didn't want to standardize benefits at first, but "Peter stuck to his guns."
As a result, Markovich said, "there was no way to game the system. The only way to compete was to work on your costs and your quality and the access that the members had."
Another Covered California initiative that was unpopular at first with health plans "but very effective," Markovich said, is its ambitious advertising and marketing strategy — across racial, ethnic and linguistic communities — which is financed by a surcharge on plans.
Because many people don't know they are eligible for subsidies, Lee believed no amount of outreach was too much, Markovich said. "And again, he was right."
Lee has frequently expressed pride in his ability to negotiate relatively low premium increases, noting that over the past three years rate hikes for exchange-based health plans have averaged only about 1%.
Some analysts believe premiums could have been even lower, and that Lee hasn't pushed the health plans hard enough.
"I think that Covered California has been too eager to see health plans as partners," said Michael Johnson, a former Blue Shield of California executive turned industry critic.
Lee said he and his team strive to ensure that insurers don't make excessive profits in the exchange. "Every year we sit down with health plans and look at their books to ask, 'What profit are you making this year? And what profit are you making next year?'" he said.
Lee has seen healthcare from the business, consumer and regulatory sides. He held two healthcare-related jobs in the Obama administration and previously served as CEO of the Pacific Business Group on Health (since renamed the Purchaser Business Group on Health), which represents large employers, and as executive director of the Center for Healthcare Rights, a consumer advocacy group.