From Medicine and Health

California Expands Privacy Protection to Public Health Workers Amid Threats

SANTA CRUZ, Calif. — California will allow public health officials to participate in a program to keep their home addresses confidential, a protection previously reserved for victims of violence, abuse and stalking and reproductive health care workers.

The executive order signed by Democratic Gov. Gavin Newsom late Wednesday is a response to threats made to health officers across California during the coronavirus pandemic. More than a dozen public health leaders have left their jobs amid such harassment over their role in mask rules and stay-at-home orders.

“Our public health officers have all too often faced targeted harassment and stalking,” wrote Secretary of State Alex Padilla in a statement. This “program can help provide more peace of mind to the public health officials who have been on the frontlines of California’s COVID-19 response.”

A community college instructor accused of stalking and threatening Santa Clara health officer Sara Cody was arrested in late August. The Santa Clara County sheriff said it believes the suspect, Alan Viarengo, has ties to the “Boogaloo” movement, a right-wing, anti-government group that promotes violence and is associated with multiple killings, including the murders of a federal security officer and a sheriff deputy in the Bay Area. Thousands of rounds of ammunition, 138 firearms and explosive materials were found in his home, the sheriff’s office said.

In Santa Cruz County, two top health officials have received death threats, including one allegedly signed by a far-right extremist group.

In May, a member of the public read aloud the home address of former Orange County health officer Nichole Quick at a supervisors’ meeting and called for protesters to go to her home. “You have seen firsthand how people have been forced to exercise their First Amendment. Be wise, and do not force the residents of this county into feeling they have no other choice than to exercise their Second Amendment,” said another attendee. Quick later resigned.

Protesters angry over mask mandates and stay-at-home orders have gone to the homes of health officers in multiple counties, including Orange and Contra Costa.

The executive order would allow health officials to register with the Secretary of State’s Safe at Home program. Those in the program are given an alternative mailing address to use for public records so that their home addresses are not revealed.

Threats of violence have added to the already immense pressure public health officials have experienced since the beginning of the year. Amid chronic underfunding and staffing shortages, they have been working to limit the spread of the coronavirus, while also deflecting political pressure from other officials and anger from the public over business closures and mask mandates.

“California’s local health officers have been working tirelessly since the start of the pandemic, using science to guide policy,” said Kat DeBurgh, the executive director of the Health Officers Association of California. “It is regrettable that this order was necessary — but we are grateful for it nevertheless.”

Nationwide, at least 61 state or local health leaders in 27 states have resigned, retired or been fired since April, according to a review by The Associated Press and KHN, a figure that has doubled since the newsrooms first began tracking the departures in June.

Thirteen of those departures have been in California, including 11 county health officials and the state’s two top public health officials.

Dr. Sonia Angell, former director of the California Department of Public Health and state public health officer, quit in early August after a series of glitches in the state’s infectious disease reporting system caused weeks-long delays in reporting cases of COVID-19.

In Placer County, north of Sacramento, health officer Dr. Aimee Sisson resigned effective Sept. 25 after the county Board of Supervisors voted to end its local COVID-19 health emergency. “It is with a heavy heart that I submit this letter of resignation,” she wrote in her resignation letter. “Today’s action by the Placer County Board of Supervisors made it clear that I can no longer effectively serve in my role.”

Organizations across the state have expressed concern over the treatment of health officials during the pandemic, including the California Medical Association.

“Basic science has become politicized in so many parts of our state, and our country,” wrote California Medical Association president Dr. Peter N. Bretan Jr. in a statement after Sisson’s departure. “Public health officers are public servants who seek to do what their job description states — to protect public health.”

The executive order also directs the state to assess impacts of the pandemic on health care providers and health care service plans, and halts evictions for commercial renters through March 31, 2021, among other pandemic-related matters.

KHN and California Healthline correspondent Angela Hart contributed to this report.

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

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These Secret Safety Panels Will Pick the COVID Vaccine Winners

Most Americans have never heard of Dr. Richard Whitley, an expert in pediatric infectious diseases at the University of Alabama-Birmingham.

Yet as the coronavirus pandemic drags on and the public eagerly awaits a vaccine, he may well be among the most powerful people in the country.

Whitley leads a small, secret panel of experts tasked with reviewing crucial data on the safety and effectiveness of coronavirus vaccines that U.S. taxpayers have helped fund, including products from Moderna, AstraZeneca, Johnson & Johnson and others. The data and safety monitoring board — known as a DSMB — is supposed to make sure the medicine is safe and it works. It has the power to halt a clinical trial or fast-track it.

Shielding the identities of clinicians and statisticians on the board is meant to insulate them from pressure by the company sponsoring the trial, government officials or the public, according to multiple clinical trial experts who have served on such panels. That could be especially important in the pressure-cooker environment of COVID vaccine research, fueled by President Donald Trump’s promises to deliver a vaccine before Election Day.

As pharmaceutical companies work to produce one as quickly as possible, the board’s anonymity has stirred concerns that the cloak of secrecy could, paradoxically, allow undue influence. Whitley, for example, represents the specialized world these experts inhabit — a professor revered in academia who also is paid by the drug industry.

Any political pressure to rush pharmaceutical companies or lean on federal regulators to prematurely greenlight a vaccine would undermine a system put in place to ensure public safety. Calls are growing for companies and the government to be more open about who’s involved in reviewing the vaccine trials and whether board members have any conflicts of interest.

“We want to know they’re truly independent,” said Dr. Eric Topol, director of the Scripps Research Translational Institute and a specialist in clinical trials. “The lack of transparency is exasperating.”

Data and safety monitoring boards have existed for decades to vet new drugs and vaccines, acting as a backstop to help ensure unsafe products don’t make their way to the public. Typically, there’s one board for each product. This time, a joint DSMB with 10 to 15 experts will review unblinded data across trials for multiple coronavirus vaccines whose development the U.S. government has helped fund, according to five people involved in the Trump administration’s Operation Warp Speed or other coronavirus vaccine work. It is run through the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and consists of outside scientists and statistical experts, not federal employees, NIH Director Francis Collins said on a call with reporters.

“Until they are convinced that there’s something there that looks promising, nothing is unblinded and sent to the FDA,” Collins said. “I doubt if there have been very many vaccine trials ever that have been subjected to this size and the rigor with which it’s being evaluated.”

The NIH safety board oversees trials in the U.S. from Moderna, Johnson & Johnson and AstraZeneca, U.S. officials and others involved in Operation Warp Speed said, but not Pfizer, which is fully funding its clinical trial work and established its own five-member safety panel. Pfizer has attested that it can conclusively determine by late October the effectiveness of its vaccine, being jointly developed with German company BioNTech. It secured a $1.95 billion purchase agreement with the Department of Health and Human Services for the first 100 million doses produced. The agreement gives HHS the option to buy an additional 500 million doses.

Moderna, Johnson & Johnson and AstraZeneca, which have either started or are aiming to soon begin large-scale trials in the U.S. involving thousands of patients, collectively have received more than $2 billion in government funds for vaccine development; billions more have been meted out under agreements similar to the HHS contract with Pfizer to buy millions of vaccine doses. Having one safety board oversee multiple trials could allow researchers to better understand the field of products and apply consistency across evaluations, clinical trial experts said in interviews.

One big advantage “could be more standardization,” said Dr. Walter Orenstein, associate director of the Emory Vaccine Center at Emory University and a former senior official at the Centers for Disease Control and Prevention. “They can look at that data and look at all the trials instead of just doing one trial.”

But it also means that one board has an outsize influence to dictate which coronavirus vaccines eventually succeed or come to a halt, all while most of their identities remain secret. The NIH declined to name them, saying they were “confidential” and could be identified only once a study was complete.

One exception to the mystery is Whitley, who was appointed as chair by Dr. Anthony Fauci, the nation’s top infectious disease official. Fauci said that following a “combination of input from us and from him and other colleagues, the people who had the greatest expertise in a variety of areas, including statistics, clinical trials, vaccinology, immunology, clinical work,” were selected for the panel.

Whitley’s role became public when his university announced it, an unusual move. He is a professor as well as a board member of Gilead Sciences, which recently signed a contract with Pfizer to manufacture remdesivir to treat COVID-19 patients. Whitley, who’s been on Gilead’s board since 2008, conducted research that led to remdesivir’s development.

In 2019, he was paid roughly $430,000 as a Gilead board member, according to documents filed with the Securities and Exchange Commission. That same year, he received more than $7,700 in payments from GlaxoSmithKline for consulting, food and travel, according to a federal database that tracks drug and device company payments to physicians.

GlaxoSmithKline and Sanofi are jointly developing a vaccine that’s received $2 billion from the U.S. government under Operation Warp Speed; however, Whitley, through a university spokesperson, said his DSMB has not seen any GlaxoSmithKline COVID protocols. The companies have yet to begin phase 3 trials. Although he chairs a separate GSK data and safety monitoring board for a pediatric vaccine, he was vetted and cleared by the NIH conflict-of-interest committee with its knowledge of his involvement, the spokesperson said.

“When handled responsibly, it is appropriate for physicians to collaborate with external entities,” said UAB spokesperson Beena Thannickal, saying the university works with physicians to ensure that industry engagement is appropriate. “It facilitates a critical exchange of knowledge and accelerates and advances clinical treatments and cures, and it fuels discovery.”

Multiple experts praised his skill — Dr. Walter Straus, an associate vice president at the drug company Merck & Co., said Whitley is an “éminence grise” in pediatrics whom people trust.

“I actually trust that process, and the fact that they asked Rich to do it makes me feel reassured because he’s so good,” said Dr. Jeanne Marrazzo, director of the University of Alabama-Birmingham’s division of infectious diseases.

Multiple scientists who have participated in data and safety monitoring boards maintain it’s important to keep the board anonymous to shield them against pressure or even for their safety. For example, when trials were conducted in San Francisco for HIV/AIDS research, the board was confidential to protect members from patients desperate for treatment, said Susan Ellenberg, a professor of biostatistics, medical ethics and health policy at the University of Pennsylvania who’s written extensively on the history of DSMBs.

If approached by a patient, it “would be very hard to tell you, ‘Oh I can’t help you.’ It’s an unreasonable burden,” said Ellenberg, who said she was involved in coronavirus-related safety boards but would not name them.

As part of a large-scale clinical trial, the DSMB and a statistician or team that prepares data for those individuals are generally the only ones who see unblinded data about the trial, making it clear who is getting what treatment. A firewall is set up between them and executives from the sponsoring company with financial interests in the trial. The companies sponsoring COVID vaccine trials are not part of any closed sessions during which unblinded data is reviewed. Those are limited to members of the DSMB, the NIAID executive secretary and the independent unblinded statistician who is presenting the data, a NIAID spokesperson said.

DSMB members or their family members should have no professional, proprietary or financial relationship with the sponsoring companies, and the NIAID DSMB executive secretary vetted all members for potential conflicts of interest, NIAID said in response to questions from KHN. Members are paid $200 per meeting.

“It’s generally done out of a sense of public service,” said Dr. Larry Corey of the Fred Hutchinson Cancer Research Center, who is working with NIH officials to oversee the U.S. coronavirus vaccine clinical trials. “You’re doing it because of your sense of altruism and obligation to knowing the important role it plays in clinical research and the important role it plays in preserving the scientific integrity of important trials.”

Moderna, AstraZeneca, Johnson & Johnson and Pfizer have each released protocols that include details on when their DSMBs would review unblinded information about trial participants, and at what points they could recommend pausing or stopping trials. The vaccine data and safety board organized by NIAID advises a broader oversight group consisting of the drug companies sponsoring the trial and representatives from NIAID and HHS’ Biomedical Advanced Research and Development Authority that reviews the DSMB recommendations. Ultimately, the drug company has final authority over whether to submit its data to the Food and Drug Administration.

Moderna and Johnson & Johnson are each aiming for their vaccines to have 60% efficacy, which means there would need to be 60% fewer COVID cases among vaccinated individuals in their trials. AstraZeneca’s target is 50%. The FDA has said any coronavirus vaccine must be at least 50% effective to secure approval from regulators. While the parameters of their clinical trials have similarities, there are some differences, including when and how many times the DSMB can conduct interim reviews to assess whether each vaccine works.

Pfizer is similarly aiming for its vaccine to be 60% effective. The company allows for four interim reviews of the data starting at 32 cases — a schedule that has been criticized by some researchers who contend it makes it easier for the company to stop the trial prematurely.

Pfizer declined to name the individuals on its monitoring committee, saying only that the group consisted of four people “with extensive experience in pediatric and adult infectious diseases and vaccine safety” and one statistician with a background in vaccine clinical trials. An unblinded team supporting its data-monitoring committee — which includes a medical monitor and statistician — will review severe cases of COVID-19 as they are received and any adverse events associated with the trial at least weekly.

“There is an irresolvable tension between speed and safety,” said Dr. Gregory Poland, the head of Mayo Clinic’s Vaccine Research Group. “Efficacy is pretty easy to figure out. It’s safety that’s the issue.”

California Healthline editor Arthur Allen contributed to this report.

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As Fires and Floods Wreak Havoc on Health, New Climate Center Seeks Solutions

For the past month, record-breaking wildfires have torched millions of acres from the Mexican border well into Canada, their smoke producing air so toxic that millions of people remained indoors for days on end while many visited hospitals because of respiratory distress.

Last week, Hurricane Sally left a trail of watery devastation in Mississippi, Alabama and the Florida Panhandle, even as more storms brewed offshore.

All of that on top of the COVID-19 pandemic, which has killed nearly 1 million people worldwide.

The timing couldn’t have been better for the opening this month of the Center for Healthy Climate Solutions at UCLA’s Fielding School of Public Health.

Its mission is to work with policymakers and community groups to help safeguard human health against the ravages of climate change. The center was founded on the premise that the long-feared effects of climate change are already here and must be met with policies not only to slow the warming of the planet but also to help people adapt to its reality.

The center’s co-directors, Dr. Jonathan Fielding and Michael Jerrett, believe the clock is running out and we must quickly reduce the amount of carbon being pumped into the atmosphere to have any hope of preserving a viable planet.

“A lot of the predictions of what could happen with climate change have been wrong. But the predictions have been wrong in that they haven’t been catastrophic enough,” Fielding, a professor of medicine and public health at UCLA and former head of the Los Angeles County Department of Public Health, said in an interview last week.

Jerrett, a professor of environmental health sciences at UCLA’s Fielding School who also participated in the interview, is the principal investigator on a study hypothesizing that long-term exposure to air pollution elevates the risk of severe COVID-19 outcomes. Other studies have yielded similar findings.

The following excerpts of the interview with Fielding and Jerrett were edited for length and clarity:

Q: Could the hazardous air quality from the wildfires burning across much of the West Coast fuel an increase in severe COVID-19 cases and deaths?

Jonathan Fielding: There’s a very good chance of that. There is no doubt the effects of air pollution on the lungs and other organs are substantial and contribute to people with chronic problems being more susceptible to the severe effects of COVID.

Michael Jerrett: When we have wildfire events like this, as people are exposed to these high levels of smoke, we see increases in those indicators of morbidity and mortality. And we’ve seen those effects for several lung diseases that have similarities to COVID, like pneumonia.

Q: How does climate change exacerbate the racial, ethnic and socioeconomic health disparities that are so prevalent in our society?

Fielding: You already have people who have a higher rate and burden of chronic illness. Just look at the rates of obesity, for example, as well as the rate of cardiovascular disease. Those are certainly exacerbated by increased heat and by where people can afford to live. A lot of people can only afford a place that’s going to have a lot of heat islands, it’s not going to be air-conditioned, it might not have much in the way even of public transportation.

Jerrett: If you look through very long periods of time, people who have more resources — whether that’s better social contacts or they’re more highly educated, or have higher incomes, or other factors that put them at a social advantage — have always been able to protect themselves from environmental risks better than people who lack those resources.

Q: Can you explain how wildfires affect mental health?

Jerrett: There’s emerging and increasingly convincing literature that shows air pollution is related to anxiety and depression. It’s thought that the change in the nervous system that seems to be stimulated by air pollution, and perhaps the vascular system changes, can affect brain function and lead people into a more depressive state. … Secondly, the loss of immediate surroundings that people are familiar with: So if you are used to looking out and seeing a beautiful forest, and you walk out and you look in your backyard and you see nothing but smoke, and the whole forest is gone, that can affect mental health.

Q: Can we expect to see pandemics more frequently?

Fielding: What I think most people are missing in discussing this issue is population growth. We’re increasing the interface between humans and other species that have viruses that may not affect them but very severely affect humans. So, that’s one issue. The second issue is that climate change is increasing the area where you have vectors that can thrive. So, for example, we’re going to wind up with mosquitoes that can transmit dengue fever and malaria in the U.S.

Q: You talk about the “health co-benefits” of programs that can help slow climate change while mitigating its impact on public health. What are some examples?

Jerrett: Some of the leading practices in terms of generating benefits involve, say, increasing the green cover. As we increase green cover, we absorb more carbon, so we’re going to reduce the risk of long-term climate change, but you can also have substantial health benefits from that. We know that the introduction of more vegetation generally lowers extreme heat, particularly in disadvantaged neighborhoods where they don’t have a lot of park space or a lot of trees. Another leading practice, where the Europeans are way ahead of us — but we do see signs of improvement across California, in places like Santa Monica — is promoting what’s known as active travel: to get people out of their cars and get them on a bicycle or walking for incidental trips or going to work. We get a benefit in terms of their increased physical activity, and we also reduce the amount of emissions.

Q: Are the climate changes we are already seeing permanent, or can they be halted or even reversed?

Jerrett: We’re already in what I would call a climate crisis. It’s elevating to a climate catastrophe, and that’s going to happen in the next 20 years. We still have a chance to pull back. If we don’t, then we’re going to start seeing massive species die-offs; it’s going to affect the ability of people all over the world to feed themselves. We’re going to have these extraordinary, extreme events like wildfires that are going to dwarf what we’ve seen in the past, and large portions of the planet may become uninhabitable.

Fielding: Here I would draw a parallel to COVID. Even though many of us predicted a pandemic, most people didn’t really believe it, the government didn’t prepare well for it, and we’re learning the same thing with climate change. The difference is we have a way, through vaccination and maybe drugs, to reverse what’s going on with COVID. We don’t know that we have the ability to do that with climate change. You have people politicizing it and calling it a hoax, and that, unfortunately, is very detrimental to what we all want, which is to have a habitable planet.

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A Fair to Remember: County Fairs Weigh Risk of Outbreak Against Financial Ruin

Laura Stutzman had no doubts that this year’s Twin Falls County Fair should go on despite the pandemic still raging across the U.S. — and several outbreaks tied to such community fairs.

Though she saw few people wearing masks from her volunteer station in the fair’s hospitality tent in southern Idaho earlier this month, she said she wasn’t concerned. Stutzman, 63, had been attending the fair off and on for 30 years, and she didn’t consider this year that different. People in rural communities know how to respect one another’s space, she said, and don’t have time to “fret and worry” about the coronavirus.

“Common sense is knowing that COVID-19 is in the picture,” she said, yet not allowing fear to “dictate how we live.”

Hundreds of state and county fairs typically take place across the U.S. each year. They are a centerpiece for the agricultural industry — particularly for the 4-H kids who raise livestock all year to show off at their local events. Thousands of people are drawn to small towns for the concerts, rodeos, races and carnivals that flesh out the experience.

But only about 1 in 5 fairs took place as scheduled this summer, while the rest were dramatically modified or outright canceled because of the pandemic, according to data provided by the International Association of Fairs & Expositions.

Fairs are the economic lifeblood and cultural high point of the year for many rural communities, so the decision to cancel one is especially consequential. Scaling back can have devastating effects on the finances of the fair organizers and local community. And organizers fear that skipping a single year could mean losing a fair permanently.

“With very few exceptions, most fairs get most of their income from one single annual event,” said Marla Calico, president and CEO of the International Association of Fairs & Expositions. “Some fairs are trying to figure out how they will survive after this.”

In pressing on with their events, many organizers cited the fair’s importance to their counties, precisely because of the pandemic — people have been isolated from one another and communities are struggling economically.

One, the Montrose County Fair and Rodeo in Colorado, wanted to give students a chance to show and sell their livestock in person, Montrose County Fairgrounds & Event Center director Emily Sanchez said. Organizers promoted the event on social media with the hashtag #spreadingjoy, which Sanchez said was not intended to be a tongue-in-cheek reference to the pandemic.

“What we noticed was a lot of people saying that this was the worst year,” Sanchez said. “We were just giving people a minute to enjoy the small things.”

Montrose and most other fairs that took place scaled back events and made other changes to try to prevent coronavirus transmission. Fairs posted signs encouraging mask use and social distancing, and some canceled concerts and carnival-type attractions. The Fresno County fair in California, which is scheduled for October and typically draws 600,000 people, has been rebranded as a “series of drive-thru and virtual experiences.”

Often, those precautions haven’t worked, though, as fairgoers shed masks and gathered in large groups to watch rodeos and other attractions.

Health officials have since traced some COVID outbreaks to fairs. For example, Ohio Gov. Mike DeWine announced restrictions to county fairs after at least 22 cases of COVID-19 were traced back to the Pickaway County Fair in June.

Another fair linked to a COVID outbreak is the Phillips County Fair in the vast plains of northeastern Montana. The organizers of the event in Dodson, a small farming community about 40 miles south of the Canadian border, have long proclaimed that theirs was the longest continuously running fair in the state.

Until the fair took place in early August, Phillips County had another unique distinction: It was one of just a handful of Montana’s 56 counties to have no confirmed cases of COVID-19.

By mid-August, an outbreak of COVID-19 occurred — 68 cases within a week in the county of 4,000 people. The county’s small public health team scrambled to perform contact tracing. They concluded the fair and other events held at the same time, including a softball tournament and a large wedding, caused the spread.

“It was really just a perfect storm that led to an outbreak,” said public health nurse Jenny Tollefson.

The number of infections in Phillips County eventually rose to 114, but county officials have since curbed the outbreak. There were no active cases in the county as of mid-September, according to state health officials.

Sue Olsen, chairperson of the Phillips County Fair board, said organizers did everything they could to safely hold a large community event amid a global pandemic. They purchased 500 gallons of hand sanitizer and encouraged attendees to wear masks, although she said few did. They also improved cleaning procedures in the bathrooms.

They canceled events in which social distancing would not be possible, such as the carnival games and rides, face painting and a clown show. The county’s Native American neighbors on the Fort Belknap Reservation disagreed with the decision to hold the fair and canceled the relay races that are a traditional part of the event.

But organizers felt they needed to hold the fair.

“If you don’t have an event one year, you might just lose it,” Olsen said.

The outbreak opened up the county to criticism. Montana Gov. Steve Bullock, a Democrat, called Phillips County an example of how the state hasn’t learned to live with the coronavirus.

Other fair organizers took notice but pressed ahead. Near Montana’s Glacier National Park, Flathead County held the Northwest Montana Rodeo and Fair in mid-August despite 140 local health care professionals writing a letter urging organizers to cancel it. Among the medical community’s chief concerns: Schools were reopening just a week after the fair.

Fair manager Mark Campbell said his team worked closely with local health officials to ensure that the event, which normally attracts upward of 80,000 people, could proceed safely.

“We had a health department that was willing to work with us on a plan when a lot of other counties or states just simply said no to public events,” he said.

Campbell said the fair was different than in past years, with a bigger focus on 4-H and agricultural education. They canceled the carnival and parade, plus ditched the beer garden during the concerts and rodeos. Masks were required to enter the fair and the grandstands, although images posted by a local newspaper that quickly circulated on social media showed many people simply took off their masks once inside.

Interim county health officer Tamalee St. James Robinson said the images of so many maskless people in the grandstands were concerning, and fair organizers should have ensured compliance. Campbell said that the organizers took corrective actions to make sure people did wear masks after the images surfaced but that his staff didn’t have time to constantly remind people.

Two weeks later, contact tracers found seven people with COVID-19 had gone to the fair.

Back in Twin Falls, Idaho, about 3,500 people — half the usual number — showed up at the fair’s opening on Sept. 2, according to news reports. Despite the smaller crowd, the carnival games and rides went ahead and so did the rodeo.

Stutzman said she spent some of her time during the rodeo sanitizing the hospitality tent — but not necessarily because of the coronavirus.

“We were all raised with manners and good hygiene and consideration for others in our neck of the woods,” she said. “So everything pretty much goes on as it always has.”

The fair ended on Sept. 7, and it remains to be seen what effect, if any, it will have on Twin Falls County’s COVID-19 cases.

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How Families Are Keeping Halloween From Turning Into a COVID Nightmare

DENVER — For Laura Stoutingburg and her family, Halloween has always been a monthlong celebration of corn mazes, pumpkin patches and, of course, trick-or-treating in their suburban Denver neighborhood.

However, the COVID-19 pandemic has forced the mother of two to change their plans.

“Traditional trick-or-treating house to house does not feel like a smart choice to me this year,” Stoutingburg said.

Families across the nation are haunted by the same dilemma: How can they safely keep the pandemic from overshadowing Halloween? Can families trick-or-treat and go to haunted houses, or should they opt for lower-risk activities at home?

Health experts say families should err on the side of caution when it comes to trick-or-treating and other traditional fall activities. Much depends on each family’s comfort with taking risks and ensuring they adhere to safety standards and common sense, they said. Masks should be worn by all, even if not part of a costume.

“My kids love going to the farm … to go pumpkin-picking, apple-picking and all those things we do in the fall,” said Dr. Aaron Milstone, a professor of pediatrics and an associate epidemiologist at Johns Hopkins University in Baltimore. But, he added, “if you show up at the pumpkin patch and it’s packed with people, that’s not the right time for you to be there.”

The Centers for Disease Control and Prevention recently released Halloween guidelines that warn against high-risk activities like traditional trick-or-treating, haunted houses and costume parties, as well as hay and tractor rides, among other things. The federal agency is also clear on the need for social distancing, mask-wearing and hand-washing to continue.

Many parents are coming up with creative alternatives for Halloween night. For Stoutingburg, 30, that means hosting a small sleepover with relatives that features pumpkin-carving, cupcake-decorating and a scavenger hunt.

Jody Allard and her family also will forgo their usual tricks and treats. Allard, 42, lives in Seattle and has a rare genetic disease putting her at higher risk for COVID-19. The mother of seven said her family will make new traditions this year.

“We’re going to make a bunch of different fun foods from the Halloween shows they like to watch on the Food Network, and we’re going to watch kid-friendly Halloween movies,” Allard said.

In Lancaster, Pennsylvania, 44-year-old writer Jamie Beth Cohen’s daughter came up with the idea that she and her brother dress up in costumes and trick-or-treat inside their own home, with their parents behind the doors of various rooms, waiting with candy.

“She’s excited to wear a costume without a jacket and get lots of the kind of candy she likes,” Cohen said.

Maya Brown-Zimmerman and her family of six never miss out on trick-or-treating in Cleveland. But they will this year, with Brown-Zimmerman, 35, at higher risk for COVID-19 because of multiple lung diseases. Instead, her family will use their costume money on new Halloween decor, and her four kids, ages 3 to 11, will search for candy at home.

“I’ll hide eggs of candy in the front yard for my little kids,” she said. “After they go to bed, the older kids will have a hunt for eggs in the dark in our backyard with flashlights.”

For families still hoping to trick-or-treat this year, though, what can be done to stay as safe as possible?

The Harvard Global Health Institute created a website to help parents assess their risk level for Halloween activities with a color-coded map of county COVID data. It shows which counties are “lower-risk” zones for COVID (green and yellow), where parents might feel more comfortable allowing their children to trick-or-treat, and which are higher-risk areas (orange and red), where online parties and very small gatherings are recommended instead.

Milstone said families should think less in terms of green versus red zones and more in terms of staying safe no matter what, especially considering asymptomatic carriers.

“Rather than people getting a false sense of security that ‘My area is a low-risk area, so I’m just gonna go and do whatever,’ I would say ideally everyone practices the same safe things,” he said.

Dr. Heather Isaacson, a pediatrician with UCHealth in Longmont, Colorado, said masks must be worn by all and has a simple suggestion for the reluctant: “Decorate those masks and incorporate them into the costumes.”

People who hand out candy also should wear masks, added Dr. Alok Patel, a pediatrician and co-host of the “Nova” and PBS Digital Studios show “Parentalogic.” If trick-or-treaters see candy-givers without masks, he suggested wishing them a “Happy Halloween” and passing them by for the next home.

“If people are outside serving candy without a mask, consider the added risk of potential respiratory droplets flying around, including in the candy bowl,” said Patel.

When it comes to handing out candy, it’s a good idea to maintain as much distance as possible.

“Think outside of the box with ideas like a reverse trick-or-treating, where kids stay home and dress up and neighbors do a parade and throw candy,” said Isaacson. She also recommended creating individual goody bags in place of bowls of treats.

“You could go all out and make candy chutes or a giant spider web with candy trapped in it. In some ways, the physically distanced candy-delivery ideas sound more fun,” said Patel.

As for the candy itself, Milstone isn’t as concerned about wrappers as about hand-washing. The primary message is, “Don’t let your kid eat candy with dirty hands,” he said. That means no eating candy until they’re able to get home to wash properly.

While you could technically sanitize wrappers, said Dr. Rita Nasseri, a Los Angeles physician and mother of three, “the safest solution is to buy your own candy and give your children that as a treat.”

As for teens, who may want more independence, Dr. Sam Dominguez, a pediatrician specializing in infectious diseases and medical director of the microbiology lab at Children’s Hospital Colorado, recommended that small groups of friends get together outside and carve pumpkins or watch a projected movie — while wearing masks, of course.

Nasseri advised something similar, adding that food served buffet-style and communal candy should be avoided.

In Boone County, Missouri, currently experiencing a rapid uptick in COVID-19 cases, Karina Koji said her family will stay home on Halloween night. They plan to dress up in costumes and face masks and give out bags of individually wrapped candies. They’ll also leave candy bags in the driveway for anyone who doesn’t feel comfortable coming up to the door.

“We shouldn’t let the pandemic take Halloween from us,” said Koji, 45. “We’ve all had to give up so much. It’s entirely possible to celebrate this fun holiday while staying healthy and keeping ourselves and others safe.”

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Public Health States

Reapertura de universidades generó 3,000 nuevos casos de COVID por día, según estudio

La reapertura de universidades en los Estados Unidos provocó un aumento de 3,000 nuevos casos de COVID-19 por día, según un nuevo estudio.

El estudio, realizado por investigadores de la Universidad de Carolina del Norte-Greensboro, la Universidad de Indiana, la Universidad de Washington y el Davidson College, rastreó los datos de teléfonos celulares y los comparó con las fechas de reapertura de 1,400 facultades, junto con las tasas de infección del condado.

“Nuestro estudio buscaba ver si podíamos observar aumentos tanto en el movimiento como en el recuento de casos, es decir, informes de casos, en los condados y en todo los Estados Unidos”, dijo Ana Bento, experta en enfermedades infecciosas y profesora asistente en la Escuela de Salud Pública de la Universidad de Indiana.

“Luego tratamos de entender si esta información era diferente en los condados donde había universidades o colegios comunitarios. En particular para ver si estos aumentos eran de mayor magnitud en los colegios con instrucción en persona”, dijo.

Casi 900 de esas escuelas abrieron principalmente a clases en persona, según el estudio.

La investigación examina el período desde el 15 de julio hasta el 13 de septiembre. No nombra instituciones o ubicaciones específicas, pero los investigadores encontraron una correlación entre las escuelas que intentaron la instrucción en persona y mayores tasas de transmisión de enfermedades.

Los investigadores comprobaron que solo reabrir una universidad agregó 1.7 nuevas infecciones por día por cada 100,000 personas en un condado, y tener clases en persona se asoció con un aumento diario de 2.4 casos por cada 100,000.

“No se observa tal aumento en los condados sin universidades, con universidades cerradas, o aquéllas que abrieron principalmente en formato virtual”, dice el estudio.

Al tener en cuenta si los estudiantes provenían de lugares donde la incidencia de la enfermedad era alta, se agregaron 1.2 casos diarios por cada 100,000 personas.

Los recuentos diarios de casos nuevos en todo el país durante el período analizado en el estudio oscilaron entre un máximo de 70,000 nuevos casos por día y un mínimo de 30,000, según datos compilados por The New York Times.

Los autores no dicen exactamente que fue un error que se hayan abierto universidades, considerando las muchas variables que enfrentó cada escuela.

Pero informes anteriores sobre los planes de reapertura en todo el país fueron confusos y caóticos, y  no se ajustaban a ningún estándar, lo que ya pronosticaba un potencial de desastres cuando los estudiantes regresaran.

De hecho, surgieron numerosos informes en todo el país que mostraban picos de COVID-19 en ciudades universitarias, a menudo atribuidos a las fiestas de los estudiantes. Incluso en la Universidad de Illinois, elogiada por sus preparativos, ha habido más de 2,000 casos en el campus desde que los estudiantes comenzaron a regresar en agosto.

Los casos alcanzaron su punto máximo una semana después de que comenzaran las clases y han disminuido desde entonces.

Los autores tampoco culpan a los jóvenes irresponsables, ya que estudiaron métodos de estudio, no comportamientos fuera del campus, donde algunos estudiantes han actuado de manera extremadamente pobre.

“Creo que es un poco injusto decir: ‘Oh, los estudiantes se están reuniendo y generando estos malos comportamientos que conducen a brotes’”, dijo Bento. “Creo que es más la idea de cuando ves una gran afluencia de todo el país, o de diferentes condados, a una ciudad universitaria que sabemos que tuvo una carga muy baja de COVID durante los primeros meses y, de repente, tenemos esta mayor probabilidad de infección, porque tenemos una gran comunidad de individuos que aún eran susceptibles”.

Agregó que, en lugar de buscar responsables, la idea del estudio era medir el problema y luego usar esos datos para averiguar cómo responder mejor, que es el tema de un estudio futuro.

“Para que la escuela pueda abrir en línea, en formato híbrido o cara a cara, debe haber una combinación diferente de estrategias que permitan detectar [casos] temprano, de modo que se pueda controlar la propagación en la comunidad, que es el mayor problema aquí “, dijo Bento.

Los investigadores esperan terminar ese trabajo relativamente pronto, mucho antes de que las universidades comiencen los nuevos semestres de primavera.

Algunas preguntas se respondieron, como cuánto del aumento en los casos se debe simplemente a que los estudiantes enfermos dan positivo cuando llegan, y cuánto proviene de la propagación del virus después de su llegada.

Otro es qué tan bien funcionaron acciones específicas para frenar la propagación, y si las diferentes medidas de seguridad locales ayudaron o perjudicaron.

Y hay una advertencia alarmante. Es casi seguro que el trabajo no capturó todo el alcance del aumento vinculado a los campus.

“Si bien este estudio estima alrededor de un aumento de 3,000 casos diarios, debemos tener en cuenta que es probable que esto sea una subestimación, porque todavía no vemos a las personas que son asintomáticas”, dijo Bento.

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Colleges’ Opening Fueled 3,000 COVID Cases a Day, Researchers Say

Reopening colleges drove a coronavirus surge of about 3,000 new cases a day in the United States, according to a draft study released Tuesday.

The study, done jointly by researchers at the University of North Carolina-Greensboro, Indiana University, the University of Washington and Davidson College, tracked cellphone data and matched it to reopening schedules at 1,400 schools, along with county infection rates.

“Our study was looking to see whether we could observe increases both in movement and in case count — so case reports in counties and all over the U.S.,” said Ana Bento, an infectious disease expert and assistant professor at Indiana University’s School of Public Health.

“Then we tried to understand if these were different in counties where, of course, there were universities or colleges, and particularly, to see if these increases were larger in magnitude in colleges with face-to-face instruction primarily,” she said.

Nearly 900 of those schools opened primarily with in-person classes, according to the draft study.

The research examines the period from July 15 to Sept. 13. It does not name specific institutions or locations, but researchers found a correlation between schools that attempted in-person instruction and greater disease transmission rates.

Just reopening a university added 1.7 new infections per day per 100,000 people in a county, and teaching classes in person was associated with a 2.4 daily case rise, the study found.

“No such increase is observed in counties with no colleges, closed colleges or those that opened primarily online,” the study says.

Factoring in whether students came from places where disease incidence was high added 1.2 daily cases per 100,000 people.

Daily new case counts nationwide during the study period ranged from a high of 70,000 to a low of 30,000, according to data compiled by The New York Times.

The authors are not calling it a mistake for colleges to have opened, considering the many variables each school faced. But earlier reporting on reopening plans around the country found a welter of chaotic efforts that did not conform to a single standard, suggesting the potential for disaster when students returned.

In fact, numerous reports surfaced around the country showing frightening COVID spikes in college towns, often blamed on partying by students. Even at the University of Illinois, a school lauded for its preparations and robust testing, more than 2,000 cases have been reported on campus since students went back last month. Cases there peaked about a week after classes began and have fallen since then.

The authors are not faulting irresponsible young people, either, since they studied class instruction methods, not behavior off campus, where some students have acted extremely poorly.

“I think that it’s slightly unfair, perhaps, to say, ‘Oh, students are congregating and creating these bad behaviors that lead to outbreaks,’” Bento said. “I think it’s more this idea of when you see a huge influx from all over the country, or from different counties, into a college town that we know had a very low burden of COVID throughout the first months, all of a sudden we have this increased probability of infection, because we have a large community of individuals that were susceptible still.”

Rather than lay blame, she said, the idea of the study was to measure the problem and then use that data to better figure out how to respond, which is the subject of a future study.

“In order for you to open online, hybrid or meet face to face, there needs to be a different combination of strategies that allows you to catch [cases] early so you’re able to control community spread, which is the biggest problem here,” Bento said.

The researchers hope to have that work done relatively soon, well before colleges start spring semesters.

There are some unanswered questions, such as how much of the surge in cases is simply from sick students testing positive when they arrive versus catching COVID-19 after they arrive — and how much students spread the virus to the community or the other way around.

Another is how well specific types of responses mitigated the spread, and whether different local safety measures helped or hurt.

And there is an alarming caveat: The work almost certainly did not capture the full extent of the campus-linked surge.

“While this study estimates around a 3,000 increase in daily cases, we have to take into account that this is actually likely an underestimate, because we still don’t see” people who are asymptomatic, Bento said.

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Public Health States

Native Americans Feel Double Pain of COVID and Fires ‘Gobbling Up the Ground’

When the first fire of the season broke out on the Hoopa Valley Reservation in Northern California in July, Greg Moon faced a dilemma.

As Hoopa’s fire chief and its pandemic team leader, Moon feared the impact of the blaze on the dense coniferous forests of the reservation, near Redwood National and State Parks, where 3,000 tribal members depend on steelhead trout and coho salmon fishing. He was even more terrified of a deadly viral outbreak in his tribe, which closed its land to visitors in March.

“We’re a high-risk community because we have a lot of diabetes, heart disease and elders that live in multigenerational homes. If a young person gets it, the whole household is going to get it,” Moon said.

Eventually, the three major blazes that burned nearly 100,000 acres around Hoopa were too much for the tribe’s 25-member fire team. Moon had no choice but to request help from federal wildland rangers and other tribal firefighters.

Native American tribes are no strangers to fire. Working with flames to burn away undergrowth and bring nutrients and biodiversity back to lands is an ingrained part of their heritage. But epidemics are also a familiar scourge. With the devastation that pathogens like smallpox and measles brought to Native populations following the arrival of Europeans, tribes are especially wary of COVID-19’s impact.

“When thinking about the potential of COVID-19 repeating history and wiping out entire communities and tribes, there is concern,” said Vernon Stearns, who as the fuels manager for the Spokane Tribe in eastern Washington is responsible for organizing controlled burns.

Some tribes have abandoned traditional fire suppression techniques, watching large swaths of land burn in order to protect a more fragile and essential resource: their people.

“The biggest fear the tribe had was COVID would hit our elders. And they are a very valuable resource of knowledge and connection to our ancestry and teaching of our ways to our children, who we also felt were at risk, and we obviously want to protect them,” said Ron Swaney, fire management officer for the Confederated Salish and Kootenai Tribes in Montana.

“I’ve seen how [the virus] has affected families close to me. I know the grief,” said Don Jones, fire chief of the Yakama Nation reservation in central Washington, where there have been at least 28 COVID-19 deaths. “I’m not going to send sick people out to fight the fire. I’m not going to say, ‘Come on, guys, toughen up, go out there.’ Life takes precedence over that.”

Around the country, many tribes have full-time fire crews that traditionally aid one another and federal firefighters, sending out teams to help with blazes. But COVID-19 has pushed them to reconsider how much help they can give and receive. (CSKT Division of Fire)

Around the country, many tribes have full-time fire crews that traditionally aid one another and federal firefighters, sending out teams to help with blazes. But this year’s COVID-19 pandemic has pushed them to reconsider how much help they can give and receive in the face of encroaching infernos.

A Centers for Disease Control and Prevention study found Native Americans and Alaskans were 3.5 times more likely than whites to test positive for the coronavirus. The rapid spread of the virus within tribes early in the pandemic led many reservations to aggressively control outside access. Casinos closed. Entrances to tourist areas such as lakes, hiking trails and fisheries were blocked off. Economically many tribes suffered, but COVID caseloads stabilized or declined.

The ongoing fire season is now threatening that progress.

Tribal families often live in multigenerational housing, sometimes in trailers or other small homes with no running water. Their isolated, tightknit communities can be sequestered from COVID-19 spikes in nearby towns but are ripe for an outbreak if the virus enters. Social distancing is a challenge on small, remote reservations. There may be only a single gas station or supermarket, where visiting fire crews would be likely to interact with the tribal population. Many tribes also lack strong internet connections, forcing fire crews to meet in person rather than stage briefings via Zoom, as federal crews have done elsewhere during the pandemic.

On the Flathead Reservation north of Missoula, Montana, COVID-19 hit the fire crew of the Confederated Salish and Kootenai Tribes before the fires did. A firefighter who came in direct contact with someone who was sick with the virus in early July took the tribe’s entire 12-person aviation team, consisting of an air attack plane and a helicopter crew, out of business for four days. While no fires were burning at the time, it was a worrisome wake-up call for Swaney.

“For a minute there, I really thought we would all be infected with COVID-19 and I was wondering who would be responding to the fires,” he said.

It was enough to convince Swaney that this year the tribe wouldn’t share any of its 60 firefighters with neighbors. It was a tough call because historically “in fire, when our neighbors need help, we go help,” he said.

At the end of July, Swaney had to accept help from nearly 300 outside firefighters when lightning started a blaze in the mountains surrounding the bison-dotted grass valley his tribe calls home.

After the 3,500-acre Magpie Rock Fire was under control, Swaney learned that a federal wildland firefighter involved had tested positive for COVID-19 during his next assignment. He didn’t appear to have infected Swaney’s team, though four members have tested positive this season.

“We’ve had a lot of close calls,” he said.

Other tribes have sought to bolster their fire crews to do without the help of off-reservation teams. The Spokane Tribe in Washington earmarked some of the $19 million it received from the CARES Act to hire an additional 10-person seasonal crew. It hoped to aggressively attack any fire and keep it small, thereby avoiding the need for outside firefighters who might also bring in the coronavirus, Stearns said.

The Yakama Nation, near the Oregon border, was still struggling with a coronavirus outbreak that had infected at least 6% of its population when fires started in July. The crews learned quickly that facing wildfire and a pandemic simultaneously would be an exercise in trade-offs.

Early in the effort, five fire crew members were taken off the line when several people got sick, leaving the 20 remaining members to make do. Federal firefighting is stretched thin as megafires consume vast areas of the West Coast — and other tribes were no help because they’ve restricted their fire teams’ movement to prevent COVID spread.

“We had no one else to call on. … It was pretty tough,” said Jones. “The stress level has gone up. You’re worried about exposure all the time.”

Ultimately, eight Yakama crew members tested positive for COVID-19. One of the firefighters who tested positive had already lost two family members to the virus. Another spread COVID-19 to a family member who ended up at the hospital on a ventilator but survived.

“Everyone in my program was affected one way or another,” Jones said. “Everyone lost somebody.”

The West’s brutal fire season is forcing tribes to concentrate on fires that start by lightning or accident, with no resources to give to prescribed burning.

“These fires are just gobbling up the ground,” said Jones. His tribe canceled the carefully controlled fires it normally conducts in September to avoid bringing together the large numbers of people needed to do them.

“Fires are just going to get bigger,” Jones said. “If we can’t do anything about it, we can’t do anything about it. We have to make sure everyone’s healthy first.”

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

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California Public Health States

Battle Rages Inside Hospitals Over How COVID Strikes and Kills

Front-line health care workers are locked in a heated dispute with many infection control specialists and hospital administrators over how the novel coronavirus is spread ― and therefore, what level of protective gear is appropriate.

At issue is the degree to which the virus is airborne ― capable of spreading through tiny aerosol particles lingering in the air ― or primarily transmitted through large, faster-falling droplets from, say, a sneeze or cough. This wonky, seemingly semantic debate has a real-world impact on what sort of protective measures health care companies need to take to protect their patients and workers.

The Centers for Disease Control and Prevention injected confusion into the debate Friday with guidance putting new emphasis on airborne transmission and saying the tiny aerosol particles, as well as larger droplets, are the “main way the virus spreads.” By Monday that language was gone from its website, and the agency explained that it had posted a “draft version of proposed changes” in error and that experts were still working on updating “recommendations regarding airborne transmission.”

Dr. Anthony Fauci, the top U.S. infectious disease expert, addressed the debate head-on in a Sept. 10 webcast for the Harvard Medical School, pointing to scientists specializing in aerosols who argued the CDC had “really gotten it wrong over many, many years.”

“Bottom line is, there’s much more aerosol [transmission] than we thought,” Fauci said.

The topic has been deeply divisive within hospitals, largely because the question of whether an illness spreads by droplets or aerosols drives two different sets of protective practices, touching on everything from airflow within hospital wards to patient isolation to choices of protective gear. Enhanced protections would be expensive and disruptive to a number of industries, but particularly to hospitals, which have fought to keep lower-level “droplet” protections in place.

The hospital administrators and epidemiologists who argue that the virus is mostly droplet-spread cite studies that show it spreads to a small number of people, like a cold or flu. Therefore, N95 respirators and strict patient isolation practices aren’t necessary for routine care of COVID-19 patients, those officials say.

On the other side are many occupational safety experts, aerosol scientists, front-line health care workers and their unions, who are quick to note that the novel coronavirus is far deadlier than the flu ― and argue that the science suggests that high-quality, and costlier, N95 respirators should be required for routine COVID-19 patient care.

The highly protective respirators have been in short supply nationwide and have soared in price, from about $1 to $7 each. Meanwhile, research has shown high rates of asymptomatic virus transmission, putting N95s in high demand among front-line health care workers in virtually every setting.

The debate has come to a head at hospitals from coast to coast, as studies have emerged showing that live virus hangs in COVID-19 patients’ hospital rooms even in the absence of “aerosol-generating” procedures (such as intubations or breathing treatments) and has contributed to outbreaks at a nursing home, shuttle bus and choir practice.

KHN and The Guardian U.S. are examining more than 1,200 health care worker deaths from COVID-19, including many in which their family or colleagues reported they worked with inadequate personal protective gear.

Yet some front-line workers and managers disagree about exactly how and why health care workers are getting sick.

The hospital infection-control and epidemiology leaders cite studies suggesting that many health care workers are contracting the virus outside of work and at rates that mirror what’s happening in their communities.

A group of Penn Medicine epidemiologists in late July characterized research on aerosol transmission as unconvincing and cited “extensive published evidence from across the globe” showing the “overwhelming majority” of coronavirus spread is “via large respiratory droplets.”

Unions, occupational health researchers and aerosol scientists, though, reference another pile of studies showing health care workers have been hit far harder than average people ― and a study that showed active viral particles can drift in the air up to 15 feet from a patient in a hospital room. Such particles can hang in the air for up to three hours.

Backing their concerns, a July 6 letter signed by 239 scientists urged the medical community and World Health Organization to recognize “the potential for airborne spread of Covid-19.”

The letter pointed to studies that say talking, exhaling and coughing emit tiny particles that remain suspended in the air far longer than droplets and “pose a risk of exposure.”

In one ward of a Dutch nursing home with recirculated air, researchers found that 81% of the residents were diagnosed with COVID-19. Half of the workers on the ward ― who all wore surgical masks during patient care but not during breaks ― also tested positive for the virus.

Although researchers couldn’t exclude transmission by another method, the “near-simultaneous detection” of the virus among nearly all the residents pointed to aerosol spread.

The idea that the virus is spread by either droplets or aerosols is an oversimplification, said Dr. Shruti Gohil, associate medical director of epidemiology and infection prevention at the University of California-Irvine School of Medicine.

Gohil said it’s more of a spectrum, with the virus being transmitted by some droplets and some large aerosol particles as well.

One metric people in the hospital infection-control field focus on, though, is how many people one sick person infects. For COVID-19, research has shown that the number is about two ― similar to a cold or the flu. For an unequivocally airborne disease like measles, the number is closer to 12 to 18.

Measles is “what airborne [transmission] looks like,” Gohil said. “If this was truly a primary aerosol-transmissible disease, we’d be in a world of hurt.”

Hospital epidemiologists are also focused on the rate of household spread of the novel coronavirus. With the measles, the risk of an unvaccinated member of a household getting sick is 85%, said Dr. Rachael Lee, a hospital epidemiologist and assistant professor at the University of Alabama-Birmingham. For COVID-19, she said, the risk is closer to 10%.

Though the virus is believed to be spread more by droplets than aerosol particles, Lee said, staffers at UAB University Hospital wear an N95 respirator for an extra layer of protection and because the patients require so many breathing treatments or procedures considered “aerosol-generating.”

Such practices are not universal. At the University of Iowa’s hospital, health care workers use N95s and face shields for aerosol-generating procedures but otherwise use surgical masks and face shields for routine care of COVID patients, said Dr. Daniel Diekema, director of the division of infectious diseases at the university.

He said such “enhanced droplet precautions” are working. Places where workers are correctly using regular medical masks and face shields are finding no significant spread of the disease among staffers, although one such report focused on the spread from a single patient.

Elsewhere, patients have also been safe on floors where COVID-19 patients and those without the virus have been placed in adjacent rooms ― a practice those concerned about aerosol spread do not endorse.

“It’s not an airborne disease the way measles or tuberculosis is,” said Dr. Shira Doron, an epidemiologist at Tufts Medical Center in Boston and an assistant professor at Tufts medical school. “We know because we don’t see outbreaks that affect multiple patients on a floor.”

Origin of the Debate

The CDC helped set the stage for the current debate. In March, the agency issued revised guidance essentially saying it was “acceptable” for health care workers to use surgical masks ― instead of N95s ― for routine care. The guidance said respiratory droplets were the most likely source of transmission and recommended N95s only for aerosol-generating procedures.

“The contribution of small respirable particles, sometimes called aerosols or droplet nuclei, to close proximity transmission is currently uncertain. However, airborne transmission from person-to-person over long distances is unlikely,” according to the guidance.

The California Hospital Association sent a letter to the state’s congressional delegation urging the revised guidance be made permanent.

“We need the CDC to clearly, not conditionally, move from airborne to droplet precautions for patients and health care workers,” the letter said. Doing so would enable hospitals to preserve PPE supplies and limit the use of special isolation rooms for COVID patients.

An association spokesperson told KHN that the group wasn’t weighing in on the science, merely pressing for clarity of the rules.

Christopher Friese, professor of nursing, health management and policy at the University of Michigan, is among the experts who think those rules have endangered health care workers.

“We lost a tremendous amount of time and, candidly, lives because the early guidance was to wear N95s only for those specific procedures,” Friese said.

Family members and union leaders from Missouri to Michigan to California have raised concerns about nurses dying of COVID-19 after caring for virus patients without N95 respirators. In such cases, hospitals have said they followed CDC guidance.

Friese echoed some occupational safety experts who suggested stronger guidance from the CDC early on calling the disease airborne might have had an impact ― perhaps pressuring President Donald Trump to invoke the Defense Production Act to boost supplies of N95s so “we might have the supply we need everywhere we need,” Friese said.

Surveys across the country show there’s still a shortage of personal protective equipment at many health care facilities.

The CDC guidance posted Friday would have put pressure on some hospitals to bolster their protective measures, something they have reportedly resisted. It said the virus can spread when a person sings, talks or breathes.

“These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection,” the site said. “This is thought to be the main way the virus spreads.”

By Monday morning, the website was back to saying the virus mainly spreads through droplets, noting that draft language had been posted in error.

The University of Nebraska Medical Center has been taking so-called airborne precautions from the start. There, Dr. James Lawler, a physician and director of the Global Center for Health Security at the university, said his colleagues documented that the virus can drift in the air and live on surfaces at an extensive distance from patients.

He said the hospital tests all admitted patients for the virus and keeps COVID-19 patients apart from the general population. He said they pay close attention to cleaning shared spaces and monitoring airflow within the restricted-access unit. Workers also had N95 respirators or PAPRS, which are fitted hoods with filtered air pumped in.

All of it has added up to a “very low” rate of health care worker infections.

Amid uncertainty about the virus, and as an unprecedented number of health care workers are dying, adopting the “highest possible” forms of protection seems the best course, said Betsy Marville, nurse organizer for the 1199SEIU United Healthcare Workers East union in Florida.

That would mean a departure from CDC guidelines that now say health care workers need an N95 respirator only for “aerosol-generating” procedures, like intubations or other breathing treatments. She said the rule has left the nurses she represents in Florida scrambling for protective gear ― or unprotected ― when patients need such treatments urgently.

“You don’t leave your patient in distress and go looking for a mask,” she said. “That’s crazy.”

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Lost on the Frontline: Explore the Database

Journalists from KHN and the Guardian have identified over 1,200 workers who reportedly died of complications from COVID-19 they contracted on the job. Reporters are working to confirm the cause of death and workplace conditions in each case. They are also writing about the people behind the statistics — their personalities, passions and quirks — and telling the story of every life lost.

Explore the new interactive tool tracking those health worker deaths.

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Rural Hospitals Teeter on Financial Cliff as COVID Medicare Loans Come Due

Note to Readers: Sarah Jane Tribble spent more than a year and half reporting on a small town in Kansas that lost its only hospital. This month, KHN and St. Louis Public Radio will launch “Where It Hurts,” a podcast exploring the often painful cracks growing in America’s health system that leave people vulnerable — and without the care they need. Season One is “No Mercy,” focusing on the hospital closure in Fort Scott, Kansas — and what happens to the people left behind, surviving the best way they know how. You can listen to Episode One on Tuesday, Sept. 29.

David Usher is sitting on $1.7 million he’s scared to spend.

The money lent from the federal government is meant to help hospitals and other health care providers weather the COVID-19 pandemic. Yet some hospital administrators have called it a payday loan program that is now, brutally, due for repayment at a time when they still need help.

Coronavirus cases have “picked up recently and it’s quite worrying,” said Usher, chief financial officer at the 12-bed Edwards County Medical Center in rural western Kansas. Usher said he would like to use the money to build a negative-pressure room, a common strategy to keep contagious patients apart from those in the rest of the hospital.

But he’s not sure it’s safe to spend that cash. Officially, the total repayment of the loan is due this month. Otherwise, according to the loan’s terms, federal regulators will stop reimbursing the hospitals for Medicare patients’ treatments until the loan is repaid in full.

The federal Centers for Medicare & Medicaid Services has not yet begun trying to recoup its investment, with the coronavirus still affecting communities nationwide, but hospital leaders fear it may come calling for repayment any day now.

Hospital leaders across the country said there has been no communication from CMS on whether or when they will adjust the repayment deadline. A CMS spokesperson had not responded to questions by press time.

“It’s great having the money,” Usher said. “But if I don’t know how much I get to keep, I don’t get to spend the money wisely and effectively on the facility.”

Usher took out the loan from Medicare’s Accelerated and Advance Payments program. The program, which existed long before the pandemic, was generally used sparingly by hospitals faced with emergencies such as hurricanes or tornadoes. It was expanded for use during the coronavirus pandemic — part of billions approved in federal relief funds for health care providers this spring.

A full repayment of a hospital’s loan is technically due 120 days after it was received. If it is not paid, Medicare will stop reimbursing claims until it recoups the money it is owed — a point spelled out in the program’s rules. Medicare reimburses nearly $60 billion in payments to health care providers nationwide under Medicare’s Part A program, which makes payments to hospitals.

More than 65% of the nation’s small, rural hospitals — many of which were operating at a deficit before the pandemic — jumped at the Medicare loans when the pandemic hit because they were the first funds available, said Maggie Elehwany, former vice president of government affairs for the National Rural Health Association.

CMS halted new loan applications to the program at the end of April.

“The pandemic has simply gone on longer than anyone anticipated back in March,” said Joanna Hiatt Kim, vice president of payment policy and analysis for the American Hospital Association. The trade association sent a letter to CMS in late July asking for a delay in the recoupment.

On Monday, the House Appropriations Committee included partial relief for all hospitals in a new government funding plan. The committee’s proposal would extend the start of the repayment period for hospitals and the amount of time they are allowed to take to repay.

The continuing resolution that includes this language about relief for hospitals (among many, many other things) is still being hammered out, though it does face its own deadline: It must be approved by the House and the Senate within the next nine days or the federal government faces a shutdown.

Tom Nickels, executive vice president at the AHA, said his organization appreciates the House committee’s effort to address the loans in the new bill, but full forgiveness of the loans is still needed.

Sen. Jeanne Shaheen (D-N.H.) has called for changes to the loan repayment period for months and said Monday “our work is far from over.”

“We are still in the middle of this crisis — from both health and economic standpoints,” Shaheen said.

Meanwhile, hospital administrators like Peter Wright are holding their breath, waiting to see if, in order to settle the debt, Medicare will stop making payments to hospitals, even as facilities continue to grapple with coronavirus in their communities.

“The feds, if you owe them money, they just take it,” said Wright, who oversees two small hospitals for Central Maine Healthcare in Bridgton, Maine. He said his health care system took the money because “we had no other choice; it was a cash flow issue.”

For many hospitals, Medicare payments make up 40% or more of their revenue. Not being reimbursed by Medicare would be crippling — akin to a household losing nearly half its income.

“We have no idea what we’re going to do if we have to pay it back as quickly as they say,” Wright said.

In rural Kentucky, hospital executive Sheila Currans said she “vacillated” for about a week or so trying to decide whether to tap the loan program for her hospital — she knew it would have to be repaid and worried that could prove difficult.

Sheila Currans, chief executive of Harrison Memorial Hospital in Cynthiana, Kentucky, with Senate Majority Leader Mitch McConnell during his recent tour of the small, rural hospital. McConnell has visited more than 30 health care providers in Kentucky since the beginning of summer, staff members say. (Lesley Roark)

“It was a desperate time,” said Currans, chief executive of Harrison Memorial Hospital in Cynthiana, Kentucky. Harrison Memorial was the first hospital in Kentucky to treat a COVID-19 patient in early March, she said.

The hospital immediately quarantined dozens of staff members and shut down elective procedures. And with COVID confirmed in the community, there was a “horrible fear,” Currans said, of getting infected that kept people from seeking outpatient care as well.

“Through March and April and most of May, I was in a complete spiral,” Currans said. By the end of April, Currans said, her hospital was losing millions of dollars. To cope with the pandemic, she furloughed staff and turned one wing of the hospital into a “cough clinic” to be used exclusively by patients whose symptoms suggested they might be infected with the coronavirus.

Currans said the hospital is still seeing COVID cases, but patients are beginning to return for other services, such as outpatient clinics.

In terms of the hospital’s finances, “it’s still not a wonderful time,” Currans said. The Medicare loan “as well as all the other support from the federal government helped us at least — for now — survive it.”

She’s hoping the repayment demand will be pushed back to 2021 or, perhaps the loan will be forgiven.

“I know it’s a pipe dream,” Currans said. “But this has been a historic event.”

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It’s Not Just Insulin: Lawmakers Focus on Price of One Drug, While Others Rise Too

Michael Costanzo, a Colorado farmer diagnosed with multiple sclerosis in 2016, has a well-honed ritual: Every six months, he takes an IV infusion of a medicine, Rituxan, to manage his disease, which has no cure. Then he figures out how to manage the bill, which costs thousands of dollars.

For a time, the routine held steady: The price billed to his health insurance for one infusion would cost $6,201 to $6,841. Costanzo’s health insurance covered most of it, and he paid the rest out-of-pocket.

But last fall the cost for the same 20-year-old drug and dosage jumped to $10,320, even though he was covered by the same insurance.

“Why does it have to increase in price all of a sudden?” wondered Costanzo, who lives in a small town about 50 miles north of Denver.

“I think greed is a huge problem,” he said.

As drug prices spiral upward, politicians in Washington, D.C., and in state governments across the country have sought to address the problem in limited ways, focusing mostly on one drug: insulin, a drug more than 7 million Americans rely on to manage diabetes and whose price tag more than doubled from 2012 to 2017.

With comprehensive drug price legislation stalled in Washington during the COVID-19 state of emergency, seven states in the midst of the pandemic enacted insulin payment caps of less than $100 per month, bringing the total to eight; five more have proposed legislation. In March, President Donald Trump’s health officials announced a Medicare test project limiting seniors’ monthly out-of-pocket costs to $35. In July, he signed four executive actions targeting insulin and a handful of other medications, boasting, “It’s going to have an incredible impact.”

Insulin took center stage last year, after moving demonstrations by mothers who caravanned to Canada to buy lifesaving medicine for their children at a tenth of the U.S. price; they swarmed the halls of Congress.

The measures that have resulted so far have not solved a far more widespread problem: escalating drug prices across the board — a problem that voters, left and right, say Congress must fix.

Underlying the problem is that lawmakers spent much of last year at loggerheads about whether the federal government should have the power to set prices or limit price increases. Prospects of comprehensive legislation already in the works slipped away this spring as Congress turned its focus to the COVID-19 pandemic that has killed more than 150,000 Americans and tanked the country’s economy.

So state lawmakers played whack-a-mole, targeting the drug with the most notoriety, and tackled insulin’s cost to patients. But patients like Costanzo — among the millions who rely on other vital drugs — struggle evermore to afford unchecked price increases for everything from HIV/AIDS and depression to asthma, autoimmune disorders and Type 2 diabetes.

A 2019 survey from the Scripps Research Translational Institute published in the Journal of the American Medical Association found that the costs of 17 top-selling brand-name drugs more than doubled from 2012 to 2017. Many of the drugs that made the list are household names: Lipitor and Zetia for high cholesterol, Advair and Symbicort for asthma, Lyrica for pain and Chantix for smoking cessation.

“The general public doesn’t realize this is happening with all sorts of drugs,” Costanzo said. “We’re all suffering from increased prices.”

***

Insulin was a natural poster child for pharmaceutical greed, encapsulating America’s problem with high drug prices in a neat package that few, if any, other medications do as effectively.

“You have an illustration of the problem — politics gone awry and capitalism gone awry,” said Celinda Lake, a veteran Democratic pollster. “They think of it as being emblematic of everything that’s going on with the system.”

Three pharmaceutical companies dominate the market for the diabetes treatment that has essentially the same formula as when it was introduced in the 1920s. Not taking insulin can quickly turn fatal. In 2017, Minnesota resident Alec Smith died at age 26 after rationing his insulin because he couldn’t afford it.

People dying “is what it takes for Congress to actually commit money and act, and then we solve these problems eventually,” said Andy Slavitt, who was acting head of the U.S. Centers for Medicare & Medicaid Services in the Obama administration.

Yet proponents of lowering drug costs say an effort centered on a single drug could backfire, and it did when COVID captured center stage.

“Everywhere in this country people are angry about their drug prices,” said David Mitchell, founder of Patients for Affordable Drugs Now, a Washington, D.C.-based group that lobbies Congress and runs campaign ads in support of lower prices. “The people with cancer, the people with autoimmune problems, the people with multiple sclerosis, the people who are taking a variety of drugs that are wildly overpriced, are going to say, ‘Now, wait a minute, what about me?’”

In early March, University of Pittsburgh researchers published research finding that, without discounts, list prices of brand-name drugs were rising about 9% a year. Late last year, House Democrats passed a bill that would let the federal government set prices for hundreds of drugs and cap seniors’ out-of-pocket costs for medication at $2,000. Trump opposed the bill, calling on Congress to send him a drug pricing bill that has bipartisan support.

“Let’s be clear — these price hikes aren’t because the medicines got better or there was a significant increase in research and development,” said Sen. Chuck Grassley (R-Iowa) in a March 5 floor speech. The chairman of the Senate’s powerful Finance Committee spearheaded a bipartisan drug pricing bill with Oregon Sen. Ron Wyden, a Democrat. “No, this was because the pharmaceutical companies could do it and get away with it.”

While Congress dithers and the topic periodically becomes the subject of a presidential tweet, patients continue to fend for themselves.

Tara Terminiello has seen the total underlying cost of her son’s anti-seizure medication, Topamax, skyrocket to about $1,300 a month, hundreds more than when he started taking it over a decade ago.

In Texas, Joseph Fabian, a public school teacher in San Antonio with health insurance through his job, has relied on inhalers since childhood to manage his allergy-induced asthma. In February 2019, he paid $330.98 for a three-pack of Symbicort inhalers, which he typically uses twice a day but more frequently during allergy season.

A year later and after a change in his health insurance plan, Fabian’s costs tripled, to $348.95 for a single inhaler, he said in an interview. According to the Scripps’ drug pricing study, the median cost of Symbicort rose from $225 in January 2012 to $308 in December 2017.

“There’s no way I can keep working out $350 every month and a half,” Fabian said.

***

Chances that Congress will pass comprehensive drug pricing legislation before the 2020 election have slipped away as lawmakers focus on additional COVID-19 relief. Moreover, the Trump administration, Congress and the public are now hoping for pandemic deliverance by the very same drug companies that have been raising prices as they develop potential virus treatments and vaccines. PhRMA, the powerful industry trade group, has seized the moment with ad campaigns emphasizing the sector’s enormous value.

The stalemate provides little solace for patients like Costanzo, whose medicine, Rituxan, made by Genentech, was first approved by the Food and Drug Administration in 1997 to treat lymphoma and can be used off-label for MS. It is one of seven medications with price increases unsupported by new clinical evidence, according to a report from the Institute for Clinical and Economic Review. ICER noted that over 24 months, the net price — the price after any discounts from drug companies are factored in — “increased by almost 14%, which results in an estimated increase in drug spending of approximately $549 million.”

In a statement, Genentech spokesperson Priscilla White said ICER’s analysis was “significantly limited” because it didn’t account for “meaningful, high-quality, and peer-reviewed evidence supporting the clinical and economic benefits of Rituxan.” White said the company did not increase Rituxan’s price during the period in which Costanzo’s bill rose and wouldn’t speculate on the change without knowing “other factors” that may have contributed.

“We take decisions related to the prices of our medicines very seriously, taking into consideration their value to patients and society, the investments required to continue discovering new treatments, and the need for broad access,” she said.

Costanzo was prescribed the drug by two neurologists and hasn’t had any acute relapses since he started the infusions. He eventually did get a financial reprieve, not thanks to Washington, but by enrolling in a patient discount program operated by the very drug company that sets Rituxan’s price, a program he said was an “absolute lifesaver” financially.

Genentech said its patient foundation provides free medicine to more than 50,000 patients each year. Costanzo got his first free dose in July.

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Señales de una “vacuna sorpresa en octubre” alarma a científicos de carrera

El presidente Donald Trump, que parece decidido a anunciar una vacuna para COVID-19 antes del día de las elecciones, podría autorizarla legalmente a pesar de las objeciones de expertos, funcionarios de la Administración de Alimentos y Medicamentos (FDA) e incluso los fabricantes, que se han comprometido a no lanzar nada a menos que haya demostrado ser seguro y eficaz.

En podcasts, foros públicos, redes sociales y revistas médicas, un número creciente de líderes de salud dicen que temen que Trump, quien ha señalado repetidamente su deseo de que la vacuna se apruebe rápido, tomará el asunto en sus manos, pasando por alto el proceso habitual.

Esto reflejaría otro intento por inyectar política en decisiones sensibles de salud pública. Trump ha contradicho repetidamente el consejo de científicos de alto nivel sobre COVID-19 y ha avalado tratamientos controversiales para tratar la enfermedad.

Las preocupaciones se intensificaron durante este fin de semana, después que Alex Azar, secretario de Salud y Servicios Humanos (HHS), afirmara la autoridad de su agencia sobre la FDA para establecer normas.

La FDA suele aprobar las vacunas. Pero Azar, que informa directamente a Trump, puede emitir una autorización de uso de emergencia, incluso antes que se haya demostrado que la vacuna es segura y eficaz en ensayos clínicos en etapa avanzada.

“Sí, este escenario es ciertamente posible legal y políticamente”, afirmó el doctor Jerry Avorn, profesor de medicina en la Escuela de Medicina de Harvard, quien describió este escenario en el New England Journal of Medicine. Dijo que “parece más aterrador y posible cada día”.

Expertos en vacunas y funcionarios de salud pública están particularmente molestos por la posibilidad porque podría arruinar la frágil confianza del público en una vacuna para COVID-19. Podría poner a las autoridades científicas en la posición de instar a las personas a no vacunarse después de años de intentar persuadir a los padres indecisos para que ignoraran temores infundados.

Los médicos podrían negarse a administrar una vacuna aprobada con datos inadecuados, dijo el doctor Preeti Malani, director de salud y profesor de medicina en la Universidad de Michigan en Ann Arbor, en un seminario virtual. “Podrías tener una vacuna segura y eficaz que nadie quiera usar”.

Una encuesta reciente de KFF encontró que el 54% de los estadounidenses no se pondría una vacuna para COVID-19 autorizada antes del día de las elecciones.

Judd Deere, vocero de la Casa Blanca, desestimó las preocupaciones de los científicos y dijo que a Trump solo le importaba la seguridad y la salud del público.

Por lo general, la FDA aprueba las vacunas solo después que las empresas presentan años de datos que demuestran que una vacuna es segura y eficaz. Pero una ley de 2004 permite a la FDA emitir una autorización de uso de emergencia con mucha menos evidencia, siempre que la vacuna “pueda ser efectiva” y sus “beneficios conocidos y potenciales” superen sus “riesgos conocidos y potenciales”.

Muchos científicos dudan que una vacuna pueda cumplir con esos criterios antes de las elecciones. Pero los términos pueden ser lo suficientemente vagos desde el punto de vista legal como para permitir que la administración tome tales medidas.

Moncef Slaoui, asesor científico jefe de Operation Warp Speed, el programa gubernamental que apunta a desarrollar más rápidamente las vacunas para COVID-19, dijo que es “extremadamente improbable” que los resultados del ensayo de una vacuna estén listos antes de finales de octubre.

Sin embargo, Trump ha insistido repetidamente en que a partir del próximo mes se distribuirá una vacuna para combatir la pandemia que ya se ha cobrado cerca de 200,000 vidas en el país. Reiteró esa afirmación el sábado 19 de septiembre en un mitín de campaña en Fayetteville, Carolina del Norte.

La vacuna estará lista “en cuestión de semanas”, dijo. “Pondremos fin a la pandemia de China”.

Aunque compañías farmacéuticas han lanzado tres ensayos clínicos en los Estados Unidos, nadie puede decir con certeza cuándo tendrán suficientes datos para determinar si las vacunas son seguras y efectivas.

  • Los funcionarios de Moderna, cuya vacuna se está probando en 30,000 voluntarios, han dicho que sus estudios podrían producir resultados para fin de año, aunque el análisis final podría realizarse la próxima primavera.
  • Los ejecutivos de Pfizer, que han ampliado su ensayo clínico a 44,000 participantes, aseguran que sabrán si su vacuna funciona a finales de octubre.
  • El ensayo de la vacuna de AstraZeneca en los Estados Unidos, que estaba programado para inscribir a 30,000 voluntarios, está entre paréntesis por una posible enfermedad relacionada con la vacuna.

Los científicos han advertido por meses que la administración Trump podría intentar ganar las elecciones con una “sorpresa de octubre”, autorizando una vacuna que no haya sido completamente probada.

En un artículo de opinión publicado en The Wall Street Journal, los ex comisionados conservadores de la FDA, Scott Gottlieb y Mark McClellan, argumentaron que la intrusión presidencial era poco probable porque el “proceso completo y transparente de la FDA no se presta a la intromisión. Cualquier desviación se haría evidente muy rápido”.

Pero la administración ha demostrado su voluntad de doblegar a la agencia a su voluntad. La FDA ha sido criticada por emitir autorizaciones de emergencia para dos tratamientos de COVID-19 que fueron impulsados ​​por el presidente, pero que carecían de evidencia sólida que los respaldara: la hidroxicloroquina y el plasma convaleciente.

Azar ha dejado de lado a la FDA de otras maneras, como impidiendo que la agencia regule las pruebas desarrolladas en laboratorio, incluidas las del nuevo coronavirus.

Aunque el comisionado de la FDA, Stephen Hahn, le dijo al Financial Times que estaría dispuesto a aprobar el uso de emergencia de una vacuna antes de que concluyeran los estudios a gran escala, los funcionarios de la agencia también se han comprometido a garantizar la seguridad de cualquier vacuna para COVID-19.

El doctor Peter Marks, alto funcionario de la FDA que supervisa las aprobaciones de vacunas, ha dicho que renunciará si su agencia aprueba una vacuna para COVID-19 que no esté bien probada.

“Creo que habría una protesta insuperable de la comunidad de salud pública, que es mi peor pesadilla, mi peor pesadilla, porque confundiremos al público”, dijo el doctor Michael Osterholm, director del Centro de Investigación de Enfermedades Infecciosas y Políticas en la Universidad de Minnesota, en su podcast semanal.

Aún así, “incluso si una empresa no quisiera que se hiciera, incluso si la FDA no quisiera que se hiciera, él podría hacerlo”, dijo Osterholm, en su podcast. “Espero que nunca veamos que eso suceda, pero tenemos que considerar que es una posibilidad”.

En el editorial del New England Journal, Avorn y el coautor, el doctor Aaron Kesselheim, se preguntaron si Trump podría invocar la Ley de Producción de Defensa de 1950 para obligar a las farmacéuticas reacias a fabricar sus vacunas.

Pero Trump tendría que demandar a una empresa para hacer cumplir esta ley, y la empresa tendría un caso sólido para negarse, dijo Lawrence Gostin, director del Instituto O’Neill para la Ley de Salud Nacional y Global de Georgetown.

Además, señaló que Trump no podría invocar la ley a menos que una vacuna estuviera “científicamente justificada y aprobada por la FDA”.

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Request an Embargoed First Episode of ‘Where It Hurts,’ a New Podcast from KHN and St. Louis Public Radio

“Where It Hurts” is a new podcast from KFF’s Kaiser Health News (KHN) and St. Louis Public Radio that explores painful cracks in America’s health system that leave millions without the health care they need.

Season One, called “No Mercy,” debuts on Sept. 29 and tells the story of what happened in Fort Scott, Kansas, when the rural town’s 132-year-old Mercy Hospital closed due to financial difficulties.  KHN Senior Correspondent Sarah Jane Tribble, who grew up on 10-acres about an hour from Fort Scott, spent more than a year reporting from the town, where locals lost vital health care, workers lost well-paying jobs and the community’s sense of identity wavered. Among the topics Tribble explores is the question of whether every community needs a hospital.

Members of the news media may request an embargoed copy of the first episode of Season One: “No Mercy” by filling out the form below. In doing so, you agree to respect the embargo, which expires at 6 a.m. Eastern/5 a.m. Central on Tuesday, September 29, 2020.

New episodes will be released weekly through Nov. 10, and will be available on major podcast platforms, including Apple Podcasts, Google Podcasts, Spotify, Stitcher, and NPR One. Find more information at whereithurts.show

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Signs of an ‘October Vaccine Surprise’ Alarm Career Scientists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.

If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.

The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health and Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Azar’s decision had no bearing on the vaccine approval process.

Vaccines are typically approved by the FDA. Alternatively, Azar — who reports directly to Trump — can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.

“Yes, this scenario is certainly possible legally and politically,” said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”

Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

Physicians might refuse to administer a vaccine approved with inadequate data, said Dr. Preeti Malani, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.

White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.

Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”

Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.

Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.

Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.

The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”

Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.

  • Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.
  • Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.
  • AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.

Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.

“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”

In an opinion piece published in The Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”

But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.

Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.

Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.

A senior FDA official who oversees vaccine approvals, Dr. Peter Marks, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.

“I think there would be an outcry from the public health community second to none, which is my worst nightmare — my worst nightmare — because we will so confuse the public,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.

Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”

In the New England Journal editorial, Avorn and co-author Dr. Aaron Kesselheim wondered whether Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.

But Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.

Also, he noted that Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”

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Trump-Biden Race Could Hinge on How Florida’s Pinellas County Swings

CLEARWATER, Fla. — Betty Jones voted for President Donald Trump in 2016, but the lifelong Republican has her doubts she will do it again this year.

The federal response to the coronavirus pandemic that has killed about 200,000 Americans and forced older adults to restrict their activities has her contemplating a leadership change.

It “makes me unsure,” said Jones, 78, of Largo, in Pinellas County, Florida. Before COVID-19, she said, she would have definitely voted for Trump.

Polls show that many people will have the pandemic and its public health and economic consequences on their minds when they cast their votes — whether by mail or in person — this fall. Early in-person voting starts Oct. 19 in most Florida counties, including Pinellas.

Even if the issue leads a tiny proportion of them to change their choice for president, it could have huge consequences in battleground states like Florida, which Trump carried in 2016 by about 1 percentage point.

Within the Sunshine State, few places loom as large in the race for the White House as here in Pinellas County, the largest swing county in the ultimate swing state.

Pinellas, with nearly 1 million residents, has been a political bellwether in recent years, having voted for the winning presidential candidate in every election since 1980 — except for the disputed race between George W. Bush and Al Gore in 2000.

This county just east of Tampa known for its sugar-white beaches is nearly evenly split between the major parties, with 251,000 registered Democrats and 245,000 registered Republicans. An additional 200,000 voters registered as independents.

The city of St. Petersburg, in the southern part of the county, is a Democratic stronghold, while the northern half of the county is more Republican. The county is largely a white suburban area, with a large, older middle-class electorate.

President Barack Obama twice won Pinellas — and Florida — but Trump outpaced Hillary Clinton here by 5,500 votes out of the nearly 500,000 cast.

Democrats are hoping Pinellas will help tip the statewide balance to former Vice President Joe Biden this fall — and they expect a boost from residents spooked by the pandemic. The county has been hit hard by COVID-19 with more than 20,000 cases, 2,000 hospitalizations and 700 deaths. It has the highest COVID-19 death rate of the state’s most populous counties.

Older voters have been deeply affected by the coronavirus since they face a high risk of serious complications and have had to curtail their lives dramatically to avoid the virus. Steve Schale, a Democratic strategist in Tallahassee, said those factors should help Biden do well with this key voting group. About 1 in 4 Pinellas voters are 65 or older.

“There is no world where we win Florida without Pinellas,” Schale said. “If we win there by a few points, it’s a harbinger of good things.”

A tiny shift in voter preferences could have major implications, he added.

“We are talking like 4% to 5% of the electorate in Florida is truly up for grabs, but in a state where the vote was decided by 1%, that is a huge chunk of the electorate,” Schale said.

While about one-third of Florida voters said the economy was their leading issue in the presidential campaign, Democrats were seven times more likely than Republicans to cite the coronavirus outbreak as their top issue, according to a KFF and Cook Political Report survey of three Sun Belt states released Thursday. Nearly a third of Democrats said the pandemic is their most important issue, while just 4% of Republicans and 17% of independents chose the coronavirus outbreak.

The poll of 1,009 Florida voters was conducted Aug. 29 to Sept. 13. The margin of error for Florida results is plus or minus 4 percentage points.

The survey found Biden and Trump virtually tied in Florida with 11% undecided.

National surveys show the pandemic — and its impact on the U.S. economy — are key issues for voters.

A Pew Research Center poll in August found that 62% of voters overall say the outbreak will be a very important factor in their decision about whom to support in the fall. For Trump supporters, however, the economy (88%) and violent crime (74%) are the most salient issues.

By contrast, the largest shares of Biden supporters view health care (84%) and the coronavirus outbreak (82%) as very important. According to an August Georgetown University poll of Florida and other battleground states, 38% of respondents said they approve of how Trump is handling COVID-19, while 60% said they disapprove.

John Andrew Barnes, 33, of Largo, said he knew he liked Biden before the pandemic, but the Trump administration’s response to COVID-19 reinforced his decision. Trump’s “blatant distrust” of the Centers for Disease Control and Prevention and other experts and what Barnes viewed as a lack of national response left him unsatisfied, he said.

Yet, among Republicans, the president’s decisions on coronavirus policies have played well and some are nervous that Biden’s efforts to curb the virus might undercut the economy even more.

Ricard Gregorie, 54, of Largo, said the federal government’s response to the pandemic has “absolutely been incredible.” For Gregorie, the quick distribution of ventilators and maintaining an open economy were decisions that reaffirmed his support for Trump. “We can’t ask for miracles,” he said.

Carl Joyner, 35, a firefighter who lives in St. Petersburg, said COVID-19 has not affected his support for Trump. He opposes anyone who wants to force him to wear a mask. He backs Trump’s position to quickly open businesses and schools.

“People are living paycheck to paycheck here and the hospitality industry here really got lambasted,” he said.

Anthony Pedicini, a GOP political consultant based in Tampa, said the pandemic may not have a big influence because most voters were locked in on their choice for president before the pandemic hit. “If you didn’t like the president before the pandemic you don’t like him after,” Pedicini said. “But if you liked him before you still will.”

That’s also what more than a dozen Pinellas voters said in interviews in shopping centers over the past month.

Pinellas has a large working-class community that is trending Republican, Pedicini said. It’s a county in transition with many elders aging out and a younger, more diverse population moving in.

Most political experts say that even in swing counties fewer than 10% of voters switch their party support from election to election. As a result, victory likely depends on who can turn out his base of voters.

In Florida, Hispanic as well as Black turnout declined markedly in 2016, from 59% in 2012 to 52%, according to the nonpartisan Brookings Institution.

Given Trump’s poor approval ratings, the upheaval in the economy and polls showing voters’ disdain of the federal response to the pandemic, there is just no way you would expect the president to win reelection, said Stephen Craig, a political science professor at the University of Florida. “If history holds, Joe Biden will be president. But Trump is a candidate who breaks all the rules.”

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Without Ginsburg, Judicial Threats to the ACA, Reproductive Rights Heighten

On Feb. 27, 2018, I got an email from the Heritage Foundation, alerting me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”

I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”

Few people took that case very seriously — barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat against the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.

Democrats are raising alarms about the future of the law without Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Donald Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.

“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”

Ginsburg’s death throws an already chaotic general election campaign during a pandemic into more turmoil. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.

Let’s take them one at a time.

The ACA Under Fire — Again

The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.

Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.

Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to O’Connor to suggest that perhaps the entire law need not fall.

Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.

While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.

But without Ginsburg, the case could wind up in a 4-4 tie, even if Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.

At least 20 million Americans — and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.

Adult children under age 26 would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.

But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.

A new Democratic president could not drop the lawsuit, because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.

As Nicholas Bagley, a law professor at the University of Michigan who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”

Reproductive Rights

A woman’s right to abortion — and even to birth control — also has been hanging by a thread at the high court for more than a decade. This past term, Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Roberts argued.

Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly three decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.

Adding a justice opposed to abortion to the bench — which is what Trump has promised his supporters — would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.

But not only is abortion on the line. The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.

And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.

For Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.

“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’’

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‘An Arm and a Leg’: A Primer on Persisting in Difficult and Uncertain Times


Can’t see the audio player? Click here to listen.


Laura Derrick lived with an undiagnosed medical condition for decades, and when she finally got answers and access to effective treatment, medical bills threatened to swamp her family. During her personal fight for affordable health care, she was inspired by and swept up in a historic political fight.

This is a great time for Derrick’s story, which is all about persistence through difficult and uncertain times. In late 2018, it was one of the first stories on “An Arm and a Leg,” and it has special resonance right now when we’re all enduring a lot.

Bonus: We catch up with Derrick for an update.


“An Arm and a Leg” is a co-production of Kaiser Health News and Public Road Productions.

To keep in touch with “An Arm and a Leg,” subscribe to the newsletter. You can also follow the show on Facebook and Twitter. And if you’ve got stories to tell about the health care system, the producers would love to hear from you.

To hear all Kaiser Health News podcasts, click here.

And subscribe to “An Arm and a Leg” on iTunesPocket CastsGoogle Play or Spotify.

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California’s Deadliest Spring in 20 Years Suggests COVID Undercount

The first five months of the COVID-19 pandemic in California rank among the deadliest in state history, deadlier than any other consecutive five-month period in at least 20 years.

And the grim milestone encompasses thousands of “excess” deaths not accounted for in the state’s official COVID death tally: a loss of life concentrated among Blacks, Asians and Latinos, afflicting people who experts say likely didn’t get preventive medical care amid the far-reaching shutdowns or who were wrongly excluded from the coronavirus death count.

About 125,000 Californians died from March through July, up by 14,200, or 13%, from the average for the same five months during the prior three years, according to a review of data from the state Department of Public Health.

By the end of July, California had logged about 9,200 deaths officially attributed to COVID-19 in county death records. That left about 5,000 “excess” deaths for those months — meaning deaths above the norm not attributed to COVID-19. Deaths tend to increase from year to year as the population grows, but typically not by that much.

A closer look at California’s excess deaths during the period reveal a disturbing racial and ethnic variance: All the excess deaths not officially linked to COVID infection were concentrated in minority communities. Latinos make up the vast majority, accounting for 3,350 of those excess deaths, followed by Asians (1,150), Blacks (860) and other Californians of color (350).

The overall number of excess deaths across all races and ethnicities was ultimately tempered because, compared with the three prior years, there were actually 383 fewer deaths among white Californians than would be expected in the absence of COVID-19. In addition, California Healthline adjusted the overall numbers to reflect more than 320 COVID deaths that could not be categorized by race or ethnicity because that information was missing from state records.

Several epidemiologists interviewed said they believe a sizable portion of the excess deaths among people of color did, in fact, stem from COVID infections but went undetected for a variety of reasons. Among them: a shortage of coronavirus tests in the early months of the pandemic; an uneven strategy for how and when to administer those tests, which persists; and inadequate access to health care providers in many low-income and immigrant communities.

Dr. Kirsten Bibbins-Domingo, chair of the Department of Epidemiology and Biostatistics at the University of California-San Francisco, is among those who suspect the excess deaths reflect a COVID undercount in minority communities. She noted that several chronic health conditions that disproportionately affect Blacks and Latinos — including diabetes, high blood pressure and heart disease — also place them at higher risk for severe complications from COVID-19.

In addition, Bibbins-Domingo said, the prolonged shutdown of medical offices in the early months of the pandemic — and with them non-urgent surgeries and routine medical care — likely accelerated death among people with those chronic conditions.

“Shutdowns always come at a cost,” she said. “It is our most marginalized communities that experience the cost of a shutdown.”

According to state Department of Public Health data, deaths in California attributed to diabetes rose 12% from March through July when compared with the average for the same period over the past three years. In addition, deaths attributed to Alzheimer’s disease rose 11%.

“Dementia is also a disease where we have racial, ethnic minorities already at greater risk,” said Andrea Polonijo, a medical sociologist at the University of California-Riverside. “Now that we have the pandemic, they’re more socially isolated. Social isolation we know can cause deeper cognitive decline.”

It’s hard to determine whether a death is due to COVID-19 if the victim never sought medical care, said Jeffrey Reynoso, executive director of the nonprofit Latino Coalition for a Healthy California. Latinos in California are less likely to have health insurance, he said. They may face language barriers if their medical provider — or contact tracer — does not speak Spanish. Latino immigrants working in the U.S. without authorization may hesitate to visit the doctor.

“Immigration is definitely a driver in creating a fear and a mistrust of systems, and that includes our health care system,” Reynoso said.

Polonijo said the fact that Latinos make up the bulk of the excess deaths correlates with their dominant role in farming, meat processing, manufacturing and food service, jobs all deemed essential during the pandemic.

“This population is also more likely to live in more crowded conditions,” she said. “So not only are they exposed at work, but they are bringing disease home and with it the possibility of spreading it to their family, bringing it to the community.”

Bibbins-Domingo noted that, while a major portion of COVID deaths overall have occurred among seniors and nursing home residents, a disproportionate number of the state’s excess deaths are of working-age adults.

“The excess deaths that we’re seeing in communities of color and in low-income communities are deaths that are occurring at younger ages,” she said. “These are deaths that are occurring in these ages from 20 to 60, generally speaking — the ages when people would be out working.”

Kathy Ko Chin, president of the Oakland-based Asian & Pacific Islander American Health Forum, said Asian Americans also tend to be overrepresented in essential worker occupations, noting that a large proportion of the state’s nurses are Filipino. In addition, she said, government officials have not done enough to translate COVID educational materials into the many languages spoken by California’s Asian Americans. The Trump administration’s rhetoric on immigration during the past four years, she added, has had a “chilling effect” that has kept many foreign-born Asian Americans from visiting a doctor.

“People were really, really scared,” Chin said.

Counties in Southern California and the largely rural Central Valley — places with a high proportion of Latino residents — tended to have high rates of excess deaths from March to July. Among counties with at least 100,000 people, Kings County, an arid expanse north of Los Angeles that is home to industrial-scale agriculture, had the highest rate of excess deaths per capita.

Officials at the Kings County Department of Public Health did not return a message seeking comment.

Bibbins-Domingo and others said it is important for state and county health officials to take a hard look at their excess death numbers. Excess deaths matter, she said, because they expose shortcomings in health care delivery. In addition, local and state responses to COVID-19 are grounded in data; if that data is inaccurate, the responses may be misguided.

“Deaths are important because they also help us to understand how much severe COVID is there in the community that we have to worry about,” Bibbins-Domingo said. “I think when we undercount that, we both fly blind for the overall pandemic management, and we might fly particularly blind in understanding the impact of the pandemic in particular communities.”

Phillip Reese is a data reporting specialist and an assistant professor of journalism at California State University-Sacramento.

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

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¿Regalo para Florida? Trump aprobaría pronto importación de medicamentos de Canadá

A pesar de las objeciones de las farmacéuticas, se espera que la administración Trump finalice, en pocas semanas, el plan que permitiría a los estados importar de Canadá algunos medicamentos de venta bajo receta.

Seis estados —Colorado, Florida, Maine, New Hampshire, New México y Vermont— tienen leyes que les permiten solicitar la aprobación federal para comprar medicamentos de Canadá a fin de dar a sus residentes acceso a medicamentos de menor costo.

Pero los expertos dicen que la importación de medicamentos propuesta por el gobierno se ha hecho pensando en Florida, el estado más poblado y disputado en las elecciones de noviembre. El apoyo de Trump a esta idea surgió, en un principo, a petición del gobernador de Florida, Ron DeSantis, un estrecho aliado republicano.

El gobierno de DeSantis confía tanto en que Trump seguirá adelante con la importación de medicamentos que, el 30 de junio, solicitó a las empresas que licitaran por un contrato de tres años y $30 millones para llevar a cabo el programa. Espera adjudicar el contrato en diciembre.

Los expertos de la industria dicen que es probable que Florida sea el primer estado en obtener la aprobación federal para un plan de importación de medicamentos, algo que podría ocurrir antes de las elecciones de noviembre.

“Aprobar a Florida sería lo más astuto políticamente”, dijo Mara Baer, una consultora de salud con sede en Colorado que ha trabajado con el estado en su propuesta de importación.

Ben England, CEO de FDAImports, una consultora de Glen Burnie, Maryland, indicó que la OMB normalmente tiene 60 días para revisar la normativa final, aunque espera que ésta se complete antes del 3 de noviembre y vaticinó que hay una pequeña posibilidad de que se finalice y se apruebe la solicitud de Florida para entonces. “Es un año de elecciones, así que veo a la actual administración tratando de usar esto como un tema electoral para decir ‘Mira lo que hemos logrado’”, señaló.

Florida es también una opción lógica debido al gran número de jubilados que se enfrentan a los altos costos de los medicamentos, a pesar de la cobertura de Medicare.

La administración de DeSantis no respondió a las solicitudes de comentarios.

Trump alardeó de su plan de importación durante un discurso, en octubre, en The Villages, una gran comunidad de jubilados a unas 60 millas al noroeste de Orlando. “Pronto permitiremos la importación segura y legal de medicamentos de venta con receta de otros países, incluido Canadá, donde, lo crean o no, pagan mucho menos por el mismo medicamento”, dijo Trump, hablando al lado de DeSantis.

La Administración de Alimentos y Medicamentos (FDA) hizo pública una detallada propuesta, en diciembre pasado, y solicitó comentarios. El plan final llegó el 10 de septiembre a la Oficina de Administración y Presupuesto para su revisión, señalando que podría ver la luz en semanas.

La propuesta regularía la forma en que los estados establecen sus propios programas para importar medicamentos de Canadá.

Los precios son más baratos porque Canadá limita la cantidad que las farmacéuticas pueden cobrar por los medicamentos. Estados Unidos deja que el mercado dicte los precios de los medicamentos.

La industria farmacéutica señaló que probablemente demandará a la administración Trump si sigue adelante con sus planes de importación, alegando que el plan incumple varias leyes federales y la Constitución de los Estados Unidos.

Pero la reprimenda más dura al plan de importación de Trump llegó de Canadá. El gobierno canadiense se quejó diciendo que ese plan haría más difícil el acceso a los medicamentos para sus ciudadanos, poniendo en riesgo su salud.

“Canadá empleará todas las medidas necesarias para salvaguardar el acceso de los canadienses a los medicamentos”, escribió el gobierno canadiense en una carta a la FDA sobre la propuesta. “El mercado de medicamentos canadiense y su capacidad de fabricación son demasiado pequeños para satisfacer la demanda de medicamentos de venta con receta, de los consumidores canadienses y estadounidenses”.

Sin la participación de Canadá, es poco probable que un plan de importación de medicamentos tenga éxito, aseguraron las autoridades.

Ena Backus, directora de Reforma de Salud en Vermont, que ha trabajado en el establecimiento de un programa de importación, señaló que los estados necesitarán ayuda de Canadá. “Nuestro programa de importación estatal depende de que Canadá se asocie con nosotros”, comentó.

Durante décadas, los estadounidenses han estado comprando medicamentos de Canadá para uso personal, ya sea conduciendo al otro lado de la frontera, ordenando medicamentos por Internet o por medio de comercios que los conectan con farmacias extranjeras. Aunque es ilegal, la FDA ha permitido, por lo general, compras para uso individual.

Unos 4 millones de estadounidenses importan cada año medicamentos de bajo costo para uso personal, y unos 20 millones dicen que ellos o alguien de su familia lo han hecho porque los precios son mucho más bajos en otros países, según las encuestas.

Esta práctica está muy extendida en Florida. Más de una docena de comercios en todo el estado ayudan a los consumidores a conectarse con las farmacias de Canadá y otros países. Varias ciudades, estados y distritos escolares de Florida ayudan a los empleados a obtener medicamentos de Canadá.

La propuesta de la administración se basa en una ley del año 2000 que abrió la puerta para permitir la importación de medicamentos de Canadá. Sin embargo, esa ley sólo podría entrar en vigor si el Secretario del Departamento de Salud y Servicios Humanos (HHS) certificara que la importación es segura, algo que administraciones demócratas y republicanas se han negado a hacer.

La industria farmacéutica ha dicho, durante años, que permitir la importación de medicamentos de Canadá perturbaría la cadena de suministro del país y facilitaría la entrada en el mercado de medicamentos inseguros o falsificados.

Trump, que hizo de la reducción de los precios de los medicamentos con receta una promesa de su campaña en 2016, ha presionado para cumplir con lo prometido. En julio de 2019, por orden de Trump, el Secretario del HHS, Alex Azar, dijo que el gobierno federal estaba “abierto al negocio” de la importación de medicamentos, cuando un año antes había calificado la importación de medicamentos como “un truco”.

La administración prevé un sistema en el que un mayorista con licencia canadiense compra directamente a un fabricante medicamentos aprobados para su venta en Canadá y los exporta a un mayorista/importador de Estados Unidos que tiene contrato con un estado.

La legislación de Florida, aprobada en 2019, establecería dos programas de importación. El primero se centraría en la obtención de medicamentos para programas estatales como Medicaid, el Departamento de Prisiones y los departamentos de Salud de los condados. Los funcionarios estatales dijeron que esperan que los programas ahorren al estado unos $150 millones anuales.

El segundo programa estaría dirigido a la población del estado en general.

En respuesta al borrador de la normativa, los estados que desean iniciar un programa de importación de medicamentos sugirieron cambios a la propuesta de la administración.

“Si la normativa final no aborda estas áreas de preocupación, Colorado tendrá dificultades para encontrar socios apropiados y lograr ahorros significativos para los consumidores”, le comunicó a la FDA, en marzo, Kim Bimestefer, directora ejecutiva del Departamento de Políticas y Financiación de Atención Médica de Colorado.

Entre las preocupaciones del estado figura la limitación a trabajar con un solo mayorista canadiense, ya que al no haber competencia el estado teme que los precios no sean tan bajos como los funcionarios esperaban. Bimestefer también señaló que, según la propuesta, el gobierno federal aprobaría el programa de importación por sólo dos años y los estados necesitan un plazo más largo para conseguir la participación de los mayoristas y otros socios.

Los funcionarios de Colorado estiman que la importación de medicamentos de Canadá podría reducir los precios en un 54% para los medicamentos contra el cáncer y en un 75% para los medicamentos del corazón. El estado también señaló que el medicamento para la diabetes Jardiance cuesta $400 al mes en los Estados Unidos y se vende por $85 en Canadá.

A algunos estados les preocupa que medicamentos caros, incluyendo los inyectables y los biológicos, no figuren en la propuesta federal. Según la ley del 2000, no se permite la importación de ese tipo de medicamentos.

Pero, según una orden ejecutiva de julio, Trump aseguró que permitiría la importación de insulina si Azar determinaba que era necesaria para la atención médica de emergencia. Un portavoz del HHS no pudo confirmar si Azar ha hecho eso.

Jane Horvath, consultora de políticas de salud en College Park, Maryland, dijo que la administración enfrenta varios desafíos para poner en marcha un programa de importación, incluyendo la posible oposición de la industria farmacéutica y los límites a las clases de medicamentos que se pueden vender al otro lado de la frontera.

“A pesar de las dificultades, vale la pena seguir solicitando estos programas”, expresó.

El principal funcionario de salud de Maine dijo que la administración debe trabajar con el gobierno canadiense para atender las preocupaciones de Canadá. Los funcionarios del HHS se negaron a decir si tales discusiones han comenzado.

Los funcionarios de Vermont, donde el programa también incluiría a los consumidores cubiertos por seguros privados, siguen esperanzados.

“Dado que queremos reducir la carga de los costos de atención médica para los residentes de nuestro estado, es importante seguir esta opción si hay un camino claro hacia adelante”, señaló Backus.

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Cory Gardner’s Bill Has as Much to Do With Politics as Preexisting Conditions

Sen. Cory Gardner, a Republican running in a tight race for reelection in Colorado, says he wants to protect people with medical conditions.

In a mid-September tweet released by his campaign, he promoted legislation he introduced in August that he says will do just that.

“People like my mother who battle chronic diseases are heroes,” read the tweet. “I authored the bill to guarantee coverage to people with pre-existing conditions — no matter what happens to Obamacare — because some things matter more than politics.”

Gardner has voted repeatedly to repeal the Affordable Care Act, the first federal law to guarantee people with health problems that they could buy insurance when shopping for their own coverage — at the same cost as for healthier consumers.

Polls show broad public support for keeping the ACA’s preexisting condition protections, while also indicating a consistent, if narrow, majority favoring the overall law.

The popularity of those protections has led Gardner, as well as other GOP candidates facing tough challengers, to swear their allegiance to protecting people with medical conditions, despite their records. In previous fact checks, we found Sen. Martha McSally’s promise always to protect preexisting conditions to be False. President Donald Trump also has made related statements, which have ranged from False to Pants on Fire.

That got us thinking: Would Gardner’s legislation, dubbed “The Pre-Existing Conditions Protection Act,” actually guarantee these protections if the ACA didn’t exist? We decided to investigate.

The bill, which was introduced in August, and has no co-sponsors. It’s very short, only 117 words in total.

The main section is a single very long sentence: “A group health plan and a health insurance issuer offering group or individual health insurance coverage may not impose any pre-existing condition exclusion with respect to such plan or coverage, factor health status into premiums or charges, exclude benefits relating to pre-existing conditions from coverage, or otherwise exclude benefits, set limits, or increase charges based on any pre-existing condition or health status.”

We reached out to the Gardner campaign to ask for more information.

A campaign spokesperson reiterated in an email that Gardner’s goal is “to guarantee coverage for individuals with preexisting conditions and ensure they cannot be charged more as a result of their underlying medical conditions.”

Thomas Miller, a resident fellow at the American Enterprise Institute, a think tank in Washington, D.C., quipped that the main goal might be something else entirely.

“It’s probably about 100 words too long,” Miller said. “It could have said, ‘I’m running for election. I’ll do whatever is necessary.’”

Past Votes, Present Messages

Proponents of the ACA emphasized that the law would help people with medical conditions as they worked to get it passed by Congress, which happened in 2010 following a yearlong failed effort by Democrats to win Republican support. Among a host of other provisions, the law bars insurers from rejecting applicants with medical conditions, as they routinely did when considering individual applicants before the law passed. Nor can insurers charge the sick more than the healthy.

Since the law went into effect in 2014, it has faced many efforts by Republicans in Congress, including Gardner, to repeal it.

It has also faced three Supreme Court challenges. It survived the first two, although one ruling allowed states to opt out of its expansion of Medicaid programs for the poor. The still-pending case was first brought in 2018 by 20 states and is supported by the Trump administration. That case could overturn the entire law, although the court won’t hear arguments on the issue before the election. And that brings us back to Gardner’s bill. An obvious difference between that proposal and the ACA is length. Gardner’s bill is one page, while the ACA runs to several hundred.

And Gardner’s claim seems pegged to the legislative language that says insurers can’t impose a “pre-existing condition exclusion,” which sounds fairly straightforward.

But it’s not, experts say.

“It’s an adorable little bill but does not address any of the main issues,” said Linda Blumberg, a fellow at the nonprofit Urban Institute’s Health Policy Center. “You need a package of policies working together in order to create real protections for people to have coverage to meet their health care needs.”

For instance, the bill does not explicitly bar insurers from outright rejecting applicants with medical conditions, something known as “guaranteed issue.”

“‘Guaranteed issue’ is not in the language of the bill,” said Miller at AEI.

Instead, the language may simply prohibit insurers from restricting services related to a medical condition only if they choose to sell an individual insurance in the first place, he said.

Compare that with the ACA, which says every insurer selling individual or group coverage must accept every employer and individual in the State that applies.”

Also needed in legislation aiming to protect people with medical problems, said Blumberg, are provisions for subsidies to help people of low and moderate income afford their premiums. The ACA has those, along with specific enrollment periods, so that people don’t wait until they are sick to sign up. Without them, mainly those with medical conditions might sign up, driving up costs and premiums. That, in turn, can price people, especially the sick, out of future coverage.

Another way Gardner’s bill differs from the ACA is that it does not list benefits that must be included in a health insurance policy. The ACA requires insurers to cover 10 broad categories of care, including hospitalization, prescription drugs, childbirth, substance abuse treatment and mental health care.

“Without that, insurers could sell products that don’t cover very much, which is what we had prior to 2014,” Blumberg added, which is one way to discourage those who are sick from even applying. “It was difficult to find a product that covered prescription drugs, and we even saw policies that didn’t cover chemotherapy.”

So, What About Costs?

Gardner’s legislation says insurers can’t “factor health status into premiums or charges.”

So insurers could not charge people more simply because they have diabetes, say, or cancer. Still, that leaves open a whole lot of other things that insurers could consider when setting premiums for individuals, such as such as gender or occupation, which could stand in as a proxy for health. Unlike the ACA, it does not bar insurers from setting annual or lifetime dollar limits on coverage, which could disproportionately affect people with costly medical conditions.

The ACA allows insurers to vary premiums for only three reasons: where people live, their age and whether they use tobacco. It sets upper limits, such as charging older folks no more than three times what younger enrollees pay.

Douglas Holtz-Eakin, president of the American Action Forum, who wrote a blog post cited by the Gardner campaign, said the proposed legislation is a starting point — a place holder, if you will. His piece mentioned it near the end of a broader look at the Trump administration’s health platform going into the election.

Responding to questions about Gardner’s legislation, Holtz-Eakin said that if the ACA were to be struck down, Gardner would likely add provisions to it.

“I don’t think it’s intended to be a replacement bill but a provision to make sure people can get coverage,” said Holtz-Eakin. “It’s quite clear on the aim to ensure that people with pre-existing conditions can get insurance, but it doesn’t address every single policy issue that’s out there.”

Health law professor Mark Hall at Wake Forest University said Gardner’s legislation could survive if the ACA were struck down by the Supreme Court, but he noted that Congress would be unlikely to adopt the Gardner bill as written.

“A freestanding protection of pre-existing conditions without any supporting provisions to keep insurance affordable or encourage people to purchase it before they become sick, is almost certain to cause serious harms to the market,” Hall wrote in an email. “Therefore, a lot more is needed to overcome legitimate objections that almost certainly will be made from both sides of the political aisle.”

Our Ruling

Because protecting people with medical conditions requires many moving parts, the brevity of Gardner’s proposal makes it appear to be a fig leaf for a political problem rather than a means to guarantee protections for people with preexisting conditions.

The legislation is unclear on whether it guarantees that people with health problems will be able to buy insurance in the first place. And, even if they can, they may well find it priced out of reach because the legislation does not bar insurers from varying premiums widely on the basis of age, gender or occupation.

Viewed in its most favorable light, Gardner’s 117-word proposal would only serve as a place holder for larger legislation, upon which more protections would have to be layered to bolster the effectiveness of its guarantee.

We rate this statement False.

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Wildfires’ Toxic Air Leaves Damage Long After the Smoke Clears

SEELEY LAKE, Mont. — When researchers arrived in this town tucked in the Northern Rockies three years ago, they could still smell the smoke a day after it cleared from devastating wildfires. Their plan was to chart how long it took for people to recover from living for seven weeks surrounded by relentless smoke.

They still don’t know, because most residents haven’t recovered. In fact, they’ve gotten worse.

Forest fires had funneled hazardous air into Seeley Lake, a town of fewer than 2,000 people, for 49 days. The air quality was so bad that on some days the monitoring stations couldn’t measure the extent of the pollution. The intensity of the smoke and the length of time residents had been trapped in it were unprecedented, prompting county officials to issue their first evacuation orders due to smoke, not fire risk.

Many people stayed. That made Seeley Lake an ideal place to track the long-term health of people inundated by wildfire pollution.

So far, researchers have found that people’s lung capacity declined in the first two years after the smoke cleared. Chris Migliaccio, an immunologist with the University of Montana, and his team found the percentage of residents whose lung function sank below normal thresholds more than doubled in the first year after the fire and remained low a year after that.

“There’s something wrong there,” Migliaccio said.

While it’s long been known that smoke can be dangerous when in the thick of it — triggering asthma attacks, cardiac arrests, hospitalizations and more — the Seeley Lake research confirmed what public health experts feared: Wildfire haze can have consequences long after it’s gone.

That doesn’t bode well for the 78 million people in the western United States now confronting historic wildfires.

Toxic air from fires has blanketed California and the Pacific Northwest for weeks now, causing some of the world’s worst air quality. California fires have burned roughly 2.3 million acres so far this year, and the wildfire season isn’t over yet. Oregon estimates 500,000 people in the state have been under a notice to either prepare to evacuate or leave. Smoke from the West Coast blazes has drifted as far away as Europe.

Extreme wildfires are predicted to become a regular occurrence due to climate change. And, as more people increasingly settle in fire-prone places, the risks increase. That’s shifted wildfires from being a perennial reality for rural mountain towns to becoming an annual threat for areas across the West.

Dr. Perry Hystad, an associate professor in the College of Health and Human Sciences at Oregon State University, said the Seeley Lake research offers unique insights into wildfire smoke’s impact, which until recently had largely been unexplored. He said similar studies are likely to follow because of this fire season.

“This is the question that everybody is asking,” Hystad said. “‘I’ve been sitting in smoke for two weeks, how concerned should I be?’”

Migliaccio wants to know whether the lung damage he saw in Seeley Lake is reversible — or even treatable. (Think of an inhaler for asthma or other medication that prevents swollen airways.)

But those discoveries will have to wait. The team hasn’t been able to return to Seeley Lake this year because of the coronavirus pandemic.

Migliaccio said more research is needed on whether wildfire smoke damages organs besides the lungs, and whether routine exposure makes people more susceptible to diseases.

The combination of the fire season and the pandemic has spurred other questions as well, like whether heavy smoke exposure could lead to more COVID-19 deaths. A recent study showed a spike in influenza cases following major fire seasons.

“Now you have the combination of flu season and COVID and the wildfires,” Migliaccio said. “How are all these things going to interact come late fall or winter?”

A Case Study

Seeley Lake has long known smoke. It sits in a narrow valley between vast stretches of thick forests.

On a recent September day, Boyd Gossard stood on his back porch and pointed toward the mountains that were ablaze in 2017.

Gossard, 80, expects to have some summer days veiled in haze. But that year, he said, he could hardly see his neighbor’s house a few hundred feet away.

“I’ve seen a lot of smoke in my career,” said Gossard, who worked in timber management and served as a wildland firefighter. “But having to just live in it like this was very different. It got to you after a while.”

When Missoula County health officials urged people to leave town and flee the hazardous smoke, many residents stayed close to home. Some said their jobs wouldn’t let them leave. Others didn’t have a place to go — or the money to get there.

Health officials warned those who stayed to avoid exercising and breathing too hard, to remain inside and to follow steps to make their homes as smoke-free as possible. The health department also worked to get air filters to those who needed them most.

But when flames got too close, some people had to sleep outside in campsites on the other side of town.

Understanding the Science of Smoke

One of the known dangers of smoke is particulate matter. Smaller than the width of a human hair, it can bypass a body’s defenses, lodging deep into lungs. Lu Hu, an atmospheric chemist with the University of Montana, said air quality reports are based on how much of that pollution is in the air.

“It’s like lead; there’s no safe level, but still we have a safety measure for what’s allowable,” Hu said. “Some things kill you fast and some things kill you slowly.”

While air quality measurements can gauge the overall amount of pollution, they can’t assess which specific toxins people are inhaling. Hu is collaborating with other scientists to better predict how smoke travels and what pollutants people actually breathe.

He said smoke’s chemistry changes based on how far it travels and what’s burning, among other factors.

Over the past few years, teams of researchers drove trucks along fire lines to collect smoke samples. Other scientists boarded cargo planes and flew into smoke plumes to take samples right from a fire’s source. Still others stationed at a mountain lookout captured smoke drifting in from nearby fires. And ground-level machines at a Missoula site logged data over two summers.

Bob Yokelson, a longtime smoke researcher with the University of Montana, said scientists are getting closer to understanding its contents. And, he said, “it’s not all bad news.”

Temperature and sunlight can change some pollutants over time. Some dangerous particles seem to disappear. But others, such as ozone, can increase as smoke ages.

Yokelson said scientists are still a long way from determining a safe level of exposure to the 100-odd pollutants in smoke.

“We can complete the circle by measuring not only what’s in smoke, but measuring what’s happening to the people who breathe it,” Yokelson said. “That’s where the future of health research on smoke is going to go.”

Coping With Nowhere to Flee

In the meantime, those studying wildland smoke hope what they’ve learned so far can better prepare people to live in the haze when evacuation isn’t an option.

Joan Wollan, 82, was one of the Seeley Lake study participants. She stayed put during the 2017 fire because her house at the time sat on a border of the evacuation zone.

The air made her eyes burn and her husband cough. She ordered air filters to create cleaner air inside her home, which helped.

On a recent day, the air in Wollan’s new neighborhood in Missoula turned that familiar gray-orange as traces of fires from elsewhere appeared. Local health officials warned that western Montana could get hit by some of the worst air quality the state had seen since those 2017 fires.

If it got bad enough, Wollan said, she’d get the filters out of storage or look for a way to get to cleaner air — “if there is someplace in Montana that isn’t smoky.”

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KHN on the Air This Week

KHN chief Washington correspondent Julie Rovner discussed what the U.S. elections mean for on the BBC’s “Business Day” on Tuesday.


KHN senior correspondent Liz Szabo discussed COVID-19 vaccines on Newsy’s “Morning Rush” on Tuesday and on iHeartRadio’s “The Daily Dive” on Wednesday.


KHN Midwest correspondent Lauren Weber spoke to Margie Shafer on KCBS Radio in San Francisco on Wednesday about how more than 20 states aren’t fully counting COVID-19 antigen tests.


Bernard J. Wolfson, columnist and senior correspondent for California Healthline, discussed masking up for both COVID-19 and smoke from wildfires on Newsy’s “Morning Rush” on Thursday.

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Election Gift for Florida? Trump Poised to Approve Drug Imports From Canada

Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.

Six states — Colorado, Florida, Maine, New Hampshire, New Mexico and Vermont — have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.

But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida — the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.

The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.

Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan — something that could occur before the November election.

“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a Colorado-based health consultant who has worked with Florida on its importation proposal.

Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.

Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.

The DeSantis administration did not respond to requests for comment.

Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”

The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.

The proposal would regulate how states set up their own programs for importing drugs from Canada.

Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.

The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.

But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.

“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”

Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.

Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.

For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the internet or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.

About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.

The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.

The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.

The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.

Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”

The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.

Florida’s legislation — approved in 2019 — would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.

The second program would be geared to the broader state population.

In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.

“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.

Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.

Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.

Several states worry some of the most expensive drugs — including injectable and biologic medicines — were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.

However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.

Jane Horvath, a health policy consultant in College Park, Maryland, said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.

“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.

Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.

Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.

“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.

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In Face of COVID Threat, More Dialysis Patients Bring Treatment Home

Maria Duenas, 60, has kidney failure and is on the kidney transplant list. But until she finds a match, she will administer her own dialysis treatment at home.(Heidi de Marco/KHN)

NIPOMO, Calif. — After Maria Duenas was diagnosed with Type 2 diabetes about a decade ago, she managed the disease with diet and medication.

But Duenas’ kidneys started to fail just as the novel coronavirus established its lethal foothold in the U.S.

On March 19, three days after Duenas, 60, was rushed to the emergency room with dangerously high blood pressure and blood sugar, Gov. Gavin Newsom implemented the nation’s first statewide stay-at-home order.

Less than one week later, Duenas was hooked up to a dialysis machine in the Century City neighborhood of Los Angeles, 160 miles from her Central Coast home, where tubes, pumps and tiny filters cleansed her blood of waste for 3½ hours, doing the work her kidneys could no longer do.

In the beginning, Duenas said she didn’t understand the severity of COVID-19, or her increased vulnerability to it. “It’s not going to happen to me,” she thought. “We’re in a small little town.”

But she was unable to find a spot in a dialysis clinic in, or near, Nipomo. So, with her husband, Jose, at her side, Duenas made long road trips to Century City for more than two months.

In May, Duenas’ doctor told her she was a good candidate for home dialysis, which would save her drive time and stress — and reduce her exposure to the virus.

The closet in Duenas’ grandchildren’s playroom is crammed with peritoneal dialysis solution, a mixture of dextrose, calcium and magnesium. She uses two bags for every treatment. Cabinets and drawers in her bedroom are filled with disinfectant wipes, gauze, masks and gloves.(Heidi de Marco/KHN)

Now, Duenas assiduously sterilizes herself and her surroundings five nights a week so she can administer dialysis to herself at home while she sleeps.

“There’s always a chance going in that somebody’s going to have COVID and still need dialysis” in a clinic, Duenas said. “I’m very grateful to have this option.”

The increase in home dialysis has accelerated recently, spurred by social-distancing requirements, increased use of telehealth and remote monitoring technologies — and fear of the virus.

Duenas starts her home dialysis routine around 8 p.m. She must maintain a sterile environment and uses masks and gloves. Her husband, Jose, installed an automatic paper towel dispenser in their bathroom to help ensure proper hygiene.(Heidi de Marco/KHN)

While recent, comprehensive data is hard to come by, experts confirm the trend based on what they’re seeing in their own practices. Fresenius Medical Care North America, one of the country’s two dominant dialysis providers, said it conducted 25% more home dialysis training sessions in the first quarter of 2020 than in the same period last year, according to Renal & Urology News.

“People recognized it would be better if they did it at home,” said Dr. Susan Quaggin, president-elect of the American Society of Nephrology. “And certainly from a health provider’s perspective, we feel it’s a great option.”

Duenas vigorously washes her hands before she cleans the area around the catheter in her abdomen. She also sterilizes the dialysis equipment before hooking herself up for the night.(Heidi de Marco/KHN)

Nearly half a million people in the United States are on dialysis, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Roughly 85% of them travel to a clinic for their treatments.

Dialysis patients are at higher risk of contracting COVID-19 and getting seriously ill with it, said Dr. Anjay Rastogi, director of the UCLA CORE Kidney Program, where Duenas is a patient.

In an analysis of more than 10,000 deaths in 15 states and New York City, the Centers for Disease Control and Prevention found about 40% of people killed by COVID-19 had diabetes. That percentage rose to half among people under 65.

But people on dialysis are also vulnerable to COVID-19 because they usually visit dialysis clinics two to three times a week for an average of four hours at a time, exposing themselves to other patients and, potentially, the virus, Rastogi said.

“Now even more so, we are strongly urging our patients to consider home dialysis,” he said.

Although patients on home dialysis reduce their exposure to COVID-19 by avoiding clinics, they face other challenges. Home dialysis requires supplies such as dialysis fluid, drain bags, tubing, disinfectant and personal protective equipment. According to a recent study, patients may have problems obtaining dialysis supplies because supply chains are strained.(Heidi de Marco/KHN)

Duenas uses her bedroom mirror to make sure her catheter is properly covered with gauze before she goes to bed. She will be tethered to the machine overnight.(Heidi de Marco/KHN)

There are two kinds of dialysis: hemodialysis and peritoneal dialysis. In hemodialysis, which is administered in a hospital or clinic, or sometimes at home, a dialysis machine pumps blood out of the body and through a special filter called a dialyzer, which clears waste and extra fluid from the blood before it is returned to the body.

Dialysis treatment centers that offer hemodialysis have intensified their infection-control procedures in response to COVID-19, said Dr. Kevin Stiles, a nephrologist at Kaiser Permanente in Bakersfield. Visitors are no longer allowed to accompany patients, and patients get temperature checks and must wear masks during treatment, he said. (KHN, which produces California Healthline, is not affiliated with Kaiser Permanente.)

In peritoneal dialysis, which is the more popular home option because it is less cumbersome and restrictive, the inside lining of the stomach acts as a natural filter. Dialysis solution cleanses waste from the body as it is washed into and out of the stomach through a catheter in the abdomen.

It takes Duenas about 45 minutes to prepare her overnight treatment. Her tubing allows her to get as far as her bathroom, but she sometimes gets tangled in it at night.(Heidi de Marco/KHN)

Not everyone is eligible for home dialysis, which comes with its own challenges.

Home dialysis requires patients or their caregivers to lift bags of dialysis solution that weigh 5 to 10 pounds, Stiles said. Good eyesight and hand dexterity are also critical because patients must be able to maintain sterile environments.

Home patients need dialysis equipment and regular deliveries of supplies such as dialysis fluid, drain bags, tubing, disinfectant and personal protective equipment. In response to COVID-19, some clinics have arranged courier services and contracted with labs to deliver supplies to patients.

The Trump administration has encouraged greater use of home dialysis and in July proposed increasing Medicare reimbursement rates for home dialysis machines, citing “the importance that this population stay at home during the public health emergency to reduce risk of exposure to the virus.”

The morning after her treatment, Duenas disinfects the dialysis machine and then disconnects her catheter tube from the machine so that she can move around freely.(Heidi de Marco/KHN)

Medicare covers almost all patients who receive dialysis treatment, including home dialysis, and patients typically pay 20% as coinsurance.

Medicare, which spends an average of $90,000 per hemodialysis patient annually, spent more than $35 billion on patients with end-stage renal disease in 2016.

Duenas is awaiting a kidney transplant. Until she finds a match, she’ll be administering her own peritoneal dialysis at home.

Duenas inspects her drain bag in the morning for fibrin, a protein that can clog her catheter. She must alert her doctor if she finds any floating in the fluid.(Heidi de Marco/KHN)

“To be honest, I didn’t want to do it,” she said of home dialysis. “It was scary having to think about taking care of my own treatment.”

Now, three months later, guided by training and the prompts on the dialysis machine, Duenas feels comfortable, capable and safe.

Looking back, she said, “it was a blessing in disguise.”

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

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