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Early Trial Results Show Promise For Johnson & Johnson And Beth Israel Vaccine

CommonHealth (WBUR) - Sat, 09/26/2020 - 7:44pm

The company will recruit 60,000 participants to take part in the trial, making it the largest test of a coronavirus vaccine to date.

Categories: Health Care

In Case You Missed It...

Center on Budget and Policy Priorities - Fri, 09/25/2020 - 3:38pm

This week at CBPP, we focused on poverty and inequality, food assistance, health, state budgets and taxes, and the economy.

Categories: Benefits, Poverty

COVID Outbreak At Brigham And Women's Hospital Grows To 19 Known Cases

CommonHealth (WBUR) - Fri, 09/25/2020 - 12:57pm

The hospital in a statement late Thursday said to date, 98 employees had been tested, with 11 testing positive. Also, 50 patients had been tested, with eight positive.

Categories: Health Care

From the Serial Set: Citizenship and Suffrage for Native Americans

In Custodia Legis - Fri, 09/25/2020 - 10:00am

Welcome to the final installment of suffrage stories from the Serial Set! Today, we will be looking at the history of Native American citizenship and how voting rights came into play.

Despite the ratification of the 15th Amendment in 1870, Native Americans were not guaranteed citizenship, nor voting rights, under the United States government. Reports from the Bureau of Indian Affairs were documented in the United States Congressional Serial Set until 1849, when the Bureau was transferred to the Department of the Interior. To better understand the origins of Native American suffrage, citizenship laws can be tracked through the Statutes at Large.

Following the 1830 passage of the Indian Removal Act (An Act to provide for an exchange of lands with the Indians residing in any of the states or territories, and for their removal west of the river Mississippi) by the 21st Congress, the United States and Native American leadership continued to negotiate and ratify land treaties until 1871.

The Dawes Severalty Act (An act to provide for the allotment of lands in severalty to Indians on the various reservations, and to extend the protection of the laws of the United States and the Territories over the Indians, and for other purposes) was passed in 1887 by the 49th Congress. Any Native American reservations established by treaty or act of Congress came under presidential authority for subdivision and re-allotment, promising citizenship to Native Americans who received land allotments. The tribes excepted from this law were the Five Civilized Tribes, along with the “Osage, Miamies and Peorias, and Sacs and Foxes…the Seneca Nation…[and] that strip of territory in the State of Nebraska.”

The 1898 Curtis Act (An Act for the protection of the people of the Indian Territory, and for other purposes), passed by the 55th Congress, dismantled remaining Native American self-governance systems. This law voided the laws of tribal governments and abolished tribal courts, directing the Secretary of the Interior to appoint a Native American inspector to carry out United States government affairs instead.

The sixth section of the Dawes Severalty Act was amended by the 59th Congress in 1906. Known as the Burke Act, or the Forced Fee Patenting Act, this amendment withheld citizenship privileges to Native Americans until “the expiration of the [25-year] trust period and when the lands have been conveyed to the Indians by patent in fee.” After one of these two criteria was met, Native Americans who lived independently of tribal lands, “adopted the habits of civilized life,” and were approved by the Secretary of the Interior, were “hereby declared…citizen[s] of the United States…entitled to all the rights, privileges, and immunities of such citizens.”

In 1919, An Act Granting citizenship to certain Indians ultimately afforded “all the privileges pertaining” to United States citizenship and honorable discharge to “every American Indian who served in the Military or Naval Establishments of the United States during [World War I],” independent of individual tribal rights.

The Serial Set documents the development of bills through the editing process and includes interdepartmental correspondence that contribute to the legislative process. Then-Secretary of the Interior Franklin K. Lane submitted his opinion as follows:

“In my judgment the controlling factor in granting citizenship to Indians should not be based upon their ownership of lands, tribal or in severalty, in trust or in fee, but upon the fact that they are real Americans, and are of right entitled to citizenship.” (H. Rpt. No. 144, 66th Cong., 1st Sess., at 4 (1919) reprinted in Serial Set vol. 7592.)

The Serial Set contains four volumes under the title “Indian affairs, laws and treaties.” Volume IV, “Laws,” is volume number 8849. It includes the full text of An Act To authorize the Secretary of the Interior to issue certificates of citizenship to Indians, also known as the Snyder Act (after New York Representative Homer P. Snyder) granted citizenship to “all non-citizen Indians born within the territorial limits of the Unites States.” An excerpt appears as follows:

S. Doc. 53, 70th Cong., 1st Sess., at 420 (1929) reprinted in Serial Set vol. 8849. Photo by Bailey DeSimone.

While United States citizenship included the right to vote in elections, disenfranchisement practices continued. According to a Senate document from 1929, Native American citizens “may be denied the privilege of voting if they fail to comply with the requirements of the law as to registration, payment of poll tax, or do not meet the educational or other qualifications for electors, etc., as provided by the State laws.” (S. Doc. 53, 70th Cong., 1st Sess., at 1165 (1929) reprinted in Serial Set vol. 8849.)

While researching further, I discovered a 1906 Senate document entitled “Proposed State of Sequoyah.” Senator Joseph B. Foraker of Ohio submitted a draft constitution for Sequoyah, a proposed state for a majority Native American population, to be located in the Oklahoma territory.

The Serial Set also contains a copy of the map of the proposed state of Sequoyah:

Article VI outlines voting rights. Apart from persons living with mental health issues, “paupers,” persons employed by the Army or Navy, and convicted felons, elections were to “be free, equal, and by secret ballot.” (59) Although the 19th Amendment had not yet been ratified, Article VI included a promise to “enact laws to extend the right of suffrage to women of rightful age, and otherwise qualified according to the provisions of this article.” (S. Doc. 143, 59th Cong., 1st Sess., at 59 (1906) reprinted in Serial Set vol. 4912.)

Doc. 143, 59th Cong., 1st Sess., at 59 (1906) reprinted in Serial Set vol. 4912. Photo by Bailey DeSimone.

Researching Native American suffrage history uncovered the pre-history of Sequoyah. While the proposal did not pass with congressional approval, the Serial Set preserves its origins, draft constitution, and proposed geography. The Serial Set is an important collection that gives rare and valuable context to this history of United States law, regardless of whether bills or memorials (like that of the proposed state of Sequoyah) become law.

S. Doc. 143, 59th Cong., 1st Sess., at 46 (1906) reprinted in Serial Set vol. 4912. Photo by Bailey DeSimone.

Although the suffrage journey for Native Americans had begun, well over 40 years passed before every state complied with the Snyder Act and enfranchised Native Americans. The history of suffrage is vastly different for many groups of people, and it has been fascinating to research just a few of them.

Categories: Research & Litigation

Trump Approves Final Plan to Import Drugs From Canada ‘for a Fraction of the Price’

Kaiser Health News - Fri, 09/25/2020 - 5:00am

President Donald Trump, outlining his “America First Health Plan” Thursday, announced that his administration will allow the importation of prescription drugs from Canada.

The final plan clears the way for Florida and other states to implement a program bringing medications across the border despite the strong objections of drugmakers and the Canadian government.

Florida, the biggest swing state in the presidential election, is one of six states to pass laws seeking federal approval to import drugs. Trump’s announcement came the same day counties in Florida began sending out vote-by-mail ballots.

Florida Gov. Ron DeSantis, a close ally of the president, is a strong advocate of importing drugs. His administration has already advertised for a contractor to run the state program and is expected to announce Tuesday which companies have bid for the three-year, $30 million state contract.

Congress has allowed drug importation since 2000 but only if the secretary of the Department of Health and Human Services certified it is safe. That has never occurred until Secretary Alex Azar did it Wednesday, according to a letter he wrote to congressional leaders.

Implementation under the administration’s final rule “poses no additional risk to the public’s health and safety and will result in a significant reduction in the cost of covered products to the American consumer,” Azar said in the letter KHN obtained Thursday.

Prices are cheaper north of the border because Canada limits how much drugmakers can charge for medicines. The United States lets free market dictate drug prices.

The pharmaceutical industry has long fought efforts on importation, arguing that it would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.

“We are reviewing the final rule and guidance that were released; however, we continue to have grave concerns with drug importation that exposes Americans unnecessarily to the dangers of counterfeit or adulterated drugs,” said a spokesperson for the Pharmaceutical Research and Manufacturers of America, an industry trade group. “It is alarming that the administration chose to pursue a policy that threatens public health at the same time that we are fighting a global pandemic.”

Drugmakers have suggested in the past that they might try to stop such a policy through a lawsuit.

Trump has dangled his drug importation plan in campaign speeches over the past year — and again on Thursday in North Carolina during a speech that provided a litany of his promises on health care.

“We will finally allow the safe and legal importation of drugs from Canada,” Trump said. States “can go to Canada and buy your drugs for a fraction of the price” in the U.S.

“This will be a game changer for American seniors,” Trump said. “We’re doing it very, very quickly.”

The administration proposed the regulation in December. The final rule says it takes effect in 60 days.

But individuals will not be allowed to import drugs on their own, Azar said in his letter. Instead, they will have to rely on programs run by states.

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 the practice is illegal, the FDA has generally permitted purchases for individual use.

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

The practice has been especially common in retiree-rich Florida, where more than a dozen stores help consumers make the purchases and where numerous cities, counties and school districts assist employees with the transactions.

The administration envisions a system in which a Canadian-licensed wholesaler buys from a manufacturer of 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 program to save the state about $150 million annually.

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

The HHS final rule said the government will “in the future” allow pharmacists to import drugs from Canada, a provision that matches the law approved by Florida in 2019.

But pharmacists in Florida and across the country oppose drug importation, saying they don’t think it will ensure that counterfeit drugs are kept out of the U.S. market.

The Canadian government told HHS last spring that the country doesn’t have enough drugs to spare and the Trump plan would only worsen shortages of medicines there.

The final rule said state importation programs will have flexibility to decide which drugs to import and in what quantities.

The rule also makes clear that drug manufacturers will have to provide to importers documentation guaranteeing the medications are the same drugs as those already sold in the United States. HHS could set up regulations that require drugmakers to comply. Importers will have to send drugs to labs to certify their authenticity.

In addition to Florida, the other states seeking federal permission to buy drugs from Canada are Colorado, Maine, New Hampshire, New Mexico and Vermont.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Categories: Health Care

Heartbreaking Bills, Lawsuit and Bankruptcy — Even With Insurance

Kaiser Health News - Fri, 09/25/2020 - 5:00am

Matthew Fentress was just 25 when he passed out while stuffing cannolis as a cook for a senior living community six years ago. Doctors diagnosed him with viral cardiomyopathy, heart disease that developed after a bout of the flu.

Three years later, the Kentucky man’s condition had worsened, and doctors placed him in a medically induced coma and inserted a pacemaker and defibrillator. Despite having insurance, he couldn’t pay what he owed the hospital. So Baptist Health Louisville sued him and he wound up declaring bankruptcy in his 20s.

“The curse of being sick in America is a lifetime of debt, which means you live a less-than-opportune life,” said Fentress, who still works for the senior facility, providing an essential service throughout the coronavirus pandemic. “The biggest crime you can commit in America is being sick.”

Financial fears reignited this year when his cardiologist suggested he undergo an ablation procedure to restore a normal heart rhythm. He said hospital officials assured him he wouldn’t be on the hook for more than $7,000, a huge stretch on his $30,000 annual salary. But if the procedure could curb the frequent extra heartbeats that filled him with anxiety, he figured the price was worth it.

He had the outpatient procedure in late January and it went well.

Afterward, “I didn’t have the fear I’m gonna drop dead every minute,” he said. “I felt a lot better.”

Then the bill came.

Patient: Matthew Fentress is a 31-year-old cook at Atria Senior Living who lives in Taylor Mill, Kentucky. Through his job, he has UnitedHealthcare insurance with an out-of-pocket maximum of $7,900 — close to the maximum allowed by law.

Total Bill: Fentress owed a balance of $10,092.13 for cardiology, echocardiography and family medicine visits on various dates in 2019 and 2020. UnitedHealthcare had paid $28,920.52 total, including $27,561.37 for the care he received on the day of his procedure.

Service Provider: Baptist Health Louisville, part of the nonprofit system Baptist Health.

Medical Service: Fentress underwent cardiac ablation this year on Jan. 23. The outpatient procedure involved inserting catheters into an artery in his groin that were threaded into his heart. He also had related cardiology services, testing and visits to a primary care doctor and a cardiologist before and after the procedure.

What Gives: Fentress said he always made sure to take jobs with health insurance, “so I thought I’d be all right.”

But like nearly half of privately insured Americans under age 65, he has a high-deductible health plan, a type of insurance that experts say often leaves patients in the lurch. When he uses health providers within his insurer’s network, his annual deductible is $1,500 plus coinsurance. His out-of-pocket maximum is $7,900, more than a quarter of his annual salary.

Fentress owed around $5,000 after his 2017 hospitalization and set up a monthly payment plan but said he was sent to collections after missing a $150 payment. He declared bankruptcy after the same hospital sued him.

He faced another bill about a year later, when a panic attack sent him to the emergency room, he said. That time, he received financial aid from the hospital.

When he got the bill for his ablation this spring, he figured he wouldn’t qualify for financial aid a second time. So instead of applying, he tried to set up a payment plan. But hospital representatives said he’d have to pay $500 a month, he said, which was far beyond his means and made him fear another spiral into bankruptcy.

This precarious situation makes him “functionally uninsured,” said author Dave Chase, who defines this as having an insurance deductible greater than your savings. “It’s a lot more frequent than a lot of people realize,” said Chase, founder of Health Rosetta, a firm that advises large employers on health costs. “We’re the undisputed leaders in medical bankruptcy. It’s a sad state of affairs.”

Jennifer Schultz, an economics professor and co-director of the Health Care Management program at the University of Minnesota-Duluth, said Fentress faces a difficult financial road ahead. “Once you declare bankruptcy, your credit rating is destroyed,” she said. “It will be hard for a young person to come back from that.”

A recent survey by the Commonwealth Fund found that just over a quarter of adults 19 to 64 who reported medical bill problems or debt were unable to pay for basic necessities like rent or food sometime in the past two years. Three percent had declared bankruptcy. In the first half of 2020, the survey found, 43% of U.S. adults ages 19 to 64 were inadequately insured. About half of them were underinsured, with deductibles accounting for 5% or more of their household income, or out-of-pocket health costs, excluding premiums, claiming 10% or more of household income over the past year.

In Fentress’ case, the $10,092 he owed the hospital was more than a third of what his insurer paid for his care. The majority of his debt — $8,271.56 — was coinsurance, about 20% of the bill, which he must pay after meeting his deductible. Because the bill covered services spanning two years, he owed more than his annual out-of-pocket maximum. If all his care had been provided during 2019, he would have owed much less and the insurer would have been responsible for more of the bill.

Dr. Kunal Gurav, an Atlanta cardiologist who wrote about medical costs for the American College of Cardiology, said ablation usually costs about $25,000-$30,000, a range also confirmed by other experts.

The insurer’s payment for Fentress’ care that January day — around $27,600 — falls into the typical cost range, Gurav said. Fentress is being asked to pay $9,296, meaning the hospital would get more than $36,000 for the care.

Schultz, a state representative from Minnesota’s Democratic-Farmer-Labor Party, said nonprofit hospitals could potentially waive or reduce costs for needy patients.

“They definitely have a moral responsibility to provide a community benefit,” she said.

Resolution: Charles Colvin, Baptist Health’s vice president for revenue strategy, said hospital officials quoted Fentress an estimated price for the ablation that was within a few dollars of the final amount, although his bill included other services such as tests and office visits on various dates. Colvin said there appeared to be some charges that UnitedHealthcare didn’t process correctly, which could lower his bill slightly.

Maria Gordon Shydlo, communications director for UnitedHealthcare, said Fentress is responsible for 100% of health costs up to his annual, in-network deductible, then pays a percentage of health costs in “coinsurance” until he reaches his out-of-pocket maximum. So he will owe around $7,900 on his bill, she said, and any new in-network care will be fully covered for the rest of the year.

A hospital representative suggested Fentress apply for financial assistance. She followed up by sending him a form, but it went to the wrong address because Fentress was in the process of moving.

In September, he said he was finally going to fill out the form and was optimistic he’d qualify.

The Takeaway: Insurance performs two functions for those lucky enough to have it. First, you get to take advantage of insurers’ negotiated rates. Second, the insurer pays the majority of your medical bills once you’ve met your deductible. It pays nothing before then. High-deductible plans have the lowest premiums, so they are attractive or are the only plans many patients can afford. But understand you will be asked to pay for everything except preventive care until you’ve hit that number. And your deductible may be only part of the picture: “Coinsurance” is the bulk of what Fentress owes.

Out-of-pocket maximums are regulated by federal law. In 2021, the maximum will be $8,550 for single coverage. Try to plan treatment and procedures with an eye on the calendar — people with chronic conditions and this kind of insurance could save a lot of money if they have an expensive surgery in December rather than January.

As always, if you face a big medical bill, ask about payment plans, financial aid and charity care. According to the Baptist Health system’s website, the uninsured and underinsured can get discounts. Those with incomes equivalent to 200%-400% of the federal poverty level — or $25,520-$51,040 for an individual — may be eligible for assistance.

If you don’t qualify for help, negotiate with the hospital anyway. Arm yourself with information about the going rate insurers pay for the care you received by consulting websites like Healthcare Bluebook or Fair Health.

As Fentress tries to move past his latest bill, he’s now worried about something else: racking up new bills if he contracts COVID-19 down the road as an essential worker with existing health problems and the same high-deductible insurance.

“I don’t have hope for a financially stable future,” he said. “It shouldn’t be such a struggle.”

Dan Weissmann, host of “An Arm and a Leg” podcast, reported the radio interview of this story. Joe Neel of NPR produced Sacha Pfeiffer’s interview with KHN Editor-in-Chief Elisabeth Rosenthal on “All Things Considered.”

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Categories: Health Care

In Los Angeles, Latinos Hit Hard By Pandemic’s Economic Storm

Kaiser Health News - Fri, 09/25/2020 - 5:00am

Working as a fast-food cashier in Los Angeles, Juan Quezada spends a lot of his time these days telling customers how to wear a mask.

“They cover their mouth but not their nose,” he said. “And we’re like, ‘You gotta put your mask on right.'”

Quezada didn’t expect to be enforcing mask-wearing. Six months ago, he was a restaurant manager, making $30 an hour, working full time and saving for retirement. But when Los Angeles County health officials shut down most restaurants in March because of the spreading pandemic, Quezada lost his job. The only work he could find pays a lot less and is part time.

“I only work three hours and four hours rather than eight or 10 or 12 like I used to work,” he said.

Quezada doesn’t know anyone who has gotten COVID-19, but the pandemic has affected nearly every aspect of his life. “I am just draining my savings — draining and draining and draining,” he said. “I have to sell my car. Uber is a luxury.” Mostly, he now bikes or rides the bus to his part-time job.

Quezada is one of hundreds of people who responded in a newly published poll by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health. Among other things, the poll, which surveyed people from July 1 to Aug. 3, found that a whopping 71% of Latino households in Los Angeles County have experienced serious financial problems during the pandemic, compared overall with 52% of Black households there and 37% of whites. (Latinos can be of any race or combination of races.)

Like Quezada, many are burning through their savings and are having a hard time paying for necessities such as food. Quezada estimated he has about six months of savings left.

In Los Angeles, more than 35% of households report serious problems with paying credit cards, loans or other bills, while the same percentage report having depleted all or most of their savings. Eleven percent of Angelenos polled said they didn’t have any savings at the start of the outbreak.

Nationally, the picture is similar. In results released last week, the poll found that 72% of Latino households around the country reported they’re facing serious financial problems, double the share of whites who said so. And 46% of Latino households reported they have used up all or most of their savings during the pandemic.

How Poverty Differs for Latinos

Nationally, the poll found that 63% of Latinos reported loss of household income either through reduced hours or wages, furloughs or job loss since the start of the pandemic.

But Latinos have kept working through the crisis, said David Hayes-Bautista, a professor of medicine and public health at UCLA.

“In Washington, the idea is you’re poor because you don’t work. That’s not the issue with Latinos,” he said. “Latinos work. But they’re poor. The problem is, we don’t pay them.”

Latinos have the highest rate of labor force participation of any group in California. In March, when state and local officials shut down many businesses, Latinos lost jobs like everyone else. But Latinos got back to work faster.

“In April, the Latino [labor force participation] rate bounced right back up and actually has continued to increase slowly, whereas the non-Latino rate is dropping,” Hayes-Bautista said. “The reward that Latinos have for their high work ethic is a high rate of poverty.”

That work ethic has also contributed to a much higher rate of COVID-19. Hayes-Bautista pointed out that in California, as in some other regions in the U.S., Latinos tend to hold many of the jobs that have been deemed essential, and that’s made them highly susceptible to the coronavirus. Latinos now account for 60% of COVID-19 cases in California, even though they’re about 40% of the population.

Not only are they getting infected, but there’s been nearly a fivefold increase in working-age Latinos dying from the coronavirus since May.

“These are workers usually in their prime years — peak earning power and everything else,” Hayes-Bautista said. “Latinos between 50 and 69, those are the ones that are being hit the hardest. That’s pretty worrying.”

Exposed — And Often Without Health Insurance

Nationally, according to the poll, 1 in 4 Latino households report serious problems affording medical care during the pandemic.

Many of the essential jobs that Latinos are more likely to perform — farmworker or nursing home aide or other contract work, for example — lack benefits. That means some Latinos are more exposed to the coronavirus and less likely to have health insurance because they don’t get coverage through an employer.

Others, such as Mariel Alvarez, lack health insurance because of citizenship restrictions. She lives with her parents and sisters in Los Angeles County’s San Fernando Valley. Alvarez lost her sales job and her employer-sponsored health insurance when the pandemic hit in March, she said. Then she got sick.

Eventually, her whole family was ill. Alvarez had to pay out-of-pocket to go to a CVS clinic near her home. But after a couple of $50 visits, it got too expensive.

“I just couldn’t afford to continue to go to the doctor,” she said. She suspected it was COVID-19 but was unable to get tested.

Now that she’s recovered, getting a job with health insurance is crucial because she doesn’t qualify for any state or federal support. Alvarez is undocumented and was brought to the U.S. by her parents as a child from Bolivia. She’s one of roughly 640,000 immigrants who has a permit allowing her to work and defer deportation under the Deferred Action for Childhood Arrivals program, or DACA.

“I don’t want to jeopardize that,” Alvarez said. “You’re not supposed to use any of the government assistance when you’re on that. You’re only supposed to work, and that’s it.”

The pandemic has created a big need for one job: contact tracers. So Alvarez completed a free certificate online in the hope it will give her an edge. She’s going through the application process; if she gets hired, she hopes to have benefits again.

In the meantime, she’ll do her best not to get sick.

Jackie Fortiér is a health reporter for KPCC and LAist.com.

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

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Categories: Health Care

KHN on the Air This Week

Kaiser Health News - Fri, 09/25/2020 - 5:00am

KHN chief Washington correspondent Julie Rovner discussed the impact of the death of Justice Ruth Bader Ginsburg on the Affordable Care Act with Noel King, host of NPR’s “Morning Edition” on Monday and “Newsy Tonight” on Tuesday.

KHN correspondent Rachana Pradhan discussed antigen testing gaps on Newsy’s “Morning Rush” on Tuesday and Big If True’s “Hard Reset” podcast on Wednesday.

KHN contributing columnist Judith Graham discussed disparities that older Black Americans face on WFAE’s “Morning Edition” on Sept. 15.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Categories: Health Care

En Los Angeles, la tormenta económica por la pandemia ha pegado fuerte en los latinos

Kaiser Health News - Fri, 09/25/2020 - 4:05am

Al trabajar como cajero de comida rápida en Los Angeles, Juan Quezada pasa mucho de su tiempo estos días diciéndole a los clientes cómo usar una máscara.

“Se cubren la boca pero no la nariz”, dijo. “Y nosotros les decimos: ‘Tienes que ponerte la máscara bien'”.

Quezada nunca imaginó que acabaría haciendo cumplir el uso de la máscara. Hace seis meses, era gerente de un restaurante, ganaba $30 la hora, trabajaba a tiempo completo y ahorraba para su jubilación.

Pero cuando los funcionarios de salud del condado de Los Angeles cerraron la mayoría de los restaurantes, en marzo, por la pandemia, Quezada perdió su trabajo. El único que pudo encontrar paga mucho menos y es de medio tiempo.

“Sólo trabajo tres o cuatro horas en lugar de ocho, 10 o 12 horas como solía trabajar”, contó.

No conoce a nadie que haya contraído COVID-19, pero la pandemia ha afectado casi todos los aspectos de su vida. “Estoy agotando mis ahorros, agotando y agotando y agotando”, dijo. “Tengo que vender mi coche. Uber es un lujo”. Ahora va en bicicleta o en autobús a su trabajo.

Quezada es una de las cientos de personas que respondieron a una encuesta publicada recientemente por NPR, la Fundación Robert Wood Johnson y la Escuela de Salud Pública T.H. Chan de la Universidad de Harvard.

Entre otras cosas, el sondeo, que encuestó a la gente del 1 de julio al 3 de agosto, encontró que un cifra enorme, el 71% de los hogares latinos en el condado de Los Angeles han experimentado serios problemas financieros durante la pandemia, en comparación con el 52% de los hogares afroamericanos, y el 37% de los blancos. (Los latinos pueden ser de cualquier raza o combinación de razas).

Como Quezada, muchos están quemando sus ahorros y tienen dificultades para pagar necesidades básicas como la comida. Al hombre le quedan unos seis meses de ahorros.

En Los Angeles, más del 35% de los hogares reportan serios problemas para pagar tarjetas de crédito, préstamos u otras cuentas, mientras que el mismo porcentaje dice haber agotado todos o la mayoría de sus ahorros.

El 11% de los angelinos encuestados dijo que no tenían ahorros al comienzo del brote.

A nivel nacional, el panorama es similar. En los resultados publicados, la encuesta reveló que el 72% de los hogares latinos en todo el país enfrentan serios problemas financieros, el doble de la proporción de los blancos no hispanos que participaron en la encuesta.

Y el 46% de los hogares latinos reportaron que han usado todos o la mayoría de sus ahorros durante la pandemia.

A nivel nacional, la encuesta encontró que el 63% de los latinos reportaron pérdida de ingresos familiares ya sea por reducción de horas o salarios, permisos o pérdida de trabajo, desde el comienzo de la pandemia.

Pero los latinos han seguido trabajando durante la crisis, dijo David Hayes-Bautista, profesor de medicina y salud pública en la UCLA.

“En Washington, la idea es que eres pobre porque no trabajas. Ese no es el problema con los latinos”, señaló. “Los latinos trabajan. Pero son pobres. El problema es que no les pagamos”.

Los latinos tienen la mayor tasa de participación en la fuerza laboral de cualquier grupo en California. En marzo, cuando los funcionarios estatales y locales cerraron muchos negocios, los hispanos perdieron sus trabajos como todos los demás. Pero volvieron a trabajar más rápido.

“En abril, la tasa de participación de los latinos [en la fuerza laboral] se recuperó y ha seguido aumentando lentamente, mientras que la tasa de los no latinos está bajando”, explicó Hayes-Bautista. “La recompensa que tienen los latinos por su alta ética de trabajo es una alta tasa de pobreza”.

Esa ética de trabajo también ha contribuido a una tasa mucho más alta de COVID-19. Hayes-Bautista señaló que en California, como en algunas otras regiones de los Estados Unidos, los latinos suelen hacer muchos de los trabajos que se han considerado esenciales, y eso los ha hecho altamente susceptibles al coronavirus.

Los latinos ahora representan el 60% de los casos de COVID-19 en California, aunque son alrededor del 40% de la población.

No sólo se están infectando, sino que, desde mayo, casi se ha quintuplicado el número de latinos en edad laboral  que mueren por el coronavirus.

“Estos son trabajadores que normalmente están en sus mejores años, con mayores ingresos y todo lo demás”, expresó Hayes-Bautista. “Los latinos de entre 50 y 69 años son los más afectados. Es muy preocupante”.

Expuestos y, a menudo, sin seguro médico

A nivel nacional, según la encuesta, 1 de cada 4 hogares latinos reportan serios problemas para pagar por la atención médica durante la pandemia.

Muchos de los trabajos esenciales que los latinos suelen realizar —como el agrícola o asistente en residencia de mayores u otro trabajo por contrato, por ejemplo— carecen de beneficios. Esto significa que algunos latinos están más expuestos al coronavirus y es menos probable que tengan seguro médico porque no reciben cobertura a través de un empleador.

Otros, como Mariel Álvarez, carecen de cobertura debido a las restricciones al no tener la ciudadanía. Vive con sus padres y hermanas en el Valle de San Fernando, condado de Los Angeles. Álvarez perdió su trabajo de ventas y su seguro médico patrocinado por el empleador cuando la pandemia golpeó en marzo, dijo. Luego se enfermó.

Luego, toda su familia se enfermó. Álvarez tuvo que pagar de su bolsillo para ir a una clínica de CVS cerca de su casa. Pero después de un par de visitas a $50 cada una, le resultó demasiado caro.

“No podía permitirme seguir yendo al médico”, explicó. Sospechaba que era COVID-19 pero no pudo hacerse la prueba.

Ahora que se ha recuperado, conseguir un trabajo con seguro médico es crucial porque no califica para ninguna ayuda estatal o federal. Álvarez es indocumentada y fue traída a los Estados Unidos por sus padres, cuando era niña, desde Bolivia. Es una de los aproximadamente 640,000 inmigrantes que tiene un permiso que le permite trabajar y aplazar la deportación bajo el programa de Acción Diferida para los Llegados en la Infancia, o DACA.

“No quiero poner en peligro eso”, dijo Álvarez. “Se supone que no debes usar ninguna de las ayudas del gobierno cuando estás en eso. Se supone que sólo debes trabajar, y eso es todo”.

La pandemia ha creado gran demanda de un trabajo: los rastreadores de contactos. Así que Álvarez completó un certificado gratuito en línea para estar más preparada. Ahora está en el proceso de solicitud; si la contratan, espera tener beneficios de nuevo.

Mientras tanto, hará todo lo posible para no enfermarse.

Fortiér es reportera de salud para KPCC y LAist.com

Esta historia es parte de una asociación que incluye a KPCC, NPR y KHN, un programa editorialmente independiente de KFF.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Categories: Health Care

Without More Action, Policymakers Will Let Food Hardship Continue

Center on Budget and Policy Priorities - Thu, 09/24/2020 - 2:33pm

The government funding package that Congress expects to pass this week includes important nutrition assistance, but policymakers don’t seem likely to agree in the near term to a comprehensive COVID-19 relief package — even with the latest data again showing that millions of adults (and many of their children) are struggling to get enough to eat, and facing significant housing hardship, which we detail further here.

Categories: Benefits, Poverty

KHN’s ‘What the Health?’: ACA in Peril With Ginsburg’s Seat in Play

Kaiser Health News - Thu, 09/24/2020 - 2:05pm

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

The death of Supreme Court Justice Ruth Bader Ginsburg — and the insistence of President Donald Trump and the GOP-led Senate to fill that vacancy this year — could have major implications for health care. The high court will hear yet another case challenging the constitutionality of the Affordable Care Act the week after the November election, and a long list of cases involving women’s reproductive rights, including both abortion and birth control, are working their way through lower federal courts.

Meanwhile, scandals at the Department of Health and Human Services continue to surface, such as the case of a media spokesperson for the National Institutes of Health who criticized his boss’s handling of the pandemic via a conservative website. And the Centers for Disease Control and Prevention continues to struggle with its credibility, after posting and then taking down another set of guidelines, this one concerning whether the COVID-19 virus is spread through aerosol particles.

This week’s panelists are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Kimberly Leonard of Business Insider and Mary Ellen McIntire of CQ Roll Call.

Among the takeaways from this week’s podcast:

  • The Supreme Court’s upcoming ACA case was brought by Republican state officials seeking to invalidate the law based Congress’ elimination of the penalty for not having insurance, a provision that the court once used to uphold the law because it was considered part of Congress’ right to impose taxes.
  • Many legal experts believe that even if the high court were to decide that the loss of the penalty invalidates the individual mandate to get insurance, other parts of the law should be able to stand. But it’s not clear conservatives on the court will agree.
  • With so much emphasis on the ACA’s insurance marketplace, the expansion of the Medicaid program for low-income people and protections for people with preexisting conditions, many consumers don’t realize that the law touches nearly all aspects of health care, including guarantees of preventive services, insurance practices and even requirements for calorie counts on restaurant menus.
  • Ginsburg’s death could also influence efforts to undermine abortion rights. Two cases are already before the court, one involving the ability of doctors to remotely prescribe drugs that can end a pregnancy and a Mississippi ban on abortions after the 15th week of pregnancy.
  • As the nation marks more than 200,000 deaths from the coronavirus, the “What the Health?” panel looks at problems in the U.S. effort to fight COVID-19, including flip-flops on the need for masks, inconsistent messaging from different parts of government and the politicization of science.
  • The Centers for Disease Control and Prevention’s decision to remove guidance on the coronavirus’s ability to spread through the air created more concerns about the politicization of the federal government’s scientific studies. The controversy over the agency’s work is a stark change from the past, when the CDC was considered among the least politicized parts of the government.
  • It may take years after these coronavirus controversies for the CDC to restore its credibility with the public, no matter who is elected president.
  • Trump has touted his efforts to lower prescription drug prices, and last week The New York Times reported that the administration tried unsuccessfully to get drugmakers to send a $100 gift card to all seniors to help cover the costs of their medicines. The companies objected because, among other reasons, they were worried the move could be seen as an effort to help the Trump campaign.

This week, Rovner also interviews KHN’s Sarah Jane Tribble, whose new podcast, “Where It Hurts,” drops Sept. 29. The podcast chronicles what happens to a small rural community in Kansas after its local hospital closes.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: KHN’s “Battle Rages Inside Hospitals Over How COVID Strikes and Kills,” by Robert Lewis and Christina Jewett

Anna Edney: The New Yorker’s “A Young Kennedy, in Kushnerland, Turned Whistle-Blower,” by Jane Mayer

Kimberly Leonard: The Wall Street Journal’s “Medicare Wouldn’t Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Authorization,” by Stephanie Armour

Mary Ellen McIntire: The New York Times’ “Many Hospitals Charge More Than Twice What Medicare Pays for the Same Care,” by Reed Abelson

Other stories discussed by the panelists this week:

The New York Times’ “A Deal on Drug Prices Undone by White House Insistence on ‘Trump Cards,’” by Jonathan Martin and Maggie Haberman

The Daily Beast’s “A Notorious COVID Troll Actually Works for Dr. Fauci’s Agency,” by Lachlan Markay

Politico’s “Trump Administration Shakes Up HHS Personal Office After Tumultuous Hires,” by Dan Diamond

The Washington Post’s “Pentagon Used Taxpayer Money Meant for Masks and Swabs to Make Jet Engine Parts and Body Armor,” by Aaron Gregg and Yeganeh Torbati

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify or Pocket Casts.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Categories: Health Care

Too Much Candy: Mass. Man Dies From Eating Bags Of Black Licorice

CommonHealth (WBUR) - Thu, 09/24/2020 - 9:09am

A Massachusetts construction worker’s love of black licorice wound up costing him his life. Eating a bag and a half every day for a few weeks threw his nutrients out of whack and caused the 54-year-old man’s heart to stop, doctors reported Wednesday.

Categories: Health Care

Research Guides In Focus – Neighbor Law: A Beginner’s Guide

In Custodia Legis - Thu, 09/24/2020 - 9:00am

The following is a guest post by Louis Myers, the Law Library’s current Librarian-in-Residence.

Now that we have reviewed several research guides on a range of topics, including How to Find Free Case Law Online and Municipal Codes: A Beginner’s Guide, Research Guides in Focus presents another guide, Neighbor Law: A Beginner’s Guide. This guide provides readers with resources covering common issues they may experience in their neighborhoods.

The guide begins with a philosophy championed by President Lincoln—the first step in a legal dispute with your neighbors is to attempt negotiation before litigation. Many researchers seek our help in clarifying their property rights with respect to their neighbors. Although we cannot give legal advice, we are happy to direct visitors to resources that may answer their questions. This guide, for example, begins by explaining some common issues between neighbors, and offers readers general resources.

Introduction page of Neighbor Law: A Beginner’s Guide, https://guides.loc.gov/neighbor-law/introduction

The guide also breaks down two popular issues, disputes involving trees and laws related to homeowners’ associations (HOAs). Trees can cause strife between neighbors, and the guide offers resources on how homeowners can protect their trees and prevent encroachment from trees on neighboring properties, with the aid of municipal laws, books, and online resources. Certain interactions with the local HOA can also result in homeowner consternation. We have compiled resources from the state and local level that provide guidance from the perspectives of both property owners and HOAs.

While we are spending more time at home, these and similar issues may come up more frequently. This guide is a great resource to consult when dealing with issues that arise with your neighbors, and can even help you when planning your next big stay-at-home yard project.

We hope you find this guide helpful in your research. As always, you can reach out to us through Ask a Librarian if you have further questions.

Categories: Research & Litigation

California Expands Privacy Protection to Public Health Workers Amid Threats

Kaiser Health News - Thu, 09/24/2020 - 8:41am

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.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Categories: Health Care

Free Mass. Virus Testing Extended Through October

CommonHealth (WBUR) - Thu, 09/24/2020 - 8:05am

Free testing through the "Stop the Spread" initiative is currently available in 18 communities: Brockton, Chelsea, Everett, Fall River, Framingham, Holyoke, Lawrence, Lynn, Marlborough, Methuen, New Bedford, Randolph, Revere, Salem, Saugus, Springfield, Winthrop and Worcester.

Categories: Health Care

These Secret Safety Panels Will Pick the COVID Vaccine Winners

Kaiser Health News - Thu, 09/24/2020 - 6:01am

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.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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

Kaiser Health News - Thu, 09/24/2020 - 5:00am

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.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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

Kaiser Health News - Thu, 09/24/2020 - 5:00am

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.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Legal Research Reports: Federal and State Executive Responses to COVID-19

Law Library of Congress: Research Reports - Wed, 09/23/2020 - 3:00pm

The Law Library of Congress is proud to present the report, Federal and State Executive Responses to COVID-19.

Although emergency rule-making has been used in response to previous emergent situations, the COVID-19 pandemic has resulted in emergency rule-making affecting every jurisdiction in the United States. The functional effects of emergency rule-making are wide-ranging and can be contentious. The nature of emergency rule-making creates difficulties for oversight at both the federal and state level. The rules and regulations enacted under the emergency framework will shape current and future generations as the United States begins to recover from COVID-19's economic and societal impacts. 

This report is one of many prepared by the Law Library of Congress. Visit the Comprehensive Index of Legal Reports page for a complete listing of reports and the Current Legal Topics page for our highlighted and newer reports. 

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How Families Are Keeping Halloween From Turning Into a COVID Nightmare

Kaiser Health News - Wed, 09/23/2020 - 3:00pm

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.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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