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Wednesday, 29 July 2020

Analysis: When Is a Coronavirus Test Not a Coronavirus Test?

03:57

Annapoorna

Desperate to continue the tradition of a family beach week, I hatched a plan that would allow some mask- and sanitizer-enhanced semblance of normality.

We hadn’t seen my two 20-something children in months. They’d spent the lockdown in Brooklyn; one of them most likely had the disease in late March, before testing was widely available. My mother had died of COVID-19 in May.

So a few weeks ago, I rented a cute house on the Delaware shore. It had a screened-in front porch and a little cottage out back, in case someone needed to quarantine.

I asked my son, who had participated in several protests and had been at a small outdoor July Fourth gathering, to get tested before he came. Testing had been recommended by the governor and the mayor, and many centers were offering an anticipated 48-hour turnaround.

He got one and downloaded the app for results. And waited. And waited. And waited. For 12 days.

Coronavirus testing in the United States has been bungled in every way imaginable. The latest fiasco is perhaps the most Kafkaesque: Tests are now widely available in many places, but results are often taking so long to come back that it is more or less pointless to get tested.

If it takes up to two weeks to get results, we can’t detect brewing outbreaks and respond with targeted shutdowns. We can’t do meaningful contact tracing. We can’t expect people to stay home from work or school for two weeks while they wait for the result of a screen. We have no way to render early treatment and attention to those who test positive, to try to prevent serious illness. It’s a disaster.

Many doctors can do a rapid strep test in half an hour, and the “slow” test takes a day. Imagine if it took 12 days before doctors knew whether to prescribe an antibiotic. You’d end up with more cases of meningitis, pneumonia and rheumatic fever. Strep could spread through families and schools like wildfire.

One canon of medical practice is that you order a test only if you can act on the result. And with a turnaround time of a week or two, you cannot. What we have now is often not testing — it’s testing theater.

For months the hue and cry was about testing not being more widely available. Even many sick people couldn’t get one. The first tests proved faulty. Then good ones were not distributed to the hot spots. Then there were not enough swabs, personal protective equipment or ingredients like reagents needed to administer the tests.

After all these missteps, the political pressure to provide widespread free testing was enormous. And with little help from the White House, many states turned somersaults and delivered. Voilà!

But there was far less pressure to make sure that labs receiving the swabs had the capacity to process all those collected specimens.

Now, in cities like New York and Washington and Los Angeles, there are dozens if not hundreds of clinics where anyone who wants a test can walk in and get the famous stick up your nose or some variant. Though the simple tests are by law “free” to patients, the clinics bill insurers (or the government) hefty fees — sometimes hundreds of dollars — for administering them. This gives clinics the incentive to throw open the doors and do as many tests as possible.

Some hospitals, clinics and cities that run the specimens themselves or outsource to an array of different labs can deliver results in a timely fashion. State labs in Texas, which is experiencing a major outbreak, say their turnaround time is two to three days. But many results take far longer.

LabCorp and Quest, the two biggest commercial labs, have both acknowledged sometimes long delays in processing the vastly increased volume of tests. Governors are furious. Gov. Jared Polis of Colorado said that the nine days it sometimes took to get a result from these companies rendered them “almost useless.”

A coronavirus test is not really a test if the result is too late to act on. So labs need to ramp up capacity, as they’ve vowed to do. More important, all those centers offering free testing need to take responsibility for delivering results within 48 or, maybe, 72 hours. That means contracting with labs that can guarantee turnaround.

“Anyone who wants a test can get one” is a nice-sounding political promise, but it’s not helping anyone. Sick people need to know if they’re sick with the coronavirus. Those who have been seriously exposed need to know if they got it. And others will need tests to be cleared for work, school or a family visit with vulnerable relatives.

This is how the coronavirus played out in my family’s vacation: While my son arrived on schedule, his test results did not. So he was consigned to the quarantine cottage. He wore a mask in the house and the car. We ate outdoors and he sat at the far end of a picnic table. We even squirted the ketchup on his burger for him, so that he wouldn’t have to touch the bottle. Each morning we checked the app, hoping for deliverance. It never came.

Finally, 12 days after my son’s last potential exposure at the Independence Day picnic, I agreed he could take off the mask. He had no symptoms and at that point he was most likely no longer contagious, either way. We hugged and enjoyed our last two days of vacation. Then he returned to New York.

The next morning, I got his text: “Test came back negative!”

Where Mask-Wearing Isn’t Gospel: Colorado Churches Grapple With Reopening

03:57

Annapoorna

COLORADO SPRINGS, Colo. — The lights dimmed. Guitars thrummed. And a nine-piece band kicked off what amounted to a rock concert inside an amphitheater of a church. “Shout for joy to the Lord,” one musician called out, quoting Scripture.

Any such shout could release the coronavirus to congregants. With some 500 people singing along, though, any concern about a deadly virus circulating was hard to find other than the spaced-out chairs in the 6,000-person hall. Although Colorado’s governor had issued a statewide order days earlier mandating masks, hardly anyone at this service at New Life Church obeyed.

“I’m finding this to be true at churches all over America: If they’re told they have to wear a mask, they’ll stay home,” said Brady Boyd, senior pastor of the 15,000-member New Life Church, a nondenominational megachurch that meets in five locations across the Pikes Peak region.

Long considered one of the country’s evangelical strongholds, Colorado Springs returned to church in ways both guarded and full of gusto after the state lifted lockdowns June 4 with limitations on how many people could gather. But as the county’s coronavirus cases and hospitalizations climb to their highest levels in months, many of the city’s largest and most well-known congregations remain undeterred — openly flouting the new statewide mask order and, in at least one instance, threatening not to stop holding in-person services again if ordered.

It all comes as church leaders across the nation navigate a growing set of political pressures: For months, President Donald Trump urged them to resume services despite pleadings from public health officials for caution and orders by some governors to stay home.

That pressure is particularly acute here at the base of Pikes Peak. Long the conservative bastion of Colorado, this city and surrounding El Paso County, home to about 720,000 people, overwhelmingly voted for Trump in 2016. (The county last voted for a Democratic candidate for president in 1964.)

The Republican sheriff has vowed not to enforce the statewide mask order that Democratic Gov. Jared Polis issued July 16. And several churches are as openly defiant.

But any indoor activities, such as worship services, pose a particularly high risk for coronavirus transmission even with masks, especially when they include singing, said Dr. Jonathan Samet, the Colorado School of Public Health’s dean. While coughing or sneezing can spread larger respiratory droplets, singing and talking release smaller infectious particles that can hang in the air and circulate in enclosed spaces.

“The circumstances of having large groups of people together without masks and doing things like singing is a setup that people talk about for superspreading events,” Samet said.

Churchgoers sit on the lawn outside Grace and St. Stephen’s Episcopal Church in Colorado Springs, Colorado, during outdoor worship services on July 19. White circles painted on the grass indicate where people can sit to remain socially distanced at 6 feet apart.(Rachel Woolf for KHN)

In Arkansas, for example, at least three people died and dozens of others tested positive in March after two people showed up at a church function with COVID symptoms. And in Washington state, dozens of choral group members were infected after a single symptomatic person attended a 2½-hour practice. Two people died.

The New Life Church, where at least 9 in 10 parishioners went without masks on the first Sunday after Colorado’s order began, was certainly not unique. Nearly all of the roughly 100 people gathered at Church for All Nations also skipped masks.

Pastor Mark Cowart kicked off his sermon there by questioning statements about masks from Dr. Anthony Fauci, the nation’s top infectious disease expert with the National Institutes of Health.

“We are not the mask police,” Cowart said, before warning state officials against trying to restrict their gatherings.

“If they come trying to tell us we can’t meet anymore, or we can’t sing, or we can’t have a Bible study anymore, that’s not going to go,” Cowart said to applause at the nondenominational church. “God does not want us to allow that to happen.”

Colorado health officials recently warned several counties that large worship services could be restricted if the rise in infections doesn’t ease. Average daily confirmed cases across the state more than doubled in July, rising from 215 a day in June to 451 as of last week, according to a state database.

The rise in COVID cases comes as residents disregard social-distancing guidelines. A recent report by the Colorado COVID-19 Modeling Group found that the share of Coloradans complying plummeted from 87% in May to 41% in late June.

Across the Pikes Peak region, dozens of pastors and parishioners described an intense and deeply spiritual desire to return to worship with their fellow believers. Meeting in person provides a unique opportunity to hug, to know they are not alone during such trying times.

“The church isn’t really a place — it’s a gathering of people,” said Brian Bone, while meeting with a dozen others at Woodmen Valley Chapel, where masks were common on a recent visit. “We get comfortable coming to a place we call church, but really it’s being with other people physically that’s important.”

Churchgoers sit on the lawn during outdoor worship services on July 19, at Grace and St. Stephen's Episcopal Church in Colorado Springs, Colorado. The church offers socially distant, outdoor Sunday worship services.(Rachel Woolf for KHN)

(From center left) Abigail Sena leads the procession as an acolyte, followed by Gary Darress, a deacon, and Claire Elser, a curate, during worship services on July 19.(Rachel Woolf for KHN)

And some ministers fear that not meeting regularly in person could lead to apathy among parishioners, causing them to drift away.

Not all congregations in Colorado Springs have been averse to the state’s new mask order. And the myriad approaches to reopening highlight the difficulty of placing a single label on churchgoers during the pandemic.

For the Rev. Jeremiah Williamson, masking up is the Christian thing to do.

“A lot of this stuff has been caught up in partisan politics, and I’m not interested in that,” Williamson said. “I’m interested in keeping our people safe. We’re one of those churches that believes science.”

At Grace and St. Stephen’s Episcopal Church, Williamson has forsaken his pulpit for the front lawn. There, on a recent Sunday, dozens of church members sat in folding chairs spaced 6 feet apart, inside white circles painted on the grass. No congregants sang. Everyone wore masks.

Nearby on North Tejon Street, more parishioners sat in parked cars, listening with their radios as the service was broadcast via a shortwave transmitter.

And, before attending, everyone was urged to provide their names and phone numbers, in case someone tests positive and public health contact tracers need to find those who may have been exposed.

Bill and Carol Whittam (center) sit on the lawn outside Grace and St. Stephen’s Episcopal Church in Colorado Springs, Colorado, during worship services on July 19. Before attending, churchgoers are urged to sign up online and provide their names and phone numbers, in case someone tests positive and public health contact tracers need to track down people who may have been exposed.(Rachel Woolf for KHN)

“It just seems, as religious people, Christians, we would want to do our best for the common good, for the greater good,” Williamson said.

Across town, Payne Chapel AME Church also has opted not to gather indoors out of concern for its predominantly Black congregation, because Blacks have been experiencing higher rates of hospitalization and death from the coronavirus. Church members recently met in their vehicles in the church’s parking lot, waving to one another through car windows and singing hymns together on a teleconference line.

For that 300-member African Methodist Episcopal church, to have met indoors also would have been “between ridiculous and stupid,” said Pastor Leslie White, who heads the congregation.

However, Calvary Worship Center, which has a racially diverse congregation, is meeting indoors and not enforcing the mask order, even though two staff members were confirmed to have COVID-19. Instead, the church, led by a team of Black and white pastors, only recommends they be worn.

For Joshua Stephens, 29, the key to staying healthy is his faith.

The pandemic hit just as he wrapped up earning a degree from Charis Bible College, headquartered in Woodland Park. The local religious school received a cease-and-desist letter in early July from the Colorado Attorney General’s Office for hosting a conference with 300 to 500 people in violation of the state’s lockdown orders that limited gatherings to 175 people. Nevertheless, the college’s pastor had vowed to ignore the order.

Stephens, who attends Church for All Nations, said his belief in God informs his approach to the pandemic, after saying he was miraculously cured of cancer four years ago.

“My personal conviction is, I don’t get sick,” said Stephens, who was not wearing a mask.

Tuesday, 28 July 2020

El color de COVID: ¿los ensayos de vacunas reflejan la diversidad de Estados Unidos?

15:46

Annapoorna

Cuando los científicos estadounidenses comiencen a lanzar este verano los primeros ensayos clínicos a gran escala de una vacuna contra COVID-19, Antonio Cisneros quiere asegurarse de que participen personas como él.

Cisneros, hispano de 34 años, forma parte de la primera ola de un millón y medio de voluntarios dispuestos a recibir las dosis, para ayudar a determinar si las vacunas que son principales candidatas pueden derrotar al virus que ha causado una pandemia mortal.

“Si me piden que participe, lo haré”, dijo Cisneros, cineasta de Los Ángeles que se ha inscrito en dos grandes ensayos. “Parece ser parte de nuestro deber”.

Sin embargo, se necesitará más que un impulso para garantizar que los ensayos clínicos que evalúan la seguridad y efectividad de una vacuna realmente incluyan un número representativo de afroamericanos, latinos y otras minorías raciales y étnicas. También a personas mayores y a otras con afecciones médicas subyacentes, como enfermedad renal.

Las personas de raza negra y las latinas (que pueden ser de cualquier raza) tienen tres veces más probabilidades de infectarse con el coronavirus que causa COVID-19 que las personas blancas no hispanas, y el doble de probabilidades de morir, según datos federales obtenidos por The New York Times a través de una demanda.

Los estadounidenses de origen asiático parecen representar menos casos, pero tienen mayores tasas de mortalidad. Ocho de cada 10 muertes por COVID reportadas en los Estados Unidos han sido de personas de 65 años o más. Y los Centros para el Control y Prevención de Enfermedades (CDC) advierten que la enfermedad renal crónica se encuentra entre los principales factores de riesgo de infección grave.

Sin embargo, históricamente, a estos grupos se los ha incluido menos en ensayos clínicos, a pesar de las normas federales que requieren la participación de minorías y personas mayores, y los esfuerzos continuos de los defensores de pacientes para diversificar estos estudios médicos críticos.

En un verano dominado por COVID-19 y por protestas contra la injusticia racial, el reclamo a los fabricantes de drogas e investigadores para que garanticen que los ensayos de vacunas reflejen a toda la comunidad es más potente.

“Si las personas de raza negra estamos siendo sido víctimas de COVID-19, seremos la clave para descubrir el misterio de COVID-19”, dijo el reverendo Anthony Evans, presidente de la National Black Church Initiative (NBCI), una coalición de 150,000 Iglesias afroamericanas.

Evans y su equipo se reunieron a mediados de julio con funcionarios de Moderna, la compañía de biotecnología de Massachusetts que lanzó el primer ensayo de una vacuna contra COVID en los Estados Unidos, para discutir una colaboración en la que el NBCI ayudaría a reclutar a participantes afroamericanos. Pero este encuentro fue menos de dos semanas antes del comienzo de la fase 3 del ensayo, que esperaba inscribir 30,000 personas, y Evans dijo que la reunión fue idea suya.

“La industria no se acercó a mí. Yo fui a la industria”, dijo.

Investigaciones muestran que las personas de raza negra representan aproximadamente el 13% de la población del país, pero en promedio el 5% de los participantes en ensayos clínicos. Para los hispanos, la participación en ensayos es de aproximadamente 1% en promedio, aunque representan cerca del 18% de la población.

Antonio Cisneros, cineasta de Los Angeles, se registró para dos grandes ensayos de vacunas contra COVID-19. Es de los primeros de la primera ola de voluntarios. "Si me dicen de participar, lo haré. Es nuestro deber", dijo.(Photo by Steven Shea)

Cuando se trata de ensayos de medicamentos y vacunas, la diversidad es importante. Estudios muestran que, por razones que no siempre se entienden completamente, las personas de diferentes razas y etnias pueden responder de manera diferente a las drogas o terapias. La respuesta inmune disminuye con la edad, por eso hay una vacuna contra la gripe en dosis altas para las personas mayores de 65 años.

Aún así, la presión por desarrollar una vacuna eficaz en tiempo récord, en medio de la pandemia, podría dejar de lado los esfuerzos para garantizar la diversidad, dijo la doctora Kathryn Stephenson, directora de la unidad de ensayos clínicos en el Centro de Investigación de Virología y Vacunas en el Centro Médico Beth Israel Deaconess, en Boston.

“Una de las preguntas que surgió es: ¿qué hacer si eres un investigador y tienes a 250 personas golpeando a tu puerta, y todos son blancos no hispanos?”, reflexionó.

¿Inscribes a esas personas, siguiendo el razonamiento de que, cuanto más rápido avance el ensayo, más rápido estará disponible una vacuna para todos? ¿O los rechazas y retrasas el estudio?

“Estás acelerando el desarrollo de una vacuna, y si alcanzas un hito, ¿cuál es el significado de ese hito si no sabes si es muy segura o efectiva para una población [determinada]? ¿Realmente el logro es para todos?”, se preguntó Stephenson.

Incluir a las personas de edad avanzada o que tienen afecciones médicas subyacentes es vital para la ciencia de las vacunas y otros tratamientos, incluso si es más difícil reclutarlos.

“Tenemos que admitir que los adultos mayores son los que tienen más probabilidades de desarrollar efectos secundarios a los tratamientos y vacunas”, dijo la doctora Sharon Inouye, directora del Aging Brain Center y profesora en la Escuela de Medicina de Harvard. “Por otro lado, esa es la población que la usará”.

Las personas con enfermedad renal, que afecta a 1 de cada 7 adultos en el país, han sido excluidos de la investigación clínica durante décadas, dijo Richard Knight, quien recibió un órgano y es presidente de la Asociación Americana de Pacientes Renales. Casi el 70% de los más de 400 pacientes con enfermedad renal que la organización encuestó en julio dijeron que nunca se les había pedido participar de un ensayo clínico.

Excluyendo el ensayo de la vacuna, una población vulnerable a COVID tan amplia no tiene sentido, sostuvo Knight. “Si estás tratando de manejar esto desde el punto de vista de la salud pública, quieres asegurarte de estar inoculando a tus poblaciones de mayor riesgo”, explicó.

La nueva guía de la Administración de Drogas y Alimentos (FDA), que regula las vacunas, “alienta” la diversidad en el desarrollo de vacunas clínicas. Eso incluye minorías raciales y étnicas, personas mayores y personas con problemas médicos subyacentes, así como mujeres embarazadas.

Pero la FDA no exige que los fabricantes de medicamentos e investigadores cumplan con esos objetivos, y no rechazará los datos de pruebas que no cumplan con esta recomendación. Y aunque el gobierno federal está derivando miles de millones de dólares para acelerar más de media docena vacunas candidatas para COVID, las farmacéuticas que las producen no están obligadas a revelar públicamente sus objetivos demográficos.

“Esto es lo de siempre”, dijo Marjorie Speers, directora ejecutiva de Clinical Research Pathways, un grupo sin fines de lucro de Atlanta que trabaja para aumentar la diversidad en la investigación. “Es muy probable que estos ensayos no incluyan minorías porque no es mandatorio”.

Los ensayos de vacunas se coordinan a través de la Red de Prevención de COVID-19 (CoVPN), con sede en el Centro de Investigación del Cáncer Fred Hutchinson, en Seattle. Se basa en cuatro redes de ensayos clínicos de larga data financiadas por el gobierno federal, incluidas tres dirigidas al VIH y al SIDA.

Esas redes de pruebas fueron elegidas en gran parte porque tienen relaciones ricas en comunidades minoritarias de raza negra, latinas y otras, dijo Stephaun Wallace, director de relaciones externas de CoVPN. La esperanza es aprovechar las conexiones existentes basadas en la confianza y la colaboración.

“Nuestros sitios de ensayos clínicos están preparados y listos para involucrar a personas de distintas comunidades”, dijo Wallace.

Sin embargo, reconoció que atraer a una población diversa requiere que los investigadores sean flexibles e innovadores. Puede haber problemas prácticos. Las horas de la clínica pueden ser limitadas o el transporte puede ser un problema. Las personas mayores pueden tener problemas de vista o audición y requerir de ayuda adicional para seguir los protocolos.

La desconfianza en el establecimiento médico también puede ser una barrera. Por ejemplo, los afroamericanos, tienen una cautela bien fundada con los ensayos médicos después del infame Estudio Tuskegee y la explotación de Henrietta Lacks. La sospecha se extiende a las vacunas recomendadas, dijo Wallace.

“No quieren sentirse como conejillos de indias o sentir que se está experimentando con ellos”, agregó.

Moderna, que lanza su prueba de fase 3 el lunes 27de julio, dijo que la compañía está trabajando para garantizar que los participantes “representen a las comunidades con mayor riesgo de COVID-19 y a nuestra sociedad diversa”.

Sin embargo, los resultados del ensayo de fase 1 de la compañía, publicados a mediados de julio, mostraron que de 45 personas incluidas en esa prueba de seguridad, seis eran hispanos, dos eran de raza negra (no hispanos), una era asiática y una era nativa americana. Cuarenta eran blancos no hispanos.

Los ensayos clínicos de fase 1 y fase 2 tienen como objetivo evaluar la mejor dosis y la seguridad de las vacunas en pequeños grupos de personas. Los ensayos de fase 3 evalúan la eficacia del medicamento en decenas de miles.

Los investigadores en casi 90 sitios en los Estados Unidos se están preparando para reclutar participantes para el ensayo de fase 3 de Moderna. El doctor Carlos del Río, decano ejecutivo asociado de la Escuela de Medicina de la Universidad Emory, buscará 750 voluntarios en tres sitios del área de Atlanta. La mitad recibirá la vacuna; la otra mitad, inyecciones de placebo.

Del Río ha tenido un éxito notable en el reclutamiento de minorías para ensayos de VIH y espera resultados similares con el ensayo de la vacuna. “Estamos haciendo nuestro mejor esfuerzo para llegar a las comunidades que están en mayor riesgo”, dijo.

Mientras tanto, los voluntarios como Cisneros solo quieren que comiencen los ensayos avanzados.

Cisneros se inscribió en los ensayos de CoVPN. Pero primero lo hizo en 1 Day Sooner, un esfuerzo para lanzar lo que se llama “ensayos de desafío en humanos”, cuyo objetivo es acelerar el desarrollo de la vacuna al infectar deliberadamente a los participantes con el virus. Estos ensayos pueden completarse en semanas en lugar de meses, pero corren el riesgo de exponer a los voluntarios a enfermedades graves o a la muerte, y los funcionarios federales siguen siendo recelosos de esta estrategia.

Cisneros está dispuesto a correr ese riesgo para ayudar a frenar a COVID-19, que ya ha matado a 143,000 estadounidenses. Dijo que es una forma de actuar en un momento en el que el gobierno de los Estados Unidos no ha podido proteger a las minorías, los adultos mayores y otras personas vulnerables.

“Se supone que el gobierno debe ayudar a aquellos que no pueden protegerse”, dijo. “Me parece que lo único que quieren proteger es a las personas con dinero, a las personas con armas de fuego, y no a las personas de minorías como yo”.

In Texas, More People Are Losing Their Health Insurance as COVID Cases Climb

09:46

Annapoorna

Steve Alvarez started feeling sick around Father’s Day weekend this year. His symptoms started as mild, but developed into a fever, chills and shortness of breath he couldn’t shake.

“Just when I started to get to feeling better and I would have a couple of good days,” Alvarez said. “I felt like I’d backtrack and I was just really run down. This thing lingered and lingered.”

Alvarez, a Tejano musician who lives in the San Antonio area, said he eventually got a free COVID-19 test provided by the city of San Antonio. A week later, he found out he tested positive for the coronavirus.

Steve Alvarez stands with his wife, Regina. Alvarez is a Tejano musician who had no health insurance when he was diagnosed with COVID-19. Money has been tight because the pandemic dried up his musical gigs.(Credit: Vic G’s Photography)

Alvarez and his wife — who also became infected — never ended up in the hospital, and they feel fine now. But, he said, there were some scary days — he knows a lot of people who got sick with COVID-19. A friend around his age — mid- to late 40s — has been in an ICU and on a ventilator for weeks now.

But it was not just their health that worried Alvarez. Financial fears loomed large, too.

“We thought if something happens and this starts getting much worse, we need to start thinking about how we are going to deal with it, how we are going to pay for it,” he said. “It was just abject terror as to what was going to happen and what we were going to do.”

Money is tight because the pandemic shut down most of his musical gigs. Alvarez also lost his health insurance a year ago when he was laid off from his day job in construction safety. While he was sick with the coronavirus he paid for remote doctor visits, some prescriptions and over-the-counter medicine all out-of-pocket, he said.

“I use discount cards for those prescriptions as much as possible,” Alvarez said. “If something is not generic, that’s just absolutely too expensive, I have to consider doing without it.”

Texas’ uninsured rate has been climbing along with its unemployment rate as COVID cases also surge in the state. Before the pandemic, Texas already had the highest rate and largest number of people without insurance among all states. And 20% of all uninsured children in the U.S. live in Texas.

The uninsurance problem has only gotten worse in Texas in 2020. According to recent data from Families USA, a consumer health advocacy group that supported the Affordable Care Act, 29% of Texas adults under 65 don’t have health insurance so far this year.

The group found that about 659,000 people in the state became uninsured between February and May as job losses soared. Texas is one of 13 states that has not expanded Medicaid under the ACA.

“Texans who lose their health insurance that is tied to jobs simply have fewer options for new insurance because we do not have Medicaid expansion,” said Elena Marks, the president and chief executive officer of the Episcopal Health Foundation in Houston.

Republican leaders in Texas have long refused to expand health coverage to more low-income adults through Medicaid, despite the state’s having had the highest uninsured rate in the country for years.

Marks said the pandemic has made the state’s existing health insurance crisis much worse.

“Everything that’s happening now was happening before — it’s just on a path of acceleration,” she said, because there are “so many more people who are sick and who are getting very sick and the costs are very expensive.”

And this is hurting patients. Stacey Pogue, a senior policy analyst at a think tank in Austin called Every Texan, said uninsured Texans could face steep costs for COVID treatment and testing.

Although some Texans are able to find free COVID-19 testing, others have had to pay as much as a few hundred dollars. Pogue said for people who are already financially strained, that’s prohibitively expensive.

“We need to do everything we can to make sure people are not afraid to get tested because of cost, or are not afraid to get treatment because of cost,” she said. “And states like Texas with such a huge uninsured population, that’s a huge barrier to our public health response.”

And when uninsured, poor Texans have no choice but to go to the hospital, those hospitals end up with much of the cost.

John Hawkins, senior vice president for advocacy and public policy at the Texas Hospital Association, said that even before the pandemic the cost of care provided to people without insurance in Texas hospitals amounted to more than $7 billion a year.

“We’ve been able to make it work, frankly, because of the growth in the state,” he said. “But as we look at COVID going forward, it really does make the case that we have to look at addressing the coverage piece.”

Hawkins said federal relief money will be directed to health care providers in the coming months. Long term, however, he said this is unsustainable for Texas hospitals. If unaddressed, this financial burden on hospitals could lead to future cuts and possibly closures, he warned.

If state lawmakers don’t start addressing the state’s coverage issues soon, Hawkins predicted, it will become a significant issue during the state’s upcoming legislative session early next year.

Even before the pandemic, health care advocates in the state had begun organizing in an effort to make Texas’ uninsured rate a political liability for state lawmakers in November.

And for Texans currently living without insurance, not having health care coverage has been an added financial stressor.

Alvarez said he and his family are already doing everything they can to defer payments and bring in money so they don’t lose their house.

“But that bottom is going to fall out soon enough,” he said. “And that’s what I am really dreading right now. And I know that that’s not an uncommon thing that’s going on.”

This story is part of NPR’s reporting partnership with KUT and Kaiser Health News.

The COVID-19 Downturn Triggers Jump in Medicaid Enrollment

03:47

Annapoorna

Reversing a three-year decline, the number of people covered by Medicaid nationwide rose markedly this spring as the impact of the recession caused by the outbreak of COVID-19 began to take hold.

Yet, the growth in participation in the state-federal health insurance program for low-income people was less than many analysts predicted. One possible factor tempering enrollment: People with concerns about catching the coronavirus avoided seeking care and figured they didn’t need the coverage.

Program sign-ups are widely expected to accelerate through the summer, reflecting the higher number of unemployed. As people lose their jobs, many often are left without workplace coverage or the money to buy insurance on their own.

Medicaid enrollment was 72.3 million in April, up from 71.5 million in March and 71 million in February, according to the latest enrollment figures released last week by the Centers for Medicare & Medicaid Services. The increase in March was the first enrollment uptick since March 2017.

About half of the people enrolled in Medicaid are children.

The increases varied widely around the country. Kentucky had the largest jump at nearly 7% from March to April. In addition, enrollment rose to 1.4 million in April from 1.2 million in February, according to the CMS data. That has continued, and today it’s up to 1.5 million, state officials said in an interview.

Kentucky has an aggressive outreach strategy using email or phone calls to contact thousands of residents who applied for state unemployment insurance, designed to make sure they know about Medicaid. “It’s been very effective, and in the past few weeks we’ve been enrolling 8,000 to 10,000 people a week,” said Eric Friedlander, secretary of the Kentucky Cabinet for Health and Family Services, which oversees Medicaid.

The Bluegrass State has also made enrollment easier by developing a one-page online form instead of having people fill out a 20-page application, he added.

“This is the right thing to do to help people get signed up for health care coverage and it supports the health industry in our state,” Friedlander said. “The health industry would collapse without Medicaid.”

Joan Alker, executive director of the Center for Children and Families at Georgetown University in Washington, D.C., said she expects Medicaid enrollment to keep rising this summer. “Given that there are no signs that the virus is coming under control anytime soon, job losses will become more permanent, and more folks will become eligible for Medicaid over time,” she said.

One reason Medicaid numbers have not grown faster, she suggested, is because people have more immediate needs than securing health coverage, especially if they are feeling well.

Many people are worried about getting unemployment insurance or getting evicted from their home, she noted. “That’s combined with the fact that many people are reluctant to go to their doctor because of safety concerns,” she said. “And, as a consequence, applying for Medicaid may not be at the top of their list.”

Chris Pope, a senior fellow at the Manhattan Institute for Policy Research, a conservative think tank, said the slower-than-expected growth in Medicaid could signal that people who were laid off had coverage through a spouse or a parent.

In addition, he said, “many jobs that went away did not offer health insurance,” citing millions of service-sector positions in industries such as hotels and restaurants that have been lost.

Beyond the surge in unemployment, Medicaid rolls have risen because states cannot discontinue coverage to people enrolled as of March 18, 2020, as a condition of receiving higher federal Medicaid funding included in a coronavirus relief package passed by Congress.

Medicaid is a countercyclical program, meaning enrollment typically rises during an economic downturn. But that forces states to face the fiscal challenge of paying for their share of the program even as tax revenue dries up.

An exception to this rule was the jump in enrollment starting in 2014 when the Affordable Care Act allowed states to expand Medicaid to cover everyone with incomes below 138% of the federal poverty level, or about $17,609 for an individual this year.

Enrollment soared by about 15 million people from 2014 to 2017, peaking at about 75 million as nearly three dozen states expanded the program. Since then, a strong economy and steadily declining unemployment levels led to a drop in Medicaid rolls until April.

Enrollment changes in April varied across the country.

California, which has the highest Medicaid enrollment in the country, saw its level hold relatively steady at 11.6 million people in April.

Nevada and Oklahoma posted nearly 4% enrollment growth rates between March and April’s data.

Florida’s Medicaid numbers jumped to 3.7 million in April from 3.6 million in March, nearly a 2.5% increase, the CMS data showed. Since then, Florida data shows enrollment has topped 4.1 million.

The Trump administration has been criticized by consumer advocates for not establishing a national campaign to promote Medicaid during the economic downturn and health crisis.

One indicator that Medicaid enrollment is still going up is the growing number of recipients in managed care plans in 16 states that reported data from March to May. Those plans have increased by a total of nearly 4%, according to a KFF report. (KHN is an editorially independent program of KFF.) Most states have shifted many of their Medicaid enrollees into these private health plans.

KFF estimated that nearly 13 million people who became uninsured after losing their jobs in March are eligible for Medicaid.

Robin Rudowitz, a KFF vice president, said there is typically a lag time of weeks or months before people who have lost their jobs and health coverage seek to enroll in Medicaid. The impact on Medicaid enrollment also lasts well after the immediate effect of a downturn, she said.

“There is a long tail,” she said.

Dental and Doctors’ Offices Still Struggling with COVID Job Loss

03:46

Annapoorna

California’s outpatient health care practices largely shrugged off two recessions, adding more than 400,000 jobs during a two-decade climb from the start of 2000 to early 2020. It was an enviable growth rate of 85% and a trend largely mirrored on the national level.

Then came COVID-19.

Anecdotal stories abound about the crushing impact the pandemic has had on a range of outpatient medical services, from pediatric and family medical practices to dental offices, medical labs and home health care. In California, as in many other states, thousands of doctors, dentists and other health care providers temporarily closed offices this spring as state health officials directed them to suspend non-urgent visits. Many others sat open but largely idle because patients were too scared to visit the doctor given the risk of running into someone with COVID-19 in the waiting room.

As the economy has reopened, so have many medical offices. But the latest state and federal employment data underscores the lingering toll the pandemic has taken on the health care sector.

In California, employment in medical offices providing an array of outpatient care fell by 159,300 jobs, or 18%, from February to April, according to California’s Employment Development Department. The sector has recovered some, but job totals in June remained 7% below pre-crisis levels, the latest figures show. Data is not yet available for July, when COVID-19 cases in California again began to rise sharply and communities across much of the state reverted to partial shutdowns.

Nationwide, employment in outpatient care fell by about 1.3 million jobs, or 17%, from February to April, and in June also remained 7% below pre-crisis levels.

Doctors’ offices typically rely on patient volume for revenue. Without it, they can’t make payroll. Many small medical clinics weren’t flush with cash before the crisis, making COVID-19 an existential threat.

“Never in our history have we had more than a month’s cash on hand,” said Dr. Sumana Reddy, owner of the Acacia Family Medical Group in Monterey County. “Think of it that way.”

Reddy operates two clinics, one in Salinas and the other in the town of Prunedale. Many of her clients come from rural areas where poverty is common. When COVID-19 hit and stay-at-home orders took effect, the number of patients coming to the practice fell by about 50%, Reddy said. To keep her patients safe and her business afloat, Reddy largely shifted to telehealth so she could provide care online.

She also turned to federal aid. “I took the stimulus money,” she said. “I asked for advances from anywhere I could get that. So, now I’m tapped out. I’ve done every single thing that I can think of to do. And there’s nothing more to do.”

By late June, patient volume at Reddy’s practice stood at roughly 70% of the level seen before the crisis.

Many dental offices have been hit even harder. From February to April, the number of dental office employees in California fell by 85,000, or 60%, a rate of decline that outpaced even job losses in the state’s restaurant industry. Nationwide, dental employment fell by about 546,000 from February to April, a 56% decline.

“March, April, mid-May — we were pretty much closed except for emergency care,” said Dr. Natasha Lee, who owns Better Living Through Dentistry, a practice in San Francisco’s Inner Sunset neighborhood. “While dental offices were considered essential, most were closed due to guidance from health departments and the CDC to postpone routine and preventative medical and dental care and just to limit things to emergency.”

Lee has reopened her clinic but is doing less business. She and her staff need extra time to clean tools and change their personal protective equipment.

“With the social distancing, the limiting [of] patients in the office at a time and the slowdown we’ve had, we’re probably seeing about, I’d say, two-thirds of our normal capacity in our practice,” she said in late June.

As for employment, California hospitals have fared better than outpatient medical offices. Hospitals shed about 2% of jobs from February to June.

“They have more capacity in a large organization to withstand the same shock,” said John Romley, a professor and economist at the University of Southern California’s Leonard D. Schaeffer Center for Health Policy and Economics.

Romley said he is optimistic the health care sector overall will recover faster than some other sectors of the economy, since health care remains a necessity.

Still, red flags abound. The recent spike in COVID-19 cases and deaths in many parts of the nation raises the specter of future shutdowns and, with them, additional health care layoffs. In California, Gov. Gavin Newsom recently ordered a second shutdown for dine-in restaurants, movie theaters and bars statewide, as well as churches, gyms and barbershops in much of the state. For now, dental and doctors’ offices can continue operating.

But it’s uncertain when patients will feel comfortable returning to the doctor for routine and preventive care. A series of Census Bureau surveys conducted between June 11 and July 7 found that 42% of Californians who responded had put off medical care in the previous four weeks because of the pandemic. About 33% said they needed medical care for something unrelated to COVID-19 but did not get it.

“I’ve been telling my staff and patients that we should prepare for things to stay not too different for six months to a year,” Reddy said, “which is pretty depressing for most people to think about.”

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.

Biden Is Right. Pay for Home Health Workers Is Paltry.

03:46

Annapoorna

In a speech this month, former Vice President Joe Biden, the presumptive Democratic presidential nominee, offered the third installment of a four-part economic plan being rolled out in advance of the Democratic National Convention in August. This set of proposals focused on caregivers — whether for children, older adults or people with disabilities — and is about “easing the squeeze on working families who are raising their kids and caring for aging loved ones at the same time,” Biden said.

His campaign’s sweeping set of initiatives, which represent a $775 billion expenditure in a variety of programs, aims to get significant traction among middle-class voters, whose struggles with caregiving issues have been exacerbated during the coronavirus pandemic.

When it came to home health workers, Biden zeroed in on their paychecks. “They’re doing God’s work,” he said. “But home health workers aren’t paid much, they have few benefits. Forty percent are still on SNAP or Medicaid. So my plan is direct. It gives caregivers and early childhood educators a much-needed raise.”

That 40% is a striking number.

After all, there are an estimated 3.3 million home health and personal care aides in the United States, according to the Bureau of Labor Statistics. These workers provide a range of daily living services to millions of older Americans and people with disabilities, chronic illness or cognitive impairment — making them an important part of the health care continuum. As baby boomers age, demand for home health workers is expected to increase rapidly. And, because Biden put a spotlight on the role caregivers could have in boosting the economy, we decided to investigate further.

We contacted the Biden campaign to find out the source for the 40% statistic. A spokesperson pointed us to information from PHI National’s Workforce Data Center. PHI is a New York-based advocacy organization that studies the direct-care workforce and is frequently cited as a source on this topic.

Sources

“Child and Elder Care Plan Speech,” former Vice President Joe Biden, July 21

Email and telephone exchanges with a spokesperson for Joe Biden for President campaign, July 22 and 23

Telephone interview with Robert Espinoza, vice president for policy, PHI National, July 22

Telephone interview with Sara Rosenbaum, a professor of health law and policy at George Washington University’s Milken Institute School of Public Health, July 24

PHI National, PHI Workforce Data Center, accessed July 22

PHI National, “U.S. Home Care Workers: Key Facts,” 2019

U.S. Department of Agriculture Food and Nutrition Service, Supplemental Nutrition Assistance Program, accessed July 22

The New York Times, “Biden Announces $775 Billion Plan to Help Working Parents and Caregivers,” July 21

Centers for Medicare & Medicaid Services, Medicaid, accessed July 23

Bureau of Labor Statistics, Home Health Aides and Personal Care Aides, Sept. 4, 2018

National Employment Law Project, “Surveying the Home Care Workforce”, Sept. 22, 2017

Department of Health and Human Services, 2020 Poverty Guidelines, Jan. 21

KFF, “Medicaid and CHIP Eligibility, Enrollment, and Cost Sharing Policies as of January 2019: Findings from a 50-State Survey”, March 27, 2019

The group indicated that in 2017 42% of direct care workers, a category composed of personal care aides, home health aides and nursing assistants, received some form of public assistance — defined by PHI as food and nutrition assistance, public health insurance or cash assistance. A further breakdown of this broad job category showed that 53% of home care workers received public assistance, with 30% having received food and nutrition assistance and 33% Medicaid insurance coverage.

Based on these figures, Robert Espinoza, PHI’s vice president of policy, said Biden was certainly in the ballpark.

More Numbers, and Some Context

But there’s more.

The two programs Biden mentioned by name — SNAP, or the Supplemental Nutritional Assistance Program, and Medicaid, the state-federal health insurance program for low-income people — peg eligibility to income limits at or near the federal poverty level, which for an individual is $12,760. Those eligibility limits vary by program and state.

Medicaid for adults depends on where they live, and ranges from 138% of poverty in states that chose to expand the program under the Affordable Care Act to a median of 40% of poverty in those states that didn’t. For SNAP, those limits are set at 130% percent of the poverty level for gross monthly income and 100% for net monthly income. For an individual, that’s $1,354 and $1,041, respectively.

According to the Bureau of Labor Statistics, the median pay for home health workers is about $24,060 per year, and a 2019 report by PHI concluded that 47% of home health workers have incomes at or below 138% of the poverty level. These numbers further back up Biden’s assertion about the number of home health workers on Medicaid or SNAP. If anything, they suggest his 40% figure may be a lowball estimate.

And one more bit of evidence that Biden was on the right track: The National Employment Law Project noted that many of these workers “supplement their home care work with other jobs to make ends meet.” That PHI report asserted that half of home care workers have only a high school education and often work part time or inconsistent schedules. These jobs are also marked by high turnover rates.

Our Ruling

Biden said home health workers were paid very little, citing a statistic that 40% of these workers relied on public assistance programs like SNAP and Medicaid as evidence.

According to the experts with whom we spoke, and the documents we consulted, Biden accurately described home health workers’ income and their reliance on these programs. His number appears to represent the low end of the spectrum.

We rate this statement True.

Monday, 27 July 2020

Watch: When a Surprise Helper During Surgery Is Out-of-Network

15:26

Annapoorna

Gayle King of “CBS This Morning” spoke with KHN Editor-in-Chief Elisabeth Rosenthal about the latest installment of KHN-NPR’s Bill of the Month. College student Izzy Benasso underwent surgery for a torn meniscus after a tennis injury last summer and was surprised to be contacted afterward by a surgical assistant, who said he would be billing her insurance more than a thousand dollars.

Last Thing Patients Need During Pandemic: Being Last to Know a Doctor Left Network

03:17

Annapoorna

NEW YORK — As the coronavirus spread silently through New York City early this year, Deborah Koeppel had an appointment with her cardiologist and two visits with her primary care doctor. Both physicians are members of Concorde Medical Group, a practice in Manhattan with an office conveniently located a few blocks from where Koeppel works.

She soon received notices telling her — after the fact — that those doctors were not in her health plan’s network of providers. According to the notices, she was on the hook for $849 in out-of-network cost sharing for three visits, which typically would cost her nothing from in-network providers.

Changes to health plan networks occur all the time as doctors retire, relocate or leave networks. And patients may be the last to find out about such changes because providers or insurers are not always required to inform them.

Koeppel also faced the loss of low-cost access to her in-network gynecologist and dermatologist.

“I felt sickened,” said Koeppel, 62, a senior social worker who kept working even as New York was hit by a brutal COVID-19 outbreak, with more than 1,000 deaths a day at its peak. “To me, it feels like physician abandonment. In the middle of something like this, you’re left without your doctors.”

Legislators, regulators and insurers have enacted special policies during the coronavirus pandemic, including paying for more virtual visits and eliminating copays for COVID-related testing and care. But long-standing issues, such as ever-shifting networks — often unbeknownst to patients — persist unchanged. And blindsiding patients with such changes is particularly hazardous at a time when many offices are partly closed, and patients are vulnerable and more likely than usual to need medical advice or attention.

That’s not how it should work, experts say. “Both parties should have responsibility for notifying their members,” said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms who co-authored a recent report examining state protections for patients who lose access to their doctors and other providers during contract disputes between providers and health plans.

The paper highlighted published examples of contract disputes that potentially affected hundreds of thousands of members, including 100,000 UnitedHealthcare members who lost access to eight Houston hospitals because of a contract dispute last year and the long-running feud in Pennsylvania between Highmark Health and the University of Pittsburgh Medical Center over in-network access to at least 11 hospitals.

Network changes that affect only a small number of patients or are the result of amicable negotiations between providers and insurers happen too, but they rarely make the news.

Health care experts agree that maintaining regular relationships with providers over time can help people manage chronic conditions and stay healthy. But patient protections from disruptions caused by network changes are scant. Most states have laws that permit health plan members to continue to see their doctors for a time after they leave the network, but only under certain limited circumstances, such as if they are pregnant or have a terminal illness. And some states require insurers to notify members in advance of network changes, Corlette said.

Deborah Koeppel learned her cardiologist and primary care doctor had been dropped from her insurance network ― shortly after her most recent appointments with both. “I felt sickened,” says Koeppel. “To me it feels like physician abandonment.” (Courtesy of David Koeppel)

But state laws don’t protect the majority of people who have coverage through health plans that are self-insured, meaning they pay members’ claims directly rather than buy insurance for that purpose. Those plans operate under federal guidelines and generally aren’t subject to state insurance regulation.

Koeppel is a member of 1199SEIU, the Service Employees International Union’s largest local, representing nearly 450,000 health care workers on the East Coast. She receives health care through the National Benefit Fund, a self-insured plan funded by contributions from the union members’ employers.

Koeppel has gone to doctors at Concorde for eight years. Until January, Concorde doctors participated in plans offered through the Independent Practice Association at NYU Langone Health, a large private health system. Eleven Concorde doctors treated members of the National Benefit Fund for 1199SEIU. In January, the physicians group joined Northwell Health, another large private health system in New York. Koeppel and 162 other 1199SEIU patients lost in-network access to their Concorde doctors as a result, said Terry Lynam, a Northwell spokesperson.

Northwell put out a press release in October announcing that Concorde Medical Group was joining the health system. In December, the Concorde Medical Group posted the upcoming change on its website.

But no one told the patients about the change.

The National Benefit Fund wasn’t notified of the change either, according to a statement from the fund. A staff member for the fund brought it to their attention.

Koeppel said she knows there are other doctors she can see — there are tens of thousands in network in the New York City area. But she was distraught to lose those with whom she’s developed a trusting relationship.

Her primary care physician “has been incredibly available by phone, just a really committed person who’s caring, warm and very reassuring,” she said.

After Koeppel complained to Northwell, administrators offered to write off any charges for her visits to Concorde physicians during the pandemic, she said.

And after a reporter contacted Northwell and the union’s National Benefit Fund about the network changes, the health system and the union agreed to a temporary contract extension from January 2020 through the end of August that allows 1199SEIU members to continue to see their Concorde doctors without cost sharing. The two parties are in negotiations for a new agreement that would give National Benefit Fund members in-network access to Concorde and other Northwell physicians after that date.

Northwell’s Lynam said that since there was no interruption in patient care, the timing of patients’ discovering the change is immaterial.

“Whether they found out in December that they had to find a new provider or they found out in June that they had to do so, the end result would be the same,” he said. “No patient was abandoned or harmed because they didn’t know earlier, and they would have been equally upset by the news whether they found out now or in December.”

Koeppel disagreed. If she had been informed of the upcoming change in October when Northwell put out its press release, Koeppel said, she would still have been upset. But she would have been better positioned to switch providers before January and would have had new physicians in place before the pandemic hit.

The Color of COVID: Will Vaccine Trials Reflect America’s Diversity?

03:17

Annapoorna

When U.S. scientists launch the first large-scale clinical trials for COVID-19 vaccines this summer, Antonio Cisneros wants to make sure people like him are included.

Cisneros, who is 34 and Hispanic, is part of the first wave of an expected 1.5 million volunteers willing to get the shots to help determine whether leading vaccine candidates can thwart the virus that sparked a deadly pandemic.

“If I am asked to participate, I will,” said Cisneros, a Los Angeles cinematographer who has signed up for two large vaccine trial registries. “It seems part of our duty.”

It will take more than duty, however, to ensure that clinical trials to establish vaccine safety and effectiveness actually include representative numbers of African Americans, Latinos and other racial minorities, as well as older people and those with underlying medical conditions, such as kidney disease.

Black and Latino people have been three times as likely as white people to become infected with COVID-19 and twice as likely to die, according to federal data obtained via a lawsuit by The New York Times. Asian Americans appear to account for fewer cases but have higher rates of death. Eight out of 10 COVID deaths reported in the U.S. have been of people ages 65 and older. And the Centers for Disease Control and Prevention warns that chronic kidney disease is among the top risk factors for serious infection.

Antonio Cisneros, a Los Angeles cinematographer, signed up for two COVID-19 vaccine trial registries. He is among the first wave of volunteers. “If I am asked to participate, I will,” says Cisneros. “It seems part of our duty.”(Photo by Steven Shea)

Historically, however, those groups have been less likely to be included in clinical trials for disease treatment, despite federal rules requiring minority and elder participation and the ongoing efforts of patient advocates to diversify these crucial medical studies.

In a summer dominated by COVID-19 and protests against racial injustice, there are growing demands that drugmakers and investigators ensure that vaccine trials reflect the entire community.

“If Black people have been the victims of COVID-19, we’re going to be the key to unlocking the mystery of COVID-19,” said the Rev. Anthony Evans, president of the National Black Church Initiative, a coalition of 150,000 African American churches.

Evans and his team met in mid-July with officials from Moderna, the Massachusetts biotech firm that launched the first COVID vaccine trial in the U.S., to discuss a collaboration in which NBCI would supply African American participants. But that was less than two weeks before the start of a phase 3 trial expected to enroll 30,000 people, and Evans said the meeting was his idea.

“It’s not that the industry came to me,” he said. “I went to the industry.”

Blacks make up about 13% of the U.S. population but on average 5% of clinical trial participants, research shows. For Hispanics, trial participation is about 1% on average, though they account for about 18% of the population.

When it comes to trials for drug treatments and vaccines, diversity matters. For reasons not always fully understood, people of different races and ethnicities can respond differently to drugs or therapies, research shows. Immune response wanes with age, so there’s a high-dose flu shot for people 65 and older.

Still, the pressure to produce an effective vaccine quickly during a pandemic could sideline efforts to ensure diversity, said Dr. Kathryn Stephenson, director of the clinical trials unit in the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.

“One of the questions that has come up is, What do you do if you’re a site investigator and you have 250 people banging on your door — and they’re all white?” she said.

Do you enroll those people, reasoning that the faster the trial progresses, the faster a vaccine will be available for everyone? Or do you turn away people and slow down the study?

“You’re accelerating development of a vaccine, and if you hit a milestone, what is the meaning of that milestone if you don’t know if it’s very safe or effective in [a given] population? Is that really hitting the milestone for everyone?” she said.

Including people who are elderly or have underlying medical conditions is vital to the science of vaccines and other treatments, even if it’s more difficult to recruit patients otherwise healthy enough to participate, advocates said.

“We have to admit that older adults are the ones who are likely to develop side effects” to treatments and vaccines, said Dr. Sharon Inouye, director of the Aging Brain Center and a professor of medicine at Harvard Medical School. “On the other hand, that is the population that will be using it.”

People with kidney disease, which affects 1 in 7 U.S. adults, have been left out of clinical research for decades, said Richard Knight, a transplant recipient and president of the American Association of Kidney Patients. Nearly 70% of more than 400 kidney disease patients the organization surveyed in July said they’d never been asked to join a clinical trial.

Excluding from the vaccine trial such a large population vulnerable to COVID doesn’t make sense, Knight contended. “If you’re trying to manage this from a public health standpoint, you want to make sure you’re inoculating your highest-risk populations,” he said.

New guidance from the federal Food and Drug Administration, which regulates vaccines, “strongly encourages” the inclusion of diverse populations in clinical vaccine development. That includes racial and ethnic minorities, elderly people and those with underlying medical problems, as well as pregnant women.

But the FDA does not require drugmakers and researchers to meet those goals, and will not refuse trial data that doesn’t comply. And while the federal government is rushing billions of dollars to fast-track more than a half-dozen leading candidates for COVID vaccines, the pharmaceutical firms producing them are not required to publicly disclose their demographic goals.

“This is business as usual,” said Marjorie Speers, executive director of Clinical Research Pathways, a nonprofit group in Atlanta that works to increase diversity in research. “It’s very likely these [COVID] trials will not include minorities because there’s not a strong statement to do that.”

The vaccine trials are being coordinated through the COVID-19 Prevention Network, or CoVPN, based at the Fred Hutchinson Cancer Research Center in Seattle. It draws on four long-standing federally funded clinical trial networks, including three that target HIV and AIDS.

Those trial networks were chosen in large part because they have rich relationships in Black, Latino and other minority communities, said Stephaun Wallace, director of external relations for CoVPN. The hope is to leverage existing connections based on trust and collaboration.

“Our clinical trial sites are prepped and ready to engage diverse people,” Wallace said.

Wallace acknowledged, however, that attracting a diverse population requires investigators to be flexible and innovative. There can be practical problems. Clinic hours may be limited or transportation may be an issue. Older people may have problems with sight or hearing and require extra help to follow protocols.

Distrust of the medical establishment also can be a barrier. African Americans, for instance, have a well-founded wariness of medical experiments after the infamous Tuskegee Study and the exploitation of Henrietta Lacks. That extends to suspicion about recommended vaccines, said Wallace.

“Part of the consideration for many groups is not wanting to feel like a guinea pig or feel like they’re being experimented on,” he said.

Moderna, which plans to launch its phase 3 trial Monday, said the company is working to ensure participants “are representative of the communities at highest risk for COVID-19 and of our diverse society.”

However, results of the company’s phase 1 trial, released in mid-July, showed that of 45 people included in that safety test, six were Hispanic, two were Black, one was Asian and one was Native American. Forty were white.

Phase 1 and phase 2 clinical trials aim to test the best dose and safety of vaccines in small groups of people. Phase 3 trials assess the efficacy of the drug in tens of thousands of people.

Investigators at nearly 90 sites across the U.S. are preparing now to recruit participants for Moderna’s phase 3 trial. Dr. Carlos del Rio, executive associate dean at the Emory University School of Medicine, will seek 750 volunteers at three Atlanta-area sites. Half will receive the vaccine; half, placebo injections.

Del Rio has had marked success recruiting minorities for HIV trials and expects similar results with the vaccine trial. “We’re trying to do our best to get out to the communities that are most at risk,” he said.

Meanwhile, vaccine volunteers like Cisneros just want the advanced trials to start. He signed up for the CoVPN trials. But earlier, he also signed up for 1 Day Sooner, an effort to launch human challenge trials, which aim to speed up vaccine development by deliberately infecting participants with the virus. Such trials can be completed in weeks rather than months but risk exposing volunteers to severe illness or death, and federal officials remain leery.

Cisneros is willing to take that risk to help halt COVID-19, which has killed 143,000 Americans. He said it’s a way to take action at a time when the U.S. government has failed to protect minorities, the elderly and other vulnerable people.

“Government is supposed to help those who can’t protect themselves,” he said. “It appears to me the only thing they want to protect is people with money, people with guns — and not brown people like me.”

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Wednesday, 29 July 2020

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Tuesday, 28 July 2020

El color de COVID: ¿los ensayos de vacunas reflejan la diversidad de Estados Unidos?

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The COVID-19 Downturn Triggers Jump in Medicaid Enrollment

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Dental and Doctors’ Offices Still Struggling with COVID Job Loss

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Biden Is Right. Pay for Home Health Workers Is Paltry.

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Monday, 27 July 2020

Watch: When a Surprise Helper During Surgery Is Out-of-Network

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Last Thing Patients Need During Pandemic: Being Last to Know a Doctor Left Network

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The Color of COVID: Will Vaccine Trials Reflect America’s Diversity?

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