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Monday 31 August 2020

Med Students ‘Feel Very Behind’ Because of COVID-Induced Disruptions in Training

COVID-19 is disrupting just about every student’s 2020 education, but medical students have it particularly hard right now.


“It’s a nightmare scenario for the class of 2021,” said Jake Berg, a fourth-year student at the Kentucky College of Osteopathic Medicine in Pikeville. In March, students were abruptly pulled out of hospitals and medical offices, where they normally work with professionals to learn about treating patients. Over the space of less than two weeks, he said, medical students in “pretty much the entire country” transitioned from seeing patients in person to learning online.


“Everyone goes along with the idea that we’re all in the same boat together,” he said. “But, really, it’s like we’re all on the Titanic and it’s sinking.”

Megan Messinger, in her fourth year at the Western University of Health Sciences in Pomona, California, calculates she has lost about 400 hours of patient time. She worries “the class of 2021 is going to be the dumb class of interns,” said Messinger, who hopes to do a combined residency in pediatrics and psychiatry. “I feel very behind.”


The problem is most acute for medical students in their third and fourth years of study. Year three is when most medical students do their “core clinical clerkships.” These are one- or two-month stints in hospitals and clinics, through which they get the flavor of specialties such as internal medicine, pediatrics, surgery and obstetrics/gynecology.


Fourth-year students tend to spend time in more specialized options, often traveling to get experience in specialties in short supply at their own medical school’s affiliated hospitals, and also to informally “audition” at places they might like to apply to for residency. Because of the coronavirus pandemic, however, “away rotations” have been suspended, and residency interviews for next year’s graduating class will be done virtually.


Schools and hospitals are trying to restore the core clerkships but, in many areas, this is a work in progress. The uncertainty adds considerably to students’ stress levels.


“I have no idea how I will learn about the culture of the hospitals I’m applying to,” said Garrett Johnson, a fourth-year student at Harvard Medical School. On one hand, this year’s class of doctors-to-be will save a lot of money — typically, travel and housing costs for away rotations and in-person residency interviews are paid by the students. On the other hand, he said, “you don’t get to meet any of the people or get a feel for the place.”


Karissa LeClair, a fourth-year student at the Geisel School of Medicine at Dartmouth, agreed. “I was looking forward to getting to know places I had not been to previously,” she said.


Left: Karissa LeClair, a fourth-year student at the Geisel School of Medicine at Dartmouth, applied to core clinical clerkships in New York City, Boston and Ann Arbor, Michigan ― but all were canceled. (Karissa LeClair) Right: Because of the pandemic, “away rotations” have been suspended for med students at the Kentucky College of Osteopathic Medicine. “It’s a nightmare scenario for the class of 2021,” says Jake Berg, a fourth-year student. (Raymunda Garza)


LeClair, who wants to become an ear, nose and throat specialist, said clerkships she applied to in New York City, Ann Arbor, Michigan, and Boston were all canceled.


Since she was not planning to be in New Hampshire for most of this year, LeClair now has no place to live near Dartmouth. “I’m piecing together sublets and staying with friends,” she said. Unless something changes, she will spend her final year of medical school only in facilities formally affiliated with Dartmouth.


Messinger is facing similar problems in Southern California. “I’m at Cedars right now, and loving it,” she said, referring to Los Angeles’s Cedars Sinai medical center. “But you can only do one rotation there. I don’t have anything scheduled after this. My only audition rotation, at Tulane, was canceled.”


Administrators are sympathetic. “They have had major disruption,” said Dr. Alison Whelan, chief medical education officer for the Association of American Medical Colleges, which oversees M.D.-degree programs. “Medical school is stressful, and with COVID it’s even more stressful.”


“I feel for the students, they’re really in a tough position,” said Dr. Robert Cain, president and CEO of the American Association of Colleges of Osteopathic Medicine, which oversees osteopathy programs. About 1 in 4 U.S. medical students pursue a doctorate in osteopathy, which is similar to an M.D. degree but includes training in hands-on manipulative techniques and more emphasis on whole-body health.


Starting this year, M.D. and D.O. students are competing for the same residency training programs and work side by side, a change planned before the pandemic.


One hurdle is that all these students, in order to become well-rounded doctors, need to see a broad mix of patients with a diverse group of medical issues. But even at hospitals and clinics that have resumed general care, patients with ailments other than those associated with COVID-19 are not showing up, because they are afraid of catching the coronavirus. Elsewhere elective procedures have been canceled or postponed.


“That has become a challenge,” Whelan said. In areas with high COVID-19 rates, hospitals and other facilities often do not have enough personal protective equipment for even essential health personnel, so students are kept out.


Fourth-year medical students like Megan Messinger tend to spend time in more specialized options, but COVID-19 is disrupting their education. “The class of 2021 is going to be the dumb class of interns,” Messinger says.(Heidi de Marco/KHN)


The AAMC in August updated its guidance on student participation in clinical rotations. It continued to leave decisions about allowing students into patient care areas up to individual teaching hospitals and medical schools. But it also noted that while students are not technically essential in day-to-day care activities, “medical students are the essential, emerging physician workforce” whose learning is necessary to prevent future medical shortages.


“The progression of students over time for relatively on-time graduation is essential to the physician workforce,” Whelan said. Enabling students to finish their education in the COVID-19 era “is an ongoing, complex, jigsaw puzzle.”


Both the M.D. and D.O. organizations said third-year students can still complete most of their required rotations, although perhaps not in the usual order, and schools have dramatically increased their use of online teaching of diagnostics and care.


“A fair amount of what students do is observation,” she said. “So schools have created step-by-step videos.”


And some educators are confident these students will catch up — eventually. “Most learning goes on during your residency,” said Dr. Art Papier, who teaches dermatology at the University of Rochester medical school. “I think it can all be made up.”


In addition to losing in-person patient contact, medical students face obstacles in taking required national board examinations — there are several types and are not always conveniently offered near their training sites.


After having one required test canceled on short notice, student Jake Berg had to reschedule. The first open seat was three hours away and a couple of weeks later; then his canceled test was reinstated.


The exam that tests clinical skills has been postponed for all M.D. students but is expected to be rescheduled.


The comparable exam for osteopathic students, however, has been made optional. That’s partly because D.O. students must demonstrate not only clinical skills, but also proficiency in physical manipulation techniques, which means they need to work with patients under the supervision of doctors as part of their test. But the D.O. clinical skills exam is offered only in two places: Chicago and outside Philadelphia.


“If there’s a self-isolation period, who can afford to spend two weeks in a hotel in Chicago or Philadelphia?” asked Messinger, of Western University.


While the travel may be a burden, the exams are needed “to protect the public” from doctors who have not demonstrated competence, said Cain, of the osteopathic colleges’ association.


Whelan and Cain said details are being worked out and changes are possible as the COVID situation evolves.


In the end, Cain said, this crop of students may emerge from COVID as better doctors than those who didn’t face such challenges.


“Hopefully, we’ll look back and see them as the class of resilience,” he said. “That they were able to work through some very hard times.”

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For Kids With Special Needs, Online Schooling Divides Haves and Have-Nots

ALHAMBRA, Calif. — It’s Tuesday morning, and teacher Tamya Daly has her online class playing an alphabet game. The students are writing quickly and intently, with occasional whoops of excitement, on the little whiteboards she dropped off at their homes the day before along with coloring books, markers, Silly Putty and other learning props — all of which she created or paid for with her own money.


Two of the seven children in her combined third and fifth grade class weren’t home when Daly came by with the gift bags. One of the two managed to find her own writing tablet, thanks to an older brother, but the other can’t find a piece of paper in her dad’s house. She sits quietly watching her classmates on Zoom for half an hour while Daly tries futilely to get the father’s attention. Maybe the student is wearing earphones; maybe the father is out of the room.


As children head back to school online across California and much of the nation, some of the disparities that plague education are growing wider. Instead of attending the same school with similar access to supplies and teacher time, children are directly dependent on their home resources, from Wi-Fi and computers to study space and parental guidance. Parents who work, are poor or have less education are at a disadvantage, as are their kids.

Daly teaches elementary students with special needs. The children in her class, who have a variety of diagnoses and intellectual disabilities, are at even higher risk — they can’t work independently and need more hands-on instruction. “The more they’re not getting those kinds of accommodations, the further they’re going to fall behind,” said Allison Gandhi, a managing director in special education at the nonprofit American Institutes for Research.


Educators and families fear devastating long-term consequences from COVID-19 for the nearly 800,000 California children who received special education services. So, in early August, the state announced it was developing a waiver application process for schools, even in COVID-plagued counties, that want to bring small groups of these students back for in-person education.


“There are simply kids that will never, ever have that quality learning that we all desire to advance online, no matter what kind of support we provide, even if we individualize it,” Gov. Gavin Newsom said at an Aug. 14 news conference.


Online learning is interfering with the students’ individualized education programs, or IEPs — legal agreements among families, school districts and specialists that set academic and behavioral goals for students and the services they’re entitled to.


The gap in online learning experience is sharply visible in Daly’s class, and the parents’ role is crucial. For parents who don’t have to work, distance learning may be tense and time-consuming, but it becomes part of a daily routine to be endured until the pandemic ebbs. For others, schooling is an unworkable nightmare burdening parents already stretched to their limits.


School started Aug. 12. By day five, Daly knew which children had the luxury of a stay-at-home parent and which were being supervised by older siblings. She knew which students struggled to get online on time every day — a new state requirement for all virtual learners — and which ones needed reminding to eat breakfast before class started.


She also knew, from last spring, that most of the parents couldn’t print the worksheets she had uploaded to Google Classroom. Their printers were broken, or printer ink cost too much, or they didn’t have printers. For this semester, she set up a time every Thursday for parents to drive by the school and pick up packets for the following week.


Daly works at Emery Park Elementary School in Alhambra, east of downtown Los Angeles, where two-thirds of the students qualified last year for free or reduced-price school meals. The school has loaned about 80% of the 434 students Chromebooks because they didn’t have computers at home, said principal Jeremy Infranca.


Like most schools in California, Emery Park started the school year in virtual classrooms — the safest option for a state with a stubbornly persistent infection rate. The Alhambra school district has yet to decide whether to apply for a waiver to bring students with special needs back on campus. Infranca and Daly would like to — if they can secure COVID-19 protective gear for themselves and their students, and if families feel comfortable with it.


In the meantime, Daly is doing her best to accommodate her families, which isn’t easy. Parents have told her to limit live group instruction to an hour a day, so as not to interfere with child care schedules or the laptop needs of other children in the household. To make up for the reduced time, Daly records several 15- to 30-minute videos explaining the work to be done and plans to schedule an individual session with each child once a week.


“I choose to be positive about this experience, and I choose to communicate and do my best to reach out to the students and connect with parents and family members,” said Daly. “We just need to be proactive, and also a little patient.”

Tamya Daly teaches elementary students with special needs — those who can’t work independently and need more hands-on instruction. When she takes attendance every morning, she greets each student personally, hoping the “circle time” will help the kids stay connected. (Anna Almendrala)

Tamya Daly delivers school supplies to Jasmine and her mother, Ivy, a stay-at-home parent. Ivy supervises Jasmine’s classwork and behavioral therapy online, and also helps Jasmine’s younger sister with her online classes. (Anna Almendrala)

Families have different opinions about whether to return their kids to the schoolhouse. It often depends more on a family’s desperation over child care than consideration of COVID-19 risks.


Cat Lee, 44, was nervous at first when she realized she had to take on the bulk of hands-on teaching for her son, Jacob, a fifth grader in Daly’s class.


“I wondered, would I be able to teach him as well, and would he be able to learn it?” she said.


Lee is a stay-at-home mom, and so far she has been able to stick to the schedule Daly lays out. She’s there with Jacob at every Zoom session and logs onto the Seesaw app to go through all the assignments. She praised Daly for her curriculum, which she felt was better and easier to teach than what the family received back in March. But she had reservations about her son’s new normal.


“It’s really slowing down his learning; plus, he doesn’t interact with kids anymore,” said Lee.


Still, if she had the chance to send Jacob for in-person learning now, Lee wouldn’t take it. She has concerns about their immune systems — Lee had a kidney transplant five years ago, and Jacob was born at just 27 weeks’ gestation — and is holding out for a COVID vaccine before allowing Jacob to resume his normal activities.


Not that she doesn’t have doubts.


“My fear is that he’s going to be home for so long, he’ll be so used to it and he won’t want to go back to school,” she said.


Danielle Musquiz, a 32-year-old mother with five elementary school-aged boys — four adopted from a relative — would favor a return to school. She gets three or four hours of sleep each night because of her 90-hour workweek with two jobs, as a home aide and a cashier at a regional park.


Four of her sons receive special education services, including an adopted middle child who is in Daly’s class and has cognitive delays linked to fetal alcohol spectrum disorder. The children, crowded together at the dining room table or in the living room, listen to their classes with earphones to keep from disturbing one another, which means she can’t hear a teacher calling out to her from the screen.


The four kids have individual education programs, but it’s hard for Musquiz to oversee them “with the minimal amount of time I have at home,” she said. She’s feeling overwhelmed by having to coordinate, supervise and respond to teachers, counselors and therapists for each child.


Musquiz is working longer hours than before the pandemic, and she picks up shifts at the park when the boys’ former stepfather takes them for the weekend.


“I’m slowly starting to say — and I know that this sounds bad — I don’t care anymore about the kids’ schooling,” Musquiz laughed nervously. “I feel like it’s chaos, and I’m drowning.”


To help with child care, her mother lives with the family Monday through Thursday, and her sons spend Thursday nights at her sister’s house. On Fridays, nine kids are all streaming their classes online from that house. On a recent Friday, the Wi-Fi broke, prompting a call from the school of one of her sons asking why he had left class early.


If she had the opportunity, Musquiz would send her children back to in-person learning in a heartbeat.


“None of my kids are really going to learn what they need to,” said Musquiz. “They need hands-on, they need interaction, they need motivation, and these classes are not doing that for them.”

Related Topics

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Friday 28 August 2020

COVID + Influenza: éste es un buen año para vacunarse, aconsejan expertos

La temporada de influenza se verá diferente este año, ya que los Estados Unidos se enfrentan a una pandemia de coronavirus que ya ha matado a más de 176.000 personas.


Muchos estadounidenses son reacios a ir al médico y los funcionarios de salud pública temen que las personas eviten vacunarse.

Aunque a veces se considera incorrectamente como un resfriado, la gripe también mata a decenas de miles de personas en el país cada año. Los más vulnerables son los niños pequeños, los adultos mayores y las personas con enfermedades subyacentes. Cuando se combina con los efectos de COVID-19, los expertos en salud pública dicen que es más importante que nunca vacunarse contra la gripe.


Si una cantidad suficiente de la población se vacuna, más del 45% lo hizo la temporada de gripe pasada, podría ayudar a evitar un escenario de pesadilla este invierno, con hospitales llenos de pacientes con COVID-19 y los que sufren los efectos graves de la influenza.


Además de la posible carga para los hospitales, existe la posibilidad de que las personas contraigan ambos virus y “nadie sabe qué sucede si se contrae influenza y COVID simultáneamente porque nunca sucedió antes”, dijo la doctora Rachel Levine, secretaria de Salud de Pennsylvania, a reporteros.


En respuesta, este año los fabricantes están produciendo más suministros de vacunas, entre 194 y 198 millones de dosis, unas 20 millones más de las que se distribuyeron la temporada pasada, según los Centros para el Control y Prevención de Enfermedades (CDC).


Mientras se acerca la temporada de gripe, aquí hay algunas respuestas a preguntas frecuentes:


P: ¿Cuándo debo vacunarme contra la gripe?


La publicidad ya ha comenzado y algunas farmacias y clínicas ya tienen sus suministros. Pero, debido a que la efectividad de la vacuna puede disminuir con el tiempo, los CDC recomiendan no recibir la dosis en agosto.


Muchas farmacias y clínicas comenzarán las inmunizaciones a principios de septiembre. Generalmente, los virus de la influenza comienzan a circular a mediados o fines de octubre, pero se expanden masivamente más tarde, en el invierno. Se necesitan aproximadamente dos semanas después de recibir la inyección para que los anticuerpos, que circulan en la sangre y frustran las infecciones, se acumulen.


“Las personas jóvenes y sanas pueden comenzar a vacunarse contra la gripe en septiembre, y las personas mayores y otras poblaciones vulnerables pueden hacerlo en octubre”, dijo el doctor Steve Miller, director clínico de la aseguradora Cigna.


Los CDC recomiendan que las personas “se vacunen contra la influenza a fines de octubre”, pero señalaron que se puede recibir la vacuna más tarde porque “aún puede ser beneficiosas y la vacunación debe ofrecerse a lo largo de toda la temporada de influenza”.


Aun así, algunos expertos recomiendan no esperar demasiado este año, no solo por COVID-19, sino también en caso de que haya escasez debido a la abrumadora demanda.


P: ¿Cuáles son las razones por las que las que debería ofrecer mi brazo para vacunarme?


Hay que vacunarse porque brinda protección contra la gripe y, por lo tanto, contra la propagación a otras personas, lo que puede ayudar a disminuir la carga para los hospitales y el personal médico.


Y hay otro mensaje que puede resonar en estos tiempos extraños.


“Le da a la gente la sensación de que hay algunas cosas que pueden controlar”, dijo Eduardo Sánchez, director médico de prevención de la American Heart Association.


Si bien una vacuna contra la gripe no evitará COVID-19, recibirla podría ayudar al médico a diferenciar entre las dos enfermedades si se desarrolla algún síntoma (fiebre, tos, dolor de garganta) que ambas infecciones comparten, explicó Sánchez.


Y aunque las vacunas contra la gripe no evitarán todos los casos de gripe, vacunarse puede reducir la gravedad si la persona se enferma, dijo.


Todas las personas elegibles, especialmente los trabajadores esenciales, los que sufren de afecciones subyacentes y aquellos en mayor riesgo, incluidos los niños muy pequeños y las mujeres embarazadas, deben buscar protección, dijeron los CDC. La entidad recomienda la vacunación a partir de los 6 meses.


P: ¿Qué sabemos sobre la efectividad de la vacuna de este año?


Se deben producir nuevas vacunas contra la gripe cada año, porque el virus muta y la efectividad de la vacuna varía, dependiendo de qué tan bien coincida con el virus circulante.


Se calculó que la formulación del año pasado tuvo una eficacia de aproximadamente un 45% para prevenir la gripe en general, con una efectividad de aproximadamente un 55% en los niños. Las vacunas disponibles en el país este año tienen como objetivo prevenir al menos tres cepas diferentes del virus, y la mayoría cubre cuatro.


Todavía no se sabe qué tan bien coincidirá el suministro de este año con las cepas que circularán en los Estados Unidos. Las primeras indicaciones del hemisferio sur, que atraviesa su temporada de gripe durante nuestro verano, son alentadoras. Allí, las personas practicaron el distanciamiento social, usaron máscaras y se vacunaron en mayor número este año, y los niveles mundiales de gripe son más bajos de lo esperado. Sin embargo, expertos advierten que no se debe contar con una temporada igual de suave en los Estados Unidos, en parte porque los esfuerzos por usar mascara facial y de distanciamiento social varían ampliamente.


P: ¿Qué están haciendo diferente los seguros y sistemas de salud este año?


Las aseguradoras y los sistemas de salud contactados por KHN dicen que seguirán las pautas de los CDC, que exigen limitar y espaciar la cantidad de personas que esperan en las filas y las áreas de vacunación. Algunos están programando citas para vacunas contra la gripe para ayudar a controlar el flujo.


Health Fitness Concepts, una compañía que trabaja con UnitedHealth Group y otras empresas para establecer clínicas de vacunación contra la gripe en el noreste del país, dijo que está “fomentando eventos más pequeños y frecuentes para apoyar el distanciamiento social” y “exigiendo que se completen todos los formularios y arremangarse las camisas antes de entrar al área de vacunación contra la influenza”.


Se requerirá que todos usen máscaras.


Además, a nivel nacional, algunos grupos médicos contratados por UnitedHealth instalarán carpas, para que las inyecciones se puedan administrar al aire libre, dijo un vocero.


Kaiser Permanente planifica las vacunas directamente en autos en algunos de sus centros médicos y está probando los procedimientos de detección y registro sin contacto en algunos lugares.


Geisinger Health, un proveedor de salud regional en Pennsylvania y Nueva Jersey, dijo que también tendría programas de vacunación contra la influenza al aire libre en sus instalaciones.


Además, “Geisinger exige que todos los empleados reciban la vacuna contra la influenza este año”, dijo Mark Shelly, director de prevención y control de infecciones del sistema. “Al dar este paso, esperamos transmitir a nuestros vecinos la importancia de la vacuna contra la influenza para todos”.


P: Por lo general, me vacunan contra la gripe en el trabajo. ¿Seguirá siendo una opción este año?


Con el objetivo de evitar riesgosas reuniones en interiores, muchos empleadores se muestran reacios a patrocinar las clínicas de gripe en oficinas como han ofrecido en años anteriores. Y con tanta gente que sigue trabajando desde casa, hay menos necesidad de llevar las vacunas contra la gripe al lugar de trabajo. En cambio, muchos empleadores están alentando a los trabajadores a que reciban vacunas de sus médicos de atención primaria, en farmacias u otros entornos comunitarios. El seguro generalmente cubrirá el costo de la vacuna.


Algunos empleadores están considerando ofrecer cupones para vacunas contra la gripe a sus trabajadores sin seguro o a aquellos que no participan en el plan médico de la compañía, dijo Julie Stone, directora general de salud y beneficios de Willis Towers Watson, una firma consultora.


Estos cupones podrían, por ejemplo, permitir a los trabajadores obtener la vacuna en un laboratorio en particular sin costo.


Algunos empleadores están comenzando a pensar en cómo podrían usar sus estacionamientos para administrar vacunas contra la gripe enlos autos, dijo el doctor David Zieg, líder de servicios clínicos para el consultor de beneficios Mercer.


Aunque la ley federal permite a los empleadores exigir a los empleados que se vacunen contra la gripe, ese paso generalmente lo toman solo los centros de atención médica y algunas universidades donde las personas viven y trabajan en estrecha colaboración, dijo Zieg.


Pero sucede. El mes pasado, el sistema de la Universidad de California emitió una orden ejecutiva que requiere que todos los estudiantes, profesores y personal se vacunen contra la gripe antes del 1 de noviembre, con limitadas excepciones.


P: ¿Qué están haciendo las farmacias para alentar a las personas a vacunarse contra la gripe?


Algunas farmacias están haciendo un esfuerzo adicional para salir a la comunidad y ofrecer vacunas contra la gripe.


Walgreens, que tiene casi 9,100 farmacias en todo el país, continúa una asociación iniciada en 2015 con organizaciones comunitarias, iglesias y empleadores que ha ofrecido alrededor de 150,000 clínicas de gripe móviles hasta la fecha.


El programa pone especial énfasis en trabajar con poblaciones vulnerables y en áreas desatendidas, dijo el doctor Kevin Ban, director médico de la cadena de farmacias.


Walgreens comenzó a ofrecer vacunas contra la gripe a mediados de agosto y está animando a las personas a no demorar en vacunarse.


Tanto Walgreens como CVS están estimulando a las personas a programar citas y hacer trámites en línea este año para minimizar el tiempo que pasan en los locales.


En los CVS MinuteClinic, una vez que los pacientes se han registrado para recibir la vacuna contra la gripe, deben esperar afuera o en su automóvil, ya que las áreas de espera interiores ahora están cerradas.


“No tenemos un arsenal contra COVID”, dijo Ban, de Walgreens. “Pero quitar la presión del sistema de atención médica proporcionando vacunas por adelantado es algo que sí podemos hacer”.

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Republican Convention, Day 4: Fireworks … and Shining a Light on Trump’s Claims

President Donald Trump accepted the Republican Party’s nomination for president in a 70-minute speech from the South Lawn of the White House on Thursday night.


Speaking to a friendly crowd that didn’t appear to be observing social distancing conventions, and with few participants wearing masks, he touched on a range of topics, including many related to the COVID pandemic and health care in general.


Throughout, the partisan crowd applauded and chanted “Four more years!” And, even as the nation’s COVID-19 death toll exceeded 180,000, Trump was upbeat. “In recent months, our nation and the entire planet has been struck by a new and powerful invisible enemy,” he said. “Like those brave Americans before us, we are meeting this challenge.”


At the end of the event, there were fireworks.


Our partners at PolitiFact did an in-depth fact check on Trump’s entire acceptance speech. Here are the highlights related to the administration’s COVID-19 response and other health policy issues:


“We developed, from scratch, the largest and most advanced testing system in the world.” 


This is partially right, but it needs context.


It’s accurate that the U.S. developed its COVID-19 testing system from scratch, because the government didn’t accept the World Health Organization’s testing recipe. But whether the system is the “largest” or “most advanced” is subject to debate.


The U.S. has tested more individuals than any other country. But experts told us a more meaningful metric would be the percentage of positive tests out of all tests, indicating that not only sick people were getting tested. Another useful metric would be the percentage of the population that has been tested. The U.S. is one of the most populous countries but has tested a lower percentage of its population than other countries.

The U.S. was also slower than other countries in rolling out tests and amping up testing capacity. Even now, many states are experiencing delays in reporting test results to positive individuals.


As for “the most advanced,” Trump may be referring to new testing investments and systems, like Abbott’s recently announced $5, 15-minute rapid antigen test, which the company says will be about the size of a credit card, needs no instrumentation and comes with a phone app through which people can view their results. But Trump’s comment makes it sound as if these testing systems are already in place when they haven’t been distributed to the public.


“The United States has among the lowest [COVID-19] case fatality rates of any major country in the world. The European Union’s case fatality rate is nearly three times higher than ours.”


The case fatality rate measures the known number of cases against the known number of deaths. The European Union has a rate that’s about 2½ times greater than the United States.


But the source of that data, Oxford University’s Our World in Data project, reports that “during an outbreak of a pandemic, the case fatality rate is a poor measure of the mortality risk of the disease.”


A better way to measure the threat of the virus, experts say, is to look at the number of deaths per 100,000 residents. Viewed that way, the U.S. has the 10th-highest death rate in the world.


“We will produce a vaccine before the end of the year, or maybe even sooner.”


It’s far from guaranteed that a coronavirus vaccine will be ready before the end of the year.


While researchers are making rapid strides, it’s not yet known precisely when the vaccine will be available to the public, which is what’s most important. Six vaccines are in the third phase of testing, which involves thousands of patients. Like earlier phases, this one looks at the safety of a vaccine but also examines its effectiveness and collects more data on side effects. Results of the third phase will be submitted to the Food and Drug Administration for approval.


The government website Operation Warp Speed seems less optimistic than Trump, announcing it “aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.”


And federal health officials and other experts have generally predicted a vaccine will be available in early 2021. Federal committees are working on recommendations for vaccine distribution, including which groups should get it first. “From everything we’ve seen now — in the animal data, as well as the human data — we feel cautiously optimistic that we will have a vaccine by the end of this year and as we go into 2021,” said Dr. Anthony Fauci, the nation’s top infectious diseases expert. “I don’t think it’s dreaming.”


“Last month, I took on Big Pharma. You think that is easy? I signed orders that would massively lower the cost of your prescription drugs.”


Quite misleading. Trump signed four executive orders on July 24 aimed at lowering prescription drug prices. But those orders haven’t taken effect yet — the text of one hasn’t even been made publicly available — and experts told us that, if implemented, the measures would be unlikely to result in significant drug price reductions for the majority of Americans.


“We will always and very strongly protect patients with preexisting conditions, and that is a pledge from the entire Republican Party.”


Trump’s pledge is undermined by his efforts to overturn the Affordable Care Act, the only law that guarantees people with preexisting conditions both receive health coverage and do not have to pay more for it than others do. In 2017, Trump supported congressional efforts to repeal the ACA. The Trump administration is now backing GOP-led efforts to overturn the ACA through a court case. And Trump has also expanded short-term health plans that don’t have to comply with the ACA.


“Joe Biden recently raised his hand on the debate stage and promised he was going to give it away, your health care dollars to illegal immigrants, which is going to bring a massive number of immigrants into our country.”


This is misleading. During a June 2019 Democratic primary debate, candidates were asked: “Raise your hand if your government plan would provide coverage for undocumented immigrants.” All candidates on stage, including Biden, raised their hands. They were not asked if that coverage would be free or subsidized.


Biden supports extending health care access to all immigrants, regardless of immigration status. A task force recommended that he allow immigrants who are in the country illegally to buy health insurance, without federal subsidies.


“Joe Biden claims he has empathy for the vulnerable, yet the party he leads supports the extreme late-term abortion of defenseless babies right up to the moment of birth.”


This mischaracterizes the Democratic Party’s stance on abortion and Biden’s position.


Biden has said he would codify the Supreme Court’s ruling in Roe v. Wade and related precedents. This would generally limit abortions to the first 20 to 24 weeks of gestation. States are allowed under court rulings to ban abortion after the point at which a fetus can sustain life, usually considered to be between 24 and 28 weeks from the mother’s last menstrual period — and 43 states do. But the rulings require states to make exceptions “to preserve the life or health of the mother.” Late-term abortions are very rare, about 1%.


The Democratic Party platform holds that “every woman should have access to quality reproductive health care services, including safe and legal abortion — regardless of where she lives, how much money she makes, or how she is insured.” It does not address late-term abortion.


PolitiFact’s Daniel Funke, Jon Greenberg, Louis Jacobson, Noah Y. Kim, Bill McCarthy, Samantha Putterman, Amy Sherman, Miriam Valverde and KHN reporter Victoria Knight contributed to this report.

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Opposition to Obamacare Becomes Political Liability for GOP Incumbents

In the 2014 elections, Republicans rode a wave of anti-Affordable Care Act sentiment to pick up nine Senate seats, the largest gain for either party since 1980. Newly elected Republicans such as Cory Gardner in Colorado and Steve Daines in Montana had hammered their Democratic opponents over the health care law during the campaign and promised to repeal it.


Six years later, those senators are up for reelection. Not only is the law still around, but it’s gaining in popularity. What was once a winning strategy has become a political liability.


Public sentiment about the ACA, also known as Obamacare, has shifted considerably during the Trump administration after Republicans tried but failed to repeal it. Now, in the midst of the COVID-19 pandemic and the ensuing economic crisis, which has led to the loss of jobs and health insurance for millions of people, health care again looks poised to be a key issue for voters this election.

With competitive races in Colorado, Montana, Arizona, North Carolina and Iowa pitting Republican incumbents who voted to repeal the ACA against Democratic challengers promising to protect it, attitudes surrounding the health law could help determine control of the Senate. Republicans hold a slim three-vote majority in the Senate but are defending 23 seats in the Nov. 3 election. Only one Democratic Senate seat — in Alabama, where incumbent Doug Jones is up against former Auburn University football coach Tommy Tuberville — is considered in play for Republicans.


“The fall election will significantly revolve around people’s belief about what [candidates] will do for their health coverage,” said Dr. Daniel Derksen, a professor of public health at the University of Arizona.


The Affordable Care Act has been a wedge issue since it was signed into law in 2010. Because it then took four years to enact, its opponents talked for years about how bad the not-yet-created marketplace for insurance would be, said Joe Hanel, spokesperson for the Colorado Health Institute, a nonpartisan nonprofit focused on health policy analysis. And they continued to attack the law as it took full effect in 2014.


Gardner, for example, ran numerous campaign ads that year criticizing the ACA and, in particular, President Barack Obama’s assertion that “if you like your health care plan, you’ll be able to keep your health care plan.”


But now, Hanel said, the ACA’s policies have become much more popular in Colorado as the costs of health exchange plans have dropped. Thus, political messaging has changed, too.


“This time it’s the opposite,” Hanel said. “The people bringing up the Affordable Care Act are the Democrats.”


Despite Gardner’s multiple votes to repeal the ACA, he has largely avoided talking about the measure during the 2020 campaign. He even removed his pro-repeal position from his campaign website.


Democratic attack ads in July blasted Gardner for repeatedly dodging questions in an interview with Colorado Public Radio about his stance on a lawsuit challenging the ACA.


His opponent, Democrat John Hickenlooper, fully embraced the law when he was Colorado governor, using the measure to expand Medicaid eligibility to more low-income people and to create a state health insurance exchange. Now, he’s campaigning on that record, with promises to expand health care access even further.


Polling Data


Polling conducted by KFF for the past 10 years shows a shift in public opinion has occurred nationwide. (KHN is an editorially independent program of KFF, the Kaiser Family Foundation.)


“Since Trump won the election in 2016, we now have consistently found that a larger share of the public holds favorable views” of the health law, said Ashley Kirzinger, associate director of public opinion and survey research for the foundation. “This really solidified in 2017 after the failed repeal in the Senate.”


The foundation’s polling found that, in July 2014, 55% of voters opposed the law, while 36% favored it. By July 2020, that had flipped, with 51% favoring the law and 38% opposing it. A shift was seen across all political groups, though 74% of Republicans still viewed it unfavorably in the latest poll.


Public support for individual provisions of the ACA — such as protections for people with preexisting conditions or allowing young adults to stay on their parents’ health plans until age 26 — have proved even more popular than the law as a whole. And the provision that consistently polled unfavorably — the mandate that those without insurance must pay a fine — was eliminated in 2017.


“We’re 10 years along and the sky hasn’t caved in,” said Sabrina Corlette, a health policy professor at Georgetown University.


Political Messaging


Following the passage of the ACA, Democrats didn’t reference the law in their campaigns, said Erika Franklin Fowler, a government professor at Wesleyan University and the director of the Wesleyan Media Project, which tracks political advertising.


“They ran on any other issue they could find,” Fowler said.


Republicans, she said, kept promising to “repeal and replace” but weren’t able to do so.


Then, in the 2018 election, Democrats seized on the shift in public opinion, touting the effects of the law and criticizing Republicans for their attempts to overturn it.


“In the decade I have been tracking political advertising, there wasn’t a single-issue topic that was as prominent as health care was in 2018,” she said.


As the global health crisis rages, health care concerns again dominate political ads in the 2020 races, Fowler said, although most ads haven’t explicitly focused on the ACA. Many highlight Republicans’ support for the lawsuit challenging preexisting condition protections or specific provisions of the ACA that their votes would have overturned. Republicans say they, too, will protect people with preexisting conditions but otherwise have largely avoided talking about the ACA.


“Cory Gardner has been running a lot on his environmental bills and conservation funding,” Fowler said. “It’s not difficult to figure out why he’s doing that. It’s easier for him to tout that in a state like Colorado than it is to talk about health care.”


Similar dynamics are playing out in other key Senate races. In Arizona, Republican Sen. Martha McSally was one of the more vocal advocates of repealing the ACA while she served in the House of Representatives. She publicly acknowledged those votes may have hurt her 2018 Senate bid.


“I did vote to repeal and replace Obamacare,” McSally said on conservative pundit Sean Hannity’s radio show during the 2018 campaign. “I’m getting my ass kicked for it right now.”


She indeed lost but was appointed to fill the seat of Sen. Jon Kyl after he resigned at the end of 2018. Now McSally is in a tight race with Democratic challenger Mark Kelly, an astronaut and the husband of former Rep. Gabby Giffords.


“Kelly doesn’t have a track record of voting one way or another, but certainly in his campaign this is one of his top speaking points: what he would do to expand coverage and reassure people that coverage won’t be taken away,” said Derksen, the University of Arizona professor.


The ACA has proved a stumbling block for Republican Sens. Thom Tillis of North Carolina and Joni Ernst of Iowa. In Maine, GOP Sen. Susan Collins cast a key vote that prevented the repeal of the law but cast other votes that weakened it. She now also appears vulnerable — but more for her vote to confirm Brett Kavanaugh’s nomination to the Supreme Court and for not doing more to oppose President Donald Trump.


In Montana, Daines, who voted to repeal the ACA, is trying to hold on to his seat against Democratic Gov. Steve Bullock, who used the law to expand the state’s Medicaid enrollment in 2015. At its peak, nearly 1 in 10 Montanans were covered through the expansion.


As more Montanans now face the high cost of paying for health care on their own amid pandemic-related job losses, Montana State University political science professor David Parker said he expects Democrats to talk about Daines’ votes to repeal cost-saving provisions of the ACA.


“People are losing jobs, and their jobs bring health care with them,” Parker said. “I don’t think it’s a good space for Daines to be right now.”

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How to Weigh Evacuation Options With Both Wildfires and COVID at Your Door

As the smoke thickened near her home in Santa Cruz, California, last week, Amanda Smith kept asking herself the same questions: Should we leave? And where would we go?


The wildfire evacuation zone, at the time, ended a few blocks from her house. But she worried about what the air quality — which had reached the second-highest warning level, purple for “very unhealthy” — would do to her children’s lungs. Her 4-year-old twins had spent time in the neonatal intensive care unit; one was later diagnosed with asthma, and last year was hospitalized with pneumonia.


By Tuesday, said Smith, “we all had headaches, the kids were coughing a little bit, and it was raining ash.” The family had been conscientiously isolating at home because of the COVID pandemic, and leaving meant potential exposures. But on Wednesday, Smith said, “I looked at my partner and said, maybe we should leave.”


She called a friend in Orange County, about 380 miles south, who offered her parents’ empty condo. But the next day, the friend’s child spiked a fever — a possible case of COVID-19 — and the plan fell through amid the distraction.


Amanda Smith takes a selfie of herself and her twin children in Santa Cruz, California, in April. (Amanda Smith)


So Smith looked on Airbnb, careful to seek out hosts who detailed their COVID precautions, and found an apartment in San Bruno, about an hour’s drive north. She stuffed photos and documents into a suitcase, grabbed the go-bags, and her family headed out.


“It’s coming out of our savings to stay here,” Smith said from the safety of her apartment rental, which runs about $1,150 a week. “It was a really fraught decision to leave, but as soon as we got over the hill and the sky was blue, I took a big sigh of relief and knew that it had been a good decision.”


As the twin disasters of COVID-19 and fire season sweep through California, thousands of residents like Smith are weighing difficult options, pitting risk against risk as they decide where to evacuate, whether from imminent flames or the toxic air. Amid a virulent pandemic, which is safest? Doubling up at a friend’s home? A hotel? An evacuation center? And when do the risks of smoke inhalation outweigh the risk of a deadly infection?


“Obviously the most important thing is for people to do what they can to protect their lives, not only from the fire, but also from COVID,” said Detective Rosemerry Blankswade, public information officer for the San Mateo County Sheriff’s Office, which is helping coordinate response to the massive CZU Lightning Complex fires.


“You have to evaluate the big picture here. If fire is your most imminent danger, maybe take the COVID risk. But if you can avoid both of them, that’s obviously going to be the best option. It’s kind of a little bit of triage that we’re asking for people to do in their own lives right now.”

In San Mateo, one of two counties where the CZU Lightning Complex fires are blazing, officials are advising people to head to an evacuation center, where county workers will assist them in finding a hotel room. Meanwhile, in neighboring Santa Cruz, where tens of thousands of residents have evacuated and shelters have limited space, officials are asking those under orders to leave to stay with family and friends whenever possible.


What’s the right choice when all options pose additional risks? We spoke with several experts to help guide your thought process.


You have to evacuate: Where should you go?


If your region is under an evacuation order, do not hesitate. Leave immediately. If you can afford it, booking a room at a hotel or motel outside the evacuation zones may be the best option, said Dr. Michael Wilkes, a professor at the University of California-Davis School of Medicine. They almost always have air-conditioning units, which help filter the air from both smoke and virus. Many hotels are implementing new cleaning processes; ask staffers to detail what they’re doing to sanitize rooms, and consider skipping the daily cleaning service during your stay. You might also check review sites such as TripAdvisor to see what other guests report. When possible, avoid the lobby and other shared spaces, and opt for contactless check-in.


Amanda Smith at home in Santa Cruz, California, with her twin children. Smith and her family decided to voluntarily evacuate their home on Aug. 20, due to heavy smoke in the area from the CZU Lightning Complex fires in the nearby Santa Cruz Mountains. (Anna Maria Barry-Jester/KHN)


With so many people in Northern California fleeing the fires, many hotels are already full, especially in more remote areas. So what about staying with family or friends? After months of being shut in and avoiding close contact beyond immediate family, moving into someone else’s home means a host of potential exposures. Consider whether you or anyone else in the home is at high risk from COVID-19 because of age or a preexisting condition.


“If so, that’s a reason to think twice before going to someone’s home,” said Dr. Gina Solomon, a program director at the Oakland-based Public Health Institute.


Consider, too, what precautions your friends or family have been taking. Sheltering with someone whose job brings them into frequent contact with other people may not be as safe as sheltering with people who largely have been staying home. Another question is how crowded the home is: If you have your own room and, preferably, your own bathroom, that makes staying with friends a better option. If a separate bedroom is not available and smoky skies are not a problem, you might consider pitching a tent in their backyard.


For those with an RV or tent, camping can present another good option — although, with hundreds of wildfires burning across California, it may be challenging to drive far enough away to avoid fire and smoke. If you do camp, try to find a site away from wooded areas. And think twice before using group bathrooms.


Is an evacuation center safe?


Many counties have implemented new precautions at emergency shelters to prevent the spread of the coronavirus. In Santa Cruz, for example, officials are scaling back the capacity in each shelter to allow for social distancing, providing tents for people to use as shielding inside and allowing camping in the parking lots.


Still, staying in a shelter should probably not be your first choice. In terms of COVID risk, deciding between a hotel and a friend’s house is “nipping at the edges,” said Dr. John Swartzberg, a clinical professor emeritus at the UC-Berkeley School of Public Health, while “being in a congregate setting is only better than being completely exposed to the elements.”


If an evacuation shelter is your best immediate option, again, do not hesitate. “You have these standards you want to practice for yourselves,” Swartzberg said, “but when something worse comes along, it trumps how careful we can be with COVID because the need for shelter is greater.” You can lower your risk of infection by wearing a mask, washing hands frequently and sanitizing surfaces.


Smith’s partner, Grant Whipple, walks with their children in Big Sur on March 7. That was their last camping trip before the COVID-19 pandemic hit, Smith says; that area is now under threat from wildfire. (Amanda Smith)


If you aren’t in a fire zone, should you invite friends and family to stay with you?


Deciding whether to open your home to friends who are evacuating is an intensely personal decision and may depend on whether anyone in your family has a preexisting condition.


“I guess it depends on how good a friend they are and how desperate they are,” said Swartzberg. It may also depend on how much space you have; if your guests can have their own bedroom and bathroom, it might be safer.


If you do offer your home, experts advise against simply considering yourself a new pod with your guests. Instead, take steps to lower your chances of infection.


“It might not be pleasant, but wearing a mask anytime you’re not in your own bedroom is the safest way to go,” said Solomon. Stay outside as much as possible, she added, and consider eating meals outdoors or eating in shifts to avoid being maskless with those outside your family unit. Sanitize surfaces and wash hands frequently. If air quality permits, keep the windows open to improve airflow.


If you’re in a region with hazardous smoke conditions, should you leave?


If your area has dense smoke but no imminent fire risk, the thought of heading somewhere else may be appealing, especially if you have respiratory issues. But in most cases, Wilkes said, it would be safer not to leave your COVID bubble. And given the expanse of California’s fires, anywhere you flee could end up having lousy air quality by the time you arrive.


“The better part of rationality,” Wilkes said, “would be to stay at home, not exercise [outdoors], stay inside as much as you can, turn on the air conditioning.”


California Healthline senior correspondent Anna Maria Barry-Jester contributed to this report.

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COVID + Influenza: This Is a Good Year to Get a Flu Shot, Experts Advise

Flu season will look different this year, as the country grapples with a coronavirus pandemic that has killed more than 172,000 people. Many Americans are reluctant to visit a doctor’s office and public health officials worry people will shy away from being immunized.


Although sometimes incorrectly regarded as just another bad cold, flu also kills tens of thousands of people in the U.S. each year, with the very young, the elderly and those with underlying conditions the most vulnerable. When coupled with the effects of COVID-19, public health experts say it’s more important than ever to get a flu shot.


If enough of the U.S. population gets vaccinated — more than the 45% who did last flu season — it could help head off a nightmare scenario in the coming winter of hospitals stuffed with both COVID-19 patients and those suffering from severe effects of influenza.


Aside from the potential burden on hospitals, there’s the possibility people could get both viruses — and “no one knows what happens if you get influenza and COVID [simultaneously] because it’s never happened before,” Dr. Rachel Levine, Pennsylvania’s secretary of health, told reporters this month.


In response, manufacturers are producing more vaccine supply this year, between 194 million and 198 million doses, or about 20 million more than they distributed last season, according to the Centers for Disease Control and Prevention.

As flu season approaches, here are some answers to a few common questions:


Q: When should I get my flu shot?


Advertising has already begun, and some pharmacies and clinics have their supplies now. But, because the effectiveness of the vaccine can wane over time, the CDC recommends against a shot in August.


Many pharmacies and clinics will start immunizations in early September. Generally, influenza viruses start circulating in mid- to late October but become more widespread later, in the winter. It takes about two weeks after getting a shot for antibodies — which circulate in the blood and thwart infections — to build up. “Young, healthy people can begin getting their flu shots in September, and elderly people and other vulnerable populations can begin in October,” said Dr. Steve Miller, chief clinical officer for insurer Cigna.


The CDC has recommended that people “get a flu vaccine by the end of October,” but noted it’s not too late to get one after that because shots “can still be beneficial and vaccination should be offered throughout the flu season.”


Even so, some experts say not to wait too long this year — not only because of COVID-19, but also in case a shortage develops because of overwhelming demand.


Q: What are the reasons I should roll up my sleeve for this?


Get a shot because it protects you from catching the flu and spreading it to others, which may help lessen the burden on hospitals and medical staffs.


And there’s another message that may resonate in this strange time.


“It gives people a sense that there are some things you can control,” said Eduardo Sanchez, chief medical officer for prevention at the American Heart Association.


While a flu shot won’t prevent COVID-19, he said, getting one could help your doctors differentiate between the diseases if you develop any symptoms — fever, cough, sore throat — they share.


And even though flu shots won’t prevent all cases of the flu, getting vaccinated can lessen the severity if you do fall ill, he said.


You cannot get influenza from having a flu vaccine.


All eligible people, especially essential workers, those with underlying conditions and those at higher risk — including very young children and pregnant women — should seek protection, the CDC said. It recommends that children over 6 months old get vaccinated.


Q: What do we know about the effectiveness of this year’s vaccine?


Flu vaccines — which must be developed anew each year because influenza viruses mutate — range in effectiveness annually, depending on how well they match the circulating virus. Last year’s formulation was estimated to be about 45% effective in preventing the flu overall, with about a 55% effectiveness in children. The vaccines available in the U.S. this year are aimed at preventing at least three strains of the virus, and most cover four.


It isn’t yet known how well this year’s supply will match the strains that will circulate in the U.S. Early indications from the Southern Hemisphere, which goes through its flu season during our summer, are encouraging. There, people practiced social distancing, wore masks and got vaccinated in greater numbers this year — and global flu levels are lower than expected. Experts caution, however, not to count on a similarly mild season in the U.S., in part because masking and social distancing efforts vary widely.


Q: What are insurance plans and health systems doing differently this year?


Insurers and health systems contacted by KHN say they will follow CDC guidelines, which call for limiting and spacing out the number of people waiting in lines and vaccination areas. Some are setting appointments for flu shots to help manage the flow.


Health Fitness Concepts, a company that works with UnitedHealth Group and other businesses to set up flu shot clinics in the Northeast, said it is “encouraging smaller, more frequent events to support social distancing” and “requiring all forms to be completed and shirtsleeves rolled up before entering the flu shot area.” Everyone will be required to wear masks.


Also, nationally, some physician groups contracted with UnitedHealth will set up tent areas so shots can be given outdoors, a spokesperson said.


Kaiser Permanente plans drive-thru vaccinations at some of its medical facilities and is testing touch-free screening and check-in procedures at some locations. (KHN is not affiliated with Kaiser Permanente.)


Geisinger Health, a regional health provider in Pennsylvania and New Jersey, said it, too, would have outdoor flu vaccination programs at its facilities.


Additionally, “Geisinger is making it mandatory for all employees to receive the flu vaccine this year,” said Mark Shelly, the system’s director of infection prevention and control. “By taking this step, we hope to convey to our neighbors the importance of the flu vaccine for everyone.”


Q: Usually I get a flu shot at work. Will that be an option this year?


Aiming to avoid risky indoor gatherings, many employers are reluctant to sponsor the on-site flu clinics they’ve offered in years past. And with so many people continuing to work from home, there’s less need to bring flu shots to employees on the job. Instead, many employers are encouraging workers to get shots from their primary care doctors, at pharmacies or in other community settings. Insurance will generally cover the cost of the vaccine.


Some employers are considering offering vouchers for flu shots to their uninsured workers or those who don’t participate in the company plan, said Julie Stone, managing director for health and benefits at Willis Towers Watson, a consulting firm. The vouchers could allow workers to get the shot at a particular lab at no cost, for example.


Some employers are starting to think about how they might use their parking lots for administering drive-thru flu shots, said Dr. David Zieg, clinical services leader for benefits consultant Mercer.


Although federal law allows employers to require employees to get flu shots, that step is typically taken only by health care facilities and some universities where people live and work closely together, Zieg said.


Q: What are pharmacies doing to encourage people to get flu shots?


Some pharmacies are making an extra push to get out into the community to offer flu shots.


Walgreens, which has nearly 9,100 pharmacies nationwide, is continuing a partnership begun in 2015 with community organizations, churches and employers that has offered about 150,000 off-site and mobile flu clinics to date.


The program places a special emphasis on working with vulnerable populations and in underserved areas, said Dr. Kevin Ban, chief medical officer for the drugstore chain.


Walgreens began offering flu shots in mid-August and is encouraging people not to delay getting vaccinated.


Both Walgreens and CVS are encouraging people to schedule appointments and do paperwork online this year to minimize time spent in the stores.


At CVS MinuteClinic locations, once patients have checked in for their flu shot, they must wait outside or in their car, since the indoor waiting areas are now closed.


“We don’t have tons of arrows in our quiver against COVID,” Walgreens’ Ban said. “Taking pressure off the health care system by providing vaccines in advance is one thing we can do.”

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Thursday 27 August 2020

5 Things to Know About Convalescent Blood Plasma

President Donald Trump told the American people this week that convalescent plasma is a potential new treatment for COVID-19. His announcement followed the Food and Drug Administration’s decision Sunday to grant fast-track authorization for its emergency use as a treatment for hospitalized COVID patients.


This “emergency use authorization” triggered an outcry from scientists and doctors, who said the decision was not supported by adequate clinical evidence and criticized the FDA for what many perceived as bowing to political pressure.


With all the news swirling around convalescent plasma this week, we thought we’d break it down for you.


1. Convalescent plasma contains antibodies against disease. Donations are being promoted as a potential COVID-19 treatment.


“Convalescent” refers to recovery from a disease. And plasma is the yellowish, liquid part of blood in which blood cells are suspended.


When someone is infected with a virus, the body generates antibodies to fight off the viral particles. Enter COVID-19. If an individual who has recovered from this virus donates their plasma, scientists can isolate the antibodies from the plasma and give it to patients who are still in the early stages of their COVID-19 infection. This infusion, in theory, should help people fight off the virus while their own body catches up and makes its own supply of antibodies.


It’s not a new concept. An infusion of antibodies via plasma has been used as a treatment for other types of diseases, such as rabies.

2. Some experts took issue with the data presented to approve the treatment and thought the FDA action crossed a political line.


An FDA emergency use authorization allows companies and medical providers to deploy unapproved treatments or medical products in a crisis. The FDA said health care providers would be authorized to distribute COVID convalescent plasma to treat suspected or confirmed patients with COVID-19 while in the hospital.


Before the authorization, some top researchers and clinicians at the National Institutes of Health felt there was not sufficient scientific evidence to support pushing the treatment forward.


“A randomized placebo control trial is the gold standard,” said Dr. Howard Koh, who was an assistant secretary at the Department of Health and Human Services from 2009 to 2014 under President Barack Obama. “If you don’t have that standard and don’t have some evidence from a high-quality study or [a randomized controlled trial], you are left with suboptimal science and treatments in the long run that may not prove to work.”


Koh also said that for other COVID-19 treatments including the medication remdesivir, a randomized clinical trial had been done before the FDA OK’d it for emergency use.


When the emergency authorization for convalescent plasma was announced, HHS officials pointed to findings from a Mayo Clinic preliminary analysis as the rationale. The analysis has not been reviewed by other scientists and doctors.


Suspicions of a political motive behind the decision were heightened because the authorization came one day before the start of the Republican National Convention.


“The timing raises so many questions,” said Koh, also a professor of the practice of public health leadership at Harvard University. “I think this announcement shakes the confidence of the medical community in the rigor of the FDA decision-making process.”


Trump tweeted just a day before the FDA’s action, “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”


Scott Gottlieb, a former Trump administration FDA commissioner, offered his take in a tweet the day after the announcement: “Plasma may provide a benefit, and it could be meaningful for certain patients, but we need more evidence to prove it. The data FDA had supports an authorization for emergency use, where the standard is ‘may be effective’ but we need better studies to confirm preliminary findings.”


3. Dr. Stephen Hahn, the current FDA commissioner, misrepresented the data on the treatment’s effectiveness during Sunday’s press conference. Hahn later corrected himself.


The Mayo Clinic analyzed outcomes of patients who were given a low dose of plasma and those given a high dose. Those who got the high dose had a lower seven-day mortality rate (8.9%) compared with the seven-day mortality rate of those given a low dose (13.7%).


Dr. Adam Gaffney, a critical care doctor and instructor in medicine at Harvard Medical School, said these two variables were used to calculate what is known as a “relative risk reduction,” or the percent difference between the risk of two different treatment outcomes. In this case, the risk reduction between the high dose and low dose of plasma is 35%.


That’s the number Hahn misrepresented.


“Many of you know I was a cancer doctor before I became FDA commissioner, and a 35% improvement in survival is a pretty substantial clinical benefit,” said Hahn. “What that means is — and if the data continue to pan out — 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.”


But, that was an incorrect statement. Hahn had confused relative risk with absolute risk, as many members of the medical community later pointed out. Absolute risk reduction refers to the number of people who experienced reduced mortality from a treatment compared with the rest of the entire population who didn’t get the treatment. The absolute risk reduction in this situation is probably closer to 3-5 cases out of 100.


On Monday night, Hahn issued a tweet to set the record straight: “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”


Hahn also noted in the Twitter thread that the agency’s decision was not political, but “made by FDA career scientists based on data submitted a few weeks ago.” He also said the approval was not final and the FDA could revoke authorization if needed.


4. President Trump referred to the use of blood plasma during the RNC, and is likely to do so throughout the remainder of his presidential campaign.


During the first night of the Republican National Convention, in a meeting with a group of first responders, Trump told a police officer who had recovered from COVID-19 that her blood was “valuable.”


“Once you’re recovered, we have the whole thing with plasma happening. That means your blood is very valuable, you know that, right?” Trump said. Vice President Mike Pence also mentioned it in his Wednesday night speech.


5. Critics of the convalescent plasma treatment say there must be randomized clinical trials to prove its effectiveness.


Koh said receiving convalescent plasma doesn’t appear to be dangerous, but a recent study in China did report that 2 in about 100 people experienced adverse events associated with the treatment.


And multiple experts said a randomized clinical trial is necessary to ensure that the mortality outcomes shown in the Mayo Clinic analysis weren’t confounded by other factors.


A randomized clinical trial would involve one group receiving a placebo and another group receiving the treatment. Who is assigned to each group would be completely random to eliminate bias.


Gaffney said he noticed that patients in the low-dose plasma group seemed to be sicker than those in the high-dose plasma group — which could have affected the Mayo Clinic’s findings.


“To ensure that the effect we see is the effect of the intervention, and not a manifestation of differences in how sick the two groups are,” the trial has to be randomized, said Gaffney.


The Mayo Clinic analysis also reported that some patients who received plasma also took remdesivir or steroids, which could have influenced their mortality outcomes.


Dr. Eric Topol, director of the Scripps Research Translational Institute, said, at best, he sees the outcomes of this analysis as a hypothesis that needs to be tested in a randomized clinical trial. “No survival benefit has been proven,” he wrote in an email.

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