Fauci dice que una vacuna contra COVID podría estar lista antes de lo esperado

Una vacuna contra COVID-19 podría estar disponible antes de lo esperado si los ensayos clínicos en curso producen resultados abrumadoramente positivos, dijo el doctor Anthony Fauci, funcionario de enfermedades infecciosas de más alto rango del país, en una entrevista con KHN.

Aunque se espera que dos ensayos clínicos en curso con 30,000 voluntarios terminen para fin de año, Fauci dijo que una junta independiente tiene la autoridad para finalizarlos semanas antes si los resultados provisionales son abrumadoramente positivos o, por el contrario, negativos.

La Junta de Monitoreo de Datos y Seguridad (DSMB) podría decir: “al momento, los datos son tan buenos que se puede decir que son seguros y efectivos”, explicó Fauci. En ese caso, los investigadores tendrían “la obligación moral” de finalizar el ensayo antes de tiempo y hacer que la vacuna esté disponible para todos en el estudio, incluidos los que recibieron placebos, y acelerar el proceso para administrarla a millones.

Los comentarios de Fauci, quien es director del Instituto Nacional de Alergias y Enfermedades Infecciosas, ocurren en un momento de creciente preocupación sobre si la presión política de la administración Trump podría influir en los reguladores federales y los científicos que supervisan la respuesta de la nación a la pandemia del nuevo coronavirus. Y erosionar la débil confianza del público en las vacunas.

Destacados expertos en vacunas han dicho que temen que Trump esté presionando por una aprobación temprana de una vacuna para ayudar a ganar la reelección.

Fauci dijo que confía en los miembros independientes del DSMB, que no son empleados del gobierno, para mantener las vacunas a altos estándares sin influencias políticas. Los miembros de la junta suelen ser expertos en inmunización y bioestadística, y suelen dar cátedra en las principales escuelas de medicina.

“Si estás tomando una decisión sobre la vacuna, es mejor asegurarse de tener muy buena evidencia de que es segura y efectiva”, dijo Fauci. “No me preocupa la presión política”.

La junta de seguridad analiza periódicamente los datos de un ensayo clínico para determinar si es ético continuar inscribiendo voluntarios, que se asignan al azar para recibir una vacuna experimental o una inyección de placebo (que no contiene la dosis de la vacuna). Ni los voluntarios ni los trabajadores sanitarios que los inyectan saben qué vacuna están recibiendo.

Los fabricantes ahora están probando tres vacunas contra COVID en ensayos a gran escala en los Estados Unidos. Los dos primeros estudios, uno dirigido por Moderna y los Institutos Nacionales de Salud y el otro dirigido por Pfizer y BioNTech, comenzaron a fines de julio.

Cada estudio fue diseñado para inscribir a 30,000 participantes. Los funcionarios de la compañía han dicho que ambos ensayos han inscrito aproximadamente la mitad de ese total. AstraZeneca, que ha estado ejecutando ensayos clínicos a gran escala en Gran Bretaña, Brasil y Sudáfrica, lanzó otro gran estudio con una vacuna en los Estados Unidos la primera semana de septiembre, en el que participan 30,000 voluntarios. Se espera que comiencen ensayos adicionales de vacunas este mes.

En ensayos de este tamaño, los investigadores sabrán si una vacuna es efectiva después de tan solo 150 a 175 infecciones, dijo el doctor Robert Redfield, director de los Centros para el Control y Prevención de Enfermedades (CDC), en una llamada con periodistas el viernes 28 de agosto.

“Puede ser sorprendente, pero el número de eventos que deben ocurrir es relativamente pequeño”, dijo Redfield.

En este momento, la junta de seguridad sólo tiene acceso a los datos del ensayo, dijo Paul Mango, subdirector de personal para Normas del Departamento de Salud y Servicios Humanos (HHS). En cuanto a cuándo estarán disponibles los resultados de la prueba, “no podemos determinar si será a mediados de octubre o diciembre”.

Las juntas de seguridad establecen “reglas de detención” al comienzo de un estudio, lo que deja muy claro sus criterios para finalizar un ensayo, dijo el doctor Eric Topol, vicepresidente ejecutivo de investigación de Scripps Research en San Diego y experto en el uso de datos en investigación médica.

Aunque la junta de seguridad puede recomendar detener un ensayo, la decisión final la toman los científicos que lo está realizando, dijo Topol.

Luego, un fabricante de vacunas podría solicitar a la Administración de Alimentos y Medicamentos (FDA) una autorización de uso de emergencia, que se puede otorgar rápidamente, o continuar a través del proceso regular de aprobación de medicamentos, que requiere más tiempo y evidencia.

Los que monitorean la seguridad también pueden detener un ensayo debido a preocupaciones de seguridad, “si parece que realmente está dañando a las personas en el brazo, o por una una gran cantidad de efectos secundarios”, dijo Fauci.

Fauci dijo que la gente puede confiar en el proceso, porque todos los datos que los monitores externos usaron para tomar sus decisiones se hacen públicos.

“Todo eso tiene que ser transparente”, dijo Fauci. “El único momento preocupante es si existe alguna presión para terminar el ensayo antes de tener suficientes datos sobre seguridad y eficacia”.

En las últimas semanas, Topol y otros científicos han criticado duramente a la FDA, acusando al comisionado Stephen Hahn de ceder ante la presión política de la administración Trump, que ha empujado a la agencia a aprobar los tratamientos para COVID más rápido.

Frenar los ensayos antes de tiempo plantea una serie de riesgos, por ejemplo,  hacer que una vacuna parezca más eficaz de lo que realmente es, dijo Topol.

“Si detienes algo antes, puedes obtener un beneficio exagerado que no es real, porque la evidencia menos positiva solo surge más tarde”, dijo Topol.

Detener los estudios antes de tiempo también podría evitar que los investigadores recluten más voluntarios de minorías. Hasta ahora, solo 1 de cada 5 participantes del ensayo son personas de raza negra o hispanos (de todas las razas). Dado que esos grupos se han visto más afectados por la pandemia que otros, es importante que constituyan una parte más importante de los ensayos de vacunas, agrego Topol.

La finalización temprana de los ensayos de vacunas también conlleva riesgos de seguridad, expresó el doctor Paul Offit, desarrollador de vacunas que forma parte de un panel asesor de los NIH sobre vacunas y tratamientos para COVID.

Un ensayo más pequeño y más corto podría no detectar efectos secundarios importantes de la vacuna, que podrían hacerse evidentes solo después de que millones de personas hayan sido inmunizadas, dijo Offit, director del Centro de Educación sobre Vacunas del Hospital de Niños de Philadelphia.

Los investigadores continuarán siguiendo a los voluntarios vacunados durante un año completo para detectar efectos secundarios a largo plazo, dijo Redfield.

Y Fauci reconoció que acortar un ensayo podría socavar la confianza del público en las vacunas contra COVID. Uno de cada tres estadounidenses no está dispuesto a recibir una vacuna contra el nuevo coronavirus, según una encuesta reciente de Gallup.

Esta historia fue producida por Kaiser Health News, un programa editorial independiente de la Kaiser Family Foundation.

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

USE OUR CONTENT

This story can be republished for free (details).

Listen: Control of U.S. Senate Could Hinge on Obamacare Positions

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

KHN senior correspondent Markian Hawryluk joined KUNC’s Erin O’Toole on “Colorado Edition” to discuss his recent story about how the Affordable Care Act is affecting the close Colorado Senate race between incumbent Republican Sen. Cory Gardner and Democratic former Gov. John Hickenlooper. That race and five others involving vulnerable Republican incumbents who sought to repeal the health care law could determine which party controls the U.S. Senate in 2021.

Public sentiment about the health care law, also known as Obamacare, has shifted. What was a political liability in 2014 for candidates has become a selling point amid the loss of jobs and health insurance for millions of people during the coronavirus pandemic.

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

USE OUR CONTENT

This story can be republished for free (details).

Long-Fought Nurse Practitioner Independence Bill Heads to Newsom

SACRAMENTO — After years of failed attempts and vociferous opposition, California lawmakers on Monday adopted a measure to grant nurse practitioners the ability to practice without doctor supervision — but only after making big concessions to the powerful doctors’ lobby, which nonetheless remains opposed.

The bill now heads to Gov. Gavin Newsom for consideration, fenced in by amendments that would stringently limit how much independence nurse practitioners — nurses with advanced training and degrees — can have to practice medicine.

Lawmakers credit these compromises, like them or not, for finally allowing them to push the issue over the finish line, capping years of political scrapping and perhaps one day altering the delivery of health care in California.

“This is not an intrusion on a hallowed profession, it’s a relief,” said state Sen. John Moorlach (R-Costa Mesa), one of four Republican senators who voted for the bill. Moorlach said the measure would get more practitioners into underserved areas that don’t have enough doctors.

“It’s like the cavalry coming up over the hill to provide reinforcements to a tired army of wonderful and overworked doctors,” he said.

California is behind most other states in empowering nurse practitioners. If the bill becomes law, the state would join nearly 40 others to grant some level of independence to nurse practitioners; 22 grant full independence, according to the American Association of Nurse Practitioners. California would have among the most restrictive policies on nurse practitioner independence in the country.

“I’m not going to say I regret any of these changes,” said Assembly member Jim Wood (D-Santa Rosa), who chairs the Assembly Health Committee and authored the bill, AB-890.

Wood opposed previous attempts to remove supervision requirements.

“I wish it could be a little less strict, quite frankly,” he said, adding that this was a reasonable compromise informed by his experiences as a dentist and what he learned from other providers.

Today, nurse practitioners must enter into a written agreement with a physician to oversee their work with patients. In exchange, physicians bill them between $5,000 and $15,000 per year, according to a report by the California Health Care Foundation and the University of California-San Francisco. (California Healthline is an editorially independent service of the California Health Care Foundation.)

“Where we are with the pandemic and the craziness of the world today, it highlights why there’s a need for this,” said Andrew Acosta, a spokesperson for the California Association for Nurse Practitioners. “The doctor shortage isn’t going away anytime soon.”

Under Wood’s measure, nurse practitioners would be able to see patients in their own practice, but only after working under physician supervision for at least three years. The bill also contains many other restrictions.

Nurse practitioners argue that the measure, even with its limitations, would ease primary care shortages, especially in rural areas — a problem the pandemic has made more stark.

Opponents, primarily the powerful California Medical Association, which is the doctors’ lobbying group, counter that stripping nurse practitioners of physician oversight would lead to a lower standard of care, and that nurse practitioners wouldn’t necessarily flock to rural areas once they’re free of physician supervision.

These arguments aren’t new in Sacramento, but lawmakers and lobbyists say this version of the bill succeeded because there are new leaders at the helm of influential legislative committees who were willing to make changes, and because the pandemic has changed health care.

“I think the legislature is starting to realize decades of evidence that nurse practitioners are safe, productive providers,” said Ed Hernandez, a former legislator who was termed out in 2018 and authored the last two failed bills. “I think the policy is finally overshadowing the politics” of the California Medical Association.

Still, the biggest difference this year is the bill itself. Hernandez’s bills, introduced in 2013 and 2015, were “clean” bills that granted independence to nurse practitioners without many requirements.

There’s nothing clean about Wood’s bill, which was heavily amended in the state Senate. Instead of simply lifting the supervision requirements on nurse practitioners, the measure imposes several hoops for nurse practitioners to jump through. Before they could practice independently, nurse practitioners would have to be certified by preapproved national nursing boards, and possibly complete additional California-specific testing if accredited out of state.

Once certified, they would have to practice under physician supervision for at least three years — up to six in some cases — before they could strike out on their own. And they would have to disclose to patients that they aren’t doctors.

The bill even prescribes a Spanish phrase for “nurse practitioner”: enfermera especializada. (Technically, this refers to a female nurse. The bill doesn’t provide the equivalent phrase for a male nurse.)

That’s not even all the amendments — and the measure wouldn’t take effect until 2023.

The requirements were inserted in response to criticism from the California Medical Association that nurse practitioners are not qualified to provide patient care without physician oversight, and that patients wouldn’t understand that they’re seeing someone with less training than a doctor, lawmakers said.

Despite the numerous amendments, the association remains opposed, saying the changes don’t address their fundamental concerns.

“We’ve increased the training required for physicians over the last couple years and now all of a sudden we’re allowing unsupervised providers to treat patients who have even less training,” said association spokesperson Anthony York.

Rounds of negotiations, major concessions and hourslong Zoom calls still could not get the doctors’ group on board, Wood said.

He said it was like chasing “goalposts that continue to move.”

“It’s very disappointing when you work with opposition and nothing is ever good enough,” Wood said. “CMA will never support this bill. They’ll never go neutral on it.”

York said that characterization is not accurate. He pointed to a different bill — SB-1237 — that would allow certified nurse midwives to attend to low-risk pregnancies without physician supervision. The association was initially opposed, but after negotiations and amendments to the bill, it changed its position to neutral. That bill is also headed to Newsom.

“You don’t have to look too far to find a case where we were willing to engage on a scope-of-practice issue,” York said.

David McCuan, a political science professor at Sonoma State University, called the association’s inability to kill Wood’s bill a political “watershed moment” for the group.

“Their M.O. for 70 years has been about blocking, stunting and preventing change,” McCuan said. “The deference toward the medical profession has changed. In that sense, it would be a momentous event if this is signed.”

Though the California Association for Nurse Practitioners is celebrating legislative passage of the measure, even in its amended form, it’s a different story at the national level. Sophia Thomas, president of the American Association of Nurse Practitioners, said in a statement that the bill is choked by too much red tape to provide any meaningful change.

“California’s so-called ‘solution,’ the flawed AB-890, would establish a cascading set of new restrictions on NP practice that would maintain California’s position among the most heavily regulated and restrictive in the nation,” Thomas said.

State Sen. Richard Pan (D-Sacramento), a pediatrician who chairs the Senate Health Committee, said he also opposed the bill, but not simply because he is a doctor or a member of the California Medical Association.

Yet many of his objections reflect those of the association, such as concerns about training and access to care in rural areas.

He also believes independence for nurse practitioners could exacerbate inequalities in the health care system, as people with less means see providers with less training.

“People with more resources are going to go with the person they think is more qualified. That’s just the way it tends to happen,” Pan said.

California Healthline’s Angela Hart contributed to this report.

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

USE OUR CONTENT

This story can be republished for free (details).

California Rx: State May Dive Into Generic Drug Market

SACRAMENTO — California is poised to become the first state to develop its own line of generic drugs, targeting soaring drug prices and stepping into a fiercely competitive drug market dominated by deep-pocketed pharmaceutical companies.

The Democratic-controlled legislature overwhelmingly approved a measure Monday that would direct the state’s top health agency to partner with one or more drug companies by January to make or distribute a broad range of generic or biosimilar drugs — including the diabetes medicine insulin — that are cheaper than brand-name products.

The bill, SB-852, also opens the door for California to make its own generic drugs in the future.

Gov. Gavin Newsom will have until Sept. 30 to sign or veto the measure.

“People need these drugs, but prices are through the roof, so we’re saying there’s a role for the state to bring prices down,” said the bill’s author, state Sen. Richard Pan (D-Sacramento).

He argued the measure is more important than ever because COVID-19 has exposed “glaring gaps” in the ability of public and private entities — from major hospitals to government drug purchasers — to maintain adequate supplies of drugs, medical equipment and devices.

“This also creates a model to address drug shortages and other supply chain issues during COVID and future pandemics,” he said.

[khn_slabs slabs=”241887″ view=”inline” /]

Newsom, a Democrat, floated his own generic drug proposal in January as part of his broader drug agenda to reduce pharmaceutical costs, but was forced to abandon his plan in May as he and lawmakers sought to address a pandemic-induced $54 billion budget deficit.

Though it could take years to successfully bring a new California generic product to the market, the move would put the nation’s most populous state in direct competition with major generic and brand-name drug manufacturers that dominate the market, and potentially allow California to use its massive purchasing power to drive down drug prices.

“Other legislative efforts in Congress and in other states have focused on government negotiating with pharmaceutical companies to lower prices on generic drugs,” said Edwin Park, research professor at the Health Policy Institute at Georgetown University.

The Pharmaceutical Research and Manufacturers of America, which represents brand-name drugmakers, has taken a neutral position on the bill and declined to comment.

But Brett Michelin, lead lobbyist for the Washington, D.C.-based trade group that represents generic drugmakers, the Association for Accessible Medicines, said generic companies aren’t threatened by the possibility of California entering the market — and even welcome it.

“Generic manufacturers are more than open to doing this kind of partnership,” Michelin said. “I think having a fair and open process to sell drugs and compete for customers is what the generic industry is very used to and comfortable with.”

Under the measure, state-developed generics would be “widely” available to public and private purchasers within California. Taxpayers would pick up the costs, roughly $1 million to $2 million in startup funding, plus ongoing staff costs estimated in the low hundreds of thousands of dollars annually, according to a state fiscal analysis.

It’s unclear which drugs the state would make or procure, though it would target drugs that could produce the biggest cost savings for the state and consumers.

But the bill specifically calls for the production of “at least one form of insulin, provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in savings.”

Insulin is a biologic drug, made with living cells. Once a biologic hits the market, rival copycat products that follow are called biosimilars.

Three major drug companies — Eli Lilly and Co., Sanofi and Novo Nordisk — have long controlled the lucrative insulin market in the U.S. The state of California would be the first entity to produce a biosimilar version of one of the newer, fast- and long-acting insulins on a not-for-profit basis, said Jane Horvath, a health policy consultant in Washington, D.C.

Although it would be costly and could take years, the Utah-based nonprofit drug company Civica Rx, which has consulted with Pan on his bill, is discussing partnering with California to produce generic or biosimilar drugs. It has already hammered out deals with major health systems running short on critical drugs, including the Department of Veterans Affairs, and is producing lower-cost generics for insurers, including Blue Shield of California.

“There’s no doubt insulin would be a more complex and expensive drug to develop, but it’s certainly possible,” said Allan Coukell, the company’s senior vice president of public policy. “We are watching how the biosimilar market develops.”

Patients who need insulin have faced huge cost spikes. A 2019 report by the Health Care Cost Institute concluded that average prices for insulin doubled from 2012 to 2016. And California health insurance regulators found last year that diabetes medications accounted for nine of the 25 costliest brand-name drugs sold in the state.

“It’s a big deal — diabetes affects a lot of people who rely on insulin for their very lives,” said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. “And insulin has probably been the poster child for unreasonable drug pricing.” (Kaiser Health News, which produces California Healthline, is an editorially independent program of the foundation.)

Laura Marston, a Washington, D.C.-based lawyer and diabetic who advocates for lower insulin prices, said she’s excited about California’s idea.

Marston has been on the same insulin, Humalog, since 1996. At that time, the price was $21 a vial, but has since ballooned to more than $275 a vial, she said.

“If there was a lower-cost option and the price wasn’t going to be raised, I would absolutely switch from Humalog,” she said. “I feel held totally hostage to these pharmaceutical companies.”

Marston said she’d like the federal government to do the same thing, “so it could apply to all patients.”

Congressional efforts to tackle rising prices for insulin and other drugs fizzled last year in the face of opposition from the influential pharmaceutical lobby. So states have increasingly sought ways to regulate a for-profit industry in which brand-name manufacturers hold near-monopoly power.

Colorado last year became the first state to cap out-of-pocket insulin costs at $100 for a 30-day supply. It was followed by at least nine other states, from New Mexico to New York, whose cost-sharing caps vary.

California had already capped out-of-pocket drug costs at $250 to $500 for a 30-day supply, but a measure that would have lowered the cap for insulin to $100 a month stalled this year — a casualty of a pandemic-shortened legislative calendar.

Newsom’s office declined to comment on the generic drug legislation. But recent changes to the proposal reflect direct negotiations with the administration, Pan’s office said.

Newsom spokesperson Jesse Melgar said in a statement that “the governor’s goal of a sustainable system of universal coverage has not changed and making prescription drugs affordable is one more step toward that goal.”

Should Newsom sign the bill into law, the state Health and Human Services Agency would have 18 months to identify a list of drugs the state could manufacture, with a report due to the legislature by July 2022. By July the following year, the state would be required to assess whether it can manufacture its own generics and biosimilars.

The bill calls for state health officials to prioritize development of generics for chronic and high-cost health conditions, and urges production of those that can be delivered through mail order.

California could emerge as a leader in the national drug debate, Levitt said.

“If California can pull it off, it would be a model for other states and federally,” he said. “For it to pull this off means it can be done at scale.”

Tourists Tote Dollars — And COVID — To U.S. Caribbean Islands

“What activities are open to do next week? Zip-lining? Jet ski? Anyone have recommendations on things still open?” a Facebook user asks.

“Stay home!” another user replies.

The Facebook group called “What’s Going on St. Thomas?” has been flooded with pointed, exasperated comments urging travelers to stay away. This is a marked change. Before the pandemic, the exchanges between vacationers and island residents resonated with promises of excitement and fun. Now, tour operators from the mainland who administer the Facebook page quickly try to delete any expressions of anger.

In nearby Puerto Rico, the friction has spilled into real life. Media reports have detailed multiple episodes in which tourists, having escaped pandemic restrictions back home, became violent and destroyed store merchandise after being asked to wear a mask.

The COVID-19 pandemic has pitted economic interests against public health guidance all across the United States. Puerto Rico and the Virgin Islands feel this tension acutely, as both U.S. territories rely on tourism to generate revenue and provide jobs. Increasingly, locals have begun to wonder now if welcoming visitors to these islands is worth the risk.

Tourism represents more than half of the Virgin Islands’ gross domestic product. In Puerto Rico, the industry accounts for 80,000 jobs and about 6.5% of the island’s total economy.

But islanders are not only vulnerable to COVID-19’s economic disruptions. Residents of both Puerto Rico and the Virgin Islands are diagnosed with chronic health conditions like diabetes and cardiovascular illness at higher rates than in most U.S. states, which puts them at higher risk for the virus’s complications.

In short, the very industry that represents an economic lifeline for islanders threatens their ability to protect their health.

[khn_slabs slabs=”241887″ view=”inline” /]

One Step Forward

When COVID-19 triggered alarms in late winter, Puerto Rico and the USVI adopted strong COVID prevention strategies before most U.S. states did.

In Puerto Rico, Gov. Wanda Vázquez issued an executive order March 15, effectively locking down the island by imposing a curfew, a stay-at-home order and business closures. The first coronavirus cases on the island were reported March 13.

Similarly, Virgin Islands Gov. Albert Bryan Jr. issued executive orders prohibiting hotels, villas and other accommodations from accepting leisure guests between March 25 and June 1. The area remained open to business travelers, flight crews, health officials, emergency personnel, government guests and residents. According to a March 20 Department of Health update, the territory had — at that time — six confirmed COVID cases and 43 pending test results.

Neither territory, however, was able to close its airports. Local officials do not have the authority to do so because the federal government regulates aviation.

“Part of the challenge of being a U.S. colony, in particular, is that, you know, we don’t have control over our borders,” said Hadiya Sewer, president and co-founder of St. JanCo: the St John Heritage Collective, a cultural heritage preservation and land rights organization on the small island of St. John, U.S. Virgin Islands.

Still, the aggressive measures — while effective — came at a price for residents like Melina Aguilar.

Before the lockdown, the 31-year-old entrepreneur worked as a tour guide for Isla Caribe, a company she founded that offers historical walking tours of Ponce, Puerto Rico. The stay-at-home order in March shut down Aguilar’s business for three months and sequestered her in her house.

Aguilar said the sacrifice would have been worth it if the island could have maintained control of the spread by closing the border and enforcing the 14-day quarantine for travelers. It didn’t work out that way. According to data from The New York Times, the seven-day average for cases on May 1 — while Puerto Rico was still in lockdown — was 42 cases per day. On July 1, the seven-day average was 102 cases. By July 15, the average was 233.

“We could’ve basically had the fruits of being locked up for three months,” Aguilar said. “But now we’re stuck.”

Reopening the Gateway

By summer, both territories were itching to get back to business. With many overseas vacation destinations banning U.S. travelers, it seemed like the nearby mainland would be full of beachgoers, who, after living under stay-at-home orders for months, would be ready to travel — no passport required — to the sun and sand.

The U.S. Virgin Islands formally welcomed tourists back to its shores on June 1 — with caveats. Travelers from coronavirus hot spots needed to submit COVID-19 test information through an online portal to receive a negative result “certification code.” Those who didn’t were required to quarantine for 14 days or until they had documentation of a negative test result.

But locals and tourists alike said COVID enforcement measures haven’t been consistent. Capt. Matthias Bitterwolf, owner of Antillean Yacht Charters on St. Thomas, said he delivered a boat to Puerto Rico and was not allowed off the vessel until local police could verify his COVID paperwork. His COVID status was not checked upon returning to St. Thomas.

The Virgin Islands’ case counts soon began ticking up. Between June and mid-July, the case count increased by more than 3,500%, according to one NBC news report.

Gov. Bryan responded by issuing other executive orders to regain control of the outbreak, including prohibiting beach visits after 4 p.m. and not allowing patrons to stand or eat at bars located in restaurants. As of Aug. 24, the USVI had a total of 984 positive COVID-19 cases and 11 deaths.

Puerto Rico formally welcomed tourists on July 15 while still imposing some COVID-related restrictions. As in the Virgin Islands, officials required travelers to present documentation of a negative COVID test result upon arrival.

Dr. Victor Ramos, president of the island’s medical association who is involved with the island’s medical task force, said these decisions tended to expose the rift “between the medical task force that favors closing things and the economic task force that wants to leave everything open.”

By July, the local economy was in shambles. The Department of Labor reported over 21% of the island’s workforce was receiving unemployment assistance related to the pandemic in the week ending Aug. 1.

But rising case counts attributed to travel prompted local officials to encourage that only essential travel be allowed. As of Aug. 24, the island had recorded over 30,700 COVID cases and at least 395 deaths, according to the New York Times database.

Government data, though, indicated Puerto Rico’s climbing case numbers were not being triggered by tourists. They are not the culprits, insisted Leah Chandler, chief marketing officer of Discover Puerto Rico, the island’s official tourism website. Rather, the spread was linked to island residents coming home after visiting COVID hot spots like Texas and Florida.

Life on the Ground

Despite the global pandemic and the restrictions, both territories have experienced no shortage of vacationers. “We would have expected this to be a slow moment for us in terms of tourism,” said Sewer. “It’s very busy.”

Still, the trend lines for COVID case counts weren’t moving in the right direction for either territory, so it was no surprise when Puerto Rico closed days after reopening and the USVI followed suit on Aug. 19.

The underlying socioeconomic and health issues put residents in both places at high risk. It’s not just the prevalence of chronic health conditions like diabetes and cardiovascular disease. The high number of multigenerational households in both areas complicates a family’s ability to socially distance from its most vulnerable members. Roughly a quarter of the population in Puerto Rico and the Virgin Islands is age 65 or older, and poverty is widespread.

At the same time, both territories have limited health care infrastructure — making it difficult to envision that they can care for their own populations in an emergency let alone visitors who could become ill and island-bound if the virus were to surge.

Currently, the USVI has two main hospitals — one in St. Thomas and one in St. Croix — and a health clinic in St. John. The territory has 20 intensive care unit beds and about 100 one-time-use ventilators for its 106,235 residents, said Justa Encarnacion, the USVI’s health commissioner. Each island has about 30 full-capacity ventilators.

In Puerto Rico, about 60% of the island’s ventilators for adults were available as of Aug. 24. However, ICU beds are harder to come by, said Ramos. They are filled with COVID patients and those whose conditions worsened after avoiding care out of fear of catching the virus, he said.

The string of problems that have besieged these islands magnifies the effects of the pandemic. That includes debt crises and infrastructure damage from hurricanes and earthquakes. Island residents also fear the possibility of battling a hurricane and a coronavirus outbreak at the same time — a reality that they’ve already confronted when COVID hampered the USVI’s emergency management agency’s ability to distribute sandbags ahead of a storm in late July.

Colorado State University hurricane researchers predict an “extremely active” 2020 Atlantic hurricane season.

“At this point, we literally have disasters layered on top of disasters,” said Sewer, of the St. John’s Collective.

Still, Joseph Boschulte, tourism commissioner for the Virgin Islands, is cautiously optimistic about finding a balance between health and economic interests.

“We appreciate the concerns of our tourism partners and stakeholders,” he said. But with the spike in cases, he said, “we must reset, take stock, safeguard human life and prepare for restarting our tourism economy at a later date.”

Public Health Officials Are Our COVID Commanders. Treat Them With Respect.

As a veteran who served back-to-back tours in Iraq, I initially cringed when commentators compared the COVID-19 crisis to wartime — no bullets, no blood and no one volunteered for this.

But after my months of reporting on the pandemic, it has become painfully clear this is like war. People are dying every day as a result of government decisions — and indecision — and the death toll is climbing with no end in sight.

Less than six months into the pandemic, COVID-19 has already killed at least 183,000 Americans, more than triple the number who died in the Vietnam War, and far more than the wars in Iraq and Afghanistan combined.

We are all being asked to make sacrifices for the good of our country. And we’re experiencing, as a nation, a deeply traumatic event. Like war, the toll will be felt for a long time.

In California, local public health officials are leading the front lines in this battle against COVID-19, dictating strategy, issuing orders and developing tactics to carry out that strategy. Every day, they make gut-wrenching calls to protect our health and livelihoods, even if those decisions may inflict initial harm on the economy or contradict politicians and popular opinion.

But instead of being celebrated for their difficult and dangerous work, as I was, they are now facing violent threats and political attacks from those who disagree with their tactics — such as requiring masks in public and ordering businesses and parks closed to prevent the spread of infection.

When I interview them, often late at night, I hear in their voices that familiar mix of emotions that often come with war: exhaustion, anxiety and devotion to duty.

“We’ve become easy scapegoats for people’s fear and anxiety during COVID-19,” said Dr. Gail Newel, the health officer for Santa Cruz County, who continues to face threats for issuing public health orders.

The latest — a menacing email sent to her in late July calling her a “communist bitch” — prompted local law enforcement to recommend she get a guard dog and firearm to protect herself. “That weighs very heavily,” she said.

I can’t imagine the burden. Although many of us serving in Iraq disagreed with the war, we remained dedicated to our mission and enjoyed broad support at home.

I joined the military as a U.S. Army reservist in 1999 and was deployed on active duty to Iraq in early 2003, when it truly was like the Wild West.

Serving first as logistics clerk and then the acting supply sergeant for a military police company out of San Jose, California, I helped ensure my military brothers and sisters had proper equipment. When the George W. Bush administration sent us to Iraq, for example, it did so without armoring our Humvees — a major failure that elevated our risk of being blown up by roadside explosives.

I returned home in July 2004 and spent years putting the battlefield behind me as I transitioned to a career in journalism. But living through COVID-19 has resurrected those feelings of being at war.

Now, just like then, there is an overall sense of fear and uncertainty because we don’t know when the crisis will end. We aren’t free to go about our lives as we once did and we yearn for the comforts we took for granted. We miss our loved ones we can’t see.

We must remain hyper-vigilant to potential threats, and even make sure to don our “armor” when we leave our homes, except now it’s masks and gloves instead of helmets and flak jackets.

There’s something that happens when you’re in a conflict zone — the air feels heavier. You can feel threats all around you, just waiting to strike. There’s deep anxiety for what the future holds, and you wonder whether you’ll be alive next week or next month.

Public health officers are shouldering the added anxiety that duty brings. For much of the pandemic, Gov. Gavin Newsom has pushed the responsibility — and blame — of reopening largely onto counties and the state’s 61 local health officers, who have worked for months without days off, giving up time with their families to attack this crisis head-on.

I have interviewed dozens of them. Some have broken into tears while talking with me, and worry chokes their voices as they lament problems with testing or explain how they don’t have enough supplies or contact tracers to safely reopen. They felt rushed into lifting stay-at-home restrictions in May and June, yet they had no choice in the face of pressure from politicians and suffering residents and businesses. After years of severe underfunding, public health agencies don’t have the money or resources to deploy an adequate response.

They’re also wrestling with the guilt and trauma that come with making decisions that affect people’s lives and livelihoods.

“It has been hard on all of us,” acknowledged Sacramento County’s health officer, Dr. Olivia Kasirye. “We’re getting phone calls daily from people saying they’re going bankrupt and they can’t pay their rent and they have loved ones who are dying that they can’t see.”

I know how that feels, having been conflicted about our long-term strategy in the Middle East and the harm we inadvertently inflicted on innocent civilians. But I can’t imagine being afraid of the people I signed up to protect.

Public health officials have become targets of aggressive and personal attacks. Some have seen their photos smeared with Hitler mustaches, while others have had their personal phone numbers and home addresses circulated publicly, prompting the need for round-the-clock security.

“Imagine treating American soldiers and military families with the kind of hatred and disrespect that local health officers are facing,” said Dr. Charity Dean, unprompted, a day after she left her job as one of the top public health officials in the Newsom administration. “They’re the ones taking all the risk, and it makes me angry to see how they’ve been treated.”

Since the start of the pandemic, at least eight career public health officials in California have resigned, and more are considering it. But most are soldiering on.

Mimi Hall, Newel’s boss and Santa Cruz County’s top public health official, told me law enforcement is investigating a threatening letter addressed to her that was allegedly signed by a far-right anti-government extremist group.

In response, Hall considered retiring early. But she didn’t want to abandon her troops and wasn’t going to let fear stop her from doing her job. So she had a perimeter fence and home security system installed over the weekend — and reported for work promptly Monday morning.

Yes, we are waging a life-or-death battle in which innocent people are hurt, but it’s these battle-scarred public health officers who are making deeply personal sacrifices to steer us to safety.

We commemorate military leaders with medals and parades. Why not treat our public health officials with the same level of appreciation?

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

USE OUR CONTENT

This story can be republished for free (details).

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.


This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

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

USE OUR CONTENT

This story can be republished for free (details).

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.”


This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

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

USE OUR CONTENT

This story can be republished for free (details).

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.

[khn_slabs slabs=”241887″ view=”inline” /]

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.”

[khn_two_photos photo-first=”353918″ photo-second=”353916″ /]

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.”