Amy Maxmen, Author at KFF Health News https://kffhealthnews.org Tue, 01 Oct 2024 14:46:15 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.5 https://kffhealthnews.org/wp-content/uploads/sites/2/2023/04/kffhealthnews-icon.png?w=32 Amy Maxmen, Author at KFF Health News https://kffhealthnews.org 32 32 161476233 Nursing Aides Plagued by PTSD After ‘Nightmare’ Covid Conditions, With Little Help https://kffhealthnews.org/news/article/essential-worker-ptsd-pandemic-massachusetts/ Thu, 26 Sep 2024 09:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1901870 One evening in May, nursing assistant Debra Ragoonanan’s vision blurred during her shift at a state-run Massachusetts veterans home. As her head spun, she said, she called her husband. He picked her up and drove her to the emergency room, where she was diagnosed with a brain aneurysm.

It was the latest in a drumbeat of health issues that she traces to the first months of 2020, when dozens of veterans died at the Soldiers’ Home in Holyoke, in one of the country’s deadliest covid-19 outbreaks at a long-term nursing facility. Ragoonanan has worked at the home for nearly 30 years. Now, she said, the sights, sounds, and smells there trigger her trauma. Among her ailments, she lists panic attacks, brain fog, and other symptoms of post-traumatic stress disorder, a condition linked to aneurysms and strokes.

Scrutiny of the outbreak prompted the state to change the facility’s name to the Massachusetts Veterans Home at Holyoke, replace its leadership, sponsor a $480 million renovation of the premises, and agree to a $56 million settlement for veterans and families. But the front-line caregivers have received little relief as they grapple with the outbreak’s toll.

“I am retraumatized all the time,” Ragoonanan said, sitting on her back porch before her evening shift. “How am I supposed to move forward?”

Covid killed more than 3,600 U.S. health care workers in the first year of the pandemic. It left many more with physical and mental illnesses — and a gutting sense of abandonment.

What workers experienced has been detailed in state investigations, surveys of nurses, and published studies. These found that many health care workers weren’t given masks in 2020. Many got covid and worked while sick. More than a dozen lawsuits filed on behalf of residents or workers at nursing facilities detail such experiences. And others allege that accommodations weren’t made for workers facing depression and PTSD triggered by their pandemic duties. Some of the lawsuits have been dismissed, and others are pending.

Health care workers and unions reported risky conditions to state and federal agencies. But the federal Occupational Safety and Health Administration had fewer inspectors in 2020 to investigate complaints than at any point in a half-century. It investigated only about 1 in 5 covid-related complaints that were filed officially, and just 4% of more than 16,000 informal reports made by phone or email.

Nursing assistants, health aides, and other lower-wage health care workers were particularly vulnerable during outbreaks, and many remain burdened now. About 80% of lower-wage workers who provide long-term care are women, and these workers are more likely to be immigrants, to be people of color, and to live in poverty than doctors or nurses.

Some of these factors increased a person’s covid risk. They also help explain why these workers had limited power to avoid or protest hazardous conditions, said Eric Frumin, formerly the safety and health director for the Strategic Organizing Center, a coalition of labor unions.

He also cited decreasing membership in unions, which negotiate for higher wages and safer workplaces. One-third of the U.S. labor force was unionized in the 1950s, but the level has fallen to 10% in recent years.

Like essential workers in meatpacking plants and warehouses, nursing assistants were at risk because of their status, Frumin said: “The powerlessness of workers in this country condemns them to be treated as disposable.”

In interviews, essential workers in various industries told KFF Health News they felt duped by a system that asked them to risk their lives in the nation’s moment of need but that now offers little assistance for harm incurred in the line of duty.

“The state doesn’t care. The justice system doesn’t care. Nobody cares,” Ragoonanan said. “All of us have to go right back to work where this started, so that’s a double whammy.”

‘A War Zone’

The plight of health care workers is a problem for the United States as the population ages and the threat of future pandemics looms. Surgeon General Vivek Murthy called their burnout “an urgent public health issue” leading to diminished care for patients. That’s on top of a predicted shortage of more than 3.2 million lower-wage health care workers by 2026, according to the Mercer consulting firm.

The veterans home in Holyoke illustrates how labor conditions can jeopardize the health of employees. The facility is not unique, but its situation has been vividly described in a state investigative report and in a report from a joint oversight committee of the Massachusetts Legislature.

The Soldiers’ Home made headlines in March 2020 when The Boston Globe got a tip about refrigerator trucks packed with the bodies of dead veterans outside the facility. About 80 residents died within a few months.

The state investigation placed blame on the home’s leadership, starting with Superintendent Bennett Walsh. “Mr. Walsh and his team created close to an optimal environment for the spread of COVID-19,” the report said. He resigned under pressure at the end of 2020.

Investigators said that “at least 80 staff members” tested positive for covid, citing “at least in part” the management’s “failure to provide and require the use of proper protective equipment,” even restricting the use of masks. They included a disciplinary letter sent to one nursing assistant who had donned a mask as he cared for a sick veteran overnight in March. “Your actions are disruptive, extremely inappropriate,” it said.

To avoid hiring more caretakers, the home’s leadership combined infected and uninfected veterans in the same unit, fueling the spread of the virus, the report found. It said veterans didn’t receive sufficient hydration or pain-relief drugs as they approached death, and it included testimonies from employees who described the situation as “total pandemonium,” “a nightmare,” and “a war zone.”

Because his wife was immunocompromised, Walsh didn’t enter the care units during this period, according to his lawyer’s statement in a deposition obtained by KFF Health News. “He never observed the merged unit,” it said.

In contrast, nursing assistants told KFF Health News that they worked overtime, even with covid, because they were afraid of being fired if they stayed home. “I kept telling my supervisor, ‘I am very, very sick,’” said Sophia Darkowaa, a nursing assistant who said she now suffers from PTSD and symptoms of long covid. “I had like four people die in my arms while I was sick.”

Nursing assistants recounted how overwhelmed and devasted they felt by the pace of death among veterans whom they had known for years — years of helping them dress, shave, and shower, and of listening to their memories of war.

“They were in pain. They were hollering. They were calling on God for help,” Ragoonanan said. “They were vomiting, their teeth showing. They’re pooping on themselves, pooping on your shoes.”

Nursing assistant Kwesi Ablordeppey said the veterans were like family to him. “One night I put five of them in body bags,” he said. “That will never leave my mind.”

Four years have passed, but he said he still has trouble sleeping and sometimes cries in his bedroom after work. “I wipe the tears away so that my kids don’t know.”

High Demands, Low Autonomy

A third of health care workers reported symptoms of PTSD related to the pandemic, according to surveys between January 2020 and May 2022 covering 24,000 workers worldwide. The disorder predisposes people to dementia and Alzheimer’s. It can lead to substance use and self-harm.

Since covid began, Laura van Dernoot Lipsky, director of the Trauma Stewardship Institute, has been inundated by emails from health care workers considering suicide. “More than I have ever received in my career,” she said. Their cries for help have not diminished, she said, because trauma often creeps up long after the acute emergency has quieted.

Another factor contributing to these workers’ trauma is “moral injury,” a term first applied to soldiers who experienced intense guilt after carrying out orders that betrayed their values. It became common among health care workers in the pandemic who weren’t given ample resources to provide care.

“Folks who don’t make as much money in health care deal with high job demands and low autonomy at work, both of which make their positions even more stressful,” said Rachel Hoopsick, a public health researcher at the University of Illinois at Urbana-Champaign. “They also have fewer resources to cope with that stress,” she added.

People in lower income brackets have less access to mental health treatment. And health care workers with less education and financial security are less able to take extended time off, to relocate for jobs elsewhere, or to shift careers to avoid retriggering their traumas.

Such memories can feel as intense as the original event. “If there’s not a change in circumstances, it can be really, really, really hard for the brain and nervous system to recalibrate,” van Dernoot Lipsky said. Rather than focusing on self-care alone, she pushes for policies to ensure adequate staffing at health facilities and accommodations for mental health issues.

In 2021, Massachusetts legislators acknowledged the plight of the Soldiers’ Home residents and staff in a joint committee report saying the events would “impact their well-being for many years.”

But only veterans have received compensation. “Their sacrifices for our freedom should never be forgotten or taken for granted,” the state’s veterans services director, Jon Santiago, said at an event announcing a memorial for veterans who died in the Soldiers’ Home outbreak. The state’s $56 million settlement followed a class-action lawsuit brought by about 80 veterans who were sickened by covid and a roughly equal number of families of veterans who died.

The state’s attorney general also brought criminal charges against Walsh and the home’s former medical director, David Clinton, in connection with their handling of the crisis. The two averted a trial and possible jail time this March by changing their not-guilty pleas, instead acknowledging that the facts of the case were sufficient to warrant a guilty finding.

An attorney representing Walsh and Clinton, Michael Jennings, declined to comment on queries from KFF Health News. He instead referred to legal proceedings in March, in which Jennings argued that “many nursing homes proved inadequate in the nascent days of the pandemic” and that “criminalizing blame will do nothing to prevent further tragedy.”

Nursing assistants sued the home’s leadership, too. The lawsuit alleged that, in addition to their symptoms of long covid, what the aides witnessed “left them emotionally traumatized, and they continue to suffer from post-traumatic stress disorder.”

The case was dismissed before trial, with courts ruling that the caretakers could have simply left their jobs. “Plaintiff could have resigned his employment at any time,” Judge Mark Mastroianni wrote, referring to Ablordeppey, the nursing assistants’ named representative in the case.

But the choice was never that simple, said Erica Brody, a lawyer who represented the nursing assistants. “What makes this so heartbreaking is that they couldn’t have quit, because they needed this job to provide for their families.”

‘Help Us To Retire’

Brody didn’t know of any cases in which staff at long-term nursing facilities successfully held their employers accountable for labor conditions in covid outbreaks that left them with mental and physical ailments. KFF Health News pored through lawsuits and called about a dozen lawyers but could not identify any such cases in which workers prevailed.

A Massachusetts chapter of the Service Employees International Union, SEIU Local 888, is looking outside the justice system for help. It has pushed for a bill — proposed last year by Judith García, a Democratic state representative — to allow workers at the state veterans home in Holyoke, along with its sister facility in Chelsea, to receive their retirement benefits five to 10 years earlier than usual. The bill’s fate will be decided in December.

Retirement benefits for Massachusetts state employees amount to 80% of a person’s salary. Workers qualify at different times, depending on the job. Police officers get theirs at age 55. Nursing assistants qualify once the sum of their time working at a government facility and their age comes to around 100 years. The state stalls the clock if these workers take off more than their allotted days for sickness or vacation.

Several nursing assistants at the Holyoke veterans home exceeded their allotments because of long-lasting covid symptoms, post-traumatic stress, and, in Ragoonanan’s case, a brain aneurysm. Even five years would make a difference, Ragoonanan said, because, at age 56, she fears her life is being shortened. “Help us to retire,” she said, staring at the slippers covering her swollen feet. “We have bad PTSD. We’re crying, contemplating suicide.”

I got my funeral dress out because the way everybody was dying, I knew I was going to die.

Debra Ragoonanan

Certain careers are linked with shorter life spans. Similarly, economists have shown that, on average, people with lower incomes in the United States die earlier than those with more. Nearly 60% of long-term care workers are among the bottom earners in the country, paid less than $30,000 — or about $15 per hour — in 2018, according to analyses by the Department of Health and Human Services and KFF, a health policy research, polling, and news organization that includes KFF Health News.

Fair pay was among the solutions listed in the surgeon general’s report on burnout. Another was “hazard compensation during public health emergencies.”

If employers offer disability benefits, that generally entails a pay cut. Nursing assistants at the Holyoke veterans home said it would halve their wages, a loss they couldn’t afford.

“Low-wage workers are in an impossible position, because they’re scraping by with their full salaries,” said John Magner, SEIU Local 888’s legal director.

Despite some public displays of gratitude for health care workers early in the pandemic, essential workers haven’t received the financial support given to veterans or to emergency personnel who risked their lives to save others in the aftermath of 9/11. Talk show host Jon Stewart, for example, has lobbied for this group for over a decade, successfully pushing Congress to compensate them for their sacrifices.

“People need to understand how high the stakes are,” van Dernoot Lipsky said. “It’s so important that society doesn’t put this on individual workers and then walk away.”

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KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Estudio revela que los casos de gripe aviar siguen sin detectarse https://kffhealthnews.org/news/article/estudio-revela-que-los-casos-de-gripe-aviar-siguen-sin-detectarse/ Mon, 23 Sep 2024 14:23:21 +0000 https://kffhealthnews.org/?post_type=article&p=1924165 Un nuevo estudio respalda los temores de que más trabajadores ganaderos puedan haber contraído la gripe aviar de lo que se haya informado.

“Estoy muy seguro de que hay más personas infectadas de las que sabemos”, dijo Gregory Gray, investigador de enfermedades infecciosas de la Universidad de Texas en el Medical Branch, quien dirigió el estudio publicado a fines de julio y en proceso de revisión para ser publicado en una revista líder en enfermedades infecciosas. “En gran parte, eso se debe a que nuestra vigilancia ha sido muy deficiente”.

Si los casos de gripe aviar no se van informando, los oficiales de salud corren el riesgo de tardar en notar si el virus se vuelve más contagioso. Un gran aumento de infecciones fuera de las comunidades de trabajadores agrícolas activaría el sistema de vigilancia de la gripe del gobierno, pero para entonces podría ser demasiado tarde para contenerlo.

“Necesitamos averiguar qué podemos hacer para detener esto”, dijo Gray. “No es algo que simplemente vaya a desaparecer”.

Los Centros para el Control y Prevención de Enfermedades (CDC) basan sus decisiones en su sistema de vigilancia. Por ejemplo, la agencia tiene vacunas contra la gripe aviar, pero ha decidido no ofrecerlas a los trabajadores agrícolas, con el argumento de que el número de casos es bajo.

Sin embargo, las pruebas de gripe aviar entre este grupo de trabajadores siguen siendo raras, por lo que la investigación de Gray se destaca como la primera en buscar signos de infecciones anteriores no diagnosticadas en personas que habían estado expuestas a ganado enfermo, y que se habían enfermado y recuperado.

El equipo de Gray detectó signos de infecciones previas de gripe aviar en trabajadores de dos granjas lecheras que registraron brotes en Texas a principios de este año. Analizaron muestras de sangre de 14 trabajadores que no habían tenido pruebas para el virus y encontraron anticuerpos en dos. Esto representa una tasa de casi el 15% en solo dos granjas lecheras de más de 170 con brotes de gripe aviar en 13 estados este año.

Uno de los trabajadores con anticuerpos estaba tomando medicamentos para una tos persistente cuando accedió a que los investigadores analizaran su sangre en abril. El otro se había recuperado recientemente de una enfermedad respiratoria. No sabía qué la había causado, pero dijo a los investigadores que otros trabajadores agrícolas a los que no se habían realizado pruebas también habían estado enfermos.

Richard Webby, director del Centro Colaborador para la Influenza de la Organización Mundial de la Salud en el Hospital de Investigación Infantil St. Jude, en Memphis, Tennessee, dijo que los resultados confirmaban sus sospechas de que había habido más casos humanos de gripe aviar que los 13 reportados este año por los CDC.

“Quizás lo que vemos no sea exactamente la punta del iceberg, pero ciertamente no es toda la historia”, dijo Webby.

Aunque el estudio es pequeño, resalta la urgencia sobre los informes de enfermedades no diagnosticadas entre trabajadores agrícolas y veterinarios. Los CDC han advertido que si las personas se infectan simultáneamente con la gripe estacional y la gripe aviar, los dos tipos de virus podrían intercambiar genes de una manera que permita que la gripe aviar se propague entre las personas tan fácilmente como las variedades estacionales.

No hay evidencia que sugiera que eso esté ocurriendo actualmente. Y los casos asintomáticos de gripe aviar parecen ser raros, según un estudio de anticuerpos en Michigan descrito por los CDC el 19 de julio. Los investigadores analizaron muestras de sangre de 35 trabajadores de tambos que habían tenido brotes en Michigan, y ninguno mostró signos de infecciones pasadas. A diferencia del estudio en Texas, estos trabajadores no se habían enfermado.

“Es un estudio pequeño, pero un primer paso”, dijo Natasha Bagdasarian, directora médica de Michigan. Agregó que el estado estaba aumentando los esfuerzos para realizar pruebas a los trabajadores agrícolas, pero que estas acciones se complicaban por problemas sistémicos, como el empleo precario que los hace vulnerables a ser despedidos por faltar al trabajo por enfermedad.

Sin más asistencia para los trabajadores agrícolas y cooperación entre el gobierno y la industria ganadera, Gray dijo que el país corre el riesgo de permanecer a oscuras sobre este virus.

“Hay muchos estudios genómicos y trabajos de laboratorio, pero en las granjas es en donde ocurre la verdadera acción”, dijo Gray, “y no estamos prestando atención”.

Problemas de comunicación

Un trabajador lechero en Colorado dijo a KFF Health News que buscó atención médica hace aproximadamente un mes debido a una irritación ocular, un síntoma común de la gripe aviar.

El médico le realizó un chequeo habitual, que incluyó un análisis de orina. Pero el trabajador no había oído hablar de la gripe aviar, y el médico no la mencionó ni realizó pruebas para detectar el virus. “Me dijeron que no tenía nada”, dijo en español, hablando bajo condición de anonimato por temor a represalias de sus empleadores.

Este trabajador y otros dos en Texas dijeron que sus empleadores no les dan gafas, máscaras N95 o delantales para protegerse de la leche y otros fluidos que podrían estar contaminados con el virus. Comprar su propio equipo es difícil porque no tienen dinero.

Lo mismo ocurre con ir al médico. Un trabajador en Texas dijo que no buscó atención por fuertes dolores de cabeza y dolor de garganta porque no tiene seguro médico y no puede permitirse el costo. Supuso que los síntomas se debían a trabajar largas horas en graneros calurosos, con poca agua. “No te dan agua ni nada”, dijo. “Tú traes tus propias botellas”. Pero no hay forma de saber la causa de los síntomas, ya sea gripe aviar u otra cosa, sin hacer pruebas.

Aproximadamente una quinta parte de los trabajadores en granjas ganaderas no tienen seguro médico, según un análisis de KFF, y una proporción similar tiene ingresos familiares de menos de $40,000 al año.

Ninguno de los empleadores de los tres trabajadores agrícolas, ni oficiales en sus estados, les habían hablado de la gripe aviar, mucho menos les ofrecieron hacerse pruebas. Los CDC se jactaron en una actualización reciente de que, a través de su asociación con Meta, la empresa propietaria de Facebook e Instagram, las publicaciones sobre la gripe aviar han aparecido en pantallas de computadoras y teléfonos inteligentes más de 10 millones de veces.

Sin embargo, este alcance no llega a los trabajadores agrícolas que no están conectados a las redes sociales, que no hablan inglés o español, o que no tienen acceso a teléfonos inteligentes e internet, dijo Bethany Boggess Alcauter, directora de investigación y programas de salud pública en el Centro Nacional de Salud de Trabajadores Agrícolas. Ella y otros dijeron que las ofertas de equipo protector de los funcionarios de salud no estaban llegando a las granjas.

“Hemos escuchado que los empleadores han sido reacios a aceptar la oferta”, dijo Christine Sauvé, gerente de política y participación del Centro de Derechos de los Inmigrantes de Michigan. “Si esto comienza a transmitirse más fácilmente de persona a persona, estamos en problemas”, dijo, “porque las unidades de vivienda de los trabajadores agrícolas están hacinadas y tienen poca ventilación”.

Las clínicas podrían alertar a los funcionarios de salud si los trabajadores agrícolas enfermos buscan atención médica. Pero muchos trabajadores agrícolas no lo hacen porque no tienen seguro médico y podrían despedirlos por faltar al trabajo.

“El mayor temor que escuchamos es la represalia de los empleadores, o que alguien pueda ser incluido en una lista negra para otros trabajos”, dijo Sauvé.

Vigilancia de la gripe

Los CDC evalúan la situación actual de la gripe aviar como un bajo riesgo para la salud pública porque el sistema de vigilancia de la gripe del país no ha detectado alertas preocupantes.

El sistema busca aumentos anormales en las visitas al hospital. No se ha detectado nada inusual hasta ahora. También analiza un subconjunto de muestras de pacientes en busca de tipos inusuales de virus de la gripe. Desde finales de febrero, la agencia ha evaluado alrededor de 36,000 muestras. Ninguna con gripe aviar.

Sin embargo, Samuel Scarpino, epidemiólogo especializado en la vigilancia de enfermedades, dijo que este sistema no detectaría muchas amenazas emergentes para la salud porque, por definición, comienzan con un número relativamente pequeño de infecciones. Aproximadamente 200,000 personas trabajan en granjas ganaderas en el país, según los CDC. Eso es solo el 0.1% de la población total del país.

Scarpino dijo que la vigilancia de los CDC se activaría si las personas comenzaran a morir por gripe aviar. Los 13 casos conocidos han sido leves. Y probablemente el sistema detectaría aumentos si el virus se propaga más allá de este grupo de trabajadores y sus contactos más cercanos, pero para entonces puede ser demasiado tarde para contenerlo.

“No queremos encontrarnos en otra situación como la de covid”, dijo Scarpino, recordando cómo las escuelas, restaurantes y negocios tuvieron que cerrar porque el coronavirus estaba demasiado extendido para controlarlo mediante pruebas y aislamiento individual. “Para cuando detectábamos casos”, dijo, “había tantos que solo nos quedaban malas opciones”.

Signos preocupantes

Los investigadores advierten que el virus H5N1 de la gripe aviar ha evolucionado en los últimos años para ser más infeccioso para los mamíferos, incluidos los humanos. Esto resalta la necesidad de monitorear lo que está ocurriendo a medida que el brote se extiende por las granjas lecheras del país.

Este virus parece estar propagándose principalmente a través de la leche y el equipo de ordeñe. Pero, por primera vez, los investigadores informaron en mayo y julio que se propagó de manera ineficiente a través del aire entre unos pocos hurones de laboratorio mantenidos a centímetros de distancia. Y en experimentos con ganado, algunas vacas se infectaron al inhalar diminutas gotas cargadas de virus, algo que podría ocurrir si una vaca infectada tose cerca de otra.

De hecho, las vacas tosen. El nuevo estudio de Texas señala que el ganado tosía durante los brotes en las granjas y mostraba otros signos de enfermedades respiratorias.

Otras observaciones fueron ominosas: aproximadamente la mitad de unos 40 gatos en una granja murieron repentinamente en el punto álgido de su brote, probablemente por lamer leche cruda contaminada con el virus de la gripe aviar.

La mayoría de las personas diagnosticadas con gripe aviar han sido infectadas por animales. En su nuevo estudio, Gray observó un indicio de que el virus puede ocasionalmente transmitirse de persona a persona, pero agregó que esto sigue siendo una conjetura. Uno de los dos individuos con anticuerpos trabajaba en la cafetería de la granja, junto al tambo y a los trabajadores agrícolas, pero no cerca del ganado.

“Necesitamos encontrar formas de tener una mejor vigilancia”, dijo, “para que podamos tomar decisiones informadas en lugar de decisiones basadas en suposiciones”.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Bird Flu Cases Are Going Undetected, New Study Suggests. It’s a Problem for All of Us. https://kffhealthnews.org/news/article/bird-flu-undetected-farmworkers-testing-contagious-mammals/ Wed, 31 Jul 2024 18:27:05 +0000 https://kffhealthnews.org/?post_type=article&p=1889499 A new study lends weight to fears that more livestock workers have gotten the bird flu than has been reported.

“I am very confident there are more people being infected than we know about,” said Gregory Gray, the infectious disease researcher at the University of Texas Medical Branch who led the study, posted online Wednesday and under review to be published in a leading infectious disease journal. “Largely, that’s because our surveillance has been so poor.”

As bird flu cases go underreported, health officials risk being slow to notice if the virus were to become more contagious. A large surge of infections outside of farmworker communities would trigger the government’s flu surveillance system, but by then it might be too late to contain.

“We need to figure out what we can do to stop this thing,” Gray said. “It is not just going away.”

The Centers for Disease Control and Prevention bases decisions on its surveillance. For example, the agency has bird flu vaccines on hand but has decided against offering them to farmworkers, citing a low number of cases.

But testing for bird flu among farmworkers remains rare, which is why Gray’s research stands out as the first to look for signs of prior, undiagnosed infections in people who had been exposed to sick dairy cattle — and who had become ill and recovered.

Gray’s team detected signs of prior bird flu infections in workers from two dairy farms that had outbreaks in Texas earlier this year. They analyzed blood samples from 14 farmworkers who had not been tested for the virus and found antibodies against it in two. This is a nearly 15% hit rate from only two dairy farms out of more than 170 with bird flu outbreaks in 13 states this year.

One of the workers with antibodies had been taking medicine for a lingering cough when he agreed to allow researchers to analyze his blood in April. The other had recently recovered from a respiratory illness. She didn’t know what had caused it but told researchers that untested farmworkers around her had been sick too.

Richard Webby, director of the World Health Organization Collaborating Center for Influenza at St. Jude Children’s Research Hospital in Memphis, Tennessee, said the results confirmed his suspicions that the 13 human bird flu cases reported this year by the CDC were an undercount.

“Maybe what we see isn’t exactly the tip of the iceberg, but it’s certainly not the whole story,” Webby said.

Little Testing of Farmworkers

Although small, the study gives fresh urgency to reports of undiagnosed ailments among farmworkers and veterinarians. The CDC has warned that if people are infected by the seasonal flu and the bird flu simultaneously, the two types of viruses could swap genes in a way that allows the bird flu to spread between people as easily as seasonal varieties.

No evidence suggests that’s happening now. And asymptomatic cases of the bird flu appear to be rare, according to a Michigan antibody study described by the CDC on July 19. Researchers analyzed blood samples from 35 workers from dairy farms that had outbreaks in Michigan, and none showed signs of missed infections. Unlike the study in Texas, these workers hadn’t fallen sick.

“It’s a small study, but a first step,” said Natasha Bagdasarian, Michigan’s chief medical executive. She said that the state was boosting outreach to test farmworkers but its efforts were complicated by systemic issues like precarious employment that renders them vulnerable to getting fired for calling out sick.

Without more assistance for farmworkers, and cooperation between the government and the livestock industry, Gray said, the U.S. risks remaining in the dark about this virus.

“There’s a lot of genomic studies and laboratory work, but farms are where the real action is,” Gray said, “and we’re not watching.”

Communication Breakdown

A dairy worker in Colorado told KFF Health News that he sought medical care about a month ago for eye irritation — a common symptom of the bird flu. The doctor conducted a usual checkup, complete with a urine analysis. But the farmworker hadn’t heard of the bird flu, and the clinician didn’t mention it or test for the virus. “They told me I had nothing,” he said in Spanish, speaking on the condition of anonymity because he feared retaliation from employers.

This dairy worker and two in Texas said their employers have not provided goggles, N95 masks, or aprons to protect them from milk and other fluids that could be contaminated with the virus. Buying their own gear is a tall order because money is tight.

As is going to the doctor. One worker in Texas said he didn’t seek care for piercing headaches and a sore throat because he doesn’t have health insurance and can’t afford the cost. He guessed the symptoms were from laboring long hours in sweltering barns with limited water. “They don’t give you water or anything,” he said. “You bring your own bottles.” But there’s no way to know the cause of symptoms — whether bird flu or something else — without testing.

About a fifth of workers on livestock farms are uninsured, according to a KFF analysis, and a similar share have household incomes of less than $40,000 a year.

The three farmworkers hadn’t heard of the bird flu from their employers or state health officials, never mind offers of tests. The CDC boasted in a recent update that, through its partnership with Meta, the company that owns Facebook and Instagram, bird flu posts have flickered across computer and smartphone screens more than 10 million times.

Such outreach is lost on farmworkers who aren’t scrolling, don’t speak English or Spanish, or are without smartphones and internet access, said Bethany Boggess Alcauter, director of research and public health programs at the National Center for Farmworker Health. She and others said that offers of protective gear from health officials weren’t reaching farms.

“We’ve heard that employers have been reticent to take them up on the offer,” said Christine Sauvé, policy and engagement manager at the Michigan Immigrant Rights Center. “If this starts to transmit more easily person to person, we’re in trouble,” she said, “because farmworker housing units are so crowded and have poor ventilation.”

Clinics might alert health officials if sick farmworkers seek medical care. But many farmworkers don’t because they lack health insurance and could be fired for missing work.

“The biggest fear we hear about is retaliation from employers, or that someone might be blacklisted from other jobs,” Sauvé said.

Flu Surveillance

The CDC assesses the current bird flu situation as a low public health risk because the country’s flu surveillance system hasn’t flagged troubling alerts.

The system scans for abnormal increases in hospital visits. Nothing odd has turned up there. It also analyzes a subset of patient samples for unusual types of flu viruses. Since late February, the agency has assessed about 36,000 samples. No bird flu.

However, Samuel Scarpino, an epidemiologist who specializes in disease surveillance, said this system would miss many emerging health threats because, by definition, they start with a relatively small number of infections. Roughly 200,000 people work on farms with livestock in the United States, according to the CDC. That’s a mere 0.1% of the country’s population.

Scarpino said the CDC’s surveillance would be triggered if people started dying from the bird flu. The 13 known cases have been mild. And the system will probably pick up surges if the virus spreads beyond farmworkers and their closest contacts — but by then it may be too late to contain.

“We don’t want to find ourselves in another covid situation,” Scarpino said, recalling how schools, restaurants, and businesses needed to close because the coronavirus was too widespread to control through testing and targeted, individual isolation. “By the time we were catching cases,” he said, “there were so many that we were only left with bad options.”

Troubling Signs

Researchers warn that the H5N1 bird flu virus has evolved to be more infectious to mammals, including humans, in the past couple of years. This drives home the need to keep an eye on what’s happening as the outbreak spreads to dairy farms across the country.

The bird flu virus appears be spreading mainly through milk and milking equipment. But for the first time, researchers reported in May and July that it spread inefficiently through the air between a few laboratory ferrets kept inches apart. And in cattle experiments, some cows were infected by breathing in virus-laden microscopic droplets — the sort of thing that could happen if an infected cow was coughing in close proximity to another.

Cows do, in fact, cough. The new study from Texas notes that cattle coughed during outbreaks on the farms and showed other signs of respiratory illness.

Other observations were ominous: About half of some 40 cats on one farm died suddenly at the peak of its outbreak, probably from lapping up raw milk suffused with bird flu virus.

Most people diagnosed with the bird flu have been infected from animals. In his new study, Gray saw a hint that the virus may occasionally spread from person to person, but he added that this remains conjecture. One of the two people who had antibodies worked in the farm’s cafeteria adjacent to the milking parlor — alongside farmworkers but not cattle.

“We need to find ways to have better surveillance,” he said, “so we can make informed decisions rather than decisions based on guesswork.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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The CDC’s Test for Bird Flu Works, but It Has Issues https://kffhealthnews.org/news/article/bird-flu-test-cdc-flaws/ Fri, 26 Jul 2024 09:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1888022 The Centers for Disease Control and Prevention says a glitch in its bird flu test hasn’t harmed the agency’s outbreak response. But it has ignited scrutiny of its go-it-alone approach in testing for emerging pathogens.

The agency has quietly worked since April to resolve a nagging issue with the test it developed, even as the virus swept through dairy farms and chicken houses across the country and infected at least 13 farmworkers this year.

At a congressional hearing July 23, Rep. Brett Guthrie (R-Ky.) asked about the issue. “Boy, that rings of 2020,” he said, referring to when the nation was caught off guard by the covid-19 pandemic, in part because of dysfunctional tests made by the CDC. Demetre Daskalakis, director of the CDC’s National Center for Immunization and Respiratory Diseases, responded that the agency rapidly developed a workaround that makes its bird flu test reliable.

“The tests are 100% usable,” he later told KFF Health News, adding that the FDA studied the tests and came to the same conclusion. The imperfect tests, which have a faulty element that sometimes requires testing a sample again, will be replaced soon. He added, “We have made sure that we’re offering a high-quality product.”

Still, some researchers were unnerved by the news coming four months after the government declared a worrisome bird flu outbreak among cattle. The CDC’s test is the only one available for clinical use. Some researchers say its flaws, though manageable, underscore the risk of relying on a single entity for testing.

The problem came to light in April as the agency prepared to distribute its test to about 100 public health labs around the country. CDC officials detected the issue through a quality control system put in place after the covid test catastrophe of 2020.

Daskalakis said the CDC’s original test design was fine, but a flaw emerged when a company contracted by the agency manufactured the tests in bulk. In these tests, one of two components that recognize proteins called H5 in the H5N1 bird flu virus was unreliable, eliminating an important safeguard. By targeting the same protein twice, tests have a built-in backup in case one part fails.

The agency developed a fix to ensure a reliable result: If only one of the two parts detected H5, the test was considered inconclusive and would be run again. With the FDA’s blessing, the CDC distributed the tests — with workaround instructions — to public health labs.

Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories, said the results of the tests have not been ambiguous, and there is no need to discard the tests.

Still, the agency has asked a different manufacturer to remake the faulty component so that 1.2 million improved tests will be available soon, Daskalakis said. Some of the updated tests are already in stock at the CDC, but the FDA hasn’t yet signed off on their use. Daskalakis declined to name the manufacturers.

Meanwhile, the outbreak has grown. Farmworkers continue to lack information about the virus and gear to protect them from it. Rural clinics may miss cases if they don’t catch a person’s connection to a farm and notify health officials rather than their usual diagnostic testing laboratories.

Those clinical labs remain unauthorized to test for the bird flu. Several of those labs have spent months working through analyses and red tape so that they can run the CDC’s tests. As part of the licensing process, the CDC alerted them to the workaround with the current test, too.

But outside select circles, the news was largely overlooked. “I’m totally surprised by this,” Alex Greninger, assistant director of the University of Washington Clinical Virology Laboratory, told KFF Health News this week. Greninger’s lab is developing its own test and has been trying to obtain CDC test kits to evaluate.

“It’s not a red alarm,” he said, but he’s worried that as the CDC and the FDA spend months developing and evaluating an updated test, the only one available relies on a single component. If the genetic code underlying that fragment of the H5 protein mutates, the test could give false results.

It’s not uncommon for academic and commercial diagnostic labs to make mistakes and catch them during quality control checks, as the CDC did. Still, this isn’t the agency’s first mishap. In 2016, well before the covid debacle, CDC officials for months directed public health labs to use a Zika test that failed about a third of the time.

The CDC caught and worked to remediate the situation far more quickly and effectively in this case. Nonetheless, the mishap raises concern. Michael Mina, chief science officer of the telemedicine company eMed.com, said diagnostic companies may be better suited to the task.

“It’s a reminder that CDC is not a robust manufacturer of tests” and lacks the resources that industry can marshal for their production, Mina said. “We do not ask CDC to make vaccines and pharmaceuticals, and we do not ask the Pentagon to manufacture missiles.”

The CDC has licensed its updated test design to at least seven clinical diagnostic labs. Such labs are the foundation of testing in the U.S. But none have FDA clearance to use them.

Diagnostic labs are developing their own tests, too. But that has been slow-going. One reason is the lack of guaranteed sales. Another is regulatory uncertainty. Recent FDA guidance could make it harder for nongovernmental laboratories to issue new tests in the early phase of pandemics, said Susan Van Meter, president of the American Clinical Laboratory Association, in a July 1 letter to the FDA.

Transparency is also critical, scientists said. Benjamin Pinsky, medical director of the clinical virology laboratory at Stanford University, said as a public agency the CDC should make its protocol — its recipe for making the test — easily accessible online.

The World Health Organization does so for its bird flu tests, and with that information in hand, Pinsky’s lab has developed an H5 bird flu test suited to the strain circulating this year in the U.S. The lab published its approach this month but doesn’t have FDA authorization for its broad use.

The CDC’s test recipe is available in a published patent, Daskalakis said.

“We have made sure that tests are out there, and that they work,” he added.

As the CDC came under fire at the July 23 congressional hearing, Daniel Jernigan, director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, noted that testing is just one tool. The agency needs money for another promising area — looking for the virus in wastewater. Its current program uses supplemental funds, he said: “It is not in the current budget and will go away without additional funding.”

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Colorado Poultry Workers Battle Bird Flu in Heat Wave as US Struggles to Contain Outbreak https://kffhealthnews.org/news/article/bird-flu-cases-colorado-poultry-workers-virus-spread/ Mon, 15 Jul 2024 17:26:21 +0000 https://kffhealthnews.org/?post_type=article&p=1882245 Six people who work at a poultry farm in northeastern Colorado have tested positive for the bird flu, the Centers for Disease Control and Prevention reported July 19. This brings the known number of U.S. cases this year to 10.

The workers were likely infected by chickens, which they had been tasked with killing in response to a bird flu outbreak at the farm. The endeavor occurred amid a heat wave, as outside temperatures soared to 104 degrees Fahrenheit.

“The barns in which culling occurs were no doubt even hotter,” said CDC principal deputy director Nirav Shah at a July 16 press briefing. Wearing N95 respirators, goggles, and other protective gear was a challenge. Industrial fans whipped feathers around the facility that could have carried the virus, Shah added.

In this environment, the farmworkers collected hundreds of chickens by hand and placed them into carts where they could be killed by carbon dioxide gas within two minutes.

“If a farm worker gets severely ill or dies from an H5N1 infection, it will be a stain on US public health that we didn’t do more with the tools we have,” Jennifer Nuzzo, director of the Pandemic Center at Brown University, posted on X. “You don’t send farm workers in to cull H5N1 infected birds without goggles and masks. Period. If it’s too hot to wear those protections, it’s too hot to cull. We need vaccines to be made available to farm workers. We have to stop gambling with peoples’ lives.”

More than 99 million chickens and turkeys have been infected with a highly pathogenic strain of the bird flu that emerged at U.S. poultry farms in early 2022. Since then, the federal government has compensated poultry farmers more than $1 billion for destroying infected flocks and eggs to keep outbreaks from spreading.

As summer temperatures rise across the country, Shah said, the agency is contending with how to offer farmworkers “safety from the virus, as well as safety from extreme heat.”

The H5N1 bird flu virus has spread among poultry farms around the world for nearly 30 years. An estimated 900 people have been infected by birds, and roughly half have died from the disease.

The virus made an unprecedented shift this year to dairy cattle in the U.S. This poses a higher threat because it means the virus has adapted to replicate within cows’ cells, which are more like human cells. The four other people diagnosed with bird flu this year in the U.S. worked on dairy farms with outbreaks.

Scientists have warned that the virus could mutate to spread from person to person, like the seasonal flu, and spark a pandemic. There’s no sign of that, yet.

So far, all 10 cases reported this year have been mild, consisting of eye irritation, a runny nose, and other respiratory symptoms. However, numbers remain too low to say anything certain about the disease because, in general, flu symptoms can vary among people with only a minority needing hospitalization.

The number of people who have gotten the virus from poultry or cattle may be higher than 10. The Centers for Disease Control and Prevention has tested only about 60 people over the past four months, and powerful diagnostic laboratories that typically detect diseases remain barred from testing for bird flu. Testing of farmworkers and animals is needed to detect the H5N1 bird flu virus, study it, and stop it before it becomes a fixture on farms.

Researchers have urged a more aggressive response from the CDC and other federal agencies to prevent future infections. Many people exposed regularly to livestock and poultry on farms still lack protective gear and education about the disease. And they don’t yet have permission to get a bird flu vaccine.

Nearly a dozen virology and outbreak experts recently interviewed by KFF Health News disagree with the CDC’s decision against vaccination, which may help prevent bird flu infection and hospitalization.

“We should be doing everything we can to eliminate the chances of dairy and poultry workers contracting this virus,” said Angela Rasmussen, a virologist at the University of Saskatchewan in Canada. “If this virus is given enough opportunities to jump from cows or poultry into people, it will eventually get better at infecting them.”

To understand whether cases are going undetected, researchers in Michigan have sent the CDC blood samples from workers on dairy farms. If they detect bird flu antibodies, it’s likely that people are more easily infected by cattle than previously believed.

“It’s possible that folks may have had symptoms that they didn’t feel comfortable reporting, or that their symptoms were so mild that they didn’t think they were worth mentioning,” said Natasha Bagdasarian, chief medical executive for the state of Michigan.

In hopes of thwarting a potential pandemic, the United States, United Kingdom, Netherlands, and about a dozen other countries are stockpiling millions of doses of a bird flu vaccine made by the vaccine company CSL Seqirus.

Seqirus’ most recent formulation was greenlighted last year by the European equivalent of the FDA, and an earlier version has the FDA’s approval. In June, Finland decided to offer vaccines to people who work on fur farms as a precaution because its mink and fox farms were hit by bird flu last year.

The CDC has controversially decided not to offer at-risk groups bird flu vaccines. Demetre Daskalakis, director of the CDC’s National Center for Immunization and Respiratory Diseases, told KFF Health News that the agency is not recommending a vaccine campaign at this point for several reasons, even though millions of doses are available. One is that cases still appear to be limited, and the virus isn’t spreading rapidly between people as they sneeze and breathe.

The agency continues to rate the public’s risk as low. In a statement posted in response to the new Colorado cases, the CDC said its bird flu recommendations remain the same: “An assessment of these cases will help inform whether this situation warrants a change to the human health risk assessment.”

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Trabajadores avícolas en Colorado en riesgo de gripe aviar, en medio de la ola de calor y con el país luchando para frenar el brote https://kffhealthnews.org/news/article/5-trabajadores-avicolas-en-colorado-dieron-positivo-para-la-gripe-aviar-duplicando-los-casos-de-este-ano/ Mon, 15 Jul 2024 16:27:00 +0000 https://kffhealthnews.org/?post_type=article&p=1882305 Cinco trabajadores de una granja avícola en el noreste de Colorado han dado positivo para la gripe aviar, informó el Departamento de Salud Pública estatal el 14 de julio. Esto eleva el número conocido de casos en Estados Unidos a nueve. Hay otro caso que espera la confirmación de los Centros para el Control y Prevención de Enfermedades (CDC).

Es probable que las cinco personas se infectaran por manipular pollos, a los que se les había encargado sacrificar en respuesta a un brote de gripe aviar en esa granja. Este esfuerzo se produjo en medio de una ola de calor, cuando la temperatura exterior se disparó a 104 grados Fahrenheit.

“Sin duda, los graneros en los que se realizan estos sacrificios son todavía más calurosos”, dijo Nirav Shah, subdirector principal de los CDC, en una conferencia de prensa el 16 de julio. Usar respiradores N95, lentes protectoras y otros equipos de protección era un desafío. Los ventiladores industriales diseminaron plumas alrededor de la instalación que podrían haber transportado el virus, agregó Shah.

Cientos de pollos fueron colocados en carros en donde murieron al inhalar dióxido de carbono en menos de dos minutos.

“Si un trabajador agrícola enferma gravemente o muere a causa de una infección por H5N1, será una mancha para la salud pública de Estados Unidos el hecho de que no hayamos hecho más con las herramientas que tenemos”, dijo Jennifer Nuzzo, directora del Centro de Pandemia de la Universidad Brown, en un posteo en X. “No se envían trabajadores agrícolas a sacrificar aves infectadas con H5N1 sin gafas y máscaras. Punto. Si hace demasiado calor para usar esas protecciones, hace demasiado calor para sacrificarlos. Necesitamos que las vacunas estén disponibles para los trabajadores agrícolas. Tenemos que dejar de jugar con la vida de las personas”.

Más de 99 millones de pollos y pavos se han infectado con una cepa altamente patógena de la gripe aviar que surgió en las granjas avícolas del país a principios de 2022.

Desde entonces, el gobierno federal ha compensado a los granjeros avícolas con más de $1,000 millones por destruir bandadas y huevos infectados para frenar la propagación de los brotes.

El virus de la gripe aviar H5N1 se ha estado propagando entre las granjas avícolas de todo el mundo durante casi 30 años. Se estima que 900 personas se han infectado por aves y aproximadamente la mitad han muerto por la enfermedad.

Este año, en Estados Unidos, el virus hizo un cambio sin precedentes “saltando” al ganado lechero. Esto representa una amenaza mayor porque significa que el virus se ha adaptado para replicarse dentro de las células de las vacas, que son más parecidas a las humanas.

Las otras cuatro personas diagnosticadas este año en el país trabajaban en tambos que estaban sufriendo brotes.

Los científicos han advertido que el virus podría mutar para propagarse de persona a persona, como la gripe estacional, y desencadenar una pandemia. Aún no hay señales de que esto esté ocurriendo.

Hasta ahora, los casos reportados este año han sido leves: con irritación ocular, secreción nasal y otros síntomas respiratorios. Sin embargo, los números siguen siendo demasiado bajos para decir algo certero sobre la enfermedad porque, en general, los síntomas de la gripe pueden variar entre las personas y solo una minoría necesita hospitalización.

El número de personas que han contraído el virus de las aves de corral o el ganado puede ser mayor que nueve. Los CDC han hecho pruebas solo a unas 60 personas en los últimos cuatro meses, y los laboratorios de diagnóstico más grandes, que típicamente detectan enfermedades, aún no tienen permitido realizar pruebas.

Es muy importante hacerles estas pruebas a los trabajadores de granjas para detectar el virus de la gripe aviar H5N1, estudiarlo y frenarlo antes que se convierta en parte de sus ecosistemas.

Los investigadores han instado a una respuesta más agresiva por parte de los CDC y otras agencias federales para prevenir futuras infecciones. Muchas personas expuestas regularmente al ganado y a las aves de corral en las granjas aún carecen de equipo de protección y no reciben ningún tipo de educación sobre la enfermedad.

Y todavía no tienen permiso para recibir una vacuna contra la gripe aviar.

Casi una docena de expertos en virología y brotes entrevistados recientemente por KFF Health News no están de acuerdo con la decisión de los CDC de no vacunar, lo que, dicen, podría ayudar a prevenir la infección y hospitalización por gripe aviar.

“Deberíamos hacer todo lo posible para eliminar las posibilidades de que los trabajadores en tambos y granjas de aves contraigan este virus”, dijo Angela Rasmussen, viróloga de la Universidad de Saskatchewan, en Canadá. “Si este virus tiene suficientes oportunidades para saltar de las vacas o las aves de corral a las personas, eventualmente se volverá mejor para infectarlas”.

Para comprobar si los casos no se están detectando, investigadores en Michigan han enviado a los CDC muestras de sangre de trabajadores de tambos. Si detectan anticuerpos contra la gripe aviar, es probable que las personas se infecten más fácilmente por el ganado de lo que se creía anteriormente.

“Es posible que las personas hayan tenido síntomas que no se sintieran cómodas informando, o que sus síntomas fueran tan leves que no pensaron que valiera la pena mencionarlos”, dijo Natasha Bagdasarian, directora ejecutiva de salud médica del estado de Michigan.

Con la esperanza de frustrar una posible pandemia, Estados Unidos, el Reino Unido, Países Bajos y una docena de otros países están almacenando millones de dosis de una vacuna contra la gripe aviar fabricada por la compañía de vacunas CSL Seqirus.

La formulación más reciente de Seqirus fue aprobada el año pasado por el equivalente europeo de la Administración de Drogas y Alimentos (FDA), y una versión anterior tiene la aprobación de la FDA. En junio, Finlandia decidió ofrecer vacunas a las personas que trabajan en granjas de pieles como medida de precaución porque sus granjas de visones y zorros sufrieron duros golpes por la gripe aviar el año pasado.

De manera controversial, los CDC han decidido no ofrecer vacunas contra la gripe aviar a los grupos de riesgo.

Aunque hay millones de dosis disponibles, Demetre Daskalakis, director del Centro Nacional para la Inmunización y Enfermedades Respiratorias de los CDC, dijo a KFF Health News que en este momento la agencia no está recomendando una campaña de vacunación por varias razones. Una de ellas es que los casos aún parecen ser limitados y el virus no se está propagando rápidamente entre las personas a medida que estornudan y respiran.

La agencia sigue calificando el riesgo público como bajo. En una declaración publicada en respuesta a los nuevos casos de Colorado, los CDC dijeron que sus recomendaciones sobre la gripe aviar siguen siendo las mismas: “Una evaluación de estos casos ayudará a determinar si esta situación justifica un cambio en la evaluación del riesgo para la salud humana”.

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Finland Is Offering Farmworkers Bird Flu Shots. Some Experts Say the US Should, Too. https://kffhealthnews.org/news/article/bird-flu-vaccines-finland-farmworkers-veterinarians-us-stockpile/ Thu, 11 Jul 2024 09:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1878299 As bird flu spreads among dairy cattle in the U.S., veterinarians and researchers have taken note of Finland’s move to vaccinate farmworkers at risk of infection. They wonder why their government doesn’t do the same.

“Farmworkers, veterinarians, and producers are handling large volumes of milk that can contain high levels of bird flu virus,” said Kay Russo, a livestock and poultry veterinarian in Fort Collins, Colorado. “If a vaccine seems to provide some immunity, I think it should be offered to them.”

Among a dozen virology and outbreak experts interviewed by KFF Health News, most agree with Russo. They said people who work with dairy cows should be offered vaccination for a disease that has killed roughly half of the people known to have gotten it globally over the past two decades, has killed cats in the U.S. this year, and has pandemic potential.

However, some researchers sided with the Centers for Disease Control and Prevention in recommending against vaccination for now. There’s no evidence that this year’s bird flu virus spreads between people or causes serious disease in humans. And it’s unclear how well the available vaccine would prevent either scenario.

But the wait-and-see approach “is a gamble,” said Jennifer Nuzzo, director of the Pandemic Center at Brown University. “By the time we see severe outcomes, it means a lot of people have been infected.”

“Now is the time to offer the vaccines to farmworkers in the United States,” said Nahid Bhadelia, director of the Boston University Center on Emerging Infectious Diseases. Even more urgent measures are lagging in the U.S., she added. Testing of farmworkers and cows is sorely needed to detect the H5N1 bird flu virus, study it, and extinguish it before it becomes a fixture on farms — posing an ever-present pandemic threat.

Demetre Daskalakis, director of the CDC’s National Center for Immunization and Respiratory Diseases, said the agency takes bird flu seriously, and the U.S. is stockpiling 4.8 million doses of the vaccine. But, he said, “there’s no recommendation to launch a vaccine campaign.”

“It’s all about risk-benefit ratios,” Daskalakis said. The benefits are blurry because there hasn’t been enough testing to understand how easily the virus jumps from cows into people, and how sick they become. Just four people in the United States have tested positive this year, with mild cases — too few to draw conclusions.

Other farmworkers and veterinarians working on dairy farms with outbreaks have reported being sick, Russo said, but they haven’t been tested. Public health labs have tested only about 50 people for the bird flu since the outbreak was detected in March.

Still, Daskalakis said the CDC is not concerned that the agency is missing worrisome bird flu infections because of its influenza surveillance system. Hospitals report patients with severe cases of flu, and numbers are normal this year.

Another signal that puts the agency at ease is that the virus doesn’t yet have mutations that allow it to spread rapidly between people as they sneeze and breathe. “If we start to see changes in the virus, that’s another factor that would be part of the decision to move from a planning phase into an operational one,” Daskalakis said.

On July 8, researchers reported that the virus may be closer to spreading between people than previously thought. It still doesn’t appear to do so, but experiments suggest it has the ability to infect human airways. It also spread between two laboratory ferrets through the air.

In considering vaccines, the agency takes a cue from a 1976 outbreak of the swine flu. Officials initially feared a repeat of the 1918 swine flu pandemic that killed roughly half a million people in the United States. So they rapidly vaccinated nearly 43 million people in the country within a year.

But swine flu cases turned out to be mild that year. This made the vaccine seem unnecessarily risky as several reports of a potentially deadly disorder, Guillain-Barré Syndrome, emerged. Roughly one of every million people who get influenza vaccines may acquire the disorder, according to the CDC. That risk is outweighed by the benefits of prevention. Since Oct. 1, as many as 830,000 people have been hospitalized for the seasonal flu and 25,000 to 75,000 people have died.

An after-action report on the 1976 swine flu situation called it a “sobering, cautionary tale” about responding prematurely to an uncertain public health threat. “It’s a story about what happens when you launch a vaccine program where you are accepting risk without any benefit,” Daskalakis said.

Paul Offit, a virologist at the Children’s Hospital of Philadelphia, sides with the CDC. “I’d wait for more data,” he said.

However, other researchers say this isn’t comparable to 1976 because they aren’t suggesting that the U.S. vaccinate tens of millions of people. Rather they’re talking about a voluntary vaccine for thousands of people in close contact with livestock. This lessens the chance of rare adverse effects.

The bird flu vaccine on hand, made by the flu vaccine company CSL Seqirus, was authorized last year by the European equivalent of the FDA. An older variety has FDA approval, but the newer variety hasn’t gotten the green light yet.

Although the vaccine targets a different bird flu strain than the H5N1 virus now circulating in cows, studies show it triggers an immune response against both varieties. It’s considered safe because it uses the same egg-based vaccine technology deployed every year in seasonal flu vaccines.

For these reasons, the United States, the United Kingdom, the Netherlands, and about a dozen other countries are stockpiling millions of doses. Finland expects to offer them to people who work on fur farms this month as a precaution because its mink and fox farms were hit by the bird flu last year.

In contrast, mRNA vaccines being developed against the bird flu would be a first for influenza. On July 2, the U.S. government announced that it would pay Moderna $176 million for their development, and that the vaccines may enter clinical trials next year. Used widely against covid-19, this newer technology uses mRNA to teach the immune system how to recognize particular viruses.

In the meantime, Florian Krammer, a flu virologist at Mount Sinai’s Icahn School of Medicine, said people who work on dairy farms should have the option to get the egg-based vaccine. It elicits an immune response against a primary component of the H5N1 bird flu virus that should confer a degree of protection against infection and serious sickness, he said.

Still, its protection wouldn’t be 100%. And no one knows how many cases and hospitalizations it would prevent since it hasn’t been used to combat this year’s virus. Such data should be collected in studies that track the outcomes of people who opt to get one, he said.

Krammer isn’t assuaged by the lack of severe bird flu cases spotted in clinics. “If you see a signal in hospitals, the cat is out of the bag. Game over, we have a pandemic,” he said. “That’s what we want to avoid.”

He and others stressed that the United States should be doing everything it can to curb infections before flu season starts in October. The vaccine could provide an additional layer of protection on top of testing, wearing gloves, and goggles, and disinfecting milking equipment. Scientists worry that if people get the bird flu and the seasonal flu simultaneously, bird flu viruses could snag adaptations from seasonal viruses that allow them to spread swiftly among humans.

They also note it could take months to distribute the vaccines after they’re recommended since it requires outreach. People who work beside dairy cows still lack information on the virus, four months into this outbreak, said Bethany Boggess Alcauter, director of research at the National Center for Farmworker Health.

Health officials have talked with dairy farm owners, but Boggess’ interviews with farmworkers suggest those conversations haven’t trickled down to their staff. One farmworker in the Texas Panhandle told her he was directed to disinfect his hands and boots to protect cows from diseases that workers may carry. “They never told us if the cow could infect us with some illness,” the farmworker said in Spanish.

The slow pace of educational outreach is a reminder that everything takes time, including vaccine decisions. When deciding whether to recommend vaccines, the CDC typically seeks guidance from its Advisory Committee on Immunization Practices, or the ACIP. A consultant to the group, infectious disease researcher William Schaffner, has repeatedly asked the agency to present its thinking on Seqirus’ bird flu vaccine.

Rather than fret about the 1976 swine flu situation, Schaffner suggested the CDC consider the 2009-10 swine flu pandemic. It caused more than 274,000 hospitalizations and 12,000 deaths in the U.S. within a year. By the time vaccines were rolled out, he said, much of the damage had been done.

“The time to discuss this with ACIP is now,” said Schaffner, before the bird flu becomes a public health emergency. “We don’t want to discuss this until the cows come home in the middle of a crisis.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Finlandia ofrece vacunas contra la gripe aviar a sus trabajadores agrícolas. Estados Unidos debería hacer lo mismo, dicen expertos https://kffhealthnews.org/news/article/finlandia-ofrece-vacunas-contra-la-gripe-aviar-a-sus-trabajadores-agricolas-estados-unidos-deberia-hacer-lo-mismo-dicen-expertos/ Thu, 11 Jul 2024 08:55:00 +0000 https://kffhealthnews.org/?post_type=article&p=1879543 A medida que la gripe aviar se propaga entre las vacas lecheras en Estados Unidos, veterinarios e investigadores han tomado nota de la decisión de Finlandia de vacunar a los trabajadores agrícolas que corren el riesgo de infectarse. Y se preguntan por qué su gobierno no se hace lo mismo.

“Los trabajadores agrícolas, veterinarios y productores están manejando grandes volúmenes de leche que pueden contener altos niveles del virus de la gripe aviar”, dijo Kay Russo, veterinaria de ganado y aves de corral en Fort Collins, Colorado. “Si una vacuna parece proporcionar algo de inmunidad, creo que también habría que ofrecérsela a ellos”.

La mayoría de una docena de expertos en virología y brotes epidémicos entrevistados por KFF Health News, está de acuerdo con Russo.

Dijeron que a las personas que trabajan en tambos se les debería ofrecer la vacuna contra una enfermedad que ha matado a aproximadamente la mitad de las personas que se sabe que la han contraído en todo el mundo durante las últimas dos décadas, que ha matado a gatos en Estados Unidos este año, y que tiene potencial pandémico.

Sin embargo, otros investigadores están de acuerdo con la posición de los Centros para el Control y Prevención de Enfermedades (CDC), que recomiendan no vacunar por ahora. Consideran que no hay evidencia de que el virus de la gripe aviar de este año se propague entre personas, o cause enfermedad grave en humanos. Y que tampoco está lo suficientemente claro qué tan eficaz es la vacuna disponible a la hora de prevenir cualquiera de estos escenarios.

Sin embargo, para Jennifer Nuzzo, directora del Centro Pandémico de la Universidad Brown, la táctica de esperar y ver “es una apuesta”. “Para cuando tengamos consecuencias graves, muchas personas ya se habrán contagiado”, aseguró.

“Ahora es el momento de ofrecer las vacunas a los trabajadores agrícolas en Estados Unidos”, dijo Nahid Bhadelia, directora del Centro de Enfermedades Infecciosas Emergentes de la Universidad de Boston. Agregó que en el país hasta las medidas más apremiantes están retrasadas.  Bhadelia considera que es urgente realizar análisis tanto a los trabajadores agrícolas como a las vacas para detectar la presencia del virus de la gripe aviar H5N1, estudiarlo y erradicarlo antes de que se establezca en las granjas, lo que representaría una amenaza pandémica constante.

Demetre Daskalakis, director del Centro Nacional de Inmunización y Enfermedades Respiratorias de los CDC, explicó que la agencia se toma muy en serio a la gripe aviar y que se están almacenando 4.8 millones de dosis de la vacuna. Pero admitió que “no hay ninguna recomendación para lanzar una campaña de vacunación”.

“Se trata de la relación riesgo-beneficio”, comentó Daskalakis. Los beneficios todavía son inciertos porque no contamos con suficientes testeos como para entender con qué facilidad el virus pasa de las vacas a las personas, y tampoco sabemos cuán grave puede ser la enfermedad.

Este año, en Estados Unidos, solo cuatro personas han dado positivo y fueron casos leves. Es un número muy limitado, que no permite sacar conclusiones definitivas.

También informaron que han estado enfermos otros trabajadores agrícolas y veterinarios que trabajan en granjas lecheras donde se han detectados casos de gripe aviar. Sin embargo, no se les hicieron los análisis correspondientes. Desde que se detectó el brote en marzo, los hospitales públicos han examinado solo a unas 50 personas que podrían haberse contagiado.

De todos modos, Daskalakis aseguró que los CDC no están preocupados por la posibilidad de que la agencia esté pasando por alto infecciones significativas de gripe aviar debido a su sistema de vigilancia de la influenza. Los hospitales reportan pacientes con casos graves de gripe y este año los números se mantienen normales.

Otro indicio que tranquiliza a la agencia es que el virus aún no ha desarrollado mutaciones que le permitan propagarse rápidamente cuando la gente estornuda o respira. “Si comenzáramos a ver cambios en el virus, ese sería un factor que incidiría en la decisión de pasar de una fase de planificación a una fase operativa”, explicó Daskalakis.

Para evaluar si administrar o no las vacunas, la agencia se basó en el brote de gripe porcina de 1976. En aquel momento, los funcionarios temían que se pudiera repetir la pandemia de gripe porcina de 1918, que mató aproximadamente a medio millón de personas en Estados Unidos. Por lo tanto, en un año vacunaron rápidamente a casi 43 millones de personas.

Pero ese año los casos de gripe porcina resultaron ser leves. Esto hizo que la campaña de vacunación se considerara innecesariamente riesgosa ya que surgieron varios informes de un trastorno potencialmente mortal, el síndrome de Guillain-Barré.

Hay que tener en cuenta que, según los CDC, aproximadamente una persona de cada millón que son vacunadas contra la influenza puede desarrollar ese síndrome. En el balance, el beneficio de la prevención supera al riesgo. Desde el 1 de octubre por lo menos 830,000 personas han sido hospitalizadas por la gripe estacional y entre 25,000 y 75,000 han muerto.

Un informe elaborado tiempo después respecto de las acciones frente a la gripe porcina de 1976 habló de una “experiencia aleccionadora y con moraleja” sobre qué pasa si se responde prematuramente a una amenaza incierta para la salud pública.

“Es una historia sobre lo que sucede cuando lanzas un programa de vacunación en el que se está aceptando correr riesgos sin que haya un beneficio demostrado”, señaló Daskalakis.

Paul Offit, virólogo del Hospital Infantil de Philadelphia, se alinea con la decisión que tomaron los CDC. “Esperaría a tener más datos”, dijo.

Sin embargo, otros investigadores dicen que el escenario de 1976 fue distinto. Nadie está sugiriendo vacunar a decenas de millones de personas: se está hablando de una vacuna totalmente voluntaria para los miles de trabajadores que están en contacto cotidiano con el ganado, lo que reduce la posibilidad de efectos adversos raros.

La vacuna contra la gripe aviar que está disponible, fabricada por la empresa de vacunas contra la gripe CSL Seqirus, fue autorizada el año pasado por el equivalente europeo de la Administración de Drogas y Alimentos (FDA). Una versión previa tiene la aprobación de la FDA, pero la más reciente aún no recibió la luz verde.

Aunque la vacuna está dirigida a una cepa diferente de gripe aviar que la H5N1, que es la que circula actualmente entre las vacas, los estudios muestran que desencadena una respuesta inmune contra ambas variantes. Se considera segura porque utiliza la misma tecnología en base a huevo que se despliega cada año en las vacunas contra la gripe estacional.

Por estas razones, Estados Unidos, el Reino Unido, Holanda y otra docena de países están almacenando millones de dosis. Finlandia espera ofrecérselas este mes también a quienes trabajan en granjas peleteras, como precaución porque sus granjas de visones y zorros fueron golpeadas por la gripe aviar el año pasado.

En contraste, las vacunas de ARNm que se están desarrollando contra la gripe aviar serían las primeras de su tipo también para la influenza. El 2 de julio, el gobierno de Estados Unidos anunció que pagaría a la farmacéutica Moderna $176 millones por su desarrollo y que las vacunas podrían entrar en la etapa de ensayos clínicos el próximo año.

Utilizadas ampliamente contra covid-19, esta nueva tecnología emplea ARNm para enseñar al sistema inmune cómo reconocer virus particulares.

Mientras tanto, Florian Krammer, virólogo especializado en gripe en la Escuela de Medicina Icahn de Mount Sinai, señaló que las personas que trabajan en tambos deberían tener la opción de recibir la vacuna basada en huevo. Esta vacuna desencadena una respuesta inmunitaria contra un componente principal del virus H5N1 de la gripe aviar, lo que debería brindar un grado de protección contra la infección y la enfermedad grave, explicó.

Aun así, la protección no sería del 100%. Y nadie sabe cuántos contagios y hospitalizaciones podría prevenir esta vacuna, ya que no se ha utilizado para combatir el virus de este año. Esos datos deben recopilarse en estudios que rastreen qué resultado tuvo en las personas que opten por ser vacunadas, agregó.

A Krammer no lo tranquiliza que no se hayan detectado casos graves de gripe aviar en las clínicas. “Porque cuando los indicios llegan a los hospitales, significa que la situación ya se encuentra fuera de control, que estamos frente a una pandemia”, dijo. “Y eso es lo que queremos evitar”.

El virólogo y otros especialistas enfatizaron que Estados Unidos debería estar haciendo todo lo posible para frenar las infecciones antes de octubre, cuando comienza la temporada de gripe. La vacuna podría proporcionar una capa adicional de protección, que se sumaría a las evaluaciones, el uso de guantes y gafas, y la desinfección del equipo de ordeñe.

Algunos científicos temen que, si las personas contraen la gripe aviar y la gripe estacional simultáneamente, los virus de la gripe aviar podrían generar adaptaciones de los virus estacionales que les permitieran propagarse rápidamente entre humanos.

También dicen que podría llevar meses distribuir las vacunas después que se recomiende oficialmente, ya que ese tipo de campaña requiere grandes esfuerzos de divulgación.

Bethany Boggess Alcauter, directora de investigación del National Center for Farmworker Health, comentó que las personas que trabajan con vacas lecheras aún carecen de información sobre el virus, cuatro meses después del inicio de este brote.

Los funcionarios de salud han hablado con los propietarios de tambos, pero las entrevistas de Boggess con los trabajadores agrícolas permiten pensar que esas conversaciones no han llegado a su personal.

Un trabajador agrícola en el Panhandle de Texas le contó a Boggess que en su trabajo le dijeron que se desinfectara las manos y las botas para proteger a las vacas de enfermedades que los trabajadores puedan transmitir. “Nunca nos dijeron que la vaca podría infectarnos con alguna enfermedad”, dijo el hombre en español.

El ritmo siempre lento en que se divulga la información es un recordatorio de que todo lleva tiempo, incluidas las decisiones sobre vacunación. Para resolver si recomendar las vacunas, los CDC normalmente buscan orientación de su Comité Asesor sobre Prácticas de Inmunización, o ACIP. Un consultor del grupo, el investigador de enfermedades infecciosas William Schaffner, ha pedido repetidamente a la agencia que presente su opinión sobre la vacuna contra la gripe aviar de Seqirus.

En lugar de preocuparse por la situación de la gripe porcina de 1976, Schaffner sugirió que los CDC consideren la pandemia de gripe porcina de 2009-10. Esta pandemia causó más de 274,000 hospitalizaciones y 12,000 muertes en Estados Unidos en un año. Para cuando comenzó la vacunación, dijo, gran parte del daño ya estaba hecho.

“El momento de discutir esto con ACIP es ahora”, sostuvo Schaffner. Es decir, antes de que la gripe aviar se convierta en una emergencia de salud pública. “No queremos que se comience a discutir cuando ya sea demasiado tarde”.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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‘We’re Flying Blind’: CDC Has 1M Bird Flu Tests Ready, but Experts See Repeat of Covid Missteps https://kffhealthnews.org/news/article/cdc-bird-flu-tests-covid-repeat-concerns/ Thu, 20 Jun 2024 09:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1869245 It’s been nearly three months since the U.S. government announced an outbreak of the bird flu virus on dairy farms. The World Health Organization considers the virus a public health concern because of its potential to cause a pandemic, yet the U.S. has tested only about 45 people across the country.

“We’re flying blind,” said Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health. With so few tests run, she said, it’s impossible to know how many farmworkers have been infected, or how serious the disease is. A lack of testing means the country might not notice if the virus begins to spread between people — the gateway to another pandemic.

“We’d like to be doing more testing. There’s no doubt about that,” said Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention. The CDC’s bird flu test is the only one the Food and Drug Administration has authorized for use right now. Shah said the agency has distributed these tests to about 100 public health labs in states. “We’ve got roughly a million available now,” he said, “and expect 1.2 million more in the next two months.”

But Nuzzo and other researchers are concerned because the CDC and public health labs aren’t generally where doctors order tests from. That job tends to be done by major clinical laboratories run by companies and universities, which lack authorization for bird flu testing.

As the outbreak grows — with at least 114 herds infected in 12 states as of June 18 — researchers said the CDC and FDA are not moving fast enough to remove barriers that block clinical labs from testing. In one case, the diagnostics company Neelyx Labs was on hold with a query for more than a month.

“Clinical labs are part of the nation’s public health system,” said Alex Greninger, assistant director of the University of Washington Medicine Clinical Virology Laboratory. “Pull us into the game. We’re stuck on the bench.”

The CDC recognized the need for clinical labs in a June 10 memo. It calls on industry to develop tests for the H5 strain of bird flu virus, the one circulating among dairy cattle. “The limited availability and accessibility of diagnostic tests for Influenza A(H5) poses several pain points,” the CDC wrote. The points include a shortage of tests if demand spikes.

Researchers, including former CDC director Tom Frieden and Anthony Fauci, who led the nation’s response to covid, cite testing failures as a key reason the U.S. fared so poorly with covid. Had covid tests been widely available in early 2020, they say, the U.S. could have detected many cases before they turned into outbreaks that prompted business shutdowns and cost lives.

In an article published this month, Nuzzo and a group of colleagues noted that the problem wasn’t testing capability but a failure to deploy that capability swiftly. The U.S. reported excess mortality eight times as high as other countries with advanced labs and other technological advantages.

A covid test vetted by the WHO was available by mid-January 2020. Rather than use it, the United States stuck to its own multistage process, which took several months. Namely, the CDC develops its own test then sends it to local public health labs. Eventually, the FDA authorizes tests from clinical diagnostic labs that serve hospital systems, which must then scale up their operations. That took time, and people died amid outbreaks at nursing homes and prisons, waiting on test results.

In contrast, South Korea immediately rolled out testing through private sector laboratories, allowing it to keep schools and businesses open. “They said, ‘Gear up, guys; we’re going to need a ton of tests,’” said Frieden, now president of the public health organization Resolve to Save Lives. “You need to get commercials in the game.”

Nuzzo and her colleagues describe a step-by-step strategy for rolling out testing in health emergencies, in response to mistakes made obvious by covid. But in this bird flu outbreak, the U.S. is weeks behind that playbook.

Ample testing is critical for two reasons. First, people need to know if they’re infected so that they can be quickly treated, Nuzzo said. Over the past two decades, roughly half of about 900 people around the globe known to have gotten the bird flu died from it.

Although the three farmworkers diagnosed with the disease this year in the United States had only mild symptoms, like a runny nose and inflamed eyes, others may not be so lucky. The flu treatment Tamiflu works only when given soon after symptoms start.

The CDC and local health departments have tried to boost bird flu testing among farmworkers, asking them to be tested if they feel sick. Farmworker advocates list several reasons why their outreach efforts are failing. The outreach might not be in the languages the farmworkers speak, for example, or address such concerns as a loss of employment.

If people who live and work around farms simply see a doctor when they or their children fall ill, those cases could be missed if the doctors send samples to their usual clinical laboratories. The CDC has asked doctors to send samples from people with flu symptoms who have exposure to livestock or poultry to public health labs. “If you work on a farm with an outbreak and you’re worried about your welfare, you can get tested,” Shah said. But sending samples to public health departments requires knowledge, time, and effort.

“I really worry about a testing scheme in which busy clinicians need to figure this out,” Nuzzo said.

The other reason to involve clinical laboratories is so the nation can ramp up testing if the bird flu is suddenly detected among people who didn’t catch it from cattle. There’s no evidence the virus has started to spread among people, but that could change in coming months as it evolves.

The fastest way to get clinical labs involved, Greninger said, is to allow them to use a test the FDA has already authorized: the CDC’s bird flu test. On April 16 the CDC opened up that possibility by offering royalty-free licenses for components of its bird flu tests to accredited labs.

Several commercial labs asked for licenses. “We want to get prepared before things get crazy,” said Shyam Saladi, chief executive officer of the diagnostics company Neelyx Labs, which offered covid and mpox tests during shortages in those outbreaks. His experience over the past two months reveals the types of barriers that prevent labs from moving swiftly.

In email exchanges with the CDC, shared with KFF Health News, Saladi specifies the labs’ desire for licenses relevant to the CDC’s test, as well as a “right to reference” the CDC’s data in its application for FDA authorization.

That “right to reference” makes it easier for one company to use a test developed by another. It allows the new group to skip certain analyses conducted by the original maker, by telling the FDA to look at data in the original FDA application. This was commonplace with covid tests at the peak of the pandemic.

At first, the CDC appeared eager to cooperate. “A right of reference to the data should be available,” Jonathan Motley, a patent specialist at the CDC, wrote in an email to Saladi on April 24. Over the next few weeks, the CDC sent him information about transferring its licenses to the company, and about the test, which prompted Neelyx’s researchers to buy testing components and try out the CDC’s process on their equipment.

But Saladi grew increasingly anxious about the ability to reference the CDC’s data in the company’s FDA application. “Do you have an update with respect to the right of reference?” he asked the CDC on May 13. “If there are any potential sticking points with respect to this, would you mind letting us know please?”

He asked several more times in the following weeks, as the number of herds infected with the bird flu ticked upward and more cases among farmworkers were announced. “Given that it is May 24 and the outbreak has only expanded, can CDC provide a date by which it plans to respond?” Saladi wrote.

The CDC eventually signed a licensing agreement with Neelyx but informed Saladi that it would not, in fact, provide the reference. Without that, Saladi said, he could not move forward with the CDC’s test — at least not without more material from the agency. “It’s really frustrating,” he said. “We thought they really intended to support the development of these tests in case they are needed.”

Shah, from the CDC, said test manufacturers should generate their own data to prove that they’re using the CDC’s test correctly. “We don’t have a shortage such that we need to cut corners,” he said. “Quality reigns supreme.”

The CDC has given seven companies, including Neelyx, licenses for its tests — although none have been cleared to use them by the FDA. Only one of those companies asked for the right of reference, Shah said. The labs may be assisted by additional material that the agency is developing now, to allow them to complete the analyses — even without the reference.

“This should have happened sooner,” Saladi told KFF Health News when he was told about the CDC’s pending additional material. “There’s been no communication about this.”

Greninger said the delays and confusion are reminiscent of the early months of covid, when federal agencies prioritized caution over speed. Test accuracy is important, he said, but excessive vetting can cause harm in a fast-moving outbreak like this one. “The CDC should be trying to open this up to labs with national reach and a good reputation,” he said. “I fall on the side of allowing labs to get ready — that’s a no-brainer.”

Clinical laboratories have also begun to develop their own tests from scratch. But researchers said they’re moving cautiously because of a recent FDA rule that gives the agency more oversight of lab-developed tests, lengthening the pathway to approval. In an email to KFF Health News, FDA press officer Janell Goodwin said the rule’s enforcement will occur gradually.

However, Susan Van Meter, president of the American Clinical Laboratory Association, a trade group whose members include the nation’s largest commercial diagnostic labs, said companies need more clarity: “It’s slowing things down because it’s adding to the confusion about what is allowable.”

Creating tests for the bird flu is already a risky bet, because demand is uncertain. It’s not clear whether this outbreak in cattle will trigger an epidemic or fizzle out. In addition to issues with the CDC and FDA, clinical laboratories are trying to figure out whether health insurers or the government will pay for bird flu tests.

These wrinkles will be smoothed eventually. Until then, the vanishingly slim numbers of people tested, along with the lack of testing in cattle, may draw criticism from other parts of the world.

“Think about our judgment of China’s transparency at the start of covid,” Nuzzo said. “The current situation undermines America’s standing in the world.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Las pruebas para la gripe aviar son difíciles de conseguir. ¿Cómo saber si estamos en una pandemia? https://kffhealthnews.org/news/article/las-pruebas-para-la-gripe-aviar-son-dificiles-de-conseguir-como-saber-si-estamos-en-una-pandemia/ Tue, 11 Jun 2024 09:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1872715 Últimamente, Abraar Karan, médico especialista en enfermedades infecciosas en la Universidad de Stanford, ha atendido a muchos pacientes con goteo nasal, fiebre e irritación en los ojos. Estos síntomas podrían ser señales de alergias, covid o un resfriado.

Y este año, existe una posibilidad más, la gripe aviar, pero la mayoría de los médicos no tienen forma de detectarla.

Médicos como Karan advierten que, si el gobierno no se prepara para que las pruebas para la gripe aviar H5N1 estén más disponibles, otra pandemia podría tomar al país por sorpresa de nuevo. 

“Estamos cometiendo los mismos errores que cometimos con el covid”, dijo Deborah Birx, quien fue coordinadora del equipo de respuesta al coronavirus bajo el ex presidente Donald Trump, en un programa de CNN el 4 de junio.

Para convertirse en una pandemia, el virus de la gripe aviar H5N1 tendría que propagarse entre las personas. La mejor manera de monitorear si eso está ocurriendo es realizando pruebas.

Muchos laboratorios de diagnóstico están capacitados para detectar el virus. Sin embargo, la burocracia, los problemas de facturación y la falta de inversión no permiten aumentar rápidamente la disponibilidad generalizada de pruebas.

Por el momento, la Administración de Alimentos y Medicamentos (FDA) ha autorizado únicamente la prueba de gripe aviar de los Centros para el Control y Prevención de Enfermedades (CDC), que se utiliza solo en personas que trabajan cerca de ganado.

Autoridades estatales y federales han detectado gripe aviar en vacas lecheras en 12 estados. Tres personas que trabajan en distintas granjas lecheras dieron positivo, presuntamente contagiadas de vacas infectadas con el virus. Sin embargo, los investigadores coinciden en que hay un subregistro de casos, dado que los CDC sólo han realizado pruebas de detección a unas 40 personas.

“Es importante saber si el virus está contenido en las granjas, pero no tenemos información porque no la estamos buscando”, dijo Helen Chu, especialista en enfermedades infecciosas de la Universidad de Washington en Seattle, quien alertó al país sobre la propagación del covid en 2020 realizando pruebas de manera más amplia.

Informes de trabajadores agrícolas enfermos a los que no se les hizo pruebas y de una partera que tenía síntomas de gripe en las áreas de Texas donde hubo brotes de H5N1 en el ganado sugieren que las cifras son más altas. Además, los síntomas de quienes dieron positivo (tos e inflamación en los ojos, sin fiebre) fueron leves, lo cual indica que las personas infectadas podrían no buscar atención médica y, por lo tanto, no hacerse la prueba.

Los CDC han pedido a los trabajadores agrícolas con síntomas de gripe que se hagan la prueba, pero a los investigadores les preocupa la falta de acceso y de incentivos para estimular a la gente a hacerse el test, sobre todo en personas con baja seguridad laboral y acceso limitado a la atención médica.

Además, al realizar las pruebas sólo en granjas lecheras, los CDC probablemente pasarían por alto las señales de un brote más amplio.

“Es difícil no comparar esto con covid, cuando al principio solo hacíamos pruebas a las personas que habían viajado”, dijo Benjamin Pinsky, director médico del laboratorio de virología clínica de la Universidad de Stanford. “Eso hizo que no reconociéramos de inmediato que el virus se estaba transmitiendo en la comunidad”.

En los primeros meses de covid, la distribución de pruebas en Estados Unidos fue catastróficamente lento. Aunque la Organización Mundial de la Salud había aprobado una prueba y otros grupos habían desarrollado sus propias versiones utilizando técnicas básicas de biología molecular, al principio los CDC insistieron en desarrollar y utilizar su propia prueba.

La primera versión que enviaron a los laboratorios estatales no funcionó, agravando las demoras.

La FDA también se retrasó. La agencia no autorizó pruebas de laboratorios de diagnóstico por fuera de la de los CDC hasta fines de febrero de 2020.

El 27 de febrero de 2020, el laboratorio de investigación de Chu detectó covid en un adolescente que no cumplía con los estrictos criterios de prueba de los CDC. Este caso fue la voz de alarma de que covid se había extendido de manera desapercibida. Ampliar los suministros para satisfacer la demanda llevó tiempo, y pasaron meses antes de que cualquier persona que necesitara una prueba de covid pudiera hacérsela.

Chu señala que no es 2020, ni mucho menos. Los hospitales no están llenos de pacientes con gripe aviar. Además, el país tiene las herramientas para actuar mucho mejor esta vez, dijo, si hay voluntad política.

Para empezar, las pruebas que detectan la amplia categoría de influenza a la que pertenece el H5N1, llamada influenza A, están aprobadas por la FDA y están disponibles. Se realizan de forma habitual durante la “temporada de gripe”, de noviembre a febrero. Si los investigadores detectan un número inusual de resultados positivos en las pruebas de gripe comunes durante la primavera y el verano, podría ser una mala señal.

Sin embargo, es poco probable que los médicos pidan pruebas de influenza A para pacientes con síntomas respiratorios fuera de la temporada de gripe, en parte porque algunas aseguradoras no las cubren excepto en circunstancias limitadas, dijo Alex Greninger, subdirector del laboratorio de virología clínica de la Universidad de Washington.

Este problema tiene solución, aclaró. En el pico de la pandemia de covid, el gobierno obligó a las compañías de seguros a cubrir las pruebas, y fijó un precio atractivo para que valiera la pena para los fabricantes. “En Manhattan, te encontrabas con un centro de testeo cada dos cuadras, porque las empresas recibían $100 cada vez que insertaban un hisopo en una nariz”, dijo Greninger.

Otro obstáculo es que la FDA aún no ha permitido que las empresas realicen pruebas de influenza A con muestras oculares, aunque los CDC y los laboratorios de salud pública sí pueden. En el caso de un trabajador agrícola infectado este año, el virus de la gripe aviar se detectó sólo en un hisopado ocular y no en muestras extraídas de la nariz o la garganta.

Superar estas barreras es esencial para aumentar el testeo de influenza A en áreas ganaderas, dijo Chu. “La estrategia más eficaz sería ofrecer estas pruebas de forma rutinaria en los consultorios que atienden a las comunidades de trabajadores agrícolas”, dijo, y sugirió que también estén disponibles en las ferias estatales.

Mientras tanto, se podrían actualizar las nuevas pruebas que detectan el virus H5N1. La prueba actual de los CDC no es muy sensible ni fácil de usar, dijeron investigadores.

Stanford, la Universidad de Washington, la Clínica Mayo y otros laboratorios de diagnóstico que prestan servicios en los sistemas hospitalarios han desarrollado alternativas para detectar el virus que está circulando. Sin embargo, su alcance es limitado, y los investigadores destacan la necesidad de poner en marcha esfuerzos para ampliar la capacidad de testeo antes de que se produzca una crisis.

“Si esto se convierte en una emergencia de salud pública, ¿cómo asegurarnos de no quedar estancados como en los primeros días de covid, cuando no podíamos avanzar rápidamente?”, dijo Pinski.

Una norma reciente que otorga a la FDA más control sobre las pruebas desarrolladas en laboratorio puede demorar la autorización. Un representante de la FDA le dijo a KFF Health News que, por ahora, la agencia tal vez permitirá que se realicen pruebas sin un proceso de aprobación completo.

Los CDC no respondieron a las solicitudes de comentarios.

Pero la Asociación Estadounidense de Laboratorios Clínicos ha exigido a la FDA y a los CDC más claridad sobre la nueva regla. “Está retrasando el proceso porque aumenta la confusión sobre lo que está permitido”, dijo Susan Van Meter, presidenta del grupo comercial de laboratorios de diagnóstico.

Labcorp, Quest Diagnostics y otras grandes empresas de pruebas son las más capacitadas para gestionar el aumento en la demanda de pruebas, ya que pueden procesar cientos al día, en lugar de docenas. Pero esto implicaría adaptar los procesos de testeo para sus equipos especializados, algo que requiere tiempo y dinero, dijo Matthew Binnicker, director de virología clínica de la Clínica Mayo.

“En los últimos años sólo ha habido unos pocos casos de H5N1 en humanos”, dijo, “por lo tanto, les resulta difícil invertir millones cuando no sabemos qué va a pasar”.

El gobierno podría proporcionar fondos para financiar la investigación o comprometerse a adquirir pruebas al por mayor, tal como en el proyecto Operación Warp Speed, que avanzó el desarrollo de la vacuna contra covid.

“Si tenemos que ampliar el testeo, necesitaríamos una inversión de dinero”, dijo Kelly Wroblewski, directora de programas de enfermedades infecciosas de la Asociación de Laboratorios de Salud Pública. Al igual que una póliza de seguro, el gasto inicial sería mínimo comparado con el golpe económico de otra pandemia.

También son fundamentales otros medios para rastrear el virus H5N1. La detección de anticuerpos contra la gripe aviar en trabajadores agrícolas ayudaría a revelar si más personas se han infectado, y si se han recuperado. Analizar las aguas residuales para detectar el virus podría indicar un aumento de las infecciones en personas, aves o ganado.

Como ocurre con todos los esfuerzos de preparación para una pandemia, la dificultad radica en enfatizar la importancia de actuar antes de que ocurra una crisis, dijo Greninger.

“Definitivamente debemos estar preparados”, dijo, “pero hasta que el gobierno no se haga cargo de parte del riesgo, es difícil dar un paso en esa dirección”.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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