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Wildfire Smoke Is Here to Stay. Here’s How to Clean the Air Inside Your Home.

Kaiser Health News - 7 hours 48 min ago

The fierce wildfires that broke out across much of the western United States this summer, spreading smoke across hundreds of miles, continue to pose a serious health hazard to millions.

More are expected this fall. That’s a major health concern because microscopic particles in wildfire smoke, carried by the wind, can penetrate deep into your lungs and travel into your bloodstream. One study linked wildfire smoke exposure to a twofold increase in the rate of asthma and a 40% rise in strokes and heart attacks. Other research tied smoke to hospital admissions, ER visits and premature deaths.

The standard advice is to stay inside when heavy smoke is in the air. But the smoke can get into your house or apartment. So you might want to consider investing in equipment to clean the air inside your home, especially with climate change likely to continue escalating the scope and intensity of the fires.

“I think we have fires enough now that people should think of this as something they want to buy,” says Deborah Bennett, a professor of public health at the University of California-Davis. “Even if they only turn it on during the fires, there’s going to be plenty of times when they’re going to have it turned on.”

There are many options for cleaning the air in your home, depending on your circumstances and — of course — your budget.

If you have an HVAC system, it likely recirculates air that’s inside the house rather than drawing in air from outside. But if you have an air conditioner with a “fresh air” system that brings in outside air, you should turn off the fresh air setting on heavy smoke days. If you don’t know how, seek professional advice.

And be sure to close all doors and windows; otherwise, your efforts will be in vain.

You can convert your HVAC unit or furnace into a better air-cleaning system by installing a higher-efficiency filter capable of catching a large proportion — though it won’t get 100% — of the tiny smoke particles.

To cope with wildfire smoke, many public health and air quality experts recommend what’s known as a MERV 13 filter. MERV, or “minimum efficiency reporting value,” is a scale from 1 to 20 that rates a filter’s ability to capture particles. MERV 1 is the lowest rating, indicating the least impact on air quality, while filters rated MERV 17 or higher are used in hospital operating rooms and clean rooms.

You can buy MERV 13 filters at large stores such as Costco, the Home Depot and Lowe’s or online from multiple vendors. A MERV 13 should cost around $20, or substantially less if you buy packages of them.

Before you install a new filter, check first with an HVAC professional to make sure your system can accommodate it. The more efficient the filter, the more it reduces airflow, diminishing the cooling capacity of an air conditioner and requiring more energy to run the heater.

If you don’t have central air, or you have it and want to augment your system’s ability to clear the air, consider buying a portable air cleaner with a high-efficiency particulate air, or HEPA, filter, which can remove almost all particles of the tiny size found in smoke.

You can put it in the room you use most during the day, then move it to your bedroom at night. If the smoke gets really bad, put it in the room of your choice and stay there as much as possible.

“If you have an appropriately sized air cleaner with a true HEPA filter and you put it in a room and close the doors and windows, you have clean air really fast,” says Sarah Coefield, an air quality specialist with the Missoula City-County Health Department in Montana, which has had its share of wildfire smoke in recent years.

If you have kids, or share the home with other people, you should ideally have one air cleaner for each bedroom. Alternatively, you may need to put everyone in one room at night during a smoke emergency.

Portable HEPA air cleaners cost anywhere from under $100 to over $1,000, depending in part on the number of square feet they can clean effectively. To clean a room, you can get a perfectly good one for under $200.

All air cleaning devices sold in California must be certified by the California Air Resources Board, which posts a list of air cleaners it has certified. You might also want to look at Consumer Reports’ list of best and worst air cleaners and at a review of those selected by The New York Times’ product review website, Wirecutter.

Public health experts warn that you should avoid devices that are sold as air cleaners but actually emit ozone, the main component of smog. The air resources board also publishes a list of ozone-emitting devices.

Gina Spadafori, a resident of West Sacramento, has both a central HVAC system with an extra-thick filter and a portable HEPA air cleaner she keeps in her bedroom. Spadafori, 63, has serious asthma and has long been concerned about the air quality in her house.

In recent years, she has endured numerous days of hazardous wildfire smoke and that has changed the way she uses her HVAC. “I probably use the fan-only setting more than I have in the past to just filter the air rather than heating or cooling it,” she says.

On bad air days, she turns the portable air cleaner on an hour before she goes to bed and closes the door so it will “super-clean that air” and she’ll get a good night’s sleep. “It’s just sort of a second line of defense,” she says.

There is a lower-cost option: Make your own air purifier by attaching a high-efficiency filter to an electric box fan. You can get a suitable fan for around $30 and the filters for around $20 — or cheaper in bulk.

The website publishes a how-to guide for building such a contraption. The Environmental Protection Agency has an FAQ on box fan air cleaners with instructions for building them.

The EPA recommends using only box fans built in 2012 or later, because earlier models could overheat and cause a fire.

Lab testing has clearly shown such do-it-yourself devices are safe, though they may heat up the room and produce more noise than a portable HEPA cleaner, according to the EPA.

For those who can’t even afford to make an air cleaner from a house fan, nonprofits and local government agencies have provided help. People who don’t have a lot of money are likely to live in older, leakier housing that lets more smoke in. They are also more likely to have chronic illness and thus be in greater need of clean air — yet less able to afford it.

Climate Smart Missoula, a Montana nonprofit, has distributed around 500 air cleaners to low-income and homebound people in recent years, said Amy Cilimburg, its executive director.

In California, the Bay Area Air Quality Management District is providing 3,000 air filtration devices to low-income people with respiratory conditions in nine counties. The American Lung Association has also donated air cleaners to people in need.

But these efforts are tiny compared with the gaping need, said Cilimburg, who thinks the federal and state governments, hospitals and insurers should step in. She envisions a day when medical staffers at a clinic will tell a patient, “‘Oh, look, given x, y or z, you should just take one of these HEPA filters home with you.’”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

An Ad’s Charge That Price Haggling Would ‘Swipe $500 Billion From Medicare’ Is Incorrect

Kaiser Health News - 7 hours 48 min ago

“These guys [insurance companies and Washington bureaucrats] are working together to swipe $500 billion from Medicare to pay for Pelosi and Schumer’s out-of-control spending spree.”

Video advertisement from the 60 Plus American Association of Senior Citizens

The advertisement opens with a doctor sitting across from his patient and holding a prescription drug pill bottle. “You want to continue with this medication?” the doctor asks while an older patient nods.

The doctor then explains that he can no longer provide the medicine to her because insurance companies and Washington bureaucrats “are working together to swipe $500 billion from Medicare to pay for [House Speaker Nancy] Pelosi and [Senate Majority Leader Chuck] Schumer’s out-of-control spending spree.”

“They’re calling it Medicare negotiation, but, really, it’s just a way to cut your benefits and no longer pay for lifesaving medicines,” the doctor says.

Medicare negotiation refers to the federal government bargaining directly with pharmaceutical companies on the price of prescription drugs. Currently, Medicare is prohibited from using its vast market-share muscle to set prices. But supporters of Medicare drug negotiations eye the Democratic-backed budget reconciliation bill now being discussed in Congress as a means to reverse the policy.

This ad, seen on television and online, is part of a multiplatform campaign by the 60 Plus American Association of Senior Citizens, a conservative group that lobbies on senior issues and brands itself as the “right alternative to AARP.” It’s one example of a swath of ads that have popped up in the past month about Medicare drug price negotiations.

Since drug pricing is a hot topic and a critical piece of the broad, politically charged debate in Congress, we thought it was important to dig into the ad’s messages.

The $500 Billion Number

First, the ad claims that Medicare drug price negotiation will take “$500 billion from Medicare.”

All five of the Medicare and drug pricing experts we consulted said that was a misleading way to frame this policy.

The reference to $500 billion most likely comes from a Congressional Budget Office estimate of a provision in H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. It’s an estimate of how much the government would save over 10 years if drug price negotiations were enacted.

That is, the government would be paying pharmaceutical companies $500 billion less for prescription drugs.

And, in that bill, $300 billion to $400 billion of the savings were to be used to expand benefits to include dental, hearing and vision coverage, said Juliette Cubanski, deputy director of the program on Medicare policy at KFF. Right now, Medicare doesn’t provide that coverage to seniors.

If this policy were to make it into the pending budget reconciliation, some of the savings would also likely address other Democratic health care priorities, such as permanently closing the Medicaid coverage gap and improving Affordable Care Act coverage and subsidies.

So the ad’s charged language — that Pelosi and Schumer are planning to “swipe” this money from Medicare — is incorrect. That $500 billion in savings would be slated for reinvestment in the program. And some experts said the changes to drug pricing could also translate into lower premiums and out-of-pocket costs for seniors.

The point of negotiations is “to spend less on the drugs we’re already buying and put the money back into the health system,” said Rachel Sachs, a law professor and expert on drug policy at Washington University in St. Louis.

But what about the ad’s other main point — that Medicare negotiation will result in seniors no longer being able to get their medications?

Since 60 Plus did not return requests for comment, it’s hard to know exactly what it is asserting will come between seniors and their medication.

It’s possible the ad is implying that drugmakers may walk away from the negotiating table if they don’t like the prices the government promotes. But experts said it’s likely a financial penalty would be in place to motivate the companies to work with the government. H.R. 3 proposed an escalating excise tax.

The U.S. has the world’s largest prescription market, so it seems unlikely companies would stop selling drugs here completely, said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University.

And the number of drugs subject to negotiation would probably be a small subset of all drugs on the market, based on the negotiation method that was proposed in H.R. 3.

In real life, the scenario shown in the ad is unlikely to happen, said Joseph Antos, senior fellow in health care policy at the American Enterprise Institute.

“The question of whether a drug would be taken off the market — it’s always a little hard to say and, clearly, that is a possibility,” said Antos. “But it’s much more plausible to say this is the kind of policy that would lead to some new drugs not coming out to the market.”

That’s an argument often wielded by the pharmaceutical industry.

Evidence suggests there’s a grain of truth in the assessment that lower industry profits results in less research and development, said Paul Van de Water, a senior fellow in health care policy at the Center on Budget and Policy Priorities. But only a grain. For the most part, the drug industry overstates the effect of lost profits.

“A lot of these drugs are what’s known as ‘me-too’ medicines, which means the drugmakers are making small innovations on existing drugs,” said Van de Water. “The loss to Medicare beneficiaries of those types of drugs would be relatively small.”

In a separate analysis, the CBO examined to what extent negotiated drug prices could squeeze the pharmaceutical industry’s R&D capacity. The agency, using a 30-year window, estimated that 59 drugs wouldn’t come to market. That’s against a baseline of about 900 drugs being released per year, said Sachs, which means it would stymie only a tiny fraction of otherwise expected drugs.

Still, some experts say the CBO report can’t precisely predict the future and a loss in profits would have a larger effect on smaller, start-up pharmaceutical companies.

“At the small operations, a scientist thinks they have an insight into some biological process and they attract venture capitalists to develop a drug,” said Antos. “But drug development is a complicated business, and the drug might not make it to market. With less funds for that type of research, that is the part of the drug business most directly affected by the drug pricing policy.”

Why It Matters

The political stakes surrounding the Medicare drug price negotiations are high.

Currently, the idea is seen as a way to help pay for the Democratic-backed health initiatives being discussed as part of the reconciliation bill.

And, a recent poll from KFF shows that almost 90% of the public supports the government’s ability to negotiate for lower drug prices.

But allowing Medicare to bargain on drugs is controversial, even among Democrats, some of whom say they don’t want to stifle drug companies’ innovation, especially if it’s a big industry in the area of the country they represent.

Meanwhile, PhRMA, the powerful pharmaceutical industry trade group, announced Sept. 15 it would be launching a seven-figure ad campaign against the drug pricing proposals, according to The Hill.

Our Rating

The 60 Plus Association ran an advertisement that claimed Medicare drug price negotiations were “swiping” $500 billion from Medicare and going to be used as a way to “cut benefits and no longer pay for lifesaving medicines.”

While the $500 billion number is based on facts, everything else this ad says is misleading.

If Congress approves a plan to let Medicare negotiate drug prices, Democrats are calling for most of the savings to be funneled directly back into the Medicare program to provide vision, dental and hearing benefits. So, it’s not true that the plan for the money is to steal from Medicare. Experts also agreed it is specious to say seniors could no longer get the medications they’re currently taking.

We rate this claim False.


60 Plus American Association of Senior Citizens, “Our Mission,” accessed Sept. 22, 2021

60 Plus American Association of Senior Citizens, “Protecting Medicare,” accessed Sept. 22, 2021

Center on Budget and Policy Priorities, Build Back Better Legislation Would Close the Medicaid Coverage Gap, Sept. 13, 2021

Congressional Budget Office, CBO’s Simulation Model of New Drug Development, August 2021

Congressional Budget Office, H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act Cost Estimate, Dec. 10, 2019, H.R.3 — Elijah E. Cummings Lower Drug Costs Now Act — 116th Congress (2019-2020), accessed Sept. 22, 2021

Email interview with Stacie Dusetzina, associate professor of health policy at Vanderbilt University, Sept. 21, 2021

Fierce Pharma, “Advocates Roll Pricey Ad Campaigns as Biden, Congress Push for Medicare Drug Negotiations,” Aug. 17, 2021

The Hill, “PhRMA Launches 7-Figure Ad Campaign Against Democrats’ Drug Pricing Measures,” Sept. 15, 2021

KFF, What’s the Latest on Medicare Drug Price Negotiations?, July 23, 2021

KFF, Public Opinion on Prescription Drugs and Their Prices, June 15, 2021

KHN/PolitiFact, “Pharma’s Take on the Pelosi Drug-Pricing Bill: Fair Warning or Fearmongering?” Dec. 5, 2019

KHN/PolitiFact, “Biden Promise Tracker — Promise: Lower Cost of Prescription Drugs,” updated July 15, 2021

Open Secrets, “Pharmaceutical Industry Backs Democratic Holdouts on Drug Pricing Plan,” Sept. 17, 2021

Politico, “House Leadership Looks to Jam Holdouts on Drug Pricing,” Sept. 21, 2021

Phone interview with Juliette Cubanski, deputy director of the program on Medicare policy at KFF, Sept. 21, 2021

Phone interview with Joseph Antos, senior fellow and Wilson H. Taylor Scholar in health care and retirement policy at the American Enterprise Institute, Sept. 21, 2021

Phone interview with Paul N. Van de Water, senior fellow at the Center on Budget and Policy Priorities, Sept. 21, 2021

Phone interview with Rachel Sachs, Treiman professor of law at Washington University in St. Louis School of Law, Sept. 21, 2021

The Washington Post, “Three Democrats Say They’ll Oppose Party’s Drug-Price Plan, Creating Roadblock for Larger Package,” Sept. 14, 2021

YouTube, 60 Plus Association Official Account, “Doctor’s Visit,” Sept. 10, 2021

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

The ‘Burn Scars’ of Wildfires Threaten the West’s Drinking Water

Kaiser Health News - 7 hours 48 min ago

Colorado saw its worst fire season last year, with the three largest fires in state history and more than 600,000 acres burned. But some of the effects didn’t appear until this July, when heavy rain pushed sediment from damaged forests down mountainsides, causing mudslides that shut down sections of Interstate 70 for almost two weeks.

Immense quantities of sediment choked the rivers that supply most of the state’s water. In western Colorado’s Glenwood Springs, the water became so murky that the town twice had to shut off the valves that pump water from nearby rivers to avoid overwhelming its filtration system. City managers sent alerts to the town’s 10,000 residents, telling them to minimize water use until the sediment moved downstream.

Wildfires and their lasting effects are becoming a way of life in the West as climate change and management practices cause fires to increase in number, intensity and acreage burned, while extending the length of the fire season. In “burn scars,” where fires decimated forest systems that held soil in place, an increase in droughts followed by heavy rainfall poses a different kind of threat to the water supplies that are essential to the health of communities.

“You know about it; it’s in the back of your head,” said Glenwood Springs resident Paula Stepp. “But until you face it, you don’t know how it’s going to impact your town.”

Dirty, turbid water can contain viruses, parasites, bacteria and other contaminants that cause illness. But experts say turbid water from burn scars is unlikely to make it to people’s taps, because water utilities would catch it first.

Still, the cost to municipal utility systems — and the residents who pay for water — is immense. Rural small towns in particular face the choice between spending millions of dollars to try to filter turbid water or shutting off their intake and risking shortages in areas where water may already be scarce.

And as fires move closer to communities, burning synthetic materials from houses and other buildings can create toxic compounds that leach into water supplies, which is what happened in California after major fires in 2017 and 2018.

“When we put [fires] out, we become less aware of them,” said hydrologist Kevin Bladon, of Oregon State University. But from a water perspective, “that’s when all the problems start.”

Montana’s capital city, Helena, gets its drinking water supply from the Upper Tenmile Creek watershed in a forest thick with trees killed by beetle infestations. City leaders worry a fire would quickly chew through that dry fuel and leave the watershed exposed to sediment contamination. Despite a logging project that cleared many of those trees two years ago, the fire threat remains and city leaders worry the resulting sediment would overwhelm the water treatment plant and shut down the primary water source for 40,000 people.

“If we had a fire up there, depending on where it is and how big it is, it could put the Tenmile plant out for a season or two,” Helena Public Works Director Ryan Leland said.

To protect against that happening, the city is in the early phases of designing a basin that can trap sediment before the water reaches the plant, Leland. The city also recently announced plans to drill three groundwater test wells, which would give them another drinking water supply option if something happens to the Upper Tenmile watershed. Treated water from the Missouri River is the city’s current backup supply.

The Rocky Mountains and about 200 miles separate Glenwood Springs from Greeley, in northeastern Colorado. But the 2020 fire season caused similar problems in both cities, creating burn scars that later flooded, contaminating water sources.

So far this year, Greeley has had to shut off its intake from the Cache la Poudre River for 39 days because the water was contaminated with sediment, ash and organic matter. “Normally we would never turn it off,” said Greeley water and sewer director Sean Chambers.

To cope, the city has been trading water with a nearby agricultural company that owns reservoirs used for irrigation. The swap gives the turbid water to farmers and redirects the reservoir water to Greeley. “If we didn’t have the trade in place, the cost [of buying water] would be astronomical,” Chambers said.

But Chambers admitted this system is a luxury that smaller towns may not enjoy. Greeley is 10 times the size of Glenwood Springs and has spent more than $40 million this year recovering from the Cameron Peak Fire — the largest fire in Colorado history, which burned for four months in 2020. Those costs may climb as rain continues, he said. Larger towns also tend to have better filtration systems that can handle more sediment, which clogs up filters and requires utilities to add chemicals to remove contaminants before the water is safe to drink.

While dry states like Colorado expect fires each year, recent blazes in wetter places like western Oregon have caught researchers off guard. Last September, fires scorched about 11% of the state’s Cascade mountain range, leaving burn scars above rivers and reservoirs that supply much of the state’s water.

“We have to be very proactive,” said Pete Robichaud, a research engineer with the U.S. Forest Service in Moscow, Idaho

After a wildfire is extinguished, Robichaud’s agency and others send teams of specialists to evaluate the risks that erosion and ash pose to water supplies. Their data can help land managers decide whether to take actions like thinning forests above rivers, dredging contaminated reservoirs, covering the area with mulch or seeds to reduce erosion, or forming a plan for alternative water sources.

Even advance notice of a flood could help immensely, said Stepp, the Glenwood Springs resident. She is the executive director of the nonprofit Middle Colorado Watershed Council, which recently worked with the U.S. Geological Survey to install rain gauges along Glenwood Canyon. These monitor weather upstream and notify downstream water users that a sediment-laden flood could be coming.

She said it is crucial for small communities in particular to partner with state and federal agencies. “Basically, we work with everybody,” she said.

Although debris flows can bring soil bacteria into water supplies, city utilities can disinfect them with chemicals like chlorine, said Ben Livneh, a hydrologist at the University of Colorado-Boulder. But those disinfectants can themselves cause a problem: Organic matter from sediment can interact with these chemicals and create carcinogenic byproducts that are difficult and expensive to remove.

Another waterborne danger comes from chemical byproducts and heavy metals from burned structures. “Those would be potentially really problematic to treat,” Livneh said.

After the 2017 Tubbs and 2018 Camp fires that devastated the Northern California communities of Santa Rosa and Paradise, researchers examining the tap water of nearby homes found benzene and other carcinogens. Public health researcher Gina Solomon at the Public Health Institute in Oakland, California, said the contamination likely came from plastic pipes that melted and leached chemicals into the water.

Smoke and ash from burned structures may also add toxic chemicals to water supplies. “The smoke from the fires is a truly nasty brew,” Solomon said.

California has been relatively lucky when it comes to sediment flow. The years-long drought in most of the state means burn scars remain intact — though a heavy rain could wash down years of debris.

It’s unclear how long burn scars continue to pose a landslide risk, said Bladon, the Oregon hydrologist. But parts of Alberta in the Canadian Rockies, for instance, continued to see extremely turbid water for a decade after a 2003 fire.

“My fear is we may not have seen the worst of it yet,” Solomon said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Bomberos en la línea de batalla se resisten a los mandatos de vacunación contra covid

Kaiser Health News - Mon, 09/27/2021 - 3:00pm

El bombero de Kentucky Jimmy Adams vio de cerca los estragos de la pandemia de coronavirus cuando se desempeñó como paramédico ayudando a cuidar a los enfermos en emergencias, en medio del aumento de casos de covid. Conocía a bomberos retirados que murieron por complicaciones de la enfermedad.

Pero su razonamiento fue que eran mayores y probablemente tenían problemas de salud subyacentes, lo que los hacía susceptibles al virus.

“Así es como haces las paces con esas cosas”, dijo Adams, teniente de 51 años. Creía que las precauciones que estaba tomando su departamento lo mantenían a salvo. Pero se negó a recibir una vacuna contra covid. La razón no era estrictamente política, dijo. Se había cansado del debate sobre las máscaras, la mitigación, la cantidad de casos, y las vacunas.

A mediados de agosto, Adams y su esposa, Sara, que estaba totalmente vacunada, dieron positivo para covid. Ella experimentó síntomas leves; sin embargo, él fue hospitalizado con neumonía intersticial bilateral. Su potasio se disparó, causando arritmia cardíaca. Recibió oxígeno durante toda su internación.

“Me equivoqué”, dijo Adams días después de recibir el alta. “Sufrí mucho. Ni siquiera sé si voy a sufrir algún efecto a largo plazo. ¿Cambia esto quien soy por el resto de mi vida? No tengo la respuesta”.

Ahora, Adams planea vacunarse tan pronto como su médico lo abilite, después que se recupere. Aún así, él, como muchos otros bomberos en todo el país, no apoya los mandatos de vacunación contra covid.

El liderazgo de los bomberos y la base trabajadora están divididos sobre estos mandatos. La International Association of Fire Chiefs ha expresado su apoyo a las vacunas obligatorias. Por el contrario, la International Association of Fire Fighters ha dicho que alienta “fuertemente” a los bomberos a vacunarse, pero no cree que deba ser obligatorio.

Los bomberos, que a menudo son proveedores médicos de emergencia certificados, han estado en el frente de batalla de la pandemia desde el principio. Por eso, funcionarios presionaron para asegurarse que fueran de los primeros en recibir las vacunas.

¿Por qué, después de haber visto tanto, de haber salvado vidas, todavía se niegan a vacunarse y hasta luchan activamente contra los mandatos?

JT Sullivan, bombero en el condado de Wyandotte, Kansas, dijo que si bien tomó precauciones para no llevar a casa el coronavirus cuando su esposa estaba embarazada, creía que la pandemia fue en gran parte “orquestada” por los medios, incluso cuando vio sus efectos en su vida profesional.

Comprendía que algo estaba sucediendo; simplemente no creía que fuera tan malo como se informaba. Creía que afectaba principalmente a los adultos mayores y vulnerables. A sus 28 años, no tenía planes de vacunarse hasta que un paramédico de su departamento murió por complicaciones de covid el 1 de enero. Sullivan se vacunó poco después.

“Simplemente me tomó por sorpresa porque era más joven que mis padres”, dijo Sullivan, quien promueve las vacunas pero también está en desacuerdo con los mandatos.

Varios bomberos dijeron que los socorristas reacios a vacunarse reflejan la variedad de puntos de vista de muchos estadounidenses promedio: algunos ven tanto la pandemia como la vacuna a través de una lente política, algunos creen información errónea y conspiraciones, otros simplemente desconfían de las vacunas y a otros no les gusta que le digan lo que tienen que hacer.

Tanto Adams como Sullivan atribuyeron cierta resistencia a las vacunas a tener una personalidad “alfa” y albergar la creencia de que pueden ejercer control sobre lo que les sucede.

El jefe de bomberos de Houston, Samuel Peña, frustrado con la tasa de vacunación de su propio departamento, que calcula que es de alrededor del 50%, cree que hay algo de verdad en eso.

“A lo largo de la carrera de un socorrista, ya sea bombero, oficial de policía, médico de emergencias, construyes una mayor tolerancia al riesgo tolerable porque respondes a todo tipo de cosas que ponen tu vida en situaciones peligrosas y la mayoría de las veces sales ileso”, dijo. “El nivel de riesgo aceptable que estamos dispuestos a asumir se encuentra en un umbral diferente al de una persona normal y razonable”.

Peña dijo que los funcionarios de Houston han discutido la obligatoriedad de la vacunación a pesar de los esfuerzos del gobernador republicano de Texas, Greg Abbott, para evitar que las escuelas y ciudades instituyan normas de mitigación de covid. La tensa relación de la ciudad con el sindicato de bomberos local podría complicar las cosas. En otros lugares, estos mandatos han encontrado una feroz resistencia.

Un capitán del Departamento de Bomberos de la ciudad de Los Ángeles está bajo investigación después de publicar un video denunciando la “tiranía” de un inminente mandato de vacunación. Según reportó San Francisco Chronicle, el Departamento de Recursos Humanos de la ciudad de San Francisco recomendó suspensiones de 10 días sin pago para 20 empleados, incluidos siete bomberos, por incumplimiento del mandato de esa ciudad. Noticias de varias ciudades muestran empleados que cuestionan la legalidad de estos mandatos.

Existe un precedente legal de larga data para la salud pública y los mandatos de vacunas, dijo Sharona Hoffman, profesora de derecho y bioética en la Universidad Case Western Reserve en Cleveland.

“No es cierto que ‘Esto es Estados Unidos y tenemos 100% de libertad’. Tenemos un millón de leyes y regulaciones que se deben cumplir”, dijo, citando, entre ellas, las leyes de tránsito y los códigos de vestimenta en el trabajo. “Eso es lo que significa estar en una sociedad civilizada. Eso es lo que se llama el ‘contrato social’ “.

Allyson Hinzman, bombero y presidente del Local 31 de Bomberos de Tacoma en Washington, dijo que los sindicatos locales se oponen al mandato de vacunas del gobernador demócrata Jay Inslee. Hinzman dijo que fue apresurado y no permite alternativas, como pruebas semanales de covid. Los trabajadores estatales presentaron una demanda este mes contra el gobernador por el mandato.

Los bomberos están amenazando con renunciar en lugar de cumplir con la norma, lo que Hinzman dijo que pondría aún más presión sobre los departamentos con ya poco personal que brindan servicios de emergencia.

Agregó que los bomberos toman precauciones para evitar la transmisión del virus cuando responden a las llamadas. Un estudio de la Universidad de Washington indica que el riesgo de propagación del virus entre los que responden a emergencias y los pacientes es bajo, debido a los protocolos de seguridad que se siguen.

“No se trata de la vacuna”, dijo Hinzman, quien se vacunó. “Se trata de brindarles a nuestros miembros la oportunidad de elegir y tomar decisiones por sí mismos. Estamos a favor de las vacunas, estamos a favor de la seguridad pública, pero solo estamos en contra del mandato”.

Bob McDonald, director ejecutivo del Departamento de Salud Pública de Denver, lo ve de manera diferente y dijo que las vacunas son la única forma de pasar de una pandemia de covid a un problema de salud que, como la gripe, se pueda controlar. Denver ha implementado un mandato de vacunas para todos los empleados de la ciudad, incluidos los bomberos.

“Una de las cosas que creo es muy, muy importante es hacer que las personas comprendan que estas vacunas, especialmente con la variante delta, ya no son solo para el individuo”, dijo McDonald, y agregó que los hospitales de Denver están al límite, o más allá, de su capacidad debido al aumento de casos de covid. Es responsabilidad de todos mitigar este riesgo para reducir la tensión en el sistema médico de la nación, enfatizó.

Peña dijo que los servidores públicos le deben a los contribuyentes vacunarse, dado que los contribuyentes finalmente son los que pagan las facturas de las compensaciones laborales u hospitalizaciones.

Incluso si los empleados renuncian en caso de un mandato de vacunación en Houston, dijo Peña, su departamento ha operado durante la pandemia con menos personal debido a que los miembros se ponen en cuarentena después de la exposición o se aíslan debido a una enfermedad. Cuatro bomberos de Houston murieron de covid.

“He estado haciendo esto durante 27 años y les puedo decir que nunca enterré a un bombero por una muerte durante el cumplimiento del deber a causa de la gripe”, dijo Peña, y agregó que si las muertes hubieran sido por otra misión, el sindicato impulsaría la acción. “El hecho de que se trate de un problema médico no significa que no debamos buscar cómo proteger mejor a nuestros bomberos. La vacuna es una forma de lograrlo”.

Según la National Fallen Firefighters Foundation, que honra y reconoce a los bomberos que mueren en el cumplimiento del deber, 170 bomberos y 78 trabajadores de emergencias habían muerto por complicaciones de covid hasta el 17 de septiembre.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

These Schools Use Weekly Testing to Keep Kids in Class — And Covid Out

Kaiser Health News - Mon, 09/27/2021 - 5:00am

On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day — and every Monday — for the foreseeable future.

At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Suchinski coached her how to carefully release — but not “spit” — about a half-teaspoon’s worth of saliva into the tube.

“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”

The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.

Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K through 12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.

Schools in other states — such as Massachusetts, Maryland, New York and Colorado — also offer regular testing; Los Angeles public schools have gone further by making it mandatory.

These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-covid strategies, places where some schools have experienced outbreaks and even teacher deaths.

Within a few weeks of schools reopening, tens of thousands of students across the U.S. were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map — with some schools offering virtual instruction and others providing little or no at-home options.

Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community — and keeps kids learning.

“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.

So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance — and benefit — of regular testing.

Every school that can manage it should consider testing students weekly — even twice a week, if possible, said Becky Smith. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies — including both peer-reviewed and preliminary research — that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.

“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Smith said. “But relying on luck isn’t what we like to do.”

Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.

“One of my friends — he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. … They were OK. They only had mild symptoms.”

Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine — and he really doesn’t want to go back to Zoom school.

“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.

Suchinski, the superintendent, said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.

Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.

Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Suchinski can vouch for.

Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire covid testers — who coordinate the collecting, transporting and processing of samples, and reporting results.

A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.

Compared with a year ago, covid testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.

“The Biden administration has allocated $11 billion to different programs for testing,” Aspinall said. “There should be no school — public, private or charter — that can’t access that money for testing.”

Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.

If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Aspinall said.

In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.

Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.

The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.

For school leaders looking to explore options, Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.

This spring — when Hillside was operating at about half capacity and before the more contagious delta variant took over — the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.

But Suchinski said that by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.

A couple of weeks into the new school year at Hillside, operating at full capacity, Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.

“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Suchinski said.

“At the same time,” he added, “we know that we’re still fighting against the delta variant and we have to keep our guard up.”

This story is from a partnership that includes Illinois Public Media, Side Effects Public Media, NPR, and KHN.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Firefighters on Front Lines, No Strangers to Risk, Push Back Against Covid Vaccine Mandates

Kaiser Health News - Mon, 09/27/2021 - 5:00am

Kentucky firefighter Jimmy Adams saw the ravages of the coronavirus pandemic when he served as a medic who helped care for the sick on medical calls amid surging covid cases. He knew retired firefighters who died of complications from covid-19. But he reasoned that they were older and likely had underlying health issues, making them susceptible to the virus.

“That’s how you make peace with those things,” said Adams, 51, a lieutenant. He believed the precautions his department was taking kept him safe. But he refused to get a covid vaccine. The reason wasn’t strictly political, he said. He had grown weary of the debate around masks, mitigation, caseloads and vaccines.

In mid-August, both Adams and his wife, Sara, who was fully vaccinated, tested positive for covid. She experienced mild symptoms; however, he was hospitalized with bilateral interstitial pneumonia. His potassium spiked, causing cardiac arrhythmia. He was on oxygen throughout his hospitalization.

“I was wrong,” Adams said several days after leaving the hospital. “I suffered a lot. I don’t even know at this point in the game if I am going to suffer any long-term effects. Does this change who I am for the rest of my life? I don’t know the answer to that. I will be sad if it does.”

Adams now plans to get vaccinated as soon as his doctor allows it, post-recovery. Still, he, like many other firefighters nationwide, does not support mandates for covid vaccines.

Firefighter leadership and the rank and file are divided over such mandates. The International Association of Fire Chiefs has expressed support for mandatory vaccinations. Conversely, the International Association of Fire Fighters has said it “strongly” encourages firefighters to get vaccinated, but does not think it should be mandated.

Firefighters, who more often than not are certified emergency medical providers, have been on the pandemic’s front lines since the beginning. Officials pushed to ensure they would be among the first to receive the vaccines, given their role in the medical system. Yet why, after having seen so much, do so many who are trained to save lives still refuse to get vaccinated — while actively fighting against mandates?

JT Sullivan, a firefighter in Wyandotte County, Kansas, said that while he took precautions not to bring home the coronavirus when his wife was pregnant, he believed the pandemic was largely “vamped up” by the media — even as he saw its effects in his professional life. He understood something was happening; he just didn’t believe it was quite as bad as was being reported. He believed it affected mostly the elderly and medically fragile. The 28-year-old had no plans to get vaccinated until a paramedic at his department died from covid complications on Jan. 1. Sullivan got vaccinated soon after.

“It just caught me off guard because he was younger than my folks,” said Sullivan, who encourages vaccinations but also disagrees with mandates.

Several firefighters said first responders reluctant to get vaccinated reflect the range of views held by many average Americans: Some view both the pandemic and vaccine through a political lens, some believe misinformation and conspiracies, some are generally wary of vaccines, and others don’t like being told what to do. Both Adams and Sullivan attributed some vaccine resistance to having a “Type A” personality and harboring a belief that they can exert control over what happens to them.

Houston Fire Chief Samuel Peña, frustrated with his own department’s vaccination rate, which he guesses to be about 50%, suspects there is some truth to that.

“Through the course of a first responder’s career — whether you’re a firefighter, police officer, EMT — you kind of get a higher tolerance for acceptable risk because you respond to all kinds of stuff that puts your life in dangerous situations and the majority of the time you come out unscathed,” he said. “The level of acceptable risk that we’re willing to take is at a different threshold than a normal, reasonable individual.”

Peña said Houston officials have discussed mandating vaccinations despite Texas Republican Gov. Greg Abbott’s efforts to prevent schools and cities from instituting covid mitigation policies. The city’s strained relationship with the local firefighters union could complicate matters. Such mandates elsewhere have met fierce resistance.

A Los Angeles City Fire Department captain is under investigation after posting a video denouncing the “tyranny” of an expected vaccine mandate there. The city of San Francisco’s Department of Human Resources has recommended 10-day unpaid suspensions for 20 employees, including seven firefighters, for noncompliance with that city’s mandate, according to the San Francisco Chronicle. News reports in multiple cities quote employees questioning the legality of such mandates.

A long-standing legal precedent exists for public health and vaccine mandates, said Sharona Hoffman, a professor of law and bioethics at Case Western Reserve University in Cleveland.

“It’s not true that ‘This is America and we have 100% freedom.’ We have a million laws and regulations you have to comply with,” she said, citing, among them, traffic laws and employer dress codes. “That’s what it means to be in a civilized society. That’s what’s called the ‘social contract.’”

Allyson Hinzman, a firefighter and the president of Tacoma Firefighters Local 31 in Washington, said local unions oppose Democratic Gov. Jay Inslee’s vaccine mandate. Hinzman said it was rushed and doesn’t allow for alternatives, such as weekly covid testing. State workers filed a lawsuit this month against the governor over the mandate.

Firefighters are threatening to quit rather than comply, which Hinzman said would further strain short-staffed departments providing emergency services.

She said firefighters take precautions to prevent virus transmission when responding to calls. A University of Washington study indicates the risk of spreading the virus between first responders and patients is low, because of safety protocols followed in the field.

“This isn’t about the vaccine,” said Hinzman, who did get vaccinated. “This is about providing our members the opportunity to choose and make decisions for themselves. We are pro-vaccine, we are pro-public safety, but we’re just anti-mandate. The fact is you can be all three things at the exact same time.”

Bob McDonald, executive director of the Denver Department of Public Health, sees it differently and said vaccines are the only way to move from a covid pandemic to a health concern that, like influenza, can be managed. Denver has implemented a vaccine mandate for all city employees, including firefighters.

“One of the things that I think is very, very important is to get people to understand that these vaccines, especially with the delta variant, are no longer just about the individual,” said McDonald, adding that hospitals around Denver are at or beyond capacity due to surging covid cases. It is everyone’s responsibility to mitigate their risk to reduce strain on the nation’s medical system, he said.

Peña said public servants owe it to taxpayers to get vaccinated given that taxpayers ultimately pay the bills for their workers’ compensation payouts or hospitalizations.

Even if employees quit in the event of a vaccine mandate in Houston, Peña said, his department has operated throughout the pandemic with reduced staffing because of members quarantining after exposure or isolating because of illness. Four Houston firefighters have died of covid.

“I have been doing this for 27 years, and I can tell you that I have never buried a firefighter for a line-of-duty death because of the flu,” said Peña, adding that if the deaths had been from other duty-related activities, the union would push for action. “Just because this is a medical issue does not mean that we should not be looking for how to better protect our firefighters. The vaccine is one way we can achieve that.”

According to the National Fallen Firefighters Foundation, which honors and recognizes firefighters who die in the line of duty, 170 firefighters and 78 EMS workers had died of covid complications as of Sept. 17.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Who Qualifies for a Covid Booster? The List Is Growing Longer

Kaiser Health News - Mon, 09/27/2021 - 5:00am

On Friday, Centers for Disease Control and Prevention Director Rochelle Walensky said people whose jobs put them at risk of coronavirus infection qualify for a shot to boost the protection of their covid-19 vaccination.

That step to include people with “institutional and occupational exposure” overrules the recommendation of her agency’s advisory panel, and the move was a surprise to many.

“It was not expected, but I think the director, Walensky, wanted to go along with what the FDA had said earlier in the week and to kind of back up the plan that President Biden had laid out in August,” said KHN senior correspondent Sarah Jane Tribble.

Others who can line up first for a covid booster include Americans age 65 and older, younger people who have underlying health conditions and nursing home residents.

So far, regulators have done a poor job of defining the universe of people considered at risk because of institutional and occupational exposure, said Arthur Allen, an editor for KHN’s California Healthline.

“We don’t know exactly who they all are. But we can think of some obvious groups who would have been very upset if they couldn’t be qualified for a booster. That includes health care workers and teachers,” Allen said.

“We have to remember this is not really just a purely scientific decision,” he said.

During the Sept. 23 meeting of the CDC’s Advisory Committee on Immunization Practices, members tried to get a handle on Americans’ demand for covid boosters: In surveys from August, as many as 87% vaccinated adults said they would get an additional dose if it were available. Another later survey found that 93% of adults would get the shot if a primary care provider recommended it.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

From the FDA’s Empty Seat to Chock-Full ICUs, Journalists Recap the Week’s Stories

Kaiser Health News - Sat, 09/25/2021 - 5:00am

KHN correspondent Rachana Pradhan discussed why President Joe Biden hasn’t yet nominated a permanent leader for the Food and Drug Administration on Newsy’s “Morning Rush” on Thursday.

KHN freelancer Nick Ehli discussed Montana’s overrun intensive care units on the Northern Broadcasting System’s “Voices of Montana” on Wednesday.

KHN chief Washington correspondent Julie Rovner discussed covid-19 vaccine booster shots on WAMU/NPR’s “1A” on Thursday. On Wednesday, she joined C-SPAN’s “Washington Journal” to discuss the reconciliation bill’s provisions related to Medicare prescription drug costs.

California Healthline reporter and producer Heidi de Marco discussed how a group of disabled migrants is organizing for better health care on KCET’s “SoCal Update” Sept. 17.

KHN senior correspondent Sarah Jane Tribble discussed how Dr. Anthony Fauci and the National Institutes of Health got ahead of the FDA and Centers for Disease Control and Prevention on the need for covid vaccine boosters on CNN’s “New Day” Sept. 17.

KHN Midwest correspondent Lauren Weber discussed public health legislation on Newsy on Sept. 17.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Científicos dicen que una píldora diaria para tratar covid estaría a meses de distancia

Kaiser Health News - Fri, 09/24/2021 - 8:29am

Un día después de dar positivo para covid-19 en junio, Miranda Kelly estaba lo suficientemente enferma como para asustarse. Con 44 años, hipertensión y diabetes, la asistente de enfermería tenía problemas para respirar, síntoma lo suficientemente grave como para terminar en la sala de emergencias.

Cuando su esposo, Joe, de 46, también se enfermó con el virus, realmente se preocupó, especialmente por sus cinco hijos adolescentes: “Pensé, ‘Espero por Dios que no terminemos con ventiladores. ¿Quién va a criar a estos niños?”.

Pero los Kelly, que viven en Seattle, Washington, acordaron justo después de sus diagnósticos unirse a un ensayo clínico en el cercano centro de investigación del cáncer Fred Hutch que es parte de un esfuerzo internacional para probar un tratamiento antiviral que podría detener a covid en una etapa temprana de la infección.

Al día siguiente, la pareja estaba tomando cuatro pastillas, dos veces al día. Aunque no se les dijo si habían recibido un medicamento activo o un placebo, en una semana, dijeron, sus síntomas mejoraron.

En dos semanas, se habían recuperado.

“No sé si recibimos el tratamiento, pero siento que sí”, dijo Miranda Kelly. “Por tener todas estas condiciones subyacentes, sentí que la recuperación fue muy rápida”.

Los Kelly juegan un papel en el desarrollo de lo que podría ser la próxima oportunidad del mundo para frustrar a covid: un régimen a corto plazo de píldoras diarias que pueden combatir el virus temprano después del diagnóstico y, posiblemente, prevenir el desarrollo de síntomas después de la exposición.

“Los antivirales orales no solo tienen el potencial de reducir la duración del síndrome de covid-19, sino también de limitar la transmisión a las personas en el hogar si estás enfermo”, dijo Timothy Sheahan, virólogo de la Universidad de Carolina del Norte-Chapel Hill, quien ha ayudado a promover estas investigaciones.

Los antivirales ya son tratamientos esenciales para otras infecciones virales, incluidas la hepatitis C y el VIH. Una de las más conocidas es Tamiflu, la píldora ampliamente recetada que puede acortar la duración de la gripe y reducir el riesgo de hospitalización si se administra rápidamente.

Estos medicamentos, desarrollados para tratar y prevenir infecciones virales en personas y animales, funcionan de manera diferente según el tipo. Pero pueden diseñarse para estimular el sistema inmunológico para combatir infecciones, bloquear los receptores para que los virus no puedan ingresar a las células sanas o reducir la cantidad de virus activo en el cuerpo.

Se están probando al menos tres antivirales prometedores para covid en ensayos clínicos, y los resultados se esperan para fines del otoño o el invierno, dijo Carl Dieffenbach, director de la División de SIDA del Instituto Nacional de Alergias y Enfermedades Infecciosas, que supervisa el desarrollo de estos fármacos.

“Creo que tendremos respuestas sobre lo que estas píldoras son capaces de hacer en los próximos meses”, dijo Dieffenbach.

El principal contendiente en esta carrera es un medicamento de Merck & Co. y Ridgeback Biotherapeutics llamado molnupiravir, dijo Dieffenbach. Este es el producto que se está probando en el ensayo de los Kelly en Seattle. Otros dos incluyen un candidato de Pfizer, conocido como PF-07321332; y AT-527, un antiviral producido por Roche y Atea Pharmaceuticals.

Actúan interfiriendo con la capacidad del virus para replicarse en las células humanas. En el caso del molnupiravir, la enzima que copia el material genético viral se ve obligada a cometer tantos errores que el virus no puede reproducirse. Eso, a su vez, reduce la carga viral del paciente, acorta el tiempo de infección y previene el tipo de respuesta inmunitaria peligrosa que puede causar una enfermedad grave o la muerte.

Hasta ahora, solo un medicamento antiviral, remdesivir, ha sido aprobado para tratar a covid. Pero se administra por vía intravenosa a pacientes lo suficientemente enfermos como para ser hospitalizados, y no está destinado a un uso temprano y generalizado.

Por el contrario, los nuevos contendientes bajo estudio se pueden empaquetar en forma de píldoras.

Sheahan, quien también realizó un trabajo preclínico sobre remdesivir, dirigió un estudio inicial en ratones que mostró que el molnupiravir podría prevenir la enfermedad temprana causada por el SARS-CoV-2, el virus que causa covid. La fórmula fue descubierta en la Universidad de Emory y luego la adquirió Ridgeback y Merck.

Se han realizado ensayos clínicos, incluido un ensayo inicial de 202 participantes la primavera pasada que mostró que el molnupiravir reducía rápidamente los niveles de virus infecciosos. El director ejecutivo de Merck, Robert Davis, dijo este mes que la compañía espera datos de sus ensayos de fase 3 más grandes en las próximas semanas, con el potencial de solicitar la autorización de uso de emergencia de la Administración de Alimentos y Medicamentos (FDA) “antes de fin de año”.

Pfizer lanzó una prueba combinada de fase 2 y 3 de su producto el 1 de septiembre, y ejecutivos de Atea dijeron que esperan resultados de las pruebas de fase 2 y 3 a finales de este año.

Si los resultados son positivos y se otorga el uso de emergencia para cualquier producto, dijo Dieffenbach, “la distribución podría comenzar rápidamente”.

Eso significaría que millones de estadounidenses pronto podrían tener acceso a un medicamento de consumo diario por vía oral, idealmente una sola pastilla, que podría tomarse durante cinco a 10 días apenas se confirma la infección por covid.

“Esa es la idea”, dijo el doctor Daniel Griffin, experto en inmunología y enfermedades infecciosas de la Universidad de Columbia. “Tener esto en todo el país, para que la gente lo reciba el mismo día en que recibe el diagnóstico”.

Alguna vez marginados por falta de interés, los antivirales orales para tratar las infecciones por coronavirus ahora son objeto de una feroz competencia y financiación.

En junio, la administración Biden anunció que había acordado obtener alrededor de 1,7 millones de ciclos de tratamiento de molnupiravir de Merck, a un costo de $1,2 mil millones, si el producto recibe autorización de emergencia o aprobación total.

El mismo mes, la administración dijo que invertiría $3.2 mil millones en el Programa Antiviral para Pandemias, cuyo objetivo es desarrollar antivirales para la crisis de covid y más allá, dijo Dieffenbach.

La pandemia revitalizó el esfuerzo en la investigación de antivirales. Aunque en 2003 el virus del Síndrome Agudo Respiratorio Severo (SARS) dio un susto a los científicos, seguido por el Síndrome Respiratorio de Oriente Medio (MERS), en 2012, los esfuerzos de investigación se desaceleraron cuando estos brotes no persistieron.

“El impulso comercial para desarrollar cualquier producto simplemente desapareció”, dijo Sheahan.

Los medicamentos antivirales ampliamente disponibles se unirían a las terapias con anticuerpos monoclonales que ya se usan para tratar y prevenir enfermedades graves y hospitalizaciones causadas por covid. Los anticuerpos monoclonales producidos en laboratorio, que imitan la respuesta natural del cuerpo a las infecciones, fueron más fáciles de desarrollar, pero deben administrarse principalmente por vía intravenosa.

El gobierno federal está cubriendo el costo de la mayoría de los productos monoclonales a $2,000 por dosis. Todavía es demasiado pronto para saber el precio de los antivirales.

Al igual que los anticuerpos monoclonales, las píldoras antivirales no sustituyen a la vacunación, dijo Griffin. Serían otra herramienta para luchar contra covid.

Un desafío en el desarrollo rápido de medicamentos antivirales ha sido reclutar suficientes participantes para los ensayos clínicos, que deben reclutar a cientos de personas, explicó la doctora Elizabeth Duke, investigadora asociada de Fred Hutch que supervisa el ensayo de molnupiravir.

Los participantes no deben estar vacunados y deben estar inscritos en el ensayo dentro de los cinco días posteriores a una prueba de covid positiva. Solo en un cualquiera, pasantes hacen 100 llamadas a personas recientemente covid-positivas en el área de Seattle, y la mayoría dice que no.

“En términos generales, hay mucha desconfianza sobre el proceso científico”, dijo Duke. “Algunas personas les dicen cosas desagradables a los pasantes”.

Si las píldoras antivirales resultan efectivas, el próximo desafío será impulsar un sistema de distribución por el que puedan llegar a las personas tan pronto como den positivo para covid. Griffin dijo que se necesitará algo similar al programa establecido el año pasado por UnitedHealthcare, que aceleró los kits de Tamiflu a 200,000 pacientes en riesgo inscritos en los planes Medicare Advantage de la aseguradora.

Ejecutivos de Merck predijeron que la compañía podría producir más de 10 millones de cursos de terapia para fin de año. Atea y Pfizer no han publicado estimaciones similares.

¿Aún más prometedor? Estudios que evalúan si los antivirales pueden prevenir la infección después de la exposición.

“Piensa en eso”, dijo Duke, quien también supervisa un ensayo profiláctico. “Podrías dárselo a todos en un hogar, o a todos en una escuela. Entonces, ahí sí estaríamos hablando tal vez de un regreso a la vida normal”.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Mounting Covid Deaths Fuel School Bus Drivers’ Fears

Kaiser Health News - Fri, 09/24/2021 - 5:00am

GRIFFIN, Ga. — Natalia D’Angelo got sick right after school started in August.

She was driving a school bus for special education students in Griffin-Spalding County School System about 40 miles south of Atlanta and contracted covid-19.

One of her three sons, Julian Rodriguez-D’Angelo, said his mother, who was not vaccinated against the covid virus, had a history of health problems, including Graves’ disease and cancer.

Rodriguez-D’Angelo said his mother “was pretty certain” she got covid from her work duties. He added that D’Angelo’s assistant on the same bus also had the disease, and that his mother said some kids on the bus did not wear masks, even though it is required.

The virus spread through the whole family, including her husband, Americo Rodriguez, who came with her to the U.S. from Uruguay 20 years ago. But D’Angelo’s illness grew worse, and she was hospitalized at a Griffin hospital in mid-August. On Aug. 28, she died. She was 43.

D’Angelo is among at least 12 school bus workers in Georgia — including three in the Griffin-Spalding district — who have died of covid since the beginning of the school year. News reports and a Twitter feed called “School Personnel Lost to Covid” show that school bus drivers in at least 10 states have died of the disease since August.

The deaths raise questions about whether school bus drivers are at higher risk of getting covid. But medical experts are split. It’s difficult, if not impossible when local infection rates are high, to determine how any particular bus worker became infected — whether it occurred at home, in a community setting or on the job.

The buses should be relatively safe. The Centers for Disease Control and Prevention requires that masks be worn on public transportation, including all school buses, public or private and regardless of whether the schools themselves require masks.

“There’s no enforcement of that,’’ said Ronna Weber, executive director of the National Association of State Directors of Pupil Transportation Services. “Police are not going to board a school bus” to make sure the students are wearing masks.

As with school employees in general, statistics on the number of covid deaths are sparse, without any central government repository, according to the National Education Association union. The Florida Education Association, though, lists seven bus workers among the more than 70 school staffers in the state who have died since July. The School Personnel Lost to Covid account says more than 185 bus drivers have died of the disease during the pandemic.

An estimated 500,000 school buses nationwide operate on a given day. Many drivers are retirees from previous occupations, so age and health conditions could contribute to the deaths. “Every life is an unfortunate loss,” said Weber.

Xiaoyan Song, chief infection control officer at Children’s National Hospital in Washington, D.C., said drivers are not at increased risk of getting covid from students because they see children up close for only a second or two, when the kids board and exit the bus.

It typically takes several minutes of exposure to an infected person to transmit the virus, she said, adding that drivers face forward with their backs to students while driving, which also diminishes their risk. She said driving with windows open is another factor that can limit transmission of the virus.

But Ye Shen, an associate professor at the University of Georgia College of Public Health, believes drivers face a greater risk.

Shen, lead author of a JAMA Internal Medicine study on covid transmission on buses in China, noted that the vehicles are enclosed spaces in which ventilation can be poor, creating an environment with a high risk of covid transmission.

The danger of airborne transmission is significantly reduced if the kids and the driver are all wearing masks, Shen said. In the China study, no one was wearing a mask and there was a high rate of virus transmission. “Kids often don’t fully comply with the mask rule,” Shen added.

Risks may climb within school districts that lack mask mandates, he said.

The Bulloch County school district in southeastern Georgia has no mask mandate in classrooms or buses. In early September, Bulloch district bus driver Norma Jean Carter, 55, died of covid.

Besides mask-wearing, the CDC recommends that, whenever possible, drivers and monitors open bus windows to increase air circulation. Bus surfaces should be cleaned and disinfected after each use of the vehicle, the agency said.

Even when precautions are taken, the fears surrounding covid have worsened a nationwide shortage of school bus drivers.

Michael Cordiello, president of the Amalgamated Transit Union local chapter in New York City, representing more than 8,000 school bus workers, said more drivers have retired in 2021 than in previous years.

Officials in several states are working to find solutions to the shortages, and some are requesting that their governors send National Guard troops to help. A Wilmington, Delaware, school is paying its students’ parents to drive buses. Some regular drivers have had to work extra shifts.

“Our drivers are scared to death,” said Jamie Michael, president of Support Personnel Association of Lee County, a union in southwestern Florida that represents bus drivers and other school staffers.

One county school bus driver there died of covid in mid-August, she said. It is unknown where the woman was infected. She said five drivers then quit Sept. 7 and the county school district is about 100 drivers short of what it needs.

The district requires drivers to wear masks, and they try to ensure that at least some windows are kept open on the bus no matter the weather.

“It’s a scary time for anyone working with students,” Michael said.

Drivers in the district get paid between $16 and $23 an hour depending on seniority, amounting to $31,000 to about $45,000 annually.

Michael said drivers like to keep the seat behind them vacant to allow for physical distancing, but that is not always possible due to demand for rides, especially amid driver shortages.

The Griffin-Spalding district temporarily switched to remote learning for students after D’Angelo, another bus driver and a bus monitor died of covid. Several more have been infected since school started Aug. 4, said Adam Pugh, spokesperson for the Griffin-Spalding County School System. The school district added a mask requirement early in the school year.

“No one has an exact answer” as to why the district’s bus workers have been hit so hard, he said. Many buses are being driven with windows open, and the vehicles are sanitized between routes, Pugh added.

Julian Rodriguez-D’Angelo said his mother “loved being a bus driver and never missed work. She drove for years.”

He said he doesn’t blame the students but does feel anger about district policies. The delta variant, the dominant strain of covid, “is spreading like crazy,” he said. He added he doesn’t think students should have been in school amid the surge.

The vaccination rate in Spalding County for all residents, 37%, is far below the state’s 46% rate. Both rates are below the national average.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

A Daily Pill to Treat Covid Could Be Just Months Away, Scientists Say

Kaiser Health News - Fri, 09/24/2021 - 5:00am

Within a day of testing positive for covid-19 in June, Miranda Kelly was sick enough to be scared. At 44, with diabetes and high blood pressure, Kelly, a certified nursing assistant, was having trouble breathing, symptoms serious enough to send her to the emergency room.

When her husband, Joe, 46, fell ill with the virus, too, she really got worried, especially about their five teenagers at home: “I thought, ‘I hope to God we don’t wind up on ventilators. We have children. Who’s going to raise these kids?”

But the Kellys, who live in Seattle, had agreed just after their diagnoses to join a clinical trial at the nearby Fred Hutch cancer research center that’s part of an international effort to test an antiviral treatment that could halt covid early in its course.

By the next day, the couple were taking four pills, twice a day. Though they weren’t told whether they had received an active medication or placebo, within a week, they said, their symptoms were better. Within two weeks, they had recovered.

“I don’t know if we got the treatment, but I kind of feel like we did,” Miranda Kelly said. “To have all these underlying conditions, I felt like the recovery was very quick.”

The Kellys have a role in developing what could be the world’s next chance to thwart covid: a short-term regimen of daily pills that can fight the virus early after diagnosis and conceivably prevent symptoms from developing after exposure.

“Oral antivirals have the potential to not only curtail the duration of one’s covid-19 syndrome, but also have the potential to limit transmission to people in your household if you are sick,” said Timothy Sheahan, a virologist at the University of North Carolina-Chapel Hill who has helped pioneer these therapies.

Antivirals are already essential treatments for other viral infections, including hepatitis C and HIV. One of the best known is Tamiflu, the widely prescribed pill that can shorten the duration of influenza and reduce the risk of hospitalization if given quickly.

The medications, developed to treat and prevent viral infections in people and animals, work differently depending on the type. But they can be engineered to boost the immune system to fight infection, block receptors so viruses can’t enter healthy cells, or lower the amount of active virus in the body.

At least three promising antivirals for covid are being tested in clinical trials, with results expected as soon as late fall or winter, said Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, who is overseeing antiviral development.

“I think that we will have answers as to what these pills are capable of within the next several months,” Dieffenbach said.

The top contender is a medication from Merck & Co. and Ridgeback Biotherapeutics called molnupiravir, Dieffenbach said. This is the product being tested in the Kellys’ Seattle trial. Two others include a candidate from Pfizer, known as PF-07321332, and AT-527, an antiviral produced by Roche and Atea Pharmaceuticals.

They work by interfering with the virus’s ability to replicate in human cells. In the case of molnupiravir, the enzyme that copies the viral genetic material is forced to make so many mistakes that the virus can’t reproduce. That, in turn, reduces the patient’s viral load, shortening infection time and preventing the kind of dangerous immune response that can cause serious illness or death.

So far, only one antiviral drug, remdesivir, has been approved to treat covid. But it is given intravenously to patients ill enough to be hospitalized, and is not intended for early, widespread use. By contrast, the top contenders under study can be packaged as pills.

Sheahan, who also performed preclinical work on remdesivir, led an early study in mice that showed that molnupiravir could prevent early disease caused by SARS-CoV-2, the virus that causes covid. The formula was discovered at Emory University and later acquired by Ridgeback and Merck.

Clinical trials have followed, including an early trial of 202 participants last spring that showed that molnupiravir rapidly reduced the levels of infectious virus. Merck chief executive Robert Davis said this month that the company expects data from its larger phase 3 trials in the coming weeks, with the potential to seek emergency use authorization from the Food and Drug Administration “before year-end.”

Pfizer launched a combined phase 2 and 3 trial of its product Sept. 1, and Atea officials said they expect results from phase 2 and phase 3 trials later this year.

If the results are positive and emergency use is granted for any product, Dieffenbach said, “distribution could begin quickly.”

That would mean millions of Americans soon could have access to a daily orally administered medication, ideally a single pill, that could be taken for five to 10 days at the first confirmation of covid infection.

“When we get there, that’s the idea,” said Dr. Daniel Griffin, an infectious diseases and immunology expert at Columbia University. “To have this all around the country, so that people get it the same day they get diagnosed.”

Once sidelined for lack of interest, oral antivirals to treat coronavirus infections are now a subject of fierce competition and funding. In June, the Biden administration announced it had agreed to obtain about 1.7 million treatment courses of Merck’s molnupiravir, at a cost of $1.2 billion, if the product receives emergency authorization or full approval. The same month, the administration said it would invest $3.2 billion in the Antiviral Program for Pandemics, which aims to develop antivirals for the covid crisis and beyond, Dieffenbach said.

The pandemic kick-started a long-neglected effort to develop potent antiviral treatments for coronaviruses, said Sheahan. Though the original SARS virus in 2003 gave scientists a scare — followed by Middle East respiratory syndrome, or MERS, in 2012 — research efforts slowed when those outbreaks did not persist.

“The commercial drive to develop any products just went down the tubes,” said Sheahan.

Widely available antiviral drugs would join the monoclonal antibody therapies already used to treat and prevent serious illness and hospitalizations caused by covid. The lab-produced monoclonal antibodies, which mimic the body’s natural response to infection, were easier to develop but must be given primarily through intravenous infusions.

The federal government is covering the cost of most monoclonal products at $2,000 a dose. It’s still too early to know how the price of antivirals might compare.

Like the monoclonal antibodies, antiviral pills would be no substitute for vaccination, said Griffin. They would be another tool to fight covid. “It’s nice to have another option,” he said.

One challenge in developing antiviral drugs quickly has been recruiting enough participants for the clinical trials, each of which needs to enroll many hundreds of people, said Dr. Elizabeth Duke, a Fred Hutch research associate overseeing its molnupiravir trial.

Participants must be unvaccinated and enrolled in the trial within five days of a positive covid test. Any given day, interns make 100 calls to newly covid-positive people in the Seattle area — and most say no.

“Just generally speaking, there’s a lot of mistrust about the scientific process,” Duke said. “And some of the people are saying kind of nasty things to the interns.”

If the antiviral pills prove effective, the next challenge will be ramping up a distribution system that can rush them to people as soon as they test positive. Griffin said it will take something akin to the program set up last year by UnitedHealthcare, which sped Tamiflu kits to 200,000 at-risk patients enrolled in the insurer’s Medicare Advantage plans.

Merck officials predicted the company could produce more than 10 million courses of therapy by the end of the year. Atea and Pfizer have not released similar estimates.

Even more promising? Studies evaluating whether antivirals can prevent infection after exposure.

“Think about that,” said Duke, who is also overseeing a prophylactic trial. “You could give it to everyone in a household, or everyone in a school. Then we’re talking about a return to, maybe, normal life.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Low Wages and Pandemic Gut Staffing Support for Those With Disabilities

Kaiser Health News - Fri, 09/24/2021 - 5:00am

Ernestine “Erma” Bryant likes her job, but the pay is a problem.

She works in a caregiver role as a “direct support professional” in Tifton, Georgia, helping people who have intellectual and developmental disabilities with basic functions such as dressing, bathing and eating.

Bryant said it’s fulfilling work. “You can help people be successful — people who are confined to the bed,” she said. “It gives me joy knowing that I can help that person get out of the house.”

But she said she’s being paid less than $10 an hour and is trying to get a second job.

In a way, Bryant is an anomaly, having worked as a support professional in the same job for five years in a field with high turnover. Even before the pandemic, the nation had a shortage of direct support professionals working in private homes, group facilities, day programs and other community settings.

Fears of contracting covid-19 at work have made the caregiver staffing problem worse. Persistent low pay amid a tight U.S. labor market makes it that much harder to attract workers.

Worker shortages across the health care spectrum — from nurses to lower-level staffers — are an unprecedented challenge for hospitals and other medical organizations. The shortage is at an “epic level,” said Elizabeth Priaulx, a legal specialist with the National Disability Rights Network.

People with disabilities who have been approved by state Medicaid programs to receive 40 hours a week in caregiver services now often get just 20 hours, Priaulx added. If family members can’t help offset the gap, a person may be forced into a nursing home, she said.

The Zoller family of Flowery Branch, Georgia, is struggling with that reduction in service hours.

Katie, 34, is developmentally disabled and lives at home. Her father, John, said that instead of the 24/7 care she previously received, she is provided less than half of that at about 60 hours a week because of caregiver shortages. So John, 65, and his wife, Weda, 63, must fill in the rest. “We have to tag-team,” he said. The staffing gap occurred after one caregiver for Katie moved away, and another took a warehouse job, each getting higher pay, he said.

Diane Wilush, CEO of Atlanta-based United Cerebral Palsy of Georgia, said her organization has more than 100 vacancies among 358 jobs in 24/7 residential programs. Many day programs, including those run by her group, have been unable to offer full services because of staffing gaps.

“We can’t compete with every retail shop paying $15 to $18 an hour,” Wilush said.

That’s because several years ago the state of Georgia chose a base Medicaid reimbursement rate for residential services providers of $10.63 per hour, though they can pay caregivers more — and sometimes pay less. “It was an inadequate rate even then,” Wilush said.

The strain from an increased workload has a negative effect on caregivers, said Bryant, the caregiver in Tifton. “When you don’t have enough help, it makes you want to find another job,” she said.

In 2019, before covid erupted, the direct support professional turnover rate was 43% nationally, according to the National Core Indicators collaboration of public developmental disability agencies. In a February 2020 survey of providers by the American Network of Community Options and Resources, two-thirds of service providers said they were turning away new referrals. Since staffing shortages became a problem, 40% have seen a higher incidence of events that could harm a person’s health or safety.

And a KFF survey released last month found that during the pandemic, two-thirds of responding states reported a permanent closure of at least one provider of Medicaid-covered home- and community-based services.

Workers have at times been forced to work 16-hour shifts during the pandemic, said Whitney Fuchs, CEO of InCommunity, an Atlanta-based provider of community services and support to people with developmental disabilities. “This crisis is going to erupt into unsafe, unhealthy situations.”

His organization needs to fill 166 openings out of 490 positions. Before the pandemic, the number of job openings was 80. Even managers, who often cover work shifts, are leaving their jobs due to overwork, Fuchs said.

“People are tired constantly,” he said. “This is somebody’s life we’re supporting. There have been adverse patient outcomes,” such as medication mistakes.

Through the recently passed American Rescue Plan Act, the Biden administration has recognized the wage gap for direct care workers by adding more Medicaid funding to help compensate them for their work. The act increases the federal matching rate for state spending on home and community-based services by 10 percentage points from April 1, 2021, through March 31, 2022.

It requires states to submit spending plans for those funds. Georgia has submitted a plan that contains rate increases, as well as a study of worker wages. The proposal is under review by the Centers for Medicare & Medicaid Services, according to the Georgia Department of Behavioral Health and Developmental Disabilities. Staffers there said the department is “acutely aware” of the shortages.

Federal covid funds have enabled Georgia to give a 10% pay increase for some provider services.

Other states are trying to buttress worker salaries on their own. Missouri recently approved $56 million to improve its direct support professional crisis.

Parents of people with disabilities, though, have concerns about the future viability of the services if the national worker shortage isn’t fixed.

Bill Clarke and his wife are in their 80s. They have two children with multiple disabilities receiving services in residential homes in the Atlanta area.

“They have physical problems that require 24/7 care,” Clarke said. “There are just not enough people willing to go into these lower-paying jobs. They are not compensated adequately.”

If these services disappear, Clarke said, “we could not handle both of our sons physically.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

California Moves on Climate Change, but Rejects Aggressive Cuts to Greenhouse Emissions

Kaiser Health News - Thu, 09/23/2021 - 5:00pm

SACRAMENTO, Calif. — As California trudges into another autumn marred by toxic wildfire smoke and drought-parched reservoirs, state lawmakers have cast climate change as a growing public health threat for the state’s 40 million residents.

But they were willing to push the argument only so far.

On Thursday, against the smoldering backdrop of Sequoia National Park, where the massive KNP Complex Fire is burning uncontained, Gov. Gavin Newsom signed a $15 billion bill that he described as an unprecedented investment by any state in climate resiliency. The legislation will fund significant new efforts to bolster wildfire prevention, expand clean water supplies and build a network of community-level safeguards to protect people from episodes of extreme and potentially deadly heat.

The measure is one of several bills targeting the health impacts of perennial seasons of fire and drought that sailed through this year’s legislative session.

Still, the Democratic-controlled legislature stopped short of taking the momentous action that climate experts argue is central to the health of current and future generations: Lawmakers failed to pass legislation to more quickly and aggressively reduce the state’s share of the greenhouse gas emissions warming the planet.

“There were good environmental bills that passed, but they were incremental,” said Mary Creasman, CEO of California Environmental Voters, formerly called the California League of Conservation Voters. “We can’t give ourselves credit for doing anything less than science tells us we have to, and science says we are nowhere near doing what we need to be doing.”

Among the climate health bills that still await Newsom’s consideration are measures to make the state’s emergency stockpile of N95 masks available to farmworkers on days of dangerously smoky air and a requirement for the state to create detailed guidelines that counties can incorporate into emergency response plans when air quality is poor because of wildfire or other pollution. Even short-term exposure to wildfire smoke can trigger asthma and heart attacks and has been linked to increased risk of infections like bronchitis and pneumonia, among other illnesses.

Newsom has until Oct. 10 to sign or veto these and hundreds of other bills lawmakers sent him in the final weeks of the legislative session.

California has endured back-to-back years of record-breaking wildfires. Epic blazes not only have destroyed thousands of homes and businesses, but also spewed toxic metal contaminants and hazardous particulate matter that can travel through the air for hundreds of miles.

For example, exposure to lead, found in the smoke plumes from the 2018 Camp Fire that destroyed the town of Paradise, over time can trigger high blood pressure and cancer in adults, and learning deficits in young children.

“As California’s wildfires intensify and ravage our state, we must do more,” said Assembly member Robert Rivas (D-Salinas), who introduced AB 73, which would classify wildfire smoke as a public health emergency.

If Newsom signs the bill, California’s more than 380,000 front-line agricultural workers would be eligible to receive N95 masks and other protective equipment from a state stockpile that lawmakers created last year for health care workers, educators and others deemed “essential” in response to the covid-19 pandemic.

“We must do all we can to ensure that our farm and agricultural workers are not risking their health and their well-being every single time they go into the field to harvest and produce the food we all eat,” Rivas said.

Despite the increasing frequency of these oppressive “smoke days,” there’s very little communication to the public about how to protect themselves, said Marc Carrel, president and CEO of Breathe Southern California, a nonprofit that advocates for clean air policies. When wildfire smoke choked much of Southern California in fall 2019, some schools sent kids home, others didn’t. Sports leagues, often run by volunteers, got conflicting advice from city and county officials.

“While the state has protocols in place to address the flames themselves, there doesn’t seem to be anyone whose focus is on the smoke that comes from those fires,” Carrel said.

AB 619, by Assembly member Lisa Calderon (D-Whittier), would require the California Department of Public Health to draft health safety guidelines for use when air quality is poor during events such as wildfires. Counties would then be required to follow up with emergency plans for alerting the public about the health threat and recommended response, and provide emergency provisions such as air purifiers, oxygen and medications to residents with respiratory and pulmonary diseases.

The climate bill Newsom signed Thursday encompasses multiple ambitious projects. Among them: $1.5 billion for wildfire prevention, including an infusion of funding to clear dry and diseased brush and trees that fuel massive fires. And $800 million for a three-year initiative to address extreme heat.

The extreme heat initiative includes $100 million in grants to create more shade and promote evaporative cooling; and $100 million to build community resources such as hydration stations, cooling centers and clean air centers “to mitigate the public health impacts of extreme heat and other emergency situations exacerbated by climate change, such as wildfire, power outages, or flooding.”

“We talk about climate change a lot and reducing greenhouse gas emissions, which is important, but we’re also experiencing climate change in the present,” said Assembly member Luz Rivas, a San Fernando Valley Democrat who advocated for the excessive heat funding. “Heat causes more emergency room visits or deaths each year in the country than all other weather-related disasters combined.”

At Thursday’s news conference, Newsom said the state’s $15 billion investment over the next three years marked major steps to “future-proof California” and make the state more capable of addressing the extremes of drought, wind, fire and heat that scientists say are the natural fallout of a warming planet.

Newsom also signed bills Thursday to help coastal communities deal with sea level rise, foster carbon sequestration projects to help meet the state’s existing greenhouse gas reduction goals, and clean up oil and gas wells.

But legislators this session opted not to send the governor several controversial climate-related bills, shelving measures to ban the oil-extraction technique of fracking or require the California Air Resources Board to conduct a comprehensive health analysis of the state’s climate plan. Most notably, they blocked a bill by Assembly member Al Muratsuchi (D-Torrance) that would have required the state to achieve a greenhouse gas emissions target of “net zero” by 2045, necessitating dramatic changes in the power Californians use and the vehicles they drive.

California has made great strides in cutting its greenhouse gas emissions in recent years, hitting its first target to cut emissions below 1990 levels four years early, in 2020. The state’s per capita emissions dropped from 14 metric tons in 2001 to 10.5 metric tons in 2019, a 25% decrease. That is about half the national average, according to the California Air Resources Board.

Three years ago, then-Gov. Jerry Brown issued an executive order calling for a zero-emissions target by 2045, but the goal isn’t adopted as law and could be overturned by a future governor. Current law requires the state to reduce emissions 40% below 1990 levels by 2030, falling behind other states that have passed more aggressive targets. Massachusetts, Nevada and Virginia are among those that have adopted carbon-neutral emission laws.

AB 1395 passed in the Assembly but didn’t draw the votes it needed in the Senate after strong opposition from labor and oil industry groups that argued the bill would lead to job losses. Many environmental groups saw it as a stunning defeat in a state that 15 years ago became the first in the nation to impose climate goals in defiance of a federal government that had abandoned global environmental talks. Still, Senate Democrats defended the work they did and said the climate bill needed further development to protect jobs, especially in poor communities.

“This bill is unfinished. Unless we seize every opportunity, the working poor will always be last in line,” Sen. María Elena Durazo (D-Los Angeles) told colleagues during floor debate. “Fighting climate change doesn’t have to mean regressive economic policies. Environmental justice doesn’t need to come at the expense of economic justice.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

KHN’s ‘What the Health?’: The Autumn of Democrats’ Discontent

Kaiser Health News - Thu, 09/23/2021 - 2:10pm

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

Democrats in Congress and the White House are feverishly negotiating to pass as much of President Joe Biden’s domestic agenda as they can agree on, even as Republicans who oppose much of the increased spending threaten to shut down the government and default on the nation’s debt.

Meanwhile, confusion over so-called booster shots for covid-19 continues, and advocates on both sides of the abortion debate try to test Texas’ novel abortion law that the Supreme Court allowed to take effect Sept. 1.

This week’s panelists are Julie Rovner of KHN, Joanne Kenen of Politico, Mary Ellen McIntire of CQ Roll Call and Sarah Karlin-Smith of the Pink Sheet.

Among the takeaways from this week’s episode:

  • As Democratic lawmakers wrestle with efforts to please different factions of the party on the giant “human infrastructure” bill, the stakes are enormous. The bill encompasses dozens of massive policy changes, and each one alone could be the subject of major legislation that in past years would have taken months to negotiate. Failure to reach enough agreement to get the bill passed could cause severe ramifications for the party in the next round of elections and for the Biden administration.
  • Among the key disagreements over health policy in that legislation is what Congress can do to hold down prescription drug prices. Negotiations are ongoing, but Sen. Ron Wyden (D-Ore.), who as head of the Finance Committee would have a strong hand in the final deal, is holding his cards close to his chest on what he will support.
  • Despite the rhetoric around the drug-pricing issue, it appears the factions of the Democratic Party are not opposed to all curbs. The dispute is over how to restrict price increases and by how much.
  • The drug industry is expecting to take a hit in the legislation, but it is using a broad advertising campaign to stress its need for funding to make medical innovations. However, the public seems inclined to want both: lower prices and better drug options. Plus, consumer advocates note that not all incentives in the current system are geared toward innovation and often reward only slight improvements in drugs.
  • The current confusion about when and who should get an additional covid shot is confusing Americans. Officials at the Centers for Disease Control and Prevention seem to want a more cohesive strategy that doesn’t single out specific vaccines, but the push by the White House earlier this month added to the pressure to get those shots moving.
  • The U.S. promised more vaccine doses this week for underdeveloped countries since one of the biggest obstacles to getting people vaccinated in developing nations is a shortage of supply. But logistical problems loom large.

Also this week, Rovner interviews Dr. Scott Gottlieb, former commissioner of the Food and Drug Administration. He has a new book, titled “Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic.”

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

Julie Rovner: The New York Times’ “Their Baby Died in the Hospital. Then Came the $257,000 Bill,” by Sarah Kliff

Joanne Kenen: The New Yorker’s “The Struggle to Define Long Covid,” by Dhruv Khullar

Mary Ellen McIntire: KHN’s “Will ‘Dr. Disinformation’ Ever Face the Music?” by Victoria Knight

Sarah Karlin-Smith: The Washington Post’s “The World’s Tallest Populace Is Shrinking, and Scientists Want to Know Why,” by Rachel Pannett

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Democrats Roll the Dice on Sweeping Abortion Rights Bill — Again

Kaiser Health News - Thu, 09/23/2021 - 5:00am

A newly conservative Supreme Court agreed to hear a case most assumed it would use to overrule the 1973 landmark abortion-rights ruling, Roe v. Wade. And Democrats on Capitol Hill, convinced the issue would play to their political favor, vowed to bring up legislation that would write abortion protections into federal law. “We’ll debate it. We’ll vote on it. And we’ll pass it,” the Senate Democratic leader promised.

Sound familiar? The year was 1992. The Supreme Court case in question was Planned Parenthood of Southeastern Pennsylvania v. Casey. After the court surprised almost everyone by upholding the right to abortion, the legislation, called the “Freedom of Choice Act,” never reached the floor of the Senate, nor the House. (Click on the hyperlink to go back in time.)

Lawmakers today face almost the same situation. The Supreme Court this week scheduled for Dec. 1 arguments on a case from Mississippi challenging that state’s ban on abortion after 15 weeks of pregnancy. And the House, as soon as this week, could vote on the latest version of the Freedom of Choice Act, now called the “Women’s Health Protection Act.”

The question now, as it was then, is whether the legislation will help or hurt Democrats on one of the most polarizing issues in politics.

Just as in 1992, opponents of the current bill complain it would go much further than merely writing the protections of Roe into federal law. In addition to securing a person’s right to abortion throughout pregnancy, the legislation would void many state restrictions the Supreme Court has allowed even as Roe stands, including those requiring parental involvement in a minor’s abortion decision.

“This may be the most extreme legislation ever,” Rep. Cathy McMorris Rodgers (R-Wash.) told the House Rules Committee on Monday. “Abortion for any reason at any stage of pregnancy until birth.”

The bill would, Republicans complained, not just overturn existing state abortion restrictions, but it could also lead to mandatory public funding for abortion. Overturning the so-called Hyde Amendment that has banned most federal abortion funding since the late 1970s is a priority for many progressive Democrats, but it also marks a line that voters in many swing districts do not want their elected officials to cross.

While the scenarios seem eerily similar, some key differences emerge. The biggest: In 1992, the threat to abortion rights was theoretical; in 2021, millions of pregnant people already have lost reproductive rights after the high court failed to block a controversial Texas law that bans nearly all abortions as early as six weeks into pregnancy. To prevent courts from blocking it, the law is to be enforced not by state officials, but by individuals suing people who “aid or abet” someone in obtaining an abortion.

Under that law, Rep. Jamie Raskin (D-Md.) told the Rules Committee on Monday, “the whole country has basically been turned into bounty hunters for women exercising a constitutionally protected right.”

“Texas has just completely changed what’s at stake,” said Cecile Richards, former president of Planned Parenthood and a longtime Texas politics observer. (Her mother, Ann Richards, who died in 2006, was governor in the 1990s.) “Women think, ‘This will never happen,’” said Richards, who now co-chairs American Bridge 21st Century, a Democratic super political action committee. “Well, it just happened.”

Yet the politics of abortion are both very much the same as they were three decades ago, and very different.

What’s the same is that the outliers in both parties — Democrats who oppose abortion rights and Republicans who support them — would prefer not to have to vote on the issue. What’s different is there are far fewer outliers today. In 1992 nearly a third of Democrats opposed abortion, including the then-governor of Pennsylvania, Robert Casey, who was the defendant in the Planned Parenthood suit and who tried, publicly and unsuccessfully, to change the party’s platform in 1992 to oppose abortion. His son, Sen. Robert “Bob” Casey Jr. (D-Pa.), is one of a handful of Senate Democrats who do not strongly support abortion rights.

But it’s not merely anti-abortion Democrats who are in shorter supply. In 1992 Republicans were as likely to lead abortion-rights fights as Democrats, and most efforts were bipartisan. Before 1972, in fact, Republicans were generally more supportive of abortion rights than Democrats.

And obviously the biggest difference between now and 1992 is that the Republican president, George H.W. Bush, vowed to veto the abortion rights bill if it passed. President Joe Biden would sign it, according to a formal “Statement of Administration Policy” issued Monday. “In the wake of Texas’ unprecedented attack, it has never been more important to codify this constitutional right and to strengthen health care access for all women, regardless of where they live,” the statement said.

Bush’s and Biden’s own abortion positions probably best demonstrate how much the parties have shifted on the issue. As a House member, the elder President Bush was the lead sponsor of the federal government’s Title X family planning program — now strongly opposed by anti-abortion Republicans. Biden, a devout Catholic, opposed abortion rights early in his Senate career and has been criticized by activists for not uttering the word “abortion” as president until the Texas law took effect.

Biden, however, almost certainly will not get a chance to sign the Women’s Health Protection Act. At least not anytime soon. Although the bill might have enough support to squeak through the House, support in the Senate remains far short of the 60 votes needed to break a filibuster.

That won’t stop the fight from happening, though. What remains to be seen is which side in the abortion debate will ultimately win the battle for public support.

HealthBent, a regular feature of Kaiser Health News, offers insight and analysis of policies and politics from KHN’s chief Washington correspondent, Julie Rovner, who has covered health care for more than 30 years.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Biosimilar Drugs Are Cheaper Than Biologics. Are They Similar Enough to Switch?

Kaiser Health News - Thu, 09/23/2021 - 5:00am

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than four years trying medications before getting her disease under control with a biologic drug called Remicade.

So Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Moxley, who recently started a job as a public relations coordinator for Kansas City Public Schools in Missouri. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the U.S. has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Dr. Jinoos Yazdany, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anti-competitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the U.S. but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the healthcare system at-large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much — 14.6% — according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the U.S.

Biosimilars provide a roughly 30% discount over brand biologics in the U.S. but have the potential to reduce spending by more than $100 billion in the next five years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Dr. Marcus Snow, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Dr. Ross Maltz, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

The Checkup Is in the Mail? Soliciting Letter Carriers to Help Deliver Health Care

Kaiser Health News - Thu, 09/23/2021 - 5:00am

Two of America’s toughest problems can be tempered with one solution.

The baby boom generation is graying, creating an ever-larger population of older people, many isolated, whose needs the nation is ill equipped to meet or even monitor.

Meanwhile, the U.S. Postal Service has gone $160 billion into debt, in part as digital communications have replaced snail mail. This year it has requested two rate increases for stamps and other services, bringing the price of a first-class stamp to 58 cents. It is running an aggressive TV ad campaign, presumably to build support for Congress to step in with some kind of rescue.

So here’s a potential win-win solution: Have letter carriers spend less time delivering mail, much of which now involves fliers and solicitations. Instead, include in their responsibilities — “the swift completion of their appointed rounds” — home visits and basic health checks on the growing population of frail and elderly.

This may sound out-of-the-box, but it’s already done successfully and profitably in other countries, like France and Japan. Indeed, the idea that the USPS could get more involved in home health services — to fill a need and earn money — was suggested by the agency’s own Office of Inspector General in March.

So far, other solutions to fill the need for home health care have proved elusive. President Joe Biden proposed $400 billion in his initial infrastructure plan to improve services for the homebound elderly, a feature that Congress didn’t retain. But Democrats’ congressional reconciliation budget resolution, currently under debate, could allot money to the cause.

Meanwhile tens of millions of older Americans — the “old old” — are not so sick that they need a hospital but are unable to live safely at home without help. In Maine, the state with the oldest population, an estimated 10,000 hours of needed and approved home care is not provided every week because of a dearth of workers. That, for example, leaves patients with early dementia fending for themselves at great risk. People who need help preparing medicine or meals can be missing both.

Postal workers are already on virtually every block of America six days a week. They are “people people,” as the recent TV ads portray, often beloved by their customers.

Yes, letter carriers are already busy, in part because of the volume of package deliveries, which jumped during the pandemic. But what about scrapping the idea of everyday delivery? That too was suggested by the agency’s inspector general, a decade ago. Mail could be delivered just a few times a week, say, every other day. And on the off days, presto — we get a new on-the-ground home health workforce.

They could do home visits, to redress an epidemic of loneliness among older homebound Americans and check on whether a customer has an adequate supply of food and medicines. With a bit of retraining, they could check and record blood pressure, test blood sugar levels in people with diabetes and even administer pills.

Letter carriers already effectively serve as informal watchdogs, noticing if an older client hasn’t picked up mail, for example. In some parts of the country, that function is formalized under a voluntary program called Carrier Alert, in which the Postal Service notifies a participating service agency, noted Brian Renfroe, executive vice president of the National Association of Letter Carriers.

But the USPS could be paid, by the government or by individuals, for this and other valuable services.

In France, since 2017, families have been able to pay a small monthly fee to La Poste — about 20 euros or $24 — to have home check-ins for an older relative. The service, called Watch Over My Parents, offers one to six visits per week, and the postal worker reports the resident’s condition to the client each time.

Japan launched a similar postal program through a public-private partnership in 2017, to underwrite paid, monthly, half-hour visits (a friendly chat and health check) with members of the aging at-home population.

The post office’s essential functions — like delivering the federal government’s $1,200 pandemic relief checks, mail-in ballots and prescription medicines — are too important to lose. And USPS finances have improved recently, in part because of package deliveries and a $10 billion loan through the 2020 American Recovery and Reinvestment Act.

But when was the last time you ran to the mailbox to hear from a friend, check the news, or collect a bank statement or bill? It just makes sense financially and socially for the agency to evolve to meet the nation’s current needs.

Of course, this alone will not close the USPS’ $160 billion budget gap, the bulk of which resulted from a government mandate that it prefund the agency’s pension plan and, especially, its retiree health benefits. Without that, the USPS would have been in the black (often just barely) for about half of the years since 2006 — though, overall, it was nearly $10 billion in debt during the period.

Solving that requirement will take congressional intervention; changes will also be needed in a law that currently requires six-day-a-week delivery and generally precludes the USPS from offering “nonpostal” products. Bipartisan legislation introduced in the Senate this year seeks to loosen the latter restriction to help the USPS earn money from services of “enhanced value to the public” (like selling hunting and fishing licenses).

Today, the postal service delivers vast amounts of “junk mail,” also called direct mail. Companies spend about $167 annually on direct mail per person, yielding good returns, the industry says. But much of it ends up unread and unopened in the trash or recycling bin, an environmental nightmare.

Why not instead redeploy some of the U.S. Postal Service’s vast supply of human resources to deliver a service our aging population — and our country — desperately needs?

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Home Births Gain Popularity in ‘Baby Bust’ Decade

Kaiser Health News - Wed, 09/22/2021 - 5:00am

In a back-to-the-future twist on birth trends, California is seeing a sustained rise in the number of women choosing to deliver their babies in settings other than a hospital, a shift that accelerated as the pandemic created more risky and onerous conditions in many hospitals.

About 5,600 people gave birth outside a hospital in California in 2020, up from about 4,600 in 2019 and 3,500 in 2010. The shift took place during a widespread “baby bust,” so the proportion of births outside hospitals rose from 0.68% in 2010 to 1.34% in 2020, according to a KHN analysis of provisional data from the California Department of Public Health. The proportion of births outside hospitals stayed relatively high — 1.28% — from January through July 2021.

From 2009 to 2019, the proportion of births nationwide outside hospitals rose from 1.01% in 2009 to 1.56% in 2019. Nationwide data for 2020 and 2021 is not yet available.

Births away from hospitals usually take place with the help of licensed midwives working at the homes of clients or at free-standing “birth centers.” In either setting, expectant parents typically meet with midwives several times during the pregnancy to get comfortable, express their hopes for the pregnancy and learn about the birthing process.

Intentional at-home births and deliveries at midwife-run birthing centers are typically restricted to “low-risk” pregnancies. Women giving birth in those settings generally do not have serious preexisting health conditions like diabetes or high blood pressure that could complicate their babies’ births; they are giving birth to one child — no twins or triplets; and they are not expected to undergo a breech delivery, in which the baby emerges feet first, said Erina Angelucci, a certified nurse midwife at Best Start Birth Center in San Diego.

Midwives interviewed said they’ve heard from far more women in recent years turning to home births to avoid epidurals, induced labor and other invasive procedures common in hospital delivery rooms.

“I think people are looking to be more empowered in their birth and less ‘just go along with whatever happens,’” said Shari Stone-Ulrich, a certified nurse midwife and midwife services clinical director at Best Start.

Many people want to avoid cesarean sections unless absolutely necessary, several midwives said. About 30% of births in California hospitals last year were via C-section, though that figure has dropped some in recent years, state data shows.

“For first-time moms, C-sections in hospitals are very high,” said Miriam Singer, 32, who gave birth to her son, Eitan, at Best Start a few weeks ago. “So, knowing that the birth center is going to work with you and understand it's going to be a longer process and just make sure everything's going well, you really minimize your chances of having a C-section or an emergency situation.”

Singer has three older children, ages 4, 6 and 9. Three of her kids were born in a free-standing birth center and one was born at home.

“Birth is just a very natural part of life, and it should be approached as something that is natural, and we should follow our body and listen to our body going through the process,” she said. “I find the approach maybe in the hospitals a little bit more like it's an emergency.”

As the coronavirus swept across California, families sought births outside hospitals for other reasons. Some didn’t want to give birth in a setting where they feared contracting covid-19. Others bristled at rules restricting when partners and family members could be present during labor.

“The home-birth practices were just filled to capacity immediately,” said Kaleem Joy, a certified professional midwife and clinical director at California Birth Center in Rocklin. More recently, when some local hospitals announced they would again restrict visitors, “we went from having maybe six to 10 calls in a week to … I think we had a hundred in a day,” Joy added.

State health data show positive outcomes for the vast majority of out-of-hospital births. However, those figures don’t account for the fact that complicated, risky deliveries are, when feasible, transferred to a hospital.

A 2015 study in the New England Journal of Medicine found that planned out-of-hospital births in Oregon were associated with higher rates of perinatal death and neonatal seizures than hospital births, though such outcomes were rare in either setting. On the other hand, the study also found that planned out-of-hospital births led more often to unassisted vaginal deliveries and lower rates of obstetrical procedures.

Out-of-hospital birth rates ranged widely among California’s urban and rural counties. These births were most prevalent in Nevada County, a rustic north state community known for its bohemian enclaves and passionate home-schooling movement. About 1 in 10 mothers gave birth at home last year in Nevada County. Four other largely rural Northern California counties also saw notably high rates: Tuolumne (6.8%), Mendocino (6.6%), Shasta (5.4%) and Humboldt (5.3%).

Among more populous counties with at least 2,500 births in 2020, the highest rates of out-of-hospital deliveries were in Sonoma (3.6%), Placer (2.9%) and Santa Barbara (2.1%). Rates were lowest in the largely agricultural Central Valley, particularly in Tulare, Merced, Solano, Fresno, San Joaquin and Kern counties.

The analysis also revealed racial and educational disparities between people giving birth in a hospital and those delivering at home or in a free-standing birth center last year.

Whites gave birth outside hospitals at a rate twice that of African Americans, about four times that of Hispanics and about six times that of Asians. In addition, people with a four-year college degree gave birth outside hospitals at a rate almost three times that of people without a four-year degree, state figures show.

Those numbers likely reflect long-standing socioeconomic disparities in health care that are exacerbated by the unwillingness of some insurance companies to cover births outside a hospital, said Katherine Hemple, a legislative consultant for the California Association of Licensed Midwives.

Also, Medi-Cal, the public insurance program for low-income Californians, typically does not cover at-home births, a policy that is the subject of intense debate. The program is more likely to cover deliveries in midwife-run birthing centers.

A client paying with cash for a delivery at the California Birth Center or Best Start Birth Center will be charged around $8,000, officials at those facilities said. By comparison, the average out-of-pocket cost for families nationwide with employer-based insurance giving birth in a hospital was about $4,500, according to a 2020 study in the journal Health Affairs.

Rosanna Davis, a certified professional midwife and president of the board of directors of the California Association of Licensed Midwives, said the preference for out-of-hospital births would increase even faster if the state and insurance companies offered more financial support for the choice.

“There are significant numbers of people who would choose midwife care,” she said, “but the access is limited.”

Phillip Reese is a data reporting specialist and an assistant professor of journalism at California State University-Sacramento.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Will ‘Dr. Disinformation’ Ever Face the Music?

Kaiser Health News - Wed, 09/22/2021 - 5:00am

Earlier this month, Dr. Rashid Buttar posted on Twitter that covid-19 “was a planned operation” and shared an article alleging that most people who got the covid vaccine would be dead by 2025.

His statement is a recent example in what has been a steady stream of spurious claims surrounding the covid vaccines and treatments that swirl around the public consciousness. Others include testimony in June by Dr. Sherri Jane Tenpenny before Ohio state legislators that the vaccine could cause people to become magnetized. Clips from the hearing went viral on the internet. On April 9, 2020, Dr. Joseph Mercola posted a video titled “Could hydrogen peroxide treat coronavirus?” which was shared more than 4,600 times. In the video, Mercola said inhaling hydrogen peroxide through a nebulizer could prevent or cure covid.

These physicians are identified as members of the “Disinformation Dozen,” a group of top superspreaders of covid vaccine misinformation on social media, according to a 2021 report by the nonprofit Center for Countering Digital Hate. The report, based on an analysis of anti-vaccine content on social media platforms, found that 12 people were responsible for 65% of it. The group is composed of physicians, anti-vaccine activists and people known for promoting alternative medicine.

The physician voices are of particular concern because their medical credentials lend credence to their unproven, often dangerous pronouncements. All three continue to hold medical licenses and have not faced consequences for their covid-related statements.

But leaders of professional medical organizations increasingly are calling for that to change and urging medical oversight boards to take more aggressive action.

In July, the Federation of State Medical Boards, the national umbrella organization for the state-based boards, issued a statement making clear that doctors who generate and spread covid misinformation could be subject to disciplinary action, including the suspension or revocation of their licenses. The American Board of Family Medicine, American Board of Internal Medicine and American Board of Pediatrics issued a joint statement Sept. 9 in support of the state boards’ position, warning that “such unethical or unprofessional conduct may prompt their respective Board to take action that could put their certification at risk.”

And the superspreaders identified by the center’s report are not alone. KHN identified 20 other doctors who have made false or misleading claims about covid by combing through published fact checks and other news coverage.

For example, at an Indiana school board meeting in August, Dr. Dan Stock claimed the surge in covid cases this summer was due to “antibody mediated viral enhancement” from people receiving covid vaccines. PolitiFact rated his claim “Pants on Fire” false.

Dr. Stella Immanuel, a member of a group America’s Frontline Doctors, which has consistently made false statements about covid, said in a video that went viral in July 2020 that masks weren’t needed because covid could be cured by hydroxychloroquine. Immanuel’s website currently promotes a set of vitamins, as well as hydroxychloroquine and ivermectin, as covid treatments.

Two of the doctors mentioned by name in this article responded to requests for comment. Mercola offered documents to rebut criticisms of his hydrogen peroxide covid treatment and took issue with the center’s “Disinformation Dozen” report methodology. Buttar defended his positions, saying via email that “the science is clear and anyone who contests it, has a suspect agenda at best and/or lacks a moral compass.” He also pointed to data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Recording System, considered inconclusive by many experts.

Since the onset of the covid pandemic, misinformation has been widespread on social media platforms. And many experts blame it for undermining efforts to curb the coronavirus’s spread. A recent poll showed that more than 50% of Americans who won’t get vaccinated cited conspiracy theories as their reasons — for example, saying the vaccines cause infertility or alter DNA.

Some physicians have gained notoriety by embracing covid-related fringe ideas, quack treatments and falsehoods via social media, conservative talk shows and even in person with patients. Whether promoting the use of ivermectin, an anti-parasitic drug for animals, or a mix of vitamins to treat covid, doctors’ words can be especially powerful. Public opinion polls consistently show that Americans have high trust in doctors.

“There is a sense of credibility that comes with being a doctor,” said Rachel Moran, a researcher who studies covid misinformation at the University of Washington. “There is also a sense they have access to insider info that we don’t. This is a very confusing time, and it can seem that if anyone knows what I should be doing in this situation, it’s a doctor.”

While covid is a novel and complicated infectious disease, physicians spreading misinformation generally have no particular expertise in infectious diseases. Dr. Scott Atlas, who endorsed former President Donald Trump’s unproven statements about the course of the pandemic, is a radiation oncologist.

Traditionally, the responsibility of policing physicians has fallen to state medical boards. Beyond overseeing the licensing process, these panels investigate complaints about doctors and discipline those who engage in unethical, unprofessional or, in extreme cases, criminal activity. Any member of the public can submit a complaint about a physician.

“The boards are relatively slow and weak and it’s a long, slow process to pull somebody’s license,” said Arthur Caplan, founding head of the Department of Medical Ethics at New York University. “In many states, they have their hands full with doctors who have committed felonies, doctors who are molesting their patients. Keeping an eye on misinformation is somewhat down on the priority list.”

To date, only two doctors have reportedly faced such sanctions. In Oregon, Dr. Steven LaTulippe had his license suspended in December 2020 for refusing to wear a face mask at his clinic and telling patients that masks were ineffective in curbing the spread of covid, and even dangerous. Dr. Thomas Cowan, a San Francisco physician who posted a YouTube video that went viral in March 2020 stating that 5G networks cause covid, voluntarily surrendered his medical license to California’s medical board in February 2021.

Dr. Humayun Chaudhry, president of the Federation of State Medical Boards, however, said it’s possible some doctors could already be the subject of inquiries and investigations, since these actions are not made public until sanctions are handed down.

KHN reached out to the medical and osteopathic boards of all 50 states and the District of Columbia to see if they had received covid misinformation complaints. Of the 43 that responded, only a handful shared specifics.

During a one-week period in August, Kansas’ medical board received six such complaints. In all, the state has received 35 complaints against 20 licensees about spreading covid misinformation on social media and in person. Indiana has received about 30 in the past year. South Carolina said it had about 10 since January. Rhode Island didn’t share the number of complaints but said it has taken disciplinary action against one doctor for spreading misinformation, though it hasn’t moved to suspend his license. (The disciplinary measures include a fine, a reprimand on the doctor’s record and a mandate to complete an ethics course.) Five states said they had received only a couple, and 11 states reported receiving no complaints regarding covid misinformation.

Confidentiality laws in 13 states prevented those boards from sharing information about complaints.

Social media companies have also been slow to take action. Some doctors’ accounts — specifically those among the Disinformation Dozen — have been suspended, but others are still active and posting misinformation.

Imran Ahmed, CEO of the Center for Countering Digital Hate, said social media platforms often don’t consistently apply their rules against spreading misinformation.

“Even when it’s the same companies, Facebook will sometimes take posts down, but Instagram will not,” Ahmed said, referring to Facebook’s ownership of Instagram. “It goes to show their piecemeal, ineffective approach to enforcing their own rules.”

A Facebook spokesperson said the company has removed over 3,000 accounts, pages and groups for repeatedly violating covid and vaccine misinformation policies since the beginning of the pandemic. Buttar’s Facebook and Instagram pages and Tenpenny’s Facebook page have been removed, while Mercola’s Facebook posts have been demoted, which means fewer people will see them. Tenpenny and Mercola still have Instagram accounts.

Part of the challenge may be that these doctors sometimes present scientific opinions that aren’t mainstream but are viewed as potentially valid by some of their colleagues.

“It can be difficult to prove that what is being said is outside the range of scientific and medical consensus,” said Caplan. “The doctors who were advising Trump — like Scott Atlas — recommended herd immunity. That was far from the consensus of epidemiologists, but you couldn’t get a board to take his license away because it was a fringe opinion.”

Even if these physicians don’t face consequences, it is likely, experts said, that the public health will.

“Medical misinformation doesn’t just result in people making bad personal and community health choices, but it also divides communities and families, leaving an emotional toll,” said Moran, the University of Washington researcher. “Misinformation narratives have real sticking power and impact people’s ability to make safe health choices.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care

Public Health Experts ‘Flabbergasted’ That Biden Still Hasn’t Picked an FDA Chief

Kaiser Health News - Wed, 09/22/2021 - 5:00am

President Joe Biden’s failure to name someone to lead the Food and Drug Administration, more than 10 months after the election, has flummoxed public health experts who say it’s baffling for the agency to be without a permanent leader during a national health crisis.

The pandemic has taxed the FDA, an 18,000-person agency whose chiefs have traditionally received bipartisan backing during the Senate confirmation process. Many leaders in public health, industry and consumer groups agree that Biden’s foot-dragging on finding a new director has demoralized the staff and sent the wrong message about the agency’s importance, even as the toll of covid-19 mounts, with an average of 130,000 new cases and 1,500 deaths daily, according to the Centers for Disease Control and Prevention.

It’s a tough job in normal times, observers say, and at the moment may be the worst top job in Washington. At the heart of the tension is finding a nominee who balances the agency’s dual responsibilities of protecting public health while also working with the drug, medical device and other industries to approve products and treatments for market. Meanwhile, the agency has been mired in controversies related to drug approvals and covid vaccines, and discord over decisions has spilled into public view.

FDA commissioner is a “particularly rough job in wartime,” said Steven Grossman, executive director of the Alliance for a Stronger FDA, an outside organization consisting of industry, research and other groups, which pushes for Congress to increase agency funding. “It is a much more difficult post to fill than it appears to the eye.”

Dr. Janet Woodcock, an agency veteran of three decades, has for months led as acting commissioner. She commands broad respect. But her perceived closeness to the drug industry, particularly with respect to the agency’s role in the opioid crisis, led some Senate Democrats to come out against her official assumption of the role. Biden would need all Democrats on board or some Republican senators to back his choice to get the votes for confirmation.

In December, Biden announced other top health appointees who would helm his pandemic response, including Health and Human Services Secretary Xavier Becerra, Surgeon General Vivek Murthy and CDC Director Rochelle Walensky. HHS oversees the FDA — as it does the office of the Surgeon General, the CDC and the National Institutes of Health.

But still no sign of an FDA nomination. Biden officials reportedly considered multiple potential candidates throughout the spring, including Woodcock; former top FDA official and Maryland health secretary Joshua Sharfstein; former FDA official Michelle McMurry-Heath; and Scripps Research Translational Institute director Dr. Eric Topol (who confirmed to KHN he wasn’t interested). Then the process seemed to deadlock.

“People are just flabbergasted,” said Dr. John Whyte, chief medical officer of WedMD and former FDA official. “We don’t even have rumors of viable candidates.”

Many of the agency’s other critical responsibilities require sustained leadership even as the FDA urgently vets covid treatments, tests and vaccines, according to people in public health, the health care industry and consumer groups. The FDA oversees much of the nation’s food supply and the regulation of tobacco products, and reviews everything from stents and catheters to cancer drugs.

Long-term decisions on tobacco regulation can’t wait, said Matthew Myers, president of the Campaign for Tobacco-Free Kids, which has pushed the FDA to move quickly to implement a ban on menthol cigarettes — something it announced in April — and decide which e-cigarettes can stay on the market. This month the agency punted on whether it would ban the sale of e-cigarettes from several major companies, including Juul, the largest maker of such products.

“What the FDA does over the next weeks or months with regard to e-cigarettes will determine whether we have a decades-long youth e-cigarette epidemic or whether we reverse it now,” Myers said. “Waiting for a new commissioner is not an option.”

He and others conceded that, regardless of qualifications, an acting commissioner’s ability to set priorities is diminished. That adds to anxiety about a leadership vacuum, even though few doubt Woodcock’s expertise.

“One significant disadvantage to being ‘acting’ is there is no time frame of how long that individual will be in that position,” said Dr. Andrew von Eschenbach, FDA commissioner in the George W. Bush administration. As important work is executed, “there is no certainty” how long an acting leader is “going to be there” to see it through, he said. “That’s an instability that is very, very difficult to deal with.”

For agency staffers, it stings to see other physicians in the Biden administration speak publicly on issues squarely in the agency’s purview, said Stacy Cline Amin, a partner at law firm Morrison & Foerster and former chief counsel of the agency.

“It’s been a morale hit for FDA,” she said.

Under federal law, Woodcock can serve as acting commissioner until mid-November unless Biden nominates a permanent commissioner, in which case she can remain until that person is confirmed by the Senate.

“People are anxious,” said Ellen Sigal, founder of the influential nonprofit Friends of Cancer Research, which receives funding from the pharmaceutical industry and supported Woodcock for the job. “Is it going to be someone that knows the agency? Is it going to be someone that people really respect and really want to work with?”

The FDA is overwhelmingly run by career scientists whose jobs don’t depend on who wins the White House. Any Senate-confirmed leader largely defers to the scientists who run FDA divisions to make decisions on products, according to former officials and experts with knowledge of the agency’s inner workings. For example, an FDA spokesperson said Woodcock was not involved in the controversial decision to approve Aduhelm, a costly Alzheimer’s drug manufactured by Biogen that went to market even though experts say there’s little evidence it works. But in July, the lingering controversy led Woodcock to ask the HHS Office of Inspector General to “conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm.”

A leader appointed by the president and confirmed by the Senate has clout in setting priorities, hiring staff and making long-term decisions.

“The commissioner has obviously tremendous influence … not on a product-by-product basis but what the philosophy is,” related to the regulatory process, said Scott Whitaker, president and CEO of AdvaMed, which lobbies for the medical device industry. The expressed paradigm “can impact how you think about developing products.”

Others said Biden’s speed in announcing a nominee is less important than selecting the right one, a calculation that’s especially fraught given the agency’s recent controversies.

Chief among them was the criticism from several scientists after the Biden administration announced a plan for widespread covid “booster” shots beginning Sept. 20, well before agency scientists had finished necessary reviews. Woodcock had signed onto an HHS statement announcing the plan, but some experts said the proposal came too far ahead of the science and unfairly jammed her staff. Two veteran FDA officials who have announced their retirements were part of an international group of scientists that published an essay in The Lancet questioning whether the general public needed additional vaccine doses at this time.

The FDA was expected to authorize booster shots for high-risk patients and those 65 and older, following the recommendation Friday of an advisory panel that overwhelmingly rejected the administration’s initial plan to offer extra shots for the general population, citing a need for additional research.

The White House didn’t respond to questions about why Biden hasn’t nominated someone as FDA commissioner or set a timeline for doing so.

“If it takes a little longer to get the right person who’s going to be more aligned in protecting public health and represent interests of the public, as opposed to the interest of industry, which is what the case has been for many years under Dr. Woodcock, then it may be worth the wait,” said Dr. Michael Carome, director of the health research group at Public Citizen, a liberal advocacy group that opposed Woodcock’s nomination. The FDA referred a request for comment to the White House, which didn’t respond.

Sigal sees it differently.

“FDA approves drugs, and they have to work with industry,” she said. “The fact that you work with industry on drug development or on diagnostics with developers, or you work with people that are manufacturing food, with manufacturers or whatever — it’s what the agency does.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.


This story can be republished for free (details).

Categories: Health Care
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