When dermatologist Adewole “Ade” Adamson sees people spritzing sunscreen as if it’s cologne at the pool where he lives in Austin, Texas, he wants to intervene. “My wife says I shouldn’t,” he said, “even though most people rarely use enough sunscreen.”

At issue is not just whether people are using enough sunscreen, but what ingredients are in it.

The Food and Drug Administration’s ability to approve the chemical filters in sunscreens that are sold in countries such as Japan, South Korea, and France is hamstrung by a 1938 U.S. law that requires sunscreens to be tested on animals and classified as drugs, rather than as cosmetics as they are in much of the world. So Americans are not likely to get those better sunscreens — which block the ultraviolet rays that can cause skin cancer and lead to wrinkles — in time for this summer, or even the next.

Sunscreen makers say that requirement is unfair because companies including BASF Corp. and L’Oréal, which make the newer sunscreen chemicals, submitted safety data on sunscreen chemicals to the European Union authorities some 20 years ago.

Steven Goldberg, a retired vice president of BASF, said companies are wary of the FDA process because of the cost and their fear that additional animal testing could ignite a consumer backlash in the European Union, which bans animal testing of cosmetics, including sunscreen. The companies are asking Congress to change the testing requirements before they take steps to enter the U.S. marketplace.

In a rare example of bipartisanship last summer, Sen. Mike Lee (R-Utah) thanked Rep. Alexandria Ocasio-Cortez (D-N.Y.) for urging the FDA to speed up approvals of new, more effective sunscreen ingredients. Now a bipartisan bill is pending in the House that would require the FDA to allow non-animal testing.

“It goes back to sunscreens being classified as over-the-counter drugs,” said Carl D’Ruiz, a senior manager at DSM-Firmenich, a Switzerland-based maker of sunscreen chemicals. “It’s really about giving the U.S. consumer something that the rest of the world has. People aren’t dying from using sunscreen. They’re dying from melanoma.”

Every hour, at least two people die of skin cancer in the United States. Skin cancer is the most common cancer in America, and 6.1 million adults are treated each year for basal cell and squamous cell carcinomas, according to the Centers for Disease Control and Prevention. The nation’s second-most-common cancer, breast cancer, is diagnosed about 300,000 times annually, though it is far more deadly.

Dermatologists Offer Tips on Keeping Skin Safe and Healthy

– Stay in the shade during peak sunlight hours, 10 a.m. to 4 p.m. daylight time.– Wear hats and sunglasses.– Use UV-blocking sun umbrellas and clothing.– Reapply sunscreen every two hours.You can order overseas versions of sunscreens from online pharmacies such as Cocooncenter in France. Keep in mind that the same brands may have different ingredients if sold in U.S. stores. But importing your sunscreen may not be affordable or practical. “The best sunscreen is the one that you will use over and over again,” said Jane Yoo, a New York City dermatologist.

Though skin cancer treatment success rates are excellent, 1 in 5 Americans will develop skin cancer by age 70. The disease costs the health care system $8.9 billion a year, according to CDC researchers. One study found that the annual cost of treating skin cancer in the United States more than doubled from 2002 to 2011, while the average annual cost for all other cancers increased by just 25%. And unlike many other cancers, most forms of skin cancer can largely be prevented — by using sunscreens and taking other precautions.

But a heavy dose of misinformation has permeated the sunscreen debate, and some people question the safety of sunscreens sold in the United States, which they deride as “chemical” sunscreens. These sunscreen opponents prefer “physical” or “mineral” sunscreens, such as zinc oxide, even though all sunscreen ingredients are chemicals.

“It’s an artificial categorization,” said E. Dennis Bashaw, a retired FDA official who ran the agency’s clinical pharmacology division that studies sunscreens.

Still, such concerns were partly fed by the FDA itself after it published a study that said some sunscreen ingredients had been found in trace amounts in human bloodstreams. When the FDA said in 2019, and then again two years later, that older sunscreen ingredients needed to be studied more to see if they were safe, sunscreen opponents saw an opening, said Nadim Shaath, president of Alpha Research & Development, which imports chemicals used in cosmetics.

“That’s why we have extreme groups and people who aren’t well informed thinking that something penetrating the skin is the end of the world,” Shaath said. “Anything you put on your skin or eat is absorbed.”

Adamson, the Austin dermatologist, said some sunscreen ingredients have been used for 30 years without any population-level evidence that they have harmed anyone. “The issue for me isn’t the safety of the sunscreens we have,” he said. “It’s that some of the chemical sunscreens aren’t as broad spectrum as they could be, meaning they do not block UVA as well. This could be alleviated by the FDA allowing new ingredients.”

Ultraviolet radiation falls between X-rays and visible light on the electromagnetic spectrum. Most of the UV rays that people come in contact with are UVA rays that can penetrate the middle layer of the skin and that cause up to 90% of skin aging, along with a smaller amount of UVB rays that are responsible for sunburns.

The sun protection factor, or SPF, rating on American sunscreen bottles denotes only a sunscreen’s ability to block UVB rays. Although American sunscreens labeled “broad spectrum” should, in theory, block UVA light, some studies have shown they fail to meet the European Union’s higher UVA-blocking standards.

“It looks like a number of these newer chemicals have a better safety profile in addition to better UVA protection,” said David Andrews, deputy director of Environmental Working Group, a nonprofit that researches the ingredients in consumer products. “We have asked the FDA to consider allowing market access.”

The FDA defends its review process and its call for tests of the sunscreens sold in American stores as a way to ensure the safety of products that many people use daily, rather than just a few times a year at the beach.

“Many Americans today rely on sunscreens as a key part of their skin cancer prevention strategy, which makes satisfactory evidence of both safety and effectiveness of these products critical for public health,” Cherie Duvall-Jones, an FDA spokesperson, wrote in an email.

D’Ruiz’s company, DSM-Firmenich, is the only one currently seeking to have a new over-the-counter sunscreen ingredient approved in the United States. The company has spent the past 20 years trying to gain approval for bemotrizinol, a process D’Ruiz said has cost $18 million and has advanced fitfully, despite attempts by Congress in 2014 and 2020 to speed along applications for new UV filters.

Bemotrizinol is the bedrock ingredient in nearly all European and Asian sunscreens, including those by the South Korean brand Beauty of Joseon and Bioré, a Japanese brand.

D’Ruiz said bemotrizinol could secure FDA approval by the end of 2025. If it does, he said, bemotrizinol would be the most vetted and safest sunscreen ingredient on the market, outperforming even the safety profiles of zinc oxide and titanium dioxide.

As Congress and the FDA debate, many Americans have taken to importing their own sunscreens from Asia or Europe, despite the risk of fake products.

“The sunscreen issue has gotten people to see that you can be unsafe if you’re too slow,” said Alex Tabarrok, a professor of economics at George Mason University. “The FDA is just incredibly slow. They’ve been looking at this now literally for 40 years. Congress has ordered them to do it, and they still haven’t done it.”

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

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When doctors began using the drug sotorasib in 2021 with high expectations for its innovative approach to attacking lung cancer, retired medical technician Don Crosslin was an early beneficiary. Crosslin started the drug that July. His tumors shrank, then stabilized.

But while the drug has helped keep him alive, its side effects have gradually narrowed the confines of his life, said Crosslin, 76, who lives in Ocala, Florida: “My appetite has been minimal. I’m very weak. I walk my dogs and get around a bit, but I haven’t been able to golf since last July.”

He wonders whether he’d do better on a lower dose, “but I do what my oncologist tells me to do,” Crosslin said. Every day, he takes eight of the 120-milligram pills, sold under Amgen’s brand name Lumakras.

Crosslin’s concern lies at the heart of an FDA effort to make cancer drugs less toxic and more effective. Cancer drug trials are structured to promote high doses, which then become routine patient care. In the face of evidence that thousands of patients become so ill that they skip doses or stop taking the drugs — thereby risking resurgence of their cancers — the FDA has begun requiring companies to pinpoint the right dosage before they reach patients.

The initiative, Project Optimus, launched in 2021 just as Amgen was seeking to market sotorasib. At the time, the FDA’s leading cancer drug regulator, Richard Pazdur, co-authored an editorial in the New England Journal of Medicine that said Amgen’s trials of the $20,000-a-month drug were “hampered by a lack of robust dose exploration.”

The FDA conditionally approved sotorasib but required Amgen to conduct a study comparing the labeled dosage of 960 mg with a dosage of 240 mg. The trial, published in November, showed that the 960-mg dose may have given patients a month more of life, on average, but caused more severe side effects than the lower dose.

Amgen is keeping the 960-mg dosage as it conducts further tests to get final approval for the drug, spokesperson Elissa Snook said, adding that the dose showed superiority in one study. Whether medically justified or not, the heavier dosage allows the company to protect 75% of its revenue from the drug, which brought in nearly $200 million in the United States last year.

And there appears to be nothing the FDA can do about it.

“There’s a gap in FDA’s authority that results in patients getting excess doses of a drug at excess costs,” said Mark Ratain, a University of Chicago oncologist who has pushed for more accurate cancer drug dosing. “We should do something about this.”

Deciding on Dosage

It may be too late for the FDA to change the sotorasib dosage, although in principle it could demand a new regimen before granting final approval, perhaps in 2028. Under Project Optimus, however, the agency is doing something about dosage guidelines for future drugs. It is stressing dose optimization in its meetings with companies, particularly as they prepare to test drugs on patients for the first time, spokesperson Lauren-Jei McCarthy said.

“When you go in front of FDA with a plan to approve your drug now, they are going to address dosing studies,” said Julie Gralow, chief medical officer of the American Society of Clinical Oncology. “A lot of companies are struggling with this.”

That’s largely because the new requirements add six months to a year and millions in drug development costs, said Julie Bullock, a former FDA drug reviewer who advocated for more extensive dosing studies and is now senior vice president at Certara, a drug development consultancy.

In part, Project Optimus represents an effort to manage the faults of the FDA’s accelerated approval process, begun in 1992. While the process gets innovative drugs to patients more quickly, some medicines have proved lackluster or had unacceptable side effects.

That’s especially true of the newer pills to treat cancer, said Donald Harvey, an Emory University pharmacology professor, who has led or contributed to more than 100 early-phase cancer trials.

A study released last month in the Journal of the American Medical Association showed that 41% of the cancer drugs granted accelerated approval from 2013 to 2017 did not improve overall survival or quality of life after five years.

Many of these drugs flop because they must be given at toxic dosages to have any effect, Harvey said, adding that sotorasib might work better if the company had found an appropriate dosage earlier on.

“Sotorasib is a poster child for incredibly bad development,” Harvey said. The drug was the first to target the KRAS G12C mutation, which drives about 15% of lung cancers and was considered “undruggable” until University of California-San Francisco chemist Kevan Shokat figured out how to attack it in 2012.

Given the specificity of sotorasib’s target, Harvey said, Amgen could have found a lower dosage. “Instead, they followed the old model and said, ‘We’re going to push the dose up until we see a major side effect.’ They didn’t need to do that. They just needed more experience with a lower dose.”

The 960-mg dose “is really tough on patients,” said Yale University oncologist and assistant professor Michael Grant. “They get a lot of nausea and other GI side effects that are not pleasant. It hurts their quality of life.”

The FDA noted in its review of sotorasib that in phase 1 studies tumors shrank when exposed to as little as a fifth of the 960-mg daily dose Amgen selected. At all doses tested in that early trial, the drug reached roughly the same concentrations in the blood, which suggested that at higher doses the drug was mostly just intensifying side effects like diarrhea, vomiting, and mouth sores.

For most classes of drugs, companies spend considerable time in phases 1 and 2 of development, homing in on the right dosage. “No one would think of dosing a statin or antibiotic at the highest tolerable dose,” Ratain said.

Things are different in cancer drug creation, whose approach originated with chemotherapy, which damages as many cancer cells as possible, wrecking plenty of healthy tissue in the bargain. Typically, a company’s first series of cancer drug trials involve escalating doses in small groups of patients until something like a quarter of them get seriously ill. That “maximum tolerated dose” is then employed in more advanced clinical trials, and goes on the drug’s label. Once a drug is approved, a doctor can “go off-label” and alter the dosage, but most are leery of doing so.

Patients can find the experience rougher than advertised. During clinical trials, the side effects of the cancer drug osimertinib (Tagrisso) were listed as tolerable and manageable, said Jill Feldman, a lung cancer patient and advocate. “That killed me. After two months on that drug, I had lost 15 pounds, had sores in my mouth and down my throat, stomach stuff. It was horrible.”

Some practitioners, at least, have responded to the FDA’s cues on sotorasib. In the Kaiser Permanente health system, lung cancer specialists start with a lower dose of the drug, spokesperson Stephen Shivinsky said.

Smaller Doses — And Revenue

Amgen was clearly aware of the advantages of the 240-mg dosage before it sought FDA approval: It filed a provisional patent application on that dosage before the agency gave breakthrough approval for the drug at 960 mg. The company doesn’t appear to have disclosed the patent filing to investors or the FDA. McCarthy said the FDA was prohibited by law from discussing the particulars of its sotorasib regulation plans.

Switching to a 240-mg dosage could register a huge hit to Amgen’s revenue. The company markets the drug at more than $20,000 for a month of 960-mg daily doses. Each patient who could get by with a quarter of that would trim the company’s revenue by roughly $180,000 a year.

Amgen declined to comment on the patent issue or to make an official available to discuss the dosage and pricing issues.

Crosslin, who depends on Social Security for his income, couldn’t afford the $3,000 a month that Medicare required him to pay for sotorasib, but he has received assistance from Amgen and a charity that covers costs for patients below a certain income.

While the drug has worked well for Crosslin and other patients, its overall modest impact on lung cancer suggests that $5,000, rather than $20,000, might be a more appropriate price, Ratain said.

In the company’s phase 3 clinical trial for advanced lung cancer patients, sotorasib kept patients alive for about a month longer than docetaxel, the current, highly toxic standard of care. Docetaxel is a generic drug for which Medicare pays about $1 per injection. The trial was so unconvincing that the FDA sent Amgen back to do another.

Ratain, a staunch critic of Amgen’s handling of sotorasib, told Centers for Medicare & Medicaid Services officials at a recent meeting that they should pay for sotorasib on a basis of 240 mg per day. But CMS would do that only “if there is a change in the drug’s FDA-approved dosage,” spokesperson Aaron Smith said.

Drug companies generally don’t want to spend money on trials like the one the FDA ordered on sotorasib. In 2018, Ratain and other researchers used their institutions’ funding to conduct a dosing trial on the prostate cancer drug abiraterone, marketed under the brand name Zytiga by Johnson & Johnson. They found that taking one 250-mg pill with food was just as effective as taking four on an empty stomach, as the label called for.

Although J&J hasn’t changed the Zytiga label, the evidence generated in that trial was strong enough for the standards-setting National Comprehensive Cancer Network to change its recommendations.

Post-marketing studies like that one are hard to conduct, Emory’s Harvey said. Patients are reluctant to join a trial in which they may have to take a lower dosage, since most people tend to believe “the more the better,” he said.

“It’s better for everyone to find the right dose before a drug is out on the market,” Harvey said. “Better for the patient, and better for the company, which can sell more of a good drug if the patients aren’t getting sick and no longer taking it.”

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

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President Joe Biden counts among his accomplishments the record-high number of people, more than 21 million, who enrolled in Obamacare plans this year. Behind the scenes, however, federal regulators are contending with a problem that affects people’s coverage: rogue brokers who have signed people up for Affordable Care Act plans, or switched them into new ones, without their permission.

Fighting the problem presents tension for the administration: how to thwart the bad actors without affecting ACA sign-ups.

Complaints about these unauthorized changes — which can cause affected policyholders to lose access to medical care, pay higher deductibles, or even incur surprise tax bills — rose sharply in recent months, according to brokers who contacted KFF Health News and federal workers who asked not to be identified.

Ronnell Nolan, president and CEO of the trade association Health Agents for America, said her group has suggested to the Centers for Medicare & Medicaid Services that it add two-factor authentication to healthcare.gov or send text alerts to consumers if an agent tries to access their accounts. But the agency told her it doesn’t always have up-to-date contact information.

“We’ve given them a whole host of ideas,” she said. “They say, ‘Be careful what you wish for.’ But we don’t mind going an extra step if you can stop this fraud and abuse, because clients are being hurt.”

Some consumers are pursued when they respond to misleading social media marketing ads promising government subsidies, but most have no idea how they fell victim to plan-switching. Problems seem concentrated in the 32 states using the federal exchange.

Federal regulators have declined to say how many complaints about unauthorized sign-ups or plan switches they’ve received, or how many insurance agents they’ve sanctioned as a result. But the problem is big enough that CMS says it’s working on technological and regulatory solutions. Affected consumers and agents have filed a civil lawsuit in federal district court in Florida against private-sector firms allegedly involved in unauthorized switching schemes.

Biden has pushed hard to make permanent the enhanced subsidies first put in place during the covid pandemic that, along with other steps including increased federal funding for outreach, helped fuel the strong enrollment growth. Biden contrasts his support for the ACA with the stance of former President Donald Trump, who supported attempts to repeal most of the law and presided over funding cuts and declining enrollment.

Most proposed solutions to the rogue-agent problem involve making it more difficult for agents to access policyholder information or requiring wider use of identity questions tied to enrollees’ credit history. The latter could be stumbling blocks for low-income people or those with limited financial records, said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University.

“That is the knife edge the administration has to walk,” said Corlette, “protecting consumers from fraudulent behavior while at the same time making sure there aren’t too many barriers.”

Jeff Wu, acting director of the Center for Consumer Information & Insurance Oversight, said in a statement that the agency is evaluating options on such factors as how effective they would be, their impact on consumers’ ability to enroll, and how fast they could be implemented.

The agency is also working closely, he wrote, with insurance companies, state insurance departments, and law enforcement “so that agents violating CMS rules or committing fraud face consequences.” And it is reaching out to states that run their own ACA markets for ideas.

That’s because Washington, D.C., and the 18 states that run their own ACA marketplaces have reported far fewer complaints about unauthorized enrollment and plan-switching. Most include layers of security in addition to those the federal marketplace has in place — some use two-factor authentication — before agents can access policyholder information.

California, for example, allows consumers to designate an agent and to “log in and add or remove an agent at will,” said Robert Kingston, interim director of outreach and sales for Covered California, the state’s ACA marketplace. The state can also send consumers a one-time passcode to share with an agent of their choice. Consumers in Colorado and Pennsylvania can similarly designate specific agents to access their accounts.

By contrast, agents can more easily access policyholder information when using private-sector websites that link them to the federal ACA market — all they need is a person’s name, date of birth, and state of residence — to enroll them or switch their coverage.

CMS has approved dozens of such “enhanced direct enrollment” websites run by private companies, which are designed to make it easier and faster for agents certified to offer insurance through healthcare.gov.

Rules went into effect last June requiring agents to get written or recorded consent from clients before enrolling them or changing their coverage, but brokers say they’re rarely asked to produce the documentation. If CMS makes changes to healthcare.gov — such as adding passcodes, as California has — it would need to require all alternative-enrollment partners to do the same.

The largest is San Francisco-based HealthSherpa, which assisted 52% of active enrollments nationally for this year, said CEO George Kalogeropoulos.

The company has a 10-person fraud investigation team, he said, which has seen “a significant spike in concerns about unauthorized switching.” They report problems to state insurance departments, insurance carriers, and federal regulators “and refer consumers to advocates on our team to make sure their plans are corrected.”

Solutions must be “targeted,” he said. “The issue with some of the solutions proposed is it negatively impacts the ability of all consumers to get enrolled.”

Most people who sign up for ACA plans are aided by agents or platforms like HealthSherpa, rather than doing it themselves or seeking help from nonprofit organizations. Brokers don’t charge consumers; instead, they receive commissions from insurers participating in state and federal marketplaces for each person they enroll in a plan.

While California officials say their additional layers of authentication have not noticeably affected enrollment numbers, the state’s recent enrollment growth has been slower than in states served by healthcare.gov.

Still, Covered California’s Kingston pointed to a decreased number of uninsured people in the state. In 2014, when much of the ACA was implemented, 12.5% of Californians were uninsured, falling to 6.5% in 2022, according to data compiled by KFF. That year, the share of people uninsured nationwide was 8%.

Corlette said insurers have a role to play, as do states and CMS.

“Are there algorithms that can say, ‘This is a broker with outlier behavior’?” Insurance companies could then withhold commissions “until they can figure it out,” she said.

Kelley Schultz, vice president of commercial policy at AHIP, the trade association for large insurance companies, said sharing more information from the government marketplace about which policies are being switched could help insurers spot patterns.

CMS could also set limits on plan switches, as there is generally no legitimate need for multiple changes in a given month, Schultz said.

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

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Researchers developed a novel nanoparticle that can cross the blood-brain barrier to target both primary breast tumors and brain metastases simultaneously. This dual-action approach utilizes a biodegradable polymer loaded with two prodrugs targeting cancer cell mitochondria.

A novel study sheds new light on the link between the APOE4 gene and Alzheimer’s disease. The study reveals that over 95% of individuals over 65 who have two copies of the APOE4 gene exhibit biological markers of Alzheimer’s in the brain or through cerebrospinal fluid and PET scans.

Los titulares explotaron después que el Departamento de Agricultura confirmara que el virus de la gripe aviar H5N1 ha infectado a vacas lecheras en todo el país.

Las pruebas han detectado el virus en el ganado en nueve estados, principalmente en Texas y Nuevo México, y más recientemente en Colorado, dijo Nirav Shah, director principal adjunto de los Centros para el Control y Prevención de Enfermedades (CDC), en un evento del 1 de mayo.

Otros animales, y al menos una persona en Texas, también se infectaron con el H5N1. Pero lo que más temen los científicos es si el virus se propagara de manera eficiente de persona a persona. Eso no ha sucedido y podría no suceder. Shah dijo que los CDC consideran que el brote de H5N1 “es un riesgo bajo para el público en general en este momento”.

Los virus evolucionan y los brotes pueden cambiar rápidamente. “Como con cualquier brote importante, esto se mueve a la velocidad de un tren bala”, dijo Shah. “De lo que hablamos ahora es de un instantánea de ese tren que se mueve rápidamente”. Lo que quiere decir es que lo que hoy se sabe sobre la gripe aviar H5N1 seguramente cambiará.

Con eso en mente, KFF Health News explica lo que se necesita saber ahora.

¿Quién contrae el virus que causa la gripe aviar?

Principalmente las aves. Sin embargo, en los últimos años, el virus de la gripe aviar H5N1 ha estado saltando cada vez más de las aves a los mamíferos en todo el mundo. La creciente lista, de más de 50 especies, incluye focas, cabras, zorrinos, gatos y perros salvajes en un zoológico en el Reino Unido. Al menos 24,000 leones marinos murieron en brotes de gripe aviar H5N1 en Sudamérica el año pasado.

Lo que hace que el brote actual en el ganado sea inusual es que se está propagando rápidamente de vaca a vaca, mientras que los otros casos, excepto las infecciones de leones marinos, parecen limitados. Los investigadores saben esto porque las secuencias genéticas de los virus H5N1 extraídos de las vacas este año eran casi idénticas entre sí.

El brote de ganado también preocupa porque agarró al país desprevenido. Los investigadores que examinan los genomas del virus sugieren que originalmente se transmitió de las aves a las vacas a finales del año pasado en Texas, y desde entonces se ha propagado entre muchas más vacas de las que se han examinado.

“Nuestros análisis muestran que esto ha estado circulando en vacas durante unos cuatro meses, bajo nuestras narices”, dijo Michael Worobey, biólogo especializado en evolución de la Universidad de Arizona en Tucson.

¿Es este el comienzo de la próxima pandemia?

Aún no. Pero es algo que vale la pena considerar porque una pandemia de gripe aviar sería una pesadilla. Más de la mitad de las personas infectadas por cepas anteriores del virus de la gripe aviar H5N1 de 2003 a 2016 murieron.

Incluso si las tasas de mortalidad resultan ser menos severas para la cepa H5N1 que circula actualmente en el ganado, las repercusiones podrían implicar muchas personas enfermas y hospitales demasiado abrumados para manejar otras emergencias médicas.

Aunque al menos una persona se infectó con el H5N1 este año, el virus no puede provocar una pandemia en su estado actual.

Para alcanzar este horrible estatus, un patógeno necesita enfermar a muchas personas en varios continentes. Y para lograrlo, el virus H5N1 necesitaría infectar a toneladas de personas. Eso no sucederá a través de saltos ocasionales del virus de los animales de granja a las personas. Más bien, el virus debe adquirir mutaciones para propagarse de persona a persona, como la gripe estacional, como una infección respiratoria transmitida principalmente por el aire cuando las personas tosen, estornudan y respiran.

Como aprendimos de covid-19, los virus transmitidos por el aire son difíciles de frenar.

Eso aún no ha sucedido. Sin embargo, los virus H5N1 ahora tienen muchas oportunidades para evolucionar a medida que se replican dentro de los organismos de miles de vacas. Como todos los virus, mutan a medida que se replican, y las mutaciones que mejoran la supervivencia del virus se transmiten a la próxima generación. Y debido a que las vacas son mamíferos, los virus podrían estar mejorando en reproducirse dentro de células más cercanas a las nuestras que las de las aves.

La evolución de un virus de gripe aviar listo para una pandemia podría facilitarse por una especie de superpoder que poseen muchos virus. Es decir, a veces intercambian sus genes con otras cepas en un proceso llamado recombinación.

En un estudio publicado en 2009, Worobey y otros investigadores rastrearon el origen de la pandemia del virus de la gripe porcina H1N1 en eventos en los que diferentes virus que causaban esta gripe, la gripe aviar y la gripe humana mezclaban y combinaban sus genes dentro de cerdos que se estaban infectando simultáneamente. Los cerdos no necesitan estar involucrados esta vez, advirtió Worobey.

¿Comenzará una pandemia si una persona bebe leche contaminada con el virus?

Aún no. La leche de vaca, así como la leche en polvo y la fórmula infantil, que se venden en tiendas se consideran seguras porque la ley requiere que toda la leche vendida comercialmente sea pasteurizada. Este proceso de calentar la leche a altas temperaturas mata bacterias, virus y otros microorganismos.

Las pruebas han identificado fragmentos de virus H5N1 en la leche comercial, pero confirman que los fragmentos del virus están muertos y, por lo tanto, son inofensivos.

Sin embargo, la leche “cruda” no pasteurizada ha demostrado contener virus H5N1 vivos, por eso la Administración de Drogas y Alimentos (FDA) y otras autoridades sanitarias recomiendan firmemente a las personas que no la tomen, porque podrían enfermarse de gravedad o algo peor.

Pero, aún así, es poco probable que se desate una pandemia porque el virus, en su forma actual, no se propaga eficientemente de persona a persona, como lo hace, por ejemplo, la gripe estacional.

¿Qué se debe hacer?

¡Mucho! Debido a la falta de vigilancia, el Departamento de Agricultura (USDA) y otras agencias han permitido que la gripe aviar H5N1 se propague en el ganado, sin ser detectada. Para hacerse cargo de la situación, el USDA recientemente ordenó que se sometan a pruebas a todas las vacas lecheras en lactancia antes que los ganaderos las trasladen a otros estados, y que se informen los resultados de las pruebas.

Pero al igual que restringir las pruebas de covid a los viajeros internacionales a principios de 2020 permitió que el coronavirus se propagara sin ser detectado, testear solo a las vacas que se mueven entre estados dejaría pasar muchos casos.

Estas pruebas limitadas no revelarán cómo se está propagando el virus entre el ganado, información que los ganaderos necesitan desesperadamente para frenarlo. Una hipótesis principal es que los virus se están transfiriendo de una vaca a la siguiente a través de las máquinas utilizadas para ordeñarlas.

Para aumentar las pruebas, Fred Gingrich, director ejecutivo de la American Association of Bovine Practitioners, dijo que el gobierno debería ofrecer fondos a los ganaderos para que informen casos y así tengan un incentivo para hacer pruebas. De lo contrario, dijo, informar solo daña la reputación por encima de las pérdidas financieras.

“Estos brotes tienen un impacto económico significativo”, dijo Gingrich. “Los ganaderos pierden aproximadamente el 20% de su producción de leche en un brote porque los animales dejan de comer, producen menos leche, y parte de esa leche es anormal y no se puede vender”.

Gingrich agregó que el gobierno ha hecho gratuitas las pruebas de H5N1 para los ganaderos, pero no han presupuestado dinero para los veterinarios que deben tomar muestras de las vacas, transportar las muestras y presentar los documentos. “Las pruebas son la parte menos costosa”, explicó.

Si las pruebas en las granjas siguen siendo esquivas, los virólogos aún pueden aprender mucho analizando secuencias genómicas del virus H5N1 de muestras de ganado. Las diferencias entre las secuencias cuentan una historia sobre dónde y cuándo comenzó el brote actual, el camino que recorre y si los virus están adquiriendo mutaciones que representan una amenaza para las personas.

Sin embargo, esta investigación vital se ha visto obstaculizada porque el USDA publica los datos incompletos y con cuentagotas, dijo Worobey.

El gobierno también debería ayudar a los criadores de aves de corral a prevenir brotes de H5N1, ya que estos matan a muchas aves y representan una amenaza constante de potenciales saltos de especies, dijo Maurice Pitesky, especialista en enfermedades de aves de la Universidad de California-Davis.

Las aves acuáticas como los patos y los gansos son las fuentes habituales de brotes en granjas avícolas, y los investigadores pueden detectar su proximidad mediante el uso de sensores remotos y otras tecnologías. Eso puede significar una vigilancia rutinaria para detectar signos tempranos de infecciones en aves de corral, usar cañones de agua para ahuyentar a las bandadas migratorias, reubicar animales de granja o llevarlos temporalmente a cobertizos. “Deberíamos estar invirtiendo en prevención”, dijo Pitesky.

Bien, no es una pandemia, pero ¿qué podría pasarle a las personas que contraigan la gripe aviar H5N1 de este año?

Realmente nadie lo sabe. Solo una persona en Texas fue diagnosticada con la enfermedad este año, en abril. Esta persona trabajaba con vacas lecheras, y tuvo un caso leve con una infección en el ojo. Los CDC se enteraron de esto debido a su proceso de vigilancia. Las clínicas deben alertar a los departamentos de salud estatales cuando diagnostican a trabajadores agrícolas con gripe, utilizando pruebas que detectan virus de la influenza en general.

Los departamentos de salud estatales luego confirman la prueba y, si es positiva, envían una muestra de la persona a un laboratorio de los CDC, donde se verifica específicamente la presencia del virus H5N1. “Hasta ahora hemos recibido 23”, dijo Shah. “Todos menos uno resultaron negativos”.

Agregó que funcionarios del departamento de salud estatal también están monitoreando a alrededor de 150 personas que han pasado tiempo alrededor de ganado. Están en contacto con estos trabajadores agrícolas con llamadas telefónicas, mensajes de texto o visitas en persona para ver si desarrollan síntomas. Y si eso sucede, les harán pruebas.

Otra forma de evaluar a los trabajadores agrícolas sería testear su sangre en busca de anticuerpos contra el virus de la gripe aviar H5N1; un resultado positivo indicaría que podrían haberse infectado sin saberlo. Pero Shah dijo que los funcionarios de salud aún no están haciendo este trabajo.

“El hecho de que hayan pasado cuatro meses y aún no hayamos hecho esto no es una buena señal”, dijo Worobey. “No estoy muy preocupado por una pandemia en este momento, pero deberíamos comenzar a actuar como si no quisiéramos que sucediera”.

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

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Marisol Pantoja Toribio se encontró un bulto en el pecho a principios de enero. Sin seguro y viviendo en California sin papeles, y sin su familia, la normalmente despreocupada mujer de 43 años se dio cuenta pronto de lo limitadas que eran sus opciones.

“Yo dije, ¿Qué voy a hacer? …. “, recordó emocionada. Inmediatamente le preocupó que pudiera tener cáncer. “Iba y venía: tengo [cáncer], no tengo, sí tengo, no tengo”. Y si estaba enferma, agregó, no podría trabajar ni pagar el alquiler. Al no tener seguro de salud, Pantoja Toribio no podía pagar para averiguar si tenía una enfermedad grave.

A partir de este año, Medi-Cal, el programa de Medicaid de California, se amplió para incluir a los inmigrantes que no tienen residencia legal, algo que podría haber funcionado perfectamente para Pantoja Toribio, que ha vivido en la ciudad de Brentwood, en el Área de la Bahía, durante tres años. Pero su solicitud de Medi-Cal fue rechazada rápidamente porque, como trabajadora agrícola que gana $16 la hora, sus ingresos anuales de unos $24,000 eran demasiado altos para calificar para el programa.

California es el primer estado en ampliar Medicaid a todos los adultos que reúnan los requisitos, independientemente de su estatus migratorio, una medida celebrada por los activistas de la salud y por líderes políticos de todo el estado. Pero muchos inmigrantes sin estatus legal permanente, especialmente los que viven en zonas de California donde el costo de vida es más alto, ganan demasiado dinero como para calificar para Medi-Cal.

El estado paga la factura de la expansión de Medi-Cal, pero la ley federal prohíbe a los que llama “indocumentados” recibir subsidios de seguros u otros beneficios de la Ley de Cuidado de Salud a Bajo Precio (ACA), dejando a muchos empleados, sin opciones viables médico.

Ahora, los mismos activistas de salud que lucharon por la expansión de Medi-Cal dicen que el siguiente paso para lograr la equidad en salud es ampliar Covered California, el mercado estatal de ACA, a todos los inmigrantes adultos mediante la aprobación de la AB 4.

“Hay personas en este estado que trabajan y son la columna vertebral de tantos sectores de nuestra economía y contribuyen con su trabajo e incluso con sus impuestos … pero están excluidos de nuestra red de seguridad social”, dijo Sarah Dar, directora del Centro de Política de Inmigración de California, una de las dos organizaciones que patrocinan el proyecto de ley, denominado #Health4All.

Para calificar para Medi-Cal, una persona no puede ganar más del 138% del nivel federal de pobreza, que actualmente es de cerca de $21,000 al año para un individuo. Una familia de tres miembros tendría que ganar menos de $35,632 al año.

Para las personas que superan esos umbrales, el mercado de Covered California ofrece varios planes de salud, a menudo con subsidios federales y estatales, con primas tan bajas como $10 al mes. La esperanza es crear lo que los activistas llaman un “mercado espejo” en el sitio web de Covered California para que a los inmigrantes, independientemente de su estatus, se les pueda ofrecer los mismos planes de salud que serían subvencionados sólo por el estado.

A pesar de la mayoría demócrata en la Legislatura, el proyecto de ley podría tener dificultades para ser aprobado, ya que el estado se enfrenta a un déficit presupuestario previsto para el próximo año de entre $38 mil millones y $73 mil millones. El gobernador Gavin Newsom y líderes legislativos anunciaron un paquete de $17 mil millones para empezar a reducir la brecha, pero parece inevitable que se produzcan recortes significativos en el gasto.

No está claro cuánto costaría extender Covered California a todos los inmigrantes, según el miembro de la Asamblea Joaquín Arambula, demócrata de Fresno que presentó el proyecto de ley.

El Centro de Política de Inmigración estima que la creación del mercado costaría al menos $15 millones. Si el proyecto de ley se aprueba, los patrocinadores tendrían que asegurar la financiación de los subsidios, que podrían ascender a miles de millones de dólares anuales.

“Es un momento difícil para pedir nuevos gastos”, señaló Dar. “El costo de la puesta en marcha del mercado espejo es una cifra relativamente baja. Así que tenemos esperanzas de que aún esté dentro de lo posible”.

Arambula dijo que es optimista en cuanto a que el estado continuará liderando en la mejora del acceso a la salud para los inmigrantes que no tienen residencia legal.

“Creo que seguiremos adelante, ya que estamos trabajando para hacer de ésta una California para todos”, expresó.

El proyecto de ley fue aprobado por la Asamblea en julio pasado en una votación de 64-9 y ahora falta la acción del Comité de Asignaciones del Senado, según la oficina de Arambula.

Se calcula que unas 520,000 personas en California podrían optar por un plan de Covered California si tuvieran un estatus legal, según el centro de investigación laboral de la Universidad de California-Berkeley. Pantoja Toribio, que emigró sola desde México huyendo de una relación abusiva, dijo que tuvo suerte. Se enteró de las opciones alternativas de atención médica cuando hizo su visita semanal a un banco de alimentos en Hijas del Campo, una organización de defensa de los trabajadores agrícolas del condado de Contra Costa, donde le dijeron que podría calificar para un plan que ayuda a personas de bajos ingresos a través de Kaiser Permanente.

Pantoja Toribio aplicó, justo antes que se cerrara el plazo de inscripción a finales de enero. Gracias al plan, supo que el bulto que tenía en el pecho no era canceroso.

“Diosito me oyó”, exclamó. “Gracias a Dios”.

Esta historia fue producida por KFF Health News, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.

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

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Every day, the scene plays out in hospitals across America: Older men and women lie on gurneys in emergency room corridors moaning or suffering silently as harried medical staff attend to crises.

Even when physicians determine these patients need to be admitted to the hospital, they often wait for hours — sometimes more than a day — in the ER in pain and discomfort, not getting enough food or water, not moving around, not being helped to the bathroom, and not getting the kind of care doctors deem necessary.

“You walk through ER hallways, and they’re lined from end to end with patients on stretchers in various states of distress calling out for help, including a number of older patients,” said Hashem Zikry, an emergency medicine physician at UCLA Health.

Physicians who staff emergency rooms say this problem, known as ER boarding, is as bad as it’s ever been — even worse than during the first years of the covid-19 pandemic, when hospitals filled with desperately ill patients.

While boarding can happen to all ER patients, adults 65 and older, who account for nearly 20% of ER visits, are especially vulnerable during long waits for care. Also, seniors may encounter boarding more often than other patients. The best estimates I could find, published in 2019, before the covid-19 pandemic, suggest that 10% of patients were boarded in ERs before receiving hospital care. About 30% to 50% of these patients were older adults.

“It’s a public health crisis,” said Aisha Terry, an associate professor of emergency medicine at George Washington University School of Medicine and Health Sciences and the president of the board of the American College of Emergency Physicians, which sponsored a summit on boarding in September.

What’s going on? I spoke to almost a dozen doctors and researchers who described the chaotic situation in ERs. They told me staff shortages in hospitals, which affect the number of beds available, are contributing to the crisis. Also, they explained, hospital administrators are setting aside more beds for patients undergoing lucrative surgeries and other procedures, contributing to bottlenecks in ERs and leaving more patients in limbo.

Then, there’s high demand for hospital services, fueled in part by the aging of the U.S. population, and backlogs in discharging patients because of growing problems securing home health care and nursing home care, according to Arjun Venkatesh, chair of emergency medicine at the Yale School of Medicine.

The impact of long ER waits on seniors who are frail, with multiple medical issues, is especially serious. Confined to stretchers, gurneys, or even hard chairs, often without dependable aid from nurses, they’re at risk of losing strength, forgoing essential medications, and experiencing complications such as delirium, according to Saket Saxena, a co-director of the geriatric emergency department at the Cleveland Clinic.

When these patients finally secure a hospital bed, their stays are longer and medical complications more common. And new research finds that the risk of dying in the hospital is significantly higher for older adults when they stay in ERs overnight, as is the risk of adverse events such as falls, infections, bleeding, heart attacks, strokes, and bedsores.

Ellen Danto-Nocton, a geriatrician in Milwaukee, was deeply concerned when an 88-year-old relative with “strokelike symptoms” spent two days in the ER a few years ago. Delirious, immobile, and unable to sleep as alarms outside his bed rang nonstop, the older man spiraled downward before he was moved to a hospital room. “He really needed to be in a less chaotic environment,” Danto-Nocton said.

Several weeks ago, Zikry of UCLA Health helped care for a 70-year-old woman who’d fallen and broken her hip while attending a basketball game. “She was in a corner of our ER for about 16 hours in an immense amount of pain that was very difficult to treat adequately,” he said. ERs are designed to handle crises and stabilize patients, not to “take care of patients who we’ve already decided need to be admitted to the hospital,” he said.

How common is ER boarding and where is it most acute? No one knows, because hospitals aren’t required to report data about boarding publicly. The Centers for Medicare & Medicaid Services retired a measure of boarding in 2021. New national measures of emergency care capacity have been proposed but not yet approved.

“It’s not just the extent of ED boarding that we need to understand. It’s the extent of acute hospital capacity in our communities,” said Venkatesh of Yale, who helped draft the new measures.

In the meantime, some hospital systems are publicizing their plight by highlighting capacity constraints and the need for more hospital beds. Among them is Massachusetts General Hospital in Boston, which announced in January that ER boarding had risen 32% from October 2022 to September 2023. At the end of that period, patients admitted to the hospital spent a median of 14 hours in the ER and 26% spent more than 24 hours.

Maura Kennedy, Mass General’s chief of geriatric emergency medicine, described an 80-something woman with a respiratory infection who languished in the ER for more than 24 hours after physicians decided she needed inpatient hospital care.

“She wasn’t mobilized, she had nothing to cognitively engage her, she hadn’t eaten, and she became increasingly agitated, trying to get off the stretcher and arguing with staff,” Kennedy told me. “After a prolonged hospital stay, she left the hospital more disabled than she was when she came in.”

When I asked ER doctors what older adults could do about these problems, they said boarding is a health system issue that needs health system and policy changes. Still, they had several suggestions.

“Have another person there with you to advocate on your behalf,” said Jesse Pines, chief of clinical innovation at US Acute Care Solutions, the nation’s largest physician-owned emergency medicine practice. And have that person speak up if they feel you’re getting worse or if staffers are missing problems.

Alexander Janke, a clinical instructor of emergency medicine at the University of Michigan, advises people, “Be prepared to wait when you come to an ER” and “bring a medication list and your medications, if you can.”

To stay oriented and reduce the possibility of delirium, “make sure you have your hearing aids and eyeglasses with you,” said Michael Malone, medical director of senior services for Advocate Aurora Health, a 20-hospital system in Wisconsin and northern Illinois. “Whenever possible, try to get up and move around.”

Friends or family caregivers who accompany older adults to the ER should ask to be at their bedside, when possible, and “try to make sure they eat, drink, get to the bathroom, and take routine medications for underlying medical conditions,” Malone said.

Older adults or caregivers who are helping them should try to bring “things that would engage you cognitively: magazines, books … music, anything that you might focus on in a hallway where there isn’t a TV to entertain you,” Kennedy said.

“Experienced patients often show up with eye masks and ear plugs” to help them rest in ERs with nonstop stimulation, said Zikry of UCLA. “Also, bring something to eat and drink in case you can’t get to the cafeteria or it’s a while before staffers bring these to you.”

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care, and advice you need in dealing with the health care system. Visit kffhealthnews.org/columnists to submit your requests or tips.

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

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More than 300 organizations specializing in housing and mental health say they are imploring Premier Legault to take concrete action to solve the ongoing crisis.

The Black Physicians’ Association of Ontario is holding a conference in Toronto on Saturday to address issues related to Black youth’s access to mental health care.