Michael Scaturro, Author at ϳԹ News Thu, 02 Apr 2026 19:48:50 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.5 /wp-content/uploads/sites/2/2023/04/kffhealthnews-icon.png?w=32 Michael Scaturro, Author at ϳԹ News 32 32 161476233 Patients Are Relying on Lyft, Uber To Travel Far Distances to Medical Care /news/article/lyft-uber-medical-georgia-atlanta-transport-rural-hospitals/ Thu, 17 Oct 2024 09:00:00 +0000 /?post_type=article&p=1926376 When Lyft driver Tramaine Carr transports seniors and sick patients to hospitals in Atlanta, she feels like both a friend and a social worker.

“When the ride is an hour or an hour and a half of mostly freeway driving, people tend to tell you what they’re going through,” she said.

Drivers such as Carr have become a critical part of the medical transportation system in Georgia, as well as in Washington, D.C., , , and elsewhere. While some patients use transportation companies solely dedicated to medical rides or nonemergency ambulance rides to get to their appointments, the San Francisco-based ride-hailing companies Uber and Lyft are also ferrying people to emergency rooms, kidney dialysis, cancer care, physical therapy, and other medical visits.

But Georgia ride-hail drivers aren’t only serving patients living in Atlanta or its sprawling suburbs. When rural Georgians are too sick to drive themselves, Uber or Lyft is often one of the only ways to reach medical care in the state capital.

have meant people battling cancer and other serious illnesses must now commute two or more hours to treatment facilities in Atlanta, said Bryan Miller, director of psychosocial support services at the , a medical practice offshoot that seeks to alleviate financial burdens for cancer patients and their families.

From April 2022 to April 2024, Lyft drivers completed thousands of rides that were greater than 50 miles each way and that began or ended at Atlanta-area medical treatment centers, including the Winship Cancer Institute of Emory University and Emory University Hospital Midtown, according to Lyft.

While 75% of those trips were under 100 miles, the company said, 21% of them were between 100 and 200 miles and 4% were over 200, showing that even Georgians who live hours away from metro Atlanta rely on the ride-hail platform to reach medical care there.

Uber Health global head Zachary Clark declined to provide comparable ridership data. Uber Health is a division of Uber that organizes medical transportation for some Medicaid and Medicare recipients, health care workers, prescription drug delivery, and others seeking reimbursement for medical-related Uber rides, .

Lyft also has a health care division, offering programs such as Lyft Assisted and Lyft Concierge to coordinate rides for patients.

Nationwide, some insurance companies and cancer treatment centers, plus Medicare Advantage and state Medicaid plans, pay for such ride-hailing services, often with the goal of reducing missed appointments, according to , an adjunct assistant professor at the University of Pennsylvania medical school.

In 2024, 36% of individual Medicare Advantage plans and 88% of special needs plans offered transportation services, said , associate director of Medicare policy at KFF, the health policy research, polling, and news organization that includes ϳԹ News. A special needs plan provides extra benefits to Medicare recipients who have severe and chronic diseases or certain other health care needs, or who also have Medicaid.

And Medicaid — the federal-state government safety net insurance plan for those with low incomes or disabilities — paid for up to to use nonemergency medical transportation services annually from 2018 through 2021, according to a Department of Health and Human Services report. Patients residing in rural areas used ride-hailing and other nonemergency transportation providers at the highest rates, the report said.

The estimated total federal and state investment in nonemergency medical transportation was approximately $5 billion in 2019, by the Texas A&M University Transportation Institute.

Even with some insurance covering trips or charities offering ride credits, social workers say, many ailing patients are still left without a ride. Nationwide, 21% of adults without access to a vehicle or public transit went without needed medical care in 2022, by the Robert Wood Johnson Foundation. People who lacked access to a vehicle but had access to public transit were less likely to skip needed care.

The data analytics company Geotab for second worst in the nation when it comes to the accessibility of its public transportation network.

“The ability to get to a doctor’s appointment can be a barrier to care,” said Rochelle Schube, a cancer support group facilitator in Atlanta. “If I give a patient $250 in Uber cards and they live far away, that gets spent quickly.”

The fact that Uber and Lyft are harder to come by in rural America compounds the lack of medical access in those areas. “When you move to rural areas — which you could argue have a higher need — you see fewer services,” Chaiyachati said.

Finding drivers who are able and willing to provide medical transportation can be a challenge. The Atlanta-based start-up connects patients and health care providers with vetted drivers, many offering wheelchair or stretcher rides, in Georgia and 16 other states. Many of its drivers have medical training, walk patients to and from medical facilities or their homes, and can handle complex situations for vulnerable patients, said Dana Weeks, the company’s co-founder and CEO.

The company’s app can also dispatch directly to Uber or Lyft for patients who do not need specialized assistance, she said.

Uber and Lyft trips can save patients and insurers money, costing a fraction of the typical fee for an ambulance ride, said , an economics professor at the University of Kansas who the impact of ride-hailing services on medicine.

But instead of all of that, argued , a history professor emeritus at Georgia State University and a former director of the school’s neighborhood-studies center, the best solution would be for , so more rural hospitals would be able to remain open and Georgians could seek medical care close to home.

The decision by Georgia lawmakers to not accept a federally funded expansion of Medicaid has left more than 1.4 million Georgians without health insurance, — and that hurts rural hospitals when those patients use the medical facilities and cannot pay their bills. In Georgia, 10 rural hospitals have either closed or ceased their inpatient care operations since 2010, according to a from health care consultant Chartis, and 18 more are in danger of shuttering.

Until more patients are insured, Crimmins said, the state should subsidize Uber and Lyft trips for less prosperous Georgians who need help reaching medical care in Atlanta. “We might be talking about $100 to $150 round-trip,” he said. “That can be subsidized.”

Still, ferrying around patients is not for every ride-hail driver. Damian Durand said his Chevrolet Equinox SUV is large enough to accommodate a medical passenger requiring a wheelchair, but he isn’t paid extra to transport those with medical needs. He said some of his recent passengers in Atlanta have been Medicaid recipients with mental health conditions or disabilities.

“It can be stressful,” he said. “I do feel like Uber and Lyft are trying to catch me off guard. When I can see that the ride is going to the hospital, I try to avoid or cancel the ride.”

While Durand’s experience with medical transport has been mostly negative, Carr loves the work and appreciates being able to help older Georgians, who she said often tip her well. For her, ride-hail work remains a good option even when it entails medical calls.

“It’s not stressful for me,” she said. “I worked a good 20 years in customer service. For me, human connection is important. I tried to work from home, and I really didn’t like it. I prefer this because I can connect with people.”

ϳԹ 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 .

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What’s Keeping the US From Allowing Better Sunscreens? /news/article/better-sunscreen-ingredients-animal-testing-us-vs-other-countries-regulations-cancer-risk/ Tue, 07 May 2024 09:00:00 +0000 /?post_type=article&p=1846793 When dermatologist 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 has required 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 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 and , which make the newer sunscreen chemicals, submitted on sunscreen chemicals to the 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 in the European Union, which 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) (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 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 in the United States. Skin cancer is the in America, and 6.1 million adults are treated each year for basal cell and squamous cell carcinomas, according to the . The nation’s second-most-common cancer, breast cancer, is diagnosed about , though it is far more deadly.

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 , according to CDC researchers. One study found that the annual cost of treating skin cancer in the United States 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 after it published a study that said some sunscreen ingredients had been found in trace amounts in human bloodstreams. When the , and then again , that older sunscreen ingredients needed to be studied more to see if they were safe, sunscreen opponents saw an opening, said , 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.”

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 .

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, 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 , 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 , 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 and , 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 .

“The sunscreen issue has gotten people to see that you can be unsafe if you’re too slow,” said , 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.”

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Telehealth Sites Promise Cure for ‘Male Menopause’ Despite FDA Ban on Off-Label Ads /news/article/telehealth-male-menopause-testosterone-replacement-risks/ Thu, 21 Mar 2024 09:00:00 +0000 /?post_type=article&p=1825773 Online stores sprang up during the covid-19 pandemic’s telehealth boom touting testosterone as a cure-all for men’s age-related illnesses — despite issued years ago restricting such “” advertising.

In ads on Google, Facebook, and elsewhere, testosterone telemedicine websites may promise a quick fix for sluggishness and low libido in men. But evidence for that is lacking, physicians said, and the midlife malaise for which testosterone is being touted as a solution is more likely caused by chronic medical conditions, poor diet, or a sedentary lifestyle. In fact, doctors — and the FDA recommends that all testosterone supplements carry a warning that they may increase the risk of heart attack and stroke.

Valid medical reasons do exist for treating some men with testosterone. The hormone as a medication has existed for decades, and today’s patients include , some transgender men who use it to help transition physically, and, sometimes, . It has also been used for decades by bodybuilders and athletes to .

However, online dispensaries can overplay the idea of what is sometimes called “male menopause,” or even “manopause,” to drive sales of highly profitable testosterone-boosting injectables, often ignoring safety guidelines that should prevent healthy men from using the hormone. Some of the websites target military veterans.

“I have seen ads online that do cross the line,” said , a physician and the chief academic officer for the Heart, Vascular, and Thoracic Institute at the Cleveland Clinic. “For mood and low energy, prescribing testosterone provides little to no benefit. They are promoting testosterone for indications that are not on the label.”

Testosterone telehealth websites almost all cite published in 2002 by New England Research Institutes scientists who found testosterone levels drop 1% a year in men over 40. , director of the Center for Reproductive Medicine and Andrology at the University of Muenster in Germany, said the data behind the statistic included older men in deteriorating health whose levels declined because of illnesses.

“Healthy men do not show a drop,” he said.

That 2002 study led to a flood of “low-T” ads on U.S. television — ads that were later banned in a that accused the pharmaceutical industry of exaggerating the low-T phenomenon to scare men into buying drugs. According to , the market for testosterone supplements stood at $1.85 billion in 2023.

The deluge of ads “has fueled demand for a largely uninsured product, allowing for high markups,” said , director of health policy at the USC Schaeffer Center for Health Policy & Economics and a research associate at the National Bureau of Economic Research. “The primary driver is manufactured demand.”

, a professor of evidence-based pharmaceutical policy at the University of Sydney’s Charles Perkins Centre in Australia, said low testosterone should really be seen as a sign of a condition that needs to be treated. She said diabetes, heart disease, high blood pressure, obesity, exposure to like PFAS, and stress can all reduce testosterone levels.

Several websites reviewed by ϳԹ News brand themselves as news and fitness magazines, with advertisements embedded in articles steering readers toward order forms for testosterone replacement therapy, shorthanded as TRT. The sites’ prices for TRT range from $120 to $135 a month, not including initial mail-back blood tests for around $60. Some sites promise increased libido and reduced stomach fat.

Male Excel’s ads on Google, for example, say TRT “improves mood” and “restores vitality.” And its site says testosterone treatment will provide “muscular definition,” “weight loss,” “explosive drive,” “deeper sleep,” and “restored energy” above a link to a free assessment on its online telehealth platform. Craig Larsen, the company’s CEO, did not reply to several attempts to contact him by phone and email.

Both and are among the sites that pitch to military veterans. Hone Health included a video of a veteran who said he was treatment by a Department of Veterans Affairs hospital.

Saad Alam, CEO and co-founder of Hone, said that his company is what he called a “conservative” player in the market. He said that Hone prescribes only to men who are hypogonadal and tests men every 90 days, unlike other companies that operate telehealth websites as what he called a “cash grab.”

“I agree that patients should be treated by their doctors. But the U.S. medical system isn’t at a point where it can service men who have this problem, and some endocrinologists would rather treat patients who are higher-profit,” Hone said. “That’s why people are coming to us.”

One popular form of TRT is injectable testosterone cypionate. According to the Medicare average sales price database, it costs $0.027 per milligram. Online purveyors who sell the drug directly to consumers in 200 mg/mL vials for an average price of $129 per month are charging the equivalent of $1.55 per mg — a markup of more than 50 times the average Medicare price.

According to a , the TRT telehealth websites create a way to circumvent doctors who refuse to prescribe the hormone. In that study, , a urologist at the Memorial Healthcare System in Florida, posed as an online mystery shopper. He reported an above-normal testosterone level, and stated his desire to start a family, even though such therapy can curb sperm production. But six of the seven unnamed online TRT clinics prescribed him testosterone via a medical professional.

“And that’s concerning,” Dubin said. “Telemedicine helps men with hypogonadism who might be too embarrassed to discuss erectile dysfunction. But we need to do a better job of understanding the appropriateness of care.”

Still, while the FDA doesn’t allow off-label marketing, it does allow such off-label prescriptions.

Off-label use of testosterone replacement has become . And among male service members who received TRT in 2017, fewer than half met the clinical practice guidelines, according to a .

Phil Palmer, a 41-year-old Marine Corps veteran who lives outside Charleston, South Carolina, said he pays out-of-pocket for bloodwork and prescriptions for a pellet skin-implant form of testosterone and for , a drug that can help counter the male infertility that is a side effect of . He said the treatment appeals to him and other veterans dealing with the aftermath of military service.

“The environment we served in and stress levels have a lot to do with it,” Palmer said. “We were exposed to burn pits. The military doesn’t teach you to eat well — we ate a lot of processed food.”

In medical settings, TRT can speed recovery of soldiers who have bone density issues or spinal cord injuries, said , a professor of physical medicine and rehabilitation at the University of Michigan Medical School. But, he said, “for men in the normal-T range, using an online prescription to buy testosterone to reduce stomach fat can be counterproductive.”

Those who use it also risk having to , because TRT can cause the body to cease its own production of the hormone.

Palmer, who that helps veterans heal through exercise, nutrition, and mentorship, said the medication has been helpful for him but urges fellow veterans to seek care from their doctors rather than what he called “bro science” websites touting testosterone.

“It’s not a magic pill,” he said.

ϳԹ 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 .

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Sitios de telesalud prometen una cura para la “menopausia masculina” a pesar de prohibiciones /news/article/sitios-de-telesalud-prometen-una-cura-para-la-menopausia-masculina-a-pesar-de-prohibiciones/ Thu, 21 Mar 2024 09:00:00 +0000 /?post_type=article&p=1828792 Durante el boom de la telemedicina por la pandemia de covid-19, surgieron tiendas online que promocionaban la testosterona como remedio para las afecciones masculinas relacionadas con la edad, a pesar de las ) emitidas hace años que restringen este tipo de publicidad sobre

En anuncios de Google, Facebook y otros medios, los sitios web de telemedicina sobre testosterona pueden prometer una solución rápida para la “lentitud” y la libido baja en los hombres. Pero los médicos dicen que no hay pruebas de su eficacia, y que es más probable que las causas del decaimiento masculino para el que se promociona la testosterona como solución sean las afecciones crónicas, una dieta inadecuada o un estilo de vida sedentario.

De hecho, los médicos piden , y la FDA recomienda que todos los suplementos de testosterona lleven la advertencia de que pueden aumentar el riesgo de infarto de miocardio y accidente cerebrovascular.

Existen razones médicas válidas para tratar a algunos hombres con testosterona. La hormona existe como medicamento desde hace décadas, y entre los pacientes actuales se encuentran , algunos transexuales que la utilizan para facilitar la transición física y, en ocasiones, . También ha sido utilizada durante décadas por fisicoculturistas y atletas para .

Sin embargo, los dispensarios en internet pueden exagerar la idea de lo que a veces se denomina “menopausia masculina”, para impulsar las ventas de inyectables potenciadores de la testosterona, muy rentables, ignorando a menudo las directrices de seguridad que deberían impedir el uso de la hormona en hombres sanos. Algunos de los sitios web se dirigen a veteranos militares.

“He visto anuncios en Internet que se pasan de la raya”, afirmó , médico y director académico del Heart, Vascular, and Thoracic Institute de la Clínica Cleveland. “Para el estado de ánimo y la baja energía, recetar testosterona aporta poco o ningún beneficio. Están promoviendo la testosterona para indicaciones que no figuran en la etiqueta”.

Casi todos los sitios web sobre testosterona citan publicado en 2002 por científicos de los New England Research Institutes, que descubrieron que los niveles de testosterona caen un 1% al año en hombres mayores de 40 años. , director del Centro de Medicina Reproductiva y Andrología de la Universidad de Muenster, en Alemania, dijo que los datos que respaldaban la estadística incluían a hombres mayores con una salud deteriorada cuyos niveles disminuían a causa de enfermedades.

“Los hombres sanos no muestran ese descenso”, señaló.

Ese estudio de 2002 dio lugar a una avalancha de anuncios de “baja T” en la televisión estadounidense, anuncios que más tarde fueron , en una que acusaba a la industria farmacéutica de exagerar el fenómeno de la baja T para asustar a los hombres y hacerles comprar medicamentos.

Según , el mercado de suplementos de testosterona se situó en $1,850 millones en 2023.

El diluvio de anuncios “ha alimentado la demanda de un producto en gran parte no cubierto, lo que permite altos márgenes de beneficio”, explicó , director de políticas de salud en el USC Schaeffer Center for Health Policy & Economics e investigador del National Bureau of Economic Research. “El motor principal es la demanda fabricada”.

, profesora de política farmacéutica basada en la evidencia en el Centro Charles Perkins de la Universidad de Sydney, Australia, dijo que el bajo nivel de testosterona debería considerarse realmente como un signo de una enfermedad que necesita tratamiento. Mintzes dijo que la diabetes, las cardiopatías, la hipertensión, la obesidad, la exposición a como los PFAS y el estrés pueden reducir los niveles de testosterona.

Varios de los sitios web analizados por ϳԹ News se presentan como revistas de noticias y fitness, con anuncios insertados en los artículos que dirigen a los lectores hacia formularios para pedidos de terapia de sustitución de testosterona, abreviada como TRT.

Los precios de la TRT oscilan entre $120 y $135 al mes, sin incluir los análisis de sangre iniciales por correo, que cuestan unos $60. Algunos sitios prometen aumentar la libido y reducir la grasa del estómago.

Por ejemplo, los anuncios de Male Excel en Google dicen que la TRT “mejora el estado de ánimo” y “restaura la vitalidad”. Y su sitio dice que el tratamiento con testosterona proporcionará “definición muscular”, “pérdida de peso”, “impulso explosivo”, “sueño más profundo” y “energía restaurada” por encima de un enlace a una evaluación gratuita en su plataforma de telesalud en línea.

Craig Larsen, director general de la empresa, no respondió a varios intentos de establecer contacto por teléfono y correo electrónico.

Tanto como se encuentran entre los sitios que se dirigen a los veteranos militares. Hone Health incluía un video de un veterano que afirmaba que un hospital del Departamento de Asuntos de Veteranos le había .

Saad Alam, CEO y cofundador de Hone, afirmó que su empresa es “conservadora” en el mercado. Dijo que Hone receta sólo a los hombres que son hipogonadales y les hace pruebas cada 90 días, a diferencia de otras empresas que operan sitios web de telesalud a las que calificó de “cazadoras de dinero”.

“Estoy de acuerdo en que los pacientes deben ser tratados por sus médicos. Pero el sistema de salud estadounidense no está en condiciones de atender a los hombres que tienen este problema, y algunos endocrinólogos prefieren tratar a pacientes que proporcionan mayores beneficios”, dijo Hone. “Por eso la gente acude a nosotros”.

Una forma popular de TRT es el cipionato de testosterona inyectable. Según la base de datos de precios de venta de Medicare, cuesta $0,027 por miligramo. Los proveedores en internet que venden el fármaco directamente a los consumidores en viales de 200 mg/mL por un precio medio de $129 al mes están cobrando el equivalente a $1,55 por miligramo, un margen de beneficio de más de 50 veces el precio promedio de Medicare.

Según , los sitios web de telesalud de TRT crean una forma de eludir a los médicos que se niegan a recetar la hormona. En ese estudio, , urólogo del Memorial Healthcare System de Florida, se hizo pasar por un consumidor. Declaró tener un nivel de testosterona por encima de lo normal y manifestó su deseo de formar una familia, a pesar de que este tipo de terapia puede frenar la producción de esperma. Sin embargo, seis de las siete clínicas online de TRT le recetaron testosterona a través de un profesional médico.

“Y eso es preocupante”, afirmó Dubin. “La telemedicina ayuda a los hombres con hipogonadismo que podrían sentirse demasiado avergonzados para hablar de disfunción eréctil. Pero tenemos que hacer un mejor trabajo para entender lo que es una atención apropiada”.

Aun así, aunque la FDA no permite la comercialización off-label (la práctica de recetar medicamentos para un uso distinto par el que han sido aprobados), sí permite las recetas off-label.

El uso off-label de reemplazo de testosterona se ha convertido en . Y entre los militares masculinos que recibieron TRT en 2017, menos de la mitad cumplieron con las pautas de práctica clínica, según un .

Phil Palmer, veterano del Cuerpo de Marines, de 41 años, que vive en las afueras de Charleston, Carolina del Sur, dijo que paga de su bolsillo los análisis de sangre y las recetas para una forma de testosterona de implante cutáneo y para el , un medicamento que puede ayudar a contrarrestar la infertilidad masculina que es un efecto secundario del .

Palmer explicó que el tratamiento es algo que le atrae tanto a él como a otros veteranos que se enfrentan a las secuelas de haber servido en las fuerzas armadas.

“El entorno en el que servimos y los niveles de estrés tienen mucho que ver”, afirmó Palmer. “Estuvimos expuestos a pozos de quema tóxicos. El ejército no te enseña a comer bien: comíamos mucha comida procesada”.

En el ámbito médico, la TRT puede acelerar la recuperación de los soldados que tienen problemas de densidad ósea o lesiones de la médula espinal, indicó , profesor de medicina física y rehabilitación en la Facultad de Medicina de la Universidad de Michigan. Pero, agregó, “para los hombres en el rango normal de T, el uso de una receta en línea para comprar testosterona para reducir la grasa del estómago puede ser contraproducente”.

Quienes la utilizan también se arriesgan a , porque la TRT puede hacer que el cuerpo deje de producir su propia hormona.

Palmer, que que ayuda a los veteranos a recuperarse a través del ejercicio, la nutrición y la tutoría, dijo que la medicación le ha sido útil, pero insta a sus compañeros veteranos a recibir atención médica en lugar de lo que él llamó sitios web de “bro science” que promocionan la testosterona. (La “bro science” surge cuando los relatos anecdóticos de personas que practican fisicoculturismo en el gimnasio se consideran más creíbles que la investigación científica)

“No se trata de una píldora mágica”, concluyó.

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US to Cover HIV Prevention Drugs for Older Americans to Stem Spread of the Virus /news/article/prep-hiv-prevention-drugs-medicare-coverage-biden/ Wed, 08 Nov 2023 10:00:00 +0000 /?post_type=article&p=1768185 A proposed aims to protect older Americans from contracting HIV by offering free preventive medication, the latest effort to catch up to much of Europe and Africa in stemming the spread of the virus.

Under the plan from the Biden administration, Medicare of preexposure prophylaxis drugs, which prevent HIV transmission. The drugs, known by the shorthand “PrEP,” would be free in pill form and — for the first time — as long-acting injectables through the government insurance program designed for those 65 and older. Those 50 and over of all people in the U.S. already living with HIV.

The proposed policy change represents a big shift because it means that even new long-acting injectable versions of PrEP drugs, which more than $20,000 a year in the U.S., would be covered fully, without requiring patients to kick in copayments. It is not yet clear what the plan would mean for taxpayers, though, either in paying for the medications or in offsetting the costs of caring for fewer Medicare patients with HIV in the future.

The final green light for the plan was expected Oct. 10, but the Centers for Medicare & Medicaid Services announced it is still working out details of how to transition coverage for patients already taking the drugs.

The U.S. is decades behind nations in Europe and Africa that are on track to end new HIV infections by 2030. But while the proposal should bring down infections in older Americans, it highlights remaining inequities: Many people under age 65 will still struggle to pay for PrEP. And, at the same time, Republican congressional leaders have threatened to cut funding for a federal HIV prevention effort championed by the Trump administration that is intended to help all at risk.

“We’ve done a very poor job in the U.S. of assuring that people who could most benefit from PrEP have access to it,” said Justin Smith, who directs the Campaign to End AIDS at in the Atlanta area.

Though PrEP has been embraced by gay and trans Americans, it is prescribed less often to heterosexuals over 50 or women of any age. In the first three months of this year, of the more than 300,000 people receiving PrEP in the U.S. were women, according to the Centers for Disease Control and Prevention. The racial gap is large, too: While 66% of white people eligible for PrEP got prescriptions for it in that period, only 8% of eligible Black people and 17% of eligible Hispanic people did.

Broadening access for gay and bisexual men of color, as well as straight and cisgender women of color — particularly Black women, who of women with HIV in the U.S. as well as the majority of new infections among women — is critical for the nation to catch up to the rest of the world, Smith said.

Leisha McKinley-Beach, a national HIV consultant and CEO of the , which prepares Black health department employees for leadership positions, noted that the Medicare proposal to cover the cost of injectable PrEP could help many women because a shot given every two months can be easier to manage than a daily pill.

But it’s just a start. She and others are lobbying for a national PrEP plan that would build on momentum from the recent Medicare proposal to expand free access to other age groups, much as with covid-19 vaccinations. McKinley-Beach also wants the U.S. government to expand the message that anyone can get HIV, encourage drug companies to advertise more on TV to women of color, and fund outreach to dispel medical mistrust in communities of color.

“Gay white men have had a narrative of dignity and respect with regards to HIV treatment, and I would never want to change that narrative,” she said. “But the message needs to be broadened. Forty-two years into the HIV epidemic, the current HIV prevention model is detrimental to Black women who could benefit from PrEP.”

Though the U.S. was to approve PrEP, in 2012, it now trails the rest of the world in equitable access. That’s mostly due to the cost of laboratory tests and medical visits. While the cost of the generic form of Truvada, an oral form of PrEP, can be as low as about $30 a month in the U.S., by University of Virginia researchers reported the cost of starting PrEP is typically about $2,670 for uninsured patients, including about $1,000 for lab tests and medical visits. The new Medicare proposal would cover up to seven counseling visits every 12 months for HIV risk assessment and reduction.

Meanwhile, PrEP pills are free for people in the United Kingdom and including France, Germany, Sweden, and Denmark. Those nations don’t yet cover the more expensive shots, although the U.K. is leading a small test on injectable PrEP in people who cannot take it in tablet form.

The U.S. also lags Western Europe and some nations in Africa in overall HIV treatment and prevention. For example, just 57% of HIV-positive Americans have attained viral suppression, according to the U.S. government website , meaning they regularly take medications to make them unable to transmit the virus. That makes PrEP, which is for people who don’t have the virus, all the more important for Americans to stay negative, according to HIV experts.

In Africa, by contrast, Botswana, Eswatini (formerly Swaziland), Rwanda, Tanzania, and Zimbabwe have already achieved the United Nations’ set for 2025 — 95% of people with HIV know their HIV status, 95% of people with diagnosed HIV infection receive sustained antiretroviral therapy, and 95% of people receiving antiretroviral therapy have achieved viral suppression, or the virus is undetectable in their blood — .

In the U.K., have achieved “undetectable” status via free antiretroviral medicines and treatment available through the country’s universal health care program, the National Health Service. Moreover, nearly anyone in the U.K. who is HIV-negative and wants to take PrEP can get it at no charge. it is now on a path to reduce new HIV infections by 80% by 2025.

The U.K. changed its PrEP approach after 2015, when Greg Owen founded “,” a website that ignited a PrEP movement by helping people in the U.K. and Europe self-source low-priced generic forms of Truvada, the first drug approved as PrEP, from pharmacies in Hong Kong and India.

“It became more affordable,” said Owen, now PrEP lead at one of the U.K.’s top HIV and sexual health charities, . “Soon people demanded it for free on the NHS.”

In the U.S., Smith said, the lack of a national PrEP program that would make the drugs and associated bloodwork free and a heated political climate around health care have hindered HIV outreach.

“In rural areas of the South, especially in places like Georgia or Tennessee, there has been outright hostility toward accepting money from the CDC and to treat and prevent HIV,” Smith said. “People think it’s just politics, but this is having an impact on public health, on people’s lives.”

Anti-queer sentiment in many quarters also creates an environment of hostility around overall sexual health, said , director of clinical research at Washington Health Institute and a professor at George Washington University School of Medicine and Health Sciences. “There’s a chilling effect for everyone, not just queer Americans,” he said.

Elion said shame surrounding sex and the feeling of vulnerability that some people get from taking any medicine may also reduce PrEP uptake among older Americans. “Taking PrEP is actually very empowering, and that needs to be the message,” he said.

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Prevención del VIH: proponen que Medicare cubra PrEP para adultos mayores /news/article/prevencion-del-vih-proponen-que-medicare-cubra-prep-para-adultos-mayores/ Wed, 08 Nov 2023 10:00:00 +0000 /?post_type=article&p=1774773 La propuesta de una nueva tiene como objetivo proteger a estadounidenses mayores de contraer el VIH ofreciendo medicamentos preventivos gratuitos, el más reciente esfuerzo para alcanzar a gran parte de Europa y África en la lucha contra la propagación del virus.

Según el plan de la administración Biden, Medicare cubriría el de los medicamentos de profilaxis previa a la exposición, que previenen la transmisión del VIH. Los medicamentos, conocidos como “PrEP”, serían gratuitos en forma de píldoras y, por primera vez, como inyectables de acción prolongada a través del programa de seguro gubernamental para personas de 65 años en adelante.

Las personas de 50 años o más representan en el país.

El cambio de política propuesto representa un gran giro porque significa que incluso las nuevas versiones inyectables de acción prolongada de los medicamentos PrEP, que en Estados Unidos, estarían completamente cubiertas, sin necesidad de que los pacientes aporten copagos.

Sin embargo, todavía no está claro qué significaría el plan para los contribuyentes, ya sea en el pago de los medicamentos o en la compensación de los costos de atender a menos pacientes de Medicare con VIH en el futuro.

Se esperaba que el nuevo plan tuviera luz verde el 10 de octubre, pero los Centros de Servicios de Medicare y Medicaid (CMS) anunciaron que todavía estaban trabajando en los detalles de cómo hacer la transición de la cobertura para los pacientes que ya toman los medicamentos.

Estados Unidos está décadas por detrás de las naciones de Europa y África que están en camino de poner fin a las nuevas infecciones por VIH para 2030.

Pero si bien la propuesta debería reducir las infecciones entre los estadounidenses de mayor edad, pone de relieve las desigualdades que persisten: muchas personas menores de 65 años todavía tendrán dificultades para pagar por PrEP.

Al mismo tiempo, los líderes republicanos del Congreso han amenazado con recortar los fondos para un esfuerzo federal de prevención del VIH liderado por la administración Trump y cuyo objetivo es ayudar a todos los que están en riesgo.

“Hemos hecho un muy pobre trabajo en Estados Unidos por asegurar que las personas que más podrían beneficiarse de la PrEP tengan acceso”, dijo Justin Smith, quien dirige la Campaign to End AIDS para los en el área de Atlanta.

Aunque la PrEP ha sido adoptada por estadounidenses homosexuales y trans, se receta con menos frecuencia a heterosexuales mayores de 50 años o a mujeres de cualquier edad.

En los primeros tres meses de este año, de las más de 300,000 personas que recibieron PrEP en Estados Unidos fueron mujeres, según los Centros para el Control y Prevención de Enfermedades (CDC).

La brecha racial también es grande: mientras que el 66% de los blancos no hispanos elegibles para PrEP obtuvieron recetas en ese período, solo el 8% de los negros no hispanos elegibles y el 17% de los hispanos elegibles las obtuvieron.

Ampliar el acceso para hombres de color homosexuales y bisexuales, así como para mujeres de color heterosexuales y cisgénero, —en particular las mujeres negras, que de las mujeres con VIH en el país así como la mayoría de las nuevas infecciones entre las mujeres— es fundamental para que la nación esté al mismo nivel que el resto del mundo, dijo Smith.

Leisha McKinley-Beach, consultora nacional sobre VIH y directora ejecutiva de la , que entrena a los empleados negros del departamento de salud para puestos de liderazgo, señaló que la propuesta de Medicare para cubrir el costo de la PrEP inyectable podría ayudar a muchas mujeres: una inyección cada dos meses puede ser más fácil de manejar que una pastilla diaria.

Pero es sólo un comienzo. McKinley-Beach y otros están presionando a favor de un plan nacional de PrEP que aprovecharía el impulso de la reciente propuesta de Medicare para ampliar el acceso gratuito a otros grupos de edad, de forma muy parecida a lo que ocurre con las vacunas contra covid-19.

McKinley-Beach también quiere que el gobierno de Estados Unidos amplíe el mensaje de que cualquiera puede contraer el VIH, aliente a las compañías farmacéuticas a hacer más publicidad en televisión dirigida a las mujeres de color, y financie actividades de divulgación para disipar la desconfianza médica en las comunidades de color.

“Los hombres blancos homosexuales han tenido una narrativa de dignidad y respeto con respecto al tratamiento del VIH, y nunca quisiera cambiar esa narrativa”, dijo. “Pero es necesario ampliar el mensaje. Cuarenta y dos años después del comienzo de la epidemia del VIH, el modelo actual de prevención es perjudicial para las mujeres negras que podrían beneficiarse de la PrEP”.

Aunque Estados Unidos fue en aprobar la PrEP, en 2012, ahora está a la zaga del resto del mundo en acceso equitativo.

Esto se debe principalmente al costo de las pruebas de laboratorio y las visitas médicas. Si bien en Estados Unidos el costo del genérico de Truvada, una forma oral de PrEP, puede ser tan bajo como alrededor de $30 por mes, un estudio realizado por investigadores de la Universidad de Virginia reveló que el costo de comenzar con la PrEP suele ser de alrededor de $2,670 para pacientes sin seguro, incluyendo alrededor de $1,000 para pruebas de laboratorio y visitas médicas.

La nueva propuesta de Medicare cubriría hasta siete visitas de asesoramiento cada 12 meses para la evaluación y reducción del riesgo de VIH.

Mientras tanto, las píldoras PrEP son gratuitas en el Reino Unido y en los países de la , incluidos Francia, Alemania, Suecia y Dinamarca. Estas naciones aún no cubren las inyecciones más caras, aunque el Reino Unido está liderando una pequeña prueba de PrEP inyectable en personas que no pueden tomarla en forma de tabletas.

Estados Unidos también está a la zaga de Europa occidental y de algunas naciones de África en el tratamiento y la prevención general del VIH.

Por ejemplo, sólo el 57% de los estadounidenses VIH positivos han logrado la supresión viral, según el sitio web del gobierno estadounidense , lo que significa que toman medicamentos regularmente por lo que no transmiten el virus. Eso hace que la PrEP, que es para personas que no tienen el virus, sea aún más importante para que los estadounidenses sigan siendo negativos, según los expertos en VIH.

En África, por el contrario, Botswana, Eswatini (anteriormente Suazilandia), Ruanda, Tanzania y Zimbabwe ya han alcanzado los de las Naciones Unidas fijados para 2025: el 95% de las personas con VIH conocen su estatus. El 95% de las personas a las que se les diagnostica una infección por VIH reciben terapia antirretroviral consistente; y el 95% de los que reciben terapia antirretroviral han logrado la supresión viral (cuando el virus es indetectable la sangre), según la (ONU).

En el Reino Unido, el VIH positivas han alcanzado el estado “indetectable” gracias a los medicamentos antirretrovirales gratuitos y al tratamiento disponible a través del programa de atención sanitaria universal del país, el (NHS).

Además, casi cualquier persona en el Reino Unido que sea VIH negativa y quiera tomar PrEP puede obtenerla sin costo alguno. La nación dice que ahora está en camino de reducir las nuevas infecciones por VIH en un 80% para 2025.

El Reino Unido cambió su enfoque de PrEP después de 2015, cuando Greg Owen fundó “”, un sitio de internet que inició un movimiento de PrEP al ayudar a las personas en el Reino Unido y Europa a autoabastecerse de formas genéricas de bajo precio de Truvada, el primer medicamento. aprobado como PrEP, en farmacias de India y Hong Kong.

“Se volvió más asequible”, dijo Owen, ahora líder de PrEP en una de las principales organizaciones benéficas de salud sexual y VIH del Reino Unido, . “Pronto la gente lo exigió de forma gratuita en el NHS”.

Smith dijo que, en Estados Unidos, la falta de un programa nacional de PrEP que hiciera que los medicamentos y los análisis de sangre asociados fueran gratuitos, y un clima político acalorado en torno a la atención médica, han obstaculizado la divulgación del VIH.

“En las zonas rurales del sur, especialmente en lugares como Georgia o Tennessee, ha habido una abierta hostilidad hacia la aceptación de dinero de los CDC y la para tratar y prevenir el VIH”, expresó Smith. “La gente piensa que es sólo política, pero esto está teniendo un impacto en la salud pública, en la vida de las personas”.

El sentimiento anti-queer en muchos sectores también crea un ambiente de hostilidad en torno a la salud sexual en general, dijo , director de investigación clínica del Washington Health Institute y profesor de la Facultad de Medicina y Ciencias de la Salud de la Universidad George Washington. “Hay un efecto paralizante para todos, no sólo para los estadounidenses queer”, dijo.

Elion dijo que la vergüenza que rodea al sexo y el sentimiento de vulnerabilidad que algunas personas sienten al tomar cualquier medicamento también pueden reducir el consumo de PrEP entre los estadounidenses mayores. “Tomar PrEP es realmente muy empoderante, y ese debe ser el mensaje”, dijo.

ϳԹ 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 .

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Proposed PFAS Rule Would Cost Companies Estimated $1B; Lacks Limits and Cleanup Requirement /news/article/epa-pfas-rule-disclosure-forever-chemicals/ Mon, 10 Jul 2023 09:00:00 +0000 /?post_type=article&p=1711497 A proposed federal rule calls for forcing companies to disclose whether their products contain toxic “forever” chemicals, the government’s first attempt at cataloging the pervasiveness of .

The Environmental Protection Agency rule would many products that contain perfluoroalkyl and polyfluoroalkyl substances. They’re a family of chemicals that don’t degrade in nature and have been linked to cancer, birth defects, and hormone irregularities.

Companies would have to disclose any PFAS that have been manufactured or imported between 2011 and when the rule takes effect, with no exemptions for small businesses or for impurities or byproducts cross-contaminating goods with PFAS. Those disclosures would be available to the public, barring any trade secrets linked to the data. The EPA will finalize the rule in the coming months, agency spokesperson Catherine Milbourn said, then require companies to report back within 12 months.

The effort excludes pesticides, foods and food additives, drugs, cosmetics, and medical devices regulated under the Federal Food, Drug, and Cosmetic Act, Milbourn said. It also is essentially a one-time reporting and record-keeping requirement — and companies wouldn’t need to provide updates.

Still, the chemical and semiconductor industries are grumbling about what the EPA estimated is a to comply with the rule. The U.S. chemical industry says it generates .

On the other side, environmental health activists say the data collection exercise would be flawed, as it accounts for only a tenth of PFAS chemicals, which are used in everything from nonstick cookware to kids’ school uniforms. Moreover, they say, it wouldn’t stop PFAS from making their way into the air, waste, or consumer products, nor would it clean up existing contamination.

Congress gave the EPA the power to track PFAS chemicals in 2016, when it revised the Toxic Substances Control Act. Then a , which President Donald Trump signed into law, called for the EPA to inventory PFAS. However, health activists warn that unless Congress overhauls U.S. chemical laws to give the EPA and other agencies more power, PFAS will continue to threaten humans and the environment.

These so-called forever chemicals went from marvel to bête noire in just 50 years. When PFAS debuted, they were revered for making Teflon pans nonstick and Gore-Tex jackets waterproof. They are effective at repelling water and oil yet so durable they don’t break down in the natural environment. That strength has become their downfall, as the chemicals accumulate in landfills, soil, drinking water supplies, and, ultimately, human bodies. As scientists learn more about PFAS’ toxic nature, governments around the world have set limits or imposed outright bans.

Because PFAS are found in thousands of products — , cosmetics, , paper plates, clothing, and dental floss, to name just a few — regulators are scrambling to gather data on the scope of the PFAS threat. The EPA data collection proposal is a move in that direction.

Milbourn told ϳԹ News that 1,364 types of PFAS may be covered by the rule, and EPA officials are reviewing public comments they received to determine whether they should modify its scope to capture additional substances.

By contrast, the European Union is discussing banning or limiting , according to Hanna-Kaisa Torkkeli, a spokesperson for the European Chemicals Agency.

“In the U.S., chemicals are innocent until proven guilty,” said , director of science policy at Public Employees for Environmental Responsibility, a nonprofit based outside Washington, D.C. “In the EU and Japan, chemicals are guilty until proven safe — and that’s why they have fewer PFAS.”

That lack of regulation in the U.S. is driving states to take matters into their own hands, pursuing PFAS bans as gridlock and in Washington thwart tougher federal laws. Minnesota’s limits the chemicals in menstrual products, cleaning ingredients, cookware, and dental floss. Maine’s law will . and ban PFAS in food packaging.

“The states are acting because our federal system doesn’t currently allow the government to say ‘no more use of PFAS,’” said , director of the federal policy program at Toxic-Free Future, a national advocacy group. “And even if it did, that wouldn’t clean up the mess already made.”

U.S. courts are also weighing in on PFAS contamination. On June 22, 3M up to $12.5 billion to settle lawsuits by communities around the country that argued their drinking water was contaminated by the company’s PFAS-containing products.

Additionally, the U.S. military is , after said more than 600,000 troops were in drinking water contaminated largely by PFAS-laden .

Just cleaning up PFAS waste could cost at least $10 billion. Removing it from U.S. drinking water supplies more than $3.2 billion annually to the bill, according to a report commissioned by the American Water Works Association.

“The CDC estimates that 99% of Americans have PFAS in their blood,” said , vice president of government affairs for the Environmental Working Group, a nonprofit that researches the ingredients in household and consumer products. “We estimate that 200 million Americans are exposed to PFAS in their drinking water right now.”

Officials with the U.S. Geological Survey released a similar finding that the agency’s researchers estimate more than 45% of U.S. tap water is contaminated with at least one PFAS chemical after they conducted a nationwide study of water samples.

As ubiquitous as PFAS are, the reason they haven’t generated more outrage among the public may be that the damage from PFAS chemicals isn’t immediate. They affect health over time, with repeated exposure.

“People aren’t getting headaches or coughing from exposure to PFAS,” Bennett said. “But they are getting cancer a few years down the line — and they don’t understand why.”

Some environmental health advocates, such as Arthur Bowman III, policy director at the , say the EPA’s data collection project could help. “It will be fairly straightforward for the EPA to gather PFAS information on cleaning products and other wet chemicals that contain PFAS,” Bowman said. “And this will lead to phaseouts of PFAS.”

Some retailers, such as and , have recently announced plans to remove the chemicals from many of their products.

But Bowman said it will be more difficult for manufacturers to remove PFAS used in the production of semiconductor chips and printed circuit boards, since alternative products are still in the research phase.

The Semiconductor Industry Association to the proposed reporting requirements because, it maintains, semiconductor manufacturing is so complex that it would be “impossible, even with an unlimited amount of time and resources, to discern the presence (if any) of PFAS in such articles.” Other industries have also asked for waivers.

The American Chemistry Council, which represents large PFAS manufacturers such as 3M, disagrees with those calling for the entire class of PFAS chemicals to be banned. “Individual chemistries have their own unique properties and uses, as well as environmental and health profiles,” said Tom Flanagin, a spokesperson for the trade group.

While the council’s member companies “support strong, science-based regulations of PFAS chemistries that are protective of human health and the environment,” Flanagin said, the rules shouldn’t harm economic growth “or hamper businesses and consumers from accessing the products they need.”

For their part, some environmental advocates welcome the reporting proposal, expecting it to reveal new and surprising uses of PFAS. “However, it’s going to be a snapshot,” said , the senior toxics policy adviser for the Sierra Club.

Lunder said even if PFAS were found in, for example, brands of baby bibs, pesticide containers, or pet food bags, it isn’t clear which federal agency would regulate the products. She said Americans should demand that Congress add PFAS and other harmful chemicals to all major environmental statutes for water, air, food, and consumer products.

And another worry: If the data does make it into the mainstream, will consumers simply tune it out — just as many do with ? Lunder doesn’t think so, since “the audience is scientists, regulators, and — for better or for worse — tort attorneys.”

Benesh, of the Environmental Working Group, said the disclosures could reach further and “embolden consumers to demand even more market change.”

ϳԹ 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 .

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Ante vacío federal, estados promueven leyes duras contra el uso de sustancias tóxicas en cosméticos /news/article/ante-vacio-federal-estados-promueven-leyes-duras-contra-el-uso-de-sustancias-toxicas-en-cosmeticos/ Thu, 23 Feb 2023 15:15:32 +0000 https://khn.org/?post_type=article&p=1627121 Washington se unió a más de una docena de estados en tomar medidas enérgicas contra las sustancias tóxicas en cosméticos después que un estudio financiado por el estado encontró plomo, arsénico y formaldehído en productos para maquillaje y alisado del cabello fabricados por CoverGirl y otras marcas.

Estados Unidos se estancó en las regulaciones químicas después de la década de 1970, según , profesora asociada de política urbana y ambiental en el Occidental College. Y eso ha dejado un vacío regulatorio, ya que la blanda supervisión federal permite que productos potencialmente tóxicos que estarían prohibidos en Europa se vendan en las tiendas estadounidenses.

“Muchos productos en el mercado no son seguros”, dijo Shamasunder. “Es por eso que los estados están ayudando a generar una solución”.

La posible exposición a sustancias tóxicas en los cosméticos es especialmente preocupante para las mujeres de color, porque que las mujeres negras usan más productos para el cabello que otros grupos raciales, y que las hispanas y asiáticas han informado que usan más cosméticos en general que las mujeres negras y blancas no hispanas.

La es un segundo intento de aprobar la Ley de Cosméticos Libres de Tóxicos, luego que, en 2022, los legisladores aprobaran que eliminó la prohibición de ingredientes tóxicos en los cosméticos.

Este año, los legisladores tienen un contexto adicional después que encargado por la Legislatura, y publicado en enero por el Departamento de Ecología del estado, encontró múltiples productos con niveles preocupantes de químicos peligrosos, incluyendo plomo y arsénico en la base CoverGirl Clean Fresh Pressed Powder de tinte oscuro.

El lápiz labial de color continuo CoverGirl y la base de maquillaje Black Radiance Pressed Powder de Markwins Beauty Brands se encuentran entre otros productos de varias marcas que contienen plomo, según el informe.

Los equipos de investigación preguntaron a mujeres hispanas, negras no hispanas y multirraciales qué productos de belleza usaban. Luego, probaron 50 cosméticos comprados en Walmart, Target y Dollar Tree, entre otras tiendas.

“Las empresas están agregando conservantes como el formaldehído a los productos cosméticos”, dijo Iris Deng, investigadora de tóxicos del Departamento de Ecología estatal. “El plomo y el arsénico son historias diferentes. Se detectan como contaminantes”.

Markwins Beauty Brands no respondió a las solicitudes de comentarios.

“Las trazas nominales de ciertos elementos a veces pueden estar presentes en las formulaciones de productos como consecuencia del origen mineral natural, según lo permitido por la ley que aplica”, dijo Miriam Mahlow, vocera de la empresa matriz de CoverGirl, en un correo electrónico.

Los autores del informe de Washington dijeron que los países de la Unión Europea prohíben productos como la base CoverGirl de tinte oscuro. Esto se debe a que el arsénico y el plomo se han relacionado con el cáncer, y daño cerebral y del sistema nervioso. “No se conoce un nivel seguro de exposición al plomo”, dijo Marissa Smith, toxicóloga reguladora sénior del estado de Washington. Y el formaldehído también es carcinógeno.

“Cuando encontramos estos químicos en productos aplicados directamente a nuestros cuerpos, sabemos que las personas están expuestas”, agregó Smith. “Por lo tanto, podemos suponer que estas exposiciones están contribuyendo a los impactos en la salud”.

Aunque la mayoría del contenido de plomo de los productos era bajo, dijo Smith, las personas a menudo están expuestas durante años, lo que aumenta considerablemente el peligro.

Los hallazgos del departamento de ecología de Washington no fueron sorprendentes: otros organismos han detectado conservantes como formaldehído o, más a menudo, agentes liberadores de formaldehído como quaternium-15, DMDM hidantoína, imidazolidinil urea y diazolidinil urea en productos para alisar el cabello comercializados especialmente para las mujeres negras.

El formaldehído es uno de los productos químicos utilizados para embalsamar los cadáveres antes de los funerales.

Además de Washington, al menos 12 estados —Hawaii, Illinois, Massachusetts, Michigan, Nevada, Nueva Jersey, Nueva York, Carolina del Norte, Oregon, Rhode Island, Texas y Vermont— están considerando leyes para restringir o exigir la divulgación de sustancias químicas tóxicas en cosméticos y otros productos de cuidado personal.

Los estados están actuando porque el gobierno federal tiene una autoridad limitada, dijo , vicepresidenta de asuntos gubernamentales del Environmental Working Group, una organización sin fines de lucro que investiga qué hay en los productos para el hogar y para el consumidor.

“La FDA ha tenido recursos limitados para intentar la prohibición de ingredientes”, agregó Benesh.

El Congreso no ha otorgado a la Agencia de Protección Ambiental (EPA) una amplia autoridad para regular estos productos, a pesar de que los contaminantes y conservantes de los cosméticos terminan en el suministro de agua.

En 2021, un hombre de California que prohibiera los químicos tóxicos en los cosméticos bajo la Ley de Control de Sustancias Tóxicas, pero la , porque los cosméticos están fuera del alcance de la jurisdicción de la ley, dijo , abogada en Washington, D.C.

Bergeson dijo que la regulación de los productos químicos está sujeta a la Ley Federal de Alimentos, Medicamentos y Cosméticos, pero la Administración de Medicamentos y Alimentos (FDA) los aditivos de color y los porque sostienen que disminuyen el riesgo de cáncer de piel.

Minnesota, por ejemplo, llena los vacíos regulatorios al realizar pruebas de mercurio, hidroquinona y esteroides en productos para aclarar la piel. También aprobó una ley en 2013 que prohíbe el formaldehído en productos para niños, como lociones y baños de burbujas.

California ha aprobado varias leyes que regulan los ingredientes y el etiquetado de los cosméticos, incluida la Ley de Cosméticos Seguros de California, en 2005. Una ley adoptada en 2022 prohíbe las sustancias de perfluoroalquilo y polifluoroalquilo agregadas intencionalmente, conocidas como PFAS, .

El año pasado, Colorado también aprobó en maquillaje y otros productos.

Pero expertos en seguridad del consumidor dijeron que los estados no deberían tener que llenar el vacío dejado por las regulaciones federales, y que un enfoque más inteligente implicaría que el gobierno federal sometiera los ingredientes de los cosméticos a un proceso de aprobación.

Mientras tanto, los estados están librando una batalla cuesta arriba, porque miles de productos químicos están disponibles para los fabricantes. Como resultado, existe una brecha entre lo que los consumidores necesitan como protección y la capacidad de acción de los reguladores, dijo , directora ejecutiva de Toxic-Free Future, una organización sin fines de lucro que investiga y defiende la salud ambiental.

“Los sistemas federales son inadecuados porque no requieren el uso de productos químicos más seguros”, dijo Valeriano. “En cambio, permiten productos químicos peligrosos en productos para el cuidado personal, como PFAS, ftalatos o incluso formaldehído”.

Además, el sistema de evaluación de riesgos del gobierno federal tiene fallas, dijo, “porque intenta determinar cuánto riesgo de exposiciones tóxicas es aceptable”. Por el contrario, el enfoque que el estado de Washington espera legislar evaluaría los peligros y preguntaría si los productos químicos son necesarios o si existen alternativas más seguras, es decir, evitar los ingredientes tóxicos en los cosméticos en primer lugar.

Es muy parecido al enfoque adoptado por la Unión Europea (UE).

“Ponemos límites y restricciones a estos productos químicos”, dijo Mike Rasenberg, director de evaluación de peligros de la en Helsinki, Finlandia.

Rasenberg dijo que debido a que la investigación muestra que el formaldehído causa cáncer nasal, la UE lo en productos de belleza, además del y el . Los 27 países de la UE también trabajan juntos para probar la seguridad de los productos.

En Alemania se examinan anualmente más de 10,000 productos cosméticos, dijo Florian Kuhlmey, vocero de la de ese país. Y no termina ahí. Este año, Alemania examinará alrededor de 200 muestras de dentífrico para niños en busca de metales pesados y otros elementos prohibidos en la UE para cosméticos, agregó Kuhlmey.

La legislación en Washington se acercaría a la estrategia europea para la regulación de productos químicos. Si se aprueba, daría a los minoristas que venden productos con ingredientes prohibidos hasta 2026 para vender los productos existentes.

Mientras tanto, los clientes pueden protegerse buscando productos de belleza naturales, dijo la dermatóloga del área de Atlanta, Chynna Steele Johnson.

“Muchos productos tienen agentes liberadores de formaldehído”, dijo Steele Johnson. “Pero no es algo que los clientes puedan encontrar en una etiqueta. Mi sugerencia, y esto también se aplica a los alimentos, sería, cuanto menos ingredientes, mejor”.

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States Seek Crackdown on Toxic Ingredients in Cosmetics to Close Gaps in Federal Oversight /news/article/states-seek-crackdown-on-toxic-ingredients-in-cosmetics-to-close-gaps-in-federal-oversight/ Thu, 23 Feb 2023 10:00:00 +0000 https://khn.org/?post_type=article&p=1624838 Washington has joined more than a dozen other states in seeking to crack down on toxic substances in cosmetics after a state-funded study there found lead, arsenic, and formaldehyde in makeup, lotion, and hair-straightening products made by CoverGirl and other brands.

The U.S. stalled out on chemical regulations after the 1970s, according to , an urban and environmental policy associate professor at Occidental College. And that has left a regulatory void, as lax federal oversight allows potentially toxic products that would be banned in Europe to be sold in American stores.

“Lots of products on the market aren’t safe,” Shamasunder said. “That’s why states are helping create a solution — it’s a patchwork approach.”

The potential exposure to toxicants in cosmetics is especially worrisome for women of color, because that Black women use more hair products than women of other racial groups and that Hispanic and Asian women have reported using more cosmetics in general than non-Hispanic Black and white women.

The is a second attempt at passing the Toxic-Free Cosmetics Act, after legislators approved a that was stripped of the ban on toxic ingredients in cosmetics. This year, lawmakers have additional context after a by the legislature and published by the state Department of Ecology in January found multiple products with concerning levels of hazardous chemicals, including lead and arsenic in dark-tint CoverGirl Clean Fresh Pressed Powder foundation. CoverGirl Continuous Color Lipstick and Markwins Beauty Brands’ Black Radiance Pressed Powder foundation were among other products from various brands containing lead, the report found.

Research teams asked Hispanic, Black, and multiracial women what beauty products they used. Researchers then tested 50 cosmetics purchased at Walmart, Target, and Dollar Tree, among other shops.

“Companies are adding preservatives like formaldehyde to cosmetics products,” said Iris Deng, a toxics researcher for the Washington State Department of Ecology. “Lead and arsenic are different stories. They’re detected as contaminants.”

Markwins Beauty Brands did not respond to requests for comment.

“Nominal traces of certain elements may sometimes be present in product formulations as a consequence of natural mineral origin, as permitted by applicable law,” Miriam Mahlow, a spokesperson for CoverGirl parent company , said in an emailed statement.

The Washington report’s authors said European Union countries ban products like the dark-tint CoverGirl foundation. That’s because arsenic and lead have been linked to brain and nervous system damage and cancer. There is “no known safe level of lead exposure,” said Marissa Smith, Washington state’s senior regulatory toxicologist, and formaldehyde is also a carcinogen.

“When we find these chemicals in products applied directly to our bodies, we know people are being exposed,” Smith added. “Therefore, we can assume these exposures are contributing to health impacts.”

Though most of the products’ lead content was low, Smith said, people are often exposed for years on end, considerably increasing the danger.

The Washington ecology department findings were not altogether surprising: Other testing bodies have picked up preservatives such as formaldehyde or, more often, formaldehyde-releasing agents such as quaternium-15, DMDM hydantoin, imidazolidinyl urea, and diazolidinyl urea in hair-straightening products marketed especially to Black women. Formaldehyde is one of the chemicals used to embalm corpses before funerals.

In addition to Washington, at least 12 states — Hawaii, Illinois, Massachusetts, Michigan, Nevada, New Jersey, New York, North Carolina, Oregon, Rhode Island, Texas, and Vermont — are considering policies to restrict or require disclosure of toxic chemicals in cosmetics and other personal care products.

States are acting because the federal government possesses limited authority, said , vice president of government affairs for the Environmental Working Group, a nonprofit that researches what’s in household and consumer products.

“The FDA has had limited resources to pursue ingredient bans,” Benesh added.

Congress has not given the Environmental Protection Agency widespread authority to regulate such products, even though contaminants and preservatives from cosmetics end up in the water supply. In 2021, a California man to ban toxic chemicals in cosmetics under the Toxic Substances Control Act, but the , said , a lawyer in Washington, D.C., because cosmetics are outside the scope of the act’s jurisdiction.

“The law is crystal clear on this,” she said.

Bergeson said the regulation of chemicals is subject to the Federal Food, Drug, and Cosmetic Act, but the FDA color additives and because those products make the medical claim of decreasing the risk of skin cancer.

Minnesota, for example, fills in the regulatory gaps by testing for mercury, hydroquinone, and steroids in skin-lightening products. It also passed a law in 2013 banning formaldehyde in children’s products such as lotions and bubble baths.

California has passed several laws that regulate cosmetics ingredients and labeling, including the California Safe Cosmetics Act in 2005. A law adopted in 2022 bans intentionally added perfluoroalkyl and polyfluoroalkyl substances, known as starting in 2025.

Last year, Colorado also in makeup and other products.

But consumer safety experts said that states should not have to fill in the void left by federal regulations, and that a smarter approach would entail the federal government subjecting cosmetics ingredients to an approval process.

In the meantime, states are fighting an uphill battle, because thousands of chemicals are available to manufacturers. As a result, a gap exists between what consumers need for protection and regulators’ ability to act, said , executive director of Toxic-Free Future, a nonprofit that researches and advocates for environmental health.

“The federal systems are inadequate in that they do not require the safest chemicals to be used,” Valeriano said. “Instead, they allow hazardous chemicals in personal care products, such as PFAS, phthalates, or even formaldehyde.”

Moreover, the federal government’s risk assessment system is flawed, she said, “because it attempts to determine how much risk from toxic exposures is acceptable.” In contrast, the approach that Washington state hopes to legislate would assess the hazards and ask whether the chemicals are necessary, or if there are safer alternatives — which is to say prevent toxic ingredients in cosmetics in the first place.

It’s a lot like the approach taken by the European Union.

“We put boundaries and restrictions around these chemicals,” said Mike Rasenberg, hazard assessment director of the in Helsinki.

Rasenberg said that because research shows formaldehyde causes nasal cancer, the EU has , plus and , in beauty products. The EU’s 27 countries also work together to test products for safety.

In Germany, more than 10,000 cosmetic products are examined annually, said Florian Kuhlmey, spokesperson for that country’s . And it doesn’t end there. This year, Germany will examine about 200 samples of children’s toothpaste for heavy metals and other elements banned in the EU for cosmetics, Kuhlmey added.

The legislation in Washington would move the state toward a more European approach to chemicals regulation. If approved, it would give retailers that sell products with banned ingredients until 2026 to sell existing stocks.

Meanwhile, customers can protect themselves by seeking out natural beauty products, Atlanta-area dermatologist Dr. Chynna Steele Johnson said.

“Lots of products have formaldehyde-releasing agents,” Steele Johnson said. “But it isn’t something customers can find on a label. My suggestion — and this goes for foods too — would be fewer ingredients are better.”

ϳԹ 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 .

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This story can be republished for free (details).

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