Michael Scaturro, Author at KFF Health News https://kffhealthnews.org Wed, 15 Nov 2023 23:54:56 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.2 https://kffhealthnews.org/wp-content/uploads/sites/2/2023/04/kffhealthnews-icon.png?w=32 Michael Scaturro, Author at KFF Health News https://kffhealthnews.org 32 32 Prevención del VIH: proponen que Medicare cubra PrEP para adultos mayores https://kffhealthnews.org/news/article/prevencion-del-vih-proponen-que-medicare-cubra-prep-para-adultos-mayores/ Wed, 15 Nov 2023 15:37:38 +0000 https://kffhealthnews.org/?post_type=article&p=1774773 La propuesta de una nueva norma federal 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 costo total 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 la mitad de los que ya viven con VIH 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 pueden costar más de $20.000 al año 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 Positive Impact Health Centers 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, sólo el 8% 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 representan la mayoría 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 Black Public Health Academy, 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 el primer país 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 Unión Europea, 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 HIV.gov, 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 objetivos “95-95-95” 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 Organización de Naciones Unidas (ONU).

En el Reino Unido, el 98% de las personas 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 Servicio Nacional de Salud (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 “iwantprepnow.co.uk”, 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, Terrence Higgins Trust. “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 ampliación de Medicaid 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 Richard Elion, 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.

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.

USE OUR CONTENT

This story can be republished for free (details).

]]>
US to Cover HIV Prevention Drugs for Older Americans to Stem Spread of the Virus https://kffhealthnews.org/news/article/prep-hiv-prevention-drugs-medicare-coverage-biden/ Wed, 08 Nov 2023 10:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1768185 A proposed federal policy 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 would cover patients’ full cost 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 make up half 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 can cost 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 Positive Impact Health Centers 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, just 8% 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 represent the majority 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.

RELATED ARTICLE

PrEP, a Key HIV Prevention Tool, Isn’t Reaching Black Women

New HIV infections occur disproportionately among Black women, but exclusionary marketing, fewer treatment options, and provider wariness have limited uptake of preexposure prophylaxis, or PrEP, drugs, which reduce the risk of contracting the virus.

Read More

Leisha McKinley-Beach, a national HIV consultant and CEO of the Black Public Health Academy, 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 the first nation 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., a study 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 European Union nations 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 HIV.gov, 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’ “95-95-95” targets 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 — according to the U.N.

In the U.K., 98% of HIV-positive people 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. The U.K. says 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 “iwantprepnow.co.uk,” 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, Terrence Higgins Trust. “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 expanding Medicaid 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 Richard Elion, 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.

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.

USE OUR CONTENT

This story can be republished for free (details).

]]>
Proposed PFAS Rule Would Cost Companies Estimated $1B; Lacks Limits and Cleanup Requirement https://kffhealthnews.org/news/article/epa-pfas-rule-disclosure-forever-chemicals/ Mon, 10 Jul 2023 09:00:00 +0000 https://kffhealthnews.org/?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 PFAS across the United States.

The Environmental Protection Agency rule would require manufacturers to report 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 potential $1 billion cost to comply with the rule. The U.S. chemical industry says it generates more than $500 billion annually.

On the other side, environmental health activists say the data collection exercise would be flawed, as it accounts for only a tenth of the more than 12,000 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 bipartisan effort in 2019, 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 — contact lenses, cosmetics, pharmaceuticals such as Prozac, 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 KFF Health 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 10,000 PFAS chemicals, according to Hanna-Kaisa Torkkeli, a spokesperson for the European Chemicals Agency.

“In the U.S., chemicals are innocent until proven guilty,” said Kyla Bennett, 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 industry lobbying in Washington thwart tougher federal laws. Minnesota’s crackdown on PFAS limits the chemicals in menstrual products, cleaning ingredients, cookware, and dental floss. Maine’s law will ban all avoidable uses of PFAS by 2030. Vermont and California 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 Liz Hitchcock, 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 agreed to pay 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 moving to limit PFAS, after a report said more than 600,000 troops were exposed to the toxic chemicals in drinking water contaminated largely by PFAS-laden firefighting foam.

Just cleaning up PFAS waste at U.S. military bases could cost at least $10 billion. Removing it from U.S. drinking water supplies could add 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 Melanie Benesh, 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 July 5 when they announced 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 Center for Environmental Health, 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 Dick’s Sporting Goods and REI, 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 has asked the EPA for an exemption 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 Sonya Lunder, 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 California’s multitudinous cancer warning signs? 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.”

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.

USE OUR CONTENT

This story can be republished for free (details).

]]>
Ante vacío federal, estados promueven leyes duras contra el uso de sustancias tóxicas en cosméticos https://kffhealthnews.org/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 Bhavna Shamasunder, 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 estudios muestran 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 legislación del estado de Washington es un segundo intento de aprobar la Ley de Cosméticos Libres de Tóxicos, luego que, en 2022, los legisladores aprobaran un proyecto de ley que eliminó la prohibición de ingredientes tóxicos en los cosméticos.

Este año, los legisladores tienen un contexto adicional después que un informe 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, Coty Inc., 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 Melanie Benesh, 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 solicitó a la EPA que prohibiera los químicos tóxicos en los cosméticos bajo la Ley de Control de Sustancias Tóxicas, pero la petición fue denegada, porque los cosméticos están fuera del alcance de la jurisdicción de la ley, dijo Lynn Bergeson, 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) regula solo los aditivos de color y los productos químicos en los protectores solares 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, en cosméticos y prendas de vestir a partir de 2025.

El año pasado, Colorado también aprobó una prohibición de PFAS 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 Laurie Valeriano, 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 Agencia Europea de Productos Químicos en Helsinki, Finlandia.

Rasenberg dijo que debido a que la investigación muestra que el formaldehído causa cáncer nasal, la UE lo ha prohibido en productos de belleza, además del plomo y el arsénico. 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 Oficina Federal de Protección al Consumidor y Seguridad Alimentaria 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”.

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.

USE OUR CONTENT

This story can be republished for free (details).

]]>
States Seek Crackdown on Toxic Ingredients in Cosmetics to Close Gaps in Federal Oversight https://kffhealthnews.org/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 Bhavna Shamasunder, 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 studies show 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 Washington state legislation is a second attempt at passing the Toxic-Free Cosmetics Act, after legislators approved a bill in 2022 that was stripped of the ban on toxic ingredients in cosmetics. This year, lawmakers have additional context after a report commissioned 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 Coty Inc., 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 Melanie Benesh, 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 petitioned the EPA to ban toxic chemicals in cosmetics under the Toxic Substances Control Act, but the petition was denied, said Lynn Bergeson, 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 regulates only color additives and chemicals in sunscreen 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 PFAS, in cosmetics and apparel starting in 2025.

Last year, Colorado also passed a ban of PFAS 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 Laurie Valeriano, 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 European Chemicals Agency in Helsinki.

Rasenberg said that because research shows formaldehyde causes nasal cancer, the EU has banned it, plus lead and arsenic, 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 Federal Office of Consumer Protection and Food Safety. 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.”

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.

USE OUR CONTENT

This story can be republished for free (details).

]]>