Seeking to Grow Market Share?

Get a FREE assessment of your CDH products —
a $3,000 value.
LEARN HOW >

Subscribe to Kaiser Health News:States feed Kaiser Health News:States
Updated: 3 hours 14 min ago

Exposed to Agent Orange at US Bases, Veterans Face Cancer Without VA Compensation

April 29, 2024

As a young GI at Fort Ord in Monterey County, California, Dean Osborn spent much of his time in the oceanside woodlands, training on soil and guzzling water from streams and aquifers now known to be contaminated with cancer-causing pollutants.

“They were marching the snot out of us,” he said, recalling his year and a half stationed on the base, from 1979 to 1980. He also remembers, not so fondly, the poison oak pervasive across the 28,000-acre installation that closed in 1994. He went on sick call at least three times because of the overwhelmingly itchy rash.

Mounting evidence shows that as far back as the 1950s, in an effort to kill the ubiquitous poison oak and other weeds at the Army base, the military experimented with and sprayed the powerful herbicide combination known colloquially as Agent Orange.

While the U.S. military used the herbicide to defoliate the dense jungles of Vietnam and adjoining countries, it was contaminating the land and waters of coastal California with the same chemicals, according to documents.

The Defense Department has publicly acknowledged that during the Vietnam War era it stored Agent Orange at the Naval Construction Battalion Center in Gulfport, Mississippi, and the former Kelly Air Force Base in Texas, and tested it at Florida’s Eglin Air Force Base.

According to the Government Accountability Office, however, the Pentagon’s list of sites where herbicides were tested went more than a decade without being updated and lacked specificity. GAO analysts described the list in 2018 as “inaccurate and incomplete.”

Fort Ord was not included. It is among about four dozen bases that the government has excluded but where Pat Elder, an environmental activist, said he has documented the use or storage of Agent Orange.

According to a 1956 article in the journal The Military Engineer, the use of Agent Orange herbicides at Fort Ord led to a “drastic reduction in trainee dermatitis casualties.”

“In training areas, such as Fort Ord, where poison oak has been extremely troublesome to military personnel, a well-organized chemical war has been waged against this woody plant pest,” the article noted.

Other documents, including a report by an Army agronomist as well as documents related to hazardous material cleanups, point to the use of Agent Orange at the sprawling base that 1.5 million service members cycled through from 1917 to 1994.

‘The Most Toxic Chemical’

Agent Orange is a 50-50 mixture of two ingredients, known as 2,4-D and 2,4,5-T. Herbicides with the same chemical structure slightly modified were available off the shelf, sold commercially in massive amounts, and used at practically every base in the U.S., said Gerson Smoger, a lawyer who argued before the Supreme Court for Vietnam veterans to have the right to sue Agent Orange manufacturers. The combo was also used by farmers, forest workers, and other civilians across the country.

The chemical 2,4,5-T contains the dioxin 2,3,7,8-tetrachlorodibenzo-p-dioxin or TCDD, a known carcinogen linked to several cancers, chronic conditions, and birth defects. A recent Brown University study tied Agent Orange exposure to brain tissue damage similar to that caused by Alzheimer’s. Acknowledging its harm to human health, the Environmental Protection Agency banned the use of 2,4,5-T in the U.S. in 1979. Still, the other weed killer, 2,4-D is sold off-the-shelf today.

“The bottom line is TCDD is the most toxic chemical that man has ever made,” Smoger said.

For years, the Department of Veteran Affairs has provided vets who served in Vietnam disability compensation for diseases considered to be connected to exposure to Agent Orange for military use from 1962 to 1975.

Decades after Osborn’s military service, the 68-year-old veteran, who never served in Vietnam, has battled one health crisis after another: a spot on his left lung and kidney, hypothyroidism, and prostate cancer, an illness that has been tied to Agent Orange exposure.

He says many of his old buddies from Fort Ord are sick as well.

“Now we have cancers that we didn’t deserve,” Osborn said.

The VA considers prostate cancer a “presumptive condition” for Agent Orange disability compensation, acknowledging that those who served in specific locations were likely exposed and that their illnesses are tied to their military service. The designation expedites affected veterans’ claims.

But when Osborn requested his benefits, he was denied. The letter said the cancer was “more likely due to your age,” not military service.

“This didn’t happen because of my age. This is happening because we were stationed in the places that were being sprayed and contaminated,” he said.

Studies show that diseases caused by environmental factors can take years to emerge. And to make things more perplexing for veterans stationed at Fort Ord, contamination from other harmful chemicals, like the industrial cleaner trichloroethylene, have been well documented on the former base, landing it on the EPA’s Superfund site list in 1990.

“We typically expect to see the effect years down the line,” said Lawrence Liu, a doctor at City of Hope Comprehensive Cancer Center who has studied Agent Orange. “Carcinogens have additive effects.”

In February, the VA proposed a rule that for the first time would allow compensation to veterans for Agent Orange exposure at 17 U.S. bases in a dozen states where the herbicide was tested, used, or stored.

Fort Ord is not on that list either, because the VA’s list is based on the Defense Department’s 2019 update.

“It’s a very tricky question,” Smoger said, emphasizing how widely the herbicides were used both at military bases and by civilians for similar purposes. “On one hand, we were service. We were exposed. On the other hand, why are you different from the people across the road that are privately using it?”

The VA says that it based its proposed rule on information provided by the Defense Department.

“DoD’s review found no documentation of herbicide use, testing or storage at Fort Ord. Therefore, VA does not have sufficient evidence to extend a presumption of exposure to herbicides based on service at Fort Ord at this time,” VA press secretary Terrence Hayes said in an email.

The Documentation

Yet environmental activist Elder, with help from toxic and remediation specialist Denise Trabbic-Pointer and former VA physician Kyle Horton, compiled seven documents showing otherwise. They include a journal article, the agronomist report, and cleanup-related documents as recent as 1995 — all pointing to widespread herbicide use and experimentation as well as lasting contamination at the base.

Though the documents do not call the herbicide by its colorful nickname, they routinely cite the combination of 2,4-D and 2,4,5-T. A “hazardous waste minimization assessment” dated 1991 reported 80,000 pounds of herbicides used annually at Fort Ord. It separately lists 2,4,5-T as a product for which “substitutions are necessary to minimize the environmental impacts.”

The poison oak “control program” started in 1951, according to a report by Army agronomist Floyd Otter, four years before the U.S. deepened its involvement in Vietnam. Otter detailed the use of these chemicals alone and in combination with diesel oil or other compounds, at rates generally between “one to two gallons of liquid herbicide” per acre.

“In conclusion, we are fairly well satisfied with the methods,” Otter wrote, noting he was interested in “any way in which costs can be lowered or quicker kill obtained.”

An article published in California Agriculture more than a decade later includes before and after photos showing the effectiveness of chemical brush control used in a live-oak woodland at Fort Ord, again citing both chemicals in Agent Orange. The Defense Department did not respond to questions sent April 10 about the contamination or say when the Army stopped using 2,4,5-T at Fort Ord.

“What’s most compelling about Fort Ord is it was actually used for the same purpose it was used for in Vietnam — to kill plants — not just storing it,” said Julie Akey, a former Army linguist who worked at the base in the 1990s and later developed the rare blood cancer multiple myeloma.

Akey, who also worked with Elder, runs a Facebook group and keeps a list of people stationed on the base who later were diagnosed with cancer and other illnesses. So far, she has tallied more than 1,400 former Fort Ord residents who became sick.

Elder’s findings have galvanized the group to speak up during a public comment period for the VA’s proposed rule. Of 546 comments, 67 are from veterans and others urging the inclusion of Fort Ord. Hundreds of others have written in regarding the use of Agent Orange and other chemicals at their bases.

While the herbicide itself sticks around for only a short time, the contaminant TCDD can linger in sediment for decades, said Kenneth Olson, a professor emeritus of soil science at the University of Illinois Urbana-Champaign.

A 1995 report from the Army’s Sacramento Corps of Engineers, which documented chemicals detected in the soil at Fort Ord, found levels of TCDD at 3.5 parts per trillion, more than double the remediation goal at the time of 1.2 ppt. Olson calls the evidence convincing.

“It clearly supports the fact that 2,4,5-T with unknown amounts of dioxin TCDD was applied on the Fort Ord grounds and border fences,” Olson said. “Some military and civilian personnel would have been exposed.”

The Department of Defense has described the Agent Orange used in Vietnam as a “tactical herbicide,” more concentrated than what was commercially available in the U.S. But Olson said his research suggests that even if the grounds maintenance crew used commercial versions of 2,4,5-T, which was available in the federal supply catalog, the soldiers would have been exposed to the dioxin TCDD.

The half dozen veterans who spoke with KFF Health News said they want the military to take responsibility.

The Pentagon did not respond to questions regarding the upkeep of the list or the process for adding locations.

In the meantime, the Agency for Toxic Substances and Disease Registry is studying potential chemical exposure among people who worked and lived on Fort Ord between 1985 and 1994. However, the agency is evaluating drinking water for contaminants such as trichloroethylene and not contamination or pollution from other chemicals such as Agent Orange or those found in firefighting foams.

Other veterans are frustrated by the VA’s long process to recognize their illnesses and believe they were sickened by exposure at Fort Ord.

“Until Fort Ord is recognized by the VA as a presumptive site, it’s probably going to be a long, difficult struggle to get some kind of compensation,” said Mike Duris, a 72-year-old veteran diagnosed with prostate cancer four years ago who ultimately underwent surgery.

Like so many others, he wonders about the connection to his training at Fort Ord in the early ’70s — drinking the contaminated water and marching, crawling, and digging holes in the dirt.

“Often, where there is smoke, there’s fire,” Duris 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).

En Colorado, reevalúan leyes formuladas para proteger a los menores

April 27, 2024

Hace más de 60 años, legisladores en Colorado adoptaron la idea de que la intervención temprana podría prevenir el abuso infantil y salvar vidas. El requisito del estado de que ciertos profesionales informaran a las autoridades cuando sospechaban que un niño había sido maltratado o descuidado fue una de las primeras leyes de informes obligatorios en la nación.

Desde entonces, estas leyes se han expandido a nivel nacional para abarcar más tipos de maltrato, incluido el abandono, que ahora representa la mayoría de los informes, y han aumentado el número de profesiones obligadas a informar. En algunos estados, se requiere que todos los adultos informen lo que sospechan que pueda ser un caso de abuso o negligencia.

Pero ahora hay esfuerzos en Colorado y otros estados para revertir estas leyes, argumentando que el resultado ha sido demasiados informes infundados, que perjudican desproporcionadamente a las familias que son pobres, negras, indígenas o tienen miembros con discapacidades.

“Hay una larga y deprimente historia basada en el enfoque de que nuestra respuesta principal a una familia en dificultades es reportar”, dijo Mical Raz, médica e historiadora de la Universidad de Rochester en Nueva York. “Ahora hay una gran cantidad de evidencia que demuestra que más informes no están asociados con mejores resultados para los niños”.

Stephanie Villafuerte, defensora del pueblo para la protección infantil de Colorado, supervisa un grupo de trabajo para reexaminar las leyes de informes obligatorios del estado. Dijo que el grupo busca equilibrar la necesidad de informar casos legítimos de abuso y negligencia con el deseo de eliminar informes inapropiados.

“Esto está diseñado para ayudar a las personas que se ven afectadas de manera desproporcionada”, dijo Villafuerte. “Espero que la combinación de estos esfuerzos pueda marcar la diferencia”.

A algunos críticos les preocupa que los cambios a la ley pueda dar lugar a que se pasen por alto casos de abuso. Los trabajadores médicos y de cuidado infantil que forman parte del grupo de trabajo han expresado preocupación sobre la responsabilidad legal.

Aunque es raro que las personas sean acusadas penalmente por no informar, también pueden enfrentar responsabilidad civil o repercusiones profesionales, incluidas amenazas a sus licencias.

El ser reportado a los servicios de protección infantil se está volviendo cada vez más común. Más de 1 de cada 3 niños en el país será objeto de una investigación de abuso y negligencia infantil para cuando cumplan 18 años, según una estimación que se cita con frecuencia, un estudio de 2017 financiado por la Oficina de Niños del Departamento de Salud y Servicios Humanos.

A las familias negras y nativas americanas, las familias pobres y los padres o niños con discapacidades se las mira con lupa. La investigación ha encontrado que, entre estos grupos, los padres tienen más probabilidades de perder los derechos parentales y los niños tienen más probabilidades de terminar en hogares temporales.

En una abrumadora mayoría de investigaciones, no se confirma ningún abuso o negligencia. Sin embargo, los que estudian cómo afectan estas investigaciones a las familias las describen como aterradoras y aislantes.

En Colorado, el número de informes de abuso y negligencia infantil ha aumentado un 42% en la última década, y alcanzó un récord de 117,762 el año pasado, según datos estatales. Aproximadamente, otras 100,000 llamadas a la línea directa no se contaron como informes porque eran solicitudes de información o se referían a asuntos como la manutención de los hijos o la protección de adultos, dijeron oficiales del Departamento de Servicios Humanos de Colorado.

El aumento de los informes se puede rastrear hasta una política que alienta a una amplia gama de profesionales —incluidos el personal escolar y médico, terapeutas, entrenadores, miembros del clero, bomberos, veterinarios, dentistas y trabajadores sociales— a llamar a una línea directa cada vez que tengan una preocupación.   

Estas llamadas no reflejan un aumento en el maltrato. Más de dos tercios de los informes que reciben las agencias en Colorado se desestiman porque no cumplen con el umbral para la investigación. De los niños cuyos casos se evalúan, se comprueba que el 21% ha sufrido abuso o negligencia. El número real de casos confirmados no ha aumentado en la última década.

Si bien los estudios no demuestran que las leyes que obligan a informar mantengan seguros a los niños, informó el grupo de trabajo de Colorado en enero, hay evidencia de daño. “El informe obligatorio impacta desproporcionadamente a las familias de color”, iniciando el contacto entre los servicios de protección infantil y familias que no presentan preocupaciones por abuso o negligencia, dijo el grupo de trabajo.

Este grupo también está analizando si una mejor selección podría mitigar “el impacto desproporcionado del informe obligatorio en comunidades con recursos limitados, comunidades de color y personas con discapacidades”.

También señaló que la única forma de informar preocupaciones sobre un niño es con un informe formal a una línea directa. Sin embargo, muchas de esas llamadas no son para informar sobre abuso en absoluto, sino intentos de conectar a niños y familias con recursos como alimentos o asistencia para la vivienda.

Los que llaman a la línea directa pueden querer ayudar, pero las familias que son objeto de informes erróneos de abuso y negligencia rara vez lo ven de esa manera.

Esto incluye a Meighen Lovelace, que vive en una zona rural de Colorado y que pidió a KFF Health News que no revelara su ciudad natal por temor a atraer la atención no deseada de funcionarios locales. Para la hija de Lovelace, que es neurodivergente y tiene discapacidades físicas, los informes comenzaron en 2015, cuando empezó el preescolar a los 4 años.

Los maestros y proveedores médicos que hacían los informes a menudo sugerían que la agencia de servicios humanos del condado podría ayudar a la familia de Lovelace. Pero las investigaciones que siguieron fueron invasivas y traumáticas.

“Nuestro mayor temor latente es, ‘¿van a llevarse a nuestros hijos?'”, dijo Lovelace, quien es defensora de la Colorado Cross-Disability Coalition, una organización que aboga por los derechos civiles de las personas con discapacidades.

“Tenemos miedo de pedir ayuda. Nos está impidiendo ingresar a los servicios debido al miedo al bienestar infantil”, expresó.

Funcionarios de servicios humanos, estatales y del condado, dijeron que no podían comentar sobre casos específicos.

El grupo de trabajo de Colorado planea sugerir aclarar las definiciones de abuso y negligencia bajo la ley de informe obligatorio del estado. Los que tienen que informar no deben “hacer un informe únicamente debido a la raza, clase o género de una familia/niño”, ni debido a una vivienda, muebles, ingresos o ropa inadecuados. Además, no debe haber un informe basado únicamente en el “estado de discapacidad del menor, padre o tutor”, según la recomendación preliminar del grupo.

También planean recomendar capacitación adicional para los que tienen la obligación de informar, ayuda para profesionales que están decidiendo si hacer una llamada o no, y un número de teléfono alternativo, o “línea directa cálida”, para casos en los que los que llaman creen que una familia necesita ayuda material, en lugar de vigilancia.

Los críticos dicen que estos cambios podrían dejar a más niños vulnerables a abusos no denunciados.

“Me preocupa que agregando sistemas como la línea directa cálida, se nos escabullan los casos en lo que los niños están en verdadero peligro, y que no reciban ayuda”, dijo Hollynd Hoskins, abogada que representa a víctimas de abuso infantil.

Hoskins ha demandado a profesionales que no informan sus sospechas.

El grupo de trabajo de Colorado incluye a funcionarios de salud y educación, fiscales, defensores de las víctimas, representantes del bienestar infantil del condado y abogados, así como a cinco personas que tienen experiencia en el sistema de bienestar infantil. Planea finalizar sus recomendaciones a principios del próximo año con la esperanza de que los legisladores estatales consideren cambios en la política en 2025. La implementación de cualquier nueva ley podría llevar varios años.

Colorado es uno de varios estados, incluidos Nueva York y California, que han considerado recientemente cambios para restringir, en lugar de expandir, el informe sobre supuestos abusos.

En la ciudad de Nueva York, se está capacitando a los maestros para que lo piensen dos veces antes de hacer un informe, mientras que el estado de Nueva York introdujo una “línea directa cálida” para ayudar a conectar a las familias con recursos como vivienda y cuidado infantil.

En California, un grupo de trabajo estatal destinado a cambiar del “informe obligatorio al apoyo comunitario” está planeando recomendaciones similares a las de Colorado.

Entre los que abogan por el cambio están las personas con experiencia en el sistema de bienestar infantil. Incluyen a Maleeka Jihad, quien lidera la Coalición MJCF con sede en Denver, que aboga por la abolición del informe obligatorio junto con el resto del sistema de bienestar infantil, citando su daño a las comunidades negras, nativas americanas y latinas.

“El informe obligatorio es otra forma de mantenernos vigilados por blancos [no hispanos]”, dijo Jihad. A él mismo cuando era niño lo arrebataron del cuidado de un padre amoroso y lo colocaron en el sistema temporal.

La reforma no es suficiente, dijo. “Sabemos lo que necesitamos, y generalmente son fondos y recursos”. Algunos de estos recursos —como vivienda asequible y cuidado infantil— no existen a un nivel suficiente para todas las familias de Colorado que los necesitan, dijo Jihad.  

Otros servicios están disponibles, pero hay que encontrarlos. Lovelace dijo que los informes disminuyeron después que la familia obtuvo la ayuda que necesitaba, en forma de una exención de Medicaid que pagaba por atención especializada para las discapacidades de su hija.

Ahora, la niña está en séptimo grado y le va bien. Ninguno de los trabajadores sociales que visitaron a la familia mencionó la exención, dijo Lovelace. “Realmente creo que no sabían nada al respecto”.

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).

Journalists Drill Down on Bird Flu Risks, Opioid Settlement Payouts, and Fluoride in Drinking Water

April 27, 2024

Céline Gounder, KFF Health News’ senior fellow and editor-at-large for public health, discussed the latest bird flu developments on CBS’ “CBS Mornings” on April 25.

KFF Health News senior correspondent Aneri Pattani discussed the details of Tennessee’s distribution of $80 million in opioid settlement funds on WPLN’s “Morning Edition” on April 22.

KFF Health News contributor Andy Miller discussed water fluoridation on WUGA’s “The Georgia Health Report” on April 19.

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).

California Is Investing $500M in Therapy Apps for Youth. Advocates Fear It Won’t Pay Off.

April 26, 2024

With little pomp, California launched two apps at the start of the year offering free behavioral health services to youths to help them cope with everything from living with anxiety to body acceptance.

Through their phones, young people and some caregivers can meet BrightLife Kids and Soluna coaches, some who specialize in peer support or substance use disorders, for roughly 30-minute virtual counseling sessions that are best suited to those with more mild needs, typically those without a clinical diagnosis. The apps also feature self-directed activities, such as white noise sessions, guided breathing, and videos of ocean waves to help users relax.

“We believe they’re going to have not just great impact, but wide impact across California, especially in places where maybe it’s not so easy to find an in-person behavioral health visit or the kind of coaching and supports that parents and young people need,” said Gov. Gavin Newsom’s health secretary, Mark Ghaly, during the Jan. 16 announcement.

The apps represent one of the Democratic governor’s major forays into health technology and come with four-year contracts valued at $498 million. California is believed to be the first state to offer a mental health app with free coaching to all young residents, according to the Department of Health Care Services, which operates the program.

However, the rollout has been slow. So slow that one of the companies has missed a deadline to make its app available on Android phones. Only about 15,000 of the state’s 12.6 million children and young adults have signed up for the apps, and school counselors say they’ve never heard of them.

Advocates for youth question the wisdom of investing taxpayer dollars in two private companies. Social workers are concerned the companies’ coaches won’t properly identify youths who need referrals for clinical care. And the spending is drawing lawmaker scrutiny amid a state deficit pegged at as much as $73 billion.

An App for That

Newsom’s administration says the apps fill a need for young Californians and their families to access professional telehealth for free, in multiple languages, and outside of standard 9-to-5 hours. It’s part of Newsom’s sweeping $4.7 billion master plan for kids’ mental health, which was introduced in 2022 to increase access to mental health and substance use support services. In addition to launching virtual tools such as the teletherapy apps, the initiative is working to expand workforce capacity, especially in underserved areas.

“The reality is that we are rarely 6 feet away from our devices,” said Sohil Sud, director of Newsom’s Children and Youth Behavioral Health Initiative. “The question is how we can leverage technology as a resource for all California youth and families, not in place of, but in addition to, other behavioral health services that are being developed and expanded.”

The virtual platforms come amid rising depression and suicide rates among youth and a shortage of mental health providers. Nearly half of California youths from the ages of 12 to 17 report having recently struggled with mental health issues, with nearly a third experiencing serious psychological distress, according to a 2021 study by the UCLA Center for Health Policy Research. These rates are even higher for multiracial youths and those from low-income families.

But those supporting youth mental health at the local level question whether the apps will move the needle on climbing depression and suicide rates.

“It’s fair to applaud the state of California for aggressively seeking new tools,” said Alex Briscoe of California Children’s Trust, a statewide initiative that, along with more than 100 local partners, works to improve the social and emotional health of children. “We just don’t see it as fundamental. And we don’t believe the youth mental health crisis will be solved by technology projects built by a professional class who don’t share the lived experience of marginalized communities.”

The apps, BrightLife Kids and Soluna, are operated by two companies: Brightline, a 5-year-old venture capital-backed startup; and Kooth, a London-based publicly traded company that has experience in the U.K. and has also signed on some schools in Kentucky and Pennsylvania and a health plan in Illinois. In the first five months of Kooth’s Pennsylvania pilot, 6% of students who had access to the app signed up.

Brightline and Kooth represent a growing number of health tech firms seeking to profit in this space. They beat out dozens of other bidders including international consulting companies and other youth telehealth platforms that had already snapped up contracts in California.

Although the service is intended to be free with no insurance requirement, Brightline’s app, BrightLife Kids, is folded into and only accessible through the company’s main app, which asks for insurance information and directs users to paid licensed counseling options alongside the free coaching. After KFF Health News questioned why the free coaching was advertised below paid options, Brightline reordered the page so that, even if a child has high-acuity needs, free coaching shows up first.

The apps take an expansive view of behavioral health, making the tools available to all California youth under age 26 as well as caregivers of babies, toddlers, and children 12 and under. When KFF Health News asked to speak with an app user, Brightline connected a reporter with a mother whose 3-year-old daughter was learning to sleep on her own.

‘It’s Like Crickets’

Despite being months into the launch and having millions in marketing funds, the companies don’t have a definitive rollout timeline. Brightline said it hopes to have deployed teams across the state to present the tools in person by midyear. Kooth said developing a strategy to hit every school would be “the main focus for this calendar year.”

“It’s a big state — 58 counties,” Bob McCullough of Kooth said. “It’ll take us a while to get to all of them.”

Brightline’s contract states that the company was required to launch downloadable apps for iOS and Android phones by January, but so far BrightLife Kids is available only on Apple phones. Brightline said it’s aiming to launch the Android version over the summer.

“Nobody’s really done anything like this at this magnitude, I think, in the U.S. before,” said Naomi Allen, a co-founder and the CEO of Brightline. “We’re very much in the early innings. We’re already learning a lot.”

The contracts, obtained by KFF Health News through a records request, show the companies operating the two apps could earn as much as $498 million through the contract term, which ends in June 2027, months after Newsom is set to leave office. And the state is spending hundreds of millions more on Newsom’s virtual behavioral health strategy. The state said it aims to make the apps available long-term, depending on usage.

The state said 15,000 people signed up in the first three months. When KFF Health News asked how many of those users actively engaged with the app, it declined to say, noting that data would be released this summer.

KFF Health News reached out to nearly a dozen California mental health professionals and youths. None of them were aware of the apps.

“I’m not hearing anything,” said Loretta Whitson, executive director of the California Association of School Counselors. “It’s like crickets.”

Whitson said she doesn’t think the apps are on “anyone’s” radar in schools, and she doesn’t know of any schools that are actively advertising them. Brightline will be presenting its tool to the counselor association in May, but Whitson said the company didn’t reach out to plan the meeting; she did.

Concern Over Referrals

Whitson isn’t comfortable promoting the apps just yet. Although both companies said they have a clinical team on staff to assist, Whitson said she’s concerned that the coaches, who aren’t all licensed therapists, won’t have the training to detect when users need more help and refer them to clinical care.

This sentiment was echoed by other school-based social workers, who also noted the apps’ duplicative nature — in some counties, like Los Angeles, youths can access free virtual counseling sessions through Hazel Health, a for-profit company. Nonprofits, too, have entered this space. For example, Teen Line, a peer-to-peer hotline operated by Southern California-based Didi Hirsch Mental Health Services, is free nationwide.

While the state is also funneling money to the schools as part of Newsom’s master plan, students and school-based mental health professionals voiced confusion at the large app investment when, in many school districts, few in-person counseling roles exist, and in some cases are dwindling.

Kelly Merchant, a student at College of the Desert in Palm Desert, noted that it can be hard to access in-person therapy at her school. She believes the community college, which has about 15,000 students, has only one full-time counselor and one part-time bilingual counselor. She and several students interviewed by KFF Health News said they appreciated having engaging content on their phone and the ability to speak to a coach, but all said they’d prefer in-person therapy.

“There are a lot of people who are seeking therapy, and people close to me that I know. But their insurances are taking forever, and they’re on the waitlist,” Merchant said. “And, like, you’re seeing all these people struggle.”

Fiscal conservatives question whether the money could be spent more effectively, like to bolster county efforts and existing youth behavioral health programs.

Republican state Sen. Roger Niello, vice chair of the Senate Budget and Fiscal Review Committee, noted that California is forecasted to face deficits for the next three years, and taxpayer watchdogs worry the apps might cost even more in the long run.

“What starts as a small financial commitment can become uncontrollable expenses down the road,” said Susan Shelley of the Howard Jarvis Taxpayers Association.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

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

USE OUR CONTENT

This story can be republished for free (details).

Mandatory Reporting Laws Meant To Protect Children Get Another Look

April 25, 2024

More than 60 years ago, policymakers in Colorado embraced the idea that early intervention could prevent child abuse and save lives. The state’s requirement that certain professionals tell officials when they suspect a child has been abused or neglected was among the first mandatory reporting laws in the nation.

Since then, mandatory reporting laws have expanded nationally to include more types of maltreatment — including neglect, which now accounts for most reports — and have increased the number of professions required to report. In some states, all adults are required to report what they suspect may be abuse or neglect.

But now there are efforts in Colorado and other states to roll back these laws, saying the result has been too many unfounded reports, and that they disproportionately harm families that are poor, Black, or Indigenous, or have members with disabilities.

“There’s a long, depressing history based on the approach that our primary response to a struggling family is reporting,” said Mical Raz, a physician and historian at the University of Rochester in New York. “There’s now a wealth of evidence that demonstrates that more reporting is not associated with better outcomes for children.”

Stephanie Villafuerte, Colorado’s child protection ombudsman, oversees a task force to reexamine the state’s mandatory reporting laws. She said the group is seeking to balance a need to report legitimate cases of abuse and neglect with a desire to weed out inappropriate reports.

“This is designed to help individuals who are disproportionately impacted,” Villafuerte said. “I’m hoping it’s the combination of these efforts that could make a difference.”

Some critics worry that changes to the law could result in missed cases of abuse. Medical and child care workers on the task force have expressed concern about legal liability. While it’s rare for people to be criminally charged for failure to report, they can also face civil liability or professional repercussions, including threats to their licenses.

Being reported to child protective services is becoming increasingly common. More than 1 in 3 children in the United States will be the subject of a child abuse and neglect investigation by the time they turn 18, according to the most frequently cited estimate, a 2017 study funded by the Department of Health and Human Services’ Children’s Bureau.

Black and Native American families, poor families, and parents or children with disabilities experience even more oversight. Research has found that, among these groups, parents are more likely to lose parental rights and children are more likely to wind up in foster care.

In an overwhelming majority of investigations, no abuse or neglect is substantiated. Nonetheless, researchers who study how these investigations affect families describe them as terrifying and isolating.

In Colorado, the number of child abuse and neglect reports has increased 42% in the past decade and reached a record 117,762 last year, according to state data. Roughly 100,000 other calls to the hotline weren’t counted as reports because they were requests for information or were about matters like child support or adult protection, said officials from the Colorado Department of Human Services.

The increase in reports can be traced to a policy of encouraging a broad array of professionals — including school and medical staff, therapists, coaches, clergy members, firefighters, veterinarians, dentists, and social workers — to call a hotline whenever they have a concern.

These calls don’t reflect a surge in mistreatment. More than two-thirds of the reports received by agencies in Colorado don’t meet the threshold for investigation. Of the children whose cases are assessed, 21% are found to have experienced abuse or neglect. The actual number of substantiated cases has not risen over the past decade.

While studies do not demonstrate that mandatory reporting laws keep children safe, the Colorado task force reported in January, there is evidence of harm. “Mandatory reporting disproportionately impacts families of color” — initiating contact between child protection services and families who routinely do not present concerns of abuse or neglect, the task force said.

The task force said it is analyzing whether better screening might mitigate “the disproportionate impact of mandatory reporting on under-resourced communities, communities of color and persons with disabilities.”

The task force pointed out that the only way to report concerns about a child is with a formal report to a hotline. Yet many of those calls are not to report abuse at all but rather attempts to connect children and families with resources like food or housing assistance.

Hotline callers may mean to help, but the families who are the subjects of mistaken reports of abuse and neglect rarely see it that way.

That includes Meighen Lovelace, a rural Colorado resident who asked KFF Health News not to disclose their hometown for fear of attracting unwanted attention from local officials. For Lovelace’s daughter, who is neurodivergent and has physical disabilities, the reports started when she entered preschool at age 4 in 2015. The teachers and medical providers making the reports frequently suggested that the county human services agency could assist Lovelace’s family. But the investigations that followed were invasive and traumatic.

“Our biggest looming fear is, ‘Are you going to take our children away?’” said Lovelace, who is an advocate for the Colorado Cross-Disability Coalition, an organization that lobbies for the civil rights of people with disabilities. “We’re afraid to ask for help. It’s keeping us from entering services because of the fear of child welfare.”

State and county human services officials said they could not comment on specific cases.

The Colorado task force plans to suggest clarifying the definitions of abuse and neglect under the state’s mandatory reporting statute. Mandatory reporters should not “make a report solely due to a family/child’s race, class or gender,” nor because of inadequate housing, furnishings, income or clothing. Also, there should not be a report based solely on the “disability status of the minor, parent or guardian,” according to the group’s draft recommendation.

The task force plans to recommend additional training for mandatory reporters, help for professionals who are deciding whether to make a call, and an alternative phone number, or “warmline,” for cases in which callers believe a family needs material assistance, rather than surveillance.

Critics say such changes could leave more children vulnerable to unreported abuse.

“I’m concerned about adding systems such as the warmline, that kids who are in real danger are going to slip through the cracks and not be helped,” said Hollynd Hoskins, an attorney who represents victims of child abuse. Hoskins has sued professionals who fail to report their suspicions.

The Colorado task force includes health and education officials, prosecutors, victim advocates, county child welfare representatives and attorneys, as well as five people who have experience in the child welfare system. It intends to finalize its recommendations by early next year in the hope that state legislators will consider policy changes in 2025. Implementation of any new laws could take several years.

Colorado is one of several states — including New York and California — that have recently considered changes to restrain, rather than expand, reporting of abuse. In New York City, teachers are being trained to think twice before making a report, while New York state introduced a warmline to help connect families with resources like housing and child care. In California, a state task force aimed at shifting “mandated reporting to community supporting” is planning recommendations similar to Colorado’s.

Among those advocating for change are people with experience in the child welfare system. They include Maleeka Jihad, who leads the Denver-based MJCF Coalition, which advocates for the abolition of mandatory reporting along with the rest of the child welfare system, citing its damage to Black, Native American, and Latino communities.

“Mandatory reporting is another form of keeping us policed and surveillanced by whiteness,” said Jihad, who as a child was taken from the care of a loving parent and placed temporarily into the foster system. Reform isn’t enough, she said. “We know what we need, and it’s usually funding and resources.”

Some of these resources — like affordable housing and child care — don’t exist at a level sufficient for all the Colorado families that need them, Jihad said.

Other services are out there, but it’s a matter of finding them. Lovelace said the reports ebbed after the family got the help it needed, in the form of a Medicaid waiver that paid for specialized care for their daughter’s disabilities. Their daughter is now in seventh grade and doing well.

None of the caseworkers who visited the family ever mentioned the waiver, Lovelace said. “I really think they didn’t know about it.”

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

USE OUR CONTENT

This story can be republished for free (details).

Tire Toxicity Faces Fresh Scrutiny After Salmon Die-Offs

April 24, 2024

For decades, concerns about automobile pollution have focused on what comes out of the tailpipe. Now, researchers and regulators say, we need to pay more attention to toxic emissions from tires as vehicles roll down the road.

At the top of the list of worries is a chemical called 6PPD, which is added to rubber tires to help them last longer. When tires wear on pavement, 6PPD is released. It reacts with ozone to become a different chemical, 6PPD-q, which can be extremely toxic — so much so that it has been linked to repeated fish kills in Washington state.

The trouble with tires doesn’t stop there. Tires are made primarily of natural rubber and synthetic rubber, but they contain hundreds of other ingredients, often including steel and heavy metals such as copper, lead, cadmium, and zinc.

As car tires wear, the rubber disappears in particles, both bits that can be seen with the naked eye and microparticles. Testing by a British company, Emissions Analytics, found that a car’s tires emit 1 trillion ultrafine particles per kilometer driven — from 5 to 9 pounds of rubber per internal combustion car per year.

And what’s in those particles is a mystery, because tire ingredients are proprietary.

“You’ve got a chemical cocktail in these tires that no one really understands and is kept highly confidential by the tire manufacturers,” said Nick Molden, CEO of Emissions Analytics. “We struggle to think of another consumer product that is so prevalent in the world and used by virtually everyone, where there is so little known of what is in them.”

Regulators have only begun to address the toxic tire problem, though there has been some action on 6PPD.

The chemical was identified by a team of researchers, led by scientists at Washington State University and the University of Washington, who were trying to determine why coho salmon returning to Seattle-area creeks to spawn were dying in large numbers.

Working for the Washington Stormwater Center, the scientists tested some 2,000 substances to determine which one was causing the die-offs, and in 2020 they announced they’d found the culprit: 6PPD.

The Yurok Tribe in Northern California, along with two other West Coast Native American tribes, have petitioned the Environmental Protection Agency to prohibit the chemical. The EPA said it is considering new rules governing the chemical. “We could not sit idle while 6PPD kills the fish that sustain us,” said Joseph L. James, chairman of the Yurok Tribe, in a statement. “This lethal toxin has no place in any salmon-bearing watershed.”

California has begun taking steps to regulate the chemical, last year classifying tires containing it as a “priority product,” which requires manufacturers to search for and test substitutes.

“6PPD plays a crucial role in the safety of tires on California’s roads and, currently, there are no widely available safer alternatives,” said Karl Palmer, a deputy director at the state’s Department of Toxic Substances Control. “For this reason, our framework is ideally suited for identifying alternatives to 6PPD that ensure the continued safety of tires on California’s roads while protecting California’s fish populations and the communities that rely on them.”

The U.S. Tire Manufacturers Association says it has mobilized a consortium of 16 tire manufacturers to carry out an analysis of alternatives. Anne Forristall Luke, USTMA president and CEO, said it “will yield the most effective and exhaustive review possible of whether a safer alternative to 6PPD in tires currently exists.”

Molden, however, said there is a catch. “If they don’t investigate, they aren’t allowed to sell in the state of California,” he said. “If they investigate and don’t find an alternative, they can go on selling. They don’t have to find a substitute. And today there is no alternative to 6PPD.”

California is also studying a request by the California Stormwater Quality Association to classify tires containing zinc, a heavy metal, as a priority product, requiring manufacturers to search for an alternative. Zinc is used in the vulcanization process to increase the strength of the rubber.

When it comes to tire particles, though, there hasn’t been any action, even as the problem worsens with the proliferation of electric cars. Because of their quicker acceleration and greater torque, electric vehicles wear out tires faster and emit an estimated 20% more tire particles than the average gas-powered car.

A recent study in Southern California found tire and brake emissions in Anaheim accounted for 30% of PM2.5, a small-particulate air pollutant, while exhaust emissions accounted for 19%. Tests by Emissions Analytics have found that tires produce up to 2,000 times as much particle pollution by mass as tailpipes.

These particles end up in water and air and are often ingested. Ultrafine particles, even smaller than PM2.5, are also emitted by tires and can be inhaled and travel directly to the brain. New research suggests tire microparticles should be classified as a pollutant of “high concern.”

In a report issued last year, researchers at Imperial College London said the particles could affect the heart, lungs, and reproductive organs and cause cancer.

People who live or work along roadways, often low-income, are exposed to more of the toxic substances.

Tires are also a major source of microplastics. More than three-quarters of microplastics entering the ocean come from the synthetic rubber in tires, according to a report from the Pew Charitable Trusts and the British company Systemiq.

And there are still a great many unknowns in tire emissions, which can be especially complex to analyze because heat and pressure can transform tire ingredients into other compounds.

One outstanding research question is whether 6PPD-q affects people, and what health problems, if any, it could cause. A recent study published in Environmental Science & Technology Letters found high levels of the chemical in urine samples from a region of South China, with levels highest in pregnant women.

The discovery of 6PPD-q, Molden said, has sparked fresh interest in the health and environmental impacts of tires, and he expects an abundance of new research in the coming years. “The jigsaw pieces are coming together,” he said. “But it’s a thousand-piece jigsaw, not a 200-piece jigsaw.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

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

USE OUR CONTENT

This story can be republished for free (details).

Neumáticos tóxicos están matando a los peces. ¿Qué pasa con los humanos?

April 24, 2024

Durante décadas, las preocupaciones sobre la contaminación automovilística se han centrado en lo que sale del tubo de escape. Ahora, investigadores y reguladores dicen que se necesita prestar más atención a las emisiones tóxicas de los neumáticos mientras los vehículos circulan por las carreteras.

Y primero en la lista de preocupaciones se encuentra un producto químico llamado 6PPD, que se agrega a los neumáticos para que duren más tiempo. Cuando los neumáticos se van desgastando por el roce con el pavimento, liberan 6PPD.

Al entrar en contacto con el ozono, esta sustancia reacciona y se convierte en un producto químico diferente, el 6PPD-q, que puede ser extremadamente tóxico, tanto que se ha relacionado con muertes de peces en el estado de Washington.

Pero los problemas no terminan ahí.

Los neumáticos están hechos principalmente de goma natural y goma sintética, pero contienen cientos de otros ingredientes, que a menudo incluyen acero y metales pesados como cobre, plomo, cadmio y zinc.

A medida que los neumáticos se desgastan, la goma desaparece en partículas, tanto trozos que se pueden ver a simple vista como micropartículas. Las pruebas realizadas por una empresa británica, Emissions Analytics, encontraron que los neumáticos de un automóvil emiten 1,000 millones de partículas ultrafinas por kilómetro conducido: entre 5 y 9 libras de goma por automóvil de combustión interna por año.

Y lo que hay en esas partículas es un misterio, porque los ingredientes de los neumáticos son de propiedad exclusiva.

“Tienes un cóctel químico en estos neumáticos que nadie realmente entiende y que los fabricantes de neumáticos mantienen en secreto”, dijo Nick Molden, CEO de Emissions Analytics. “Nos resulta difícil pensar en otro producto de consumo tan prevalente en el mundo y utilizado prácticamente por todos, donde se sepa tan poco sobre lo que contiene”.

Los reguladores apenas han comenzado a abordar el problema de la toxicidad en los neumáticos, aunque ha habido algunas acciones sobre el 6PPD.

El producto químico fue identificado por un equipo de investigadores, dirigido por científicos de la Universidad Estatal de Washington y de la Universidad de Washington, que estaban tratando de determinar por qué estaban muriendo masivamente los salmones coho que regresaban a arroyos del área de Seattle para desovar.

Trabajando para el Washington Stormwater Center, los científicos probaron alrededor de 2,000 sustancias para determinar cuál estaba causando las muertes, y en 2020 anunciaron que habían encontrado al culpable: 6PPD.

La Tribu Yurok en el norte de California, junto con otras dos tribus nativas de la costa oeste, han pedido a la Agencia de Protección Ambiental (EPA) que prohíba el producto químico. La EPA dijo que está considerando nuevas normas que lo regulen.

“No podríamos quedarnos de brazos cruzados mientras el 6PPD mata a los peces que nos sostienen”, dijo Joseph L. James, presidente de la Tribu Yurok, en un comunicado. “Esta toxina letal no tiene lugar en ninguna cuenca salmonera”.

California ha comenzado a tomar medidas para regular el producto químico. El año pasado comenzó a calificar a los neumáticos que lo contienen como un “producto prioritario”, lo que requiere que los fabricantes busquen y prueben sustitutos.

“El 6PPD juega un papel crucial en la seguridad de los neumáticos en las carreteras de California y, actualmente, no hay alternativas más seguras ampliamente disponibles”, dijo Karl Palmer, subdirector del Departamento de Control de Sustancias Tóxicas del estado. “Por esta razón, nuestro marco es ideal para identificar alternativas al 6PPD que sigan garantizado la seguridad de los neumáticos en las carreteras de California, protegiendo al mismo tiempo las poblaciones de peces y las comunidades que dependen de ellas”.

La Asociación de Fabricantes de Neumáticos de EE.UU. (USTMA) dice que ha movilizado un consorcio de 16 fabricantes para llevar a cabo un análisis de alternativas. Anne Forristall Luke, presidenta y CEO de la USTMA, dijo que “proporcionará la revisión más efectiva y exhaustiva posible de si existe una alternativa más segura al 6PPD en los neumáticos”.

Sin embargo, Molden dijo que hay un inconveniente. “Si no investigan, no se les permite vender en el estado de California”, dijo. “Si investigan y no encuentran una alternativa, pueden seguir vendiendo. No tienen que encontrar un sustituto. Y hoy no hay alternativa al 6PPD”.

California también está estudiando una solicitud de la California Stormwater Quality Association para clasificar los neumáticos que contienen zinc, un metal pesado, como un producto prioritario, lo que requeriría que los fabricantes busquen una alternativa. El zinc se utiliza en el proceso de vulcanización para aumentar la resistencia del caucho.

Sin embargo, cuando se trata de partículas de neumáticos, no ha habido ninguna acción, incluso cuando el problema empeora con la proliferación de automóviles eléctricos. Debido a su aceleración más rápida, los vehículos eléctricos desgastan los neumáticos más rápido y emiten aproximadamente un 20% más de partículas que los de un automóvil de gasolina promedio.

Un estudio reciente en el sur de California encontró que las emisiones de neumáticos y frenos en Anaheim representaban el 30% de PM2.5, un contaminante atmosférico de partículas pequeñas, mientras que las emisiones de escape representaban el 19%.

Las pruebas realizadas por Emissions Analytics han encontrado que los neumáticos producen hasta 2,000 veces más contaminación por partículas en masa que los tubos de escape. Estas partículas acaban en el agua y el aire y a menudo se ingieren. Los neumáticos también emiten partículas ultrafinas, incluso más pequeñas que PM2.5, que pueden ser inhaladas y viajar directamente al cerebro.

Nuevas investigaciones sugieren que las micropartículas de neumáticos deberían ser clasificadas como un contaminante de “alta preocupación”. En un informe el año pasado, investigadores del Imperial College de Londres dijeron que las partículas podrían afectar al corazón, los pulmones y los órganos reproductivos, y causar cáncer.

Las personas que viven o trabajan junto a carreteras, muchas veces de bajos ingresos, están expuestas a más de estas sustancias tóxicas.

Los neumáticos también son una fuente importante de microplásticos. Más de tres cuartas partes de los microplásticos que llegan al océano provienen de la goma sintética de los neumáticos, según un informe del Pew Charitable Trusts y la empresa británica Systemiq.

Y todavía hay muchas incógnitas sobre las emisiones de neumáticos, que pueden ser especialmente complejas de analizar porque el calor y la presión pueden transformar los ingredientes del neumático en otros compuestos.

Una pregunta pendiente de investigación es si el 6PPD-q afecta a las personas y qué problemas de salud, si los hay, podría causar. Un estudio reciente publicado en Environmental Science & Technology Letters encontró altos niveles del producto químico en muestras de orina de una región del sur de China, con niveles más altos en mujeres embarazadas.

Molden dijo que el descubrimiento del 6PPD-q ha generado un nuevo interés en el impacto sanitario y ambiental de los neumáticos, y espera una gran cantidad de nuevas investigaciones en los próximos años. “Las piezas del rompecabezas se están armando”, dijo. “Pero es un rompecabezas de mil piezas, no de doscientas”.

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).

En Montana, investigan una nueva y poderosa vacuna contra la tuberculosis

April 23, 2024

Un equipo de investigadores de Montana está jugando un papel clave en el desarrollo de una vacuna más efectiva contra la tuberculosis, una enfermedad infecciosa que ha matado a más personas que ninguna otra.

La BCG (Bacille Calmette-Guérin), desarrollada en 1921, sigue siendo la única vacuna contra la tuberculosis (TB). Si bien tiene una eficacia del 40% al 80% en niños pequeños, su efectividad es muy baja en adolescentes y adultos, lo que impulsó un esfuerzo mundial para encontrar una vacuna que sea más potente.

El Centro de Medicina Translacional de la Universidad de Montana está llevando a cabo una iniciativa en este sentido. El Centro se especializa en mejorar y crear vacunas, agregando los que se denominan “adyuvantes novedosos”.

Un adyuvante es una sustancia que se incluye en la vacuna, por ejemplo moléculas grasas o sales de aluminio, y que potencia la respuesta inmunitaria. Los adyuvantes novedosos son los que aún no se han utilizado en humanos. Los científicos están comprobando que estos adyuvantes generan una inmunidad más fuerte, precisa y duradera que los antígenos, que solo crean anticuerpos.

Provocar respuestas específicas del sistema inmunológico, y profundizar y ampliar su efectividad con adyuvantes, es algo que se conoce como “vacunación de precisión”.

“No es una solución única para todos, no se trata de una vacuna única”, explicó Ofer Levy, profesor de Pediatría de la Universidad de Harvard y director del Programa de Vacunas de Precisión del Hospital Infantil de Boston. “Una vacuna puede funcionar de forma diferente en un recién nacido, un adulto mayor o en una persona de mediana edad”, agregó.

Una vacuna de precisión definitiva, según Levy, brindaría protección de por vida contra una enfermedad con un solo pinchazo. “Una protección de una sola dosis que fuera efectiva contra la gripe o contra el covid sería el Santo Grial”, enfatizó Levy.

Jay Evans dirige el Centro de la Universidad de Montana y, a la vez, es cofundador y director científico y de estrategias, de Inimmune, una empresa privada de biotecnología de Missoula. Evans contó que su equipo lleva 15 años trabajando en una vacuna contra la tuberculosis y que aún faltan cinco años para que ésta pueda distribuirse ampliamente. La asociación público-privada está desarrollando vacunas e intentando mejorar las existentes, afirmó.

En el Centro no ha pasado inadvertido que este trabajo de investigación y producción de vacunas de vanguardia se realiza en Montana, el estado que aprobó una de las leyes antivacunas más extremas del país en 2021, durante la pandemia.

La ley prohíbe a empresas y gobiernos dar un trato diferente a las personas que no estén vacunadas contra covid u otras enfermedades. De hecho, prohíbe a los empleadores públicos y privados que les exijan a los trabajadores que se vacunen contra covid o cualquier otra enfermedad. Un juez federal dictaminó después que la ley no puede aplicarse en entornos sanitarios, como hospitales y consultas médicas.

A mediados de marzo, el Instituto de Investigación Médica Bill y Melinda Gates anunció que había iniciado en siete países la tercera y última fase de los ensayos clínicos de la nueva vacuna contra la tuberculosis. Los ensayos tardarán unos cinco años en completarse. La investigación y la producción se están llevando a cabo en varios lugares, incluida una planta de fabricación en Hamilton, propiedad de GSK, un gigante farmacéutico.

Conocida como “la pandemia olvidada”, la tuberculosis, a pesar de que se puede prevenir y tratar, mata hasta a 1,6 millones de personas al año, la mayoría en zonas empobrecidas de Asia y África.

En Estados Unidos se ha producido un aumento de esta enfermendad en la última década. Muchos inmigrantes tienen TB sin saberlo; en 2022 el número de casos aumentó un 16%. La tuberculosis es la principal causa de muerte entre las personas que viven con VIH, cuyo riesgo de contraer esta enfermedad es 20 veces mayor que el de las personas sin el virus.

“La tuberculosis es un patógeno complejo que ha acompañado a los seres humanos durante siglos”, dijo Alemnew Dagnew, que dirige el programa para la nueva vacuna en el Instituto de Investigación Médica Gates. “Debido a esta situación, ha evolucionado y ha podido desarrollar mecanismos para evadir al sistema inmunológico. Y la inmunología de la TB aún no se comprende completamente”.

En conjunto, el Centro de Medicina Translacional de la Universidad de Montana e Inimmune tienen 80 empleados especializados en la investigación de una variedad de adyuvantes con el propósito de comprender los detalles de las respuestas inmunitarias a diferentes sustancias. “Hay que adaptarlos al patógeno contra el que se vacuna, como si fueran un instrumento en una caja de herramientas”, dijo Evans. “Tenemos toda una biblioteca de moléculas y formulaciones de adyuvantes”.

Las vacunas se vuelven en gran medida más precisas mediante el uso de adyuvantes. Hay tres tipos básicos de adyuvantes naturales: sales de aluminio; escualeno, que se obtiene del hígado de tiburón; y algunos tipos de saponinas, que son moléculas grasas. No se sabe muy bien cómo estimulan el sistema inmunitario. El Centro de Missoula también ha creado y patentado un adyuvante sintético, el UM-1098, que induce un tipo específico de respuesta inmunitaria y que se añadirá a las nuevas vacunas.

Una de las moléculas más prometedoras que se están utilizando para potenciar la respuesta del sistema inmunológico a las vacunas es una molécula de saponina de la corteza del árbol de quillay, recolectada en Chile de árboles que tienen por lo menos una década.

Estas moléculas fueron utilizadas por Novavax en su vacuna contra covid y por GSK en Shingrix, su vacuna contra la culebrilla (shingles), de uso generalizado. Estas moléculas también son un componente clave en la nueva vacuna contra la tuberculosis, conocida como la vacuna M72.

Pero hay margen para mejorar.

“La vacuna muestra una eficacia del 50%, lo que no parece mucho, pero como actualmente se carece de otra vacuna más efectiva, el 50% es bastante mejor que lo que hay”, sostuvo Evans. “Buscamos aprovechar lo que aprendimos de ese desarrollo de la vacuna con adyuvantes adicionales para tratar de mejorarla y llevar ese índice desde el 50% hasta el 80% o más”.

Las vacunas contra el sarampión, en cambio, han alcanzado una efectividad del 95%.

Según el sitio web Medscape, en este momento se están desarrollando alrededor de 15 vacunas que son candidatas a reemplazar la BCG, y tres de ellas se encuentran en la fase 3 de ensayos clínicos.

Una alternativa que el Centro de Evans está investigando para mejorar la eficacia de la nueva vacuna es tomar una parte de la bacteria que causa la tuberculosis, sintetizarla y combinarla con el adyuvante QS-21, elaborado a partir del árbol de quillay. “Estimula el sistema inmunológico de una manera específica para la tuberculosis y genera una respuesta inmune que se acerca aún más a lo que obtenemos de las infecciones naturales”, dijo Evans.

Por su parte, el Centro de la Universidad de Montana está investigando el tratamiento de varias afecciones que generalmente no se consideran susceptibles de ser abordadas mediante vacunación. Por ejemplo, están ingresando en la primera fase de ensayos clínicos para una vacuna contra las alergias y para otra, contra el cáncer.

Avanzado este año, comenzarán los ensayos clínicos para obtener vacunas capaces de bloquear los efectos de opioides como la heroína y el fentanilo. La Universidad de Montana recibió la mayor subvención de su historia, $33 millones, para investigar una vacuna contra los opioides. Funciona creando un anticuerpo que se une a la droga en el torrente sanguíneo, evitando que entre al cerebro y produzca el efecto de euforia.

Por ahora, sin embargo, los expertos en salud de todo el mundo tienen sus ojos puestos en los ensayos de las nuevas vacunas contra la tuberculosis, que, si tienen éxito, podrían ayudar a salvar innumerables vidas en las regiones más pobres del mundo.

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).

Para frenar las muertes por fentanilo, reparten kits para revertir las sobredosis puerta por puerta

April 23, 2024

En una estrecha calle de townhouses y un taller mecánico en el vecindario Kensington, en el norte de Philadelphia, Marsella Elie subió los escalones y golpeó fuerte las puertas de las casas.

Un hombre de mediana edad abrió, con mirada cautelosa.

“Hola, señor, ¿cómo está hoy?”, le preguntó Elie, que tenía puesta una chaqueta con el logo de la Campana de la Libertad, del gobierno de la ciudad. “Mi nombre es Marsella. Estoy trabajando con la ciudad. ¿Ha oído hablar de las sobredosis que están ocurriendo en el vecindario, verdad?”.

El hombre asintió. Elie señaló los folletos que tenía sobre sobredosis de drogas y programas de tratamiento para la adicción. Levantó una caja de Narcan, una marca de naloxona, que puede revertir una sobredosis de opioides.

“Lo que estamos tratando de hacer es que esto llegue a todos los hogares. ¿Alguna vez ha oído hablar de esto antes?”, preguntó Elie antes de entregarle al hombre una bolsa de tela llena de folletos, tiras de prueba de fentanilo y la caja de Narcan.

Elie y otros trabajadores de medio tiempo de la ciudad y voluntarios forman parte de una campaña puerta a puerta a gran escala en Philadelphia que tiene como objetivo equipar los hogares con naloxona y otros suministros para prevenir sobredosis de drogas.

Los funcionarios de la ciudad esperan que este enfoque proactivo transforme a la naloxona en un artículo que esté en los botiquines, para evitar que las personas mueran por sobredosis, especialmente los residentes negros.

En Philadelphia, en 2022, según datos de la ciudad, un récord de 1,413 personas murieron por sobredosis de drogas. Entre los residentes negros, las muertes aumentaron un 20% respecto al año anterior, y muchas ocurrieron en casas.

“Lo mejor que podemos hacer para que estos productos sean más accesibles es simplemente dárselos a las personas”, dijo Keli McLoyd, subdirectora de la Unidad de Respuesta a Opioides de la ciudad, hablando sobre la bolsa de tela con naloxona y otros suministros.

“No le estamos preguntando si está usando drogas. El objetivo aquí es realmente construir una responsabilidad colectiva. Como personas de comunidades minoritarias, como vimos durante la epidemia de covid, nadie viene a salvarnos. Para nosotros, esta es una herramienta que podemos usar para salvarnos a nosotros mismos”.

Esta iniciativa de distribución tiene como objetivo llevar suministros de prevención directamente a personas que de otro modo no los buscarían por sí mismas, y concientizar sobre las sobredosis más allá de Kensington, el epicentro de la epidemia de adicción de la ciudad.

Los encuestadores planean golpear más de 100,000 puertas en los “puntos calientes” de Philadelphia, códigos postales con tasas crecientes de sobredosis de opioides, muchos en comunidades minoritarias.

El aumento de las disparidades raciales en las muertes por sobredosis es una de las consecuencias a largo plazo de la guerra contra las drogas, dijo McLoyd. Las políticas de esa campaña nacional llevaron a décadas de tácticas policiales agresivas, perfil racial y largas condenas de prisión, afectando de manera desproporcionada a personas de color y a sus comunidades.

La investigación muestra que los afroamericanos siguen representando un número desproporcionado de arrestos por drogas y servicios de protección infantil.

“Por eso, está muy claro por qué las personas de minorías podrían ser reacias a levantar la mano y decir: ‘Soy una persona que usa drogas, necesito esos recursos'”, dijo McLoyd.

Otras comunidades han distribuido naloxona y otros suministros, aunque en menor escala que Philadelphia. Lo que está haciendo Philadelphia podría convertirse en un modelo para otros lugares densamente poblados, dijo Daliah Heller, vicepresidenta de iniciativas sobre el uso de drogas en Vital Strategies, una organización de salud pública que trabaja con gobiernos locales en siete estados para abordar la epidemia de opioides.

“Hay algo intensamente personal en un compromiso humano”, dijo Heller. “Y que alguien toque a tu puerta para hablar sobre el uso de drogas y el riesgo de sobredosis y que haya algo que se pueda hacer, creo que es realmente poderoso”.

A lo largo de los años, la naloxona se ha vuelto más accesible que nunca, apuntó Heller. Ahora se puede pedir por internet y se puede recibir por correo, está disponible en máquinas expendedoras especializadas y algunas farmacias ahora venden el spray nasal de Narcan sin receta.

Pero decenas de miles de estadounidenses siguen muriendo por sobredosis de opioides cada año.

Eso significa que los esfuerzos de prevención y los mensajes sobre la crisis aún no llegan a algunas personas, dijo Heller. Y para Heller, llegar a las personas significa ir donde están. “Tenemos que pensar así cuando pensamos en la distribución de naloxona”.

El proyecto de divulgación en Philadelphia está financiado en parte por los pagos de acuerdos de demandas nacionales contra fabricantes y distribuidores de opioides, parte de los cuales recibió la ciudad.

Se espera que la ciudad reciba alrededor de $200 millones en aproximadamente 18 años de acuerdos con AmerisourceBergen, Cardinal Health, McKesson y Johnson & Johnson.

De la iniciativa forman parte muchas de las mismas personas que comenzaron a hacer divulgación como parte del censo de 2020.

No todos responden a la puerta. Algunos no están en casa. En esos casos, los trabajadores dejan un volante en el picaporte de la puerta que ofrece información sobre los riesgos de las sobredosis, y contactos para obtener más recursos.

Los equipos de encuestadores, a menudo con intérpretes de idiomas, hacen una segunda ronda de visitas en el vecindario para llegar a las personas que no vieron la primera vez.

En un jueves reciente, los encuestadores de Philadelphia estaban tocando puertas en los vecindarios de Franklinville y Hunting Park. Según datos de la ciudad, en este código postal, aproximadamente 85 personas murieron por sobredosis de drogas en 2022. Eso es menos que las 193 personas que murieron por sobredosis en Kensington el mismo año, pero mucho más que las pocas muertes vistas en los vecindarios más ricos de la ciudad.

Los encuestadores se acercaron a una residente, Katherine Camacho, en la acera, cuando salía de su garage. Camacho les dijo que estaba al tanto del problema de las sobredosis en su comunidad y luego aceptó con entusiasmo una caja de Narcan. “Voy a llevar esto conmigo, porque, como dije, a veces estás en la calle conduciendo a algún lugar y podrías salvar una vida”, les dijo Camacho.

En cuanto al esfuerzo de divulgación de Philadelphia, Camacho dijo que cree que “Dios está poniendo a estas personas para ayudar”. Mientras entraba en su casa llevando la caja de Narcan, agregó que quería hacer su parte para ayudar.

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).

Rural Jails Turn to Community Health Workers To Help the Newly Released Succeed

April 22, 2024

MANTI, Utah — Garrett Clark estimates he has spent about six years in the Sanpete County Jail, a plain concrete building perched on a dusty hill just outside this small, rural town where he grew up.

He blames his addiction. He started using in middle school, and by the time he was an adult he was addicted to meth and heroin. At various points, he’s done time alongside his mom, his dad, his sister, and his younger brother.

“That’s all I’ve known my whole life,” said Clark, 31, in December.

Clark was at the jail to pick up his sister, who had just been released. The siblings think this time will be different. They are both sober. Shantel Clark, 33, finished earning her high school diploma during her four-month stay at the jail. They have a place to live where no one is using drugs.

And they have Cheryl Swapp, the county sheriff’s new community health worker, on their side.

“She saved my life probably, for sure,” Garrett Clark said.

Swapp meets with every person booked into the county jail soon after they arrive and helps them create a plan for the day they get out.

She makes sure everyone has a state ID card, a birth certificate, and a Social Security card so they can qualify for government benefits, apply to jobs, and get to treatment and probation appointments. She helps nearly everyone enroll in Medicaid and apply for housing benefits and food stamps. If they need medication to stay off drugs, she lines that up. If they need a place to stay, she finds them a bed.

Then Swapp coordinates with the jail captain to have people released directly to the treatment facility. Nobody leaves the jail without a ride and a drawstring backpack filled with items like toothpaste, a blanket, and a personalized list of job openings.

“A missing puzzle piece,” Sgt. Gretchen Nunley, who runs educational and addiction recovery programming for the jail, called Swapp.

Swapp also assesses the addiction history of everyone held by the county. More than half arrive at the jail addicted to something.

Nationally, 63% of people booked into local jails struggle with a substance use disorder — at least six times the rate of the general population, according to the federal Substance Abuse and Mental Health Services Administration. The incidence of mental illness in jails is more than twice the rate in the general population, federal data shows. At least 4.9 million people are arrested and jailed every year, according to an analysis of 2017 data by the Prison Policy Initiative, a nonprofit organization that documents the harm of mass incarceration. Of those incarcerated, 25% are booked two or more times, the analysis found. And among those arrested twice, more than half had a substance use disorder and a quarter had a mental illness.

“We don’t lock people up for being diabetic or epileptic,” said David Mahoney, a retired sheriff in Dane County, Wisconsin, who served as president of the National Sheriffs’ Association in 2020-21. “The question every community needs to ask is: ‘Are we doing our responsibility to each other for locking people up for a diagnosed medical condition?’”

The idea that county sheriffs might owe it to society to offer medical and mental health treatment to people in their jails is part of a broader shift in thinking among law enforcement officials that Mahoney said he has observed during the past decade.

“Don’t we have a moral and ethical responsibility as community members to address the reasons people are coming into the criminal justice system?” asked Mahoney, who has 41 years of experience in law enforcement.

Swapp previously worked as a teacher’s aide for those she calls the “behavior kids” — children who had trouble self-regulating in class. She feels her work at the jail is a way to change things for the parents of those kids. And it appears to be working.

Since the Sanpete County Sheriff’s Office hired Swapp last year, recidivism has dropped sharply. In the 18 months before she began her work, 599 of the people booked into Sanpete County Jail had been there before. In the 18 months after she started, that number dropped to 237.

In most places, people are released from county jails with no health care coverage, no job, nowhere to live, and no plan to stay off drugs or treat their mental illness. Research shows that people newly released from incarceration face a risk of overdose that is 10 times as high as that of the general public.

Sanpete wasn’t any different.

“For seven to eight years of me being here, we’d just release people and cross our fingers,” said Jared Hill, the clinical director for Sanpete County and a counselor at the jail.

Nunley, the programming sergeant, remembers watching people released from jail walk the mile to town with nothing but the clothes they’d worn on the day they were arrested — it was known as the “walk of shame.” Swapp hates that phrase. She said no one has made the trip on foot since she started in July 2022.

Swapp’s work was initially funded by a grant from the U.S. Health Resources and Services Administration, but it has proved so popular that commissioners in Sanpete County voted to use a portion of its opioid settlement money to cover the position in the future.

Swapp doesn’t have formal medical or social work training. She is certified by the state of Utah as a community health worker, a job that has become more common nationwide. There were about 67,000 people working as community health workers in 2022, according to the U.S. Bureau of Labor Statistics.

Evidence is mounting that the model of training people to help their neighbors connect to government and health care services is sound, said Aditi Vasan, a senior fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania who has reviewed the research on the relatively new role.

The day before Swapp coordinated Shantel Clark’s release, she sat with Robert Draper, a man in his 50s with long white hair and bright-blue eyes. Draper has been in and out of jail for decades. He was sober for a year and had been taking care of his ill mother. She kept getting worse. Then his daughter and her child came to help. It was all a little too much.

“I thought, if I can just go and get high, I can deal with this shit,” said Draper. “But after you’ve been using for 40 years, it’s kinda easy to slip back in.”

He didn’t blame his probation officer for throwing him back in jail when he tested positive for drugs, he said. But he thinks jail time is an overreaction to a relapse. Draper sent a note to Swapp through the jail staff asking to see her. He was hoping she could help him get out so he could be with his mom, who had just been sent to hospice. He had missed his father’s death years ago because he was in jail at the time.

Swapp listened to Draper’s story without interruptions or questions. Then she asked if she could run through her list with him so she would know what he needed.

“Do you have your Social Security card?”

“My card?” Draper shrugged. “I know my number.”

“Your birth certificate, you have it?”

“Yeah, I don’t know where it is.”

“Driver’s license?”

“No.”

“Was it revoked?”

“A long, long time ago,” Draper said. “DUI from 22 years ago. Paid for and everything.”

“Are you interested in getting it back?”

“Yeah!”

Swapp has some version of this conversation with every person she meets in the jail. She also runs through their history of addiction and asks them what they most need to get back on their feet.

She told Draper she would try to get him into intensive outpatient therapy. That would involve four to five classes a week and a lot of driving. He’d need his license back. She didn’t make promises but said she would talk to his probation officer and the judge. He sighed and thanked her.

“I’m your biggest fan here,” Swapp said. “I want you to succeed. I want you to be with your mom, too.”

The federal grant that funded the launch of Sanpete’s community health worker program is held by the regional health care services organization Intermountain Health. Intermountain took the idea to the county and has provided Swapp with support and training. Intermountain staff also administer the $1 million, three-year grant, which includes efforts to increase addiction recovery services in the area.

A similarly funded program in Kentucky called First Day Forward took the community health worker model a step further, using “peer support specialists” — people who have experienced the issues they are trying to help others navigate. Spokespeople from HRSA pointed to four programs, including the ones in Utah and Kentucky, that are using their grant money for people facing or serving time in local jails.

Back in Utah, Sanpete’s new jail captain, Jeff Nielsen, said people in small-town law enforcement weren’t so far removed from those serving time.

“We know these people,” Nielsen said. He has known Robert Draper since middle school. “They are friends, neighbors, sometimes family. We’d rather help than lock them up and throw away the key. We’d rather help give them a good life.”

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).

Newsom Offers a Compromise to Protect Indoor Workers from Heat

April 18, 2024

SACRAMENTO, Calif. — Gov. Gavin Newsom’s administration has compromised on long-sought rules that would protect indoor workers from extreme heat, saying tens of thousands of prison and jail employees — and prisoners — would have to wait for relief.

The deal comes a month after the administration unexpectedly rejected sweeping heat standards for workers in sweltering warehouses, steamy kitchens, and other dangerously hot job sites. The rules had been years in the making, and a state worker safety board voted to adopt them March 21. But in a controversial move, the administration upended the process by saying the cost to cool state prisons was unclear — and likely very expensive.

So the Democratic administration said the rules can proceed but must exempt tens of thousands of workers at 33 state prisons, conservation camps, and local jails, “in recognition of the unique implementation challenges,” said Eric Berg, of California’s Division of Occupational Safety and Health, at a Thursday hearing. A separate regulation will be drafted for correctional facilities, which could take a year, if not longer.

It’s unclear if the standards will become law in time to protect millions of other workers from summer’s intensifying heat. The compromise rules must go through a 15-day public comment period, and legal reviews within 100 days, which could push implementation well into summer. But that can’t even happen until the original regulation is rejected by the Office of Administrative Law, which has until next month.

“Summer is arriving, and many workers, unfortunately, are going to suffer heat conditions,” said Tim Shadix, legal director at the Warehouse Worker Resource Center. “Some will likely get really sick, potentially even die from heat illness, while we continue to wait for the standard.”

Berg told members of the Occupational Safety and Health Standards Board on April 18 that Cal/OSHA would try to accelerate the timeline and get protections in place for summer.

California has had heat standards on the books for outdoor workers since 2005, and rules for indoor workplaces have been in the works since 2016. The proposed standards would require work sites to be cooled below 87 degrees Fahrenheit when employees are present and below 82 degrees in places where workers wear protective clothing or are exposed to radiant heat, such as furnaces. Buildings could be cooled with air conditioning, fans, misters, and other methods.

The rules allow workarounds for businesses that can’t cool their workplaces sufficiently, such as laundries or restaurant kitchens.

Because the rules would have a sweeping economic impact, state law requires Newsom’s Department of Finance to sign off on the financial projections, which it refused to do last month when it was unclear how much the regulations would cost state prisons. The California Department of Corrections and Rehabilitation said implementing the standards in its prisons and other facilities could cost billions, but the board’s economic analysis pegged the cost at less than $1 million a year.

Department of Finance spokesperson H.D. Palmer couldn’t promise that the compromise rules would be signed off on, but “given that the earlier correctional estimates were the issue before, not having them in the revised package would appear to address that issue,” he said.

Business and agricultural groups complained repeatedly during the rulemaking process that complying with the rules would burden businesses financially. At the April 18 hearing, they highlighted the administration’s lack of transparency and questioned why one sector should be given an exemption over another.

“The massive state costs that are of concern, specifically around prisons in the billions of dollars, are also costs that California employers will bear,” said Robert Moutrie, a senior policy advocate at the California Chamber of Commerce.

Labor advocates asked board members not to exempt prisons, saying corrections workers need protection from heat, too.

“It’s a huge concern that prison workplaces all over are being excluded from the heat standard, leaving out not just guards, but also nurses, janitors, and the other prison workers across California unprotected from heat,” said AnaStacia Nicol Wright, an attorney with Worksafe, a workplace safety advocacy nonprofit. “California needs to prioritize the safety and well-being of their workers, regardless of whether they work in corrections, a farm, or a sugar refinery.”

Prisons will continue to provide cooling stations in air-conditioned areas, and make water stations, fans, portable cooling units, and ice more available to workers, according to the California Department of Corrections and Rehabilitation. Prison housing units, which house roughly 93,000 inmates as of April 17, all can be cooled, usually with evaporative coolers and fans. The department has 58,135 staff members, spokesperson Terri Hardy said.

Only Minnesota and Oregon have adopted heat rules for indoor workers. Legislation has stalled in Congress, and even though the Biden administration has initiated the long process of establishing national heat standards for outdoor and indoor work, they may take years to finalize.

Seven workers died in California from indoor heat between 2010 and 2017. Heat stress can lead to heat exhaustion, heatstroke, cardiac arrest, and kidney failure. In 2021, the Centers for Disease Control and Prevention reported, 1,600 heat-related deaths occurred nationally, which is likely an undercount because health care providers are not required to report them. It’s not clear how many of these deaths are related to work, either indoors or outdoors.

“These are not overly cumbersome things to implement, and they are easy ways to keep people safe and healthy,” said Jessica Early, patient advocacy coordinator at the National Union of Healthcare Workers. “Now is the urgent time to make our workplaces safer and more resilient in the face of rising temperatures.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

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

USE OUR CONTENT

This story can be republished for free (details).

The Path to a Better Tuberculosis Vaccine Runs Through Montana

April 18, 2024

A team of Montana researchers is playing a key role in the development of a more effective vaccine against tuberculosis, an infectious disease that has killed more people than any other.

The BCG (Bacille Calmette-Guérin) vaccine, created in 1921, remains the sole TB vaccine. While it is 40% to 80% effective in young children, its efficacy is very low in adolescents and adults, leading to a worldwide push to create a more powerful vaccine.

One effort is underway at the University of Montana Center for Translational Medicine. The center specializes in improving and creating vaccines by adding what are called novel adjuvants. An adjuvant is a substance included in the vaccine, such as fat molecules or aluminum salts, that enhances the immune response, and novel adjuvants are those that have not yet been used in humans. Scientists are finding that adjuvants make for stronger, more precise, and more durable immunity than antigens, which create antibodies, would alone.

Eliciting specific responses from the immune system and deepening and broadening the response with adjuvants is known as precision vaccination. “It’s not one-size-fits-all,” said Ofer Levy, a professor of pediatrics at Harvard University and the head of the Precision Vaccines Program at Boston Children’s Hospital. “A vaccine might work differently in a newborn versus an older adult and a middle-aged person.”

The ultimate precision vaccine, said Levy, would be lifelong protection from a disease with one jab. “A single-shot protection against influenza or a single-shot protection against covid, that would be the holy grail,” Levy said.

Jay Evans, the director of the University of Montana center and the chief scientific and strategy officer and a co-founder of Inimmune, a privately held biotechnology company in Missoula, said his team has been working on a TB vaccine for 15 years. The private-public partnership is developing vaccines and trying to improve existing vaccines, and he said it’s still five years off before the TB vaccine might be distributed widely.

It has not gone unnoticed at the center that this state-of-the-art vaccine research and production is located in a state that passed one of the nation’s most extreme anti-vaccination laws during the pandemic in 2021. The law prohibits businesses and governments from discriminating against people who aren’t vaccinated against covid-19 or other diseases, effectively banning both public and private employers from requiring workers to get vaccinated against covid or any other disease. A federal judge later ruled that the law cannot be enforced in health care settings, such as hospitals and doctors’ offices.

In mid-March, the Bill & Melinda Gates Medical Research Institute announced it had begun the third and final phase of clinical trials for the new vaccine in seven countries. The trials should take about five years to complete. Research and production are being done in several places, including at a manufacturing facility in Hamilton owned by GSK, a giant pharmaceutical company.

Known as the forgotten pandemic, TB kills up to 1.6 million people a year, mostly in impoverished areas in Asia and Africa, despite its being both preventable and treatable. The U.S. has seen an increase in tuberculosis over the past decade, especially with the influx of migrants, and the number of cases rose by 16% from 2022 to 2023. Tuberculosis is the leading cause of death among people living with HIV, whose risk of contracting a TB infection is 20 times as great as people without HIV.

“TB is a complex pathogen that has been with human beings for ages,” said Alemnew Dagnew, who heads the program for the new vaccine for the Gates Medical Research Institute. “Because it has been with human beings for many years, it has evolved and has a mechanism to escape the immune system. And the immunology of TB is not fully understood.”

The University of Montana Center for Translational Medicine and Inimmune together have 80 employees who specialize in researching a range of adjuvants to understand the specifics of immune responses to different substances. “You have to tailor it like tools in a toolbox towards the pathogen you are vaccinating against,” Evans said. “We have a whole library of adjuvant molecules and formulations.”

Vaccines are made more precise largely by using adjuvants. There are three basic types of natural adjuvants: aluminum salts; squalene, which is made from shark liver; and some kinds of saponins, which are fat molecules. It’s not fully understood how they stimulate the immune system. The center in Missoula has also created and patented a synthetic adjuvant, UM-1098, that drives a specific type of immune response and will be added to new vaccines.

One of the most promising molecules being used to juice up the immune system response to vaccines is a saponin molecule from the bark of the quillay tree, gathered in Chile from trees at least 10 years old. Such molecules were used by Novavax in its covid vaccine and by GSK in its widely used shingles vaccine, Shingrix. These molecules are also a key component in the new tuberculosis vaccine, known as the M72 vaccine.

But there is room for improvement.

“The vaccine shows 50% efficacy, which doesn’t sound like much, but basically there is no effective vaccine currently, so 50% is better than what’s out there,” Evans said. “We’re looking to take what we learned from that vaccine development with additional adjuvants to try and make it even better and move 50% to 80% or more.”

By contrast, measles vaccines are 95% effective.

According to Medscape, around 15 vaccine candidates are being developed to replace the BCG vaccine, and three of them are in phase 3 clinical trials.

One approach Evans’ center is researching to improve the new vaccine’s efficacy is taking a piece of the bacterium that causes TB, synthesizing it, and combining it with the adjuvant QS-21, made from the quillay tree. “It stimulates the immune system in a way that is specific to TB and it drives an immune response that is even closer to what we get from natural infections,” Evans said.

The University of Montana center is researching the treatment of several problems not commonly thought of as treatable with vaccines. They are entering the first phase of clinical trials for a vaccine for allergies, for instance, and first-phase trials for a cancer vaccine. And later this year, clinical trials will begin for vaccines to block the effects of opioids like heroin and fentanyl. The University of Montana received the largest grant in its history, $33 million, for anti-opioid vaccine research. It works by creating an antibody that binds with the drug in the bloodstream, which keeps it from entering the brain and creating the high.

For now, though, the eyes of health care experts around the world are on the trials for the new TB vaccines, which, if they are successful, could help save countless lives in the world’s poorest places.

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).

Pages