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Statement by HHS Secretary Xavier Becerra on House Republicans Introducing Legislation to Rip Away Women’s Access to Contraception and Abortion Medication

HHS Gov News - September 14, 2022
Today, HHS Secretary Xavier Becerra released the following statement on House Republicans introducing legislation to deny women essential medications

Expertos cuestionan el rol de la morera blanca en la muerte de la esposa del congresista

Kaiser Health News:Health Industry - September 14, 2022

SACRAMENTO, California. — Científicos, médicos y patólogos están cuestionando la conclusión del forense del condado de Sacramento de que la muerte de Lori McClintock estuvo relacionada con la morera blanca (white Mulberry), una planta que se ha utilizado como remedio herbal durante siglos, y que el botánico consultor del forense llamó “no tóxica” en una carta a su oficina.

McClintock, la esposa del representante estadounidense Tom McClintock (republicano de California), murió repentinamente en diciembre por deshidratación debido a una gastroenteritis, una inflamación del estómago y los intestinos, que fue causada por “efectos adversos de la ingestión de hojas de morera blanca”, según un informe del forense del condado de Sacramento. El forense dictaminó que la muerte fue un accidente.

Pero la forense del condado de Sacramento Kimberly Gin, no explicó —ni proporcionó registros que lo expliquen—, por qué determinó que la hoja de morera blanca condujo a la deshidratación que mató a McClintock a los 61 años, generando escepticismo entre una variedad de expertos. 

Según el informe de la autopsia, se encontró una hoja de morera blanca “parcialmente intacta” en el estómago de Lori McClintock. Pero no hay otra referencia a su uso de estas hojas, suplementos, extractos, polvos, o cualquier otro método para ingerir la planta, en los documentos que la oficina forense ha publicado en relación con el caso.

“Haría falta literalmente enormes cestas de hojas de morera blanca para causar algún tipo de efecto adverso. E incluso entonces, no ves nada letal”, dijo Bill Gurley, científico principal del Centro Nacional de Investigación de Productos Naturales de la Universidad de Mississippi, que colabora con oficiales académicos, gubernamentales y de la industria para investigar y desarrollar productos naturales.

Gurley, experto en interacciones entre hierbas y medicamentos, calificó la hoja de morera blanca, que se utiliza para una variedad de dolencias, como diabetes, presión arterial alta y obesidad, “probablemente como una de las hojas más seguras del mundo” y dijo que “su historial de seguridad es insuperable”.

“Solo me estoy preguntando sobre cómo diablos podrían llegar a la conclusión de que esta señora falleció al ingerir, al menos hasta donde sabemos, solo una hoja de morera”, dijo.

La doctora Mary Hardy, fundadora de la clínica de medicina integral en el Centro Médico Cedars-Sinai en Los Ángeles, quien investigó la seguridad de algunas medicinas y terapias alternativas para el Centro de Investigación de Suplementos Dietéticos en Botánica de la UCLA, ahora cerrado, dijo que la conclusión del forense es “no convincente”.

“La causa aproximada de la muerte no está respaldada” por los registros disponibles, dijo Hardy.

Gin, contactada a través de la vocera del condado de Sacramento, Kim Nava, rechazó repetidamente las solicitudes de entrevista de KHN y se ha negado a proporcionar información que explique cómo su oficina concluyó que un pedazo de hoja de morera blanca contribuyó a la muerte de McClintock.

Las hojas y el fruto del árbol de morera blanca, originario de China, se han utilizado durante siglos en la medicina tradicional. Estudios académicos realizados en la última década han encontrado que el extracto de sus hojas puede reducir los niveles de azúcar en la sangre y ayudar a perder peso.

Las personas lo toman en forma de cápsulas o píldoras, como extracto o en polvo. También pueden comer las hojas tiernas crudas o prepararlas como un té de hierbas.

No está claro cómo McClintock ingirió la hoja de morera blanca —ya sea que la comió cruda o la bebió en forma de té—, y de dónde la obtuvo.

Tom McClintock, un republicano que representa a un distrito que abarca varios condados en el centro y el norte de California, encontró a su esposa inconciente en su casa de Elk Grove, el 15 de diciembre de 2021, según el informe del forense. McClintock no ha respondido a las repetidas solicitudes de comentarios.

En el funeral de su esposa en enero, Tom McClintock les dijo a los dolientes que estaba bien cuando habló con ella el día antes de su muerte. Pero según el informe del forense, el día antes de su muerte “tuvo quejas de malestar estomacal”.

McClintock también les dijo a los dolientes que “estaba haciendo una dieta cuidadosa” y que “acababa de empezar en un gimnasio”.

KHN obtuvo el informe del forense, fechado el 10 de marzo, además del informe de la autopsia y el certificado de defunción, en julio, e informó los hallazgos en agosto.

La oficina del forense examinó el cuerpo de McClintock para detectar gripe, otros virus respiratorios y covid-19. Ninguno fue detectado. También encargó pruebas de laboratorio independientes que mostraron que el cuerpo de McClintock tenía niveles elevados de nitrógeno ureico, sodio y creatinina, todos signos de deshidratación, según cinco patólogos entrevistados por KHN. Solo uno de ellos dijo que era plausible que la hoja de morera blanca pudiera haber contribuido a la deshidratación.

Todos los patólogos dijeron que los documentos del forense dados a conocer públicamente no brindaban una imagen completa de cómo murió McClintock, y que no incluían detalles clave como qué encontró la oficina del forense en su casa, y si McClintock podría haber estado tomando alguna medicación o suplementos.

“El indicio de que puede haber algo de deshidratación es cierto. Realmente no tienen mucho más”, dijo el doctor Gregory G. Davis, director de la división forense del Departamento de Patología de la Universidad de Alabama-Birmingham y jefe médico forense del condado de Jefferson, en Alabama.

“No sé si la hoja de morera necesariamente jugó algún papel en la muerte”, dijo Davis, y agregó, al igual que otros expertos, que no se considera tóxica.

“Mirando los resultados de su autopsia, pareciera ser que estaba razonablemente sana, y realmente no hubieras esperado que muriera en ese momento. Eso ya lo convirtió en un caso difícil porque no es obvio”.

El doctor James Gill, presidente del Comité de Patología Forense del Colegio de Patólogos Estadounidenses y jefe médico forense de Connecticut, agregó que alguien puede tardar días en morir de deshidratación. Una sola hoja, que no se había digerido por completo, un proceso que generalmente toma solo un par de horas, no “habría contribuido a la muerte”, dijo.

“Se tarda al menos una semana más o menos para que alguien muera por deshidratación por no beber”, dijo Gill. Según los registros disponibles, “hay algunas cosas que realmente no encajan”.

Gill dijo que habría dictaminado que la muerte de McClintock fue una muerte natural por causas desconocidas, lo que ocurre en aproximadamente el 5% de las muertes que investiga.

No se han informado muertes por la planta de morera blanca a los funcionarios de control de intoxicaciones en los últimos 10 años, según la Asociación Estadounidense de Centros de Control de Intoxicaciones.

Desde 2002, se han informado a la FDA dos casos de personas que pueden haber enfermado por los suplementos de morera, según su base de datos que rastrea “eventos adversos”. Lindsay Haake, vocera de la FDA, se negó a decir si la agencia está investigando este caso porque no revela sus investigaciones.

Después de que KHN revelara la historia sobre la causa de la muerte de McClintock, la oficina del forense publicó un par de documentos adicionales, incluida una carta del 29 de diciembre de 2021 de Alison Colwell, curadora del Centro para la Diversidad de Plantas de la Universidad de California-Davis. El forense le había pedido a Colwell que identificara el fragmento de hoja de 1 1/8 pulgadas por 1 7/8 pulgadas encontrado en el estómago de McClintock durante la autopsia.

Colwell lo identificó como morera blanca y concluyó, en base a su flexibilidad y “algo de color verde”, que “probablemente se ingirió cuando estaba fresca”, dijo su carta.

Aunque los árboles de morera blanca son comunes en la región de Sacramento, señaló que, en diciembre, sus hojas son “duras, amarillentas y en su mayoría se han caído de los árboles”.

Colwell también declaró simplemente: “La morera blanca no es tóxica”.

“Comparé el espécimen con especies letalmente tóxicas que se sabe que están plantadas o son nativas en el área de Sacramento y no encontré coincidencias”, decía su carta. Colwell rechazó una solicitud de entrevista.

La industria de productos a base de hierbas, la industria de suplementos dietéticos y sus aliados se han irritado ante la posibilidad de que McClintock haya muerto después de ingerir suplementos que contenían hojas de morera blanca, y mucho menos una hoja de morera blanca en sí.

“Se ha usado como alimento, como medicina”, dijo Rick Kingston, profesor clínico de la Facultad de Farmacia de la Universidad de Minnesota. También es cofundador de SafetyCall International, una empresa que ayuda a la industria de los suplementos y a otros clientes a registrar y rastrear eventos adversos relacionados con sus productos.

La Asociación Estadounidense de Productos Herbales, que representa a los cultivadores y fabricantes de hierbas, encargó a Kingston que revisara el caso de McClintock. “Veo muchos informes de autopsias”, dijo Kingston. “Tengo que admitir que éste fue bastante escaso en términos de datos de apoyo”.

Varios especialistas en plantas también cuestionan si la hoja encontrada en el estómago de McClintock era morera blanca.

Élan Sudberg, director ejecutivo de Alkemist Labs, con sede en California, que realiza pruebas de plantas botánicas para la industria de suplementos y otros clientes, dijo que la carta de Colwell carece de detalles de su evaluación de la hoja, lo que ayudaría a otros que lean el informe a identificarla definitivamente como morera blanca. Eso, o la hoja no era morera blanca, dijo.

Agregó que el forense debería publicar más información, reabrir el caso y realizar pruebas más rigurosas.

“Me encantaría ver un nuevo examen y entender por qué llegaron a la conclusión de que murió por una hoja básicamente inerte”, dijo Sudberg.

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

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

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Impending Hospital Closure Rattles Atlanta Health Care Landscape and Political Races

Kaiser Health News:Health Industry - September 14, 2022

ATLANTA — Like many neighborhoods in cities across the country, Atlanta’s Old Fourth Ward is changing.

Condo buildings and modern minimalist homes punctuate city blocks of low-income housing. Many longtime residents of the historic neighborhood where Martin Luther King Jr. was born have been priced out and pushed to other parts of town.

Atlanta Medical Center, a 460-bed Level 1 trauma center, will be the next fixture to change.

Despite banners proclaiming the hospital’s commitment to the area — “120 Years Caring For Atlanta,” one reads — its nonprofit owner, Wellstar Health System, recently announced plans to close the hospital’s doors on Nov. 1.

Georgia has seen several rural hospitals shutter in the past decade, but this year Atlanta has joined other urban centers with facility closures, including a previous downsizing at a facility in the nearby city of East Point.

The Wellstar announcement has stoked the political debate over Medicaid expansion ahead of the Nov. 8 midterm elections. Like 11 other states, Georgia has not expanded eligibility rules for its Medicaid program under the Affordable Care Act, and hospital officials across the state say inaction has hurt their bottom lines because they still treat high numbers of uninsured patients, many of whom cannot pay for treatment.

The Wellstar announcement shocked city officials, including the mayor, Andre Dickens, as well as other members of the community.

On a recent weekday morning, Teresa Smith, 60, who lives in the neighborhood, said she frequently receives care there for a chronic digestive issue. “This hospital will be missed by the whole community,” she said.

Liliana Bakhtiari, the Atlanta City Council member whose district includes the hospital, was sharp in her assessment. “There will be loss of life and critical injuries that will not be taken care of, and I wish that mattered more to Wellstar,” she said.

Wellstar declined KHN’s request for an interview about the closure.

Nancy Kane, an adjunct professor at Harvard’s T.H. Chan School of Public Health, sees connections between the Atlanta situation and hospital closures in other major cities.

Many were acquired by large health care companies as part of package deals, and served largely low-income, minority populations.

“If you acquire a hospital, you should have an obligation to fix it up,” said Kane. “Wellstar has the funds to invest in this hospital. It’s a choice.”

Some community members wonder whether the hospital closure will lead to a pricey real estate development on the roughly 20 acres Wellstar owns in the neighborhood.

Randy Pimsler, an architect whose firm has designed projects in the area, said “it could become a blank slate, either for redevelopment or for new development.”

Politicians have been quick to turn the closing into a campaign issue. And at the center of the debate is Gov. Brian Kemp’s health care policy.

The Kemp team is working to put together a long-term plan for strengthening health care in the area after the closure, said Andrew Isenhour, a Kemp spokesperson. Kemp, a Republican who’s running for a second term in November, is unlikely to try to keep the facility open.

But officials at the nonprofit Grady Health System said this week that they have met with Kemp’s office, Dickens, and officials from Fulton and DeKalb counties about a financial infusion of state funding that would support capital needs at Grady Memorial Hospital, a Level 1 trauma center about a mile from Atlanta Medical Center.

Grady is expecting as many as 2,500 extra emergency room visits a month after Atlanta Medical Center shuts its doors.

“We can absorb all the trauma,” said John Haupert, CEO of Grady Health System. Still, the added ER crunch will be a challenge with more patients arriving, said Ryan Loke, chief health policy officer for Grady.

State funding would accelerate Grady’s existing plans to convert offices into inpatient care spaces, which would add more than 180 adult beds as soon as a year from now. The hospital also is adding 40 to 45 beds over the next six weeks, and is planning to install a 24-bed field hospital to help handle the patient flow from the closed hospital.

The closing puts Medicaid expansion “front and center” in the political conversation, Haupert said. Kemp has proposed a limited plan that would offer access to the state-federal insurance program to people who can fulfill a work requirement or similar obligation.

His challenger, Democrat Stacey Abrams, has long made expanding Medicaid a top campaign issue.

“This is no longer a surprise,” Abrams said. “It is expected to happen because the Kemp administration refuses to take action.”

U.S. Sen. Raphael Warnock (D-Ga.), pastor of Ebenezer Baptist Church, which is less than a mile from the hospital, has also decried the closure and cited the strain on health care facilities caused by Georgia’s refusal to expand Medicaid. Wellstar officials have said that Medicaid expansion alone wouldn’t have kept the Atlanta facility open.

Earlier this year, Wellstar stopped providing emergency room and inpatient services at its hospital in East Point, just southwest of Atlanta. At the time, it said those patients could be seen at Atlanta Medical Center, about 8 miles away. Haupert estimated it would cost hundreds of millions of dollars to modernize the soon-to-close Atlanta hospital, which is what made a rescue difficult.

The closures just a few months apart could help Abrams’ arguments for Medicaid expansion resonate with voters, said Andra Gillespie, an associate professor of political science at Emory University. “An issue that was probably tailored more towards rural Georgia now all of a sudden becomes an Atlanta-area issue,” she said.

Gillespie cautioned that other issues, such as inflation, crime, and abortion, are likely to be more motivating to Georgia voters.

Wellstar, based in suburban Marietta, acquired AMC and the East Point hospital from Tenet Healthcare during an acquisition push in 2016, part of a $575 million deal that included three other hospitals in the metro region.

Todd Greene, formerly a member of Wellstar’s community board for AMC, said the system put more resources into its suburban facilities.

“Wellstar’s suburban hospital-oriented management approach unfortunately has resulted in large portions of Atlanta’s black and brown communities not having access to proximate and critical health care services,” he said in a written statement.

In Wellstar’s announcement of the closure, it said it had invested more than $350 million in capital improvements at the facility since 2016 and sustained “$107 million in losses in just the last 12 months, amid decreasing revenue and increasing costs for staff and supplies due to soaring inflation.”

The decision to close the hospital didn’t come as a surprise to some staff members, said Dr. Sulieman Wazeerud-Din, an emergency medicine physician at the hospital, who said doctors “were aware of financial losses.”

But the abrupt announcement caused a profound sense of grief among doctors, nurses, and other nonmedical employees, he said.

In the days since the closure announcement, Grady has offered jobs to a range of Atlanta Medical Center employees, from physicians and nurses to housekeeping and security staffers.

David Patton has lived in Atlanta’s Old Fourth Ward for 30 years and said Atlanta Medical Center has been a big part of his life.

His grandfather died in a nursing home on the campus, he has gotten care at the ER, and his son took swimming lessons at the hospital’s athletic club, all while he has seen the neighborhood transform from a “forgotten” part of the city to one that’s become a lightning rod for new development.

“It boggles my mind that an institution like that would just shut down virtually overnight,” he said.

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

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HHS Announces Melanie Fontes Rainer as Director of the Office for Civil Rights

HHS Gov News - September 14, 2022
Xavier Becerra formally swore in Melanie Fontes Rainer as Director of the Office for Civil Rights

Experts Question the Role of White Mulberry in the Death of Congressman’s Wife

Kaiser Health News:Marketplace - September 14, 2022

SACRAMENTO, Calif. — Scientists, doctors, and pathologists are questioning the Sacramento County coroner’s conclusion that Lori McClintock’s death was related to white mulberry, a plant that has been used as an herbal remedy for centuries — and one that the coroner’s botanical consultant called “not toxic” in a letter to her office.

McClintock, the wife of U.S. Rep. Tom McClintock (R-Calif.), died suddenly in December from dehydration due to gastroenteritis — an inflammation of the stomach and intestines — that was caused by “adverse effects of white mulberry leaf ingestion,” according to a report from the Sacramento County coroner. The coroner ruled the death an accident.

But Sacramento County Coroner Kimberly Gin has not explained — nor provided records that explain — why she determined white mulberry leaf led to the dehydration that killed McClintock at age 61, fueling skepticism among a variety of experts.

A “partially intact” white mulberry leaf was found in Lori McClintock’s stomach, according to the autopsy report. But there is no other reference to her use of white mulberry leaves, supplements, extracts, powders — or any other method of ingesting the plant — in the documents the coroner’s office has released relating to the case.

“It would take literally bushel baskets of white mulberry leaves to cause some type of untoward effect. And even then, you don’t see anything lethal,” said Bill Gurley, principal scientist at the University of Mississippi’s National Center for Natural Products Research, which collaborates with academic, government, and industry officials to research and develop natural products.

Gurley, an expert in herb and drug interactions, called white mulberry leaf — which has been used for a variety of ailments, including diabetes, high blood pressure, and obesity — “probably one of the safest leaves in the world” and said “its track record for safety is unsurpassed.”

“I’m just scratching my head as to how in the world they could jump to the conclusion that this lady passed away by ingesting, at least as far as we know, only one mulberry leaf,” he said.

Dr. Mary Hardy, who founded the integrative medicine clinic at Cedars-Sinai Medical Center in Los Angeles and researched the safety of some alternative medicines and therapies for the now-closed UCLA Center for Dietary Supplements Research in Botanicals, said the coroner’s conclusion is “not convincing.”

“The proximate cause of death is not supported” by the available records, Hardy said.

Gin, contacted through Sacramento County spokesperson Kim Nava, repeatedly declined interview requests from KHN and has refused to provide information that explains how her office concluded that a partial white mulberry leaf contributed to McClintock’s death.

The leaves and fruit of the white mulberry tree, native to China, have been used for centuries in traditional medicine. Academic studies over the past decade have found that the extract from its leaves can lower blood sugar levels and help with weight loss. People take it in capsule or pill form, as an extract or powder. They can also eat the young leaves raw or brew leaves as an herbal tea.

It’s unclear how McClintock ingested the white mulberry leaf — whether she ate it raw or drank it in a tea — and where she got it.

Tom McClintock, a Republican who represents a district that spans multiple counties in central and Northern California, found his wife unresponsive at their Elk Grove, California, home on Dec. 15, 2021, according to the coroner’s report. He has not responded to repeated requests for comment.

At his wife’s funeral in January, Tom McClintock told mourners she was fine when he spoke with her the day before she died. But according to the coroner’s report, the day before her death “she had complaints of an upset stomach.”

McClintock also told mourners that “she was carefully dieting” and that “she just joined a gym.”

KHN obtained the coroner’s report, dated March 10, in addition to the autopsy report and death certificate, in July and reported the findings in August.

The coroner’s office tested McClintock’s body for the flu, other respiratory viruses, and covid-19. None were detected. It also commissioned independent lab tests that showed McClintock’s body had elevated levels of urea nitrogen, sodium, and creatinine — all signs of dehydration, according to five pathologists interviewed by KHN. Just one of them said it was plausible that white mulberry leaf could have contributed to the dehydration.

All the pathologists said that the coroner’s publicly released documents didn’t provide a complete picture of how McClintock died and that it didn’t include key details such as what the coroner’s office found at the house, and whether McClintock might have been taking any medications or supplements.

“The indication that there may be some dehydration is true. They don’t really have much else to go with,” said Dr. Gregory G. Davis, director of the forensic division of the University of Alabama-Birmingham’s Department of Pathology and chief coroner-medical examiner for Jefferson County, Alabama.

“I don’t know that mulberry leaf necessarily played any role in the death,” Davis said, adding, as other experts did, that it’s not considered toxic.

“She seemed, looking at her autopsy results, like she was reasonably healthy, and you wouldn’t have really expected her to die at this time. So that’s already made it a difficult case because it’s not obvious.”

Dr. James Gill, chair of the College of American Pathologists’ Forensic Pathology Committee and chief medical examiner of Connecticut, added it can take days for someone to die of dehydration. One leaf alone, which hadn’t been fully digested, a process that usually takes only a couple of hours, would not “have contributed to death,” he said.

“It takes about at least a week or so for someone to die from not drinking from dehydration,” Gill said. Based on the available records, “there are some things that really don’t fit.”

Gill said he would have ruled McClintock’s death a natural death of unknown causes, which happens in about 5% of his death investigations.

No deaths from the white mulberry plant have been reported to poison control officials in the past 10 years, according to the American Association of Poison Control Centers. Two cases of people who may have been sickened by mulberry supplements have been reported to the FDA since 2002, according to its database that tracks “adverse events.” FDA spokesperson Lindsay Haake declined to say whether the agency is looking into the case because it does not disclose investigations.

After KHN broke the story about McClintock’s cause of death, the coroner’s office released a couple of additional documents, including a Dec. 29, 2021, letter from Alison Colwell, curator of the University of California-Davis Center for Plant Diversity. The coroner had asked Colwell to identify the 1 1/8-inch-by-1 7/8-inch leaf fragment found in McClintock’s stomach during the autopsy.

Colwell identified it as white mulberry and concluded, based on its flexibility and “some green color,” that it “was likely ingested when fresh,” her letter said.

Although white mulberry trees are common in the Sacramento region, she noted that their leaves in December are “tough, yellowing and have mostly fallen off of the trees.”

Colwell also stated simply: “White mulberry is not toxic.”

“I compared the specimen to lethally toxic species that are known to be planted or are native in the Sacramento area and found no matches,” her letter said. Colwell declined an interview request.

The herbal products industry, the dietary supplements industry, and their allies have chafed at the possibility that McClintock may have died after ingesting supplements containing white mulberry leaf — let alone a white mulberry leaf itself.

“It’s been used as a food, used as a medicine,” said Rick Kingston, a clinical professor at the University of Minnesota’s College of Pharmacy. He’s also co-founder of SafetyCall International, a company that helps the supplements industry and other clients log and track adverse events related to their products.

The American Herbal Products Association, which represents herbal growers and manufacturers, commissioned Kingston to review McClintock’s case. “I see a lot of autopsy reports,” Kingston said. “I have to admit this was pretty sparse in terms of supporting data.”

Several plant specialists also question whether the leaf found in McClintock’s stomach was white mulberry. Élan Sudberg, CEO of California-based Alkemist Labs, which conducts botanical plant testing for the supplements industry and other clients, said Colwell’s letter lacks details of her assessment of the leaf that would help others reading the report definitively identify it as white mulberry. Either that, he said, or the leaf wasn’t white mulberry.

He said the coroner should release more information, reopen the case, and conduct more rigorous tests.

“I’d love to see a reexamination and understand why they went to the conclusion that she died from a basically inert leaf,” Sudberg said.

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

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

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This story can be republished for free (details).

Experts Question the Link to White Mulberry in the Death of Congressman’s Wife

Kaiser Health News:Health Industry - September 14, 2022

SACRAMENTO, Calif. — Scientists, doctors, and pathologists are questioning the Sacramento County coroner’s conclusion that Lori McClintock’s death was related to white mulberry, a plant that has been used as an herbal remedy for centuries — and one that the coroner’s botanical consultant called “not toxic” in a letter to her office.

McClintock, the wife of U.S. Rep. Tom McClintock (R-Calif.), died suddenly in December from dehydration due to gastroenteritis — an inflammation of the stomach and intestines — that was caused by “adverse effects of white mulberry leaf ingestion,” according to a report from the Sacramento County coroner. The coroner ruled the death an accident.

But Sacramento County Coroner Kimberly Gin has not explained — nor provided records that explain — why she determined white mulberry leaf led to the dehydration that killed McClintock at age 61, fueling skepticism among a variety of experts.

A “partially intact” white mulberry leaf was found in Lori McClintock’s stomach, according to the autopsy report. But there is no other reference to her use of white mulberry leaves, supplements, extracts, powders — or any other method of ingesting the plant — in the documents the coroner’s office has released relating to the case.

“It would take literally bushel baskets of white mulberry leaves to cause some type of untoward effect. And even then, you don’t see anything lethal,” said Bill Gurley, principal scientist at the University of Mississippi’s National Center for Natural Products Research, which collaborates with academic, government, and industry officials to research and develop natural products.

Gurley, an expert in herb and drug interactions, called white mulberry leaf — which has been used for a variety of ailments, including diabetes, high blood pressure, and obesity — “probably one of the safest leaves in the world” and said “its track record for safety is unsurpassed.”

“I’m just scratching my head as to how in the world they could jump to the conclusion that this lady passed away by ingesting, at least as far as we know, only one mulberry leaf,” he said.

Dr. Mary Hardy, who founded the integrative medicine clinic at Cedars-Sinai Medical Center in Los Angeles and researched the safety of some alternative medicines and therapies for the now-closed UCLA Center for Dietary Supplements Research in Botanicals, said the coroner’s conclusion is “not convincing.”

“The proximate cause of death is not supported” by the available records, Hardy said.

Gin, contacted through Sacramento County spokesperson Kim Nava, repeatedly declined interview requests from KHN and has refused to provide information that explains how her office concluded that a partial white mulberry leaf contributed to McClintock’s death.

The leaves and fruit of the white mulberry tree, native to China, have been used for centuries in traditional medicine. Academic studies over the past decade have found that the extract from its leaves can lower blood sugar levels and help with weight loss. People take it in capsule or pill form, as an extract or powder. They can also eat the young leaves raw or brew leaves as an herbal tea.

It’s unclear how McClintock ingested the white mulberry leaf — whether she ate it raw or drank it in a tea — and where she got it.

Tom McClintock, a Republican who represents a district that spans multiple counties in central and Northern California, found his wife unresponsive at their Elk Grove, California, home on Dec. 15, 2021, according to the coroner’s report. He has not responded to repeated requests for comment.

At his wife’s funeral in January, Tom McClintock told mourners she was fine when he spoke with her the day before she died. But according to the coroner’s report, the day before her death “she had complaints of an upset stomach.”

McClintock also told mourners that “she was carefully dieting” and that “she just joined a gym.”

KHN obtained the coroner’s report, dated March 10, in addition to the autopsy report and death certificate, in July and reported the findings in August.

The coroner’s office tested McClintock’s body for the flu, other respiratory viruses, and covid-19. None were detected. It also commissioned independent lab tests that showed McClintock’s body had elevated levels of urea nitrogen, sodium, and creatinine — all signs of dehydration, according to five pathologists interviewed by KHN. Just one of them said it was plausible that white mulberry leaf could have contributed to the dehydration.

All the pathologists said that the coroner’s publicly released documents didn’t provide a complete picture of how McClintock died and that it didn’t include key details such as what the coroner’s office found at the house, and whether McClintock might have been taking any medications or supplements.

“The indication that there may be some dehydration is true. They don’t really have much else to go with,” said Dr. Gregory G. Davis, director of the forensic division of the University of Alabama-Birmingham’s Department of Pathology and chief coroner-medical examiner for Jefferson County, Alabama.

“I don’t know that mulberry leaf necessarily played any role in the death,” Davis said, adding, as other experts did, that it’s not considered toxic.

“She seemed, looking at her autopsy results, like she was reasonably healthy, and you wouldn’t have really expected her to die at this time. So that’s already made it a difficult case because it’s not obvious.”

Dr. James Gill, chair of the College of American Pathologists’ Forensic Pathology Committee and chief medical examiner of Connecticut, added it can take days for someone to die of dehydration. One leaf alone, which hadn’t been fully digested, a process that usually takes only a couple of hours, would not “have contributed to death,” he said.

“It takes about at least a week or so for someone to die from not drinking from dehydration,” Gill said. Based on the available records, “there are some things that really don’t fit.”

Gill said he would have ruled McClintock’s death a natural death of unknown causes, which happens in about 5% of his death investigations.

No deaths from the white mulberry plant have been reported to poison control officials in the past 10 years, according to the American Association of Poison Control Centers. Two cases of people who may have been sickened by mulberry supplements have been reported to the FDA since 2002, according to its database that tracks “adverse events.” FDA spokesperson Lindsay Haake declined to say whether the agency is looking into the case because it does not disclose investigations.

After KHN broke the story about McClintock’s cause of death, the coroner’s office released a couple of additional documents, including a Dec. 29, 2021, letter from Alison Colwell, curator of the University of California-Davis Center for Plant Diversity. The coroner had asked Colwell to identify the 1 1/8-inch-by-1 7/8-inch leaf fragment found in McClintock’s stomach during the autopsy.

Colwell identified it as white mulberry and concluded, based on its flexibility and “some green color,” that it “was likely ingested when fresh,” her letter said.

Although white mulberry trees are common in the Sacramento region, she noted that their leaves in December are “tough, yellowing and have mostly fallen off of the trees.”

Colwell also stated simply: “White mulberry is not toxic.”

“I compared the specimen to lethally toxic species that are known to be planted or are native in the Sacramento area and found no matches,” her letter said. Colwell declined an interview request.

The herbal products industry, the dietary supplements industry, and their allies have chafed at the possibility that McClintock may have died after ingesting supplements containing white mulberry leaf — let alone a white mulberry leaf itself.

“It’s been used as a food, used as a medicine,” said Rick Kingston, a clinical professor at the University of Minnesota’s College of Pharmacy. He’s also co-founder of SafetyCall International, a company that helps the supplements industry and other clients log and track adverse events related to their products.

The American Herbal Products Association, which represents herbal growers and manufacturers, commissioned Kingston to review McClintock’s case. “I see a lot of autopsy reports,” Kingston said. “I have to admit this was pretty sparse in terms of supporting data.”

Several plant specialists also question whether the leaf found in McClintock’s stomach was white mulberry. Élan Sudberg, CEO of California-based Alkemist Labs, which conducts botanical plant testing for the supplements industry and other clients, said Colwell’s letter lacks details of her assessment of the leaf that would help others reading the report definitively identify it as white mulberry. Either that, he said, or the leaf wasn’t white mulberry.

He said the coroner should release more information, reopen the case, and conduct more rigorous tests.

“I’d love to see a reexamination and understand why they went to the conclusion that she died from a basically inert leaf,” Sudberg said.

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

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

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California y Nueva York buscan frenar la venta de píldoras para adelgazar a menores

Kaiser Health News:States - September 14, 2022

California y Nueva York están a punto de ir un paso más allá que la Administración de Drogas y Alimentos (FDA) en la restricción de la venta de píldoras dietéticas sin receta a menores de edad, mientras pediatras y defensores de la salud pública tratan de protegerlos de las trampas para perder de peso de forma extrema que circulan por internet.

Un proyecto de ley presentado al gobernador Gavin Newsom prohibiría a los menores de 18 años en California la compra de suplementos para adelgazar sin receta, ya sea en línea o en tiendas. Otro proyecto similar aprobado por los legisladores de Nueva York está en la mesa de la gobernadora Kathy Hochul. Ninguno de los dos demócratas han indicado qué harán.

Si ambas medidas se convierten en ley, sus defensores esperan que den impulso a la  restricción de la venta de píldoras dietéticas a niños y adolescentes en más estados. Massachusetts, Nueva Jersey y Missouri han presentado proyectos de ley similares y sus defensores planean seguir presionando el próximo año.

Casi 30 millones de personas en Estados Unidos padecerán un trastorno alimentario a lo largo de su vida; el 95% de ellas tiene entre 12 y 25 años, según el Johns Hopkins All Children’s Hospital. Agrega que los trastornos alimentarios conforman el mayor riesgo de mortalidad de todos los trastornos mentales. Y ahora es más fácil que nunca que los menores consigan las pastillas que se venden en internet o en las estanterías de las farmacias.

Todos los suplementos dietéticos, incluidos los destinados a la pérdida de peso, representaron casi el 35% de los  productos de salud que se venden sin receta dentro de una industria que generó $63,000 millones en 2021, según Vision Research Reports, una empresa de investigación de mercado.

Los suplementos dietéticos, que abarcan una amplia gama de vitaminas, hierbas y minerales, están clasificados por la FDA como alimentos y no se someten a pruebas científicas y de seguridad como se hace con los medicamentos que se venden con y sin receta.

Los defensores de la salud pública quieren mantener los productos para adelgazar —con anuncios que pueden prometer “¡Baja 2 libras a la semana!” y nombres de pastillas como Slim Sense— alejados de los jóvenes, sobre todo de las chicas, ya que investigaciones han relacionado algunos productos con los trastornos alimentarios.

Un estudio publicado en el American Journal of Public Health, en el que se realizó un seguimiento a más de 10,000 mujeres de entre 14 y 36 años durante 15 años, halló que “las que usaban píldoras para adelgazar tenían una probabilidad ajustada cinco veces mayor de recibir un diagnóstico de trastorno alimentario por parte de un proveedor de atención médica en un plazo de 1 a 3 años que las que no las utilizaban”.

Se ha descubierto que muchas píldoras están contaminadas con ingredientes prohibidos y peligrosos que pueden causar cáncer, ataques cardíacos, derrames cerebrales y otros males. Por ejemplo, la FDA aconsejó al público que evitara Slim Sense de Dr. Reade porque contiene lorcaserina, que puede causar trastornos psiquiátricos y alteraciones de la atención y de la memoria. La entidad ordenó su retiro y no se pudo contactar con la empresa para que ofreciera declaraciones.

“Los fabricantes sin escrúpulos están dispuestos a correr riesgos con la salud de los consumidores, y están mezclando sus productos con ingredientes farmacéuticos ilegales, esteroides, estimulantes excesivos e incluso estimulantes experimentales”, dijo Bryn Austin, director fundador de Strategic Training Initiative for the Prevention of Eating Disorders, o STRIPED, que apoya las restricciones. “Los consumidores no tienen ni idea de que esto es lo que hay en este tipo de productos”.

STRIPED es una iniciativa de salud pública con sede en la Escuela de Salud Pública T.H. Chan de Harvard y el Hospital Infantil de Boston.

La Natural Products Association, un grupo comercial que representa a la industria, refuta que las píldoras dietéticas causen trastornos alimentarios y citan la ausencia de quejas de los consumidores a la FDA sobre efectos adversos de los productos de sus miembros. “Según los datos de la FDA, no existe ninguna relación entre ambas cosas”, dijo Kyle Turk, director de asuntos gubernamentales de la asociación.

La asociación sostiene que sus miembros adhieren a procesos de fabricación seguros, pruebas aleatorias de los productos y directrices de comercialización adecuadas. A los representantes también les preocupa que si los menores no pueden comprar suplementos sin receta, puedan comprarlos a “delincuentes” en el mercado negro y socavar la integridad de la industria. Según los proyectos de ley, los menores que compren productos para adelgazar deberán presentar una identificación junto con una receta médica.

No todos los grupos empresariales se oponen a la prohibición. La American Herbal Products Association, un grupo comercial que representa a fabricantes y minoristas de suplementos dietéticos, dejó de oponerse al proyecto de ley de California una vez que se modificó para eliminar las categorías de ingredientes que se encuentran en suplementos no dietéticos y vitaminas, según Robert Marriott, director de asuntos regulatorios de esa entidad.

Los defensores de los niños han encontrado tendencias preocupantes entre los jóvenes que imaginan su tipo de cuerpo ideal según lo que ven en las redes sociales. De acuerdo a un estudio encargado por Fairplay, una organización sin fines de lucro que trata de poner fin a las prácticas de marketing perjudiciales dirigidas a los niños, descubrió que niños de tan solo 9 años seguían tres o más cuentas de desórdenes alimentarios en Instagram, mientras que la edad media era de 19 años. Los autores lo llamaron una “burbuja a favor de los trastornos alimentarios“.

Meta, propietaria de Instagram y Facebook, dijo que el informe carece de matices, como reconocer la necesidad humana de compartir los momentos difíciles de la vida. La compañía sostiene que la censura generalizada no es la respuesta.

“Los expertos y las organizaciones de seguridad nos han dicho que es importante encontrar un equilibrio y permitir que la gente comparta sus historias personales al tiempo que se elimina cualquier contenido que fomente o promueva los trastornos alimentarios”, dijo Liza Crenshaw, una vocera de Meta, en un correo electrónico.

El doctor Jason Nagata, pediatra que atiende a niños y adultos jóvenes con trastornos alimentarios que ponen en peligro su vida, cree que el fácil acceso a las pastillas para adelgazar contribuye a las condiciones de sus pacientes en el Hospital Infantil UCSF Benioff de San Francisco. Ese fue el caso de una de sus pacientes, una niña demacrada de 11 años.

“Básicamente había entrado en un estado de inanición porque no recibía suficiente nutrición”, dijo Nagata, que aportó un testimonio de apoyo al proyecto de ley de California. “Estaba tomando estas píldoras y teniendo otro tipo de comportamientos extremos para perder peso”.

Nagata dijo que el número de pacientes con trastornos alimentarios que atiende se ha triplicado desde que comenzó la pandemia. Están desesperados por conseguir pastillas para adelgazar, algunas con resultados modestos. “Hemos tenido pacientes que han sido tan dependientes de estos productos que son hospitalizados y siguen pidiendo estos productos por Amazon”, dijo.

Los defensores de la salud pública recurrieron a las legislaturas estatales en respuesta a la limitada autoridad del gobierno federal para regular las píldoras dietéticas. En virtud de una ley federal de 1994 conocida como Ley de Educación y Salud sobre Suplementos Dietéticos, la FDA “no puede intervenir hasta que haya un problema claro de daño a los consumidores”, dijo Austin.

Al no poder hacer frente a la fuerte presión de la industria de los suplementos en el Capitolio, defensores de la salud pública han optado por centrarse en los estados. Sin embargo, existe una presión para que la FDA mejore la supervisión de lo que se incluye en las píldoras dietéticas.

El senador federal Dick Durbin, de Illinois, presentó en abril un proyecto de ley que exigiría a los fabricantes de suplementos dietéticos registrar sus productos, junto con los ingredientes, ante el organismo regulador.

Sus defensores afirman que el cambio es necesario porque se sabe que los fabricantes incluyen ingredientes peligrosos. C. Michael White, de la Facultad de Farmacia de la Universidad de Connecticut, encontró que el 35% de los productos sanitarios contaminados procedía de suplementos para la pérdida de peso, en una revisión de una base de datos sobre fraudes sanitarios.

Algunos ingredientes han sido prohibidos, como la sibutramina, un estimulante. “Era un suplemento para adelgazar muy utilizado que acabó siendo retirado del mercado estadounidense por su elevado riesgo de provocar cosas como ataques cardíacos, derrames cerebrales y arritmias”, dijo White.

Otro ingrediente era la fenolftaleína, que se utilizaba en los laxantes hasta que se identificó como presunto carcinógeno y se prohibió en 1999. “Pensar que ese producto siga en el mercado estadounidense es simplemente inconcebible”, dijo.

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

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

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Fact Sheet: HHS Takes Action on Executive Order Launching a National Biotechnology and Biomanufacturing Initiative

HHS Gov News - September 14, 2022
HHS announced actions the department will take following the Executive Order signed by President Biden.

California and New York Aim to Curb Diet Pill Sales to Minors

Kaiser Health News:States - September 14, 2022

California and New York are on the cusp of going further than the FDA in restricting the sale of non-prescription diet pills to minors as pediatricians and public health advocates try to protect kids from extreme weight-loss gimmicks online.

A bill before Gov. Gavin Newsom would bar anyone under 18 in California from buying over-the-counter weight loss supplements — whether online or in shops — without a prescription. A similar bill passed by New York lawmakers is on Gov. Kathy Hochul’s desk. Neither Democrat has indicated how he or she will act.

If both bills are signed into law, proponents hope the momentum will build to restrict diet pill sales to children in more states. Massachusetts, New Jersey, and Missouri have introduced similar bills and backers plan to continue their push next year.

Nearly 30 million people in the United States will have an eating disorder in their lifetime; 95% of them are between ages 12 and 25, according to Johns Hopkins All Children’s Hospital. The hospital adds that eating disorders pose the highest risk of mortality of any mental health disorder. And it has become easier than ever for minors to get pills that are sold online or on drugstore shelves. All dietary supplements, which include those for weight loss, accounted for nearly 35% of the $63 billion over-the-counter health products industry in 2021, according to Vision Research Reports, a market research firm.

Dietary supplements, which encompass a broad range of vitamins, herbs, and minerals, are classified by the FDA as food and don’t undergo scientific and safety testing as prescription drugs and over-the-counter medicines do.

Public health advocates want to keep weight loss products — with ads that may promise to “Drop 5 pounds a week!” and pill names like Slim Sense — away from young people, particularly girls, since some research has linked some products to eating disorders. A study in the American Journal of Public Health, which followed more than 10,000 women ages 14-36 over 15 years, found that “those who used diet pills had more than 5 times higher adjusted odds of receiving an eating disorder diagnosis from a health care provider within 1 to 3 years than those who did not.”

Many pills have been found tainted with banned and dangerous ingredients that may cause cancer, heart attacks, strokes, and other ailments. For example, the FDA advised the public to avoid Slim Sense by Dr. Reade because it contains lorcaserin, which has been found to cause psychiatric disturbances and impairments in attention or memory. The FDA ordered it discontinued and the company couldn’t be reached for comment.

“Unscrupulous manufacturers are willing to take risks with consumers’ health — and they are lacing their products with illegal pharmaceuticals, banned pharmaceuticals, steroids, excessive stimulants, even experimental stimulants,” said Bryn Austin, founding director of the Strategic Training Initiative for the Prevention of Eating Disorders, or STRIPED, which supports the restrictions. “Consumers have no idea that this is what’s in these types of products.”

STRIPED is a public health initiative based at the Harvard T.H. Chan School of Public Health and Boston Children’s Hospital.

An industry trade group, the Natural Products Association, disputes that diet pills cause eating disorders, citing the lack of consumer complaints to the FDA of adverse events from their members’ products. “According to FDA data, there is no association between the two,” said Kyle Turk, the association’s director of government affairs.

The association contends that its members adhere to safe manufacturing processes, random product testing, and appropriate marketing guidelines. Representatives also worry that if minors can’t buy supplements over the counter, they may buy them from “crooks” on the black market and undermine the integrity of the industry. Under the bills, minors purchasing weight loss products must show identification along with a prescription.

Not all business groups oppose the ban. The American Herbal Products Association, a trade group representing dietary supplement manufacturers and retailers, dropped its opposition to California’s bill once it was amended to remove ingredient categories that are found in non-diet supplements and vitamins, according to Robert Marriott, director of regulatory affairs.

Children’s advocates have found worrisome trends among young people who envision their ideal body type based on what they see on social media. According to a study commissioned by Fairplay, a nonprofit that seeks to stop harmful marketing practices targeting children, kids as young as 9 were found to be following three or more eating disorder accounts on Instagram, while the median age was 19. The authors called it a “pro-eating disorder bubble.”

Meta, which owns Instagram and Facebook, said the report lacks nuance, such as recognizing the human need to share life’s difficult moments. The company argues that blanket censorship isn’t the answer. “Experts and safety organizations have told us it’s important to strike a balance and allow people to share their personal stories while removing any content that encourages or promotes eating disorders,” said Liza Crenshaw, a Meta spokesperson, in an email.

Dr. Jason Nagata, a pediatrician who cares for children and young adults with life-threatening eating disorders, believes that easy access to diet pills contributes to his patients’ conditions at UCSF Benioff Children’s Hospital in San Francisco. That was the case for one of his patients, an emaciated 11-year-old girl.

“She had basically entered a starvation state because she was not getting enough nutrition,” said Nagata, who provided supporting testimony for the California bill. “She was taking these pills and using other kinds of extreme behaviors to lose weight.”

Nagata said the number of patients he sees with eating disorders has tripled since the pandemic began. They are desperate to get diet pills, some with modest results. “We’ve had patients who have been so dependent on these products that they will be hospitalized and they’re still ordering these products on Amazon,” he said.

Public health advocates turned to state legislatures in response to the federal government’s limited authority to regulate diet pills. Under a 1994 federal law known as the Dietary Supplement Health and Education Act, the FDA “cannot step in until after there is a clear issue of harm to consumers,” said Austin.

No match for the supplement industry’s heavy lobbying on Capitol Hill, public health advocates shifted to a state-by-state approach.

There is, however, a push for the FDA to improve oversight of what goes into diet pills. U.S. Sen. Dick Durbin of Illinois in April introduced a bill that would require dietary supplement manufacturers to register their products — along with the ingredients — with the regulator.

Proponents say the change is needed because manufacturers have been known to include dangerous ingredients. C. Michael White of the University of Connecticut’s School of Pharmacy found 35% of tainted health products came from weight loss supplements in a review of a health fraud database.

A few ingredients have been banned, including sibutramine, a stimulant. “It was a very commonly used weight loss supplement that ended up being removed from the U.S. market because of its elevated risk of causing things like heart attacks, strokes, and arrhythmias,” White said.

Another ingredient was phenolphthalein, which was used in laxatives until it was identified as a suspected carcinogen and banned in 1999. “To think,” he said, “that that product would still be on the U.S. market is just unconscionable.”

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

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

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Newborns Get Routine Heel Blood Tests, but Should States Keep Those Samples?

Kaiser Health News:Health Industry - September 14, 2022

Close to 4 million babies are born in the United States every year, and within their first 48 hours nearly all are pricked in the heel so their blood can be tested for dozens of life-threatening genetic and metabolic problems. The heel-stick test is considered such a crucial public health measure that states typically require it and parents aren’t asked for their permission before it’s done.

But the lab tests for newborn screenings generally don’t use all of the half-dozen or so drops of blood collected on filter paper cards. So states hold on to the leftover “dried blood spots,” as they’re called, often without parents’ knowledge or consent. In recent years, privacy-related concerns have grown about the sometimes decades-long storage and use of the material.

Some states allow the blood spots to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement personnel investigating a crime. Permitting these or other uses without parents’ informed consent that they understand and agree to the use has prompted lawsuits from parents who want to make those decisions themselves and who seek to protect their children’s medical and genetic information.

In May, Michigan officials reportedly agreed to destroy more than 3 million blood spots as a partial settlement in a lawsuit brought by parents who said they didn’t receive enough clear information to provide informed consent for the blood to be used in research the state might conduct. The fate of millions of additional blood spots stored by the state will be determined at trial.

Philip L. Ellison, an attorney in Hemlock, Michigan, who is spearheading the suit, said he became aware of the issue when his son was born five years ago. Ellison’s son, Patton, spent his first days in the neonatal intensive care unit after his blood sugar levels dropped precipitously after birth. The next morning, Ellison said, he was approached by a hospital staffer who asked whether he wanted to sign a consent form allowing the blood from Patton’s heel-stick test to be donated for research.

The unexpected request set off alarm bells for Ellison.

“We don’t know what the future will bring in terms of information that can be extracted from our blood,” he said. How the rules for using that blood might evolve over time, he said, is difficult to know. “A program that first starts out for one purpose, to test for disease, has now crept into medical research and then to law enforcement,” he said.

Michigan is the rare state that asks parents for permission to use leftover newborn blood spots in research. Most do not, experts said. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because identifying and treating such illnesses early in a child’s life are crucial.

Afterward, whatever is left over is stored for up to 100 years and, if parents agree to it, may be used in research approved by the Michigan Department of Health and Human Services. Some recent studies have used de-identified blood spots to study the relationship between viral infection at birth and the development of autism later in life, as well as the impact of maternal exposure to manufactured chemicals known as PFAS on health outcomes.

Parents have also asked that their children’s blood spots be sent to researchers to help diagnose a disorder or to try to find a reason for a child’s death, said Chelsea Wuth, a spokesperson for the Michigan Department of Health and Human Services.

Michigan parents can request that the state destroy the leftover blood spots if they don’t want the state to hold on to them.

Since the 1960s, states have screened newborn blood for conditions that can lead to devastating physical or mental disabilities or death if they are not diagnosed and treated. The federal government recommends that roughly three dozen screening tests be performed, but some states conduct many more. Every year, an estimated 13,000 infants with serious medical conditions are identified through newborn screening programs, according to data published by the federal Centers for Disease Control and Prevention.

Many public health experts strongly support mandatory newborn screening as a critical component of infants’ clinical care. But some are receptive to giving parents a say in what happens to the blood after the screening.

“I have always believed that parents should be able to have the opportunity to say ‘yes’ or ‘no’” to having their newborns’ leftover blood used in research, said Dr. Beth Tarini, a pediatrician and the associate director of the Center for Translational Research at Children’s National Research Institute in Washington, D.C. “Since it is not part of the clinical care, it is a different standard of engagement with the parents.”

In Michigan, 64% of parents consented to participate, according to court documents in Ellison’s case.

Encouraging people to participate is important, some public health experts say, because the blood spot repositories provide a rare opportunity for population-level research. People of European descent are often overrepresented in genetic databases, which can skew the results of studies. But the newborn screening program includes virtually everyone born in the U.S.

“There’s strong evidence that research conducted on samples of white people creates disparities in the benefits of biomedical research for people who are not white,” said Dr. Kyle Brothers, a pediatrician and bioethicist at Norton Children’s Research Institute in Louisville, Kentucky.

After privacy-related lawsuits were brought in 2009 and 2011 by parents in Texas and Minnesota, respectively, millions of blood spots were destroyed.

Brothers said an unwillingness to participate in research programs reflects larger trends, including more emphasis on the individual and less on contributing to the general good.

To those who might argue that parents’ privacy concerns are overblown, a recent lawsuit in New Jersey raises troubling questions.

In a public records lawsuit, the New Jersey Office of the Public Defender and the New Jersey Monitor, a nonprofit news site, charge that the state police used a subpoena to obtain an infant blood spot of a child who is now 9 years old from the state’s newborn screening laboratory. The lawsuit says a DNA analysis was conducted on the blood spot so evidence could be gathered against the child’s father, who was being represented by the public defender’s office, in connection with a sexual assault committed in 1996. The effort allowed police to get the DNA information without having to show a court probable cause, the suit alleges.

The lawsuit seeks to find out how often in the past five years New Jersey law enforcement agencies have used the newborn screening lab as a tool in investigations and subjected defendants to “warrantless searches and seizures.”

New Jersey keeps the records on file for 23 years, said CJ Griffin, a lawyer representing the public defender’s office and the New Jersey Monitor in the lawsuit.

Griffin said her clients aren’t challenging the program to test newborn blood for diseases. “It’s more the lack of transparency, and safeguards, and information about storage, and we don’t have any information about appropriate use,” she said.

The New Jersey Department of Health doesn’t comment on pending litigation, spokesperson Nancy Kearney said. Kearney didn’t respond to a request for information about the state’s practices and policies related to the newborn screening program.

A recent Texas Law Review article found that more than a quarter of states lack policies on law enforcement access to newborn blood spot samples and related information and that nearly a third may allow access in certain circumstances.

In Michigan, the state gives law enforcement agencies dried blood spots only to identify the victim of a crime, Wuth said. “Typically, this means someone has been killed or gone missing,” she added.

Many clinicians and bioethicists say that standards for the use of blood spots need to be set.

“It’s nearly impossible for us to monitor the potential uses of our data,” said Andrew Crawford, senior policy counsel for the privacy and data project at the Center for Democracy and Technology. “That’s why need to put limitations on the use.”

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

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Southern States’ Lackluster Monkeypox Efforts Leave LGBTQ+ Groups Going It Alone

Kaiser Health News:Health Industry - September 14, 2022

Dan DeChellis started looking for a monkeypox vaccine around July Fourth but was unable to find a place that offered one in Orlando, Florida, where he lives.

After about a week of searching online, he and three friends made an appointment in Wilton Manors, a city about 3½ hours south by car. DeChellis, who is gay, said he doesn’t understand why the vaccine wasn’t available closer to home or why getting answers about who was eligible from his local health department was so difficult.

“My biggest takeaway from our experience has been just the difference in the state of Florida from county to county,” said DeChellis, 30, a supply chain manager who lost a half-day of work while traveling to get his first vaccine dose.

The perception that the response to the monkeypox virus in the South has lacked coordination has rekindled familiar concerns about recent state policies that leave members of the region’s LGBTQ+ communities feeling marginalized and discriminated against. More urgently, it raises questions about whether state and local health departments are doing enough to protect the people principally affected by the virus: men who have sex with men.

States like New York and California have followed the Centers for Disease Control and Prevention’s recommendation to prioritize gay and bisexual men in outreach, vaccination, and treatment for monkeypox. Such states have declared a public health emergency and initiated aggressive, targeted vaccination campaigns. Although New York and California are the states with the highest number of cases, Florida, Georgia, and Texas are home to robust gay communities and together have just over a quarter of the country’s confirmed monkeypox cases.

But in Florida, and in other areas of the South, gay men fear that the monkeypox response is not being consistently prioritized because the virus affects the health of gay men, especially those who are Black or Hispanic. And they worry that local governments are not responding with urgency to diseases that primarily affect marginalized communities.

“They are not going to go out of their way to help us,” said Hank Rosenthal, 74, a gay man and retired emergency medicine physician who lives in Fort Lauderdale, Florida.

Jeremy Redfern, a spokesperson for the Florida Department of Health and speaking on behalf of the local health departments, said the agency is “fully integrated” to respond to public health needs across the state’s 67 counties. “There are no jurisdictional boundaries to our reach in Florida,” he said. “There is no politics with monkeypox.”

But recent laws like a Florida one that prohibits instruction on gender identity and sexual orientation in some elementary school grades — referred to as the “Don’t Say Gay” bill by opponents — and the state’s ban on transgender care for people with Medicaid have created a hyperpoliticized atmosphere around issues related to sexual orientation and gender identity, LGBTQ+ advocacy groups say. And that has some groups feeling the need to take matters into their own hands, especially in states that downplayed the covid-19 pandemic and banned face mask and vaccine mandates to limit the spread of the virus.

“We mobilize, and we try to make stuff happen because our job is to take care of our community,” said Ricardo Martinez, CEO of Equality Texas, an advocacy group for LGBTQ+ rights. “We can’t depend on the state to provide the relief and safety that we need, so we have to organize ourselves.”

Florida’s first suspected case of monkeypox was reported in Broward County in late May. Since then, the health department has reported that most of the state’s more than 2,200 cases — about 2 in 3 — have occurred in South Florida’s Miami-Dade and Broward counties, where DeChellis and his friends traveled to obtain a monkeypox vaccine.

The vaccine, called Jynneos, ships from the strategic national stockpile directly to five county health departments. From there, the state sends vaccines to doctors, hospitals, and other county health departments “as needed,” Redfern said.

The national stockpile ships vaccines to five sites per state and at first used a distribution system that was unfamiliar to state officials; it required them to track doses manually and place orders by email instead of through an automated system, creating a bottleneck. On Sept. 6, the U.S. Department of Health and Human Services announced it had awarded a $20 million contract to a private wholesale company to “significantly” expand vaccine distribution to more sites in the coming weeks.

As government responses improve, LGBTQ+ advocates and people who have tried to get vaccinated in Florida say vaccine access and information during the first months of the virus’s spread were inconsistent. They said local health departments used different eligibility criteria, appointment scheduling systems, and public outreach.

Brandon Lopez of Orlando said that when he first tried to get vaccinated through his local health department in June, he was told that only health care workers in laboratories and those who draw blood were eligible. Lopez, 30, said he considered driving to Miami after hearing that friends there got the shots but was told appointments were only for local residents.

Some counties announced online scheduling for appointments in mid-July, but many people who tried to sign up said that no slots were available or that they received an error message prompting them to create a new email account.

“I’m looking at my friends that live in Chicago, that live in San Francisco, that live in Washington, D.C., and they’re able to just walk up to a place,” said Josh Roth, 33, of Orlando, who waited nearly three weeks to get his first vaccine dose. “They may have a couple of hours to wait, but they’re able to get the shots.”

Advocates are also concerned that people with more education, money, and time might be better able to access the shots.

Early data suggests that Black and Hispanic men are disproportionately affected by monkeypox cases, yet non-Hispanic white patients have received more first doses of the vaccine than any other group, according to the CDC.

More appointments began to open up in Florida in mid-August after the FDA authorized a new method of giving the vaccine that required training and special equipment but stretched the nation’s limited supply.

DeChellis did not have to drive to Wilton Manors for his second shot on Aug. 23, and Roth received his second dose as scheduled. After trying for weeks to get an online appointment, Lopez got vaccinated in early August at the Orange County health department in Orlando.

But the experience made him feel as though monkeypox was not an urgent matter for local health officials. “My expectation is that if it doesn’t affect a mass group of people, it’s not going to be a priority,” Lopez said.

After the monkeypox outbreak began, some health departments in the South began partnering with so-called trusted messengers in the LGBTQ+ community to raise awareness and host vaccine clinics.

In South Florida, for example, Broward County’s health department reached out to high-risk groups in the community for help getting people vaccinated, said Robert Boo, CEO of the Pride Center at Equality Park, a nonprofit that provides health and social services for LGBTQ+ people and that hosted a vaccine drive. In Texas, Equality Texas held a webinar with doctors and other experts who answered questions from the public.

But in other areas, gay and bisexual men said they could not get answers, not even from their local health departments.

Florida, Georgia, and Texas together make up 26% of the nearly 22,000 confirmed cases reported as of Sept. 9, but their response has been unlike California’s and New York’s, where emergency declarations from governors have allowed more health care workers to administer the vaccine and local health departments to access more money from the state for vaccinations, education, and outreach.

“An emergency declaration does nothing for the response,” said Redfern, the spokesperson at the Florida health department, which is responding to a concurrent outbreak of meningococcal disease also primarily affecting gay and bisexual men.

“There is nothing a new state of emergency order would do for Georgians that isn’t already being done,” said Andrew Isenhour, a spokesperson for Republican Gov. Brian Kemp. He also said the Georgia Department of Public Health has been raising awareness about monkeypox and recently launched a statewide portal for scheduling vaccinations.

In Texas, Austin and Dallas officials declared local emergencies in early August. The Texas Department of State Health Services declined to comment on whether a declaration is warranted statewide.

Some providers, like Dr. Ivan Melendez of the Hidalgo County Health Authority in South Texas, agree that because monkeypox is spreading primarily among men who have sex with men, a statewide declaration is not needed. Lab testing, vaccines, and guidance for both clinicians and the public are available.

But others say an emergency declaration would signal that a threat exists, free up funding, require additional reporting, and cut bureaucratic red tape.

“It gives us a concerted response,” said Jill Roberts, an epidemiologist and associate professor at the University of South Florida. “It allows for more information: Where are vaccines going? Where are cases happening? Where are the hot spots we can hit?”

Dr. Melanie Thompson, an Atlanta physician who provides care for people living with HIV, said she would like the state and governor to play a stronger role in coordinating a uniform response across Georgia’s 159 counties. Not all local health departments are adequately staffed or funded, Thompson said.

“They’re all out there doing their own thing,” she said. “Some counties do a really good job with that. Other counties don’t.”

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

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As State Institutions Close, Families of Longtime Residents Face Agonizing Choices

Kaiser Health News:Health Industry - September 13, 2022

GLENWOOD, Iowa — Mike Lee’s way of life has faded away in most of the United States, and it soon will vanish from southwestern Iowa.

Lee, 57, has spent 44 years at the Glenwood Resource Center, a state-run institution for people with intellectual or developmental disabilities. He has autism and epilepsy, and his parents decided when he was 13 that he needed the structure and constant oversight offered by a large facility.

Theirs was a common decision at the time. It no longer is.

The number of Americans living in such institutions has dropped more than 90% since the late 1960s. Seventeen states have closed all their large public institutions for people with disabilities. Just five states — Iowa, Nebraska, South Carolina, Utah, and Wyoming — haven’t closed any, according to a University of Minnesota expert.

Iowa announced in April that in 2024 it would shutter the Glenwood Resource Center, a sprawling campus near the state’s western border. State leaders cited federal pressure to improve conditions for the facility’s residents or place them elsewhere.

Many of the remaining residents of such places have lived there for decades, leaving their families with wrenching choices when closures loom.

Lee knows he will move soon, even if he doesn’t understand all the implications.

His sister, Connie Bowen, broached the subject during a recent visit. She picked her brother up from the one-story house where he lives with several other residents on the institution’s grounds and drove him to a nearby Pizza Hut for lunch.

As he sipped on a root beer, she asked how he felt. “Does it make you sad or happy that you’re leaving?” she said.

“Happy! I’m happy,” he replied.

Lee wore a black T-shirt decorated with a bald eagle, the American flag, and the words “land of the free, home of the brave.” He said he is looking forward to a calmer life away from the institution, where he said other residents often become disruptive.

Bowen, who is her brother’s legal guardian, agrees in theory with the idea of caring for people with disabilities in homes or apartments. But like many other relatives of Glenwood Resource Center residents, she worries that the new arrangements might not be safe for people who have been institutionalized for decades.

“I hope I can find a good place that’ll take good care of you,” Bowen told Lee.

“Yeah, I know,” he said.

Dwindling Census

The Glenwood Resource Center, founded as an orphanage in the 1860s, housed more than 1,900 people at its peak in the 1950s. Now, 134 people live there.

Many residents face more hurdles than Lee does. Some can’t speak. Many also have physical disabilities that make getting around difficult and can pose life-threatening risks. Some residents can become confused or agitated.

Sheryl Larson, a University of Minnesota researcher who tracks institutional care for people with disabilities, said Iowa lags behind most other states in winding down such facilities.

The number of Americans living in state-run institutions plummeted from 194,650 in 1967 to 17,596 in 2018, according to a recent paper that Larson helped write.

The closures partly stemmed from the U.S. Supreme Court’s 1999 decision in Olmstead v. L.C., which held that Americans with disabilities have a right to live in the least restrictive setting that is practical.

Like Glenwood, most state institutions opened more than a century ago, and they typically were constructed in rural areas. “There was a movement to create a bucolic environment for individuals,” said Mary Sowers, executive director of the National Association of State Directors of Developmental Disabilities Services.

Many of the big institutions included farms, where residents helped grow their food. Conventional wisdom held that country life would be healthful. Now, Sowers said, “we recognize that the larger settings really didn’t wind up living up to that promise, and individuals are able to thrive more when they’re able to live in communities.”

Sowers said about 1.3 million Americans are served by public programs for people with intellectual or developmental disabilities. Only about 1% of them live in large state institutions.

Larson said families of the institutions’ remaining residents may feel whipsawed by experts’ advice. Years ago, medical professionals told parents that their children could best be served in such places. Now, those same families are urged to move their loved ones out. “They did what they thought was the right thing to do — and now to be told it wasn’t the right thing to do is really, really hard for them to accept,” she said.

The transition away from institutions for people with intellectual or developmental disabilities has been handled better than the wave of state mental hospital closures over the past 50 years, Larson said. Critics contend that as large state mental hospitals were shuttered, they weren’t replaced with sufficient community services. That sparked a surge in people with untreated mental illnesses living on the streets or in jails and prisons.

Facilities like the Glenwood Resource Center serve people with intellectual disabilities, such as severe autism and brain injuries. Larson said that community services for people with intellectual disabilities have increased and that surveys find most families are satisfied with the results after their loved ones move from institutions to community placements.

Scandals Preceded Closure

The Iowa closure decision came after a series of scandals at the Glenwood Resource Center. Allegations included that insufficient medical care led to several deaths and that administrators planned unethical research on residents. Top administrators were ousted, and the U.S. Justice Department began investigating as allegations of poor care continued.

Federal investigators determined that Iowa violated Glenwood Resource Center residents’ rights and that the state relied too much on institutional care.

Justice Department officials declined to comment for this article, noting that negotiations over a legal settlement with the state are ongoing.

In the scandal’s wake, Iowa leaders assured residents’ families that they had no plans to close either of the state’s two institutions for people with disabilities. But the message abruptly changed in April, when state officials announced the Glenwood Resource Center would close. They cited the high cost of complying with federal expectations if it were to stay open.

The state and federal governments spend about $392,000 per resident annually at the institution.

Kelly Garcia, Iowa’s director of health and human services, said she understands that contemplating a move can be stressful for residents and their families. But she said Iowa clung too long to an outdated role for such institutions. “This notion that you are admitted at age 2 and you live 80 years there is no longer the way we as a society would want to support a human being,” she said.

Garcia said administrators are trying to arrange for longtime roommates and friends to stay together when they move out and for people to be placed near their families.

She said the state is committed to providing money and expertise to the private agencies that will support former Glenwood Resource Center residents. She noted the state has already helped such agencies raise wages so they can hire and retain caregivers. Those that take on clients with high needs could qualify for extra payments to make the transition, Garcia said.

Garcia said the state’s commitment is one reason more than 30 agencies showed up in July for a “provider fair” in the institution’s gym. Residents’ families and guardians met with private care providers and considered their options.

Crest Services, a residential care company for people with disabilities, sent representatives to the event. Director Bob Swigert said in a recent interview that his agency is looking to arrange community placements for 10 residents of the Glenwood Resource Center. The main hurdle has been finding suitable housing for the residents, including those who use wheelchairs, Swigert said. His company might retrofit some homes for that purpose.

Swigert said he and his staff are reassuring residents’ families that they will continue to have necessary services, including round-the-clock staffing. “They’re concerned, they’re anxious — which is very understandable,” he said. “These individuals are being required to move from what has pretty much been their lifetime home.”

The institution’s 380-acre campus includes numerous ranch-style homes, where residents live with oversight from staff. It has several large old buildings, from days when people with disabilities were warehoused. It also includes a fire station, a greenhouse, a water tower, and a cemetery containing the graves of hundreds of people who have died at the institution since the 1800s.

The facility has been a vital part of life in Glenwood, a town of about 5,000 people near the Missouri River. The institution has nearly 470 workers, making it the largest employer in the area, with relatively good wages and benefits. Two or three generations of many local families have worked there.

Some may find new jobs in the Omaha, Nebraska, area, which is less than an hour away, but town leaders worry others will move away. A few may transfer to a similar institution owned by the state in the town of Woodward, which is 150 miles to the northeast.

‘Last Ones Out’

Some of the institution’s residents will never understand the situation. One is Seth Finken, 43, who has lived at the Glenwood Resource Center since 1984. Childhood meningitis damaged his brain and left him blind, deaf, and medically fragile.

His mother, Sybil Finken, lives in the town of Glenwood and sees few options for her son in the region. The most advanced care programs she has talked to are in bigger cities, such as Des Moines or Dubuque. “This is Seth’s community,” she said. “I don’t want him moving two or four hours away.”

For years, Sybil Finken called for Iowa to keep operating the Glenwood Resource Center. She knew most other states had closed institutions for people with disabilities. She figured Iowa would follow suit eventually, but she believed assurances that longtime residents could live out their lives there.

Now, she said, all she can do is keep talking to private care agencies and hope someone figures out how to keep her son safe in a community setting.

“Seth and I are going to be the last ones out the door,” she said.

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

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Medical Coding Creates Barriers to Care for Transgender Patients

Kaiser Health News:Health Industry - September 13, 2022

Last year, Tim Chevalier received the first of many coverage denials from his insurance company for the hair removal procedure he needed as part of a phalloplasty, the creation of a penis.

Electrolysis is a common procedure among transgender people like Chevalier, a software developer in Oakland, California. In some cases, it’s used to remove unwanted hair from the face or body. But it’s also required for a phalloplasty or a vaginoplasty, the creation of a vagina, because all hair must be removed from the tissue that will be relocated during surgery.

Chevalier’s insurer, Anthem Blue Cross, told him he needed what’s known as a prior authorization for the procedure. Even after Chevalier received the authorization, he said, his reimbursement claims kept getting denied. According to Chevalier, Anthem said the procedure was considered cosmetic.

Many trans patients have trouble getting their insurers to cover gender-affirming care. One reason is transphobia within the U.S. health care system, but another involves how medical diagnoses and procedures are coded for insurance companies. Nationwide, health care providers use a list of diagnostic codes provided by the International Classification of Diseases, Tenth Revision, or ICD-10. And many of those, advocates for transgender people say, haven’t caught up to the needs of patients. Such diagnostic codes provide the basis for determining which procedures, such as electrolysis or surgery, insurance will cover.

“It’s widely regarded that the codes are very limited in ICD-10,” said Dr. Johanna Olson-Kennedy, medical director of the Center for Transyouth Health and Development at Children’s Hospital Los Angeles.

She advocates for a move to the 11th edition of the coding system, which was endorsed by the World Health Organization in 2019 and began to be adopted around the globe in February. Today, more than 34 countries use ICD-11.

The new edition has replaced outdated terms like “transsexualism” and “gender identity disorder” with “gender incongruence,” which is no longer classified as a mental health condition, but as a sexual health one. This is crucial in reducing the stigmatization of trans people in health care, said Olson-Kennedy.

A move away from the mental health classification may also mean more coverage of gender-affirming care by insurance companies, which sometimes question mental health claims more rigorously than those for physical illnesses. WHO officials have said they hope that adding gender incongruence to a sexual health chapter will “help increase access to care for health interventions” and “destigmatize the condition,” according to the WHO website.

However, history suggests that ICD-11 likely won’t be implemented in the U.S. for years. The WHO first endorsed ICD-10 in 1990, but the U.S. didn’t implement it for 25 years.

Meanwhile, patients who identify as transgender and their doctors are spending hours trying to get coverage — or using crowdfunding to cover big out-of-pocket bills. Chevalier estimated he has received 78 hours of electrolysis at $140 per hour, costing $10,920.

Anthem spokesperson Michael Bowman wrote in an email that “there has been no medical denials or denial of coverage” because Anthem “preapproved coverage for these services.”

However, even after the preapproval was given, Anthem responded to Chevalier’s claims by stating the electrolysis would not be reimbursed because the procedure is considered cosmetic, rather than medically necessary. This is regardless of Chevalier’s diagnosis of gender dysphoria — the psychological distress felt when someone’s biological sex and gender identity don’t match — which many doctors consider a medically legitimate reason for hair removal.

Bowman wrote that “once this issue was identified, Anthem implemented an internal process which included a manual override in the billing system.”

Still, Chevalier filed a complaint with the California Department of Managed Health Care, and the state declared Anthem Blue Cross out of compliance. Additionally, after KHN started asking Anthem questions about Chevalier’s bills, two claims that had not been addressed since April were resolved in July. So far, Anthem has reimbursed Chevalier around $8,000.

Some procedures that trans patients receive can also be excluded from coverage because insurance companies consider them “sex-specific.” For example, a transgender man’s gynecological visit may not be covered because his insurance plan covers those visits only for people enrolled as women.

“There is always this question of: What gender should you tell the insurance company?” said Dr. Nick Gorton, an emergency medicine physician in Davis, California. Gorton, who is trans, recommends his patients with insurance plans that exclude trans care calculate the out-of-pocket costs that would be required for certain procedures based on whether the patient lists themselves as male or female on their insurance paperwork. For example, Gorton said, the question for a trans man becomes “what’s more expensive — paying for testosterone or paying for a Pap smear?” — since insurance likely won’t cover both.

For years, some physicians helped trans patients get coverage by finding other medical reasons for their trans-related care. Gorton said that if, for instance, a transgender man wanted a hysterectomy but his insurance didn’t cover gender-affirming care, Gorton would enter the ICD-10 code for pelvic pain, as opposed to gender dysphoria, into the patient’s billing record. Pelvic pain is a legitimate reason for the surgery and is commonly accepted by insurance providers, Gorton said. But some insurance companies pushed back, and he had to find other ways to help his patients.

In 2005, California passed a first-of-its-kind law that prohibits discrimination by health insurance on the basis of gender or gender identity. Now, 24 states and Washington, D.C., forbid private insurance from excluding transgender-related health care benefits.

Consequently, Gorton no longer needs to use different codes for patients seeking gender-affirming care at his practice in California. But physicians in other states are still struggling.

When Dr. Eric Meininger, an internist and pediatrician at Indiana University Health’s Gender Health Program, treats a trans kid seeking hormone therapy, he commonly uses the ICD-10 code for “medication management” as the primary reason for the patient’s visit. That’s because Indiana has no law providing insurance protections for LGBTQ+ people, and when gender dysphoria is listed as the primary reason, insurance companies have denied coverage.

“It’s frustrating,” Meininger said. In a patient’s billing record, he sometimes provides multiple diagnoses, including gender dysphoria, to increase the likelihood that a procedure will be covered. “It’s not hard usually to come up with five or seven or eight diagnoses for someone because there’s lots of vague ones out there.”

Implementing ICD-11 won’t fix all the coding problems, as insurance companies may still refuse to cover procedures related to gender incongruence even though it is listed as a sexual health condition. It also won’t change the fact that many states still allow insurance to exclude gender-affirming care. But in terms of reducing stigma, it’s a step forward, Olson-Kennedy said.

One reason the U.S. took so long to switch to ICD-10 is that the American Medical Association strongly opposed the move. It argued the new system would put an incredible burden on doctors. Physicians would have to “contend with 68,000 diagnosis codes — a five-fold increase from the approximately 13,000 diagnosis codes in use today,” the AMA wrote in a 2014 letter. Implementing software to update providers’ coding systems would also be costly, dealing a financial blow to small medical practices, the association argued.

Unlike past coding systems, ICD-11 is fully electronic, with no physical manual of codes, and can be incorporated into a medical facility’s current coding system without requiring a new rollout, said Christian Lindmeier, a WHO spokesperson.

Whether these changes will make the adoption of the new edition easier in the U.S. is yet to be seen. For now, many trans patients in need of gender-affirming care must pay their bills out-of-pocket, fight their insurance company for coverage, or rely on the generosity of others.

“Even though I did get reimbursed eventually, the reimbursements were delayed, and it burned up a lot of my time,” Chevalier said. “Most people would have just given up.”

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

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HHS Approves Nation’s First Medicaid Mobile Crisis Intervention Services Program, To Be Launched in Oregon

HHS Gov News - September 12, 2022
New Medicaid option will strengthen behavioral health care and make our communities safer by involving mental health counselors or social workers

Statement by HHS Secretary Xavier Becerra on the Appointment of the Inaugural Director of Advanced Research Projects Agency for Health

HHS Gov News - September 12, 2022
President Biden announces his intention to appoint Dr. Renee Wegrzyn to be director of the Advanced Research Projects Agency for Health (ARPA-H)

Did the US Jump the Gun With the New Omicron-Targeted Vaccines?

Kaiser Health News:Marketplace - September 12, 2022

Last month, the FDA authorized omicron-specific vaccines, accompanied by breathless science-by-press release and a media blitz. Just days after the FDA’s move, the Centers for Disease Control and Prevention followed, recommending updated boosters for anyone age 12 and up who had received at least two doses of the original covid vaccines. The message to a nation still struggling with the covid-19 pandemic: The cavalry — in the form of a shot — is coming over the hill.

But for those familiar with the business tactics of the pharmaceutical industry, that exuberant messaging — combined with the lack of completed studies — has caused considerable heartburn and raised an array of unanswered concerns.

The updated shots easily clear the “safe and effective” bar for government authorization. But in the real world, are the omicron-specific vaccines significantly more protective — and in what ways — than the original covid vaccines so many have already taken? If so, who would benefit most from the new shots? Since the federal government is purchasing these new vaccines — and many of the original, already purchased vaccines may never find their way into taxpayers’ arms — is the $3.2 billion price tag worth the unclear benefit? Especially when these funds had to be pulled from other covid response efforts, like testing and treatment.

Several members of the CDC advisory committee that voted 13-1 for the recommendation voiced similar questions and concerns, one saying she only “reluctantly” voted in the affirmative.

Some said they set aside their desire for more information and better data and voted yes out of fear of a potential winter covid surge. They expressed hope that the new vaccines — or at least the vaccination campaign that would accompany their rollout — would put a dent in the number of future cases, hospitalizations, and deaths.

That calculus is, perhaps, understandable at a time when an average of more than 300 Americans are dying of covid each day.

But it leaves front-line health care providers in the impossible position of trying to advise individual patients whether and when to take the hot, new vaccines without complete data and in the face of marketing hype.

Don’t get us wrong. We’re grateful and amazed that Pfizer-BioNTech and Moderna (with assists from the National Institutes of Health and Operation Warp Speed) developed an effective vaccine in record time, freeing the nation from the deadliest phase of the covid pandemic, when thousands were dying each day. The pandemic isn’t over, but the vaccines are largely credited for enabling most of America to return to a semblance of normalcy. We’re both up-to-date with our covid vaccinations and don’t understand why anyone would choose not to be, playing Russian roulette with their health.

But as society moves into the next phase of the pandemic, the pharmaceutical industry may be moving into more familiar territory: developing products that may be a smidgen better than what came before, selling — sometimes overselling — their increased effectiveness in the absence of adequate controlled studies or published data, advertising them as desirable for all when only some stand to benefit significantly, and in all likelihood raising the price later.

This last point is concerning because the government no longer has funds to purchase covid vaccines after this autumn. Funding to cover the provider fees for vaccinations and community outreach to those who would most benefit from vaccination has already run out. So updated boosters now and in the future will likely go to the “worried well” who have good insurance rather than to those at highest risk for infection and progression to severe disease.

The FDA’s mandated task is merely to determine whether a new drug is safe and effective. However, the FDA could have requested more clinical vaccine effectiveness data from Pfizer and Moderna before authorizing their updated omicron BA.5 boosters.

Yet the FDA cannot weigh in on important follow-up questions: How much more effective are the updated boosters than vaccines already on the market? In which populations? And what increase in effectiveness is enough to merit an increase in price (a so-called cost-benefit analysis)? Other countries, such as the United Kingdom, perform such an analysis before allowing new medicines onto the market, to negotiate a fair national price.

The updated booster vaccine formulations are identical to the original covid vaccines except for a tweak in the mRNA code to match the omicron BA.5 virus. Studies by Pfizer showed that its updated omicron BA.1 booster provides a 1.56 times higher increase in neutralizing antibody titers against the BA.1 virus as compared with a booster using its original vaccine. Moderna’s studies of its updated omicron BA.1 booster demonstrated very similar results. However, others predict that a 1.5 times higher antibody titer would yield only slight improvement in vaccine effectiveness against symptomatic illness and severe disease, with a bump of about 5% and 1% respectively. Pfizer and Moderna are just starting to study their updated omicron BA.5 boosters in human trials.

Though the studies of the updated omicron BA.5 boosters were conducted only in mice, the agency’s authorization is in line with precedent: The FDA clears updated flu shots for new strains each year without demanding human testing. But with flu vaccines, scientists have decades of experience and a better understanding of how increases in neutralizing antibody titers correlate with improvements in vaccine effectiveness. That’s not the case with covid vaccines. And if mouse data were a good predictor of clinical effectiveness, we’d have an HIV vaccine by now.

As population immunity builds up through vaccination and infection, it’s unclear whether additional vaccine boosters, updated or not, would benefit all ages equally. In 2022, the U.S. has seen covid hospitalization rates among people 65 and older increase relative to younger age groups. And while covid vaccine boosters seem to be cost-effective in the elderly, they may not be in younger populations. The CDC’s Advisory Committee on Immunization Practices considered limiting the updated boosters to people 50 and up, but eventually decided that doing so would be too complicated.

Unfortunately, history shows that — as with other pharmaceutical products — once a vaccine arrives and is accompanied by marketing, salesmanship trumps science: Many people with money and insurance will demand it whether data ultimately proves it is necessary for them individually or not.

We are all likely to encounter the SARS-CoV-2 virus again and again, and the virus will continue to mutate, giving rise to new variants year after year. In a country where significant portions of at-risk populations remain unvaccinated and unboosted, the fear of a winter surge is legitimate.

But will the widespread adoption of a vaccine — in this case yearly updated covid boosters — end up enhancing protection for those who really need it or just enhance drugmakers’ profits? And will it be money well spent?

The federal government has been paying a negotiated price of $15 to $19.50 a dose of mRNA vaccine under a purchasing agreement signed during the height of the pandemic. When those government agreements lapse, analysts expect the price to triple or quadruple, and perhaps even more for updated yearly covid boosters, which Moderna’s CEO said would evolve “like an iPhone.” To deploy these shots and these dollars wisely, a lot less hype and a lot more information might help.

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

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‘An Arm and a Leg’: The New Cap on Medicare Drug Costs

Kaiser Health News:Health Industry - September 12, 2022

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On a Sunday afternoon in August, health services researcher Stacie Dusetzina was sitting alone in her office at Vanderbilt University, watching C-SPAN and crying.

The U.S. Senate was voting on the Inflation Reduction Act, which among other things is designed to ensure that people on Medicare pay less for expensive drugs.

It’s a big deal. Lots of seniors pay $10,000 a year or more for drugs or do without lifesaving treatment; once the new law kicks in, it sets an out-of-pocket limit of $2,000 a year. 

Dusetzina and her colleagues have spent years making the case for this change, documenting the ways current policies leave people in the lurch. 

The pharmaceutical industry fought this change tooth and nail — for decades. Julie Rovner, chief Washington correspondent for KHN, takes listeners on a journey back to the late 1980s, when Congress learned the cost of messing with Big Pharma. 

“An Arm and a Leg” is a co-production of KHN and Public Road Productions.

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

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Journalists Delve Into Inflation Policy, Hospital Closures, and Needle Exchanges

Kaiser Health News:States - September 10, 2022

KHN chief Washington correspondent Julie Rovner discussed provisions of the Inflation Reduction Act with Newsy’s “The Why” on Sept. 2.

KHN senior editor Andy Miller discussed the upcoming closure of a trauma hospital in metro Atlanta with WUGA’s “The Health Report” on Sept. 6.

KHN correspondent Jazmin Orozco Rodriguez discussed rural needle exchanges with The Nevada Independent’s “IndyMatters” on Sept. 6.

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

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Niños del norte de California aprenden a lidiar con el trauma que dejan los incendios

Kaiser Health News:States - September 09, 2022

SONOMA, California. – Maia y Mia Bravo salieron de su casa en un brillante día de verano y sintieron el peligro.

Humo de madera quemada flotaba sobre su jardín. Maia, de 17 años, buscó la fuente mientras Mia, de 14, buscaba la manguera, abría el grifo y rociaba el perímetro de la propiedad con agua.

Ese olor a humo transportó a las hermanas a una ventosa tarde de octubre de 2017, cuando un incendio forestal llegó a su anterior casa. Desde la parte trasera de la minivan, las niñas vieron las llamas que rodeaban su trailer en Glen Ellen, un pueblo en la región vinícola del norte de California.

Abandonaron sus pertenencias, incluida la muñeca favorita de Mia, y se fueron sin su gata, Misi, que estaba asustada por el fuego. Lo único que la familia salvó fue una manta del bebé de 3 meses.

La familia se alejó por caminos oscuros iluminados por árboles y plantas en llamas. Mía estaba tranquila. Maia vomitó.

A medida que los incendios forestales de California se vuelven más intensos, frecuentes y generalizados, muchos niños que los sobreviven experimentan traumas psicológicos duraderos, como ansiedad, depresión y trastorno de estrés postraumático.

Los niños también pueden desarrollar problemas de sueño o de atención, o tener dificultades en la escuela. Si no se aborda, el trauma emocional puede afectar su salud física, lo que puede conducir a problemas de salud crónicos, enfermedades mentales y adicciones.

Desde 2020, el estado ha pedido a los médicos que participan en el programa estatal de Medicaid para personas de bajos ingresos que evalúen a niños y adultos para detectar eventos potencialmente traumáticos relacionados con experiencias infantiles adversas.

En el último reporte ACE (Adverse Childhood Experiences) del estado, que se llevó a cabo entre enero de 2020 y septiembre de 2021, se descubrió que los niños y adultos tenían un mayor riesgo de estrés tóxico o trauma si vivían en los condados del norte, una región principalmente rural castigada por los incendios.

Si bien hay las evaluaciones pueden ayudar a detectar negligencia, abuso o disfunción en el hogar,  médicos y funcionarios de salud han sugerido que los incendios forestales contribuyeron a las altas puntuaciones de ACE en las zonas rurales del norte de California.

En un informe anual, se descubrió que el 70% de los niños y adultos del condado de Shasta, donde ardió el incendio de Carr en 2018, tenían un alto riesgo de trauma. En el condado de Napa, donde el incendio de Tubbs arrasó la región vinícola en 2017, se consideró que el 50% de los niños y adultos tenían un alto riesgo de trauma.

En un análisis complementario, investigadores encontraron que el 75% de los adultos en algunos condados del norte de California han experimentado uno o más eventos traumáticos, en comparación con el 60% en todo el estado. Eso incluye el condado de Butte, donde el Camp Fire se cobró la vida de 85 personas.

“Para empezar, cuando la población ya tiene un alto rango de trauma y se agrega el  trauma ambiental, simplemente vuelve todo más difícil”, dijo el doctor Sean Dugan, pediatra en el Centro de Salud Comunitario de Shasta que realizó algunas de las evaluaciones ACE.

Los incendios forestales interrumpen las rutinas, obligan a las personas a mudarse y crean inestabilidad para los niños que necesitan consuelo y seguridad. En los últimos años, los demógrafos de California han atribuido algunos cambios dramáticos en la población a los incendios forestales que destruyen hogares y desplazan familias.

“No hay nada más estresante para un niño que ver a sus padres enloquecidos”, dijo Christopher Godley, director de manejo de emergencias del condado de Sonoma, que desde 2015 ha sido afectado por cinco de los incendios forestales más devastadores del estado.

Los niños también pueden ser víctimas indirectas de los incendios forestales. Según un estudio publicado por los Centros para el Control y la Prevención de Enfermedades, aproximadamente 7,4 millones de niños en el país se ven afectados anualmente por el humo de los incendios forestales, que no solo afecta el sistema respiratorio sino que puede contribuir al trastorno por déficit de atención/hiperactividad, autismo, deterioro del rendimiento escolar y problemas de memoria.

En 2017, la familia Bravo escapó del Incendio Tubbs, que quemó partes de los condados de Napa y Sonoma y la ciudad de Santa Rosa. En ese momento, fue el incendio más destructivo en la historia del estado, arrasó vecindarios y mató a casi dos docenas de personas.

La primera noche durmieron en su minivan y luego se refugiaron con su familia en las cercanías de Petaluma.

“Tenía miedo, estaba en estado de shock”, recordó Maia. “Me quedaba despierta toda la noche”.

Las hermanas encontraron a su gato Misi acurrucado debajo del trailer de un vecino 15 días después de que evacuaran. Sus patas tenían graves quemaduras.

Durante los primeros años después del incendio, Maia tuvo pesadillas llenas de llamas, cenizas y casas carbonizadas. Se despertaba sobresaltada con el sonido de las sirenas de los camiones de bomberos.

Los niños pueden responder de manera diferente al trauma dependiendo de su edad. Los más pequeños pueden sentirse ansiosos y temerosos, comer mal o desarrollar ansiedad por la separación de sus padres o adultos de confianza. Los niños mayores pueden sentirse deprimidos y solos, desarrollar trastornos alimentarios o comportamientos autodestructivos, o comenzar a consumir alcohol o drogas.

“Cuando tienes a estos niños que han tenido estas evacuaciones intensas, experimentado pérdidas de vidas, destrucción completa de la propiedad, es importante que tengan apoyo social”, dijo Melissa Brymer, directora de programas contra el terrorismo y desastres del  UCLA-Duke University National Center for Child Traumatic Stress.

Brymer dijo que los niños también necesitan herramientas para mantener la calma. Esas incluyen mantener rutinas, jugar juegos familiares, hacer ejercicio o ver a un consejero, explicó Sarah Lowe, psicóloga clínica y profesora asociada de la Escuela de Salud Pública de Yale.

“Para los niños, es realmente importante infundir una sensación de estabilidad y restablecer cierta sensación de rutina y normalidad”, agregó.

Los socorristas han comenzado a integrar el bienestar mental, tanto para adultos como para niños, en sus planes de respuesta ante desastres.

Funcionarios del condado de Sonoma ahora publican recursos para las personas que enfrentan el estrés durante los incendios forestales junto con consejos para armar kits de emergencia, y desarrollar un plan de escape.

Y el condado desplegará trabajadores de salud mental durante los desastres como parte de su nuevo plan de operaciones de emergencia, dijo Godley. Enviará especialistas en salud conductual a refugios de emergencia y trabajará con grupos comunitarios para rastrear las necesidades de los sobrevivientes de incendios forestales.

“Muchas de las poblaciones más vulnerables van a necesitar salud conductual especializada y eso será especialmente cierto para los niños”, dijo Godley.

Maia y Mia se mudaron tres veces desde que se incendio su trailer. Maia comenzó a ver al consejero escolar unas semanas después de regresar a la escuela. Mia era más reacia a aceptar ayuda y no comenzó a recibir asesoramiento hasta enero de 2018.

“Hablar de eso con el consejero me tranquilizó”, dijo Maia. “Ahora, puedo dormir. Pero cuando escucho sobre incendios, me pongo nerviosa de que vuelva a suceder”.

Su madre, Erandy Bravo, alentó a sus hijas a controlar su ansiedad escribiendo en un diario, pero las hermanas optaron por un enfoque más práctico para sobrellevar su trauma: preparon un bolso con sus libros escolares, computadoras portátiles y objetos personales que querrían en caso de otro incendio.

Las niñas asisten a talleres sobre cómo manejar la ansiedad en un centro local para adolescentes y se han convertido en líderes de un grupo de apoyo. Maia, quien se graduó de la secundaria en junio, estudiará psicología cuando comience en Santa Rosa Junior College en el otoño. Mia, que está en décimo grado, quiere ser despachadora de emergencias.

Aún así, las hermanas Bravo permanecen alertas.

En su nuevo hogar, cuando las hermanas olieron humo en su patio a principios de este año, pronto se dieron cuenta de que provenía de la chimenea del vecino. Se sintieron seguras y volvieron a la casa.

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

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

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HHS Secretary: 988 Transition Moves Us Closer to Better Serving the Crisis Care Needs of People Across America

HHS Gov News - September 09, 2022
$35 million announced today to better link 988 Lifeline services to Tribal communities

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