Comments on: Neighborhood News Archives – North Denver Tribune.com

Latest – North Denver News
more info...
Drive-Thru Baby Showers Serve Express Needs of Pregnant Veterans in Atlanta
Thu, 11 May 2023 13:42:18 +0000

When 28-year-old Navy veteran Carisma Carter pulled her car up to the front of the Atlanta VA Clinic, her seat was pushed far back from the steering wheel to make room for her big belly. Carter was 8 months pregnant.

“I’m having two boys, twins. It’s my first pregnancy,” she said.

Carter knows the pregnancy risks she could face as a Black woman, especially in Georgia, where data shows Black women are more than twice as likely as white women to die during or within a year after a pregnancy.

“I take care of my body during the pregnancy, but, yeah, I’m very aware,” Carter said. “And I just try to stay positive.”

In 2021, women made up about 17% of the U.S. military’s active-duty force. And women are the fastest-growing group of veterans in the country, according to the Department of Veterans Affairs.

A recent report from Rand Corp. outlines some of the ways the health needs of women differ from men’s, including pregnancy and childbirth. And health researchers have said women veterans may be at heightened risk for pregnancy complications, compared with their civilian counterparts.

A few years ago, the Atlanta VA Clinic got creative with its outreach to pregnant patients. It began throwing surprise baby showers for small groups of patients. The goal is to cement relationships with the clinical staff, make sure pregnant veterans get to all their regular and specialist appointments, and help ensure pregnant people have the supplies they need as they near delivery. A trained maternity care coordinator manages each pregnant veteran’s care.

After the covid-19 pandemic emerged, the VA transformed the showers into low-contact “drive-thru” events, which occur about every three months, and serve roughly 20 pregnant veterans each time.

At a shower in February, volunteers set up in front of the main entrance of the Atlanta VA. The building is concrete, beige, and bland. But the volunteers created a celebratory atmosphere by decorating a folding table and stacking it high with free diaper bags and other baby supplies.

A car pulled up to the table and a volunteer with a clipboard began hyping up the small crowd, which then burst into applause and cheers.

“Thank you for your service!” they called out. “Congratulations!”

The pregnant veteran behind the wheel looked surprised at first. Then she broke into a big smile. She rolled down her car window.

Volunteers and VA staff members clustered around the car and offered her a tiara of green, white, and pink flowers.

“Would you like to wear it?” one asked. “Stunning! Remind us what you’re having?”

“I’m having a girl,” the woman said.

While they chatted through the open window about her due date and health, other volunteers rushed forward with supplies. Some piled boxes of diapers into the back seat. The final, parting gesture was a $100 gift card.

Kathleen O’Loughlin, who manages the women veterans program at the Atlanta VA, said the events offer “last-minute baby needs.”

“Because we know there’s a lot,” she said.

O’Loughlin said the health center can’t invite every pregnant veteran to these group baby showers, so they focus on women with higher-risk pregnancies, including veterans carrying multiples or those who have a disability related to their military service.

“Now, a lot of the women have different musculoskeletal issues because of their service, [or] a lot of service-connected disabilities that civilian women aren’t exposed to because they don’t have those same job responsibilities,” O’Loughlin said. “This is an extra set of eyeballs on them. Are you making sure you’re taking your blood pressure medicines? Are you getting all of your appointments, are you meeting with your doctors?”

U.S. maternal mortality rates increased again during the pandemic years of 2020 and 2021, according to the Centers for Disease Control and Prevention.

Physical and psychological injuries linked to military service can increase the risk of poor maternal outcomes, according to Jamya Pittman, an internist and the medical director for the women veterans program in Atlanta.

“A lot of our women veterans have the diagnoses of anxiety, depression. They may also have PTSD, in addition to a myriad of other diagnoses like hypertension and diabetes,” Pittman said. “We also know that pregnancy in itself can be a stressor on the body.”

The Atlanta VA designed the baby showers to boost veterans’ well-being, she explained. Program volunteers are predominantly also women veterans.

“This visible showing of support, this community engagement, this celebration,” she said, “is our way of helping to decrease stress and allow the woman veteran to know that she has a partner in her health care and with the arrival of the baby.”

Nationally, the Department of Veterans Affairs is focusing on women’s health at all life stages.

The Atlanta women veterans program serves more than 24,000 veterans in the region, and about 9% of them are pregnant at any time.

Two years ago, Congress passed bipartisan legislation mandating a national study of pregnancy outcomes among veterans, including any racial disparities.

“There has never been a comprehensive evaluation of how our nation’s growing maternal mortality crisis is impacting our women Veterans, even though they may be at higher risk due to their service,” wrote co-sponsor Sen. Tammy Duckworth (D-Ill.) on the day the bill was introduced.

The law, called the Protecting Moms Who Served Act, also provided $15 million to support maternity care coordination programs at VA facilities.

The Atlanta VA is using some of its share of that money to make sure pregnant veterans receive ongoing medical care for a full year after giving birth.

Carter, the Navy veteran who stopped by the baby shower, said she appreciated the outreach from the VA.

“Just checking on the women, supporting them, making sure that they have everything that they need for the baby,” she said, “because a lot of people don’t have that support, they don’t have family, they’re doing this on their own.”

Carter gave birth to her twins on Feb. 25. She and the babies are doing well, she said. The women veterans program’s maternity care coverage continues for 12 months after the twins’ birth.

This article is from a partnership that includes WABE, NPR, and KFF Health News.

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

USE OUR CONTENT

This story can be republished for free (details).

Category: Latest
more info...
La inteligencia artificial puede estar llegando a los consultorios, pero no está lista para ver pacientes
Mon, 15 May 2023 15:28:25 +0000

¿Qué uso podría tener para la atención médica alguien que inventa cosas, no puede guardar un secreto, realmente no sabe nada y, al hablar, simplemente completa la siguiente palabra en función de la frase anterior? Mucho, si ese “individuo” es la forma más nueva de inteligencia artificial, según algunas de las compañías más grandes que existen.

Cada vez más empresas impulsan la última tecnología de inteligencia artificial (IA), conocida como “IA generativa”: Google y Microsoft quieren usarla para la atención de salud. También las firmas familiares para los profesionales de salud como los gigantes de registros médicos electrónicos Epic y Oracle Cerner.

Y este campo está lleno de nuevas empresas.

Las empresas quieren que sus IA tomen notas para los médicos y ofrezcan una segunda opinión, suponiendo que puedan evitar que la inteligencia “alucine” o divulgue la información privada de los pacientes.

“Hay algo en marcha que es bastante emocionante”, dijo Eric Topol, director del Scripps Research Translational Institute en San Diego. Topol, como muchos otros observadores, se pregunta cuántos problemas podría causar, como filtrar datos de pacientes. “Vamos a averiguarlo”, aseguró.

El espectro de estos problemas inspiró a más de 1,000 líderes tecnológicos a firmar una carta abierta en marzo, instando a las empresas a frenar el desarrollo de sistemas avanzados de IA hasta que “tengamos confianza en que sus efectos serán positivos y sus riesgos serán manejables”. Aún así, algunas están invirtiendo más dinero en empresas de inteligencia artificial.

La tecnología subyacente se basa en sintetizar grandes porciones de texto u otros datos (por ejemplo, algunos modelos médicos se basan en 2 millones de notas de la unidad de cuidados intensivos del Centro Médico Beth Israel Deaconess en Boston) para predecir el texto que seguiría a una consulta determinada. La idea ha existido durante años, pero el frenesí empresarial y mediático es más reciente.

Comenzó en diciembre de 2022 con OpenAI respaldado por Microsoft y su producto insignia, ChatGPT, que responde preguntas con autoridad y estilo. Por ejemplo, puede explicar la genética con un soneto.

OpenAI, que comenzó como una empresa de investigación fundada por élites de Silicon Valley como Sam Altman, Elon Musk y Reid Hoffman, ha llevado el entusiasmo a los bolsillos de los inversores.

La empresa tiene una estructura compleja e híbrida con y sin fines de lucro. Pero una nueva ronda de financiación de $10 mil millones de Microsoft elevó el valor de OpenAI a $29 mil millones, informó The Wall Street Journal.

En este momento, la empresa otorga licencias de su tecnología a compañías como Microsoft y vende suscripciones a los consumidores. Otras nuevas empresas están considerando vender transcripción de IA u otros productos a sistemas hospitalarios o directamente a pacientes.

Los comentarios están en todas partes. Larry Summers, ex secretario del Tesoro, tuiteó recientemente: “Reemplazará lo que hacen los médicos (escuchar síntomas y hacer diagnósticos) antes de que cambie lo que hacen las enfermeras: ayudar a los pacientes a levantarse y manejarse en el hospital”.

Pero solo unas semanas después de que OpenAI recibiera otra gran inyección de efectivo, incluso Altman, su director ejecutivo, desconfía de la fanfarria. “La exageración sobre estos sistemas, incluso si todo lo que esperamos es correcto a largo plazo, está totalmente fuera de control a corto plazo”, dijo para un artículo de marzo en The New York Times.

Pocos en la atención de salud creen que esta última forma de IA esté a punto de reemplazarlos en sus trabajos (aunque algunas compañías están experimentando, de manera controversial, con chatbots que actúan como terapeutas o guías para la atención).

A photo of ChatGPT's website.El sitio de internet de ChatGPT en una pantalla.(Jakub Porzycki / NurPhoto via Getty Images)

Aquellos que son optimistas en la tecnología piensan que hará que algunas partes de su trabajo sean mucho más fáciles.

Eric Arzubi, psiquiatra de Billings, Montana, solía administrar a colegas psiquiatras para un sistema hospitalario. Una y otra vez, obtenía una lista de proveedores que aún no habían terminado sus notas: sus resúmenes de la condición de un paciente y un plan de tratamiento.

Escribir estas notas es uno de los grandes factores de estrés en el sistema de salud: es una carga administrativa. Pero es necesario desarrollar un registro para los futuros proveedores y, por supuesto, las aseguradoras.

“Cuando la gente está muy atrasada en la documentación, eso crea problemas”, dijo Arzubi. “¿Qué sucede si el paciente ingresa al hospital y hay una nota que no se ha completado y no sabemos lo que le pasa?”

La nueva tecnología podría ayudar a aliviar esas cargas. Arzubi está probando un servicio, llamado Nabla Copilot, que participa en las visitas virtuales de los pacientes y luego las resume automáticamente, organizando en un formato estándar el reclamo, el historial de enfermedades y un plan de tratamiento.

Los resultados son sólidos después de unos 50 pacientes, dijo: “Es el 90% del camino”. Copilot produce resúmenes útiles que Arzubi edita. Los beneficios son significativos: no tiene que preocuparse por tomar notas y, en cambio, puede concentrarse en hablar con los pacientes. Y ahorra tiempo.

“Si tengo un día completo de pacientes, donde podría ver a 15, diría que esto me ahorra una buena hora al final del día”, dijo. (Si la tecnología se adopta ampliamente, espera que los hospitales no aprovechen el tiempo ahorrado simplemente programando más pacientes. “Eso no sería justo”, dijo).

Nabla Copilot no es el único servicio de este tipo; Microsoft está probando el mismo concepto. En la conferencia de abril de la Sociedad de Sistemas de Gestión e Información de Salud, los analistas de inversiones de Evercore destacaron la reducción de la carga administrativa como una de las principales posibilidades para las nuevas tecnologías.

Pero escucharon críticas mixtas: muchos expertos en tecnología y médicos son ambivalentes.

Por ejemplo, si estás desconcertado acerca de un diagnóstico, ingresar los datos del paciente en uno de estos programas “puede proporcionar una segunda opinión, sin duda”, dijo Topol. “Estoy seguro de que los médicos lo están haciendo”. Sin embargo, eso se topa con las limitaciones actuales de la tecnología.

Joshua Tamayo-Sarver, médico y ejecutivo de la startup Inflect Health, alimentó en un sistema escenarios ficticios de pacientes basados en su propia práctica en un departamento de emergencias para ver cómo funcionaba. El sistema no se dio cuenta de afecciones que amenazan la vida, dijo. “Eso parece problemático”.

La tecnología también tiende a “alucinar”, o inventar información que suena convincente.

Los estudios formales han encontrado una amplia gama de rendimiento. Un trabajo de investigación preliminar que examinó ChatGPT y los productos de Google utilizando preguntas de examen abiertas de neurocirugía encontró una tasa de alucinaciones del 2%.

Investigadores de Stanford examinaron la calidad de las respuestas de IA en 64 escenarios clínicos y encontraron citas inventadas el 6% de las veces, dijo el coautor Nigam Shah a KFF Health News. Otro artículo preliminar encontró que, en casos complejos de cardiología, ChatGPT estuvo de acuerdo con la opinión de expertos la mitad de las veces.

La privacidad es otra preocupación. No está claro si la información que se introduce en este tipo de sistema basado en IA no se revelará. Los usuarios emprendedores de ChatGPT, por ejemplo, han logrado que la tecnología les diga la receta del napalm, que se puede usar para fabricar bombas químicas.

En teoría, el sistema tiene “vallas” que impiden que se escape información privada. Por ejemplo, cuando KFF Health News le preguntó a ChatGPT su dirección de correo electrónico, el sistema se negó a divulgarlo.

Pero cuando se le pidió que interpretara a un personaje y se le preguntó sobre la dirección de correo electrónico del autor de este artículo, entregó feliz la información. (De hecho, era la dirección de correo electrónico correcta del autor en 2021, cuando finaliza el archivo de ChatGPT).

“No pondría datos de pacientes”, dijo Shah, científico jefe de datos de Stanford Health Care. “No entendemos qué sucede con estos datos una vez que llegan a los servidores de OpenAI”.

Tina Sui, vocera de OpenAI, le dijo a KFF Health News que uno “nunca debe usar nuestros modelos para brindar servicios de diagnóstico o tratamiento para afecciones médicas graves”. No están “afinados para proporcionar información médica”, dijo.

Con la explosión de nuevas investigaciones, “no creo que la comunidad médica tenga una buena idea de lo que está por suceder”, agregó Topol.

Darius Tahir:
DariusT@kff.org,
@dariustahir

Category: Latest
more info...
Journalists Give Status Reports on the ‘Personhood’ Debate and the HIV Epidemic
Sat, 13 May 2023 19:15:11 +0000

This season’s note-worthy narrative.

KFF Health News Midwest correspondent Bram Sable-Smith discussed personhood laws in Missouri and beyond on “Texas Standard” and KCUR’s “Kansas City Today” on May 11. He discussed the expansion of personhood laws also on KMOX’s “Total Information AM” on May 8.

Click here to hear Sable-Smith on Texas Standard Click here to hear Sable-Smith on “Kansas City Today” Click here to hear Sable-Smith on “Total Information AM” Read Sable-Smith’s “Can a Fetus Be an Employee? States Are Testing the Boundaries of Personhood After ‘Dobbs’”

KFF Health News former senior editor Andy Miller discussed access to HIV testing and treatment on WUGA’s “The Georgia Health Report” on May 5.

Click here to hear Miller on “The Georgia Health Report” Read Miller’s “US Officials Want to End the HIV Epidemic by 2030. Many Stakeholders Think They Won’t.”

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

USE OUR CONTENT

This story can be republished for free (details).

Check out our twitter feed.

F1!! 
Billionaire hot wives

Trading News: https://www.coinblock.asia/2022/02/05/cryptos-could-be-a-speculative-mania-economist-eswar-prasad-says/299818

Exciting Finds: Atheist politician

Stay up to date on China: https://www.chinapulse.com/data-news/2021/05/12/analysis-of-57-thousand-large-companies-globally-the-average-tax-burden-of-google-apple-facebook-and-amazon-is-only-about-60-of-their-peers-nikkei-asia/

Category: Latest
more info...
A Rural County’s Choice: Use Opioid Funds to Pay Off Debt, or Pay Them Forward to Curb Crisis
Tue, 16 May 2023 15:31:27 +0000

Over the past two years, rural Greene County in northeastern Tennessee has collected more than $2.7 million from regional and national settlements with opioid manufacturers and distributors. But instead of helping people harmed by addiction, county officials are finding other ways to spend it.

They have put $2.4 million toward paying off the county’s debt and have directed another $1 million arriving over more than a decade into a capital projects fund. In March, they appropriated $50,000 from that fund to buy a “litter crew vehicle” — a pickup truck to drive inmates to collect trash along county roads.

“It’s astounding,” said Nancy Schneck, a retired nurse who has seen addiction infiltrate the community, where employers avoid drug testing for fear of losing too many employees and mental health crises and homelessness are rampant. She wants to see the money go toward mental health and addiction treatment. Why can’t county leaders “see treating some people and maybe getting them out of this cycle might be advantageous?” she said.

In 2021, the latest year for which comparable data is available, Greene County’s rate of drug overdose deaths topped state and national figures.

But Mayor Kevin Morrison said the county has borne the costs of the opioid epidemic for years: It has funded a beleaguered sheriff’s office, improved the jail — which is packed with people who’ve committed addiction-related crimes — and supported a drug court to divert some people to treatment. It has also suffered indirect costs of the crisis: people dropping out of the workforce due to addiction, schools and welfare services caring for more children who’ve experienced trauma, and some taxpayers leaving the county altogether. Addiction is not the sole reason for Greene County’s economic woes, but it has contributed to more than $30 million of debt.

Greene County, Tennessee, is directing some of its opioid settlement money into the county’s capital projects fund. In March, $50,000 from that fund was appropriated to buy a “litter crew vehicle,” a pickup truck used to drive inmates assigned to collect trash by the side of the road. The new truck is not in use yet but looks just like this white truck, the sheriff’s office says. (Greene County Sheriff’s Office)

“We’ve been dealing with this crisis for quite some time, but nobody wants to pay the bill as it comes,” Morrison said. “So when these funds are made available, then we are paying bills that have been due for quite some time.”

The debate in this Appalachian county is reverberating nationwide as state and local governments receive billions of dollars from companies that made, distributed, or sold opioid painkillers, like Johnson & Johnson, Cardinal Health, and CVS. The companies were accused of fueling the overdose epidemic, and the money is meant to remediate that harm. About $3 billion has already landed in state, county, and city coffers, and about $50 billion more is expected in the coming decade and beyond.

States are required to spend at least 85% of the money on opioid-related programs, but KFF Health News’ ongoing investigation into how the cash is used — and misused — shows there is wide interpretation of that standard and little oversight.

That restriction didn’t apply to the money Greene County moved to its capital projects fund.

In many rural communities, which have been struggling to pay addiction-related costs for decades, local officials justify using the settlement funds to reimburse past expenses. Most of Tennessee’s 95 counties are in significant debt, which can present difficult choices about how to use this money, said Robert Pack, co-director of East Tennessee State University’s Addiction Science Center.

Still, he and many advocates hope the settlement funds are spent on tackling the current crisis. After all, more than 200 people nationwide are dying of overdoses each day. Investing in treatment and prevention can save lives and protect future generations, they say.

“There is no good excuse to sit on the funds or put them into a general fund,” said Tricia Christensen, policy director for the nonprofit Community Education Group. The organization is tracking settlement spending across Appalachia, which Christensen called the epidemic’s ground zero. “These dollars should be used to support people who have been most impacted by the overdose crisis.”


Nationally, there has been little oversight of the settlement dollars. President Joe Biden’s administration pledged to ensure the funds went toward tackling the addiction crisis, but has taken little action. Accountability at the state level varies.

In Tennessee, 15% of the state’s opioid settlement funds are controlled by the legislature and another 15% by local governments. Those two buckets have few restrictions.

The other 70% is controlled by an Opioid Abatement Council, which has more rigorous standards. When the council, which must give 35% of its funds to local governments, recently distributed more than $31 million to counties, it required the funds be spent on a list of approved interventions, such as building recovery housing and increasing addiction treatment for uninsured people.

“I can guarantee we’re going to bird-dog” those funds, said Stephen Loyd, chair of the council and a physician in recovery from opioid addiction. If counties use them for unapproved purposes, the counties will not receive future payouts, he said.

Greene County’s reimbursement of its capital projects fund comes from its own pot — the 15% that is controlled entirely by local governments.

In such cases, the public can hold officials accountable, Loyd said. “If you don’t like the way the money is being spent, you have the ability to vote.”

Local leaders are generally not being “nefarious” with these decisions, he said. They make hundreds of budgetary choices a month and simply don’t have experience with addiction or health policy to guide them in using the money.

Loyd and other local experts are trying to fill that gap. He meets with county officials and recommends they speak with their local anti-drug coalitions or hold listening sessions to hear from community members. Pack, from East Tennessee State, urges them to increase access to medications that have proven effective in treating opioid addiction.

Both men point counties to an online recovery ecosystem index, where leaders can see how their area’s resources for recovery compare with those of others.

In Greene County, for example, the index indicates there are no recovery residences and the number of treatment facilities and mental health providers per 100,000 residents is below state and national averages.

“That’s a great place to get started,” Loyd said.

Some Greene County residents want to see opioid settlement funds go to local initiatives that are already operating on the ground. The Greene County Anti-Drug Coalition, for instance, hosts presentations to educate young people and their parents on the risks of drug use. They meet with convenience store owners to reinforce the importance of not selling alcohol, cigarettes, or vaping devices to minors. In the future, the coalition hopes to offer classes on life skills, such as how to budget and make decisions under pressure.

“If we can do prevention work with kids, we can change the trajectory of their lives as adults,” said Wendy Peay, secretary of the anti-drug coalition and executive director of United Way of Greene County.

The coalition has asked the county for settlement funds but has not received any yet.

Nine people and a dog stand in front of a building and two police vehicles. Some of the people hold a banner that reads "Greene County Anti-Drug Coalition". The Greene County Anti-Drug Coalition gives presentations at local schools and community events to educate youth and their parents on the risks of drug use. Despite asking, as of April 2023, the coalition had not received any opioid settlement funds from the county. (Wendy Peay/Greene County Anti-Drug Coalition)
A woman a black and white top with dark pants and sneakers stands on the limbs of a tree. Greene County, Tennessee, resident Nancy Schneck wants opioid settlement funds to be used for addiction and mental health treatment. She says “it’s astounding” that most of the money so far has gone to repaying county debt. (Paul Ferrari)

Nearby in Carter County, a new residential treatment facility is taking shape at the site of a former prison. At least seven counties, cities, and towns in the region have committed a combined $10 million in opioid settlement funds to support it, said Stacy Street, a criminal court judge who came up with the idea. Greene County is among the few local governments that did not contribute.

It will be part of the region’s drug recovery court system, in which people with addiction who have committed crimes are diverted to intensive treatment instead of prison.

Currently there are no long-term residential facilities in the area for such patients, Street said. Too often, people in his court receive treatment during the day but return home at night to “the same sandbox, playing with the same sand-mates,” increasing their risk of relapse.

Street said the new facility will not offer medications to treat opioid addiction — the gold standard of medical care — because of security concerns. But some patients may be taken to receive them off campus.

Morrison, the Greene County mayor, said he worried about contributing to the facility because it is a recurring cost and the settlement funds will stop flowing in 2038.

“There’s been great pressure put on local entities like Greene County to try to solve this problem with this limited amount of funding,” he said, when “the federal government, which has the ability to print money to solve these problems, is not in this business.”

The county is still deciding how to spend nearly $334,000 of settlement funds it recently received from the state’s Opioid Abatement Council. Morrison said they’re considering using it for the anti-drug coalition’s education efforts and the county drug court. Given the guidelines from the abatement council, these funds can’t be used to pay old debts.

Aneri Pattani:
apattani@kff.org,
@aneripattani

Category: Latest
more info...
PBMs, the Brokers Who Control Drug Prices, Finally Get Washington’s Attention
Thu, 11 May 2023 14:43:43 +0000

For two decades, patients and physicians eagerly awaited a lower-cost version of the world’s bestselling drug, Humira, while its maker, AbbVie, fought off potential competitors by building a wall of more than 250 patents around it.

When the first Humira biosimilar — essentially a generic version — finally hit the market in January, it came with an unpleasant surprise. The biosimilar’s maker, Amgen, launched two versions of the drug, which treats a host of conditions including rheumatoid arthritis. They were identical in every way but this: One was priced at about $1,600 for a two-week supply, 55% off Humira’s list price. But the other was priced at around $3,300, only about 5% off. And OptumRx, one of three powerhouse brokers that determine which drugs Americans get, recommended option No. 2: the more expensive version.

As Murdo Gordon, an Amgen executive vice president, explained in an earnings call, the higher price enabled his company to give bigger rebates, or post-sale discounts, to Optum and other intermediaries. Most of that money would be passed on to insurers, and patients, he said. Gordon did not mention that the higher-priced option would leave some patients paying much more out-of-pocket, undermining the whole rationale for generic drugs.

The Optum-Amgen announcements perfectly elucidated why, after years of thundering against drugmakers, Congress and the administration have now focused on regulating the deal-makers known as pharmacy benefit managers, or PBMs. Sen. Bernie Sanders’ health committee grilled a panel of PBM and pharmaceutical executives Wednesday in preparation for a vote on PBM legislation, expected Thursday.

The three biggest PBMs — OptumRx, CVS Caremark, and Express Scripts — control about 80% of prescription drug sales in America and are the most profitable parts of the health conglomerates in which they’re nestled. CVS Health, the fourth-largest U.S. corporation by revenue on Fortune’s list, owns CVS Caremark and the insurer Aetna; UnitedHealth Group, a close fifth, owns Optum; and Cigna, ranking 12th, owns Express Scripts. While serving as middlemen among drugmakers, insurers, and pharmacies, the three corporations also own the highest-grossing specialty drug and mail-order pharmacies.

“John D. Rockefeller would be happy to be alive today,” said David Balto, a former Federal Trade Commission attorney who represents clients suing PBMs. “He could own a PBM and monopolize economic power in ways he never imagined.”

Drug manufacturers claim that exorbitant PBM demands for rebates force them to set high list prices to earn a profit. Independent pharmacists say PBMs are driving them out of business. Physicians blame them for unpredictable, clinically invalid prescribing decisions. And patients complain that PBMs’ choices drain their pocketbooks.

With PBMs driving prices, competition has had the opposite effect from what economic theory predicted Medicare patients would spend out-of-pocket on drugs, one large study showed. Over a five-year period, patients were paying 50% more for branded drugs that had competitors than for those that didn’t.

All this makes the PBMs ripe targets for politicians of both parties. Yet the complexity and obscurity of their role in the drug marketplace have skeptics wondering whether legislation advancing in the House and Senate will actually help patients or lower prices at the pharmacy counter.

“We may try to make things better and actually make things worse,” Sen. Rand Paul (R-Ky.) said at Wednesday’s hearing.

The PBMs pass along most of their rebates to health plans, which will bear a larger share of patient drug costs in coming years under Medicare changes that are part of the 2022 Inflation Reduction Act. It’s likely that pressure on insurers will be passed along to PBMs and result in even more aggressive limits on physician prescription decisions, said Troyen Brennan, an adjunct Harvard University professor who was chief medical officer for CVS Health from 2008 to 2022.

Several congressional bills target drug company rebates to PBMs and what’s known as “spread pricing” — the extra money PBMs collect from insurers over what they pay pharmacies for drugs.

But those aren’t the big PBM revenue sources anymore, Brennan said. PBMs today mostly make money by owning mail-order and specialty pharmacies and from the government’s 340B program, created to help hospitals that treat a disproportionately elderly and poor population. Medicare requires drugmakers to provide big discounts to participating hospitals and the growing rosters of affiliated physician groups they own, and some of those discounts end up with PBMs.

Employers and the federal government decide where most of the rebate money goes, PBM leaders testified Wednesday — and health plans decide what out-of-pocket costs their covered members will pay.

In other words, drug companies blame PBMs for high drug counter prices, PBMs blame insurers, and insurers blame the drug companies, all part of a health care system that hinges on an unspoken bargain: Make life comfortable for some — mostly the upper and middle classes — at the expense of lower-income and poorly insured people who get what they get.


 PBMs’ extraction of money from patients in the name of “copayments” at the pharmacy counter “reintroduces medical underwriting” that was stripped away by the Affordable Care Act, Craig Garthwaite, a health care researcher at Northwestern’s Kellogg School of Management, told a Senate panel last year. Insurers can no longer pick and choose whom to insure, as they could before the landmark 2010 health law. But they are finding ways to make the sickest pay.

“People with expensive conditions are paying more for insurance so healthy people can pay less,” he said.

PBMs Evolve From Minnows to Whales

In 1967, a year before the first PBM was founded, spending on prescription drugs outside of a hospital in the U.S. totaled around $3.3 billion, compared with more than $600 billion in net payments last year. By 2005, when Medicare expanded to include coverage of outpatient drugs, government and private insurers depended on PBMs’ negotiating power to keep rising drug prices in check.

The Federal Trade Commission and Justice Department allowed the largest PBMs to gobble up competitors and merge with insurers during the Bush and Obama administrations on the grounds that bolstering their powers might rein in prices. The FTC fought state investigations of anti-competitive behavior, saying that pressure on PBMs would benefit consumers.

The FTC under President Joe Biden has switched course, at least partly because of the arrival of Chair Lina Khan, a vigorous proponent of antitrust policy who launched an investigation of the PBMs last June.

It came partly at the request of independent pharmacists, who rely on PBM reimbursements for the drugs they purchase and provide consumers. Thousands of pharmacists complained to the FTC that PBMs force them to accept unfairly low reimbursements — then slam them with opaque rules requiring them to pay back some of the money months later. Pharmacists returned $12.6 billion to PBMs in 2021, according to a recent Medicare Payment Advisory Commission report.

During a recent week, said Ashley Seyfarth, who owns Kare Drug in Aztec, New Mexico, a PBM reclaimed money from one prescription because the paperwork was faxed. It clawed back cash from another sale because Kare had kept the drug on the shelf an extra day, beyond the PBM’s time limit, to accommodate a patient delayed getting to the store.

And her reimbursements are “beyond low,” Seyfarth said. She laughed when asked whether contract terms with the PBMs were negotiable. “You aren’t negotiating anything,” she said. “It’s take it or leave it.”

PBMs “have the right to audit whether contract terms are agreed to,” Angela Banks, vice president of policy at the Pharmaceutical Care Management Association, the PBM trade group, said at a recent conference. “A lot of the complaints about PBMs come from two parties from whom we are extracting money: manufacturers and pharmacists.”

PBM pricing decisions are often murky. According to a recent study, in 2018 Medicare spent $2.6 billion more through PBMs for a year’s worth of 184 generic drugs than they would have cost at Costco. Doctors and hospitals find PBM formularies baffling, with dozens of variations depending on a patient’s health plan.

When Philadelphia-area internist Amy Davis writes a prescription, she has no idea what the pharmacy will bill her patients, she said, or whether a PBM has decided the drug needs prior authorization. Sometimes she doesn’t find out until a patient returns months later saying they skipped the drug because it was too expensive.

“We physicians are completely in the dark,” she said. “And it’s designed that way.”

The PBMs’ growing use of proprietary pharmacies, including mail-order operations, can interfere with the care of patients like Jasmine St. Clair, a 45-year-old restaurant manager and mother of six in Mount Juliet, Tennessee.

In October 2021, St. Clair’s treatment for a rare, non-smoking-related lung cancer was delayed three weeks after PBM giant Express Scripts insisted her prescription be filled by Accredo, the mail-order pharmacy it owns.

In the meantime, her fatigue and lower-back and neck pain became so bad “I couldn’t pick up my daughter, who was 2,” St. Clair said. “And I was really getting scared.”

After St. Clair started the four-pills-twice-a-day regimen, her tumor rapidly shrank. But in January, her husband’s insurance changed and the medications didn’t arrive on time. When she called Accredo to see what was wrong, “they said, ‘You owe $8,000. Would you like to pay by card?’”

The pharmacy attached to her oncology practice straightened out the payment issue and ensured her continued use of the drug, St. Clair said. Her oncologist, Johnetta Blakely, said these are daily occurrences in her practice.

“The problem with the PBMs and the specialty pharmacies they own is that they are so complicated and intertwined it’s hard to figure out what the heck they are doing,” Blakely said. “All this bureaucratic stuff is a distraction and takes away from things I could be doing, like asking Jasmine about her kids.”

What’s the Remedy?

Bipartisan House and Senate bills would require PBMs to reimburse pharmacies serving Medicaid patients based on an authorized price list, rather than using standards that allegedly allow PBMs to lowball pharmacies. The Congressional Budget Office has estimated the bills would save the federal government $1 billion over 10 years. Another Senate bill would require PBMs to report more of their earnings to the FTC, and would ban deceptive and unfair fees.

But PBMs have shown themselves adept at finding ways around regulation. A federal rule scheduled to take effect next year would curtail PBM “clawbacks” on independent pharmacies. But PBM contracts sent out to pharmacies in recent weeks get around that by lowering reimbursement fees and putting a percentage of their payments to pharmacies into a kind of escrow, said Douglas Hoey, CEO of the National Community Pharmacists Association.

When the Trump administration considered banning brand-name drug rebates in 2017, PBMs set up companies in Ireland and Switzerland to take over the negotiations and purchases. Doing so offered a tax advantage and allowed the PBMs to avoid scrutiny of the quantity and nature of those deals. Recently, Express Scripts set up another company to purchase generic drugs, in the Cayman Islands.

And PBMs appear adept at moving money from one pocket to another. “Yesterday’s rebates are today’s fees and potentially tomorrow’s something else,” said John O’Brien, CEO of the pharmaceutical industry-funded research group, the National Pharmaceutical Council.

Every arrangement that PBMs make with manufacturers, employers, and insurers is secret and proprietary, said Barak Richman, a Duke University Law School professor. This makes it nearly impossible to examine what kind of deals PBMs are making.

Antitrust law could be brought to bear on the PBMs, Richman said. And the Biden administration has shown an eagerness to possibly reverse mergers that have increased PBM clout. The Justice Department has taken similar steps.

But federal officials will have to move fast to slow the PBMs. Insurers that don’t have PBMs as part of their business have been shrinking in recent years because of the growing clout and buying power of the companies.

“I predict that any health insurer that doesn’t have a PBM is going to disappear in 10 years,” said Neeraj Sood, a professor at the University of Southern California Sol Price School of Public Policy. “Otherwise, there is no way to compete with the big three.”

Arthur Allen:
ArthurA@kff.org,
@ArthurAllen202

Category: Latest
more info...
ER Doctors Vow to Pursue Case Against Envision Even in Bankruptcy
Sat, 13 May 2023 02:15:10 +0000

If Envision Healthcare files for bankruptcy, a group of emergency room doctors would seek permission to continue their federal lawsuit that claims the private equity-backed company is violating California’s ban on corporate control of medical practices.

“I anticipate that we would ask the bankruptcy judge to let our case proceed,” said David Millstein, an attorney representing the Milwaukee-based American Academy of Emergency Medicine Physician Group. “Among other things, Envision’s practices violate the law, are continuing, and need to be addressed.”

Still, the future of the lawsuit is uncertain since it’s unclear how a judge might rule.

On May 9, The Wall Street Journal reported that Envision planned to file for Chapter 11 bankruptcy protection, possibly as early as this weekend. That would allow the company, based in Nashville, Tennessee, to reduce its debt while reorganizing its business. The Journal said Envision failed to report quarterly financial results by a March 31 deadline and missed an interest payment in April.

Envision spokesperson Aliese Polk declined to comment.

The emergency doctors’ lawsuit does not ask for monetary damages, so the Milwaukee group would presumably not have a financial claim against Envision. Instead, the doctors are seeking a declaration by the court that the company’s alleged use of shell business structures to retain de facto ownership of ER staffing groups is illegal. A trial in San Francisco had been scheduled to start next January, but the date has been pushed back.

The doctors believe that a victory in their case would lead to a ban on that business strategy across California — not just in ERs run by Envision but also by TeamHealth, another private equity-owned medical staffing firm, and in other medical services the two companies provide, including anesthesiology, hospital-based medicine, and gynecology.

Many doctors, nurses, consumer advocates, and even some lawmakers, hope a legal victory would spur prosecutors and regulators in other states to take the issue of medical practices controlled by corporations more seriously.

Envision runs 467 emergency departments across the country and TeamHealth operates 511, according to Ivy Clinicians, a startup job search website for emergency physicians. Together, the two companies control more than 17% of emergency departments, the data shows.

Envision was acquired by the investment firm KKR in 2018 for $9.9 billion, making it the largest private equity deal in health care during that decade. The deal saddled Envision with about $7 billion in debt. Last September, analysts at S&P Global Ratings estimated that the company’s debt was 29 times its earnings in 2022, a staggeringly high figure that raised alarms about its ability to pay its obligations.

At the same time, Envision’s revenue picture has deteriorated. The federal No Surprises Act, which protects patients from unexpected bills sent by out-of-network providers, sapped a key source of revenue. The pandemic shrank patient volumes, and burnout among health care workers fueled staffing shortages that have jacked up labor costs. A fierce battle with insurance giant UnitedHealthcare over payments for patient care also hit Envision.

“The financial profile of the company is just not strong enough to manage the debt they have on the balance sheet, and I think that’s really what the bottom line is,” said David Peknay, a director at S&P Global Ratings.

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

Bernard J. Wolfson:
bwolfson@kff.org,
@bjwolfson

Category: Latest
more info...
‘A System in Crisis’: Dysfunctional Federal Disability Programs Force the Poor to Pass Up Money
Fri, 12 May 2023 14:02:30 +0000

Brenda Powell had suffered a stroke and was in debilitating pain when she called the Social Security Administration last year to seek disability benefits.

The former Louisiana state office worker struggled at times to write her name or carry a glass of water. Powell, then 62, believed she could no longer work, and she was worried about how to pay for medical care with only a $433 monthly pension.

Although the Social Security Administration agreed that Powell’s condition limited the work she could do, the agency rejected her initial application for Supplemental Security Income. She had the choice to appeal that decision, which could take months or years to resolve, or take early retirement. The latter option would give her $302 a month now but might permanently reduce the full Social Security retirement payment she would be eligible for at age 66 and 10 months.

“I didn’t know what to do. These decisions are not easy,” said Powell, who lives in Alexandria, Louisiana, about 200 miles northwest of New Orleans. She decided to appeal the decision but take early retirement in the meantime.

“I had to have more money to pay my bills,” she said. “I had nothing left over for gas.”

Every year, tens of thousands of people who are disabled and unable to work consider taking early retirement benefits from Social Security. The underfunded federal disability system acknowledges that it is stymied by delays and dysfunction, even as over 1 million people await a decision on their benefits application.

The United States, which has one of the least generous disability programs among developed Western nations, denies most initial claims, leaving applicants to endure a lengthy appeals process.

At the same time, Social Security agents may neglect to explain the financial downside of taking retirement benefits too early, said attorneys who help patients file disability claims. The result is a growing population of vulnerable people who feel stuck between a proverbial rock and a hard place — to live with little money while they wait it out or agree to a significantly lower payment for the rest of their lives.

“They don’t have the luxury of waiting,” said Charles T. Hall, a disability attorney based in Raleigh, North Carolina. “The vast majority of people need the money now, and you can get early retirement benefits in two months or less.”

In a nation where more than a quarter of residents have a disability, Social Security Disability Insurance and Supplemental Security Income programs are intended to provide financial help to people who cannot work.

Retirement experts generally recommend senior citizens tap into their Social Security benefits as late as they can, to maximize the amount of money they receive from the federal government. For someone born after 1960, taking benefits at age 62 — the earliest age people are eligible — instead of 67 reduces each monthly payment by as much as 30% for the rest of a person’s life, said Richard Johnson, a senior fellow and the director of the Program on Retirement Policy at the Urban Institute, a nonprofit research organization.

Someone who applies for Supplemental Security Income, or early retirement, would get $914 a month if they can prove they are older than 65, blind, or have a disabling medical condition. Social Security Disability Insurance pays an average monthly benefit of $1,483 to those who suffered a disabling injury or illness and paid a federal tax that was deducted from their paychecks in the past.

Social Security agents will inform people of their ability to obtain early retirement benefits. But they might not explain the downsides, said Sam Byker, CEO and founder of Atticus, a California-based group that connects people seeking disability benefits with attorneys around the country. His organization found that among a sample of 765 clients ages 62-66 seeking Social Security Disability Insurance, 44% were already receiving early retirement.

Disability takes too long, and the decision about who gets approved can seem arbitrary, Byker said. “It cannot be counted on,” he said.

An initial decision on an application for disability benefits can take an average of over seven months, according to a March letter signed by more than 100 members of Congress.

Most callers to the Social Security Administration are unable to reach an agent, and people seeking local field office assistance with an application can wait at least a month for an appointment, the letter said.

More than 1,200 Social Security Administration field offices exist across the country, like this one in Charlotte, North Carolina. People seeking assistance with disability applications can wait at least a month for an appointment. (Fred Clasen-Kelly / KFF Health News)
A sign at a Social Security Administration field office in Charlotte, North Carolina, encourages visitors to consider calling the agency for assistance if they don’t have an appointment. Most callers to the agency are unable to reach an agent, federal lawmakers say. (Fred Clasen-Kelly / KFF Health News)

Earlier this year, acting Social Security Commissioner Kilolo Kijakazi warned in a letter to congressional leaders that months-long delays in processing disability applications and phone assistance are likely to worsen in 2023, even as officials vow to improve service over time.

In a written statement, Social Security Administration spokesperson Darren Lutz acknowledged that wait times are “far too long,” citing inconsistent and insufficient funding, staffing shortages, and other challenges. The agency refused to make officials available for a phone call to discuss the issue in more detail.

Caught in the tangle of dysfunction are disabled people with little or no income, who often take early retirement because they are struggling to pay for basics like housing, food, and medicine. In some cases, people end up homeless or die waiting for their disability benefits, lawyers told KFF Health News.

The problems can hit especially hard in the South and Appalachia, since those regions tend to have an older workforce than most other parts of the country, more workers in manufacturing, and people with lower educational attainment who tend to rely more on disability benefits.

“It is a system in crisis,” said Ida Comerford, a managing partner for the Kenneth Hiller law firm, which handles disability cases in New York, Michigan, and Illinois. “This is not going to cut it. It is the worst I’ve ever seen it.”

The Social Security Administration said its workers are required to notify applicants about all the benefits they could receive and provide enough details for them to make an informed decision.

For someone who has no income and no ability to cover their expenses, it might make sense to take early retirement benefits, said Kurt Czarnowski, a former Social Security Administration regional communications director who now works as a retirement consultant.

If a person has a medical condition that suggests a shorter life span, Czarnowski said, it is probably wise to consider taking the smaller payments now instead of waiting for bigger checks later.

But there is a huge financial advantage for those who can wait, Czarnowski said.

People born after 1960 can collect full retirement benefits at age 67. In addition, each year they wait to collect Social Security between ages 67 and 70, their monthly check increases by 8%.

“Ultimately, it is a longevity decision,” Czarnowski said.

Hall also said he advises certain clients to take early retirement benefits while applying for disability. If the person wins their disability case, they can still collect full retirement benefits instead of the reduced amount, he said.

But Byker, of Atticus, said that strategy comes with risk. Most applicants need an attorney to help obtain disability through the lengthy appeals process. But lawyers are less likely to take a client who is already receiving early retirement benefits because that scenario significantly reduces the amount of money they can make on a case, he said.

More than 60% of applications for Supplemental Security Income are rejected, according to the Center on Budget and Policy Priorities, a nonprofit research organization. About two-thirds of applications for Social Security Disability Insurance are denied, the group says.

Six months after she applied, the Social Security Administration notified Powell in a February letter that her Supplemental Security Income claim had been denied. The letter said that while medical evidence shows her condition limits her ability to hold a job, she can do work in keeping with her skills as a finance assistant.

Lutz, the Social Security spokesperson, said in a written statement that privacy laws preclude the agency from answering questions about Powell’s case. Lutz said the agency uses a “stringent definition of disability.”

Powell has hired an attorney and filed an appeal, but she doesn’t know when the case will be resolved.

“I don’t want to say ‘poor, poor me,’” Powell said. “It has not been easy. I don’t wish this on nobody.”

Fred Clasen-Kelly:
fredck@kff.org,
@fred_ckelly

Category: Latest
more info...
Michael Milken Wants to Speed Up Cures
Tue, 16 May 2023 13:14:33 +0000

Years ago, a top chemical biologist pondered ditching his cancer research to take a more lucrative commission growing healthier apples. Michael Milken stopped him.

“I told him we could probably eat the same apples for the next 20 years and be OK, but we wouldn’t be OK if he didn’t continue his potential groundbreaking work,” Milken, 76, said. “Then we funded him.”

Driven by a family history of disease and his own experience with prostate cancer, Milken, the onetime junk-bond wizard whose spectacular downfall on securities charges led to a 22-month prison term in the 1990s, has spent the last three decades trying to advance medical science so that people “can find cures to life-threatening diseases within their own lifetimes.”

In “Faster Cures,” a book that is part memoir and part medical history, the financier-turned-philanthropist argues for applying business principles to foster quicker medical breakthroughs: more collaboration and information-sharing among researchers, a more streamlined path through government regulations, and more public and private funding to keep the best and brightest working in the field. The book was written with Geoffrey Evans Moore, a longtime associate of Milken’s.

Milken, whose net worth is estimated at $6 billion, has donated $1.2 billion to medical research and public health causes and raised another $1 billion for them from donors, according to a spokesperson. Much of that money is distributed through the Santa Monica-based Milken Institute, which funds organizations around the world that support research and education.

This interview has been edited for length and clarity.

Q: Was it difficult to write about your father’s death from cancer and your own diagnosis of advanced prostate cancer in 1993, which was thought at the time to be terminal?

Life-threatening diseases are not separated by wealth or anything else. One in 2 men are going to get diagnosed with cancer in their lifetime; for women, it’s 1 in 3. In the hospital room or in surgery, we’re all equal. That’s why I wanted to personalize it because my family is no different. In the 1970s, science could not move fast enough to save my father’s life.

Q: Is the U.S. too slow in reaching cures?

A train today in Europe or Asia can travel at 200 miles an hour, but the average train in the U.S. travels at the same speed as 100 years ago because you can’t put faster trains on tracks that aren’t more modern. Science is this train that’s moving fast, but the tracks are 20th-century tracks. As science moves quickly — sequencing your genome and your microbiome, for example — many of the ways we deal with our health system still relate to what it was in the 1900s, not in this century.

Q: What are those outdated practices?

One is collaboration. Thirty years ago, after my diagnosis, I attended a prostate cancer conference at MD Anderson Cancer Center in Houston, and I noticed that no one from Memorial Sloan Kettering [in New York City] was presenting, and they were the other recognized top experts in the field. When I asked why, I was told by MD Anderson’s people that they felt Sloan Kettering was a competitor. I said, “They’re not a competitor to patients.” We’ve done a huge amount of work in that area to get researchers and scientists sharing information and working together.

Q: Are cancer patients getting into clinical trials at earlier stages?

Yes, but there’s another element here relating to health equity. The demographics of America have changed considerably. Sixty years ago, 75% of everyone living in the U.S. who was not born here came from Europe. Today, more than 70% of everybody living here who wasn’t born here came from Latin America or Asia, but our clinical trials are still largely Caucasian. We’re not including people who will someday make up the majority of people in this country.

Q: You also spend a lot of time writing about prevention, especially as it pertains to diet. Why?

If you went to medical school in China 30 or 40 years ago, you wouldn’t have even studied diabetes because it was so rare there. Today, because of changes in the food chain and what they’re eating — meat-based and fat-based diets — China has the most people with diabetes of any country in the world. That’s what thousands of McDonald’s and KFC and other franchises will do. We also know that eating certain foods can slow the growth of certain kinds of cancers, or that changing your diet can accelerate the growth. The CEO of one of the largest medical research companies in the world told me, “The next great drug is going to be prevention.”

Q: But isn’t the medical industry oriented toward selling treatment and not prevention?

When we proposed the idea to the medical community in the ’90s that you are what you eat, they said, “Prove it.” And we didn’t sequence the genome until 2003, so prior to that the evidence was mostly anecdotal, but there was plenty of it. The notion is mainstream today, but teaching doctors that nutrition makes a difference is still a minor, minor part of medical school. It should be at the forefront. We often refer to the produce section of the grocery store as the pharmacy of the 21st century.

Q: Your financial theories revolved around finding lower-graded bonds that produced great returns — essentially, identifying an undervalued segment of the market. Is there an undervalued equivalent in medicine or science?

It’s about the democratization of capital. In medicine and science, access to financial capital serves as a multiplier effect, but the largest asset is human capital. I’ve spent considerable time trying to identify the future Ted Turners or [telecommunications giant] John Malones of the world of medicine, then convincing them to go into research and funding them.

Q: How do you provide financing to the most talented people in the field?

That includes private and public funding. In 1998, we organized a march on Washington, and a few months later President Clinton signed into law a massive increase in the NIH [National Institutes of Health] budget. Since then, there’s been an incremental half a trillion dollars invested into the NIH, and that has made all the difference for so many organizations working on specific diseases or types of cancer.

Q: Why do you fund medical research?

My interest in medicine and science started when I was 8 years old. It accelerated in the ’70s when my wife’s mother was diagnosed with breast cancer and my father’s melanoma returned. That began a search for medical solutions that I brought into my existing philanthropy in 1982. Who a person is and what they believe in — there has always been a lot of misinformation out there, and it’s only going to get worse with artificial intelligence chat. It’s not just related to me. But I think the thousands of companies that we financed, and the millions of jobs created, are evidence that the ideas I put forth are today in the mainstream. All of the facts are there for one to see.

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

Mark Kreidler:

@MarkKreidler

Category: Latest
more info...
Marihuana legal es más potente que nunca pero no está bien regulada
Thu, 11 May 2023 18:48:47 +0000

La marihuana y otros productos que contienen THC, el principal ingrediente psicoactivo de la planta, se han vuelto más potentes y peligrosos a medida que la legalización los ha vuelto más accesibles.

Décadas atrás, el contenido de THC de la hierba solía ser inferior al 1,5%. Hoy, algunos productos tienen más de un 90%.

La euforia de antaño ha dado paso a algo más alarmante. Cientos de miles de personas llegan a salas de emergencias por crisis relacionadas con la marihuana, y millones sufren trastornos psicológicos vinculados al consumo de cannabis, según investigaciones federales.

Pero los organismos reguladores no están a la altura.

En los estados que permiten la venta y el consumo de la marihuana y sus derivados, la protección al consumidor no es consistente.

“En muchos estados, los productos tienen una etiqueta de advertencia y poco más por parte de las entidades reguladoras”, dijo Cassin Coleman, vicepresidente del comité de asesoramiento científico de la Asociación Nacional de la Industria del Cannabis.

En general, el gobierno federal no ha intervenido. Sigue prohibiendo la marihuana como sustancia catalogada en la Lista 1 —como droga sin uso médico aceptado y con un alto riesgo de abuso— en virtud de la Ley de Sustancias Controladas (CSA). Pero en lo que respecta a la venta de cannabis, que muchos estados han legalizado, no regula características como la pureza o la potencia.

La Administración de Drogas y Alimentos (FDA) “básicamente se ha cruzado de brazos y no ha cumplido con su deber de proteger la salud pública”, afirmó Eric Lindblom, de la Facultad de Derecho de la Universidad de Georgetown que anteriormente trabajó en el Centro para Productos del Tabaco de la FDA.

La marihuana se ha transformado profundamente desde que generaciones de estadounidenses la usaron por primera vez.

El cannabis se cultiva para suministrar dosis mucho más altas de THC. En 1980, el contenido de THC de la marihuana confiscada era inferior al 1,5%. Hoy en día, muchas variedades de flores de cannabis —la materia vegetal que se puede fumar en un porro— tienen más de un 30% de THC.

Recientemente, en un dispensario de California el menú incluía una variedad con un 41% de THC.

La legalización también ha abierto la puerta a productos que se extraen de la marihuana pero que no siquiera parecidos: concentrados de THC aceitosos, cerosos o cristalinos que se calientan e inhalan mediante el vapeo o el dab, utilizando dispositivos parecidos a un soplete.

Los concentrados actuales pueden tener más de un 90% de THC. Algunos se anuncian como THC casi puro.

Pocos personifican la expansión de la marihuana de forma tan clara como John Boehner, ex presidente de la Cámara de Representantes de Estados Unidos. El republicano de Ohio se opuso durante mucho tiempo a la marihuana y, en 2011, se declaró “inalterablemente contrario” a su legalización.

Ahora forma parte del consejo directivo de Acreage Holdings, un productor de derivados de la marihuana.

A photo of a man holding an amber sheet of crystallized THC concentrate in gloved hands up to the light. Una lámina de una forma concentrada de THC, recién sacada del horno. (Brennan Linsley / AP)
A photo of a glass container filled with liquid marijuana concentrate. THC se conserva en un recipiente de vidrio luego de ser extraído para su uso en productos de vapeo y alimentos. (Erin Clark / The Boston Globe via Getty Images)

Y Acreage Holdings ilustra la evolución del sector. Su marca Superflux comercializa un producto para vapear —”resina pura en un formato cómodo e instantáneo”— y concentrados como “budder”, “sugar”, “shatter” y “wax”. La empresa anuncia su concentrado de “THCa cristalino” como “lo último en potencia”.

Según el Instituto Nacional sobre el Abuso de Drogas, las concentraciones más elevadas entrañan mayores riesgos. “Los riesgos de dependencia física y adicción aumentan con la exposición a altas concentraciones de THC, y las dosis más altas de THC tienen más probabilidades de producir ansiedad, agitación, paranoia y psicosis”, se explica en su sitio web.

En 2021, 16,3 millones de personas en Estados Unidos —el 5,8% de las personas de 12 años en adelante— habían sufrido un trastorno por consumo de marihuana en el último año, según una encuesta publicada en enero por el Departamento de Salud y Servicios Humanos (HHS).

Esta cifra es muy superior a la suma de los trastornos por consumo de cocaína, heroína, metanfetamina, estimulantes de venta bajo receta, como Adderall, o analgésicos recetados, como fentanilo y OxyContin.

Otras drogas son más peligrosas que la marihuana, y la mayoría de las personas afectadas por su consumo padecieron un caso leve. Pero aproximadamente 1 de cada 7 —más de 2,6 millones de personas— padecieron un caso grave, según la encuesta federal.

La mayoría de los médicos equiparan el término “trastorno grave por consumo de sustancias” con la adicción, señaló Wilson Compton, subdirector del Instituto Nacional sobre el Abuso de Drogas.

El trastorno por consumo de cannabis “puede ser devastador”, afirmó Smita Das, psiquiatra de Stanford y presidenta de un consejo sobre adicciones de la Asociación Americana de Psiquiatría.

Das dijo que ha visto vidas destrozadas por el cannabis: personas de éxito que han perdido familias y trabajos. “Se encuentran en una situación en la que no saben cómo han llegado, porque sólo era un porro, sólo era cannabis, y no se suponía que el cannabis les creara adicción”, explicó Das.

Entre los diagnósticos médicos atribuidos a la marihuana figuran la “dependencia del cannabis con trastorno psicótico con delirios” y el síndrome de hiperémesis cannabinoide, una forma de vómito persistente.

Se estima que unas 800,000 personas realizaron visitas a emergencias relacionadas con la marihuana en 2021, según un estudio del gobierno publicado en diciembre de 2022.

Derecho a desintoxicación.

Un padre de Colorado pensó que era cuestión de tiempo para que el cannabis matara a su hijo.

En la primavera de 2021, el adolescente pasó un semáforo en rojo, chocó contra otro auto —resultando heridos él y el otro conductor— y huyó del lugar, según recordó el padre en una entrevista.

En los restos del accidente, el padre encontró porros, envases vacíos de un concentrado de THC de alta potencia conocido como “wax” y un vaporizador de THC.

En el teléfono móvil de su hijo descubrió mensajes de texto y decenas de referencias al “dabbing” y a la hierba. El adolescente dijo que había estado fumando antes del accidente y que intentó suicidarse.

Semanas después, la policía ordenó su ingreso involuntario en un hospital para una evaluación psiquiátrica. Según un informe policial, creía que lo perseguían francotiradores de un cártel de drogas.

El médico que evaluó al adolescente le diagnosticó “abuso de cannabis”.

“Deja de consumir dabs o wax, ya que pueden volverte extremadamente paranoico”, escribió el médico. “Vete directamente al programa de desintoxicación que elijas”.

Según el relato del padre, en los dos últimos años el adolescente sufrió varias retenciones involuntarias, docenas de encuentros con la policía, repetidos encarcelamientos y una serie de estadías en centros de tratamiento hospitalario.

A veces parecía fuera de la realidad, y enviaba mensajes de texto diciendo que Dios le hablaba y le daba superpoderes.


Los daños también fueron económicos. Los reclamos al seguro médico por su tratamiento ascendieron a casi $600,000 y los gastos de la familia llegaron a casi $40,000 hasta febrero.

En las entrevistas para este artículo, el padre habló bajo condición de anonimato para no perjudicar la recuperación de su hijo.

Está convencido de que la enfermedad mental de su hijo fue el resultado del consumo de drogas. Dijo que los síntomas remitían cuando su hijo dejaba de consumir THC y volvían cuando usaba de nuevo.

Su hijo tiene ahora 20 años, ha dejado la marihuana y le va bien, dijo el padre, y añadió: “No me cabe la menor duda de que el consumo de cannabis fue lo que le causó la psicosis, los delirios y la paranoia”.

Regulación estatal desigual

Ahora, el uso médico de la marihuana es legal en 40 estados y el Distrito de Columbia, y el uso recreativo o para adultos es legal en 22 estados más el Distrito de Columbia, según MJBizDaily, una publicación especializada.

Al principio de la pandemia de covid-19, mientras gran parte de Estados Unidos cerró sus negocios, los dispensarios de marihuana siguieron abiertos. Muchos estados los declararon negocios esenciales.

Pero sólo dos estados que permiten el uso para adultos, Vermont y Connecticut, han puesto límites al contenido de THC —30% para la flor de cannabis y 60% para los concentrados de THC— y eximen de los límites a los cartuchos precargados, dijo Gillian Schauer de la Asociación de Reguladores de Cannabis, un grupo de reguladores estatales.

Algunos estados limitan el número de onzas o gramos que los consumidores pueden comprar. Sin embargo, incluso un poco de marihuana puede equivaler a mucho THC, apuntó Rosalie Liccardo Pacula, profesora de políticas de salud, economía y derecho en la Universidad del Sur de California.

Algunos estados sólo permiten el uso médico de productos con bajo contenido de THC; por ejemplo, en Texas, las sustancias que no contienen más de un 0,5% de THC en peso. Y algunos estados exigen etiquetas de advertencia. En Nueva Jersey, los productos de cannabis con más de un 40% de THC deben declarar: “Este es un producto de alta potencia y puede aumentar el riesgo de psicosis”.

La normativa sobre marihuana de Colorado tiene más de 500 páginas. Sin embargo, se enfatizan los límites de las protecciones al consumidor: “Este producto se ha producido sin supervisión reglamentaria en materia de salud, seguridad o eficacia”.

Determinar las normas adecuadas puede no ser sencillo. Por ejemplo, las etiquetas de advertencia podrían proteger a la industria de la marihuana de su responsabilidad, al igual que hicieron con las empresas tabacaleras durante años. Poner un tope a la potencia podría limitar las opciones de las personas que toman dosis elevadas para aliviar problemas médicos.

En general, en el ámbito estatal, la industria del cannabis ha frenado los esfuerzos reguladores argumentando que unas normas onerosas dificultarían la competencia entre las empresas legítimas y las ilícitas, explicó Pacula.

Pacula y otros investigadores han pedido al gobierno federal que intervenga.

Meses después de terminar su mandato como comisionado de la FDA, Scott Gottlieb hizo un llamamiento similar.

Al quejarse de que los estados habían llegado “muy lejos mientras el gobierno federal permanecía al margen”, Gottlieb pidió “un esquema nacional uniforme para el THC que proteja a los consumidores.”

Eso fue en 2019 y poco ha cambiado desde entonces.

A photo of glass dab rigs used to consume THC concentrate backed by colorful lights.Pipas que se pueden usar para inhalar productos con concentrados de THC en la sala de un dispensario de marihuana.(Carlos Avila Gonzalez / San Francisco Chronicle via Getty Images)

¿Dónde está la FDA?

La FDA supervisa los alimentos, los medicamentos recetados, los de venta libre y los dispositivos médicos. Regula el tabaco, la nicotina y los vapes de nicotina. Supervisa las etiquetas de advertencia del tabaco. En interés de la salud y la seguridad públicas, también regula los productos botánicos, productos médicos que pueden incluir material vegetal.

Sin embargo, cuando se trata de la marihuana para fumar, los concentrados de THC derivados del cannabis que se vapean o dabean y los comestibles infundidos con THC, la FDA parece estar muy al margen.

La marihuana medicinal que se vende en los dispensarios no está aprobada por la FDA. La agencia no ha avalado su seguridad o eficacia ni ha determinado la dosis adecuada. No inspecciona las instalaciones donde se producen los productos ni evalúa el control de calidad.

La agencia sí invita a los fabricantes a someter los productos del cannabis a ensayos clínicos y a su proceso de aprobación de medicamentos.

El sitio web de la FDA señala que el THC es el ingrediente activo de dos medicamentos aprobados por la FDA para el tratamiento del cáncer. Aparentemente, sólo por eso la sustancia está bajo la jurisdicción de la FDA.

La FDA tiene “todo el poder que necesita para regular de forma mucho más eficaz los productos de cannabis legalizados por los estados”, afirmó Lindblom, ex funcionario de la agencia.

Al menos públicamente, la FDA no le ha prestado atención a los concentrados de THC derivados del cannabis o la hierba fumada en porros, sino más bien en otras sustancias: una variante del THC derivada del cáñamo, que el gobierno federal ha legalizado, y un derivado diferente del cannabis llamado cannabidiol o CBD, que se ha comercializado como terapéutico.

“La FDA se ha comprometido a vigilar el mercado, identificar los productos de cannabis que plantean riesgos y actuar, dentro de nuestras competencias, para proteger al público”, declaró Courtney Rhodes, vocera de la FDA.

“Muchos, la mayoría de los productos con THC se ajustan a la definición de marihuana, que es una sustancia controlada. La Drug Enforcement Administration (DEA) regula la marihuana en virtud de la Ley de Sustancias Controladas (CSA). Le remitimos a la DEA para preguntas sobre la regulación y aplicación de las disposiciones de la CSA”, escribió Rhodes en un correo electrónico.

La DEA, dependiente del Departamento de Justicia, no respondió a las preguntas formuladas para este artículo.

En cuanto al Congreso, quizá su medida más importante haya sido limitar la aplicación de la prohibición federal.

“Hasta ahora, la respuesta federal a las acciones estatales para legalizar la marihuana ha consistido, sobre todo, en permitir que los estados apliquen sus propias leyes sobre la droga”, señaló un informe de 2022 del Servicio de Investigación del Congreso.

En octubre, el presidente Joe Biden ordenó al secretario de Salud y Servicios Humanos y al fiscal general que revisaran la postura del gobierno federal respecto a la marihuana: si debería seguir clasificada entre las sustancias más peligrosas y estrictamente controladas.

En diciembre, Biden firmó un proyecto de ley que ampliaba la investigación sobre la marihuana y obligaba a las agencias federales a estudiar sus efectos. La ley dice que las agencias tienen un año para publicar sus conclusiones.

Algunos defensores de la marihuana dicen que el gobierno federal podría desempeñar un papel más constructivo.

“La NORML no opina que el cannabis sea inocuo, sino que la mejor forma de mitigar sus riesgos potenciales es mediante la legalización, la regulación y la educación pública”, afirmó Paul Armentano, subdirector del grupo antes conocido como Organización Nacional para la Reforma de las Leyes sobre la Marihuana (NORML).

“Los productos tienen que someterse a pruebas de pureza y potencia”, añadió, y “el gobierno federal podría ejercer cierta supervisión en la concesión de licencias a los laboratorios que prueban esos productos”.

Mientras tanto, según Coleman, asesor de la Asociación Nacional de la Industria del Cannabis, los estados se quedan “teniendo que actuar como si fueran USDA + FDA + DEA, todo al mismo tiempo”.

¿Y dónde deja eso a los consumidores? Algunos, como Wendy E., jubilada en sus 60 años, luchan contra los efectos de la marihuana.

Wendy, que habló con la condición de que no se revelara su nombre, empezó a fumar marihuana en la secundaria en los años 70 y la convirtió en su estilo de vida durante décadas.

Luego, cuando su estado la legalizó, la compró en dispensarios “y enseguida me di cuenta de que la potencia era mucho mayor que la que yo había consumido tradicionalmente”, contó. “Parecía haber aumentado de manera exponencial”.

En 2020, explicó, la marihuana legal —mucho más fuerte que la hierba ilícita de su juventud— la llevó a obsesionarse con el suicidio.

Antes, la mujer que se define como “hippie de la madre tierra” encontraba camaradería pasando un porro con sus amigos. Ahora asiste a reuniones de Marihuana Anónimos, con otras personas que se recuperan de esta adicción.

Category: Latest
more info...
New Mexico Program to Reduce Maternity Care Deserts in Rural Areas Fights for Survival
Mon, 15 May 2023 13:26:49 +0000

CLAYTON, N.M. — Thirteen weeks into her pregnancy, 29-year-old Cloie Davila was so “pukey” and nauseated that she began lovingly calling her baby “spicy.”

Davila was sick enough that staffers at the local hospital gave her 2 liters of IV fluids and prescribed a daily regimen of vitamins and medication. This will be Davila’s third child and she hopes the nausea means it’s another girl.

Davila had moved back to her hometown of Clayton, New Mexico, so her kids could grow up near family — her dad, aunts, uncles, and cousins all live in this remote community of about 2,800 people in the northeastern corner of the state. But Clayton’s hospital stopped delivering babies more than a decade ago.

Aside from being sick, Davila was worried about making the more than 3½-hour round trip to the closest labor and delivery doctors in the state.

“With gas and kids and just work — having to miss all the time,” Davila said. “It was going to be difficult financially, kind of.”

Then, Davila spotted a billboard advertising the use of telehealth at her local hospital.

In rural regions, having a baby can be particularly fraught. Small-town hospitals face declining local populations and poor reimbursement. Those that don’t shutter often halt obstetric services to save money — even as the number of U.S. mothers who die each year while pregnant or shortly after has hit historic highs, particularly for Black women.

More than half of rural counties lack obstetric care, according to a U.S. Government Accountability Office report released last year. Low Medicaid reimbursement rates and a lack of health workers are some of the biggest challenges, the agency reported. New Mexico Medicaid leaders say 17 of the state’s 33 counties have limited or no obstetric care.

Those realities prompted the Federal Office of Rural Health Policy, which is part of the Health Resources and Services Administration, to launch the Rural Maternity and Obstetrics Management Strategies Program, RMOMS. Ten regional efforts nationwide — including one that serves Davila in northeastern New Mexico — have been awarded federal grants to spend on telehealth and creating networks of hospitals and clinics.

“We’ve never done this sort of work before,” said Tom Morris, associate administrator for the office at HRSA. “We were really testing out a concept … could we improve access?”

After joining the telehealth program, Davila didn’t have to take the afternoon off work for a recent prenatal checkup. She drove less than a mile from her job at the county courthouse and parked near the hospital. As she stepped inside a ranch-style yellow-brick clinic building, staffers greeted Davila with hugs and laughter. She then sat on a white-papered exam table facing a large computer screen.

“Hello, everybody,” said Timothy Brininger, a family practice doctor who specializes in obstetrics. He peered out the other side of the screen from about 80 miles away at Miners Colfax Medical Center in Raton, New Mexico.

The visit was a relief — close enough for a lunchtime appointment — and with staff “I’ve known my whole life,” Davila said. She heard her baby’s heartbeat, had her blood drawn, and laughed about how she debated the due date with her husband in bed one night.

“They’re nice,” Davila said of the local staff. “They make me feel comfortable.”

Yet, Davila may be one of the last expectant mothers to benefit from the telehealth program. It is slated to run out of money at the end of August.

Jade Vandiver sits with her husband, Zane, and sons, Zachary (left) and Ezra (right), and their small dog. They are on a couch in their home.Jade Vandiver sits with her husband, Zane, and sons, Zachary (left) and Ezra, at home in Clayton, New Mexico. After medical issues during her second pregnancy, Vandiver joined the state’s rural maternity program. She used the telehealth appointments and began traveling to specialists in Albuquerque for often weekly visits — with the program covering travel and hotel costs for her family.(Joe Garcia III for KFF Health News)

‘Oh My God, It Really Made a Difference’

The day after Davila’s prenatal checkup, Brininger sat at his desk in Raton and explained, “The closest OB doctor besides the one sitting in front of you who’s working today is over 100 miles in any direction.”

When the telehealth program runs out of money, Brininger said, he wants to keep devices the grant paid for that enable some patients to home-monitor with blood pressure cuffs, oxygen sensors, and fetal heart rate monitors “so they don’t have to drive to see us.”

The retired military doctor has thoughts about the pilot program ending: “I will hope that our tax dollars have been utilized effectively to learn something from this because otherwise it’s a shame.”

Because of the grant, 1,000 women and their families in northeastern New Mexico have been connected to social services like food assistance and lactation counselors since 2019. More than 760 mothers have used the program for medical care, including home, telehealth, and clinic appointments. In its first year, 57% of the women identified as Hispanic and 5% as Indigenous.

Jade Vandiver, 25, said she feels “like I wouldn’t have made it without them.”

In the early months of her pregnancy, Vandiver slept during the day and struggled with diabetic hypoglycemic episodes. Vandiver’s husband repeatedly rushed her to the Clayton hospital’s emergency room because “we were scared I was going to go into a coma or worse.”

There, hospital staffers suggested Vandiver join the program. She eventually began traveling to specialists in Albuquerque for often weekly visits.

The program covered travel and hotel costs for the family. After months of checkups, she had a planned delivery of Ezra, who’s now a healthy 6-month-old. The boy watched his mother’s smile as she talked.

Without the program, Vandiver likely would have delivered at home and been airlifted out — possibly to the smaller Raton hospital.

Raton’s Miners Colfax is a small critical access hospital that recently closed its intensive care unit. The hospital sits just off Interstate 25, less than 10 miles south of the Colorado border, and its patients can be transient, Chief Nursing Officer Rhonda Moniot said. Maintaining the hospital’s obstetric program “is not easy, financially it’s not easy,” she said.

Moms from the area “don’t always seek care when they need to,” she said. Substance use disorders are common, she said, and those babies are often delivered under emergency conditions and prematurely.

“If we can get them in that first trimester … we have healthier outcomes in the end,” Moniot said, pulling up a spreadsheet on her computer.

At Raton’s hospital, 41% of mothers who gave birth before the RMOMS program began failed to show up for their first-trimester prenatal exams. But over two years — even as the covid-19 pandemic scared many patients away from seeking care — the number dropped to only 25% of mothers missing prenatal checkups during their first three months of pregnancy.

“I was, like, oh my God, it really made a difference,” said Moniot, who helped launch the program at Miners Colfax in 2019.

Dr. Timothy Brininger is visible on a computer screen. He is talking with a patient over a video call.Timothy Brininger, a family practice doctor who specializes in obstetrics, is based in Raton, New Mexico. He reviews chart information while speaking via video call with prenatal patient Cloie Davila in Clayton, New Mexico.(Sarah Jane Tribble / KFF Health News)

‘Let’s Not Let It Die’

Just a few weeks before Davila’s checkup in Clayton, the New Mexico program’s executive director, Colleen Durocher, traveled nearly 1,600 miles east to Capitol Hill to lobby for money.

Durocher said she cornered HRSA’s Morris at an evening event while in Washington, D.C. She said she told him the program is working but that the one year of planning plus three years of implementation paid for by the federal government was not enough.

“Let’s not let it die,” Durocher said. “It would be a real waste to let those successes just end.”

By April, Sen. Martin Heinrich (D-N.M.) said he was impressed by the program’s “lifesaving” work and asked for $1 million in the federal budget for fiscal year 2024. But the money, if approved, would likely not arrive before Durocher runs out of funding in late summer.

As the August deadline looms, Durocher said one obvious option would be to simply extend the grant. HRSA spokesperson Elana Ross said the agency cannot extend funding for the program. Each site, though, can reapply by offering to target a new population, include new hospitals or clinics, or provide services in a new area.

Of the 10 regional programs across the country, the one in New Mexico and two others are slated to end their pilots this year. Seven other programs — from Minnesota to Arkansas — are scheduled to end in 2025 or 2026. During their first two years, the 2019 awardees reported more than 5,000 women received medical care, and all three recorded a decrease in preterm births during the second year of implementation, according to HRSA.

The three initial programs also expanded their patient navigation programs to connect “hundreds of women to emotional support, insurance coverage, and social services, such as transportation and home visiting,” agency spokesperson Ross wrote in an email.

New Mexico Medicaid’s interim Director Lorelei Kellogg said her agency would like to “emulate” the program’s care coordination among hospitals and health staff in other areas of the state but also alter it to work best for different Indigenous and tribal cultures as well as African American partners.

There is money in the state’s budget to pay for patient navigators or community health workers, but there are no funds dedicated to support the maternity program, she said.

In the meantime, the program’s funding is set to run out just days before Davila’s baby is due in early September. In the coming months, Davila, like many mothers with an uncomplicated pregnancy, will have monthly prenatal telehealth visits, then biweekly and, as her due date nears, weekly.

“It’s nicer to be able to just pop in,” she said, adding that “it would be harder for the community” if the program didn’t exist.

Still, Davila may be one of the last moms to benefit from it.

Zane Vandiver holds his 6-month-old son, Ezra, up above his head. Erza is wearing a green onesie and is smiling down at his father.Zane Vandiver holds his son, Ezra, at home in Clayton, New Mexico.(Joe Garcia III for KFF Health News) Sarah Jane Tribble:
sjtribble@kff.org,
@SJTribble

Category: Latest