En los últimos dos años, más de 200 pacientes han acudido en tropel para ver a después de enterarse que dos medicamentos que receta podrían prevenir el envejecimiento. Una mujer de 95 años estaba tan decidida a no perder su cita que le pidió a su hijo que la llevara desde Maryland después que se cerraran las escuelas por una tormenta de nieve.

Green forma parte de un pequeño pero creciente número de médicos que recetan medicamentos “off-label” (fuera de etiqueta, es decir drogas que se aprobaron para tratar otras condiciones) por sus posibles efectos antienvejecimiento. La metformina generalmente se usa para la diabetes, y la rapamicina previene el rechazo de órganos después de un trasplante, pero los médicos pueden recetar medicamentos “fuera de etiqueta” para otros propósitos, en este caso, para el envejecimiento.

Los efectos antienvejecimiento de la rapamicina en animales y la metformina en personas con diabetes han alentado a Green y a sus pacientes a probarlos como remedios antienvejecimiento, aunque hay pocas pruebas de que personas sanas puedan beneficiarse.

“Muchos de [mis pacientes] tienen doctorados”, dijo Green, quien tiene 76 años y ha tomado los medicamentos durante tres años. “Ellos han leído la investigación y piensan que vale la pena intentarlo”.

De hecho, es más fácil para los pacientes experimentar con los medicamentos, ya sea “off-label” o adquiridos ilegalmente de un proveedor extranjero, que para los investigadores iniciar ensayos clínicos que demuestren que funcionan en seres humanos.

preHasta ahora, la Administración de Drogas y Alimentos (FDA) no ha aprobado un tratamiento para retrasar el proceso de envejecimiento o las enfermedades relacionadas con la edad, resaltando preguntas sobre si la investigación puede demostrar un efecto general sobre el envejecimiento en lugar de solo sobre una enfermedad específica.

Dadas estas reservas, las compañías farmacéuticas tienen pocos incentivos para financiar ensayos costosos a gran escala. Además, tanto la metformina como la rapamicina son genéricas y relativamente baratas.

“No hay ganancias”, dijo , profesor de patología en la facultad de medicina de la Universidad de Washington, cuyo equipo recibió una subvención de $15 millones de los Institutos Nacionales de Salud (NIH) para estudiar los efectos de la rapamicina en perros, pero ha destacado la falta de fondos para estudios en humanos. “Sin fines de lucro, no hay incentivo”.

Los suplementos con supuestos efectos antienvejecimiento ingresan habitualmente al mercado con poco control y menos evidencia.

Sin embargo, a fines del año pasado, los NIH rechazaron una de subvención de $77 millones de un grupo prominente de investigadores para determinar si la metformina podría atacar a la vez a varias enfermedades relacionadas con la edad. Fue el segundo rechazo de la ambiciosa, pero poco ortodoxa apuesta.

“Vamos a seguir intentando”, dijo uno de los autores principales de la propuesta de metformina, Stephen Kritchevsky, codirector del Sticht Center for Healthy Aging and Alzheimer’s Prevention. “Estas cosas toman tiempo”.

Se sabe poco sobre los efectos antienvejecimiento de la rapamicina y sus posibles efectos secundarios en la población general, incluida la posibilidad de que pueda provocar resistencia a la insulina. Sin embargo, una serie de estudios muestra que la rapamicina extiende la vida de los animales. También se ha demostrado en este tipo de investigaciones que previene condiciones relacionadas con la edad, desde cáncer hasta enfermedades cardiovasculares y cognitivas.

“Debería haber habido un ensayo clínico para la rapamicina y la enfermedad de Alzheimer hace años”, dijo Kaeberlein, quien ha instado públicamente a los NIH a utilizar un aumento histórico en la financiación de la enfermedad de Alzheimer para . “Pero el hecho es que los ensayos clínicos son realmente difíciles y caros”.

Alexander Fleming, ex funcionario de la FDA y defensor de la propuesta sobre la metformina, dijo que creía que era difícil para los reguladores y los financistas comprender que el envejecimiento se puede abordar como un todo, no solo una enfermedad a la vez.

De hecho, los que revisan las propuestas en los NIH, los que rechazaron la de metformina, mencionaron problemas con el objetivo del proyecto de probar múltiples enfermedades relacionadas con la edad al mismo tiempo. Los investigadores consideraron la posibilidad de apelar la decisión, afirmando que los que revisan las propuestas tenían prejuicios contra el estudio del envejecimiento en general. Los NIH, que no quisieron hacer comentarios, desalentaron el intento.

El , director de la división de geriatría y gerontología clínica del Instituto Nacional sobre el Envejecimiento, le dijo a Kaiser Health News que los NIH no están descartando los proyectos de financiamiento dirigidos al envejecimiento, y dijo que tales propuestas siguen siendo “de interés”.

La FDA también está abierta a considerar tales esfuerzos “basados ​​en la evidencia científica presentada”, dijo Amanda Turney, vocera de la entidad.

Fleming, quien supervisó la controversial aprobación de la FDA de la metformina para la diabetes tipo 2, dijo que se podría argumentar que se podría aprobar un medicamento como la metformina para prevenir enfermedades relacionadas con la edad en lugar de solo tratarlas. Señala a las ahora ampliamente utilizadas estatinas, que fueron aprobadas para prevenir enfermedades del corazón.

“Hay algún tipo de creencia de que la FDA no puede aprobar una terapia para reducir la progresión del envejecimiento o las afecciones relacionadas con la edad”, dijo Fleming, un endocrinólogo. “Simplemente no es cierto”.

Debido a la falta de consenso, otros investigadores han avanzado con ensayos clínicos enfocados en afecciones específicas relacionadas con la edad.

Investigadores han demostrado que un “primo” de la rapamicina aumenta la efectividad de las vacunas contra la gripe y reduce la incidencia de infecciones del tracto respiratorio superior en personas mayores hasta en un 30%. Este grupo, dirigido por el doctor Joan Mannick, obtuvo la licencia de Novartis y ahora está trabajando para obtener la aprobación para atacar la enfermedad de Parkinson.

“Estamos tratando de ser pragmáticos”, dijo Mannick sobre el .

Algunos médicos y pacientes han decidido no esperar. En un foro científico reciente sobre el envejecimiento, uno de los investigadores de la propuesta de los NIH pidió a las 300 personas presentes que levantaran la mano si ya estaban tomando metformina para el envejecimiento.

“La mitad de la audiencia levantó sus manos”, recordó el doctor , director del Instituto de Investigación sobre el Envejecimiento de la Escuela de Medicina Albert Einstein, quien dijo que un representante farmacéutico recientemente estimó que las ventas de metformina aumentaron un 20%.

Barzilai está preocupado por la tendencia “fuera de etiqueta”, aunque considera que la metformina es prometedora. Sostiene que los investigadores en el campo de la longevidad primero deben establecer un marco para realizar pruebas en ensayos clínicos. Incluso si la metformina no funciona como el fármaco más eficaz, afirma que se necesita un modelo como el de la propuesta de metformina para que se lleve a cabo cualquier ensayo clínico importante. Su grupo ahora está tratando de obtener aproximadamente la mitad de la cantidad de fondos que solicitó a los NIH de una combinación de inversión sin fines de lucro y privada.

“Gran parte del campo del envejecimiento son charlatanes”, dijo Barzilai. “Te dicen que tomes esto o aquello y vivirás para siempre. Pero se tiene que hacer un ensayo clínico que esté controlado con placebo y, solo entonces, se podrá decir qué es realmente y si es seguro”.

No obstante, Green dijo que planea seguir recetando estos medicamentos. Él estima que alrededor del 5% de sus pacientes son médicos. Otros tienen estudios en ciencias o están en la categoría de ingresos superiores. Según su sitio web, cobra $350 por una visita inicial y no acepta seguro.

“Vuelan para verme en sus propios aviones”, dijo.

Pero otros médicos que están abiertos a recetar metformina están retrasando la rapamicina, dado los efectos secundarios en dosis más altas en pacientes enfermos.

“Necesito ver más pruebas”, dijo el doctor Garth Denyer, médico en The Woodlands, un suburbio rico de Houston, quien dijo que le recetó metformina a un pequeño número de pacientes pero que está esperando la rapamicina. “Espero ver más datos sobre seguridad”.

Michael Slattery, quien ha sido VIH positivo desde 1983, dijo que está tomando ambos medicamentos porque es probable que el virus acorte su esperanza de vida.

Hasta el momento, no ha notado ningún efecto secundario o beneficio. Sin embargo, su compañero, que también es VIH positivo, dejó de tomar rapamicina después de contraer infecciones renales.

“Siento que no tengo nada más que perder”, dijo Slattery, un consultor de biotecnología retirado.

Otros pacientes siguen siendo optimistas, aunque es poco probable que la evidencia sea definitiva en un futuro cercano.

Linda Mac Dougall, de 70 años, de Port Hueneme, California, dijo que participó en un pequeño estudio que no tenía un control de placebo. No está segura si tuvo algún efecto.

“Realmente no he notado nada, pero eso no significa que no haya funcionado”, dijo Mac Dougall, terapeuta masajista de adultos mayores. Dijo que tiene un poco más de confianza en la amplia gama de suplementos que toma, y ​​agregó: “si vivo hasta los 110, lo sabremos”.

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Over the past two years, more than 200 patients have flocked to see after learning that two drugs he prescribes could possibly stave off aging. One 95-year-old was so intent on keeping her appointment that she asked her son to drive her from Maryland after a snowstorm had closed the schools.

Green is among a small but growing number of doctors who prescribe drugs “off-label” for their possible anti-aging effects. Metformin is typically prescribed for diabetes, and rapamycin prevents organ rejection after a transplant, but doctors can prescribe drugs off-label for other purposes — in this case, for “aging.”

Rapamycin’s anti-aging effects on animals and metformin’s on people with diabetes have encouraged Green and his patients to experiment with them as anti-aging remedies, even though there’s little evidence healthy people could benefit.

“Many of [my patients] have Ph.D.s,” said Green, who is 76 and has taken the drugs for three years. “They have read the research and think it’s worth a try.”

In fact, it’s easier for patients to experiment with the drugs — either legally off-label or illegally from a foreign supplier — than it is for researchers to launch clinical trials that would demonstrate they work in humans.

No rigorous large-scale clinical trials have been conducted aimed at aging. The FDA so far has not agreed that a treatment could be approved for delaying the onset of aging or age-related diseases, citing questions about whether research can demonstrate an overall effect on aging rather than just on a specific disease.

Given such reservations, pharmaceutical companies have little incentive to fund costly, large-scale trials. Also, both metformin and rapamycin are generic and relatively cheap.

“There’s no profit,” said , a professor of pathology at the University of Washington medical school whose team received a $15 million grant from the National Institutes of Health to study the effects of rapamycin in dogs, but has noted the lack of funds for studies in people. “Without profit, there’s no incentive.”

Supplements with purported anti-aging effects routinely enter the market with little scrutiny and less evidence.

Yet, late last year, the NIH rejected a $77 million grant by a prominent group of researchers to determine whether metformin could target multiple age-related diseases at once. It was the second rejection of the ambitious but unorthodox bid.

“We’re going to keep trying,” said a lead author of the metformin proposal, Stephen Kritchevsky, a co-director of the Sticht Center for Healthy Aging and Alzheimer’s Prevention. “These things take time.”

Less is known about rapamycin’s anti-aging effects and its possible side effects in the general population, including the possibility it could lead to insulin resistance. Yet a litany of studies show that rapamycin extends animal life spans. It also has been shown in such studies to stave off age-related diseases, from cancer to cardiovascular diseases to cognitive diseases.

“There should have been a clinical trial for rapamycin and Alzheimer’s disease years ago,” said Kaeberlein, who has publicly urged NIH to use a historic boost in Alzheimer’s funding to . “But the fact is, the clinical trials are really hard and expensive.”

Alexander Fleming, a former FDA official and advocate for the metformin proposal, said he believed it was difficult for regulators and funders to grasp that aging can be tackled as a whole — not just one disease at a time.

In fact, NIH reviewers who rejected the metformin proposal cited problems with the project’s aim of testing multiple age-related diseases at once. The researchers considered appealing the decision, asserting those reviewers were biased against studying aging as a whole. NIH, which declined to comment, discouraged the attempt.

, director of the National Institute on Aging’s division of geriatrics and clinical gerontology, told Kaiser Health News that NIH is not ruling out funding projects that target aging, saying such proposals are still “of interest.”

The FDA also is open to considering such efforts “based on the scientific evidence presented to us,” said FDA spokeswoman Amanda Turney.

Fleming, who oversaw the controversial FDA approval of metformin for Type 2 diabetes, said an argument could be made that it could approve a drug like metformin for preventing age-related diseases instead of just treating them. He points to now widely used statins, which were approved to prevent heart disease.

“There is some kind of belief that the FDA can’t approve a therapy to reduce the progress of aging or age-related conditions,” said Fleming, an endocrinologist. “It’s just not true.”

Given the lack of consensus, other researchers have moved ahead with clinical trials focused on specific age-related conditions.

Researchers have shown that a “cousin” of rapamycin boosts the effectiveness of flu shots and lowers the incidence of upper respiratory infections in seniors by up to 30 percent. This group, led by Dr. Joan Mannick, has licensed it from Novartis and is now working on getting approval to target Parkinson’s disease.

“We’re trying to be pragmatic,” Mannick said of .

Some doctors and patients have decided not to wait. At a recent scientific forum on aging, one of the researchers on the NIH proposal asked the 300 or so people in attendance to raise their hands if they were already taking metformin for aging.

“Half the audience raised their hands,” recalled the researcher, director of the Institute for Aging Research at the Albert Einstein College of Medicine, who said a pharmaceutical rep recently estimated that metformin sales are up 20 percent.

Barzilai is concerned about the off-label trend, although he sees metformin as promising. He contends that researchers in the longevity field first need to set up a framework for testing in clinical trials. Even if metformin doesn’t pan out as the most effective drug, he asserts a model like the metformin proposal is needed for any major clinical trial to proceed. His group is now trying to secure about half the amount of funding it requested from NIH from a mix of nonprofit and private investment.

“Much of the aging field is charlatans,” Barzilai said. “They tell you take this or that and you’ll live forever. But you have to do a clinical trial that is placebo-controlled and only then can you say what it really is and whether it’s safe.”

Green nonetheless said he plans to continue prescribing. He estimates about 5 percent of his patients are doctors themselves. Others have backgrounds in science or are in the upper-income bracket. According to his website, he charges $350 for an initial visit and does not accept insurance.

“They fly to see me on their own planes,” he said.

But other doctors who are open to prescribing metformin are holding off on rapamycin, given side effects in higher doses in sick patients.

“I need to see more evidence,” said Dr. Garth Denyer, a doctor in The Woodlands, a wealthy Houston suburb, who said he prescribed metformin to a small number of patients but is waiting on rapamycin. “I’m hoping to see more data on safety.”

Michael Slattery, who has been HIV-positive since 1983, said he is taking both drugs because the virus is likely to shorten his life expectancy.

So far, he has not noticed any side effects or benefits. His partner, however, who is also HIV-positive, stopped taking rapamycin after getting kidney infections.

“I feel I have nothing left to lose,” said Slattery, a retired biotech consultant.

Other patients remain hopeful, even though the evidence is unlikely to be definitive anytime soon.

Linda Mac Dougall, 70, of Port Hueneme, Calif., said she participated in a small study that did not have a placebo control. She’s uncertain whether it had any effect on her.

“I really haven’t noticed anything, but that doesn’t mean it didn’t work,” said Mac Dougall, a massage therapist for seniors. She has slightly more confidence in the wide array of supplements she takes, she said: “If I live until I’m 110, we’ll know.”

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¿Cuál es el secreto de este hombre de 49 años? Él dice que su régimen diario incluye ingerir una molécula que, según su propia investigación, mejoró la salud y alargó la vida útil de ratones. Sinclair ahora cuenta en que tiene la capacidad pulmonar, el colesterol y la presión arterial de un “adulto joven” y el “ritmo cardíaco de un atleta”.

A pesar de su entusiasmo, la investigación científica publicada aún no ha demostrado que la molécula funcione en humanos como lo hace en ratones. Y, por otra parte, Sinclair tiene un considerable interés económico en que se demuestre que sus afirmaciones son correctas, ya que ha puesto sus conocimientos científicos al servicio de la comercialización de productos que supuestamente extienden la vida, como las moléculas conocidas como “potenciadores NAD”.

Entre sus intereses financieros está el hecho de figurar como inventor en una patente con licencia de Elysium Health, una compañía de suplementos que vende los potenciadores NAD en forma de píldoras por $60 cada frasco. Además es un inversor en , la compañía que, según él, mide su edad.

Separar la realidad de la exageración en el campo que estudia la longevidad se ha vuelto más difícil que nunca, ya que científicos respetados como Sinclair, e importantes instituciones como Harvard, se vinculan con conceptos prometedores, pero no probados, y en ocasiones los promueven y se benefician de ellos.

“Si usted dice que es un científico excelente y que tiene un tratamiento para el envejecimiento, recibe mucha atención”, dijo Jeffrey Flier, ex decano de la Escuela de Medicina de Harvard que es muy crítico de la ola de exageraciones. “Existe un incentivo financiero y un aliciente para prometer en exceso antes de que se complete toda la investigación”.

Elysium, cofundada en 2014 por un destacado científico del MIT para comercializar la molécula nicotinamida ribósido, un tipo de potenciador NAD, destaca su acuerdo de licencia “exclusivo” con Harvard y la Clínica Mayo, y el papel de Sinclair como inventor. Según el de la compañía, el acuerdo apunta a suplementos que “retrasan el envejecimiento y las enfermedades relacionadas con la edad”.

Además de agregar seriedad científica a su marca, el sitio web enumera y otros 19 científicos prominentes que forman parte de su consejo asesor. La compañía también anuncia con la universidad de Harvard, así como Cambridge y Oxford en el Reino Unido.

Pero a algunos científicos e instituciones les resultan incómodos este tipo de vínculos. anunció en 2017 que recibiría fondos de Elysium, lo que consolidaría una “asociación” de investigación. Pero luego de escuchar las quejas de la facultad de que el instituto se estaba asociando con un suplemento no probado, decidió no renovar los fondos o la membresía de la compañía a su junta de “innovación”.

“La venta de suplementos nutricionales de beneficios clínicos no comprobados es habitual”, explicó Stephen O’Rahilly, director de los Laboratorios de Investigación Metabólica de Cambridge que aplaudió a su universidad por reevaluar el acuerdo. “Lo que es inusual en este caso es hasta qué punto las instituciones y los individuos de los niveles más altos de la academia han sido elegidos para proporcionar credibilidad científica para un producto cuyos beneficios para la salud humana no están probados”.

Promesas

Una generación atrás, los científicos a menudo ignoraban o desmentían a quienes anunciaban una píldora para la “fuente de la juventud”.

“Hasta principios de los 90, parecía ridículo que se pudiera desarrollar una píldora que retrasara el envejecimiento”, expresó Richard Miller, biogerontólogo de la Universidad de Michigan quien dirige uno de los tres laboratorios financiados por los Institutos Nacionales de Salud (NIH) para evaluar estas prometedoras sustancias en ratones. “Se consideraba ciencia ficción. Pero investigaciones recientes han demostrado que el pesimismo es incorrecto”.

Los ratones que reciben moléculas como la rapamicina viven hasta un 20% más. Se ha demostrado que otras sustancias, como el 17 alfa estradiol y el medicamento para la diabetes Acarbose, son igual de efectivos en estudios con ratones.

Pero el metabolismo humano es diferente al de los roedores. Y nuestra existencia es diferente a la vida de un ratón en una jaula. Lo que es teóricamente posible en el futuro sigue sin probarse en los seres humanos y no está listo para la venta, dicen expertos.

“Nada de esto está listo para el público. La conclusión es que no pruebo ninguna de estas cosas”, dijo Felipe Sierra, director de la división de biología del envejecimiento en el Instituto Nacional sobre el Envejecimiento de los NIH. “¿Por qué no? Porque no soy un ratón”.

La exageración

Las preocupaciones acerca de si la investigación en animales podría traducirse en una terapia humana no han impedido a los científicos competir en el mercado, lanzar nuevas empresas o atraer inversores.

“Si bien en investigaciones valiosas el rumor fomenta la inversión, los científicos deben evitar promocionar sustancias específicas”, dijo S. Jay Olshansky, profesor especialista en envejecimiento en la Escuela de Salud Pública de la Universidad de Illinois en Chicago.

Algunos hallazgos científicos se exageran para ayudar a comercializarlos antes que los ensayos clínicos en humanos demuestren seguridad y eficacia, añadió.

La investigación de Sinclair y otros ayudó a despertar interés en el resveratrol, un ingrediente del vino tinto, por sus potenciales propiedades antienvejecimiento. En 2004, Sinclair cofundó una empresa, Sirtris, para probar los posibles beneficios del resveratrol y declaró en una entrevista con la revista Science que era “lo más parecido a una molécula milagrosa”. GlaxoSmithKline compró la compañía en 2008 por $720 millones. Cuando Glaxo detuvo la investigación en 2010 debido a resultados discretos con posibles efectos secundarios, Sinclair ya había recibido $8 millones de la venta, según los documentos de la Comisión de Valores y Bolsa. También había ganado $297,000 al año en honorarios de consultoría de la compañía, según The Wall Street Journal.

Sinclair practica lo que predica, o promueve. En su biografía de LinkedIn y en entrevistas con los medios de comunicación, cuenta que toma regularmente el resveratrol; el medicamento para la diabetes metformina, que promete frenar el envejecimiento; y el mononucleótido de nicotinamida, una sustancia conocida como NMN que según su propia investigación rejuveneció a los ratones.

En una entrevista con KHN, Sinclair dijo que no está recomendando que otros tomen esas sustancias.

“No estoy diciendo que en realidad soy más joven. Solo le estoy dando a la gente los hechos”, comentó, y agregó que está compartiendo los resultados de las pruebas de sangre de InsideTracker, que calculan la edad biológica en función de los biomarcadores en la sangre. “Me asignaron 58 años, y luego de uno o dos análisis de sangre me indicaron que tenía 31,4”.

InsideTracker vende un paquete de seguimiento de edad en línea a los consumidores por hasta . El destaca el apoyo de Sinclair como miembro de su consejo asesor científico.

Sinclair es fundador, inversionista, accionista, consultor o miembro de la junta de 28 compañías, según de sus intereses financieros. También es un inventor nombrado en la patente con licencia de Harvard y la Clínica Mayo para Elysium, y una de sus compañías, MetroBiotech, ha presentado una relacionada con el mononucleótido de nicotinamida, la sustancia que dice que él mismo está tomando.

Sinclair y Harvard se negaron a revelar detalles sobre la cantidad de dinero que él, o la universidad, están generando a partir de estos intereses financieros externos.

Sinclair citó acuerdos de confidencialidad para no revelar sus ganancias, pero agregó que “la mayoría de estos ingresos se han reinvertido en compañías que desarrollan medicamentos innovadores, utilizados para ayudar a mi laboratorio o donados a organizaciones sin fines de lucro”.

¿Vacío legal?

La Administración de Alimentos y Medicamentos (FDA) no clasifica el envejecimiento como una enfermedad, lo que significa que los medicamentos dirigidos a la longevidad generalmente no se someten a los ensayos clínicos tradicionales destinados a probar sus efectos en el envejecimiento humano. Además, la FDA no requiere que los suplementos se sometan a las mismas pruebas de seguridad o eficacia que los productos farmacéuticos.

El titular principal en el sitio web de Elysium dice que “los resultados de los ensayos clínicos demuestran la seguridad y la eficacia” de su suplemento Basis, que contiene las moléculas nicotinamida ribósido y pterostilbeno. Pero la no demostró que el suplemento fuera efectivo contra el envejecimiento en humanos, como podría ser en ratones. Simplemente mostró que la píldora aumentaba los niveles de la sustancia en las células sanguíneas.

La propia investigación de Elysium documentó un “pequeño pero significativo aumento en el ”, pero agregó que se necesitan más estudios para determinar si los cambios fueron “reales o debidos al azar”. Un independiente sugirió que un componente de NAD puede influir en el crecimiento de algunos cánceres, pero los investigadores involucrados en el estudio advirtieron que era demasiado pronto para saberlo.

, cofundador y científico principal de Elysium, dijo a KHN que no le preocupan los efectos secundarios de Basis, y enfatizó que su compañía se dedica a realizar investigaciones sólidas. Añadió que supervisa los informes de seguridad de los clientes y aconseja a quienes tengan problemas de salud que consulten con sus médicos antes de usarlo.

Si una sustancia cumple con la definición de la FDA de suplemento y se anuncia de esa manera, entonces la agencia no puede tomar medidas a menos que resulte un peligro, explicó Alta Charo, ex asesora de política de bioética en la administración Obama. Los productos farmacéuticos deben demostrar seguridad y eficacia antes de ser comercializados.

“Lo que sucede aquí es una manera muy cuidadosa de decir para qué es el producto”, señaló Charo, profesor de derecho en la Universidad de Wisconsin. “Si lo están comercializando como una cura para una enfermedad, entonces se meten en problemas con la FDA. Si lo comercializan como un rejuvenecedor, entonces la FDA está paralizada hasta que se demuestre que existe un peligro para el consumidor”.

“Esta es una receta para que ocurra algo desafortunado en el futuro”, agregó Charo. “Podemos tener suerte y puede resultar que muchos de estos productos resulten ser inútilmente benignos. Pero por lo que sabemos, será peligroso”.

El debate sobre los riesgos y beneficios de las sustancias que aún no se han probado que funcionen en humanos ha provocado un debate sobre si las instituciones de investigación están examinando la relación entre los intereses económicos y la participación de su cuerpo docente, o el de la propia institución.

Flier, el ex decano de la Escuela de Medicina de Harvard, había escuchado quejas y estudió las relaciones entre los científicos y Elysium después que se retiró como decano. Dijo que que muchos de los miembros de la junta que permitieron que sus nombres y fotos se publicaran en el sitio web de la compañía sabían poco sobre la base científica para el uso del suplemento.

Flier recuerda que un científico nunca asesoró a la compañía y nunca asistió a una reunión. Aun así, Elysium le estaba pagando por su papel en la junta.

Caroline Perry, directora de comunicaciones de la Oficina de Desarrollo Tecnológico de Harvard, dijo que acuerdos como la de investigación de Elysium cumplen con las políticas universitarias y “protegen la independencia académica tradicional de los investigadores”.

Al igual que Harvard, la Clínica Mayo se negó a revelar detalles sobre cuánto dinero ganaría con el acuerdo de licencia de Elysium. Mayo y Harvard llevaron a cabo una “diligencia sustancial y extendieron las negociaciones” antes de entrar en el acuerdo, dijo una portavoz de Mayo.

“La compañía proporcionó pruebas convincentes de que están comprometidos con el desarrollo de productos respaldados por evidencia científica”, dijo la portavoz, Duska Anastasijevic.

Guarente de Elysium se negó a decir cuánto ganaba él o Elysium con la venta del suplemento Basis. MIT se negó a hacer públicas sus declaraciones de conflicto de intereses.

Mientras tanto, los fondos de inversión privados continúan apoyando la investigación sobre la longevidad a pesar de las preguntas sobre si las sustancias funcionan en las personas.

clave de Elysium es el Morningside Group, una firma de capital privado dirigida por el donante principal de Harvard, Gerald Chan, quien también donó

El multimillonario y cofundador de WeWork, Adam Neumann, ha invertido en Life Biosciences de Sinclair.

Una compañía de inversión dirigida por el ingeniero y médico Peter Diamandis le dio a un grupo de investigadores de Harvard $5.5 millones para su “startup” luego que su investigación fuera cuestionada públicamente por varios científicos.

Al anunciar la financiación inicial, la compañía, Elevian, dijo que su objetivo era desarrollar “nuevos medicamentos” que aumenten los niveles de actividad de la hormona GDF11

Describió la investigación realizada por sus fundadores, que incluye a de Harvard, como la demostración de que “reponer un solo factor circulatorio, GDF11, en animales viejos refleja los efectos de la sangre joven, reparando el corazón, el cerebro, los músculos y otros tejidos”.

Otros respetados en este campo no han podido replicar o contradecir elementos clave de sus observaciones.

El director ejecutivo de Elevian, Mark Allen, dijo que los primeros datos científicos sobre el GDF11 son alentadores, pero que “el descubrimiento y desarrollo de fármacos es un proceso regulado, arriesgado y requiere muchos años de investigación, estudios preclínicos en animales y ensayos clínicos en humanos para colocar nuevos medicamentos en el mercado”.

A Flier le preocupa que la investigación sobre la longevidad se pueda ver comprometida, aunque reconoce la importancia y la promesa de la ciencia. Dijo que le preocupa que las alianzas entre multimillonarios y científicos puedan reducir el escepticismo.

“Un multimillonario susceptible se encuentra con un científico que es un buen vendedor, lo mira a los ojos y le dice: ‘No hay ninguna razón para que no podamos tener una terapia que permita vivir 400 o 600 años'”, contó Flier. “El multimillonario verá entonces a alguien que está en MIT o en Harvard y le dirá: ‘Muéstrame lo que puedes hacer'”.

A pesar de las preocupaciones sobre la exageración, los científicos tienen la esperanza de encontrar un camino para seguir confiando en pruebas sólidas. El consenso: una pastilla es algo posible. Es sólo una cuestión de tiempo, y de una investigación sólida.

“Si quieres ganar dinero, contratar a un representante de ventas para impulsar algo que no se ha probado es una estrategia realmente genial”, señaló Miller, quien está probando sustancias en ratones. “Si, por el contrario, quieres encontrar medicamentos que funcionen en las personas, adoptas un enfoque muy diferente. No implica lanzamientos de ventas. Implica el largo, laborioso y lento proceso de una investigación”.

El corresponsal principal de KHN, Jay Hancock, contribuyó con este informe.

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What’s the 49-year-old’s secret? He says his daily regimen includes ingesting a molecule his own research found improved the health and lengthened the life span of mice. Sinclair now boasts that he has the lung capacity, cholesterol and blood pressure of a “young adult” and the “heart rate of an athlete.”

Despite his enthusiasm, published scientific research has not yet demonstrated the molecule works in humans as it does in mice. Sinclair, however, has a considerable financial stake in his claims being proven correct, and has lent his scientific prowess to commercializing possible life extension products such as molecules known as “NAD boosters.”

His financial interests include being listed as an inventor on a patent licensed to Elysium Health, a supplement company that sells a NAD booster in pills for $60 a bottle. He’s also an investor in the company that he says measured his age.

Discerning hype from reality in the longevity field has become tougher than ever as reputable scientists such as Sinclair and pre-eminent institutions like Harvard align themselves with promising but unproven interventions — and at times promote and profit from them.

Fueling the excitement, investors pour billions of dollars into the field even as many of the products already on the market face fewer regulations and therefore a lower threshold of proof.Ìý

“If you say you’re a terrific scientist and you have a treatment for aging, it gets a lot of attention,” said Jeffrey Flier, a former Harvard Medical School dean who has been critical of the hype. “There is financial incentive and inducement to overpromise before all the research is in.”

Elysium, co-founded in 2014 by a prominent MIT scientist to commercialize the molecule nicotinamide riboside, a type of NAD booster, highlights its “exclusive” licensing agreement with Harvard and the Mayo Clinic and Sinclair’s role as an inventor. According to the company’s , the agreement is aimed at supplements that slow “aging and age-related diseases.”

Further adding scientific gravitas to its brand, the website lists and 19 other prominent scientists who sit on its scientific advisory board. The company also advertises with Harvard and U.K. universities Cambridge and Oxford.

Some scientists and institutions have grown uneasy with such ties. announced in 2017 it would receive funding from Elysium, cementing a research “partnership.” But after hearing complaints from faculty that the institute was associating itself with an unproven supplement, it quietly decided not to renew the funding or the company’s membership to its “innovation” board.

“The sale of nutritional supplements of unproven clinical benefit is commonplace,” said Stephen O’Rahilly, the director of Cambridge’s Metabolic Research Laboratories who applauded his university for reassessing the arrangement. “What is unusual in this case is the extent to which institutions and individuals from the highest levels of the academy have been co-opted to provide scientific credibility for a product whose benefits to human health are unproven.”

The Promise

A generation ago, scientists often ignored or debunked claims of a “fountain of youth” pill.

“Until about the early 1990s, it was kind of laughable that you could develop a pill that would slow aging,” said Richard Miller, a biogerontologist at the University of Michigan who heads one of three labs funded by the National Institutes of Health to test such promising substances on mice. “It was sort of a science fiction trope. Recent research has shown that pessimism is wrong.”

Mice given molecules such as rapamycin live as much as 20 percent longer. Other substances such as 17 alpha estradiol and the diabetes drug Acarbose have been shown to be just as effective — in mouse studies. Not only do mice live longer, but, depending on the substance, they avoid cancers, heart ailments and cognitive problems.

But human metabolism is different from that of rodents. And our existence is unlike a mouse’s life in a cage. What is theoretically possible in the future remains unproven in humans and not ready for sale, experts say.

History is replete with examples of cures that worked on mice but not in people. Multiple drugs, for instance, have been effective at targeting an Alzheimer’s-like disease in mice yet have failed in humans.

“None of this is ready for prime time. The bottom line is I don’t try any of these things,” said Felipe Sierra, the director of the division of aging biology at the National Institute on Aging at NIH. “Why don’t I? Because I’m not a mouse.”

The Hype

Concerns about whether animal research could translate into human therapy have not stopped scientists from racing into the market, launching startups or lining up investors. Some true believers, including researchers and investors, are taking the substances themselves while promoting them as the next big thing in aging.

“While the buzz encourages investment in worthwhile research, scientists should avoid hyping specific [substances],” said S. Jay Olshansky, a professor who specializes in aging at the School of Public Health at the University of Illinois at Chicago.

Yet some scientific findings are exaggerated to help commercialize them before clinical trials in humans demonstrate both safety and efficacy, he said.

“It’s a great gig if you can convince people to send money and use it to pay exorbitant salaries and do it for 20 years and make claims for 10,” Olshansky said. “You’ve lived the high life and get investors by whipping up excitement and saying the benefits will come sooner than they really are.”

Promising findings in animal studies have stirred much of this enthusiasm.

Research by Sinclair and others helped spark interest in resveratrol, an ingredient in red wine, for its potential anti-aging properties. In 2004, Sinclair co-founded a company, Sirtris, to test resveratrol’s potential benefits and declared in an interview with the journal Science it was “as close to a miraculous molecule as you can find.” GlaxoSmithKline bought the company in 2008 for $720 million. By the time Glaxo halted the research in 2010 because of underwhelming results with possible side effects, Sinclair had already received $8 million from the sale, according to Securities and Exchange Commission documents. He also had earned $297,000 a year in consulting fees from the company, according to The Wall Street Journal.

At the height of the buzz, Sinclair accepted a paid position with Shaklee, which sold a product made out of resveratrol. But he resigned after The Wall Street Journal highlighted positive comments he made about the product that the company had posted online. He said he never gave Shaklee permission to use his statements for marketing.

Sinclair practices what he preaches — or promotes. On his LinkedIn bio and in media interviews, he describes how he now regularly takes resveratrol; the diabetes drug metformin, which holds promise in slowing aging; and nicotinamide mononucleotide, a substance known as NMN that his own research showed rejuvenated mice.

Of that study, he said in a video produced by Harvard that it “sets the stage for new medicines that will be able to restore blood flow in organs that have lost it, either through a heart attack, a stroke or even in patients with dementia.”

In an interview with KHN, Sinclair said he’s not recommending that others take those substances.

“I’m not claiming I’m actually younger. I’m just giving people the facts,” he said, adding that he’s sharing the test results from InsideTracker’s blood tests, which calculate biological age based on biomarkers in the blood. “They said I was 58, and then one or two blood tests later they said I was 31.4.”

InsideTracker sells an online age-tracking package to consumers for up to about . The company’s Sinclair’s support for the company as a member of its scientific advisory board. It also touts a study that describes the benefits of such tracking, which Sinclair co-authored.

Sinclair is involved either as a founder, an investor, an equity holder, a consultant or a board member with 28 companies, according to a of his financial interests. At least 18 are involved in anti-aging in some way, including studying or commercializing NAD boosters. The interests range from longevity research startups aimed at humans and even pets to developing a product for a to advising a longevity investment fund. He’s also an inventor named in the patent licensed by Harvard and the Mayo Clinic to Elysium, and one of his companies, MetroBiotech, has filed a related to nicotinamide mononucleotide, which he says he takes himself.

Sinclair and Harvard declined to release details on how much money he — or the university — is generating from these disclosed outside financial interests. Sinclair estimated in a 2017 interview with Australia’s Financial Review that he raises $3 million a year to fund his Harvard lab.

Liberty Biosecurity, a company he co-founded, estimated in Sinclair’s online bio that he has been involved in ventures that “have attracted more than a billion dollars in investment.” When KHN asked him to detail the characterization, he said it was inaccurate, without elaborating, and the comments later disappeared from the website.

Sinclair cited confidentiality agreements for not disclosing his earnings, but he added that “most of this income has been reinvested into companies developing breakthrough medicines, used to help my lab, or donated to nonprofits.” He said he did not know how much he stood to make off the Elysium patent, saying Harvard negotiated the agreement.

Harvard declined to release Sinclair’s conflict-of-interest statements, which university policy requires faculty at the medical school to file in order to “protect against any faculty bias that could heighten the risk of harm to human research participants or recipients of products resulting from such research.”

“We can only be proud of our collaborations if we can represent confidently that such relationships enhance, and do not detract from, the appropriateness and reliability of our work,” the policy states.

Elysium advertises both Harvard’s and Sinclair’s ties to its company. It was co-founded by Massachusetts Institute of Technology professor , Sinclair’s former research adviser and an investor in Sinclair’s .

Echoing his earlier statements on resveratrol, Sinclair is quoted on Elysium’s website as describing NAD boosters as .”

Supplement Loophole?

The Food and Drug Administration doesn’t categorize aging as a disease, which means potential medicines aimed at longevity generally can’t undergo traditional clinical trials aimed at testing their effects on human aging. In addition, the FDA does not require supplements to undergo the same safety or efficacy testing as pharmaceuticals.

The banner headline on Elysium’s website said that “clinical trial results prove safety and efficacy” of its supplement, Basis, which contains the molecule nicotinamide riboside and pterostilbene. But the did not demonstrate the supplement was effective at anti-aging in humans, as it may be in mice. It simply showed the pill increased the levels of the substance in blood cells.

“Elysium is selling pills to people online with the assertion that the pills are ‘clinically proven’” said O’Rahilly. “Thus far, however the benefits and risks of this change in chemistry in humans is unknown.”

“Many interventions that seem sensible on the basis of research in animals turn out to have unexpected effects in man,” he added, citing a large clinical trial of beta carotene that showed it increased rather than decreased the risk of lung cancer in smokers.

Elysium’s own research documented a “small but significant increase in ,” but added more studies were needed to determine whether the changes were “real or due to chance.” One independent has suggested that a component of NAD may influence the growth of some cancers, but researchers involved in the study warned it was too early to know.

Guarente, Elysium’s co-founder and chief scientist, told KHN he isn’t worried about any side effects from Basis, and he emphasized that his company is dedicated to conducting solid research. He said his company monitors customers’ safety reports and advises customers with health issues to consult with their doctors before using it.

If a substance meets the FDA’s definition of a supplement and is advertised that way, then the agency can’t take action unless it proves a danger, said Alta Charo, a former bioethics policy adviser to the Obama administration. Pharmaceuticals must demonstrate safety and efficacy before being marketed.

“A lot of what goes on here is really, really careful phrasing for what you say the thing is for,” said Charo, a law professor at the University of Wisconsin. “If they’re marketing it as a cure for a disease, then they get in trouble with the FDA. If they’re marketing it as a rejuvenator, then the FDA is hamstrung until a danger to the public is proven.”

“This is a recipe for some really unfortunate problems down the road,” Charo added. “We may be lucky and it may turn out that a lot of this stuff turns out to be benignly useless. But for all we know, it’ll be dangerous.”

The debate about the risks and benefits of substances that have yet to be proven to work in humans has triggered a debate over whether research institutions are scrutinizing the financial interests and involvement of their faculty — or the institution itself — closely enough. It remains to be seen whether Cambridge’s decision not to renew its partnership will prompt others to rethink such ties.

Flier, the former dean of Harvard Medical School, had earlier heard complaints and looked into the relationships between scientists and Elysium after he stepped down as dean. He said he that many of the board members who allowed their names and pictures to be posted on the company website knew little about the scientific basis for use of the company’s supplement.

Flier recalls that one scientist had no real role in advising the company and never attended a company meeting. Even so, Elysium was paying him for his role on the board, Flier said.

Caroline Perry, director of communications for Harvard’s Office of Technology Development, said agreements such as of research funds from Elysium comply with university policies and “protect the traditional academic independence of the researchers.”

Harvard “enters into research agreements with corporate partners who express a commitment to advancing science by supporting research led by Harvard faculty,” Perry added.

Like Harvard, the Mayo Clinic refused to release details on how much money it would make off the Elysium licensing agreement. Mayo and Harvard engaged in “substantial diligence and extended negotiations” before entering into the agreement, said a Mayo spokeswoman.

“The company provided convincing proof that they are committed to developing products supported by scientific evidence,” said the spokeswoman, Duska Anastasijevic.

Guarente of Elysium refused to say how much he or Elysium was earning off the sale of the supplement Basis. MIT would not release his conflict-of-interest statements.

Private investment funds, meanwhile, continue to pour into longevity research despite questions about whether the substances work in people.

One key Elysium is the Morningside Group, a private equity firm run by Harvard’s top donor, Gerald Chan, who also gave

Billionaire and WeWork co-founder Adam Neumann has invested in Sinclair’s Life Biosciences.

An investment firm led by engineer and physician Peter Diamandis gave a group of Harvard researchers $5.5 million for their startup company after their research was publicly challenged by several other scientists.

In its announcement of the seed money, the company, Elevian, said its goal was to develop “new medicines” that increase the activity levels of the hormone GDF11

It described research by its founders, which include Harvard’s , as demonstrating that “replenishing a single circulating factor, GDF11, in old animals mirrors the effects of young blood, repairing the heart, brain, muscle and other tissues.”

Other in the field have either failed to replicate or contradict key elements of their observations.

Elevian’s CEO, Mark Allen, said the early scientific data on GDF11 is encouraging, but “drug discovery and development is a time-intensive, risky, regulated process requiring many years of research, preclinical [animal] studies, and human clinical trials to successfully bring new drugs to market.”

Flier worries research in the longevity field could be compromised, although he recognizes the importance and promise of the science. He said he’s concerned that alliances between billionaires and scientists could lead to less skepticism.

“A susceptible billionaire meets a very good salesman scientist who looks him deeply in the eyes and says, ‘There’s no reason why we can’t have a therapy that will let you live 400 or 600 years,’” Flier said. “The billionaire will look back and see someone who is at MIT or Harvard and say, ‘Show me what you can do.’”

Despite concerns about the hype, scientists are hopeful of finding a way forward by relying on hard evidence. The consensus: A pill is on the horizon. It’s just a matter of time — and solid research.

“If you want to make money, hiring a sales rep to push something that hasn’t been tested is a really great strategy,” said Miller, who is testing substances on mice. “If instead you want to find drugs that work in people, you take a very different approach. It doesn’t involve sales pitches. It involves the long, laborious, slogging process of actually doing research.”

KHN senior correspondent Jay Hancock contributed to this report.

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Among the most prominent: Dr. Robert Redfield, director of the Centers for Disease Control and Prevention. Smith said he enthusiastically urged administration officials to pick his longtime friend and associate, who now oversees one of the agencies that fund the multibillion-dollar international prevention and treatment program known as the President’s Emergency Plan for AIDS Relief (PEPFAR).

And within the White House itself are certain aides the activist has known for years, as he acknowledged during a series of interviews with Kaiser Health News. They include Katy Talento, a leading conservative voice on health care policy, and staffers in Vice President Mike Pence’s office who court religious conservatives on a variety of issues.

Even Smith’s wife, who has had her own high-profile activism over the years, is working on abstinence efforts within the administration. Anita Smith was hired recently as a part-time PEPFAR consultant by one of the couple’s longtime allies.

“This is the new in crowd,” said Paul Zeitz, an expert on global AIDS epidemic control who worked for the State Department from mid-2014 until last August. “These are the people who are likely to be influencing how we spend taxpayer money on AIDS efforts for the rest of the administration.”

Such connections signal a resurgence of religious conservatives’ influence over health care issues well beyond abstinence education. Last year, President Donald Trump announced that PEPFAR must now follow the , which bans foreign, non-governmental organizations from using their funds for abortion-related services such as counseling.

The origins of Shepherd Smith’s high-profile contacts are detailed in memos, letters and military documents in an archive of KHN examined hundreds of pages there to help assess the Trump administration’s approach to health policy and AIDS treatment and prevention.

While PEPFAR is credited with saving millions of lives in Africa and elsewhere, several of its programs, especially those encouraging abstinence, have been criticized by scientists and relief experts as ineffective and impractical.

In the late 1980s, Smith developed relationships with government scientists even as other religious leaders balked at the idea of getting involved in AIDS prevention efforts. That included recruiting Redfield, at what was then Walter Reed Army Medical Center, to join the advisory board of the Smiths’ fledgling Americans for a Sound AIDS/HIV Policy. The now-defunct organization strongly supported abstinence education.

“We sought [the scientists] out because we thought they were doing the right thing,” the 73-year-old Smith told KHN. “It’s not rocket science. We figured out a plan for our message to become important.”

Redfield also served as chairman and an advisory board member of another organization that Smith and his wife later founded. He stepped down from Children’s AIDS Fund International, which also backs abstinence education, only to comply with government ethics rules after he joined the CDC in March.

In recent media interviews, the physician-researcher said he has rethought his opposition to promoting condom use in the fight against AIDS. He elaborated on that in a statement in July to KHN, saying he supports programs that encourage people who are not sexually active to delay sex and have fewer partners — an approach hailed by conservative activists.

“We know that abstinence is the only 100 percent effective way to prevent HIV and other transmitted diseases,” he noted in the statement.

Anita Smith is now a consultant within PEPFAR to Deborah Birx, a physician and ambassador-at-large who oversees the program’s estimated $5 billion annual budget. Birx is also a former board member of Children’s AIDS Fund International and served until she was hired by the CDC in 2005, a PEPFAR spokesman said. (The organization received PEPFAR grants between 2004 and 2008 despite an early evaluation from experts who deemed it “not suitable for funding,” at the time.)

Smith’s hiring earlier this year was part of a strategy to improve prevention programs aimed at preteen girls, including support for “decision-making around whether to delay, abstain or protect,” according to a statement from Birx’s office.

“The administration is trying to put sweeteners in there for religious conservatives,” said Heather Boonstra, director of public policy at the Guttmacher Institute, a nonprofit focused on reproductive health. “It’s not as if these concepts are a problem if they are included as part of a whole array of programs. The concern is that these changes are opening the door for a greater number of programs that focus solely on abstinence.”

Through her husband, Anita Smith declined to answer any questions. “My wife is an expert on these types of programs,” he said, “so it’s not surprising she would be asked to weigh in.” She remains president of the children’s AIDS organization, which is based in Sterling, Va. Shepherd Smith no longer has an official position there.

Birx’s statement explained her connection to the couple, noting that she became involved in the children’s organization through an annual Christmas event of gift-wrapping presents for families affected by HIV. “When they asked me to join their board, I did so to show my support for the concept of services to others in need,” she said.

Shepherd Smith’s alliances can be traced through the University of Michigan archive. It was set up by science writer Jon Cohen, whose 2001 book, “” examined what went wrong in the epidemic’s early years. According to a government transcript there, Smith sized up Redfield swiftly when they first met. “He was as happy to see us, as we were him,” Smith said in an interview with military investigators. Their relationship deepened as the activist and scientist rose in prominence, Smith’s letters to Walter Reed officials suggest.

Smith, who secured CDC dollars for Americans for a Sound AIDS/HIV Policy (ASAP) in the 1980s, regularly stopped by Walter Reed to see Redfield and others who joined the organization’s board, according to military records in the archive. Under Smith’s direction, ASAP touted Redfield’s vaccine research as being “the most important scientific advancement in the epidemic to date.” In turn, as ASAP chairman, Redfield called the group “the most effective AIDS/HIV organization I know” in its 1991 annual report.

The archive reveals that some Walter Reed scientists complained to Army officials about the organization’s possible influence with Redfield. The complaints triggered an inquiry into allegations that Smith was pressuring researchers to skew Redfield’s vaccine data to help secure congressional funding.

Though Redfield insisted he did not give Smith preferential treatment, a military investigator found that the researcher violated military rules and recommended the “close relationship” between Walter Reed and ASAP be “severed so there is not an appearance of endorsement or favoritism.” A separate inquiry concluded that Redfield had publicly overstated his data but cleared him of scientific misconduct charges.

In 1996, Redfield left the military and helped to establish the University of Maryland’s Institute of Human Virology.

To this day, Smith remains a fierce supporter. After controversy stirred over Redfield’s $375,000 salary — significantly more than previous CDC leaders earned — Smith told KHN the amount was well deserved. It ultimately was reduced to $209,700.

Smith describes himself as still pushing others hard for both information and action to stop the AIDS epidemic, but he demurred when asked how regularly he contacts administration officials, including the CDC director.

“I have no control over the guy,” Smith said when asked whether he expected Redfield to implement policy changes he supports. “I can only hope we’ll have a little more balance than we’ve seen in the last few years.”

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Previously, the administration’s “zero-tolerance” immigration stance meant splitting children from parents.Ìý Immigration authorities acknowledged that during that policy 2,322 children 12 and under Ìýwere detained and placed in facilities run by the Department of Health and Human Service.

The policy of detaining families “during the pendency of their immigration cases” was announced Friday night in a . But experts and former government officials warn the new approach — which places parents and children in the custody of the Department of Homeland Security for months or even longer — won’t improve the situation.

The DOJ declined to comment. DHS did not immediately respond to requests for comment.

“We’re seeing a repeat pattern of this administration,” said Sarah Pierce, a policy analyst with the Migration Policy Institute and former immigration attorney. “The president makes laws and policies and the administration then struggles to implement what he does.”

For longer detentions, DHS will need resources for young children that the agency doesn’t generally set up, such as educational facilities.

“They even need diapers, formula and bottles,” Pierce said. “We’re talking about the basics for caring for children.”

Making matters more complicated, DHS’ family facilities under the indefinite detention policy. The White House has also asked the Department of Defense to make detention facilities available.

“DHS’ primary focus — [its facilities] were designed to hold these people, and not let them out,” said Peter Boogaard, a former DHS spokesman under the Obama administration. “It is not in any way designed to protect the health and well-being of families and young children.”

While the Obama administration grappled with a sudden influx of families in 2014, the detention of families triggered litigation under the agreement, which required that families be detained together at DHS facilities and the children be released within 20 days. The Obama administration then began releasing the families under the agreement.

“Most of these families were released before the 20 days were up,” Pierce said.

The has also requested the Flores settlement be modified to permit longer detention of families being prosecuted, including children.

People who are stopped by the U.S. Border Patrol receive some baseline health screenings. And the Office of Refugee Resettlement, the HHS program in charge of “unaccompanied alien children,” typically provides some medical care for children detained at the border, including consultations with child psychologists and social workers.

In recent weeks, ORR — which took responsibility for children who had been separated from their parents — has come for providing reportedly substandard care, including reports that children’s psychiatric records and case files were being used in immigration court. Many experts have also suggested ORR couldn’t handle the number of kids being detained, and lacked expertise in caring for the many 12-and-under children detained who were separated from their families.

Still, unlike DHS, many noted, ORR has some expertise in providing children’s health services. Boogaard said he was unfamiliar with any protocols to ensure kids receive adequate vaccinations, or consultations with child psychologists and social workers.

“They are not resourced and not staffed to be able to deal with the unique challenges of dealing with children,” he said.

U.S. Immigration and Customs Enforcement, the DHS agency that operates detention centers, redirected questions to on standards for family centers. It says residents will have access to “health care education and maintenance services that are determined by the health care authority to be necessary and appropriate,” including “prevention, diagnosis, and treatment of medical, dental, and mental health conditions.”

Advocates and watchdog organizations, though, suggest that hasn’t been the case.

A argued “dangerously substandard medical care” had contributed to eight out of the 15 deaths documented in records released by ICE from December 2015 to April 2017. Medical reviewers also noted instances of poor medical care in six of the other deaths.

“ICE’s record of providing inadequate care to adults does not bode well if the agency is put in charge of providing care to increasing numbers of children,” said Alison Parker, who directs HRW’s U.S. program.

Meanwhile, children currently crossing the border have particularly intense health needs — in no small part because many are fleeing violent circumstances. Lengthy detention can add to that trauma, experts said.

“Historically thinking about what family detention has looked like in this country, we have reason to be concerned,” said Shadi Houshyar, who directs early childhood and child welfare initiatives at Families USA, an advocacy group. “Detention is no place for children.”

Prior to the 2015 ruling, she added, children in detention facilities were found “dehydrated, and not eating, and having intestinal problems.” Many new mothers, she added, experienced depression and trouble nursing.

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Su bienestar está siendo supervisado por una pequeña división del Departamento de Salud y Servicios Humanos, la Oficina de Reasentamiento de Refugiados (ORR), que tiene poca o ninguna experiencia en el cuidado de niños pequeños.

El número de niños bajo custodia se ha disparado en las últimas seis semanas, desde que la administración Trump comenzó a detener a los padres y a sus hijos en la frontera de los Estados Unidos, separándolos y enviándolos a diferentes instalaciones. Un total de 11.786 menores de 18 años están detenidos actualmente, dijo el funcionario.

El presidente Donald Trump firmó una el miércoles 20 de junio para que se detenga a los padres y a sus hijos juntos.Ìý La orden también pasa la supervisión de este proceso del HHS al Departamento de Seguridad Nacional. Pero no está claro cuándo los niños se reunirán con sus padres, y si esta orden cumplirá con los estandares para el tratamiento de niños bajo custodia, conocido como el acuerdo Flores.

Desde 2003, la ORR ha estado a cargo de albergar y encontrar hogares adecuados para “niños extranjeros no acompañados”, generalmente inmigrantes adolescentes que llegan a los Estados Unidos sin un padre o tutor.

Pero sus responsabilidades han cambiado y han aumentado exponencialmente desde abril por las nuevas políticas migratorias, lo que significa que la oficina ahora es responsable de tener bajo custodia no solo a más niños, sino también a niños mucho más pequeños que los que llegaron en el pasado, dijeron expertos.

Más allá de la atención médica especializada, los niños más pequeños tienen diferentes necesidades de alimentos y vivienda, y requieren una atención personalizada.

“Los niños son más chiquitos y estarán allí por un tiempo más prolongado, y están profundamente traumatizados al ser separados de sus padres por la fuerza”, dijo Mark Greenberg, ex funcionario de la Administración para Niños y Familias del HHS, que supervisa la ORR. “Todo eso hace que sea mucho más difícil operar el programa”.

La compleja crisis se magnifica por la inexperiencia de algunos de los responsables políticos que lideran estas acciones, dijeron los críticos, entre ellos ex funcionarios de las administraciones republicana y demócrata de la última década.

Scott Lloyd, director de la ORR, es un abogado cuya carrera se ha centrado en impulsar estrategias contra el aborto. Fue el que dirigió los esfuerzos legales de la administración Trump para prohibir abortos en inmigrantes adolescentes detenidas. La principal experiencia de inmigración de Lloyd antes de liderar la ORR fue la investigación para un informe sobre refugiados realizada para los Knights of Columbus, una organización católica con una postura antiabortista, según .

Kenneth Wolfe, el vocero de HHS que proporcionó las cifras de menores detenidos, se negó a contestar preguntas sobre cuántas personas trabajan actualmente en la ORR o si la oficina ha asegurado personal adicional o la experiencia necesaria para hacer frente a la afluencia de niños pequeños. Tampoco dijo cuántos de los 2,322 niños menores de 13 años han sido separados de sus familias.

Antes, la administración se había negado a proporcionar las edades de los niños separados de sus familias, diciendo solamente que alrededor de 2,300 niños han sido separados y detenidos desde que la política entró en vigencia.

Las condiciones de detención, que incluyen a niños retenidos en corrales y tiendas de campaña, han encendido una tormenta política sobre posibles abusos en el tratamiento de niños de tan solo 4 años. Algunos de estos niños, incluidos los más pequeños, están siendo enviados a refugios especiales para niños pequeños, según informes de medios. La atención también es costosa: solo las tiendas le cuestan al HHS $775 por persona por día, según estos reportes.

Los republicanos, incluida la , han pedido a la administración que ponga un freno a estas acciones. El presidente Donald Trump ha culpado al Congreso por las detenciones, pero los principales asesores de la Casa Blanca han promovido activamente las separaciones familiares como un cambio de política.

Los han descrito a los niños de hasta 5 años siendo regañados por jugar, un adolescente enseñando a otros cómo cambiar el pañal de un niño pequeño, y cuidadores a los que no se les permite tocar a los niños. ProPublica informó que .

La ORR, agregan los expertos, ya está en desventaja.

“Es muy difícil y costoso crear esa capacidad”, señaló Robert Carey, ex director de la ORR durante la administración Obama. “Todos los aspectos de la atención son dramáticamente diferentes en función de la edad… se necesitan personas capacitadas en el desarrollo o cuidado de la primera infancia”.

Esa es una carga pesada para una oficina que, insisten expertos, nunca fue pensada para servir como un sistema de vivienda a largo plazo.

Carey y otros dijeron que no está claro si la administración tuvo suficiente tiempo o apoyo para adaptarse.

Muchos empleados de la ORR, agregó Carey, son personal de carrera con amplios conocimientos sobre inmigración y bienestar infantil, con quienes él mismo trabajó frecuentemente durante su mandato.

“Los niños están bajo la custodia de la ORR sin los recursos adecuados”, dijo Shadi Houshyar, quien dirige las iniciativas de primera infancia y bienestar infantil en Families USA, un grupo de defensa. “Definitivamente va a dar lugar a que se tomen decisiones potencialmente perjudiciales”. La capacidad, el entrenamiento y la orientación fundamentales, como la comprensión de las necesidades de los niños, no es la orientación que tiene la ORR”.

Mientras la ORR tiene un historial de ubicar a adolescentes que llegan solos con parientes en los Estados Unidos, ese desafío crece por la política de separar a los niños, que son pequeños y pueden entender muy poco sobre esta experiencia, o pueden no ser capaces de identificar a los familiares que podrían acogerlos.

Para complicar más las cosas, cuando las familias están separadas, los padres e hijos son monitoreados por diferentes agencias federales: los padres por el Departamento de Seguridad Nacional y los niños por la ORR. A los niños pequeños se los trata de la misma manera que a los menores que llegaron por su cuenta. Todo esto hace que la reunificación sea más difícil. Y ese es un problema que preocupa a los expertos, incluso si se termina con las separaciones familiares.

“No parece que hayan encontrado una solución a este proceso”, dijo un ex funcionario de HHS, que solicitó el anonimato porque podría enfrentar problemas profesionales por hablar en público. Como resultado, agregó, “el tiempo que el niño permanece en la ORR podría ser significativamente más prolongado”, lo que a su vez aumenta el trauma y causa otros problemas a largo plazo.

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The Trump administration has detained 2,322 children 12 years old or younger amid its border crackdown, a Department of Health and Human Services official told Kaiser Health News on Wednesday. They represent almost 20 percent of the immigrant children currently held by the U.S. government in the wake of its latest immigrant prosecution policy.

Their welfare is being overseen by a small division of the Department of Health and Human Services — the Office of Refugee Resettlement (ORR) — which has little experience or expertise in handling very young children.

The number of children has exploded in the past six weeks since the Trump administration moved to stop parents and their children at the U.S. border and separate and detain them in different facilities. A total of 11,786 children under age 18 are currently detained, the official said.

President Donald Trump signed an Wednesday that seeks to detain parents and children together. The order also changes oversight of detention from HHS to the Department of Homeland Security. But it’s unclear whether the children currently detained by HHS will be transferred and whether the order will comply with a court standard for the treatment of children in custody, known as the Flores agreement.

Since 2003, ORR has been charged with sheltering and finding suitable homes for “unaccompanied alien children” — generally teenaged immigrants who reach the United States without a parent or guardian.

But its responsibilities have morphed and multiplied since April because the immigration crackdown means that the ORR is now responsible for detaining not only more children, but minors who are far younger than those who had arrived in the past, experts said.

Beyond specialized medical care, younger children have different food and housing needs, and require more personal attention.

“The children are younger and will be there for a longer time and are deeply traumatized by being forcibly separated from their parents,” said Mark Greenberg, a former administration official at HHS’ Administration for Children and Families, which oversees the ORR. “All of that makes it much more difficult to operate the program.”

The complex crisis is magnified by the inexperience of some of the political appointees leading the response, said critics who include former officials from both Republican and Democratic administrations of the past decade.

ORR Director Scott Lloyd is a lawyer whose career has been focused on anti-abortion efforts. He led the Trump administration’s legal efforts to prevent abortions for detained teen immigrants. Lloyd’s main immigration experience before leading ORR was research for a report on refugees for the Knights of Columbus, a Catholic service organization with an anti-abortion stance,

Kenneth Wolfe, the HHS spokesman who provided the figures, declined to address how many people are currently working at ORR or whether ORR had secured additional staff or expertise to cope with the influx of young children. He also would not say how many of the 2,322 children 12 and younger have been separated from their families.

The administration had previously refused to provide the ages of the children separated from their families — saying only that about 2,300 children have been separated and detained since the policy took effect.

The detention conditions, which include children being held in chain-link holding pens and “tent cities,” have ignited a political firestorm over possible abuse in the treatment of children as young as 4. Some of these younger children — including toddlers — are being sent to “tender age” shelters, according to media reports. The care is also costly: Tents alone cost HHS $775 per person per day, according to media reports.

Republicans, including former , have called on the administration to stop the policy. Trump has blamed Congress for the detentions, but top White House advisers were actively promoting family separations as a policy shift.

have described children as young as 5 being scolded for playing, one teenager teaching others how to change a small child’s diaper, and caretakers not being permitted to touch children. ProPublica reported that detained are younger than 4.

ORR, experts add, is already at a disadvantage.

“It’s significantly challenging to create that capacity, and quite expensive,” noted Robert Carey, a former ORR director from the Obama administration. “All the aspects of care are dramatically different based on age. … You need people who are trained in early childhood development or care.”

That’s a heavy lift for an office that, experts stress, was never built to serve as a long-term housing system.

It’s not clear, Carey and others said, that the administration has had sufficient time or support to adapt.

Many ORR employees, Carey added, are career staffers with deep knowledge about immigration and child welfare, with whom he frequently worked while in office.

“The kids are going into the custody of ORR without adequate resources,” said Shadi Houshyar, who directs early childhood and child welfare initiatives at Families USA, an advocacy group. “It’s definitely going to result in some potentially damaging decisions being made. The capacity, training and fundamental orientation — while understanding the needs of children — is not the orientation that ORR has.”

While ORR has a history of placing teenagers who arrive on their own with relatives of families in the U.S., that challenge is heightened by the policy of separating children, who are young and may understand little of the experience or be able to identify relatives who could take them in.

Making matters more complicated, when families are separated, parents and children are tracked by different federal agencies — the parents by the U.S. Department of Homeland Security, and the children by ORR. Children are also tracked and treated the same as minors who arrived on their own. Together, that makes reunification more difficult. And that’s a problem experts worry will persist, even if family separations cease.

“It does not look like they’ve figured out this process,” said a former HHS official, who requested anonymity because she could face professional ramifications for speaking publicly. As a result, she added, “the time the child stays in ORR could be significantly longer” — which in turn adds to trauma and causes other long-term problems.

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The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned.

SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.

According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.

The FDA rarely prosecutes research violations, usually choosing to administratively sanction or ban researchers or companies from future clinical trials, legal experts said. Even so, the agency is empowered to pursue as a crime the unauthorized development of vaccines and drugs — and sometimes goes after such cases to send a message.

In this case, human-subject violations would be deemed especially serious given Halford was not a medical doctor and had injected people with his experimental vaccine without any routine oversight, experts said.

“Since the research appears to be an effort to totally evade FDA oversight and is egregious, it makes sense the FDA would investigate it as a criminal matter,” said Patricia Zettler, a former FDA lawyer who was told of the criminal investigation by KHN. “There is a deterrent effect for others who might consider this a very brazen way to get out of human subject and FDA requirements.”

The FDA declined to comment. Rational Vaccines did not respond to requests for comment. An SIU spokeswoman said, without elaboration, “The government is investigating and we are cooperating.”

Sen. Chuck Grassley (D-Iowa), the chair of the Judiciary Committee, applauded the FDA’s action after he had called on the agency to look into the matter, citing Kaiser Health News’ investigation.

“We ought to find out if the research was done with the knowledge of those who should’ve acted to stop it instead of turning a blind eye …” he said in a statement. “This research broke just about every rule in the book and put human subjects at extreme health risk.”

Any resulting criminal prosecution from the investigation could have political ramifications.

Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III and the company received millions of dollars in private investment from investors after the Caribbean trial, including from billionaire Peter Thiel.

Thiel, who for months has refused to respond to questions from KHN, contributed to President Donald Trump’s campaign and is a high-profile critic of the FDA. Thiel is part of a larger libertarian movement to roll back FDA regulations to speed up medical innovation.

The sources familiar with the inquiry said the FDA’s Office of Criminal Investigations,Ìý, began to aggressively pursue the case weeks ago.

The investigators have interviewed witnesses across the country, asking them to identify Halford’s associates, and have described his actions as possible violations of human-subject guidelines and of FDA regulations, the sources told KHN.

The investigators also have expressed interest in whether Halford’s former associates at the university or other researchers and medical professionals outside the university might have helped or known about his conduct, the sources said. They also have raised questions about the company’s knowledge of the violations.

Rational Vaccines helped oversee the Caribbean trial, but the 2013 hotel injections took place before the company was formed.

Under a Supreme Court , a corporate official may be prosecuted for a criminal misdemeanor offense under the even without proof that the official acted with intent or actual knowledge of the offense.

Initially, university officials and Rational Vaccines publicly defended Halford’s research. Rational Vaccines has said it considered the 2016 trial a success — though it is unclear what data it used to support that claim.

After KHN’s investigation revealed that Halford injected people in the United States, not just in the Caribbean, Rational Vaccines took down its website, although it had vowed to continue research.

SIU, a state university with a medical school in Springfield, Ill., initially said it bore no responsibility for the experiments because Halford conducted the research independently and overseas.

After Kaiser Health News raised questions about Halford’s practices, the Department of Health and Human Services asked the university to determine whether his activities violated the institution’s pledge to HHS to follow human-subject safety protocols for all research. SIU’s medical school receives about $ 9 million a year in federal research dollars.

SIU has since acknowledged that Halford’s conduct violated university rules and U.S. laws. University officials have denied knowing about his misconduct, an assertion that FDA investigators are still probing, the sources said.

Halford’s actions already raised unusual legal questions because the FDA would not ordinarily have jurisdiction over clinical trials when they occur overseas and the researchers have not sought FDA approval.

It’s also unclear where Halford manufactured the vaccine.

If it was manufactured in the United States, the FDA likely has jurisdiction, said Zettler, a law professor at Georgia State University.

The OCI often goes after such cases of contaminated food, counterfeit or off-label pharmaceuticals. The office was created in the wake of a 1988 scandal in which pharmaceutical executives bribed FDA officials in exchange for speeding up generic drug approvals.

While rare, the OCI occasionally pursues research abuses as a crime. A , for instance, pleaded guilty in 2010 to charges related to her fabrication of data in a study of children taking the antidepressant Paxil. later agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability in the case.

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For four years, her doctor prescribed the 61-year-old a wide range of opioids for her transverse myelitis, a debilitating disease that caused pain, muscle weakness and paralysis.

The drugs not only failed to ease her symptoms, they hooked her.

When her home state of New York legalized marijuana for the treatment of select medical ailments, Owens decided it was time to swap pills for pot. But her doctors refused to help.

“Even though medical marijuana is legal, none of my doctors were willing to talk to me about it,” she said. “They just kept telling me to take opioids.”

While 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Owen who use marijuana and the doctors who treat them are caught in the middle of a conflict in federal and state laws — a predicament that is only worsened by thin scientific data.

Because the federal government classifies marijuana a Schedule 1 drugÌý— by definition a substance with no currently accepted medical use and a high potential for abuse — research on marijuana or its active ingredients is highly restricted and even discouraged in some cases.

Underscoring the federal government’s position, Health and Human Services Secretary Alex Azar recently pronounced that there was “no such thing as medical marijuana.”

Scientists say that stance prevents them from conducting the high-quality research required for FDA approval, even as some early research indicates marijuana might be a promising alterative to opioids or other medicines.

Patients and physicians, meanwhile, lack guidance when making decisions about medical treatment for an array of serious conditions.

“We have the federal government and the state governments driving a hundred miles an hour in the opposite direction when they should be coming together to obtain more scientific data,” said Dr. Orrin Devinsky, who is researching the effects of cannabidiol, an active ingredient of marijuana, on epilepsy. “It’s like saying in 1960, ‘We’re not going to the moon because no one agrees how to get there.’”

The problem stems partly from the fact that the federal government’s restrictive marijuana research policies have not been overhauled in more than 40 years, researchers say.

Only one federal government contractor grows marijuana for federally funded research. Researchers complain the pot grown by the contractor at the is inadequate for high-quality studies.

, which comes in a micronized form, is less potent than the pot offered at dispensaries, researchers say. It also differs from other products offered at dispensaries, such as so-called edibles that are eaten like snacks. The difference makes it difficult to compare the real-life effects of the marijuana compounds.

Researchers also face time-consuming and costly hurdles in completing the complicated federal application process for using marijuana in long-term clinical trials.

“It’s public policy before science,” said Dr. Chinazo Cunningham, a primary care doctor who is the lead investigator on one of the few federally funded studies exploring marijuana as a treatment for pain. “The federal government’s policies really make it much more difficult.”

Cunningham, who received a five-year, $3.8 million federal grant, will not be administering marijuana directly to participants. Instead, she will follow 250 HIV-positive and HIV-negative adults with chronic pain who use opioids and have been certified to get medical marijuana from a dispensary.

“It’s a catch-22,” said Cunningham, who is with the Albert Einstein College of Medicine. “We’re going to be looking at all of these issues — age, disease, level of pain — but when we’re done, there’s the danger that people are going to say ‘Oh, it’s anecdotal’ or that it’s inherently flawed because it’s not a randomized trial.’’

Without clear answers, hospitals, doctors and patients are left to their own devices, which can result in poor treatment and needless suffering.

Hospitals and other medical facilities have to decide what to do with newly hospitalized patients who normally take medical marijuana at home.

Some have a “don’t ask, don’t tell” approach, said Devinsky, who sometimes advises his patients to use it. Others ban its use and substitute opioids or other prescriptions.

Young adults, for instance, have had to stop taking cannabidiol compounds for their epilepsy because they’re in federally funded group homes, said Devinsky, the director of NYU Langone’s Comprehensive Epilepsy Center.

“These kids end up getting seizures again,” he said. “This whole situation has created a hodgepodge of insanity.”

The Trump administration, however, has resisted policy changes.

Last year, the had been gearing up to allow facilities other than the University of Mississippi to grow pot for research. But after the DEA received 26 applications from other growers, Attorney General Jeff Sessions halted the initiative.

The Department of Veterans Affairs also recently announced it would not fund studies of using marijuana compounds to treat ailments such as pain.

The DEA and HHS have cited concerns about medical supervision, addiction and a lack of “well-controlled studies proving efficacy.”

Patients, meanwhile, forge ahead.

While experts say they don’t know exactly how many older Americans rely on marijuana for medicinal purposes, the number of Americans 65 and older who say they are using the drug from 2006 to 2013.

Some patients turn to friends, patient advocacy groups or online support groups for information.

Owen, for one, kept searching for a doctor and eventually found a neurologist willing to certify her to use marijuana and advise her on what to take.

“It’s saved my life,” said the retired university administrative assistant who credited marijuana for weaning her off opioids. “It not only helps my pain, but I can think, walk and talk again.”

Mary Jo, a Minnesotan, was afraid of being identified as a medical marijuana user, even though she now helps friends navigate the process and it’s legal in her home state.

“There’s still a stigma,” said Mary Jo, who found it effective for treating her pain from a nerve condition. “Nobody helps you figure it out, so you kind of play around with it on your own.”

Still, doctors and scientists worry about the implications of such experimentation.

In a sweeping report last year, the National Academies of Sciences, Engineering and Medicine called on the federal government to support better research, decrying the “lack of definitive evidence on using medical marijuana.”

The national academies’ committee reviewed more than 10,000 scientific abstracts related to the topic. It made 100 conclusions based on its review,Ìý finding evidence that marijuana relieves pain and chemotherapy-induced nausea. But it found “inadequate information” to support or refute effects on Parkinson’s disease.

Yet those who find that medical marijuana helps them can become fierce advocates no matter what their doctors say.

Caryl Barrett, a 54-year-old who lives in Georgia, said she decided to travel out of state to Colorado to treat her pain from her transverse myelitis and the autoimmune disease neurosarcoidosis.

“I realized it worked and I decided to bring it back with me,” she said. “I broke federal law.”

Georgia, meanwhile, permitted limited medicinal use of marijuana but did not set up dispensaries. As a result, patients resort to ordering it online or driving to another state to get it.

The conflict in the law makes her uneasy. But Barrett, who had been on opioids for a decade, said she feels so strongly about it working that “if someone wants to arrest me, bring it on.”

Others experience mixed results.

Melodie Beckham, who had metastatic lung cancer, tried medical marijuana for 13 days in a clinical trial at Connecticut Hospice before deciding to quit.

“She was hopeful that it would help her relax and just kind of enjoy those days,” said her daughter, Laura Beckham.

Instead, it seemed to make her mother, who died in July at age 69, “a little more agitated or more paranoid.”

The marijuana “didn’t seem effective,” nor did it keep her mother from hitting her pain pump to get extra doses of an opioid, her daughter said.

The researchers running the trial at Connecticut Hospice spent two years getting necessary approvals from the Food and Drug Administration, the National Institute on Drug Abuse (NIDA) and the DEA.

Started in May, the trial has enrolled only seven of the 66 patients it plans to sign up because many patients were too sick, too close to death or simply couldn’t swallow the pills. So far, the trial has shown “mixed results,” said James Prota, director of pharmacy for the hospice.

Researchers point out they are still exploring the basics when it comes to marijuana’s effects on older adults or the terminally ill.

“We just have no data on how many older adults are using medical marijuana, what they are using it for and most importantly what are the outcomes,” said Brian Kaskie, a professor at the University of Iowa’s College of Public Health. “It’s all anecdotal.”

Kaskie, who specializes in public policy and the aging, received grants from the state of Colorado and the Chicago-based to survey the use of medical marijuana by older Americans.

In many quarters, there’s a growing appetite for solid information, he said.

“When I first started this, my colleagues joked we were going to find all the aging hippies who listen to the Grateful Dead,” said Kaskie, who has been studying medicinal marijuana for years. “Now, they’re starting to realize this is a legitimate area of research.”

Twenty researchers received marijuana from the federal program last year, which was more than any previous year since 2010, according to NIDA statistics.

In a recent funding announcement, the National Institutes of Health requested grant applications to study the effects of on older adults and .

NIH, however, continues to funnel much of its funding into studying the adverse effects of marijuana, researchers said.

Although NIH acknowledged in one of the announcements that some research supports “possible benefits” of marijuana, it emphasized “there have not been adequate large controlled trials to support these claims.”

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