Nueva vacuna para el tratamiento de la fibromialgia que realmente funciona

Si alguien pudiera administrarte una vacuna que pudiera curar tu fibromialgia, ¿harías eso? Puede sonar como un sueño, pero está más cerca de la realidad de lo que piensas. La biomédica con sede en Los Ángeles,    EpicGenetics    y el Hospital General de Massachusetts están buscando la aprobación de la FDA   para probar la vacuna Bacillus Calmette-Guerin (BCG) el próximo año como un posible tratamiento para la fibromialgia.

BCG es una vacuna genérica contra la tuberculosis que tiene casi 100 años y se ha administrado de manera segura millones de veces “, dice el Dr. Denise Faustman, directora del laboratorio Faustman en el Hospital General de Massachusetts. “Durante más de diez años, nuestro grupo de investigación en el Hospital General de Massachusetts ha estado explorando activamente el papel de la vacuna BCG en el tratamiento de varias formas de autoinmunidad. Nuestro objetivo actual es la diabetes tipo 1, pero en general, BCG se está probando en una serie de enfermedades autoinmunes. En los próximos dos años, comenzaremos ensayos clínicos sobre BCG en fibromialgia. “

Según la Organización Mundial de la Salud, más de 100 millones de niños reciben la vacuna BCG cada año. Se utiliza principalmente en los países en desarrollo donde la TB todavía está activa. La vacuna BCG no está disponible en los Estados Unidos debido al bajo riesgo de infección. En los Estados Unidos, BCG se usa en un pequeño número de pacientes para tratar el cáncer de vejiga.

La pregunta obvia es: ¿por qué debería usarse una vacuna contra la enfermedad pulmonar infecciosa contra la fibromialgia? La respuesta está en el sistema inmunológico.

Las vacunas se administran generalmente a personas sanas para prevenir infecciones. En este caso, sin embargo, la vacuna BCG se administraría a pacientes con fibromialgia para aliviar sus síntomas.

Cuando se encargó a EpicGenetics que produjera una prueba de diagnóstico para la fibromialgia hace unos años, los investigadores realizaron todos los tipos de pruebas de laboratorio en pacientes con fibromialgia para determinar su diferencia con respecto a los controles saludables y sus síntomas. Los investigadores han descubierto varias anomalías de los glóbulos blancos en pacientes con fibromialgia, lo que lleva a la conclusión de que los síntomas están relacionados con un sistema inmunitario debilitado.

“Creemos que [el término] fibromialgia es un término inadecuado”, dijo el Dr. Bruce Gillis, CEO de EpicGenetics. “Estas personas, por ejemplo, no sufren de algo que afecta los músculos. Entre ellos, sufren que su sistema inmunológico no puede producir niveles normales de proteínas protectoras. … Hay células en el sistema inmunológico llamadas células mononucleares de sangre periférica. No producen niveles normales de proteínas protectoras llamadas quimiocinas y citoquinas. “

El descubrimiento llevó al desarrollo de un análisis de FM / sangre para la fibromialgia. (Sí, a pesar de las declaraciones de sus médicos, hay un análisis de sangre para la fibromialgia que no se acepta en la medicina). La prueba analiza los niveles de cuatro quimiocinas y citoquinas encontradas en cantidades reducidas en pacientes con fibromialgia: estas cuatro quimiocinas y citoquinas Son los mismos que los estimulados por la vacuna BCG.

“Dado lo que se ha publicado en la literatura médica, creemos que esta vacuna revertirá las anomalías del sistema inmunitario [fibromialgia]”, dijo Gillis.

Gillis y Faustman están buscando la aprobación de la FDA para entregar las primeras vacunas BCG en pacientes con fibromialgia a principios del próximo año.

“Esta es la primera vez que se realiza un tratamiento directo para la fibromialgia”, dijo Gillis. “Como saben, los medicamentos contra la fibromialgia actualmente en el mercado solo tratan los síntomas. No tienen ninguna ventaja sobre el sistema inmunológico. [Las compañías farmacéuticas] admiten que solo necesitan tratar los síntomas, pero necesitan tratar la enfermedad, por lo que estamos progresando en el uso de la vacuna [en la FDA]. “

Si la teoría de Gillis es cierta, entonces “las quimiocinas y las citoquinas deficientes en pacientes con fibromialgia ya no serán deficientes [una vez que se administre la vacuna BCG”, dijo Gillis. “Los niveles de producción se están normalizando y hay que asumir que sus síntomas desaparecen. Creemos que estamos al borde de algo grande. “

Dado que la vacuna tiene una larga historia, no debe causar efectos secundarios importantes en los pacientes.

La vacuna BCG debería costar entre $ 20 y $ 25 por dosis, una cantidad nominal en comparación con el costo actual de la medicación diaria.

“Creemos que un paciente con fibromialgia necesita una o dos dosis para comprender por qué no recibo mucho apoyo de las compañías farmacéuticas”, dijo Gillis.

Además del ensayo de la vacuna, EpicGenetics colabora con la Universidad de California en Los Ángeles (UCLA) y el Colegio de Medicina de Chicago en la Universidad de Illinois para secuenciar los genomas de 250,000 pacientes con fibromialgia.

“Estamos buscando patrones genéticos, anomalías o mutaciones”, dijo Gillis.

Los pacientes con fibromialgia positiva que usan la prueba de FM / a pueden participar en el estudio del genoma.

La prueba de FM / A actualmente cuesta $ 936, pero está cubierta por algunas compañías de seguros y Medicare. El equipo de apoyo de EpicGenetics ayuda a los pacientes a determinar si su seguro cubre la prueba. Para aquellos que no están asegurados o cuyo seguro no cubre la prueba, hay disponible un plan de pago sin intereses.

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