Si alguien pudiera darle una vacuna que curaría su fibromialgia, ¿lo haría? Eso puede sonar como un sueño, pero está más cerca de la realidad de lo que podrías pensar. La firma biomédica con sede en Los Ángeles EpicGenetics y los investigadores del Hospital General de Massachusetts están buscando la aprobación de la Administración de Alimentos y Medicamentos de los EE. UU. Para realizar un ensayo clínico el próximo año para probar la vacuna Bacille Calmette-Guerin (BCG) como tratamiento potencial para la fibromialgia.
BCG es una vacuna genérica contra la tuberculosis que tiene casi 100 años y se ha administrado en forma segura millones de veces “, explicó la Dra. Denise Faustman, directora del Laboratorio Faustman del Hospital General de Massachusetts. “Durante más de 10 años, nuestro grupo de investigación en el Hospital General de Massachusetts ha estado investigando activamente el papel que la vacuna BCG podría desempeñar en el tratamiento de diversas formas de autoinmunidad. Nuestro enfoque actual es la diabetes tipo 1, pero a nivel mundial se está probando la BCG en varias enfermedades autoinmunes. En los próximos dos años comenzaremos las pruebas clínicas de BCG en la fibromialgia “.
Según la Organización Mundial de la Salud, más de 100 millones de niños reciben la vacuna BCG cada año. Se usa principalmente en países en desarrollo donde la tuberculosis aún 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.
Entonces, la pregunta obvia es por qué se usaría una vacuna para una condición pulmonar infecciosa para la fibromialgia? La respuesta se encuentra dentro del sistema inmune.
Las vacunas generalmente se administran a personas sanas para prevenir infecciones. En este caso, sin embargo, la vacuna BCG se administrará a pacientes con fibromialgia en un esfuerzo por calmar sus síntomas.
Cuando EpicGenetics se encargó de crear una prueba de diagnóstico para la fibromialgia hace varios años, los investigadores realizaron todo tipo de pruebas de laboratorio en pacientes con fibromialgia para averiguar cómo diferían de los sujetos de control sanos y lo que podría estar causando sus síntomas. Los investigadores descubrieron varias anormalidades de glóbulos blancos en pacientes con fibromialgia, lo que los llevó a concluir que los síntomas están asociados con un sistema inmune suprimido.
“Creemos que [el término] fibromialgia es un nombre inapropiado”, dijo el Dr. Bruce Gillis, CEO de EpicGenetics. “Estas personas no están sufriendo con nada que esté afectando los músculos, por decir. Lo que están sufriendo es que su sistema inmune no puede producir cantidades normales de proteínas protectoras. … Hay células en el sistema inmune llamadas células mononucleares de sangre periférica. No están produciendo cantidades normales de proteínas protectoras llamadas quimiocinas y citoquinas “.
El hallazgo condujo al desarrollo de la prueba de sangre FM / a para la fibromialgia. (Sí, a pesar de lo que sus médicos le hayan dicho, ¡HAY una prueba de sangre para la fibromialgia! Simplemente no es ampliamente aceptada en la comunidad médica). La prueba analiza los niveles de cuatro quimiocinas y citoquinas encontradas en niveles reducidos en pacientes con fibromialgia. Estas cuatro quimiocinas y citocinas son simplemente las mismas que se potencian con la vacuna BCG.
“Dado lo que se ha publicado en la literatura médica, creemos que esta vacuna revertirá las anomalías del sistema inmunitario [de la fibromialgia]”, dijo Gillis.
Gillis y Faustman están buscando la aprobación de la FDA para administrar las primeras vacunas BCG a pacientes con fibromialgia a principios del próximo año.
“Esta es la primera vez que se realiza un tratamiento directo de la fibromialgia”, dijo Gillis. “Como saben, los medicamentos [actualmente en el mercado] para la fibromialgia solo tratan los síntomas. No tienen beneficios para el sistema inmune. [Las compañías farmacéuticas] reconocen que solo están tratando los síntomas, pero necesitan tratar la enfermedad, y es por eso que estamos avanzando con la aplicación de la vacuna [a la FDA] “.
Si la teoría de Gillis es cierta, entonces “las quimiocinas y las citoquinas que son deficientes en pacientes con fibromialgia ya no serán deficientes [una vez que se administre la vacuna BCG]”, dijo Gillis. “Los niveles de producción se normalizarán, y debes asumir entonces que sus síntomas desaparecerán. Creemos que estamos en la cúspide de algo importante “.
Debido a que la vacuna tiene una historia tan larga, no se espera que cause ningún efecto secundario importante en los pacientes.
Se prevé que la vacuna BCG costará entre $ 20 y $ 25 por dosis, una cantidad nominal en comparación con el costo constante de tomar productos farmacéuticos todos los días.
“Creemos que un paciente con fibromialgia necesitaría una o dos dosis como máximo para que pueda entender por qué no recibo mucho apoyo de las compañías farmacéuticas”, dijo Gillis.
Además de la prueba de la vacuna, EpicGenetics se está asociando con la Universidad de California, Los Ángeles (UCLA) y la Facultad de Medicina de la Universidad de Illinois en Chicago para secuenciar los genomas de hasta 250,000 pacientes con fibromialgia.
“Estamos buscando cualquier tipo de patrones genéticos o anomalías o mutaciones”, dijo Gillis.
Los pacientes que dan positivo para fibromialgia usando la prueba FM / a podrán participar en el estudio genómico.
La prueba FM / a cuesta actualmente $ 936, pero está cubierta por algunas compañías de seguros y Medicare. El equipo de soporte de EpicGenetics ayuda a los pacientes a determinar si su compañía de seguros cubrirá la prueba. Un plan de pago sin intereses está disponible para personas que no tienen seguro o cuyo seguro no cubrirá la prueba.
Si desea obtener más información sobre la prueba FM / a, visite FMTest.com. Haga clic aquí para leer más sobre el proyecto del genoma de la fibromialgia de EpicGenetics y el estudio de la vacuna BCG. Si le interesa realizar la prueba de FM / a, complete el formulario de solicitud en la página de inicio en FMTest.com. Si tiene preguntas adicionales o experimenta problemas al enviar el formulario, puede enviar un correo electrónico a la compañía a ask@epicgtx.com o llamar al (310) 277-4600.
Sobre el autor:
Donna Gregory Burch fue diagnosticada con fibromialgia en 2014 después de varios años de dolor inexplicable, fatiga y otros síntomas. Más tarde fue diagnosticada con la enfermedad de Lyme crónica. Donna cubre noticias, tratamientos, investigaciones y consejos prácticos para vivir mejor con fibromialgia y Lyme en su blog, FedUpwithFatigue.com . También puedes encontrarla en Facebook y Twitter . Donna es una periodista premiada cuyo trabajo ha aparecido en línea y en periódicos y revistas en Virginia, Delaware y Pennsylvania. Ella vive en Delaware con su esposo y sus muchos bebés de pieles.
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