Por Donna Gregory Burch 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 usted podría pensar. La firma biomédica EpicGenetics y los investigadores del Hospital General de Massachusetts están buscando la aprobación de la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) para llevar a cabo un ensayo clínico el próximo año para probar la vacuna Bacilo 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 con seguridad 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 globalmente BCG se está probando en una serie de enfermedades autoinmunes. Durante los próximos dos años comenzaremos las pruebas clínicas de BCG en 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 sigue activa. La vacuna BCG no está disponible en los Estados Unidos debido al bajo riesgo de infección. En los Estados Unidos, BCG se utiliza en un pequeño número de pacientes para tratar el cáncer de vejiga.
Por lo tanto, la pregunta obvia es ¿por qué una vacuna para una condición pulmonar infecciosa se utiliza para la fibromialgia? La respuesta está dentro del sistema inmunológico.
Las vacunas se dan típicamente a la gente sana para prevenir la infección. En este caso, sin embargo, la vacuna BCG se administraría a pacientes con fibromialgia en un esfuerzo por sofocar 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 se diferenciaban de los sujetos de control sanos y lo que podría estar causando sus síntomas. Los investigadores descubrieron varias anomalías de los glóbulos blancos en pacientes con fibromialgia, lo que los lleva a concluir que los síntomas están asociados con un sistema inmunológico suprimido.
“Creemos [el término] fibromialgia es un nombre incorrecto”, dijo el Dr. Bruce Gillis, CEO de EpicGenetics. “Estas personas no están sufriendo con nada que está afectando a los músculos, por decir. Lo que están sufriendo es que su sistema inmunológico no puede producir cantidades normales de proteínas protectoras. … Hay células en el sistema inmunológico llamado células sanguíneas mononucleares de sangre periférica. No están produciendo cantidades normales de las proteínas protectoras llamadas quimiocinas y citoquinas “.
El hallazgo condujo al desarrollo del análisis de FM / a para la fibromialgia. La prueba analiza los niveles de cuatro quimiocinas y citoquinas encontradas a niveles reducidos en pacientes con fibromialgia. Estas cuatro quimiocinas y citoquinas son las mismas que son potenciadas por la vacuna BCG.
“Dado lo que se ha publicado en la literatura médica, creemos que esta vacuna revertirá las anormalidades del sistema inmunológico [de la fibromialgia]”, dijo Gillis.
Gillis y Faustman están buscando la aprobación de la FDA para administrar las primeras vacunas BCG a los 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 ustedes saben, los medicamentos [actualmente en el mercado] para la fibromialgia sólo tratan los síntomas. No tienen beneficios del sistema inmunológico. [Las compañías farmacéuticas] reconocen que sólo están tratando los síntomas, pero usted necesita 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 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 hay que suponer entonces que sus síntomas desaparecerán. … Creemos que estamos en la cúspide de algo importante. ”
Debido a que la vacuna tiene una larga historia, no se espera que cause efectos secundarios importantes en los pacientes.
Se anticipa que la vacuna BCG costará entre 20 y 25 dólares por dosis, una cantidad nominal si se compara con el gasto continuo de tomar fármacos todos los días.
“Creemos que un paciente de fibromialgia necesitaría una o dos dosis máximas para que pueda entender por qué no estoy recibiendo mucho apoyo de las compañías farmacéuticas”, dijo Gillis.
Además de la prueba de vacunas, EpicGenetics se está asociando con la Universidad de California, Los Angeles (UCLA) y la Universidad de Illinois College of Medicine 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 resulten positivos para fibromialgia mediante la prueba FM / a podrán participar enEl estudio genómico. La prueba FM / a actualmente cuesta 936 dólares, pero está cubierta por algunas compañías de seguros y Medicare. El equipo de apoyo 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 cuentan con seguro o cuyo seguro no cubrirá la prueba.
LA VACUNA CENTENARIA DA NUEVA ESPERANZA A LA COMUNIDAD DE FIBROMIALGIA
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