Se alguém pudesse lhe dar uma vacina que curasse sua fibromialgia, você faria isso? Isso pode parecer um sonho, mas está mais próximo da realidade do que você imagina. A empresa de biomedicina Los Angeles EpicGenetics e os pesquisadores do Massachusetts General Hospital estão buscando a aprovação da Administração de Alimentos e Medicamentos dos EUA (FDA) para realizar um teste clínico no próximo ano para testar a vacina Bacille Calmette-Guerin (BCG) como um possível tratamento para a fibromialgia.
O BCG é uma vacina genérica contra a tuberculose que tem quase 100 anos de idade e foi administrada com segurança milhões de vezes ”, explicou a Dra. Denise Faustman, chefe do laboratório Faustman no Massachusetts General Hospital. “Por mais de 10 anos, nosso grupo de pesquisa no Massachusetts General Hospital tem investigado ativamente o papel que a vacina BCG poderia desempenhar no tratamento de várias formas de autoimunidade. Nosso foco atual é o diabetes tipo 1, mas globalmente o BCG está sendo testado em várias doenças autoimunes. Nos próximos dois anos, iniciaremos o teste clínico do BCG na fibromialgia. ”
Segundo a Organização Mundial da Saúde, mais de 100 milhões de crianças recebem a vacina BCG a cada ano. É usado principalmente em países em desenvolvimento, onde a tuberculose ainda está ativa. A vacina BCG não está disponível nos Estados Unidos por causa do baixo risco de infecção. Nos EUA, o BCG é usado em um pequeno número de pacientes para tratar o câncer de bexiga.
Então, a pergunta óbvia é por que uma vacina para uma doença pulmonar infecciosa seria usada para a fibromialgia? A resposta está no sistema imunológico.
As vacinas são normalmente dadas a pessoas saudáveis para prevenir a infecção. Neste caso, no entanto, a vacina BCG seria administrada a pacientes com fibromialgia em um esforço para sufocar seus sintomas.
Quando EpicGenetics foi encarregado de criar um teste de diagnóstico para a fibromialgia há vários anos, os pesquisadores realizaram todos os tipos de testes de laboratório em pacientes com fibromialgia para descobrir como eles diferem de indivíduos saudáveis e o que pode estar causando seus sintomas. Os pesquisadores descobriram várias anormalidades nas células brancas do sangue em pacientes com fibromialgia, levando-os a concluir que os sintomas estão associados a um sistema imunológico suprimido.
“Acreditamos que [o termo] fibromialgia é um equívoco”, disse o Dr. Bruce Gillis, CEO da EpicGenetics. “Essas pessoas não estão sofrendo com nada que esteja afetando os músculos, por exemplo. O que eles estão sofrendo é que seu sistema imunológico não pode produzir quantidades normais de proteínas protetoras. … Existem células no sistema imunológico chamadas células mononucleares do sangue periférico. Eles não estão produzindo quantidades normais de proteínas protetoras chamadas quimiocinas e citocinas. ”
A descoberta levou ao desenvolvimento do teste de sangue FM / a para fibromialgia. (Sim, apesar do que seus médicos podem ter lhe dito, existe um exame de sangue para fibromialgia! Simplesmente não é amplamente aceito na comunidade médica.) O teste analisa os níveis de quatro quimiocinas e citocinas encontradas em níveis reduzidos em pacientes com fibromialgia. Essas quatro quimiocinas e citocinas são as mesmas que são estimuladas pela vacina BCG.
“Dado o que foi publicado na literatura médica, acreditamos que esta vacina irá reverter as anormalidades do sistema imunológico [da fibromialgia]”, disse Gillis.
Gillis e Faustman estão buscando aprovação da FDA para administrar as primeiras vacinas BCG em pacientes com fibromialgia no início do próximo ano.
“Esta é a primeira vez que um tratamento direto da fibromialgia será feito”, disse Gillis. “Como você sabe, os medicamentos [atualmente no mercado] para a fibromialgia só tratam os sintomas. Eles não têm benefícios no sistema imunológico. [As companhias farmacêuticas] admitem que estão apenas tratando os sintomas, mas você precisa tratar a doença, e é por isso que estamos avançando com a aplicação da vacina [ao FDA] ”.
Se a teoria de Gillis for verdadeira, então “as quimiocinas e citocinas que são deficientes em pacientes com fibromialgia não serão mais deficientes [uma vez administrada a vacina BCG]”, disse Gillis. “Os níveis de produção se normalizarão e você terá que assumir que os sintomas desaparecerão. Achamos que estamos à beira de algo importante ”.
Como a vacina tem uma história tão longa, não se espera que cause efeitos colaterais importantes nos pacientes.
Prevê-se que a vacina BCG custará de US $ 20 a US $ 25 por dose – uma quantia nominal quando comparada à despesa contínua de tomar medicamentos todos os dias.
“Achamos que um paciente com fibromialgia precisaria de uma ou duas doses no máximo, para que você possa entender por que não estou recebendo muito apoio das empresas farmacêuticas”, disse Gillis.
Além do teste de vacina, a EpicGenetics está em parceria com a Universidade da Califórnia, Los Angeles (UCLA) e a Faculdade de Medicina da Universidade de Illinois em Chicago para sequenciar os genomas de até 250.000 pacientes com fibromialgia.
“Estamos procurando por qualquer tipo de padrões genéticos ou anomalias ou mutações”, disse Gillis.
Pacientes com teste positivo para fibromialgia usando o teste FM / a poderão participar do estudo genômico.
O teste FM / a atualmente custa US $ 936, mas é coberto por algumas companhias de seguros e Medicare. A equipe de suporte da EpicGenetics ajuda os pacientes a determinar se sua companhia de seguros cobrirá o teste. Um plano de pagamento sem juros está disponível para pessoas sem seguro ou cujo seguro não cobre o teste.
Se você quiser saber mais sobre o teste FM / a, visite o site FMTest.com. Clique aqui para ler mais sobre o projeto genoma da fibromialgia da EpicGenetics e o estudo da vacina BCG. Se você estiver interessado em fazer o teste FM / a, preencha o formulário de inscrição na página inicial do FMTest.com. Se você tiver dúvidas adicionais ou tiver algum problema ao enviar o formulário, envie um e-mail para a empresa em ask@epicgtx.com ou ligue para (310) 277-4600.
Sobre o autor:
Donna Gregory Burch foi diagnosticada com fibromialgia em 2014 após vários anos de dor inexplicável, fadiga e outros sintomas. Mais tarde, ela foi diagnosticada com doença de Lyme crônica. Donna cobre notícias, tratamentos, pesquisas e dicas práticas para viver melhor com fibromialgia e Lyme em seu blog, FedUpwithFatigue.com . Você também pode encontrá-la no Facebook e no Twitter . Donna é uma jornalista premiada cujo trabalho apareceu online e em jornais e revistas em toda a Virginia, Delaware e Pensilvânia. Ela mora em Delaware com o marido e seus muitos bebês de pêlo.
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