Fiocruz inicia plano de pesquisa para usar maconha

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hempadao 19 junho, 2018

A Fundação Oswaldo Cruz (Fiocruz) vai desenvolver um projeto de pesquisa para o uso medicinal da Cannabis sativa (maconha). A proposta prevê um conjunto de atividades, que vão desde análises de formas de cultivo da planta, metodologia para extração de substâncias ativas, testes clínicos e controle de qualidade até desenvolvimento do medicamento.

Fonte: Isto É

O trabalho prevê investimento de R$ 3,4 milhões – os R$ 400 mil iniciais seriam recursos da própria fundação. O restante deverá fazer parte de linhas de crédito disponíveis para a instituição a partir do próximo ano, de acordo com informações do coordenador do Grupo de Trabalho Cannabis Medicinal da Fiocruz, Hayne Felipe da Silva. O coordenador esteve reunido semana passada com o secretário executivo do Ministério da Saúde, Adeilson Cavalcante. O aporte de recursos, segundo a pasta, está em negociação.

A meta primordial do Grupo de Trabalho da Fiocruz é o desenvolvimento de um fitoterápico para epilepsia refratária, denominação dada para a forma da doença de difícil controle com medicamentos atualmente disponíveis no mercado.

O projeto da Fiocruz é um dos que aguardam a regulamentação da Agência Nacional de Vigilância Sanitária (Anvisa) para o plantio de maconha com fins medicinais e para pesquisa no País. “Sem essa autorização, não podemos colocar em prática a pesquisa. Somente vamos trabalhar com folhas plantadas no País”, disse Felipe da Silva.

O primeiro passo para a regulação na Anvisa deverá ser dado em julho, com a apresentação na reunião da diretoria colegiada de um documento batizado de “proposta de iniciativa”. Ao jornal O Estado de S. Paulo, o presidente da Anvisa, Jarbas Barbosa, disse acreditar que, uma vez apresentada tal proposta, a discussão não deverá ser longa. “O assunto vem sendo discutido há tempos pela agência.”

Para Barbosa, a regulamentação do plantio da maconha no País para fins de pesquisa ou para fabricação de remédios poderá reduzir de forma expressiva o valor gasto atualmente por pacientes para se tratar com produtos à base de derivados da Cannabis. “Temos algumas famílias que ganharam na Justiça o direito de cultivar em casa a planta para fazer o extrato, justamente para tornar mais acessível o tratamento.” A proposta de iniciativa de regulação, no entanto, não vai tratar do plantio artesanal. “Esse assunto é do Legislativo. O que vamos fazer é apenas regulamentar algo que a lei já permite: o plantio para uso medicinal e pesquisa.”

O texto que será levado para consideração da diretoria colegiada da Anvisa prevê uma série de requisitos no plantio. Vão desde a iluminação e irrigação, indispensáveis para se garantir a qualidade e um padrão do extrato de canabidiol, até a segurança que deve ser feita na área plantada. As exigências variam de acordo com a finalidade do plantio, a pesquisa ou a produção de medicamentos.

Farmacopeia

Ano passado, a Cannabis foi incluída na lista de plantas medicinais da Anvisa. A mudança abriu caminho para que a planta possa integrar a farmacopeia brasileira, publicação que detalha como sua fabricação deve ser feita, e para que fabricantes peçam registro de medicamentos.

Plantio

A regulação pela Anvisa do plantio da maconha para pesquisa e para o desenvolvimento de medicamentos pode ajudar a reduzir o custo da terapia no País, afirma Margarete Brito, integrante da Associação de Apoio à Pesquisa e Pacientes de Cannabis Medicinal (Apepi). A estimativa é de que o tratamento com extratos com canabidiol, uma das substâncias presentes na maconha, custe entre R$ 1 mil e R$ 5 mil por mês. “Com produção nacional, esse valor certamente vai cair.”

Mas ela avalia que, além da regulamentação da Anvisa, seria essencial a existência de uma lei para permitir o plantio doméstico de Cannabis sativa para o preparo doméstico do extrato usado por pacientes. Uma audiência pública sobre o assunto está marcada para esta quarta-feira, 20, no Senado. Há quatro anos, Margarete iniciou o tratamento da filha, Sofia, que tem uma doença genética. Ao lado de outros familiares de pacientes, Margarete liderou um movimento bem-sucedido pela liberação da importação do produto pela Anvisa.

Há dois anos, diante de dificuldades na importação e com risco de ficar sem o extrato, Margarete decidiu iniciar o plantio em casa. Conseguiu autorização na Justiça e passou a auxiliar outras famílias na atividade. Todos com autorização da Justiça. “Em casa, o investimento pode ser mínimo.”

Pelo menos 150 pessoas já fizeram cursos coordenados pelo seu grupo para orientar a melhor forma do plantio. “Além de facilitar o acesso, o extrato doméstico pode dar mais fôlego na terapia”, conta. A experiência das famílias mostra que o uso por longos períodos faz com que o extrato importado, aos poucos, perca sua eficácia. As famílias notam que com o uso intercalado há um ganho na qualidade de vida do paciente.

De acordo com Margarete, ainda há várias perguntas que precisam ser respondidas sobre efeitos colaterais e interações. “E isso novos estudos poderão responder.” As informações são do jornal O Estado de S. Paulo.



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