[Therapeutic indications in lawsuits seeking medical Cannabis in Brazil: a cross-sectional study in light of scientific evidence].

Abstract

In recent years, the rapid expansion of the medical Cannabis products (MCP) market has led to increased consumption and a rise in lawsuits seeking access to MCP in Brazil. This study aimed to analyze therapeutic indications cited in lawsuits filed against the Brazil's Federal Government requesting MCP and to assess these indications in light of the available scientific evidence. This cross-sectional study was conducted analyzing cases filed between 2020 and 2023. Additionally, a rapid qualitative evidence synthesis (RQES) was performed addressing the medical Cannabis indications reported in the lawsuits. Across 2,024 lawsuits, 1,962 primary diagnoses were identified. The most frequent conditions were epilepsy (36.24%), autism spectrum disorder (ASD) (25.54%), and pain (8.92%). A high proportion of claimants in the 1 to 19 age range was observed for epilepsy, ASD, paralysis, and intellectual disabilities. The RQES retrieved 115 reviews that applied quality assessment tools and reported on the effectiveness of MCP. The most frequently studied conditions were pain (40.86%), neoplasms (10.43%), and epilepsy (9.56%). Only five diagnoses - epilepsy, multiple sclerosis, anxiety, neoplasms, and pain - had some degree of support in the literature, varying in strength and with a low proportion of high-quality reviews. The substantial pressure from health-related litigation and the large number of indications lacking supporting evidence highlight a significant public health risk that has not been addressed in a timely manner in Brazil. Regulation of MCP and appropriate prescribing practices are urgently needed, restricting public provision to indications supported by robust evidence.