Judiciary branch and scientific evidence: An analysis of judicial decisions about the drug Galsulfase*

Marin dos Santos, DH; Atallah, AN, Dallari Jr., HA; Barroso L

*Trabalho apresentado no Health Technology Assessment International (HTAi), em Julho de 2011, no Rio de Janeiro

Backgroung: The judiciary branch, in Brazil and other countries, has been an active actor in public health policies, especially regarding drug policies. In the present paper, we will evaluate the judicial response to cases regarding Galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, designed for the treatment of patients suffering from mucopolysaccharidosis type VI.

Objectives: To identify the prevalence of scientifically grounded judicial decisions and the knowledge of Brazilian judges about Evidence-based medicine.

Methods: We searched the electronic database of the Supreme Court (STF), the Superior Court of Justice (STJ) and all Federal Regional Courts (TRFs), looking for the keywords \”naglazyme\” OR \”galsulfase”.

Results: We found 31 judgments, including collegial judgments (5, 16.12%) and monocratic decisions (26; 83.87%). Of these, 9 were excluded due to procedural reasons (29.03%) and 22 met the eligibility criteria. Out of them, 20 (90.09%) decisions determined the government to supply galsulfase. Only 1 decision (4.54%) considered it improper to deliver the drug due to lack of evidence about its effectiveness. And 1 decision (4.54%) determined the performance of forensic expertise.

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Out of the 22 decisions examined, 18 (81.81%) were not substantiated by scientific evidence. Other 2 (9.09%) referred to evidence-based medicine (EBM), without, however, taking it as a plea for the decision-making. Only 2 decisions (9.09%) considered EBM as the basis of the decision-making process.

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Decisions unaware about evidence (81,81%) Decisions which only mentioned evidence (9,09%) Decisions which considered evidence as a plea for decision-making (9,09%) On the other hand, 7 decisions (31.81%) referred to medical expert opinion. Medical outcomes incompatible with the administration of galsulfase were found in 7 (31,81%) decisions.

Conclusions: The judiciary ignores scientific evidence as an aid to the decision-making process. In order to preserve the right to health and sustainability of the system, it is necessary that judicial decisions find ground on high-grade medical evidence.

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