TY - JOUR KW - Adolescent KW - Adult KW - Brazil KW - Child KW - Child, Preschool KW - Drug Approval KW - Drug Monitoring KW - Humans KW - Legislation, Drug KW - leprosy KW - Syndrome KW - Thalidomide AU - Oliveira M A AU - Bermudez J A AU - Souza A C AB -

This paper discusses issues related to the regulation and rational use of thalidomide in Brazil, by means of a historical approach comprising three different stages. The first part is a historical review of the controversial drug since it was first synthesized, then marketed and subsequently banned during the 1950s and 60s, until the present, when an apparently irreversible process of rehabilitating the drug is under way. Brazilian experience with the use of thalidomide is described, emphasizing legal, political, and institutional work led by two social movements, the Brazilian Association of People with Thalidomide Syndrome (ABPST) and the Movement for Reintegration of People with Hansen's Disease (Morhan). The article describes the results and analyzes an active search of new cases in what is a second generation of thalidomide syndrome in Brazil. Finally, based on clinical and scientific evidence of thalidomide's therapeutic efficacy, the growth of social movements struggling both for and against authorization of the drug, and a restrictive regulation proposed by the Ministry of Health, the article discusses the implementation of policies for the regulation and rational use of thalidomide in Brazil.

BT - Cadernos de saude publica C1 - http://www.ncbi.nlm.nih.gov/pubmed/10203451?dopt=Abstract CN - OLIVEIRA 1999 DA - 1999 Jan-Mar DO - 10.1590/s0102-311x1999000100011 IS - 1 J2 - Cad Saude Publica LA - por N2 -

This paper discusses issues related to the regulation and rational use of thalidomide in Brazil, by means of a historical approach comprising three different stages. The first part is a historical review of the controversial drug since it was first synthesized, then marketed and subsequently banned during the 1950s and 60s, until the present, when an apparently irreversible process of rehabilitating the drug is under way. Brazilian experience with the use of thalidomide is described, emphasizing legal, political, and institutional work led by two social movements, the Brazilian Association of People with Thalidomide Syndrome (ABPST) and the Movement for Reintegration of People with Hansen's Disease (Morhan). The article describes the results and analyzes an active search of new cases in what is a second generation of thalidomide syndrome in Brazil. Finally, based on clinical and scientific evidence of thalidomide's therapeutic efficacy, the growth of social movements struggling both for and against authorization of the drug, and a restrictive regulation proposed by the Ministry of Health, the article discusses the implementation of policies for the regulation and rational use of thalidomide in Brazil.

PY - 1999 SP - 99 EP - 112 T2 - Cadernos de saude publica TI - [Thalidomide in Brazil: monitoring with shared responsibility?]. TT - Talidomida no Brasil: vigilância com responsabilidade compartilhada? UR - http://www.scielo.br/pdf/csp/v15n1/0040.pdf VL - 15 SN - 0102-311X ER -