Novel thalidomide analogues, “me too” drugs and the Brazilian law

  • Francisco José Roma Paumgartten Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/FIOCRUZ)
Palavras-chave: lenalidomida, pomalidomida, custo efetividade, mieloma múltiplo, medicamentos teratogênicos, embriopatia por talidomida

Resumo

In Brazil, thalidomide has been used virtually without interruption since it was launched as a new and revolutionary sedative drug in 1956. After 1965, when its efficacy to treat erythema nodosum leprosum (ENL) was discovered, it was regarded as an essential drug because the prevalence of Hansen’s disease is high in the country. In the 1990s and thereafter myriad novel therapeutic uses for thalidomide (autoimmmune diseases, multiple myeloma, aphthous ulcers in AIDS, and others) have emerged owing to its immunomodulatory and antiangiogenic activities. Owing to a marked teratogenicity, however, the prescription and dispensing of thalidomide to patients is strictly controlled in Brazil and elsewhere. Notwithstanding the stringent regulations, a number of post-1965 cases of thalidomide embryopathy have occurred in Brazil. In 2003, a federal law (Law 10.651/2003) prohibited the sale and dispensing of thalidomide in commercial pharmacies. The law, however, made no provision for teratogenic drug analogues such as lenalidomide and pomalidomide, which have been cleared for marketing in the USA, Europe and other countries. Although they are much more expensive than thalidomide, the clinical superiority of novel ana-logues over thalidomide in multiple myeloma and other conditions remains unproven. Therefore, so far novel analogues can be considered as thalidomide “me too” drugs. This author strongly recommends that an amendment to the current law prohibiting the sale and dispensing of thalid-omide in commercial pharmacies be extended to thalidomide analogues. Moreover, we consider that a demonstration of clinical superiority over thalidomide (through gold-standard comparative efficacy trials) should be an essential requirement for registration of any teratogenic analogue.

Biografia do Autor

Francisco José Roma Paumgartten, Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz (INCQS/FIOCRUZ)

Possui graduação em Medicina pela Universidade Federal do Rio de Janeiro(1974), especialização em Biofísica pela Universidade Federal do Rio de Janeiro(1975), especialização em Psiquiatria pela Universidade do Estado do Rio de Janeiro(1978), doutorado em Farmacologia pela Universidade Federal de São Paulo(1983) e pós-doutorado pela Freie Universitaet Berlin Institut f Toxikologie u Embryopharmakologie(1989). Atualmente é Pesquisador Titular III do Fundação Oswaldo Cruz e Membro de corpo editorial da The Open Environmental Pollution and Toxicology Journal. Tem experiência na área de Farmacologia, com ênfase em Toxicologia. Atuando principalmente nos seguintes temas:Apomorphine, Behavioral Effects, Dopaminergic Systems, Dopaminergic Agonists, REM-sleep deprivation.

CV: http://lattes.cnpq.br/6626554938516040

Publicado
2013-08-30
Como Citar
Paumgartten, F. (2013). Novel thalidomide analogues, “me too” drugs and the Brazilian law. Vigilância Sanitária Em Debate: Sociedade, Ciência & Tecnologia, 1(3), 2 - 10. Recuperado de https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/57
Seção
Debate