GSK sued for Retrovir death in Sth Africa

A South African woman is claiming 1.5 million rand ($182,550) in damagesfrom Glaxo Wellcome South Africa (now trading as GlaxoSmithKline), alleging that her husband died as a direct result of the cellular toxicity of GSK's antiretroviral drug Retrovir (zidovudine, referred to in the case as AZT).

Annet Hayman says in court papers that the death in 1998 of her attorney husband was brought about by GSK's "wrongful and negligent act in supplying him with an unreasonably dangerous and defective drug, and doing so on the basis of false and misleading representations contained in the package insert." SA President Thabo Mbeki and Health Minister Manto Tshabalala-Msimang are listed as defendants in the case because of their "interest in the outcome," the statements that have been made on the toxicity of Retrovir and their questioning of the efficacy of the drug. However, no relief is sought against them.

Mrs Hayman argues that "AZT cannot be and is not metabolized by human cells in vivo into its active triphosphorylated form to the minimum intracellular concentration necessary for the drug to exert its putative pharmacological action as a nucleoside analog terminator of proviral HIV DNA chain synthesis, irrespective of the oral dose at which it is taken; [and] is therefore unable to inhibit the reverse transcription of HIV RNA to HIV DNA and thereby prevent viral replication in vivo." In fact, she claims "it does not do so, according to all direct markers for this pharmacological activity." Accordingly, she says, AZT has no antiretroviral action against HIV in vivo, is "extremely poisonous" to all human cells and has "no proven anti-HIV effects in vivo countervailing against its proven profound cellular toxicity for patients taking it."