Dutch NGO's CT claims rebutted by GSK

A Netherlands-based non-governmental organization, the Wemos Foundation, has launched a report making a number of allegations against  pharmaceutical firms conducting clinical trials in India. Among the  charges made by the group's FairDrugs.org campaign are criticisms of  UK-headquartered majors GlaxoSmithKline and AstraZeneca.

Annelies den Boer, a spokeswoman for the Wemos Foundation, said: "the  Indian Center for Studies in Ethics and rights has examined, among other  things, the way GSK tested a breast cancer drug on seriously ill women  in India." She claimed that the agent, Tyverb (lapatinib), had been  granted conditional approval for the European market by the European  Medicines Agency (EMEA). However, the agency's Committee for Medicinal  Products for Human Use (CHMP) offered a positive opinion for the drug in  late 2007, a decision subsequently confirmed by the European Commission  (Marketletters passim).

Ms den Boer also argued that "participation in the lapatinib trial was  practically inevitable since it was the only treatment option available  to the women. They just had to accept the risks entailed in an  experimental drug." FairDrugs.org accused GSK of "taking advantage" of  vulnerable people and that "most cancer patients cannot afford it." When  pressed by the Marketletter, Ms de Boer admitted that patients involved  in the trial had been guaranteed access to cancer therapies by the  sponsor.