We are no longer accepting Actos cases.
An MAA is a Marketing Authorization Application – an application to market a drug that is submitted to the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency committee that oversees medicines for human use. The CHMP was formerly known as the Committee for Proprietary Medicinal Products, or CPMP, the acronym by which it is referred in this document.
In this document we find the 2002 battle plan from Takeda International on how Takeda’s European division successfully fended off a bladder cancer warning when they applied for an application to market Actos in Europe.
As in the previous document (El-Hage TPNA Conference Call Notes, July 2002) we find the European agency, like the FDA in the United States, did not accept Takeda’s explanations for why studies showing bladder cancer growth in rodents were not applicable to humans – the so-called “Cohen hypothesis” (again, see El-Hage).
As the last slide demonstrates, Takeda’s response was to stick to the Cohen hypothesis, argue against clinical testing and not undertake database searches. Despite the fact the Cohen hypothesis was contradicted by research findings (by 2008 the theory had been thoroughly disproven despite the fact that previous drugs in the same class as Actos had been abandoned due to adverse events, and despite the fact that numerous animal studies demonstrated a link between Actos and bladder tumors), Takeda chose to turn its back on any real effort to establish the true risk of bladder cancer in humans.
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