Advancing healthcare policy

Transparent, independent health authorities

Summary

Pioglitazone (Actos°) was authorised in 2000 by the European Medicines Agency for diabetic patients. The application already revealed a risk of bladder cancer that had been observed in animals, and Prescrire advised right away against using this drug.
In January 2011, Prescrire requested pharmacovigilance data from the European Medicines Agency regarding the bladder cancer risk. It took EMA two months to get back to Prescrire with basic information explaining the studies underway, but with no details whatsoever on the cases of cancer reported.
The Agency is keeping Actos° on the market, a drug that is more dangerous than it is useful, to the detriment of patients, and all the while refusing to provide the data in its possession to an independent editorial team.
It is time that the European Commission firmly redirects EMA back to its mission of protecting the public, in particular by insisting on a major clean-up in the Agency's conflicts of interest with pharmaceutical companies.

For more information: