EMA: bis repetita.
I thank you for your paper which is very neutral (1).
As a matter of fact, the last EMA procrastination regarding
pioglitazone was expected. Following the same figures as in Pandemrix
narcolepsy cases, EMA prefers to avoid predictable financial problems over
patients' safety (40% rise in the risk of bladder cancer among those taking pioglitazone for longer than one year). We agree that the French report
has several methodological limitations but pioglitazone's overall risk-benefit ratio has several medical limitations as well (2).
The analysis of the same data can lead to discrepancies in
Better transparency will be very pleasing in the EMA's decision-making.
(1) Moynihan R. European drug agency extends review of safety of
pioglitazone. BMJ 2011; 342:d4105
(2) Richter B, Bandeira-Echtler E, Bergerhoff K, Clar C, Ebrahim SH.
Pioglitazone for type 2 diabetes mellitus. Cochrane Database of Systematic
Reviews 2006, Issue 4. Art. No.: CD006060. DOI:
Competing interests: No competing interests