This is a suite to my post of 1rst june. The pharmaceutical firm of actos® and competact®, two drugs retired from the market by the french regulator, respond that “other studies, including two ongoing trials being conducted by health insurer Kaiser Permanente, have thus far shown no risk to patients of bladder cancer or other cancers from Actos….The FDA has had a look at all our data and have not given us an indication at this time of a need to recall Actos” said Robert Spanheimer, Takeda’s vice president of medical and scientific affairs. The European medicine agency does not recommend any change for now.
The argument developed by an other pharmaceutical firm facing an other study that detected adverses effects for two more diabetes 2 drugs Byetta® and Januvia® were: “The adverse event reporting system database, they said, cannot be used to quantify risk or calculate the incidence of an adverse event, for several reasons:…” read the suite here. In his post “Paper OK title wrong” Prof Nicholas Moore highlight that incidence of reporting of adverse events is not incidence of adverse events.
But in the study that provoked the withdrawal of 2 drugs actos® and competact® in France the outcome was not reporting of adverse event but hospitalization bills recruited in the national French database PMSI.