We are no longer accepting Actos cases.
This exhibit contains the December 2003 results of a survey Takeda did on physicians after Takeda was approached by the FDA to make a labeling change to reflect the risk of bladder cancer shown in drugs very similar to Actos. As can be seen in the exhibit labeled Thom31, Takeda was worried about the public becoming aware of the risk. But they wanted to know what would happen to sales if a warning about a possible bladder cancer risk was added to the Actos label.
Takeda needed to come up with a clever way of assessing that risk without revealing the Actos/bladder cancer association. They did so by means of a physician survey that asked general questions about the class of drugs to which Actos belongs – thiazolidinediones, or TZDs. This class includes two other diabetes drugs with troubled histories, Avandia and Rezulin. Avandia has been withdrawn from the market in Europe and its use in the U.S. is severely restricted by the FDA due to cardiovascular problems. Rezulin was withdrawn from the market in both the U.S. and Europe after being linked to liver failure in patients taking the drug
Significantly, though 28 physicians were surveyed, only 12 were asked about a possible bladder cancer label change and the questions came at the very end of the survey (see results page, 68-70 – pages 75-77 of the document. To keep the doctors even more in the dark, they were presented with a description of a hypothetical new product that was not a TZD, but required monitoring of the urine for the presence of blood:
I would like you to assume that there is a new class of oral antidiabetic agents that is similar to the TZDs or glitazones [another name for TZDs]. I'd like to give you a very brief description of a potential product in this new class and get your reactions to it.
The doctors were then asked how they would react if the new drug carried a bladder cancer risk. Four said they would not use the product. Interest declined greatly in six others and declined slightly for the remaining two.
The message for Takeda was clear: any mention of a bladder cancer risk linked to Actos would be extremely damaging to drug sales.
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