When it released Actos onto the market, Takeda knew, from testing it had conducted on male rats, of a link between Actos and bladder cancer. Rather than conducting further studies that may have delayed production, the company downplayed the risks and released the drug anyway. When discussing the rat studies, it used phases such as “the relationship of these findings in male rats to humans is unclear”.

In fact, before placing the drug on the market, Takeda conducted no studies at all of the risks of Actos on human volunteers. It conducted studies only on rats. The FDA allowed Actos to proceed to market nonetheless. But it required Takeda to conduct a 10 year observational safety study. Effectively, the entire global population of Actos users unknowingly became human lab animals.

In 2010, Takeda released preliminary data to the FDA from the first half of the 10-year study. The data reveals that patients taking Actos for the longest period had an increased risk of developing bladder cancer; however, Takeda decided that the risk was not important enough for a warning to be issued.

If Takeda had not ignored the lab rat study results and if it had properly tested Actos before it hit the global market, how many victims might have been spared bladder cancer?