Actos News

Drug Regulation Expert Testifies Against Takeda Regarding Internal
2005 Emails Which Discussed Actos Bladder Cancer Risk
Monday, March 11, 2013

One of the key plaintiff’s witnesses in the trial of Jack Cooper who claims Takeda Pharmaceuticals’ diabetes drug Actos caused his terminal bladder cancer, took the stand last week in state court in Los Angeles.

Dr. Howard Greenburg, an expert in pharmacology and drug regulation, was questioned about internal Takeda emails that he says demonstrate the drug maker’s intent to forestall label changes that would have warned of an Actos-bladder cancer link, a change that Takeda knew would seriously damage sales of its top selling drug.

The timing of the emails, which were sent in August of 2005, is critical. By then Takeda had results from two studies that plaintiff’s claim showed a statistically significant increased risk of bladder cancer in patients taking Actos. One of those studies, known as the PROactive study, had failed to prove its primary endpoint of demonstrating that patients taking Actos lived longer and was the subject of considerable criticism for questionable conclusions and inappropriate analysis of the study data.  

The second study, the first interim analysis of a Kaiser Permanente study, showed a statistically significant increase in risk of bladder cancer for patients exposed to Actos at high doses and exposure over one year.

Takeda was also aware at this time that the U.S. Food and Drug Administration (FDA) and its equivalent in Europe, the European Medicines Agency, had both rejected Takeda’s argument that the significant increase in bladder tumors associated with Actos in rat studies was not applicable to humans.

According to Greenburg, the emails, including one from Takeda executive Kiyoshi Kitazawa, show that Takeda’s response to the growing weight of evidence linking Actos to bladder cancer, was a coordinated plan to protect its bottom line by stopping FDA recommended label changes, which could damage the drug’s profitability. Takeda officials considered any label changes incorporating bladder cancer findings or any effort to inform doctors by means of a “Dear Healthcare Provider” letter, to be a “worst case scenario."