Actos and its potential links to bladder cancer are now on trial. And already, lawyers have brought out incriminating emails, in which Takeda Pharmaceutical executives discuss damage-control plans. It's the first case pitting a patient with bladder cancer against Japan's Takeda, which built Actos into a $4.5 billion product before safety questions took hold. The company faces at least 3,000 similar claims.
As Bloomberg reports, an expert witness highlighted a 2005 email exchange, in which executives discussed new data on Actos patients' risks of bladder cancer. The "worst-case scenario," they said, would be label warnings highlighting the drug's links to cancer. So, employees needed to work with regulators for a "positive outcome," the emails noted.
"Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally," executive Kiyoshi Kitazawa wrote (as quoted by the news service).
Company lawyers sought to emphasize that employees' messages might not reflect Takeda policy. And in opening statements, the company's attorney pointed out that the plaintiff, Jack Cooper, was a smoker, which put him at greater risk of developing bladder cancer.
Two years ago, German and French regulators forced Takeda to pull Actos off the market after their analyses of company data showed that some users faced higher risks of bladder cancer or heart problems, Bloomberg notes. The company says that the same study, which is still ongoing, indicates that patients' cancer risk tended to diminish over time.
- read the Bloomberg piece
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