Sales, Not Safety Were Paramount at Takeda as Regulators Pondered Actos bladder Cancer WarningMar 6, 2013
Executives at Takeda Pharmaceuticals were more interested in sales of its type 2 diabetes drug Actos than they were with patient safety.
Jurors, at the trial of the first person to have claims that taking Actos resulted in developing bladder cancer get this far in a court, heard from one witness privy to internal emails between Takeda officials said there is ample evidence to support this claim, Bloomberg reports.
Jack Cooper is the first person to have his claim make it to a jury and a trial convened this week as he attempts to prove that taking Actos in the treatment of type 2 diabetes caused him to develop bladder cancer.
One of the first witnesses at the trial, clinical pharmacologist Howard Greenberg, said that he reviewed emails sent between executives at Japan-based Takeda Pharmaceuticals that debated whether the company should address concerns that its top-selling drug could be causing recipients to develop life-threatening bladder cancer.
During opening statements at this trial, an attorney representing Cooper said that his client has less than a year to live and that might not be the case had Takeda come forward with evidence that its drug caused this dangerous side effect. Greenberg backed that assertion and said that emails indicate that at Takeda, “the product came first.”
Cooper took Actos for more than four years until he was diagnosed with bladder cancer in 2011. While Takeda claims that his smoking habit is responsible for the development of bladder cancer, there is ample evidence to suggest otherwise and point the blame at the top-selling diabetes drug.
Greenberg said he reviewed internal Takeda documents made available from an online source in preparation for his testimony at trial this week. He previously has worked as a drug researcher for other major pharmaceutical companies and based on his recent review of Takeda communications, it was clear that boosting sales of Actos was paramount to patient safety.
In one specific message, Greenberg noted that Takeda’s Kiyoshi Kitazawa became worried in 2005 that health regulators would force the company to place a warning on the labels of Actos to indicate that there was a risk of bladder cancer associated with it. After surveying a sample of doctors previously, Takeda knew that this warning would have an immediate and dramatic impact on sales. Greenberg presented a sample from that Kitazawa email which read, “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.” Further, Takeda considered the inclusion of a warning about the risk of bladder cancer would be the company’s “worst-case scenario” because of its impact on sales, not anything to do with the safety of the patient.
Actos, at its best, generated $4.5 billion in 2011 for Takeda. Now that the patent protection on the drug is expiring and generic forms of it will be available, the company is putting its support behind a newly-approved type 2 diabetes drug, Nesina, which was recently approved by the Food and Drug Administration.