Actos Bladder Cancer Risk Discussed in Takeda Email in 2005: Trial

E-mails dating back to 2005 appear to show that Takeda Pharmaceuticals executives not only knew there was a potential increased risk of bladder cancer with Actos, but suggest that the drug maker was attempting to develop strategies to avoiding placing the risk information on the warning label for their blockbuster diabetes medication. 

The e-mails have been publicly revealed as part of the first Actos trial in the country, involving allegations that the drug maker failed to adequately warn users and the medical community about the risk of bladder cancer.

Trial is currently underway in the Superior Court of California for Los Angeles County, involving a lawsuit filed by Jack Cooper, who claims he was diagnosed with bladder cancer after using Actos for a number of years. The case was given an expedited trial date due to Cooper’s grave health.

Takeda Pharmaceuticals currently faces more than 3,000 similar Actos bladder cancer lawsuits pending in state and federal courts throughout the United States. Those involved in the litigation are closely watching the outcome of the Cooper trial, as it may give an indication as to how juries will respond to certain evidence and testimony that is likely to be repeated throughout a number of cases, and could lead to possible Actos settlement discussions.

E-Mail Stressed Maintaining Actos Global Image

Actos (pioglitazone) was approved by the FDA for treatment of type 2 diabetes in July 1999. It is a once-daily pill that increases the body’s sensitivity to insulin.  However, new warnings were added to the medication in 2011, which indicate that use of the medication for more than one year may increase the risk of developing bladder cancer.

Takeda reportedly considered adding warnings to the label as early as 2003, when the drug maker surveyed doctors to evaluate whether such a warning would scare them away from prescribing the drug.  After determining that warning about the possible risk of bladder cancer from Actos would damage sales, the drug maker did not add the information to the label, according to allegations in Cooper’s lawsuit.

Among documents presented at trial this week were Takeda emails from August 2005, which were discussed during the testimony of clinical pharmacologist Howard Greenburg, an expert witness for the plaintiff. According to a report by Bloomberg News, the e-mail was from Kiyoshi Kitazawa, a Takeda executive, in which Kitazawa discusses what regulators might do if they decide that Actos does increase the risk of bladder cancer. He advised colleagues at the company to “manage the issue” to ensure Actos had a good global image and described a label for bladder cancer as a “worst-case scenario.”

The FDA first announced that there may be a possible connection between bladder cancer and Actos in September 2010, after preliminary data from an on-going 10 year study suggested that there may be an increased risk the longer the drug is taken.

In May 2011, a study by Italian researchers found a disproportionate number of Actos bladder cancer reports in the FDA’s own Adverse Event Reporting System Records. However, that study did not establish a causal effect between Actos and bladder cancer.

However, the Actos bladder cancer concerns did not reach the public until the summer of 2011, after a study by French insurers revealed an increased risk of bladder cancer. In June 2011, the FDA placed new Actos bladder cancer warnings on the diabetes drug and all drugs containing pioglitazone, the active ingredient.

Takeda attorneys have suggested at trial that Cooper’s history as a smoker and the fact that he is male were likely the contributing factors to his bladder cancer, and maintain that the views expressed in Kitazawa’s e-mail do not represent a company policy.