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Doctors Secretly Surveyed to Determine Impact of Known Bladder Cancer Risk Linked to Actos

Feb 20, 2013

Executives at Takeda Pharmaceuticals secretly surveyed doctors about a decade ago to determine if they would prescribe a drug that was linked to cancer, the most troubling side effect of its top-selling drug, Actos.

According to a Bloomberg report, the company asked a dozen doctors back in 2003 if they would prescribe Actos if it had a warning about its link to bladder cancer. Based on the answers they received, Takeda officials determined that sales of the company’s top-selling drug at the time would plummet and have a major impact on the company’s viability.

So for about a decade the company hid data that showed that taking Actos could cause patients to develop life-threatening bladder cancer. Sales representatives were told explicitly to ignore questions regarding this side effect if a doctor asked and they were in no way supposed to mention this risk unless the subject was brought up by doctors who were considering prescribing it.

These details are likely to play a large role in the trial of a man who claims taking Actos to treat his type 2 diabetes led to his bladder cancer diagnosis. The first trial among thousands of lawsuits is expected to begin on Feb. 19 in Los Angeles Superior Court, where those lawsuits were consolidated.

The number of lawsuits consolidated in that court increased exponentially in the last few years after the Food and Drug Administration warned last year that taking Actos in the treatment of type 2 diabetes could result in bladder cancer. The risk increases the longer a patient takes the drug or depending on the strength of the prescription. The FDA required Takeda to update its safety label on Actos to indicate this risk last year when it issued its safety warning.

Takeda continues to deny this risk. The company was prompted to conduct its secret survey on the impact of this risk factor based on the results of another drug trial that found taking another diabetes drug caused cancerous tumors to grow in the bladders of lab animals. It was after that failed test on Novo Nordisk’s Ragaglitazar that the FDA began questioning Takeda about Actos’ safety.

Despite being aware of the risks, those who believe Actos is responsible for this specific side effect assert that Takeda figured the best way to handle the FDA’s inquiries were to ignore them. One internal memo indicates this to be true. According to the Bloomberg report, one executive at Takeda wrote regarding the FDA: “If there are negative findings they ignore it and if there are positive findings, they gotcha.”

The company informed its sales force and others that if doctors raised questions they should ignore them. They were in no way supposed to bring up this risk to doctors when they approached them. Another memo to salespeople, acquired by Bloomberg from evidence to be entered into the record for this first trial this week, spells it out: “If no questions/concerns, do not discuss bladder cancer and sell, sell, sell!”

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