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Takeda, Manufacturer of Actos® Type 2 Diabetes Drug, Accused of Prioritizing Sales Over Safety in Second Trial Case

According to a recent report from Bloomberg News, in a case pending in Maryland State Court (the second Actos® case to go to trial), it has been alleged that Takeda, the manufacturer of Actos®, put sales over safety by failing to warn consumers that Actos® could cause bladder cancer. The attorney representing the family of a man who died from “high-grade bladder cancer” after taking Actos® to treat his diabetes, argued at trial that by 2005 officials at Osaka (Japan-based Takeda) knew of studies  demonstrating a link between Actos® and bladder cancer, but did not warn of this link until six years later. The attorney also stated that Takeda executives “knew the value of the drug and they knew the risks” it posed, and consciously chose not to warn Plaintiff or his doctors so that Takeda could continue its efforts to “sell, sell, sell” Actos®.

Takeda’s model of making Actos® sales the priority, as opposed to safety, echoes the testimony of clinical pharmacologist, Howard Greenberg, who stated during the first Actos® trial that “multiple e-mails from different levels of Takeda management … indicate the product came first.” At trial, Dr. Greenberg testified about an August 2005 e-mail from a Takeda executive, Kiyoshi Kitazawa, addressing regulatory concerns that Actos® might cause bladder cancer. In the wake of studies showing Actos® users may be at a higher risk for bladder cancer, Takeda officials feared regulators would demand a warning regarding this risk. However, Kitazawa responded to these concerns by stressing the value of Actos® to the company as a whole: “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.” The email also emphasized that the “worst-case scenario” would be for regulators to require the inclusion of a bladder cancer warning in the Actos® label. Therefore, according to Kitazawa, company officials needed to seek a “positive outcome” on the warning issue from “regulatory authorities.”

The Food and Drug Administration (“FDA”) approved Actos® in 1999. The drug subsequently became the world’s best-selling diabetes treatment. Actos® sales peaked between March 2010 and March 2011 at $4.5 billion, or 27 percent of Takeda revenue, according to data compiled by Bloomberg News.

More than 3,000 Actos® lawsuits have been filed against Takeda.  Former Actos® users allege in court filings that Takeda researchers minimized concerns that Actos® caused bladder cancer, or ignored those concerns entirely, before the drug received FDA approval. In fact, a 2011 review of a company-sponsored study led the FDA to conclude that some Actos® users were at an increased risk of developing bladder cancer. Thereafter, Takeda pulled Actos® from the market in France at the request of regulators. At the same time, the German government removed Actos® from its list of drugs that they will reimburse. However, Actos® remains available in the U.S., despite mounting concerns over its safety.

 

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