Witness in Actos Lawsuit: Takeda Put Drug Sales Ahead of Consumer Safety

takeda-put-drug-sales-ahead-safetyIn the first Actos lawsuit, witness testimony indicates that drug maker, Takeda Pharmaceutical Co., put money before patient safety when it came to its Type II diabetes drug, Actos.

As we’ve explained, a growing body of research suggests that Actos (pioglitazone) is associated with an increased risk of developing bladder cancer. In fact, in June 2011, the U.S. Food & Drug Administration (FDA) announced that the warning label on Actos would be updated to include this risk. The new label also warns that using Actos for more than one year may significantly increase the risk of developing bladder cancer; data is based on an ongoing, 10-year study conducted by Kaiser Permanente.

Last May, the BMJ published a study that revealed that patients who took Actos for two years were twice as likely to develop bladder cancer. Another study, published last summer in the Canadian Medical Association Journal, found that use of Actos was linked to a 22 percent increased risk of developing bladder cancer.

Thousands of people have come forward who believe they’ve either contracted bladder cancer or have unknowingly been put at risk of this life-threatening disease because Takeda Pharmaceutical hid evidence that revealed its popular drug was linked to this dangerous side effect.

In testimony, Howard Greenberg, a clinical pharmacologist testifying as an expert for Cooper, said that e-mails dated in 2005 involved discussions concerning the possibility that US and European regulators would seek warning labels over the Actos-bladder cancer risk. Takeda officials, said Greenberg, focused on protecting Actos, not Actos users. “There are multiple e-mails from different levels of Takeda management that indicate the product came first,” Greenberg told jurors, according to Bloomberg News.

Greenberg said he reviewed a number of internal Takeda files, among them, the August 2005 e-mail from Takeda executive, Kiyoshi Kitazawa, Bloomberg News said. Greenberg was testifying in Los Angeles state court on the first day of a lawsuit brought by Jack Cooper over allegations that Actos caused his bladder cancer, said Bloomberg News. The lawsuit accuses Takeda of neglecting to warn doctors of the cancer risk associated with its Type 2 diabetes drug and is the first of more than 3,000 Actos cases to go to trial. Cooper, a retired cable splicer for Pacific Bell, was diagnosed with bladder cancer in 2011, according to his attorney. He was in “good shape” before taking Actos, routinely going for five-mile walks, handling his own home repairs, and enjoying deep-sea fishing with his grandchildren, his lawyer noted, said Bloomberg News.

In the e-mail, Kitazawa focused on the drug’s value and was written for colleagues who reviewed what regulators might do concerning research revealing the increased risk of cancer for Actos users, explained Bloomberg News. The e-mail also indicated that Takeda officials were concerned that regulators would mandate it include warnings about the cancer risk to the Actos label. “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,” Kitazawa said. A change to the Actos label, said Takeda officials, would be the “worst-case scenario,” according to the e-mail, said Bloomberg News. Kitazawa also urged his peers to find a “positive outcome” on the warning issue from “regulatory authorities.”

We also previously wrote that another study funded, in part, by the European Association for the Study of Diabetes, found that taking thiazolidinedione (TZD) drugs, such as Actos, instead of other drugs that aim to lower glucose, increases a person’s risk of suffering a hip fracture. The risk is highest for a distal hip fracture, mostly among women, though men do face a significantly increased risk of suffering similar consequences while taking TZDs. The study found that the risk of suffering a hip fracture while taking Actos appears to increase with time on the drug. There are warnings on the labels of Actos that specifically acknowledge the risk of bone fractures (particularly of the hip) while taking Actos for the treatment of Type II diabetes.

Meanwhile, noted Bloomberg News previously, in 2011, FDA officials discovered that a review of a Takeda-sponsored study revealed some Actos users were at an increased risk of developing, not just bladder cancer, but heart problems as well, Takeda pulled Actos from the German and French market that year in response to regulators there.

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