A new lawsuit accuses Takeda Pharmaceutical Co. of neglecting to warn doctors of the cancer risk associated with its Type 2 diabetes drug, Actos. The case is the first of more than 3,000 Actos lawsuits to go to trial.
According to Jack Cooper’s attorney, Takeda sales representative never warned Cooper’s physician about the risk of bladder cancer; this despite more than 195 visits the drug maker’s representative made to the physician’s office to discuss Takeda products, said Bloomberg.com. Cooper took Actos for more than four years before he was diagnosed with cancer in 2011, according to court filings. “Jack Cooper will be dead in the next seven months from bladder cancer,” his attorney said in opening statements, “A reasonable pharmaceutical company would have warned doctors” about Actos’s links to cancer, he added, wrote Bloomberg.com.
Once Actos received approval, Takeda hired 600 sales representatives to market the drug and worked to retain doctors as “key opinion leaders” for the purpose of discussing Actos’ benefits with other doctors, Cooper’s attorney said. Sales representatives visited with Cooper’s physicians every two weeks for eight years from 1999, taking the doctor to dinners and lunches as part of Takeda’s Actos marketing campaign, wrote Bloomberg.com. When Takeda sales representatives mentioned the Actos-cancer risk to Cooper’s doctor in 2011, the physician ceased issuing new prescriptions and banned Takeda sales staff from his office.
Not surprisingly, a Takeda attorney said that Cooper, 78, developed bladder cancer, not from Actos, but from his gender and his years of smoking. Cooper “already was at high risk” for developing bladder cancer “for reasons that had nothing to do with Actos,” Sara Gourley, a Takeda attorney said in opening statements, said Bloomberg.com. Cooper is a retired cable splicer for Pacific Bell and 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.com.
As we’ve explained, a growing body of research suggests that Actos is associated with an increased risk of 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 Pharmaceuticals hid evidence that revealed its popular drug was linked to this dangerous side effect.
Meanwhile, we previously wrote that another study, funded, in part, by the European Association for the Study of Diabetes, found that taking thiazolidinedione (TZD) drugs, like pioglitazone (Actos) and rosiglitazone, 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, specifically, that acknowledge the risk of bone fractures (particularly of the hip) while taking Actos for the treatment of Type II diabetes.
Meanwhile, noted Bloomberg.com, 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.