Just two years ago, Takeda Pharmaceuticals' Actos (dabigatran) was the top-selling diabetic drug in the world. With over $4.5 billion in sales, it accounted for 27% of the company's revenue.
Today, the drug has been been implicated in the development of bladder cancer. It has been pulled from pharmacy shelves in the E.U. and is under increasing scrutiny by the U.S. Food and Drug Administration (FDA). The British Medical Journal (BMJ) recently published a study which demonstrated an increasing risk of developing bladder cancer with long-term use.
During the week of 18 February, the first of some 3000 civil cases against Takeda Pharmaceuticals got underway in a California court, the Honorable Judge Kenneth Freeman presiding. Grounds for the lawsuits: “failure to warn.” Plaintiffs' attorneys allege that Takeda executives were aware of the hazards associated with their flagship product and – in order to protect their profits – chose to downplay the information. According to an article in the Chicago Daily Herald, Takeda sponsored its own study, which showed an increased risk of bladder cancer among Actos patients, which was later reviewed by officials at the FDA.
The information from this study appears to be contradictory. When the FDA reviewed Takeda's own study, they came to the same conclusion as the BMJ – certain Actos patients face an increased risk of developing bladder cancer. Takeda executives insist that their study is “ongoing,” and is showing that bladder cancer risks actually decrease over time. A lawyer for Takeda insists that “studies do not establish a causal link between Actos and bladder cancer.”
Plaintiff's attorney's on the other hand allege that Takeda's researchers were aware of the risks even before it was approved by the FDA in 1999 – and that they had actually misled the agency when they applied for the drug's approval. Later on, Takeda resisted the FDA when that agency attempted to have the company place stronger warnings on its packaging. At the same time, the court filing states that Takeda management instructed its sales staff not to initiate any conversations about cancer dangers with potential customers in the medical community. A company memo said: “If no questions/concerns [about bladder cancer], do not discuss...and sell, sell, sell!”
It's worth noting that clinical tests of a similar drug from Danish pharmaceutical firm Novo Nordisk, known as ragaglitazar, was canceled after laboratory rats developed bladder cancer.
Takeda has allegedly been up to other shenanigans as well. Actos has been implicated in a number of cases involving congestive heart failure – but when these cases weren't fatal, Takeda management told its reviewers not to file the reports. A former Takeda employee, Dr. Helen Ge, was summarily fired when she attempted to blow the whistle. Sadly, when Dr. Ge took her case to court, it was dismissed on grounds that her allegations against her former employer were not clear or specific enough.
Feely, Jeff and Margaret Cronin Fisk. “Takeda Worried About Actos’s Cancer Link, Filing Shows.” Bloomberg, 15 February 2013.
N/A. “Takeda Faces First Trial Over Actos Diabetes Drug in California.” Daily Herald, 19 February 2013.
Stanton, Tracy. “Takeda Preps for First Actos Trial Now Opening in L.A.” Fierce Pharma, 19 February 2013. Available at http://www.fiercepharma.com/story/takeda-preps-first-actos-trial-now-opening-la/2013-02-19.
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