More than 10 years ago during animal trials of the diabetes drug Actos, its manufacturer (Takeda International) learned that rats exposed to Actos developed more bladder tumors than rats exposed to a placebo. Takeda did not research the cause of increased rate of tumor formation, nor did it conduct further studies with human volunteers. Instead, Takeda minimized the risks, pushed through production and sought FDA approval. Takeda claimed “the evidence did not point to a risk in humans.”
Despite the results of the rat study and though Takeda never tested on human volunteers, the FDA approved Actos for sale in the U.S.
As a condition of its approval, the FDA required Takeda to conduct a 10-year observational safety study. In effect, the FDA gave its endorsement to use the entire global population of Actos users as “human lab rats”. When interim data was available in 2010 , it revealed that patients taking Actos for the longest period had an increased risk of developing bladder cancer — a result consistent with the rat study.
Again, Takeda decided not to warn users. But this time, the FDA disagreed and advised the public that taking Actos for more than a year may indeed carry an increased risk of bladder cancer. The European regulators went even further, banning Actos altogether from the European market.
Takeda’s failure to properly investigate Actos’ side effects and the FDA’s lackadaisical approach raises questions: What purpose do investigative studies serve? Why conduct animal studies if the correlation to humans is ultimately ignored? Can a drug manufacture use patients as “lab rats” and get away with it? If Actos had been properly tested before it hit the global market, how many victims might have been spared bladder cancer?
Actos victims are hopeful that their attorneys will find answers through the newly created multi-district litigation, In Re: Actos (Pioglitazone) Products Liability Litigation.