Actos Whistleblower Claims Takeda Downplayed CHF Data

San Francisco, CAAccording to the latest reports from the Actos Whistleblower lawsuit, Dr. Helen Ge, a former consultant to Takeda Pharmaceuticals for Actos, claims the drug company routinely downplayed Actos-related congestive heart failure (CHF) cases to make the drug look better and thereby increase profits.

Actos (pioglitazone hydrochloride) is a member of a class of drugs known as thiazolidinediones, which have been linked to liver and cardiovascular issues. Actos side effects include increased risk of CHF, increased risk of rare but serious liver problems, an increased risk of fractures, and an increased risk for bladder cancer. The link between Actos and heart failure is strong enough that in 2007 the FDA increased the warnings on the drug concerning congestive heart failure. Actos is used to treat type 2 diabetes.

Dr. Ge is the plaintiff in the lawsuit U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043, U.S. District Court, District of Massachusetts (Boston). In the suit, she alleges that Takeda wanted to "scuttle" findings which showed the diabetes medication actually increased the risk of heart failure for some who used it.

Specifically, Dr. Ge claims she was let go from Takeda because she raised concerns over the company's handling of the safety data. Dr. Ge claims that as public concern grew over Actos side effects, and the drug came under intensified scrutiny, officials at Takeda tried to direct medical reviewers, which included Dr. Ge, to "change their professional opinion" regarding the potential dangers of Actos side effects with regards to heart problems. When she raised concerns over this, she was let go.