Actos Recall | Actos Bladder Cancer Lawsuit

Takeda Whistleblower: Company Culture “Riddled With Systematic Fraud”

Seth Harris | May 11th, 2012

According to a whistleblower lawsuit, Takeda Pharmaceutical’s U.S. unit failed to accurately report adverse side effects, namely Actos heart failure, to the Food and Drug Administration (FDA). The suit was filed in Boston in 2010, but only recently unsealed and made public. The allegations in the suit were brought forward by Helen Ge, a former medical reviewer for the company, who claims that the company’s culture is “riddled with systematic fraud and deceit.”

Despite thousands of reports from patients who claim to have developed Actos bladder cancer, neither Takeda nor the FDA has implemented an Actos recall.

Company concealed Actos heart failure data

Ms. Ge alleges that Takeda purposefully misclassified “non-hospitalized or non- fatal” congestive heart failure cases as less serious in the FDA’s adverse event reporting system. The company also allegedly downplayed data linking its popular type II diabetes medication with Actos cancer.

The company’s actions were “driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales,” according to Ms. Ge. Sales of Actos accounted for 27 percent of Takeda’s profits last year, though that percentage is expected to decline when generic versions of the drug become available in August.

Hiding data may have been effort to avoid Actos recall

While Ms. Ge’s complaint links Takeda’s actions to a simple desire to maximize profit, other observers may see the alleged misclassification of data as part of a strategy to keep the controversial drug on the U.S. market. Ever since research has shown that patients using Actos to control their diabetes face a nearly 22 percent risk of developing bladder cancer, patient advocates have called for removing Actos from pharmacy shelves. An Actos recall was issued in France in 2011, and Germany has also halted sales.

Though the FDA has not ordered an Actos recall, regulators are currently reviewing patient data to assess the drug’s risks. To order a recall of a medication in the U.S., the FDA must conclude with “reasonable probability” that the subject drug will cause “serious adverse health consequences or death.”