Takeda Pharmaceuticals, the maker of the type-2 diabetes drug Actos, never warned the medical community about the risk of getting all types of cancer from the drug and only reported few to the federal adverse event reporting system, a whistleblower said in a lawsuit.
Dr. Helen Ge, who worked for Takeda as a safety consultant in Takeda’s pharmacovigilance division, said the company knew about the drug’s link to at least a dozen different types of cancer but refused to recognize it. In the company’s own adverse event database, there were more than 100 bladder cancer cases, but only 72 were reported to the U.S. Food and Drug Administration (FDA).
Whistle Blower: Takeda Knew About Actos Cancer Risk
Ge, the former associate medical director at the Harvard Clinical Research Institute, worked for Takeda as an independent contractor from 2008 to 2010. While there, she was assigned to review all adverse events associated with Actos. She said Takeda executives constantly challenged her when she tried to report adverse events linked to Actos, such as bladder cancer or congestive heart failure. She was eventually fired for whistleblowing, she said.
In the lawsuit, Ge said from 1999 to 2010 there were 1,813 reports of Actos-related cancers to the FDA’s adverse events reporting system (AERS). Most of them were reported within one year of taking Actos, she said. Of them, there were 161 cases of pancreatic cancer, 102 cases of breast cancer, 104 cases of blood cancers, 72 cases of bladder cancer, 94 cases of lung cancer and several other cancers including lymphomas, renal cancers and gastrointestinal cancers.
Ge said that clinical testing of Actos clearly showed a link between the drug and bladder cancer. In the 10 years since the FDA approved the drug, Takeda received more than 180 cancer reports each year but the company never included these reports in the drug label, Ge said. The company never issued a warning letter to doctors to alert the medical community about the risks, she said.
“Most notably, during the first three quarters of 2010, Takeda received 21 reports of multiple myeloma, alone, among other cancers reported from domestic sources, but Takeda did not change the Actos label to address these cancers,” she said. She added that the FDA’s federal code requires that this type of information be disclosed.
Takeda Never Warned Doctors About Cancer Risk
She said that during the first post-market study, there were 16 Actos-related bladder cancers, “which was four times higher than those who received other drugs.” Takeda never warned the medical community about the cancers and only added a clause to the drug label that 16 bladder cancer case were found in the post-market study, called the PROactive study.
She said that the results of the 10-year study that Takeda is performing on Actos to determine if there is a link to bladder cancer was purposely arranged to be released after Takeda’s patent has expired. The study results will not be available to the public until 2013. The patent on Actos will run out in August.
“Takeda will get the benefits of tens of billions of dollars in Actos sales while awaiting the bladder cancer results which ought to have been labeled and warned of to begin with,” she said.