Did Takeda downplay reports of bladder cancer and congestive heart failure in Actos patients? Helen Ge, former Takeda medical reviewer, accuses the Japanese pharmaceutical company of exactly that in her whistleblower lawsuit which was unsealed last week.
Takeda's Type2 Diabetes drug, Actos (pioglitazone), grew in popularity after use of Avandia, GlaxoSmith Kline's controversial drug, was severely restricted in the US because of concerns of an increased risk of heart attack and heart failure.
However, like Avandia before it, the safety issues surrounding Actos have come to the attention of the FDA and have left the public questioning whether there is a diabetes drug worth the risk.
On June 15, 2011, the FDA issued a warning regarding the link between Actos and the increased risk of bladder cancer amongst those who had used the drug the longest. According to the warning, there is also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.
The FDA issues warnings such as the one on Actos as a result of clinical reviews of information provided in a database called the Adverse Event Reporting System (AERS). These reports come to the FDA from three places – physicians, the public and from the drug manufacturer. It is imperative to the safety of the public that the FDA receive all adverse event reports that occur with a product.
Helen Ge was hired to review these adverse event reports on behalf of Takeda. According to Ge’s complaint Takeda underreported the instances of bladder cancer in Actos patients to the FDA by nearly thirty cases, creating what she called a “serious discrepancy.” According to Ge, Takeda asked her to change her assessment of the reports from "related" to "unrelated" to the diabetes drug Actos. In so doing, Takeda would not be required to submit the adverse event report to the FDA.
These allegations from Ge are potentially damaging to Takeda, who is already facing hundreds of lawsuits as a result of its link to bladder cancer, the exact risk that was allegedly underreported as described by Ge. We plan to investigate these claims very thoroughly and will continue to closely monitor this lawsuit and Takeda's responses.