A recently unsealed complaint filed by whistleblower Helen Ge reveals that over four years, Takeda Pharmaceuticals failed to report to the FDA congestive heart failure cases in patients taking Actos. Takeda manufactures the Type II diabetes drug Actos. Actos is the third in a long line of failed Type II diabetes medicines.
By way of history, Rezulin, launched in the late 1990’s and was almost immediately found to cause liver failure. Within just a short while it was removed from the market. Many Rezulin takers were transitioned to Glaxo Smith Kline’s new wonder drug Avandia. Over time it became apparent that Avandia placed patients at significantly higher risk of developing congestive heart failure. The FDA intervened and required a stern, black box warning to be placed in the label and sales of Avandia slowed to a trickle.
Takeda was quick to pounce on the void left by the Avandia and Rezulin failures. It aggressively marketed Actos as the “safe alternative” to other Type II diabetes drugs. That despite Actos containing the exact same active ingredient as Avandia.
Now we come to find out that Actos only seemed to be the safer alternative. I guess one way to make your drug “appear” safer is to simply lie to the FDA about the number of reported adverse events. It seems no coincidence that Takeda representatives were reluctant to report these events while Avandia was getting pummeled in the press and in scientific circles for causing congestive heart failure.
As Actos filled the void left by Avandia, Takeda was raking in billions. In 2010, the New York Times reported that by 2009 Actos was outselling Avandia seven to one and grossing 3.4 billion dollars. That is 3.4 billion strong reasons to cover up the fact Takeda’s drug was causing the exact same problems that were bringing Avandia to its knees.
The fact Actos too frequently causes congestive heart failure as alleged by Ms. Ge is just the tip of the iceberg. As bad as Avandia was, its potentially life threatening properties were limited to heart failure. Unlike Actos, Avandia was never linked to bladder cancer.
This report causes one to wonder what Takeda knew about its drug causing cancer and when it knew it. If as alleged Takeda is willing to withhold heart failure reports from the FDA, why not keep reports about bladder cancer a secret? It would be interesting to hear what Ms. Ge or other former Takeda employees have to say about that.
I for one can’t wait to hear.