Judge Sets Dates for Actos Test Trials While Jury Is Still Out

A federal judge has scheduled proceedings for the first of two test trials in the Actos litigation. The bellwether trials, as they are known, are set for November 3, 2014, and January 12, 2015 in the multidistrict litigation consolidated in the U.S. District Court for the Western District of Louisiana. These will be essentially test cases to gauge how future litigation will proceed and how jurors will react to the egregious cases of injury from the diabetes drug.

Stay tuned. Actos lawyers from both sides are preparing their cases and theories, but a recently published Canadian study is doing nothing to further fact finding.

The Canadian researchers from the University of Alberta conclude that diabetics have an additional risk of bladder cancer due to their type 2 diabetes. One theory is that type 2 diabetics have higher levels of insulin, a hormone that is produced by the body to convert carbohydrates consumed into sugar to be used for energy or stored. Since insulin is a hormone and cancer cells have insulin receptors, the presence of insulin could theoretically cause cancer to grow, however there is no consensus on what role insulin plays in increasing the risk of bladder complications.

What appears more likely is that in a patient taking Actos, the drug may cause some crystallization to take place inside the bladder irritating it and causing bladder cancer to develop.

The Canadian researchers conclude their review of the literature only suggests a connection between pioglitazone (Actos) and bladder cancer in diabetics downplaying the increased risk to practitioners.

The lead researcher Johnson said, “The bladder cancer risk appears to be real, but is pretty small. If you’re not at risk of bladder cancer in the first place, the benefits of pioglitazone [Actos] may outweigh the potential risk,” according to senior author Jeffrey A. Johnson, PhD of the University of Alberta in Edmonton.

However this conclusion runs contrary to a recent British Medical Journal study that supported a 2-fold increase in the risk. And if you are a patient how do you justify taking a 22 percent increased risk of bladder cancer by taking Actos?

The estimated 40 percent enhanced risk of contracting bladder cancer by virtue of being a diabetic has not been firmly established in the literature. As a class of drug, thiazolidinediones diabetes drug (Actos) make the body more sensitive to insulin, thereby reducing the level of insulin the body needs. Because the drug works to reduce the amount of available insulin, the risk of bladder cancer would have to be the result of the direct effect of the medication.

It is reckless and irresponsible to suggest that by virtue of having diabetes you have a 40% increase risk of developing bladder cancer. There is too much science pointing to the direct action of the drug which appears to be causing increases across multiple populations. The FDA even warned last year of an increase in bladder cancer risk with Actos that is now reflected in the drug’s product label.

What more do we need to tell us there is a problem?