The Avandia witch hunt saga just gets more and more absurd. Guess what just popped up from the FDA’s Division of Drug Information? Notice of an ongoing safety review of pioglitazone (the "safer alternative" generic pushed by those urging Avandia be pulled from the market.). Apparently "an increased risk of bladder cancer was observed among patients with the longest exposure to Actos (pioglitazone) as well as in those exposed to the highest cumulative dose of Actos."

So does this mean that pioglitazone ought to be banned? Does this mean that the ongoing study of pioglitazone users needs to be discontinued because it’s unethical? That’s what the anti-Avandia activists argued re: Avandia and the TIDE trial; they wanted everyone off Avandia, on pioglitazone and the experiment halted - pronto.

No; it ought not mean any of those things. What it does mean is that it’s foolish to let our decisions be bound by the results of a single data dredge.

For more on the Avandia issue see: "Avandia: Burn Her Anyway?" For more on the perils of data mining see "Lies, Damned Lies and P-Values". Here’s the full text of today’s FDA missive on pioglitazone:

 

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.



The U.S. Food and Drug Administration (FDA) is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone), is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study.

Actos is used along with diet and exercise to control blood sugar or improve control of blood sugar in adults with type 2 diabetes mellitus.

Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the United States and is thought to be higher in diabetics.

The drug manufacturer, Takeda, has conducted a planned analysis of the study data at the five-year mark, and submitted their results to FDA. Overall, there was no statistically significant association between Actos exposure and bladder cancer risk. However, further analyses were also performed looking at how long patients were on Actos and the total amount of the drug they received during that time. An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.

At this time, FDA has not concluded that Actos increases the risk of bladder cancer. Its review is ongoing, and the Agency will update the public when it has additional information.

For more information, please visit: Actos