Takeda Ignored Bladder Cancer Warning Signs

More than 10 years ago during animal trials of the diabetes drug Actos, its manufacturer (Takeda International) learned that rats exposed to Actos developed more bladder tumors than rats exposed to a placebo. Takeda did not research the cause of increased rate of tumor formation, nor did it conduct further studies with human volunteers. Instead, Takeda minimized the risks, pushed through production and sought FDA approval. Takeda claimed “the evidence did not point to a risk in humans.”

Despite the results of the rat study and though Takeda never tested on human volunteers, the FDA approved Actos for sale in the U.S.

As a condition of its approval, the FDA required Takeda to conduct a 10-year observational safety study. In effect, the FDA gave its endorsement to use the entire global population of Actos users as “human lab rats”. When interim data was available in 2010 , it revealed that patients taking Actos for the longest period had an increased risk of developing bladder cancer -- a result consistent with the rat study.

Again, Takeda decided not to warn users. But this time, the FDA disagreed and advised the public that taking Actos for more than a year may indeed carry an increased risk of bladder cancer. The European regulators went even further, banning Actos altogether from the European market.

Takeda’s failure to properly investigate Actos' side effects and the FDA’s lackadaisical approach raises questions: What purpose do investigative studies serve? Why conduct animal studies if the correlation to humans is ultimately ignored? Can a drug manufacture use patients as “lab rats” and get away with it? If Actos had been properly tested before it hit the global market, how many victims might have been spared bladder cancer?

Actos victims are hopeful that their attorneys will find answers through the newly created multi-district litigation, In Re: Actos (Pioglitazone) Products Liability Litigation.

 

Who is Takeda International?

Takeda International is a global pharmaceutical company headquartered in Japan.  It’s top selling product, Actos,  improves the body's insulin use; while it also reduces blood sugar levels.  In 1998 Takeda entered into a marketing partnership with Eli Lilly and Co. to push Actos in the United States and obtain FDA approval.  Remarkably, one year later Actos was approved for release in the U.S. market and Takeda set up shop in Deerfield, Illinois, its U.S. corporate headquarters.  Actos has been a huge success for Takeda, as Both Takeda  and Eli Lilly marketed the drug in Japan, the United States, France and Germany.  In 2010, Takeda’s global sales revenue from Actos was an estimated $4.8 billion with an estimated 2.3 million prescriptions filled in the United States.  Recently Takeda has been on the defensive.  In 2011 researchers determined that users of Actos are at an increased risk of bladder cancer.  And , the top-selling drug is now the center of hundreds of lawsuits with Takeda as their target.  

Are U.S. Scientists in Actos Manufacturer's Pocket?

In April, U.S. scientists reported that short term use of the popular diabetes drug, Actos (pioglitazone), posed no risk of bladder cancer, while use for more than two years was only weakly associated with an increased risk.

But last month a French study found diabetics who used Actos for longer than 12 months were exposed to a 40 percent increase in risk for bladder cancer compared to diabetics who had never used Actos.

In a footnote to their study the U.S. scientists admit:

  • The study was funded by a grant from Takeda the manufacturer of the Actos. 
  • Takeda reviewed and commented on the study before it was submitted for publication.
  • The scientists are paid consultants of Takeda, as well as, other drug manufacturers GlaxoSmithKline and the Actos distributor Eli Lily. 

When the U.S. study was published the U.S. Food and Drug Administration did not take any action against Actos or its manufacturer Takeda.

But, when the French study was published, France and Germany pulled Actos from the market.  In response to the French study, the FDA issued a warning to consumers that Actos may increase the risk of bladder cancer when used for more than a year.

Did the funding from the drug manufacturers influence the results of the U.S. study?  It sure looks that way. How did the French study uncover such a strong association of risk of bladder cancer, when the U.S. researchers missed it?  

FDA Links Diabetes Drug Actos to Bladder Cancer

Actos has become one of the most popular treatments for type 2 diabetes melliActos linked to bladder cancertus.  Now the FDA is warning of a link between Actos and bladder cancer. A recent study showed that the risk increases by 40% after 12 months on the drug.  That risk is significant enough that the use of the drug has been suspended in France and no new patients are to be started on the drug in Germany. The FDA is suggesting that doctors limit the use of Actos while it continues to study the matter.

According to class action law firm Girard Gibbs, who is investigating the drug, early symptoms include blood in the urine, an urgent need to urinate or pain while urinating, and low back or lower abdomen pain.

The irony is why Actos is so popular:

Actos, despite links to heart failure risk and other serious side effects, became the No. 1 diabetes pill after Avandia, the only other drug in that class, was found in 2007 to sharply increase risk of heart attacks. Avandia’s use was banned in the EU and sharply restricted here. Actos sales jumped from about $2.9 billion in 2006 to more than $4.3 billion last year.

More at the Actos lawyers' website.