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Dangerous Diabetes Drug Must Be Pulled From the Market and Unethical Clinical Trial Stopped

April 28, 2010  
Dangerous Diabetes Drug Must Be Pulled From the Market and Unethical Clinical Trial Stopped

Testifying Before Congress, Public Citizen Says Drug Is Needlessly Putting Thousands in Study, More Across Country At Risk

WASHINGTON, D.C. – Not only should a dangerous diabetes drug be pulled from the market immediately, but an unethical international trial involving that drug – ordered by the Food and Drug Administration (FDA) and done by the drug maker – must be halted, Public Citizen said in congressional testimony today.

Public Citizen has long opposed the diabetes drug Avandia and has told the FDA about the dangers of the drug for a decade. Now, the health and safety of thousands of innocent people are being jeopardized by allowing a clinical trial to continue, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, told the House Committee of Appropriations’ Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies at a hearing about Avandia.

Public Citizen first petitioned the FDA in 2000 to issue warnings about the dangers that the diabetes drug Avandia (whose generic name is rosiglitazone) poses to the heart. In 2008, Public Citizen called for the FDA to remove the drug from the market because of multiple serious risks, including increased risk of heart attacks, heart failure, bone fractures, anemia and vision loss.

In the experiment known as TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), the FDA requested that the manufacturer of Avandia, GlaxoSmithKline, compare the drug to a competitor’s, even though some FDA officials have called the trial “exploitive of patients.” The study involves 16,000 people from 14 countries. It is supposed to evaluate the cardiac safety of rosiglitazone compared to standard treatment and to another drug in the same family, pioglitazone (better known as Actos).

“The TIDE trial defies a basic tenet of clinical trial design – that trials should be conducted to determine the balance of risk and benefit and not simply to provide absolute proof on harm,” Wolfe said. “Because Avandia has no advantage in safety or effectiveness – not even a theoretical one – over Actos, and because a wealth of data now suggests Avandia carries greater risks than Actos, thousands of high-risk patients with diabetes are being needlessly exposed to a drug with an unfavorable safety profile and no clinical advantage over its competitor.”

It is unlikely that the participants are making an informed decision about the trial; the consent form for participating in the trial does not present an accurate portrayal of existing safety concerns, Wolfe said.

“It is difficult to imagine that a patient would willingly participate in a trial involving a drug that, according to the American Diabetes Association and its European equivalent, has safety concerns that leave it with no present-day role in the management of type 2 diabetes,” Wolfe said.

Wolfe also told lawmakers about new data gathered since Public Citizen filed the 2008 petition that underscore Avandia’s risks. A study released in January showed a significant doubling of heart failure deaths or hospitalizations in patients given Avandia, and among those admitted to the hospital with heart failure, there was more than four-fold increase in subsequent cardiovascular deaths.

In addition, a Canadian study published in August 2009 found major differences in the risk of congestive heart failure and death from any cause in patients taking Avandia compared to Actos.

To read the full testimony, visit www.citizen.org/hrg1907.

Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org