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

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.