Another Critic Comes out Against Avandia Safety Trial

May 18, 2010, 6:00PM. By Heidi Turner

Bellingham, WAAnother researcher has joined the calls to end the Avandia safety trial, calling the study unethical and dangerous. Reports have also emerged that GlaxoSmithKline, maker of Avandia, has settled 700 lawsuits regarding Avandia side effects. Those lawsuits claim that Avandia exposed patients to an increased risk of heart attack.

The most recent criticism came from Canadian physician David Juurlink, who led a 2009 study comparing Avandia to rival drug Actos. Juurlink's study found that patients who took Avandia were approximately 30 percent more likely to suffer heart failure or death than those who took Actos.

Juurlink and Public Citizen Director Dr. Sidney Wolfe called for the US Food and Drug Administration (FDA) to put an end to a current study comparing the safety of Avandia and Actos. Critics say the trial, known as TIDE, unnecessarily puts patients at risk of serious side effects.

Avandia is currently available on the market. A black box warning on its label indicates that patients could be at risk of ischemic heart attack or heart failure.

In 2007 the FDA also ordered that GlaxoSmithKline conduct a safety trial of Avandia. That trial, called TIDE, or Thiazolidinedione Intervention in Vitamin D Evaluation, is now under fire. Both Juurlink and Wolfe argue that there is little proof the TIDE trial will provide more reliable evidence of Avandia's safety than previous research has already shown. In a letter to FDA Commissioner Margaret Hamburg, the two contend that thousands of patients would be exposed to a drug "with an unfavorable safety profile."

Juurlink's Avandia study was published on 8/19/09 in the British Medical Journal The study found that 6.9 percent of patients who took Avandia died or were hospitalized for heart attack or heart failure, compared with 5.3 percent who took Actos.

GlaxoSmithKline defended the TIDE trial as ethically conducted. The company also defended the diabetes medication, saying it is an important treatment option for physicians. The FDA responded to the concerns, saying some scientists feel the issue of safety regarding the two drugs is unresolved and further study is necessary to determine whether one drug is safer than the other.

Meanwhile, GlaxoSmithKline reportedly agreed to settle 700 Avandia-related lawsuits for around $60 million. Bloomberg announced the settlement, citing sources close to the accord. Thousands of other lawsuits are still pending.