Avandia's Fate is Sealed, Says Doctor. "The Drug is Done"

Washington, DCWhile the US Food and Drug Administration (FDA) has yet to decide on the fate of Avandia in the wake of an expert panel's various recommendations and positions at a summit held in July, some in the medical community say that given the Avandia risks—including heart attack, liver failure and bone fractures—the disappearance of Avandia is all but assured.

"Nobody should be prescribing it," said Dr. Clifford Rosen, an endocrinologist and senior scientist with the Maine Medical Center Research Institute in Scarborough who served on the expert panel in July and spoke to reporters after the meeting. "Anybody who went to or heard this meeting would never prescribe rosiglitazone (Avandia) under any circumstances."

While a slim majority of panelists voted to keep Avandia on the market (by a vote of 20 out of 33), half of those voting in the affirmative tied their 'yay' votes to tighter restrictions.

Noted cardiologist Dr. Steven Nissen of the Cleveland Clinic, who co-authored the 2007 study that launched public scrutiny of the GlaxoSmithKline (Glaxo) drug, said in a statement that such restrictions could lead to a 95 percent drop in prescriptions by doctors in the US.

Sales of Avandia have already dropped considerably since 2007, when the debate about the Type 2 diabetes drug alleging serious Avandia side effects first heated up. From a peak of 5.6 million US prescriptions three years ago, IMS Health says that the number has plummeted to about one million as of this past May.

"It's not like we have a scarcity of options for lowering blood sugar," Nissen said, in comments published July 20th in USA Today.

In a related issue that may also hint at the future of Avandia, the FDA chose not to follow the recommendation of the expert panel to keep the TIDE trial going, by ordering Glaxo to stop enrolling new participants in the study. Those already enrolled may continue if they so choose. However, news that the FDA has effectively called a halt to a study the agency itself requested in 2007 is, some may argue, a sign of further things to come.

An FDA reviewer, in documents released in advance of the expert panel meeting in Gaithersburg, Maryland, called the TIDE study unethical and exploitive.

Avandia has been battling for market share with Actos, the only other drug in the glitazone class that shares similar concerns with Avandia—namely a risk for fractures, weight gain, fluid retention and heart failure. However, Rosen suggested that evidence points to Actos—manufactured by Takeda Pharmaceuticals—as having a lower risk for heart attack than Avandia. Market share for Actos has grown, while that for Avandia has dropped.

Glaxo has been consistent in its defense of Avandia, even in the face of lawsuits.

Mayo Clinic endocrinologist Victor Montori said fewer than 10 percent of US diabetes patients still take the drug. "If the FDA does not do anything, I think the market will continue to shrink," he says.

The FDA is expected to make its overall recommendation with regard to the fate of Avandia—in light of the various Avandia risks and Avandia side effects—in the fall. Montori and other diabetes specialists note that a number of other drugs are cheaper and safer than Avandia and Actos. Montori says there's no evidence to support the notion that Avandia might work better than Actos for some.

As for diabetes patients worried about what happens if Avandia goes, senior diabetes specialist at Group Health, David McCulloch said "there are plenty of other good alternatives."

Rosen is convinced Avandia cannot survive.

'I'm telling you, the drug is done."