Renewed call to ban Avandia

9/17/2007- A consumer watchdog group stands by its belief that Avandia, the embattled type 2 diabetes drug, should be removed from the market, a demand the group's leadership says was fortified last week by additional research.

Avandia, made by GlaxoSmithKline, is designed to lower glucose in the blood, but it has been under a spotlight -- and on the hot seat -- for months, along with rival drug Actos, manufactured by Takeda Pharmaceutical Co.

Studies reported last week confirmed earlier ones demonstrating that the drugs raise the risk of congestive heart failure and that Avandia also raises the likelihood of heart attack and stroke.

"We've been pushing for a ban on Avandia for a while," said Dr. Peter Lurie of Public Citizen's Health Research Group. "Our angle has always been about the risk of congestive heart failure and that's what the latest study shows. We think the new research amplifies the case for removing Avandia from the market."

The evidence so far does not suggest that Actos should be banned, Lurie added, but he underscored that because it carries risks, it should not be used as first-line therapy.

Dr. Leonid Poretsky, an endocrinologist at Beth Israel Medical Center in Manhattan, said Avandia excels in controlling blood sugar. "The public has to realize that there is a risk with taking any medication. ... The benefits of a drug sometimes outweigh the risks."

Lurie thinks differently. "Does the overall risk-benefit of Avandia support it remaining on the market?" he asked. "We believe the answer is no."

Dr. Daniel Solomon, a professor of medicine at Harvard Medical School who critiqued the Actos and Avandia studies in last week's Journal of the American Medical Association, said the drugs belong to the class of medications known as the thiazolidinediones.

Solomon said the drug family is extraordinarily complex and affects numerous biological pathways. It's likely that not all the side effects are known.

He likened problems linked to Avandia and Actos to those involving Vioxx, the painkiller voluntarily pulled from the market in 2003 by Merck & Co.. Vioxx, a so-called COX-2 inhibitor, also elevated the risk of heart attacks and strokes.

Problems with Avandia and Actos, Solomon said, came into sharper focus once they were widely prescribed. Pre-clinical tests indicated that they raised the risk of congestive heart failure, he added, but it took years for that concern to register with the public. Both drugs were approved by the Food and Drug Administration in 1999.

"It really calls into question the drug safety process," Solomon said. "Concerns are raised but it takes several years before we have enough information to understand all of the safety issues. ... Everyone should be asking whether there is a way to create a drug safety-monitoring system so that concerns can be brought to the fore more quickly."

As of August, Avandia and Actos have carried "black box" warnings, the FDA's most stringent level of caution.

Executives at Takeda said last week that Actos is safe. And Mary Anne Rhyne, spokeswoman for GlaxoSmithKline, insisted Friday that Avandia is as well. "We stand firmly behind the medication when it is used appropriately," she said.

However, alternative-medicine physicians on Long Island are giving Avandia and Actos to children with autism under the unproven theory that it effectively treats the disorder. And a GlaxoSmithKline-sponsored clinical trial is under way testing Avandia in patients with Alzheimer's disease. Rhyne said patient's in that study are being closely monitored.

Lurie noted that in addition to cardiovascular risks, Avandia and Actos also increase the chances of bone fractures and vision impairment.