Avandia Escapes New FDA Recommendation

Washington, DCAnd the lawsuits just keep on coming over Avandia, a diabetes drug suspected of increasing the risk for heart attack. And it's not just in the US either, where the US Food and Drug Administration (FDA) continues in its much-criticized role as industry watchdog.

The concern over Avandia has spread across the globe.

In Canada, a Nova Scotia man has launched a class action lawsuit against GlaxoSmithKline (GSK), the manufacturer of Avandia, citing fatigue, weakness, weight gain, vision problems, shortness of breath, angina and heart problems. Ronald Finck, of Shinimicas Village has since stopped taking Avandia, but says he still has difficulty walking and performing routine daily tasks.

The suit, which could have thousands of plaintiffs, also names the Canadian government as a defendant, alleging that it should have known that Avandia, which was approved by Health Canada in 2000, was unsafe for patients. Court documents claim that Avandia continues to be one of the highest-selling drugs in Canada with sales topping $150 million CDN. in 2006.

It is that risk for mortality that has some critics up in arms over the way in which drugs are approved, at least in the United States, anyway.

In many instances, medicines are approved on the basis of surrogate endpoints—evidence of some kind of benefit. That, as opposed to having been shown to reduce the risk of death or disease.

Researchers defend this approval structure as sensible in certain circumstances. For example if no treatments exist for a disease, the FDA may approve a drug based on its potential suggested within the context of short-term trials, together with the hope that the drug succeeds after the fact in larger trials where its potential to reduce death and disease could be examined directly.

But that's not what happened with Avandia. In 1999 Avandia was approved on the basis that it reduced blood sugar. Sales of Avandia, and two related drugs soared to $3 billion by 2006. But a year later, according to a September 2nd, 2008 article published in the New York Times, an analysis of 44 clinical trials of Avandia showed that it could increase heart attacks. Since then, prescriptions for Avandia have plunged, although the drug remains on the market.

Critics say it shouldn't be, and there are a number if individual lawsuits, as well as class action lawsuits, to back that up.

Dr. Curt D. Furberg, an epidemiologist and drug safety expert at Wake Forest University, said that before approving drugs the FDA should require that drug companies conduct large trials on whether they reduce death and disease, except in rare cases where no alternatives exist.

Not surprisingly, pharmaceutical companies argue against changing the current approval system. Determining whether a drug reduces death or disease can require a trial that enrolls 10,000 or more patients and lasts four years or more. Requiring longer and costlier trials might discourage the development of new medicines.

Critics have, at least, taken some solace in a slightly more combative FDA. Probably due to unrelenting public criticism and pressure from Congress, the federal drug watchdog has been taking a harder line of late. And in July an FDA advisory panel overwhelmingly recommended that pharmaceutical companies conduct long-term trials on new diabetes drugs.

However, that recommendation doesn't apply for drugs already on the market.