-Lawyers and Settlements

06/06/2008- When the American Diabetes Association convenes here June 6th for their annual meeting, there is little doubt that amongst the topics up for discussion will be the fall of Avandia, a drug which has been linked to serious heart and liver problems, and weight gain—and what might be in the pipeline to replace it.

You know there will be something coming, given the size of the diabetes market. Roughly 21 million Americans suffer from some form of diabetes—that represents seven percent of the total population—and diabetic drug sales last year hit $12 billion.

While still in the race GlaxoSmithKline, the UK-based manufacturer of Avandia, has fallen far back of the pack, with Barron's Online reporting that safety issues have gutted sales of Avandia in the last year. And the concern raised in this country over Avandia over the past 12 months continues to reverberate around the world, with Scotland the latest to target the risks associated with Avandia.

To the latter point, drug experts from NHS Greater Glasgow and Clyde—Scotland's largest health authority—have indicated that only diabetes specialists should be allowed to initiate treatment with Avandia, given the risks. While GPs retain the capacity to treat Type 2 Diabetes with Avandia at present, that capacity could be removed in deference to growing concern.

That concern relates to a mounting chorus amongst health and drug experts in Glasgow that there is "no defense" for the continued use of Avandia, and while an outright ban is not likely, new restrictions will seriously impact who can be prescribed Avandia, and who can't.

That's because unlike other drugs that have been recalled from the global market due to real health risks to patients, Avandia is still around. Even the US Food and Drug Administration (FDA), which has mandated a black box warning for Avandia (rosiglitazone), has not lobbied to have the drug banned in the United States, even though there are safer alternatives available.

And there will be more. Given the challenges facing Avandia this past year, and the fact that two years have gone by since the last new diabetes drug was introduced, new products are on the horizon. Two manufacturers are scheduled to present data on new diabetes drugs at the ADA powwow this weekend, one of which hopes to have their new product on the market as early as next year.

Meanwhile overseas, the European Medicines Agency concluded that Avandia should carry additional warnings, in spite of the fact that a review of the glitazone family of drugs concluded that the benefits of Avandia outweighed the risks. This, in spite of published studies, which found Avandia had the potential to raise the risk of heart attack in diabetic patients by 43 percent, and the risk of cardiovascular death by 64 percent.

Such risk has empowered the Managed Clinical Network for Diabetes in Glasgow to voice its concern regarding the continued use of Avandia, to the Area Drug and Therapeutics Committee (ADTC).

"It was agreed rosiglitazone would remain on the Greater Glasgow and Clyde (drug list) with the restriction it is initiated only on the advice of a consultant diabetologist. Subsequent prescriptions can be repeated via the GP," a spokesperson siad.

"Patients who are being prescribed rosiglitazone and suffer an acute coronary syndrome should have their treatment reviewed by a diabetes clinic at the earliest opportunity. Patients who do not have cardiac risk factors should have their treatment reviewed at their next scheduled diabetic clinic visit."

In the wake of growing concern over Avandia, many doctors have switched their diabetic patients to safer alternatives. However, the move away from Avandia has come too late for those who have lost their lives, or have sufferred irrepairbale damage to their heart and liver while taking Avandia.

Those lucky enough to survive are taking GlaxoSmithKline to court…