Tougher U.S. rules for diabetes drugs debated

By Lisa Richwine

SILVER SPRING, Maryland (Reuters) - Drug makers should do more testing to see if proposed new diabetes medicines may damage patients' hearts, a prominent cardiologist told a U.S. advisory panel on Tuesday.

Other experts warned that tough standards could stifle development of new treatments by requiring longer and more expensive clinical trials. The U.S. market for the top-selling diabetes medicines now exceeds $6 billion.

"We have to rule out some level of harm prior to approval," Cleveland Clinic cardiologist Steven Nissen told a panel of experts that advises the Food and Drug Administration.

Nissen co-authored an analysis last year that found patients who took GlaxoSmithKline's pill Avandia had a higher chance of having a heart attack.

Another government-funded study found diabetics given intensive therapy to lower blood sugar died at a higher rate than others who were allowed a higher blood sugar level. It said no one drug was to blame.

Both studies raised questions about the FDA's current standard for judging diabetes drugs. Companies generally need to show only that the drugs control blood sugar.

The FDA, criticized for its oversight of Avandia and other drugs, is asking the panel of outside experts how much data to demand on cardiovascular effects for new and already approved diabetes drugs.

Recommendations are expected from the panel on Wednesday. The agency usually follows its panels' advice.