Dr. Steve Nissen, a noted cardiologist, wants the Food and Drug Administration to raise its standards for approving diabetes drugs. Dr. Nissen, who is with the Cleveland Clinic, says that new drugs need to prove they don’t increase cardiovascular disease, the leading killer of diabetics. He believes the FDA should require companies to prove their drugs don’t raise risks of cardiovascular disease before they are approved. Dr. Nissen, who believes there are more than enough diabetes drugs on the market that lower blood-glucose levels, says it’s time for the FDA to raise its standards. In this regard, he observed:

Merely lowering blood-glucose levels in diabetes is too simplistic. We must reduce the complications of diabetes, including cardiovascular disease.

Dr. Nissen suggested that, in addition to requiring more preapproval studies, companies should have large, long-term studies in place when a drug is approved to monitor whether the drug increases the risk of cardiovascular disease. About 75% of all deaths in diabetes patients are a result of cardiovascular disease.

The FDA is weighing whether to require that new and already-approved diabetes drugs have a positive impact on cardiovascular disease and life span, which are more difficult to measure than current benchmarks such as lower blood sugar. It’s reported that no drug that regulates sugar levels has shown beneficial cardiac effects in Type 2 diabetics, who make up more than 90% of all diabetes patients. A shift away from current research benchmarks, known as surrogate endpoints, might change the entire framework of drug approval because research on most medicines – from anemia to cancer drugs – relies on such interim measures.

About one in 12 Americans has diabetes, according to the federal Centers for Disease Control and Prevention. The FDA is trying to decide what to do on the issue of diabetes-drug standards. This was the subject of a two-day meeting last month. The meeting was prompted in part by controversies about research on cholesterol-lowering drug Vytorin and Avandia, a diabetes drug.

Source: Wall Street Journal

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