A new drug study has caught the attention of millions of diabetics around the world and doctors who treat them. VOA's Melinda Smith has more about the study which links a popular insulin controlling drug to an alarmingly high rate of heart attacks and death.
The news cannot be good for the 180 million people around the world who are diabetics. The drug is the top selling oral treatment for type-2 diabetes. It is sold worldwide under the brand names Avandia, Glimide and Rezult. Avandia is commonly used to control blood sugar levels when the pancreas fails to produce enough insulin.
But the drug that might be good for controlling diabetes is generating a lot of criticism about its effect on the heart.
A review of 42 clinical trials in which 27,000 patients were given Avandia showed dramatic results. Type-2 diabetics in the study had a 43 percent higher risk of having a heart attack - and a 64 percent greater chance of dying from a heart attack - than those not taking the drug.
Dr. Steven Nissen of the Cleveland Clinic authored the report. He says patients began having heart problems in the first six months of taking the drug. "That is alarming," he says. "It needs to be confirmed with other analyses, but if the data hold up, and I believe that they will hold up, it does represent a huge public health concern."
The report was published in the prestigious New England Journal of Medicine. The Journal's editors called the approval of Avandia by the U.S. Food and Drug Administration and its release by the manufacturer GlaxoSmithKline "a major failure of the drug use and drug approval process in the United States."
Dr. David Nathan of Massachusetts General Hospital in Boston, Massachusetts, believes a closer review might have avoided these problems. "Both the [Food and Drug Administration] and the drug company presumably had this data in hand," he says. "So why didn't they ever look at it the way Dr. Nissen and his colleagues did?"
Data from the study was reportedly presented to the Food and Drug Administration almost a year ago. Dr. Robert Meyer of the FDA explains why the government has not taken further action about the drug. "We want to be proactive about safety, but we also don't want to needlessly disrupt the diabetic care of hundreds of thousands or millions of diabetic patients."
The drug company has disclosed other problems associated with Avandia. It can stimulate extra body fluid, leading to swelling and weight gain. It increases LDL cholesterol levels by as much as 18 percent. High cholesterol is an early contributor of heart disease.
GlaxoSmithKline stands by its drug. Meanwhile U.S. Congressional hearings are scheduled to investigate the approval process of Avandia and whether its use for type two diabetics is worth the risks.