For area diabetes patients, treatment options for the chronic disease are clouded by uncertainty as experts spar over the safety of Glaxo Smith Kline's controversial drug, Avandia
Many, spooked by reports of increased heart-attack risk, have ditched Avandia, while some swear by the pill, one of the world's most effective treatments for Type II diabetes.
A recommendation whether to pull Avandia off the shelves could come as early as today from a panel of experts that meets in Maryland for a second day of testimony on the drug. The experts will advise the U.S. Food and Drug Administration whether evidence of heart attack risk is strong enough to withdraw the drug or whether Avandia requires stronger label warnings.
"Until these folks hash it all out and get a green light going, I just don't want to take it," said Henry Barsky, a Morrisville retiree who had quadruple bypass surgery. "If anything has the remotest possibility of killing me, I'm against it."
Avandia was the world's best-selling diabetes pill with more than $3 billion in annual sales in 2006, but sales took a nose dive when a 2007 New England Journal of Medicine study linked the drug to an increased risk of heart attacks. Last year Avandia generated $1.1 billion for GSK, the British pharmaceutical giant with North American headquarters in Research Triangle Park.
Barsky, 67, stopped taking Avandia about two years ago, soon after the negative reports surfaced. He had been participating three years in a clinical trial of the drug and pulled himself out of the study. "I had all the markers for having a heart attack," he said. "Why push my luck?"
Avandia, introduced in 1999, belongs to a class of drugs that help patients control diabetes without having to inject insulin.
Patients who have stopped using Avandia have the option of using Actos, a drug similar to Avandia made by a Japanese competitor, Takeda Pharmaceutical Co. But Avandia has been the drug of choice for many years because it's cheaper than Actos and preferred by insurers.
Brian Forrest, a family physician in Apex, has moved about 150 patients to Actos but has kept using Avandia for about a dozen who are happy with the results. He said many patients asked to be taken off Avandia, and he doesn't put new patients on the drug even though he thinks it's safe.
"If a patient won't take the medicine, it won't work," he said.
Still, finding the right combination of diabetes drugs is a struggle for some. Avandia and Actos both contribute to weight gain and are not recommended for patients with heart problems.
Mary Hall of Wake Forest tried several medications that caused nausea and vomiting before trying Avandia last year. She quit Avandia after just two months after experiencing heart palpitations and frequent bruising.
"I was afraid to get in a car and go out to dinner," she said. "I would have rather taken nothing than take Avandia. I was like a prisoner in my own home."
Staff writer David Ranii contributed to this report.