...review of dozens of studies showed the drug, taken by millions of diabetics, significantly raises the risk of heart attack. Six days later, he submitted the paper to the New England Journal of Medicine, which moved "at lightning speed" to get it out on Monday.Click here to read the entire article.
"I felt I had an ethical and a moral obligation to work as fast as I could," Nissen said.
He previously warned of heart risks from the painkiller Vioxx, which was pulled off the market in 2004, and three other drugs that nearly won approval: the diabetes drug Pargluva, the anticoagulant Exanta and the blood pressure drug Vanlev. He was the only FDA adviser to vote against Natrecor, a heart failure drug that some research has tied to a risk of death.
"I didn't really ask for this role," Nissen said. "I would rather spend my time doing studies that develop medications. But what happened was the FDA seems to have lost its way, and seems to be incapable of monitoring drug safety adequately. So it's fallen upon individuals to do independent analyses. I would love for that to change."
Tuesday, May 22, 2007
The Nissen "Net" that caught Avandia
That'd be Cleveland Clinic's cardiology chief, Dr. Steven Nissen, who is also the immediate past president of the American College of Cardiology. From the Houston Chronicle article: