A new "safety net" has helped keep four dangerous drugs out of the American public's hands and this week may have snared another by sounding an alarm on the diabetes drug Avandia. This watchdog is no federal agency. It is Dr. Steven Nissen, cardiology chief at the Cleveland Clinic in Ohio.
As criticism of the federal Food and Drug Administration mounts, Nissen, aided by powerful medical journals and government officials, has become a de facto drug regulator.
Nissen says that when he saw results from an analysis he and a statistics expert did on Avandia, "I was physically sick to my stomach and I couldn't sleep."
That 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.
"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."
Nissen, 58, joined Cleveland Clinic in 1992 and succeeded Dr. Eric Topol as department chief last year. He is immediate past president of the American College of Cardiology. Time magazine just named him one of the 100 most influential people, with Al Gore, Queen Elizabeth II and Oprah Winfrey.
He takes no money from drug companies, directing them to pay his fees for consulting or research to charity and the clinic's foundation.
He is not anti-industry and takes plenty of medicine himself, though he will not say what. "Drug safety affects all of us," he said.
Have breakfast with him and you had better order oatmeal and a banana, maybe a little lox.
"You're not going to have eggs, are you?" he'll ask.
For pain, he takes: over-the-counter naproxen.
How he has fun: "My wife says I don't know how." He says he likes biking, "and I always wear a helmet."
Copyright 2007 AP Features
