Cardiologist is whistle-blower

A new watchdog has helped keep four dangerous drugs out of the public's stomachs, and this week might have snared another by sounding an alarm about the diabetes drug Avandia. Who's watching? Cleveland Clinic's cardiology chief, Steven Nissen.

As criticism of the 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 that 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 that the drug, taken by millions of people with diabetes, significantly raises the risk of heart attack. Six days later, Nissen submitted the paper to the New England Journal of Medicine, which moved "at lightning speed" to publish it Monday. "I felt I had an ethical and a moral obligation to work as fast as I could," Nissen said.

Nissen previously warned of heart risks from the painkiller Vioxx, which was pulled from the market in 2004, and three other drugs that nearly won approval: the diabetes drug Pargluva, anticoagulant Exanta and 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."

Nissen, 58, joined Cleveland Clinic in 1992 and succeeded 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, along with Al Gore, Queen Elizabeth II and Oprah Winfrey.

Nissen 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 won't say what. "Drug safety affects all of us," he said.

Have breakfast with him and you'd better order oatmeal and a banana, maybe a little lox.

"You're not going to have eggs, are you?" he'll ask.

He drives a 2002 BMW 530i, "but my wife drives a Prius" and wants him to do the same.

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."