The Defacto Drug Regulator Responds

  • by: |
  • 06/05/2007
Diedtra Henderson interviews Steve Nissen who responds -- sort of-- to my blog calling him "small and craven" as he shifts positions and engages in self promotion in a campaign to become defacto FDA commissioner....

Just remember these words from St. Steven the Pure because they will come back to haunt him and those who have annointed him the savior of drug safety in the weeks ahead:

“Even the appearance of bias can damage trust as actual impropriety"

Watchdog draws growls in return
Cardiologist-FDA adviser says his goal is drug safety; critics say he's bucking to run agency

By Diedtra Henderson, Globe Staff | June 5, 2007

WASHINGTON -- Vioxx . Ritalin. Drug-eluting stents .

Those popular drugs and medical devices are on a growing list of therapies used by millions of people that have shown up on the radar of Dr. Steven E. Nissen , a prominent heart specialist.

Leveraging his power as a federal adviser, tapping the reach of medical publications, and whispering in the ears of key members of Congress, the Cleveland Clinic cardiologist has questioned the heart safety of each product. In doing so, he's chipped away at the credibility of the Food and Drug Administration as the nation's top drug safety watchdog.

Avandia , the world's best-selling oral diabetes treatment, is the latest drug targeted by Nissen. In a New England Journal of Medicine article last month, he said it increases the risk of heart attack. Avandia's manufacturer, GlaxoSmithKline , called Nissen's analysis flawed. But Nissen is scheduled to testify tomorrow at a congressional hearing on Avandia , again commanding the media spotlight.

Nissen, son of a physician and husband of a journalist , calls himself the "point on the end of the spear" during drug safety debates, raising awareness on matters he says the FDA has overlooked. Time magazine last month included the 58-year-old among 100 people "whose power, talent, or moral example is transforming the world."

Others say his motivation has more to do with wanting to run the FDA. And that worries the drug industry. If a Democrat is elected president next year and Nissen -- or someone like him -- becomes FDA commissioner, they say it could make the FDA more cautious, slowing new product approvals to a crawl and stifling innovation.

Nissen, who joined the Cleveland Clinic in 1992 , now chairs its department of cardiovascular medicine . He is immediate past president of the board of trustees of the American College of Cardiology . He has been published more than 250 times, including books and journals, and has been an early leader in the development of a type of imaging that spots artery damage at its earliest stage and can determine whether anti cholesterol medicines are effective.

But on Capitol Hill and in pharmaceutical company boardrooms, those achievements are trumped by his role as a drug-safety watchdog.

Years before Vioxx was pulled from the market in 2004, Nissen pointed to its heightened heart attack and stroke risks. In 2005, as the FDA was on the verge of approving Pargluva, a diabetes drug known generically as muraglitazar that works like Avandia , Nissen pointed out cardiovascular problems, effectively killing the drug's development. And he also rallied other federal advisers to prod the FDA to put its harshest warnings on attention- deficit hyperactivity disorder drugs, like Ritalin and Adderall , due to cardiovascular risks.

Such public stands have unleashed a firestorm of criticism. FDA spokesman Douglas Arbesfeld , in an e-mail to reporters days after Nissen's Avandia analysis was published by the New England Journal -- derisively dubbed him "St. Steven ," and wondered whether his feet were made of clay.

Arbesfeld, responding to a Boston Globe question about the e-mail message, said the correspondence -- sent using his FDA e-mail address -- reflected his personal views and not the agency's.

After the Avandia news broke, Robert Goldberg , a conservative pundit and vice president of the Center for Medicine in the Public Interest New York, posted a message on his blog,, that said Nissen is campaigning to become FDA commissioner in a way that "makes him look craven and small."

Told of Goldberg's blog entry, Nissen asked, "Who would say such a thing?"

"I'm not running for anything," Nissen added. "I've got a great job here, and I'm not going anywhere."

Goldberg, however, does have more clout than the average blogger. As a senior fellow at New York's Manhattan Institute , he once wrote that a front-runner to become FDA commissioner would so stymie the drug-approval process that the shorthand message to patients would be: "Drop dead." The candidate, Dr. Alastair J.J. Wood, foundered in the face of stiff industry opposition.

In an interview, Goldberg said the cardiovascular risks of such drugs as Vioxx have been highlighted by others, but Nissen is "the most aggressive in promoting himself, whether he is accurately depicting the risks and benefits of products."

Nissen's word carries weight with influential members of Congress intent on FDA reform, including US Representative Henry A. Waxman , a California Democrat, whose assistance Nissen sought when he had difficulty obtaining details about Avandia, and US Senator Charles E. Grassley , an Iowa Republican, who wants to create a separate drug safety center at the FDA.

In a key switch, Nissen now agrees with Grassley on the need for such separation.

Nissen has also earned the praise of US Senator Hillary Rodham Clinton of New York , a Democratic front-runner in the 2008 presidential race.

Like other FDA critics, he says the agency is so reliant on drug industry funding that it is reluctant to swiftly tamp down on drug-safety problems. He seeks to reduce the number of FDA advisers with financial ties to drug and device companies, and wants more and larger clinical trials conducted after drugs are approved for sale. He favors restricting advertising for products that have questionable safety records. And he champions public access to results of the clinical trials that drug makers conduct to gain FDA approval for their products.

To W. Mark Lanier , an attorney nationally known for representing patients in cases against drug companies, such positions would make Nissen a fine candidate for FDA commissioner.

"The current FDA commissioner is, at best, a passivist before a ravenous beast named Big Pharma. At worst, he is their actual lap dog," Lanier said.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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