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Drug Safety Critic Hurls His Darts From the Inside
NY Times ^ | July 22, 2007 | STEPHANIE SAUL

Posted on 07/21/2007 8:56:37 PM PDT by neverdem

Back in the ’60s, when University of Michigan students were holding protests over civil rights and the Vietnam War, an undergraduate named Steven E. Nissen was at the center of the political dissent.

Four decades later, that former campus activist is now Dr. Nissen, who is shaking up the nation’s pharmaceutical industry.

His questioning of the safety of the Avandia diabetes medication in late May, for example, prompted a federal safety alert and led to a sales decline of about 30 percent for the drug, which brought in $3.2 billion for GlaxoSmithKline last year. Now, with a federal panel soon to decide whether it can remain on the market, Avandia’s future is uncertain.

The drug is the latest example of why Dr. Nissen, 58, whose day job is chairman of cardiovascular medicine at the Cleveland Clinic, has emerged as a Naderesque figure and the nation’s unofficial arbiter of drug safety.

Admirers laud him not only for raising safety questions about Avandia, but also for sounding early warnings about the painkiller Vioxx, as well as other drugs. By digging deeply into companies’ own clinical trial data — information that used to be available only to federal drug regulators who did not always mine it as aggressively — Dr. Nissen is among a new cadre of activist scientists demanding greater vigilance on drug safety.

But Dr. Nissen also has critics, who say he seeks the spotlight as much as the safety of medicine. Others see a conflict of interest in his self-appointed role as the drug industry watchdog while he also presides over industry-financed research worth millions of dollars. “I’m an insider and an outsider at the same time,” Dr. Nissen says in an official Cleveland Clinic biography.

His crusading for drug safety, and his recent informal advisory role to members of...

(Excerpt) Read more at nytimes.com ...


TOPICS: Business/Economy; Government; News/Current Events; Politics/Elections
KEYWORDS: avandia; drugs; fda; pharmaceuticals
Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes
1 posted on 07/21/2007 8:56:41 PM PDT by neverdem
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To: neverdem
Back in the ’60s, when University of Michigan students were holding protests over civil rights and the Vietnam War, an undergraduate named Steven E. Nissen was at the center of the political dissent.

A better headlines would have been: Loser. A lifetime of undermining America.

2 posted on 07/21/2007 9:01:38 PM PDT by Rodney King (No, we can't all just get along.)
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To: Rodney King

So you’re against civil rights and for Johnson’s Killing Fields?


3 posted on 07/21/2007 9:09:48 PM PDT by jwh_Denver (In the Rise and Fall of United States I hope the Fall part is more than one chapter.)
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To: jwh_Denver

Huh? I didn’t RTFA, which might explain my confusion.


4 posted on 07/21/2007 9:14:19 PM PDT by Rodney King (No, we can't all just get along.)
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To: Rodney King

Read The effing Article? Or? RTFA?


5 posted on 07/21/2007 10:02:05 PM PDT by jwh_Denver (In the Rise and Fall of United States I hope the Fall part is more than one chapter.)
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