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Video: FDA issues mixed verdict on Avandia

  1. Transcript of: FDA issues mixed verdict on Avandia

    WILLIAMS: And, Bob , I want to transition now into another major health story that actually has you in Washington tonight to cover it, the fate of this diabetes drug Avandia that affects millions of people who are on it.

    BAZELL: Yeah, Brian . Avandia is controversial because some say it increases heart attack risk. Today an FDA panel voted to leave it on the market, but with restrictions.

    Unidentified Man #1: There clearly are adverse signals of harm coming...

    BAZELL: Seventeen members of the expert panel wanted restrictions, 12 voted to ban the drug altogether, and only three opted to do nothing.

    Unidentified Man #1: It's very difficult for me to then justify that this is meeting the definition of shown to be safe.

    BAZELL: Dr. Steven Nissen of the Cleveland Clinic first raised the alarm about heart disease risk three years ago.

    Dr. STEVEN NISSEN: The committee clearly understands that there's a lot of risk here. There's very little evidence of any unique benefits.

    BAZELL: Before the first warnings, GlaxoSmithKline sold $1.8 billion worth of Avandia every year, in part because of a very heavy advertising campaign.

    BAZELL: But sales have gone way down, although doctors still wrote 2.6 million prescriptions for the drug last year, according to the research firm IMS Health . GlaxoSmithKline still maintained today that " Avandia does not increase the overall risk of heart attack , stroke or death."

    Mr. JEFF TENPENNY: What were you barking at, huh?

    BAZELL: Jeff Tenpenny took Avandia for his type 2 diabetes, and in 2005 he had a bad heart attack .

    Mr. TENPENNY: The pain was radiating out of my left shoulder, in particular, and down my arm, and in the jaw it was really excruciating.

    BAZELL: One case does not prove anything, but new studies that have come out in recent weeks made the case even stronger that there is a heart risk. Dr. Margaret Hamburg , the FDA commissioner , will make the final decision on what, if anything, to do next. Many people are waiting for the FDA 's final decision as an indication of how tough this agency's new leadership will be on pharmaceutical companies when danger signs appear about drugs that are already on the market. Brian :

    WILLIAMS: All right. Robert Bazell in our Washington bureau tonight with that. Bob , thanks.

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