invincible summers

in the middle of winter I at last discovered that there was in me an invincible summer. (albert camus)

Seroquel documents at FDA website April 4, 2009

Filed under: antipsychotics,big pharma,FDA — clementine @ 12:37 pm
Tags: , ,

From the WSJ health blog:

The FDA was a bit quick on the trigger in making public some documents about AstraZeneca’s Seroquel this morning.

The agency posted briefing documents on its Web site for an advisory committee meeting coming up on Wednesday to discuss AstraZeneca’s application for approval of an extended-release version of Seroquel for generalized anxiety disorder and major depression. Later, the documents were taken down.

Since some people had already gotten their hands on the documents before they disappeared, AstraZeneca responded by posting them on its own site “to ensure that all investors have access to the information contained in the previously released FDA briefing materials,” the company said.

The FDA also returned the documents to its site. FDA spokeswoman Sandy Walsh tells the Health Blog that the materials “were inadvertently posted by the FDA” the first time around. Normally, such documents are made available 48 hours before the meeting, she explains. But given they went up early, the documents “should have remained posted,” Walsh says. “We regret any confusion that may have resulted.”

As for the documents’ contents, Jennifer Corbett-Dooren of Dow Jones Newswires managed to get this article done amid the snafus. The FDA expressed concern about expanding use of Seroquel to a wide population amid possible increased risk of heart problems, Corbett-Dooren reports.

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4 Responses to “Seroquel documents at FDA website”

  1. stan Says:

    I’ll be very surprised that this isn’t just another step in the rubber stamp process over at the bought and paid for FDA.

    Isn’t interesting they are supposedly worried about sudden heart attack, but made make a brew Haa Haa about diabetes risk and direct consequences related to Seroquel use; and then tell me they are not covering AZ’s ass in the litigation now on going.

    As we have been reading lately in other pharma news; it’s not beyond Pharma’s reach to threaten and destroy dissenters in the medical profession and else where. I guess they have their minions over at the FDA Running with their tail between their legs scared too again.

    OH, by the way! My compliments on the whole new blog look and feel here. I hope you got some much valued rest, and are back to shaken some crumbs off that frazzled cookie.

    You’re Bloggery pal,
    Stan

  2. clementine Says:

    Stan,

    yes, i really don’t trust anyone in the government these days. they are all bought and paid for. sad.

    oh, thanks…this is one i used a year or so ago. i’m trying to find a theme to allow everyone to subscribe to comments. i should have this figured out by now and i don’t.

    and…i’m finally resting, catching up on blogs, news, etc. slowly shaking off those crumbs!

  3. stan Says:

    You should check this out! This so called committee the FDA formed is stacked with AZ pimps. They make the cards, stack the deck, deal every hand from the bottom of the deck, and they @ AZ and the Industry plan to win every hand in what they see as a high stakes poker game for Billions and Billions.

    check out Steph’s newest post: Conflict of interest!: FDA Psychopharmacologic Drugs Advisory Committee: AstraZeneca & child psychiatrist, Chair Armenteros

    Conflict of interest: Seroquel FDA:

    Stan

  4. clementine Says:

    um, speechless. thanks for alerting me, stan.


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