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Friday, May 21, 2010

Is the Penny Dropping for the FDA? [Avandia]


Image: scrapetv.com

You may recall, a few days ago I wrote about the FDA sanctioning new Avandia trials.

Now, it appears, Glaxo are having trouble recruiting.

The Triangle Business Journal is reporting that Glaxo have confirmed that two 21 research sites, including Wake Forest University Baptist Medical Center in Winston-Salem, have withdrawn from the study because of poor enrollment. William Applegate, dean of Wake Forest’s medical school.

Furthermore, The U.S. Food and Drug Administration [FDA] have also said that it is weighing whether to end the trial early due to the drug’s safety concerns.

Could this just be a penny dropping moment for the FDA?



Image: glaxosmithkline.co.jp

Maybe the Japanese drug regulator should also take a close look at the way GlaxoSmithKline are STILL trying to recruit young children for their Paxil study?

For those that don't know, Paxil [UK name, Seroxat] is not safe for children. It took a good few years before Glaxo acknowledged this - but now, it seems, it could be safe in kids from Japan.

See Glaxo's recruitment criteria for their current Paxil study in children from Japan HERE.

Also note that they won't accept healthy volunteers, thus leaving the door open for "favourable" results.

I'm really surprised there isn't more about this in the mainstream press?

Maybe I'm barking up the wrong tree and Paxil is safe for depressed children?

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