Comments on: FDA Halts A Controversial Avandia Study

By: Skeptical

Skeptical — Thu, 22 Jul 2010 18:27:56 +0000

Vince, FDA has not yet decided the fate of Avandia. This action is only on the TIDE trial. Putting the trial on partial hold and not allowing new pts on drug makes you wonder how they can continue to allow the drug to stay on the market at all.

By: anon

anon — Thu, 22 Jul 2010 01:42:56 +0000

TIDE -is a marketing study, only use is to sell drug. high volume of patients translates into high volume of hospitals that interact with GSK, allows access, which helps open the doors to the GSK sales force, and sell the drug, Woodcock maintains that the protocol protects patients. This is how she addressed criticisms of blatant violations of study patients safety raised by the inspector general, which the FDA ignored.

try and sell your FDA protocol TIDE now Ms. Woodcock to all the poor third world patients both in the US and around the world. they are no longer going to be guinea pigs used for profit on your behalf.

By: Vince

Vince — Wed, 21 Jul 2010 20:13:46 +0000

The best result pharma could hope for. The drug is not to dangerous to remove but is to dangerous to study.The shills can still spin the story that both are equally dangerous: also kill a vitamin d study that was powered to show benefit in both heart disease and cancer. Had that arm showed risk reductions with vitamin d equal to or better than oh lets say the statins well that would be a dangerous development. Any belief that the FDA cares about costumers I mean patients is rapidly fading.

By: Matthew Holford

Matthew Holford — Wed, 21 Jul 2010 18:34:24 +0000

Oh, I forgot to say: I think it’s really good that GSK has managed to have two beliefs, in as many days (presumably the two, with respect to Paxil, yesterday, and this one, *are* GSK’s own(?))… I believe that believing is so important. What do you think, Baldrick?

Matt

By: Matthew Holford

Matthew Holford — Wed, 21 Jul 2010 18:29:51 +0000

“We believe that Avandia is an important treatment option for patients with type 2 diabetes,” Strahlman said.”

Well, everything else in that statement is laid down as fact, which is so boring - it leaves no room for argument, when people are dogmatic about what is True! Fortunately, GSK partially redeems itself, above, by allowing for the possibility that others will have the belief that Avandia is, in their experience, a dangerous pile of shit, which doesn’t necessarily exclude the possibility that it’s also an important treatment option!!!

Oh, what tangled webs we weave for ourself, when we start playing word games!

Matt

By: Stephany

Stephany — Wed, 21 Jul 2010 17:18:23 +0000

One thing I’ve often wondered, is why any patient in litigation due to injury from one of these conflicted drugs (such as Avandia, or Seroquel…)has not taken the FDA into a lawsuit.

This just blows my mind, that the Avandia scandal story just keeps on unraveling, with the drug still on the market, and the FDA appears to be scrambling to understand every part of the picture, covering ass, making statements, what a bunch of fools.

The FDA approved these drugs for market and use, and should stand by SAFETY OF THE PATIENT first, and foremost, and remove the drug, which can at best save a few lives—while sorting out the corruption, unethical behaviors of panel members, and figuring out who was paid by whom….come on, this is ridiculous.

Seroquel is another example of this approval process by the FDA, where they continue to keep the drug for sale, all the while people are injured on a daily basis, while taking it. Diabetes, weight gain…..well why not take Avandia for that?

My opinion, but the FDA is a corporate affiliate without any regard for patient safety.

I suppose Insel and Nemeroff wonder what all of the fuss is about with disclosure commentary.