FDA Halts A Controversial Avandia Study
6 CommentsBy Ed Silverman // July 21st, 2010 // 12:00 pm
Less than a week after an FDA advisory panel voted to allow the controversial Avandia diabetes pill to remain on the market - but with either warnings or restrictions - the agency says new patients should not be enrolled in a long-term, randomized, controlled study known as the TIDE trial, which is designed to compare the drug with the rival Actos pill (see the FDA statement).
The trial has been criticized for being unethical, since it compares one pill with known cardiac risks, GlaxoSmithKline’s Avandia, with a seemingly safer alternative (back story here. To gain some guidance and political cover, FDA commish Margaret Hamburg recently asked an Institute of Medicine committee to explore the ethical issues the FDA faces when requiring a drugmaker to run a randomized clinical trial for an approved drug when a safety issue exists. Last week, the committee offered a framework for deciding the issue (see here). The FDA, meanwhile, is deciding what to do about Avandia.
In a statement, Glaxo says it plans to work with the TIDE Steering Committee to send a summary of recent safety data and a summary of the FDA Advisory Committee meeting on Avandia to all TIDE investigators and Institutional Review Boards to ensure they have the latest information for patients.
“This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory Committee and the Committee’s recommendations,” Ellen Strahlman, Glaxo’s chief medical officer, says in a statement sent us. “We are committed to working with the FDA in the best interest of diabetic patients. We believe that Avandia is an important treatment option for patients with type 2 diabetes,” Strahlman said. “Patients with questions about the use of Avandia should talk with their physicians.”
Stephany
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.
Matthew Holford
“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
Matthew Holford
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
Vince
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.
anon
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.
Skeptical
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.