Replies to post #38873 on Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

The Boston Globe: Ariad fears that the FDA has "created a lot of confusion and questions” among doctors and patients.

The Boston Globe news, Nov. 13, 2013:

When one analyst questioned the wisdom of publicly taking issue with US regulators, Ariad chief scientific officer Timothy P. Clackson said, “We felt obligated to, in a very careful way, explain our understanding” of the clinical data because of fears the FDA “created a lot of confusion and questions” among doctors and patients.

“The FDA cannot provide a comment, as these issues are under review,” an agency spokeswoman said Tuesday. “It’s important to note though that this action was not only based on event rates, but also the seriousness of these rates, where significant harm to patients was identified.”

Some people think the FDA obviously hate Ariad for some reason. Analyst Jason Kantor at Crédit Suisse probably agrees with bocci911 as he asked Ariad at the 2013 3Q Earnings Call :

"I really appreciate all the information on the event rates for Iclusig, but there just seems to be a pattern where FDA says one thing and then you guys come on the call publicly and say something else. So I'm just wondering, what's the logic of having this debate in a public forum? It just seems like every time you guys do that, they come down hard on you at the next possible opportunity. So I'm just wondering why you think this should be prosecuted in public rather than just in meetings with FDA?"

Is it was reported by The Boston Globe on 11/13/2013 that Ariad was publicly taking issue with US regulators again.

If Jason Kantor's observation is right, the FDA will come down even harder on Ariad at the next possible opportunity.

How hard will the FDA come down on Ariad at the next possible opportunity? Anybody has a clue?

[grandma_of_jbraika]

Doctors: Ponatinib is a good drug. We don’t want it to be killed and not given to patients.

“Without this medication, they won’t have long to live. My patients are panicked. I have patients right now who are benefiting from this medication with very few side effects.” said Dr. Brian Druker, the director of the Knight Cancer Institute at Oregon Health and Science University.

“What we don’t want to have happen is for a good drug, ponatinib, to be killed and not given to patients,” said Dr. Javid Moslehi, a co-director of the cardio-oncology program at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.

Source: Doctors Fear Losing Leukemia Drug Deemed Risky,The New York Time, November 1, 2013

The doctors will tell more truth about the Efficacy and Safety of Iclusig at the 55th ASH, December 7-10, 2013. They believe Ponatinib is well tolerated and Adverse Events are manageable.

Dr. Javid Moslehi, a co-director of the cardio-oncology program at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston, said in an interview that if, for instance, the problems were known to occur because of excessive blood clotting from a cancer drug, then patients could also be given another medication to prevent clots. Or, if the cancer drug were causing plaque to build up in the arteries, patients might be given a statin to try to prevent it.

“What we don’t want to have happen is for a good drug, ponatinib, to be killed and not given to patients,” Dr. Moslehi said.

Obviously, the doctors disagree with the FDA as 23 leukemia specialists and 3 patient advocacy groups have sent the FDA a letter saying they were concerned on the FDA's withdrawal of Iclusig.

I believe the doctors who conduct the clinical trials of Iclusig and treat the patients in person know about the safety/toxicity more than anybody else. They believe Ponatinib is well tolerated and Adverse Events are manageable. They know more about Iclusig than the FDA.