Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

EPIC trial had problems? Dr. Cortes and other 10 doctors disagree as they are going to present what they believe on 12/07/2013 at the 55th ASH:

Ponatinib As Initial Therapy For Patients With Chronic Myeloid Leukemia In Chronic Phase (CML-CP)
https://ash.confex.com/ash/2013/webprogram/Paper64338.html

The 11 doctors' Conclusion is

"Ponatinib is effective as initial therapy for CML-CP resulting in high rates of cytogenetic and molecular responses at early timepoints. Therapy with ponatinib is well tolerated with transient elevated lipase being the most common toxicity. In view of the frequency of dose reductions and considering the excellent responses achieved, the trial has been modified to explore 30 mg as initial dose."

The doctors' clinical trail finding is: the most common toxicity transient elevated lipase. No blood clots or cardiovascular events were observed at all.
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55 presentations to be presented at the 55 ASH are related to Iclusig's Efficacy and Safety:
https://ash.confex.com/ash/2013/webprogram/start.html#srch=words%7CPonatinib%7Cmethod%7Cand%7Cpge%7C6%7CbyDayany%7Cany%7CbySymposiumany%7Cany

According to these doctors' clinical trail data, Ponatinib is well tolerated and Adverse Events are manageable.

There is an exception, the French presentation. But the authors of that presentation admit that the number of their sample patients is small (only 19 patients). In principle of statistics, a small amount of data is not enough to make a meaningful conclusion.
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The FDA: "24% patients (median treatment duration 1.3 years) have experienced serious adverse vascular events.

2-Year Follow-Up Of The PACE Trial by clinical trial doctors (to be presented on 12/09/2013): "Serious cardiovascular, cerebrovascular, and peripheral vascular AEs occurred in 6%, 3%, and 2% of pts (drug-related: 2%, 1%, 1%)."

Who is right? Whom to believe? I incline to believe the doctors who did the actual clinical trials and treated the patients in person.

Should not the FDA and Ariad explain the unbelievable discrepancy to the public scientifically, mathematically and statistically?
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I strongly doubt the FDA is involved in any conspiracy. But where does the unbelievable discrepancy come from. Is it the clinical trial doctors' conspiracy?