Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

They must've changed the SAE definition intentionally. The FDA officials are not idiots, are they?

The researchers had since submitted findings from the PACE trial for publication in the New England Journal of Medicine, which were published on November 7 (2013;369:1783-1796). That paper noted that with an additional 13 months of exposure, in patients who continued in the trial, the cumulative incidence of serious arterial thrombotic events was 11.8 percent and the incidence of all arterial thrombotic events—serious or not—was 17.1 percent.
...
The EMA said their review of the data had found the rate of serious occlusive vascular events to be 22 percent for the Phase I trial and 13.8 percent for the Phase II trial, as of September 2013—both of which were much lower than what the FDA had reported.

Michael J. Mauro, MD, Leader of the Myeloproliferative Diseases Program at Memorial Sloan-Kettering Cancer Center who was an investigator on both the drug’s Phase I and II trials, said that the different interpretation and calculation of rates of toxicity as reported by the manufacturer versus the FDA was concerning, given that everyone was looking at the same raw data. This is an example of the need for common parameters for calculating such risks, he said. “One can render different opinions on their impact and their weight, but there shouldn’t be different ways of interpreting the risks or different ways of categorizing them. That’s a lesson this experience has taught us.”
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902

"Ponatinib was pulled by the FDA under VERY suspicious circumstances. They changed the definition of what constitutes an adverse event, then attributed every event to the drug, despite the fact that these patients were heavily pretreated and in BLAST phase. They came to the study at deaths door after failing all other options."
http://news.yahoo.com/fda-cancer-czar-floats-change-drug-review-process-120000099.html

"You went through a lot of the differences in how the thrombotic events are counted. I guess, why was the change in the FDA methodology? Where did that come from?", asked Michael J. Yee, RBC Capital Markets.

"I think that's not anything that we can comment on or know. So we're just not really in a position to comment on that.", answered Timothy P. Clackson.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93998347

Hadn't the FDA changed the definition of AE, the agency would not have been able to come to its 24% SAE rate in order to justify Dr. Pazdur's intentionally wrong decision.