BR, your comments are completely of the mark!
A couple of researchers indicated higher rate of CV events, most others did not. The bulk of the Key Opinion Leaders did not see this a a significant issue, as Iclusig was saving their CML patient's lives daily and they felt that many of the CV events were not Iclusig-related (medical opinion). Even with CV events, most MDs would still take those (treatable) over patient death...
Secondly, the FDA commissioner did not take Iclusig off the market. The Government was in "Shutdown" and the decision for a Clinical Hold was made by one person in the office of Oncology, who listed ALL CV events as "drug-related" in contradiction to the opinion of the clinical community. Immediately a letter signed by over 200 Hematologist/Oncologists was sent to FDA decrying this abrupt move. Patients taking Iclusig (Who's lives had been saved) publicly stated that they were ready to picket FDA and Congress. ARIAD voluntarily took Iclusig off the market as a precaution, to show good faith.
The shutdown ended about ten days after this FDA decision and when the rest of the FDA team came back, the clinical hold was lifted almost immediately. Too late for ARIAD, as multiple trials were cancelled and the stock was manipulated down 90%. It took months to get the trails restarted and about two months to bring back Iclusig to the market with the Black Box warning regarding CV events.
If ARIAD's Safety Advisory Board had been concerned about the rate of CV events, they would have advised the company differently.
