I'd like to hear more clarification from the FDA and Merck on the following media statements:
"Merck believes that the data support the continued use of Singulair in appropriate patients with asthma and allergic rhinitis.”
But, the agency also noted that the trials were not designed to examine such behavior, and that the safety review will continue, probably for several more months."
If the trials were not designed to examine psychiatric events what good is the data and why would it take 9 months to rehash submitted data that does not contain appropriate information?
Another statement that needs clarification is, "Merck believes that the data support the continued use of Singulair in appropriate patients with asthma and allergic rhinitis.”
Why such careful wording as "appropriate patients"? That is to suggest that Singulair is "inappropriate" for some, perhaps many people.
Lastly, "We have finished our analyses of all the data the companies submitted," FDA spokeswoman Karen Riley told the Associated Press. "But that doesn't mean we have closed the book on suicidality."
My questions are were there any unsubmitted data and why would they leave the book open unless there were a legitimate reason to?
This is definitely not over and as well it should not be.