From: Janne
To: Tonya Gillis
Cc: Others at NICE ORG, DH GSI Gov, MHRA
Sent: Friday, May 12, 2006 11:48 AM
Subject: Re: Request for data and FOIA request about Strattera's effect on sexual maturation
Dear Tonya,
Thank you for your swift answer.
Then I know that NICE has the information about the harmful effects of Strattera.
This would mean that NICE has access to:
1. Lilly's review of the 431 reports of suicidality (130, September - October 2005) - Annex 4 in the CHM ad hoc expert advisory group on Strattera January 2006;
2. Lilly's cumulative review of reports of other psychiatric adverse events associated with atomoxetine - the review that was "awaited" in the report from January 2006 (p 49).
It means that NICE can compare the data in these unpublished papers with the FDA report published in March
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4210b_11_01_AdverseEvents.pdf
It means that the data about hostility and aggression, mania and psychosis and the evalution from FDA experts that the great majority of such cases had no prior history of hostility, agression, mania, psychosis, can be compared to Lilly's evalution of these disastrous effects. It means that NICE has the opportunity to question the data submitted by Eli Lilly - which very likely are explaining away the drug induced states as a result of "comorbidity".
As NICE has the information I count on the agency to a) reveal the data in the concealed documents, and b) protect the children by changing the guidelines about treatment.
Regards
Janne Larsson
