Looking beyond the spin of Big Pharma PR. But encouraging gossip. Come in and confide, you know you want to! “I’ll publish right or wrong. Fools are my theme, let satire be my song.”
Email: jackfriday2011(at)hotmail.co.uk
Wednesday, October 07, 2009
The Side Effect Sidestep - side effects, what side effects?!
2 comments:
Anonymous
said...
FDA Advisory Committee Meeting June 9 - 10, 2009
Safety of Olanzapine in Adolescents Robert R. Conley, MD (lilly)
Slide #40 D/C's with 3 weeks of Rx 179 subjects (3.3%)
ALT increased 2 AST increased 1 Hepatic enzyme increased 1 Liver function test abnormal 1 Transaminases increased 1
LFTs inc 3 x ULN including non-DCs ~1/8 (12.1%) (approx 80 subjects)
Background package 2 children dead due to hepatic steatosis, 16 yo - 2 yrs of Rx and a 3 yo.
Tom Laughren FDA Psychiatry Division Director
"There were liver enzyme increases for olanzapine, although I would point out that even though olanzapine has been out there now for, I think probably 13 years, . And we do see transaminitis for a number of drugs that are out there, drugs that never turn out to be significant hepatotoxins. But there's clearly a signal for transaminitis for this drug."
Shirley Murphy - ex VP of Pediatric Marketing Strategy Glaxo
Head of Office of Pediatrics and Counterterrorism later head of Office of Translational Sciences (drug disease modeling - genetic devices, new statistical tests to approve psych drugs that don't pass old tests)
Bob Powell ex Drug Metab PK VP of Glaxo, Pharmacia, Pfizer, Pharsight.
involved in GSK's safety database for Paxil. Setting up FDA's safety database and drug disease modeling to approve drugs in alzheimers, Providing Pharsight with inside FDA develeped drug disease models. Set up Thorough QT studies that won't catch the true problems so Pfizer won't have a 3 year hold up on their next drug like they did with Geodon.
Gwen Zornberg - Psych medical Reviewer Pfizer neuropsych ghostwriter. Tried to push through bifeprunox (died thankfully due to others). Team leader to push through asenapine (organon/pfizer).
Then there's the Pfizer people in endocrine and from the other companies placed in different spots some higher and some lower.
2 comments:
FDA Advisory Committee Meeting June 9 - 10, 2009
Safety of Olanzapine in Adolescents
Robert R. Conley, MD (lilly)
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM177119.pdf
Slide #40 D/C's with 3 weeks of Rx
179 subjects (3.3%)
ALT increased 2
AST increased 1
Hepatic enzyme increased 1
Liver function test abnormal 1
Transaminases increased 1
LFTs inc 3 x ULN including non-DCs
~1/8 (12.1%) (approx 80 subjects)
Background package 2 children dead due to hepatic steatosis, 16 yo - 2 yrs of Rx and a 3 yo.
Tom Laughren FDA Psychiatry Division Director
"There were liver enzyme increases for olanzapine, although I would point out that even though olanzapine has been out there now for, I think probably 13 years, . And we do see transaminitis for a number of drugs that are out there, drugs that never turn out to be significant hepatotoxins. But there's clearly a signal for
transaminitis for this drug."
See transcripts
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM172870.pdf
page 24
Laughren's final recommendation:
Olanzapine 2nd line b/c of weight gain.
Comment:
2 children dead due to hepatic steatosis and Laughren says: "there hasn't been any signal emerged for severe liver toxicity"
Conclusion: Laughren doesn't count death as a signal.
Our people in the FDA.
Placements:
Shirley Murphy - ex VP of Pediatric Marketing Strategy Glaxo
Head of Office of Pediatrics and Counterterrorism later head of Office of Translational Sciences (drug disease modeling - genetic devices, new statistical tests to approve psych drugs that don't pass old tests)
Bob Powell ex Drug Metab PK VP of Glaxo, Pharmacia, Pfizer, Pharsight.
involved in GSK's safety database for Paxil. Setting up FDA's safety database and drug disease modeling to approve drugs in alzheimers, Providing Pharsight with inside FDA develeped drug disease models. Set up Thorough QT studies that won't catch the true problems so Pfizer won't have a 3 year hold up on their next drug like they did with Geodon.
Gwen Zornberg - Psych medical Reviewer Pfizer neuropsych ghostwriter. Tried to push through bifeprunox (died thankfully due to others). Team leader to push through asenapine (organon/pfizer).
Then there's the Pfizer people in endocrine and from the other companies placed in different spots some higher and some lower.
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