Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Saturday, March 24, 2007

PAXIL STUDY 329 - The Documents

These documents have been made available here through the work of Healthy Skepticism. To visit Health Skepticism please go here


Documents from study 329

DRAFTS/PEER REVIEWS
Draft ?II with ?Keller’s annotations. 11 Feb, 1999.
Draft III. 22 Mar, 1999.
Draft submitted to JAMA, 30 July 1999.
JAMA Reviews, Oct 22, 1999
Response to JAMA reviews, 10 Dec, 1999.

POSTERS
Keller M et al. American Psychiatric Association, Toronto, 2 Jun, 1998
Wagner K et al. NCDEU. Boca Raton, Florida. 11 Jun, 1998.
Berard R, Ryan N. European College of Neuropsychopharmacology, Paris, Oct 1998.
Gagiono C. World Congress of Psychiatry, Hamburg, Oct, 1999.

LETTERS/ MEMOS/EMAILS/MINUTES
Minutes:Teleconference.Paroxetine Study 329 Efficacy Analysis. 22 Apr, 1997
Top Line Results 21 Jan, 1998
Oakes to McCafferty 5 Mar, 1999
McCafferty to Laden 9 Mar, 1999
Katz to Kline, 18 May, 1999
McCafferty to Laden, 19 Jul, 1999
McCafferty to Laden, 21 Jul, 1999
Dulcan to Keller 27 Jul, 2000
White to Hood, 5 Mar, 2001
Battin to Laden, 27 Apr, 2001
Hawkins to all sales representatives selling Paxil, Aug 16, 2001
Ryan to Keller and Strober, 4 Feb, 2004
Keller to Carpenter et al, 14 May, 2004
Keller to Ryan et al, 13 Jun, 2004

DEPOSITIONS
McCafferty Deposition, 24-26 Aug, 2006
Ryan Deposition, 5 Oct, 2006
Oakes Deposition, 7 Nov, 2006

MEDICAL QUERIES/DEAR HEALTH CARE PROFESSIONAL LETTERS
SKB Med Query. Jul, 1998
SKB Med Query. Jul, 1999
GSK Med Query. Jan, 2000
GSK Med Query. Sep, 2001
Dear Health Care Professional. Jul, 2003
Dear Health Care Professional. May, 2004

INFORMATION FOR SALES REPRESENTATIVES
SmithKline Beecham. Nulli Secundus. 8 Dec, 1999
GlaxoSmithKline. GSK Sales Connection. 10 Sep, 2003

OTHER
Proposal: 'Adolescent Unipolar Major Depression: Multisite Psychopharmacology Study' Dec, 1992
Position piece on the phase III clinical studies, 14 Oct, 1998
STI Release Form for JAACAP paper, 3 Nov, 2000
FDA Clinical Review, 2002
Statement of David Wheadon Sep 9, 2004


Now read the statement from GSK after the recent Panorama programme which highlighted much of what the above documents refer to:

This statement was made in 2007 - These people ARE STILL denying they knew despite the evidence I have just provided. How DO they get away with it?

'GSK utterly rejects any suggestion that it has improperly withheld drug trial information,' announced the company in a release issued last night. 'Results from its paediatrics studies were documented and submitted to regulators in accordance with regulatory requirements. Results were also presented publicly, published in scientific journals and are available on GSK's website.'

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