Paxil (Seroxat) Litigation Court Archive Now Online….


I hadn’t noticed this before, it’s documents relating to various Paxil trials over the years..
Looks interesting..

http://dida.library.ucsf.edu/search?query=desc%3Apogo&ct=1&l=Show+all+fields

    CLICK ON THE LINK ABOVE FOR FULL ACCESS TO THE PAXIL COURT DOCUMENTS

(thanks to Bunker, I just noticed you linked it in a comment, thank you, hadn’t seen it)

Showing 1-10 of 296 documents
1. Minor changes to draft
Document Date: 19990211
Author: Keller, MB
Corporate Author: Brown University
Recipient: Laden, SK
Document Type: letter
Named Person: Brand, B
Case Number: In Re Paxil, C.P.Ct.PA
Bates Number: par000212926-par000212926
Search Terms in Context: 02-25-99 17:43 SALLY K LADEN STI ID- P . 01 Martin B. Keller, M.D. Mrtry ii. ZurJur hvftam & CJtaumm D^partmwu nf Psyrhiatry ft Unman Behavior BROWN UNIVERSITY Prnvirli-nr*-, Rhode Island 02912 Bmlet Hriiplral Extcuttv* PrjckialriM-irrCknf Emmt Pcn
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Person Copied: McCafferty, JP
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/anu38h10

2. Unipolar adolescent study: proposed titration schedule
Document Date: 19930302
Author: NEAL
Recipient: Birmaher, B; Feinstein, C; Geller, B; Keller, MB; Klein, R; Koplewiss, H; Kutcher, S; Meltzer, B; Small, E; Robbins, D; Strober, M; Williamson, D; Waterman, S; Janosky, S; Ryan, N; McCafferty, JP
Document Type: email
Named Person: Lavori, P; Steinhard, R; Shekim, W
Case Number: Smith v. GSK (SuperCtCA)
Bates Number: par000754923-par000754923
Search Terms in Context: TO: Jim McCafferty >4cris Birmaher , VO – 6 ^ V- 3?Oi ^^Cari Feinstein – ¦-• X 1 ^ ¦ ^Barbara Gelier 314 362-6335, •”Marty Keller 401 455-6441, i/Rachei Klein 211 566-6656, ¦¦t^r.ar-z-Ld Kopiewicz “15 470-9291, •Stan Kutcher 416 460-6616, Bruce Meltzer 4C1-435-C515, — ^ileen Small 401-4=5-0516, “tug Robbins 401 436-5149, Ri. ¦i”"0l*Li ‘EL’ ‘fOi’Cll 2700; w<^ike Strober 310 206-4446, 7i\7-! 1 1 ' =rr, ;rr <" ¦", t rem: Scott Waterman , Sy 1 vi a Ja no s kv, l/Neai Ryan, Jim McCafferty 215-632-3450 NZAL Organization: WF1C Child Psychobioicgy Date: 3 Feb 93 12:59:59 FST Subject: Unipolar Adolescent Study: F r i o r i ty: n o rrr.a 1 X-mailer: Pegasus Mail v2.3 (R5) . ton siei****** it>iur-?Y*f (AJhjLj> s*rtrr±m (/Kite S7&*c± SfiZ&ty re* v Proposed titration schedule After today’s ;2/3/93) conference phone call it is ver/ clear that reaching consensus on th
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/aou38h10

3. Manuscript 2000/1310
Document Date: 20000215
Author: Dulcan, MK
Corporate Author: Children’s Memorial Hospital
Recipient: Keller, MB
Document Type: letter
Case Number: Steinberg v. GSK (SuperCtCA)
Bates Number: par000757240-par000757240
Search Terms in Context: J tl ‘; l “lit > IS!( … v ,!.’ >\ ;\. 505 Morris Avenue Springfield. New lersev 07081 August 7, 2001 James McCafferty Senior Scientist GlaxoSmithKline 1250 S Collegeville Rd UP4410 PO Box 5089 Collegeville, PA 19426-0980 RE: PAXIL ADOLESCENT DEPRESSION PAPER Dear Jim: I am pleased to enclose a small supply of reprints of the paroxetine-imipramine adolescent depression paper that was recently published in journal of the American Academy of Child and Adolescent Psychiatry. GSK funded the purchase of the reprints. A total of 300 went to Marty Keller, who is corresponding author on the paper, and the balance is being sent to Zach Hawkins for distribution to the Neuroscience sales force. Samples are also being sent to Rocco and Neil. The paper looks excellent and demonstrates the commitment of GSK to the field of psychiatry. Thank you for your support. Sincerely, Sally K. Laden, MS Associate Editorial Director end cc: .1301 PAR001380128 (973) 376-5655 telephon
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/asu38h10

7. US Senate inquiry: removal of Mosholdor from FDA advisory committee meeting and other matters
Document Date: 20040803
Author: Grassley, C
Recipient: Viehbacher, C
Document Type: letter; report
Case Number: In Re Paxil, C.P.Ct.PA
Bates Number: par004177597-par004177616
Search Terms in Context: 08/03/04 14:18 FAI 215 751 4184 GLA10SMITHKLINE rB6M£iJ^ 59029 .^46Ph chris vichbrcher “** ,’,.,’I'I’.”’¦’•’¦¦> .^ J ‘^——”^^ 1^ 1*1”’ – ¦ ®001 TD:919 315 U2^60 P’VtVS I ¦¦’ I . .TV •• Facsimile Transmittal SQ4 Hart Senate Pffice Building PHONI Fax _Redacted Redacted To: Mr, Christopher Viehbacher Fax: Redacted From: Chairman Chuck Grasaley Date: August 3,2004 Number of pages transmitted, including cover sheet Notes: Pteasft can Tom Novelll an 202224-C447 for problems with transmissions jE Qj^h_clfluki*L JXintMJu \i^i\Uj/}k (Uwcjl fr, < WRING K*7W.VWJ 1MCN7MTT MlMiKBWl T31YM'V»J SNPWI MtfW CIUiaTf4QMAS. WYDMNG uU.HWTnNNMin cg)|ixa* OM
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 20
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/atu38h10

8. Re: Paxil Data request SAEs
Document Date: 20030716
Author: Kline, T
Recipient: Worth, BJ
Document Type: email
Named Person: David, PA; Murray, JF
Named Organization: Food and Drug Administration
Case Number: Smith v. GSK (SuperCtCA)
Bates Number: par008184244-par008184247
Search Terms in Context: From: Thomas F Kline/SB-OTHER/PHRD/SB PLC To: Brian J Worth/SB-OTHER/PHRD/SB_PLC@SB_PHARM_RD Subject: Re: Paxil data Request Date: 07/16/2003 13:32:26 (GMT-05:00) I sent the below document to FDA via email on Monday July 14th. I needs to be sent hardcopy to FDA also, so can you prepare a submission accordingly. I'll route a cover letter to you in Cards. Thanks, Tom -— Forwarded by Thomas F Kline/SB-OTHER/PHRD/SB_PLC on 16-Jul-2003 13:30 -— Thomas F Kline 14-Jul-2003 15:20 U.S. Regulatory Affairs – Director, Psychiatry Group One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929 (Mail code: FP 1005) Phone: (215) 751-4054; Fax (215)751-4926; GSK Network: Phone 8-288-4054; email: Thomas_F_Kline@GSK.com To: DAVID@cder.fda.gov cc: RAID@SB Subject: Re: Paxil data Request Paul, In response to the Agency's request, please see the attached document regarding possibly related suicide-related SAEs. The two cases of hostility that were identified
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 4
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/auu38h10

9. Publication date for Paroxetine Depression Study
Document Date: 20010227
Author: Laden, SK
Recipient: McCafferty, JP; Im, J; Battin, MR; Kumar, R; Zaninelli, R; Sproull, SA; Hood, SX; Vitale, SM; Smith, TE
Document Type: email
Named Person: Keller, MB
Case Number: In Re Paxil, C.P.Ct.PA
Bates Number: par008960642-par008960642
Search Terms in Context: From: SallyL@stimedinfo.com To: James P McCafferty/DEV/PHRD/SB_PLC; Johnny lm/FPL/Pharms/SB_PLC; Matt R Battin/FPL/Pharms/SB_PLC; Rajinder Kumar/DEV/PHRD/SB_PLC; Rocco 2 Zaninelli/DEV/PHRD/SB_PLC; Scott A Sproull/FPL/Pharms/SB_PLC; Sheila X Hood/FPL/Pharms/SB_PLC;sherriJaffe@cohnwolfe.com; Steven M Vitale/FPL/Pharms/SB_PLC;tania_lyons@mccann.com; Terri E Smith/FPL/Pharms/SB_PLC CC: File@stimedinfo.com;johnr@stimedinfo.com; MarionP@stimedinfo.com;UnaK@stimedinfo.com Subject: Publication date for Paroxetine Adolescent Depression stud y (PAR 329) Date: 02/27/2001 13:20:56 (GMT-05:00) cc: 1301 Hello Paxil Team: We learned this morning that the Journal of the American Academy of Child and Adolescent Psychiatry has scheduled a tentative publication date for this manuscript. According to their editorial offices, proofs will be available in mid-May with publication scheduled for August, 2001. We have offered to help Dr Keller's office proof the galleys in
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/avu38h10

10. GSK psychiatry projects: Status report March 2003. Seroxat/Paxil Projects (ghostwrite studies 676, 701)
Document Date: 20030301
Document Type: table
Case Number: Smith v. GSK (SuperCtCA)
Bates Number: par010671035-par010671036
Search Terms in Context: A randomized, 676 Wa JAMA January Agreed 3rd draft – some queries Provide comments on multicenter, double-blind, gne 2003 budget of still outstanding 3rd draft placebo-controlled study r 23,800; to assess the efficacy 15,200 and safety of paroxetine already in children and paid; 8,600 adolescents with social still to be anxiety disorder invoiced [12539] D On track S Some delay I Significant delay Updated: [ TIME @ "d-MMM-yy" ] Page 5 pgNbr=1 GSK PSYCHIATRY PROJECTS : STATUS REPORT [MARCH 2003] SEROXAT/PAXIL PROJECTS Publication title Stud iST Target journal [Project code] y™ aut hor Timeline Paroxetine treatment in 704 Ge\\ J Am Acad Child A January children and adolescents er Adoles Psych 2003 with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled clinical trial
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 2
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/awu38h10

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Connecting to %s