Paxil 329 is actually 3 way trial inc Imipramine & placebo

[Guest guest]

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in Adolescents

by Jon Jureidini

This page was published earlier in 2008 in our old website at:http://www.healthyskepticism.org/documents/PaxilStudy329.php

GlaxoKline's Study 329 of medication for adolescent depression failed to demonstrate any benefit for paroxetine over placebo in adolescents and demonstrated a worrying profile of adverse events for paroxetine. The study was ultimately published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry with Keller as the primary author. This misleading paper has been a focus of interest for Healthy Skepticism since 2002. In 2003 we wrote to the Editor of JAACAP raising concerns about the misleading reporting by the authors that exaggerated benefit and downplayed adverse effects. (We also questioned editorial functioning, which drew an angry response from the Editor). In 2004 CMAJ published an Editorial which showed that in 1998 an internal GSK document clearly acknowledged that GSK were aware that 329 was negative. A subsequent law suit by New York Attorney General, Eliot Spitzer, was settled out of court.

In 2006, we wrote to the Lancet to point out that internal documents from another United States law suit ( versus GSK) revealed further concerns about study 329: -

The study was ghostwritten - see here.

Misleadingly positive interpretations of the study were promoted to drug reps and other GSK staff - see here.

An illusion of efficacy was achieved by re-inventing primary and secondary end points - see here.

Eventually GSK had to acknowledge the failure of all three of their child and adolescent paroxetine depression studies - see here.

Click here for Mansfield's summary of all trials of newer antidepressants in children and adolescents

Click here for J & E Jureidini's summary of citations of the Keller paper

Documents regarding study 329

Jon Jureidini, Leemon McHenry and Mansfield's analysis of these documents is published as Jureidini JN, McHenry LB, Mansfield PR.Clinical trials and drug promotion: Selective reporting of study 329International Journal of Risk and Safety in Medicine 2008 May;20(1-2):73-81Link to source with long URL

The confidential internal Final Clinical Report 24 November 1998

DRAFTS/PEER REVIEWS

Draft I. 18 Dec 1998

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.

Draft VI, submitted to JAACAP, 25 Apr, 2000.

JAACAP Reviews

Response to JAACAP reviewers.

Response to Dulcan.

Comparison of first to final draft

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, 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

Keller to Laden 11 Feb, 1999

Oakes to McCafferty 5 Mar, 1999

McCafferty to Laden 9 Mar, 1999

e to 30 Mar, 1999

Klein to B. 15 Apr, 1999

Katz to Kline, 18 May, 1999

McCafferty to Laden, 19 Jul, 1999

McCafferty to Laden, 21 Jul, 1999

Laden to McCafferty 26 Apr 2000

Dulcan to Keller 27 Jul, 2000

Laden to Keller 4 Oct 2000

Laden to Brand et al, 11 Jan, 2001

Pretre to Keller, 6 Feb, 2001

White to Hood, 5 Mar, 2001

Battin to Laden, 27 Apr, 2001

Laden to McCafferty, 7 Aug, 2001

Hawkins to all sales representatives selling Paxil, Aug 16, 2001

to Keller and Strober, 4 Feb, 2004

Keller to Carpenter et al, 14 May, 2004

Keller to et al, 13 Jun, 2004

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

GSK Med Query. Feb, 2002

Dear Health Care Professional. Jul, 2003 (Canada)

Dear Health Care Professional. Jul, 2003

Dear Health Care Professional. May, 2004

INFORMATION FOR SALES REPRESENTATIVES

Kline Beecham. Nulli Secundus. 8 Dec, 1999

GlaxoKline. GSK Sales Connection. 10 Sep, 2003

OTHER

Proposal: 'Adolescent Unipolar Major Depression: Multisite Psychopharmacology Study' Dec, 1992

Investigator Agreement, August, 1993

The study protocol, as amended March 24,1994

Position piece on the phase III clinical studies, 14 Oct, 1998

STI proposal for a journal article, 3 April, 1998

STI Release Form for JAACAP paper, 3 Nov, 2000

FDA Clinical Review, 2002

Statement of Wheadon Sep 9, 2004

HS Int News index

Page views since 15 March 2010: 1290

[Guest guest]

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in Adolescents

by Jon Jureidini

This page was published earlier in 2008 in our old website at:http://www.healthyskepticism.org/documents/PaxilStudy329.php

GlaxoKline's Study 329 of medication for adolescent depression failed to demonstrate any benefit for paroxetine over placebo in adolescents and demonstrated a worrying profile of adverse events for paroxetine. The study was ultimately published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry with Keller as the primary author. This misleading paper has been a focus of interest for Healthy Skepticism since 2002. In 2003 we wrote to the Editor of JAACAP raising concerns about the misleading reporting by the authors that exaggerated benefit and downplayed adverse effects. (We also questioned editorial functioning, which drew an angry response from the Editor). In 2004 CMAJ published an Editorial which showed that in 1998 an internal GSK document clearly acknowledged that GSK were aware that 329 was negative. A subsequent law suit by New York Attorney General, Eliot Spitzer, was settled out of court.

In 2006, we wrote to the Lancet to point out that internal documents from another United States law suit ( versus GSK) revealed further concerns about study 329: -

The study was ghostwritten - see here.

Misleadingly positive interpretations of the study were promoted to drug reps and other GSK staff - see here.

An illusion of efficacy was achieved by re-inventing primary and secondary end points - see here.

Eventually GSK had to acknowledge the failure of all three of their child and adolescent paroxetine depression studies - see here.

Click here for Mansfield's summary of all trials of newer antidepressants in children and adolescents

Click here for J & E Jureidini's summary of citations of the Keller paper

Documents regarding study 329

Jon Jureidini, Leemon McHenry and Mansfield's analysis of these documents is published as Jureidini JN, McHenry LB, Mansfield PR.Clinical trials and drug promotion: Selective reporting of study 329International Journal of Risk and Safety in Medicine 2008 May;20(1-2):73-81Link to source with long URL

The confidential internal Final Clinical Report 24 November 1998

DRAFTS/PEER REVIEWS

Draft I. 18 Dec 1998

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.

Draft VI, submitted to JAACAP, 25 Apr, 2000.

JAACAP Reviews

Response to JAACAP reviewers.

Response to Dulcan.

Comparison of first to final draft

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, 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

Keller to Laden 11 Feb, 1999

Oakes to McCafferty 5 Mar, 1999

McCafferty to Laden 9 Mar, 1999

e to 30 Mar, 1999

Klein to B. 15 Apr, 1999

Katz to Kline, 18 May, 1999

McCafferty to Laden, 19 Jul, 1999

McCafferty to Laden, 21 Jul, 1999

Laden to McCafferty 26 Apr 2000

Dulcan to Keller 27 Jul, 2000

Laden to Keller 4 Oct 2000

Laden to Brand et al, 11 Jan, 2001

Pretre to Keller, 6 Feb, 2001

White to Hood, 5 Mar, 2001

Battin to Laden, 27 Apr, 2001

Laden to McCafferty, 7 Aug, 2001

Hawkins to all sales representatives selling Paxil, Aug 16, 2001

to Keller and Strober, 4 Feb, 2004

Keller to Carpenter et al, 14 May, 2004

Keller to et al, 13 Jun, 2004

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

GSK Med Query. Feb, 2002

Dear Health Care Professional. Jul, 2003 (Canada)

Dear Health Care Professional. Jul, 2003

Dear Health Care Professional. May, 2004

INFORMATION FOR SALES REPRESENTATIVES

Kline Beecham. Nulli Secundus. 8 Dec, 1999

GlaxoKline. GSK Sales Connection. 10 Sep, 2003

OTHER

Proposal: 'Adolescent Unipolar Major Depression: Multisite Psychopharmacology Study' Dec, 1992

Investigator Agreement, August, 1993

The study protocol, as amended March 24,1994

Position piece on the phase III clinical studies, 14 Oct, 1998

STI proposal for a journal article, 3 April, 1998

STI Release Form for JAACAP paper, 3 Nov, 2000

FDA Clinical Review, 2002

Statement of Wheadon Sep 9, 2004

HS Int News index

Page views since 15 March 2010: 1290

[Guest guest]

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in Adolescents

by Jon Jureidini

This page was published earlier in 2008 in our old website at:http://www.healthyskepticism.org/documents/PaxilStudy329.php

GlaxoKline's Study 329 of medication for adolescent depression failed to demonstrate any benefit for paroxetine over placebo in adolescents and demonstrated a worrying profile of adverse events for paroxetine. The study was ultimately published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry with Keller as the primary author. This misleading paper has been a focus of interest for Healthy Skepticism since 2002. In 2003 we wrote to the Editor of JAACAP raising concerns about the misleading reporting by the authors that exaggerated benefit and downplayed adverse effects. (We also questioned editorial functioning, which drew an angry response from the Editor). In 2004 CMAJ published an Editorial which showed that in 1998 an internal GSK document clearly acknowledged that GSK were aware that 329 was negative. A subsequent law suit by New York Attorney General, Eliot Spitzer, was settled out of court.

In 2006, we wrote to the Lancet to point out that internal documents from another United States law suit ( versus GSK) revealed further concerns about study 329: -

The study was ghostwritten - see here.

Misleadingly positive interpretations of the study were promoted to drug reps and other GSK staff - see here.

An illusion of efficacy was achieved by re-inventing primary and secondary end points - see here.

Eventually GSK had to acknowledge the failure of all three of their child and adolescent paroxetine depression studies - see here.

Click here for Mansfield's summary of all trials of newer antidepressants in children and adolescents

Click here for J & E Jureidini's summary of citations of the Keller paper

Documents regarding study 329

Jon Jureidini, Leemon McHenry and Mansfield's analysis of these documents is published as Jureidini JN, McHenry LB, Mansfield PR.Clinical trials and drug promotion: Selective reporting of study 329International Journal of Risk and Safety in Medicine 2008 May;20(1-2):73-81Link to source with long URL

The confidential internal Final Clinical Report 24 November 1998

DRAFTS/PEER REVIEWS

Draft I. 18 Dec 1998

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.

Draft VI, submitted to JAACAP, 25 Apr, 2000.

JAACAP Reviews

Response to JAACAP reviewers.

Response to Dulcan.

Comparison of first to final draft

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, 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

Keller to Laden 11 Feb, 1999

Oakes to McCafferty 5 Mar, 1999

McCafferty to Laden 9 Mar, 1999

e to 30 Mar, 1999

Klein to B. 15 Apr, 1999

Katz to Kline, 18 May, 1999

McCafferty to Laden, 19 Jul, 1999

McCafferty to Laden, 21 Jul, 1999

Laden to McCafferty 26 Apr 2000

Dulcan to Keller 27 Jul, 2000

Laden to Keller 4 Oct 2000

Laden to Brand et al, 11 Jan, 2001

Pretre to Keller, 6 Feb, 2001

White to Hood, 5 Mar, 2001

Battin to Laden, 27 Apr, 2001

Laden to McCafferty, 7 Aug, 2001

Hawkins to all sales representatives selling Paxil, Aug 16, 2001

to Keller and Strober, 4 Feb, 2004

Keller to Carpenter et al, 14 May, 2004

Keller to et al, 13 Jun, 2004

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

GSK Med Query. Feb, 2002

Dear Health Care Professional. Jul, 2003 (Canada)

Dear Health Care Professional. Jul, 2003

Dear Health Care Professional. May, 2004

INFORMATION FOR SALES REPRESENTATIVES

Kline Beecham. Nulli Secundus. 8 Dec, 1999

GlaxoKline. GSK Sales Connection. 10 Sep, 2003

OTHER

Proposal: 'Adolescent Unipolar Major Depression: Multisite Psychopharmacology Study' Dec, 1992

Investigator Agreement, August, 1993

The study protocol, as amended March 24,1994

Position piece on the phase III clinical studies, 14 Oct, 1998

STI proposal for a journal article, 3 April, 1998

STI Release Form for JAACAP paper, 3 Nov, 2000

FDA Clinical Review, 2002

Statement of Wheadon Sep 9, 2004

HS Int News index

Page views since 15 March 2010: 1290

[Guest guest]

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in Adolescents

by Jon Jureidini

This page was published earlier in 2008 in our old website at:http://www.healthyskepticism.org/documents/PaxilStudy329.php

GlaxoKline's Study 329 of medication for adolescent depression failed to demonstrate any benefit for paroxetine over placebo in adolescents and demonstrated a worrying profile of adverse events for paroxetine. The study was ultimately published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry with Keller as the primary author. This misleading paper has been a focus of interest for Healthy Skepticism since 2002. In 2003 we wrote to the Editor of JAACAP raising concerns about the misleading reporting by the authors that exaggerated benefit and downplayed adverse effects. (We also questioned editorial functioning, which drew an angry response from the Editor). In 2004 CMAJ published an Editorial which showed that in 1998 an internal GSK document clearly acknowledged that GSK were aware that 329 was negative. A subsequent law suit by New York Attorney General, Eliot Spitzer, was settled out of court.

In 2006, we wrote to the Lancet to point out that internal documents from another United States law suit ( versus GSK) revealed further concerns about study 329: -

The study was ghostwritten - see here.

Misleadingly positive interpretations of the study were promoted to drug reps and other GSK staff - see here.

An illusion of efficacy was achieved by re-inventing primary and secondary end points - see here.

Eventually GSK had to acknowledge the failure of all three of their child and adolescent paroxetine depression studies - see here.

Click here for Mansfield's summary of all trials of newer antidepressants in children and adolescents

Click here for J & E Jureidini's summary of citations of the Keller paper

Documents regarding study 329

Jon Jureidini, Leemon McHenry and Mansfield's analysis of these documents is published as Jureidini JN, McHenry LB, Mansfield PR.Clinical trials and drug promotion: Selective reporting of study 329International Journal of Risk and Safety in Medicine 2008 May;20(1-2):73-81Link to source with long URL

The confidential internal Final Clinical Report 24 November 1998

DRAFTS/PEER REVIEWS

Draft I. 18 Dec 1998

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.

Draft VI, submitted to JAACAP, 25 Apr, 2000.

JAACAP Reviews

Response to JAACAP reviewers.

Response to Dulcan.

Comparison of first to final draft

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, 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

Keller to Laden 11 Feb, 1999

Oakes to McCafferty 5 Mar, 1999

McCafferty to Laden 9 Mar, 1999

e to 30 Mar, 1999

Klein to B. 15 Apr, 1999

Katz to Kline, 18 May, 1999

McCafferty to Laden, 19 Jul, 1999

McCafferty to Laden, 21 Jul, 1999

Laden to McCafferty 26 Apr 2000

Dulcan to Keller 27 Jul, 2000

Laden to Keller 4 Oct 2000

Laden to Brand et al, 11 Jan, 2001

Pretre to Keller, 6 Feb, 2001

White to Hood, 5 Mar, 2001

Battin to Laden, 27 Apr, 2001

Laden to McCafferty, 7 Aug, 2001

Hawkins to all sales representatives selling Paxil, Aug 16, 2001

to Keller and Strober, 4 Feb, 2004

Keller to Carpenter et al, 14 May, 2004

Keller to et al, 13 Jun, 2004

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

GSK Med Query. Feb, 2002

Dear Health Care Professional. Jul, 2003 (Canada)

Dear Health Care Professional. Jul, 2003

Dear Health Care Professional. May, 2004

INFORMATION FOR SALES REPRESENTATIVES

Kline Beecham. Nulli Secundus. 8 Dec, 1999

GlaxoKline. GSK Sales Connection. 10 Sep, 2003

OTHER

Proposal: 'Adolescent Unipolar Major Depression: Multisite Psychopharmacology Study' Dec, 1992

Investigator Agreement, August, 1993

The study protocol, as amended March 24,1994

Position piece on the phase III clinical studies, 14 Oct, 1998

STI proposal for a journal article, 3 April, 1998

STI Release Form for JAACAP paper, 3 Nov, 2000

FDA Clinical Review, 2002

Statement of Wheadon Sep 9, 2004

HS Int News index

Page views since 15 March 2010: 1290

[Guest guest]

Why anyone who studied this would ever trust a drug from this

manufacturer again is beyond me.

On 3/19/2011 6:13 PM, jeremy9282 wrote:

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in

Adolescents

by Jon Jureidini

This page was published earlier in 2008 in our old website at:

http://www.healthyskepticism.org/documents/PaxilStudy329.php

GlaxoKline's Study 329 of medication for adolescent

depression failed to demonstrate any benefit for paroxetine over

placebo in adolescents and demonstrated a worrying profile of

adverse events for paroxetine. The study was ultimately

published in 2001 by the Journal of the American

Academy of Child and Adolescent Psychiatry with

Keller as the primary author. This misleading

paper has been a focus of interest for Healthy Skepticism since

2002. In 2003 we wrote to the Editor of JAACAP

raising concerns about the misleading reporting by the authors

that exaggerated benefit and downplayed adverse effects. (We

also questioned editorial functioning, which drew an angry response from the Editor).

In 2004 CMAJ published an Editorial which

showed that in 1998 an internal GSK document clearly

acknowledged that GSK were aware that 329 was negative. A

subsequent law suit by New York Attorney General, Eliot Spitzer,

was settled out of court.

In 2006, we wrote to the Lancet to point out that internal

documents from another United States law suit ( versus GSK)

revealed further concerns about study 329: -

The study was ghostwritten - see here.

Misleadingly positive interpretations of the study were

promoted to drug reps and other GSK staff - see here.

An illusion of efficacy was achieved by re-inventing primary

and secondary end points - see here.

Eventually GSK had to acknowledge the failure of all three

of their child and adolescent paroxetine depression studies -

see here.

Click

here for Mansfield's summary of

all trials of newer antidepressants in children and adolescents

Click here for J &

E Jureidini's summary of citations of the Keller paper

Documents regarding study 329

Jon Jureidini, Leemon McHenry and Mansfield's analysis of

these documents is published as

Jureidini JN, McHenry LB, Mansfield PR.

Clinical trials and drug promotion: Selective reporting of study

329

International Journal of Risk and Safety in Medicine

2008 May;20(1-2):73-81

Link to source with long URL

The confidential internal Final Clinical

Report 24 November 1998

DRAFTS/PEER REVIEWS

Draft I. 18 Dec 1998

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.

Draft VI, submitted to JAACAP,

25 Apr, 2000.

JAACAP Reviews

Response to JAACAP reviewers.

Response to Dulcan.

Comparison of first to final draft

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, 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

Keller to Laden 11 Feb, 1999

Oakes to McCafferty 5 Mar, 1999

McCafferty to Laden 9 Mar, 1999

e to 30 Mar, 1999

Klein to B. 15 Apr, 1999

Katz to Kline, 18 May, 1999

McCafferty to Laden, 19 Jul,

1999

McCafferty to Laden, 21 Jul,

1999

Laden to McCafferty 26 Apr 2000

Dulcan to Keller 27 Jul, 2000

Laden to Keller 4 Oct 2000

Laden to Brand et al, 11 Jan,

2001

Pretre to Keller, 6 Feb, 2001

White to Hood, 5 Mar, 2001

Battin to Laden, 27 Apr, 2001

Laden to McCafferty, 7 Aug,

2001

Hawkins to all sales representatives

selling Paxil, Aug 16, 2001

to Keller and Strober, 4

Feb, 2004

Keller to Carpenter et al, 14

May, 2004

Keller to et al, 13 Jun,

2004

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

GSK Med Query. Feb, 2002

Dear Health Care Professional.

Jul, 2003 (Canada)

Dear Health Care Professional.

Jul, 2003

Dear Health Care Professional.

May, 2004

INFORMATION FOR SALES REPRESENTATIVES

Kline Beecham. Nulli Secundus. 8 Dec,

1999

GlaxoKline. GSK Sales Connection.

10 Sep, 2003

OTHER

Proposal: 'Adolescent Unipolar Major Depression:

Multisite Psychopharmacology Study' Dec, 1992

Investigator Agreement, August,

1993

The study protocol, as amended

March 24,1994

Position piece on the phase III clinical

studies, 14 Oct, 1998

STI proposal for a journal article,

3 April, 1998

STI Release Form for JAACAP paper,

3 Nov, 2000

FDA Clinical Review, 2002

Statement of Wheadon Sep

9, 2004

HS Int News index

Page views since 15 March 2010: 1290

[Guest guest]

Why anyone who studied this would ever trust a drug from this

manufacturer again is beyond me.

On 3/19/2011 6:13 PM, jeremy9282 wrote:

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in

Adolescents

by Jon Jureidini

This page was published earlier in 2008 in our old website at:

http://www.healthyskepticism.org/documents/PaxilStudy329.php

GlaxoKline's Study 329 of medication for adolescent

depression failed to demonstrate any benefit for paroxetine over

placebo in adolescents and demonstrated a worrying profile of

adverse events for paroxetine. The study was ultimately

published in 2001 by the Journal of the American

Academy of Child and Adolescent Psychiatry with

Keller as the primary author. This misleading

paper has been a focus of interest for Healthy Skepticism since

2002. In 2003 we wrote to the Editor of JAACAP

raising concerns about the misleading reporting by the authors

that exaggerated benefit and downplayed adverse effects. (We

also questioned editorial functioning, which drew an angry response from the Editor).

In 2004 CMAJ published an Editorial which

showed that in 1998 an internal GSK document clearly

acknowledged that GSK were aware that 329 was negative. A

subsequent law suit by New York Attorney General, Eliot Spitzer,

was settled out of court.

In 2006, we wrote to the Lancet to point out that internal

documents from another United States law suit ( versus GSK)

revealed further concerns about study 329: -

The study was ghostwritten - see here.

Misleadingly positive interpretations of the study were

promoted to drug reps and other GSK staff - see here.

An illusion of efficacy was achieved by re-inventing primary

and secondary end points - see here.

Eventually GSK had to acknowledge the failure of all three

of their child and adolescent paroxetine depression studies -

see here.

Click

here for Mansfield's summary of

all trials of newer antidepressants in children and adolescents

Click here for J &

E Jureidini's summary of citations of the Keller paper

Documents regarding study 329

Jon Jureidini, Leemon McHenry and Mansfield's analysis of

these documents is published as

Jureidini JN, McHenry LB, Mansfield PR.

Clinical trials and drug promotion: Selective reporting of study

329

International Journal of Risk and Safety in Medicine

2008 May;20(1-2):73-81

Link to source with long URL

The confidential internal Final Clinical

Report 24 November 1998

DRAFTS/PEER REVIEWS

Draft I. 18 Dec 1998

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.

Draft VI, submitted to JAACAP,

25 Apr, 2000.

JAACAP Reviews

Response to JAACAP reviewers.

Response to Dulcan.

Comparison of first to final draft

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, 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

Keller to Laden 11 Feb, 1999

Oakes to McCafferty 5 Mar, 1999

McCafferty to Laden 9 Mar, 1999

e to 30 Mar, 1999

Klein to B. 15 Apr, 1999

Katz to Kline, 18 May, 1999

McCafferty to Laden, 19 Jul,

1999

McCafferty to Laden, 21 Jul,

1999

Laden to McCafferty 26 Apr 2000

Dulcan to Keller 27 Jul, 2000

Laden to Keller 4 Oct 2000

Laden to Brand et al, 11 Jan,

2001

Pretre to Keller, 6 Feb, 2001

White to Hood, 5 Mar, 2001

Battin to Laden, 27 Apr, 2001

Laden to McCafferty, 7 Aug,

2001

Hawkins to all sales representatives

selling Paxil, Aug 16, 2001

to Keller and Strober, 4

Feb, 2004

Keller to Carpenter et al, 14

May, 2004

Keller to et al, 13 Jun,

2004

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

GSK Med Query. Feb, 2002

Dear Health Care Professional.

Jul, 2003 (Canada)

Dear Health Care Professional.

Jul, 2003

Dear Health Care Professional.

May, 2004

INFORMATION FOR SALES REPRESENTATIVES

Kline Beecham. Nulli Secundus. 8 Dec,

1999

GlaxoKline. GSK Sales Connection.

10 Sep, 2003

OTHER

Proposal: 'Adolescent Unipolar Major Depression:

Multisite Psychopharmacology Study' Dec, 1992

Investigator Agreement, August,

1993

The study protocol, as amended

March 24,1994

Position piece on the phase III clinical

studies, 14 Oct, 1998

STI proposal for a journal article,

3 April, 1998

STI Release Form for JAACAP paper,

3 Nov, 2000

FDA Clinical Review, 2002

Statement of Wheadon Sep

9, 2004

HS Int News index

Page views since 15 March 2010: 1290

[Guest guest]

Why anyone who studied this would ever trust a drug from this

manufacturer again is beyond me.

On 3/19/2011 6:13 PM, jeremy9282 wrote:

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in

Adolescents

by Jon Jureidini

This page was published earlier in 2008 in our old website at:

http://www.healthyskepticism.org/documents/PaxilStudy329.php

GlaxoKline's Study 329 of medication for adolescent

depression failed to demonstrate any benefit for paroxetine over

placebo in adolescents and demonstrated a worrying profile of

adverse events for paroxetine. The study was ultimately

published in 2001 by the Journal of the American

Academy of Child and Adolescent Psychiatry with

Keller as the primary author. This misleading

paper has been a focus of interest for Healthy Skepticism since

2002. In 2003 we wrote to the Editor of JAACAP

raising concerns about the misleading reporting by the authors

that exaggerated benefit and downplayed adverse effects. (We

also questioned editorial functioning, which drew an angry response from the Editor).

In 2004 CMAJ published an Editorial which

showed that in 1998 an internal GSK document clearly

acknowledged that GSK were aware that 329 was negative. A

subsequent law suit by New York Attorney General, Eliot Spitzer,

was settled out of court.

In 2006, we wrote to the Lancet to point out that internal

documents from another United States law suit ( versus GSK)

revealed further concerns about study 329: -

The study was ghostwritten - see here.

Misleadingly positive interpretations of the study were

promoted to drug reps and other GSK staff - see here.

An illusion of efficacy was achieved by re-inventing primary

and secondary end points - see here.

Eventually GSK had to acknowledge the failure of all three

of their child and adolescent paroxetine depression studies -

see here.

Click

here for Mansfield's summary of

all trials of newer antidepressants in children and adolescents

Click here for J &

E Jureidini's summary of citations of the Keller paper

Documents regarding study 329

Jon Jureidini, Leemon McHenry and Mansfield's analysis of

these documents is published as

Jureidini JN, McHenry LB, Mansfield PR.

Clinical trials and drug promotion: Selective reporting of study

329

International Journal of Risk and Safety in Medicine

2008 May;20(1-2):73-81

Link to source with long URL

The confidential internal Final Clinical

Report 24 November 1998

DRAFTS/PEER REVIEWS

Draft I. 18 Dec 1998

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.

Draft VI, submitted to JAACAP,

25 Apr, 2000.

JAACAP Reviews

Response to JAACAP reviewers.

Response to Dulcan.

Comparison of first to final draft

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, 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

Keller to Laden 11 Feb, 1999

Oakes to McCafferty 5 Mar, 1999

McCafferty to Laden 9 Mar, 1999

e to 30 Mar, 1999

Klein to B. 15 Apr, 1999

Katz to Kline, 18 May, 1999

McCafferty to Laden, 19 Jul,

1999

McCafferty to Laden, 21 Jul,

1999

Laden to McCafferty 26 Apr 2000

Dulcan to Keller 27 Jul, 2000

Laden to Keller 4 Oct 2000

Laden to Brand et al, 11 Jan,

2001

Pretre to Keller, 6 Feb, 2001

White to Hood, 5 Mar, 2001

Battin to Laden, 27 Apr, 2001

Laden to McCafferty, 7 Aug,

2001

Hawkins to all sales representatives

selling Paxil, Aug 16, 2001

to Keller and Strober, 4

Feb, 2004

Keller to Carpenter et al, 14

May, 2004

Keller to et al, 13 Jun,

2004

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

GSK Med Query. Feb, 2002

Dear Health Care Professional.

Jul, 2003 (Canada)

Dear Health Care Professional.

Jul, 2003

Dear Health Care Professional.

May, 2004

INFORMATION FOR SALES REPRESENTATIVES

Kline Beecham. Nulli Secundus. 8 Dec,

1999

GlaxoKline. GSK Sales Connection.

10 Sep, 2003

OTHER

Proposal: 'Adolescent Unipolar Major Depression:

Multisite Psychopharmacology Study' Dec, 1992

Investigator Agreement, August,

1993

The study protocol, as amended

March 24,1994

Position piece on the phase III clinical

studies, 14 Oct, 1998

STI proposal for a journal article,

3 April, 1998

STI Release Form for JAACAP paper,

3 Nov, 2000

FDA Clinical Review, 2002

Statement of Wheadon Sep

9, 2004

HS Int News index

Page views since 15 March 2010: 1290

[Guest guest]

Why anyone who studied this would ever trust a drug from this

manufacturer again is beyond me.

On 3/19/2011 6:13 PM, jeremy9282 wrote:

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in

Adolescents

by Jon Jureidini

This page was published earlier in 2008 in our old website at:

http://www.healthyskepticism.org/documents/PaxilStudy329.php

GlaxoKline's Study 329 of medication for adolescent

depression failed to demonstrate any benefit for paroxetine over

placebo in adolescents and demonstrated a worrying profile of

adverse events for paroxetine. The study was ultimately

published in 2001 by the Journal of the American

Academy of Child and Adolescent Psychiatry with

Keller as the primary author. This misleading

paper has been a focus of interest for Healthy Skepticism since

2002. In 2003 we wrote to the Editor of JAACAP

raising concerns about the misleading reporting by the authors

that exaggerated benefit and downplayed adverse effects. (We

also questioned editorial functioning, which drew an angry response from the Editor).

In 2004 CMAJ published an Editorial which

showed that in 1998 an internal GSK document clearly

acknowledged that GSK were aware that 329 was negative. A

subsequent law suit by New York Attorney General, Eliot Spitzer,

was settled out of court.

In 2006, we wrote to the Lancet to point out that internal

documents from another United States law suit ( versus GSK)

revealed further concerns about study 329: -

The study was ghostwritten - see here.

Misleadingly positive interpretations of the study were

promoted to drug reps and other GSK staff - see here.

An illusion of efficacy was achieved by re-inventing primary

and secondary end points - see here.

Eventually GSK had to acknowledge the failure of all three

of their child and adolescent paroxetine depression studies -

see here.

Click

here for Mansfield's summary of

all trials of newer antidepressants in children and adolescents

Click here for J &

E Jureidini's summary of citations of the Keller paper

Documents regarding study 329

Jon Jureidini, Leemon McHenry and Mansfield's analysis of

these documents is published as

Jureidini JN, McHenry LB, Mansfield PR.

Clinical trials and drug promotion: Selective reporting of study

329

International Journal of Risk and Safety in Medicine

2008 May;20(1-2):73-81

Link to source with long URL

The confidential internal Final Clinical

Report 24 November 1998

DRAFTS/PEER REVIEWS

Draft I. 18 Dec 1998

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.

Draft VI, submitted to JAACAP,

25 Apr, 2000.

JAACAP Reviews

Response to JAACAP reviewers.

Response to Dulcan.

Comparison of first to final draft

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, 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

Keller to Laden 11 Feb, 1999

Oakes to McCafferty 5 Mar, 1999

McCafferty to Laden 9 Mar, 1999

e to 30 Mar, 1999

Klein to B. 15 Apr, 1999

Katz to Kline, 18 May, 1999

McCafferty to Laden, 19 Jul,

1999

McCafferty to Laden, 21 Jul,

1999

Laden to McCafferty 26 Apr 2000

Dulcan to Keller 27 Jul, 2000

Laden to Keller 4 Oct 2000

Laden to Brand et al, 11 Jan,

2001

Pretre to Keller, 6 Feb, 2001

White to Hood, 5 Mar, 2001

Battin to Laden, 27 Apr, 2001

Laden to McCafferty, 7 Aug,

2001

Hawkins to all sales representatives

selling Paxil, Aug 16, 2001

to Keller and Strober, 4

Feb, 2004

Keller to Carpenter et al, 14

May, 2004

Keller to et al, 13 Jun,

2004

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

GSK Med Query. Feb, 2002

Dear Health Care Professional.

Jul, 2003 (Canada)

Dear Health Care Professional.

Jul, 2003

Dear Health Care Professional.

May, 2004

INFORMATION FOR SALES REPRESENTATIVES

Kline Beecham. Nulli Secundus. 8 Dec,

1999

GlaxoKline. GSK Sales Connection.

10 Sep, 2003

OTHER

Proposal: 'Adolescent Unipolar Major Depression:

Multisite Psychopharmacology Study' Dec, 1992

Investigator Agreement, August,

1993

The study protocol, as amended

March 24,1994

Position piece on the phase III clinical

studies, 14 Oct, 1998

STI proposal for a journal article,

3 April, 1998

STI Release Form for JAACAP paper,

3 Nov, 2000

FDA Clinical Review, 2002

Statement of Wheadon Sep

9, 2004

HS Int News index

Page views since 15 March 2010: 1290