Study 329 (English Wikipedia)

Analysis of information sources in references of the Wikipedia article "Study 329" in English language version.

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15doi.org

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13nih.gov

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12ucsf.edu

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7nationalarchives.gov.uk

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6bmj.com

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6bbc.co.uk

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5justice.gov

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5web.archive.org

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4nytimes.com

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3theguardian.com

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2jstor.org

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2findlaw.com

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2healthyskepticism.org

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2fda.gov

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1jaacap.com

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1browndailyherald.com

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1newscientist.com

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1cmaj.ca

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1pogoarchives.org

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1pqarchiver.com

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1boston.com

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1columbia.edu

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1publicationethics.org

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bbc.co.uk

news.bbc.co.uk

"Seroxat: Statement from GlaxoSmithKline", 29 January 2007, courtesy of BBC News.
"The Secrets of Seroxat", BBC Panorama, 13 October 2002 (transcript).
"Emails from the edge", BBC Panorama, 11 May 2003 (transcript).
"Taken on Trust", BBC Panorama, 3 October 2004 (transcript).
"Secrets of the drugs trials", BBC Panorama, 29 January 2007 (transcript).
"Company hid suicide link", BBC News, 29 January 2007.

"Seroxat: Statement from GlaxoSmithKline", BBC Panorama, 29 January 2007.
"Seroxat: Emails from the edge", BBC News, undated.

bmj.com

Jureidini, Jon. (26 April 2013). Letter to Andrew Witty, CEO, GlaxoSmithKline, courtesy of BMJ.
Doshi, Peter (16 September 2015). "No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility", BMJ, 351. doi:10.1136/bmj.h4629
Godlee, Fiona (17 September 2015). "Study 329", BMJ, 351, 17 September 2015. doi:10.1136/bmj.h4973
Le Noury, Joanna, et al. (16 September 2015). "Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence", BMJ, 351. doi:10.1136/bmj.h4320 PMID 26376805 PMC 4572084
Henry, David; Fitzpatrick, Tiffany (16 September 2015)). "Liberating the data from clinical trials", BMJ, 351. doi:10.1136/bmj.h4601
Jureidini, Jon N. (13 June 2013). "Restoring invisible and abandoned trials: a call for people to publish the findings" (letter), BMJ, 13(346). doi:10.1136/bmj.f2865
Jon Jureidini–GSK correspondence, BMJ, 347, 12 November 2013.

For RIAT, see Loder, Elizabeth, et al. (13 June 2013). "Restoring the integrity of the clinical trial evidence base", BMJ, 346. doi:10.1136/bmj.f3601

boston.com

archive.boston.com

Leddy, Chuck (5 July 2008). "The unhealthy ties that bind FDA to drug firms", The Boston Globe.

browndailyherald.com

Heck, Isabel (2 April 2014). "Controversial Paxil paper still under fire 13 years later", The Brown Daily Herald.

cmaj.ca

Kondro, Wayne; Sibbald, Barbara (2 March 2004). "Drug company experts advised staff to withhold data about SSRI use in children", Canadian Medical Association Journal, 170(5), p. 783. doi:10.1503/cmaj.1040213 PMID 14993169

columbia.edu

web.law.columbia.edu

Kagle, Abigail (undated). "Driven to Settle: Eliot Spitzer v. GlaxoSmithKline and Undisclosed Clinical Trials Data Regarding Paxil", University of Columbia Law School, p. 4.

doi.org

Jureidini, Jon; Tonkin, Ann (May 2003). "Paroxetine in major depression", Journal of the American Academy of Child and Adolescent Psychiatry, 42(5), p. 514. doi:10.1097/01.CHI.0000046825.95464.DA PMID 12707552
Doshi, Peter (16 September 2015). "No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility", BMJ, 351. doi:10.1136/bmj.h4629
Keller, Martin B.; Ryan, Neal D.; Strober, Michael, et al. (July 2001). "Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial", Journal of the American Academy of Child and Adolescent Psychiatry, 40(7), pp. 762–772. doi:10.1097/00004583-200107000-00010 PMID 11437014
McGoey, Linsey; Jackson, Emily (February 2009). "Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity", Journal of Medical Ethics, 35(2), pp. 107–112. doi:10.1136/jme.2008.025361 PMID 19181884 JSTOR 27720271
Godlee, Fiona (17 September 2015). "Study 329", BMJ, 351, 17 September 2015. doi:10.1136/bmj.h4973
Kondro, Wayne; Sibbald, Barbara (2 March 2004). "Drug company experts advised staff to withhold data about SSRI use in children", Canadian Medical Association Journal, 170(5), p. 783. doi:10.1503/cmaj.1040213 PMID 14993169
Newman, Melanie (11 December 2010). "The Rules of Retraction", BMJ, 341(7785), pp. 1246–1248. doi:10.1136/bmj.c6985 PMID 21138994 JSTOR 20800711, p. 1246.
Le Noury, Joanna, et al. (16 September 2015). "Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence", BMJ, 351. doi:10.1136/bmj.h4320 PMID 26376805 PMC 4572084
Henry, David; Fitzpatrick, Tiffany (16 September 2015)). "Liberating the data from clinical trials", BMJ, 351. doi:10.1136/bmj.h4601
Jureidini, Jon N.; McHenry, Leemon B.; Mansfield, Peter R. (2008). "Clinical trials and drug promotion: Selective reporting of study 329", International Journal of Risk & Safety in Medicine, 20(1–2) (pp. 73–81), p. 74. doi:10.3233/JRS-2008-0426
Apter, Alan, et al. (22 March 2006). "Evaluation of Suicidal Thoughts and Behaviors in Children and Adolescents Taking Paroxetine," Journal of Child and Adolescent Psychopharmacology, 16(1–2), pp. 77–90. doi:10.1089/cap.2006.16.77 PMID 16553530;
Kmietowicz, Zosia (7 February 2013). "GSK backs campaign for disclosure of trial data", BMJ, 346. doi:10.1136/bmj.f819 PMID 23393115
Peter Doshi, "Putting GlaxoSmithKline to the test over paroxetine," BMJ, 12 November 2013. doi:10.1136/bmj.f6754 PMID 24222673
Jureidini, Jon N. (13 June 2013). "Restoring invisible and abandoned trials: a call for people to publish the findings" (letter), BMJ, 13(346). doi:10.1136/bmj.f2865
Jon Jureidini–GSK correspondence, BMJ, 347, 12 November 2013.

For RIAT, see Loder, Elizabeth, et al. (13 June 2013). "Restoring the integrity of the clinical trial evidence base", BMJ, 346. doi:10.1136/bmj.f3601
Hetrick, Sarah E.; McKenzie, Joanne E.; Cox, Georgina R., et al. (14 November 2012). "Newer generation antidepressants for depressive disorders in children and adolescents", Cochrane Database of Systematic Reviews. doi:10.1002/14651858.CD004851.pub3 PMID 23152227

fda.gov

"Antidepressant Use in Children, Adolescents, and Adults", Food and Drug Administration, 2 May 2007, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.
"Medication guide Paxil", FDA, June 2014, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.

findlaw.com

news.findlaw.com

The People of the State of New York against GlaxoSmithKline, 2 June 2004, p. 2, para. 3.
The People of the State of New York against GlaxoSmithKline, 2 June 2004, courtesy of FindLaw.

healthyskepticism.org

"Study drug: BRL29060/Paroxetine (Paxil)" Archived 12 July 2018 at the Wayback Machine, SmithKline Beecham, 20 August 1993, amended 24 March 1994.
Also see Letter from Jon Jureidini to Mina K. Dulcan, 26 December 2002, courtesy of Healthy Skepticism.

jaacap.com

Jureidini, Jon; Tonkin, Ann (May 2003). "Paroxetine in major depression", Journal of the American Academy of Child and Adolescent Psychiatry, 42(5), p. 514. doi:10.1097/01.CHI.0000046825.95464.DA PMID 12707552

jstor.org

McGoey, Linsey; Jackson, Emily (February 2009). "Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity", Journal of Medical Ethics, 35(2), pp. 107–112. doi:10.1136/jme.2008.025361 PMID 19181884 JSTOR 27720271
Newman, Melanie (11 December 2010). "The Rules of Retraction", BMJ, 341(7785), pp. 1246–1248. doi:10.1136/bmj.c6985 PMID 21138994 JSTOR 20800711, p. 1246.

justice.gov

"GSK's off-label marketing of Paxil", United States v. GlaxoSmithKline, United States District Court for the District of Massachusetts, 26 October 2011, pp. 3–19.

"GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data", United States Department of Justice, 2 July 2012.
Keller, Martin B.; Ryan, Neal D.; Strober, Michael, et al. (July 2001). "Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial", Journal of the American Academy of Child and Adolescent Psychiatry, 40(7), pp. 762–772. doi:10.1097/00004583-200107000-00010 PMID 11437014
"Seroxat/Paxil Adolescent Depression: Position piece on the phase III clinical studies", SmithKline Beecham, October 1998, courtesy of the Drug Industry Documents Archive, University of California, San Francisco; also available here, courtesy of the United States Department of Justice.
"GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data", United States Department of Justice, 2 July 2012.
"GSK's off-label marketing of Paxil", United States v. GlaxoSmithKline], United States District Court for the District of Massachusetts, 26 October 2011, pp. 3–19.
United States v. GlaxoSmithKline, United States District Court for the District of Massachusetts, 26 October 2011 (for paroxetine, pp. 3–19).

Thomas, Katie; Schmidt, Michael S. (2 July 2012). "Glaxo Agrees to Pay $3 Billion in Fraud Settlement", The New York Times.
Jackie Westaway, SmithKline Beecham (14 October 1998) Memo, courtesy of the United States Department of Justice.

nationalarchives.gov.uk

webarchive.nationalarchives.gov.uk

"MHRA Investigation into GlaxoSmithKline/Seroxat", Medicines and Healthcare products Regulatory Agency, 6 March 2008(a), (pp. 1–13), p. 2, para. 2.
"MHRA Investigation into GlaxoSmithKline/Seroxat", Medicines and Healthcare products Regulatory Agency, 6 March 2008(a).
"GSK investigation concludes", Medicines and Healthcare products Regulatory Agency, press release, 6 March 2008(b).
Letter from Kent Woods, MHRA, to Jean-Pierre Garnier, GSK, Medicines and Healthcare products Regulatory Agency, 6 March 2008(c).

"Transcription of a meeting at MHRA about Seroxat", Medicines and Healthcare products Regulatory Agency, meeting with patient group, 29 April 2008.
For university or hospital psychiatric departments, "Paroxetine (Seroxat) – Variation assessment report", MHRA, 4 June 2003, p. 6.
"Paroxetine (Seroxat) – Variation assessment report", MHRA, 4 June 2003, p. 8.
"Paroxetine (Seroxat)—Variation Assessment Report—Proposal to contraindicate in adolescents and children under 18 years with major depressive disorder", Medicines and Healthcare products Regulatory Agency, 4 June 2003, pp. 1–18 (hereinafter MHRA, 4 June 2003), p. 5.
GlaxoSmithKline (20 May 2003). "Paroxetine, BRL–029060: Critical evaluation of paroxetine hydrochloride for the treatment of Paediatric Obsessive Compulsive Disorder and Social Anxiety Disorder in children and adolescents", in MHRA, 22 May 2003, Annex 1, pp. 1–79 (hereinafter GSK briefing paper)

newscientist.com

Wilson, Clare (16 September 2015). "New look at antidepressant suicide risks from infamous trial", New Scientist.

nih.gov

pubmed.ncbi.nlm.nih.gov

Jureidini, Jon; Tonkin, Ann (May 2003). "Paroxetine in major depression", Journal of the American Academy of Child and Adolescent Psychiatry, 42(5), p. 514. doi:10.1097/01.CHI.0000046825.95464.DA PMID 12707552
Keller, Martin B.; Ryan, Neal D.; Strober, Michael, et al. (July 2001). "Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial", Journal of the American Academy of Child and Adolescent Psychiatry, 40(7), pp. 762–772. doi:10.1097/00004583-200107000-00010 PMID 11437014
McGoey, Linsey; Jackson, Emily (February 2009). "Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity", Journal of Medical Ethics, 35(2), pp. 107–112. doi:10.1136/jme.2008.025361 PMID 19181884 JSTOR 27720271
Kondro, Wayne; Sibbald, Barbara (2 March 2004). "Drug company experts advised staff to withhold data about SSRI use in children", Canadian Medical Association Journal, 170(5), p. 783. doi:10.1503/cmaj.1040213 PMID 14993169
Newman, Melanie (11 December 2010). "The Rules of Retraction", BMJ, 341(7785), pp. 1246–1248. doi:10.1136/bmj.c6985 PMID 21138994 JSTOR 20800711, p. 1246.
Le Noury, Joanna, et al. (16 September 2015). "Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence", BMJ, 351. doi:10.1136/bmj.h4320 PMID 26376805 PMC 4572084
Carrey, Normand; Pharm, Adil Virani (November 2003). "Suicidal Ideation Reports From Pediatric Trials for Paroxetine and Venlafaxine", The Canadian Child and Adolescent Psychiatry Review, 12(4), pp. 101–102. PMID 19030150 PMC 2533826
Apter, Alan, et al. (22 March 2006). "Evaluation of Suicidal Thoughts and Behaviors in Children and Adolescents Taking Paroxetine," Journal of Child and Adolescent Psychopharmacology, 16(1–2), pp. 77–90. doi:10.1089/cap.2006.16.77 PMID 16553530;
Kmietowicz, Zosia (7 February 2013). "GSK backs campaign for disclosure of trial data", BMJ, 346. doi:10.1136/bmj.f819 PMID 23393115
Peter Doshi, "Putting GlaxoSmithKline to the test over paroxetine," BMJ, 12 November 2013. doi:10.1136/bmj.f6754 PMID 24222673
Hetrick, Sarah E.; McKenzie, Joanne E.; Cox, Georgina R., et al. (14 November 2012). "Newer generation antidepressants for depressive disorders in children and adolescents", Cochrane Database of Systematic Reviews. doi:10.1002/14651858.CD004851.pub3 PMID 23152227

ncbi.nlm.nih.gov

Le Noury, Joanna, et al. (16 September 2015). "Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence", BMJ, 351. doi:10.1136/bmj.h4320 PMID 26376805 PMC 4572084
Carrey, Normand; Pharm, Adil Virani (November 2003). "Suicidal Ideation Reports From Pediatric Trials for Paroxetine and Venlafaxine", The Canadian Child and Adolescent Psychiatry Review, 12(4), pp. 101–102. PMID 19030150 PMC 2533826

nytimes.com

Harris, Gardiner (27 August 2004). "Maker of Paxil to Release All Trial Results", The New York Times.
"GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data", United States Department of Justice, 2 July 2012.
"GSK's off-label marketing of Paxil", United States v. GlaxoSmithKline], United States District Court for the District of Massachusetts, 26 October 2011, pp. 3–19.
United States v. GlaxoSmithKline, United States District Court for the District of Massachusetts, 26 October 2011 (for paroxetine, pp. 3–19).

Thomas, Katie; Schmidt, Michael S. (2 July 2012). "Glaxo Agrees to Pay $3 Billion in Fraud Settlement", The New York Times.
Hilts, Philip J. (8 June 2001). "Jury Awards $6.4 Million In Killings Tied to Drug", The New York Times.
Kagle, pp. 7–8; Jackson 2012, p. 109; Gardiner Harris, "Maker of Paxil to Release All Trial Results", The New York Times, 27 August 2004.

pogoarchives.org

Romankiewicz, John A. (1 October 1993). "Paxil Advisory Board Meeting", Scientific Therapeutics Information.

pqarchiver.com

secure.pqarchiver.com

Bass, Alison (4 October 1999). "Drug companies enrich Brown professor" Archived 8 August 2017 at the Wayback Machine, The Boston Globe.

publicationethics.org

Elizabeth Wager, et al., "Retraction guidelines", Committee on Publication Ethics, September 2009.

scot.nhs.uk

sehd.scot.nhs.uk

Duff, Gordon (10 June 2010). "Safety of Seroxat (paroxetine) in children and adolescents under 18 years—contradindication in the treatment of depressive illness", Committee on Safety of Medicines, Scottish Executive.

theguardian.com

Boseley, Sarah (16 September 2015). "Seroxat study under-reported harmful effects on young people, say scientists", The Guardian.
Boseley, Sarah (9 August 2001). "'Four people dead is four too many'", The Guardian.
Simon Neville, "GlaxoSmithKline fined $3bn after bribing doctors to increase drugs sales", The Guardian, 3 July 2012.

ucsf.edu

dida.library.ucsf.edu

"Seroxat/Paxil Adolescent Depression: Position piece on the phase III clinical studies", SmithKline Beecham, October 1998, courtesy of the Drug Industry Documents Archive, University of California, San Francisco; also available here, courtesy of the United States Department of Justice.
Letter from FDA to GlaxoSmithKline, 21 October 2002, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.
Hawkins, Zachary (18 August 2001). "To all sales representatives selling Paxil", Paxil Product Management, GlaxoSmithKline, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.
"FDA statement regarding the anti-depressant Paxil for pediatric population", Food and Drug Administration, 19 June 2003, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.
Laden, Sally K.; Romankiewicz, John A. (3 April 1998). "Adolescent Depression Study 329: Proposal for a Journal Article", Scientific Therapeutics Information, Inc.
Laden, Sally K. (18 December 1998). Sally Laden, STI, to Jim McCafferty, SmithKline Beecham, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.
Pretre, Caroline (6 February 2001). Caroline Pretre (STI) to Martin Keller, courtesy of the Drug Industry Documents Archive, University of California, San Francisco; Jureidini, McHenry, and Mansfield 2008.
Laden, Sally K. (7 December 1998). Sally Laden, STI, to Jim McCafferty, SmithKline Beecham, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.
McCafferty, James P. (21 July 1999). James McCafferty, SmithKline Beecham, to Sally Laden, STI, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.
Newman 2010, p. 1247.
Laden, Sally K. (24 August 2000). Sally Laden–Michael Strober–Boris Birmaher correspondence, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.
Laden, Sally K. (11 January 2001). Sally Laden to the Paxil Team, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.
Bass, Alison (2008). Side Effects, Chapel Hill: Algonquin Books, p. 171.
Laden, Sally (7 August 2001). Sally Laden to Jim McCafferty, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.
Laden, Sally (25 April 2001). Sally Laden to the Paxil Marketing Team, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.

Laden, Sally (27 April 2001). SmithKline Beecham to Sally Laden, courtesy of the Drug Industry Documents Archive, University of California, San Francisco.

web.archive.org

Feeley, Jeff; Fisk, Margaret Cronin (14 December 2009). "Glaxo Said to Have Paid $1 Billion in Paxil Suits (Update2)", Bloomberg.
"Study drug: BRL29060/Paroxetine (Paxil)" Archived 12 July 2018 at the Wayback Machine, SmithKline Beecham, 20 August 1993, amended 24 March 1994.
Deposition of Sally K. Laden, United States District Court, Northern District of California, 15 March 2007.
Bass, Alison (4 October 1999). "Drug companies enrich Brown professor" Archived 8 August 2017 at the Wayback Machine, The Boston Globe.
Alison Bass, "Drug companies enrich Brown professor", The Boston Globe, 4 October 1999.