Editing GSK plc (section)

===2012 criminal and civil settlement===
====Overview====
In July 2012, GSK pleaded guilty in the United States to criminal charges, and agreed to pay US$3{{nbsp}}billion, in what was the [[List of Largest Pharmaceutical Settlements|largest settlement]] until then between the Justice Department and a drug company. The US$3{{nbsp}}billion included a criminal fine of US$956,814,400 and forfeiture of US$43,185,600. The remaining US$2{{nbsp}}billion covered a civil settlement with the government under the [[False Claims Act]]. The investigation was launched largely on the basis of information from four whistleblowers who filed [[qui tam]] (whistleblower) lawsuits against the company under the False Claims Act.<ref name="USDOJJuly2012">[https://www.justice.gov/opa/pr/2012/July/12-civ-842.html "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data"] {{Webarchive|url=https://web.archive.org/web/20140909141736/http://www.justice.gov/opa/pr/2012/July/12-civ-842.html |date=9 September 2014 }}, United States Department of Justice, 2 July 2012.{{pb}}
Katie Thomas and Michael S. Schmidt, [https://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html "Glaxo Agrees to Pay $3 Billion in Fraud Settlement"] {{Webarchive|url=https://web.archive.org/web/20170302145001/http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html |date=2 March 2017 }}, ''[[The New York Times]]'', 2 July 2012.{{pb}}
Simon Neville, [https://www.theguardian.com/business/2012/jul/03/glaxosmithkline-fined-bribing-doctors-pharmaceuticals "GlaxoSmithKline fined $3bn after bribing doctors to increase drugs sales"], ''[[The Guardian]]'', 3 July 2012.</ref>

The charges stemmed from GSK's promotion of the anti-depressants Paxil ([[paroxetine]]) and Wellbutrin ([[bupropion]]) for unapproved uses from 1998 to 2003, specifically as suitable for patients under the age of 18, and from its failure to report safety data about Avandia ([[rosiglitazone]]), both in violation of the [[Federal Food, Drug, and Cosmetic Act]]. Other drugs promoted for unapproved uses were two inhalers, Advair ([[fluticasone/salmeterol]]) and Flovent ([[fluticasone propionate]]), as well as Zofran ([[ondansetron]]), Imitrex ([[sumatriptan]]), Lotronex ([[alosetron]]) and Valtrex ([[valaciclovir]]).<ref name=USDOJJuly2012/>

The settlement also covered reporting false best prices and underpaying rebates owed under the [[Medicaid Drug Rebate Program]], and kickbacks to physicians to prescribe GSK's drugs. There were all-expenses-paid spa treatments and hunting trips for doctors and their spouses, speakers' fees at conferences, and payment for articles [[Medical ghostwriter|ghostwritten]] by the company and placed by physicians in medical journals.<ref name=USDOJJuly2012/> The company set up a ghostwriting programme called CASPPER, initially to produce articles about Paxil but which was extended to cover Avandia.<ref>[[Max Baucus]], [[Chuck Grassley]], [http://finance.senate.gov/newsroom/chairman/download/?id=a5c07780-6351-4905-8c63-52e4a7a7a66b "Finance Committee Letter to the FDA Regarding Avandia"] {{Webarchive|url=https://web.archive.org/web/20100805051726/http://finance.senate.gov/newsroom/chairman/download/?id=a5c07780-6351-4905-8c63-52e4a7a7a66b |date=5 August 2010 }}, United States Senate Finance Committee, 12 July 2010.<br />
Jim Edwards, [http://www.cbsnews.com/news/inside-gsks-cassper-ghostwriting-program/ "Inside GSK's CASSPER Ghostwriting Program"], CBS News, 21 August 2009.</ref>

As part of the settlement GSK signed a five-year [[corporate integrity agreement]] with the [[Department of Health and Human Services]], which obliged the company to make major changes in the way it did business, including changing its compensation programmes for its sales force and executives, and to implement and maintain transparency in its research practices and publication policies.<ref name=USDOJJuly2012/> It announced in 2013, that it would no longer pay doctors to promote its drugs or attend medical conferences, and that its sales staff would no longer have prescription targets.<ref name=Reuters17Dec2013>[http://sustainability.thomsonreuters.com/2013/12/17/gsk-stop-paying-doctors-major-marketing-overhaul "GSK to stop paying doctors in major marketing overhaul"] {{Webarchive |url=https://web.archive.org/web/20141028041032/http://sustainability.thomsonreuters.com/2013/12/17/gsk-stop-paying-doctors-major-marketing-overhaul/ |date=28 October 2014 }}, Thomson/Reuters, 17 December 2013.</ref>

====Rosiglitazone (Avandia)====
{{further|Rosiglitazone#Adverse effects|Rosiglitazone#Lawsuits}}
[[File:Avandia 2mg oral tablet.jpg|thumb|[[Rosiglitazone]]]]
The 2012 settlement included a criminal fine of US$242,612,800 for failing to report safety data to the FDA about Avandia ([[rosiglitazone]]), a [[Diabetes mellitus type 2|diabetes]] drug approved in 1999, and a civil settlement of US$657{{nbsp}}million for making false claims about it. The Justice Department said GSK had promoted rosiglitazone to physicians with misleading information, including that it conferred cardiovascular benefits despite an FDA-mandated label warning of cardiovascular risks.<ref name=USDOJJuly2012/>

In 1999, [[John Buse]], a diabetes specialist, told medical conferences that rosiglitazone might carry an increased risk of cardiovascular problems. GSK threatened to sue him, called his university head of department, and persuaded him to sign a retraction.<ref>{{Cite web |title=United States Senate Committee on Finance Report: The Intimidation of Dr. John Buse and the Diabetes Drug Avandia |url=https://www.finance.senate.gov/download/committee-staff-report-the-intimidation-of-dr-john-buse-and-the-diabetes-drug-avandia |url-status=live |archive-url=https://web.archive.org/web/20161111000154/https://www.finance.senate.gov/imo/media/doc/prb111507a.pdf |archive-date=11 November 2016 |access-date=11 September 2023 |website=www.finance.senate.gov |language=en}}</ref> GSK raised questions internally about the drug's safety in 2000, and in 2002, the company [[Medical ghostwriter|ghostwrote]] an article in ''[[Circulation (journal)|Circulation]]'' describing a GSK funded clinical trial that suggested rosiglitazone might have a beneficial effect on cardiovascular risk.<ref>[[Max Baucus]], [[Chuck Grassley]], [http://finance.senate.gov/newsroom/chairman/download/?id=a5c07780-6351-4905-8c63-52e4a7a7a66b "Finance Committee Letter to the FDA Regarding Avandia"] {{Webarchive|url=https://web.archive.org/web/20100805051726/http://finance.senate.gov/newsroom/chairman/download/?id=a5c07780-6351-4905-8c63-52e4a7a7a66b |date=5 August 2010 }}, United States Senate Finance Committee, 12 July 2010; for internal concerns, p. 2 and attachment E, pp.&nbsp;20–35; for ghostwriting, p. 3 and attachment H, pp. 58–109; for the ghostwriting, attachment I, p. 110ff; for cover letter to ''[[Circulation (journal)|Circulation]]'', attachment I, p.&nbsp;143; for the ghostwritten article, attachment I, pp.&nbsp;152–158.{{pb}}
{{cite journal |vauthors=Haffner SM, Greenberg AS, Weston WM, Chen H, Williams K, Freed MI |display-authors=3 |date=August 2002 |title=Effect of rosiglitazone treatment on nontraditional markers of cardiovascular disease in patients with type 2 diabetes mellitus |journal=Circulation |volume=106 |issue=6 |pages=679–84 |doi=10.1161/01.CIR.0000025403.20953.23 |pmid=12163427 |doi-access=free}}</ref> From 2001, reports began to link the [[thiazolidinedione]]s (the class of drugs to which rosiglitazone belongs) to [[heart failure]].<ref name="pmid20154334"/> In April that year, GSK began a six-year, [[Open-label trial|open-label]], [[Randomized controlled trial|randomized trial]], known as RECORD, to examine rosiglitazone and cardiovascular events.<ref name="RECORDLancet">{{cite journal |vauthors=Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ |display-authors=3 |title=Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial |journal=Lancet |volume=373 |issue=9681 |pages=2125–35 |date=June 2009 |pmid=19501900 |doi=10.1016/S0140-6736(09)60953-3 |s2cid=25939495}}{{pb}}
{{cite journal |vauthors=Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Dargie H, Komajda M, Gubb J, Biswas N, Jones NP |display-authors=3 |title=Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol |journal=Diabetologia |volume=48 |issue=9 |pages=1726–35 |date=September 2005 |pmid=16025252 |doi=10.1007/s00125-005-1869-1 |doi-access=free}}{{pb}}
{{cite journal |title=RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes - Full Text View |website=ClinicalTrials.gov |date=21 March 2017 |url=https://clinicaltrials.gov/ct2/show/NCT00379769 |access-date=12 March 2020 |archive-date=17 June 2018 |archive-url=https://web.archive.org/web/20180617115741/https://clinicaltrials.gov/ct2/show/NCT00379769 |url-status=live }}</ref> Two GSK [[Meta-analysis|meta-analyses]] in 2005, and 2006, showed an increased risk of cardiovascular problems with rosiglitazone; the information was passed to the FDA and posted on the company website, but not otherwise published. By December 2006, rosiglitazone had become the top-selling diabetes drug, with annual sales of US$3.3{{nbsp}}billion.<ref name="pmid20154334">{{cite journal |vauthors=Nissen SE |date=April 2010 |title=The rise and fall of rosiglitazone |journal=European Heart Journal |volume=31 |issue=7 |pages=773–776 |doi=10.1093/eurheartj/ehq016 |pmid=20154334 |doi-access=free}} see table 1 for timeline.</ref>

In June 2007, ''[[The New England Journal of Medicine]]'' published a meta-analysis that associated the drug with an increased risk of [[Myocardial infarction|heart attack]].<ref>{{cite journal |vauthors=Nissen SE, Wolski K |year=2007 |title=Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes |journal=New England Journal of Medicine |volume=356 |issue=24 |pages=2457–71 |doi=10.1056/NEJMoa072761 |pmid=17517853 |doi-access=free |quote=Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance.}}</ref> GSK had reportedly tried to persuade one of the authors, [[Steven Nissen]], not to publish it, after receiving an advance copy from one of the journal's peer reviewers, a GSK consultant.<ref>{{cite news |last=Saul |first=Stephanie |date=30 January 2008 |title=Doctor Accused of Leak to Drug Maker |website=[[The New York Times]] |url=https://www.nytimes.com/2008/01/30/business/30cnd-censure.html |url-status=live |access-date=12 March 2020 |archive-url=https://web.archive.org/web/20230405075959/https://www.nytimes.com/2008/01/30/business/30cnd-censure.html |archive-date=5 April 2023}}</ref><ref>{{cite news |last=Harris |first=Gardiner |date=22 February 2010 |title=A Face-Off on the Safety of a Drug for Diabetes |website=[[The New York Times]] |url=https://www.nytimes.com/2010/02/23/health/23niss.html |url-status=live |access-date=12 March 2020 |archive-url=https://web.archive.org/web/20230605132307/https://www.nytimes.com/2010/02/23/health/23niss.html |archive-date=5 June 2023}}</ref> In July 2007, FDA scientists suggested that rosiglitazone had caused 83,000 excess heart attacks between 1999 and 2007.<ref name=Senatereport/>{{rp|4}}<ref name=Graham>[[David Graham (epidemiologist)|David Graham]], [https://www.fda.gov/ohrms/dockets/ac/07/slides/2007-4308s1-08-fda-graham_files/frame.htm "Assessment of the cardiovascular risks and health benefits of rosiglitazone"] {{Webarchive|url=https://web.archive.org/web/20170517113056/https://www.fda.gov/ohrms/dockets/ac/07/slides/2007-4308s1-08-fda-graham_files/frame.htm |date=17 May 2017 }}, Office of Surveillance and Epidemiology, Food and Drug Administration, 30 July 2007.</ref> The FDA placed restrictions on the drug, including adding a [[boxed warning]], but did not withdraw it.<ref>{{Cite web |date=14 November 2007 |title=FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109026.htm |url-status=dead |archive-url=https://web.archive.org/web/20090618090859/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109026.htm |archive-date=18 June 2009 |website=U.S. Food and Drug Administration}}</ref> (In 2013, the FDA rejected that the drug had caused excess heart attacks.)<ref name=FDAheart/> A [[United States Senate Committee on Finance|Senate Finance Committee]] inquiry concluded in 2010, that GSK had sought to intimidate scientists who had concerns about rosiglitazone.<ref name="Senatereport">[http://www.finance.senate.gov/newsroom/chairman/download/?id=9e4b091f-de21-4df1-b65e-b227d74bec12 "Staff report on GlaxoSmithKline and the diabetes drug Avandia"] {{Webarchive|url=https://web.archive.org/web/20141206153734/http://www.finance.senate.gov/newsroom/chairman/download/?id=9e4b091f-de21-4df1-b65e-b227d74bec12 |date=6 December 2014 }}, Committee on Finance, United States Senate, January 2010.{{pb}}
[http://www.finance.senate.gov/newsroom/chairman/release/?id=bc56b552-efc5-4706-968d-f7032d5cd2e4 "Grassley, Baucus Release Committee Report on Avandia"] {{Webarchive|url=https://web.archive.org/web/20141206040504/http://www.finance.senate.gov/newsroom/chairman/release/?id=bc56b552-efc5-4706-968d-f7032d5cd2e4 |date=6 December 2014 }}, The United States Senate Committee on Finance, 20 February 2010.{{pb}}
Andrew Clark, [https://www.theguardian.com/business/2010/feb/22/glaxosmithkline-avandia-concerns-senate "Glaxo's handling of Avandia concerns damned by US Senate committee"], ''[[The Guardian]]'', 22 February 2010.</ref> In February that year the company tried to halt publication of an editorial about the controversy by Nissen in the ''European Heart Journal''.<ref>{{Cite journal |author1=Thomas F. Lüscher |author2=Ulf Landmesser |author3=Frank Ruschitzka |title=Standing firm—the European Heart Journal, scientific controversies and the industry |journal=European Heart Journal |volume=31 |issue=10 |pages=1157–1158 |date=23 April 2010 |doi=10.1093/eurheartj/ehq127 |doi-access=free}}{{pb}}
{{cite journal |pmid=20154334 |doi=10.1093/eurheartj/ehq016 |volume=31 |title=The rise and fall of rosiglitazone |date=April 2010 |journal=Eur. Heart J. |pages=773–6 |last1=Nissen |first1=SE |issue=7 |doi-access=free}}{{pb}}
{{cite journal |pmid=20499440 |volume=31 |title=The rise and fall of rosiglitazone: reply |year=2010 |journal=Eur. Heart J. |pages=1282–4 |last1=Slaoui |first1=M |issue=10 |doi=10.1093/eurheartj/ehq118 |doi-access=free}}{{pb}}
{{cite journal |pmid=20118174 |doi=10.1093/eurheartj/ehp604 |volume=31 |title=Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial |pmc=2848325 |year=2010 |journal=Eur. Heart J. |pages=824–31 |last1=Komajda |first1=M |last2=McMurray |first2=JJ |last3=Beck-Nielsen |first3=H |last4=Gomis |first4=R |last5=Hanefeld |first5=M |last6=Pocock |first6=SJ |last7=Curtis |first7=PS |last8=Jones |first8=NP |last9=Home |first9=PD |issue=7}}</ref>

The results of GSK's RECORD trial were published in June 2009. It confirmed an association between rosiglitazone and an increased risk of heart failure and fractures, but not of heart attack, and concluded that it "does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs."<ref name=RECORDLancet/> Steven Nissan and Kathy Wolkski argued that the study's low event rates reduced its statistical power.<ref>{{cite journal |last1=Nissen |first1=Steven E. |last2=Wolski |first2=Kathy |title=Rosiglitazone RevisitedAn Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality |journal=Archives of Internal Medicine |volume=170 |issue=14 |pages=1191–1202 |doi=10.1001/archinternmed.2010.207 |pmid=20656674 |date=July 2010 |quote=That study was limited by low event rates, which resulted in insufficient statistical power to confirm or refute evidence of an increased risk for ischemic myocardial events. |doi-access=free}}</ref> In September 2009, rosiglitazone was suspended in Europe.<ref>{{Cite web |date=17 September 2018 |title=European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim |url=https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-avandia-avandamet-avaglim |url-status=live |archive-url=https://web.archive.org/web/20190629145612/https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-avandia-avandamet-avaglim |archive-date=29 June 2019 |access-date=11 September 2023 |website=European Medicines Agency |language=en}}</ref> The results of the RECORD study were confirmed in 2013, by the Duke Clinical Research Institute, in an independent review required by the FDA.<ref>{{cite journal |last1=McHaffey |first1=Kenneth W. |display-authors=etal |year=2013 |title=Results of a reevaluation of cardiovascular outcomes in the RECORD trial |journal=American Heart Journal |volume=166 |issue=2 |pages=240–249 |doi=10.1016/j.ahj.2013.05.004 |pmid=23895806 |doi-access=free}}</ref> In November that year the FDA lifted the restrictions it had placed on the drug.<ref>[https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376516.htm "FDA requires removal of certain restrictions on the diabetes drug Avandia"] {{Webarchive|url=https://web.archive.org/web/20150504051733/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376516.htm |date=4 May 2015 }}, Food and Drug Administration, 25 November 2013.{{pb}}
[https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM354859.pdf "Readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes Trial (RECORD)"] {{Webarchive|url=https://web.archive.org/web/20170509191833/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM354859.pdf |date=9 May 2017 }}, Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Food and Drug Administration, 5–6 June 2013.{{pb}}
Steven Nissen, [https://www.forbes.com/sites/matthewherper/2013/05/23/steven-nissen-the-hidden-agenda-behind-the-fdas-avandia-hearings/ "Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings"] {{Webarchive|url=https://web.archive.org/web/20170508133620/https://www.forbes.com/sites/matthewherper/2013/05/23/steven-nissen-the-hidden-agenda-behind-the-fdas-avandia-hearings/ |date=8 May 2017 }}, ''[[Forbes]]'', 23 May 2013.{{pb}}
[https://www.forbes.com/sites/matthewherper/2013/05/23/the-fda-responds-to-steve-nissens-criticism-of-upcoming-avandia-meeting/ "The FDA Responds To Steve Nissen's Criticism Of Upcoming Avandia Meeting"], ''[[Forbes]]'', 23 May 2013.</ref> The boxed warning about heart attack was removed; the warning about heart failure remained in place.<ref name=FDAheart>{{cite web |url=https://www.fda.gov/Drugs/DrugSafety/ucm376389.htm |title=FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines |publisher=Food and Drug Administration |date=25 November 2013 |access-date=16 December 2019 |archive-date=24 April 2019 |archive-url=https://web.archive.org/web/20190424011624/https://www.fda.gov/Drugs/DrugSafety/ucm376389.htm |url-status=dead }}<br />
[https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM143413.pdf Avandia. Prescribing information"] {{Webarchive|url=https://web.archive.org/web/20190327025224/https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM143413.pdf |date=27 March 2019 }}, Food and Drug Administration.</ref>

====Paroxetine (Paxil/Seroxat)====
{{main|Study 329}}
[[File:Paroxetine pill.jpg|thumb|[[Paroxetine]], known as Paxil and Seroxat]]
GSK was fined for promoting Paxil/Seroxat ([[paroxetine]]) for treating depression in the under-18s, although the drug had not been approved for pediatric use.<ref name=USDOJJuly2012/>
Paxil had US$4.97{{nbsp}}billion worldwide sales in 2003.<ref name=CMAJ2004/> The company conducted nine clinical trials between 1994, and 2002, none of which showed that Paxil helped children with depression.<ref>Goldacre 2013, p. 58.</ref> From 1998, to 2003, it promoted the drug for the under-18s, paying physicians to go on all-expenses paid trips, five-star hotels and spas.<ref name=USDOJJuly2012/> From 2004, Paxil's label, along with those of similar drugs, included an FDA-mandated boxed warning that it might increase the risk of suicidal ideation and behaviour in patients under 18.<ref name=USDOJJuly2012/>

An internal SmithKline Beecham document said in 1998, about withheld data from two GSK studies: "It would be commercially unacceptable to include a statement that [pediatric] efficacy had not been demonstrated, as this would undermine the profile of paroxetine."<ref name=CMAJ2004>{{cite journal |author1=W. Kondro |author2=B. Sibbald |title=Drug company experts advised staff to withhold data about SSRI use in children |journal=Canadian Medical Association Journal |volume=170 |issue=5 |page=783 |date=March 2004 |pmid=14993169 |pmc=343848 |doi=10.1503/cmaj.1040213}}</ref><ref>{{cite journal |last=Samson |first=Kurt |title=Senate probe seeks industry payment data on individual academic researchers |journal=Annals of Neurology |volume=64 |issue=6 |pages=A7–9 |date=December 2008 |pmid=19107985 |doi=10.1002/ana.21271 |s2cid=12019559 |doi-access=free}}</ref> The company [[Medical ghostwriter|ghostwrote]] an article, published in 2001, in the ''Journal of the American Academy of Child and Adolescent Psychiatry'', that misreported the results of one of its clinical trials, [[Study 329]].<ref name=USDOJJuly2012/><ref>[http://dida.library.ucsf.edu/pdf/otu38h10 Letter showing authorship of Study 239] {{Webarchive|url=https://web.archive.org/web/20150505021115/http://dida.library.ucsf.edu/pdf/otu38h10 |date=5 May 2015 }}, Drug Industry Document Archive, University of California, San Francisco.{{pb}}
Isabel Heck, [http://www.browndailyherald.com/2014/04/02/controversial-paxil-paper-still-fire-13-years-later/ "Controversial Paxil paper still under fire 13 years later"] {{Webarchive|url=https://web.archive.org/web/20150505040638/http://www.browndailyherald.com/2014/04/02/controversial-paxil-paper-still-fire-13-years-later/ |date=5 May 2015 }}, ''The Brown Daily Herald'', 2 April 2014.{{pb}}
{{cite journal |doi=10.3233/JRS-2008-0426 |volume=20 |title=Clinical trials and drug promotion: Selective reporting of study 329 |year=2008 |journal=International Journal of Risk & Safety in Medicine |pages=73–81 |last1=Jureidini |first1=Jon N. |last2=McHenry |first2=Leemon B. |last3=Mansfield |first3=Peter R. |issue=1–2}}{{pb}}
[http://news.bbc.co.uk/2/hi/health/6308871.stm "Company hid suicide link"] {{Webarchive|url=https://web.archive.org/web/20150504225137/http://news.bbc.co.uk/2/hi/health/6308871.stm |date=4 May 2015 }}, BBC News, 29 January 2007; "Secrets of the Drug Trials," BBC Panorama, 29 January 2007; Goldacre 2013, pp. 296–297.</ref> The article concluded that Paxil was "generally well tolerated and effective for major depression in adolescents."<ref>{{cite journal |last1=Keller |first1=Martin |author-link=Martin Keller (psychiatrist) |display-authors=etal |title=Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial |url=http://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/complaint-ex2.pdf |journal=Journal of the American Academy of Child and Adolescent Psychiatry |volume=40 |issue=7 |pages=762–772 |doi=10.1097/00004583-200107000-00010 |pmid=11437014 |date=July 2001 |access-date=27 April 2015 |archive-date=12 February 2021 |archive-url=https://web.archive.org/web/20210212183811/https://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/complaint-ex2.pdf |url-status=live }}</ref> The suppression of the research findings is the subject of the 2008 book ''[[Side Effects (Bass book)|Side Effects]]'' by [[Alison Bass]].<ref>Alison Bass (2008). ''Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial''. Algonquin Books of Chapel Hill.</ref><ref>{{cite news |last=Angell |first=Marcia |author-link=Marcia Angell |date=15 January 2009 |title=Drug Companies & Doctors: A Story of Corruption |volume=56 |work=The New York Review of Books |issue=1 |url=http://www.nybooks.com/articles/archives/2009/jan/15/drug-companies-doctorsa-story-of-corruption/ |url-status=live |archive-url=https://web.archive.org/web/20230828153024/https://www.nybooks.com/articles/2009/01/15/drug-companies-doctorsa-story-of-corruption/ |archive-date=28 August 2023}}</ref>

For 10 years GSK marketed Paxil as non-habit forming. In 2001, 35 patients filed a class-action suit alleging they had had withdrawal symptoms, and in 2002, a Los Angeles court issued an injunction preventing GSK from advertising that the drug was not habit forming.<ref>{{cite news |date=20 August 2002 |title=Judge: Paxil ads can't say it isn't habit-forming |agency=Associated Press |url=https://www.usatoday.com/news/health/2002-08-20-paxil-ads_x.htm |url-status=usurped |archive-url=https://web.archive.org/web/20030714070927/https://www.usatoday.com/news/health/2002-08-20-paxil-ads_x.htm |archive-date=14 July 2003}}</ref> The court withdrew the injunction after the FDA objected that the court had no jurisdiction over drug marketing that the FDA had approved.<ref>Drug and Device Law. 14 December 2006 [http://druganddevicelaw.blogspot.com/2006/12/fdas-amicus-briefs-on-preemption.html The FDA's Amicus Briefs on Preemption] {{Webarchive|url=https://web.archive.org/web/20150929132909/http://druganddevicelaw.blogspot.com/2006/12/fdas-amicus-briefs-on-preemption.html |date=29 September 2015 }}{{pb}}
Ronald D. White for the Los Angeles Times. 21 August 2002 [https://www.latimes.com/archives/la-xpm-2002-aug-21-fi-paxil21-story.html U.S. Opposes Order to Pull Paxil TV Ads]</ref> In 2003, a World Health Organization committee reported that Paxil was among the top 30 drugs, and top three antidepressants, for which dependence had been reported.<ref name=WHOdependence>[https://web.archive.org/web/20150418195400/http://apps.who.int/medicinedocs/collect/medicinedocs/pdf/s4896e/s4896e.pdf "WHO Expert Committee on Drug Dependence"], Thirty-third Report, World Health Organization, 2003, pp. 20, 25.</ref>{{refn|group=n|[[World Health Organization]] Expert Committee on Drug Dependence, 2003: "The Committee noted the striking number of reports on paroxetine and 'withdrawal syndrome' ... The representative of Consumers International reported that a number of patients had experienced difficulty in withdrawing from SSRIs in general. It was agreed that withdrawal was indeed a problem in some patients, but there was a difference of opinion on the degree of dependence that was involved, given the possibility that the need for treatment of resistant or relapsing disease could make these drugs indispensable for patient care. The Committee expressed concern about the possibility of inappropriate prescribing resulting in the risk of problems of withdrawal outweighing the benefits of treatment with SSRIs."<ref name=WHOdependence/>}}

====Bupropion (Wellbutrin)====
The company was also fined for promoting Wellbutrin ([[bupropion]])&nbsp;– approved at the time for [[major depressive disorder]] and also sold as a smoking-cessation aid, Zyban&nbsp;– for weight loss and the treatment of [[attention deficit hyperactivity disorder]], sexual dysfunction and substance addiction. GSK paid doctors to promote these off-label uses, and set up supposedly independent advisory boards and [[Continuing Medical Education]] programmes.<ref name=USDOJJuly2012/>