Editing GSK plc (section)

==Controversies==
===1973 Antitrust case over griseofulvin===
In the 1960s, Glaxo Group Ltd. (Glaxo) and Imperial Chemical Industries (ICI) each owned patents covering various aspects of the antifungal drug [[griseofulvin]].<ref name="GSKICI">{{Cite web |title=UNITED STATES v. GLAXO GROUP LTD., 410 U.S. 52 (1973) |url=https://caselaw.findlaw.com/court/us-supreme-court/410/52.html |url-status=live |archive-url=https://archive.today/20230911005137/https://caselaw.findlaw.com/court/us-supreme-court/410/52.html |archive-date=11 September 2023 |website=FindLaw}}</ref>{{rp|54, nn. 1–2}}<ref name=LaHatte>{{cite journal |last1=LaHatte |first1=Gabrielle |title=Reverse Payments: When the Federal Trade Commission can Attack the Validity of Underlying Patents |url=http://scholarlycommons.law.case.edu/cgi/viewcontent.cgi?article=1051&context=jolti |journal=Case Western Reserve Journal of Law, Technology & the Internet |date=2011 |volume=2 |pages=37–73 |access-date=19 June 2015 |archive-date=18 November 2020 |archive-url=https://web.archive.org/web/20201118203407/https://scholarlycommons.law.case.edu/cgi/viewcontent.cgi?article=1051&context=jolti |url-status=live }}</ref> They created a [[patent pool]] by [[cross-licensing]] their patents, subject to express licensing restrictions that the chemical from which the "finished" form of the drug (tablets and capsules) was made must not be resold in bulk form, and they licensed other drug companies to sell the drug in finished form and subject to similar restrictions.<ref name=GSKICI/>{{rp|54–55}}<ref name=LaHatte /> The effect and intent of the [[bulk-sale restriction]] was to keep the drug chemical out of the hands of small companies that might act as price-cutters, and the effect was to maintain stable, uniform prices.<ref name=Leslie>{{cite book |last1=Leslie |first1=Christopher R. |title=Antitrust Law and Intellectual Property Rights: Cases and Materials |date=2011 |publisher=Oxford University Press |isbn=9780195337198 |pages=574–75}}</ref><ref>[https://caselaw.findlaw.com/us-supreme-court/410/52.html ''United States v. Glaxo Group Ltd''.] {{Webarchive|url=https://web.archive.org/web/20201204030146/https://caselaw.findlaw.com/us-supreme-court/410/52.html |date=4 December 2020 }} at 62-63.</ref><ref name=Jacobson>{{cite book |last1=Jacobson |first1=Jonathan M. |title=Antitrust Law Developments |date=2007 |publisher=American Bar Association |isbn=9781590318676 |page=1162}}</ref>

The United States brought an antitrust suit against the two companies—''[[United States v. Glaxo Group Ltd.]]''—charging them with violation of the Sherman Act and also seeking to have the patents declared invalid.<ref name=GSKICI/>{{rp|55}}<ref name=LaHatte /> The trial court found that the defendants had engaged in several unlawful conspiracies, but dismissed the part of the suit seeking invalidation of patents and refused to grant as relief mandatory sales of the bulk drug chemical and compulsory licensing of the patents.<ref name=GSKICI/>{{rp|56}}<ref name=LaHatte /> The government appealed to the Supreme Court, which reversed, in ''[[United States v. Glaxo Group Ltd.]]'', 410 U.S. 52 (1973).<ref name=LaHatte />

===2000s Ribena===
{{Multiple image
| align = right
| direction = vertical
| width = 220
| header =
| image1 = Ribena bottle (front label closeup).jpg
| alt1 = photograph
| caption1 =
| image2 = Ribena bottle (back label closeup).jpg
| alt2 = photograph
| caption2 = Old Ribena bottle, year unknown, made by Beecham Products, Brentford, Middlesex; the label states: "widely used in hospitals and clinics."
}}
There were concerns in the 2000s about the sugar and vitamin content of [[Ribena]], a [[blackcurrant]]-based [[syrup]] and [[soft drink]] owned by GSK until 2013. Produced in England by H.W. Carter & Co from the 1930s, the company's unbranded syrup was distributed to children as a source of [[vitamin C]] during World War II, which gave the drink a reputation as good for health. [[Beecham Group|Beecham]] bought H. W. Carter in 1955.<ref>Oliver Thring, [https://www.theguardian.com/lifeandstyle/wordofmouth/2010/sep/07/consider-squash-cordial "Consider squash and cordial"] {{Webarchive|url=https://web.archive.org/web/20170510110645/https://www.theguardian.com/lifeandstyle/wordofmouth/2010/sep/07/consider-squash-cordial |date=10 May 2017 }}, ''[[The Guardian]]'', 7 September 2010.{{pb}}
[http://www.bristolpost.co.uk/Frank-Vernon-thank-Ribena/story-19804329-detail/story.html "We have Frank and Vernon to thank for Ribena"] {{Webarchive|url=https://web.archive.org/web/20150418215501/http://www.bristolpost.co.uk/Frank-Vernon-thank-Ribena/story-19804329-detail/story.html |date=18 April 2015 }}, ''The Bristol Post'', 17 September 2013.</ref>

In 2001, the British [[Advertising Standards Authority (United Kingdom)|Advertising Standards Authority]] (ASA) required GSK to withdraw its claim that Ribena Toothkind, a lower-sugar variety, did not encourage tooth decay. A company poster showed bottles of Toothkind in place of the bristles on a toothbrush. The ASA's ruling was upheld by the High Court.<ref>{{Cite web |last=Gregoriadis |first=Linus |date=18 January 2001 |title=Makers of Ribena lose fight over anti-decay claims |url=https://www.telegraph.co.uk/news/uknews/1318417/Makers-of-Ribena-lose-fight-over-anti-decay-claims.html |url-status=live |archive-url=https://web.archive.org/web/20100324132820/https://www.telegraph.co.uk/news/uknews/1318417/Makers-of-Ribena-lose-fight-over-anti-decay-claims.html |archive-date=24 March 2010 |access-date=11 September 2023 |website=The Telegraph |language=en}}</ref> In 2007, GSK was fined US$217,000 in New Zealand over its claim that ready-to-drink Ribena contained high levels of vitamin C, after two schoolgirls showed it contained no detectable vitamin C.<ref>{{Cite news |url=http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10431253 |title=Judge orders Ribena to fess up |work=[[The New Zealand Herald]] |last=Eames |first=David |date=28 March 2007 |access-date=15 April 2018 |archive-date=18 June 2018 |archive-url=https://web.archive.org/web/20180618025623/https://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10431253 |url-status=live }}{{pb}}
Tony Jaques, [http://issueoutcomes.publishpath.com/Websites/issueoutcomes/Images/Ribena%20icon%20stumbles%20CCIJ.pdf "When an Icon Stumbles – The Ribena Issue Mismanaged"] {{Webarchive|url=https://web.archive.org/web/20160304044727/http://issueoutcomes.publishpath.com/Websites/issueoutcomes/Images/Ribena%20icon%20stumbles%20CCIJ.pdf |date=4 March 2016 }}, ''Corporate Communications: An International Journal'', 13(4), 2008, pp.&nbsp;394–406.{{pb}}
Michael Regester, Judy Larkin, ''Risk Issues and Crisis Management in Public Relations'', Kogan Page Publishers, 2008, p.&nbsp;[https://books.google.com/books?id=MIIx4NVTz6EC&pg=PA67 67ff].</ref> In 2013, GSK sold Ribena and another drink, [[Lucozade]], to the Japanese multinational [[Suntory]] for £1.35{{nbsp}}billion.<ref name="Monaghan"/>

===SB Pharmco Puerto Rico===
In 2010, the US Department of Justice announced that GSK would pay a US$150{{nbsp}}million criminal fine and forfeiture, and a civil settlement of US$600{{nbsp}}million under the False Claims Act. The fines stemmed from production of improperly made and adulterated drugs from 2001 to 2005, at GSK's subsidiary, SB Pharmco Puerto Rico Inc., in Cidra, Puerto Rico, which at the time produced US$5.5&nbsp;billion of products each year. The drugs involved were [[Kytril]], an antiemetic; [[Bactroban]], used to treat skin infections; Paxil, the anti-depressant; and [[Avandamet]], a diabetes drug.<ref>{{Cite web |date=26 October 2010 |title=Office of Public Affairs {{!}} GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant {{!}} United States Department of Justice |url=https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-pay-750-million-resolve-criminal-and-civil-liability-regarding |url-status=live |archive-url=https://web.archive.org/web/20141019113737/https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-pay-750-million-resolve-criminal-and-civil-liability-regarding |archive-date=19 October 2014 |access-date=11 September 2023 |website=www.justice.gov |language=en}}</ref> GSK closed the factory in 2009.<ref name="NYTPuerto">{{cite news |last1=Harris |first1=Gardiner |last2=Wilson |first2=Duff |date=26 October 2010 |title=Glaxo to Pay $750 Million for Sale of Bad Products |work=[[The New York Times]] |url=https://www.nytimes.com/2010/10/27/business/27drug.html |url-status=live |archive-url=https://web.archive.org/web/20230405082107/https://www.nytimes.com/2010/10/27/business/27drug.html |archive-date=5 April 2023}}</ref>

The case began in 2002, when GSK sent experts to fix problems cited by the FDA. The lead inspector recommended recalls of defective products, but they were not authorised; she was fired in 2003, and filed a whistleblower lawsuit. In 2005, federal marshals seized US$2{{nbsp}}billion worth of products, the largest such seizure in history. In the 2010 settlement SB Pharmco pleaded guilty to criminal charges, and agreed to pay US$150&nbsp;million in a criminal fine and forfeiture, at that time the largest such payment ever by a manufacturer of adulterated drugs, and US$600&nbsp;million in civil penalties to settle the civil lawsuit.<ref name=NYTPuerto/>

=== 2010 Pandemrix connected with narcolepsy ===
'''The [[Pandemrix]]''' [[influenza vaccine]] was developed by GlaxoSmithKline in 2006. It was used by Finland and Sweden in the [[2009 swine flu pandemic vaccine|H1N1 mass vaccination]] of the population against the [[2009 swine flu pandemic]]. In August 2010, [[Medical Products Agency (Sweden)|The Swedish Medical Products Agency (MPA)]] and [[National Institute for Health and Welfare (THL), Finland|The Finnish National Institute for Health and Welfare (THL)]] launched investigations regarding the development of [[narcolepsy]] as a possible side effect to Pandemrix flu vaccination in children,<ref name="lakemedelsverket.se">{{cite news |date=18 August 2010 |title=The MPA investigates reports of narcolepsy in patients vaccinated with Pandemrix |work=The Swedish Medical Products Agency |url=http://www.lakemedelsverket.se/english/All-news/NYHETER-2010/The-MPA-investigates-reports-of-narcolepsy-in-patients-vaccinated-with-Pandemrix/ |access-date=19 August 2010 |archive-date=17 February 2011 |archive-url=https://web.archive.org/web/20110217101203/http://www.lakemedelsverket.se/english/All-news/NYHETER-2010/The-MPA-investigates-reports-of-narcolepsy-in-patients-vaccinated-with-Pandemrix/ |url-status=live }}</ref> and found a 6.6-fold increased risk among children and youths, resulting in 3.6 additional cases of narcolepsy per 100,000 vaccinated subjects.<ref>[http://www.lakemedelsverket.se/english/All-news/NYHETER-2011/Report-from-an-epidemiological-study-in-Sweden-on-vaccination-with-Pandemrix-and-narcolepsy-/ Report from an epidemiological study in Sweden on vaccination with Pandemrix and narcolepsy] {{Webarchive|url=https://web.archive.org/web/20181215134007/https://lakemedelsverket.se/english/All-news/NYHETER-2011/Report-from-an-epidemiological-study-in-Sweden-on-vaccination-with-Pandemrix-and-narcolepsy-/ |date=15 December 2018 }}, Swedish medical product agency, 30 June 2011.</ref>

In February 2011, [[National Institute for Health and Welfare (THL), Finland|The Finnish National Institute for Health and Welfare (THL)]] concluded that there is a clear connection between the Pandemrix vaccination campaign of 2009 and 2010, and the narcolepsy epidemic in Finland. A total of 152 cases of narcolepsy were found in Finland during 2009–2010, and ninety per cent of them had received the Pandemrix vaccination.<ref>{{cite web |title=THL: Pandemrixilla ja narkolepsialla on selvä yhteys |url=http://www.mtv3.fi/uutiset/kotimaa.shtml/2011/02/1265779/thl-pandemrixilla-ja-narkolepsialla-on-selva-yhteys%7B%7Bfull%7D%7D |access-date=8 September 2018 |website=Mtv3.fi |archive-date=2 June 2020 |archive-url=https://web.archive.org/web/20200602231645/https://www.mtvuutiset.fi// |url-status=live }}</ref><ref>{{cite web |title=Terveyden ja hyvinvoinnin laitos - THL |url=http://www.thl.fi/en_US/web/en/pressrelease?id=24103 |url-status=dead |archive-url=https://web.archive.org/web/20120905230223/http://www.thl.fi/en_US/web/en/pressrelease?id=24103 |archive-date=5 September 2012 |access-date=8 September 2018 |website=Terveyden ja hyvinvoinnin laitos}}</ref><ref>{{cite web |title=Narkolepsia ja sikainfluenssarokote - THL |url=http://www.thl.fi/fi_FI/web/fi/rokotteet/narkolepsia_ja_sikainfluenssarokote |url-status=dead |archive-url=https://web.archive.org/web/20130517225553/http://www.thl.fi/fi_FI/web/fi/rokotteet/narkolepsia_ja_sikainfluenssarokote |archive-date=17 May 2013 |access-date=8 September 2018 |website=Terveyden ja hyvinvoinnin laitos}}</ref> Sweden however observed very few influenza cases totally in 2009 and especially 2010 as compared to most other years.<ref>{{cite web |title=Statistikdatabas för dödsorsaker (den öppna delen av dödsorsaksregistret) |url=https://sdb.socialstyrelsen.se/if_dor/val.aspx |publisher=Socialstyrelsen |access-date=24 March 2020 |language=sv |archive-date=13 February 2021 |archive-url=https://web.archive.org/web/20210213123151/https://sdb.socialstyrelsen.se/if_dor/val.aspx |url-status=live }}, diagnoskod J09, J10 och J11</ref> In 2015, it was reported that the British [[Department of Health (United Kingdom)|Department of Health]] was paying for [[Sodium oxybate]] medication for 80 patients who are taking legal action over problems linked to the use of the swine flu vaccine, at a cost to the government of £12,000 per patient per year.<ref>{{cite news |last=Lintern |first=Shaun |date=20 July 2015 |title=DH funds private prescriptions for drug denied to NHS patients |publisher=Health Service Journal |url=http://www.hsj.co.uk/5087926.article?WT.tsrc=email&WT.mc_id=Newsletter2 |url-status=live |access-date=20 July 2015 |archive-url=https://web.archive.org/web/20210225070637/https://www.hsj.co.uk/home/exclusive-dh-funds-private-prescriptions-for-drug-denied-to-nhs-patients/5087926.article?WT.tsrc=email&WT.mc_id=Newsletter2 |archive-date=25 February 2021}}</ref>

===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/>

===Bribery in China===
{{main|GSK China Scandal}}
In 2013, Chinese authorities announced that, since 2007, GSK had funnelled HK$3.8{{nbsp}}billion in kickbacks to GSK managers, doctors, hospitals and others who prescribed their drugs, using over 700 travel agencies and consulting firms.<ref>{{cite web |author1=Alice Yan |author2=Toh Han Shih |url=http://www.scmp.com/news/china/article/1283207/glaxosmithkline-suspects-drug-bribery-probe-identified |title=Shanghai travel agent's revenue surge led to arrests in GSK bribery case |work=South China Morning Post |date=16 July 2013 |access-date=17 July 2013 |archive-date=19 November 2017 |archive-url=https://web.archive.org/web/20171119050535/http://www.scmp.com/news/china/article/1283207/glaxosmithkline-suspects-drug-bribery-probe-identified |url-status=live }}<br />
{{cite news |url=https://www.bbc.co.uk/news/business-23265958 |title=GlaxoSmithKline executives face China bribery probe |work=BBC News |date=11 July 2013 |access-date=20 June 2018 |archive-date=11 February 2021 |archive-url=https://web.archive.org/web/20210211035141/https://www.bbc.co.uk/news/business-23265958 |url-status=live }}</ref> Chinese authorities arrested four GSK executives as part of a four-month investigation into claims that doctors were bribed with cash and sexual favours.<ref>Rupert Neate and Angela Monaghan, [https://www.theguardian.com/business/2013/jul/22/glaxosmithkline-admits-bribery-china "GlaxoSmithKline admits some staff in China involved in bribery"] {{Webarchive|url=https://web.archive.org/web/20160916165857/https://www.theguardian.com/business/2013/jul/22/glaxosmithkline-admits-bribery-china |date=16 September 2016 }}, ''[[The Guardian]]'', 22 July 2013.{{pb}}
Rupert Neate, [https://www.theguardian.com/business/2013/jul/24/gsk-china-crisis-ceo-andrew-witty-live "GSK's China crisis: chief executive Andrew Witty speaks - as it happened"] {{Webarchive|url=https://web.archive.org/web/20160811212236/https://www.theguardian.com/business/2013/jul/24/gsk-china-crisis-ceo-andrew-witty-live |date=11 August 2016 }}, ''[[The Guardian]]'', 24 July 2013.{{pb}}
{{cite news |last=Philips |first=Tom |url=https://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/10204304/Chinese-police-allege-Glaxo-sales-reps-trained-to-offer-sexual-bribes.html |archive-url=https://ghostarchive.org/archive/20220111/https://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/10204304/Chinese-police-allege-Glaxo-sales-reps-trained-to-offer-sexual-bribes.html |archive-date=11 January 2022 |url-access=subscription |url-status=live |title=Chinese police allege Glaxo sales reps trained to offer sexual bribes |work=The Daily Telegraph |date=26 July 2013}}{{cbignore}}</ref> In 2014, a Chinese court found the company guilty of bribery and imposed a fine of US$490{{nbsp}}million. Mark Reilly, the British head of GSK's Chinese operations, received a three-year suspended prison sentence after a one-day trial held in secret.<ref>{{cite news |last1=Bradsher |first1=Keith |last2=Buckley |first2=Chris |date=19 September 2014 |title=China Fines GlaxoSmithKline Nearly $500 Million in Bribery Case |work=[[The New York Times]] |url=https://www.nytimes.com/2014/09/20/business/international/gsk-china-fines.html |url-status=live |archive-url=https://web.archive.org/web/20230408024838/https://www.nytimes.com/2014/09/20/business/international/gsk-china-fines.html |archive-date=8 April 2023}}</ref> Reilly was reportedly deported from China and dismissed by the company.<ref>{{Cite web |last1=Moore |first1=Malcolm |last2=Roland |first2=Denise |date=19 September 2014 |title=China fines Glaxo £297m for bribery, Mark Reilly sentenced |url=https://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/11108376/China-fines-Glaxo-297m-for-bribery-Mark-Reilly-sentenced.html |url-status=live |archive-url=https://web.archive.org/web/20230404113212/https://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/11108376/China-fines-Glaxo-297m-for-bribery-Mark-Reilly-sentenced.html |archive-date=4 April 2023 |access-date=11 September 2023 |website=The Telegraph |language=en}}</ref>

===Market manipulation in the UK===
In February 2016, the company was fined over £37{{nbsp}}million in the UK by the [[Competition and Markets Authority]] for paying Generics UK, [[Alpharma]] and [[Norton Healthcare]] more than £50m between 2001, and 2004, to keep generic varieties of [[paroxetine]] out of the UK market. The generics companies were fined a further £8{{nbsp}}million. At the end of 2003, when generics became available in the UK, the price of paroxetine dropped by 70 per cent.<ref>{{cite news |title=Watchdog fines GSK £37m for paying to keep generic drugs out of UK market |last=Bradshaw |first=Julia |url=https://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/12153450/Watchdog-fines-GSK-37m-for-paying-to-keep-generic-drugs-out-of-UK-market.html |archive-url=https://ghostarchive.org/archive/20220111/https://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/12153450/Watchdog-fines-GSK-37m-for-paying-to-keep-generic-drugs-out-of-UK-market.html |archive-date=11 January 2022 |url-access=subscription |url-status=live |work=The Daily Telegraph |date=12 February 2016}}{{cbignore}}</ref>

===Miscellaneous===
Italian police sought bribery charges in May 2004, against 4,400 doctors and 273 GSK employees. GSK and its predecessor were accused of having spent £152m on physicians, pharmacists and others, giving them cameras, computers, holidays and cash. Doctors were alleged to have received cash based on the number of patients they treated with a cancer drug, [[topotecan]] (Hycamtin).<ref>{{Cite web |last1=Hooper |first1=John |last2=Stewart |first2=Heather |date=27 May 2004 |title=Over 4,000 doctors face charges in Italian drugs scandal |url=http://www.theguardian.com/world/2004/may/27/italy.heatherstewart |access-date=31 August 2022 |website=The Guardian |language=en |archive-date=31 August 2022 |archive-url=https://web.archive.org/web/20220831183705/https://www.theguardian.com/world/2004/may/27/italy.heatherstewart |url-status=live }}</ref> The following month prosecutors in Munich accused 70–100 doctors of having accepted bribes from SmithKline Beecham between 1997 and 1999. The inquiry was opened over allegations that the company had given over 4,000 hospital doctors money and free trips.<ref>{{cite journal |pmc=420312 |year=2004 |last1=Burgermeister |first1=J. |title=German prosecutors probe again into bribes by drug companies |journal=BMJ |volume=328 |issue=7452 |page=1333 |doi=10.1136/bmj.328.7452.1333-a |pmid=15178593}}</ref><ref>{{Cite news |date=12 March 2002 |title=Glaxo probed over doctor freebies |language=en-GB |work=BBC News |url=http://news.bbc.co.uk/2/hi/business/1869162.stm |access-date=31 August 2022 |archive-date=17 October 2015 |archive-url=https://web.archive.org/web/20151017042412/http://www.ncbi.nlm.nih.gov/pmc/articles/PMC420312/pdf/bmj3281333a.pdf |url-status=live }}</ref> All charges were dismissed by the Verona court in January 2009.<ref>{{cite web |url=https://www.gsk.com/media/2684/annual-report-2008.pdf |title=GlaxoSmithKline Annual Report 2008 |page=177 |access-date=8 October 2015 |archive-date=26 November 2017 |archive-url=https://web.archive.org/web/20171126032619/http://www.gsk.com/media/2684/annual-report-2008.pdf |url-status=live }}</ref>

In 2006, in the United States GSK settled the largest tax dispute in IRS history, agreeing to pay US$3.1&nbsp;billion. At issue were Zantac and other products sold in 1989 to 2005. The case revolved around intracompany [[transfer pricing]]—determining the share of profit attributable to the US subsidiaries of GSK and subject to tax by the IRS.<ref>[https://www.nytimes.com/2006/09/12/business/worldbusiness/12glaxo.html "GlaxoSmithKline to Settle Tax Dispute With U.S."] {{Webarchive|url=https://web.archive.org/web/20170329043037/http://www.nytimes.com/2006/09/12/business/worldbusiness/12glaxo.html |date=29 March 2017 }}, Reuters, 12 September 2006</ref><ref>[https://www.irs.gov/uac/IRS-Accepts-Settlement-Offer-in-Largest-Transfer-Pricing-Dispute "IRS Accepts Settlement Offer in Largest Transfer Pricing Dispute"] {{Webarchive|url=https://web.archive.org/web/20201113224040/https://www.nytimes.com/2006/09/12/business/worldbusiness/12glaxo.html |date=13 November 2020 }}, IRS, 11 September 2006.</ref>

The UK's [[Serious Fraud Office (United Kingdom)|Serious Fraud Office]] (SFO) opened a criminal inquiry in 2014 into GSK's sales practices, using powers granted by the [[Bribery Act 2010]].<ref>{{Cite news |url=https://www.theguardian.com/business/2014/may/28/serious-fraud-office-investigates-glaxosmithkline |title=GlaxoSmithKline faces criminal investigation by Serious Fraud Office |last=Kollewe |first=Julia |work=The Guardian |date=28 May 2014 |access-date=11 December 2016 |archive-date=5 December 2020 |archive-url=https://web.archive.org/web/20201205172034/https://www.theguardian.com/business/2014/may/28/serious-fraud-office-investigates-glaxosmithkline |url-status=live }}</ref> The SFO said it was collaborating with Chinese authorities to investigate bringing charges in the UK related to GSK's activities in China, Europe and the Middle East.<ref>{{Cite news |last=Ridley |first=Kirstin |date=23 July 2014 |title=UK fraud office liaising with China on GSK bribery case |language=en |work=Reuters |url=https://www.reuters.com/article/us-britain-fraud-sfo-gsk-idUSKBN0FS1U320140723 |access-date=31 August 2022 |archive-date=21 February 2022 |archive-url=https://web.archive.org/web/20220221193748/https://www.reuters.com/article/us-britain-fraud-sfo-gsk-idUSKBN0FS1U320140723 |url-status=live }}</ref> Also {{as of|2014|lc=yes}}, the US Department of Justice was investigating GSK with reference to the [[Foreign Corrupt Practices Act]].<ref>{{Cite news |date=12 August 2014 |title=GlaxoSmithKline faces bribery claims in Syria |work=The Telegraph |agency=Reuters |url=https://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/11027538/Serious-Fraud-Office-opens-criminal-investigation-into-GlaxoSmithKline.html |url-access=subscription |access-date=31 August 2022 |archive-date=18 June 2018 |archive-url=https://web.archive.org/web/20180618013944/https://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/11027538/Serious-Fraud-Office-opens-criminal-investigation-into-GlaxoSmithKline.html |url-status=live }}</ref>

In October 2020, GSK told some staff that while at work they should disable the contact tracing function of the NHS test-and-trace app which monitors the spread of COVID-19. GSK explained the reason for this was due to social distancing measures in place at their sites rendering the technology unnecessary.<ref>{{cite news |url=https://www.theguardian.com/business/2020/oct/06/gsk-tells-staff-turn-off-covid-test-trace-app-work |title=GSK tells UK staff: turn off Covid test-and-trace app while at work |website=[[TheGuardian.com]] |date=6 October 2020 |access-date=6 October 2020 |last=Davies |first=Rob |archive-date=3 February 2021 |archive-url=https://web.archive.org/web/20210203105828/https://www.theguardian.com/business/2020/oct/06/gsk-tells-staff-turn-off-covid-test-trace-app-work |url-status=live }}</ref>

In November 2023, GSK filed a lawsuit against Moderna Inc. in U.S. federal court in Delaware, accusing the company of violating GSK's patents related to messenger RNA (mRNA) technology. The lawsuit claims that Moderna's COVID-19 vaccine Spikevax and RSV vaccine mResvia infringe on several of GSK's patents, particularly those related to lipid nanoparticles used for delivering mRNA into the human body.<ref name=":2">{{Cite web |title=GSK Sues Pfizer, Pharmacia & Upjohn & BioNTech for Infringing mRNA Vaccine Patents {{!}} Insights & Resources {{!}} Goodwin |url=https://www.goodwinlaw.com/en/insights/blogs/2024/04/gsk-sues-pfizer-pharmacia--upjohn--biontech-for-infringing-mrna-vaccine-patents |access-date=2024-11-08 |website=www.goodwinlaw.com |language=en}}</ref> This legal action follows a similar lawsuit GSK filed against Pfizer and BioNTech earlier in 2024, also over patent infringement concerning their mRNA-based COVID-19 vaccine. The current litigation seeks unspecified monetary damages from Moderna.<ref name=":2" />

=== Operation in Russia ===
Following Russia's invasion of Ukraine in 2022, GlaxoSmithKline (GSK) was criticized for continuing its operations in Russia, despite the ongoing conflict and international sanctions. Although GSK suspended clinical trials, advertising, and promotion in Russia, the company has maintained its supply of essential medicines, vaccines, and medical equipment, with proceeds reportedly directed towards humanitarian aid. Critics argue that GSK's decision to continue exporting products—resulting in increased sales and profit volumes in 2022 compared to 2021—undermines the intended impact of sanctions, raising ethical concerns.<ref>{{Cite web |last=Dunn |first=Catherine |date=2022-03-11 |title=U.S. pharma companies are staying in Russia as other industries exit |url=https://www.inquirer.com/business/big-pharma-russia-ukraine-merck-johnson-and-johnson-pfizer-gsk-20220311.html |access-date=2024-12-05 |website=www.inquirer.com |language=en}}</ref><ref>{{cite news |date=2022-03-17 |title=GSK to supply essential medicines in Russia, halts clinical trials |url=https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-supply-essential-medicines-russia-halts-clinical-trials-2022-03-17/ |access-date=2024-12-05 |publisher=Reuters}}</ref><ref>{{Cite news |last=Kollewe |first=Julia |date=2022-03-17 |title=GlaxoSmithKline says it will not start any new clinical trials in Russia |url=https://www.theguardian.com/business/2022/mar/17/glaxosmithkline-says-it-will-not-start-any-new-clinical-trials-in-russia |access-date=2024-12-05 |work=The Guardian |language=en-GB |issn=0261-3077}}</ref>