Editing GSK plc (section)

====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/>}}