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GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical company headquartered in Brentford, London. It was the world's sixth-largest pharmaceutical company in 2014, after Pfizer, Novartis, Sanofi, Hoffmann-La Roche and Merck. The company was established in 2000 by the merger of Glaxo Wellcome (formed from Glaxo's 1995 acquisition of Burroughs Wellcome) and SmithKline Beecham (from the 1989 merger of Beecham Group and SmithKline Beckman Corporation).

The company has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. As of 2 May 2014 it had a market capitalisation of £79 billion, the fourth-largest of any company listed on the London Stock Exchange. It has a secondary listing on the New York Stock Exchange. Andrew Witty has been the chief executive officer since May 2008.

GSK has a portfolio of products for major disease areas such as asthma, cancer, infections, mental health, diabetes and digestive conditions. Its drugs and vaccines earned £21.3 billion in 2013; its top-selling products that year were Advair, Avodart, Flovent, Augmentin, Lovaza and Lamictal. The company applied for regulatory approval in 2014 for the first malaria vaccine, RTS,S, which it plans to make available for five percent above cost. GSK's consumer healthcare products, which earned £5.2 billion in 2013, include Sensodyne and Aquafresh toothpaste, the malted-milk drink Horlicks, Abreva for cold sores, Breathe Right nasal strips, Nicoderm and Nicorette nicotine replacements, and Night Nurse, a cold remedy.

In 2012 GSK pleaded guilty to criminal charges in the United States, and agreed to pay a $3 billion (£1.9bn) settlement, including a criminal fine of $1 billion. It was the largest health-care fraud case to date in that country and the largest settlement by a drug company. The charges related to GSK's promotion of drugs for unapproved uses, including the anti-depressants Paxil and Wellbutrin, failure to report safety data about the diabetes drug Avandia, reporting false prices to Medicaid, and kickbacks to physicians. The company announced in 2013 that it would no longer pay physicians to promote its drugs or attend medical conferences, and would abolish prescription targets for its sales staff.

History

Glaxo Wellcome

Glaxo was founded in the 1850s as a general trading company in Bunnythorpe, New Zealand, by a Londoner, Joseph Nathan. In 1904 it began producing dried-milk baby food, first known as Defiance, then as Glaxo, under the slogan "Glaxo builds bonny babies". The Glaxo Laboratories sign is still visible (right) on what is now a car repair shop on the main street of Bunnythorpe.

Glaxo Laboratories opened new units in London in 1935. The company bought two companies, Joseph Nathan and Allen & Hanburys in 1947 and 1958 respectively. After the company bought Meyer Laboratories in 1978, it began to play an important role in the US market. In 1983 the American arm, Glaxo Inc., moved to Research Triangle Park (US headquarters/research) and Zebulon (US manufacturing) in North Carolina.

Burroughs Wellcome & Company was founded in 1880 in London by the American pharmacists Henry Wellcome and Silas Burroughs. The Wellcome Tropical Research Laboratories opened in 1902. In 1959 the Wellcome Company bought Cooper, McDougall & Robertson Inc. to become more active in animal health. Glaxo and Burroughs Wellcome merged in 1995 to form Glaxo Wellcome. Glaxo restructured its R&D operation that year, cutting 10,000 jobs worldwide, closing its R&D facility in Beckenham, Kent, and opening a Medicines Research Centre in Stevenage, Hertfordshire. Also that year, Glaxo Wellcome acquired the California-based Affymax, a leader in the field of combinatorial chemistry.

By 1999 Glaxo Wellcome had become the world's third-largest pharmaceutical company by revenues (behind Novartis and Merck), with a global market share of around 4 per cent. Its products included Imigran (for the treatment of migraine), salbutamol (Ventolin) (for the treatment of asthma), Zovirax (for the treatment of coldsores), and Retrovir and Epivir (for the treatment of AIDS). In 1999 the company was the world's largest manufacturer of drugs for the treatment of asthma and HIV/AIDS. It employed 59,000 people, including 13,400 in the UK, had 76 operating companies and 50 manufacturing facilities worldwide, and seven of its products were among the world's top 50 best-selling pharmaceuticals. The company had R&D facilities in Hertfordshire, Kent and London, and manufacturing plants in Scotland and the north of England. It had R&D centres in the US and Japan, and production facilities in the US, Europe and the Far East.

SmithKline Beecham

In 1843 Thomas Beecham launched his Beecham's Pills laxative in England, giving birth to the Beecham Group. Beecham opened its first factory in St Helens, Lancashire, England, for rapid production of medicines in 1859. By the 1960s Beecham was extensively involved in pharmaceuticals.

In 1830 John K. Smith opened its first pharmacy in Philadelphia. In 1865 Mahlon Kline joined the business, which 10 years later became Smith, Kline & Co. In 1891 it merged with French, Richard and Company, and in 1929 changed its name to Smith Kline & French Laboratories as it focused more on research. Years later it bought Norden Laboratories, a business doing research into animal health, and Recherche et Industrie Thérapeutiques in Belgium in 1963 to focus on vaccines. The company began to expand globally, buying seven laboratories in Canada and the US in 1969, and in 1982 bought Allergan, a manufacturer of eye and skincare products.

SmithKline & French merged with Beckman Inc. in 1982 and changed its name to SmithKline Beckman. In 1988 it bought its biggest competitor, International Clinical Laboratories, and in 1989 merged with Beecham to form SmithKline Beecham plc. The headquarters moved from the US to England. To expand R&D in the US, the company bought a new research center in 1995; another opened in 1997 at New Frontiers Science Park, Harlow, England.

GlaxoSmithKline

Glaxo Wellcome and SmithKline Beecham announced their intention to merge in January 2000. The merger was completed in December that year, forming GlaxoSmithKline (GSK). The company's global headquarters are at GSK House, Brentford, London, officially opened in 2002 by then-Prime Minister Tony Blair. The building was erected at a cost of £300 million, and as of 2002 was home to 3,000 administrative staff. Andrew Witty took over as CEO in May 2008. Witty joined Glaxo in 1985, and had been president of GSK's Pharmaceuticals Europe since 2003. Chris Gent, former CEO of Vodaphone, has been the chair since January 2005. Philip Hampton, chair of the Royal Bank of Scotland, will replace Gent in September 2015.

Facilities

Template:GSKsidebar As of 2013 GSK had offices in over 115 countries and employed over 99,000 people, 12,500 in R&D. The company's single largest market is the United States. Its US headquarters are in The Navy Yard, Philadelphia, and Research Triangle Park, North Carolina; its consumer-products division is in Moonship Town, PA. Company facilities include:

• R&D sites: England (Stevenage, Stockley Park, Ware), the US (Research Triangle Park, North Carolina, and Collegeville, Pennsylvania), Canada, China, Croatia, France and India. GSK is also planning to open a R&D centre in partnership with McLaren Technology Group at the McLaren Technology Campus.

• Centres for biopharmaceutical products: the US (Marietta, Pennsylvania, and Hamilton, Montana), Belgium, Canada, Germany and Hungary.

• Manufacturing sites for prescription products: (Scotland (Irvine and Montrose), England (Ware, Barnard Castle, Worthing and Ulverston), Ireland (Cork), the US (Bristol, Tennessee; King of Prussia, Pennsylvania; Zebulon, North Carolina]), as well as Australia, Belgium, France, Italy, Malaysia, Poland, Puerto Rico, Romania and Singapore.

• Manufacturing sites for consumer products: England (Maidenhead), Ireland (Dungarvan), the US (Aiken, South Carolina; Oak Hill, New York; St. Louis, Missouri), Brazil, Canada and Kenya.

Products

GSK manufactures products for major disease areas such as asthma, cancer, infections, diabetes and mental health. Its biggest-selling in 2013 were Advair, Avodart, Flovent, Augmentin, Lovaza, and Lamictal; its drugs and vaccines earned £21.3 billion that year. Other top-selling products include its asthma/COPD inhalers Advair, Ventolin, and Flovent; its diphtheria/tetanus/pertussis vaccine Infanrix and its hepatitis B vaccine; the epilepsy drug Lamicatal; the antihyperlipemia drug Lovaza; and the antibacterial Augmentin.

Medicines historically discovered or developed at GSK and its legacy companies and now sold as generics include amoxicillin and amoxicillin-clavulanate, ticarcillin-clavulanate, mupirocin, and ceftazidime for bacterial infections, zidovudine for HIV infection, valacyclovir for herpes virus infections, albendazole for parasitic infections, sumatriptan for migraine, lamotrigine for epilepsy, bupropion and paroxetine for major depressive disorder, and cimetidine and ranitidine for gastroesophageal reflux disorder. Among these, amoxicillin, amoxicillin-clavulanate, mupriocin, zidovudine, albendazole, and ranitidine are listed on the World Health Organization's list of essential medications.

GSK's consumer healthcare division, which earned £5.2 billion in 2013, sells oral healthcare, including Aquafresh, Maclean's and Sensodyne toothpastes; and drinks such as Horlicks, Boost, a chocolate-flavoured malt drink sold in India, and formerly Lucozade and Ribena, sold in 2013 to Suntory for £1.35bn. Other products include Abreva to treat cold sores; Night Nurse, a cold remedy; Breathe Right nasal strips; and Nicoderm and Nicorette nicotine replacements.

Operations and acquisitions

2001–2010

GSK completed the acquisition of New Jersey-based Block Drug in 2001 for US$1.24 billion. In 2006 GSK acquired the US-based consumer healthcare company CNS Inc., whose products included Breathe Right nasal strips and FiberChoice dietary supplements, for US$566 million in cash. GSK opened its first R&D centre in China in 2007, in Shanghai, initially focused on neurodegenerative diseases.

In 2009 GSK acquired Stiefel Laboratories, then the world's largest independent dermatology drug company , for US$3.6bn. In November the FDA approved GSK's vaccine for 2009 H1N1 influenza protection, manufactured by the company's ID Biomedical Corp in Canada. Also in November 2009 GSK formed a joint venture with Pfizer to create ViiV Healthcare, which specializes in HIV research. In 2010 the company acquired Laboratorios Phoenix, an Argentine pharmaceutical company, for US$253m, and the UK-based sports nutrition company Maxinutrition for £162 million (US$256 million).

2011–present

In 2011, in a $660-million deal, Prestige Brands Holdings took over 17 GSK brands with sales of $210 million, including BC Powder, Beano, Ecotrin, Fiber Choice, Goody's Powder, Sominex and Tagamet. In 2012 the company announced that it would invest £500 million in manufacturing facilities in Ulverston, northern England, designating it as the site for a previously announced biotech plant. In May that year it acquired CellZome, a German biotech company, for US$98 million, and in June worldwide rights to alitretinoin (Toctino), an eczema drug, for $302 million. In 2013 GSK acquired Human Genome Sciences (HGS) for $3 billion; the companies had collaborated on developing the lupus drug Belimumab (Benlysta), albiglutide for type 2 diabetes, and darapladib for atherosclerosis.

In 2014 GSK paid $1 billion to raise its stake in its Indian pharmaceutical unit, GlaxoSmithKline Pharmaceuticals, to 75 percent as part of a move to focus on emerging markets. Also that month it recalled Alli, an over-the-counter weight-loss drug, in the US and Puerto Rico because of possible tampering, following customer complaints. In April Novartis and Glaxo agreed on more than $20 billion in deals, with Novartis selling its vaccine business to GSK and buying GSK's cancer business. In February 2015 GSK announced that it would acquire GlycoVaxyn, a Swiss pharmaceutical company, for $190 million.

Political activity, philanthropy

Corporate social responsibility

Since 2010 GlaxoSmithKline has several times ranked first among pharmaceutical companies on the Global Access to Medicines Index, which is funded by the Bill and Melinda Gates Foundation. In 2014 the Human Rights Campaign, an LGBT-rights advocacy group gave GSK a score of 100% in its Corporate Equality Index.

GSK has been active, with the World Health Organization (WHO), in the Global Alliance to Eliminate Lymphatic Filariasis (GAELF). Around 120 million people globally are believed to be infected with lymphatic filariasis. In 2012 the company endorsed the London Declaration on Neglected Tropical Diseases, a collaborative disease eradication programme. Under this agreement GSK committed to donating 400 million albendazole tablets to the WHO each year to fight soil-transmitted helminthiasis, and to continue to provide 600 million albendazole tablets every year for lymphatic filariasis until the disease is eradicated.

In 2009 the company said it would cut drug prices by 25 percent in 50 of the poorest nations, release intellectual property rights for substances and processes relevant to neglected disease into a patent pool to encourage new drug development, and invest 20 percent of profits from the least-developed countries in medical infrastructure for those countries. Médecins Sans Frontières welcomed the decision, but criticized GSK for failing to include HIV patents in its patent pool, and for not including middle-income countries in the initiative.

In 2013 GSK joined AllTrials, a British campaign to ensure that all clinical trials are registered and the results reported. The company said it would make its past clinical-trial reports available and future ones within a year of the studies' end.

Malaria vaccine development

In 2014 GSK applied for regulatory approval for the first malaria vaccine. Known as RTS,S, the vaccine was developed as a joint project with the PATH vaccines initiative and the Bill and Melinda Gates Foundation. The company has committed to making the vaccine available in developing countries for five percent above the cost of production. Malaria is responsible for over 650,000 deaths per year, mainly in Africa. As of 2013 RTS,S, which uses GSK's proprietary AS01 adjuvant, was being examined in a Phase 3 trial in eight African countries. PATH reported that "n the 12-month period following vaccination, RTS,S conferred approximately 50% protection from clinical Plasmodium falciparum disease in children aged 5-17 months, and approximately 30% protection in children aged 6-12 weeks when administered in conjunction with Expanded Program for Immunization (EPI) vaccines." In 2014 Glaxo said it had spent more than $350 million, and expected to spend an additional $260 million before seeking regulatory approval.

Lobbying, political donations

In 2013 GlaxoSmithKline spent between €600,000 and €650,000 lobbying European Union institutions and $3,720,000 on federal lobbying activities in the United States. Additional indirect expenditures were made through membership in national and international trade organizations. The company does not directly contribute to the political candidates, but in 2013 U.S. members of the GSK employee political action committee contributed $484,810 to political campaigns in the United States. Approximately 60% of this amount was donated to Republican candidates and 40% to Democrats.

2012 criminal and civil settlement

Overview

In July 2012 GSK pleaded guilty in the United States to criminal charges, and agreed to pay $3 billion, in what was the largest settlement until then between the Justice Department and a drug company. The $3 billion included a criminal fine of $956,814,400 and forfeiture of $43,185,600. The remaining $2 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.

The charges stemmed from GSK's promotion of the anti-depressants Paxil (paroxetine) and Wellbutrin (bupropion) for unapproved uses from 1998–2003, 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).

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 ghostwritten by the company and placed by physicians in medical journals. The company set up a ghostwriting programme called CASPPER, initially to produce articles about Paxil but which was extended to cover Avandia.

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. 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.

Rosiglitazone (Avandia)

The 2012 settlement included a criminal fine of $242,612,800 for failing to report safety data to the FDA about Avandia (rosiglitazone), a diabetes drug approved in 1999, and a civil settlement of $657 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.

In 1999 John Buse, a diabetes specialist, told medical conferences that rosiglitazone might carry an increased risk of cardiovascular problems. GSK persuaded Buse to sign a retraction, after threatening to sue him and calling his university department head. A congressional inquiry reported that GSK had raised questions internally about the drug's safety in 2000, and that in 2002 the company ghostwrote an article in Circulation describing a GSK-funded clinical trial that suggested rosiglitazone might have a beneficial effect on cardiovascular risk. From 2001 reports began to link the thiazolidinediones (the class of drugs to which rosiglitazone belongs) to heart failure. In April that year GSK began a six-year, open-label, randomized trial, known as RECORD, to examine rosiglitazone and cardiovascular events. Two GSK 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 billion.

In 2007 a meta-analysis by Steven Nissen and Kathy Wolski, published in June in the New England Journal of Medicine, associated the drug with a significant increase in the risk of heart attack. GSK reportedly tried to persuade Nissen not to publish, after receiving an advance copy from one of the journal's peer reviewers, a GSK consultant. In July 2007 FDA scientists suggested that rosiglitazone had caused 83,000 excess heart attacks between 1999 and 2007. The FDA placed restrictions on the drug, including adding a boxed warning about heart attacks, but did not withdraw it. (In 2013 the FDA rejected that the drug had caused excess heart attacks.) A two-year inquiry by the Senate Finance Committee concluded in January 2010 that GSK had sought to intimidate several scientists who had concerns about rosiglitazone. In February that year the company tried to halt publication of an editorial about the controversy by Nissen in the European Heart Journal.

The final results of GSK's RECORD trial were published in June 2009. The study 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." Nissen and Wolksi criticized the trial's open-label design and argued that its low event rates reduced its statistical power. In September 2009 rosiglitazone was suspended in Europe. The results of the RECORD study were confirmed in 2013 by the Duke Clinical Research Institute, in an independent review required by the FDA. In November that year the FDA lifted the restrictions it had placed on the drug. The boxed warning about heart attack was removed; the warning about heart failure remained in place.

Paroxetine (Paxil/Seroxat), bupropion (Wellbutrin)

GSK paid a criminal fine and forfeiture of $757,387,200 for misbranding Paxil/Seroxat (paroxetine), an SSRI anti-depressant released by GSK in 1992, and Wellbutrin (bupropion), an anti-depressant also used as a smoking-cessation aid, Zyban.

The company promoted Wellbutrin, approved at the time for major depressive disorder, 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.

Paxil had $4.97 billion worldwide sales in 2003. From 2004 its 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. The company conducted nine trials between 1994 and 2002, none of which showed that Paxil helped children with depression. From 1998 to 2003 GSK promoted Paxil for the under-18s, paying for promotional speakers, spas, lunches and dinners.

The company withheld data from clinical trials, and prepared an article that misreported the results of a trial, according to the Justice Department. Known as study 329, the article – which has not been retracted – was published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry; it listed 20 authors but had been ghostwritten by GSK. The article concluded that Paxil was "generally well tolerated and effective for major depression in adolescents," although 11 subjects on Paxil, against two on placebo, had experienced serious adverse events during the trial, including emotional lability, suicidal ideation, and behavioral problems. The data behind the article came to light in 2004 during a class-action suit. 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 efficacy had not been demonstrated, as this would undermine the profile of paroxetine." The suppression of the research findings and the legal discovery process that uncovered it is the subject of Side Effects (2008) by Alison Bass.

For 10 years GSK marketed Paxil as non-habit forming. In 2001 35 patients filed a class-action suit alleging they had suffered withdrawal symptoms, and in 2002 a Los Angeles court issued an injunction preventing GSK from advertising that the drug was not habit forming. The court subsequently withdrew the injunction after the FDA directly, and through an amicus brief filed by the Department of Justice, objected that the court had no jurisdiction over drug marketing that the FDA had approved. 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. The committee "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."

Other controversies

Ribena

There were concerns throughout 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 blackcurrant syrup was distributed to children there as a source of vitamin C during World War II, which gave Ribena a reputation with customers in the UK and Commonwealth as good for health. Beecham bought H.W. Carter in 1955.

In 2001 the British Advertising Standards Authority (ASA) required GSK to withdraw its claim that Ribena Toothkind, a syrup with less sugar than regular Ribena, 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. In 2007 GSK pleaded guilty to 15 charges in New Zealand over its claim that ready-to-drink Ribena, sold already diluted in cartons, contained high levels of vitamin C. The country's Commerce Commission found that it contained no detectable vitamin C, and the company was fined $217,000. In 2013 GSK sold Ribena and Lucozade, another drink, to the Japanese multinational Suntory for £1.35 billion.

SB Pharmco Puerto Rico

In 2010 the US Department of Justice announced that GSK would pay a $150 million criminal fine and forfeiture, and a civil settlement of $600 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 $5.5 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. GSK closed the factory in 2009.

According to the New York Times, 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 authorized; she was fired in 2003 and filed a whistleblower lawsuit. In 2005 federal marshals seized $2 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 $150 million in a criminal fine and forfeiture, at that time the largest such payment ever by a manufacturer of adulterated drugs, and $600 million in civil penalties to settle the civil lawsuit.

China

In 2013 Chinese authorities announced that GSK had funnelled HK$3.8 billion since 2007 in kickbacks to GSK managers, doctors, hospitals and others who prescribed their drugs, using over 700 travel agencies and consulting firms. Chinese authorities arrested four GSK executives as part of a four-month investigation into claims that doctors were bribed with cash and sexual favours. In 2014 a Chinese court found the company guilty of bribery, imposed a fine of $490 million, and gave Mark Reilly, the British head of GSK's Chinese operations, a three-year suspended prison sentence. Reilly was reportedly deported from China and dismissed by the company.

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). 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.

In 2006 in the United States GSK settled the largest tax dispute in IRS history, agreeing to pay $3.1 billion. At issue were Zantac and other products sold in 1989–2005. 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.

The UK's Serious Fraud Office (SFO) opened a criminal inquiry in 2014 into GSK's sales practices, using powers granted by the Bribery Act 2010. 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. Also as of 2014 the US Department of Justice was investigating GSK with reference to the Foreign Corrupt Practices Act.

See also

• Recherche et Industrie Thérapeutiques (R.I.T.)
• "Drug industry document archive", University of California, San Francisco.

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44. "GSK confirms 500 mln stg UK investment plans", Reuters, 22 March 2012.
45. European Biotechnology News 16 May 2012. GSK acquires Cellzome 100%: Britain's largest drugmaker GlaxoSmithKline will pay about €75m in cash to acquire Cellzome AG completely; John Carroll for FierceBiotech 15 May 2012 GSK snags proteomics platform tech in $98M Cellzome buyout
46. John Carroll for FiercePharma. 12 June 2012 GSK continues deal spree with $302M pact for Basilea eczema drug; Basilea Pharmaceutica Press Release. 11 June 2012 Basilea enters into global agreement with Stiefel, a GSK company, for Toctino® (alitretinoin)
47. Matthew Herper, "Three Lessons From GlaxoSmithKline's Purchase Of Human Genome Sciences", Forbes, 16 July 2012.
48. Hirschler, Ben (10 March 2014). "GSK pays $1 billion to lift Indian unit stake to 75 percent". Reuters. Retrieved 10 March 2014.
49. Aaron Smith for CNN Money, March 27, 2014 Alli weight-loss drug recalled for tampering
50. Chad Bray, David Jolly, "Novartis and Glaxo Agree to Trade $20 Billion in Assets", The New York Times', 22 April 2014.
51. Jonathan D. Rockoff, Jeanne Whalen, Marta Falconi, "Deal Flurry Shows Drug Makers' Swing Toward Specialization", The Wall Street Journal, 22 April 2014.
52. "GEN - News Highlights:GSK Acquires GlycoVaxyn for $190M". GEN.
53. "Access to medicine" (PDF).
54. Human Rights Campaign. Profle: Buyers Guide entry for GlaxoSmithKline. Accessed May 16, 2014
55. "Global alliance to eliminate Lymphatic Filariasis". Ifpma.org. Archived from the original on 27 December 2008.
56. "Private and Public Partners Unite to Combat 10 Neglected Tropical Diseases by 2020". Bill & Melinda Gates Foundation. 30 January 2012.

    "Research-based pharma pledges on neglected tropical diseases". The Pharma Letter. 31 January 2012.

57. Sarah Boseley, "Drug giant GlaxoSmithKline pledges cheap medicine for world's poor", The Guardian, 13 February 2009.
58. UNITAID 16 February 2009. UNITAID Statement on GSK Patent Pool For Neglected Diseases
59. Dr Tido von Schoen-Angerer, director of Médecins Sans Frontières' Campaign for Access to Essential Medicines. 16 February 2009. The Guardian: Letter in response to GSK's patent pool proposal
60. Ben Goldacre, Bad Pharma, Fourth Estate, 2013 , p. 387.
61. "Glaxo Files Its Entry in Race for a Malaria Vaccine". Wall Street Journal.
62. "Press release: Malaria vaccine candidate reduces disease over 18 months of follow-up in late-stage study of more than 15,000 infants and young children". PATH.
63. Birkett AJ et al. Malaria vaccine R&D in the Decade of Vaccines: breakthroughs, challenges and opportunities. Vaccine. 2013 Apr 18;31 Suppl 2:B233-43. PMID 23598488
64. "Malaria vaccine candidate reduces disease over 18 months of follow-up in late-stage study of more than 15,000 infants and young children, Malaria vaccine candidate reduces disease over 18 months of follow-up in late-stage study of more than 15,000 infants and young children | 2013 | Press releases | Media | GlaxoSmithKline".
65. Donald G. McNeil Jr (18 October 2011). "Glaxo's RTS, S Malaria Vaccine Shows Promise, Scientists Say". The New York Times.
66. "www.gsk.com" (PDF).
67. Max Baucus, Chuck Grassley, "Finance Committee Letter to the FDA Regarding Avandia", United States Senate Finance Committee, 12 July 2010.

    Jim Edwards, "Inside GSK's CASSPER Ghostwriting Program", CBS News, 21 August 2009.

68. "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data", United States Department of Justice, 2 July 2012: "The United States alleges that, between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA ... The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of (1) congestive heart failure, and (2) myocardial infarction (heart attack). GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine in the amount of $242,612,800 for its unlawful conduct concerning Avandia. ... In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile ... Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. ..."
69. "The Intimidation of Dr. John Buse and the Diabetes Drug Avandia", Committee on Finance, United States Senate, November 2007, pp. 2–4.
70. Max Baucus, Chuck Grassley, "Finance Committee Letter to the FDA Regarding Avandia", United States Senate Finance Committee, 12 July 2010; for internal concerns, p. 2 and attachment E, pp. 20–35; for ghostwriting, p. 3 and attachment H, pp. 58–109; for the ghostwriting, attachment I, p. 110ff; for cover letter to Circulation, attachment I, p. 143; for the ghostwritten article, attachment I, pp. 152–158.

    Steven M. Haffner, et al, "Effect of Rosiglitazone Treatment on Nontraditional Markers of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus," Circulation, 106(6), 6 August 2002, pp. 679–684. PMID 12163427 doi:10.1161/01.CIR.0000025403.20953.23

71. ^ Steven E. Nissen, "The rise and fall of rosiglitazone," European Heart Journal, 31(7), April 2010, pp. 773–776; see table 1 for timeline. PMID 20154334 doi:10.1093/eurheartj/ehq016
72. ^ Philip D. Home, et al, "Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial," The Lancet, 373(9681), 20 June 2009, pp. 2125–2135: "Methods: In a multicentre, open-label trial, 4447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy with mean haemoglobin A1c (HbA1c) of 7·9% were randomly assigned to addition of rosiglitazone (n=2220) or to a combination of metformin and sulfonylurea (active control group, n=2227). ... Interpretation: Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women. Although the data are inconclusive about any possible effect on myocardial infarction, rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs." PMID 19501900 doi:10.1016/S0140-6736(09)60953-3

    Philip D. Home, et al, "Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol," Diabetologia, 48(9), September 2005, pp. 1726–1735. PMID 16025252 doi:10.1007/s00125-005-1869-1

    "RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes", clinicaltrials.gov.

73. Steven E. Nissen, Kathy Wolski, "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes," New England Journal of Medicine, 356(24), 2457-2471, 14 June 2007 (online 21 May 2007): "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." PMID 17517853 doi:10.1056/NEJMoa072761
74. Stephanie Saul, "Doctor Accused of Leak to Drug Maker", The New York Times, 30 January 2008.

    Gardiner Harris, "A Face-Off on the Safety of a Drug for Diabetes", The New York Times, 22 February 2010.

75. ^ "Staff report on GlaxoSmithKline and the diabetes drug Avandia", Committe on Finance, United States Senate, January 2010.

    "Grassley, Baucus Release Committee Report on Avandia", The United States Senate Committee on Finance, 20 February 2010.

    Andrew Clark, "Glaxo's handling of Avandia concerns damned by US Senate committee", The Guardian, 22 February 2010.

76. David Graham, "Assessment of the cardiovascular risks and health benefits of rosiglitazone", Office of Surveillance and Epidemiology, Food and Drug Administration, 30 July 2007.
77. "FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia. Agency says drug to remain on market, while safety assessment continues", Food and Drug Administration, 14 November 2007.
78. ^ "FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines". Food and Drug Administration. 25 November 2013.

    Avandia. Prescribing information", Food and Drug Administration.

79. Thomas F. Lüscher, Ulf Landmesser, Frank Ruschitzka (May 2010). "Standing firm—the European Heart Journal, scientific controversies and the industry". European Heart Journal. 31 (10): 1157–1158. doi:10.1093/eurheartj/ehq127. PMID 20418345.{{cite journal}}: CS1 maint: multiple names: authors list (link)

    Steven E. Nissen, "The rise and fall of rosiglitazone," European Heart Journal, 31(7), April 2010, pp. 773–776. PMID 20154334 doi:10.1093/eurheartj/ehq016

    Moncef Slaoui, "The rise and fall of rosiglitazone: reply," European Heart Journal, 31(7), April 2010, pp. 1282–1284. PMID 20499440 doi:10.1093/eurheartj/ehq118

    Michel Komajda, et al, "Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial," European Heart Journal, 31(7), April 2010, pp. 824–831. PMID 20118174 doi:10.1093/eurheartj/ehp604

80. Steven E. Nissen, Kathy Wolski, "Rosiglitazone RevisitedAn Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality," Archives of Internal Medicine, 170(14), July 2010, pp. 1191–1202: "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." PMID 20656674 doi:10.1001/archinternmed.2010.207
81. "European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim", European Medicines Agency, 23 September 2010.
82. Kenneth W. McHaffey, et al, "Results of a reevaluation of cardiovascular outcomes in the RECORD trial," American Heart Journal, 166(2), August 2013, pp. 240–249. PMID 23895806 doi:10.1016/j.ahj.2013.05.004
83. "FDA requires removal of certain restrictions on the diabetes drug Avandia", Food and Drug Administration, 25 November 2013.

    "Readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes Trial (RECORD)", 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.

    Steven Nissen, "Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings", Forbes, 23 May 2013.

    "The FDA Responds To Steve Nissen's Criticism Of Upcoming Avandia Meeting", Forbes, 23 May 2013.

84. ^ W. Kondro, B. Sibbald (March 2004). "Drug company experts advised staff to withhold data about SSRI use in children". Canadian Medical Association Journal. 170 (5): 783. doi:10.1503/cmaj.1040213. PMC 343848. PMID 14993169.
85. Goldacre 2013, p. 58.
86. Isabel Heck, "Controversial Paxil paper still under fire 13 years later", The Brown Daily Herald, 2 April 2014.
87. Jon N. Jureidini, Leemon B. McHenry, Peter R. Mansfield, "Clinical trials and drug promotion: Selective reporting of study 329", International Journal of Risk & Safety in Medicine, 20, 2008, pp. 73–81 (for self-harm, pp. 77–78; for litigation, pp. 73–74). doi:10.3233/JRS-2008-0426

    "Company hid suicide link", BBC News, 29 January 2007; "Secrets of the Drug Trials," BBC Panorama, 29 January 2007.

    Goldacre 2013, pp. 296–297; Letter showing authorship of Study 239, Drug Industry Document Archive, University of California, San Francisco.

    For study 329, see Martin Keller, et al, "Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial", Journal of the American Academy of Child and Adolescent Psychiatry, 40(7), July 2001, pp. 762–772. PMID 11437014 doi:10.1097/00004583-200107000-00010

    Martin Keller, et al, "Paroxetine in adolescent major depression" (reply), Journal of the American Academy of Child and Adolescent Psychiatry, 41(4), April 2002, p. 364. doi:10.1097/00004583-200204000-00004

    Martin Keller, et al, "Paroxetine in major depression" (reply), Journal of the American Academy of Child and Adolescent Psychiatry, 42(5), May 2003, pp. 514–515. doi:10.1097/S0890-8567(09)60933-3

88. Kurt Samson (December 2008). "Senate probe seeks industry payment data on individual academic researchers". Annals of Neurology. 64 (6): A7–9. doi:10.1002/ana.21271. PMID 19107985.
89. Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, Algonquin Books of Chapel Hill, 2008.

    Marcia Angell (15 January 2009). "Drug Companies & Doctors: A Story of Corruption". The New York Review of Books. Vol. 56, no. 1.

90. "Judge: Paxil ads can't say it isn't habit-forming". Associated Press. 20 August 2002.
91. Drug and Device Law. December 14, 2006 The FDA's Amicus Briefs on Preemption
92. Ronald D. White for the Los Angeles Times. August 21, 2002 U.S. Opposes Order to Pull Paxil TV Ads
93. "WHO Expert Committee on Drug Dependence", Thirty-third Report, World Health Organization, 2003, p. 25: "Three SSRIs are among the 30 highest-ranking drugs in the list of drugs for which drug dependence has ever been reported to the Uppsala Monitoring Centre database; a total of 269 reports had been received as of June 2002 (109 reports for fluoxetine, 91 for paroxetine and 69 for sertraline)." In addition there were 2,384 reports of withdrawal symptoms." page 20: "The Committee noted the striking number of reports on paroxetine and “withdrawal syndrome” (see list of SSRIs in the Table in the Annex). 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. The Committee agreed that there was a possible therapeutic problem with these drugs, but that there was no evidence of diversion of the drug for abuse because SSRIs are so widely available. The Committee recommended that SSRIs be placed on the agenda of the next Committee for consideration, not in the context of control, but to promote education and information on the appropriate use of psychoactive drugs.".
94. Oliver Thring, "Consider squash and cordial", The Guardian, 7 September 2010.

    "We have Frank and Vernon to thank for Ribena", The Bristol Post, 17 September 2013.

95. Linus Gregoriadis, "Makers of Ribena lose fight over anti-decay claims", The Daily Telegraph, 18 January 2001.
96. David Eames (28 March 2007). "NZ Herald".

    Tony Jaques, "When an Icon Stumbles – The Ribena Issue Mismanaged, Corporate Communications: An International Journal, 13(4), 2008, pp. 394–406.

97. "GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant", U.S. Department of Justice, 26 October 2010.
98. ^ "Glaxo to Pay $750 Million for Sale of Bad Products". The New York Times. 27 October 2010.
99. Alice Yan and Toh Han Shih (16 July 2013). "Shanghai travel agent's revenue surge led to arrests in GSK bribery case". South China Morning Post.

    "GlaxoSmithKline executives face China bribery probe". BBC News. 11 July 2013.

100. Rupert Neate and Angela Monaghan, "GlaxoSmithKline admits some staff in China involved in bribery", The Guardian, 22 July 2013.

     Rupert Neate, "GSK’s China crisis: chief executive Andrew Witty speaks - as it happened", The Guardian, 24 July 2013. Tom Philips (26 July 2013). "Chinese police allege Glaxo sales reps trained to offer sexual bribes". The Daily Telegraph.

101. Malcolm Moore, Denise Roland, "China fines Glaxo £297m for bribery, Mark Reilly sentenced", The Daily Telegraph, 19 September 2014.
102. John Hooper, Heather Stewart, "Over 4,000 doctors face charges in Italian drugs scandal", The Guardian, 27 May 2004.
103. Jane Burgermeister, "German prosecutors probe again into bribes by drug companies", BMJ, 328, 5 June 2004; "Glaxo probed over doctor freebies", BBC News, 12 March 2002.
104. "GlaxoSmithKline to Settle Tax Dispute With U.S.", Reuters, 12 September 2006; "IRS Accepts Settlement Offer in Largest Transfer Pricing Dispute", IRS, 11 September 2006.
105. Julia Kollewe (28 May 2014). "GlaxoSmithKline faces criminal investigation by Serious Fraud Office". The Guardian.
106. Kirsten Ridley, "UK fraud office liaising with China on GSK bribery case", Reuters, 23 July 2014.
107. "GlaxoSmithKline faces bribery claims in Syria", Reuters, 12 August 2014.

External links

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v t e Pharmaceutical and biotechnology industry in the United Kingdom
Manufacturing in the United Kingdom Economy of the United Kingdom
Companies	Current AAH Pharmaceuticals Alliance Boots Astex AstraZeneca (MedImmune) BTG Cyclacel Dechra Pharmaceuticals GE HealthCare Genus GSK Hikma Pharmaceuticals Indivior IXICO MacFarlan Smith Mundipharma Norbrook Group Oxford Biomedica Pfizer UK Proximagen Silence Therapeutics TBS GB Vectura Vernalis ViiV Healthcare Defunct Allen & Hanburys Amersham Beecham Group Cambridge Antibody Technology Celltech Chiroscience The Distillers Company Fisons Glaxo Wellcome ICI Phytopharm Reliant Pharmaceuticals Renovo Shire Unipath Zeneca
Government and regulatory bodies	Commission on Human Medicines Department of Health European Directorate for the Quality of Medicines & HealthCare Medicines and Healthcare products Regulatory Agency National Collaborating Centre for Mental Health Pharmaceutical Price Regulation Scheme Pharmaceutical Society of Northern Ireland General Pharmaceutical Council Scottish Medicines Consortium Veterinary Medicines Directorate
Industry and professional bodies	Association of the British Pharmaceutical Industry Chemical Industries Association European Federation of Biotechnology European Federation of Pharmaceutical Industries and Associations Faculty of Pharmaceutical Medicine Pharmacists' Defence Association Royal Pharmaceutical Society of Great Britain Worshipful Society of Apothecaries
Books and journals	Bandolier Bad Pharma (2012) British National Formulary British National Formulary for Children British Pharmaceutical Codex Journal of Pharmacy and Pharmacology Monthly Index of Medical Specialities Side Effects (2008) The Pharmaceutical Journal
Other	British Approved Name British Pharmacopoeia DrugScope European and Developing Countries Clinical Trials Partnership European Pharmacopoeia List of world's largest pharmaceutical companies Pharmaceutical Services Negotiating Committee Wellcome Trust
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