GlaxoSmithKline

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GlaxoSmithKline
Public limited company
Traded as LSE: GSK
NYSE: GSK
Industry Pharmaceutical
Biotechnology
Consumer goods
Predecessor Glaxo plc
Wellcome plc
Beecham Group plc
Kline & French
Beckman Companies
Smith plc
Founded 2000 (2000)
Headquarters Brentford, London
Key people
Products Pharmaceuticals, vaccines, oral healthcare, nutritional products, over-the-counter medicines
Revenue £23.006 billion (US$34.9 billion) (2014)[1]
£3.597 billion (US$5.4 billion) (2014)[1]
£2.831 billion (US$4.2 billion) (2014)[1]
Number of employees
 96,575 (2015)[2]
Subsidiaries Stiefel Laboratories
Slogan "Do more, feel better, live longer"
Website www.gsk.com

GlaxoSmithKline plc (GSK) is a British pharmaceutical company headquartered in Brentford, London. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham, GSK was the world's sixth largest pharmaceutical company as of 2015, after Pfizer, Novartis, Merck, Hoffmann-La Roche and Sanofi.[n 1][3] Andrew Witty has been the chief executive officer since 2008.[4]

The company has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. As of December 2015 it had a market capitalisation of £65 billion, the fifth largest on the London Stock Exchange.[5] It has a secondary listing on the New York Stock Exchange.

GSK's drugs and vaccines earned £21.3 billion in 2013; its top-selling products that year were Advair, Avodart, Flovent, Augmentin, Lovaza and Lamictal. GSK's consumer 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.[6] The company developed the first malaria vaccine, RTS,S, which it said in 2014 it would make available for five percent above cost.[7] Legacy products developed at GSK include several listed in the World Health Organization Model List of Essential Medicines, such as amoxicillin, mercaptopurine, pyrimethamine and zidovudine.

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.[8] 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.[9]

History

Glaxo Wellcome

The historic Glaxo factory in Bunnythorpe, New Zealand, with the Glaxo Laboratories sign still visible

Glaxo was founded in the 1850s as a general trading company in Bunnythorpe, New Zealand, by a Londoner, Joseph Nathan.[10] In 1904 it began producing dried-milk baby food, first known as Defiance, then as Glaxo, under the slogan "Glaxo builds bonny babies".[11][12] 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.[12]

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.[12] Glaxo and Burroughs Wellcome merged in 1995 to form Glaxo Wellcome.[13] 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.[14][15][16] Also that year, Glaxo Wellcome acquired the California-based Affymax, a leader in the field of combinatorial chemistry.[17]

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.[18] 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.[19] 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.[20]

SmithKline Beecham

Beecham's Clock Tower, constructed 1877, part of the Beecham's factory, St Helens

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.[12]

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.[12]

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.[12]

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).[21][22] 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.[23] 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.[24] Chris Gent, former CEO of Vodaphone, has been the chair since January 2005.[25] Philip Hampton, chair of the Royal Bank of Scotland, will replace Gent in September 2015.[26]

Research, products

Facilities

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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 Moon Township, Pennsylvania.[27]:7[28] Company facilities include:

Products

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Further information: List of GlaxoSmithKline 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 Lamictal, and the antibacterial Augmentin.[27]:220

Medicines historically discovered or developed at GSK and its legacy companies and now sold as generics include amoxicillin[29] and amoxicillin-clavulanate,[30] ticarcillin-clavulanate,[31] mupirocin,[32] and ceftazidime[33] 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, cimetidine and ranitidine for gastroesophageal reflux disorder, mercaptopurine[34] and thioguanine[35] for the treatment of leukemia, allopurinol for gout,[36] pyrimethamine for malaria,[37] and the antibacterial trimethoprim.[35] Among these, albendazole, amoxicillin, amoxicillin-clavulanate, allopurinol, mercaptopurine, mupriocin, pyrimethamine, ranitidine, thioguanine, trimethoprim and zidovudine are listed on the World Health Organization's list of essential medications.[38]

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.[39] Other products include Abreva to treat cold sores; Night Nurse, a cold remedy; Breathe Right nasal strips; and Nicoderm and Nicorette nicotine replacements.[40]

Scientific recognition

Four GlaxoSmithKline scientists have been recognized by the Nobel Committee for their contributions to basic medical science and/or therapeutics development.

  • Henry Dale, a former student of Paul Ehrlich, received the 1936 Nobel Prize in Medicine for his work on the chemical transmission of neural impulses. Dale served as a pharmacologist and then as Director of the Wellcome Physiological Research Laboratories from 1904 to 1914, and later served as Trustee and Chairman of the Board of the Wellcome Trust.[41]
  • John Vane of Wellcome Research Laboratories shared the 1982 Nobel Prize for Medicine for his work on prostaglandin biology and the discovery of prostacyclin. Vane served as Group Research and Development Director for The Wellcome Foundation from 1973 to 1985.[42]
  • Gertrude B. Elion and George Hitchings, both of the Wellcome Research Laboratories, shared the 1988 Nobel Prize in Medicine with Sir James W. Black ""for their discoveries of important principles for drug treatment"." Elliot and Hitchings were responsible for the discovery of a plethora of important drugs, including mercaptopurine[34] and thioguanine[35] for the treatment of leukemia, the immunosuppressant azothioprine,[43] allopurinol for gout,[36] pyrimethamine for malaria,[37] the antibacterial trimethoprim,[35] acyclovir for herpes virus infection,[44] and nelarabine for cancer treatment.[45]

Operations and acquisitions

2001–2010

photograph
Andrew Witty, GSK's CEO since May 2008

GSK completed the acquisition of New Jersey-based Block Drug in 2001 for US$1.24 billion.[46] 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.[47] GSK opened its first R&D centre in China in 2007, in Shanghai, initially focused on neurodegenerative diseases.[48]

In 2009 GSK acquired Stiefel Laboratories, then the world's largest independent dermatology drug company, for US$3.6bn.[49] In November the FDA approved GSK's vaccine for 2009 H1N1 influenza protection, manufactured by the company's ID Biomedical Corp in Canada.[50] Also in November 2009 GSK formed a joint venture with Pfizer to create ViiV Healthcare, which specializes in HIV research.[51] In 2010 the company acquired Laboratorios Phoenix, an Argentine pharmaceutical company, for US$253m,[52] and the UK-based sports nutrition company Maxinutrition for £162 million (US$256 million).[53]

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.[54] 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.[55] In May that year it acquired CellZome, a German biotech company, for US$98 million,[56] and in June worldwide rights to alitretinoin (Toctino), an eczema drug, for $302 million.[57] 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.[58]

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.[59] 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.[60] 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.[61][62] In February 2015 GSK announced that it would acquire GlycoVaxyn, a Swiss pharmaceutical company, for $190 million.[63] In June 2015, the company announced it would sell two meningitis drugs to Pfizer, Nimenrix and Mencevax, for around $130 million.[64]

Philanthropy and social responsibility

Overview

GlaxoSmithKline, Center City, Philadelphia

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.[65] In 2014 the Human Rights Campaign, an LGBT-rights advocacy group gave GSK a score of 100% in its Corporate Equality Index.[66]

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.[67] 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.[68] As of 2014, over 5 billion treatments have been delivered and 18 of 73 countries in which the disease is considered endemic have progressed to the surveillance stage based on a preliminary assessment that the infection has been eliminated.[69]

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.[70][71] 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.[72] In 2013 GSK licensed its HIV portfolio to the Medicines Patent Pool for use in children, and agreed to negotiate a license for dolutegravir, an integrase inhibitor then in clinical development.[73] In 2014 this license was extended to include dolutegravir and adults with HIV. The licenses include countries in which 93% of adults and 99% of children with HIV live.[74]

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.[75]

Malaria vaccine development

In 2014 GSK applied for regulatory approval for the first malaria vaccine.[76] 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.[7] Malaria is responsible for over 650,000 deaths per year, mainly in Africa.[77] 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 "[i]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."[78] In 2014 Glaxo said it had spent more than $350 million, and expected to spend an additional $260 million before seeking regulatory approval.[79][80] A second generation malaria vaccine is being evaluated in Phase 2 clinical trials.[81]

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.[8]

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).[8]

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.[8] The company set up a ghostwriting programme called CASPPER, initially to produce articles about Paxil but which was extended to cover Avandia.[82]

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.[8] 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.[9]

Rosiglitazone (Avandia)

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Further information: Rosiglitazone § Adverse effects, and Rosiglitazone § Lawsuits
Rosiglitazone

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.[8]

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.[83] GSK raised questions internally about the drug's safety in 2000, and 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.[84] From 2001 reports began to link the thiazolidinediones (the class of drugs to which rosiglitazone belongs) to heart failure.[85] In April that year GSK began a six-year, open-label, randomized trial, known as RECORD, to examine rosiglitazone and cardiovascular events.[86] 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.[85]

In June 2007 the New England Journal of Medicine published a meta-analysis that associated the drug with an increased risk of heart attack.[87] 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.[88] In July 2007 FDA scientists suggested that rosiglitazone had caused 83,000 excess heart attacks between 1999 and 2007.[89]:4[90] The FDA placed restrictions on the drug, including adding a boxed warning, but did not withdraw it.[91] (In 2013 the FDA rejected that the drug had caused excess heart attacks.)[92] A Senate Finance Committee inquiry concluded in 2010 that GSK had sought to intimidate scientists who had concerns about rosiglitazone.[89] In February that year the company tried to halt publication of an editorial about the controversy by Nissen in the European Heart Journal.[93]

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."[86] Steven Nissan and Kathy Wolkski argued that the study's low event rates reduced its statistical power.[94] In September 2009 rosiglitazone was suspended in Europe.[95] The results of the RECORD study were confirmed in 2013 by the Duke Clinical Research Institute, in an independent review required by the FDA.[96] In November that year the FDA lifted the restrictions it had placed on the drug.[97] The boxed warning about heart attack was removed; the warning about heart failure remained in place.[92]

Paroxetine (Paxil/Seroxat)

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Main article: Study 329
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.[8] Paxil had $4.97 billion worldwide sales in 2003.[98] The company conducted nine clinical trials between 1994 and 2002, none of which showed that Paxil helped children with depression.[99] 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.[8] 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.[8]

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."[98][100] The company 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.[8][101] The article concluded that Paxil was "generally well tolerated and effective for major depression in adolescents."[102] The suppression of the research findings is the subject of Side Effects (2008) by Alison Bass.[103]

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.[104] The court withdrew the injunction after the FDA objected that the court had no jurisdiction over drug marketing that the FDA had approved.[105] 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.[106][n 2]

Bupropion (Wellbutrin)

The company was also fined for promoting Wellbutrin (bupropion) – approved at the time for major depressive disorder and also sold as a smoking-cessation aid, Zyban – 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.[8]

Other controversies

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.[107]:54, nn. 1–2[108] 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.[107]:54–55[108] 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.[109][110][111]

The United States brought an antitrust suit against the two companies, charging them with violation of the Sherman Act and also seeking to have the patents declared invalid.[107]:55[108] 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.[107]:56[108] The government appealed to the Supreme Court, which reversed, in United States v. Glaxo Group Ltd., 410 U.S. 52 (1973).[108]

In 1973 the Supreme Court held that (1) when a patent is directly involved in an antitrust violation, the Government may challenge the validity of the patent; and (2) ordinarily, in patent-antitrust cases, "[m]andatory selling on specified terms and compulsory patent licensing at reasonable charges are recognized antitrust remedies."[107]:62–64[108][111]

Ribena

photograph
photograph
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 bought H. W. Carter in 1955.[112]

In 2001 the British 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.[113] In 2007 GSK was fined $217,000 in New Zealand over its claim that ready-to-drink Ribena contained high levels of vitamin C, after it was found to contain no detectable vitamin C.[114] In 2013 GSK sold Ribena and another drink, Lucozade, to the Japanese multinational Suntory for £1.35 billion.[39]

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.[115] GSK closed the factory in 2009.[116]

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.[116]

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.[117] Chinese authorities arrested four GSK executives as part of a four-month investigation into claims that doctors were bribed with cash and sexual favours.[118] In 2014 a Chinese court found the company guilty of bribery, imposed a fine of $490 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.[119] Reilly was reportedly deported from China and dismissed by the company.[120]

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).[121] 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.[122] All charges were dismissed by the Verona court in January 2009.[123]

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.[124]

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.[125] 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.[126] Also as of 2014 the US Department of Justice was investigating GSK with reference to the Foreign Corrupt Practices Act.[127]

See also

Notes

  1. ↑ Glaxo Wellcome was formed from Glaxo's 1995 acquisition of Burroughs Wellcome and SmithKline Beecham from the 1989 merger of the Beecham Group and the SmithKline Beckman Corporation.
  2. ↑ 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."[106]

References

  1. ↑ 1.0 1.1 1.2 Lua error in package.lua at line 80: module 'strict' not found.
  2. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  3. ↑ "The World's Biggest Public Companies", 2015 ranking, Forbes.
  4. ↑ "Corporate Executive Team", GlaxoSmithKline. Retrieved 16 November 2013. Archived 14 October 2012 at the Wayback Machine
  5. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  6. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  7. ↑ 7.0 7.1 Lua error in package.lua at line 80: module 'strict' not found.

    Lua error in package.lua at line 80: module 'strict' not found.

  8. ↑ 8.00 8.01 8.02 8.03 8.04 8.05 8.06 8.07 8.08 8.09 8.10 "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.

    Katie Thomas and Michael S. Schmidt, "Glaxo Agrees to Pay $3 Billion in Fraud Settlement", The New York Times, 2 July 2012.

    Simon Neville, "GlaxoSmithKline fined $3bn after bribing doctors to increase drugs sales", The Guardian, 3 July 2012.

  9. ↑ 9.0 9.1 "GSK to stop paying doctors in major marketing overhaul", Thomson/Reuters, 17 December 2013.
  10. ↑ R. P. T. Davenport-Hines, Judy Slinn, Glaxo: A History to 1962, Cambridge University Press, 1992, pp. 7–13.
  11. ↑ David Newton, Trademarked: A History of Well-Known Brands, from Airtex to Wright's Coal Tar, The History Press, 2012, p. 435.
  12. ↑ 12.0 12.1 12.2 12.3 12.4 12.5 Lua error in package.lua at line 80: module 'strict' not found.
  13. ↑ Mark S. Lesney, "The ghosts of pharma past", Modern Drug Discovery, January 2004, pp. 25–26.

    David J. Ravenscraft, William F. Long. "Paths to Creating Value in Pharmaceutical Mergers," in Steven N. Kaplan (ed.), Mergers and Productivity, University of Chicago Press, 2000.

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  17. ↑ "Glaxo to Acquire Affymax", The New York Times, 27 January 1995.
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  24. ↑ "Andrew Witty's journey from Graduate to GSK CEO", GlaxoSmithKline, 12 August 2008; "Andrew Philip Witty", Bloomberg.
  25. ↑ "Sir Christopher Gent to exit GlaxoSmithKline", The Daily Telegraph, 28 October 2012.
  26. ↑ James Quinn, "Sir Philip Hampton to chair Glaxo", The Daily Telegraph, 25 September 2014.
  27. ↑ 27.0 27.1 Lua error in package.lua at line 80: module 'strict' not found.
  28. ↑ "About us: what we do", GlaxoSmithKline, accessed 16 November 2013 Archived 13 October 2013 at the Wayback Machine
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  39. ↑ 39.0 39.1 Angela Monaghan "Ribena and Lucozade sold to Japanese drinks giant", The Guardian, 9 September 2013
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  52. ↑ GSK Acquires Laboratorios Phoenix for $253m, InfoGrok.
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  55. ↑ "GSK confirms 500 mln stg UK investment plans", Reuters, 22 March 2012.
  56. ↑ 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
  57. ↑ 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)
  58. ↑ Matthew Herper, "Three Lessons From GlaxoSmithKline's Purchase Of Human Genome Sciences", Forbes, 16 July 2012.
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  60. ↑ Aaron Smith for CNN Money, March 27, 2014 Alli weight-loss drug recalled for tampering
  61. ↑ Chad Bray, David Jolly, "Novartis and Glaxo Agree to Trade $20 Billion in Assets", The New York Times', 22 April 2014.
  62. ↑ Jonathan D. Rockoff, Jeanne Whalen, Marta Falconi, "Deal Flurry Shows Drug Makers' Swing Toward Specialization", The Wall Street Journal, 22 April 2014.
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  70. ↑ Sarah Boseley, "Drug giant GlaxoSmithKline pledges cheap medicine for world's poor", The Guardian, 13 February 2009.
  71. ↑ UNITAID 16 February 2009. UNITAID Statement on GSK Patent Pool For Neglected Diseases
  72. ↑ 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
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  82. ↑ 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.

  83. ↑ "The Intimidation of Dr. John Buse and the Diabetes Drug Avandia", Committee on Finance, United States Senate, November 2007, pp. 2–4.
  84. ↑ 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. doi:10.1161/01.CIR.0000025403.20953.23 PMID 12163427

  85. ↑ 85.0 85.1 Steven E. Nissen, "The rise and fall of rosiglitazone," European Heart Journal, 31(7), April 2010, pp. 773–776; see table 1 for timeline. doi:10.1093/eurheartj/ehq016 PMID 20154334
  86. ↑ 86.0 86.1 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 doi:10.1016/S0140-6736(09)60953-3 PMID 19501900
    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. doi:10.1007/s00125-005-1869-1 PMID 16025252

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

  87. ↑ 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), pp. 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." doi:10.1056/NEJMoa072761 PMID 17517853
  88. ↑ 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.

  89. ↑ 89.0 89.1 "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.

  90. ↑ David Graham, "Assessment of the cardiovascular risks and health benefits of rosiglitazone", Office of Surveillance and Epidemiology, Food and Drug Administration, 30 July 2007.
  91. ↑ "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.
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    Moncef Slaoui, "The rise and fall of rosiglitazone: reply," European Heart Journal, 31(7), April 2010, pp. 1282–1284. doi:10.1093/eurheartj/ehq118 PMID 20499440

    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. doi:10.1093/eurheartj/ehp604 PMID 20118174

  94. ↑ 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." doi:10.1001/archinternmed.2010.207 PMID 20656674
  95. ↑ "European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim", European Medicines Agency, 23 September 2010.
  96. ↑ 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. doi:10.1016/j.ahj.2013.05.004 PMID 23895806
  97. ↑ "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.

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  106. ↑ 106.0 106.1 "WHO Expert Committee on Drug Dependence", Thirty-third Report, World Health Organization, 2003, pp. 20, 25.
  107. ↑ 107.0 107.1 107.2 107.3 107.4 United States v. Glaxo Group Ltd., 410 U.S. 52 (1973).
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  110. ↑ The Court explained: "There is little reason to think that the appellees or their licensees, now that the bulk-sales restrictions have been declared illegal, will begin selling in bulk. It is in their economic self-interest to maintain control of the bulk form of the drug in order to keep the dosage-form, wholesale market competition-free. Bulk sales would create new competition among wholesalers, by enabling other companies to convert the bulk drug into dosage and microsize forms and sell to retail outlets, and would presumably lead to price reductions as the result of normal competitive forces. There is, in fact, substantial evidence in the record to the effect that other drug companies would not only have entered the market, had they been able to make bulk purchases, but also would have charged substantially lower wholesale prices." United States v. Glaxo Group Ltd. at 62-63.
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    "We have Frank and Vernon to thank for Ribena", The Bristol Post, 17 September 2013.

  113. ↑ Linus Gregoriadis, "Makers of Ribena lose fight over anti-decay claims", The Daily Telegraph, 18 January 2001.
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    Michael Regester, Judy Larkin, Risk Issues and Crisis Management in Public Relations, Kogan Page Publishers, 2008, p. 67ff.

  115. ↑ "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.
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  118. ↑ Rupert Neate and Angela Monaghan, "GlaxoSmithKline admits some staff in China involved in bribery", The Guardian, 22 July 2013.

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  120. ↑ Malcolm Moore, Denise Roland, "China fines Glaxo £297m for bribery, Mark Reilly sentenced", The Daily Telegraph, 19 September 2014.
  121. ↑ John Hooper, Heather Stewart, "Over 4,000 doctors face charges in Italian drugs scandal", The Guardian, 27 May 2004.
  122. ↑ 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.
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  124. ↑ "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.
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  126. ↑ Kirsten Ridley, "UK fraud office liaising with China on GSK bribery case", Reuters, 23 July 2014.
  127. ↑ "GlaxoSmithKline faces bribery claims in Syria", Reuters, 12 August 2014.

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