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==Controversies==
==Controversies==

{{criticism-section|date=April 2015}}
===2012 criminal and civil settlement===
===2012 criminal and civil settlement===
In July 2012 GSK pleaded guilty to criminal charges and agreed to a pay $3 billion in the [[List of Largest Pharmaceutical Settlements|largest settlement by a drug company at the time]]. The criminal charges were for promoting its antidepressants, [[Paxil]] and [[Wellbutrin]], for unapproved uses from 1998-2003, and failing to report safety data about [[Avandia]], both in violation of the [[Federal Food, Drug, and Cosmetic Act]]; GSK paid $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.<ref name=USDOJ2012>U.S. Department of Justice Press Release. 2 July 2012 [http://www.justice.gov/opa/pr/2012/July/12-civ-842.html GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data]</ref> The remaining $2 billion were part of the civil settlement over (1) promoting the drugs Paxil, Wellbutrin, [[Advair]], [[Lamictal]] and [[Zofran]] for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs [[Imitrex]], [[Lotronex]], [[Flovent]] and [[Valtrex]]; (2) making false and misleading statements concerning the safety of Avandia; and (3) reporting false best prices and underpaying rebates owed under the [[Medicaid Drug Rebate Program]].<ref name=USDOJ2012/> GSK also signed a five-year Corporate Integrity Agreement with the U.S. [[Department of Health and Human Services]], which obligated GSK to make major changes to the way it did business, including changing the way its sales force is compensated and its executive compensation program, and to implement and maintain transparency in its research practices and publication policies.<ref name=USDOJ2012/> The government investigation was launched largely on the basis of information provided by four whistleblowers who filed [[qui tam]] (whistleblower) lawsuits against the company under the U.S. [[False Claims Act]].<ref name=GSKfraudNYT2012>{{cite news|url=http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html|title=Glaxo Agrees to Pay $3 Billion in Fraud Settlement|date=2 July 2012|author=Katie Thomas and Michael S. Schmidt |work=The New York Times}}</ref>
In July 2012 GSK pleaded guilty to criminal charges and agreed to a pay $3 billion in the [[List of Largest Pharmaceutical Settlements|largest settlement by a drug company at the time]]. The criminal charges were for promoting its antidepressants, [[Paxil]] and [[Wellbutrin]], for unapproved uses from 1998-2003, and failing to report safety data about [[Avandia]], both in violation of the [[Federal Food, Drug, and Cosmetic Act]]; GSK paid $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.<ref name=USDOJ2012>U.S. Department of Justice Press Release. 2 July 2012 [http://www.justice.gov/opa/pr/2012/July/12-civ-842.html GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data]</ref> The remaining $2 billion were part of the civil settlement over (1) promoting the drugs Paxil, Wellbutrin, [[Advair]], [[Lamictal]] and [[Zofran]] for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs [[Imitrex]], [[Lotronex]], [[Flovent]] and [[Valtrex]]; (2) making false and misleading statements concerning the safety of Avandia; and (3) reporting false best prices and underpaying rebates owed under the [[Medicaid Drug Rebate Program]].<ref name=USDOJ2012/> GSK also signed a five-year Corporate Integrity Agreement with the U.S. [[Department of Health and Human Services]], which obligated GSK to make major changes to the way it did business, including changing the way its sales force is compensated and its executive compensation program, and to implement and maintain transparency in its research practices and publication policies.<ref name=USDOJ2012/> The government investigation was launched largely on the basis of information provided by four whistleblowers who filed [[qui tam]] (whistleblower) lawsuits against the company under the U.S. [[False Claims Act]].<ref name=GSKfraudNYT2012>{{cite news|url=http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html|title=Glaxo Agrees to Pay $3 Billion in Fraud Settlement|date=2 July 2012|author=Katie Thomas and Michael S. Schmidt |work=The New York Times}}</ref>

Revision as of 20:40, 18 April 2015

GlaxoSmithKline
Company typePublic limited company
LSE: GSK
NYSE: GSK
IndustryPharmaceutical
Biotechnology
Consumer goods
PredecessorGlaxo plc
Wellcome plc
Beecham Group plc
Kline & French
Beckman Companies
Smith plc
Founded2000
HeadquartersBrentford, England
Key people
Chris Gent (Chairman)
Andrew Witty (CEO)
ProductsPharmaceuticals, vaccines, oral healthcare products, nutritional products, over-the-counter medicines
Revenue£23.006 billion (2014)[1]
£3.597 billion (2014)[1]
£2.831 billion (2014)[1]
Number of employees
Over 100,000 (2015)[2]
SubsidiariesStiefel Laboratories
Websitewww.gsk.com

GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical, biologics, vaccines and consumer healthcare company which has its headquarters in Brentford, London. As of March 2014, it was the world's sixth-largest pharmaceutical company after Johnson & Johnson, Novartis, Hoffmann-La Roche, Pfizer, and Sanofi, measured by 2013 revenue.[3] The company was established in 2000 by the merger of Glaxo Wellcome (formed from the acquisition of Wellcome plc by Glaxo plc) and SmithKline Beecham plc (formed from the merger of Beecham Group plc and SmithKline Beckman Corporation, which in turn was formed by combining the Smith, Kline & French and Beckman companies).

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.[4] It has a secondary listing on the New York Stock Exchange. Andrew Witty has been the chief executive officer since May 2008.[5]

GSK manufactures drugs and vaccines for major disease areas such as asthma, cancer, infections, diabetes, digestive and mental health conditions, the biggest selling of which were Advair, Avodart, Flovent, Augmentin, Lovaza, and Lamictal in 2013. Many medicines were historically discovered or developed at GSK and its predecessor companies and are now sold as generics. Its drugs and vaccines earned £21.3 billion in 2013. Its consumer healthcare division, which earned £5.2 billion in 2013, sells oral healthcare and nutritional products, drinks and over-the-counter medicines, including Sensodyne, Boost and Horlicks.[6]

In July 2012 GSK pleaded guilty to criminal charges and agreed to a pay $3 billion to settle the criminal charges as well as civil qui tam lawsuits in the largest settlement paid by a drug company at the time. The criminal charges were for promoting Paxil and Wellbutrin for unapproved uses and failing to report safety data about Avandia; GSK paid $1 billion to settle the criminal charges. The remaining $2 billion were part of the civil settlement over unapproved promotion and paying kickbacks, making false statements concerning the safety of Avandia; and reporting false prices to Medicaid. GSK also signed an agreement which obligated it to make major changes to the way it did business.

On December 17, 2013, GSK announced that it would stop paying professionals for speaking at medical conferences. The company stated that it would still pay fees to doctors for functions it regards as critical to obtaining insights into specific diseases, including performing company sponsored clinical trials, scientific advisory services, and market research.[7]

GlaxoSmithKline received top ranking among international pharmaceutical companies in the Access to Medicines Index in 2010, 2012 and 2014.[8] In 2014 the company applied for regulatory approval for the first vaccine against malaria.[9] 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 make the vaccine available in developing countries for a price set at 5% above the cost of production.[10]

Overview

Products

Template:GSKsidebar

Further information: List of GlaxoSmithKline products

GSK manufactures drugs and vaccines for major disease areas such as asthma, cancer, infections, diabetes, digestive and mental health conditions, the biggest selling of which were Advair, Avodart, Flovent, Augmentin, Lovaza, and Lamictal in 2013. Its drugs and vaccines earned £21.3 billion in 2013. Top-selling products include its asthma/COPD therapeutics 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.[11]: 220  Its consumer healthcare division, which earned £5.2 billion in 2013, sells oral healthcare, and nutritional products, drinks and over-the-counter medicines, including Sensodyne, Boost and Horlicks.[6]

Medicines historically discovered or developed at GSK and its legacy companies and now sold as generics include amoxicillin[12] and amoxicillin-clavulanate,[13] ticarcillin-clavulanate,[14] mupirocin,[15] and ceftazidime[16] 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.[17]

The company's over-the-counter health-care products include Abreva to treat cold sores; Aquafresh, Maclean's and Sensodyne toothpastes; Night Nurse, a cold remedy; Breathe Right nasal strips; and Nicoderm and Nicorette nicotine replacements. It also sells several drinks, including Horlicks, a malted milk drink and Boost, a chocolate-flavoured drink, and formerly sold Lucozade, marketed as an energy drink, and Ribena, a fruit drink.[18]

Facilities, employees

As of 2013 GSK has offices in over 115 countries. Its global headquarters are in the UK at GSK House in Brentford, a suburb of west London, and its US headquarters are in The Navy Yard, Philadelphia and Research Triangle Park, North Carolina. The company employs over 99,000 people, 12,500 of whom work in research and development.[11]: 7 [19] The company's single largest market is the United States. Its consumer-products division is based in the Pittsburgh suburb of Moon Township, Allegheny County, Pennsylvania. The research-and-development division has major facilities in south-east England, Philadelphia and North Carolina. Company facilities include:

History

Glaxo Wellcome

The historic Glaxo factory in Bunnythorpe, New Zealand

Burroughs Wellcome & Company was founded in 1880 in London by the American pharmacists Henry Wellcome and Silas Burroughs.[20] The Wellcome Tropical Research Laboratories opened in 1902.[21]

Glaxo was founded in Bunnythorpe, New Zealand, in 1904. It was originally a baby food manufacturer, processing milk into a baby food of the same name. The product was sold under the slogan "Glaxo builds bonny babies" from 1908. Still visible on the main street of Bunnythorpe is a dairy factory (factory for drying and processing cows' milk into powder) with the original Glaxo logo clearly visible; it is now a car repair shop.[20]

Glaxo became Glaxo Laboratories and opened new units in London in 1935. Glaxo Laboratories bought two companies, Joseph Nathan and Allen & Hanburys in 1947 and 1958 respectively. After the company bought Meyer Laboratories in 1978, it started 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.

In March 1995 Glaxo and Burroughs Wellcome Co. merged to form Glaxo Wellcome.[20][22][23] In that year Glaxo restructured is R&D operation, cutting about 10,000 jobs worldwide, closing its research and development facility in Beckenham, Kent, which was formerly Wellcome's principal research and development facility in the United Kingdom, and opening a Medicines Research Centre at Stevenage in England[24][25][26] Also in that year, Glaxo Wellcome acquired the California-based Affymax, a leader in the field of combinatorial chemistry.[27] Valtrex (valaciclovir) was launched as an anti-herpes successor to Zovirax (acyclovir).

The research center of GlaxoSmithKline in the business cluster of Paris-Saclay, France.

In 1999 Glaxo Wellcome was the world's third-largest pharmaceutical company by revenues (behind Novartis and Merck), with a global market share of around 4 per cent.[28] Glaxo Wellcome's 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).[29] As of 2000, seven of Glaxo Wellcome's products were among the world's top 50 best-selling pharmaceutical products[29] and was the world's largest maker of drugs for the treatment of asthma and HIV/AIDS.[30] It employed around 59,000 people worldwide, of whom around 13,400 were based in the United Kingdom.[29] Glaxo Wellcome had 76 operating companies.[29] It had 50 manufacturing facilities worldwide.[29] In the United Kingdom, the company had research and development facilities at Ware and Stevenage, Hertfordshire; Dartford and Beckenham, Kent; and Greenford in London.[29] It had manufacturing plants in the UK at Ulverston in Cumbria, Barnard Castle in County Durham, Speke on Merseyside and Montrose in north-east Scotland.[29] Outside of the UK, Glaxo Wellcome had research and development centres in North Carolina, United States and Japan, and production facilities in the United States, Europe and Far East.[29]

Glaxo Wellcome and SmithKline Beecham announced their intention to merge on 17 January 2000. The merger was completed in December that year, forming GlaxoSmithKline (GSK).[31][32]

SmithKline Beecham

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

In 1843 Thomas Beecham launched his Beecham's Pills laxative in England giving birth to the Beecham Group.[20] Beecham opened its first factory in St Helens, Lancashire, England, for rapid production of medicines in 1859. The original factory was closed in 1994 and passed to the local college for re-development. 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. It changed its name to Smith Kline & French Laboratories in 1929 as it focused more on research. Years later Smith Kline & French Laboratories opened a new laboratory in Philadelphia; it then bought Norden Laboratories, a business doing research into animal health. Smith Kline & French Laboratories bought Recherche et Industrie Thérapeutiques (Belgium) in 1963 to focus on vaccines. The company started to expand globally, buying seven laboratories in Canada and the US in 1969. In 1982 it bought Allergan, a manufacturer of eye and skincare products. The company merged with Beckman Inc. later that year and changed its name to SmithKline Beckman.[20]

In 1988 SmithKline Beckman bought its biggest competitor, International Clinical Laboratories, and in 1989 merged with Beecham to form SmithKline Beecham plc. The headquarters of the company was moved to England. To expand research and development in the US, SmithKline Beecham bought a new research center in 1995. Another new research centre at New Frontiers Science Park in Harlow, England, was opened in 1997.[20]

Glaxo Wellcome and SmithKline Beecham announced their intention to merge on 17 January 2000. The merger was completed in December that year, forming GlaxoSmithKline (GSK).[31][32]

Operations and acquisitions

2001–2009

Andrew Witty has been GSK's chief executive officer since May 2008.

In 2001 GSK completed the acquisition of New Jersey-based Block Drug for US$1.24 billion.[33] In July 2002 GSK House, located in Brentford, London, was officially opened as GSK's new world headquarters by then-Prime Minister Tony Blair. The building was erected at a cost of £300 million and is home to around 3,000 staff.[34] In October 2006 GSK acquired the US-based consumer healthcare company CNS Inc., whose products included Breathe Right nasal strips and FiberChoice dietary fibre supplements, for US$566 million in cash.[35] GSK opened its first R&D centre in China in May 2007, located in Shanghai, and initially focused on neurodegenerative diseases.[36]

In April 2009 GSK acquired Stiefel Laboratories, the world's largest independent dermatology drug company at the time, for US$2.9 billion, assuming $400 million in debt and with a potential of $300 million in performance-based milestone payments, for a total of US$3.6 billion (£2.5 billion).[37][38]

On 16 November that year the US Food and Drug Administration (FDA) announced that a vaccine for 2009 H1N1 influenza protection (manufactured by GSK's ID Biomedical Corp. subsidiary) would join the four vaccines approved on 15 September.[39] Also in November 2009 GSK formed a joint venture with Pfizer to create ViiV Healthcare. Viiv Healthcare received all of Pfizer and GSK's HIV assets. ViiV Healthcare is 85 percent owned by GSK and 15 percent by Pfizer.[40]

2010–present

GlaxoSmithKline, Center City, Philadelphia

In June 2010 the company acquired Laboratorios Phoenix, an Argentine pharmaceutical company focused on the development, marketing and sale of branded generic products, for a cash consideration of approximately $253m.[41] In December that year GSK announced its acquisition of the UK-based sports nutrition company Maxinutrition, at that time Europe's leading sports nutrition company by market share, for £162 million (US$256 million), as part of its efforts to build up its consumer business.[42] In February 2011 GSK announced plans to sell some of its "non-core" brands. In December that year the company agreed to a $660 million deal with Prestige Brands Holdings, taking over 17 brands with sales of $210 million, including BC Powder, Beano, Ecotrin, Fiber Choice, Goody's Powder, Sominex and Tagamet.[43]

In March 2012 the company announced that it planned to invest around £500 million in manufacturing facilities in Ulverston, northern England, designating it as the site for a previously announced biotech plant.[44]

In May 2012, GSK acquired CellZome, a German biotech company with a proteomics-based drug discovery platform, with which GSK had collaborated for the past four years, for US$98 million.[45][46]

In June 2012, GSK, through its Stiefel subsidiary, acquired worldwide rights to alitretinoin (Toctino), an eczema drug developed by Basilea Pharmaceutica for $302 million - about $225 million in cash and the remaining amount as a milestone for a U.S. approval of the drug.[47][48]

In July 2013 GSK acquired United States-based biopharmaceutical company Human Genome Sciences for $14.25 a share or $3 billion, including cash and debt. GSK had originally offered $13 per share, or about $2.6 billion, in April of that year, which HGS had rejected, leading GSK to make a hostile bid directly to shareholders, before raising its bid to the figures that HGS finally accepted.[49] HGS and GSK had already collaborated on the development of two drugs that received marketing approval, the lupus drug Belimumab (Benlysta) and albiglutide for type 2 diabetes, and on a drug in development darapladib for atherosclerosis.[49]

In 2013 the company said it would seek marketing approval for the world's first malaria vaccine in 2014, after trial data showed the vaccine had significant effects in cutting cases of the disease in African children.[50]

In March 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.[51]

Also in March 2014, GlaxoSmithKline announced that Alli, a popular over-the-counter weight loss drug, was being recalled in the US and Puerto Rico because of possible tampering following customer complaints in seven states. "A range of tablets and capsules of various shapes and colors were reported to be found inside bottles," the company said. "Additionally, some bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic."[52]

In April 2014 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.[53][54]

In February 2015 the company announced it would acquire GlycoVaxyn for $190 million after taking a minority stake in the company two years previously, thus valuing the company at $212 million.[55]

Corporate social responsibility and philanthropy

Developing world access to medicines

In both 2010 and 2012 GlaxoSmithKline ranked first among 20 global pharmaceutical companies on the Global Access to Medicines Index. The Index is a composite ranking taking into account factors such as product donations, capability advancement, patent and licensing policies, pricing, research and development, public policy initiatives, and general access to medicines management. The Index is funded by the Bill and Melinda Gates Foundation.[8]

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.[56] The company endorsed the London Declaration on Neglected Tropical Diseases, a collaborative disease eradication programme launched on 30 January 2012 in London. 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.[57]

Since 2004 the company has collaborated with the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative in the development of a preventative vaccine for malaria, which is responsible for over 650,000 deaths per year, mainly in Africa.[58] As of 2014, the lead vaccine candidate, called "RTS,S", which uses Glaxo's proprietary AS01 adjuvant, is being examined in a large Phase 3 trial conducted 7 African countries. Interim results were published in 2013. Over the first 12 months of evaluation, children aged 5–17 months experienced 50% fewer cases of clinical malaria. Infants age 6–12 weeks experienced a 30% reduction in malaria cases.[59] As of 2014, Glaxo has stated that it has spent more than $350 million, and expected to spend an additional $260 million on further development activities prior to seeking regulatory approval.[60] The vaccine has been in development for more than 25 years.[61]

In February 2009 GSK head Andrew Witty announced that the company 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 would invest 20 percent of profits from the least developed countries in medical infrastructure for those countries.[62] The decision received mixed reactions from medical charities.[63] Médecins Sans Frontières welcomed the decision, encouraging other companies to follow suit, but criticized GSK for failing to include HIV patents in their patent pool, and for not including middle-income countries in the initiative.[64]

Human Rights

As of 2014, the Human Rights Campaign, an LGBT-rights advocacy group, gave GSK a perfect score of 100% in its Corporate Equality Index, an annual report card of corporate America's treatment of lesbian, gay, bisexual and transgender employees, customers and investors.[65]

Lobbying and political activities

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.[66]

Controversies

2012 criminal and civil settlement

In July 2012 GSK pleaded guilty to criminal charges and agreed to a pay $3 billion in the largest settlement by a drug company at the time. The criminal charges were for promoting its antidepressants, Paxil and Wellbutrin, for unapproved uses from 1998-2003, and failing to report safety data about Avandia, both in violation of the Federal Food, Drug, and Cosmetic Act; GSK paid $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.[67] The remaining $2 billion were part of the civil settlement over (1) promoting the drugs Paxil, Wellbutrin, Advair, Lamictal and Zofran for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex; (2) making false and misleading statements concerning the safety of Avandia; and (3) reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.[67] GSK also signed a five-year Corporate Integrity Agreement with the U.S. Department of Health and Human Services, which obligated GSK to make major changes to the way it did business, including changing the way its sales force is compensated and its executive compensation program, and to implement and maintain transparency in its research practices and publication policies.[67] The government investigation was launched largely on the basis of information provided by four whistleblowers who filed qui tam (whistleblower) lawsuits against the company under the U.S. False Claims Act.[68]

Rosiglitazone (Avandia)

Rosiglitazone

Studies of the cardioivascular safety of rosiglitazone have yielded inconsistent results.[69] On 14 June 2007 a meta-analysis by Steve Nissen, Chair of the Division of Cardiovascular Medicine at the Cleveland Clinic, published in the New England Journal of Medicine, showed an increased odds ratio of myocardial infarction in patients taking rosiglitazone, marketed as Avandia. The New York Times published an article detailing Nissen's conversation with pharmaceutical executives; the conversations were recorded, unbeknownst to the GSK executives. In February 2010 GSK tried to suppress publication of a critical article[70] concerning rosiglitazone.[71] In July a US Finance Committee Letter asserted GSK had "to publish studies in a timely manner that found problems with Avandia."[72] In November 2007 a United States congressional committee released a report describing intimidation of Dr. John Buse (University of North Carolina at Chapel Hill) by GSK over his concerns about the cardiovascular risks associated with rosiglitazone.[73]

In 2013 the FDA held a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the results of RECORD, an open label, randomized trial comparing rosiglitazone to the combination of a sulfonylurea with metformin.[74] In contrast to the mostly short term trials included in the Nissen meta analysis, RECORD was specifically designed specifically to examine cardiovascular safety in a trial of 14,000 people observed over 3 years or more. An independent analysis of the data from this trial conducted at the Duke Clinical Research Institute found a non-statistically significant reduction in all-cause mortality, for rosiglitazone compared to the combination of metformin with a sulfonylurea (hazard ratio 0.86) and a non-statistically significant increase in the risk of myocardial infarction (hazard ratio 1.15). The reliability of the conclusions of the RECORD trial has been criticized based on its open label design and the low rate of cardiovascular events observed, which limits its statistical power.[75]

In November 2013, the US FDA lifted restrictions on the sale of Avandia, stating that the results of the RECORD trial had failed to confirm Nissen's analysis.[76]

Paroxetine

Main article: Paroxetine § Society and culture

Glaxo-SmithKline has paid substantial fines, paid settlements in class action lawsuits, and become the subject of several highly critical books in relation to its marketing of paroxetine, in particular the off-label marketing of paroxetine to children, the suppression of negative research results relating to its use in children, and allegations that it failed to warn consumers of substantial withdrawal effects associated with use of the drug.

SB Pharmco Puerto Rico

In October 2010 the US Department of Justice announced that SB Pharmco Puerto Rico Inc., a subsidiary of GSK, agreed to pay $750 million in fines related to problems at GSK's premier manufacturing plant in Puerto Rico between 2001 and 2005. The factory had been closed by GSK in 2009.[77] GSK agreed to pay the settlement in response to complaints stemming from production of adulterated drugs at its manufacturing plant in Puerto Rico, which at the time produced $5.5 billion of products each year.[78] According to the New York Times, the case began in 2002 when GSK sent a team of quality experts to fix problems cited by an FDA warning letter a month earlier. The lead inspector complained to senior managers and recommended recalls of defective products, but they were not authorised, and she was fired in 2003. She eventually notified the FDA 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 pled 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.[78]

Other

  • A bribery investigation was opened in Bavaria, Germany in 1999, with thousands of doctors and nearly all of SmithKline Beecham's sales force under investigation; by 2004, only 71 doctors and dozens of employees remained under investigation.[79][80] As of 2014, further information on the outcome of the German investigations was not available.
  • On 12 September 2006 GSK settled the largest tax dispute in IRS history, agreeing to pay $3.1 billion. At issue in the case were Zantac and the other Glaxo Group heritage products sold in 1989–2005. The case was about an area of taxation dealing with intracompany "transfer pricing"—determining the share of profit attributable to the US subsidiaries of GSK and subject to tax by the IRS. Taxes for large multi-divisional companies are paid to revenue authorities based on the profits reported in particular tax jurisdictions, so how profits were allocated among various legacy Glaxo divisions based on the functions they performed was central to the dispute in this case.[81][82]
  • In July 2013 Chinese authorities announced that since 2007 more than 700 travel agencies and consulting firms had been used by GSK to funnel nearly three billion yuan (HK$3.8 billion) in kickbacks to GSK managers, doctors, hospitals and others who prescribed their drugs.[83] GSK issued a statement expressing concern and disappointment, and said it would co-operate with the investigation.[84] In July the company admitted that some of its senior Chinese executives broke the law; Chinese authorities arrested four executives as part of a four-month investigation into claims that doctors were bribed with cash and sexual favours in return for prescribing GSK's drugs.[85] By July 2014 the four executives had yet to be put on trial, when a former GSK investigator described the bribery claims as credible. In September 2014, a Chinese court found the company guilty of bribery, fined the company $490 million, and gave Mark Reilly, the former head of Chinese operations, a three-year suspended prison sentence.[86]
  • In May 2014, the UK's Serious Fraud Office launched a formal criminal investigation using powers granted by the Bribery Act 2010 into commercial practices at GSK, but it was not revealed what connection there was to other investigations.[87][88]

Ribena

Main article: Ribena
photograph
Ready-to-drink Ribena

Ribena is an English brand of blackcurrant-based uncarbonated and carbonated soft drink and fruit drink concentrate originally marketed by HW Carter in the 1930s. The brand originally had a strong reputation as a healthy product for children in the UK and commonwealth, stemming from its distribution to children as a vitamin C supplement during World War II by the British government.[89] Beecham bought HW Carter in 1955 and developed many soft drink versions. A series of scandals in the 2000s concerning vitamin C levels, sugar levels, and the amounts of actual fruit in some of the brands, along with criminal cases of deceptive advertising in New Zealand over vitamin C levels and a case of deceptive advertising in the UK over sugar levels and damage to teeth, damaged the brand's reputation as a healthy product; GSK was criticized not only for the problems but for their handling of them.[89]

By 2013 the brand was widely seen as being similar to other soft drinks. In 2013 annual worldwide sales were around £500M (approximately US$747.25M). That year, GSK sold Ribena and another consumer line, Lucozade, to the Japanese multinational Suntory for for £1.35 billion.[90][91]

See also

References

  1. ^ a b c "Preliminary Results 2014" (PDF). Retrieved 15 March 2015.
  2. ^ "About us". GlaxoSmithKline. Retrieved 15 May 2015.
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