|Public limited company|
|Traded as||LSE: GSK
Beecham Group plc
Kline & French
|Chris Gent (Chairman)
Andrew Witty (CEO)
|Products||Pharmaceuticals, vaccines, oral healthcare products, nutritional products, over-the-counter medicines|
|Revenue||£23.006 billion (2014)|
|£3.597 billion (2014)|
|£2.831 billion (2014)|
Number of employees
|Over 100,000 (2015)|
|Slogan||"Do more, feel better, live longer"|
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 merger of Beecham Group 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. It has a secondary listing on the New York Stock Exchange. Andrew Witty has been the chief executive officer since May 2008.
GSK manufactures drugs and vaccines for major disease areas such as asthma, cancer, infections, diabetes and mental-health 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 in developing countries for five percent above cost. GSK's consumer healthcare division, which earned £5.2 billion in 2013, sells over-the-counter medicines, oral healthcare, nutritional products and drinks, including Sensodyne and Horlicks.
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.
- 1 History
- 2 Products
- 3 Facilities, employees
- 4 Operations and acquisitions
- 5 Political activity, philanthropy
- 6 Controversies
- 7 See also
- 8 References
- 9 External links
Glaxo was founded by a Londoner, Joseph Nathan, in the 1850s in Bunnythorpe, New Zealand, as a general trading company. 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 on what is now a car repair shop on the main street of Bunnythorpe.
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 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 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 and Glaxo merged in 1995 to form Glaxo Wellcome. Glaxo restructured is 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 in that year, Glaxo Wellcome acquired the California-based Affymax, a leader in the field of combinatorial chemistry.
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. 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). As of 2000 seven of its products were among the world's top 50 best-selling pharmaceutical products, and it was the world's largest maker of drugs for the treatment of asthma and HIV/AIDS. It employed 59,000 people worldwide, including 13,400 in the UK, had 76 operating companies and 50 manufacturing facilities worldwide. In the UK the company had R&D facilities at Ware and Stevenage, Hertfordshire, Dartford and Beckenham, Kent, Greenford in London, and manufacturing plants at Ulverston in Cumbria, Barnard Castle in County Durham, Speke on Merseyside, and Montrose in north-east Scotland. Outside the UK, it had R&D centres in North Carolina, United States and Japan, and production facilities in the United States, Europe and the Far East.
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. 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.
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. Glaxo Wellcome and SmithKline Beecham announced their intention to merge in January 2000; the merger was completed in December that year, forming GlaxoSmithKline (GSK).
GSK House, world headquarters of GlaxoSmithKline in Brentford, London
GSK manufactures drugs and vaccines for major disease areas such as asthma, cancer, infections, diabetes and mental-health conditions. Its biggest-selling products 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.:220
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.
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.:7 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:
- R&D sites in Stockley Park, Stevenage and Ware, England; Zagreb, Croatia; Évreux and Les Ulis, France; Research Triangle Park, North Carolina, and Collegeville, Pennsylvania, US; Laval, Quebec, Canada; Shanghai, China; and Nashik, Maharashtra, India.
- Centres for biopharmaceutical products in Wavre and Rixensart, Belgium; Dresden, Germany; Gödöllő, Hungary; Quebec City, Canada; Marietta, Pennsylvania and Hamilton, Montana, US.
- Manufacturing sites for prescription products in Irvine and Montrose, Scotland; Ware, Barnard Castle, Worthing and Ulverston, England; Cork, Ireland; Évreux, France; Poznań, Poland; Parma, Italy; Brașov, Romania; Brussels, Belgium; Bristol, Tennessee, King of Prussia, Pennsylvania and Zebulon, North Carolina, US; Cidra, Puerto Rico; Jurong, Singapore; Ulu Klang, Malaysia; Boronia, Australia.
- Manufacturing sites for consumer products in Maidenhead, England; Dungarvan, Ireland; Mississauga, Ontario, Canada; Aiken, South Carolina, Oak Hill, New York and St. Louis, Missouri, US; and Kenya; Rio de Janeiro, Brazil.
Operations and acquisitions
In 2001 GSK completed the acquisition of New Jersey-based Block Drug for US$1.24 billion. 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. In 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. GSK opened its first R&D centre in China in 2007, located in Shanghai and initially focused on neurodegenerative diseases.
In 2009 GSK acquired Stiefel Laboratories, the world's largest independent dermatology drug company at the time, for US$3.6bn. On 16 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). 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 for $3 billion. HGS and GSK had collaborated on the development of the lupus drug Belimumab (Benlysta) and 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
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.
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 "[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." 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
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.
The 2012 criminal fine included $242,612,800 for failing to report safety data to the FDA about Avandia (rosiglitazone), a diabetes drug approved in 1999. That year John Buse, a diabetes specialist, told medical conferences that the drug might carry an increased risk of cardiovascular problems; GSK threatened to sue, called his university's department head and persuaded Buse to sign a retraction. A congressional inquiry reported that GSK had raised questions internally about the drug's safety in 2000, and that at least one academic article about rosiglitazone had been ghostwritten by GSK. Published in Circulation in 2002, the article described a company-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. In 2005 and 2006 two GSK meta-analyses 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 June 2007 a meta-analysis by Steven Nissen and Kathy Wolski, published 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 the article, 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.:4 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.:2ff 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)
Paroxetine is an SSRI anti-depressant released by GSK in 1992, sold as Paxil, Seroxat, Aropax, Brisdelle, Pexeva and Sereupin. GSK paid substantial fines, as well as settlements in class-action lawsuits, in relation to its marketing of the drug, 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. For 10 years the drug was marketed as "not habit forming". In 2003 the World Health Organization reported that it was among the top 30 drugs, and top three antidepressants, for which dependence had been reported (91 cases). In 2004 GSK agreed to settle charges of consumer fraud for $2.5 million; the drug had annual sales worth $2.7 billion at the time. The suppression of the unfavorable research findings was the subject of Side Effects (2008) by Alison Bass.
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. 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. 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.
Originally marketed by HW Carter in the 1930s, Ribena is a blackcurrant-based soft drink that had a reputation as a healthy product in the 20th century in the UK and Commonwealth; this stemmed from its use as a source of Vitamin C for children during World War II. Beecham bought HW Carter in 1955. A series of scandals in the 2000s damaged its reputation. In 2001 the Advertising Standards Authority in the UK ruled that GSK's claim that Ribena Toothkind, which contains sugar, did not encourage tooth decay was misleading. The drink's sugar content is lower than regular Ribena; company ads included a poster showing bottles of Toothkind in place of the bristles on a toothbrush. The ruling was upheld by the High Court.
In 2007 GSK pleaded guilty to 15 charges brought by New Zealand's Commerce Commission over the claim that ready-to-drink Ribena contained high levels of vitamin C. The Commission's testing 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.
- In 2002 German prosecutors opened a bribery inquiry after allegations that GSK had given over 4,000 hospital doctors money and free trips. Two years later Italian police sought bribery charges against almost 5000 people, including 273 GSK employees. GSK and its predecessor were accused of having spent £152m on cameras, computers, holidays and cash for thousands of physicians, pharmacists and others. Doctors were alleged to have received cash based on the number of patients treated with a certain drug.
- In September 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.
- In July 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 September 2014 a Chinese court found the company guilty of bribery, imposed a fine of $490 million, and gave Mark Reilly, the former head of Chinese operations, a three-year suspended prison sentence.
- In May 2014 the UK's Serious Fraud Office (SFO) opened a criminal inquiry into GSK's sales practices, using powers granted by the Bribery Act 2010. The SFO said it had been collaborating with Chinese authorities to investigate bringing charges in the UK related to GSK's activities in China, Europe and the Middle East.
- As of 2014 the US Department of Justice was investigating GSK with reference to the Foreign Corrupt Practices Act.
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- "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".
- 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
- "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".[dead link]
- Donald G. McNeil Jr (18 October 2011). "Glaxo's RTS, S Malaria Vaccine Shows Promise, Scientists Say". The New York Times.
- "www.gsk.com" (PDF).
- "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.
- 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.
- "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 that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. 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."
- "The Intimidation of Dr. John Buse and the Diabetes Drug Avandia", Committee on Finance, United States Senate, November 2007, pp. 2–4.
- 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. PubMed doi:10.1161/01.CIR.0000025403.20953.23
- Steven E. Nissen, "The rise and fall of rosiglitazone," European Heart Journal, 31(7), April 2010, pp. 773–776; see table 1 for timeline. PubMed doi:10.1093/eurheartj/ehq016
- 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." PubMed 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. PubMed doi:10.1007/s00125-005-1869-1
- 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." PubMed doi:10.1056/NEJMoa072761
- 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.
- "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.
- David Graham, "Assessment of the cardiovascular risks and health benefits of rosiglitazone", Office of Surveillance and Epidemiology, Food and Drug Administration, 30 July 2007.
- "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.
- "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.
- 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.
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. PubMed doi:10.1093/eurheartj/ehp604
- 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." PubMed doi:10.1001/archinternmed.2010.207
- "European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim", European Medicines Agency, 23 September 2010.
- 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. PubMed doi:10.1016/j.ahj.2013.05.004
- "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.
- "Glaxo Agrees to Pay $3 Billion in Fraud Settlement". The New York Times. 2 July 2012.
- "Judge: Paxil ads can't say it isn't habit-forming". USA Today. 20 August 2002.
- Simon Garfield (29 April 2002). "The Chemistry of Happiness". The Guardian.
- W. Kondro and B. Sibbald (March 2004). "Drug company experts advised staff to withhold data about SSRI use in children". CMAJ 170 (5): 783. doi:10.1503/cmaj.1040213. PMC 343848. PMID 14993169.
- "WHO Expert Committee on Drug Dependence - Thirty-third Report", - WHO Technical Report Series, No. 915, 2003, pp. 20, 25.
- Marcia Angell (15 January 2009). "Drug Companies & Doctors: A Story of Corruption". New York Review of Books 56 (1).
- Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, Algonquin Books of Chapel Hill, 2008.
- U.S. Department of Justice Press Release. 26 October 2010 GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant
- "Glaxo to Pay $750 Million for Sale of Bad Products". The New York Times. 27 October 2010.
- Tony Jaques, "When an Icon Stumbles – The Ribena Issue Mismanaged, Corporate Communications: An International Journal, 13(4), 2008, pp. 394–406.
- Linus Gregoriadis, "Makers of Ribena lose fight over anti-decay claims", The Daily Telegraph, 18 January 2001.
- David Eames (28 March 2007). "NZ Herald".
- "Glaxo probed over doctor freebies", BBC News, 12 March 2002; Jane Burgermeister, German prosecutors probe again into bribes by drug companies, BMJ, 328, 5 June 2004.
- John Hooper, Heather Stewart, "Over 4,000 doctors face charges in Italian drugs scandal", The Guardian, 27 May 2004.
- "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.
- 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.
- Rupert Neate and Angela Monaghan, GlaxoSmithKline admits some staff in China involved in bribery , The Guardian, 22 July 2013.
Tom Philips (26 July 2013). "Chinese police allege Glaxo sales reps trained to offer sexual bribes". The Daily Telegraph.
- "China fines GlaxoSmithKline $490m over bribery". BBC. 19 September 2014. Retrieved 19 September 2014.
- Julia Kollewe (28 May 2014). "GlaxoSmithKline faces criminal investigation by Serious Fraud Office". The Guardian.
- Kirsten Ridley, "UK fraud office liaising with China on GSK bribery case", Reuters, 23 July 2014.
- "GlaxoSmithKline faces bribery claims in Syria", Reuters, 12 August 2014.
- Official website
- GlaxoSmithKline companies grouped at OpenCorporates
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