GLAXOSMITHKLINE PLC (GSK) is a British pharmaceutical company
Brentford , London. Established in 2000 by a merger
Glaxo Wellcome and SmithKline Beecham, GSK was the world's sixth
largest pharmaceutical company as of 2015, after
The company has a primary listing on the
London Stock Exchange
GSK's drugs and vaccines earned £21.3 billion in 2013. Its
top-selling products that year were
In 2012, GSK pleaded guilty to promotion of drugs for unapproved uses, failure to report safety data, and kickbacks to physicians in the United States and agreed to pay a $3 billion (£1.9bn) settlement, the largest settlement in the country by a drug company.
* 1 History
* 2 Research, products
* 2.1 Pharmaceuticals * 2.2 Malaria vaccine * 2.3 Consumer healthcare * 2.4 Facilities * 2.5 Scientific recognition
* 3 Operations and acquisitions since 2001
* 3.1 2001–2010 * 3.2 2011–present
* 4 Philanthropy and social responsibility
* 5 2012 criminal and civil settlement
* 6 Other controversies
* 7 Diagram of acquisition history * 8 See also * 9 Notes * 10 References * 11 External links
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 Edward Nathan . In 1904 it began producing dried-milk baby food, first known as Defiance, then as Glaxo (from _lacto_), under the slogan "Glaxo builds bonny babies." :306 The Glaxo Laboratories sign is still visible _(right)_ on what is now a car repair shop on the main street of Bunnythorpe. The company's first pharmaceutical product, produced in 1920, was vitamin D. :306
Glaxo Laboratories opened new units in
Burroughs Wellcome ">:18 which served as the US headquarters until the company moved to Research Triangle Park in North Carolina in 1971. The Nobel Prize winning scientists Gertrude B. Elion and George H. Hitchings worked there and invented drugs still used many years later, such as mercaptopurine . In 1959 the Wellcome Company bought Cooper, McDougall ">:309 Glaxo restructured its R&D operation that year, cutting 10,000 jobs worldwide, closing its R&D facility in Beckenham, Kent, and opening a Medicines Research Centre in Stevenage, Hertfordshire. Also that year, Glaxo Wellcome acquired the California-based Affymax, a leader in the field of combinatorial chemistry .
Glaxo Wellcome had become the world's third-largest
pharmaceutical company by revenues (behind
In 1843 Thomas Beecham launched his Beecham\'s Pills laxative in
England, giving birth to the
Beecham Group . In 1859 Beecham opened
its first factory in St Helens ,
John K. Smith opened his first pharmacy in
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 United States to England. To expand R another opened in 1997
in England at New Frontiers Science Park,
Glaxo Wellcome and SmithKline Beecham announced their intention to
merge in January 2000. The merger was completed in December that year,
SR One was established in 1985 by SmithKline Beecham to invest in new biotechnology companies and continued operating after GSK was formed; by 2003 GSK had formed another subsidiary, GSK Ventures, to out-license or start new companies around drug candidates that it did not intend to develop further. As of 2003, SR One tended to invest only if the company aligned with GSK's business.
SR One was led by:
* 1985 to 1999: Peter Sears * 1999 to 2001: Brenda Gavin * 2001 to 2003: Barbara Dalton * 2004 to ? Maxine Gowen * ? to ?: Joyce Lonergan * ? to ?: Tamar Howson * 2008 to 2010: Russell Greig * 2010 to 2011: Christoph Westphal * 2011: Jens Eckstein
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
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 , cimetidine and ranitidine for gastroesophageal reflux disorder , mercaptopurine and thioguanine for the treatment of leukemia, allopurinol for gout , pyrimethamine for malaria , and the antibacterial trimethoprim .
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.
In 2014 GSK applied for regulatory approval for the first malaria vaccine . Malaria is responsible for over 650,000 deaths annually, mainly in Africa. 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.
As of 2013 RTS,S, which uses GSK's proprietary AS01 adjuvant, was being examined in a Phase 3 trial in eight African countries. PATH reported that "n the 12-month period following vaccination, RTS,S conferred approximately 50% protection from clinical Plasmodium falciparum disease in children aged 5-17 months, and approximately 30% protection in children aged 6-12 weeks when administered in conjunction with Expanded Program for Immunization (EPI) vaccines." In 2014 Glaxo said it had spent more than $350 million and expected to spend an additional $260 million before seeking regulatory approval. A second generation malaria vaccine is being evaluated in Phase 2 clinical trials.
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 and a
chocolate-flavoured malt drink sold in India. GSK also previously
Ribena brands of soft drinks, but they were
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
Nicorette nicotine replacements. In March
2014 it recalled Alli , an over-the-counter weight-loss drug, in the
United States and
As of 2013 GSK had offices in over 115 countries and employed over 99,000 people, 12,500 in R its consumer-products division is in Moon Township, Pennsylvania . :7 Company facilities include:
* R&D sites: England (
* 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 . * 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. * 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 and thioguanine for the treatment of leukemia, the immunosuppressant azothioprine, allopurinol for gout, pyrimethamine for malaria, the antibacterial trimethoprim, acyclovir for herpes virus infection, and nelarabine for cancer treatment.
OPERATIONS AND ACQUISITIONS SINCE 2001
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. In 2006 GSK acquired the US-based consumer healthcare company CNS Inc., whose products included Breathe Right nasal strips and FiberChoice dietary supplements, for US$566 million in cash.
GSK opened its first R the companies had collaborated on developing the lupus drug Belimumab (Benlysta), albiglutide for type 2 diabetes , and darapladib for atherosclerosis .
In March 2014 GSK paid $1 billion to raise its stake in its Indian
In September 2016 the company announced that Witty would be succeeded
as CEO by
Emma Walmsley in March 2017; Walmsley was a management
professional originally from
PHILANTHROPY AND SOCIAL RESPONSIBILITY
GlaxoSmithKline, Center City, Philadelphia
GSK has been active, with the
World Health Organization (WHO), in the
Global Alliance to Eliminate Lymphatic
In 2009 the company said it would cut drug prices by 25 percent in 50 of the poorest nations, release intellectual property rights for substances and processes relevant to neglected disease into a patent pool to encourage new drug development, and invest 20 percent of profits from the least-developed countries in medical infrastructure for those countries. Médecins Sans Frontières welcomed the decision, but criticized GSK for failing to include HIV patents in its patent pool and for not including middle-income countries in the initiative.
In 2013 GSK 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. In 2014 this license was extended to include dolutegravir and adults with HIV. The licenses include countries in which 93 percent of adults and 99 percent of children with HIV live. Also 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.
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 settlement included a criminal fine of $242,612,800 for failing to report safety data to the FDA about Avandia (rosiglitazone ), a diabetes drug approved in 1999, and a civil settlement of $657 million for making false claims about it. The Justice Department said GSK had promoted rosiglitazone to physicians with misleading information, including that it conferred cardiovascular benefits despite an FDA-mandated label warning of cardiovascular risks.
In 1999 John Buse , a diabetes specialist, told medical conferences that rosiglitazone might carry an increased risk of cardiovascular problems. GSK threatened to sue him, called his university head of department, and persuaded him to sign a retraction. 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. From 2001 reports began to link the thiazolidinediones (the class of drugs to which rosiglitazone belongs) to heart failure . In April that year GSK began a six-year, open-label , randomized trial , known as RECORD, to examine rosiglitazone and cardiovascular events. Two GSK meta-analyses in 2005 and 2006 showed an increased risk of cardiovascular problems with rosiglitazone; the information was passed to the FDA and posted on the company website, but not otherwise published. By December 2006 rosiglitazone had become the top-selling diabetes drug, with annual sales of US$3.3 billion.
In June 2007 the _New England Journal of Medicine_ published a meta-analysis that associated the drug with an increased risk of heart attack . 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. 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 , but did not withdraw it. (In 2013 the FDA rejected that the drug had caused excess heart attacks.) A Senate Finance Committee inquiry concluded in 2010 that GSK had sought to intimidate scientists who had concerns about rosiglitazone. In February that year the company tried to halt publication of an editorial about the controversy by Nissen in the _European Heart Journal_.
The 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." Steven Nissan and Kathy Wolkski argued that the study's 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.
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. Paxil had $4.97 billion worldwide sales in 2003. The company conducted nine clinical trials between 1994 and 2002, none of which showed that Paxil helped children with depression. 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. 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.
An internal SmithKline Beecham document said in 1998, about withheld data from two GSK studies: "It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine." The 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 . The article concluded that Paxil was "generally well tolerated and effective for major depression in adolescents." The suppression of the research findings is the subject of _Side Effects _ (2008) by Alison Bass .
For 10 years GSK marketed Paxil as non-habit forming. In 2001 35 patients filed a class-action suit alleging they had suffered withdrawal symptoms, and in 2002, a Los Angeles court issued an injunction preventing GSK from advertising that the drug was not habit forming. The court withdrew the injunction after the FDA objected that the court had no jurisdiction over drug marketing that the FDA had approved. In 2003, a World Health Organization committee reported that Paxil was among the top 30 drugs, and top three antidepressants, for which dependence had been reported.
The 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.
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 . :54, nn. 1–2 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. :54–55 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.
The United States brought an antitrust suit against the two companies—_ United States v. Glaxo Group Ltd. _—charging them with violation of the Sherman Act and also seeking to have the patents declared invalid. :55 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. :56 The government appealed to the Supreme Court, which reversed, in _ United States v. Glaxo Group Ltd. _, 410 U.S. 52 (1973).
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 Bactroban , used to treat skin infections; Paxil, the anti-depressant; and Avandamet , a diabetes drug. GSK closed the factory in 2009.
According to the _New York Times_, the case began in 2002 when GSK sent experts to fix problems cited by the FDA. The lead inspector recommended recalls of defective products, but they were not authorized; she was fired in 2003 and filed a whistleblower lawsuit. In 2005 federal marshals seized $2 billion worth of products, the largest such seizure in history. In the 2010 settlement SB Pharmco plead 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.
In 2013 Chinese authorities announced that, since 2007, GSK had funnelled HK$3.8 billion in kickbacks to GSK managers, doctors, hospitals and others who prescribed their drugs, using over 700 travel agencies and consulting firms. Chinese authorities arrested four GSK executives as part of a four-month investigation into claims that doctors were bribed with cash and sexual favours. In 2014 a Chinese court found the company guilty of bribery and 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. Reilly was reportedly deported from China and dismissed by the company.
MARKET MANIPULATION IN THE UK
In February 2016 the company was fined more than £37 million by the
Competition and Markets Authority for paying Generics UK, Alpharma and
Norton Healthcare more than £50m between 2001 and 2004, in order to
keep generic varieties of
Italian police sought bribery charges in May 2004 against 4,400 doctors and 273 GSK employees. GSK and its predecessor were accused of having spent £152m on physicians, pharmacists and others, giving them cameras, computers, holidays and cash. Doctors were alleged to have received cash based on the number of patients they treated with a cancer drug, topotecan (Hycamtin). The following month prosecutors in Munich accused 70–100 doctors of having accepted bribes from SmithKline Beecham between 1997 and 1999. The inquiry was opened over allegations that the company had given over 4,000 hospital doctors money and free trips. All charges were dismissed by the Verona court in January 2009.
In 2006 in the United States GSK settled the largest tax dispute in IRS history, agreeing to pay $3.1 billion. At issue were Zantac and other products sold in 1989–2005. The case revolved around intracompany transfer pricing —determining the share of profit attributable to the US subsidiaries of GSK and subject to tax by the IRS.
The UK's Serious Fraud Office (SFO) opened a criminal inquiry in 2014 into GSK's sales practices, using powers granted by the Bribery Act 2010 . The SFO said it was collaborating with Chinese authorities to investigate bringing charges in the UK related to GSK's activities in China, Europe and the Middle East. Also as of 2014 the US Department of Justice was investigating GSK with reference to the Foreign Corrupt Practices Act .
DIAGRAM OF ACQUISITION HISTORY
The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):
SmithKline Beecham plc (renamed 1989)
SmithKline Beckman (renamed 1982)
SmithKline-RIT (renamed 1968)
Smith, Kline padding:0;">
French, Richards and Company (Acq 1891)
Smith, Kline and Company (Founded 1830)
Lever Brothers (Angio-seal div. Acq 1900
Recherche et Industrie Thérapeutiques (Acq 1968)
Beckman Instruments, Inc. (Merged 1982, Sold 1989)
Specialized Instruments Corp. (Acq 1954)
Offner Electronics (Acq 1961)
Allergan (Acq 1982, Sold 1989)
International Clinical Laboratories (Acq 1989)
Reckitt border-left:1px solid;vertical-align:top;text-align:center;">
Stiefel Laboratories (Acq 2000 by SmithKline Beckman)
Sanofi-Synthelabo (Acq 2001)
Beecham Group Plc (merged 1989)
Norcliff Thayer (Acq 1986)
Beecham Group Ltd
S. E. Massengill Company (Acq 1971)
Beecham Group Ltd (Renamed 1945)
C.L. Bencard (Acq 1953)
County Chemicals (Acq 1929)
Glaxo Wellcome (Renamed 1995)
Glaxo (Merged 1995)
Glaxo (Founded 1850)
Joseph Nathan (Acq 1947)
Allen border-left:1px solid;vertical-align:top;text-align:center;">
Margarine Unie (Angio-seal div, Acq 1924)
Meyer Laboratories (Acq 1978)
Affymax (Acq 1995)
Burroughs Wellcome (Merged 1995)
McDougall border-left:1px solid;vertical-align:top;text-align:center;">
Burroughs Wellcome vertical-align:top;text-align:center;">
Block Drug (Acq 2001)
CNS Inc. (Acq 2006)
Stiefel Laboratories (Acq 2009)
Laboratorios Phoenix (Acq 2010)
Maxinutrition (Acq 2010)
CellZome (Acq 2011)
Human Genome Sciences (Acq 2013)
GSK Cancer division (Sold 2014 to Novartis)
GlycoVaxyn (Acq 2015)
* Companies portal
* ^ 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 . * ^ 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."
* ^ _A_ _B_ _C_ "Annual Report 2016" (PDF). Retrieved 7 April 2017.
* ^ "GlaxoSmithKline". Statista. Retrieved 7 April 2017.
* ^ "The World\'s Biggest Public Companies", 2015 ranking,
* ^ "FTSE All-Share Index Ranking". stockchallenge.co.uk.
* ^ _A_ _B_ _C_ "Annual Report 2013" (PDF). GlaxoSmithKline.
Retrieved 26 May 2014.
* ^ "Products".
* ^ _A_ _B_ Hester Plumridge (24 July 2014). "Glaxo Files Its Entry in Race for a Malaria Vaccine". _Wall Street Journal_.
Laura Lorenzetti (24 July 2014). "
Simon Neville, "
* ^ Ben Hirschler (24 May 2007). "Glaxo China R&D centre to target neurodegeneration". Reuters.
David Cyranoski (29 October 2008). "
Pharmaceutical futures: Made in
China?". _Nature_. * ^ "Corporate Executive Team",
GlaxoSmithKline. Retrieved 16 November 2013. Archived 14 October 2012
Wayback Machine .
* ^ "Andrew Witty\'s journey from Graduate to GSK CEO",
GlaxoSmithKline, 12 August 2008; "Andrew Philip Witty", _Bloomberg_.
* ^ Graham Ruddick (20 April 2009). "
* ^ "Private and Public Partners Unite to Combat 10 Neglected Tropical Diseases by 2020". Bill & Melinda Gates Foundation. 30 January 2012.
"Research-based pharma pledges on neglected tropical diseases". _The
Pharma Letter_. 31 January 2012. * ^ "Global programme to
eliminate lymphatic filariasis: progress report, 2014" (PDF). World
Health Organization. 18 September 2015. p. 490.
* ^ Sarah Boseley, "Drug giant
Jim Edwards, "Inside GSK\'s CASSPER Ghostwriting Program", CBS News, 21 August 2009. * ^ "GSK to stop paying doctors in major marketing overhaul", Thomson/Reuters, 17 December 2013. * ^ "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.
Haffner SM, et al. (2002). "", 2002 "Effect of Rosiglitazone Treatment on Nontraditional Markers of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus". _Circulation_. 106 (6): 679–684. PMID 12163427 . doi :10.1161/01.CIR.0000025403.20953.23 . * ^ _A_ _B_ Nissen SE (2010). "The rise and fall of rosiglitazone". _European Heart Journal_. 31 (7): 773–776. PMID 20154334 . doi :10.1093/eurheartj/ehq016 . see table 1 for timeline.
* ^ _A_ _B_ 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. * ^ Nissen SE, Wolski K (2007). "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes". _New England Journal of Medicine_. 356 (24): 2457–2471. PMID 17517853 . doi :10.1056/NEJMoa072761 . 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.
* ^ 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.
* ^ _A_ _B_ "Staff report on
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.
* ^ _A_ _B_ "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 (23 April 2010). "Standing firm—the European Heart Journal, scientific controversies and the industry". _European Heart Journal_. 31 (10): 1157–1158. doi :10.1093/eurheartj/ehq127 . Steven E. Nissen, "The rise and fall of rosiglitazone," _European Heart Journal_, 31(7), April 2010, pp. 773–776. doi :10.1093/eurheartj/ehq016 PMID 20154334 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 * ^ Steven E. Nissen,
Kathy Wolski, "
Rosiglitazone RevisitedAn Updated
* ^ "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.
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