Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, January 29, 2009

GSK Controvosy

Source: Nation Master

Controversy

Paroxetine (Seroxat, Paxil) is an SSRI antidepressant released in 1992 by GlaxoSmithKline. In March 2004 the FDA ordered a black box warning placed on SSRI and other antidepressants, warning of the risk for potential suicidal thinking in children and adolescents. Since the FDA approved paroxetine in 1992, approximately 5,000 U.S. citizens have sued GSK. On January 29 2007, the BBC in the UK broadcast a fourth documentary in its 'Panorama' series about Seroxat.[4] One clinical trial indicated that adolescents were six times more likely to become suicidal after taking it.


In November 2007, a United States Congressional committee released a report [5] describing intimidation of Dr John Buse (University of North Carolina at Chapel Hill[6][7]) by GlaxoSmithKline over his concerns about the cardiovascular risks associated with the company's antidiabetes drug Rosiglitazone (Avandia).[8]


In March 2006, California Attorney General Bill Lockyer announced that "GlaxoSmithKline (GSK) will pay $14 million to resolve allegations that state-government programs paid inflated prices for the firm’s anti-depressant drug Paxil because GSK engaged in patent fraud, antitrust violations and frivolous litigation to maintain a monopoly and block generic versions from entering the market."[9]


At the AGM on 19 May 2003, GSK shareholders rejected a motion regarding a £22 million pay and benefits package for CEO, JP Garnier. This was the first time such a rebellion by shareholders against a major British company has occurred, but was regarded as a possible turning point against other so-called "fat cat" deals within executive pay structure.


The company and its shareholders have been targeted by animal rights activists because it is a customer of the controversial animal-testing company, Huntingdon Life Sciences (HLS).[10] HLS has been the subject since 1999 of an international campaign by Stop Huntingdon Animal Cruelty (SHAC) and the Animal Liberation Front (ALF), ever since footage shot covertly by People for the Ethical Treatment of Animals (PETA), which was shown on British television, showed staff punching, kicking, screaming and laughing at the animals in their care. On September 7, 2005, the ALF detonated a bomb containing two litres of fuel and four pounds of explosives on the doorstop of the Buckinghamshire home of Paul Blackburn, GSK's corporate controller, causing minor damage.


In November 2005, AIDS Healthcare Foundation accused the company of boosting its short-term monopoly profit by not increasing production of the anti-AIDS drug AZT despite a surge in demand, hence creating a shortage that affected many AIDS patients in Africa. GSK announced that it had halted clinical trials of the CCR5 entry inhibitor, aplaviroc (GW873140), in HIV-infected, treatment-naive patients because of concerns about severe hepatotoxicity.[11] In June of 2006 GSK said it was further cutting, by about 30%, the not-for-profit prices it charges for some of these medicines in the world's poorest countries.[12]

Legal


In 2003 GSK signed a corporate integrity agreement and paid $88 million in a civil fine for overcharging Medicaid for the antidepressant Paxil, and nasal-allergy spray Flonase. Later that year GSK also ran afoul of the Internal Revenue Service (IRS) and was facing a demand for $7.8 billion in backdated taxes and interest, the highest in IRS history. Medicaid is the US health insurance program for individuals and families with low incomes and resources. ...

On September 12, 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 from 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.[13]


In February 2007, the Serious Fraud Office in the UK launched an investigation into allegations of GSK being involved in the discredited oil-for-food sanctions regime in Iraq. They are accused of paying bribes to Saddam Hussein's regime.[14]

Paroxetine


On December 22, 2006, a US court decided in Hoorman, et al. v. SmithKline Beecham Corp that individuals who purchased Paxil(R) or Paxil CR(TM) (paroxetine) for a minor child may be eligible for benefits under a $63.8 million Proposed Settlement.[15] The lawsuit won the argument that GSK promoted Paxil(R) or Paxil CR(TM) for prescription to children and adolescents while withholding and concealing material information about the medication's safety and effectiveness for minors.

The lawsuit stemmed from a consumer advocate protest against Paroxetine manufacturer GSK. Since the FDA approved paroxetine in 1992, approximately 5,000 U.S. citizens and thousands more worldwide – have sued GSK. Most of these people feel they were not sufficiently warned in advance of the drug's side effects and addictive properties.


According to the Paxil Protest website, http://www.paxilprotest.com/, hundreds more lawsuits have been filed against GSK.[16] The Paxil Protest website was launched August 8, 2005 to offer both information about the protest and information on Paxil previously unavailable to the public. Just three weeks after its launch, the site received more than a quarter of a million hits. The original Paxil Protest website was removed from the internet in 2006. It is understood that the action to take down the site was undertaken as part of a confidentiality agreement or 'gagging order' which the owner of the site entered into as part of a settlement of his action against GlaxoSmithKline. (However, in March 2007, the website Seroxat Secrets [1]discovered that an archive of Paxil Protest site [2] was still available on the internet via Archive.org)

Gagging orders are common in such cases and can extend to documents that defendants wish to remain hidden from the public. However in some cases, such documents can become public at a later date, such as those made public by Dr. Peter Breggin in February of 2006.[17]


In January 2007, according to the Seroxat Secrets website,[18] the national group litigation in the United Kingdom, on behalf of several hundred people who allege withdrawal reactions through their use of the drug Seroxat, against GlaxoSmithKline plc, moved a step closer to the High Court in London, with the confirmation that Public Funding had been reinstated following a decision by the Public Interest Appeal Panel. The issue at the heart of this particular action claims Seroxat is a defective drug in that it has a propensity to cause a withdrawal reaction. Hugh James Solicitors have confirmed this news.[19]


In March 2008 The Medicines and Healthcare Products Regulatory Agency concluded that GSK should have warned of the possible ill effects of taking Seroxat a lot sooner[20]. GSK could not be prosecuted under the old legislation, but the law has now been changed.

Ribena


On March 27, 2007, GSK pleaded guilty in an Auckland District Court to 15 charges relating to misleading conduct brought against them under the Fair Trading Act by New Zealand's Commerce Commission. The charges related to a popular blackcurrant fruit drink Ribena which the company had lead consumers to believe contained high levels of vitamin C. As part of a school science project, two 14-year-old school girls (Anna Devathasan and Jenny Suo) from Pakuranga College in Auckland (New Zealand) discovered that ready-to-drink juice sold in 100ml containers contained very little vitamin C. Approaches by the two teens to the company didn't resolve the issue but after the matter was publicised on a national consumer affairs television show (Fair Go) the matter came to the attention of the Commerce Commission (a government funded 'consumer watch-dog'). The commission's testing found that ready-to-drink Ribena contained no detectable vitamin C.


The company was fined $217,000 for the 15 charges. The number of charges was reduced from 88 and covered a period from March 2002 to March 2006.

GSK maintains that it did not intend to mislead consumers and that the advertising claims were based on testing procedures that have since been changed. It was ordered to run an advertising campaign to provide the facts after it admitted misleading the public about the vitamin C component in its Ribena drink. Through its lawyer, Adam Ross, the company accepted Commerce Commission allegations that claims that ready-to-drink Ribena contained 7mg of vitamin C per 100ml, or 44 per cent of the recommended daily intake, were incorrect. The company also agreed television advertising claiming the blackcurrants in Ribena had four times the vitamin C of oranges, while literally true, were likely to mislead consumers about the relative levels of vitamin C in Ribena.[21]




*Hat Tip - The Truthman


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