SEROXAT AND OTHER SSRIs

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Don’t take my word for it ….

Posted by shutah on January 8, 2011

http://en.wikipedia.org/wiki/GlaxoSmithKline

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.[19] There is as yet no proven link between SSRI’s and actual suicide, and the addition of blackbox warning labels was said to be controversial [20][21][22] But many recent analyses prove the link, even with older patients[23]
  • 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.”[28]
  • 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).[29] 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 7 September 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.[30] In June 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.[31]
  • In December 2003, Allen Roses, the then worldwide vice-president of genetics at GlaxoSmithKline, admitted that most prescription medicines do not work on most people who take them. “The vast majority of drugs – more than 90 per cent – only work in 30 or 50 per cent of the people,” Dr Roses said. “I wouldn’t say that most drugs don’t work. I would say that most drugs work in 30 to 50 per cent of people.” [32]
  • The U.S. Department of Justice announced in October 2010 that GlaxoSmithKline would pay $150 million in criminal fines and $600 million in civil penalties. GlaxoSmithKline agreed to pay the $750 million settlement in response to criminal and civil complaints against the company stemming from production of improperly made and adulterated drugs at their subsidiary SB Pharmco Puerto Rico Inc inCidra, Puerto Rico.[33]

[edit]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.

On August 26, 2004, New York State Attorney General Eliot Spitzer‘s office announced it had settled legal action against GlaxoSmithKline. The settlement required GSK to post a registry which would include much more information about pretrial and clinical drug study results than what the U.S. Food and Drug Administration (FDA) and other pharmaceutical companies had thus far been willing to make public. Attorney General Spitzer hailed the settlement as “transformational in that it will provide doctors and patients access to the clinical testing data necessary to make informed judgments.” This part of the settlement was the main objective of the New York AG and Rose Firestein, who worked in the office of the AG and initially argued the case should be undertaken. As for the monetary compensation, both sides finally agreed to $2.5 million. On August 3, 2004, shortly before the settlement, Senator Charles Grassley, a Republican senator from Iowa sent a letter to GSK, stating that he was concerned that “some drug companies” may not have provided the FDA with all the information at their disposal. His letter was spurred by statements earlier in 2008 by Dr. Andrew Mosholder, an FDA official, who had told senators at a February 2, 2004 hearing that “GlaxoSmithKline, in his opinion, was attempting to ‘sugar-coat’ the adverse effects of Paxil on children by ‘miscoding’ suicidal ideations and/or suicidal behavior.” Glaxo officials never commented on whether there was any connection between Senator Grassley’s letter and their decision to pursue a settlement with the New York State attorney general’s lawsuit.[34]

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 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.[35]

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.[36]

[edit]Paroxetine

For the first 10 years of paroxetine‘s availability, GlaxoSmithKline’s marketing of the drug stated falsely that it was “not habit forming”.[37] In 2001, the BBC reported the World Health Organization had found paroxetine to have the hardest withdrawal problems of any antidepressant.[38] In 2002, the U.S. Food and Drug Administration published a new product warning about the drug, and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) declared GSK guilty of misleading the public about paroxetine on US television.[39] The British Medical Journal quoted Charles Medawar, head of Social Audit: “This drug has been promoted for years as safe and easy to discontinue…. The fact that it can cause intolerable withdrawal symptoms of the kind that could lead to dependence is enormously important to patients, doctors, investors, and the company. GlaxoSmithKline has evaded the issue since it was granted a licence for paroxetine over 10 years ago, and the drug has become a blockbuster for them, generating about a tenth of their entire revenue. The company has been promoting paroxetine directly to consumers as ‘non-habit forming’ for far too long.”[39]

On 22 December 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.[40] 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,[41] hundreds more lawsuits have been filed against GSK. 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[42] discovered that an archive of Paxil Protest site[43] was still available on the internet via Archive.org)

In January 2007, according to the Seroxat Secrets website,[44] 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 has a propensity to cause a withdrawal reaction. Hugh James Solicitors have confirmed this news.[45]

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.[46] GSK could not be prosecuted under the old legislation.

As of 2008, GlaxoSmithKline’s prescribing information acknowledges that “serious discontinuation symptoms” may occur.[47]

[edit]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 led 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 7 mg 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.[48]

[edit]Avandia

On June 14, 2007, an article was published by Steve Nissen, Chair of the Division of Cardiovascular Medicine at the Cleveland Clinic in the New England Journal of Medicine. This meta-analysis demonstrated an increased odds ratio of myocardial infarction in patients taking rosiglitazone marketed as Avandia. More recently, the New York Times published an article detailing Nissen’s conversation with pharmaceutical executives. These conversations were recorded unbeknownst to the GSK executives but are legal in the State of Ohio as long as one participating party is aware. Currently, a Congressional investigation has been initiated to determine what information was known at the time of the approval of rosiglitazone as well as post approval and whether or not GSK willfully suppressed such information. On February 2010 GlaxoSmithKline tried to suppress publishing of a critical article[49] concerning rosiglitazone.[50] In July a US Finance Committee Letter accessed GSK of failing “to publish studies in a timely manner that found problems with Avandia”.[51]

 

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