GSK's Data Transparency Initiatives: Will They Trigger a Change in Pharma Industry Practices?
Case Code: BSTR483
Case Length: 14 Pages
Pub Date: 2015
Teaching Note: Available
Organization: GlaxoSmithKline plc.
Industry: Pharmaceutical Industry
Themes: Radical Openness, Data Transparency
Abstract Case Intro 1 Case Intro 2 Excerpts
GlaxoSmithKline (GSK), headquartered in the UK, was created with the merger of two established companies, US-based Glaxo Wellcome and England-based SmithKline Beecham, in 2000. Glaxo Wellcome and SmithKline Beecham were formed as a result of several mergers and acquisitions in the 1800s.
GSK started its operations on January 1, 2001. In 2001, it launched the African Malaria Partnership, boosting global awareness about malaria, a disease known to kill more than 1 million people every year.
However, in 2003, GSK’s reputation was tarnished when Britain regulators warned that the company's antidepressant drug Paxil was known to increase the risk of suicide in children and should not be prescribed to them.
In June 2004, Eliot Spitzer (Spitzer), New York Attorney General, filed a suit against GSK accusing it of suppressing research that had arrived at negative conclusions on the efficacy of Paxil. The lawsuit alleged that GSK had been hiding data from clinical trials dating back to 1998 that suggested that children and adolescents should not be treated with Paxil for depression. However, GSK did not disclose that information. The drug had also not received approval in the US for being marketed to treat children and adolescents with depression. In addition to this, the US DoJ alleged that GSK had participated in preparing, publishing, and distributing a misleading article in a medical journal that misreported that a clinical trial of Paxil had demonstrated efficacy in the treatment of depression in patients under age 18, when actually the study had failed to demonstrate the drug's efficacy....
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