GSK's Data Transparency Initiatives: Will They Trigger a Change in Pharma Industry Practices?
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Case Code: BSTR483 Case Length: 14 Pages Period: 2012-2014 Pub Date: 2015 Teaching Note: Available |
Price: Rs.600 Organization: GlaxoSmithKline plc. Industry: Pharmaceutical Industry Countries: US Themes: Radical Openness, Data Transparency |
Abstract Case Intro 1 Case Intro 2 Excerpts
Introduction
In October 2012, UK-based pharmaceutical major, GlaxoSmithKline plc (GSK), announced its plans to make its clinical trial data publicly available, thereby setting a precedent in an industry not known for its transparency. Commenting on the announcement, Andrew Witty (Witty), CEO, GSK, said, "Because of our unique role, we recognize that society holds us to higher standards than for other industries. This is how it should be. Over the last four or so years we at GSK have been working hard to be more open and transparent. As I have shown these new approaches are helping to provide new solutions for serious global health issues. They will also help build society's trust." Industry observers opined that GSK's commitment to transparency stemmed from the lawsuits the pharma giant had faced earlier for concealing negative data related to its drugs.
Founded in 2000, GSK was known for its global initiative of making affordable medicines in developing countries. However, since 2004, the company's reputation had taken a beating when it was revealed that it had not disclosed negative data for its antidepressant Paxil (branded Seroxat in Britain) that caused suicidal thoughts in children.
This was followed by a 2010 scandal when studies by scientists revealed that GSK's diabetes drug Avandia increased the risk of heart attacks. Consequently, the sales of Avandia were suspended in Europe and temporarily restricted in the US. In 2012, another scandal rocked the company, with its being accused of illegally marketing several of its drugs not approved by regulators such as Food and Drug Administration (FDA) and withholding data of Avandia, two antidepressants, Paxil and Wellbutrin, and its asthma drug, Advair. These drugs were known to cause devastating side effects including heart attacks, suicidality, and birth defects.
In July 2012, GSK, admitting to charges of illegally marketing its drugs and not disclosing data to the regulators, agreed to pay a fine of US$ 3 billion to the US government. The US Department of Justice (DoJ) termed the settlement as the largest healthcare fraud settlement in the history of the US....
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