Unethical research

Topics: GlaxoSmithKline, Attention-deficit hyperactivity disorder, Pharmacology Pages: 3 (763 words) Published: October 7, 2013


Unethical Research Conduct

RES/351

Unethical Research Conduct

The pharmaceutical company GSK also known as GlaxoSmithKline plead guilty to resolve fraud allegations and failure to report safety data that was essential to the FDA. This as of July 2, 2012 was the largest health care fraud settlement in United States history. There were criminal and civil liabilities that came from the unlawful promotion and failure to report data for certain prescription drugs. GSK is a top the three global vaccine manufacturers and was also fined 88,000 dollars during illegal vaccine trials during the years of 2007 and 2008. This resulted in the death of 14 babies. This three billion dollar settlement wasn’t the only time GSK has been fined and under the close watch of the FDA.

According to Belkin (2013)“GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA).’’ From the years of 1998 to 2003 GSK wrongly promoted Paxil to minors under the age of 18. Although the FDA never approved the drug for use under the age of 18. GSK also distributed a medical journal that mislead clinical trials of Paxil of treating depression under the ages of 18. There were allegations stating that GSK held activities to promote the use of Paxil for depression for adolescents under the age of 18. All of these factors contributed to the false and misleading use Paxil for adolescence. Although their medical journal promoted the use of Paxil the black label box warning stated, “Antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18” (Belkin, 2013). By not disclosing all the information correctly and the false promotion of the drug patients were subject to...
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