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    Avandia Scandal: (Glaxosmithkline)

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    Duane Po
    GlaxoSmithKline's diabetes drug Avandia was found to significantly increase risks of heart attack, heart failure, and death. GSK attempted to bury evidence of these risks, including a study showing Avandia was no better and riskier than a competing drug. After a 2007 study revealed a 43% increased heart attack risk, GSK faced lawsuits and restrictions on Avandia sales in Europe and the US. GSK ultimately pleaded guilty to failing to report drug safety information and paid $3.4 billion in fines, the largest fraud settlement against a pharmaceutical company at that time.

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    Avandia Scandal: (Glaxosmithkline)

    Uploaded by

    Duane Po
    42 views21 pages
    GlaxoSmithKline's diabetes drug Avandia was found to significantly increase risks of heart attack, heart failure, and death. GSK attempted to bury evidence of these risks, including a study showing Avandia was no better and riskier than a competing drug. After a 2007 study revealed a 43% increased heart attack risk, GSK faced lawsuits and restrictions on Avandia sales in Europe and the US. GSK ultimately pleaded guilty to failing to report drug safety information and paid $3.4 billion in fines, the largest fraud settlement against a pharmaceutical company at that time.

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    GSKAVANDIA-SCANDAL

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    GlaxoSmithKline's diabetes drug Avandia was found to significantly increase risks of heart attack, heart failure, and death. GSK attempted to bury evidence of these risks, including a study showing Avandia was no better and riskier than a competing drug. After a 2007 study revealed a 43% increased heart attack risk, GSK faced lawsuits and restrictions on Avandia sales in Europe and the US. GSK ultimately pleaded guilty to failing to report drug safety information and paid $3.4 billion in fines, the largest fraud settlement against a pharmaceutical company at that time.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    42 views21 pages

    Avandia Scandal: (Glaxosmithkline)

    Uploaded by

    Duane Po
    GlaxoSmithKline's diabetes drug Avandia was found to significantly increase risks of heart attack, heart failure, and death. GSK attempted to bury evidence of these risks, including a study showing Avandia was no better and riskier than a competing drug. After a 2007 study revealed a 43% increased heart attack risk, GSK faced lawsuits and restrictions on Avandia sales in Europe and the US. GSK ultimately pleaded guilty to failing to report drug safety information and paid $3.4 billion in fines, the largest fraud settlement against a pharmaceutical company at that time.

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    AVANDIA SCANDAL

    (GlaxoSmithKline)

    Gabbie Ong
    Nieca Parrenas
    Aaron Bayer
    Serena Sy
    GSK’S PRODUCTS
    ◦ Adartrel

    ◦ Bactroban

    ◦ Ceftin

    ◦ Daraprim

    ◦ Eumovate

    ◦ Avandia
    GSK

    ◦ One of the top pharmaceutical manufacturers in the world.

    ◦ Their offices are situated in 115 countries including USA, Spain, Canada, and the
    Philippines.

    ◦ Three segments: Pharmaceuticals, Vaccines and Consumer Healthcare. 

    ◦ Spent around ₤4B in research and development In medicines


    ◦ May 25, 1999 – Avandia is introduced

    ◦ Incorporated on December 27, 2000.


    ◦ SmithKline Beecham + Glaxo Wellcome
    THE SCANDAL
    AVANDIA
    ◦ Generic Name: rosiglitazone

    ◦ First introduced to the market on May 25, 1999.

    ◦ It worked by helping diabetics balance their blood-sugar levels.

    ◦ known as an “insulin sensitizer”

    ◦ Has been found to increase risk for heart attacks, heart failure, and even
    death

    ◦ Became the best-selling diabetes drug in the world


    AVANDIA

    ◦ In late 1999, SmithKline Beecham conducted a study to compare the risks of


    Avandia and their competing diabetes drug, Actos, for heart patients.
    “Not only was Avandia no better than Actos, but the study also
    provided clear signs that it was riskier to the heart.”

    - THE NEW YORK TIMES


    UNETHICAL ISSUES
    ◦ Rather than publish the results from the study, the company tried to bury them.

    ◦ In April 2001, at the FDA’s request, GSK commissions RECORD, a large, six-year study
    comparing cardiovascular outcomes of Avandia to other commonly-used diabetes medicines. 
    ◦ GSK responds that the study results show no heart risks. Critics of the study later say RECORD was inadequately
    designed and conducted to provide any reassurance about Avandia’s cardiovascular safety. 
    43 PERCENT INCREASED HEART
    ATTACK RISK

    ◦ Steven Nissen + Kathy Woksi


    ◦ Avandia increased heart attack risk by 43 percent. His peer-reviewed article appeared in the June 2007 issue of the
    New England Journal of Medicine.

    ◦ Lawsuits against GSK


    “We cannot undermine the numbers, but I think they can be
    explained so we must concentrate on effective risk
    management.”
    -GSK consultant, 2007
    Journal Article Authors
    ◦ Avandia does NOT increase the risk – 86% had financial
    relationships with GlaxoSmithKline

    ◦ Unfavorable news – 18% had relationships with GSK

    ◦ FDA conflict of interest


    2004 LAWSUIT

    ◦ In June 2004, Eliot Spitzer, then New York attorney general, sues GSK for
    hiding results showing that its antidepressant sold under the name Paxil caused
    an increase in suicidal behavior in children and teens. In a settlement, GSK
    agrees to post details about all of its clinical trials on the company website.
    THE RESULT
    STRONG WARNING LABEL
    ◦ FDA
    ◦ Black box warning
    STOP SALES IN EUROPE

    ◦ The European Medicines Agency withdrew Avandia from


    the European market because of the increased heart risks.
    RESTRICTED SALES

    ◦ FDA restricted Avandia sales


    ◦ Avandia-Rosiglitazone Medicines Access Program.
    ◦ mail order through certain pharmacies
    OTHER CHARGES AND RESULTS
    ◦ Plead guilty to failing to report drug safety information to the FDA, among other
    charges.

    ◦ The company agreed to pay the U.S. Justice Department $3.4B in fines. (Jan. 18, 2011)
    ◦ $600M – Avandia

    ◦ 2006 Sales - $3B annual sales for Avandia

    ◦ Largest fraud settlement in US history & largest fine ever paid by a drug company

    ◦ GSK shares fall 9.3 percent.


    Sources:
    ◦ New England Journal of Medicine. Retrieved from: www.nejm.org
    ◦ www.businessethicscases.blogspot.com
    ◦ www.justice.gov
    ◦ https://ethicalnag.org
    ◦ www.forbes.com
    ◦ https://articles.mercola.com

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