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