Timeline: The story of Avandia

GlaxoSmithKline’s (GSK) controversial diabetes drug Avandia (generic name Rosiglitazone) works by helping diabetics balance their blood-sugar levels. Since its inception, it has been found to increase the risk of heart attacks and strokes — and even death. Nearly half a million people are taking the medication, which translates into approximately $900 million in annual sales. Below is a Need to Know chronology highlighting Avandia’s history leading up to a big decision by the FDA on whether to pull it from the shelves.

May 25, 1999: Avandia is introduced. Company buries an alarming study.

May 25, 1999  

Avandia is introduced. Company buries an alarming study.

FDA approves Avandia for regulating blood sugar in people with diabetes. A few months later, its creator, SmithKline Beecham buries the results of a study showing the drug to have riskier side effects to patients’ hearts than competing diabetes drug Actos.
 
December 27, 2000: Companies merge to form GSK

December 27, 2000  

Companies merge to form GSK

British company SmithKline Beecham merges with Glaxo Wellcome to become GlaxoSmithKline. Today, GSK is the world's second largest drug maker by revenue.
 
April 2001: GSK begins study of Avandia

April 2001  

GSK begins study of Avandia

At the FDA’s request, GSK commissions RECORD, a large, six-year study comparing cardiovascular outcomes of Avandia to other commonly used diabetes medicines. Critics of the study later say RECORD was inadequately designed and conducted to provide any reassurance about Avandia’s cardiovascular safety. GSK responds that the study results show no heart risks.
 
June 2004: Lawsuit results in GSK’s agreement to make all clinical trials available online

June 2004  

Lawsuit results in GSK’s agreement to make all clinical trials available online

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.
 
Dr. Nissen discovers increased heart risks for patients taking Avandia

May 2, 2007  

May 2, 2007: Dr. Nissen discovers increased heart risks for patients taking Avandia

Skeptical of Avandia’s safety, Dr. Steven Nissen, chief cardiologist at the Cleveland Clinic, conducts analysis of 42 clinical trials of Avandia posted on GSK’s website. He and co-author Kathy Wolski submit an independent article to the New England Journal of Medicine stating that Avandia increases heart attack risk by 43 percent. A peer reviewer secretly faxes a copy to GSK.
 
May 9, 2007: GSK sets out to defend Avandia against Nissen’s findings

May 9, 2007  

GSK sets out to defend Avandia against Nissen’s findings

A GSK consultant acknowledges Dr. Nissen’s alarming conclusions regarding Avandia in an e-mail statement reproduced in a January 2010 report for the Senate Finance Committee. He concludes by saying, “We cannot undermine the numbers but I think they can be explained so we must concentrate on effective risk management.”
 
June 14, 2007: Nissen publishes his findings despite GSK’s efforts to stop him

June 14, 2007  

Nissen publishes his findings despite GSK’s efforts to stop him

Nissen and coauthor Wolski publish the peer-reviewed article of Avandia’s potentially dangerous side effects in the New England Journal of Medicine. Nissen decides to publish his analysis despite GSK executives’ efforts to persuade him otherwise in a secret meeting 11 days before publication.
 
November 14, 2007: FDA requires strong warning label for Avandia

November 14, 2007  

FDA requires strong warning label for Avandia

During fierce Senate Finance Committee hearings led by Chuck Grassley (R-Iowa) and Max Baucus (D-Mont.), senators accuse GSK of mishandling scientific evidence regarding Avandia and the FDA of having a conflict of interest with the drug. These hearings result in an FDA advisory committee reviewing Nissen’s research and GSK’s interim RECORD study. The FDA ultimately allows Avandia to stay on the market with the addition of the FDA’s strictest “black-box” warning label.
 
November 24, 2008: Harvard study shows heart risks

November 24, 2008  

Harvard study shows heart risks

Archives of Internal Medicine publishes a study of nearly 30,000 patients led by Dr. Wolfgang C. Winkelmayer and colleagues at Harvard Medical School revealing that Avandia patients were 15 percent more likely to die and 13 percent more likely to suffer congestive heart failure than patients on Actos.
 
February 20, 2010: Senate Finance Committee report deals blow to GSK

February 20, 2010  

Senate Finance Committee report deals blow to GSK

After two years of hearings, the Senate Finance Committee accuses GSK of knowing that Avandia had potential cardiac risks for years, and choosing to hide that data, suppress its critics and promote sales of the drug anyway.
 
June 28, 2010: Additional prominent studies of Avandia’s risks released

June 28, 2010  

Additional prominent studies of Avandia’s risks released

The Journal of the American Medical Association and the Archives of Internal Medicine publish separate studies concluding that Avandia should be yanked from the market. Another study from a professor at University of Washington in St. Louis argues that Avandia did not pose a significant cardiovascular risk, though this study was not originally designed to measure the effectiveness of Avandia.
 
July 9, 2010: FDA medical researchers criticize GSK’s study on Avandia

July 9, 2010  

FDA medical researchers criticize GSK’s study on Avandia

FDA researchers release a memo revealing that RECORD, the GSK-sponsored trial of Avandia, omitted crucial data and was therefore flawed. GSK releases a statement expressing confidence in Avandia. The New England Journal of Medicine publishes an editorial accusing GSK of tampering with the trial and hiring biased experts.
 
July 13-14, 2010: FDA advisory panel considers pulling Avandia from the shelf

July 13-14, 2010  

FDA advisory panel considers pulling Avandia from the shelf

An FDA advisory panel meets, recommends that the drug should stay on the market but with new label warnings and prescription restrictions. New FDA Commissioner Margaret Hamburg gets final say on whether to enact this recommendation.
 
July 19-22, 2010: Europe puts Avandia on trial

July 19-22, 2010  

Europe puts Avandia on trial

The European Medicines Agency will assess the safety of Avandia to determine whether the drug should be pulled from European markets.
 
2015: GSK will announce the results of a revised study it plans to conduct on Avandia’s heart risks

2015 

GSK will announce the results of a revised study it plans to conduct on Avandia’s heart risks

GSK is expected to release results of a large trial that was initially requested by the FDA in May 2010. A trial called Tide is meant to determine whether Avandia causes heart problems. Critics want to stop the trial, worried it may lead to increase risk of deaths for participants.
 

 
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