Firm is Aggressively Investigating NY Times Allegations that GlaxoSmithKline Endeavored to Conceal Avandia's Deadly Cardiovascular Side Effects
PORT WASHINGTON, N.Y.--(BUSINESS WIRE)-- Parker Waichman Alonso LLP has been retained by a number of individuals who suffered cardiovascular problems, including heart attacks, while taking GlaxoSmithKline's diabetes medication, Avandia. The firm expects to file numerous lawsuits on behalf of such individuals in the coming weeks.
Since November 2007, Avandia's label has included a black box warning – the Food & Drug Administration’s (FDA) strongest safety alert – detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack.
Since the addition of the black box, evidence linking Avandia to an increased risk of heart attacks has continued to accumulate. Today, the FDA convened a panel of outside experts to discuss the drug's safety issues. Tomorrow, the advisory panel will be asked to make a recommendation as to whether or not Avandia should be allowed to remain on the market.
According to a New York Times report published on the eve of the advisory panel meeting, GlaxoSmithKline has engaged in a campaign to obscure Avandia’s deadly health risks since 1999, the same year it was approved in the U.S. Parker Waichman Alonso LLP is currently investigating these disturbing allegations.
According to The Times' article, SmithKline Beecham - now Glaxo - began and completed a study in 1999 comparing Avandia to Actos, a competing diabetes drug. Not only did the study find Avandia held no benefit over Actos, it also found Avandia could be more dangerous to the heart. According to The Times, SmithKline Beecham did not submit the study's results to federal drug regulators, as is required in most cases by law.
“This was done for the U.S. business, way under the radar,” Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.”
The New York Times also found that Glaxo conducted trials comparing Avandia with glyburide, a cheaper and older diabetes medicine. When asked by a company official via email about publishing two of those studies, Freed responded in message dated July 20, 2001: “Not a chance. These put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm."
Finally, The New York Times reported that an FDA reviewer who examined a Glaxo-funded Avandia clinical trial called RECORD found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial’s tally of adverse events. RECORD was released in 2009, and touted by Glaxo as evidence of Avandia's safety.
Parker Waichman Alonso LLP continues to offer free consultations to the victims of Avandia side effects. If you or a loved one uses or have used Avandia, and suffered a heart attack or other cardiovascular problems, please contact our office by visiting www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
About Parker Watchman Alonso LLP
Parker Waichman Alonso LLP is a leading personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York, New Jersey and Florida. Parker Waichman Alonso LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective drugs, medical devices and other products.
For more information on Parker Waichman Alonso LLP, please visit: www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
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