Startling Facts Uncovered About Avandia
GlaxoSmithKline PLC is facing difficulties recruiting victims…I mean patients…in the US for a clinical trial of its diabetes drug Avandia, also known as Rosiglitazone. It must already tell you something about your drug’s prospects when no-one wants to join your clinical trial for fear of dying.
Today’s consumers have a much greater aversion to death than consumers of the past. The FDA approved the use of Avandia to control blood sugar levels in type 2 diabetes in 1999.
Two Year Study Of Avandia
In late February this year, US Senators Max Baucus and Chuck Grassley released a finance committee report that revealed some troubling aspects of the ongoing relationship between the FDA, our watchdog group on drug efficacy, and Glaxo Smith Kline the manufacturer of the drug Rosiglitazone, better known as Avandia.
This report is the result of a two year study of more than a quarter of a million pages of documents by committee investigators. The documents were provided by GlaxoSmithKline, the FDA, and related research institutes.
The senators have asked the Food and Drug Administration to describe the steps they have taken to protect patient’s lives in the ongoing Avandia clinical trial. The senators also want an answer to why the study is allowed to continue in the first place, when the FDA, in its own estimation, believes the drug has caused more than 83,000 excess heart attacks between 1999 when the drug was first approved and 2007.
Rosiglitazone Clinical Trial Deemed Unethical
In 2008, FDA officials described the clinical trial, as “unethical and exploitative” of patients. “There’s a real problem when FDA’s office that reviews drugs that are on the market is an unequal player in drug safety efforts,” Grassley said.
“It doesn’t make any sense to have these experts, who study drugs after they have been on the market for several years, under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision.
The Avandia case may be the most alarming example of the problem with this set-up. Both the FDA and Congress need to take every step possible to establish independence for post-market surveillance. The Institute of Medicine has made recommendations. It’s a matter of sound science and public safety.”
The report delves into the timeline of when Avandia manufacturer, GlaxoSmithKline, first became aware of the heart attack risks associated with the drug. It looks into whether or not the patients and the FDA were sufficiently warned of the dangers of Rosiglitazone. The report also uncovers the steps taken by Glaxo Smith Kline to stir up doubt regarding the negative findings associated with Avandia.
The report got to the heart of the problem when it exposed the imbalance between the office responsible for continuously monitoring the safety of Avandia after approval and the office that put Avandia on the market to begin with. The FDA overlooked the concerns of its own officials when it allowed the ongoing study of Rosiglitazone.
Contact Our Product Liability Lawyers
About one million Americans take Avandia today. If you or a loved one has suffered a heart attack that you feel could be related to your use of the drug Rosiglitazone, brand name Avandia, please contact a qualified product liability lawyer today at The Law Offices of Nadrich & Cohen, we can help you.