Truemors
is reporting from
Member
NP Rank:
NP Rank:
Avandia FDA Review: GlaxoSmithKleine Misinterpreted Drug Study
Share:
by NowPublic Staff | July 9, 2010 at 09:24 am
363 views | 4 Recommendations | 1 comment
Videos
FDA Reviewer Conlcudes GlaxoSmithKleine Misinterpreted Conclusions Of Avandia Study
The questions surround the safety of the popular drug Avandia (Rosiglitazone) just keep growing.
Friday the most recent news in the FDA's re-examination of the safety af $1.2 billion selling drug Avandia (Rosiglitazone) was released.
A FDA panel concluded that GlaxoSmithKleine was mistaken in its conclusions surround a study that explored the safety of Avandia.
Correctly interpreted, the study actually supports critics’ contentions that Avandia may cause heart attacks, said the reviewer, Dr. Thomas Marciniak, in a posting on the F.D.A.’s Web site.
The company’s misreadings of the study, known as the Record trial, were so profound, he concluded, that they “suggest serious flaws with trial conduct.”
“One does not have to be a mathematician or to perform calculations,” he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes heart attacks.
The latest findings from the FDA will be used by a panel next week that is determining if Avandia should be pulled after 11 years of mutli-billion dollar sales on the market.
Meanwhile, the FDA equivalent in Europe the EMA (European Medicines Association) is also reviewing Avandia (Rogsiglitazone)
Dr Tony Hoos, European Medical Director for GlaxoSmithKline said: “GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate Type 2 diabetes patients. It is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients.
Clearly, a lot is at stake - for GlaxoSmithKleine and for the Food and Drug Administration. If Avandia is pulled then the drug manufacturer will be open to massive liability claims and the entire effectiveness of the FDA in keeping consumers safe may well be questioned.
Advertisement
What is NowPublic?
NowPublic lets people work together to cover news events around the world.
Crowd Power
NowPublic Staff
Vancouver, Canada
Most Recommended Stories in Health
Recommendations (4)
Barry ORegan
Burnaby, British Columbia, CanadaRené
New Orleans, Louisiana, United States
Most RecentMost Recommended Comments (1)
at 13:15 on July 9th, 2010
who cares how much the company will lose? Think about the people whose lives are threatened, and who have already lost their lives from this drug.
Just taking Avandamet for a few weeks last year, my ankles, feet and lower legs swelled up and wouldn't go down. It was painful to walk.
and it took over six months for those effects to finally go away, once I was off the drug.
Not only that, my 'specialist' doctor refused to take me off it, I just stopped on my own and had to go to another doctor to get decent treatment and a substitute for Avandamet.
But I have had fortunate doctors in the past who explained my choices and let me make them.
Most people are not aware of the "Patients' Bill of Rights."
Diabetes Drug Deaths _ lawyer's letter regarding Avandia