Avandia dangers disclosed because of prior problems with drug maker
Last month, a study was published in the New England Journal of Medicine after independent researchers reviewed data from clinical trials which showed that Avandia side effects could increase the risk of heart attacks and cardiovascular death. The only reason those independent researchers had access to that data was because the drug maker, GlaxoSmithKline, agreed to publicly disclose the results of all of their clinical trials as part of a settlement with the State of New York following problems with their antidepressant Paxil.
>>INFORMATION: Avandia side effects
Three years ago, GlaxoSmithKline settled a lawsuit filed by New York state where they agreed to publicly disclose data from all clinical trials for Paxil and other medications made by the company. The drug maker was previously criticized for failing to disclose the results of all trials involving the use of Paxil in children. They were accused of only releasing the positive results, when full clinical data showed the drug provided little, if any, benefit for treatment in children.
GlaxoSmithKline created a special web site for posting clinical data, and the first posting involved the results of 65 studies involving their popular diabetes drug Avandia. A researcher at the Cleveland Clinic, Dr. Steven Nissen, found the posting and completed an independent analysis of the data. His research discovered that the Type 2 diabetes drug carries a heightened cardiac risk. The Avandia dangers discovered were of such concern to public safety, that the New England Journal of Medicine released the findings on their website well in advance of publication.
Currently drug makers and medical device manufacturers are not required to publicly disclose study results. Many legislatures and public watch groups are calling for legislation requiring companies to do so, in hopes that it will reduce future problems and provide a checks and balances system for monitoring the safety of products on the market.
Many drug companies have resisted posting results of all studies or trials, fearful that information about all studies will hurt sales or benefit their competitors. It is unclear how resistance to complete disclosure is justified, unless the manufacturers are placing profits ahead of the safety of the consumer. The relative efficacy and side effects of competing drugs can only be truly weighed and evaluated by doctors and patients if all studies are released, not just those that the company chooses.
AVANDIA LAWYERS
The lawyers at Saiontz & Kirk, P.A. are reviewing Avandia lawsuits nationwide for users who suffered a heart attack, stroke, heart failure or death. The manufacturers were aware that clinical data demonstrated an increased risk, and they failed to disclose the results. To determine if compensation may be available, request a free claim evaluation.
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