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A lot of press was dedicated to the recent hearings before a panel of experts with Congressional ties regarding Avandia, the diabetes drug that’s come under scrutiny for its link to heart attacks. The hearing has been completed, and recommendations have been made. The result was that the panel recommended that Avandia remain available for prescription, but that it now come with stern warnings on the label.
Below we’ll take a look at what this hearing was meant to accomplish and what the results of the recommendations will mean for Avandia and its manufacturer, GlaxoSmithKline, going forward.The Hearing
The Avandia hearing was held in reaction to a growing concern about the drug and its potential causal relationship with heart attacks. A study published in May by the New England Journal of Medicine produced some troubling statistics that suggested an elevated risk of heart problems in those who took Avandia. As a result, evidence from both sides of the issue was presented to the panel so that the body could make its recommendations.The Recommendation
The panel of experts heard and saw the evidence, and after deliberating on the issue decided that the risk of heart attacks was not sufficient enough to warrant pulling the drug from distribution. The panel did recommend, however, that the label affixed to all future containers of Avandia come with a warning that alerts users to its potential risks.What it Means
While the panel’s recommendations were not the be-all-end-all of this issue, their stance is quite persuasive towards the entity that will make the ultimate decision on whether or not Avandia remains in circulation – the FDA. The FDA is not required to follow these recommendations, but general practice in the past has shown that the FDA will follow the leanings of their advisers.
In a pragmatic sense, no one knows whether or not Avandia will continue its market dominance that it enjoyed before this issue arose. Despite the panel’s recommendations, doctors may still hesitate to prescribe the drug to patients, and patients may hesitate to accept such a prescription based on the reports that have surfaced recently.
One tangible result of this hearing was definitely a positive for GlaxoSmithKline, as the company’s stock value rose immediately after the panel’s recommendation was made public.