FDA Seeks Avandia Decision


July 13, 2010

FDA Seeks Avandia Decision

This week a two day advisory committee is meeting to decide the fate of GlaxoSmithKline’s popular diabetes medication Avandia. This meeting is about the drug itself, as well as the larger issue that the FDA faces concerning drug safety. The FDA is under pressure to regulate Avandia and many experts want the drug taken off the market.

When it comes to the FDA, this decision is one that will show either a continuance of previous policies or a break from the past of the Bush Administration.  Before the 1990’s the reputation of the FDA supported
three kinds of power: directive, gate keeping and conceptual in order to protect consumers and maintain a scientific vigilance.  Directive power meant being able to order a company or researcher to do something. Gate keeping involved the FDA’s veto power within the development of drugs. Conceptual power is the ability to shape our vocabularies and notions as well as methods used when studying and discussing drugs. Each of these areas of power is at stake in the Avandia situation.

Avandia was approved for treating diabetes a decade ago based upon a small study to show its effectiveness at controlling the way bodies react to insulin. In 2007 the drug came under fire as being linked to heart problems, including heart attack and death. Since 2007 dozens of studies have been performed concerning the safety of Avandia by different agencies including the drug manufacturer GlaxoSmithKline.

This week a committee is set to determine what action to take concerning this diabetes drug. Their options include more warnings, limiting who can prescribe the drug, and removing the drug from the market. While the FDA does not have to follow the recommendations of this panel, historically it has done so.

However no matter what the FDA decides Avandia has received so much negative publicity that it has dropped from the 2nd most popular drug manufactured by GSK to the 8th since 2007. After this committee
meeting and the resulting awareness of the consumers, it is hard to imagine that current Avandia users will continue using the drug, and even harder to imagine doctors prescribing a drug surrounded by such
controversy. This leaves the door open for other diabetes medications such as Actos to submit studies and move to the top of the heap when it comes to the diabetic drug market.

At times like these consumers should be aware that the results of the committee meeting are based upon presentations that they were given during the meeting, and as we all know, a lackluster presentation can
take all the power away from an ideal, much the same as a wonderful presentation can sway even the most opposed to an ideal. Is this committee meeting simply politics or will the panel take into consideration the thousands of patients whose lives will be affected based on their decision?

Publisher: Salient News


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