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AVANDIA Settlement

September 24, 2010

Avandias Legal Settlement Saves Lives
Theres isnt too much to add to the news yesterday about Avandia, the dangerous diabetes drug, the sales of which the FDA finally restricted in the United States and Europe suspended entirely - except to note again the important role that litigation played in this long-awaited result. As the New York Times noted in its article today:
The Avandia story also begins a new and unsettling period for pharmaceutical companies because Avandias risks became known only after [Cleveland Clinic cardiologist Dr. Steve Nissen] analyzed data from clinical trials that GlaxoSmithKline, the maker of the drug, had been forced to post on its Web site as a result of a legal settlement. Such public postings are increasingly the norm, which means that drugmakers can no longer easily hide or control scientific information about their medicines.

In Avandias case, GlaxoSmithKline engaged in a massive 11-year cover-up of these health risks. Dr. Nissen told the Times, the decision brought an end to one of the worst drug safety tragedies in our lifetime, adding that it was essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future. One study estimated that from 1999 to 2009, more than 47,000 people taking Avandia needlessly suffered a heart attack, stroke or heart failure, or died.

Of course, unlike Europes decision to ban the drug, the FDAs actions still reflect the FDAs willingness to compromise with the drug industry. As Dr. Sidney Wolfe, Director of Public Citizens Health Research Group, put it, the FDA again caved to industry pressure. Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product.

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