Two days of complex statistical and sometimes convoluted debate on the drug against diabetes Avandia ended today, but left his ultimate fate uncertain. A joint committee of endocrinology, drug safety, and diabetes experts advising the Food and Drug Administration (FDA) divided its vote today on whether to recommend the removal of the drug from the US market. The final decision will be made by the FDA at a later date, although the future of Avandia seems unclear, it could remain on the market in a limited capacity.
The drug, whose generic name is rosiglitazone, has been under surveillance since 07 to possibly increase the risk of heart attacks. The increased risks were relatively low, and many people on the committee of 33 reviews have criticized the quality of contradictory and obscure data they had to base their decision. However, a plurality of members, 12 voted that the FDA should remove the drug.
The committee members also had the opportunity to vote to keep Avandia on the market and change the warning label, and 17 members voted to do so. But their votes were divided among the proposals to change the warning label in various ways: seven people wanted to extend the warnings on the label, and 10 wanted to expand the warning and also limit the use of drugs in particular cases.
Three members voted to leave the label as it is. One member abstained. No members voted for the most favorable option for the drug, keeping Avandia on the market and removing the warning of increased cardiac risk.
Many expected FDA eliminate the drug market after the agency has published more than 700 pages of documents Friday that raised safety issues and criticized the conduct of the company that makes Avandia, GlaxoSmithKline ( GSK). Particularly noteworthy was the criticism of the FDA a trial undertaken by GSK, called RECORD, often cited by the company to justify keeping Avandia on the market. But some members thought that the low RECORD criticism; they argued that no one could really take the risk of Avandia without a retrial, scientifically rigorous.
Of the 20 submissions, hundreds of slides, and thousands of pages of testimony yesterday and today, the Committee has many questions to consider about the evidence for the safety of Avandia . First, they debated whether Avandia caused more heart problems compared to the general treatment of diabetes compared to a similar drug, pioglitazone. Second, the committee had to decide whether Avandia has caused more deaths than any of these options. Significantly, the committee voted that Avandia caused more heart problems than either alternative. But members wavered on the second question, suggesting that they were of two minds about ultimate evil of drugs.
Meanwhile, behind the scenes, GSK agreed yesterday to pay $ 460 million to settle approximately 10,000 lawsuits alleging that the drug caused heart attacks.
In addition, India announced that it ordered GSK to stop a large-scale study of Avandia, known as TIDE name within its borders. TIDE, which is taking place in the world, was designed to provide a rigorous proof of the safety of the drug, and the designers of the study had plans to enroll up to 15,000 other patients with diabetes. Some members argued today that nobody will ever know the true risk of Avandia without such a study, but others fear that large scope of the test and measure long it will run for eight years-could putting more patients at risk. In the final vote of the day, 20 members voted, if Avandia remains on the US market, the TIDE trial should continue.
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