Brandon Keim
Science

FDA Advisors Condemn Arcoxia

The FDA advisory committee charged with reviewing Arcoxia voted 20-1 against approving the drug. The vote is non-binding, but will likely be followed. A final decision is expected by April 27. Panel member Dr. Richard Cannon said the decision came down to whether patients needed another nonsteroidal anti-inflammatory drug, or NSAID. There are about 20 […]

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The FDA advisory committee charged with reviewing Arcoxia voted 20-1 against approving the drug. The vote is non-binding, but will likely be followed. A final decision is expected by April 27.

Panel member Dr. Richard Cannon said the decision came down to whether patients needed another nonsteroidal anti-inflammatory drug, or NSAID. There are about 20 drugs in this class and they are common treatments for osteoarthritis, which affects an estimated 21 million people in the United States.

"We don't have strong data that there is a need for this drug, compared to what's already available," said Cannon, a cardiologist with the
National Heart, Lung and Blood Institute.

Fellow panelist Dr. James Fries, a Stanford University rheumatologist, called it a "weak argument" that there was a "crying need" for more treatment options.

In our last post, we quoted MSNBC's Robert Bazell, who asked, "Will the drive for profits once again trump sound science and proper medical practice?" The answer, it seems, is no.

Federal Health Advisers Recommend Vioxx Successor Not Be Approved [Associated Press]

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