WASHINGTON, Nov 28 (Reuters) - A Pfizer Inc. trial of pain reliever Celebrex has design limitations that raise questions about the drug's effectiveness for treating juvenile rheumatoid arthritis, U.S. Food and Drug Administration staff said in an analysis released on Tuesday.
"Nonetheless, there are limitations to the design of this non-inferiority trial that raise questions about whether it provides adequate evidence of efficacy of celecoxib in juvenile RA," said FDA reviewers. U.S. drug reviewers have questioned Pfizer about data showing the pain reliever Celebrex was as effective as an older drug, naproxen, in treating juvenile rheumatoid arthritis.
The Cargo Cult Scientist has pointed out that Pfizer and the FDA meet tomorrow to talk about the real issues. We wonder why huge pharmaceutical companies and the FDA don't meet more often to avoid these kinds of issues? If a non-inferiority trial was not adequate evidence of efficacy, why did Pfizer do it? Does the FDA not get involved until after a trial has been conducted?
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