FDA official on Arcoxia. [first time I've seen FDA send letter to editor] From WSJ.
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FDA Clears the Air About Drug Rejection
The comments of David F. Henderson and Charles L. Hooper about the FDA's grounds for not approving Arcoxia (etoricoxib), a new osteoarthritis drug developed by Merck & Co., were based on an erroneous assumption and a misunderstanding ("Our Lawless FDA," editorial page, May 17).
The mistaken assumption was that our agency turned down the application merely because Arcoxia does not offer any therapeutic advantage over a number of similar drugs already on the market. Our decisions are based on rigorously documented scientific evidence -- etoricoxib's risks outweighed its benefits given the currently available data.
One set of clinical trials showed that patients on Arcoxia experienced significantly more cardiovascular adverse episodes (such as strokes, heart attacks and deaths) than patients on Naprosyn (naproxen). In another set of large trials comparing etoricoxib with Arthrotec (diclofenac sodium/misoprostol), an older drug for arthritis pain, the risks of adverse cardiovascular events were similar, but Arcoxia was associated with a greater incidence of high blood pressure and swelling. Persistently elevated blood pressure, even by small amounts, can lead to significant long-term harm. Finally, when compared with diclofenac sodium/misoprostol, etoricoxib was better tolerated but caused the same number of bleeding ulcers and cases of blockage or bowel perforation.
The misunderstanding involved Dr. Meyer's observation about "simply having another drug on the market" being an insufficient justification for a product approval. As Dr. Meyer specifically said, this was the message that the FDA heard from members of the Advisory Committee who voted 20 to 1 against etoricoxib's approval -- not the opinion of the FDA.
Steven Galson, M.D., M.P.H.
Director, Center for Drug Evaluation and Research
Food and Drug Administration
Washington |
