Based on the 14 to 2 “against” vote of an Oncology Drugs Advisory Committee meeting late last year, the U.S. Food & Drug Administration has rejected the application to approve dutasteride (Avodart) for prevention of prostate cancer in men at potentially elevated risk for a future postive biopsy.
This is hardly a surprising decision … even though some among us are less than enthralled by it. For earlier commentary on the implications of this deicision, please see here and here. There is a media release from the manufacturer of durasteride available on line.
Filed under: Drugs in development, Prevention Tagged: | dutasteride, FDA, Prevention
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Can’t let the treatment community lose any market share.
Tracy: Actually that is absolutely not the reason for the non-approval. Many of the “treaters” wanted dutasteride approved for this indication.
“… Can’t let the treatment community lose any market share.”
That is a common statement usually made by a VERY uniformed person in regards to the medical community.
Very sad actually, that anyone can be this cynical in regards to physicians that spend 12 years in training to treat us in the best way they know how.
Believe me, physicians have a lot more right to be cynical about their patients than the patients do about physicians … Given that 70% of disease in this nation is lifestyle related.
I will acquiesce to the comments in the “here” and “here” portion of the above of my friend and fellow PC advocate/mentor Jim Waldenfels whose thoughts and conclusions are the same as I would provide could I write as well. He and I have traveled many years of on/off/on/off intermittent androgen deprivation with constant 5AR inhibitors — he with finasteride, me with dutasteride.
Unless I am mistaken, this ruling won’t prevent anybody from still getting whatever supply of dutasteride they want. It just means the box can’t be labeled in that way.