Tuesday, November 30, 2010

Check Here | Live-Streaming-Video | Wednesday's Proscar® FDA Panel

About ten minutes before 8 am EST on Wednesday, I'll provide a live-stream feed of the video, slides and audio -- from inside the Advisory Committee room, meeting on Merck's Proscar® (finasteride), in Silver Spring, Maryland. [The FDA's draft agenda has it that Merck's drug experts will speak, and present, beginning at about 8:15 am EST.]

As I earlier mentioned, here is some of the non-trivial argument for denying reimbursement, per Susan Heavey, writing for Reuters, tonight:

. . . .[FDA] staff, in documents released ahead of a public advisory meeting on Wednesday, said overall, large trials for each of the drugs showed benefits after . . . seven years with Merck's drug, Proscar -- mostly in men with certain grades of the cancer.

They noted that "neither trial was adequately designed and conducted to characterize the ultimate outcomes of interest," such as death. "In both trials, there was also an unexpected finding of an increased incidence of high-risk prostate cancers among men receiving" the drugs, they added. . . ."

[FDA] advisers will also consider whether the new data should be included on the Proscar's label, although Merck is not seeking formal approval for wider use. . . .

"The benefit of finasteride for the risk reduction in prostate cancer is uncertain since the observed risk reduction of prostate cancer was present only in the subgroup of participants diagnosed" with certain tumors, FDA staff wrote. . . .

Interestingly, as to finasteride, the type of cancer it was shown to be most likely to shrink is one that is almost never lethal -- and some doctors now argue should not be treated aggressively -- except in the rarest of cases.

And so, the committee will likely have its hands quite full, here. Stay tuned.

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