Wednesday, December 1, 2010

Proscar® FDA Advisory Committee Meeting Underway -- Live Video Feed; Slides

Click right here (you'll need the latest version of Adobe Reader -- it may load it for you), enter as a "Guest" -- no password, to watch and listen and follow along. Merck is now finished presently presenting its case for the new indication -- from inside the Advisory Committee room, meeting on Merck's Proscar® (finasteride), in Silver Spring, Maryland.

~ An FDA staff scientitst just opined that the data (a post hoc analysis) may be the result of detection bias. That is, it may well be an artifact. That is, since all study participants were given very thorough MRI exams at study end, it was much easier to track tumors in them. In the general population, a very different survivability picture may emerge. The tumors found (and reduced in size by Proscar) may well not matter a bit to how long a patient actually survives overall. [The JAMA published study data backs this notion pretty powerfully.]

~ He just said that 40 percent dropped out -- most due to sexual side-effects.

~ He also opined that a major subgroup -- one bearing the largest burden of the disease -- African Americans -- were "extremely underrepresented" in the data (4 percent, as opposed to 12 percent of the US population -- underpowered by a factor of three).

. . . .Merck's Proscar® and prostate cancer efficacy. . . .

[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. . . .

Be sure to read of the overnight JAMA-published developments, advocating a "wait and see" approach here, as opposed to such aggressive treatment for this largely non-life threatening condition.

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