Propecia approval: FDA vs. Merck advisory meeting transcript

#1

AN ABSOLUTE MUST READ.

fda.gov/ohrms/dockets/ac/97/ … 3352t1.rtf

Transcript of FDA meeting held November 13, 1997 to discuss dermatologic & opthalmic drugs – specifically, Finasteride’s approval as Propecia 1mg for hairloss.

MERCK presents (via Dr. Kaufman and other hired experts) their clinical data showcasing the efficacy of Finasteride for MPB, and try to reaffirm that any side effects were “rare” during treatment.

Next, FDA panel members begin dissecting Merck’s argument over concerns about side effects, particularly towards the end of the document.

It is interesting to note the FDA’s conclusions that Merck’s sample sizes and results are not correct, concerns over sexual function, ejaculate volume, fertility, bone mineral density, birth defects, Finasteride’s steroid-like properties, hormone influence, and other such issues. They also note that 5AR influences Progesterone, Cortisol, and Aldosterone.
3352t1.rtf (243 KB)

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#2

If you want to see the people responsible for launching and approving Propecia, and how this global catastrophe was created, read this document. (Available as a download at the end of the previous post).

P A R T I C I P A N T S

Committee Members:

Joseph McGuire, Jr., M.D., Chairman

Frank Parker, M.D.
S. James Kilpatrick, Ph.D.
Joel Mindel, M.D.
Susan Cohen, B.S.
Milton Orkin, M.D.
Madeleine Duvic, M.D.
William Rosenberg, M.D.

Consultants:

Eva Simmons-O’Brien, M.D. (voting)
Fred Miller, M.D. (voting)
Eduardo Tschen, M.D. (voting)
Henry Lim, M.D. (non-voting)

FOOD AND DRUG ADMINISTRATION STAFF:

Tracy Riley, Executive Secretary
R. Srinivasan, Ph.D.
Hon-Sum Ko, M.D.
Jonathan Wilkin, M.D.
Michael Weintraub, M.D.

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