2004 4082OPH1 01 Tiefer

Information about 2004 4082OPH1 01 Tiefer

Published on June 16, 2007

Author: Peppar

Source: authorstream.com

Content

Wrong Turn on the Highway to Love:  Wrong Turn on the Highway to Love Leonore Tiefer,PhD Department of Psychiatry NYU School of Medicine Prepared for FDA Advisory Committee Hearing on Intrinsa 12/2/04 Selected Sexology Credentials:  Selected Sexology Credentials Past-President International Academy of Sex Research Author or co-author of over 100 sexology publications since 1969 Editorial Board of 11 sexology journals 2004 Distinguished Scientific Achievement Award, Society for the Scientific Study of Sexuality Intrinsa: An “experiment” on women (Handout available on each topic):  Intrinsa: An 'experiment' on women (Handout available on each topic) Dangers of Extended Testosterone Treatment Problems with HSDD Definitions and Measures Limitations of Intrinsa Trials Pandamp;G’s Plans to Promote Off-label Use of Intrinsa to Professionals and Consumers Recommendations:  Recommendations 1) Postpone application until a) Larger and longer safety and efficacy trials with likely marketing targets: Postmenopausal intact women (w/ and w/o E andamp; P) Premenopausal intact women Women on oral contraceptives b) Affordable testosterone assay for women 2) Add qualitative research component to assess individual experience 3) DDMAC monitoring of Pandamp;G CME and DTC advertising materials Endorsers of this Presentation(list with contact information available):  Endorsers of this Presentation (list with contact information available) Peggy Kleinplatz, PhD Richard B. Krueger, MD Meg Kaplan, PhD Anne Katz, RN, PhD Ellen Cole, PhD Marilyn Safir, PhD Maureen McHugh, PhD Lucy M.. Candib, MD Lisa Cosgrove, PhD Gina Ogden, PhD Sharon B. Diamond, MD Susan E. Bennett, MD Linda Perlin Alperstein, MSW Petra Boynton, PhD Arthur Zitrin, MD Patricia Whelehan, PhD Brunhild Kring, MD Anne Peplau, PhD Susan Mahler, MSW Peter R. Mansfield, MD Healthy Skepticism Canadian Women’s Hlth Netwrk Nat’l Women’s Hlth Netwrk Women andamp; Health Protection Our Bodies Our Selves (As of 11/29/04)

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