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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.

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Wrong Turn on the Highway to Love

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  1. 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

  2. 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

  3. 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 • P&G’s Plans to Promote Off-label Use of Intrinsa to Professionals and Consumers

  4. 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 & 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 P&G CME and DTC advertising materials

  5. 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 & Health Protection Our Bodies Our Selves (As of 11/29/04) Endorsers of this Presentation(list with contact information available)

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