Presentation Transcript
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)