We, the undersigned health care professionals who specialize in the
treatment of sexual health, write asking for your help on a medical
inequity for women that has gone on long enough. Your leadership in
making women’s issues a legislative priority and your appreciation that
when a women’s health is improved so, too, are her partner’s and
family’s is why we know you’ll be as concerned as we are that there
are now 26 FDA-approved medical treatment options for male sexual
dysfunction, but still ZERO for women’s most common sexual
complaint.
This is despite the fact that:
• More women than men suffer from sexual dysfunction;
• 1 in 10 women’s lives are impacted by living with this condition,
hypoactive sexual desire disorder, meaning 16 million women in
the U.S. today;
• This condition has been medically recognized for over 30 years;
• The FDA has a historic data package of more than 11,000
patients tested on a drug that could be the first ever product
approved, but they keep asking for more data out of line with
their own precedents for other new drug approvals.
For clarity, no one of us with our academic appointments, practices and
commitment to comprehensive patient care would ever advocate for a
single therapy. If the FDA cannot approve this therapy that has met its
clinical endpoints in study and is worthy of approval by any other
comparison of what has sufficed for the male drugs or countless others,
you can imagine our significant concern that if we remain silent, further
research and development in the field will terminate. Many of us have
completed the clinical trials for the product being reviewed by the
FDA, Flibanserin, as well as the products in development for this
condition. I, as well as the undersigned, would be happy to discuss the
strength of the data to confirm that there is no scientific confusion and
no room for societal bias that could incorrectly obscure that decision.
We have these questions specifically:
• How is it that Viagra was granted a priority review but this drug
was denied it? Isn’t meeting this unmet need for women as
significant as meeting the unmet need of ED for men was?
• How is it that 11,000 women worth of data where endpoints were
met and the most common side effects are well characterized and
consistent is not enough for approval, but the first in class, first in
category male drug FDA approved in December only needed 832
patients and has more serious side effects?
• How can there have been a public meeting on this drug four years
ago that set a path forward where all the requests were completed
with success only to ask for more work yet again? Will FDA
keep moving the goalposts?
• How is this the only condition lacking a medical therapy we can
find where the FDA guidance document was withdrawn and
never replaced?
Can you understand our palpable frustration and growing concern? We
hope that you will acknowledge and share it. We are not alone.
Thousands of our medical peers find themselves in the same
circumstance. The medical societies we are members of have written
the FDA. Women’s interests groups have written the FDA. And beyond
signing here, we have also all signed on to www.eventhescore.org to
call for the FDA to make this a priority action – it is time to give
women medical treatment options of their own for their most common
sexual complaint.
Thanking you in advance for your action:
Michael L Krychman MD, MPH
Executive Director of the Southern California Center for Sexual Health
and Survivorship Medicine
Associate Clinical Professor University of California Irvine
AASECT Certified Sexual Counselor
Certified Sex Therapist
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LETTER SUPPORTERS
1) Leah Millheiser, MD, FACOG
Clinical Assistant Professor
Director, Female Sexual Medicine Program
Department of OB/GYN
Stanford University School of Medicine
Stanford, CA 94305
2) Alan W. Shindel, MD
Editor in Chief, Sexual Medicine
Assistant Professor in Residence
Department of Urology
University of California at Davis
3) Sheryl A. Kingsberg, PhD
Chief, Division of Behavioral Medicine
University Hospitals Case Medical Center
MacDonald Women's Hospital
Professor, Departments of Reproductive Biology and Psychiatry
Case Western Reserve University School of Medicine
4) Sharon J. Parish, MD
Professor of Clinical Medicine,
Albert Einstein College of Medicine
President, International Society for the Study of Women’s Sexual
Health
5) Tara Allman, MD
Center For Menopause, Hormonal Disorders and Women's Health,
NYC
New York, NY
6) Susan Kellogg Spadt, PhD, CRNP, CST
Professor, OBGYN Drexel University College of Medicine
Professor Human Sexuality Widener University
Adjunctive Professor OBGYN Rutgers/ UMDNJ University College
of Medicine
Director of Female Sexual Medicine Center for Pelvic Medicine, at
Academic Urology of PA, LLC
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Bryn Mawr, PA
7) Susan Lee, EdD, LCSW
State of Florida Provider of Sex Therapy Continuing Education
AASECT Certified Diplomate Sex Therapist
Executive Director: Sex Therapy PostGraduate Training Institute
Palm Beach, FL
8) George Carroll, MD
Orlando Sexual Medicine
Orlando, FL
9) Risa Kagan, MD
Clinical Professor,
Dept of Ob/Gyn and Reproductive Sciences
University of California, San Francisco
Sutter East Bay Medical Foundation
Berkeley, CA
10) James A. Simon, MD, CCD, NCMP, IF, FACOG
Clinical Professor
George Washington University
President and Medical Director
Women's Health & Research Consultants®
Washington, DC
11) Pamela Gallup Gaudry, MD
Obstetrician and Gynecologist
Assistant Professor of Obstetrics and Gynecology
Mercer University School of Medicine - Savannah campus
Savannah, GA
12) Adeeti Gupta, MD
Obstetrician and Gynecologist
Sexual Medicine
FusionGyn
13) Lee P. Shulman, MD
Professor of Ob/Gyn
Feinberg School of Medicine
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Northwestern University
Chicago, IL
14) Barb DePree, FACOG NCMP, MMM
Lakeshore Health Parnters Women's Health,
MIdlife Women’s Health Director
Founder of MiddlesexMD
2013 NAMS Practitioner of the Year
15) Maureen Whelihan, MD, FACOG
Elite GYN Care of the Palm Beaches
Palm Beach, FL
16) Michael P Goodman, MD, FACOG
Medical Director, Caring For Women Wellness Center
Integrative Menopausal and Sexual Medicine
NAMS-Certified Menopause Practitioner
Fellow, International Society for the Study of Sexual Health
Certified Clinical Bone Densiometrist
Davis, CA
17) Robert Marx, MD
Professor of Orthopedic Surgery Hospital for Special Surgery
Weill Medical College of Cornell University
New York, NY
18) Stephanie Cruz Lee, MD, FACOG
Capital Regional Women's Health
19) Laurie Birkholz, MD
Family Medicine
Lakeshore Health Partner’s Women’s Health
20) Stephanie Faubion, MD
Internal Medicine – Women’s Health
Rochester, MN
21) Cynthia M Coughlin Hanna, MD, FACOG
Clinical Assistant Professor of Ob/Gyn
Warren Alpert School of Medicine of Brown University
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22) Irwin Goldstein, MD
Director of Sexual Medicine, Alvarado Hospital
Clinical Professor of Surgery, University of California San Diego
Editor-in-Chief, The Journal of Sexual Medicine
Director, San Diego Sexual Medicine
23) Lamia Gabal, MD
Diplomate American Board of Urology
Chief of Urology Section, St Joseph Hospital, Orange
Associate Clinical Professor, UC Irvine
Irvine, CA
24) Marian E. Dunn, PhD
Clinical Associate Professor of Psychiatry ad Behavioral Medicine
Director of the Center for Human Sexuality
State University of New York- Downstate Medical Center
Brooklyn, NY
25) Eva Martin, MD
Medical Director of Family Planning Services
South Central Health District, Department of Health
Dublin, GA
26) Lauren F. Streicher, MD
Clinical Associate Professor of Obstetrics and Gynecology
Feinberg School of Medicine
Northwestern Memorial Hospital
Chicago, IL
27) Diane Parks, MSN, WHNP
AASECT Certified Sexuality Counselor
28) Chris Creatura, MD
Fellow ISSWSH, NAMSCMP, ACOG
Gynecology and Sexual Medicine
29) Sandra Finestone, PsyD
Hope and Wellness Center for Breast Cancer Survivors
Santa Ana, CA
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30) Lila Nachtigall, MD, NCMP
Professor of Ob/Gyn NYU School of Medicine
Co-director Inter-discipline Menopause Unit
NYU School of Medicine
New York, NY
31) Anita H. Clayton, MD
David C. Wilson Professor
Interim Chair Department of Psychiatry & Neurobehavioral Sciences
Professor of Clinical Obstetrics & Gynecology
University of Virginia
Charlottesville, VA
32) Sally A. Towne, CNM
33) Abdulmaged M. Traish, MBA, PhD
Professor of Biochemistry
Professor of Urology
Research Director,
Institute of Sexual Medicine
Boston University School of Medicine
34) Lisa Larkin, MD, FACP, NCMP
Associate Professor of Obstetrics and Gynecology
Director of Division Midlife Women’s Health and Primary Care
Director of UC Health Women’s Center
35) Rose Marie Kunaszuk, DrNP, CNM
36) Michele L LeMay, MD
37) Dr. Serena McKenzie
Medical Director, Northwest Institute for Healthy Sexuality
ISSWSH Fellow
AASECT certified Sex Counselor
38) Len R. Derogatis, PhD
Director, Maryland Center for Sexual Medicine
Associate Professor of Psychiatry
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Johns Hopkins University School of Medicine.
39) David J Portman, MD
Director, Columbus Center for Women's Health Research.
40) Michael A. Perelman, PhD
Clinical Professor of Psychology in Psychiatry,
Reproductive Medicine and Urology
Weill Medical College, Cornell University
Co-Director, Human Sexuality Program,
The New York Presbyterian Hospital
New York, NY
42) Katherine King-Goodrich, MSN, CNM
43) Barbara Seidel, ANP-BC
Gynecology Oncology Nurse
Female Sexual Medicine and Women’s Health Clinic
Memorial Sloan Kettering Cancer Center
44) Mary K Huges, MS, RN, CNS, CT
45) Murray A. Freedman, MS, MD
Clinical Professor
Department of Obstetrics and Gynecology
Medical College of Georgia @ Georgia Regents University
Augusta, GA
46) Alan M. Altman, MD
Past President ISSWSH
Consultative Gynecologist for Menopause and Sexual Dysfunction
Aspen, CO
47) Alyse Kelly-Jones, MD
Mintview Women’s Care
1918 Randolph Road
Suite 300
Charlotte, NC
48) Ira D. Sharlip, MD
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Clinical Professor of Urology
University of California at San Francisco
49) Steven R. Goldstein, MD
Professor of Obstetrics and Gynecology
New York University School of Medicine
530 First Avenue, Suite 10N
New York, NY
50) James E Clark, MD
51) Lorraine Dennerstein
Professor Emeritus
The University of Melbourne
Vic. Australia
52) Rafael Carrion, MD
Associate Professor of Urology
Director of Research
Residency Program Director
Department of Urology
USF College of Medicine
53) Susan Wysocki WHNP, FAANP
President
IwomensHealth
Washington, DC
54) June La Valleur, MD FACOG
Sexual Health Counselor
Associate Professor
University of Minnesota
55) Teresa M. Vanderlinde, DO, FACOG
56) Rossella E. Nappi, MD, PhD
Associate Professor of Obstetrics and Gynecology,
Department of Clinical, Surgical, Diagnostic and Pediatric Sciences,
Research Center of Reproductive Medicine,
Unit of Gynecological Endocrinology and Menopause,
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IRCCS S. Matteo Foundation,
University of Pavia
Piazzale Golgi 2, 27100 Pavia, Italy
57) Elaine E. Jolly, OC, MD, FRCS(C)
Professor of Obstetrics and Gynecology
University of Ottawa
Senior Advisor
Shirley E. Greenberg Women's Health Centre
Department of Obstetrics and Gynecology
The Ottawa Hospital, Riverside Campus
1967 Riverside Drive, Box 503
Ottawa, Ontario K1H 7W9
58) Miriam Sivkin, MD
59) Nydia Conrad, Psy.D.
Licensed Clinical Psychologist
60) Jane Parker, CNP
61) Jess Waldura, MD MAS
Associate Professor, Family and Community Medicine
Research Scholar, Clinical and Translational Science Institute
University of California San Francisco
62) Carolyn Stahlhut, MSN, CRNP, CUNP
Urologic Consultants of Southeast Pennsylvania
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