Sildenafil, 25 Years Later

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Sildenafil: 25 Years Later – Summary​

Twenty-five years ago, the FDA’s approval of sildenafil (Viagra) radically reshaped the treatment of erectile dysfunction. Editor-in-Chief of Grand Rounds in Urology, E. David Crawford, MD, sits down to discuss the history and future of PDE5 inhibitors with three of the people responsible for their initial approval: Mark Hirsch, MD, Raymond Rosen, Ph.D., and Irwin Goldstein, MD.

Dr. Hirsch, Dr. Rosen, and Dr. Goldstein reflect on the approval process, particularly the development of the International Index of Erectile Function (IIEF) in response to the need for sensitive, reliable, and validated measures for Phase 3 outcomes. They give their perspectives on the benefits of PDE5 inhibitors have had on patient QoL over the past 25 years, and the treatment advantages it gives physicians today. They conclude by discussing ideas for the future of PDE5 inhibitors, including the potential benefits and obstacles for over-the-counter PDE5 inhibitors, and possible expansion of conditions treatable by sildenafil.

About the Panel​

Irwin Goldstein, MD, is Director of Sexual Medicine at Alvarado Hospital, Clinical Professor of Surgery, and Voluntary Clinical Professor of Obstetrics, Gynecology & Reproductive Sciences at the University of California San Diego, and practices medicine at San Diego Sexual Medicine. He is also Editor-in-Chief of Sexual Medicine Reviews and past Editor of The Journal of Sexual Medicine. He is a Past President of the International Society for the Study of Women’s Sexual Health (ISSWSH) and of the Sexual Medicine Society of North America (SMSNA). He holds a degree in engineering from Brown University and received his medical degree from McGill University. The World Association for Sexual Health awarded the Gold Medal to Dr. Goldstein in 2009 in recognition of his lifelong contributions to the field, in 2012 he received the ISSWSH Award for Distinguished Service in Women’s Sexual Health, in 2013 he received the Lifetime Achievement Award from the SMSNA, and in 2014 he received the Lifetime Achievement Award from the International Society for Sexual Medicine. He is happily married to his college sweetheart Sue, and together they have three children and five grandchildren.

Mark Hirsch, MD, has been involved in scientific and clinical research on erectile dysfunction (ED) for the past 32 years. Beginning with a 1990 fellowship in male sexual dysfunction (with Dr. Arnold Melman at the Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York) and continuing with a 25-year career (to date) as a medical officer and medical team leader at the Center for Drug Evaluation and Research (CDER) in the United States Food & Drug Administration (FDA), Dr. Hirsch has consistently advocated for the health and well-being of men with ED. Under the tutelage of Drs. George Christ and Arnold Melman, and Dr. Hirsch participated in both bench and clinical research related to ED. As CDER/FDA medical team leader in urology for the past 23 years, Dr. Hirsch has played an active and ongoing role in the development of safe and effective drugs for the treatment of various urological conditions, including drugs for the treatment of ED.

Raymond Rosen, PhD, founded and co-directed the first inter-disciplinary training program in Sexual Health with Dr. Sandra Leiblum, and served as founding director of the Comprehensive Sleep Disorders Center. Other academic and administrative positions during his 35-year tenure at Robert Wood Johnson Medical School include Chief Psychologist in the Department of Psychiatry and Director of Medical Education in Psychiatry from 1992-2001. He also served as Chair of the Medical School Appointments and Promotions Committee and Associate Dean of Robert Wood Johnson Medical School from 2001-2003. In 2007, he accepted a full-time appointment to New England Research Institutes (NERI) and served as Chief Scientist at NERI until 2018. He serves currently as a Full Adjunct Professor in the Department of Psychiatry at the University of California, San Francisco (UCSF) School of Medicine and as an adjunct professor of Medicine at Rutgers – Robert Wood Johnson Medical School.
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