Sildenafil: 25 Years Later

Posted by E. David Crawford, MD | May 2023

Irwin Goldstein, MD; Mark Hirsch, MD; Raymond Rosen, PhD; and E. David Crawford, MD, recorded “Sildenafil: 25 Years Later” for the Grand Rounds in Urology audience in May 2023.

How to cite: Crawford, E. David., Goldstein, Irwin., Hirsch, Mark., and Rosen, Raymond. “Sildenafil: 25 Years Later” May 2023. Accessed Apr 2024. https://grandroundsinurology.com/sildenafil-25-years-later/

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, PhD, and Irwin Goldestein, 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 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 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, 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 Full Adjunct Professor in the Department of Psychiatry at the University of California, San Francisco (UCSF) School of Medicine and as adjunct professor of Medicine at Rutgers – Robert Wood Johnson Medical School.

Irwin Goldstein, MD
President and Director,
San Diego Sexual Medicine

Mark Hirsch, MD,
Medical Team Leader,
Division of Bone, Reproduction and Urologic Products,
Center for Drug Evaluation and Research,

Raymond-Rosen

Raymond Rosen, PhD,
Full Adjunct Professor of Psychiatry,
University of California, San Francisco
Adjunct Professor of Medicine,
Rutgers – Robert Wood Johnson Medical School

About The Author

E. David Crawford, MD

Researcher-physician E. David Crawford, MD, has devoted his career in medicine to educating the public about men's health issues and finding effective techniques and procedures to address prostate cancer, the most common malignancy affecting men in the United States. He is currently a Professor of Urology and Jack A. Vickers Director of Prostate Research at the University of California, San Diego. Dr. Crawford received his medical degree from the University of Cincinnati and his postgraduate training included an internship and residency in urology at the Good Samaritan Hospital in Cincinnati. He subsequently completed a genitourinary cancer fellowship at the University of California Medical Center in Los Angeles. Dr. Crawford is an internationally recognized expert in benign prostate hypertrophy, urologic cancers, and in particular, prostate cancer. He has conducted research in the treatment of advanced bladder cancer, metastatic adenocarcinoma of the prostate, hormone-refractory prostate cancer, and other areas of urological infections and malignancies. He has authored or coauthored over 810 scientific articles, has published seven textbooks, authored over 60 book chapters, and provided more than 2,200 educational talks for patients and physicians. In an effort to raise public awareness about prostate health, Crawford in 1989 founded the Prostate Conditions Education Council (PCEC). The non-profit organization is comprised of a consortium of leading physicians, health educators, scientists, and men's health advocates. PCEC's advocacy for free or low-cost prostate screening has affected the lives of millions of American men. He currently chairs the PCEC. Crawford is an active member of many national and international organizations, including the American Society of Clinical Oncology, the American Urological Association (AUA), and the American Association for the Advancement of Science. Within the AUA, he has been a member of the Committee to Study Urologic Research Funding and the prostate cancer clinical trials subcommittee. Crawford served on the board of governors, the scientific advisory board of the Southwest Oncology Group, and was chairman of the Genitourinary Cancer Committee for 27 years. This group is the largest clinical trials group in the world. Crawford's involvement in the national prostate cancer arena has been widely recognized. He has received many honors and awards, including the CAP Cure Annual Award for Scientific Presentation in 1999 In 1997, he was presented with a 'Freddie Award" at the AMA International Health and Medical Film Competition for the program, ITV: The Cutting Edge Medical Report (Prostate Cancer: Understanding, Diagnosing, and Defeating), which Crawford hosted with special guest, retired General Norman Schwarzkopf. Crawford again won a prestigious 'Freddie Award" 5 years ago... He is a member of Best Doctors of America and was named Healthcare Provider of the Year in the Denver Metro area by the Denver Business Journal. He has been recognized as one of the Best Doctors of America for the past two decades and is recognized as one of the top 20 urologists in the country, for men, by Men’s Health Magazine. In 2018 he received the honor of being named the Distinguished Alumnus of the Year from the University of Cincinnati School of Medicine. In May of 2019, he received the Presidential citation from the American Urological Association recognizing for his “tireless role in genitourinary cancer research that has benefited countless urologic cancer patients.” He accepted the position of Editor in Chief of Grand Rounds in Urology in June of 2019. In 2021, he was the recipient of the Merle Stringer, M.D. annual award for excellence in medicine by the Florida State Medical Association.

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