Testosterone Therapy Studies Should Determine Benefits First, Then Risks; Study Participants Should Be Limited, Carefully Screened

Washington, DC, November 12, 2003---A major report on testosterone research needs was released today by the Institute of Medicine (IOM), the medical branch of the National Academy of Sciences. After several years of study, the blue-ribbon panel recommended to the NIH that future studies should be small, focused ‘Phase II types,’rather than large ‘Phase III types’, and that emphasis should be on the “nature and extent of potential benefits.” Further, the panel recommended

This report is of great interest at Urological Sciences Research Foundation (USRF) because just such a project is currently underway now in the Los Angeles offices of USRF

The report further said currently available evidence suggests that testosterone therapy may have potential benefit for older men in terms of improving strength, sexual function, cognitive function, and general well-being. The committee found no compelling evidence of major adverse side effects resulting from testosterone therapy, but the evidence is inadequate to document safety, the report says.

Testosterone information now available is limited to short studies in small groups of men. The need for testosterone information in older men is great, because according to the Census Bureau, there are now in the U.S. nearly 15 million men over the age of 65, and this number is expected to grow. to 17 million by 2010. Testosterone usage appears to be growing rapidly, partly due to improved delivery systems. More than 1.75 million prescriptions for testosterone therapy were written in 2002, a 30% jump from 2001.

The IOM report was commissioned by the National Institute of Aging and the National Cancer Institute. The IOM is the medical branch of the National Academy of Sciences (NAS), which is the nation’s premier advisory body regarding the establishment of priorities and allocation of resources in the sciences. The NAS was signed into being in 1863 by President Abraham Lincoln with a mission to "investigate, examine, experiment, and report upon any subject of science or art" whenever called upon to do so by any department of the government.

ADDITIONAL RELATED LINKS:

• Complete press release from National Academy of Sciences
• Executive Summary of IOM Report (pdf)
• Full IOM report online or order the book
• New York Times editorial on IOM Report
• USRF Report: “Male Menopause – Does it Exist?”