[GRG] FDA Limits Use of Testosterone HRT

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FDA Panel: Limit Testosterone Drug Use

Joint committee also calls for drug makers to run heart-risk tests on popular ‘Low T’ products 

WebMD News from HealthDay

By Dennis Thompson

HealthDay Reporter

THURSDAY, Sept. 18, 2014 (HealthDay News) — There is little evidence that testosterone replacement therapy effectively treats normally sagging levels of the hormone in aging American males, a U.S. Food and Drug Administration advisory panel said Wednesday.

The panel, from two key FDA committees, overwhelmingly voted, 20-1, to tighten use of the popular drugs and require drug makers to conduct tests assessing the drugs’ risk of heart attack and stroke, according to Bloomberg News.

“The whole idea is to try to rein in the inappropriate advertising and use of these drugs,” Dr. Michael Domanski, a panel member who is director of heart failure research at Mount Sinai School of Medicine in New York City, told The New York Times.

The FDA is not required to follow the recommendations of its expert panels, but usually does.

Along with sharply curtailing how many men might be prescribed testosterone supplements, insurance companies could also limit coverage for their use if the FDA follows its panel’s advice, experts told the Times.

In what has become known as the Low-T fad, Baby Boom generation men have turned to testosterone replacement therapy in response to the sagging muscles, lower energy levels and sexual problems that often accompany natural aging, the FDA noted in a review provided to committee members in advance of the meeting.

“There’s a large group of men out there who are getting older, and they are looking for ways to evade the consequences of aging,” Dr. Bradley Anawalt, an endocrinologist from the University of Washington in Seattle, said ahead of the meeting.

The FDA review pointed out there’s no clear scientific evidence showing testosterone replacement can reverse some of the effects of aging. Yet the “Low-T” craze has been aided by consumer advertising for remedies that promise renewed vitality and strength for aging men, the report said. It also noted that there’s growing evidence many men who are receiving testosterone replacement therapy do not need it.

Anawalt said he hoped the FDA hearing signals increased government oversight of testosterone therapy and increased public funding for studies on its effectiveness.

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About Johnny Adams

My full-time commitment is to slow and ultimately reverse age related functional decline to increase healthy years of life. I’ve been active in this area since the 1970s, steadily building skills and accomplishments. I have a good basic understanding of the science of aging, and have many skills that complement those of scientists so they can focus on science to advance our shared mission. Broad experience Top skills: administration, management, information technology (data and programming), communications, writing, marketing, market research and analysis, public speaking, forging ethical win-win outcomes among stakeholders (i.e. high level "selling"). Knowledge in grant writing, fundraising, finance. Like most skilled professionals, I’m best described as a guy who defines an end point, then figures out how to get there. I enjoy the conception, design, execution and successful completion of a grand plan. Executive Director Gerontology Research Group (GRG). Manages Email discussion forum, web site, meetings and oversees supercentenarian (oldest humans, 110+ years) research. CEO / Executive Director Carl I. Bourhenne Medical Research Foundation (Aging Intervention Foundation), an IRS approved 501(c)(3) nonprofit. http://www.AgingIntervention.org Early contributor to Supercentenarian Research Foundation. Co-Founder Geroscience Healthspan Forum. Active contributor to numerous initiatives to increase healthy years of life. Co-authored book on conventional, practical methods available today to slow the processes of aging – nutrition, exercise, behavior modification and motivation, stress reduction, proper supplementation, damage caused by improper programs, risk reduction and others. Fundamental understanding of, and experience in the genomics of longevity (internship analyzing and curating longevity gene papers). Biological and technical includes information technology, software development and computer programming, bioinformatics and protein informatics, online education, training programs, regulatory, clinical trials software, medical devices (CAT scanners and related), hospital electrical equipment testing program. Interpersonal skills – good communication, honest, well liked, works well in teams or alone. Real world experience collaborating in interdisciplinary teams in fast paced organizations. Uses technology to advance our shared mission. Education: MBA 1985 University of Southern California -- Deans List, Albert Quon Community Service Award (for volunteering with the American Longevity Association and helping an elderly lady every other week), George S. May Scholarship, CA State Fellowship. BA psychology, psychobiology emphasis 1983 California State University Fullerton Physiological courses as well as core courses (developmental, abnormal etc). UCLA Psychobiology 1978, one brief but fast moving and fulfilling quarter. Main interest was the electrochemical basis of consciousness. Also seminars at the NeuroPsychiatric Institute. Other: Ongoing conferences, meetings and continuing education. Aging, computer software and information technology. Some molecular biology, biotech, bio and protein informatics, computer aided drug design, clinical medical devices, electronics, HIPAA, fundraising through the Assoc. of Fundraising Professionals. Previous careers include: Marketing Increasing skill set and successes in virtually all phases, with valuable experience in locating people and companies with the greatest need and interest in a product or service, and sitting across the table with decision makers and working out agreements favorable to all. Information Technology: Management, data analysis and programming in commercial and clinical trials systems, and bioinformatics and protein informatics. As IT Director at Newport Beach, CA based technology organization Success Family of Continuing Education Companies, provided online software solutions for insurance and financial professionals in small to Fortune 500 size companies. We were successful with lean team organization (the slower moving competition was unable to create similar software systems). Medical devices: At Omnimedical in Paramount CA developed and managed quality assurance dept. and training depts. for engineers, physicians and technicians. Designed hospital equipment testing program for hospital services division. In my early 20’s I was a musician, and studied psychology and music. Interned with the intention of becoming a music therapist. These experiences helped develop valuable skills used today to advance our shared mission of creating aging solutions.
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