http://www.nytimes.com/2014/09/18/health/testosterone-drugs-fda.html 2014-09-17 21:14:45 F.D.A. Panel Weighs Restrictions on Testosterone Drugs New rules could reduce the number of men who would be prescribed the medicines, as well as coverage from insurance companies for their use. === HYATTSVILLE, Md. — An expert panel is considering whether the Food and Drug Administration should tighten rules for the $2 billion testosterone industry and is expected to make its recommendations this afternoon at the conclusion of a hearing here. Once used by a small group of men for medical reasons, testosterone drugs are now being prescribed to millions of American men for symptoms that are largely related to aging, a pattern that has alarmed some medical experts. The F.D.A. has said that the benefits of such treatments for healthy, aging men are unproven, and that the drugs could even be risky. Men who take them have been found to have higher rates of heart problems in some studies. The agency is asking its expert panel what limits, if any, it should impose. The F.D.A. often takes the advice of such panels. A restrictive recommendation could reduce the number of men who would be prescribed the medicines, as well as coverage from insurance companies for their use. “The FDA convened this meeting to ask the question, ‘Is it O.K. to give testosterone without any limits to all older men with low testosterone levels,'  ” said Dr. Brad Anawalt of the University of Washington in Seattle, an author of a study that found testosterone could help certain veterans. “Since the number is now millions of men, this has major implications.” Testosterone usage has quadrupled since the early 2000s for men in their 40s, driven in part by marketing that suggests the drugs are a solution for low energy, low libido and other ills, many of them associated with aging. By 2011, nearly one in 25 men in their 60s was taking testosterone. In 2013, 2.3 million Americans were being treated with testosterone therapy, according to material distributed at the panel meeting. Many experts began raising alarms, saying that the benefits and longer term risks of the drugs were unknown, and called on regulators to step in. Earlier this year, the F.D.A. said it was “This is now the new thing,” said Dr. Aaron Katz, chairman of the Department of Urology at Winthrop University Hospital in Mineola, N.Y. “People are looking for the fountain of youth. The F.D.A. is trying to decipher which patients are appropriate to treat.” The panel is being consulted on what criteria should be used to prescribe testosterone therapy for aging men who have low testosterone, but no other medical conditions. It is also being asked to sift through the evidence for safety risks. Specifically, they are being asked to determine the strength of the evidence, and to recommend whether those risks should be included on the drug labels. A clinical trial, whose results were published in 2010, found an elevated risk of heart attacks and strokes among men who took testosterone, and the trial was ended early as a result. Other trials have found no increased risk. The panel heard some surprising facts from industry experts: A fifth to a quarter of men who are prescribed testosterone have not had a baseline test for their testosterone level. And 60 percent of the prescribing is done by primary care doctors, while just 20 percent of the drugs are prescribed by specialists like endocrinologists and urologists. Some experts said it took too long for the F.D.A. to act. “Why did the F.D.A. allow this huge push for the creation and the selling of ‘aging is optional for men,’ when we don’t know the benefits,” said Trung-Hieu Brian Tran, a regulator review officer at the F.D.A.'s Office of Prescription Drug Promotion, said the agency has issued warning letters to sponsors over inappropriate and misleading promotions. One concerned an ad claiming that patients who had taken the product “start chasing their wives around the room a little bit — they just feel like guys again,” implying that the product can be used to successfully treat sexual dysfunction, when there is no data to support that, he said. Dr. Schwartz said the marketing of what is popularly known as Low-T, or low testosterone, was “eerily reminiscent” of the aggressive promotion of hormone replacement for post-menopausal women. For years physicians were convinced the treatment protected women from heart disease, and promoted it as a long-term preventive regimen to treat symptoms such as hot flashes, mood swings and low sexual desire. But a gold-standard randomized trial, the Women’s Health Initiative, found that the popular treatment —– 20 percent of menopausal women were taking it at the time — actually increased risks of blood clots, strokes and breast cancer, and did not protect from heart disease. Experts on the panel cited an Institute of Medicine call for trials to assess whether there are benefits to taking testosterone, and if so, who would benefit. The National Institutes of Health is