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Cleveland Clinic's Dr. Nissen Warns Against AndroGel

Sarah N. Emery
Associate Attorney at Schachter Hendy & Johnson PSC
Posted on May 02, 2014

The Cleveland Clinic's Dr. Steve Nissen, Chair of the Department of Cardiovascular Medicine, recently issued the following warning concerning testosterone medications, like AndroGel:

If you turn on your television set or read the popular press, you can't miss clever and seductive advertisements directed at middle-aged and older men. If you don't have the energy or sexual performance of your youth, you may have "low T," a medical condition with a simple and effective treatment: testosterone replacement therapy (TRT). TRT promises men a nearly magical cure for their lost youth—a safe and effective treatment with few, if any, adverse effects. These advertisements take advantage of the natural desire of aging men who want to feel stronger and regain the "performance" they enjoyed when they were young. As a consequence of these marketing efforts, in recent years, a variety of testosterone products have enjoyed an astonishing increase in sales and profitability for drug makers.

To physicians with a sense of history, the rush toward hormone replacement therapy (HRT) for men, in the immortal words of Yogi Berra, seems like "déjà vu all over again." Two decades ago, women were routinely treated with estrogen-containing therapies to maintain a youthful appearance and ostensibly ward off diseases of aging, including cardiovascular disease. The Women's Health Initiative eventually demonstrated cardiovascular harm, rather than benefit, for HRT.

The lessons learned about HRT in women should serve as a warning to the medical community about the potential risks of testosterone replacement therapy in men. In recent months, these concerns have transitioned from theoretical to tangible. Two important observational studies provide considerable evidence that TRT may represent a serious cardiovascular risk to men's health. In November 2013, a study performed in the Veteran's Affairs system reported the risk of death, myocardial infarction (MI), or stroke was higher in men treated with testosterone compared with men who were not treated: 25.7% vs. 19.9%. There is solid biological plausibility for the hypothesis that TRT might increase adverse cardiovascular outcomes.

In the wake of the recent publications, the US Food and Drug Administration (FDA) announced in January 2014 that the Agency is investigating the risk of stroke, MI, and death in men taking testosterone products. Unfortunately, once again on a drug safety issue, the FDA is too late and too slow to recognize an important public health concern. The FDA unwisely approved TRT products based upon short-term data showing that the products raise testosterone levels, but without requiring evidence of cardiovascular safety. History has repeatedly shown that approving products based upon "surrogate endpoints" (biochemical effects) is risky and may lead to unintended consequences.

Given these concerns about the safety of TRT, what is the best course of action for the cardiovascular community? In my opinion, we should counsel our patients that TRT is not a panacea and warn that the cardiovascular effects are uncertain and potentially catastrophic. We should insist that the FDA require marketers of testosterone products to conduct proper randomized controlled trials to determine the long-term effects of these drugs on cardiovascular outcomes. Anything less exposes American men to a gigantic uncontrolled experiment that may ultimately result in serious damage to public health.

If you or a loved one had a heart attack, stroke, pulmonary embolism or blood clot while taking AndroGel or another testosterone, please call our experienced AndroGel attorneys at (888) 606-5297 for a free consultation about your potential AndroGel lawsuit.

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