FDA Finally Poses The Hard Questions on Testosterone | Levin Papantonio Rafferty - Personal Injury Lawyers

FDA Finally Poses The Hard Questions on Testosterone

It's no secret that Americans – held captive by a corporate, for-profit health care “system” (the ACA notwithstanding) – are the most over-medicated people on the planet. In its insatiable quest to maximize profits at any cost, Big Pharma will “identify” or even create so-called “conditions” and “health problems,” then use fear to sell patients their solutions – which, more often than not, cause side effects ranging from mildly irritating to deadly. Even when dealing with legitimate health concerns, if they can be treated with simple diet, exercise or other lifestyle changes, fear-based advertising will invariably trumpet that “diet and exercise may not be ENOUGH!”

This is most certainly the case with testosterone supplements, originally intended to treat the rare patient whose own endocrine system fails to produce the hormone naturally in adequate amounts (the condition is known as hypogonadism).  It is true that abnormally low testosterone levels (less than 300 nanograms per deciliter) can affect energy, sex drive, and even put a man at risk for osteoporosis. However, there is little to no evidence that these mean or men whose testosterone levels are in the normal range (300-900 nanograms per deciliter) will benefit from testosterone therapy.   Even worse these men may even put themselves at risk for blood clots, heart attacks, strokes, and even prostate cancer.

Nonetheless, the number of men who are being prescribed testosterone went up by nearly a hundred percent over a three-year period, jumping from 1.3 million to 2.3 million between 2010 and 2013.  Importantly, according to the U.S. Food and Drug Administration, the vast majority of these men have no medical need for testosterone treatment. Furthermore, a quarter of those men have not undergone any medical testing for hypogonadism. 

Fortunately, the FDA is finally starting to take a hard look at these figures. According to endocrinologist Dr. Bradley Anawalt of the University of Washington in Seattle, testosterone “...has been used as a therapy for decades without much scrutiny.” 

That long-overdue scrutiny has now come to fruition.  Yesterday, an FDA advisory committee meeting panel voted nearly unanimously that the product labeling for testosterone treatments need to be drastically overhauled to clearly define the population of patients that will likely benefit from testosterone therapy.  This will undoubtedly serve as a huge financial blow to testosterone manufacturers and will hopefully serve as the first step toward properly limiting the use of testosterone treatment.