Posted 20 March 2017
Six sets of defendants are being sued for inappropriate marketing of testosterone-replacement therapy (TRT) with misleading claims. Separate cases have been consolidated into a master complaint that is proceeding in proceeding in Illinois Federal Court. The third amended master complaint summarizes the case this way:
“TRTs were approved for use in the treatment of a medical condition known as hypogonadism, but widely marketed by Defendants for off-label use for a condition invented by Defendants and referred to as “Low T.” . . . Defendants marketed TRTs as safe and effective for this off-label use, when in fact (a) TRTs confer little or no benefit for so-called “Low T” in the absence of”classical hypogonadism”; and (b) the drugs cause serious medical problems, including life-threatening cardiac, cerebrovascular, and thromboembolic events, for which Defendants failed to provide adequate warnings.”
The fact that testosterone levels normally decline as men get older does not mean that it is beneficial to administer medication to raise them. A 2015 editorial in the Journal of the American Geriatrics Society referred to the “Low-T” campaign as “disease-mongering” and called on the FDA, the FTC, and Health Canada to ban educational and product advertising of testosterone for contrived “indications.” The FDA has tightened labeling requirements and issued a public warning but has taken no enforcement action against the companies listed as defendants in the lawsuit. Truth in Advertising has published an insightful overview of the situation.
Source: Consumer Health Digest #17-12, March 19 2017
The 2015 editorial in the Journal of the American Geriatrics Society referring to the “Low-T” campaign as “disease-mongering”, makes a number of other salient points, including: