During March 2014, we explored the rise of Testosterone Lawsuits and then recently released science in “Testosterone Lawsuits – Therapy Risks Give Rise to Lawsuits & FDA Warning.” Since then, the U.S. Food & Drug Administration (FDA) has continued to scrutinize the pervasive writing of Testosterone replacement therapy to treat “Low T” as coordinated national litigation has grown. In coming months, we anticipate more updates and the progressive release of information. Recently, on June 19, 2014 the FDA announced that a general warning would be added to testosterone products regarding venous blood clots. This communication appears in the graphic below.
Venous blood clots are found in the legs – deep vein thrombosis – or may travel in to the lungs – pulmonary emboli. They can become life threatening if undetected or untreated and lead to other complications. For some treatment requires a lifetime of anti-coagulant therapy which comes with other risks and side effects. This risk exposes patients to other drugs and therapies that have been linked to deaths and lawsuits, like PRADAXA (DABIGATRAN).
As previously noted here, the FDA has been evaluating the potential risk for increased risk of stroke, heart attack and sudden death in users of testosterone replacement therapy to treat “Low T” for some time. Low T has become associated with ailments many men face during middle age as a result of diet, stress, inactivity and the loss of their youth. The use of testosterone to treat middle age malaise has grown popular as marketing materials have encouraged and facilitated self-diagnosis creating a cottage industry that continues to gain momentum with few obstacles in sight. The FDA granted limited approval for testosterone therapy in conjunction with discrete associated medical conditions that include a failure of the testicles to produce testosterone due to genetic problems or chemotherapy. Most uses fueling the Low T economy are “off-label” and not FDA approved. As a consequence, scrutiny and questions linger about safety and efficacy. Advertisements provide little emphasis on safety, but are heavy handed on claimed “effectiveness” thus not providing FDA mandated “fair balance”.
In the mind of modern men or lay people, the symptoms of Low T have come to be associated with many ailments men have suffered with for decades without an elixir. Yet, Low T itself is arguably not a medical diagnosis or one that is linked to a particular reimbursement code with insurers. In the masterful making of a Blockbuster industry, demand for Low T therapy has been created by clever marketers and a willing public that has not been well informed of risks associated with the product. This image from the Health & Fitness section of MENS JOURNAL, “The Complex Truth About Low Testosterone“, illustrates how marketing has conditioned a generation of men to seek a cure to their middle aged loss of youth. Men through unquestioning prescribers, taught in residency to trust the manufacturers, have answered with a Pavlovian devotion. As the title suggest, the discussion is complex and educated advocates abound leading to even more confusion and debate.
Regardless, Low T is arguably the brainchild of modern marketing that appeals to the vanity and insecurities of middle aged men searching to reconnect their inner Alpha Male. Too harsh? Don’t take my word for it, TIME magazine is about to help the term “Manopause” become synonymous with Low T as explained below and Americans should take note around their water coolers, dinner tables, end of summer barbeques and more importantly behind closed doors with their physicians.
The August 18, 2014, print edition of TIME will feature the cover pictured below. Inside TIME and explore “MANOPAUSE?! Aging, Insecurity and the $2 Billion Testosterone Industry” while providing some insight into the rise, or fall, of MANOPAUSE and a generation of men. In promoting the term “Manopause” a middle aged disease has been reborn anew outside the name given to it by the pharmaceutical industry and their marketing. It is not the ugly stepchild of Low T past, nor its ghost, but rather an equally appealing sibling born in the midst of controversy and scrutiny. However, it is not the end of Low T but only part of the continuing metamorphosis linked to the Blockbuster industry. The future of this Blockbuster cottage industry will be forged in coming months as the FDA weighs in, coordinated lawsuits mount and awareness of serious side effects, including death, gain an association with the search for lost youth and an elusive medical diagnosis. A generation of men did not lose their way; rather they were led astray by overpromotion of off label use of an FDA approved product.
The rise of Blockbuster sales has coincided with reports of adverse events and a rising tide of meritorious lawsuits. Along with the medical community, the FDA has scrutinized related data and responded by debating and revisiting data for red flags and answers. Off label use lies below the surface of the phenomena that has become MANOPAUSE or LOW T. The debate has been longstanding as explored here. The lack of “fair balance” in advertisements also shifted the scales in favor increased sales that may prove to have been marked by a reckless abandonment of basic analysis.
As victims have come forward, the legal community has answered the call, and taken on contingency fee (no recovery – no fee) cases across the United States. Our office is investigating Low T lawsuits resulting in death, strokes, heart attacks and serious complications. Hopefully, the newly coined vernacular – Manopause – will help raise awareness and help victims of side effects realize that they may not have been adequately informed of risks due to over marketing. Contact us for help at (954) 524-2820 or e-mail [email protected] Alternatively, submit information for a free and confidential case evaluation.
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Click here for more related content and periodical updates from the author Gabriel F Zambrano