Testosterone Replacement Therapy

The Drug

The boom in marketing testosterone replacement therapy (TRT) to men is overwhelming, driving sales into the billions of dollars.  At its very essence, testosterone replacement therapy is marketed as a wellspring of youth, including claims such as improved libido, sexual performance, energy, mood, and strength.  By boosting levels of testosterone to youthful levels, many ‘symptoms’ of old-age can be countered or neutralized.  However, little to no marketing goes into educating the public about the lack of substance behind these claims, or the risk.

The Controversy

In 2004, in part due to the disastrous results associated with estrogen replacement therapy[i], the Institute of Medicine issued clinical research directions to guide and educate the medical community on the future of TRT.[ii]  Notably, the Institute stated that there was no clear evidence of benefit for any health outcomes examined, and in fact evidence of both safety and efficacy was greatly needed to make informed decisions about TRT.  These suggestions have been largely ignored in the decade since, with minimal progress made on any IOM recommendations.

Since the IOM report in 2004, multiple researchers have published data from clinical trials and meta-analyses involving TRT.  The results have not been positive.  For example, one study exhibited a significant increase in the risk for cardiovascular disorders and adverse events, ultimately leading the institutional safety review board to end the study early, citing a 10:1 rate of adverse cardiac events in the TRT group compared to placebo.[iii]  Similar results have exhibited increased risk of myocardial infarction,[iv] stroke, death,[v] and adverse effects involving cholesterol and red blood cell counts.[vi]  Importantly, many of these effects are masked in meta-analyses due to inclusion of industry funded studies.  Interestingly, when data is sorted by funding source and collapsed, significant adverse events were observed in the non-industry funded cohort, but not the industry-funded group.[vii]

Collectively, these issues have lead at least one research team to conclude that TRT should be recognized for what it is: “a mass, uncontrolled experiment that invites men to expose themselves to the harms of treatment unlikely to fix problems that may be wholly unrelated to testosterone levels.”[viii]

Symptoms

Adverse events which have been or may be associated with TRT include:

  • Stroke
  • Heart attack
  • Heart failure
  • Prostate cancer
  • Deep vein thrombosis
  • Coronary artery disease
  • Polycythemia
  • Gynecomastia
  • Death

We Want to Help

If you or a loved one has experienced any of these symptoms following the use of testosterone replacement therapy, please contact Freese & Goss today. Attorneys are available by phone, e-mail, or by clicking here.


[i] Estrogen is also a hormone, and a metabolite of testosterone.

[ii] Institute of Medicine, Testosterone and Aging: Clinical Research Directions, National Academies Press (2004).

[iii] Shehzad Basaria et al., Adverse Events Associated with Testosterone Administration, 323(2) N.E.J.M. 109-122 (2010).

[iv] William Finkle et al., Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men, 9(1) PLoS ONE e85805 (2014).

[v] Rebecca Vigen et al., Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels, 310(17) JAMA 1829-1836 (2013).

[vi] M. Merce Fernandez-Balsells et al., Adverse Effects of Testosterone Therapy in Adult Men: a Systematic Review and Meta-Analysis, 95(6) J. Clin. Endocrinol. Metab. 2560-2575 (2010).

[vii] Lin Xu et al., Testosterone Therapy and Cardiovascular Events among Men: a Systematic Review and Meta-Analysis of Placebo-Controlled Randomized Trials, 11 BMC Medicine 108 (2013).

[viii] Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS, Low “T” as in “Template” How to Sell Disease, 173(15) JAMA 1460-1462 (2013)

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