By Levin Simes
March 4, 2014

Did Studies Sponsored by Pharmaceutical Companies Hide Risks of Testosterone?

An article published in November in BioMed Central discovered serious differences between studies funded by pharmaceutical companies selling testosterone therapy drugs, and those that were independent of pharmaceutical companies pushing the drugs. Combined with the FDA warning1 in January on the risks of testosterone therapy, including heart attacks and strokes, this paints a troubling picture on how the testosterone therapy market was promoted and grew to more than 5 million prescriptions per year by 20132.

Xu et al.3 completed a meta-analysis of placebo-controlled randomized trials of testosterone therapy. 27 studies met their eligibility requirements, including 2,994 mainly older men. An analysis of the 27 studies showed a 54% increase in the risk of cardiovascular-related events. This risk factor was independent of baseline testosterone, meaning the risks increased regardless of whether testosterone therapy was given for those with diagnosed low testosterone (“low T”), or those given testosterone with normal levels.

The most disturbing aspect was revealed when the studies were divided into two groups: 1) studies sponsored by pharmaceutical companies who promoted the products, and 2) studies independent from companies selling testosterone therapy products. Among the studies sponsored by pharmaceutical companies, the risk among those taking testosterone was less than those not taking therapy. The exact opposite findings of independent studies showed a more than double the risk (206 percent). Only when the pharmaceutical sponsored studies were combined with those studies not sponsored did the overall risks factor average out to 54 percent.

Millions of Americans took testosterone therapy without being told of the risks of heart attack, stroke, blood clots, and death. Many Americans who suffered injuries while taking testosterone would not have taken the drugs had they received fair and full warning. These products include:

  • Androgel
  • Androderm
  • Axirom
  • Bio-T-Gel
  • Delatestryl
  • Depo-Testosterone
  • Fortesta
  • Striant
  • Testim
  • Testopel

(1) January 31, 2014 FDA Safety Announcement – FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA-approved Testosterone Products
(2) IMS Data on U.S. testosterone prescriptions for gel, patch and oral dosage forms, 2013
(3) Xu, et al. 2013. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials. BMC Medicine 2013, 11:108

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