This Uncertainty About Drug Safety Of AndroGel, Axiron, Testim, And The Like Is Causing Concern Among Doctors
(Posted by Tom Lamb at DrugInjuryWatch.com)
For patients and doctors who have questions about whether cardiovascular side effects associated with testosterone products are real or not, they may be looking forward to the results from the Testosterone Trial in Older Men clinical study (known as the T Trial) that was sponsored by the US National Institutes of Health.
Unfortunately, however, the lead investigator on that study, Dr. Peter J. Snyder, of the University of Pennsylvania, has already warned that this T Trial, designed to enroll fewer than 800 men, will only be large enough to detect the benefits of testosterone drugs, but not any of the risks.
From this April 4, 2014 Philadelphia Inquirer article, "As testosterone use grows, questions on risks await answers":
In another echo of the female hormone saga, the federal government has stepped in to do the kind of costly, rigorous, placebo-controlled clinical trial that drug companies have no incentive to do. The $50 million Testosterone Trial is now wrapping up and will present results next year, said the leader, University of Pennsylvania endocrinologist Peter J. Snyder.
But size and duration do matter - in life and in research.
The Women's Health Initiative - with 16,600 women taking estrogen-progestin pills for five years - had what scientists call "statistical power." That's why, despite criticism, the results have held sway.
The T Trial - 788 men on hormone or placebo for a year - is designed to detect benefits, but not risks.
"It is nowhere near large enough to determine any important risk," Snyder said. "Not on prostate cancer, or heart disease."
A government advisory panel said in 2003 that a more definitive trial would be premature, given testosterone's scant research record. Still, if pluses emerge without the proper counterbalance of minuses, could that fuel misguided use of testosterone?
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In fact, this continuing uncertainty about the possible cardiovascular side effects, e.g., heart attacks and strokes, caused by AndroGel, Axiron, Testim, and other testosterone replacement drugs -- "uncertainty" because there has never been an appropriate clinical study to assess the drug risks -- is increasingly a drug safety issue being discussed among doctors.
From an April 1, 2014 Medscape article (free registration required), "Don't Prescribe 'T' Without 'E'", under the Risks Associated With Testosterone Therapy section:
At this time, it is prudent to avoid very high dosages of testosterone in older men with known cardiac disease while we await more definitive evidence from future randomized, controlled trials on the benefits and safety of testosterone therapy on men.
And from The Lancet Diabetes & Endocrinology medical journal (free registration required), there is this April 28, 2014 (early online publication) article, with a most-telling title, "Testosterone, cardiovascular disease, and mortality in men: living in the dark":
Observational studies such as those done by Vigen (1) and Finkle (2) and their collaborators should serve to galvanise both the public and medical communities to fund an appropriate clinical study to assess the risks and benefits of testosterone treatment in older men in an era when millions of men are using testosterone every day....
What then can older patients be told about the risks associated with testosterone, and in particular about cardiovascular risk? Testosterone is a billion dollar industry, probably fuelled partly by direct-to-consumer advertising and, undoubtedly, some degree of overprescription. Physicians need to admit they simply do not know and use conservative treatment guidelines (12) to guide therapeutic decisions.
- 1 Vigen R, O'Donnell CI, Barón AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA 2013; 310: 1829-1836.
- 2 Finkle WD, Greenland S, Ridgeway GK, et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One 2014; 9: e85805.
- 12 Bhasin S, Cunningham GR, Hayes FJ, et alfor the Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010; 95: 2536-2559.
We will continue to monitor the medical literature for more discussion and information about the safety or side effects of testosterone products like AndroGel, Axiron, and Testim.