Testosterone Replacement is Safe in Hypogonadal Men

Testosterone replacement therapy (TRT) is an effective means of restoring testosterone levels to normal in men who are unable to maintain serum levels on their own.   However, controversy surrounds TRT; the FDA has revisited the appropriateness of TRT and many private payers are putting up roadblocks to paying for it.   Certainly no one would argue to refrain from replacing thyroid hormone in patients who are hypothyroid or to refrain from administering insulin in insulin dependent diabetics, so how did TRT become so controversial?

TRT, until fairly recently was limited to injection therapy.  The medication has been available for decades and was relatively inexpensive and administration into the muscle was somewhat uncomfortable.    This may have served to constrain testosterone usage.

The popularity of TRT has taken off over the past several years due in large part to two related factors:

1. The development of testosterone gels, a relatively easy and seemingly safe method of replacing testosterone in a manner which more closely approximates normal physiology.
2. Marketing by Big Pharma direct to consumers using very effective advertising, leading to a tremendous increase in demand for these expensive gels over a fairly short period of time.

The surge in popularity was accompanied by additional research questioning whether there is any increase risk of myocardial infarction or other serious thrombotic events, particularly in elderly men.   Enough concern was raised that the FDA revised its guidelines for testosterone replacement.   Suddenly, advertisements from attorneys recommending patients sue their physicians for giving them TRT began to outnumber advertisements by Pharma promoting use of the medications.’

Study results

Good news for TRT users:   A retrospective study from Baylor colleges of Medicine in Houston by Ramasamy et al evaluated the records of 217 men aged 65 years and older.   153 were on TRT.   After a mean follow up f of 3.8 years,  the researchers observed no difference between the TRT and control groups in the occurrence of heart attack, coronary artery disease or pulmonary embolus.  In fact the control group had a significantly higher prevalence of death from any cause when compared to the TRT group.

As time passes, the reality of the consequences of TRT, both beneficial and, harmful (if any) will manifest.  Until that time, patients are best advised to perform TRT only under the direction of their physician.