Testosterone Therapy Might Carry Heart Risks

Among the subjects we’ve filed under “disease mongering” – “the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments,” as defined by the journal PLoS Medicine – are men who take hormones for testosterone deficiency when they don’t need them.

Some people have legitimate medical reasons for using these prescriptions, but whether the problem is real or perceived, testosterone therapy might not be a good idea, according to a study published in the Journal of the American Medical Association (JAMA). “A recent randomized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety,” researchers wrote.

That’s huge – studies are not interrupted mid-course unless there are serious safety concerns.

Researchers studied more than 8,700 men with low testosterone levels. Of 1,223 patients who took testosterone treatments, 67 died within a year and a half; 23 had heart attacks; and 33 had strokes. The rate of events was 25.7% in the group that took testosterone therapy drugs, and 19% among the 7,486 patients who did not.

As JAMA noted, testosterone therapy prescriptions have boomed in the U.S. over the last decade. In 2011, there were about 5.3 million prescriptions at a market price of $1.6 billion. Clinical guidelines recommend testosterone therapy for patients with what’s come to be called in ad copy “Low T,” known clinically as hypogonadism.

There’s a wide range of symptoms, including:

• reduced libido
• erectile dysfunction (ED)
• reduced intensity of orgasm and genital sensation
• osteoporosis or low bone mineral density
• decreased spontaneous erection
• lower sperm count
• very small or shrinking testes
• hot flushes, sweats
• breast discomfort, gynecomastia (enlarged breasts)
• loss of pubic and axillary hair, reduced shaving
• decreased energy or vitality, increased fatigue
• depressed mood
• reduced muscle mass and strength
• poor concentration and memory
• sleep disturbance; increased sleepiness
• mild anemia
• increased body fat, body mass index
• diminished physical or work performance

Many of those symptoms, however, are a consequence simply of aging. Others are characteristic of a lot of problems, some of them worthy of medical intervention, others more suitably treated by lifestyle modifications. Taking prescription hormones is not something a man should do simply because he feels less masculine – that’s not a disease, that’s somebody – somebody selling something? – mongering disease.

For people who need testosterone, it not only improves sexual function, muscle mass and strength, but bone mineral density, lipid (blood fat) profiles and insulin resistance. For them, the JAMA study is especially concerning.

It says that “the effects of testosterone therapy on cardiovascular outcomes and mortality are unknown,” and refers to previous testosterone therapy studies that haven’t detected adverse cardiac events. But those studies had limitations – short duration – and focused on intermediate rather than clinical end points. A clinical end point is something that’s measured in a trial, such as response or survival rates.

Not all men taking testosterone therapy have been diagnosed with hypogonadism, and especially for them, we would echo JAMA’s conclusion: “Our findings raise some uncertainty regarding the potential safety of testosterone use in men. Although physicians should continue to discuss the symptomatic benefits of testosterone therapy with patients, it is also important to inform patients that long-term risks are unknown and there is a possibility that testosterone therapy may be harmful.”