Push to Sell Testosterone Gels Is Not Without Major Side Effects

As a wTexas Medical Doctor and a Dallas Dangerous Drug attorney, I am concerned by the onslaught of tv advertisements that specifically target older men. The ads ask the questions with a concerned male voice over, “Have you noticed a recent deterioration of your ability to play sports?” “Do you have a decrease in sex drive?” “Do you have a lack of energy?”

If so, the ads warn, you should “talk to your doctor about whether you have low testosterone” — “Low T,” is the new buzz word.

According to media experts in 2012, drug makers in the United States spent $3.47 billion on advertising directly to consumers. Abbott Laboratories spent $80 million advertising AndroGel last year. Sales of prescription testosterone gels that are absorbed through the skin generated over $2 billion in American sales last year.

The FDA approved testosterone treatment for people suffering from testosterone hormonal deficiencies caused by medical problems like endocrine tumors or the disruptive effects of chemotherapy, a medical condition called hypogonadism. Now the prescription gels are being sold as lifestyle products, to raise falling levels of the male sex hormone as men age.

Testosterone Treatment Benefit?

“The market for testosterone gels evolved because there is an appetite among men and because there is advertising,” said Dr. Joel Finkelstein, an associate professor at Harvard Medical School who is studying male hormone changes with aging. “The problem is that no one has proved that it works and we don’t know the risks.”

The gels are of questionable medical benefit for many of the millions of men who now take them, doctors say, and their side effects may well prove dangerous.

“These medicines come with a risk of coronary artery disease,” according to Dr. Topol, a cardiologist expert.

Low T No Such Disease

Many experts say that pharmaceutical advertising promotes excessive and inappropriate drug use by convincing patients that they are ill or have a more serious condition and they need medicine to treat it. While television viewers are pummeled with advertising warning men they may have “low T,” Dr. Finkelstein said, “There is no such disease.”

Patients of any age may benefit from testosterone replacement if their levels are severely low because of serious medical problems, experts say. But testosterone normally declines as men age — just as estrogen does in women.

The F.D.A. has approved the gels “for use in men who either no longer produce the male sex hormone testosterone or produce it in very low amounts.” But that directive is ambiguous.

Unanswered Questions About Testosterone

Should testosterone be replaced in older men, and will it safely redress frequent ordinary symptoms of male aging, like decreased muscle mass and libido? And what constitutes a very low amount? Dr. Finkelstein said, “Until there are big long-term studies to address the issues of testosterone replacement, we’re not ready to make recommendations on that.”

Sex Drive in Men Related to Estrogen

New research shows a different hormone may play a role in less sex drive and more fat as men age. Estrogen, the female hormone, is needed by men, too, and a new study gives the first clear evidence that too little of it can cause certain “male menopause” symptoms.

“A lot of things we think are due to testosterone deficiency are actually related to the estrogen deficiency that accompanies it,” said Dr. Joel Finkelstein. He led the U.S.-government funded study, which published recently in the New England Journal of Medicine.

Men’s bodies convert some testosterone into estrogen, and levels of both decline with age. Until now, there was no way to tell which hormone was responsible for complaints of diminished libido, strength and energy. While strength and libido do decrease with falling testosterone levels, that effect may not be significant until testosterone levels are very low, Dr. Finkelstein said. Low testosterone is rarely the main cause of erectile dysfunction. No one has really defined what is a “normal” or “physiological” testosterone level. And yet, physicians often order tests for “low T.”