The federal Food and Drug Administration announced within the past month that it was investigating the risk of heart attack, stroke and death in men taking testosterone.
According to Bloomberg, doctors are prescribing testosterone at twice the rate they did in 2006 and sales are expected to triple in the next couple of years. The market for testosterone is expected to reach $5 billion by 2017.
Research has shown that men’s testosterone levels peak in late adolescence and decrease by about 1 percent per year after age 30.
Does this mean that older men who have expectedly lower levels of testosterone – and some of the things that go along with that such as decreased energy, decreased libido and changes in body composition – suffer from a disease that needs treatment? Or are they just experiencing what comes with old age? Has old age become a condition that we should treat with drugs?
These questions were answered for women more than a decade ago in the Women’s Health Initiative. The results were spectacularly alarming, especially since doctors had been prescribing estrogen and progestin to women for decades for not only symptoms associated with menopause but also to make women feel better and more “feminine.”
This long-term study that included thousands of women showed that the combination of estrogen and progestin increased the risk of breast cancer by 26 percent, stroke by 41 percent, heart attack by 29 percent and blood clots by 100 percent.
In women who received only estrogen, the risk of stroke was increased by 39 percent and blood clots by 47 percent.
Can we learn from the past? Are we headed in this direction for men?
While the question has not been answered by the gold-standard, randomized clinical trial, one large study published in the Journal of the American Medical Association showed that men in their 60s who received testosterone suffered from a higher risk of heart attack, stroke and death.
In another study published in PLOS One, an international, peer-reviewed, open-access, online publication of the Public Library of Science, the authors found that men ages 65 and older experienced a twofold to threefold increase in the risk of heart attacks in the first 90 days after being prescribed testosterone. In men younger than 65 with pre-existing heart disease, there was a twofold increase in the risk of a heart attack.
While the FDA has not gone as far as to say that men should not receive testosterone, it was explicitly said that testosterone replacement should only be used in men who have both a low testosterone and a medical condition that causes low testosterone such as genetic problems, chemotherapy or other problems that disrupt the regulation of hormone levels.
Implicit in this is that patients should not be prescribed testosterone based on symptoms alone (fatigue, decreased sex drive, loss of muscle mass), something that is being done increasingly by many providers.
Only after a large-scale study is done, something which will certainly happen in the next few years, will we know the truth. In the meantime, it may be prudent to proceed with a little bit of caution.
Dr. Tin Ngo is a urologist for the Center for Specialty Care, a NorthBay Affiliate, in Fairfield. He writes a blog, “In the Know with Dr. Ngo,” every other week on men’s health issues, which can be found on www.NorthBay.org.