Are you a middle-aged man experiencing low libido, weaker erections, fatigue, irritability, or muscle loss? If so, you’ve probably noticed the ubiquitous drug company advertisements touting testosterone therapy as the panacea for these and other conditions. According to a statement from the Endocrine Society, you should be aware that there are serious heart-related risks of testosterone therapy.
In its statement, the Endocrine Society cautioned against widespread use of testosterone drugs until large-scale trials can be completed. The statement was partly a response to a decision by the FDA to investigate the risk of stroke, heart attack and death in men taking prescription testosterone. The FDA’s decision to investigate came two days after a publication of a study in the peer reviewed medical journal, PLOS ONE, showing that men over age 65 had a two-fold increase in the risk of heart attack within 90 days of filling an initial prescription for a testosterone drug. In men under 65 with preexisting heart risk factors, there was a two-to-three-fold increase in the risk of heart attack. There was no reported increased risks in younger men without a history of heart disease. The study analyzed nearly 56,000 patients, and was consistent with the results of a study published November in the Journal of the American Medical Association (JAMA), which concluded that older men had a 30 percent increased risk of death, heart attack, and stroke after taking tesosterone therapy.
A co-author of the Endocrine Society statement, Shalender Bhasin, M.D. of Harvard Medical School, said that “Testosterone isn’t approved for age-related conditions and age-related decline in testosterone levels.” Indeed, testosterone levels begin to decline naturally after age 30. The FDA has approved testosterone products only for a medical condition called “hypogonadism,” which occurs when the testicles do not produce enough testosterone. Dr. Bhasin said that it is important for men to remember that “‘low T is not a condition, it is a number- and a number is not a disease.'”
This warning echos a recent article published in the Los Angeles Times entitled, ‘Low T’ and the peril of medicating grumpy old men. In the article, the authors characterize the advertising campaign called “Is It Low T?” run by Abbott Laboratories (now AbbVie) as “a highly effective effort to change how doctors and the public think about managing aging in men.” This massive marketing campaign, designed to sell AndroGel, has helped result in more than an 1,800% increase in testosterone sales. Sales in 2012 approached $2 billion.
The marketing of testosterone to men is similar to the hyped-up marketing of hormone replacement drugs for post-menopausal women. This marketing came to a halt and estrogen prescriptions dropped off rapidly after a gold-standard study from the Women’s Health Initiative was published in the early 2000’s. The marketing of testosterone to men is even more intense than that of estrogen to women. One suspects that the drug companies understand that a product touted as being able to produce stronger erections will sell itself.
The doctors who authored the L.A. Times article concluded that, “When it comes to testosterone, the pharmaceutical industry has gone too far — and the FDA not far enough. Maybe the problem isn’t low T; maybe instead it is low R — low regulation.” The marketing campaigns for testosterone therapy imply unproven benefits and are silent about the risk of heart attack, stroke, and death. Since the regulators and the industry have let the consumer down, it’s no wonder that testosterone lawsuits have already been filed. Use of drugs like AndroGel for “Low T” is not an FDA-approved use. Indeed, hypgonadism is diagnosed by blood testing, and most of the men responding to the “Is It Low T” marketing blitz are getting their prescriptions without a blood test.