Testosterone has been in the news in the last several months. In October 2013 the New York Times published an article, “A Push to Sell Testosterone Gels Troubles Doctors.” It touched on two of my pet peeves—the gross exaggeration of the benefits of testosterone replacement for men and women who have normal hormone levels for their age, and the influence of direct to consumer pharmaceutical advertising. Then JAMA published a paper based on 8,709 veterans whose serum testosterone tested as below 300 ng/dl. This is the bottom end of normal levels for men (although that “normal” is based on blood tests from healthy, young subjects). The average age of the veterans was 61 and according to angiogram results, many had disease in their coronary arteries (the major vessels that bring blood to the heart). The article compared 1,223 men who were started on testosterone replacement with all the other men in the group. Men taking testosterone had a 29% greater risk of death, heart attack, and stroke. The increase in health problems was seen in both men who did and did not have heart disease. Since the study was observational, rather than a randomized trial, it is possible that other factors, and not the hormone treatment, accounted for the health risks. However, the findings are troubling, given the way testosterone is being used in medical practice.
An article published earlier this year in JAMA Internal Medicine showed that prescriptions for replacement testosterone have tripled since 2001, including a 5-fold increase in sales of the gel products, which are heavily advertised to consumers. In 2013, sales of testosterone gels alone are expected to reach 2 billion dollars. Testosterone replacement was approved by the US Food and Drug Administration to treat men with endocrine disease. In fact it is usually prescribed “off label” for men who have slightly low, but normal testosterone. Typically these men are over age 40, get little exercise, are overweight, and have been convinced by ads that increasing their testosterone will rev up their sex drive, harden their erections, chase away the blues, and reduce their belly fat. Nobody seems to be suggesting that they try changing their diet, exercising, or being nicer to their partners. (I would note, however, that there is a group of men whose cancer treatment interferes with testosterone levels, and who benefit from replacement testosterone–especially some men who have had intensive chemotherapy or radiation therapy to the pelvic area. Giving testosterone to men who have had prostate cancer remains controversial.)
As a health care professional involved in treating sexual dysfunction, this is not news to me. The pharmaceutical industry has also repeatedly tried to foist testosterone patches or gels on aging women to improve their sexual desire—ignoring the fact that large studies of healthy women around the age of menopause agree that 1) most women do not lose desire for sex as they go through the hormone changes of menopause, and 2) those who do lose desire are typically depressed, under higher than usual life stress, and have conflict in their intimate relationships (not to mention the sad fact that over half of women over age 50 in the United States do not have a functional sexual partner), and 3) at least according to the blood tests routinely used in women, testosterone levels have no relationship to lust after menopause . I got involved in writing about testosterone therapy and women when I noticed a number of studies suggesting that high testosterone levels may increase a woman’s risk for breast cancer. Not everyone agrees with my concern, but it is clear that rates of breast cancer in the United States fell sharply when women stopped taking estrogen and progesterone after menopause because of press coverage of the Women’s Health Initiative findings of a link with breast cancer. After menopause, most of the extra testosterone given as “replacement” is directly converted into estrogen.
I have a bad habit of watching CNN while I eat dinner. Commercials for underarm testosterone gel are some of the most frequent advertisements. In all of the direct-to-consumer TV spots, the litany of possible side effects is recited in hushed tones while attractive models cavort around, enjoying the improved quality of life that surely occurs for the vast majority who persuade their physicians to prescribe the drug in question. Whether it is Axiron®, Cialis®, or Cymbalta®, I interpret the message as: the company is dutifully informing you of the risks–but you should not really worry about them.
I think all pharma direct-to-consumer ads should devote a sizable corner of the screen to Morbidity Max (or Maxine), a cartoon patient for all seasons and side effects. Morbidity Max should demonstrate each of the possible negative outcomes of taking the medication in the ad, including rashes (Max with itchy dots), liver failure (Max tinted an unhealthy yellow), lymphoma (Max hooked up to a chemotherapy IV), priapism (Max slinking into the ER in a long robe clutching a painful, penile protrusion), suicidal thoughts (Max perched on a windowsill many stories above the street), and death (Max with X’s for eyes, lying on his back clutching a funereal bouquet of lilies). Occasional sound effects would add to the fun, especially some groans and curses. It makes me wish I had talent for drawing. Perhaps somebody out there could make Morbidity Max a reality?
This educational material is intended for informational purposes only and is not intended to replace, or substitute for, professional advice, counseling, diagnosis, or treatment. Always seek the advice of a qualified health provider with any questions you may have regarding a condition. Never disregard professional advice or delay in seeking treatment because of something you have read in this educational material.
Vigen R, O’Donnell CI, Baron AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with lowtestosterone levels. JAMA 2013;310(17):1829-1836. doi:10.1001/jama.2013.280386
Low “T” as in “Template”: How to Sell Disease. Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS. JAMA Intern Med. 2013; 173(15):1460-1462. doi: 10.1001/jamainternmed.2013.7579
Research Letter: Trends in Androgen Prescribing in the United States, 2001 to 2011. Jacques Baillargeon, PhD; Randall J. Urban, MD; Kenneth J. Ottenbacher, PhD, OTR; Karen S. Pierson, MA; James S. Goodwin, MD. JAMA Intern Med. 2013; 173(15):1465-1466. doi: 10.1001/jamainternmed.2013.6895
Schover LR. Androgen therapy for loss of desire in women: is the benefit worth the breast cancer risk? Fertility and Sterility 2008 Jul;90(1):129-40. PMID: 18023435 [PubMed – indexed for MEDLINE]