Bioethics Forum Essay

Low-T, High Profit?

An unusually lengthy and undoubtedly expensive 90-second commercial for Androgel aired during men’s swimming and volleyball events in NBC’s coverage of the Olympics. The ad touts Androgel 1.62%, a more concentrated formulation of Abbott Laboratories’ testosterone treatment, and starts by addressing “the millions of men who have used Androgel 1%.”

Millions of men may have used Androgel, sales of which were $874 million last year in the United States. But many of the product’s consumers probably do not need this potent hormone. Testosterone treatment can be beneficial in cases where men have missing or damaged testes, but it seems unlikely that this population numbers in the millions. So, whom exactly is this particular commercial targeting?

The ad opens by announcing “big news” that seems anything but – the main advantage of the reformulation seems to be that fewer pumps of gel need be applied.  Big, however, is a theme of the ad, the imagery of which repeatedly emphasizes size and growth. In addition to the front man calling the reformulation “big news,” middle-aged men behind him are using heavy equipment to move around large numbers and letters, spelling, for example, “less gel.” Many things rise during the ad, including the cranes lifting and the front man’s arms in excitement; the word “raises” is uttered as the camera scrolls up a giant bottle of Androgel.

Placing this commercial during the Olympics is brilliant marketing. The commercial makes no claims other than increased testosterone levels, but it evokes associations that viewers may already have with testosterone – that it boosts strength, libido, and general masculinity.  The larger-than-life props may call to mind two common testosterone connotations: increased muscle mass and sexual prowess. The spareness of visuals and dialogue lets the viewers fill in the gaps of information with imagination. Without information about symptoms, any male viewer may see himself as a candidate for Androgel.

Generic competition to Androgel 1% is expected by 2015, so it is important for the manufacturer to convert customers to the 1.62% branded preparation prior to the availability of a generic for the original formula. The commercial may serve to normalize the use of testosterone treatment among healthy middle-aged and older men. If  “millions of men” have used Androgel, its use seems commonplace. The claim that Androgel is the “number one prescribed testosterone replacement therapy” establishes its credibility. The oversized visual images reinforce the impression that testosterone therapy will make everything bigger and better.

In recent years, low testosterone or “low-T syndrome” has become part of the popular vernacular. Symptoms associated with low testosterone include fatigue and reduced libido – symptoms that highly overlap with aspects of normal aging.

Testosterone declines naturally, by approximately 1 percent to 2 percent every year after the age of 40, but this does not necessarily mean that low testosterone causes symptoms of aging. No consistent relationship between low-T symptoms and testosterone levels has been proven.

Although the Androgel ad never mentions any symptoms, it may be part of a campaign aimed to convince men and their doctors that an epidemic of low-T has begun. Self-administered tests for the syndrome are widely available online, and the bar for failure is low. For example, the questionnaire on Abbott’s “Is it low-T?” site asks:

Do you have a decrease in strength and/or endurance?

Do you have a lack of energy?

Are you falling asleep after dinner?

Have you noticed a recent deterioration in your ability to play sports?

By airing their ad during men’s sporting events, Androgel may reach men made acutely aware of the limitations of aging after watching feats performed by the fittest and most talented athletes in the world. Men may feel encouraged to accept the purported aesthetic benefits of hormonal treatment, even in the face of significant risks.

Serious health risks of testosterone include increasing the growth of prostate cancer and exacerbating congestive heart failure. In July 2010, the New England Journal of Medicine published a placebo-controlled study that tested testosterone gel on 209 older, community-dwelling men over the age of 65 with low testosterone and mobility limitations – a group for which testosterone was thought to be particularly beneficial. The study was stopped early because of harm: there were 10 adverse cardiac events (including three heart attacks, one fatal) among the 106 men in the treated group, compared with one cardiac event (arrhythmia) among 103 subjects in the placebo group. The study was cut short on the recommendation of the Data Safety Monitoring Board.

The Androgel commercial mentions some but omits other serious risks of testosterone replacement therapy. The risk of cardiovascular events, for instance, is not mentioned. The risk described as “blood clots in the legs” is accurate but misleading: While blood clots may form in the veins of the legs, the danger from these clots is that they may break off and travel to the lungs, causing pulmonary embolism, which can be fatal. The link between blood clots in the leg and pulmonary embolism may not be apparent to many consumers. Blood clots in the legs sound much more benign.

The benefits of administering testosterone to aging men are questionable and the potential risks are serious. The Androgel ad appears to target a larger population that, in the context of watching the Olympic games, could be intrigued by the product. Advertising testosterone to millions of normally aging men may be good business, but is it an ethical marketing practice?

Nicole Dubowitz is the project manager of PharmedOut, a Georgetown University Medical Center project that advances evidence-based prescribing and educates health care professionals about pharmaceutical marketing practices. Matthew Puretz is a student at Haverford College who authored the article as part of an internship with PharmedOut. Adriane Fugh-Berman, M.D., is an associate professor in the Department of Pharmacology and Physiology and the director of PharmedOut. Dr. Fugh-Berman is also a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical marketing practices. Follow PharmedOut on Twitter

Posted by Susan Gilbert at 08/20/2012 04:48:27 PM |

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