Low testosterone therapy is a hot-button issue, with some accusing drugmakers of marketing the meds to men who don't need them--and might even be hurt by them. Yet despite recent backlash, companies are touting testosterone testing as part of Men's Health Week, drawing fire from a pair of Dartmouth professors via a Cochrane Group blog.
While the week may be billed as a campaign to "heighten the awareness of preventable health problems" among men and boys, to Drs. Steven Woloshin and Lisa Schwartz, the event--sponsored by AbbVie ($ABBV) and Pfizer ($PFE), key manufacturers of testosterone replacement products--is also a convenient way for companies to promote Low-T testing and sign more men on to therapies.
"By targeting men worried about weight, muscle tone, energy levels, mood and sexual satisfaction, the campaigns imply that treatment will help them become thinner, more muscular, more energetic, less grumpy and more sexually satisfied. But there's a big problem: We really don't know if diagnosing and treating 'Low T' does any good," Woloshin and Schwartz wrote in an Evidently Cochrane blog post.
AbbVie is no stranger to Low-T marketing; the company launched its first massive campaign in 2008 to change men's attitudes toward testing and treatment. "Is it Low T?" targeted middle-aged consumers with complaints about weight, muscle tone and sexual satisfaction, promoting Low-T therapy as a way to boost energy levels and improve their day-to-day lives,. The company's AndroGel is a top-selling testosterone therapy, with Eli Lilly's ($LLY) testosterone med Axiron and Auxilium's ($AUXL) Testim trailing not too far behind.
The companies' efforts have paid off, if some more so than others. AndroGel racked up $1.15 billion in 2012 sales, and Testim brought in $237 million the same year. According to IMS Health, sales of testosterone drugs grew by 90% over 5 years, reaching $1.9 billion by 2011. The entire testosterone market is expected to hit $5 billion by 2017.
However, it isn't all rainbows and butterflies for pharma companies looking to make a profit. AbbVie and Abbott ($ABT) face a mounting heap of lawsuits over their $80 million advertising campaign to promote AndroGel as a way to counteract typical signs of aging. Earlier this month, a panel of judges decided to consolidate lawsuits against multiple manufacturers of testosterone products, including Lilly's Axiron, Pfizer's injectable version of the hormone, and a hormone patch from Actavis ($ACT).
The drugs also face scrutiny from regulators, who cite studies with worrisome testosterone treatment data as reason to investigate the approach. In January, the FDA said it would examine potential cardiovascular risks associated with testosterone supplements used to treat Low T. The agency based its inquiry on a study published in the Journal of the American Medical Association in November, which found a 29% increase in risk of heart attack or stroke for men taking the hormone. In April, the European Medicines Agency (EMA) decided to launch its own review of Low-T drugs, and will issue an opinion on whether to revoke marketing authorization for the products in the EU.
- read the blog post from Evidently Cochrane