Testosterone drug sales may be ahead of science

At just under $2 billion a year in sales, the testosterone replacement drug business is small by industry standards, but it is growing as the population ages and sophisticated marketing ramps up.

Some doctors and researchers want to dampen the enthusiasm for the new drugs among aging men until further studies can indicate whether they are safe and effective, the Associated Press reports.

IMS Health reports that sales of testosterone prescriptions are up 90% in the last 5 years to $1.9 billion in 2011. Some of that growth is being prompted by direct-to-consumer advertising, the AP says, with spending on TV and print ads going up 170% in three years. Ad tracking firm Kantar Media tells the news service DTC advertising hit about $14 million last year. Androderm, Watson Pharmaceuticals' ($WPI) patch, racked up $87 million in sales last year, and Axiron from Eli Lilly ($LLY) notched $48 million in 2011. Abbott's ($ABT) Androgel is in blockbuster territory.

There are indications, some of it anecdotal, that testosterone can improve energy and sexual function among older men who have low levels of the hormone--although what constitutes a low level in older men is not really defined. The evidence on effectiveness versus safety is mixed. A study in the Netherlands found no real benefits. A larger National Institutes of Health study to determine whether it helps is not slated to be complete until 2014.

"The problem is that we don't have any evidence that prescribing testosterone to older men with relatively low testosterone levels does any good," Dr. Sergei Romashkan, with the National Institute on Aging, tells the AP.

Abbott Laboratories, whose Androgel product sold more than $1 billion, agrees more study is needed, the AP reports. "Abbott believes that the long-term effects of testosterone replacement therapy should be studied, which is why we continually fund and support additional clinical trials, such as the National Institute of Aging's testosterone trial."

- read the Associated Press story 

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