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In June 2015, professors of medicine Steven Woloshin and Lisa M. Schwartz from the Dartmouth Institute for Health Policy and Clinical Practice published an editorial on testosterone drug risks in the Washington Post.

In it, the authors criticized testosterone drug therapy manufacturers for creating “disease-awareness” campaigns that put many men at risk of serious side effects, including heart attack and stroke.

Advertising Campaigns Encourage Men to Ask for Testosterone Therapy

In 2007, Abbott Laboratories (now AbbVie) started a new marketing campaign meant to sell more of their testosterone therapy drugs. The problem was that it overstated the benefits of the medication while downplaying the potential risks. Further, it urged thousands of men to ask their doctors about testosterone therapy they most likely didn’t need.

A 2014 study published in the Journal of Clinical Endocrinology & Metabolism reported that 40.2 percent of U.S. men did not have a testosterone test in the 180 days before beginning therapy, and 50 percent had only one test. Rather than checking with their doctors for true diagnoses of hypogonadism—the only condition for which the FDA approved the use of testosterone replacement drugs—they were responding to advertisements that convinced them of the need for extra testosterone, based on a group of symptoms typical of many aging men.

The “Is It Low-T?” campaign conducted by Abbott urged men to take an online quiz to see if low testosterone might be behind symptoms like fatigue, weight gain, muscle loss, mood changes, and reduced libido. This campaign and others like it were extremely effective, resulting in a 10-fold increase in testosterone prescriptions between 2007 and today.

A 2010 study examined the potential connection between low-T and these types of symptoms, and reported that only three sexual symptoms—poor morning erection, low sexual desire, and erectile dysfunction—were actually related to decreasing testosterone levels.

FDA Late to Act Concerning Testosterone Risks

Today, over 1,800 testosterone therapy lawsuits are pending in the Northern District of Illinois, where all federal testosterone lawsuits have been consolidated. Plaintiffs claim that manufacturers overstated the benefits of these drugs without providing adequate warnings of the risks.

When the FDA approved testosterone, they did so only for the treatment of hypogonadism, which is caused by trauma, genetic abnormalities, undescended testes, chemotherapy, or other serious issues. It wasn’t until 2014, however, that the administration warned that the broad use of testosterone in men could increase risk of serious side effects like heart attack and stroke. And it wasn’t until March 2015 that testosterone labels were updated to reflect this risk.

Woloshin and Schwartz encourage the FDA to “flex its regulatory muscle” and eliminate any so-called “disease-awareness” campaign such as that promoted by testosterone manufacturers. Meanwhile, plaintiffs will have their voices heard as proceedings continue in the testosterone MDL and in state courts around the country.

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