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Androgel and Low Testosterone: Attorneys Analyze a Case Study in “Health Awareness Campaigns”

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

If you have ever seen an ad for a prescription drug (often memorable only for the uncomfortable questions your kids ask afterwards), you know they can sound strained. With so many disclaimers, they can sound something like this:

“If you’ve ever had a bad day, talk to your doctor about Flambevin. Side effects may include sweating, nausea, tooth loss, vivid hallucination, skeletal glanding, pancreatic islets, Scott Bakulanemia, tooth gain, certain doomitis, and athlete’s foot.”

It might not surprise you that there is a legal reason for these laundry lists of side-effects. Under FDA regulations, if an advertisement claims that a prescription drug offers health benefits, the ad must give a fair description of the drug’s risks as well (the regulation is much more complicated, but that is the basic point).

However, there is a loophole. The FDA puts far fewer restrictions on a subtler form of medical advertising called “health awareness campaigns”—ads that raise awareness of a disease itself, rather than the prescription drug used to treat that disease. FDA regulations give these ads much more latitude, with the freedom to make bold claims regarding the disease, without disclosing any risks of treating the disease.

There’s only one catch: health awareness adscan mention a general form of treatment (e.g. “talk to your doctor about blood thinners”), but theycannot mention any brand of that treatment (e.g. “talk to your doctor about Pradaxa”).

Some pharmaceutical companies have exploited this loophole to indirectly boost demand for their products, pumping millions into “health awareness” ad campaigns that convert everyday inconveniences of life into symptoms of dubious “diseases”—which, conveniently, their patented product is designed to treat.

One of the most recent examples is the so-called “Low T” or “Low Testosterone” campaign, a series of ads created by Abbott Labs and its spin-off company, AbbVie. The ads claimed that many men were suffering from an undiagnosed condition called low testosterone, which caused symptoms as vague as “unwanted body changes,” “decreased energy,” and “mood changes.”

What was once simply identified asgetting a little older was rebranded as a treatable disease.

Under FDA rules, Abbott and AbbVie were not required to mention any side-effects of treating this “condition” so long as they did not mention their product Androgel, the most-prescribed brand of testosterone in the US. These rules lead to truly eye opening results: in 2013 alone, AbbVie spent about $80 million marketing Androgel, yet often did so without ever mentioning its product’s name.

The side-effects that were unmentioned, however, may have put millions at risk. Given that testosterone fits into the same family as chemical steroids, people should be aware that some studies of testosterone have reported side-effects including heart attacks, strokes, and life-threatening blood clots in adults, and other tragic effects if children are accidentally exposed.

Many victims of the testosterone craze have begun to fight back, using the court system to accomplish what the regulatory process failed to do.