- A study published this week in the Journal of the American Medical Association (JAMA) showed that direct-to-consumer advertising substantially increased the use of testosterone treatments from 2009 to 2013.
- The study looked at 75 designated markets that showed that exposure to regional advertising increased new testosterone testing of 0.6%, new initiation of 0.7%, and initiation without a recent baseline test of 0.8%.
- Of the approximately 17 million insured men in those 75 markets, nearly 1 million men had new serum tests initiated and more than 280,000 starting taking the testosterone treatments.
"Low-T" was not a common term before 2009, but direct-to-consumer advertising by the makers of testosterone medications made it a household condition, despite there being little evidence of an actual problem.
Testosterone gels and creams are typically approved for men with pathological hypogonadism, a low hormone condition that can arise after chemotherapy for prostate cancer. Yet, the pharmaceutical industry spent years advertising the products to treat an unsubstantiated "lifestyle" condition for men who weren’t feeling quite "manly" or had a low sex drive, despite little to no safety or efficacy data supporting these claims.
"Advertising intensity varied by geographic region and time, with the highest intensity seen in the southeastern United States and with months ranging from no ad exposures to a mean of 13.6 exposures per household," noted the JAMA report. "Non-branded advertisements were common prior to 2012, with branded advertisements becoming more common during and after 2012. Each household advertisement exposure was associated with a monthly increase in rates of new testosterone testing."
The "Low-T" craze became an exercise in how pharma companies can abuse the direct-to-consumer advertising paradigm. DTC ads are common across therapeutics areas in the U.S., but generally not allowed in other countries. The practice of advertising drugs directly to patients has long been criticized by those within and outside the industry.
AbbVie precursor Abbott Laboratories acquired AndroGel, a major player in the low-T segment, in 2010 from Solvay Pharmaceuticals. The commercialization engine at AbbVie then began promoting the drug. By 2013, AndroGel became AbbVie’s best-selling drug behind its blockbuster rheumatoid arthritis treatment Humira, with more than $1 billion in sales. The drug had grown by more than 55% during the course of 2012 alone, largely driven by the off-label use in "Low-T" patients.
AndroGel was the dominant player in this space until the Food and Drug Administration began cracking down on the treatments. In 2016, the FDA issued its third warning in three years about the testosterone category, reporting that abuse of the treatments could cause “heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility.”
The first of the product liability suits for AndroGel are expected to begin in June of this year, alleging that the company did not adequately warn of the risks of the drug and promoted it off-label for the use of "Low-T."