AndroGel, approved in 2000, had a small market until its maker rewrote the disease as 'Low T', a phrase with no diagnostic threshold. An unbranded awareness site and a self-scoring quiz helped US testosterone sales climb from about $324 million in 2002 to roughly $2 billion in 2013. The FDA later found about a quarter of men prescribed testosterone in those years never had their levels tested.
Who's who
- John MorleyGeriatrician who created the ADAM questionnaire
- Adriane Fugh-Berman+1 more episodeGeorgetown pharmacologist who criticized the quiz as a test everyone fails
- Thomas PerlsBoston University researcher who named 'disease mongering' in an editorial
- David HandelsmanSydney researcher who co-wrote the disease-mongering editorial
- Sophia SinhaMichigan Medicine lead author of the 2026 testing study
- Maria PapaleontiouMichigan Medicine senior author of the 2026 testing study
Where it happens
- Northern District of IllinoisCourt overseeing the consolidated testosterone litigation, MDL 2545
- Chicago, Illinois+15 more episodesSite of the Endocrine Society meeting in June 2026
Timeline
- 2000FDA approves AndroGel
- 2002'Low T' enters use; US testosterone sales about $324 million
- 2013Sales peak near $2 billion
- March 2015Class-wide label change adds a cardiovascular warning
- September 2018About 4,200 lawsuits settled on undisclosed terms
- February 28, 2025FDA removes the cardiovascular boxed warning class-wide
Still debated
The exact origin and date of 'Low T' are not documented in a corporate record, and the 2014 cardiovascular signal was contested at the time. Whether influencer culture drove the post-2021 prescribing rise is an unproven link.
