October 19, 2015 — Drug-makers are funding continuing medical education (CME) courses to promote testosterone for “off-label” purposes, according to a Watchdog Report by MedPage Today and the Milwaukee Journal Sentinel.
Forty-five states require doctors to take CME courses to maintain their medical licenses. The courses are supposed to be evidence-based, unbiased lectures that help doctors stay up-to-date on medical issues.
Last year, income from the courses hit $2.7 billion — $676 million of which (about 25%) was paid by drug-makers to course providers.
Critics say drug-makers are using the courses to sell diseases — medicalizing normal conditions like declining testosterone, inventing conditions like “Low T,” and convincing doctors that the condition is under-diagnosed and under-treated.
Another problem is “off-label” (unapproved) promotion. An online CME course led by Dr. Martin Miner declared that testosterone was “no longer ruled out” in men with active, low-grade prostate cancer — in direct contradiction to FDA warnings and the label.
Several other industry-funded CME courses implied that low testosterone was associated with a wide range of health conditions:
- Heart of the Matter: Hypogonadism Management with Testosterone Therapy: Claims that “mounting evidence” links testosterone with cardiovascular disease and death — funded by Eli Lilly, Abbot, and Endo Pharmaceuticals.
- Male Hypogonadism: Improving Recognition and Refining Management: Low testosterone associated with high blood pressure, obesity, diabetes, and Alzheimer’s — funded by Eli Lilly.
The courses are part of a wildly-successful promotional strategy that has created a $2.1 billion industry for testosterone as a central part of men’s health — all while skirting laws prohibiting “off-label” promotion of drugs for anything except what the FDA has explicitly approved.
Testosterone is only approved for men with hypogonadism, a rare condition that occurs when testicles stop producing testosterone due to an injury or disease.
Boosting an aging man’s testosterone levels to that of a 25 year-old is marketed as a way to improve health. However, a number of recent studies have suggested that it may also boost a man’s risk of heart attack, stroke, and death.