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.
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
