Prescription testosterone products such as AndroGel and Androderm can be an effective treatment for men with low testosterone levels caused by certain medical conditions. Use of these products have skyrocketed in recent years, in large part because they are being marketed and prescribed to older men. But the benefit and safety of testosterone therapies have not been established for age-related low testosterone.
A growing body of research suggests that testosterone products increase heart attack and stroke risk. Manufacturers, however, only recently placed warning labels for cardiovascular side effects on their products. For years they’ve promoted testosterone therapy for a wide range of unapproved uses, exposing millions of men to potentially deadly side effects.
Did you take AndroGel or a similar testosterone treatment and experience a heart attack, stroke, pulmonary embolism, or other cardiovascular injury? Get in touch with ClassAction.com and learn your legal options.
A Brief History of Synthetic Testosterone
Manufacturers such as AbbVie, Eli Lilly, Pfizer, and GlaxoSmithKline have captured the modern market for testosterone therapies, but synthetic testosterone has been around for nearly a century and scientific interest in the use and effects of testosterone date back to the 19th century.
A self-experiment by French physiologist Edouard Brown-Séquard laid the groundwork for modern investigations into testosterone. In 1889 the 72-year old Brown-Séquard announced to the Société de Biologie in Paris that he had reversed the effects of old age by injecting himself with an extract derived from dog and guinea pig testicles. While his claim that the extract increased his physical and mental powers could not be substantiated and may well have been a placebo, Brown-Séquard inspired other researchers and helped spawn modern endocrinology.
Two Dutch researchers shared the 1939 Nobel Prize for Chemistry for isolating the male hormone testosterone.
Testosterone products were already popular and profitable—and producing unintended side effects—during Brown-Séquard’s time. An article from The Journal of Urology describes how, within months of the Frenchman’s experiment, “more than 12,000 physicians were administering his extract, and chemists were making fortunes selling the new ‘Elixir of Life’” for ailments that included tuberculosis, epilepsy, influenza, migraines, and hysteria. Some early patients, however, were also developing infection and inflammation from the questionable therapy.
Once researchers understood that the testicles are responsible for male hormone secretion, competing pharmaceutical companies funded the race to isolate the hormone we now know as testosterone. Dutch researchers funded by the Organon Company published the now-famous paper “On Crystalline Male Hormone from Testicles (Testosterone)” in 1935, giving the newly isolated hormone its name. Later in 1935 German researchers published a paper describing how to synthesize testosterone. The researchers shared the 1939 Nobel Prize for Chemistry for their discovery.
Human clinical trials with synthetic testosterone started in 1937, with early research focusing on the treatment of hypogonadism—a condition in which the body doesn’t produce enough testosterone. Yet as Brown-Séquard’s early experiments show, there had long been an interest in the rejuvenating effects of testosterone.
Following in Brown-Séquard’s footsteps, researchers around the world pursued the new field of “organotherapy,” or injecting testicular derivatives and transplanting animal and human testicles into patients. Researchers began to discover in the 1940s that testosterone increases lean muscle mass and boosts athletic performance, leading to testosterone use among Olympic athletes and bodybuilders.
The 1980s and 90s saw researchers turn their attention to the effects of testosterone on aging men. In pilot studies men over the age of 54 with low or normal testosterone levels were given testosterone supplements and the reports were positive overall, as men showed improved musculature, higher reported sexual desire, and better cognition.
Testosterone Therapy Use On the Rise Thanks to Drug Company Efforts
Testosterone use certainly isn’t new. What’s new is the large number of men now being given these products and the wide range of symptoms they are prescribed for.
Until around 2000 men were prescribed testosterone primarily to treat the rare condition hypogonadism. But drug companies have pushed to make testosterone products central to male health. Particularly, they have promoted the products to treat natural drops in testosterone that accompany the aging process, a much more nebulous condition that advertisements often refer to as “Low T,” the symptoms of which, men are told, can include simply feeling tired or grumpy.
“This is a great experiment with American men as the guinea pigs.”
From 2000 to 2014 annual prescriptions for testosterone increased more than 6-fold, from 1 million to 6.5 million. This isn’t because men’s need for testosterone has drastically increased in recent years. Rather, drug companies have sunk billions of dollars into doctor education courses that play up the health benefits of testosterone and downplay its risk, according to an investigation published in the Milwaukee Journal Sentinel.
In 2014 alone pharmaceutical companies provided $676 million in funding for testosterone courses. The Journal Sentinel found that drug companies, to obscure their involvement in the scheme, pay third-party organizations to design and put on the courses.
During a 2009 congressional investigation into drug company funding of continuing medical education (CME) courses, a Cleveland Clinic doctor testified that, “CME has become an insidious vehicle for aggressive promotion of drugs and medical devices. CME has largely evolved into marketing, cleverly disguised as education.”
As for testosterone products specifically, the same doctor did not mince words when he said “This is a great experiment with American men as the guinea pigs.”
Drug Companies Never Warned About Cardiovascular Side Effects
Prescribing testosterone for “Low T” is a practice known as off-label prescribing. Off-label drug uses are those uses which the FDA has not evaluated for safety and efficacy. While doctors are free to prescribe drugs as they see fit, it is illegal for drug companies to promote their products for uses not approved by the FDA.
The FDA has only approved testosterone therapy for hypogonadism. While it recognizes that these products do increase testosterone levels, there are no clinical measures to support their use for “Low T.”
Studies suggest that testosterone therapy significantly increases the risk for heart attacks, strokes, and blood clots.
Those studies on testosterone products that have been done—including work published in the New England Journal of Medicine, Journal of the American Medical Association, and PLOS ONE—suggest that they significantly increase the risk for cardiovascular events such as heart attacks, strokes, and blood clots. A 3-year JAMA study, furthermore, found that testosterone, compared to placebo, did not improve sexual function or quality of life.
But it wasn’t until 2015 that testosterone therapy makers, at the FDA’s behest, included product labels warning about a possible increase risk of heart attacks and strokes. The FDA noted in a March 2015 safety announcement that, “The benefit and safety of [testosterone] medications have not been established for the treatment of low testosterone levels due to aging.”
Over a recent 5-year period, testosterone products were linked to nearly 4,000 serious health complications, thousands of hospitalizations, and hundreds of death. About ¼ of these complications involved cardiovascular issues.
Testosterone Therapy Products
Testosterone therapy is available as gels, patches, injections, creams, nasal gels, capsules, tablets, subcutaneous implants, and “buccal systems” (applied to the upper gums) and is sold under such names as:
Testosterone Therapy Lawsuits Seek Compensation for Injuries, Deaths
AbbVie, Eli Lilly, Endo Pharmaceuticals, and other testosterone makers are facing lawsuits that allege they did not sufficiently warn users about their products’ cardiovascular risks and that they aggressively marketed their products for unapproved uses.
More than 5,000 testosterone therapy product lawsuits have been consolidated as part of a multidistrict litigation in Illinois federal court. Men who were prescribed testosterone for Low T and suffered cardiovascular injuries—as well as those who believe a loved one’s death was caused by testosterone therapy—may be eligible to file a lawsuit. The first cases are expected to go to trial in 2017.
Lawyers for ClassAction.com are filing lawsuits on behalf of testosterone therapy victims nationwide. Learn more about these cases and whether you qualify for legal action during a free consultation.