Testosterone Treatments Ineffective Against Most “Low T” Symptoms: Study

While the use of testosterone supplements and hormone replacement drugs have exploded over the past decade, the findings of a new study suggests that the treatments may be ineffective at correcting reduced energy levels, lack of sex drive and other symptoms of “low T” for which the products are commonly prescribed, unnecessarily exposing men to the potential side effects of testosterone treatments. 

Researchers from Georgetown University Medical Center looked at how well testosterone supplements actually impacted symptoms of low testosterone, or “low T” as it is commonly advertised. Findings published last week in the medical journal PLOS One found that in many cases the products provide no clear benefits.

Use of testosterone treatments among aging men has increased dramatically in recent years, amid aggressive marketing by drug makers, which encourage men to seek treatment if they experience symptoms of “low T”, such as reduced energy levels, strength, sex drive or other symptoms. However, the widespread use of medications and supplements have drawn criticism from some experts, which point out that there is no medical condition known as “low T”, which is a term that originated with drug marketing.

Testosterone replacement therapy, which includes blockbuster drugs like Androgel, Testim, Axiron and others, were initially expected to be a niche treatment for men suffering from testosterone deficiency caused by a medical condition, known as hypogonadism. However, as men receive prescription of the drugs for life-style reasons, the industry grew to generate more than $2 billion in sales annually in recent years.

In this latest study, researchers conducted a systematic review of 156 randomized controlled trials comparing the effects of testosterone to those of a placebo. This latest study looked at testosterone replacement therapy’s effects on cardiovascular health, erectile dysfunction and sexual function, muscle weakness, mood, behavior and cognition.

“Testosterone supplementation did not show consistent benefit for cardiovascular risk, sexual function, mood and behavior, or cognition,” the researchers found. “Testosterone is ineffective in treating erectile dysfunction, and controlled trials did not show a consistent effect on libido.”

Researchers did find that it appeared to increase muscle strength, but did not have significant effects on actual physical function.

“The prescription of testosterone supplementation for low-T for cardiovascular health, sexual function, physical function, mood or cognitive function is without support from randomized clinical trials,” the researchers concluded.

The new questions about the benefits of testosterone treatments come amid mounting concerns about the safety of the drugs, as prior studies have highlighted potential testosterone drug heart risks, finding that some users may be prone to suffer a heart attack, stroke, blood clot or sudden death from the medications.

Last year, the FDA required AbbVie and other drug makers to add new warnings about the potential risk of heart attacks and strokes from testosterone replacement therapy, urging doctors to only prescribe the drugs to men diagnosed with hypogonadism backed up by laboratory testing.

Testosterone Litigation

Following decades of aggressive marketing without providing warnings about the potential health risks, thousands of Androgel lawsuits, Axiron lawsuits, Testim lawsuits and other testosterone treatment lawsuits are currently pending nationwide over the failure to adequately warn consumers and the medical community.

Given the similar allegations raised in the lawsuits, more than 5,000 cases filed throughout the federal court system have been consolidated for pretrial proceedings as part of a multidistrict litigation (MDL), which is centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

As part of the coordinated proceedings, a series of Androgel trials are expected to begin between April and November 2017, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

If testosterone treatment settlements are not reached following bellwether trials in the MDL, the drug makers may face hundreds of individual trial dates in U.S. District Courts nationwide over failure to warn about the heart risks associated with their medications.