Study Finds Testosterone Treatments Boost Sex Drive Of Older Men, But Health Concerns Remain

New research suggests that older men who undergo testosterone replacement therapy do experience an increase in sexual desire and activity, but the findings come amid continuing concerns about the heart risks linked to testosterone drugs and whether the medications are already overused among men without any true medical need for the treatment.

Testosterone replacement therapy, which includes blockbuster drugs like Androgel, Testim, Axiron and others, was initially expected to be a niche treatment for men suffering from testosterone deficiency caused by a medical condition, known as hypogonadism.

Amid aggressive marketing by the drug makers, which have promoted use of the “low T” drugs for life style reasons, such as drops in energy, strength or sex drive that are commonly seen among men as they age, the industry has grown to generate more than $2 billion in sales annually in recent years.

In a study published last week in the Journal of Clinical Endocrinology & Metabolism, researchers from Baylor College in Texas report that increasing testosterone levels among older men does result in an increased libido, supporting the advertising claims made by drug makers.

The research was funded by AbbVie, which manufactures and sells the blockbuster testosterone gel AndroGel, and the findings do not address the side effects of testosterone drugs, which have recently caused federal regulators to warn that the drugs should only be prescribed to men with a true medical need.

Testosterone Gel Benefits

In this new study, researchers conducted a placebo-controlled clinical trial involving 470 men ages 65 and older with low libido and low testosterone levels. Some were given a placebo and others were given a testosterone gel treatment, like AndroGel.

The findings indicate that the men given actual testosterone reported significant improvements in 10 of the 12 measures of sexual activity that the researchers investigated. They did not report improvements in cases of erectile dysfunction, however.

“Our findings indicate low testosterone is one cause contributing to reduced libido and erectile dysfunction in older men,” lead author, Dr. Glenn R. Cunningham, of Baylor College of Medicine and Baylor St. Luke’s Medical Center, said in an Endocrine Society press release. “Men experiencing these symptoms should be evaluated for testosterone deficiency.”

The study raises additional questions that the findings may be used to further promote the use of Androgel and other testosterone drug among men without a true medical need, potentially exposing men to serious health risks in an effort to reverse natural symptoms associated with aging.

Testosterone Drug Health Risks

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.

The recommendations came after an FDA advisory panel met in September 2014 and reviewed concerns about the link between testosterone therapy and heart risks, and evaluated the widespread overuse of the drugs.

Several studies published since late 2013 have highlighted potential cardiovascular risks men may face from testosterone replacement therapy, including findings that suggest some men may be more prone to suffer a heart attack, stroke, blood clots or die.

Just weeks before this latest study was released by the Endocrine Society, other researchers warned that men may face a higher risk of heart problems from testosterone even after short-term use.

That research was published in the medical journal The Lancet in May, indicating that men who were only given testosterone for a short period of time faced an increased risk of both heart problems and death, noting that those short-term uses are often associated with “lifestyle” uses of the drug by men who do not truly suffer from a medically diagnosed testosterone deficiency.

In the press release announcing the recent findings about the benefits of testosterone replacement therapy, the Endocrine Society did warn that the drugs should only be used by men with symptoms of androgen deficiency and low levels of testosterone.

“The study was designed to investigate the effectiveness of testosterone therapy,” The Endocrine Society stated. ” It was not large enough or long enough to address issues related to cardiovascular events or clinical prostate cancer.”

Testosterone Litigation

Following decades of aggressive marketing without providing warnings about the potential health risks, Abbvie and other drug makers now face thousands of Androgel lawsuits, Axiron lawsuits, Testim lawsuits and other testosterone treatment lawsuits 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 drug 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.