Testosterone Risks Highlighted at Medical Conference

As concerns over the potential health risks with testosterone replacement therapy continue to mount, more researchers are warning doctors to be cautious about prescribing the drugs as a fountain of youth to combat the effects of aging.

Dr. Adriane Fugh-Berman, an associate professor of pharmacology at Georgetown University, spoke earlier this month at the annual meeting of the American Urological Association, cautining doctors not to be swayed by the constant barrage of testosterone advertisements seeking to encourage men to seek prescription treatment for “low T”, an industry catchphrase for low testosterone.

Dr. Fugh-Berman, the director of PharmedOut.org, a Georgetown project that promotes evidence-based prescribing and fights deceptive pharmaceutical marketing practices, warned that the pharmaceutical industry was promoting products like AndroGel, Axiron and Testim as “fountains of youth,” despite increasing evidence that there are serious and potentially life threatening testosterone risks.

The doctor pointed out that in recent years the medications have been increasingly being prescribed to men who show no signs of low testosterone. She also noted that there is no evidence that the medications provide any actual benefit for most users, yet may increase the risk that men suffer a heart attack, stroke or sudden death.

Dr. Fugh-Berman warned that testosterone replacement therapy’s rise in popularity is similar to what was seen in recent decades with the use of hormone replacement therapy among older women. In both cases, the drugs are designed to treat hormone losses that many say are the natural result of aging.

However, studies eventually revealed that hormone replacement therapy (HRT) for women may increase the risk of breast cancer. The estrogen treatments were marketed heavily to women in the same fashion as many low T drugs, and Dr. Fugh-Berman warned that doctors and men should be concerned about history repeating itself as more evidence of emerges about the potential side effects of testosterone replacement therapy.

Dr. Fugh-Berman was not the only doctor at the conference to advise caution in prescribing testosterone drugs. Both Drs. Ajay Nangia and Alvin Matsumoto also gave presentations that raised concerns about testosterone.

Drs. Matsumoto and Nangia warned that doctors are using an extremely low standard for testosterone prescribing. Dr. Matsumoto asked if they would treat someone for a heart problem after just one low reading; the way they are prescribing testosterone to men after one blood test, which many experts say are unreliable.

Testosterone Health Concerns

Between 2002 and 2012, the use of testosterone replacement therapy has increased more than five-fold, despite the drugs originally being introduced as a “niche” treatment for men suffering from testosterone deficiency caused by a medical condition, such as hypogonadism.

Amid aggressive direct-to-consumer advertising, AndroGel, Androderm, Testim, Axiron and other similar Low T drugs have generated more than $2 billion per year in sales, with more than five million men filling a prescription for testosterone last year in the U.S. alone.

Low T drug advertising has been described as disease mongering by PharmedOut, as the direct-to-consumer marketing encourages men to talk to their doctors if they suffer any number of general symptoms common among all men as they age, including weight gain, reduced energy or decreased sex drive.

While concerns about the potential link between heart attacks and testosterone side effects have existed for years, recent studies have presented increasing evidence of the potential health risk.

In November 2013, a study published in the Journal of the American Medical Association (JAMA) suggested that older users of testosterone drugs experienced more heart attacks, strokes and death. Dr. Morgentaler and his allies have tried to get JAMA to retract the study, claiming it was flawed, but the prominent medical journal has stood behind the decision to publish the findings.

That study was followed by a report published in the medical journal PLoSOne in January 2014, which found that Low T drugs may double the risk of heart attack for young men with a prior history of heart disease, as well as for men age 65 and older who had no prior heart problems.

Following these studies the FDA announced that it is reviewing the heart safety of testosterone drugs, and it is widely expected that the regulatory agency will require stronger warnings to ensure that consumers and the medical communmity are aware of the potential risks associated with the medications.

In February 2014, the Endocrine Society warned about the serious concerns raised by recent studies, suggesting men face cardiovascular risks from testosterone drugs, urging doctors to follow their clinical practice guidelines on appropriate use of the medications. The Society called for additional studies to be completed, and suggested that doctors and patients need to discuss the risks and benefits, particularly among men with pre-existing heart disease.

In recent months, a growing number of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone drug claims have been filed by men throughout the United States, alleging that the manufacturers have knew or should have known about the potential heart risks for years, yet failed to provide adequate warnings and information for consumers or the medical community.

In the federal court system, a motion is currently pending that seeks to consolidate and centralize all cases filed in U.S. District Courts nationwide before one judge for coordinated handling as part of an MDL, or multidistrict litigation. Following coordinated pretrial proceedings and any early “bellwether” trials, if testosterone settlement agreements are not reached to resolve the litigation, hundreds of individual trials may ultimately be scheduled throughout the country.