On one side of the debate is a group of expert doctors and scientists known as the Androgen Study Group that has served JAMA (Journal of the American Medical Association) with an unprecedented petition, demanding it retract a recent study that links treatment for testosterone deficiency with increased rates of heart attack and stroke.
“I call this ‘medical literature malpractice,’” says Dr. Abraham Morgantaler.
“For 30 years there has been a substantial body of literature that has shown that low levels of testosterone are associated with increased cardiovascular risks,” says urologist, hypogonadism expert and proponent of the positive effects of testosterone, Dr. Morgantaler.
JAMA (Journal of the American Medical Association) has already had to print two corrections related to the controversial November 2013 study linking testosterone with a sharply elevated risk of cardiovascular events. Among other problems, Morgantaler and the Androgen Study Group discovered that 10 percent of the study group were women and not even testosterone users.
Meanwhile, another group of respected researchers and doctors is demanding that the FDA warn testosterone patch users of the potential risk of heart attack, stroke and death. In February 2014, Public Citizen, a health research watchdog in Washington D.C., asked the FDA to put a so-called black box label on testosterone gels and creams.
“The JAMA study is probably the weakest of the studies on this issue,” says Dr. Michael Carome from Public Citizen. “However, in combination with all the other information and recent studies and evidence of increased risk of cardiovascular disease with these drugs, there is a clear need for a stronger warning on the labels.”
In its petition to the FDA, Public Citizen cited a number of studies including a National Institute of Health (NIH) study, where a randomized trial involving 209 men with low testosterone was ended early due to a “five-fold-increase” in heart attacks and stroke.
The role of testosterone and its role in men’s health is nothing new. A review of decades of scientific literature published in the Journal of the American Heart Association (November 15, 2013) reported mixed results and concluded with the need for more study.
There is a well-established medical condition known as hypogonadism. It can be a congenital problem where testes, for example, fail to descend, or it can be a secondary issue such as chemotherapy that depletes testosterone levels. Testosterone treatments are considered appropriate for these conditions.
What is new, however, is the availability of easy-to-use testosterone gels and creams being heavily advertised and marketed as a solution for Low T syndrome characterized by everything from a lack of energy to decreased sexual desire.
“The problem is these drugs are being over prescribed in the US and many people who do not have hypogonadism are being prescribed these drugs,” says Dr. Carome.
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At the same time, there is a growing number of heart attack and stroke victims who have filed personal injury and failure-to-warn lawsuits against the makers of testosterone gels and creams.
Dr. Morgantaler is critical of the legal profession’s entry into the debate. “There’s very little risk (due to testosterone),” he says. “This issue has been hijacked by the media creating concerns that were not supported by the data (in JAMA). It is my intention not to let the beneficial aspects of testosterone for men with testosterone deficiency get lost in the cacophony of noise.”