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Testosterone Wars

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Boston, MAThe row over the use and efficacy of testosterone gels and creams for men with less than optimal levels of male hormone has reached an incendiary pitch. Virtually everyone involved in the debate is convinced they are on the right side of an issue with very serious consequences for the health of hundreds of thousands of men.

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.

“There was a recent study that showed many people are being prescribed these drugs and they haven’t even had their testosterone levels checked in a blood test,” Dr. Carome adds.

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.”

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READER COMMENTS

Posted by

on
I have had similar lumps in my armpits appear from the antiperspirants I had frequently used. I've since switched to anti-deodorants which do not clog the sweat pores and have never had those kinds of problems anymore.

Later in life when I was prescribed testosterone therapy for low T I never experienced any problems with any such lumps. I have however experienced periodic headaches and occasional diarrhea but I can't say for sure that testosterone caused those problems because I've had similar problems before I was ever on testosterone.

Be aware that sebaceous cysts and acne can form in some people with high testosterone levels.

Hope that helps.

Posted by

on
For the past 30 months or so I have been on testosterone regiment using the Androderm Patch. Recently, in December 2013 and January 2014, I was having headaches and diarrhea like symptoms and then developed a lump under left armpit. At first, the lump was tender to the touch then pain subsided but the lump did not. After about a month I told a doctor, who was on call for my regular primary doctor, and he scheduled two tests. The ct scan showed nothing but the ultrasound showed an abnormally shaped lymph node. An axillary biopsy was conducted the results stating no evidence of cancer. I was told to keep an eye on it. I believe that the testosterone patch I was taking may be the underline cause. What do you think?

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