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medingenuityTexas Urology Response to Testosterone Replacement Therapy Recent News

Probably, like you, I have received numerous calls and questions from men on testosterone therapy who have seen advertisements by attorneys regarding lawsuits related to deaths, heart attacks, and strokes from testosterone replacement therapy. The following is a revision of my email update of November 10, 2013, discussing the article in JAMA (JAMA.2013;310(17):1829-1836.doi:10.1001/jama.2013.280386) that set off all the controversy.

It continues to be my belief that there is no data that shows testosterone replacement therapy is associated with an increased incidence of cardiovascular issues or deaths. To quote Dr. Abraham Morgentaler, a leading expert and frequent presenter at American Urologic Association seminars and courses on testosterone, "A rich body of literature suggests that normal testosterone levels have an important role in maintaining cardiovascular health."

Let's look at some facts. The human body is always trying to achieve homeostasis which is defined as "the ability or tendency of an organism or cell to maintain internal equilibrium by adjusting its physiological processes." What does this mean? It means that the body is always trying to stay normal without deviations from the norm. For example, if a man drinks too much water, the kidneys will increase the excretion of water. If a man is dehydrated, the kidneys will try and conserve water to prevent the problems associated with dehydration. If a man has diabetes, the doctor will recommend a treatment to lower the blood sugar. These actions are what we do every day; we attempt to achieve a normal equilibrium in the body as this is the best way to restore and maintain health. This same reasoning applies to men who are deficient in testosterone. Testosterone is a necessary hormone produced in the testicles that is responsible for a man's sex drive, muscle mass, energy level, bone strength, and even a man's mood which may cause depression if the hormone is low and not returned to normal. The unstudied/published issue is what is the target value? Most experts feel that there is no absolute "correct" value, but rather treatment is targeted at relief of symptoms.

There are more than 13 million men in the United States who reportedly suffer from testosterone deficiency. For men who receive treatment, they usually report significant improvement in their symptoms. There are many conflicting reports about testosterone and heart disease. There are even studies that support that low testosterone increases the risk of heart disease and that treating the deficiency with hormone replacement therapy may be protective of heart disease.

The list below outlines numerous comments about the Journal of the American Medical Association (AMA) study in questions:

  • Of the nearly 7,500 men who did not get extra T, about 1 in 5 had adverse cardiovascular outcomes, including stroke, heart attack, or death. In the more than 1,200 men who got testosterone, nearly 1 in 4 had those significant problems, with an increased risk of these problems by nearly 30 percent. A well-powered scientific study has a similar number of study patients in each group, not 7,500 of control group and 1,200 in the experimental group as is present in this recent JAMA article. The researchers concluded that taking testosterone came with an increased risk of an adverse outcome.

  • Since publication, the authors have been obligated to revise their article removing the term "absolute risk", which falsely indicated that the raw data supported their conclusion and replace this term with "Kaplan-Meier estimated cumulative percentages with events". This wording more accurately reflects the highly statistical methodology, with adjustments made for over 50 variables to reach their conclusion.

  • No follow-up or research was done on whether or not the men on testosterone therapy achieved therapeutic levels or if they stayed on treatment. It is not accurate to assume that all men treated had their testosterone levels elevated by therapy.

  • Very few of the patients studied were placed on 1.1% Testosterone gel (which is the most common form of treatment in men under the age of 60 - they used an old formula for Androgel that was not very effective in raising testosterone levels and led to the re-formulization of the product). 35.7% of the men were on injection therapy which is associated with spikes in testosterone levels in excess of over a 1,000 ng/dl as well as nadirs below normal levels. The remaining patients were on the patch product, Androderm, which is rarely used in private practice and also is shown to be poorly tolerated, rarely prescribed and minimally changed testosterone levels. Although there was no difference in the results in any of these three therapeutic groups, there is no documentation as to whether or not therapeutic levels were obtained and maintained for the period of the study.

  • There is no documentation as to whether or not Endrocrine Association guidelines were followed, including morning testosterone level assessments and repeating the test at least once.

  • There is no way of knowing if the "untreated group" received testosterone therapy outside of the VA hospital system.

  • Dr. Anna Cappola of the Perelman School of Medicine at the University of Pennsylvania wrote in an accompanying editorial, "The most important question is the generalizability of the results of this study to the broader population of men taking testosterone." The take home message is that it is not possible to generalize from this study to the entire population of men, some of whom may have had a low testosterone level.

  • This is a very big caveat: By definition, all the men in the study were older than 60 and all had heart problems. It's still not clear whether those same risks apply to younger healthier men.

  • "These were sick, older veterans," Dr. Michael Ho, a Cardiologist with the VA Eastern Colorado Health Care System who helped direct the study, said in an interview. "Many were obese, had diabetes and other ailments", he said. Obese men with diabetes and other co-morbid conditions are certainly independently at higher risk for heart disease, stroke and even death.

Additionally, we have found in many of our patients on Depo Injections, not only are their testosterone levels at peak point over 1000, but their estrogen and estradiols are also significantly elevated.

Summary

It should not be surprising that with the natural reaction to the hype, advertising and plethora of Low-T Centers that have emerged, attorneys would take any opportunity to piggy-back any issue into potential lawsuits.

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