Nelson Vergel
Founder, ExcelMale.com
This is a great short summary of the storm of ill-based bad publicity fueled by poorly done studies that have been disputed by over 26 medical groups and which fed hysteria by the media and money-hungry lawyers. The FDA fell pray to these flawed data even after admitting their errors.
"The concept of the thyroid storm is well known in medicine. Today we are dealing with what might be called a “testosterone storm” surrounding the scientific and public health debate over the use of testosterone replacement therapy. Last year, after a September 2014 FDA Advisory Committee meeting, manufacturers were required to include a label addition about a “possible” increased risk of heart attacks and strokes in patients taking testosterone. A large-scale study to assess cardiovascular risk was also recommended. The uncertainty of whether or not testosterone supplementation increases cardiovascular risks is the primary driver of the conflict.
There have been major improvements in the safety, quality, and ease of administration of testosterone replacements over the last few years. With these new routes of administration such as transdermal, subcutaneous and transmucosal, there has been an increase in interest in this aspect of men’s health with growth in both marketing and prescribing of testosterone supplements.
The 2014 meeting also included a rejection of a petition by Public Citizen to add a black box warning to testosterone supplements. In a published analysis prior to the meeting the FDA identified only 4 studies suggesting increased risk. In contrast, a systematic analysis of the literature identified over 80 studies demonstrating contradictory evidence. These note that low testosterone levels are associated with all-cause and cardiovascular mortality, and trials in men with angina showing improved exercise capability with testosterone supplementation. Testosterone therapy can improve metabolic syndrome (reduce fat and waist circumference, improve insulin resistance). Unfortunately, media focused attention on very few flawed studies and turned attention away from the positive accumulating evidence.
Could potentially flawed data have fueled the debate? Dr. Abe Morgentaler, Associate Clinical Professor, Urology, Harvard Medical School and more than 150 academic and clinical leaders questioned the veracity of one of the major studies that prompted the FDA action and called for its retraction on the basis of the data being “no longer credible”.1 The paper contained methodologic flaws and the inclusion of females in the analysis. In the publication erratum the rates of adverse cardiac events were actually reduced by half in the testosterone treated group. This was followed by 29 medical societies from around the world joining the petition for retraction."
http://www.canjurol.com/article.php?ID=2875
"The concept of the thyroid storm is well known in medicine. Today we are dealing with what might be called a “testosterone storm” surrounding the scientific and public health debate over the use of testosterone replacement therapy. Last year, after a September 2014 FDA Advisory Committee meeting, manufacturers were required to include a label addition about a “possible” increased risk of heart attacks and strokes in patients taking testosterone. A large-scale study to assess cardiovascular risk was also recommended. The uncertainty of whether or not testosterone supplementation increases cardiovascular risks is the primary driver of the conflict.
There have been major improvements in the safety, quality, and ease of administration of testosterone replacements over the last few years. With these new routes of administration such as transdermal, subcutaneous and transmucosal, there has been an increase in interest in this aspect of men’s health with growth in both marketing and prescribing of testosterone supplements.
The 2014 meeting also included a rejection of a petition by Public Citizen to add a black box warning to testosterone supplements. In a published analysis prior to the meeting the FDA identified only 4 studies suggesting increased risk. In contrast, a systematic analysis of the literature identified over 80 studies demonstrating contradictory evidence. These note that low testosterone levels are associated with all-cause and cardiovascular mortality, and trials in men with angina showing improved exercise capability with testosterone supplementation. Testosterone therapy can improve metabolic syndrome (reduce fat and waist circumference, improve insulin resistance). Unfortunately, media focused attention on very few flawed studies and turned attention away from the positive accumulating evidence.
Could potentially flawed data have fueled the debate? Dr. Abe Morgentaler, Associate Clinical Professor, Urology, Harvard Medical School and more than 150 academic and clinical leaders questioned the veracity of one of the major studies that prompted the FDA action and called for its retraction on the basis of the data being “no longer credible”.1 The paper contained methodologic flaws and the inclusion of females in the analysis. In the publication erratum the rates of adverse cardiac events were actually reduced by half in the testosterone treated group. This was followed by 29 medical societies from around the world joining the petition for retraction."
http://www.canjurol.com/article.php?ID=2875
