FDA Releases “Safety Alert” Based On Flawed, Refuted Study
If you are concerned by what you’ve heard on national media about the FDA’s safety alert regarding “possible” cardiovascular risk associated with testosterone therapy, you’ll want to hear “the rest of the story” as Paul Harvey used to say.
Dozens of studies over the last 30 years have shown that higher levels of testosterone, either naturally occurring or the result of testosterone therapy done correctly, have shown a positive effect on cardiovascular risk factors. In fact, two of those studies showed that men treated with testosterone had a 50% reduction in mortality compared to untreated men who also had low testosterone.
The study at the heart of the FDA’s thinking was published in the Journal of the American Medical Association (JAMA) in November of 2014. Since then, 29 medical societies and 160 of the world’s foremost experts in endocrinology, cardiology, etc. from 32 countries have demanded JAMA retract the paper citing “gross data mismanagement.”
“People find it hard to believe that JAMA would publish a study in which the percentages of men who suffered an adverse event was lower by half in men who received testosterone than untreated men, yet results were reported as if the opposite were true, thanks to absurdly complicated statistical manipulations of the data,” stated Andre Guay, Clinical Professor of Endocrinology, Tufts University School of Medicine. “There is nothing believable in this study.”
For a quick video overview of this controversy, we invite you to watch this 8 minute video from Dr. Morgentaler, Professor of Urology, Harvard University:
Testosterone is a major component of men’s health and as testosterone levels fall, overall health suffers. Low levels have been associated with diabetes, metabolic syndrome, obesity, high blood pressure, memory loss, erectile dysfunction and other conditions.
As with all medical practices, testosterone therapy should only be managed by experienced professionals with extensive experience in the use of this powerful substance.
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DISCLAIMER: This blog is for informational purposes only. It does not replace medical care from a licensed physician. If you have a medical concern, please contact DzLogic at 1-866-225-4877.