FDA Warning on Testosterone Contradicts Medical Experts

March 4, 2015

Raymond Ishman, M.D.FDA Warning Director of Medical Quality Assurance Cenegenics Elite Health President, Cenegenics Philadelphia At Cenegenics, we frequently employ testosterone therapy, if clinically indicated, as part of our comprehensive wellness programs following a thorough evaluation and blood testing. Yet many have lingering doubts regarding the safety of testosterone therapy in light of recent media hype, lawyer’s ads and even the FDA statement released on March 3rd, read what the medical experts at Harvard and The Mayo Clinic have to say. A 2015 review in the Mayo Clinic Proceedings, titled Testosterone Therapy and Cardiovascular Risk: Advances and Controversies, concluded: “In summary, there is no convincing evidence of increased CV (cardiovascular) risks with T (testosterone) therapy. On the contrary, there appears to be a strong beneficial relationship between normal T and CV health that has not yet been widely appreciated.” You also might want to read

Posted in Blog, Medical News by rishman
February 9, 2015

shapeimage_1 Raymond Ishman, MD Director of Medical Quality Assurance, Cenegenics Elite Health President, Cenegenics Philadelphia It’s no surprise to anyone that as we age, waistlines tend to increase in both men and women. Waist circumference and abdominal fat are major risk factors for heart attack, stroke, diabetes and even Alzheimer’s disease. Many people think that to lose fat, they need to predominantly do aerobic, or cardio type training, generally at the expense of strength training. However, according to a new study by Harvard researchers published in the journal Obesity, this strategy is counterproductive. The study followed over 10,000 men for 12 years. The researchers found that compared to aerobic exercise, weight training led to less of an age related increase in abdominal fat. While not specifically stated in the study, the men who weight trained likely had significantly more muscle to go along with their smaller waistlines. The authors of t

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January 13, 2015

Raymond Ishman, M.D. Director of Medical Quality Assurance Cenegenics Elite Health President, Cenegenics Philadelphia Testosterone replacement therapy (TRT) in men who are deficient has multiple health benefits and can be truly life changing. However, TRT is viewed with great skepticism by many in the medical community. Recently, two poorly done studies questioned the cardiovascular safety of testosterone, only fueling the controversy. These 2 studies have been largely discredited. POPD0109g-1For decades, there has probably been no greater medical myth than the notion that testosterone causes prostate cancer. While not a single study supports this idea, generations of physicians have been trained that testosterone is fuel for prostate cancer, like “pouring gasoline on a fire,” as if this were written in stone. There have been numerous studies that failed to reveal any correlation between testosterone levels and the risk of prostate cancer. Nonetheless, many in the medical community insist that supplementing with testosterone will increase ones risk, citing the lack of long-term safety studies. A new study in The Journal of Urology dispels this long held medical myth. 1023 men on testosterone replacement were followed

Posted in Blog, Medical News by rishman
January 12, 2015

From MedScape, January 12, 2015 by John Mandrola MD (cardiologist) I think and write a lot about the role of lifestyle choices as a treatment strategy. As an endurance athlete, I know that exercise, diet, sleep, and finding balance in life are the key components of success. It is the same in cardiology. In a randomized controlled trial of primary prevention (preventing the first heart attack or stroke), no cardiologist would want to be compared against a good physical trainer or nutritionist (assuming patients were compliant).” We would get trounced. Our calcium scores, biomarkers, pills, and procedures would not stand a chance. The study would be terminated early due to obvious superiority of lifestyle coaching over doctoring—which would blunt the true treatment effect and make us look less bad. (Wink to my epidemiology friends) But this is a dreadfully tired message. It is, as Dr. Bryan Vartabedian writes in his book The Public Physician , another pool-safety post: “Every summer, pediatricians and children’s hospitals write posts about keeping kids safe around pools. We don’t need another pool-safety post.” Doctor V, as he is known on social media, warns us that dry, empty writing on less-than-unique health topics does not stand a chance of being heard over the noise. He suggests overcoming this problem by coming at it with a new angle, viewpoint, or voice. I am not s

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November 12, 2014

Raymond Ishman, M.D. President, Cenegenics Philadelphia Director of Quality Assurance, Cenegenics Elite Health You know the old saying: If it sounds too good to be true, it probably is. From time to time we see an article that indicates being overweight is okay, or even good. The term “fat and fit” is often used. One such article published last year in JAMA, the Journal of the American Medical Association, reported that those who were overweight or mildly obese, but not severely obese, had a decreased overall mortality. Many would interpret this as a reason to not watch what they eat. Not so fast! There are too many variables to draw that kind of a conclusion from this study. Below are a few reasons you should take the results of this study with a grain of salt and continue to be diligent about maintaining a low body fat. •First, keep in mind that even the authors didn’t suggest that we should strive to be overweight. •This study used a single endpoint of BMI, not % body fat. BMI is simply weight divided by height squared. It doesn’t tell you if you have too much fat, which is the real issue. •If you work out and have some extra muscle, your BMI will be higher and you are quite healthy. This puts healthy people who aren’t fat in the high BMI group. •Some people have a normal BMI but increased abdominal fat and low muscle mass. These “Skinny Fat” people are

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October 17, 2014

Raymond Ishman, M.D. President, Cenegenics Philadelphia Director of Quality Assurance Cenegenics Elite Health The CDC recently released statistics on obesity in the US, and the numbers are downright scary, almost hard to believe. The data reveals that in the US: •About 35% of adults are obese, not just overweight! •Non-Hispanic blacks have the highest rates at 47.8% •Hispanics are next at 42.5% •Non-Hispanic whites follow at 32.6% •Asians have the lowest rate at 10.8% •Middle aged adults (ages 40-59) are the fattest age group at 39.5% •Low income people are more likely to be obese than those with higher income •17% of children (12.7 million) ages 2-19 are obese! •The estimated annual medical cost of obesity in the U.S. was $147 billion in 2008 Obesity-related medical conditions are among the leading causes of preventable death and include: •Heart disease and stroke (which kills more people than all forms of cancer combined) •Diabetes •Arthritis •Certain types of cancer In general, Americans have a very distorted perception of the terms overweight and obese, as well as their associated health consequences. This is because we are the fattest country in the world with our 35% obesity rate. People of healthy weight are frequently referred to as “skinny.” Overweight and obese indiv

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October 14, 2014

by Lisa Nainggolan from Medscape There is no consistent evidence that the use of testosterone in men with hypogonadism increases the risk for cardiovascular problems, according to a new review by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).

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September 25, 2014

Raymond Ishman, M.D. President, Cenegenics Philadelphia Director of Quality Assurance, Cenegenics Elite Health Cenegenics Philadelphia is excited to announce a major step forward in our comprehensive evaluation of cardiovascular health with the acquisition of the VENDYS Endothelix device that measures endothelial function.

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September 5, 2014

Raymond Ishman, M.D. President, Cenegenics Philadelphia Director, Quality Assurance, Cenegenics Elite Health The recent controversy surrounding testosterone replacement therapy (TRT) is rapidly losing steam. The two studies that questioned the safety of TRT have been exposed as being flawed and misleading. Even the FDA has cited the studies’ significant flaws and weaknesses in their Rejection of Citizens Petition for More Stringent Warnings on Testosterone Products! An article published in the October 2014 issue of CurrentOpinion in Endocrinology, Diabetes and Obesity titled Testosterone and Weight Loss: The Evidence, is an extensive literature review of recent data linking long-term TRT in overweight and obese men with low testosterone to increased lean body mass, decreased fat mass, improvement in overall body composition and sustained weight loss. Low testosterone is common in overweight middle-aged men. Key points from the review were that long-term TRT: •Improves body composition (reduces body fat and improves muscle mass) •Produce

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July 23, 2014

Raymond Ishman, M.D. President, Cenegenics Philadelphia Director of Quality Assurance, Cenegenics Elite Health Two studies over the last nine months have raised much concern over the safety of testosterone replacement therapy. These studies essentially contradict over 30 years of medical literature. Nonetheless, these studies have made headlines, spurred numerous lawsuits and have led to labeling changes on testosterone products, even though the data has not been validated. On July 16th, 2014, in a surprising yet enlightening statement, the FDA rejected a Citizens Petition to add a “black box” warning to all testosterone products in addition to other demands included in the petition stating: “After careful consideration, and, in light of the foregoing, we herby deny your Petition in its entirety. The FDA will continue to evaluate the cardiovascular risks of testosterone, and, if warranted, will take appropriate regulatory action to protect the public when its evaluation has concluded.” In a rather lengthy response, the FDA echoed the concerns of many physicians, including the Androgen Study Group, in citing significant flaws/weaknesses in the recent studies that questioned the safety of testosterone therapy. Among the many study weaknesses, the FDA cited: •Unclear statistical methods •Conflicting resul

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