Testosterone for Men: What the FDA does not want you to know about ‘Low T’ and your heart

Charles Mok, D.O. Hormone Replacement

Testosterone for Men What the FDA does not want you to know about ‘Low T’ and your heart

You probably remember the “Low T” public awareness campaign that was on the nightly news, sports broadcasts, and in various magazines.

Testosterone had been long FDA-approved for men with specific conditions such as damage to the brain or testicles, or having an extra female chromosome. But science has shown us that an age-related decline in testosterone responds to testosterone replacement as well.

Numerous studies show that testosterone, aided with weight maintenance or weight loss, protects the heart, increases energy, preserves muscle and bone mass, increases sexuality, improves quality of life, and can reverse depression.

So testosterone replacement therapy prescriptions went up tenfold over 10 years. That came to a halt between 2014 and 2015, when the FDA warned drug manufacturers that testosterone should not be prescribed in men who have low testosterone secondary to aging. It should only be prescribed, said the FDA, to men who had damage to the brain or testicles, or an extra female chromosome.  The FDA noted that the vast majority of testosterone prescriptions were for men whose testicles and brain were intact, and they sent several communications to try to get this to stop.

Additionally, the FDA required manufacturers to label testosterone prescriptions as possibly causing an increased risk of heart attack or stroke. There have been hundreds of studies showing that testosterone protects the heart. But one study done on 8,000 men at the Veterans Administration, published late in 2013, reported there was an increased risk of nonfatal myocardial infarctions or stroke in men who started testosterone replacement therapy. Within two days of that published study, the FDA began an investigation into the labeling of testosterone products – and shortly thereafter labeled testosterone as possibly causing these conditions.

But that study on 8,000 men at the Veterans Administration turned out to be incorrect. There was, in fact, a 30 to 50 percent in the number of heart attacks and strokes, not an increased risk. There were some statistical flaws and errors in the way they pooled the data. The corrections were published but did not make the news.

What make the news was that the FDA advised manufacturers to label testosterone as possibly increasing the risk of heart disease or stroke. Even though the data from which they drew their conclusion was false and later corrected, the FDA still maintains its position that it could “increase the risk of heart disease or stroke.” In subsequent publications they acknowledge there is no evidence of this, but they still require manufacturers to list that it can. It seems amazingly absurd, but this is a fact.

Try googling “biggest blunders by the FDA” and you will see thousands of results.

So, a study published in a respectable journal showing more than 8,000 men having an increased risk of heart disease or stroke when starting testosterone turned out to be incorrect. There’s actually about a 30 to 50 percent reduction in heart attack and stroke in men with low testosterone who are given testosterone placement.

Another study was done at the Veterans Administration primarily in Kansas City, Missouri, in which they followed 83,010 men with low testosterone levels. They addressed cardiovascular events and all causes of mortality relative to whether or not the men had testosterone replacement.

The men with low testosterone who received replacement were half as likely to die in the subsequent six years as those who were not given testosterone replacement therapy. And these men were followed into their late 60s and early 70s. Additionally, they found about a 50 percent reduction in cardiovascular disease such as heart attack and stroke.

Numerous medical societies have spoken out against the FDA’s absurd labeling that testosterone is possibly causing heart attacks and strokes, when in fact an overwhelming amount of evidence shows the opposite. By following the FDA guidelines, a man with low testosterone doubles his risk of heart attack, stroke, and premature death. It makes absolutely no sense.

Additionally, the men in the large studies showing 50 percent reduction in mortality didn’t specifically have something wrong with their testicles or brain, or have an extra female chromosome. These men had age-related declines in testosterone levels, which is the typical. If the physicians at the Veterans Administration had followed the FDA guidelines, all of the men would have had increased rates of heart attacks and death.

Various medical societies including endocrine societies and hormone specialists have written position papers at total odds with the FDA position. There is no rationale to only treat the condition if it is caused by a specific FDA-outlined disease.

Not treating low testosterone in men simply because it’s part of “normal aging” would be as ridiculous as not treating hypertension, diabetes, cardiovascular disease, cancer, or arthritis because these are also associated with “normal aging.”

Testosterone replacement therapy in men with low testosterone, regardless of the cause, reduces the rate of heart attacks, strokes, and premature death. Additionally, testosterone replacement therapy reverses weight gain and the obesity that is associated with low testosterone. It improves diabetes and, in some cases, resolves it. It also improves quality of life, sexuality, energy, and lean body mass.

Testosterone has no major negative effects at normal dosing. It is not linked to any prostate cancer or changes in prostate symptoms.

There are various questionnaires you can use to determine if you have low testosterone. Typical symptoms are low sex drive, difficulty achieving erection, low semen volume, loss of body and facial hair, loss of muscle mass, fatigue and lack of energy, increase in body fat, decrease in bone mass, A testosterone blood test may correlate the symptoms, but is not very reliable. Numerous medical societies and expert consensus panels have agreed that there is no reliable testosterone level that predicts who will respond to testosterone placement therapy.

Men who have symptoms of low testosterone should be offered testosterone replacement therapy and determine whether or not it helps them.

 

Thank you,

Dr. Charles Mok