With the constant drumbeat of headlines in the news about the risks of Testosterone, it would be easy to believe that there are no health benefits in Testosterone Replacement Therapy (TRT) for middle-aged men, only health hazards.
Heart attacks and strokes are mentioned prominently in the television advertisements by law firms that are just lying in wait to file lawsuits against the Testosterone manufacturers.
If that weren’t bad enough, there is a seemingly endless trail of “recommendations” by “medical experts,” including the Food and Drug Administration (FDA) that call for severe restrictions on a physician’s ability to prescribe Testosterone for general health and anti-aging.
However, there are two sides to every story, and for the most part, we only hear one side: the negative.
But more and more studies are discovering that low Testosterone (“low-T”) may be a far more significant problem than any complication from Testosterone Replacement Therapy.
For example, a recent Houston-area study concluded that Testosterone replacement for men with little or no amounts of this hormone did not increase the risk of heart attack.
The study, conducted by researchers at the University of Texas Medical Branch at Galveston, refutes the notion that Testosterone therapy increases a man’s risk of heart attack.
Testosterone is a very timely topic since more men than ever are supplementing Testosterone to prevent or at least delay the maladies of aging.
“I hope this study brings some balance to the debate, that it’s weighed alongside all the evidence.”
Baillargeon, whose 2013 research documented a tripling in Testosterone use in the past decade, said he conducted the new study because of confusion about Testosterone’s effect.
Before recent studies found a cardiovascular risk, he noted, there was a significant body of evidence that found the treatment does not increase the possibility of heart attack.
Baillargeon admitted that the retrospective study isn’t likely to be “the final word on the subject” and said that a large-scale, randomized trial is needed to provide more definitive evidence.
Testosterone therapy was approved by the Food and Drug Administration in the 1950s for men whose doctors diagnosed hypogonadism, which occurs when the function of the testicles is impaired.
Some men are born with hypogonadism while others develop it later in life, typically as a result of injury or illness.
But thanks to several advertising campaigns touting pills, patches, and formulations for men with “Low-T,” Testosterone is now a $1.6 billion market.
The ads claim the products boost libido, energy and muscle tone, which they state decrease because Testosterone levels decline roughly 1 percent a year after age 35.
But as with all things concerning health, there’s considerable debate in the medical community, which questions whether the therapy provides such benefit.
The FDA is still weighing the evidence, but an advisory panel recommended the agency restrict Testosterone therapy to recently diagnosed cases of hypogonadism, meaning companies couldn’t market it for age-related Testosterone decline.
The FDA is not required to follow the recommendations of its advisory panels but usually, does.
The group delved into safety risks, including the recent studies, and concluded that the evidence for risks of cardiovascular problems was uncertain.
Baillargeon’s study was published in the Annals of Pharmacology.
It not only concluded that Testosterone therapy prescribed for diagnosed cases of hypergonadism was not associated with an increased risk of heart attack.
It also discovered that such patients with a higher probability of cardiovascular problems had a lower rate of heart attacks compared to patients with the same likelihood of cardiovascular issues who received no Testosterone therapy.
Testosterone cut the risk by 30 percent!
“Based on recent studies, there has been concern about treating hypogonadism with testosterone, but based on our study there should also be concern about not treating the condition with testosterone,” Baillargeon said.
Baillargeon added that the finding that Testosterone is protective needs to be replicated in future studies.
He said the FDA panel’s recommendation “sounds reasonable while we await the results of the major clinical trials.”
For those with normal or low-normal Testosterone, as opposed to hypogonadism, he said, the risk-benefit ratio seems unfavorable.
Baillargeon’s team compared Medicare records of 6,355 men who had at least one injection between 1997 and 2005 with 19,065 non-Testosterone users.
Patients receiving the therapy had an average of 8.2 injections over the study period, including 4.4 in the first year. They were more likely to have a high degree of co-morbid disease than non-users.
The research was funded by the National Institutes of Health and the Agency for Healthcare Research and Quality.
And Another Study Agrees…
In another study, research again suggests that low Testosterone levels may indicate that men face a higher risk of sudden cardiac arrest.
An investigation team from Cedars-Sinai Heart Institute, which published its findings in Heart Rhythm, analyzed Testosterone levels in 149 patients who experienced sudden attacks and found unusually low Testosterone levels (“low-T”) among the men and extraordinarily high estradiol levels among both the men and the women.
“Because [sudden cardiac arrest] is usually fatal, we are constantly looking for ways to predict which patients are susceptible so we can concentrate on prevention,” said study author Sumeet Chugh, MD, in a news release that accompanied the publication of the results.
“If we wait until someone has a sudden cardiac arrest, it is usually too late for treatment.”
Chugh and his colleagues compared hormone levels from the heart attack victims with those from a group of demographically similar control subjects.
The median Testosterone level for men who suffered cardiac arrest was 4.4 ng/mL.
The median Testosterone level for men from the control group was 5.4 ng/mL (P =.01).
Median estradiol levels, however, varied between victims and controls for both men (68 pg/mL vs. 52 pg/mL; P<.001) and women (54 pg/mL vs. 36 pg/mL; P<.001).
Multivariate analysis indicated that higher Testosterone levels were associated with a significantly lower risk of sudden cardiac arrest for men (odds ratio [OR] = 0.75; 95% CI, 0.58-0.96).
The association between high estradiol levels and the increased risk was even more dramatic in both men (OR=2; 95% CI, 1.5-2.6) and women (OR=3.5; 95% CI, 1.9-6.4).
High ratios of Testosterone to estrogen were associated with considerably reduced risk in men (OR=0.5; 95% CI, 0.4-0.7) but not in women.
“This is the first time it has been reported that there is an association between sex hormone levels and [sudden cardiac arrest],” Chugh said. “While these findings need to be confirmed by other studies, they suggest that higher testosterone levels in men may offer protection from sudden cardiac arrest and lower levels of estrogen may protect both men and women.”
The new research appears to provide more evidence that Testosterone protects the heart rather than hurting it, but different studies have come down on different sides of that issue.
The US Food and Drug Administration has been investigating the matter since the publication of two extensive studies that linked Testosterone therapy with adverse events.
The first paper, published in JAMA, found a significant positive correlation between Testosterone replacement and the likelihood of stroke, myocardial infarction (MI) and death.
The second study, published in PLoS ONE, correlated Testosterone therapy with a dramatically higher risk of heart disease among older patients and younger men with a history of heart disease.
However, the PloS study was loaded with flaws.
Here is the main one: the authors of the survey compared the groups of men started on Testosterone therapy to men who were started on PDE5 inhibitors and found a lower risk of heart disease in the PDE5 inhibitor group.
PDE5 inhibitors are drugs used to treat men with erectile dysfunction (Viagra and others are in this class). The authors state they used this group so there would theoretically be an increase in sexual activity in both teams.
They ignored one vital point, though.
PDE5 inhibitors work throughout the body and have substantial positive effects on the cardiovascular system.
Two of the PDE5 inhibitors were approved for treatment of idiopathic pulmonary hypertension because of the ability of PDE5 inhibitors to relax blood vessels.
A new study out this month in the Journal of Cardiovascular Pharmacology and Therapeutics states that PDE5 inhibitors have potential as cardiovascular drugs in patients with coronary artery disease and even possible improvement in heart failure patients.
With the data that PDE5 inhibitors can decrease the risk of heart disease and help to relax blood vessels in men with cardiovascular disease, the authors never should have concluded that men on PDE5 inhibitors would be a good control group against the men placed on Testosterone therapy.
Since then, however, journals have published some studies that have correlated Testosterone therapy (or higher Testosterone levels) with cardiac health.
The largest of those, an analysis of records from 25,000 patients found no overall correlation between Testosterone therapy and MI but a significant negative association between treatment and MI among the 25% of men who faced the highest risk of MI.
The confusion over this issue rages on.
Recently, in another study, the FDA said that there’s no convincing evidence of any significant association between Testosterone therapy and adverse cardiovascular events.
A pair of FDA advisory committees will meet later this year to consider the matter further.
The Most Recent FDA Recommendations
As mentioned earlier, still another FDA committee voted 20 to 1 to make it more difficult for doctors to prescribe Testosterone products.
The committee also recommended that pharmaceutical companies that sell Testosterone products be required to perform additional safety tests, based mostly on a few studies indicating that patients with heart problems are more likely to experience cardiac events when they start using Testosterone.
This is a case of deja vu.
The prostate cancer link has been widely discredited, and the hormone is now prescribed widely.
As aging baby boomers flood into the realm of andropause, the use of Testosterone Replacement Therapy has exploded.
Men who use the products often experience an increase in muscle mass, bone density, libido, deeper sleep, and a sense of well-being.
If true, this raises even more questions, because the inability to sleep is linked to all manner of conditions including Alzheimer’s, diabetes, and heart disease.
Many people report an improvement in their Body Mass Index (BMI).
A presentation given at the American Urological Association Annual Scientific Meeting in 2012 reviewed two studies that demonstrated dramatic improvements in body weight for subjects taking testosterone undecanoate, a long-acting form of the hormone available in Germany.
The weight loss reported in studies could significantly improve health for overweight men.
On the other side of the scale, some people with preexisting heart conditions might experience an increase in cardiac problems during the first few months of usage.
The science, however, remains unsettled.
Some studies, including this one from the University of Texas, have refuted the thesis.
As reported in WebMD, “men at greater risk for heart problems who used testosterone had a lower rate of heart attacks than similar men who did not receive this treatment, the researchers said.”
This Harvard Medical School article points out that men with the lowest Testosterone have higher levels of cholesterol, a risk factor for heart disease.
No one is saying that Testosterone does not have risks.
Everything has risks, even exercise.
This does not mean exercise is bad for you.
The key is moderation and educating yourself.
Another indicator that the deck was stacked against Testosterone therapy comes from an article written by journalist Dennis Thompson.
According to the article, the FDA review pointed out there’s no clear scientific evidence showing Testosterone replacement can reverse some of the effects of aging.
The “Low-T” craze is aided by consumer advertising for remedies that promise renewed vitality and strength for aging men.
It also noted that there’s growing evidence many men who are receiving Testosterone Replacement Therapy do not need it.
The last sentence is correct.
However, it is flat out wrong to say there is “no clear scientific evidence showing testosterone replacement can reverse some of the effects of aging.”
You can raise valid questions about the safety of Testosterone, but please don’t say with a straight face that it doesn’t work.
It’s like claims made years ago that anabolic steroids should be banned because they didn’t work.
In the same article, the writer quotes a University of Washington endocrinologist, who said, “There’s a large group of men out there who are getting older, and they are looking for ways to evade the consequences of aging.”
The word “evade” is telling.
In tax law, tax avoidance is permitted.
Tax evasion is not.
The clear implication of this statement is that men who would like to put off the symptoms of aging are illegitimately “evading” the natural order of things.
Let’s see what that endocrinologist (who is not yet in his 50’s) says when his Testosterone levels drop.
He just might change his mind about age “evasion.”
The Final Word
Everyone knows living longer is preferable to the alternative of early death, but considering life extension technologies are just now becoming available, we just don’t yet know what the long-term implications are of people living at 80 the way they did at 50.
Furthermore, like in the case of Testosterone products, regulatory bureaucracy seems to set up against what could be useful life extension technologies.
In the years ahead, not only will society have to reach a scientific consensus on the implications of longer life, but political attitudes will need to change as well.
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