Ever since I learned about testosterone and Testosterone replacement therapy (TRT) and had personal experience I have looked for opportunities to publicize this.
On September 7, 2015, I published on this blog post #43: What is the role of Testosterone Replacement Therapy for Optimal Health? There I discussed the downside and upside of undergoing TRT for men.
Well, at least two men that I know of, inspired by these conversations and the blog post went to their doctors, got their testosterone (T) levels checked and found that their clinical conditions were correlated with the very low T levels. However, on both cases their doctors told them they would not recommend TRT since it would increase their chances of heart attack.
When I learned of this, I decided to research this notion of increased chances of heart attack with TRT and hence this blog post.
An article was published in Journal of American Medical Association September 2013 issue: Vigen R, O’Donnell CI, Barón AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013;310(17):1829-36. The conclusion of the research was:
“Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of adverse outcomes. These findings may inform the discussion about the potential risks of testosterone therapy.”
Basically, they looked at the historical patient data on the computers (not patient charts) for those who had heart health issues (they had undergone angiography) and had low-T. Researchers then compared the mortality results of those who had undergone TRT against those who had not. Based on their statistical analysis of this data, they presented the above conclusion.
Media picked up this story and ran with it. Of course, adding all kinds of media color on these results. If you Google the title of this article, you will see many media stories.
And, of course, medical malpractice lawyers picked up the story and started to put together class action law suits against doctors and practices.
Prospect of the Malpractice law suits will scare the dickens out of any doctor, who is not expert in TRT. No wonder, the two men that I referred to above got the response they got from their doctors.
Of course, you know that there are at least three sides to every story. So, here are the three sides of this story.
RESPONSE FROM FDA
Here is the most recent word from the FDA on this topic as a result of the study and the various Advisory Committee Meetings (See http://www.fda.gov/drugs/drugsafety/ucm436259.htm for full text):
“Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established… Based on our findings, we are requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy…
RESPONSE FROM Urology Care Foundation
The official foundation of the American Urological Association (specialists who you would normally consult for TRT had the following response (See http://www.urologyhealth.org/patient-magazine/magazine-archives/2014/summer-2014/testosterone-replacement-therapy-is-it-right-for-you for full response)
“On January 31, 2014, the Food and Drug Administration (FDA) stated they would study the risk of heart attack, stroke and death in men taking testosterone replacement therapy (TRT). This was after two recent studies suggested that TRT raises the risk of heart attack in men.
The American Urological Association (AUA) has followed these reports closely. The AUA notes there are also conflicting studies suggesting TRT may lower heart attack risk. More studies need to be done to be certain whether and how TRT changes men’s risk of heart attack.
The AUA is also concerned about misuse of TRT. You should not take testosterone for non-medical reasons, such as bodybuilding, preventing aging changes or performance enhancement. Men should not take TRT if they have normal testosterone levels or if their testosterone levels have not been tested. If you have normal testosterone levels, using TRT will not help your health problems.”
RESPONESE FROM Life Extension Foundation
Life Extension Foundation is generally at the cutting edge of evidence-based recommendations for supplements and therapies for optimal health that might not yet be in the mainstream. Here is summary of their take on the controversy: (See the full article at http://www.lifeextension.com/magazine/2014/3/response-to-media-reports-associating-testosterone-treatment-with-greater-heart-attack-risk/page-01)
The age-related decline of men’s testosterone levels is inevitable.
Unless aging men replace their diminishing testosterone, they could succumb to any of the numerous health problems linked to low testosterone levels: frailty, muscle loss, weight gain, impaired cognition, fatigue, loss of self-confidence, depression, declining bone health, increased risk of type II diabetes, stroke, and cardiovascular disease.
A number of studies show that testosterone replacement therapy improves multiple measures of men’s vitality, especially related to cardio-metabolic health.
Therefore, on November 5, 2013, we were startled to see media headlines like “Testosterone Treatments Linked to Heart Risks.”
This headline and others like it were prompted by a retrospective, observational study in the September 5, 2013, issue of the Journal of the American Medical Association (JAMA). The study suggests testosterone therapy may increase risk of death and certain cardiovascular events.5
There are several significant shortcomings in the study’s design and methodology, and the results conflict with an existing body of research showing that low testosterone increases a man’s risk of heart problems:
- Woefully inadequate Testosterone Replacement (T should be over 550 ng/dL to accrue benefits)
- Failure To Account For Impact Of Estrogen (To much Estrogen can increase heart attack/stroke risk)
- Significant Difference In Baseline Testosterone Levels Between Groups (hard to reach the right conclusion)
- Achieving Higher Testosterone Levels Has Clear Cardiovascular Benefits (Again total T should be over 550 ng/dL to accrue benefits0
- Additional Studies Demonstrate The Benefits Of Maintaining Higher Testosterone Levels (See the articles for cited research that has shown higher T actually lowers the risk of heart attack/stroke)
- Study Conflicts with Previous Research
- Retrospective Observational Study – Unmeasured Confounding Or Hidden Bias Might Exist
- Unnatural Forms Of Testosterone Used By 1/3 Of Subjects (Proper form is bio-identical testosterone gel to maintain even levels as opposed to injection which promote peaks and valleys)
So, there you have it at least three sides of this story.
Are you sufficiently confused, yet? Here is what I would recommend as a bottom line:
- Talk to a specialist who knows what he/she is doing. Not just your primary physician.
- Read the life extension article in full. For optimal health through “non-mainstream methods”, I constantly find that I have to show up at the doctor’s office armed with information.
- Doctors often rather prescribe meds for individual symptoms than get to the root cause. To avoid prospect of litigation, they also have to engage in defensive medicine.
- Know your numbers and their implications: Total Testosterone, Free Testosterone, DHEA, Estradiol, LH, FSH.
- Your numbers should correlate with your health issue for TRT to be effective or advised.
- Ask for testosterone in the form of gel from a compounding pharmacy. That is the right therapy and is much cheaper.
I would love to hear from you, learn and share with others what I learn.
Bruce Buchanan said:
thanks for tackling this complex and somewhat confusing topic, Ashok. I appreciate the “balanced” approach you take, when sharing information. I found your “what is the bottom line” suggestions very helpful!