FDA: The FDA Exposes the Issues with the Recent Anti-HRT Cardiovascular Studies


The FDA, Testosterone and the Cardiovascular Studies
First of all, thanks to Nelson Vergel at Excel Male for alerting me to this FDA Denial of Petition Letter from July of 2014. Nelson wrote that this was a must-read letter and he was dead on.

When I read this letter, my jaw dropped, because in it the FDA rebutted the anti-HRT studies better than any other corporate or private source that I have read.  The charges against testosterone therapy were very serious, claiming thatte that HRT increases the risk of cardovascular disease.  For a year or two, I was on pins and needles wondering if the FDA would create restriction or limit access to testosterone.  To my great delight, the FDA actually did the opposite and left detractor licking their wounds.  For once, I feel that the FDA is powerfully watching for us little guys – the ones whose lives have been so transformed by the “Power of T.”  (Not everyone has a great experience with HRT, but for many of us, it was a miraculous and life-changing experience.)

The FDA’s response was so compelling, in my opinion at least, that I would urge anyone that is either on or considering going on testosterone therapy to read it. It is definitely not light reading but is definitely worth the effort.

NEWS FLASH:  There have been two major studies, one in 2014 and one in 2015, that showed greatly improved cardiovascular outcomes for men on TRT.  The latter, in particular, showed a 50% reduction in all cause mortality and an 18% and 30% reduction in risk of heart attacks and stroke, respectively.   See my page on The Latest Testosterone Therapy Cardiovascular Studies for details.

BACKGROUND:  The letter is actually responding to a petition filed by two physicians, Drs. Wolfe and Carome, who were asking for the FDA to force a black box warning on testosterone products that would state increased CVD (cardiovascular disease) risks.  I looked up these doctors, expecting them to be endocrinologists, who seem to almost universely dislike HRT, and found that they were actually part of an organization called Public Citizen’s Health Research Group, a Big Pharma watchdog lobbying organization.  Now, while I agree that the pharmaceutical industry needs some monitoring, the authors seem to be assuming that everything they do is big, bad and ugly.

However, I always thought the study was laughable when I heard the following fact:  the post-HRT testosterone levels were on average 332 ng/dl!!  And the FDA went for the jugular with that argument.  After all, that is the testosterone of an 85-year-old man and probably not a very healthy one at that!  In my book, Low Testosterone by the Numbers, I document how right around 350 ng/dl, the risk factors increase for many chronic diseases, including osteoporosis, diabetes, Metabolic Syndrome, anemia, depression, erectile dysfunction and hardening of the arteries. In other words, this study deliberately left most of the participants at a testosterone level that has been shown to elevate their risk to be sick. This is a completely unfair way to study HRT as more youthful levels of testosterone greatly lower insulin levels and improve arterial health. It also shows how many docs out there administer crappy HRT protocols!

Some of the other criticisms and analysis of the data are much more involved.  One study was not actually designed to measure heart outcomes but just used peripheral data.  One of the other studies on testosterone did not have the testosterone levels of the patients available – oy vay!  The FDA pulled no punches and pointed out what I stated above:  a significant block of the patients might have had low testosterone and thus been exposed to increased risk of heart disease not lowered.  The devil is always in the details, eh?

The bottom line is that the FDA insisted upon better data and better research and that is entirely appropriate in my opinion. And this is especially true in light of the fact that two recent studies have shown the exact opposite of these four studies, i.e. that testosterone therapy actually improves cardiovascular outcomes.  And, in my page on the recent Testosterone Class Action Lawsuits, I discuss the fact that the original anti-HRT studies do not control estradiol levels, which can have a significant effect on cardiovascular outcomes according to some research.

Regardless of your position, I encourage you to read the FDA’s response.  They did a nice job in my opinion of stating the strengths and weaknesses of all the cardiovascular studies mentioned in the appeal and so you can judge for yourself.  Of course, you HRT readers know that testosterone is something that you will likely be on decades, so there is simply no more important topic than long term safety in opinion.

Testosterone survived all the early attacks surrounding prostate cancer and I believe it will weather this storm as well.  Now, I do want to say that in my non-researcher, non-physician opinion, there are 3 cases where heart disease outcomes may be worse when going on HRT and that these need to be studied or education increase based on what I have seen:

  • Pre-existing Clotting Disorders. Thansk to Nelson for alerting me to this one. A percent or two of men going on HRT have a genetic predisposition to clotting that may, according to one research, leave them vulnerable to stroke and possible heart attacks. See my Potential Risks of Testosterone Therapy (Pt. #7) for details.

Did you know you can inexpensively do your own testing for most hormones? The industry leader is Discounted Labs..

  • Some Hypertension Patients. Some hypertenions patients will experience an elevation in blood pressure for reasons that poorly understood. Obviously, this is bad. We just had a man on the forum whose systolic pressure went up to 199 after going on TRT!
  • Unchecked RBC/Hemtocrit/Hemoglobin. Some doctors forget to regularly check their patients hematocrit and hemoglobin. This can be life-threatening if a man goes too high: we’ve had a few guys on the forum with this issue and occasionall the doctor seems unaware.


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