The Testosterone Lawsuits

We have all seen the ads on TV and on our Google searches, a “new study finds association of CVD with testosterone therapy”. The sharks are out in full force and every lawyer in the country has an ad or commercial somewhere begging people to call them.

The saddest part about it all is so far it is hurting more people than doing good. Men who really need testosterone are being turned down everywhere now, and it’s those with low testosterone that have the highest risk for cardio vascular malfunction. We have now known for years that men with low testosterone have a high risk for CVD and diabetes. So why all the sudden have we switched directions entirely?

I don’t like starting rumors and this could be far fetched, but is possible the makers of sexual enhancement pills are behind this? Who knows for sure, but read on to find out why I am not sold on any of it.

November 6, 2013. A study is published in JAMA (Journal of the American Medical Association).

THE CONCLUSION OF THE STUDY IS AS FOLLOWS:

Use of testosterone therapy in this cohort of veterans with significant medical comorbidities was associated with increased risk of mortality, MI, or ischemic stroke. These findings were not modified by the presence of CAD. Future studies including randomized controlled trials are needed to properly characterize the potential risks of testosterone therapy in men with comorbidities.

I’ve read countless studies and the one thing I have learned, is to always read the full study myself. Most of the time I am surprised with what I read and how many of the studies don’t add up to the real world application we all had in mind.

Let's look at some of the things that make this study unrealistic to the average guy on TRT.

1. This was not a study where researchers gathered groups and administered testosterone therapy. Researchers essentially went through a pile of data that was in the system to come to their conclusion. This means there are going to be tons of variables because the groups were not controlled, so discrepancies on how exactly the administration of testosterone and the follow up could be very large. It states on the publication “First, given that this was an observational study, unmeasured confounding or hidden bias might exist”

2. All patients in this study had received coronary angiography. This basically means they drank a dye, then had their heart imaged to see the blood flow. So it’s obvious everyone had some risk of cardiovascular events to begin with. Lets look at the numbers:

TOTAL MEN IN THE STUDY: 8,709

MEN ON TESTOSTERONE: 1,223
67 deaths, 23 MI’s and 33 strokes for a total of 123 = 10%

MEN NOT ON TESTOSTERONE: 7,486
681 deaths, 420 MI’s and 486 strokes for a total of 1,587 = 20%

I’m not great a math but I am failing to see the correlation. It seems to me the testosterone actually helped.

3. Nowhere in the study does it say what form of testosterone or how much they were given. No one has a clue what these patients were actually taking since they were not being controlled, the study of the “data” was done long after the men were placed on testosterone.

The study honestly sounds more like a lawyer wrote it than researchers because it links numerous other studies to it in order to come to its conclusion, in my humble opinion its no more than very biased school report.

JANUARY 29, 2014 – A UNIVERSITY OF CALIFORNIA STUDY REPORTS:

“A study has observed a two-fold increase in the risk of a heart attack in men under 65 with a history of heart disease, shortly after use of testosterone therapy; that is, the external application of testosterone. Further, the study also confirmed earlier studies that found a two-fold increase in the risk of heart attack shortly after treatment in men older than 65.”

This study, like the last one was an “observational study”. So basically they went through a bunch of data laying around, to come to their conclusion.

LET'S GO OVER THE SOME OF THE THINGS I HAVE CONCERNS WITH:

1. Men were either 65, or had a history of heart disease. Why didn’t they also use a group of men that were generally healthy other than a testosterone deficiency? This doesn’t tell me anything except you should be careful about taking testosterone if you have a pre existing condition, which is what I’ve known for years. This is why you need baseline lab work before deciding if TRT is right for you.

2. The study just “coincidentally” compared testosterone to Viagra and Cialis, it really does sound more like a sales pitch than a study when you sit down and read it.

3. Its noted in the study that most of the men also had high estrogen levels stating:

TRT also increases circulating estrogens which may play a role in the observed excess of adverse cardiovascular-related events, given that estrogen therapy has been associated with this excess in both men and women”

It also notes in the study they did not do anything or give them anything for their high estrogen. If you’ve been on TRT before, or have a clue what you’re doing, then you know E2 is the most important part of any TRT program for males. If your E2 goes up it increases your risk for cardiovascular disease, can damage organs and even contribute to BPH and prostate cancer. It sounds more to me like someone gave a lot of men testosterone that had little experience in prescribing it, E2 tests need to be done in the firs 3-12 weeks depending on the application. Its important to reduce your dose or use an aromatase inhibitor to lower your estrogen if need be.

4. The study does not give us the raw numbers like the first one I pointed out. It merely says, “Increased by 2-3 fold”, it does not get into specifics at all. I guess we are just supposed to trust their methods of coming to this conclusion were accurate.

5. And lastly I will quote a part of the study and let it speak for itself:

“Despite plausible biologic mechanisms linking TT prescription to an elevated risk of MI, our study has limitations related to use of a health-care database that did not include information on the serologic or diagnostic indications for treatment. It also identified only subjects with non-fatal MIs, typically representing about 75% of the total incidence, and was based on the diagnosis of an attending physician, rather than a structured evaluation as might occur in a randomized trial. However, the accuracy of an MI diagnosis is considered to be reliable in such databases, and the established risk factors for MI apply to both fatal and non-fatal events. We were also unable to examine whether this excess was related to indications such as level of serum testosterone or hypogonadism.”

WRAPPING IT UP:

These studies, if you can call them a study since no one actually got studied, make leaps and bounds through assumptions. The faults are easy to spot and to cover their butts they have placed them in the full article for everyone to see, but no one usually reads the full article. Both are very biased in the groups they picked and don’t actually fit the context of a single client at IMT today. We are proud to say we have never had a single cardio vascular event with any of our clients that we are aware of and we have been helping those with testosterone deficiencies for 4 years.

The key to any successful TRT program is proper monitoring and follow up diagnostics through lab work. Dosages need to be titrated individually since we all respond differently to different amounts of testosterone. This crucial time in TRT history reminds me of a time when we believed that testosterone “fueled prostate cancer” and that women cannot take HRT without getting a heart attack. Both of which came about from studies that were proved completely wrong later.

It’s a sad time in our country when lawyers and pharmaceutical companies volley for market share of an ever-growing treatment, all at the expense of our health. Don’t take my word for it, do the research yourself and ask yourself where are all the dead bodies from testosterone use? Testosterone is not new and men having been using it since the 1930’s. The real focus should be put on the physicians and manufactures supplying opioid pain medications that now are producing more overdose deaths than heroine and cocaine combined.

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