The Testosterone Lawsuits

We've all seen the ads on TV and in our Google searches: "A new study finds an association between cardiovascular disease (CVD) and testosterone therapy." The sharks are circling, with lawyers across the country running ads and commercials begging people to call them.

The saddest part is that this is hurting more people than it's helping. Men who truly need testosterone are now being turned away everywhere. Yet, those with low testosterone face the highest risk of cardiovascular issues. For years, we've known that low testosterone increases the risk of CVD and diabetes. So why the sudden complete reversal?

I don't like starting rumors—this might be a stretch—but could the makers of sexual enhancement pills be behind this? Who knows for sure? Read on to learn why I'm not convinced by any of it.

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

The Study's Conclusion

"Use of testosterone therapy in this cohort of veterans with significant medical comorbidities was associated with increased risk of mortality, myocardial infarction (MI), or ischemic stroke. These findings were not modified by the presence of coronary artery disease (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 one thing I've learned is to always review the full report myself. Most of the time, I'm surprised by what I find—and how often the results don't align with real-world applications.

Let's examine some factors that make this study unrealistic for the average man on testosterone replacement therapy (TRT).

1. Uncontrolled Data: This wasn't a controlled study where researchers gathered groups and administered testosterone. Instead, they analyzed existing data, leading to numerous uncontrolled variables. Discrepancies in administration and follow-up could be significant. The publication even notes: "First, given that this was an observational study, unmeasured confounding or hidden bias might exist."
2. High-Risk Population: All patients had undergone coronary angiography, meaning they drank a dye and had their hearts imaged to check blood flow. Clearly, everyone started with some cardiovascular risk. Here's the breakdown:
   • Total Men in Study: 8,709
   • Men on Testosterone: 1,223
   • 67 deaths, 23 MIs, and 33 strokes—for a total of 123 events = 10%
   • Men Not on Testosterone: 7,486
   • 681 deaths, 420 MIs, and 486 strokes—for a total of 1,587 events = 20%

   I'm no math whiz, but I don't see the correlation. It looks like testosterone actually helped.

3. Lack of Details: The study doesn't specify the form of testosterone or the dosage. Since it wasn't controlled, no one knows exactly what these patients received—the analysis happened long after treatment began.

The study feels more like something a lawyer wrote than objective research. In my opinion, it links other studies to reach its conclusion, resembling a biased school report more than science.

January 29, 2014: A University of California study reports:

"A study observed a two-fold increase in heart attack risk in men under 65 with a history of heart disease shortly after starting testosterone therapy (external application). It also confirmed earlier studies showing a two-fold increase in risk shortly after treatment in men over 65."

Like the previous one, this was an observational study—researchers sifted through existing data to draw conclusions.

Key Concerns with This Study

1. Pre-Existing Conditions: Participants were either over 65 or had a history of heart disease. Why not include a group of generally healthy men with only testosterone deficiency? This tells us little except to be cautious with pre-existing conditions—which we've known for years. That's why baseline lab work is essential before starting TRT.
2. Odd Comparisons: The study conveniently compared testosterone to Viagra and Cialis. It reads more like a sales pitch than impartial research.
3. Unmanaged Estrogen: The study notes most men had high estrogen levels: "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 admits they did nothing to address it. If you've been on TRT or know the basics, you understand estrogen (E2) management is crucial. Elevated E2 raises cardiovascular risk, damages organs, and may contribute to BPH or prostate cancer. It seems inexperienced prescribers were involved—E2 should be tested 3–12 weeks after starting, depending on the method. Reduce the dose or use an aromatase inhibitor if needed.
4. Vague Results: It claims a "two- to three-fold increase" without raw numbers or specifics. We're left to trust their methods blindly.
5. Study Limitations (Quoted Directly): "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 observational data dives that—make massive leaps based on assumptions. Their flaws are obvious and disclosed in the full reports, but few people read beyond the headlines. Both are biased in participant selection and don't reflect a typical client at IncreaseMyT today. We're proud to report no known cardiovascular events among our clients in twenty years of helping men with testosterone deficiencies.

The key to successful TRT is proper monitoring and follow-up labs. Dosages must be individualized, as we all respond differently. This moment in TRT history reminds me of past myths: testosterone "fuels prostate cancer" or women can't take HRT without heart attacks. Both were debunked by later research.

It's a sad time when lawyers and pharmaceutical companies battle for market share in a growing treatment—at the expense of our health. Don't take my word for it: Do your own research. Where are all the "dead bodies" from testosterone? It's been used since the 1930s. The real focus should be on physicians and manufacturers pushing opioid pain meds, which now cause more overdose deaths than heroin and cocaine combined.