MEDIA'S 'ROID RAGE' OVER TESTOSTERONE GEL: Prescription testosterone gels have been all over the news after JAMA published a study. Photo: Ferring Pharmaceuticals
MEDIA’S ‘ROID RAGE’ OVER TESTOSTERONE GEL: Prescription testosterone gels have been all over the news after JAMA published a study. Photo: Ferring Pharmaceuticals

Testosterone therapy (specifically the prescription testosterone gels advertised on TV) has been vilified in the press after a controversial study was published last week in JAMA, the Journal of the American Medical Association (http://jama.jamanetwork.com/article.aspx?articleid=1764051), but some doctors say the study was seriously flawed.

The UMHS Pulse looks at the results of the study and the media reaction, and the reasons why some leading physicians believe that, despite the risks, testosterone therapy is necessary for men with low testosterone, hypogonadism and other medical conditions.

Mainstream media, such as ABC News, reported on the findings of the study. “Men who take testosterone supplements may be putting themselves at increased risk of death, heart attacks and strokes,” ABC’s Chaitanya Madamanchi, M.D. wrote (http://abcnews.go.com/blogs/health/2013/11/05/testosterone-supplements-tied-to-heart-attacks-strokes-early-death/ ).

“The new research looks at more than 8,000 male veterans with low testosterone,” ABC News continued. “Researchers compared the rates of cardiovascular ills among those who’d received testosterone supplementation and those who had not, and found that men who used testosterone were 29 percent more likely to die, have a heart attack or a stroke after three years of use.”

ANDROGEL: One of the most popular prescription testosterone gels. Photo: Courtesy of AbbVie Inc.
ANDROGEL: One of the most popular prescription testosterone gels. Photo: Courtesy of AbbVie Inc.

Wall St. Journal: Testosterone Meds Made Billions in 2012

In addition to the JAMA study, the Wall Street Journal published a story, “Testosterone Therapy Tied to Heart Risks, JAMA Study Shows” on November 5, 2013 (http://online.wsj.com/news/articles/SB10001424052702303661404579180294201174958). The Wall St. Journal reported that sales of prescription testosterone were $2.0 billion in 2012. The newspaper quoted cardiologist Dr. Steven Nissen of the Cleveland Clinic. Dr. Nissen told the Journal that he and other experts “saw trouble on the horizon” with the burgeoning use of prescription testosterone. “I get it—men want to feel stronger. But we should insist on long-term, well-designed safety trials,” he told the newspaper.

In Defense of Men with ‘Low T’

Doctors began to defend testosterone therapy shortly after JAMA published the study. Testosterone therapy is usually prescribed for men over 40 with “Low T,” or low testosterone if a blood test indicates abnormally low levels of the male hormone. It is often prescribed for men with hypogonadism, the diminished functional activity of the gonads. However, urologists and endocrinologists have said some doctors are overprescribing the medication. It is expensive and can have negative side effects, such as blood clots, male breast growth and infertility.

However, the positive benefits (more energy, improved bone density, decreased body fat and increased muscle mass, improved sexual desire and performance, better sleep) outweigh the risks in most cases.

Jen Landa, M.D., an OB/GYN, hormone specialist and Chief Medical Officer of BodyLogicMD, defended testosterone therapy in her article “How to Make Testosterone Therapy Safe for Men,” published November 11, 2013 in the Huffington Post (http://www.huffingtonpost.com/jen-landa-md/testosterone-therapy_b_4246148.html). “There are multiple problems with the current study that must be considered before men get scared off testosterone therapy as women were scared off their potentially beneficial hormone replacement therapy,” Dr. Landa wrote.” The current study misses so many important facets of testosterone replacement therapy that the results are practically meaningless.”

Dr. Landa made the following arguments for testosterone therapy:

• “Multiple prior studies have shown that testosterone therapy may protect against heart disease and decrease mortality. In a study published in June 2012 in the Journal of Clinical Endocrinology and Metabolism that also examined veterans, the authors concluded that testosterone treatment resulted in a 39 percent decreased mortality risk vs. men not treated with testosterone. Importantly, many studies have shown that men with lower testosterone levels are at a higher risk of mortality.”

• “A 2007 study also in the Journal of Clinical Endocrinology and Metabolism studied 794 men aged 50-91 years old for over 11 years and showed that men with testosterone levels in the lowest quartile were 40 percent more likely to die than those with higher levels. In this study, low testosterone also predicted increased risk of cardiovascular disease.”

• “So, the important question here is why testosterone therapy was associated with increased risks in this study when lower testosterone levels are clearly associated with increased risks of death and disease whereas higher levels of testosterone are associated with protection against cardiovascular disease and mortality. There are multiple reasons for this outcome. In this study, the authors mention that only 60 percent of the patients had an additional testosterone level checked after starting treatment. Without follow-up testing, it would be impossible to know if therapeutic increases in testosterone were achieved with the testosterone treatment.”

• “There are several risk factors of testosterone replacement therapy that were not addressed in this study and do not tend to be addressed by doctors who prescribe testosterone hormone therapy in general, unfortunately. Testosterone therapy may cause increased concentration of red blood cells (erythrocytosis). A study published in the journal Therapeutics and Clinical Risk Management regarding risks and benefits of testosterone replacement therapy states that elevations in hemoglobin (concentration of red blood cells) may have bad outcomes because the blood can become thick, which could exacerbate vascular disease. The study authors state that the treatment for this increase in concentration of red blood cells is either dose adjustment of the testosterone and/or periodic phlebotomy (drawing off blood as in blood or blood donation). This monitoring wasn’t done in the JAMA study.”

• “In conclusion, testosterone therapy should not be taken lightly but when managed properly can improve low testosterone levels, which is associated with a lower risk of cardiovascular disease and a lower mortality risk. This elevation of testosterone can be accomplished safely only when proper additional monitoring is undertaken. Consider consulting a hormone specialist who is knowledgeable in this area to experience optimal results from testosterone therapy.”

NOT JUST FOR BUILDING MUSCLE: Testosterone gels help men regain lost energy, improve bone density, sexual desire & performance & help decrease body fat. Photo: David Castillo Dominici/FreeDigitalPhotos.net
NOT JUST FOR BUILDING MUSCLE: Testosterone gels help men regain lost energy, improve bone density, sexual desire & performance & help decrease body fat. Photo: David Castillo Dominici/FreeDigitalPhotos.net

Natural Hormone Replacement Left Out of Study

BioTE Medical Founder Dr. Gary Donovitz, whose company makes a natural hormone therapy using subcutaneous pellets, told PR Newswire (ttp://www.prnewswire.com/news-releases/natural-hormone-replacement-pioneer-challenges-incomplete-testosterone-studies-231183781.html“>http://www.prnewswire.com/news-releases/natural-hormone-replacement-pioneer-challenges-incomplete-testosterone-studies-231183781.html”>ttp://www.prnewswire.com/news-releases/natural-hormone-replacement-pioneer-challenges-incomplete-testosterone-studies-231183781.html) that the study published in JAMA was incomplete. “The study referenced in the Wall Street Journal article is limited to the synthetic gels, patches and shots which are being heavily promoted on television and radio,” he said. “These pharmaceutical products use synthetic hormones and we’ve known about the dangers of synthetics for years. However, to be accurate and complete, any study of testosterone therapy needs to also include data for natural hormone replacement.”

Criticism of Study from Top Doctors

In an article for the website HealthDay (http://consumer.healthday.com/cardiovascular-and-health-information-20/heart-attack-news-357/study-raises-safety-questions-about-testosterone-therapy-681828.html) reporter Randy Dotinga quoted doctors that found fault with the study.

The article contained the following key points:

• “ ‘The investigators simply do not know all of the potential differences between the men who were treated with testosterone and those who were not,’ said Dr. Bradley Anawalt, an endocrinologist and chief of medicine service at the University of Washington Medical Center in Seattle. He was not involved with the study.”

• “VA Eastern Colorado Health Care System cardiologist Dr. P. Michael Ho, a study co-author, acknowledged that the results don’t confirm that testosterone supplements are especially risky for men with suspected heart problems. However, ‘this hopefully provides information that doctors can use when they discuss with their patients about whether to start or continue testosterone therapy,’ he noted.”

• “Testosterone therapy has become a hot topic in doctor’s offices in recent years as late-night TV ads warn male viewers that ‘low T’ could explain fatigue and low libidos. A study earlier this year found that the use of testosterone therapy by U.S. men aged 40 and up tripled between 2001 and 2011.”

6 COMMENTS

  1. It is interesting that if you look at the data that it agrees with the 2009 VA study that says those men on TRT have half the risk of those men with low testosterone who are not on testosterone.

    I find it curious that the data in the 2013 study does not support the conclusion, and no one seems to spot that obvious error.

    Form the report:

    Of the 8709 men with a total testosterone level lower than 300 ng/dL, 1223 patients started testosterone therapy after a median of 531 days following coronary angiography. Of the 1710 outcome events, 748 men died, 443 had MIs, and 519 had strokes. Of 7486 patients not receiving testosterone therapy, 681 died, 420 had MIs, and 486 had strokes. Among 1223 patients receiving testosterone therapy, 67 died, 23 had MIs, and 33 had strokes. The absolute rate of events were 19.9% in the no testosterone therapy group vs 25.7% in the testosterone therapy group, with an absolute risk difference of 5.8% (95% CI, -1.4% to 13.1%) at 3 years after coronary angiography. In Cox proportional hazards models adjusting for the presence of coronary artery disease, testosterone therapy use as a time-varying covariate was associated with increased risk of adverse outcomes (hazard ratio, 1.29; 95% CI, 1.04 to 1.58). There was no significant difference in the effect size of testosterone therapy among those with and without coronary artery disease (test for interaction, P?=?.41).

    Testosterone
    Total Yes No
    Total 8709 1223 7486
    Death 748 67 681
    Heart attack 443 23 420
    Strokes 519 33 486
    All Causes 1710 123 1587

    Death 8.6% 5.5% 9.1%
    Heart attack 5.1% 1.9% 5.6%
    Strokes 6.0% 2.7% 6.5%
    All Causes 19.6% 10.1% 21.2%

  2. There are contradicting opinions from medical experts regarding testosterone therapy. While there are some who defend the procedure, there are also alarming incidences associating testosterone therapy to life-threatening complications. To ensure the safety of people, further studies should be done to come up with a valid conclusion regarding the use of this therapy.

  3. There may be many rumors spreading about the disadvantage of using TRT patients however, it is still best to know it directly to your doctor about its effectiveness and if you are suitable on using it.

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