I have received dozens of calls from men who are concerned about the recent study that reports that testosterone replacement therapy increases the risk of heart attacks and strokes. This blog is intended to clarify some of the misinformation that is attracting so much media attention. The Androgen Study Group, a large group of physicians and researchers of which I am a member, is calling for the retraction of the paper that appeared in the Journal of American Medical Association linking testosterone and cardiovascular risks — data that its authors of the paper in the journal are standing firmly behind.
In a letter to Howard Bauchner, MD, editor-in-chief of the Journal of the American Medical Association, members of the group — formed in response to the paper and comprised of more than 125 doctors — said the study’s credibility was compromised by at least two corrections and should be pulled from the journal.
A close friend and colleague, Dr. Abraham Morgentalker pointed out the there’s no misconduct, no one faked any data, it’s just sloppy. The group called it “gross data mismanagement.”
The paper, published in JAMA in November by Michael Ho, MD, PhD, of the Eastern Colorado VA, and colleagues, found that testosterone therapy was associated with a greater risk of death, heart attack, and stroke in male veterans who’d had coronary angiography. (If the men were having coronary angiography, it stands to reason that they already had some heart disease or they wouldn’t have been subjected to this invasive procedure)
But two corrections have since been published. The first, in the Jan. 15 issue, was a clarification that the results were based on “estimates” and not raw data.
The second, which Morgentaler and colleagues focus on in their letter to the editor of the journal, involved reclassivication of patient who were excluded from the study. More than 1,000 excluded patients were assigned to different categories of exclusion, including 100 who were women!
The authors included almost 10% women in an all-male study, so why should we believe any of the other data? The Androgen Study Group points out that the data were so off that it’s hard to believe the data for the entire study are accurate.
However, Ho and colleagues said they “stand firmly by the results of our study,” noting that the overall number of excluded patients remains the same, as does the total number of included patients, and the main results of the study were not changed.
The study group said that these claims run contrary to 40 years’ worth of research on testosterone, which suggests that the hormone has some beneficial effects in certain heart patients.
But the testosterone therapy field has garnered much media attention for its financial relationships with industry. Several articles in the New York Times, including one on the marketing of “Low T”, another on the selling of testosterone gels, and an editorial, have questioned the potential overselling of the therapy.
It is true that several members of the Androgen Study Group, myself included, have relationships with testosterone drug makers, such as AbbVie, Watson, and Endo Pharmaceuticals.
It is my opinion that men who are symptomatic for low testosterone and have complaints such as lethargy, decreased libido, loss of muscle mass, and decrease in erections or potency AND who have a documented decrease in the blood level of testosterone, are good candidates for hormone replacement therapy. These men who are going to receive testosterone should have a normal digital rectal exam and a normal PSA test if they are less than 75 years of age.
Bottom Line: Low testosterone has effects that impact a man’s quality of life. If a man has symptoms of low T and a documented decrease in the blood testosterone level, he should speak to his physician about testosterone replacement therapy.