The Androgen Study Group, a newly formed multidisciplinary group of clinicians and researchers focused on the science of testosterone deficiency in men and its treatment, is calling for the retraction of a paper published in the Journal of the American Medical Association (JAMA) that linked testosterone replacement therapy to an increased risk of heart attacks, strokes and death. In a letter to JAMA editor-in-chief, the group claims that the study the paper was based on was compromised and should be removed from the journal.
The paper by Michael Ho, MD, PhD focused on a study that found a higher rate of cardiovascular events in male veterans taking testosterone supplements who also had had coronary angiography. Since it was published by JAMA in November, the journal has run two corrections. The first was a clarification that the results were based on Kaplan-Meier estimates rather than raw data. The second involved reclassification of patients who were excluded from the study. More than 1,000 excluded patients were assigned to different categories, including 100 women.
Despite the clarifications, Ho and colleagues say they stand by the results of the study. Other research in recent months has pointed to similar cardiovascular concerns regarding testosterone therapy, prompting the Food and Drug Administration (FDA) to launch an investigation into the safety of the drugs.
Concerns – and lawsuits – have also surfaced regarding the unscrupulous marketing practices by the drug industry promoting testosterone supplements for so-called “Low T” syndromes resulting in skyrocketing testosterone product sales and raising questions about the possibility of overselling the therapy.
The Androgen Study Group may have the right idea with its mission centered on promoting education and accurate reporting on testosterone therapy; however, several of its members have relationships with testosterone supplement makers, including the makers of AndroGel and Testim.