The study was meant to determine whether testosterone therapy could improve mild cases of anemia — a condition in which the blood does not have enough healthy red blood cells — in male patients with low testosterone. The National Institutes of Health backed the study as a part of the agency’s Testosterone Trials. Researchers designed trials to examine the possible benefits of testosterone therapy for conditions like poor bone density and anemia. The trials were conducted at 12 sites across the country and involved 790 men age 65 and older with low levels of testosterone.
For the study on anemia and testosterone therapy, researchers examined the blood of 788 participants. Among them, 126 proved to be anemic. Researchers excluded men with more severe anemia from the trial and referred them to their primary care physicians for evaluation. However, men with moderate anemia were not told of their condition during their participation in the trial. The researchers found testosterone treatment corrected anemia among the participants more than a placebo.
“Abnormal results on this simple blood test could have been an early warning sign of a serious illness which, if diagnosed and treated early could have greatly improved patient outcomes,” said Bernard Lo, MD, a bioethicist who runs the nonprofit Greenwall Foundation in New York City and a coauthor of the editorial that identified the ethical lapse, according to NPR.
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The trial was designed and conducted by approximately two dozen well-regarded scientists and the protocols and ethical implications of the study were examined by 12 university institutional review boards prior to its onset.
It is unclear if any patients in the study were harmed by the lapse, but Dr. Lo told NPR the fact that the lapse occurred — despite the many protections implemented to prevent such an occurrence from happening — indicates larger systemic issues.
“My own feeling is if it happened once, despite all these safeguards, it could happen again [in another major study],” said Dr. Lo. “It’s a warning sign that there’s a major problem in the system that needs to be addressed.”
Peter Snyder, MD, a professor at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia and the organizer of the study, admits this was an oversight.
“We put an enormous amount of time and effort into attempting to protect the participants [from the side effects of testosterone], and that’s where our focus was,” Dr. Snyder told NPR. “Men who had a mild degree of anemia weren’t informed because we just didn’t think of that. It didn’t occur to anybody until this review pointed it out.”
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