Lines Blurred on "Normal" Testosterone Level, Physicians Prescribe Therapy Without Need

A new analysis of insurance company records indicates that doctors frequently give testosterone therapy to men with "normal" hormone levels and that they fail, more often than not, to screen patients for prostate cancer each year.

A new analysis of insurance company records indicates that doctors frequently give testosterone therapy to men with “normal” hormone levels and that they fail, more often than not, to screen patients for prostate cancer each year.

Endocrine Society guidelines recommend that doctors prescribe testosterone exclusively to men with little testosterone, symptoms of hypogonadism and no signs of prostate cancer.

Researchers from the University of Texas Medical Branch (UTMB) checked compliance rates by examining health insurance data for 61,474 men aged 40 and over who were prescribed testosterone replacement therapy between 2001 and 2010.

Their analysis, which appears in Public Health Reports, found that 19.5% of the men received prescriptions despite initial testosterone levels that exceeded Endocrine Society guidelines.

“These findings show that there may not be a consensus among physicians regarding the definition of ‘low testosterone,” said Jacques Baillargeon, PhD, in a news release that accompanied publication of the study results. Baillargeon is the lead author of the study and professor of epidemiology in UTMB’s department of Preventive Medicine and Community Health. “It’s possible that in some cases physicians judge that a patient’s symptoms, such as fatigue and loss of muscle mass, merit testosterone therapy without clinically defined low testosterone levels,” he said.

Even the Endocrine Society guidelines acknowledge some ambiguity about what constitutes “low” testosterone among middle-aged and elderly men. Its guidelines suggest that doctors estimate what’s right for any given patient by considering symptoms and using age to adjust from the 300 ng/dl that many consider the low end of normal for younger men.

There is no ambiguity, however, in the recommendations that urge physicians to measure patient testosterone levels before and after they begin treatment, yet compliance rates were still poor. The analysis found that 26.6% of the men in the cohort did not get their testosterone levels checked before they received their first prescription and that 47.6% of them did not get levels checked for a full year after they began treatment.

Compliance rates were even worse for recommendations related to prostate cancer screening.

The Endocrine Society urges physicians to review a recent test of prostate specific antigen (PSA) and make sure levels are normal before they prescribe testosterone replacement therapy, but only60.7% of the men in the study cohort had been screened for prostate cancer in the 12 months before they began testosterone therapy.

Only 43.3% of them, moreover, underwent a PSA test in the 12 months after they began testosterone therapy, a step that is universally recommended (no more than 6 months after the start of treatment) to make sure the growth-promoting hormone doesn’t spur tumor development.

Multivariate analysis found that men who received their prescriptions from endocrinologists or urologists were more likely to be in compliance with standards of care than those who received it from primary care doctors.

In general, studies based on insurance company claims rather than more complete repositories of patient records are prone to errors of omission, for they cannot detect procedures that patients finance out-of-pocket, with previous insurance or with alternate insurance.

That said, the study authors believe that the size of their cohort and the strength of their findings lend weight to their conclusions, particularly given the dearth of research into the topics they studied.

“These findings are very important from a medical and public health standpoint given the rapidly increasing number of men receiving testosterone in the U.S.” said Baillargeon. “Further research on the medical decision-making processes involved in monitoring and prostate cancer screening will be important, given our limited knowledge of the risks of this therapy.”