Biotech Values

[biotech jim]

Here is the editorial in the NEJM on the Snyder et al. Testosterone Trials study.

http://www.nejm.org/doi/full/10.1056/NEJMe1600196

The overall design of the Testosterone Trials is complex.5 It includes seven independent, double-blind, placebo-controlled trials intended to address specific outcomes that are postulated to be related to testosterone deficiency (sexual function, vitality, physical function, cognitive function, anemia, bone density, and cardiovascular status). The trials are knitted together by common methods and some shared measures, thus maximizing the power of the overall investigation. This inaugural report describes the findings of the three main studies (with primary outcomes related to sexual function, physical function, and vitality).

Importantly, the study participants were recruited on the basis of stringent criteria (age ≥65 years, total testosterone levels below the normal range in men 19 to 40 years of age [<275 ng per deciliter], symptoms related to predetermined outcomes, and no contraindications to participation). Only 1.5% of those screened (790 of 51,085 men) were eligible and enrolled. The average participant was 72 years of age; almost 90% of participants were white, most were obese, most had hypertension, more than one third had diabetes, and almost 20% had sleep apnea. The select nature of the participants reflects the scientific rigor of the trials (and the causes of low testosterone levels) but also clearly limits the generalizability of the conclusions. We should not assume that the benefits, lack of benefits, or adverse-event profile observed in these studies would be similar in younger men (most testosterone prescriptions are written for middle-aged men3), men with higher testosterone levels, or those with different demographic or clinical characteristics.