This news release summarizes an observational study that compared the records of older men with low testosterone levels and who receive testosterone therapy with those who have chosen to take a pass on such treatment. The study observed that over a period of 8 years, those in the therapy category experienced significantly fewer strokes and deaths related to cardiovascular disease than did those who weren’t on testosterone therapy.
The release does a good job of reminding readers that this study design is not as robust as a randomized clinical trial, but it does claim that the findings lend clarity to an otherwise murky landscape in which the impact of hormone-replacement therapy remains uncertain. It also offers transparency in the form of a list of financial ties three researchers have with Bayer Pharma, but unfortunately the release neglects to go one step further and mention that Bayer, which also markets hormone replacement drugs, funded the study.
While many argue that “medicalizing” low testosterone levels in older men is inappropriate, the possibility that supplementing testosterone might minimize cardiovascular problems is being explored by many researchers and drug companies.
Cost estimates for long-term testosterone therapy are missing from this release. This matters because, although health insurance often covers testosterone treatments if a physician deems them warranted, a month’s worth of medication can cost hundreds of dollars.
The text does a good job of describing the differences in cardiovascular outcomes between men receiving testosterone treatment and those who chose not to. But the release never tells us how many people were in each group or what the event rate was, which makes it difficult to make a comparison. And, as the release alludes, the observational design of the study means the cardiovascular outcomes are not conclusive.
Harms are not on this text’s radar screen. Testosterone treatment does have a few side effects including sleep apnea, stimulation of benign growths in the prostate, enlarged breasts and increased risk of blood clots. The study on which this release was based does not appear to discuss these outcomes either, but their inclusion here would have been helpful.
The release does a nice job of describing the study and reflecting on the relative value of an observational study compared to more rigorous clinical trial designs. That comparison should serve as a signal to journalists to explain these differences in more detail. For example, patients are not randomly assigned to study conditions in observational studies such as this; rather, they end up in one or another treatment arm by choice, thus opening the door for confounding variables to play a role in the outcome. The study did statistically control for a number of possible confounds, and a mention of that in the news release would have been useful.
It’s because of the study’s large risk for confounding that leads to uncertainty that we rate this unsatisfactory. The control group (those not taking testosterone therapy) had more prevalent cardiovascular disease and more cardiovascular risk factors. Even with the statistical adjustment used in the study, the validity of the results is highly questionable. The other measures that were addressed — including diabetes and lipid levels — are surrogate endpoints and were likely confounded by factors other than testosterone replacement. The comment that testosterone has a “protective effect” is an egregious misstatement given the important limitations of the study design. Randomized controlled trials have addressed this issue and found there does not necessarily appear to be a risk from testosterone, but there is certainly no indication of a protective effect.
We credit the release for not referring to the manufactured disease label “low T” that others have ascribed to the natural decline in testosterone levels as men age.
Given the controversies over the necessity for testosterone replacement, the study results beg the question of why these men were on testosterone replacement in the first place — and whether it was successfully addressing the symptoms for which it was prescribed. If not disease mongering, then this is product mongering.
A study funder, Bayer Pharma, is not acknowledged although several coauthors are identified as receiving compensation from the company. Missing entirely from the press release is an acknowledgement that Bayer Pharma markets hormone replacement drugs to treat low levels of testosterone.
No other options are discussed.
Testosterone treatment is clearly available although topical preparations are more expensive than injections and insurance companies may balk at covering these treatments.
The release notes that testosterone therapy is controversial but then makes a pitch for the novelty of the study’s ability to clarify that landscape. Unfounded hyperbolic conclusions are not novel. As noted above, randomized trials have addressed this issue.
The wording is cautious in most respects.