“Adult-onset hypogonadism:” real disorder or stealth testosterone marketing strategy?

Alan Cassels is a drug policy researcher at the University of Victoria and a regular contributor to the blog. He is also the author, most recently, of The Cochrane Collaboration: Medicine’s Best-Kept Secret. He tweets as @AKEcassels.

Sometimes journalists may take a look at a news release presenting new research on a widely used pharmaceutical treatment, but they don’t touch the story. This seems to have happened recently with two news releases making some claims that just maybe couldn’t pass the sniff test from journalists. One, from the Baylor College of Medicine, made an assertion that there is a “new medical condition identified for men suffering with low testosterone.” And a Tulane University School of Medicine news release on the same study asks: “Is hormone therapy for ‘low-T’ safe?” and concludes that such treatment is, indeed, “safe and beneficial.”

Low-T or AOH: Is disease in the eye of the beholder?

low testosterone low sex driveOne cynical interpretation of these news releases, highlighting research published in the Mayo Clinic Proceedings, is that this appears to be a serious effort to remake the “disease” of Low Testosterone or “Low-T.” Certainly with researchers introducing a new term that scores high on the “medical sounding” index — “adult-onset hypogonadism,” or AOH — this new condition could either be completely legit, or another case of disease mongering which will undoubtedly help boost the flagging sales of some testosterone-replacement therapy products.

It’s not clear why these news releases failed to gain any traction with news media outlets that in the past have seemed all too eager to hype the issue of “male menopause” and how to treat it. Maybe journalists were all working on other big stories or on vacation. Or, just maybe they wrote the research off as nothing more than a drug in a mad search for a new disease, or at least a revamped definition of disease in order to expand the markets for it.

Whatever the case, the issue addressed by these releases seems to be the small segment of the population who might benefit from testosterone because of increasingly strict rules around how testosterone should be used.  As the lead researcher of the Mayo Clinic Proceedings review noted: “Testosterone therapy is currently only indicated for men with classical primary or secondary hypogonadism” — which are conditions that result in low T levels because of damage or trauma to the testes, or because the areas of the brain that control the gonads (hypothalamus and pituitary) do not function properly. The symptoms of these disorders are typically far more definitive and noticeable than the complaints of “low energy” that are used to justify most testosterone treatment. As the researcher explained, “the problem is that only 15 percent currently being treated for low testosterone meet this criteria.” 

News release claims that go way beyond the evidence 

Dr. Richard Hoffman, a reviewer at HealthNewsReview.org and the Director of the Division of General Internal Medicine for the University of Iowa Carver College of Medicine/Iowa City VA Medical Center, is a physician who occasionally prescribes testosterone. His take on these news releases is that there is perhaps legitimate uncertainty about identifying men who merit treatment with testosterone.  He told me he thought “the vague symptoms (low energy, fatigue, etc.) pushed as indications by T manufacturers do need to be further evaluated by clinicians—even if T levels are low—for other causes.”  He says that if he prescribes testosterone, he would continue it only “if it was working–such as satisfactory erectile function–and not causing harm.”

But when a large majority of men don’t meet the established indications for treatment, do you assert that the drug would probably help those other 85% anyway, and do you try to establish a new condition –adult-onset hypogonadism — that matches the symptoms these men describe? That would certainly fit the possible disease-mongering angle.

Asked to comment on this question, Dr. Hoffman looked at the published data and said that the researchers’ analysis and conclusions — as presented in the study itself — seemed reasonable enough. He said the authors “did highlight the challenge of identifying men with testosterone deficiencies and that we have only limited evidence for the benefits and harms of testosterone replacement.” However, he said the news release publicizing the study went quite a bit further than was justified by the data. For example, “the claim that these 85% [of men who do not meet the criteria for treatment] would ‘typically experience an improvement in their quality of life’ is not based on any evidence presented in the review,” according to Hoffman.

‘The blatant request for insurance coverage…is quite self serving’

Hoffman added, “The review indicates that the understanding of indications and benefits of testosterone for AOH patients is still evolving, so it’s a bit of a stretch to imply that these suffering patients were denied appropriate treatment.” He further took issue with the release’s appeal to insurance and regulatory agencies to “recognize AOH as a true condition” and give patients “greater access and more affordable means to testosterone therapy.”

In Hoffman’s view, “The blatant request for insurance coverage and the heart-tugging appeal to help these sufferers understand their true condition and have greater access to testosterone is quite self serving—especially given the acknowledged gaps in the literature.”

What about undisclosed conflicts of interest?

It is worth reminding readers that this research — as with previous studies that were instrumental in expanding the use of testosterone —  is being done by those with substantial financial conflicts of interest that would naturally favor the manufacturers’ point of view. The lead researcher on the new disease definition study, Dr. Mohit Khera, a professor of urology at Baylor College of Medicine, is a consultant for AbbVie, Endo Pharmaceuticals, Lipocine, and Repros Therapeutics, Inc.  Many of his study’s multiple coauthors similarly have multiple ties to drug companies that manufacture a variety of testosterone products, among other treatments. Neither news release mentions the researchers’ financial relationship with drugmakers.

While journalists have seemingly been reluctant to give too much air time to AOH and the related potential to expand testosterone therapy, at least some outlets have recently been covering evidence that cuts the other way. For example, this study published in the CMAJwhich garnered some Canadian coverage in CBC online, looked at the accuracy of signs and symptoms associated with “low testosterone” in older men to see how well they corresponded to actual testosterone levels.  What they found was somewhat surprising:  After doing a systematic review of 40 studies on hypogonadism in men (average age 40) the researchers found the relationship to be “quite weak.”  The biggest surprise of all was that the “estimated prevalence varied widely, from 2 percent to 77 percent.”  Which is to say that older men who exhibit symptoms of “low testosterone,” such as erectile dysfunction or low libido, may indeed have testosterone in the “normal” range. They also might have other medical things going on.

Another piece at MedPageToday looks at the checkered history of libido-linked drugs like testosterone and highlights the financial incentives that have driven their rising use over the past two decades. It also notes the safety concerns that continue to plague these products, which in the case of testosterone include some 14,000 reports to the FDA of serious medical complications, including more than 1,900 hospitalizations and 444 deaths, since 2013.

A possible sign of progress

Let’s be clear: This is a potentially important story because it concerns the expanding use of a drug that is currently used by millions of men who are spending upwards of $2 billion per year on it without much evidence that it will work and even some evidence that it might be dangerous.

But we’d much rather see no coverage of this story than the fawning, promotional pieces that so often get written on these topics. 

Maybe this is what progress looks like.

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