The latest installment of John Fauber’s ongoing expose of University of Wisconsin’s shady CME practices was published in the Milwaukee Journal Sentinel this past Saturday: “UW tied to male hormone marketing: Testosterone prescriptions soar despite weak research, risks.”Aided by UW’s lucrative alliance with Solvay Pharmaceuticals, AndroGel, a form of testosterone that you can slather over your body like sunscreen, has won 70% of the transdermal testosterone market share.
AndroGel is approved by the FDA for use in men with documented “low T” (as the company’s catchy ads call low testosterone levels). However, the actual science documenting benefits of testosterone replacement therapy (TRT) is weak. The largest and best designed study of TRT was published last year in the Journal of the American Medical Association. It did something that Solvay did not do in its FDA studies: it randomly assigned half of the 207 men to placebo. The Solvay AndroGel studies used another form of transdermal testosterone as its control.
According to the JAMA study, TRT (they used an injectable version of testosterone [correction--a reader pointed out that they used an oral form of testosterone rather than injectable]) mildly increased muscle mass and reduced fat, both by about 1%. But neither of these changes resulted in any subjective improvement. The TRT-treated patients felt no stronger and noted no improvement in the quality of their lives in comparison to those on placebo. On the other hand, the study hinted that TRT can cause heart disease: 47.8 % of the testosterone group vs. 35.5 % of the placebo group had the metabolic syndrome (a strong risk factor for cardiovascular disease and type 2 diabetes, a group of several metabolic components in one individual including obesity and dyslipidemia), though the difference was not statistically significant.
The authors concluded: “This study is, as far as we know, the largest study of testosterone supplementation with the most end points and a randomized, double-blind design. Adherence was high and the dropout rate was low,” the authors write. “The findings in this study do not support a net benefit on several indicators of health and functional and cognitive performance with 6 months of modest testosterone supplementation in healthy men with circulating testosterone levels in the lower range.”
To be fair, the UW promotional CME articles (you can read one here) were produced before the JAMA study, but that, really, is the point, isn’t it? UW allowed its reputation to be purchased by Solvay and medical education companies in order to create a buzz for AndroGel before good evidence was available. This is how the pharmaceutical industry often manipulates academic institutions and top scientists—not by inducing them to tell lies, but by paying them to say a whole lot about a topic in which the company has a commercial interest. This, in turn, generates wide interest in their product, more prescriptions, and greater profit.
How many more examples of this corrupt industry do we need before we see needed reforms?
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2 comments:
John Fauber's article features George Mejicano, director of UW's Office of Continuing Professional Development. But there is no statement of ethics principles from the Dean of the medical school, Robert Golden, MD. The buck stops with him.
This is the same Robert Golden who defended Charles Nemeroff in the Wall Street Journal some years ago. Hmmm.
I don't expect an answer to this, but what I'm wondering is why no one paid attention to this encroachment when it started truly ramping up.
I recall that to be at least by the early 1980s. I remember, because I wrote an editorial about it in a business newspaper. I remember asking some medical professionals for their opinion and received what should have been a convincing argument in favor of industry infiltrating research institutions. I was still skeptical.
Why would these issues be so clear to a journalist and not to the entire medical profession?
I'm no judge. Maybe the net benefit has still been huge but the excesses still seem, well, excess.
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