Critics Of "Low-T" Drugs Like Axiron, AndroGel, And Testim Blame Medically Unnecessary Use Of Androgen Therapy On Drug Company Advertising
FDA MedWatch Alert issued on January 31, 2014
Drug Injury Watch article posted January 31, 2014
Testosterone replacement therapy (TRT), also called androgen replacement therapy (ART), is medically recommended for men whose body makes too little of this male hormone. For those men who have been tested and diagnosed with this condition, which is called hypogonadism, testosterone drugs like Axiron, AndroGel, and Testim can serve to boost strength and sexual functioning.
But how does one explain the fact that it is estimated the number of middle-aged men in the U.S. getting testosterone treatments has more than tripled over the last decade?
At least according to one study, this may be due to advertising campaigns for testosterone products that are arguably aimed men who do not have clinically low testosterone levels, i.e., had not undergone a blood test to see if they really needed TRT or ART. In fact, there seems to be a growing number of older men using drugs like Axiron, AndroGel, and Testim for so-called "Low-T syndrome" (men who are tired or depressed) or for anti-aging reasons -- and some younger men taking these testosterone drugs for other physical purposes.
From a June 2013 Reuters Health news report, "More men treated for low T, some without evidence":
Androgen replacement therapy is recommended for men who make too little testosterone on their own, a condition known as hypogonadism. That's different from the natural decline in testosterone that happens to all men as they age.
But advertising campaigns may be reaching a bigger pool of men - who are tired or depressed, for example, but don't have clinically low testosterone.
"There's all sorts of messages out there that men should be aware of this thing called low T, that low testosterone levels can be the reason for almost all of the problems with life and aging" and that treatment can fix that, said Dr. Steven Woloshin from the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire.
"The promise goes well beyond what we know, and that's what's worrisome," Woloshin, who co-wrote a commentary about testosterone marketing published in the same journal, told Reuters Health.
That marketing includes quizzes asking men about their energy, sex drive and mood, such as the "Is It Low T?" quiz [http://bit.ly/18LeuHk] sponsored by AbbVie, which makes the testosterone gel AndroGel.
Strictly Confidential, No Obligation.
And from an April 2013 piece in The Atlantic Monthly, "Should the Modern Man Be Taking Testosterone?":
Dr. Adriane Fugh-Berman, associate professor of pharmacology and director of the industry watchdog group PharmedOut.org at Georgetown University School of Medicine, calls this kind of direct-to-consumer pharmaceutical advertising "evil." She likened the efforts to sell TRT to earlier campaigns to push hormone replacement therapy for post-menopausal women. "They stole the playbook," she said. "This hormone is being thrown around like sugar water."
In our recent article about these testosterone drugs like Axiron, AndroGel, and Testim, "Increasingly Popular Testosterone Replacement Therapy Drugs Are Linked To Myocardial Infarctions Or Heart Attacks, Strokes, And Deaths", we referenced a relatively recent medical journal article, "Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels".
In an accompanying editorial, "Testosterone therapy and risk of cardiovascular disease in men", also published in the November 6, 2013 edition of the Journal of American Medical Association, Anne R. Cappola, MD, ScM, of the Perelman School of Medicine at the University of Pennsylvania, wrote:
Perhaps the most important question is the generalizability of the results of this study to the broader population of men taking testosterone: men of this age group who are taking testosterone for "low T syndrome" or for antiaging purposes and younger men taking it for physical enhancement. Does the 29% increased risk of myocardial infarction, ischemic stroke, or mortality apply to these groups? Are the benefits -- real or perceived -- for these groups of men worth any increase in risk?
In more detail, from a November 2013 MedPage Today report, "'Low T' Tx Tied to Higher Stroke Risk in Veterans":
"What is missing from the literature are data from randomized trials that include a sufficient number of men for an adequate amount of time to assess the long-term benefits and risks of testosterone therapy," said Cappola.
Establishing long-term risks will be difficult, she said. "There is no study involving men that is equivalent to the Women's Health Initiative, nor is it likely that there will be a trial of equal scale," she wrote. Because of this, she said, scientists will have to rely on observational data from existing cohorts of men, as the authors did in the current study.
The big question with the current study, said Cappola, is how generalizable the results are, because the men in the VA system are known to have more comorbidities and health problems than men in the general population.
But in light of the "mounting evidence of a signal of cardiac risk," cautious prescribing and additional investigation are called for, she said. [Emphasis added]
We are monitoring the medical literature and news reports for more information about cardiac risks associated with testosterone products like Axiron, AndroGel, and Testim, which have became so popular while so little is known about their long-term safety.