A clinical trial delving into testosterone is, according to an original report in The Philadelphia Inquirer and reprinted in the Daily Press of Newport News, Virginia (5/3/14), about to conclude, with trial results expected next year. But even though the trial comes in at a price tag of $50 million, it is not expected to yield the kind of conclusive results stemming from the Women’s Health Initiative, an exhaustive study involving over 16,000 women taking estrogen-progestin tablets for five years.
The aforementioned study concluded that hormonal therapy did more harm than good, according to the report. However, a similar definitive conclusion is not expected from the so-called “T” Study, as fewer than 1,000 men are involved.
Peter Snyder, an endocrinologist with the University of Pennsylvania is lead researcher in the study. “It is nowhere near large enough to determine any important risk,” Snyder said, in comments published in The Inquirer. “Not on prostate cancer or heart disease.” The trial involved 788 men on testosterone, or a placebo, for a year.
Testosterone therapy has always been available for men suffering from true testosterone depletion - either low levels of testosterone, or none at all (hypogonadism, a rare condition). According to the well-written report in The Inquirer, testosterone is not readily absorbed in pill form, and testosterone shots prove to be an unpleasant experience. Those suffering from real testosterone deficiency would undertake the shots nonetheless as a necessary evil to overcome the sometimes serious health consequences stemming from a very real testosterone deficiency.
Shots hurt lots. But gel is swell…
But then along came AndroGel, the makers of which received approval from the US Food and Drug Administration (FDA) in 2000. Gel is a lot easier to stomach than injections. Suddenly, testosterone has become “a thing” for men feeling the effects of reduced energy in midlife. By 2013, testosterone supplementation had grown to a $2 billion industry. By 2018 - just four years from now - that figure is expected to more than double, to $5 billion a year in sales.
Advocates for men’s health (and perhaps men’s vanity) along with manufacturers and proponents of testosterone feel bullish about such potential. But it doesn’t come without risks - risks that will be exacerbated across the population as more and more men fuel that growth.
The FDA has commenced an investigation following the release of two recent studies that suggested testosterone supplementation can raise the risk for testosterone heart attack and other serious adverse reactions.
Those side effects can include testosterone stroke and even death.
Many a testosterone lawsuit has been filed, alleging health problems.
Advocates for men’s health are correct when they speak of the benefits of testosterone supplements for men with serious deficiencies. Just as too much testosterone can foster serious testosterone side effects, so too can too little - and for those patients, the risk/benefit profile for testosterone definitely swings to the benefit side.
However, the ease of use of testosterone gels together with an increased focus toward men’s health issues as baby boomers age has unleashed a monster. The Inquirer reports that between 2001 - the year following FDA approval of the first topical gel - and 2011, usage tripled amongst men 40 years of age and over.
What’s more, a recent British analysis of the Medicare database revealed that a quarter of testosterone users engaged in zero testing for their testosterone levels before pursuing testosterone supplementation. The analysis also found that 9 percent of supplementation patients who undertook testing showed testosterone levels to be at normal, or even spiking into the high range.
The Inquirer revealed that one professional medical writer based in Massachusetts served as ghostwriter on behalf of a number of physicians for articles appearing in various magazines and professional journals. Stephen Braun would later write that his undertakings served as “an unbalanced presentation of ‘facts’ that serves primarily to drive people to their physicians seeking the holy grail of ‘energy, positive mood and sexuality’ in the form of testosterone.”
Further marketing efforts include the capacity for online self-diagnosis, the basis for which was created by a medical doctor working at the behest of a testosterone manufacturer, jotting suggested criteria for a self-test on a couple of strips of toilet paper while on a bathroom break.
Such online tests, many a testosterone lawsuit claims, are weighted heavily in favor of a suggested diagnosis for low testosterone. While manufacturers promote the need for prospective patients to consult with their physician, most doctors appear to be buying into the cause as a means to increase their patients’ health and well-being.
Testosterone: medically necessary therapy or an expensive vitamin?
Apart from suffers of hypogonadism where testosterone levels can be dangerously low or even non-existent, testosterone levels do not usually dip below a serious threshold in most men. Yes, they drop with age. A young man would be expected to carry a testosterone level of 800 nonograms per deciliter of blood (800 ng/dl), whereas a middle-age man might have levels between 200 and 300 ng/dl. Yes, it saps your energy. Yes, you may not be quite as active in the art of lovemaking as you once were. But dips in testosterone over time are normal, and levels can actually fluctuate according to the time of day.
A panel of experts called to discuss the matter by the Endocrine Society in 2006 agreed that a cutoff for testosterone supplementation would be 275 ng/dl. Anything below that could be fodder for treatment - but above that, leave well enough alone. The task force panel also agreed that determination for supplementation should be based on two readings, taken in the morning, over two separate days.
READ MORE TESTOSTERONE TREATMENT LEGAL NEWS
Testosterone supplementation is not a vitamin. But it appears an increasing number of men and their doctors view it as such. The tragedy is that the debate weakens the importance of testosterone supplementation for those patients with a very real need, for whom the benefits outweigh the risks.
Instead, manufacturers appear to be lining their pockets with revenue from men for whom testosterone supplementation is not medically necessary. And for many, unnecessary adverse health events are driving them to the courts to file a testosterone lawsuit.
Sadly, for those otherwise healthy men having died a testosterone death, it’s their family carrying on the fight without them…