A recent study has provided new evidence that widely prescribed testosterone drugs Androgel and Axiron – advertised as a way to help men improve a low sex drive and reclaim diminished energy – might increase the risk of heart attacks.
The new study, conducted by researchers at the University of California, Los Angeles; the National Institutes of Health; and Consolidated Research, was published last week in the online journal PLoS One. The study provides compelling evidence that testosterone is being overprescribed to American men and that pharmaceutical companies continue to aggressively market the drug in spite of dangerous side effects associated with it.
In an excellent piece in the New York Times by Roni Caryn Rabin, (Weighing Testosterone’s Benefits and Risks, Februry 3, 2014), she outlines how testosterone replacement drugs for men have been heavily promoted by drug companies in a manner that is eerily reminiscent of how hormone replacement drugs (estrogen) for women were aggressively marketed before a federal study in 2002 showed how dangerous they were.
Testosterone has traditionally been prescribed to treat abnormally low levels of the hormone because of genetic or pathological causes, a condition known as hypogonadism. But in recent years drug companies have begun to shamelessly market their testosterone-boosting drugs to doctors and the public, promoting it as a product that can overcome a supposed disease called “low T.” According to the marketing low T is characterized by feelings of fatigue, loss of sexual drive, depressed moods, an increase in body fat and decrease in muscle strength, among other symptoms – all common problems associated with aging.
As men age, their production of natural testosterone declines – approximately 1 percent per year after age 30 – but it is rare for testosterone levels to drop low enough to become a medical problem. Instead, millions of American men are resorting to testosterone drugs as lifestyle drugs out of simple reluctance to accept the fact that they are getting older .
Drug companies have seized on this insecurity and waged extensive marketing campaigns designed to help men fight the dreaded “low T.” This has led to a tripling of the number of testosterone prescriptions given to American men since 2001. Physicians are now more willing to prescribe testosterone to people who don’t fit the classical diagnosis of hypogonadism and have only borderline low levels that may be related to normal age-related hormonal declines. Many of these prescriptions are given without ever determining the patient’s hormone levels and one in four prescriptions are given without a blood test.
The study released in PLoS One found taking testosterone replacement drugs caused dangerous health problems. Within three months, taking the hormone doubled the rate of heart attacks in men 65 and older, as well as in younger men who had heart disease. In light of this study, and a similar one conducted in 2010 officials at the Food and Drug Administration announced that they were reassessing testosterone replacement products and will begin investigating rates of stroke, heart attack and death in men using the drugs.
Indeed the 2010 study was actually cancelled early because of risk to patients. William Finkle, lead author the newly released study wants the FDA to require warnings on the labels of testosterone drugs such as Androgel and Axiron. “We have a 2010 study that was canceled because of unexpected cardiovascular risks. I think that was sufficient to justify a warning. Why withhold that from the patient?” he asks. At the very least he thinks the risk of heart attack should be added to the discussion between patients and physicians before anyone starts testosterone treatment.
Drug companies have reacted predictably and shown they continue to place profits above the welfare of their patients. Advocates of testosterone therapy immediately attacked the study and claimed the evidence of risks was overblown. They also criticized the new study for not following patients long enough and encouraged a long-term study. This would be in their best interest to have a trial continue for years since it would allow them to continue to market and sell testosterone replacement drugs.
The stakes are high, testosterone drugs routinely average $300 to $400 a month per patient. Drug companies frequently offer to cover patients’ insurance copayments and often give away the first month’s supply. Sales of all testosterone-boosting drugs are estimated to have been $2 billion in 2012, and are projected to hit $5 billion by 2017.
What the drug companies never mention in their marketing is that there are other factors aside from aging that cause a decline in testosterone levels. Chief among them are being overweight and lack of exercise. According to the New York Times, “Losing weight is a tried and true way to naturally boost testosterone levels. According to findings presented at the annual meeting of the Endocrine Society in 2012, obese men who lost an average of 17 pounds saw their testosterone levels increase by 15 percent. In general, a man’s waist should be half his height.”
Instead of promoting a healthy lifestyle the drug companies will continue to promote dangerous drugs for a trumped up disease.
The profits are better.
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