In today's Ottawa Citizen:
Health Canada is re-evaluating the safety of testosterone gels, patches and tablets as controversial, back-to-back studies link hormone replacement therapy for men with increased risks of heart attack, stroke and death.
In Canada, prescriptions for the drugs are increasing dramatically, a phenomenon driven by heavy marketing of the products to aging baby boomers obsessed with youth and holding off the normal body changes that come with aging, observers say.
But several leading Canadian urologists say no compelling evidence exists that “T therapy” increases heart attack or other cardiovascular risks in men when used properly and that the controversy could set back efforts to help more men with genuine “testosterone deficiency syndrome” seek treatment.
Last year, Canadian retail drugs stores filled more than 550,000 prescriptions for testosterone-containing drugs, up from 378,000 in 2009, according to prescription-drug tracking firm IMS Brogan.
The Health Canada review, expected to be complete by summer, could lead to new safety warnings.
Observers worry the drugs are being prescribed indiscriminately to men experiencing normal, expected, age-related biological dips in testosterone, and not abnormally low levels that are causing medical problems.
Concern, too, is growing that hormone replacement therapy is being aggressively marketed to men with the same fervour that once had women prescribed estrogen at the first sign of a hot flash, and that the successful advertising hype around “low T” campaigns will now build with the U.S. Food and Drug Administration’s approval Thursday of a long-acting injectable testosterone.
Dr. Sidney Wolfe, founder of the U.S. consumer advocacy group, Public Citizen, says testosterone products are being “grossly overused” and their benefits oversold. “Something needs to be urgently done about it,” he said.
Ottawa urologist Dr. Anthony Bella says there has been an explosion of clinics in the U.S. “that are basically testosterone mills, where a person comes in, they have a non-specific set of symptoms but they have a pulse and therefore they’re put on testosterone.”
“There are men who legitimately are suffering from the side effects of having not enough androgen floating around in the system,” said Bella, the Greta and John Hansen Chair in Men’s Health Research at the University of Ottawa.
“Is there a (safety) signal here? Absolutely. Should every clinician who deals with men who potentially are hypogonadal be aware of this? Absolutely,” said Bella, an associate scientist at the Ottawa Hospital Research Institute.
But, “it actually applies to the minority of men, if we are safe and careful in selecting who should be treated,” he said.
Testosterone products have been available in Canada in different formulations since the mid-1950s.
Testosterone can make blood rich in red blood cells, making blood thicker and potentially more vulnerable to clotting. If the red cell count isn’t monitored, “and it continues to go up, similar to the guy who is abusing steroids at the gym, that can be dangerous to your health,” Bella said.
A study published in January, based on the records of 55,000 men in the U.S. who had been prescribed testosterone, reported a two-fold increase in the risk of heart attack among men 65 and older in the first 90 days following the first prescription, and a two- to three-fold increased heart attack risk for younger men with a history of heart disease.
Another study published last year involving 8,700 older men in the U.S. Veterans Affairs health system that had undergone coronary angiography, imaging of the blood vessels, reported an increased rate of heart attacks, strokes and deaths in men who received a testosterone prescription compared to men who had not.
But, according to a statement from the Sexual Medicine Society of North America, both studies were analyses of data collected for other reasons and contradict “a large body of literature” linking low testosterone with increased heart risks.
Dr. Alvaro Morales, a professor emeritus at Queen’s University said that while experts are concerned about the indiscriminate use of testosterone among men who do not need it, “at the other extreme is this brouhaha about how dangerous testosterone is. The evidence is not there,” he said.
Another paper published last year, where researchers reviewed 27 randomized, placebo-controlled trials testing testosterone in men, found, overall, about a 50 per cent increase in cardiovascular disease in men prescribed testosterone.
Of the 27 studies, 13 were drug-industry funded. Those studies did not show an increased risk. The 14 studies not funded by drug makers showed a doubling of risk.
According to guidelines for Canadian doctors, an estimated 25 per cent of men aged 40 to 62 are “biochemically” deficient in testosterone.
Morales said testosterone therapy has been shown to improve mood, sexual desire, energy, and cognition and muscle strength.
But studies in the U.S. suggest one quarter of men are given the drug without ever having had their blood tested for abnormal T levels.
Meanwhile, websites such as LowT.ca, sponsored by Abbott which markets AndroGel, the top-selling prescription testosterone in Canada, ask men: “Not feeling like the man you used to be? You may have low testosterone.”
Men are invited to take the “Low T” quiz (“do you have a decrease in libido? Are you falling asleep after dinner? Have you noticed a recent deterioration in your ability to play sports?”)
“To be convinced that you’re somehow diseased and have a low testosterone level that needs to be augmented is an industry constructed narrative,” said Canadian drug policy researcher Alan Cassels.
In an emailed statement, Abbott said AndroGel “has more than 10 years of clinical, safety, published and post-marketing data, with therapeutic risks well-documented in the prescribing label.”
The LowT.ca website is part of AndroGel’s “disease awareness initiatives” in Canada, Abbott said, adding that it is in full compliance with Health Canada regulations.
“In all instances, consumers are encouraged to have the appropriate dialogue with their physician to determine if testing and treatment may be appropriate,” the company said.
skirkey(at)postmedia.com