New national guidelines aim to help doctors and patients navigate the complex – and controversial – diagnosis and treatment of low testosterone.
The guidelines, published Monday in the Canadian Medical Association Journal, were created by a task force of researchers who note many Canadian men are taking testosterone replacement medication despite not having a medically diagnosed condition. While the authors write that diagnosis and treatment of low testosterone are "highly controversial" and the evidence is "of doubtful quality," they say men with deficiency should be treated with replacement therapy "in most cases," even if they have stable cardiovascular disease.
Over the past decade, the marketing of testosterone replacement products has increased considerably and the number of men taking the medication to combat symptoms that include fatigue, lower sex drive, lack of energy and feelings of depression has soared. Health Canada says that men between the ages of 40 and 59 are most likely to be prescribed testosterone replacement, followed by those 65 and older. Market research firm Global Industry Analysts predicts the worldwide market for testosterone replacement will reach $6.5-billion (U.S.) by 2020.
But some experts are challenging the credibility of the guidelines because of financial relationships between several of the authors and the drug companies that sell testosterone replacement products, the serious risks posed by the drugs and the fact there is significant skepticism over the need to treat men for a condition that is a natural part of aging.
"This is a classic case of 'disease mongering,' expanding the definition of disease in order to sell a product," Dr. Barbara Mintzes, senior lecturer in the faculty of pharmacy at the University of Sydney, said in an e-mail.
Testosterone replacement products were approved to treat medical conditions when the body doesn't produce enough testosterone, or hypogonadism. They have not been approved to treat fatigue, lower sex drive or other symptoms that accompany normal reductions of testosterone due to aging.
But advertising campaigns – such as a website hosted by Abbott, a company that sells testosterone replacement therapy – that suggest men ask their doctor to be screened for testosterone deficiency have coincided with a rise in prescriptions for these products.
Mintzes compared the current situation to major problems that emerged with hormone replacement therapy for menopausal women. Many took those drugs to combat hot flashes and mood swings, but research later confirmed the therapies increased the risk of cancer.
Testosterone replacement therapy can also cause serious health issues.
Last year, Health Canada warned testosterone replacement therapy may lead to "serious and possible life-threatening health and blood vessel problems such as heart attack, stroke," blood clots and irregular heart beat. Some research suggests men with pre-existing heart conditions may face an even greater risk. Health Canada also stated men with low testosterone should not be prescribed medication if other possible causes haven't been ruled out. As of August, 2013, the department had received 35 reports of cardiovascular problems potentially linked to testosterone replacement, including 11 reports of heart attack, blood clots in the lungs and irregular heart beat.
Dr. Thomas Perls, a professor of medicine at Boston University School of Medicine and staff geriatrician at Boston Medical Center, co-authored a paper this year calling attention to the disease mongering. In an interview, he highlighted the fact that the Canadian guidelines gloss over risks of testosterone replacement and don't discuss whether low testosterone should be treated.
"To me, the controversy is whether or not this syndrome actually exists," Perls said.
Dr. Baiju Shah, an endocrinologist and scientist at Toronto's Institute for Clinical Evaluative Sciences, questioned the task force's recommendation that men be treated with replacement therapy even if they have low to normal testosterone levels.
"I think it's a bit irresponsible," he said.
The U.S. Food and Drug Administration issued a safety advisory earlier this year stating labels on testosterone replacement products must state that they may increase the risk of heart attack and stroke and that it should only be prescribed to men who have low testosterone caused by certain medical conditions.
The guidelines were funded by the Canadian Men's Health Foundation. Wayne Hartrick, foundation president, said the organization does not receive money from drug companies and the guidelines are designed to give clarity.
"There's such a big gap in reliable information for doctors we thought it was important for us to step into that," he said.
Six of the 13 task-force members disclosed they had financial relationships with companies that sell testosterone replacement therapy, including task force chair Dr. Alvaro Morales.
Dr. Larry Goldenberg, founder of the Canadian Men's Health Foundation and another member of the task force, did not disclose any potential conflicts of interest. But in a paper published last August in the Canadian Urological Association Journal, he said he received honoraria from companies that produce testosterone replacement therapy, including Abbott Canada and Eli Lilly.
Morales said doctors and researchers get involved with drug companies because they are the experts in their fields and get tapped to conduct studies or give lectures. "It's an unavoidable situation," he said.
Perls argued the appearance of conflict of interest can undermine the guidelines. Simply disclosing ties to drug companies doesn't go far enough either, he said. The potential conflicts have to be managed and reduced.
"It behooves such panels to not have any appearance of conflict of interest," Perls said.
Mintzes said there should be a firewall between drug companies and the development of treatment guidelines.