Canadian Society for the Study of the Aging Male: Response to Health Canada's position paper on testosterone treatment

Introduction. Testosterone treatment of older symptomatic men with reduced testosterone availability is increasing. There is an expanding body of literature to support such treatment in a large subset of aging men, but there has not yet been a long-term placebo-controlled double-blind study of several thousand men to confirm the efficacy and safety of this treatment as indicated by shorter-term studies. The absence of a long-term study has been used by governmental agencies as a limiting factor in providing full access and payment for this treatment in government-sponsored health care plans. Health Canada issued a testosterone analysis document to the pharmaceutical industry, the implications of which may make it more difficult for appropriate patients to receive such treatment. The Canadian Society for the Study of the Aging Male (CSSAM) believed it had an obligation to advocate on behalf of men requiring this treatment. Aim. To provide an international consensus on the use of testosterone treatment in appropriately selected hypogonadal men. Main Outcome Measure. To determine whether the literature supports the use of testosterone treatment in a selected population of hypogonadal men, to achieve consensus on this point among an international consulting group, and to transmit this view to health care workers and insuring and governmental agencies. Methods. Email communication among the consulting group to prepare a response to Health Canada, followed by a review of appropriate literature and international practice guidelines, incorporating the literature and guidelines together with the CSSAM letter and Health Canada's response. Result. The literature and international guidelines support the initiation of testosterone therapy in symptomatic hypogonadal men, recognizing that there is no universal agreement on the criteria for the diagnosis of hypogonadism in each suspected case. The need for careful monitoring of such men is stressed. Conclusion. CSSAM acted as an advocate for hypogonadal men who may benefit from treatment with testosterone. Short-term studies and 60 years of experience with testosterone therapy attest to its efficacy. Long-term studies are desirable, but it may take many years before results could be forthcoming. There is no evidence to suggest that testosterone treatment increases the risk of prostate cancer or cardiovascular disease. Current evidence suggests, in fact, that testosterone treatment may be cardioprotective. It is important to bring this information to the attention of governments and insuring agencies through the collaboration of groups devoted to the diagnosis and treatment of hypogonadal men.