I recently received the Therapeutics Letter, September/October 2017, from the government-funded Therapeutics Initiative.
I recently received the Therapeutics Letter, September/October 2017, from the government-funded Therapeutics Initiative. In this TI letter they quote a publication, Prescrire, from Europe, which they claim has credibility because of the authors’ absence of conflicts of interest. Unfortunately, it appears that the authors do not read medication product inserts or the published clinical trials that have led to the registration of pharmaceutical agents both in Europe and internationally. I have participated in clinical trials funded by both government and various pharmaceutical sponsors, which have contributed to our evidence-based knowledge of osteoporosis and its treatment. In addition, I have, in the past, been elected for two terms to the Board of Doctors of BC, these being my potential conflicts of interest.
Prescrire lists denosumab (Prolia) under drugs for prevention of osteoporosis, which is not an indication for denosumab. The management of osteoporosis with medications is limited to patients with risk of fracture; denosumab is not recommended for widespread use to prevent postmenopausal bone loss. Furthermore, they conclude the medication is of “modest efficacy” with “disproportionate adverse effects such as back pain and serious infections.” In the published phase-3 clinical trial of 7808 postmenopausal women randomized to denosumab or placebo for 3 years, vertebral fractures were reduced by 68% and hip fractures reduced by 40%. Back pain was commonly reported in this elderly female population, occurring in 34.7% of patients on denosumab and 34.6% of patients on placebo. Infections occurred in 54.4% of placebo patients and 52.9% of denosumab-treated patients. Serious adverse events of infections were reported in 3.4% of placebo subjects and 4.1% of denosumab subjects (P = 0.14).
The references quoted by the Therapeutics Initiative are limited to two of their previous bulletins and two Prescrire publications.
As a physician with knowledge of the osteoporosis peer-reviewed literature, I resent my provincial tax dollars being used to mislead colleagues with non-evidence-based information. The TI’s provincial government budget is being used not just to create these materials but also to aggressively promote their views by mailing them to physicians in the province. The result is confusion with consequent deterioration in patient care.
—David Kendler, MD
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