Concerns with the Therapeutics Initiative. Therapeutics Initiative replies

Issue: BCMJ, Vol. 60, No. 2, March 2018, page(s) 80 Letters
Jim Wright, MD, PhD, FRCPC

We thank Dr Kendler for the opportunity to respond to his comments on Therapeutics Letter #108, which summarized Prescrire’s 2017 list of Drugs to Avoid.[1] In letter #108 we explain why we have confidence in the systematic reviews and conclusions of the completely independent French group, Prescrire.

In the original article that letter #108 summarized in tables, Prescrire wrote that “denosumab 60 mg in osteoporosis has very modest efficacy in the prevention of osteoporotic fractures and no efficacy for ‘bone loss’ during prostate cancer, but carries a disproportionate risk of adverse effects, including back pain, musculoskeletal pain, and serious infections (including endocarditis) due to the immunosuppressive effects of this monoclonal antibody.”[2] We note that Prescrire’s just-published 2018 list of Drugs to Avoid, also includes denosumab.[3] Prescrire provides references to the research that they conducted to come to that conclusion. We strongly encourage Dr Kendler to study those articles and to take up any issues he has with Prescrire’s editors. 

Dr Kendler cites a single trial[4] and relative risk reductions, which are well known to be a misleading way to present efficacy data. We refer readers to an excellent critical appraisal of that trial by another European independent bulletin.[5]

Prescrire’s editors are health care professionals with no conflicts of interest. In contrast to an opinion from one clinician, Prescrire’s reviews are critiqued by 10 to 40 reviewers prior to publication. Independent analysis of drugs and clinical trial results must remain the cornerstone of evidence-based decision making.
—Jim Wright, MD, PhD, FRCPC
Editor-in-Chief, Therapeutics

References Top

1.    Therapeutics Initiative. Drugs to Avoid. Therapeutics Letter. 2017;108:1-2.
2.    Prescrire Editorial Staff. Towards better patient care. Drugs to avoid in 2017. Rev Prescrire 2017;37:137-148.
3.    Prescrire in English. Independent French journal Prescrire publishes its annual update of drugs to avoid, in the name of better patient care. Accessed 21 February 2018.
4.    Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 2009;361:756-765.
5.    Erviti J. Denosumab in osteoporosis-related fractures. A critical appraisal of the FREEDOM trial. Drug and Therapeutics Bulletin of Navarre. 2012;20(2).