I must have been taking an extended nap the week the May 3 New England Journal of Medicine came out, or curiosity alone would have prompted me to look up an article that claimed you only had to treat patients with a once-a-year dose of a drug. A group calling itself HORIZON, which stands for Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly by some alphabetical legerdemain that I cannot fathom, reported that when 3889 women with postmenopausal osteoporosis were randomized to either a once-yearly IV infusion of the drug or placebo, and followed for 3 years, the drug group showed significant reductions in both hip and vertebral fractures. The only downside was an increase in serious atrial fibrillation in the drug group. No surprise that the study was funded by the maker of the drug, Novartis.
Fortunately this study was pointed out to me by my colleagues Rick Bukata and Jerry Hoffman in their Primary Care Medical Abstracts monthly tapes (www.ccme.org). They went on to point out the editorial that accompanied the HORIZON paper, by Dr. Juliet Compston of Cambridge, England. The editorial reads like a long, glowing advertisement for zoledronic acid. Besides being sure to include the glitzty acronym HORIZON in the title of the editorial, she gushes about the relative risk reductions instead of the more informative absolute risk reductions (e.g. noting a 70% reduction in the rate of vertebral fractures, which translates into an absolute risk reduction of from 10.9% to 3.3%). The fine print at the end lists a number of drug companies for which Dr. Compston consults and speaks, and notes among other things that she serves on data and safety monitoring boards for Novartis.
At one time the NEJM prided itself on having strict policies that prevented editorials from being written by those with financial ties to the makers of the drug being studied. Apparently such policies are old-fashioned.
Rick Bukata also chided NEJM for leaving out the key fact that a single IV dose of zoledronic acid runs about $1000, independent of any administration fees or physician costs.
Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 356:1809-22, May 3, 2007.
Compston J. Treatments for osteoporosis--looking beyond the HORIZON. N Engl J Med 356:1878-80, May 3, 2007.
Friday, October 26, 2007
NEJM: Conflicted Editorialist?
Posted by Howard Brody at 3:50 PM
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