A new study suggests that once-a-year infusions with zoledronic acid (Reclast) prevent second fractures in people with osteoporosis. The researchers randomly assigned 1054 people who had previously suffered a hip fracture to receive either intravenous zoledronic acid or placebo infusions. This 15-second broadcast about the study provides virtually no information that might be helpful to a consumer of medicine. In fact, the under-reporting is arguably harmful.
The broadcast does not mention whether intravenous zoledronic acid (Reclast) is FDA-approved. It makes no mention of cost, an important issue for a drug estimated to cost about $1000 per infusion. The story fails to report whether the drug infusions are safe—a key bit of information for a drug previously associated with a number of adverse side effects, including episodes of serious atrial fibrillation and osteonecrosis of the jaw. The story may also oversell the benefits. (See Quantification of Benefits above).
The broadcast fails to adequately describe the quality of the new evidence or other interventions that might prevent osteoporotic fractures and the deaths that sometimes follow them. It does not report that one group received only placebo and minimal additional interventions that might have reduced their chances of fracture—a design feature that has raised ethical questions and potentially elevated both the fracture rate among those on placebo and the apparent efficacy of the drug. The story does not mention simple interventions to reduce the falls that so often lead to hip fractures. (See Treatment Options above.) The story does not cite any source other than the published study or note the numerous potential conflicts of interest among the study’s lead author or his colleagues.
Along the way the story has the potential to leave viewers with mistaken impressions about important matters—perhaps suggesting that osteoporosis is itself deadly, that the drug reduces hip fractures, that treatment is free of risks.
With a little more broadcast time, viewers might have taken away a more accurate and nuanced picture of the potential benefits and harms of this treatment. When the final, precious few seconds of a story conclude with the statement, “These are said to be the best test results for an osteoporosis drug in 15 years,” more disclosures and caveats are clearly in order.
There is no mention of cost, an important issue. The drug is estimated to cost about $1000 per infusion, about the same cost as a year’s supply of pills containing the same drug.
The broadcast cites data on reductions in deaths and fractures among people who received zoledronic acid infusions, but it quantifies these in relative terms only. (28% and 35% reductions, respectively). To make sense of these, the story should cite the actual numbers. (See our primer on this topic.) Curiously, the reduction in deaths is confined to cardiovascular deaths, but the reason is not obvious. The story should also say that the people who received placebo received minimal additional therapy (vitamin D and calcium supplements) that might have reduced their chances of fracture—a design feature that has raised ethical questions and potentially elevated both the fracture rate among those on placebo and the apparent efficacy of the drug. Finally, the story could easily lead a viewer to wrongly believe that the fracture reductions are in hip fractures. In fact, there was no significant reduction in hip fractures, which tend to be most debilitating and dangerous.
The story fails to report whether the drug infusions are safe—key information for a drug previously associated with a number of adverse side effects, including episodes of serious atrial fibrillation and osteonecrosis of the jaw.
The broadcast refers to a “study” in which some people received an “injection.” It is impossible to determine anything about the quality of the research. In fact, the study is a randomized controlled trial comparing intravenous zoledronic acid to placebo infusions in 1054 people who had previously suffered a hip fracture. The primary goal of the study was to determine whether the infusions prevented second hip fractures. The brief report does not describe the demographics of the population or the duration of the study.
Hearing that an osteoporosis drug reduces deaths by 28%, a viewer of the evening news might reasonably conclude that osteoporosis is a fatal disease. But people with osteoporosis who die after a hip fracture typically have a number of other medical conditions that complicate their recovery and contribute to a high death rate. Osteoporosis does not kill people.
The story cites no independent researchers or clinicians. It also does not mention that the study was underwritten by the drug maker Novartis or that the lead author received grants and consulting fees from Novartis and is listed as an inventor on two patent application filings for zoledronic acid.
The broadcast fails to mention other treatment options. These include interventions to reduce falls—such as removing obstacles that trip up the elderly and adding railings and other assistive devices to steady their gait. Strengthening, balance training, and hip protectors may also offer help, though the evidence is conflicting.
The story does not mention the availability of intravenous zoledronic acid (Reclast) or whether it is FDA-approved. It is approved for use in postmenopausal women with osteoporosis.
The story does not mention that the infusions represent a new way of delivering a class of drugs (bisphosphonates; e.g., brand names Fosamax and Actonel) that are currently available in pill form and approved for the treatment and prevention of osteoporosis in postmenopausal women.
There is no way to know if the story relied solely or largely on a press release. However, there is also no way to know if any independent reporting went into the 60 words that were reported.