No panacea. Ads for Fosamax, Boniva, and Actonel have certainly helped generate multibillion-dollar-a-year demand for the osteoporosis treatments. And indeed, the bisphosphonate medications have helped many women avoid major fractures in the hip and spine, a leading cause of death in the over-65 population. But even the National Osteoporosis Foundation, which previously recommended using the drugs for prevention in women with osteopenia, or mild bone loss, now agrees that a pullback is in order; its newer guidelines exclude most women with osteopenia.
In those with full-blown osteoporosis, the drugs' benefits far outweigh their risks, says Steven Cummings, who directs the San Francisco Coordinating Center, a nonprofit research group. "For every 1,000 patients that we treat for 10 years, we'll prevent 100 major fractures," he estimates. But "those without osteoporosis really shouldn't take bisphosphonates." They'll gain little if any benefit, and may put themselves at risk for rare but serious side effects like thigh fractures and osteonecrosis of the jaw, a painful bone deterioration.
Several planned changes to the drug safety system may help doctors and patients make wiser treatment choices. In 2007, Congress granted the FDA stronger powers to check on post-marketing studies yearly and issue harsh fines if promises to conduct them aren't kept. The agency also plans to install a surveillance system by 2012 that periodically scans 100 million anonymous electronic medical records for adverse drug effects; experts say this might have detected Vioxx's problems years earlier. Psaty, who served on an Institute of Medicine panel that criticized the system a few years ago, says he's hopeful the new approach will prove both safe and effective.