Bones of Contention

Drugmakers are stoking fears of fracture among middle-aged women. But experts say the risk is low

"Up to half of women over age 50 will break a bone due to osteoporosis in their lifetime." Consumers likely have heard such claims hundreds of times in commercials for drugs to treat osteoporosis, a bone-thinning disease primarily afflicting women. As a result, sales of drugs such as Merck's Fosamax, Procter & Gamble's (PG) Actonel, and Eli Lilly's (LLY) Evista totaled some $7 billion last year. But the medical community is hardly of one mind about how many women over 50 should be taking these drugs.

The odds of having an osteoporosis-related fracture before age 70 are low: Half of all hip fractures occur after age 80. And in a paper just published in the Jan. 19 issue of the British Medical Journal (BMJ), a group of researchers concluded after combing through several drug-company-sponsored studies that the benefits of osteoporosis meds for prevention were overstated. It's a classic case of disease-mongering, according to the researchers: "A risk factor has been transformed into a medical disease in order to sell tests and drugs to relatively healthy women."

Medical experts don't dispute the value of drug treatment for osteoporosis, a disease that accounts for some 1.5 million fractures in the U.S. each year. The controversy centers on osteopenia—the risk of developing osteoporosis. Osteopenia typically starts after menopause, when the decline of estrogen sets off bone loss. But it has not been linked to an increase in fractures. The term osteopenia, says Dr. Nelson B. Watts, director of the University of Cincinnati's osteoporosis center, is "meaningless when applied to otherwise healthy patients."

No drugs have been approved in the U.S. for osteopenia, but that hasn't kept doctors from prescribing osteoporosis drugs off-label, often at the request of patients. There is no proof the medicines prevent fractures in women with osteopenia, but "try telling that to a 50-year-oldParagraph who is willing to do whatever it takes to avoid a fracture in 20 years," says Dr. Harold Rosen of Beth Israel Deaconess Medical Center in Boston. Merck, for one, says it doesn't market Fosamax for off-label uses.

Still, Merck and others have delved into their osteoporosis studies to show that Evista, Fosamax, and the like can help when taken early. But the proof is absent, says Dr. Pablo Alonso-Coello of Hospital de Sant Pau in Barcelona, leader of the team reporting in BMJ. His team found that up to 270 women with osteopenia would have to take Evista for three years to avoid a single vertebral fracture.

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