Medical Breakthroughs

In the movie “Cocoon,” aliens turn back the clock for a group of senior citizens. A pharmaceutical version might be the osteoporosis drug teriparatide, which is marketed as Forteo by Eli Lilly. An early study showed that the drug enabled older patients who are confined to wheelchairs because of nonhealing, painful fractures to finally heal—and walk again. Doctors at University of Rochester, who are leading a National Institutes of Health-funded investigation of the drug, are calling the drug’s effects “miraculous.”

The researchers believe that the drug might boost the body’s production of stem cells—so much so that adult patients are healed from fractures at a rate that typically is seen in kids. In essence, researchers believe that it will set the “body clock” back to when fractures didn’t kill. The university reported that the drug promotes the healing of broken bones within 1-1/2 months, compared with the typical recovery time of 6 months in older patients, although healing times vary.

(Fifty percent of women and 25 percent of men who are over the age of 50 will have an osteoporosis-related fracture, according to National Osteoporosis Foundation. One-fourth of men and women who are over the age of 50 who suffer from a hip fracture die of complications within 1 year. So, the drug’s success would appear to be an important development.)

Dr. Elton Strauss, who is chief of trauma and adult reconstructive surgery in the department of orthopedics at Mount Sinai School of Medicine in New York, hails teriparatide’s potential but urges more study. He expects that the drug will have a major positive impact on the costs that are incurred by elderly individuals in regard to the treatment  and rehabilitation from fractures.

But there’s a cautionary tale to this story. We found that the watchdog group Public Citizen released a warning in 2003 that teriparatide causes bone cancer (osteosarcoma) in animals. The Forteo Web site acknowledges that study finding but counters that it is not known whether the drug does the same in humans. The drug’s maker, Lilly, tells Consumers Digest that it has a system in place to detect any rise in osteosarcoma risk, but the drug-maker says there are no data to report at this point.

Food and Drug Administration approved teriparatide in November 2002 but issued a warning in 2004 that it should be prescribed to patients only when potential benefits outweigh potential risks. Who fits into this category? FDA directed us to the drug’s label, which warns against use in patients who are at increased risk of developing osteosarcoma. They include patients who have Paget’s disease of the bone or who have unexplained elevation of alkaline phosphatase (which could indicate this disease), and children and patients who have had radiation treatment that involves the skeleton.

The teriparatide study underscores the fact that medical breakthroughs don’t pop up overnight, and often they are a mixed bag.

BRAIN POWER. Glioblastoma was an affliction that was rarely in the spotlight until Sen. Edward Kennedy was diagnosed with glioma, which is an early stage of this aggressive form of brain cancer, in 2008. (You might also have heard of the condition referred to as glioblastoma multiforme, GBM and grade IV astrocytoma.) For those who are afflicted, the clock is ticking—of the 10,500 people who are diagnosed annually, fewer than 6 percent of them are expected to survive for 3 years.