Osteoporosis drugs' "broken" promise.

• Author: Klebanow, Diana
• Position: Medicine & Health

THE FOOD AND DRUG Administration was established in 1906 to protect the health and safety of the American people. Drugs in this country cannot be sold unless approved by the agency. In order to ensure the safety of medication, the FDA establishes guidelines for clinical trials. However, these trials last only a few years, and the long-term consequences of the drugs can remain unknown. When the FDA has reason to believe that the drugs may pose a risk, it will issue a warning. However, the drug still may be prescribed--and taken by patients. One class of drugs that is subject to FDA warnings is bisphosphonates, which are used to combat the bone loss associated with osteoporosis. In August 2004, the FDA asked Merck, the manufacturer of Fosamax (the largest selling bisphosphonate), to issue a warning that the drug could lead to osteonecrosis, or decay of the jawbone. In January 2008, the FDA issued a warning on all bisphosphonates regarding a link to severe musculoskeletal pain. The latest one was in October 2010, when it warned about the risk of atypical femur fractures, which occur without any apparent trauma. Although the risk is small in all of these instances, there is no way to determine which patients will be harmed.

Bisphosphonates illustrate the problem of how drags that once were thought to be safe may turn out to be harmful to a small percentage--but significant number--of patients. The incidence of atypical femur fractures illustrates this point. Initially, the FDA had clinical data indicating that the use of bisphosphonates led to a rapid reduction in fractures for patients taking them for a period of three years. The picture would change when studies began to appear in medical journals some five years ago describing an increased incidence of atypical femur fractures in patients taking these drugs for an extended period of lime. Since these fractures also appear in patients not taking bisphosphonates, it is unclear whether the drugs are the cause. Nevertheless, the fractures predominately have been reported in patients who take them. As of now, these fractures appear to be rare and account for less than one percent of all known hip and femur fractures. It is not a comforting statistic to the patients who fall into this category: the fractures are debilitating, and patients do not always regain complete mobility.

This subject is of particular interest to me because I fall into this category. In April, 2002, I was standing in my kitchen when my right leg suddenly collapsed. At the time, I had been taking a bisphosphonate for five years. I eventually joined "The Femur Fractures Victims' Group," an online support organization. It consists of 30 women and one man, and managed to set up a meeting with the FDA on May 24, 2010, to discuss its difficulties with bisphosphonates. We wanted to show the FDA that there is a human dimension behind every statistic about the unforeseen side effects of drugs.

The group had been started by a semiretired internist from Arizona. In 2001, she was riding in the subway while on a trip to New York. The train jolted, and she shifted her weight to one leg. In the process, she...