Saturday, June 5, 2010

Femur Fracture Friends Meet with FDA

On May 24, seventeen members of our on-line Femur Fracture support group* met with eleven key officials of the Food and Drug Administration (FDA) in Silver Spring, MD. We came from as far away as Arizona, California, Georgia, Illinois, New Jersey, New York, Oregon, Pennsylvania and Virginia to tell our stories and ask the FDA to put a black-box warning on the packaging of Fosamax and other  bisphosphonates about the side effects and risks of these drugs. 

All of us suffered low-energy fractures or stress fractures of the femur (thigh bone), which is one of the strongest and least fracture-prone bones in our bodies. All of us had taken Fosamax or similar drugs for at least four years. Most of us had been put on Fosamax by our doctors for osteoporosis, but some had been put on it merely for osteopenia ( thinning bones, not actual osteoporosis). Most of us had to have surgery after "completed" fractures, with placement of a titanium rod. Most of us are still in pain several months or years post-surgery. A few have fractures that refuse to heal after a year or more. 

Each of us made brief statements about our situations. The organizer of our group, Dr. Jennifer Schneider, reviewed the research that establishes an association between bisphosphonates and femur fractures. She also pointed out flaws in the research that finds no such association. Dr. Toby Morgan, the husband of one of the victims, noted that the FDA, unlike its counterparts in Europe, Australia, and New Zealand, was still maintaining, as late as March of this year, that no association has been proven to exist between bisphosphonates and femur fractures. He also observed that the drug manufacturers have buried the information about the risks and side effects of these drugs in the finest of fine print on roadmap-sized enclosures.  

The FDA officials listened for over an hour. They seemed receptive. We hope that they will act.

PS. I am second to the left in the back row, the one with the gleaming white hair. 
*Our group has doubled in size since the beginning of 2010. We now have about 55 members, including one man.