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Ethics in Biology, Engineering and Medicine: An International Journal

ISSN Print: 2151-805X
ISSN Online: 2151-8068

Ethics in Biology, Engineering and Medicine: An International Journal

DOI: 10.1615/EthicsBiologyEngMed.2015013293
pages 353-364

Ethics in Osteoporosis and Osteopenia: The Bare Bones of a Surrogate Marker

Loren Wissner Greene
Clinical Professor of Medicine (Endocrinology) and ObGyn Affiliate Faculty of Division of Medical Ethics and NYU Center for Bioethics 650 First Avenue, 7th Floor, New York, NY 10016


First you have a drug, and then you create the perception of need. The diagnosis of osteoporosis determined by bone density testing was promoted in 1995, simultaneously, and not coincidentally, with the FDA approval of the first major drug indicated for osteoporosis treatment. The use of bone density criteria greatly expanded the number of people who might be "diagnosed" to have osteoporosis or low bone density (commonly called "osteopenia") and therefore "eligible" for, or even requiring, medication to treat or prevent osteoporosis.
Osteoporosis is a true medical syndrome, but does this make low bone mineral density measurement (BMD) the equivalent? BMD is a surrogate for fracture risk, but it does not have as good a predictive value as other indicators, especially previous fracture or even advanced age. BMD improvement became a standard measure of drug efficacy in many clinical trials rather than the prevention of fracture, the true important outcome. Marketing to and by the medical community, as well as to prospective "patients", has created a huge medical market for a disease that followed the creation of new drugs.
Physicians are susceptible to influences from pharmaceutical companies and device manufacturers. While helpful in establishing understanding and awareness of osteoporosis as a common disease, this marketing served to identify additional patients for pharmacologic prevention and treatment of osteoporosis, with questionable results.