Hinshaw: My wife, with whom I share a gynecological practice for women of menopause age, and I have not prescribed them since 1998 when it became apparent to us that their action does not make sense metabolically or chemically. They suppress bone remodeling as if bone remodeling were the "bad guy" in osteoporosis and doesn't have the purpose of renewing and strengthening bone. They create a temporary improvement in the balance between bone loss and bone formation which are normally linked--but in a short time bone formation is suppressed, too.
Rosenberg: So the drugs do not even work?
carefully controlled clinical trials showed a reduction in fracture risk, usually
over 3 years of use, for a subset of the types of patients currently being
treated, but the use of these drugs has been extended to many persons with
clinical profiles which do not correspond to the trial evidence. The use of these drugs in community medicine is very
different than in the monitored trials. One major difference is that the drugs
have been used for prolonged periods greatly exceeding the length of the
trials. The problems have mostly
developed after approximately 6 years. Some studies
have been unable to detect any benefit at all like one of thousands of women at Kaiser Permanente treated between 1996 and 2006
and finally published in 2009. Roughly one in
500 bisphosphonate patients sustains an unusual thigh fracture on the drugs which
adds up to a large and increasing
ly number of cases because of their
widespread international use. In 81 patients whose cases we studied, fractures
occurred not just in the thigh but in the pelvis, feet and ribs as well and
many were "announced" by persistent pain. Subsequent or simultaneous
fracture of the opposite thigh was also common.
Rosenberg: Clinical trials of bisphosphonates has been impeded by the difficulty in finding women who don't have the drug in their system. How long do the drugs remain?
Hinshaw: Bisphosphonates are nonmetabolizable, resident drugs that never completely leave the body--never. After treatment stops, the burden decreases but there is no point when the resident molecules can be expected to be completely gone. They are not found in circulating serum (except temporarily with an injectable bisphosphonate like Reclast) because they attach s o rapidly to calcium/bone. When they happen to be released from one cache, they can be "recycled" into others. They have such a strong attachment to calcium that patients who swallow calcium supplements when they take bisphosphonates, against directions I may add, may be doing themselves a favor--because bisphosphonates will bind to the calcium instead of their bone.
Rosenberg: There have been media reports of the whole bone density craze and the term "osteopenia"--the risk of thinning bones--as being concocted by the drug industry to sell drugs.
Hinshaw: The risk of
fracture from fragile bones exists for some individuals, but I think the selling of bisphosphonates is a prime
example of disease mongering, among the many such examples that we are immersed
in today. "Osteoporosis" as defined by the World Health
Organization's assignment of specific risk to bone mineral density measures is
a fiction and has become, frankly, a fraud. Analysis of the risk has been so
skewed by the efforts of drug companies who make these drugs like Merck,
Procter & Gamble/Warner-Lambert, Ciba-Geigy/Sandoz (Novartis), and Glaxo-SmithKlein/Roche
Rosenberg: It is clear that women have been sold a bill of goods with these drugs but it is not as clear how women can prevent osteoporosis and fractures. What advice do you give your patients?
Hinshaw: First I make sure a patient needs an anti-osteoporosis drug to begin with because many people currently being treated don't need anything. If they do, there are alternative non-bisphosphonate drugs I prescribe. I caution patients about other risk factors in their lives like environmental hazards, sedatives and excess alcohol which can cause falls, and proton pump inhibitors for GERD which can disturb calcium metabolism and increase the risk of hip fractures. Even progressive eyeglass lenses can contribute to falls by providing confusing visual images. I highly recommend Vitamin D and weight bearing exercises as the medical community has done for years, though lately there have been questions about the safety of calcium supplements. When it comes to bone health, the less we mess with Mother Nature the better and bisphosphonates do a real job of messing with Mother Nature. END
Martha Rosenberg is a health reporter whose food and drug expose, Born with a Junk Food Deficiency (Prometheus Books, 2012), was named in the American Society of Journalists and Authors 2013 Outstanding Book Awards. Material from Born has been included in a TED lecture and cited by the Memorial Sloan-Kettering Cancer Center Library . A former medical copywriter and medical school lecturer, Rosenberg has appeared on CSPAN, RTV, NPR and Ed Schultz. She spoke at the Mid-Manhattan Public Library this summer.
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