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Osteoporosis: Many Drugs Prescribed, Not So Many Hip Fractures Avoided

Posted by medconsumers on April 1, 2008

Fracture prevention is focused on bone density, but other factors like bone quality and muscle strength are also important, according to a recent commentary by two Toronto physicians for the Journal of the American Medical Association. They advocate a broader view of osteoporosis prevention but first, here is an historical context for this disease that has become a major health concern for women.

Osteoporosis was unknown to the public until the 1980s. The disease used to be diagnosed in the elderly only after a “fragility fracture” had occurred. But a new definition, based on bone mineral density, was established in 1993 at a World Health Organization meeting of osteoporosis researchers. Soon bone scans became a must for all women over age 50.

In 1995, the first non-hormonal drug to prevent osteoporotic fractures—Fosamax—came on the market. Its manufacturer, Merck, sponsored an aggressive ad campaign initially aimed at doctors, featuring a woman who looked no more than 45 and this message: “Don’t wait for a fracture.” Merck’s ads aimed at women simply told them to “ask your doctor whether a bone density test is right for you.” Chances are high that widespread use of bone scans would identify many women as having bone loss. The first step toward a drug prescription.

Many middle-aged women who had never had a fracture were put on Fosamax. It is unlikely that they were told that the drug had been tested only in elderly women who already had a fracture, and the results were unimpressive. After three years, hip fractures occurred in 1% of those on Fosamax, compared with 2% of those on a placebo. (A 50% reduction in hip fracture!” screamed some of the ads.) In time, another “condition” called osteopenia, or pre-osteoporosis, was created by drug makers. By then, other drug companies had introduced their own Fosamax knockoffs like Actonel, Boniva, Reclast, Zometa, etc. All are in the same drug class called bisphosphonates.

Drug prescribing is clearly tied in with bone mineral testing, but the now-popular scanning technique known by the acronym DEXA is not good at predicting which women in their early 50s will have a hip fracture at age 80 years, when it would most likely occur. This was the conclusion of a 1998 report from the British Columbia Office for Health Technology Assessment. The report was ignored in the U.S. where Merck was financing the installation of DEXA machines in doctors’ offices.

In 2005, The Seattle Times published an investigative series of medical articles. The in-depth report on the selling of osteoporosis revealed that two multi-national pharmaceutical giants had financed that 1993 World Health Organization meeting. (Ostensibly, the meeting was about a multi-country study of the prevalence of osteoporosis.) The pharmaceutical funding of this WHO meeting sheds new light on the revised definition of osteoporosis. What had been simply a risk factor (bone loss) became a disease (osteoporosis) at that meeting, where an arbitrary definition of bone loss was also created. Overnight, the number of potential customers for bone drugs had been expanded greatly.

The story of Fosamax and its knockoffs perfectly illustrates how the pharmaceutical industry starts creating a market for a new drug years before it is approved. First industry must sell you fear of a disease, then comes the drug to “prevent” its most serious consequences.

Today, the guidelines for bone density measurement recommend testing not begin before age 60, but now there’s a bigger problem Researchers have known, at least since 2000, that bone strength or bone quality are better predictors of hip fracture than bone density. In 2001, the National Institutes of Health redefined osteoporosis as a combination of bone mineral density and bone quality. But here’s the rub: There is no test for bone quality or bone strength.

In their recent commentary for the Journal of the American Medical Association, the Toronto physicians, Angela M. Cheung, MD, and Allan S. Detsky, MD, said that bone density and bone quality are just two of many factors to be taken into consideration for fracture prevention—in addition to the usual advice about calcium intake, vitamin D, exercise, smoking cessation and reducing alcohol intake. They call for more research into the reasons why elderly people fall, such as oversedation with prescription drugs, orthostatic hypotension (low blood pressure upon standing), impaired gait or balance, poor eyesight and hearing, arthritis, etc. They also want more attention given to tai chi exercises to improve balance and muscle strength. Research for fracture prevention should move beyond the realm of endocrinologists and rheumatologists to include neurologists, physiatrists, physiotherapists, engineers and muscle activation therapists.

Where can someone with osteoporosis find an engineer or a muscle activation therapist? “At an osteoporosis center based at an academic medical center,” answered Dr. Cheung in a telephone interview. “We have much to learn from these folks, and we need to engage in a dialogue with them to help people reduce their fracture risk.” Dr. Cheung, who is at the University Health Network and Mount Sinai Hospital in Toronto, was asked why she still sees a role for bisphosphonates when the trials cited in her commentary had such negative findings. [“…in two well-designed randomized controlled trials in which high-risk elderly people without fracture but low bone mineral density, treatment with bisphosphonates did not decrease the risk of hip fractures.”] “These drugs are not just for hip fractures, but for overall fractures,” she answered, citing the example of her patients who have difficulty eating because the rib cage has collapsed due to spinal fractures. She also praised a 2007 study by Black and colleagues, which showed that hip fracture can be reduced with a more potent bisphosphonate given intravenously to participants, aged 70 to 90 years. [Note: This study showed only a 1% difference between the drug-treated and the placebo groups in terms of hip fracture reduction.]

Unfortunately, the current TV ads for this intravenous once-a-year bisphosphonate drug are conveying the same misleading message shown in the early ads for Fosamax. They feature a thin, fit 60ish woman—far younger than those who participated in the clinical trial.

Maryann Napoli, Center for Medical Consumers ©
April 2008


FDA Alert about Osteoporosis Drugs

The FDA posted an alert on its Web site, “…highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.”

Bisphosphonates are a popular class of drugs prescribed to reduce the risk of fractures from osteoporosis. The alert applies to all drugs in this class, including Fosamax, Boniva, Actonel, Aredia and Didronel. The FDA reports, “The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution.”

WWW.FDA.gov/medwatch/safety
, 1/7/08

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