The Osteoporosis Controversy, Part I: Are We Over-Screening?

Apr 02, 2018

Although the screening controversy has been smoldering for some time, a recent article may have added fuel to the fire.

A debate surrounding osteoporosis screening and bisphosphonate use has been roiling both physicians and patients. The controversy has been brewing for some time, but a recent article in the New York Times may have added fuel to the fire.

In it, Jane Brody wrote that a “perfect storm” is threatening to erase decades of progress in bone health for Americans.1 She highlighted her point by quoting a study of Medicare claims data that showed hip fracture rates for postmenopausal women had decreased each year between 2002 and 2012. But after that, fracture rates curiously levelled off. Had the decline continued, 11,000 additional hip fractures could have been avoided between 2013 and 2015.2

What happened?
In 2010 the US FDA added a warning to the drug label of bisphosphonates about the risk of atypical fractures, specifically femur fractures and osteonecrosis of the jaw, and added that these fractures may be the result of long-term use. Even though the FDA also stated that these fractures are “very uncommon,” occurring in fewer than 1% of all people who experience hip and femur fractures, the issue may have been enough to make many patients jittery about taking these drugs.3 Some physicians who have seen a patient experience one of these devastating fractures may also think twice before prescribing bisphosphonates aggressively.

A likely result is that use of Fosamax decreased by 50% between 2008 and 2012, about the time of media reports about these safety concerns, according to one study.4

But is a “perfect storm” really brewing? Are patients putting their bones at risk by not taking bisphosphonates?

The issue may not be so straightforward. Critics have accused Ms. Brody of writing a one-sided story in favor of drug-pushing, without presenting the current controversies surrounding osteoporosis: the role of drug companies in reconceptualizing risk as a disease that needs treatment, expanding disease definitions that lead to overdiagnosis, and marketing of drugs whose benefit vs harm ratio is questionable for some patients.5

“For every research group claiming that osteoporosis is underdiagnosed and undertreated, there are those on the other side-including patients, researchers and clinicians-pointing to evidence that it is overdiagnosed and overtreated,” wrote Allan Cassel in Health News Review.5

That raises a question about screening: are we over-diagnosing in some women who don’t need bisphosphonates?

To screen or not to screen
In 2009, NPR's Alix Spiegel argued that Merck plotted to increase bone screening rates as a way to sell more prescriptions of their blockbuster drug Fosamax.6

Her argument goes like this: Merck promoted peripheral bone scanners that measure bone density in areas like the forearm and heel, rather than at the hip and spine. As a result, patients had easier access to less costly bone scans in their doctor’s office. At that time, Merck also successfully lobbied to get Medicare to reimburse these new machines. So peripheral bone scans became profitable, with a resultant jump in Medicare claims from 70,000 annually in 1994 to 1.5 million annually in 1999.

It’s no surprise that sales of Fosamax also skyrocketed.

You would think that using screening to get more patients who might develop a fracture on treatment would be a good thing. But here’s the problem: peripheral bone scans might not say much about what’s going on in the hip and spine.

Richard Mazess, PhD, founder of Lunar Corp., one of the largest manufacturers of bone density machines, says that peripheral scans are “diametrically opposed” to what scientists think are best for diagnosis, and that they are just “bad medicine.”6

Sanford Baim, MD, of Rush University in Chicago and a former president of the International Society for Clinical Densitometry, also argues against the peripheral machines for diagnosing osteoporosis. That’s because menopausal women lose bone at different rates in different parts of their skeleton. The best way to predict hip and spine fracture, he says, is to go for gold and directly measure the hip and spine.6

Teppo Järvinen, an orthopedic surgeon at the University of Helsinki in Finland, is skeptical even of DXA scans that screen the hip and spine. He argues that most people experience a fracture because they’ve fallen, not necessarily because they have osteoporosis. Falls in older people are related to frailty and decreased physical functioning, which bone scans don’t measure.7

“Fewer than one in three hip fractures are attributable to osteoporosis as defined by total hip bone mineral density. Thus, sufficiently accurate identification of fracture‐prone individuals is not possible on the basis of DXA‐defined osteoporosis,” he writes.

Also, DXA scans don’t differentiate between fat, muscle, and bone marrow. So they may inaccurately measure T-scores by about 1 SD in either direction, which can mean the difference between clear osteoporosis and slight osteopenia.

Järvinen even questions the World Health Organization’s Fracture Risk Assessment Tool (FRAX score), citing design flaws and other problems that promote overdiagnosis and overtreatment.

“[I]f the FRAX®â€based guidelines were applied, at least 72% of white women >65 years and 93% of those >75 years in the USA would be recommended for drug therapy. For comparison, using the bone mineral density‐based diagnosis of osteoporosis (the current trigger for drug treatment), the corresponding values for the EU are 34% and 43%, respectively,” he argues.

Perhaps as a result of the screening debate, Medicare has decreased reimbursement for bone density tests. What that means for rates of treatment and fracture has yet to be seen.

But screening isn’t the only issue. Here’s another problem: at about the same time that Merck started pushing peripheral bone scans, the company also developed low-dose Fosamax intended for patients with osteopenia. As a result, Fosamax started to be prescribed for more women with osteopenia, who might not have needed it.

Read on for the bisphosphonate debate in Part II.

References:

1. Brody J. A perfect storm for broken bones. New York Times. February 12, 2018. Accessed March 20, 2018.

2. Lewiecki EM, Wright NC, Curtis JR, et al. Hip fracture trends in the United States, 2002 to 2015. Osteoporos Int. 2018;29:717-722. doi: 10.1007/s00198-017-4345-0.

3. FDA Drug Safety Communication. Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures 10/13/2010. Accessed March 20, 2018.

4. Jha S, Wang Z, Laucis N, Bhattacharyya T. Trends in media reports, oral bisphosphonate prescriptions, and hip fractures 1996-2012: an ecological analysis. J Bone Miner Res. 2015;30:2179-2187.

5. Cassel A. Perfect storm for broken bones or for disease-mongering of osteoporosis? HealthNewsReview.org. Accessed March 20, 2018.

6. Spiegel A. How a bone disease grew to fit the prescription. NPR. December 21, 2009

7. Järvinen TL, Michaëlsson K, Aspenberg P, et al. Osteoporosis: the emperor has no clothes. J Intern Med. 2015;277:662-673. doi: 10.1111/joim.12366.

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