Any woman who’s been told by her doctor that she has osteopenia (low bone density, but not low enough to be osteoporosis) — and especially any woman who’s taking medication for it — needs to read (or listen to) Monday’s National Public Radio (NPR) story on how pharmaceutical companies successfully “changed the definition of a disease and created a whole new category of people who saw themselves as needing treatment.”
Warning: The story may make you want to strike an arm or leg (with one of those bones you’ve been told is worrisomely thinning) against a hard surface.
The broad outline of the story isn’t that new. For well over a decade, various women’s health advocates have been trying to tell women not to fall for this rendition of Big Pharma’s disease mongering. But NPR reporter Alix Spiegel does a superb job of walking listeners/readers through this sadly all-too-common medical cautionary tale.
(Men also become susceptible to bone fractures as they age, but not as much as women, which is why drugs for osteoporosis and osteopenia are most heavily marketed to women.)
At the creation
There’s so much good information in the NPR report, it’s difficult to know what to highlight. One of the most telling anecdotes involves a 1994 meeting in Rome (financed by the pharmaceutical industry, according to the New York Times) during which a World Health Organization panel of experts rather arbitrarily defined osteoporosis — and invented the concept of osteopenia.
The question before the experts in Rome then was this: Since after the age of 30 all bones lose density, how much bone loss was normal? And, how much put women at risk and therefore should be considered a disease?
Anna Tosteson is a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and Dartmouth Medical School who attended the meeting. She says that over a two- or three-day period the experts in the room went back and forth and back and forth, looking at research and trying to decide precisely where on a graph of diminishing bone density to draw a line.
“Ultimately it was just a matter of, ‘Well … it has to be drawn somewhere,’ ” Tosteson says. “And as I recall, it was very hot in the meeting room, and people were in shirt sleeves and, you know, it was time to kind of move on, if you will. And, I can’t quite frankly remember who it was who stood up and drew the picture and said, ‘Well, let’s just do this.’ “
So there in the hotel room someone literally stood up, drew a line through a graph depicting diminishing bone density and decreed: Every woman on one side of this line has a disease [osteoporosis].
Then a new question arose: How do you categorize the women who are just on the other side of that line?
To address this issue, Tosteson says, the experts — more or less off the cuff — decided to use the term osteopenia. Tosteson says they created the category mostly because they thought it might be useful for public health researchers who like clear categories for their studies. They never imagined, she says, that people would come to think of osteopenia as a disease in itself to be treated.
Making a “disease” go viral
Ah, but the pharmaceutical company Merck immediately saw how this newly coined term, osteopenia, could potentially widen the then-sluggish sales of its osteoporosis drug Fosamax.
“To get large numbers of women on Fosamax, large numbers of women needed to get their bones scanned and be diagnosed with osteoporosis,” reports Spiegel. “But in America in 1995, there was simply no way to do that.”
The only diagnostic machines at the time were tabletop bone densitometers, which measured bone density at the hips and in the spine — the two parts of the body that, if fractured, increased a person’s risk of death.
But these machines were available only in a few hundred testing centers and cost up to $300 per test — an expense that was not usually reimbursed by insurance companies.
“To sell Fosamax, then, Merck and Allen needed to do two things: place machines that could measure bone density in doctors’ offices all across America and bring down the price of the tests,” writes Spiegel.
And that is exactly what Merck and Allen did. You’ll have to read Spiegel’s story for all the details, but here are some highlights:
- Merck set up a nonprofit Bone Measurement Institute to “help increase the availability of bone measurement technologies, increase their accessibility to physicians and reduce the cost of bone mass measurement to health care payers.” Allen was its only employee. In 1997, the Institute, along with several other interested organizations (including some funded by Merck), successfully lobbied Congress to pass legislation to have bone scans covered by Medicare.
- Merck pressured the manufacturers of bone density machines to produce smaller, cheaper peripheral machines that could be used in doctors’ offices. These machines don’t measure bone density in the hip or spine, however, but only in the finger, forearm, wrist or heel — measurements that many experts believe have little value for predicting future hip or spine fractures.
- When one of these manufacturers balked at producing the smaller machines, it was threatened with losing all future support from Merck. In fact, “to encourage companies to take Merck’s goals seriously, Merck itself purchased a bone measurement business,” reports Spiegel. This move forced other companies to lower their prices, at which point Merck sold the company.
- In 1997, Merck got the FDA to clear a lower (5-milligram) dose of Fosamax that could be used by women with osteopenia. It began running ads to promote drugs for osteoporosis — but ads that now featured young-looking women in their 40s and 50s rather than “humped grannies,” writes Spiegel.
The idea that osteopenia exists — and needs to be treated with a drug like Fosamax — soon went viral.
Not without side effects
There’s a moral to this story, and its one with health consequences. Millions of people — in this case, mostly middle-aged women — are now on drugs for an essentially non-existent “disease.” And those drugs have potentially harmful side effects.
As the National Women’s Health Network points out, Fosamax and other bisphosphonate drugs have been associated with an increased risk of irregular heart rhythms (atrial fibrillation), a hardening of the jaw bone (jaw necrosis) that may require removing the bone, and unusual spontaneous fractures of the thigh bone. Some women who take these drugs also develop severe heartburn and stomach-damaging ulcers, as well as severe bone, joint and/or muscle pain.
Granted, some of these side effects appear to be rare, but no one can really say with any certainty what the long-term effects of these drugs actually are. Nor are we likely to know any time soon.
“There are no long-term studies that look at what happens to women with osteopenia who start Fosamax in their 50s and continue treatment long-term in the hopes of preventing old-age fractures,” reports Spiegel. “And none are planned.”