Wednesday, December 23, 2009

NPR: How Osteopenia Became a Treatable Disease

Alix Spiegel at NPR did a fabulous story on drug treatment for osteopenia:

The story lays out the history of how Merck addressed the problem it first faced with its new drug, alendronate (Fosamax): It seemed to be a breakthrough drug for treating osteoporosis and preventing hip and spine fractures in post-menopausal women; but sales were very slack.

So they brought in a marketing whiz named Jeremy Allen. And he did nothing less than invent the medical industry of bone mineral density (BMD) testing.

When Allen came along, there were very few BMD testing machines, because the machines were huge and expensive, and tests cost a lot and were not reimbursed by Medicare.

Allen's first response was to create an organization called the Bone Measurement Institute. Its board included 6 highly respected osteoporosis investigators. Its physical plant consisted of Allen's desk at Merck. Its funding was all Merck money.

Eventually Merck went so far as to buy out a medical device company to prove that it could make cheap BMD testing machines that would easily work in a physician's office, and do screening tests at reasonable cost. Merck claims that these smaller machines are effective. The device companies that make the bigger machines protested that the smaller machines were not accurate because they did not measure density at the hip and spine, but rather measured limb bone density, which research has shown change at different rates from the sites of the worst fractures. (Spiegel's story does not go this way, but please read John Abramson's excellent chapter on osteoporosis in his book, Overdo$ed America, explaining why drugs like Fosamax may make BMD numbers look great without doing anything really to reduce risk of fractures in most cases--especially in osteopenia.)

The Bone Measurement Institute eventually lobbied Congress to pass a law to get Medicare to pay for BMD scans. It now was profitable for docs to buy smaller machines for their offices and to offer the tests widely to patients.

Once patients began getting the tests wholesale, they saw that a paper printed out with three colored zones, green, red, and yellow. Green was normal and red was osteoporosis. Yellow was a thing called osteopenia which women had never heard of. When the term was formalized at a 1992 scientific meeting in Rome, it was seen simply as a name for the statistical condition of not-quite-osteoporosis, and not as a diagnosis, certainly not a disease that needed drug treatment. But the women who saw the yellow zone worried about their higher risk for fractures and started to demand that their doctors do something. Thus was born the widespread pharmaceutical therapy for osteopenia, which according to most research is essentially useless.

The dynamic at play here is the classic "disease mongering" as publicized by Ray Moynihan, the Australian journalist. It also highlights how often the best way to sell drugs is to sell screening instead.

Here's a good summation from Spiegel's article:

"I get a great sense of satisfaction that I was able to rejigger the marketplace so that women could be treated for osteoporosis before it got them," Allen says. "That was a good episode of my life."
From Allen's perspective, by making a treatment for osteoporosis widely available, he helped save millions of lives.
But [Richard] Mazess, from the Lunar Corp., [a maker of large BMD machines], doesn't see it that way. "He was complicit in a plot to misdiagnose American women," Mazess says of Allen.
From Mazess' perspective, millions of women with osteopenia are now needlessly exposed to the risks of a medication that may not ultimately help them.
The paradox of our health care system is that both of these men are probably right. That is, drug companies produce incredible drugs that can greatly relieve suffering. But one way they profit from those drugs is to extend their use to as many people as possible, which frequently means that medications are used in populations with milder and milder versions of a disease, so that the risks of medicating can come to outweigh the benefits.

This morning my e-mail included no less than two notices about how physicians should be prescribing statin drugs for healthy people with normal cholesterol but with some heart-disease risk factors. Jeremy Allen at work behind the scenes again?


Michael Kirsch, M.D. said...

The strategy is to devise the treatment, and then to find the disease. We spend tons of money on bone densitometry and medications to diagnose,delay and reverse bone loss. The actual benefit that the individual woman receives would be shockingly low. 'Normal' cholesterol levels are being lowered periodically. Soon, the whole country will be afflicted with hyperlipidemia. When therapies searching out diseases, then overutilization is guaranteed.

Michael S. Altus, PhD, ELS said...

Letters: Marketing Drugs For Osteopenia []:

A very different reaction [contrasting with favorable reactions from other listeners] came in from Melvin Nutig(ph). He’s an orthopedic surgeon in Beverly Hills. He writes, I'm usually quite pleased with your health coverage, but this story, he says, really angered me. Dr. Nutig continues, the point is not whether osteopenia is over-diagnosed and treated but rather that osteopenia is an early stage of osteoporosis. And if it can be diagnosed early and treated, through a variety of means including medicine and weight-bearing activity, then middle-aged women will likely avoid the fate of their mothers and grandmothers of hip fractures.

So if Dr. Nutig is correct, then it is worthwhile for women to take Fosamax and similar drugs.

Michael Kirsch, M.D. said...

The comment from Dr. Altus is very problematic. "So if Dr. Nutig is correct, then it is worthwhile for women to take Fosamax and similar drugs." The profession often lurches ahead with expensive treatments based on faulty or flimsy data. Dr. Altus's ocmment indicates support for Rx IF there is evidence of efficacy. Shouldn't the evidence come first?

Michael S. Altus, PhD, ELS said...

Dr. Kirsch, For sure! That's why I wrote "If". I have not studied the literature about the effect of taking Fosamax and similar drugs on preventing deterioration (medicalese would use "progression" here) to osteoporosis in women with osteopenia.

(Use of the word “progression” instead of “deterioration” or “worsenening” is my “favorite” medical oxymoron. But I digress....)

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Joe said...

There is also a question about whether densitometry measurements correlate that highly with the actual strength of the bone against the various forces that could cause a fracture when the densitometry measurements are in the uncertain zone. And this is for densitometry of the hip and spine.

Its nonsense to say that measurements at the periphery can be that clear about fracture risk. Dr. Nutig's statements are nonsense because osteopenia is not an early stage of osteoporosis, any more than a mole is an early stage of malignant melanoma.

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Michael Kirsch, M.D. said...

Even the term 'osteopenia' sounds like a severe bone disease. Another effort to lure patients toward treatment of questionable value. While a 'skin mole', mentioned by a commenter sounds benign, give it a fancy derm term, and the patient will want the nasty thing excised.

rethoryke said...

Would anyone care to shine the same spotlight on "metabolic syndrome"?

[I'm not saying that it isn't worthwhile to intervene before someone develops Type II diabetes -- what I am saying is that creating a "condition" so that particular drugs become the "right answer" for treatment, rather than lifestyle changes....there's a few ethical problems with that strategy.]