MICHELE NORRIS, host:
From NPR News, this is ALL THINGS CONSIDERED. I'm Michele Norris.
And today, we have an unusual biography. It's the biography of a box of pills, how it got into a medicine cabinet in Richmond, Virginia, and into the medicine cabinets of millions of women all across America.
NPR's Alix Spiegel explains how the marketing of the pills changed the definition of a disease and created a whole new category of people who saw themselves as needing treatment.
ALIX SPIEGEL: The box of medicine is very ordinary: a white rectangle covered in writing that spends most of its life in Katie Benghauser's medicine cabinet, sandwiched between a bottle of aspirin and a small army of pet medications.
Ms. KATIE BENGHAUSER: We have the flea treatment for the dog, the flea treatment for the cat, heartworm for the cat...
SPIEGEL: So the box and its neighbors just sit there, day after day in dark. But then, exactly once a month, Katie comes. She unsticks the door, lifts the box and coaxes a pill from the package.
Ms. BENGHAUSER: And press and hold it, then you fold.
SPIEGEL: Now, like most people, Katie has no concept of all of the forces that combined to bring these pills into her home. All she knows is that three years ago, she went to her doctor and was told that it was time to take a test. Not that there was anything about Katie that suggested sickness. Katie is 57, but can outrun most 20-year-olds. She's a model of health. Still, she is a little bit thin and she's a woman in her 50s, so her doctor thought it best to be careful.
Ms. BENGHAUSER: She felt like because my frame is slight and just the risk factors of being female and white just were at risk for developing osteoporosis.
SPIEGEL: Osteoporosis is a disease where bones thin, lose density and can easily fracture. It can be devastating to older women who fall and break a hip. Now, osteoporosis mostly afflicts the elderly. But just to make sure, Katie went in for a test, which measured the density of her bones. Two weeks later, a letter came with an unsettling message.
Ms. BENGHAUSER: The results of your bone density show that you have osteopenia and you need to start taking medication.
SPIEGEL: Now, let's pause here. Katie's diagnosis was for osteopenia. Osteopenia is different than osteoporosis. In fact, though Katie is very health conscious, she wasn't familiar with it. But then Katie asked around and it turned out that many of her peers had osteopenia. For example, Katie works in an office with seven other women, several of whom had also been diagnosed.
Ms. BENGHAUSER: There's four of us that are over 50.
SPIEGEL: And three of the four are...
Ms. BENGHAUSER: The four are on some type of medication for osteopenia.
SPIEGEL: Osteopenia, it turns out, is a slight thinning of the bones, which occurs naturally as women get older and typically doesn't result in disabling bone breaks. In fact, it's a condition that only recently started to be thought of as a problem that required treatment. And to understand its full evolution from non-problem to problem, you need to go back to the beginning, to 1992 and a place very far away from Katie Benghauser's suburban Richmond home.
Dr. ANNA TOSTESON (Professor of Medicine, Dartmouth College): The meeting took place in Rome, Italy, in a hotel near the top of the Spanish Steps.
SPIEGEL: This is Anna Tosteson, professor of medicine at Dartmouth College. In 1992, Tosteson was one of a small group of experts on osteoporosis, invited to Rome for a meeting organized by the World Health Organization. One focus of which was a definition for osteoporosis. You see, for a long time, doctors were only able to diagnose osteoporosis after a woman got a fracture. But bone scanning machines had made it possible to figure out if bones were weak before fractures occurred. The question before the experts 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 so should be categorized as a disease? Anna Tosteson says the experts in the room went back and forth, looking at research and trying to decide where on a graph of diminishing bone loss to draw the line.
Dr. TOSTESON: Ultimately, it was just a matter of, well, it has to be drawn somewhere. And as I recall, it was very hot in the meeting room.
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Dr. TOSTESON: And people were kind of in shirtsleeves, and 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.
SPIEGEL: So a line is drawn and every woman on one side had osteoporosis, but what about the women just on the other side of that line? Well, for that group, the experts, more or less off the cuff, decided to use the term osteopenia. Anna Tosteson told me that 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 said, that people would come to think of osteopenia as a condition to be treated, though she does admit that the term sounds a little forbidding.
Dr. TOSTESON: Osteopenia sounds like something that, you know, your medicalizing this problem. Low bone mass sounds a little bit less scary.
SPIEGEL: Of course, 17 years later in Richmond, Virginia, Katie Benghauser is not only treated for osteopenia, but literally spends her days worried about her diagnosis.
Ms. BENGHAUSER: I'm much more aware of making sure I lift my feet up and I don't trip on the sidewalks. And, you know, if I didn't know I had osteopenia, maybe I wouldn't be so cautious.
SPIEGEL: So, how does osteopenia change from a category for researchers into a condition that millions of women swallow pills to control? To find out, I drove to the sprawling Pennsylvania home of a man named Jeremy Allen and sat my recording equipment down on his highly polished dining room table.
Can you scoot out just a teeny tiny little bit? Okay. So tell me, where are you from originally?
Mr. JEREMY ALLEN (President, Bone Measurement Institute): I'm from England.
SPIEGEL: Jeremy Allen came to the United States in the 1980s and went to work for a large pharmaceutical company. He had success, much success at various drug and drug research companies. Then in 1995, Allen was approached by the drug company Merck. The pharmaceutical giant had just released a new drug, Fosamax.
Mr. ALLEN: Fosamax was the first drug that could credibly make a claim to stop the progress of osteoporosis.
SPIEGEL: Now, osteoporosis is a serious problem that affects millions of women, and Fosamax was the first nonhormonal treatment, so the potential market was enormous. But Allen says that after its release, sales of Fosamax were slow. Allen had known the president of Merck America, this guy named David Anstice, for years; they'd worked together at another company. And so, Allen says Anstice came to him with a proposition: Figure out this problem and then fix it.
Mr. ALLEN: My job description read: Provide some out of the box thinking. That was a great job description.
SPIEGEL: Allen set to work. He talked to doctors, researchers, and soon, the issue with Fosamax sales became clear: In order to get large numbers of women on Fosamax, large numbers of women needed to be diagnosed with osteoporosis by getting their bones scanned. But in America in 1995, there was simply no way to do that.
Mr. ALLEN: The only diagnostic procedure was an expensive machine called a bone densitometer that was costing the patient between 200, 250, $300 per test. And there were only a couple of hundred testing centers in the United States, which meant that almost everybody had a day's ride, or had to go from the suburbs downtown to get the test. It was expensive and it was inaccessible, so lo and behold, nobody did it.
SPIEGEL: 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.
But Allen says for him, this wasn't just about selling drugs; it was about helping people. He points out that one in five elderly women will die within a year of a hip break.
Mr. ALLEN: Clearly, that's not very good.
SPIEGEL: And so, armed with the firm conviction that he was about to do good in the world, and coincidentally sell a ton of drugs for Merck, Jeremy Allen set out to completely rework the way that bone was measured in America.
Now, to do this, he figured, the first thing he needed was an institution, an entity whose mission was not to sell drugs, but to serve the public good. So he decided to create one. In 1995, Allen convinced Merck to establish a nonprofit called the Bone Measurement Institute. On its board were six of the most respected osteoporosis researchers in the country. But the institute itself had a rather slim staff: Allen, you see, was its only employee.
Mr. ALLEN: There was no payroll, there was no building, there was no office with the name Bone Measurement Institute.
SPIEGEL: It was literally like your desk at Merck?
Mr. ALLEN: Yes, I was it.
SPIEGEL: Now, once this institute was established, Allen sought some alternative to the usual way that bone was measured in America. Instead of machines that were big and expensive, he wanted machines that were cheap and small, and soon, he found them.
Mr. ALLEN: You could use what was called peripheral machines, measure bone density at the forearm or at the heel, rather than the hip and spine.
SPIEGEL: Allen felt these smaller machines were the perfect solution. The problem he says was that few companies produced them.
Mr. ALLEN: So we went very strongly to the six or seven manufacturers who were either in this business or wanted to get into this business and said, we will fund your development of these other machines.
SPIEGEL: But several of the machine companies weren't as enthusiastic as Allen had hoped. In fact, according to Allen, two of the dominant players were downright hostile.
Mr. ALLEN: Because it wasn't as profitable. I was a threat to their business model. Their business model was to sell just a few machines at a very, very high price. And I wanted them to sell a lot of machines at a much lower price.
SPIEGEL: And you were going to their competitors and help subsidize their competitors if they didn't change their model?
Mr. ALLEN: Yes.
SPIEGEL: Jeremy Allen, though, isn't the only person with a version of this story.
Dr. RICHARD MAZESS (Founder, Lunar Corporation): We had a - not a very comfortable relationship with Jeremy Allen and his so-called Bone Measurement Institute.
SPIEGEL: This is Richard Mazess, founder of the Lunar Corporation, one of the largest producers of bone density machines. Now, Mazess does remember Allen's proposal, but says his resistance had absolutely nothing to do with money. The problem with peripheral machines, Mazess says, is that taking a measurement of someone's finger or forearm isn't going to tell you what you need to know about the bones in the part of the body which, if fractured, actually threaten a woman's health: the spine and the hip. And therefore, Mazess says, the machines could only lead to bad medicine.
Dr. MAZESS: We were not about to go ahead and tell physicians to use inadequate diagnostic equipment simply because Merck wanted that. And we were threatened, basically, that we will support your competitors and that we will tell the people that are working with Merck not to use Lunar machines. They were going to make sure that we paid the price.
SPIEGEL: And Lunar wasn't the only company put on notice. Jeremy Allen says that to encourage other companies to take seriously Merck's goal of dropping the price of measuring machines, Merck actually purchased a bone measurement business.
Mr. ALLEN: We bought one of the companies and showed how low the price could become purely to get everybody's attention. And we got everybody's attention. And subsequently, when everybody else moved, we let it go, and the company closed. And we cheered its demise.
SPIEGEL: Now, there is a third version of this story. Paul Strain is a lawyer who represents Merck's corporate office. And though he wasn't able to comment on many of the particulars of Jeremy Allen's story, he did confirm the broad outline: that the Bone Measurement Institute worked to spread the number of machines. However, Strain completely rejects this idea that the smaller machines Merck promoted were inferior, that a scan of the wrist or forearm doesn't provide good information about the risk of hip fracture.
Mr. PAUL STRAIN (Attorney): Oh, I think there definitely is a clear correlation, and I think there are many, many studies that have shown that.
SPIEGEL: But others disagree. In fact, according to Sanford Baim, former president of the International Society for Clinical Densitometry, smaller machines should only rarely be used in diagnosis. Nevertheless, Allen says Merck helped to get the smaller machines through the FDA process by funding trials and assisting with submissions. He says pamphlets from each company were sent out with a Fosamax sales force. Merck even created a leasing program so that doctors could finance the purchase of a machine, big or small.
More importantly, Merck worked to change the very economics of measuring bone by getting bone scans reimbursed by Medicare.
Now, Jeremy Allen actually left the Bone Measurement Institute before much of this work took place. But in 1997, the institute and several other interested organizations successfully lobbied to pass the Bone Mass Measurement Act, which changed Medicare reimbursement rules. Several of those other organizations, by the way, also got funding from Merck. And according to Steve Cummings, director of clinical research at California Pacific Medical Center Research Institute, and a major bone researcher who's followed these issues for years, it is impossible to overemphasize just how important this legislation was.
Dr. STEVE CUMMINGS (Former Director of Clinical Research, California Pacific Medical Center Research Institute): Up to that point, patients needed to pay for bone densitometry out of their own pocket. Now that it's reimbursed, clinicians can now be reimbursed if they buy the machines. They get paid for making measurements of bone density. And in the 1990s and into the early 2000s, measuring bone density is a profitable thing to do.
SPIEGEL: Now, as Cummings points out, 1997 was also the year that Merck got clearance from the FDA for a new version of its drug.
Dr. CUMMINGS: Merck developed a dose of Fosamax, a five-milligram, lower dose that was intended for use by women who had osteopenia.
SPIEGEL: And here is where we get back to this question of how osteopenia, Katie Benghauser's diagnosis, ultimately became a widely treated condition.
Cummings says that in order to understand how come so many women today are treated for osteopenia, what you need to do is look more closely at all of the machines - big and small - that Merck helped to place in doctors' offices.
Dr. CUMMINGS: I think the critical event in turning osteopenia into a condition that people believe needs treatment is the report that comes from the bone density machine that says osteopenia.
SPIEGEL: See, when these tests are done, the machines produce a report, or chart, really. Recently, my producer Gisele Grayson and I went to a doctor to get tested at the Fairfax Radiology Center in Fairfax, Virginia. A technician named Jasmine Wilson(ph) loaded Gisele onto a large machine that measured the hip and spine.
Ms. JASMINE WILSON (Technician, Fairfax Radiology Center): Have you ever had a bone density before? Super easy. I'm just going to ask you to lie down on your back for me, head at the pillow.
SPIEGEL: A button was pushed, and two minutes later, Wilson was holding a paper with a clear, color-coded chart at the bottom.
Ms. WILSON: We have a color graph: green, yellow and red. Green indicates normal bone density. Yellow is osteopenia, and then red is osteoporosis.
SPIEGEL: Now, Gisele is 38 years old, the mother of two. And I know she often says this about herself, so I feel comfortable saying it. Pretty much everything about her screams perky, except apparently her bone density.
Ms. WILSON: So according to the color graph here, you're in the yellow, which indicates osteopenia.
SPIEGEL: Now, it's highly unlikely that a doctor would medicate Gisele. She's too young. But Steve Cummings argues that the very existence of this word osteopenia on these medical reports has this incredible impact.
Dr. CUMMINGS: When millions of women are getting the word osteopenia from the bone density test that they're getting in their 50s and 60s, they get worried. When a clinician sees the word osteopenia on a report, they think it's a disease. They want to know: What should I do?
SPIEGEL: Now, Merck, and eventually other companies, are running commercials advertising drugs to prevent osteoporosis. And those commercials don't feature humped grannies but young-looking women. And, says Cummings, at a certain stage, it simply reaches this tipping point.
Dr. CUMMINGS: Bone densitometry becomes increasingly available. And women start wanting it, and they hear their friends have had a measurement of bone density, and their friend was told that they have osteopenia, and they want to know whether they should be treated. And so, it's almost viral.
SPIEGEL: And through this process of testing, at least 1.5 million tests by 1999, and advertising, eventually a cultural consensus takes hold. Osteopenia simply becomes a condition that should be seriously considered for treatment. And for many people, particularly Jeremy Allen, this is all for the good. Everyone has won.
Mr. ALLEN: Fosamax became a successful drug, and there are a lot less women dying of hip fractures or stooped over than there were a couple of generations ago.
SPIEGEL: Well, maybe. Yes, there is a scientific consensus that it's beneficial to give Fosamax to women with osteoporosis, especially older women and any woman who has already had a fracture.
Paul Strain, the lawyer from Merck, argues that Fosamax also is good for women with osteopenia. He says it builds bones and therefore prevents fractures in osteopenic women.
Mr. STRAIN: It's well-established that there is a clear correlation between bone mineral density and fracture risk. And by preserving and maintaining bone mineral density, Fosamax lowers their risk of fracture.
SPIEGEL: But increasingly, bone scientists say Fosamax is not necessarily a win for women with osteopenia.
Both Steve Cummings and Susan Ott, professor of medicine at the University of Washington, say studies in women with osteopenia show that while very rare spinal fractures are reduced, the types of bone fractures most common among women with osteopenia are not affected. Susan Ott.
Professor SUSAN OTT (Medicine, University of Washington): There was no difference in how many fractures you had, whether you took the medicine or a placebo. It does make your bone density go up higher, but the number of fractures is what really matters, and that didn't really change.
SPIEGEL: And what about the long-term? Among women with osteopenia who start Fosamax, say, at age 50 and continue to 60 and beyond in the hopes of preventing old-age fractures. Well, there are no studies of what happens to those women more than 10 years out, and none are planned.
So Steve Cummings says treatment should start only when risk is significant or a woman already has a spine fracture. Susan Ott even worries that taking these medications long-term - over 10 years or more - might actually make bones brittle.
Ott points to a very small number of case reports about spontaneous breaks in the upper leg, which - though rare - could be important, she says, given what's at stake.
Prof. OTT: Instead of preventing fractures, you might get fractures. But it certainly doesn't happen in the first five years.
SPIEGEL: So among specialists, there is still controversy about when women with osteopenia should get this medication. But what is clear is that getting that box of pills into Katie Banghauser's medicine cabinet wasn't a simple matter. Jeremy Allen told me it just took a huge amount of work, work he loved because from his perspective, he helped save lives.
Mr. ALLEN: I get a great sense of satisfaction that I was able to re-jigger the marketplace so that women could be treated for osteoporosis before it got them. That was a good episode of my life.
SPIEGEL: But Richard Mazess from the Lunar Corporation doesn't see it that way.
Dr. MAZESS: He was complicit in a plot to misdiagnose American women.
SPIEGEL: From Mazess' perspective, millions of women with osteopenia are now needlessly exposed to the risks of a medication that may not ultimately help them.
And the paradox of our health care system is that both of these men are probably right. That is, drug companies produce these incredible drugs that greatly relieve suffering. But one way they profit from those drugs is to extend their use so that medications are used in populations with milder and milder versions of a disease, and the risks of medicating can come to outweigh the benefits. I've told you a story about osteoporosis and osteopenia. But there are versions of this story about a lot of diagnoses. Caleb Alexander is a pharmacoepidemiologist at the University of Chicago, and he says the dynamic is well understood:
Mr. CALEB ALEXANDER (Pharmacoepidemiologist, University of Chicago): Whether you consider treatments for osteoporosis or treatments for depression or treatments for high cholesterol - in all of these settings - pharmaceutical firms stand to benefit if the therapies for these diseases are broadly used, even if they're being used among people that have very mild forms of these diseases.
SPIEGEL: So, tonight before bed, open your medicine cabinet. There you will see a shelf of pillboxes, many with complicated biographies.
Alix Spiegel, NPR News, Washington.
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NORRIS: At our Web site, you can see an image from a bone density scan and find a chart of Fosamax sales over the years. You can find that at npr.org.
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NORRIS: You're listening to ALL THINGS CONSIDERED from NPR News.
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