Editore"s Note
Tilting at Windmills

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March 30, 2008
By: Kevin Drum

CONDITION BRANDING....Shannon Brownlee writes in the Washington Post about "condition branding" in the pharmaceutical industry:

Condition branders use "information" about medical conditions to forge links between disease and treatment in the minds of both patients and doctors. If they have a drug but no condition, they will simply invent a disease.

....One of the best examples is "osteopenia," a diagnosis that millions of women my age are given every year.....Before the 1990s, doctors decided that you had osteoporosis if you were elderly and you broke a bone. When the pharmaceutical company Merck came up with its anti-bone-loss durg Fosamax, it wanted a broader market than just elderly fracture patients. The solution? The company helped fund a panel of medical experts to create diagnostic criteria for osteoporosis so that a diagnosis could be made before the patient actually broke a bone.

The panel's first step was to define "normal" bone density as that of the average 30-year-old woman. Next, the experts chose as their cutoff for osteoporosis a statistical point that was slightly below the bone density of their normal 30-year-old — a definition they admitted was "somewhat arbitrary." Finally, they came up with a completely new disease — osteopenia — for bone density that fell somewhere between that normal 30-year-old and their arbitrary definition of osteoporosis.

Voila — 30 percent of post-menopausal women suddenly had a disease that needed to be treated early in order to prevent a problem — hip fracture — that wouldn't occur for many years, if ever. According to the new guidelines, millions more women now had osteopenia, which their doctors needed to watch like hawks so that their patients could be treated once they progressed to osteoporosis. Merck then took the added step of helping doctors buy DEXA scanners, X-ray machines needed to scan your bones to get that all-important diagnosis.

Read the whole thing. And while you're at it, you might want to buy her book, Overtreated, and read that too. It's very, very good.

Kevin Drum 2:57 PM Permalink | Trackbacks | Comments (26)

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Comments

The only real question is whether Merck's drug does indeed reduce the probability that a patient will have a hip fracture. If it does, then we have a benefit (reduction in hip fractures) that must be balanced against a cost (cash costs of the drug plus the "worry factor").

Perhaps the benefit is not worth the cost. Who knows. But if there's a benefit you can hardly point to the fact that Merck is trying to market the drug as evidence that they are eeeevil. Some patients will be helped, and even if that's not worth the cost in the aggregate its not nothin' either.

If there is no benefit to the drug then its snake oil.

Posted by: sd on March 30, 2008 at 3:03 PM | PERMALINK

Yeah, but do they give out those nifty pens and note pads?

Posted by: on March 30, 2008 at 3:31 PM | PERMALINK

Not all preventative medicine is a bad idea.

Posted by: scarshapedstar on March 30, 2008 at 3:43 PM | PERMALINK

I don't know-- I'm not convinced by that example alone. If I was a post-menopausal woman, I would prefer tp take a pill every day rather than have an increased chance that I would have to go through all the trouble that could come with a hip fracture as an elderly woman.

If people are offended by their being a lot of medicine and medical treatment, I think there is a legion of examples of stuff that is frivolous that are a lot better examples. Create generous subsidies for doctors to become poor-neighborhood general practitiioners instead of having Iraq wars, and then you'll get less people becoming plasitc surgeons so they can get paid handsomely to do boob-jobs and collagen injections. Some may say that doctors who become plastic surgeons wouldn't want to prescribe penicillin for kids in a ghetto, but at least their would be less doctors becoming specialists (podiatrists, orthopedic specialists, etc) that plastic surgeons might actually pefer becoming, if their were less doctors becoming those kinds of specialists (so it was easier to set up, get a client-base, and even charge a little more for excellent service in those specialties).

Posted by: Swan on March 30, 2008 at 3:47 PM | PERMALINK

Oops, sorry for all those "theirs" that should have been "theres" in my comments above.

Posted by: Swan on March 30, 2008 at 3:49 PM | PERMALINK

A woman's lifetime risk of dying of a complication of an osteoporotic fracture is not much less than her lifetime risk of dying from breast cancer. Admittedly, most of the women who die from those complications are either very elderly or very frail. However, even in younger healthier women osteoporotic fractures are painful and debilitating. Besides, you can buy a lot of generic alendronate for the cost of one hip replacement.

The FIT trial demonstrated that treating "osteopenia" resulted in decreased vertebral fractures, but not hip or wrist fractures.

A better example of this phenomenon might be "erectile dysfunction" -- a term that was invented by marketers so that men could go to the doc and ask for medication to treat "ED" rather than say the word "impotence".

Posted by: J Bean on March 30, 2008 at 4:08 PM | PERMALINK

"Perhaps the benefit is not worth the cost. Who knows".

I think this might be the mission statement of drug and medical device manufacturers worldwide. They might add "...and we don't want to know".

Posted by: dwight on March 30, 2008 at 4:14 PM | PERMALINK

Another example of the superiority of private sector medicine over its old socialistic public sector counterpart. Lazy government doctors would never have bothered inventing all these pseudo-diagnoses! Don't they realize the whole point of prescribing drugs is to enhance pharmaceutical bottom lines?

Posted by: jimBOB on March 30, 2008 at 4:17 PM | PERMALINK

While it's pretty clear that the pharmaceutical industry takes this too far, isn't the idea of creating "diagnostic criteria for osteoporosis so that a diagnosis could be made before the patient actually broke a bone" exactly the sort of thing that we'd like the healthcare system to foster?

Posted by: TW Andrews on March 30, 2008 at 4:42 PM | PERMALINK

If I was a post-menopausal woman, I would prefer to take a pill every day rather than have an increased chance that I would have to go through all the trouble that could come with a hip fracture as an elderly woman.

"Some people using medicines similar to Fosamax have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums."

So take a (cheap) calcium pill.

Posted by: Don Bacon on March 30, 2008 at 4:44 PM | PERMALINK

I guess a key question would be (in addition to "is it snake oil?") whether the drug is any more effective than good diet, cheap calcium supplements, exercise, etc.? IOW, is the drug company inventing a preventative need that could be met much more simply and cheaply, without dangerous side-effects? That seems to be an implicit question in the article.

Posted by: Tim Morris on March 30, 2008 at 4:48 PM | PERMALINK

The so-called "disease" or "condition" that they're talking about here doesn't sound like such a terrible thing to get treatment for. Enhancing bone density: a good thing.

What would be ludicrous would be treatments and products for things that are--ludicrous. We were cackling at our house recently because we saw a print ad for Provigil, with its talk about how it can treat "Excessive Sleepiness" or "E.S." We're not talking about people who have narcolepsy here or true medical conditions. We're talking about a bullshit new condition called Excessive Sleepiness.

"Madge, have you had your Excessive Sleepiness checked out? You should really really see a doctor. Help is on the way! A lifelong treatment regimen including the daily consumption of expensive tablets could be the answer!"

And then of course you have Restless Legs Syndrome, which is just symptoms or a symptom in search of a disease. Which is basically all "syndrome" means--"Oooh, you have a symptom! I'll bet that means you have a symptom!" People with "R.L.S." are simply getting old and they don't like it. They need to excercise, move, and stretch. If they wake up with leg discomfort in the middle of the night they just need to flex and point and stretch their legs until the feeling goes away.

Posted by: Anon on March 30, 2008 at 5:03 PM | PERMALINK

Just had a relatively superficial discussion about this with my wife, a university clinician/researcher (MD) working primarily on bone wasting in the elderly. Quick summary of things she had to say (please note this is me summarizing a casual conversation, not the public testimony of a physician; I offer it for what it's worth):

- There's a lot of data out there on osteoporosis and -penosis, and a lot of it is pretty nuanced. Politicially driven actors are going to be able to argue it one way or the other.
- By the same token there's a huge range of factors that go into the judgment of how to follow and treat a patient who by crude metrics may be at risk for bone loss. Certain kinds of patients she would follow very closely, others she wouldn't worry about. Takes experience, judgment, evaluation.
- There definitely has been some unwarranted hyperventilation about acquiring and tracking "fracture data" among doctors, but that's a generalization, not a law.
- She thinks Fosamax is generally a very effective drug, that it's made a huge difference in many patients' lives, that it can make fractures just stop.
- She notes that hip fractures have a very high mortality rate, and that the social cost of treatment and care for fracture survivors is also very high.

All of which tends to nuance the argument made above. But I'll add the context that changes the whole picture, which is that:

- she's working on improving low-cost treatments to fortify patients against bone and muscle loss, exactly the sort of initiative that should help get past the underlying problem here --- but will probably leave her position soon because there is essentially no funding available.

That's a problem I imagine most progressives can agree on solutions for.

Posted by: andrew on March 30, 2008 at 5:04 PM | PERMALINK

As far as Restless Legs Syndrome goes, I can attest that it is real. I've had it for as long as I can remember. I finally got a prescription from my doctor and now I can't imagine not taking it.

I know it's a pretty rare condition for young people. It's pretty much unbearable. I took a sleep study and they found that I kicked myself awake 80 times that night.

In regards to "preventative medicine", it's clear that there is often huge overreach here. The most obvious example is the circumcision/mutilation of children to prevent stuff like UTIs (rare and easily treatable) or HIV (preventable with safe sex).

Posted by: Steve on March 30, 2008 at 5:20 PM | PERMALINK

They should name a drug company Google.

Posted by: Jet on March 30, 2008 at 5:55 PM | PERMALINK

So take a (cheap) calcium pill. - Don Bacon at 4:44

I agree. I belong to Kaiser HMO, which believes in preventative (cheap) medicine. As an older woman, I have been taking one calcium pill a day for years, plus one calcium chew (a chocolate candy.)

Also, according to Wikipedia, I have been doing several things right over the years. Namely, not smoking, not drinking excessive amounts of alcohol (especially when I was young) or any soft drinks, and not using steroids. On the plus side, I have done a lot of walking over the years and climbing of stairs, both weight-bearing exercises that strengthen bones.

I haven’t taken any bone density tests yet, but I have performed my own tests that I wouldn’t recommend to anyone. Twice, I have fallen flat on my face, because I wasn’t paying attention. (I am a daydreamer.) The last time was at the age of 65 and I was wearing a thick coat when I didn’t notice a curb and fell hard, face down, on a sidewalk. Both times I hurt a lot for days, but didn’t break any bones.


Posted by: emmarose on March 30, 2008 at 6:02 PM | PERMALINK

People with "R.L.S." are simply getting old and they don't like it. They need to excercise, move, and stretch. If they wake up with leg discomfort in the middle of the night they just need to flex and point and stretch their legs until the feeling goes away.

Au contraire, Pierre. I had it off and on for years in my 30s and 40s (I'm now in my 60s), when I was getting plenty of exercise. In my case, it didn't wake me up at night but rather prevented me from going to sleep. Flexing and pointing and stretching did bubkes. Absolutely maddening, intolerable sensation. Thank God it eventually went away almost completely, for no good reason that I can discern.

Posted by: Swift Loris on March 30, 2008 at 6:08 PM | PERMALINK

I've often wondered about this very question. My wife undergoes a bone density scan every year and has been prescribed Boniva. I'm very skeptical about the benefits of this given how much easier calcium should be able to be obtained.

I am lucky in that I don't have to visit the doctor often, but, when I do, I notice the young and very attractive drug salespersons who are constantly coming and going. On the last visit I also noticed that there were several tissue boxes around the office all advertising some drug.

I subscribe to several magazines, but I notice that the magazines in my doctor's office seem to have a preponderance of drug ads leading me to believe that the magazines are specifically provided by drug companies.

Interesting stuff!

Posted by: tommy on March 30, 2008 at 6:20 PM | PERMALINK

...And of course, there's no evidence that this treatment actually prevents the result.

Posted by: Crissa on March 30, 2008 at 9:37 PM | PERMALINK

Don Bacon wrote:

So take a (cheap) calcium pill.

Wow, is this really right?

I thought the condition was related to having a problem absorbing calcium that simply adding more calcium alone doesn't necessarily solve.

Watch out for med advice from non-MDs on the Internet!

Posted by: Swan on March 30, 2008 at 10:08 PM | PERMALINK

Before the 1990s, doctors decided that you had osteoporosis if you were elderly and you broke a bone.

Before the 1990s there was no good way to measure osteoporosis. Now we have pretty good data (for caucasian women, anyway) that correlates bone mineral density as quantified by bone scans with risk for fracture. We also have good data that shows that bisphosphonates decrease fracture risk.

Calcium is very important for preventing osteoporosis, but is not effective for reversing osteoporosis, so "cheap calcium" is not an effective substitute for (over-priced!!) bisphosphonates.

Posted by: on March 30, 2008 at 10:34 PM | PERMALINK

I just read this book this weekend and it was very good.

Posted by: Britta on March 31, 2008 at 9:53 AM | PERMALINK

Calcium is very important for preventing osteoporosis, but is not effective for reversing osteoporosis, so "cheap calcium" is not an effective substitute for (over-priced!!) bisphosphonates. --[blank] at 10:34

I was probably being a little flippant when I said that I take cheap calcium; but, I, also, tried to point out all the things I have done over a lifetime to prevent osteoporosis. That is the message that gets missed in all the TV ads promoting new wonder drugs that you admit, in this case, are not meant for all women.

I am very aware of how devastating osteoporosis can be. My own mother died shortly after breaking her hip in 1992. She was taking calcium tablets, but canceling out all the benefits by continuing to smoke. And, last December, one of her sisters died at age 83 of congestive heart failure. But, she also broke her back 18 months before, due to osteoporosis, and lived in constant pain during her final months. I visited her many times, especially during her last stay in a rehab center, the month before her death, after she fell and cracked her pelvis. I saw lots of crumpled old ladies sitting in the hallway of the center in wheelchairs. So, you are right. Treatment for reversing osteoporosis is very important.

My aunt, who belonged to Kaiser, was taking Fosomax. I know that because she tried to give me her extra pills, because, as she said, they were so expensive. But, I don’t know how long she had been taking them. She was an obstinate person. If someone recommended that she do A, she invariably chose to do B. So, I doubt that Kaiser was stringing her along with cheap calcium, instead of expensive Fosomax. The Fosomax would have been much cheaper than all the medical care she got in her last 18 months of life.

I guess I get upset about treating people, after the fact, with expensive treatments, instead of emphasizing prevention in the first place—like Kaiser does. I get annual mammograms, regular pap smears, blood tests to watch cholesterol, annual flu shots, etc.

Six years ago I took a short temp job to replace a clerical worker who went on sudden maternity leave when her baby came early. The job was in a famous, national health insurance company (not an HMO.) On the first day, my supervisor took me around to all the cubicles to introduce me to the section staff, about 15 women. The cubicles were tall, so you couldn’t see a person, until you got to their desk. At first, I was amazed by the number of overweight women, then it almost became a private joke, and extremely sad, to me to discover how overweight the next person on the tour was going be. The next shocker was to discover all the empty soft drink bottles and drawers of junk food I found in the cubicle of the new mother I was replacing. But, that turned out to be the norm in the office. Everyone was sitting at their desks all day, working right through lunch and breaks, and constantly wolfing down unhealthy food. (If someone had to go to another floor, they invariably took the elevator, instead of using the stairs.) As I got to know the women, I learned about the many health problems that they had, most of which were completely preventable. (One extremely overweight woman had a blood clot in her lung.) To me, they symbolized how completely out of whack our health system is.

There should be more TV ads promoting a healthy life style.

P.S. I saw a report on the TV news last night that a panel of doctors has criticized the effectiveness of Vytorin for treating high cholesterol and they recommend that patients be given the generic drug simvastatin, which I currently take. They said it was more effective (and it is much cheaper.)

Posted by: emmarose on March 31, 2008 at 1:42 PM | PERMALINK

That was me at 10:34.

Most bone mineralization takes place by age 25 with very little continuing through about age 35. Then bone mineralization is static until there is an abrupt drop off after menopause. Unfortunately, that means that calcium is most effective for osteoporosis prevention when given to teenagers. Believe it or not, it's hard to get a 17 year old to take calcium pills to prevent a fracture in her 80s.

Although there are studies that show that fractures are reduced by bisphosphonates, studies have never shown that fractures are reduced by post-menopausal calcium supplements.

Talk about overtreating. Vitamins have been over used since they were discovered in the 1920s. Ditto mineral supplements. Even when they have been shown to be useless, the vitamin pushers continue to insist that people need to take them.

Posted by: J Bean on March 31, 2008 at 2:22 PM | PERMALINK

Believe it or not, it's hard to get a 17 year old to take calcium pills to prevent a fracture in her 80s. -- J Bean at 4:44

Thank you for your informative response. I have often thought that someone should invent a board game for teenagers with little nuggets of information like the above. There could be piles of cards that players could draw from, when they landed on certain squares that said things like, “Congratulations! You remembered to take your calcium pill today. You have reduced your chances of breaking your back when you are 80.”

I offer this idea for free to anyone who wants to pursue it.

Posted by: emmarose on March 31, 2008 at 4:53 PM | PERMALINK

Oops. That should have been J Bean at 2:22

One reason that I have thinking about health advice for teens is that my 8th-grade class graduated 52 years ago this spring. Some of us decided to contact as many classmates as possible and put together an address list, plus a blog of information about what people are doing.

Out of 85 in our class, 19 have already passed away, including two this month. It is very sobering to see this happen.

Posted by: emmarose on March 31, 2008 at 6:07 PM | PERMALINK




 

 

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