How did osteopenia, the precursor to osteoprosis, come about?
Fascinating story from NPR, detailing how a drug company popularized the condition in order to expand the market for their drug, Fosamax.
Osteopenia is diagnosed via a bone density study showing a “T-score” between -1.0 and -2.5. But how that definition came about was quite arbitrary.
In 1994, a group of researchers from the World Health Organization poured over data, and eventually, a decision had to be made. Here’s what happened, according to Dartmouth professor of medicine Anna Tosteson:
“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.
Doesn’t sound very evidence-based.
But Merck ran with it, and lobbied Medicare to cover bone density studies – key to popularizing the condition. Once they did, the tests become more accessible, and more and more women wanted it. Many were then diagnosed with osteopenia, and subsequently, were put on Fosamax.
Voila, the birth of a disease, and one that was quite profitable for Merck.
The whole NPR piece is well worth reading.
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{ 8 comments }
This is a very interesting article. Unfortunately, it also points to the difficulty faced by primary care health professionals when trying to provide the best care for patients. In the case of osteopenia, the move to start treating it happened so slowly. It was like a big grey area moved in and before long, everyone was confused and just had to make a decision about whether they’d buy in or hold out for more evidence. I think it really put both patients and their care givers in an awkward position.
Then again, how much of the osteopenia / osteoporosis is due to people (a) not getting any weight bearing exercise, (b) following dermatologists’ recommendations to avoid all sunlight exposure (resulting in vitamin D deficiency), and (c) not eating enough calcium containing foods?
Find a symptom or a laboratory ‘abnormality’. Medicalize it. Manufacture a drug against it, or better yet, use an existing medicine. Then, let the marketers take over. Eureka!
Here’s another way Dr. Kirsch.
Take a drug that grandfathered in to the FDA. A drug that was used with success long before there even was a FDA. So no safety and efficacy studies were ever done.
Do the studies proving what doctors had known for years. Get FDA approval and exclusivity.
Litigate the generic manufacturers out of the market. They are using “unapproved” drug. It’s the same drug, same dose, but not approved by the FDA. It was OK last year, but not now.
Then with the market all to yourself, take the drug that used to cost five cents a pill, and charge five dollars a pill.
Quinine to Qualaquin
Colchicine to Colcrys
http://www.kaiserhealthnews.org/Stories/2009/December/29/FDA-approval.aspx
Why wait to treat until a t score of -1.0? What about 0- -1.0 range- these women should be treated if were concerned about prevention, right?? and no, no lifestyle recommendations were made. Studies show either drug or no drug..
I agree that many of the tactics used by the pharmaceutical companies are aggressive, perhaps unethical. But doctors are also to blame because they are too stupid to realize that drug reps are not their friends, but are salesman, compensated by commission. Many doctors prescribe meds based on who brought the best jelly donuts, and not the facts.
But everyone is missing the benefit of Merck’s actions here. You can’t deny that osteoporosis and the resulting morbidity and mortality are very real. Prior to the introduction of bisphosphonates, there was no effective treatment other than diet/lifestyle changes. I agree that diet and lifestyle changes are very important and should be first line, but medication can add to that.
It was Merck’s actions that enabled more women to be screened with pushing for Medicare coverage for bone density scans. You forget the women who were screened and treated, preventing the morbidity and mortality of osteoporosis.
Was the diagnostic criteria of osteopenia arbitrary? Probably, but so are many other medical diagnoses. Did Merck benefit from this? Yes. Should doctors recognize this and evaluate the data themselves and reach there own conclusions and prescribe accordingly? Yes. But as I said before, most doctors are too stupid to realize that Drug reps are salesmen, not friends, and are wooed by the free diners and cheap pens.
I believe that Doctors are as much to blame as the pharmaceutical companies for the overuse of some medications
By the way, i am a practicing physician. We have banned drug reps and their samples from our offices.
Nice post Chris. Too bad more doctors don’t think AND act like you have. Get rid of those reps!
Read Overdosed America by John Abramson, M.D., on Osteoporosis for eye-opening information.
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