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Analysis

Drugs for pre-osteoporosis: prevention or disease mongering?

BMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39435.656250.AD (Published 17 January 2008) Cite this as: BMJ 2008;336:126
  1. Pablo Alonso-Coello, family practitioner1,
  2. Alberto López García-Franco, family practitioner2,
  3. Gordon Guyatt, professor3,
  4. Ray Moynihan, conjoint lecturer4
  1. 1Iberoamerican Cochrane Center, Department of Clinical Epidemiology and Public Health, Hospital de Sant Pau (Universidad Autónoma de Barcelona), 08041, Barcelona, Spain
  2. 2Servicio Madrileño de Salud, Madrid, Spain
  3. 3Department of Clinical Epidemiology and Biostatistics and Department of Medicine, McMaster University Faculty of Health Sciences, Hamilton, ON, Canada
  4. 4Faculty of Health, University of Newcastle, Callaghan, New South Wales, Australia
  1. Correspondence to: P Alonso-Coello palonso{at}santpau.es
  • Accepted 9 December 2007

After looking at data used to support treatment of women with slightly lowered bone mineral density, Pablo Alonso-Coello and colleagues argue thatproponents have overstated the benefits and underplayed the harms

Osteoporosis is a controversial condition. An informal global alliance of drug companies, doctors, and sponsored advocacy groups portray and promote osteoporosis as a silent but deadly epidemic bringing misery to tens of millions of postmenopausal women.1 For others, less entwined with the drug industry, that promotion represents a classic case of disease mongering—a risk factor has been transformed into a medical disease in order to sell tests and drugs to relatively healthy women.2 Now the size of the osteoporosis market seems set to greatly expand, as the push begins to treat women with pre-osteoporosis. These are women who are apparently at risk of being at risk, a condition known as osteopenia that is claimed to affect more than half of all white postmenopausal women in the United States.3 We examine the evidence from four post-hoc analyses of trials of osteoporosis drugs that is claimed to support this move.

Expanding an already controversial condition

In 1994 a small study group associated with the World Health Organization defined “normal” bone mineral density as that of young adult women, instantly categorising many older women as having abnormal bones.4 The working group proposed osteoporosis should be diagnosed when bone mineral density is 2.5 standard deviations below the mean for healthy young adult women and osteopenia be diagnosed when bone density was 1.0 to 2.5 standard deviations below the mean (table 1⇓). The authors of the definition stated these cut-off values were “somewhat arbitrary,” and as others have subsequently observed, these criteria were intended for epidemiological studies and not as the clinical treatment thresholds they are being used for today.6

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Table 1

 WHO classification of osteoporosis …

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