Intended for healthcare professionals

Rapid response to:

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

Rapid Response:

Drugs for pre-osteoporosis: an example of prejudice-based medicine?

Dr Alonso-Coello and colleagues attack industry and some health care
professionals for advocating bone protective therapy for women with
osteopenia. In putting their case they reveal their ignorance of major
advances
that have occurred in the prediction of fracture risk, in particular the
utility of
clinical risk factors in improving fracture risk prediction. The majority
of
women who suffer a fragility fracture do not have osteoporosis as defined
by
a bone mineral density T-score below -2.5 SD,1 and one reason for this is
that many women have clinical risk factors that increase fracture risk
independently of bone mineral density.2 Hence, a woman with osteopenia (a
term that covers a wide range of bone densities) may have a higher
fracture
probability than one with a T score below -2.5 SD.. The recommendation by
the authors that treatment decisions should be based on the assessment of
absolute risk of fracture is hardly a revelation; similar statements by
experts
in the field can be found in numerous publications over the past 5 years
and
this strategy forms the basis of current European guidelines and of the
forthcoming WHO report and risk algorithm. Investigation of the ability of

drug therapies to reduce fracture incidence in high risk women, regardless
of
whether they have osteopenia or osteoporosis, has necessitated the
analyses
that are so maligned by Alonso-Coello and colleagues.

Other misconceptions and inaccuracies must also be mentioned. Whilst
there
may have been isolated examples of inappropriate marketing, there is
widespread acceptance among health care professionals for the need to
incorporate cost-effectiveness into decisions about treatment and, as
acknowledged by the authors, treatment of women at high risk of fracture
is
cost-effective.3 The description of the “rare but catastrophic
osteonecrosis of
the jaw” as a side-effect of oral alendronate therapy is scare-mongering
and
unbalanced; a causal relationship between oral bisphosphonates in the
doses
used for osteoporosis and osteonecrosis of the jaw has not been firmly
established.4 Finally, potential conflicts of interest exist in many
forms:
personal prejudices, as well as financial incentives can be a barrier to
objectivity.

For those of us fortunate enough to have been involved in
osteoporosis
research and patient care over these last two decades, the emergence of
technologies for non-invasive assessment of bone mass and of a range of
effective therapeutic options has heralded a revolution in care for what
was
previously regarded as an inevitable consequence of aging. Indeed, the
pace
of these advances and their translation to improving human health has
resulted in more rapid progress in management than that seen in
cardiovascular disease and diabetes mellitus. Furthermore, the health
economic basis for appropriate utilisation of these translational
discoveries is
established and provides a rational use of scarce healthcare resources.
At a
time when governmental research agencies such as the MRC and NIHR are
calling for translation of medical research to improve human health, it
seems
anachronistic for our national medical journal to be espousing the view
that
such research, honestly undertaken, simply represents the end-product of
an
unholy alliance between corporate giants and unethical investigators. The
tone and content of the analysis by Dr Alonso-Coello and colleagues does a

disservice both to sufferers from the disease and to those in the field
who
strive to reduce the enormous mortality and morbidity attributable to
osteoporotic fractures.

1. Siris ES, Chen YT, Abbott TA, Barrett-Connor E, Miller PD, Wehren
LE et al.
Bone mineral density thresholds for pharmacological intervention to
prevent
fractures.
Arch Intern Med. 2004;164:1108-12.

2. Kanis JA, Oden A, Johnell O, Johansson H, De Laet C, Brown J et
al.The use
of clinical risk factors enhances the performance of BMD in the prediction
of
hip and osteoporotic fractures in men and women. Osteoporos Int.
2007;18:1033-46.

3. Kanis JA, Adams J, Borgström F, Cooper C, Jönsson B, Preedy D et
al. The
cost-effectiveness of alendronate in the management of osteoporosis. Bone.

2008;42:4-15.

4. Khosla S, Burr D, Cauley J, Dempster DW, Ebeling PR, Felsenberg D
et al for
the American Society for Bone and Mineral Research. Bisphosphonate-
associated osteonecrosis of the jaw: report of a task force of the
American
Society for Bone and Mineral Research. J Bone Miner Res 2007;22:1479-91.

Competing interests:
Prof Compston has received
payment for consultancy work
and/or speaking engagements
from Procter & Gamble, Eli Lilly,
GSK/Roche, Amgen, Pfizer,
Servier, Shire, Novartis,
Nycomed and Wyeth and has
been reimbursed for attending
scientific conferences by Procter
& Gamble, Eli Lilly, and Servier.
She receives funding for a grant
from Procter & Gamble and
Servier and has acted as an
expert witness in several cases
of glucocorticoid-induced
osteoporosis and in an
alendronate patent dispute.

Competing interests: No competing interests

10 February 2008
Juliet E Compston
Professor of Bone Medicine
Alun Cooper, Cyrus Cooper, Roger Francis, John Kanis, Eugene McCloskey, David Reid, Peter Selby for the National Osteoporosis Guideline Group
University of Cambridge School of Clinical Medicine, Cambridge CB2 2QQ