Twenty-four of the world’s leading experts in postmenopausal health have condemned current European prescribing information for the prevention of osteoporosis as detrimental to female health and well being. Putting their names to a paper in the April issue of the journal Human Reproduction, the experts say that the present regulatory restrictions are based on a misinterpretation of recent studies and should be “revised as a matter of urgency”.

Behind the conclusions lies an “urgent safety request” made by the heads of European regulatory agencies – including the UK – in December 2003 which relegated the use of hormone replacement therapy (HRT) to a second-line treatment in the prevention of osteoporosis.

This move, enacted on the grounds of safety, was largely based on two studies, the Women’s Health Initiative (WHI) and the Million Women Study (MWS). Interpretation of these studies – especially by the regulatory agencies and their advisors – has created uncertainty about the use of HRT amongst both clinicians and patients. The result has been a decrease in HRT use, which has left many postmenopausal women suffering ill health as a result.

Today’s paper, published online by Human Reproduction ahead of print, comes from an ad hoc consensus group led by Dr John Stevenson, consultant endocrinologist at the Royal Brompton Hospital in London and Chairman of the independent charity Women’s Health Concern. The group, which now challenges the views of the regulatory authorities on HRT, is composed of 24 internationally acclaimed experts from various specialties relating to the efficacy and safety of HRT and constitutes the largest expert group to assess its risks and benefits.

The group was concerned that the evidence base for the recommendations made by many regulatory authorities, including the UK’s Committee on Safety of Medicines, was mainly restricted to the two studies, the WHI and MWS, both of which have been heavily criticised. The authorities also ignored a large body of other evidence showing that benefits far outweigh risks when HRT is given for its appropriate indications. These studies show that, in terms of benefits, there is nothing more effective or inexpensive than HRT for the prevention of osteoporosis.

With respect to safety, the group found that the safety issues raised by the regulatory authorities – increases in breast cancer and blood clots – were not new findings. Risks from both these conditions are extremely small and do not pertain to all types of HRT. In particular, the risk of breast cancer associated with HRT been overestimated by the MWS.

The paper’s lead author, Dr John Stevenson, says:

“With any treatment there will always be risks as well as benefits, and the balance must be weighed in each individual. In the current guidelines on osteoporosis prevention, the only treatment which is completely free of risks is the one that does not work.”

The group was concerned that regulatory authorities worldwide have been badly advised and have misinterpreted data from these recent studies. The group calls on the authorities to revise their recommendations as a matter of urgency – to restore confidence in the use of HRT which, as many studies have shown, has major health benefits for many women.

Reference of the paper

Stevenson JC, on behalf of the International Consensus Group on HRT and Regulatory Issues. HRT, osteoporosis and regulatory authorities. Quis custodiet ipsos custodes? Human Reproduction 2006; published online.