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CSM stands by HRT advice

The Committee on Safety of Medicines has refuted calls to withdraw 'unsound' advice on hormone replacement therapy based on the Million Women Study.

In August the CSM issued warnings over combined HRT after the study suggested it caused a 'substantially greater' risk of breast cancer than other types. But women's health experts, including consultant oncologists, rheumatologists and epidemiologists, have argued in medical journals that the study's 'flawed' meth- odology overestimated HRT's risks.

Concerns centred around the study's follow-up period being 'too short' and the results contradict findings of previous major studies and are of 'borderline statistical significance'.

Dr John Stevenson, executive member and past-chair of the British Menopause Society, branded the CSM's advice 'premature'.

Dr Stevenson, consultant physician at the Royal Brompton Hospital in London and fellow of the European Society of Cardiology, has written to the CSM as chair of charity Women's Health Concern to demand its withdrawal.

'If you're going to base advice on something it's got to be absolutely sound. Enough concerns have been raised to say we shouldn't be using the Million Women Study as major evidence on which to base recommendations,' he said.

The CSM said it had no intention of withdrawing its advice as the study authors had reviewed the concerns and believed they did not invalidate their 'main conclusions'.

CSM member Dr Ross Taylor, a GP and former member of its HRT working group who attended meetings over the study findings, said the committee's advice was there to protect GPs from legal claims over HRT as well as inform women.

Dr Taylor, senior lecturer in general practice and primary care at the University of Aberdeen, said he was 'quite convinced' the study findings were valid.

'It wasn't just accepted without question,' he added.

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