'Women must have brittle bone drug', campaigners beg NHS

The Health Secretary must overturn 'farcical' rules that deny thousands of women medicine for thinning bones, campaigners say. In an unprecedented move, the National Osteoporosis Society, of which the Duchess of Cornwall is president, is writing to Alan Johnson asking him to intervene over the 'unfair and clinically unworkable' guidance.

Guidelines set by the Government's drug regulator mean doctors are only able to give women with osteoporosis the cheapest drug available - even though a quarter cannot take it. Those who cannot tolerate alendronate will have to prove that their condition has worsened by up to 60 per cent before they are allowed to have alternative treatment. It is unethical as some women will have to get 'significantly worse' than other patients before receiving a treatment they need, the charity said.

It is likely to affect thousands who experience crippling stomach pains as a side-effect or do not respond to alendronate, which costs $100 a year. Other drugs cost $34 a month. A woman in her early seventies who cannot tolerate alendronate would have to get 20 per cent worse - using a clinical scoring system - to qualify for medication such as risedronate or etidronate. The same woman would have to deteriorate 60 per cent to be eligible for strontium ranelate.

Doctors fear that the restrictions proposed for England by the rationing body, the National Institute for Health and Clinical Excellence, could lead to an epidemic of broken bones among older women. Osteoporosis can affect anyone because of natural bone loss caused by ageing. But women are at greater risk. Up to 14,000 a year die as a result of an osteoporotic hip fracture. Many others experience debilitating pain and disability from fractures.

Last year, the charity won an appeal against even more draconian restrictions put forward by NICE. But it says this has made little difference in practice. It has decided not to appeal again - which would result in the same NICE team reviewing drug treatments for a third time - but it wants a fresh appraisal. In a letter to Mr Johnson, chief executive Claire Severgnini said: 'The recommendations remain unnecessarily restrictive, denying many patients treatment at a point where treatment might make most difference to longterm quality of life. 'Their condition must be allowed to get progressively worse before each alternative treatment will be prescribed. 'Using barriers to limit treatment without regard to clinical or cost effectiveness is not how NICE is meant to appraise treatment options.'

Nick Rijke, of the charity, said the whole process is a 'farce', based on a computer model of pricing options in which the cost of treating hip fractures was grossly under-estimated. NICE had failed to give the charity access to the model despite a legal judgment this year which ruled against similar secrecy used in a drugs ban imposed on thou-with Alzheimer's disease. Mr Rijke said: 'We have been left with no option other than to plead with the Department of Health to secure a fresh, open-minded and fair appraisal.

A Department of Health spokesman said NICE is appraising 'a number of treatments for primary and secondary prevention of osteoporotic fractures. 'Stakeholders have recently had the opportunity to lodge appeals against NICE's revised draft guidance and I understand that NICE has now received an appeal which will be heard in public. NICE will not issue final guidance to the NHS until the appeal has been heard and considered. 'It would be inappropriate for ministers to intervene in the conduct of an ongoing NICE appraisal.'

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