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Last Updated: Thursday, 26 July 2007, 11:29 GMT 12:29 UK
Fears over bone drug restrictions
By Jane Elliott
BBC News, health reporter

Lorna Young
Lorna had four vertebrae fractures

One minute Lorna was well and healthy - the next she was in agony for nine months after fracturing four vertebrae in her spine.

Doctors discovered that at the age of 56 she had severe osteoporosis and had lost 40% of her bone mass - making her very susceptible to fractures.

Osteoporosis - literally "porous bones" - causes a loss of mineral density in the bones, which makes them more likely to break.

The first three treatments Lorna was prescribed were "ineffective", but a fourth worked and her bones are now starting to show some improvements.

Appeal launched

However, campaigners say a decision by NHS drug advisors means that in the future women like Lorna could be left without suitable treatments or forced to pay out thousands of pounds each year to protect their bones.

The National Osteoporosis Society (NOS) has announced that it is to launch an appeal against what it feels are over-restrictive policies.

They said I had the bones of a 90 year-old
Lorna Young

The National Institute for Health and Clinical Excellence (NICE) say one drug called alendronate (Fosamax) should be prescribed to osteoporotic patients at high risk of breaking a bone.

But the NOS says the drug is unsuitable for one in four patients and that without mandatory options hundreds of thousands could be left without viable treatments.

They claim that with NHS resources being stretched, PCTs are only funding mandatory treatments and will not consider others.

NICE stressed it had not yet released its final guidance, which is expected in August 2007.

A spokesperson said future guidelines would consider the treatment of women who cannot take or have withdrawn from treatment with alendronate.

Terrible struggle

Lorna Young, 69 and from Inverness, was initially placed on HRT after her first spinal fracture. A scan showed her bones were in a terrible state.

"They say it is a silent disease and that is true - that bone loss did not happen over night," she said.

"They said I had the bones of a 90-year-old.

"A fracture does heal, but it is excruciating. I felt destroyed."

Lorna had worked in a bank, but after her fractures she never returned, spending nine months recovering.

Almost half of UK women aged over 50 will break a bone due to osteoporosis
The lifetime risk of fractures for women aged 50 is greater than risk of breast cancer or cardiovascular disease
The number of annual hip fractures doubled last century and is expected to double again to 117,000 a year by 2016
Broken hips cost hospitals an estimated 12,000 per incidence, not to mention the additional personal and social costs
The combined cost of hospital and social care for patients with a hip fracture is more than 1.73 billion annually - similar to the cost of coronary heart disease

"It was diabolical. I could not get into a car to go to hospital. I had terrible problems and had to sleep in a chair for three weeks and it was nine months before I could lie down in bed.

"The doctors could find no reason why my bones had broken at that point."

Next doctors prescribed Lorna with alendronate, but it did not work for her.

She was then given daily injections of Forsteo (teriparatide) for 18 months, but again this was ineffective.

So she was prescribed strontium ranelate, which is showing positive signs of bone improvement.

Drug tolerance problems

Sarah Leyland, NOS nurse, said under the new guidance, patients might not be as lucky as Lorna.

"The fact is that this drug can not be tolerated by a number of people including those with gastric problems."

She added that people denied drug options could find themselves with serious problems.

"If there are not any mandatory second-line treatments the GPs will not fund them and the PCTs will not fund them."

An osteoporotic bone. Photo Credit: Steve Gschmeissner/SPL
Osteoporosis sufferers are likely to break bones

Claire Severgnini, NOS chief executive, said NICE was taking the short-term view.

"This is a false-economy by NICE that leaves hundreds of thousands of people unnecessarily at increased risk of painful and life-threatening fractures.

"This appraisal needs to look beyond first line treatment: NICE must recognise the needs of the hundreds of thousands of osteoporosis patients for whom alendronate will not be a viable treatment.

"NICE should support a range of cost effective treatment options in order to protect all patients from fractures according to their individual needs - a 'one treatment for all' policy is unfair and short-sighted."

Professor David Reid, chair of the NOS Medical Board said: "The NOS are appealing because if a woman is assessed as requiring treatment and is either intolerant of generic alendronate or it is contra-indicated, there is no guidance on how to treat.

These new draft recommendations widen access to primary prevention treatment
Professor Peter Littlejohns

"A range of fairly inexpensive treatment options are available and it is bad clinical practice to determine that a patient requires therapy and then withdraw that treatment without instituting alternatives."

NICE said that until the new guidelines were published, its existing guidance on secondary prevention of osteoporosis in postmenopausal women will apply, which recommends alternative treatment options for those women who cannot take or who have withdrawn from alendronate.

Earlier this year, NICE issued draft recommendations increasing access to drugs for those over 70 years old or those who have broken bones, but not for those who are younger and at risk of a break.

Professor Peter Littlejohns, NICE clinical and public health director and lead for the appraisal, said this would make alendronate available to more.

"The new draft recommendations make it easier for postmenopausal women to start treatment to either prevent a first osteoporotic fracture or to help stop an osteoporotic fracture from happening again.

"In particular these new draft recommendations widen access to primary prevention treatment to include postmenopausal women aged under 70 with the clinical criteria indicating low bone mineral density and increased fracture risk." .


SEE ALSO
Women can stop bone-saving drug
27 Dec 06 |  Health
New way to build stronger bones
08 Oct 06 |  Health

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