Fracture warning over bone drugs

18 October 2010 Last updated at 20:24 ET By Michelle Roberts Health reporter, BBC News

US regulators are warning patients that drugs used to protect brittle bones may increase fracture risk in rare cases.

The Food and Drugs Administration (FDA) says all drugs in the bisphosphonate class must carry an alert on their label about this unusual side effect.

They say patients should keep taking the pills unless they are told by their doctor to stop.

In the UK, only one bisphosphonate drug - alendronate - carries the warning but regulators are reviewing this decision.

Nearly three million people in the UK have osteoporosis, a condition that makes the bones brittle and causes about 230,000 fractures a year.

Bisphosphonates are given to more than half a million of these patients in a bid to strengthen their bones and reduce their risk of a fracture.

But experts are becoming increasingly concerned that the drugs may cause the very thing they are trying to prevent after finding a link between their use and an unusual type of leg fracture.

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At present it is uncertain whether these fractures are directly related to treatment but an association has not been excluded"

End Quote A spokesman for the National Osteoporosis Society

The FDA says it is not clear whether bisphosphonates are the cause of these thigh bone breaks, but they are concerned enough to tell manufacturers to add warnings to medication packets.

FDA medical officer Theresa Kehoe said they would continue to monitor the safety of the drugs, adding: "In the interim, it's important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis."

The FDA says patients should keep taking their medication unless they are advised by their doctor to stop.

Under review

The UK's drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), said it had begun to look at the possible increased risk of fractures in patients taking bisphosphonates in case it was an effect common to all members of that drug family, not just alendronate.

A spokeswoman said: "The committee will now review all available data thoroughly, including published data, non-clinical and clinical data, and post-marketing reports, to clarify whether atypical stress fractures are a class effect of bisphosphonates, and will assess their impact on the balance of risks and benefits of these medicines."

A spokesman for the National Osteoporosis Society said: "At present it is uncertain whether these fractures are directly related to treatment but an association has not been excluded.

"Bisphosphonates slow down the rate at which bone is destroyed and replaced, by reducing the activity of osteoclast cells that break down bone.

"Although this is a useful process to prevent bone loss and fractures, there are concerns that over a prolonged period of time, this may result in bones becoming 'older' and more brittle."

He said it should be remembered that these unusual fractures are rare and that in the vast majority of patients the benefits of treatment will far outweigh the risks.

A recent study, published last month in the British Medical Journal, linked bisphosphonate use to cancer of the gullet.

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Violent images 'boost aggression'

18 October 2010 Last updated at 20:10 ET

Repeated viewing of violent scenes in films, television or video games could make teenagers behave more aggressively, US research suggests.

The National Institutes of Health study of 22 boys aged 14 to 17 found that showing dozens of violent clips appeared to blunt brain responses.

Dr Jordan Grafman said it might make aggression feel more "acceptable".

However, a UK expert said the reasons behind violence were too complex to be explained by laboratory research.

The effect of violent imagery on young people has been debated from the early days of television, and, more recently, that debate has expanded to include video games.

Various studies have suggested that exposure appears to have an effect on the way that the brain processes emotional responses, yet it is unclear whether this can have a direct impact on behaviour.

The US study, published in the journal Social Cognitive & Affective Neuroscience, involved 60 violent scenes from videos being collated, mostly involving street brawling and fist fights.

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The suggestion is that, over a period of time, people can develop a kind of tolerance to these images - but another word for that is just boredom"

End Quote Professor David Buckingham Director of the Centre for the Study of Children, Youth and Media

The violence was ranked "low", "mild" or "moderate", and there were no "extreme" scenes.

The response of the boys as they watched the clips was measured in a number of ways.

They were asked to rate whether they thought each clip was more or less aggressive than the one which preceded it, and were brain scanned using functional magnetic resonance imaging, which shows in real time which areas of the brain are active.

In addition, electrodes attached to the fingers detected increasing sweat - a sign of an emotional response.

The longer the boys watched videos, particularly the mild or moderate ones, the less they responded to the violence within them.

In particular, an area of the brain known as the lateral orbitofrontal cortex, thought to be involved in emotional processing, showed less activity to each clip as time went on.

'Social problem'

Dr Grafman said: "Exposure to the most violent videos inhibits emotional reactions to similar aggressive videos over time and implies that normal adolescents will feel fewer emotions over time as they are exposed to similar videos."

He said that this could actually produce more violent reactions from the teenager.

"The implications of this include the idea that continued exposure to violent videos will make an adolescent less sensitive to violence, more accepting of violence, and more likely to commit aggressive acts since the emotional component associated with aggression is reduced and normally acts as a brake on aggressive behaviour."

However, another academic said it was almost impossible to explain violence in these terms.

Professor David Buckingham, the director of the Centre for the Study of Children, Youth and Media, said that violence was a "social problem" with many contributing factors, not simply a matter of looking at how the brain worked.

"The suggestion is that, over a period of time, people can develop a kind of tolerance to these images - but another word for that is just boredom.

"This debate has been going on since before we were all born. In the 19th Century people were panicking about the effect of 'Penny Dreadfuls'.

"If we are truly interested in violence and aggression, rather than blaming the media for everything wrong in the world, we need to look at what motivates it in real life."

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Patients to control NHS records

18 October 2010 Last updated at 08:12 ET

Patients are to be put in charge of their medical records online under proposals for an "information revolution" in the NHS.

In the future, patients will be able to log on to keep track of their treatment and make choices about the care they will receive.

England's Department of Health says the moves, put out for consultation, should drive up standards.

It says everyone should have choice and control over their care by 2013/14.

Everyone who is cared for by the NHS in England already has formal rights to make choices about the service that they receive.

These include the right to choose a GP surgery, to state which GP you want to see, to choose which hospital you are treated at, and to receive information to support your choices.

But the government says it wants to extend this offer of choice to mental health services and end of life care too.

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The NHS should ensure that for patients, "no decision about me, without me" is the invariable practice"

End Quote Andrew Lansley Health Secretary

Health Secretary Andrew Lansley said: "We want to go further than simply offering people a choice of hospital.

"Patients should have choice at every stage of the journey - where they register with a GP, where they go for tests, who they see for treatment, and what care or treatment they receive from any willing provider.

"Above all, they should be able to change these choices at any stage."

And the government sees the internet as the key tool for patients to be able to exercise these choices.

Information revolution

It promises in its consultation an "information revolution", starting with accurate online records that summarise each patient's care.

Every patient would have a username and password and could update their records with information like blood pressure and cholesterol levels.

And those requiring treatment would be able to check out different options - comparing the performance of different hospitals and doctors, for example.

Mr Lansley said: "The NHS should ensure that for patients, "no decision about me, without me" is the invariable practice.

"To realise this means patients must have more say and more choice."

Professor John Williams, Director of the Health Informatics Unit at the Royal College of Physicians said the moves were much needed.

"As it stands the management of data in the NHS leaves much to be desired.

"Useful information rarely follows the patient through the system, making it more difficult for doctors and nurses to provide them with the personalised treatment they have a right to expect."

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Early menopause genes unravelled

17 October 2010 Last updated at 19:10 ET

Research into the genetics of early menopause may lead to a simple test for women, says a UK scientist.

One in 20 women starts their menopause before the age of 46 - which can affect their chances of conceiving even a decade earlier.

The study, published in Human Molecular Genetics, found that four genes working in combination appeared to raise the risk significantly.

This could eventually help identify women at greatest risk.

Menopause is normally triggered when the number of remaining eggs in the ovary falls below about 1,000.

However, the biological controls which determine how quickly this ovarian egg reserve is used up are less well understood.

The researchers, from the University of Exeter and the Institute of Cancer Research, looked at four genes already thought to have some link to the menopause.

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A woman's ability to conceive decreases on average 10 years before she starts the menopause."

End Quote Dr Anna Murray University of Exeter

They took 2,000 women who had experienced early menopause, and a similar number of women who had entered the menopause at the normal age.

They found that the presence of each of the four genes appeared to have some influence on the age of menopause.

Egg depletion

When more than one was found in a woman's genetic makeup, the impact was even greater.

Dr Anna Murray, from the University of Exeter, said that the ability to predict menopause was not just important at the time, but could be crucial to decisions made many years earlier.

In particular, the quicker-than-expected depletion of the egg reserve could make a difference to a woman's ability to conceive.

She said: "It is estimated that a woman's ability to conceive decreases on average 10 years before she starts the menopause.

"Therefore, those who are destined to have an early menopause and delay childbearing until their 30s are more likely to have problems conceiving."

She added: "These findings are the first stage in developing an easy and relatively inexpensive genetic test which could help the one in 20 women who may be affected."

Professor Anthony Swerdlow, from the Institute of Cancer Research, described the findings as a "valuable step" towards helping women work out if they are at risk.

"This may in turn allow them to make informed decisions about their future fertility," he said.

This is not the first attempt to find a way to identify those women who are at greatest risk of an early menopause.

Other methods include using ultrasound to assess the number of eggs left in the ovary, to try to work out how quickly that number is falling.

The latest study is part of a major effort - the Breakthrough Generations Study - following the fortunes of 100,000 women in an effort to reveal the causes of diseases such as breast cancer.

Iranian scientists also say that measuring levels of a hormone called AMH on a three-yearly basis may also be able to predict the problem years in advance.

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