Monday, November 8, 2010

Statin increase 'will save lives'

Raising the dose of cholesterol-lowering drugs could prevent many more heart attacks and strokes, say researchers.

UK and Australian teams compared a standard statin treatment with a more intensive therapy, publishing results in the Lancet medical journal.

They concluded that higher doses cut heart attacks and deaths by 13%.

Experts warned that a bigger dose of the most popular statin could produce many more cases of side effects.

Statins cut levels of so-called "bad" LDL cholesterol, and the risk of heart attacks and strokes in higher risk patients.

Almost two million people in the UK are prescribed them, and one type is even available over the counter at pharmacies to patients assessed as at "moderate" cardiovascular risk.

Some studies have suggested that even greater benefits could be achieved if bigger doses of the drug were prescribed.

"Start Quote

It may be safer to lower cholesterol using low doses of the more potent statins rather than increasing the dose of simvastatin"

End Quote Dr Louise Bowman Study author
Aggressive therapy

The two studies in the Lancet were carried out at the universities of Oxford and Sydney, and pooled the results of dozens of other trials to give a more reliable verdict on the likely benefits and risks of doing this.

In the first study, when a standard statin regime was compared to an "intensive" regime, further drops in LDL cholesterol levels were produced.

In turn, there was a 15% further reduction in "major vascular events" - which included a 13% drop in heart deaths and non-fatal heart attacks, 19% fewer operations to treat heart disease, and a fall of 16% in the number of strokes.

The other study also revealed falls in LDL cholesterol and "vascular events".

Commenting on the study, two academics, Professor Bernard Cheung and Professor Karen Lam, from the University of Hong Kong, said that people with a "substantial" heart or stroke risk should have intensive statin treatment.

Even those with apparently low LDL cholesterol could benefit, they said.

They added: "At the population level, statins are underused, so the urgent priority is to identify people who would benefit most from statin therapy and to lower their LDL cholesterol aggressively, with the more potent statins if necessary."

Balance of risks

However, the study authors warned that simply raising the dose of the most commonly-used statin in the UK, simvastatin, the version available direct from pharmacies, might be counterproductive.

A rare side-effect of low-dose simvastatin is muscle weakness, known as myopathy. In some cases this can lead to more serious muscle damage.

At a low dose, three in 10,000 (0.03%) patients developed myopathy, but when a higher dose of simvastatin was prescribed, this jumped to nine in a 1,000 (0.9%).

Dr Louise Bowman, one of the researchers, said: "It may be safer to lower cholesterol using low doses of the more potent statins rather than increasing the dose of simvastatin."

This advice was echoed by the British Heart Foundation, which part-funded the study.

Professor Jeremy Pearson, associate medical director at the British Heart Foundation, said that simply "ramping up the dose" of simvastatin might not be the best option.

He said: "We know that cholesterol is a major risk factor for heart disease - cutting it cuts your risk of a heart attack. However it's been unclear whether going the extra mile to lower cholesterol even further, pays off."



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Failing care homes may 'slip net'

A new way of checking up on care homes for the elderly in England will put vulnerable residents at greater risk, says a union representing inspectors.

Unison says the new system of written self-assessments will mean thousands of homes will avoid inspections altogether if they look good on paper.

But the Care Quality Commission, which introduced the system, said it would let inspectors focus on failing homes.

It also released figures it said showed adult care had improved significantly.

Whistleblowers

The new system replaces yearly automatic inspections for all homes.

It came into force in October and now means that homes which provide a good written self-assessment may not be inspected again, unless there is a serious complaint made about them to the commission (CQC).

Unison, which now represents about 700 inspectors, claims that the workforce numbers have halved since 2004.

Its officer for the CQC, Helga Pile, is concerned about the changes, and said the new inspections would take just a couple of hours, instead of a whole day.

She said: "Our members are really concerned about the lack of ability to really go into homes, spend enough time on site, really talking to people finding out about what is going on."

The carer who blew the whistle on a care home scandal in Somerset in 2007 is also warning the new system would have meant her own care home could have avoided inspections for years on end.

It was because Sarah Barnett raised her concerns over several deaths at Parkfields Care home in Butleigh in Somerset, that its nurse manager was found guilty of killing a 97-year-old resident and stealing drugs to feed her own addiction.

"Start Quote

We just don't know what's going on in care homes"

End Quote A senior inspector for the CQC in England

Rachel Baker was sentenced to 10 years in prison earlier this year for the manslaughter of Lucy Cox.

Ms Barnett said: "My personal experience is that people will not blow the whistle, even if they have clear knowledge of what's been happening.

"And as for relying on relatives or people in the community, then you are relying on people who have no medical knowledge and are assuming they will raise concerns."

But the CQC has defended the new arrangements, which it says will allow time to concentrate on homes that are failing.

CQC director for the South West Ian Briggs said: "I can see that a move away from a one-size-fits-all regulatory regime of inspecting every six months, or every year… to a system that is more flexible that acts swiftly when we get information, is a new system.

"And everybody needs to get confident about how that system can work.

"I think we can rely on whistleblowers. We need to encourage them and we need to show them that if they report and whistleblow to us then we will act quickly and responsibly."

'Poor practice'

But a senior inspector for the CQC in England, who wants to remain anonymous, told the BBC: "Larger private providers could be good at filling out forms that can hide a multitude of sins.

"Therefore there will be no need for us to go out and check. As long as the assessments are done, we look like we have done our job.

"It is only when there are gaps in paperwork that we need to seek more information from a provider. We just don't know what's going on in care homes."

The CQC has published its final assessment of care provision under the old system.

It said 83% of care homes, home care services, nursing agencies and shared lives schemes were rated good or excellent, compared with 69% in 2008.

People were increasingly being supported to live in their own homes, rather in residential facilities, it said, and overall the quality of social care commissioned by councils was improving.

But CQC chief executive Cynthia Bower said "pockets of poor practice" remained.

The regulator also warned that further growth in provision would be needed to meet future needs.

Do you have a relative in a care home? What do you think of the shift to self-assessments? You can send us your views and experiences using the form below.



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Painkillers 'risky in pregnancy'

Prolonged use of paracetamol and other painkillers during pregnancy may pose a health risk to baby boys, warn experts.

Research suggests the drugs increase the risk of undescended testicles in male babies, a condition linked to infertility and cancer in later life.

Doctors already advise pregnant women to avoid taking painkillers if possible to protect their unborn child.

Experts said the Human Reproduction journal findings warranted further research "as a matter of priority".

But they reassured women that taking the occasional painkiller for a headache should not cause any harm.

Current advice from the NHS is that women should avoid taking medicines while pregnant but that paracetamol is considered safe if used in small doses for short-term pain relief.

Yet more than half of pregnant women in Europe and the US report taking mild painkillers.

"Start Quote

Clearly further research is needed as a matter of priority"

End Quote Dr Allan Pacey Andrology expert at Sheffield University

In this latest investigation, researchers from Denmark, Finland and France studied more than 2,000 pregnant women and their babies.

They found those women who used more than one painkiller simultaneously, such as paracetamol and ibuprofen, had a seven-fold increased risk of giving birth to sons with some form of undescended testes, or cryptorchidism, compared to women who took nothing.

The second trimester - 14 to 27 weeks of pregnancy - appeared to be a particularly sensitive time.

Increased risk

Any analgesic use at this point in the pregnancy was linked to more than double the risk of cryptorchidism.

Of the individual painkillers, ibuprofen and aspirin use were linked with a quadrupled risk.

Paracetamol alone also appeared to raise the risk, although this result was not statistically significant.

Simultaneous use of more than one painkiller, including paracetamol, during the second trimester increased the risk 16-fold.

Taking painkillers for more than two weeks at a time also appeared to raise the risk significantly.

The researchers suspect that painkillers upset the natural balance of male hormones at work in unborn baby boys and this hinders normal development. Studies of rats back this theory.

Analysis

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This large study, while interesting is not without limitations.

Of the individual painkillers, ibuprofen and aspirin approximately quadrupled the risk of cryptorchidism. Paracetamol doubled the risk, but the was not statistically significant.

This suggests that a link between paracetamol use in pregnancy and male fertility problems is not clear-cut.

Pregnant women who are alarmed by these studies should note:

It is only prolonged use that has an effect, and most women in this study who used paracetamol did not have a baby boy with cryptorchidism.

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Dr Henrik Leffers, senior scientist at Rigshospitalet in Copenhagen, who led the research, said: "If exposure to endocrine disruptors is the mechanism behind the increasing reproductive problems among young men in the Western world, this research suggests that particular attention should be paid to the use of mild analgesics during pregnancy, as this could be a major reason for the problems."

Despite some limitations in the study - not all of the women may have accurately recalled how often they took painkillers, for example - the researchers say their findings suggest that advice to pregnant women on analgesic use should be reconsidered.

They called for more research into the link.

Dr Allan Pacey, senior lecturer in andrology at the University of Sheffield, said: "Scientists have been concerned for some time about chemicals that the mother may be exposed to during pregnancy having the potential to cause reproductive problems in male babies.

"However, there are relatively few concrete examples and much of the work to date has been theoretical.

"That makes these studies somewhat alarming as I doubt that anyone would have suspected that common painkillers would have these effects.

"Clearly further research is needed as a matter of priority."

Dr Basky Thilaganathan of the Royal College of Obstetricians and Gynaecologists said the findings needed to be interpreted with caution. For example, he explained: "The study shows an association rather than causation; it is entirely possible that mothers took these analgesics for an ailment, for example, a viral infection, in pregnancy that may have been the real cause for the noted problems."

Cryptorchidism affects about one in 20 boys in the UK.



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Stafford Hospital inquiry begins

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Frank and Janet Robinson's son John died after being mis-diagnosed and discharged

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A public inquiry into the scandal-hit Stafford Hospital is due to open later, years after campaigners first demanded an open hearing.

A 2009 report condemned conditions at the hospital, said to have caused hundreds of unnecessary deaths.

The last government ordered a private investigation, but refused a wider public inquiry.

But in June the coalition government said the families of those who died deserved to know what went wrong.

The problems at Stafford Hospital - run by the Mid Staffordshire NHS Trust - were first exposed by the NHS regulator in March 2009.

The Healthcare Commission said there had been hundreds more deaths than there should have been between 2005 and 2008.

Catalogue of failings

It listed a catalogue of failings, including cases where untrained A&E receptionists had assessed emergency cases.

The Labour government then launched several investigations.

These included an independent inquiry, led by Robert Francis QC. However, this was held in private and did not have the power to compel witnesses to give evidence.

When it reported in February it said the trust had been driven by targets and cost-cutting.

Managers had been focused on winning elite foundation trust status during the problem years.

But campaigners said the failings went far wider than the hospital itself, and that the broader NHS and regulators should have realised there were problems and stepped in.

They demanded a full public inquiry with stronger legal powers.

In June, Health Secretary Andrew Lansley announced that Robert Francis would continue the work he had already done on investigating the hospital by leading just such an inquiry.

Mr Lansley said this would focus on how the culture in the NHS had allowed the failings to happen.

He said the families of patients who suffered at the hospital deserved to know that.

The inquiry will consider more than a million pages of evidence and will hear from dozens of witnesses.

Hoping for answers

Campaigners are hoping they will now get some of the answers they have been seeking for years.

They want to hear from the chief executive who was in charge at the time, as well as senior managers from the NHS in Staffordshire and Whitehall, and former health ministers.

Julie Bailey, who set up the campaign group Cure the NHS, said it was an important day for her.

"It means such a lot to us," she said. "I hope this will lead to a big culture change in the NHS. We deserve to know why it was allowed to happen, and whether it could happen anywhere else."

Stafford Hospital has been working hard to improve patient care over the last 18 months.

The new chief executive, Anthony Sumara, said they had taken on 140 more nurses, improved training, and changed procedures in the areas which had problems.

He welcomed the public inquiry and hoped it would help improve confidence in the hospital.

"It's desperately important for the NHS in general that we get some answers," he said.

He worries that the impending reorganisation of the NHS and a tougher financial climate could provide the ingredients for similar problems to be repeated.

"We need to make sure we don't take our eye off the ball again," he warned.

Have you been affected by the issues raised in this story? You can send us your stories using the form below:



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Legal aid lost in drug court case

Dozens of families who blame an epilepsy drug for causing birth defects in their children say they are devastated that legal aid to sue its maker has been withdrawn.

Women who took sodium valproate in the 1990s claim they were not given adequate warnings of possible harm.

The Legal Services Commission, which runs legal aid, has concluded the case is not sufficiently likely to succeed.

Manufacturer Sanofi Aventis denies failing to provide proper warnings.

Spina bifida

About 80 families have begun action for damages against the firm, claiming the drug - also known as epilim - caused severe disabilities in children including spina bifida, heart damage and learning difficulties.

BBC health correspondent Adam Brimelow said the refusal of legal aid meant this action, which had been seven years in the planning, now appeared close to falling apart just days before it was due to go to the High Court.

Karen Buck and John Coyle, whose daughter Bridget is severely handicapped, said they were devastated legal aid had been pulled just before the case was due to be heard.

Mr Coyle, from Stanmore in north-west London, told the BBC: "As a family we feel devastated because the case has gone on for over six years and the legal aid have funded it all the way along.

"Everybody has the belief that it [the case] has a better chance of winning than not, and just everybody is devastated that the finances have been pulled."

Bridget's mother took an increased dose of epilim during her pregnancy in 1997/8, but said she was not made aware of any potential risks to her child.

Her daughter has spina bifida, is unable to walk or talk, is herself epileptic, and requires 24-hour care.

Mr Coyle said: "There didn't seem to be any information available at the time Karen fell pregnant about taking epilim in pregnancy.

"I think the information has definitely improved quite a lot. They've become more aware and have accepted more that there are a lot of risks of problems in pregnancy with epilim, I'm not sure the drug company has accepted full responsibility."

Sanofi Aventis said it had sympathy for the claimants but insisted it had always provided appropriate warnings.

The company said it regularly provided authorities with updated safety data.

Epilepsy is the most common serious neurological disorder affecting people of all ages, with one person in 50 expected to develop it at some time in their life.

Sodium valproate is prescribed to people with epilepsy to prevent seizures in the brain.



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