Faulty implant action 'too slow'

1 November 2012 Last updated at 05:01 ET By Smitha Mundasad BBC News

The European Commission is not acting quickly enough to protect patients from potential harm from medical implants, a parliamentary committee warns.

Current Europe-wide regulation on medical implants, such as hip replacement joints, is too slow to change, they say.

The EC is revising the regulation, but changes are not expected to take effect until at least 2015.

The report comes after recent concerns about the safety of hip implants.

"I think in the interests of patients we would get a better system in place if the commission speeded up the process to revise current regulations," said Andrew Miller, chairman of the Science and Technology Select Committee.

Continue reading the main story

There is an urgent need for more transparency in the regulatory system.."

End Quote Andrew Miller Science and Technology Select Committee

Under the present system new devices must gain the Europe-wide mark of approval - the CE mark - from one of 70 regulatory organisations, known as notified bodies.

The committee raised concerns that notified bodies might vary in quality and that manufacturers might be shopping around for regulators based in the country with the least stringent regulations.

"There is an urgent need for more transparency in the regulatory system so that patients and doctors know where their implant is coming from, and crucially whether the product has previously been turned down by other regulatory bodies," Mr Miller said.

'Inadequate' safety testing

He is calling for there to be a public record every time a manufacturer approaches a notified body for approval, allowing this "forum shopping" to be spotted more easily.

The report also warns some patients may be given medical implants that have had little known safety testing, as currently regulators may rely on safety information gathered from similar, equivalent products.

This means an implant may be used across the European Union without evidence of its own safety and performance, the report says.

The committee recommends that for all medical implants that are currently in use, any existing data must be published immediately.

It also calls for compulsory reporting by doctors of any faulty products they come across.

"The British Association of Aesthetic Plastic Surgeons is pleased that the government has moved to better regulate all CE-marked medical devices, and in particular, we praise the call for all existing evidence on medical devices to be published immediately," said consultant plastic surgeon and former BAAPS president Nigel Mercer.

"Without these changes the public cannot be sure that they can ever be safe from another PIP-like fiasco."

Professor Norman Williams, president of the Royal College of Surgeons, agreed there urgently needed to be an "increase of transparency and accountability across the entire regulatory framework for medical implants".

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New MS drug is 'most effective'

1 November 2012 Last updated at 05:03 ET By James Gallagher Health and science reporter, BBC News

A new drug is the "most effective" treatment for relapsing-remitting multiple sclerosis, say UK researchers.

During MS the body's immune system turns on its own nerves causing debilitating muscle problems.

Researchers at the University of Cambridge say a cancer drug, which wipes out and resets the immune system, has better results than other options.

However, there is concern that a drugs company is about to increase the cost of the drug as a result.

Around 100,000 people in the UK have multiple sclerosis. When the condition is diagnosed most will have a form of the disease know as relapsing-remitting MS, in which the symptoms can almost disappear for a time, before suddenly returning.

Built from scratch

The researchers tested a leukaemia drug, alemtuzumab, which had shown benefits for MS in small studies.

In leukaemia, a blood cancer, it controls the excess production of white blood cells. In MS patients, the dose eliminates the immune cells entirely, forcing a new immune system to be built from scratch which should not attack the nerves.

Two trials, published in the Lancet medical journal, compared the effectiveness of alemtuzumab with a first-choice drug, interferon beta-1a.

One compared the effectiveness in patients given the drug after being diagnosed, the other looked at patients given the drug after other treatments had failed.

Both showed the drug was around 50% more effective at preventing relapses and patients had less disability at the end of the study than when they started.

Dr Alasdair Coles, from the University of Cambridge, said: "Although other MS drugs have emerged over the last year, which is certainly good news for patients, none has shown superior effects on disability when compared to interferon except alemtuzumab."

He told the BBC: "It is certainly the most effective MS drug, based on these clinical trials, but this is definitely not a cure."

However, he warned there were side-effects. These include developing other immune disorders.

He said he thought the drug would be most useful for patients for whom standard treatment had failed and in a "minority" of patients as a first-choice drug.

Eventually relapsing-remitting MS can become progressive MS as the good spells become shorter and less frequent. The drug will have no effect on this form of the disease.

Expense fears

The drug has been withdrawn from the market in Europe and the US as the manufacturer, Genzyme, intends to have it licensed as a treatment for MS.

A Lancet editorial warns: "There is concern that with a licence for multiple sclerosis, the cost of alemtuzumab could rise and might become too expensive for many patients and health systems.

"Finding promising treatments such as alemtuzumab is important. But so is keeping alemtuzumab accessible and affordable."

Dr Doug Brown, head of biomedical research at the MS Society, said: "These results are great news for people with relapsing-remitting multiple sclerosis.

"Alemtuzumab has been found to be an effective treatment for people with MS - but it's only useful to them if it's available on the NHS.

"We urge Genzyme to price the treatment responsibly so that if it's licensed, it's deemed cost-effective on the NHS."

The company said it would not come up with a price for the drug "until it is approved by regulatory authorities" and that it would "engage constructively" with the National Institute for Health and Clinical Excellence, which evaluates the cost-effectiveness of drugs for use in the NHS.

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NHS use of private sector 'rises'

1 November 2012 Last updated at 09:09 ET

The number of routine NHS operations and treatments carried out by the private sector has risen by more than 10% in a year, official figures show.

The data from the Health and Social Care Information Centre revealed that private providers treated 345,200 non-emergency NHS patients in 2011-12, a 32,900 rise on the previous year.

These were for planned care, such as knee and cataract operations.

The figure represents 4.3% of all the routine NHS treatments.

The rise is partly explained by a jump in the number of people needing non-emergency treatments as well as reflecting a shift towards more people choosing to use private providers - something they are entitled to do under patient choice.

'Highest quality services'

The figures showed the number of non-emergency procedures carried out by the NHS rose from 7.7m to 8m over the past year.

The 4.3% figure was up from 4% on the year before.

Health Minister Lord Howe said: "The crucial thing here is that patients have access to the highest quality services possible. Letting patients choose how and where they are treated is not new.

"We want to give patients more choice about where, when and how they can access their health services and these figures show that patients are making decisions about services that meet their needs.

"Private hospitals have to comply with exactly the same quality and safety regulation and contractual standards as any NHS provider."

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Mental health loophole 'closed'

30 October 2012 Last updated at 12:36 ET

Emergency legislation designed to close a loophole in the law on mental health has been approved by the Commons.

It corrects a technical error affecting up to 5,000 patients sectioned under the Mental Health Act since 2002.

The error meant doctors who sectioned patients in England did not have the right authority to do so.

Health Secretary Jeremy Hunt insists all were qualified to make the clinical decisions and that no patient was wrongly detained.

He has ordered an independent review.

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"Start Quote

We believe that no one is in hospital who shouldn't be and no patients have suffered because of this"

End Quote Jeremy Hunt Health Secretary

Mr Hunt said: "We believe that all the proper clinical processes were gone through when these patients were detained. They were detained by medically qualified doctors. We believe that no one is in hospital who shouldn't be and no patients have suffered because of this.

"But for the avoidance of any remaining doubt, and in the interests of the safety of patients themselves, as well as the potential concerns of their families and the staff who care for them, we are introducing emergency legislation to clarify the position."

Approval error

Continue reading the main story

"Start Quote

We believe that the Department of Health and Strategic Health Authorities are taking swift action and we will continue to monitor the situation"

End Quote Paul Jenkins Chief Executive of Rethink Mental Illness

A patient can be sectioned if they are perceived to be a threat to themselves or other people.

Generally, a patient can be sectioned only if two doctors and a mental-health professional believe it is necessary.

Doctors who assess patients and make recommendations under the Mental Health Act, are required to be "approved" to do so by the Secretary of State.

Since 2002, the Secretary of State has delegated that approval function to strategic health authorities (SHAs).

However, four out of the 10 SHAs in England asked mental health trusts to carry out the validation and approval process for them, but did not ask for it to be referred back to them for final confirmation.

This is the error that Mr Hunt says needs rectifying as a matter of urgency.

He said up to 2,000 doctors working for the four SHAs - North East, Yorkshire and The Humber, West Midlands and East Midlands - did not have the right approval to section patients sent to hospitals that included Ashworth and Rampton Secure Hospital.

The Department of Health has asked Dr Geoffrey Harris, chairman of NHS South and former chairman of Buckinghamshire Mental Health Trust, to undertake an independent review to look at how this responsibility was delegated by these four SHAs, and, more broadly, the governance and assurance processes that all SHAs use for delegating any responsibilities.

He will report back to the Secretary of State by the end of the year.

All doctors involved have now been approved under the correct processes.

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Elderly 'housebound' by fall fear

30 October 2012 Last updated at 20:45 ET

A fear of falling is making many elderly people prisoners in their own homes, a survey has suggested.

More than one in five of the 500 people aged 75 and older, interviewed by the Women's Royal Voluntary Service charity, lived in fear of falling.

And 5% are so fearful that they will not leave their homes unaccompanied, the report found.

A third of them had suffered falls in recent years and a fifth of these said they had lost confidence as a result.

Many said they were especially worried during winter months.

'Bleak' findings

A quarter said poor street conditions - poor lighting and uneven pavements - made them feel less confident about leaving the house.

Continue reading the main story

• Try not to panic if you have a fall. It is likely that you will feel shocked and a bit shaken, but staying calm will help you to gather your thoughts and remember what to do
• Do not get up quickly. Roll onto your hands and knees and find a stable piece of furniture, such as a chair or bed, to support you as you slowly get up
• Rest for a while before carrying on with your daily activities
• If you are injured or cannot get up, call for help

David McCullough, chief executive of the WRVS, said: "These are bleak findings.

"With winter approaching, older people have little confidence to get out and about because they fear they will fall and, as this research shows, the psychological effects of worrying about a fall can be as debilitating and devastating as physical injuries."

Every year in the UK nearly three-quarters of a million people aged over 60 end up in the local A&E department after a fall, and one in three of these will end up staying in hospital because of their injuries.

Figures show around a third of adults who are over 65 and living at home will experience at least one fall a year. This rises to half of adults over 80 who are either at home or in residential care.

'Not inevitable'

In 2009 in England and Wales, there were 3,593 deaths as a result of falls.

Making small changes at home, such as using non-slip rugs and mats and ensuring that rooms are clutter-free and well lit, can help prevent falls.

Michelle Mitchell, of the charity Age UK, said: "At their worst falls can be the cause of death, but falls are not an inevitable part of ageing - many falls can be prevented and there is much that can be done to help people who have fallen not to fall again."

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Backing for malaria drugs subsidy

31 October 2012 Last updated at 05:07 ET By Jane Dreaper Health correspondent, BBC News

Researchers who evaluated a global subsidy for malaria treatment say it had a substantial impact in a short space of time.

Publishing their results in The Lancet, the global health experts acknowledged that the scheme had been "highly controversial".

The Affordable Medicines Facility for malaria (AMFm) was called into question by Oxfam last week.

The research says it reduced the price of drugs and led to more treatment.

AMFm was launched in seven African countries by the Global Fund with the aim of bringing down the price of the most effective form of malaria treatment, to discourage problems with resistance.

Continue reading the main story

"This programme rapidly met its benchmarks despite the many constraints, expectations and unrealistic timelines imposed on it"

End Quote Comment article by scientists The Lancet

The researchers, led by a team from London School of Hygiene and Tropical Medicine, found the subsidy led to large falls in the price of drugs in most of the pilot schemes.

They said: "There had been concern that the poorest would not benefit from the programme, because the drugs were not free.

"The effect of AMFm in Niger and Madagascar was limited, with low orders.

"In all other pilots, it's likely AMFm had a dramatic effect on drugs sold through the private for-profit market.

"These changes were substantial and achieved in only a few months, which showed the power of tapping into the distributional capacity of the private sector."

Oxfam has criticised the scheme for focusing on "untrained shopkeepers" to help deliver treatment in rural communities - but supporters of AMFm claim these objections are purely ideological.

US opposition

The evaluation did not measure health outcomes, and the researchers said data on the use of treatment was not yet available.

In an accompanying comment article, 10 eminent scientists noted "unremitting opposition" to AMFm from the United States, and appealed for the scheme to be preserved in its current form when the Global Fund's board decides its future next month.

The scientists said: "This programme, when fully implemented, rapidly met its benchmarks despite the many constraints, expectations and unrealistic timelines imposed on it.

"We must acknowledge that an efficient approach to subsidising anti-malarial drugs has worked, making them available in the private sector where people go to buy them."

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Failure regime in NHS 'unclear'

29 October 2012 Last updated at 21:09 ET By Nick Triggle Health correspondent, BBC News

The way financially-troubled parts of the NHS are being dealt with appears to be done "on the hoof", MPs say.

The Public Accounts Committee also expressed concern that ministers could not offer adequate assurances that access to good quality care would be maintained when trusts had problems.

And the MPs also suggested the reforms being introduced next year could make the situation worse.

It comes as a number of NHS bodies in England are struggling with debt.

The cross-party group of MPs said that while overall the NHS finished last year with a £2bn surplus, the figure masked the problems developing in a number of trusts.

A total of 34 organisations - nearly one in 12 - failed to balance their books in 2011-12.

It represents a significant rise on the year before and would have been even higher if local health chiefs and the Department of Health had not provided bailouts

'Short-term decisions'

But despite this growing problem the MPs said the government was unable to explain what would trigger action in a trust with serious financial problems and how essential services would be maintained while this happened.

One trust - South London Healthcare - has already been put into administration. A report published on Monday recommended the trust be dissolved, paving the way for a radical reorganisation of services across the area.

Continue reading the main story

We need the government to accept that financial pressures are the biggest facing the NHS at the moment"

End Quote Mike Farrar

But the committee said there were no clear rules or thresholds that trigger such steps.

Committe chairman Margaret Hodge said: "It very much looks like the department [of health] is inventing the rules and processes on the hoof rather than anticipating problems and establishing risk protocols."

The committee said keeping control of finances was only going to get more difficult as the NHS was in the middle of a £20bn savings drive.

And it said the introduction of clinical commissioning groups - the GP-led organisations that will take charge of the NHS budget next year - could lead to short-term decisions being taken that could make the problems worse.

The MPs also criticised the impact of the private finance initiative (PFI).

Under the programme, private money was used to fund building schemes which NHS trusts then paid back over time - similar to a mortgage on a house.

But the committee said there was a number of trusts where those repayments were so high that they were struggling to break even and priorities were being "distorted".

Mike Farrar, chief executive of the NHS Confederation, which represents trusts, said he agreed there needed to be greater clarity for dealing with financial failure.

"We need the government to accept that financial pressures are the biggest facing the NHS at the moment. We cannot deal with these issues on a piecemeal basis. We need a frank conversation with the public about how we deal with these problems.

"Propping up struggling trusts with short term solutions is not the answer. We need to take action before we reach crisis point."

But Health Minister Lord Howe denied there were problems on the scale being described, adding: "This NHS is in robust financial health."

He said the government was working with NHS trusts and regulators to ensure where financial problems developed they were dealt with properly.

"To be clear - we are not 'making these rules' up," he added.

Shadow health minister Andrew said: "Ministers must get a grip on the turmoil and put staff and patients first."

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Breast screening harm highlighted

30 October 2012 Last updated at 02:43 ET By James Gallagher Health and science reporter, BBC News

Please turn on JavaScript. Media requires JavaScript to play.

Christine Davidson: ''I went for screening because I thought if I had cancer it was better to discover early''

Women invited for breast cancer screening in the UK are to be given more information about the potential harms of being tested.

An independent review was set up to settle a fierce debate about whether the measure did more harm than good.

It showed that for every life saved, three women had treatment for a cancer which would never have been fatal.

The information will be included on leaflets to give women an "informed choice", the government said.

Cancer charities said women should still take up the offer of screening.

Controversy

Screening has been a fixture in diagnosing breast cancer for more than two decades. Women aged between 50 and 70 are invited to have a mammogram every three years. It helps doctors catch cancer early so treatment can be given when it is more likely to save lives.

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Screening in numbers

• More than two million women are screened each year in the UK
• Women between 50 and 70 are screened every three years.
• 48,000 women are diagnosed each year.
• One in eight women will develop breast cancer at some point in their lives.
• More than 11,000 women die from breast cancer each year

However, the national cancer director Prof Sir Mike Richards said it had become "an area of high controversy".

The debate centres around the concept of "overdiagnosis", that is screening which correctly identifies a tumour, but one which would never have caused harm. It leads to women who would have lived full and healthy lives having treatments - such as surgery, hormone therapy, radiotherapy and chemotherapy - which have considerable side-effects.

There is no way of knowing which tumours will be deadly and which could have been left alone.

The review, published in the Lancet medical journal, showed that screening saved 1,307 lives every year in the UK, but led to 3,971 women having unnecessary treatment. From the point of view of a single patient they have a 1% chance of being overdiagnosed if they go for screening.

The independent review panel was led by Prof Michael Marmot, from University College London. He said screening had "contributed to reducing deaths" but also "resulted in some overdiagnosis".

He said it was "vital" women were told about the potential harms and benefits before going for a mammogram.

Prof Richards said: "My view is that the screening programme should happen, we should invite women to be screened and give women the information to make their own choice."

He said the leaflets on breast cancer screening sent to women would be updated in the "next few months" to "give the facts in a clear, unbiased way".

Current advice does not highlight the scale of the risk.

To screen?

Cancer charities have unanimously argued that women should still choose to be screened.

Continue reading the main story

Analysis: Debate over?

The national cancer director described the findings as the "best data" available on the issue. However, this is unlikely to be the final word on breast cancer screening.

One of the lead voices questioning screening, Prof Peter Gotzsche from the University of Copenhagen, has told the BBC he has "serious reservations" about the findings.

His previous research suggested 10 women were treated unnecessarily for every life saved and questioned whether screening had any overall benefit.

He said "the estimate of the balance [of benefit vs harm] is still too positive" in this study.

He criticised the independent panel for using old data and ignoring more recent studies showing no benefit of screening.

He will be publishing a response in a medical journal soon.

A joint statement by Breakthrough Breast Cancer, Breast Cancer Campaign and Breast Cancer Care said: "We encourage all women to attend their screening appointments."

It said the review provided "much-needed clarity" that screening saves lives, but women must be given "clear and balanced information" to highlight the harms.

Cancer Research UK, which commissioned the review alongside the Department of Health, said that "on balance" it thought that women should go ahead with screening.

Its chief executive Dr Harpal Kumar said: "Because we can't yet tell which cancers are harmful and which are not, we cannot predict what will happen in an individual woman's case.

"Research is advancing at pace and we hope that in the future there will be a number of new techniques that we can use alongside the screening programme to make it more sophisticated and reduce the numbers of women having unnecessary treatment."

Richard Winder, the deputy director of the NHS Cancer Screening Programmes, said: "This was a robust review and we appreciate the rigour and efforts of the panel in conducting it.

"We are pleased that the panel concluded the NHS Breast Cancer Screening Programme confers significant benefit and should continue.

"Where they have made recommendations, we will work with all partners to take these forward."

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Care home abuse must end - Lamb

30 October 2012 Last updated at 09:53 ET

Abuse at care homes such as Winterbourne View was a "national scandal" that "has to end", health minister Norman Lamb has said.

Last week six people were jailed for their role in abusing patients at the private hospital near Bristol after an investigation by BBC's Panorama.

"What has been exposed by Panorama is utterly intolerable and has to come to an end," Mr Lamb told the Commons.

He confirmed that there were still safety concerns about six ex-patients.

The government's full response to the abuse at Winterbourne View will be published in November, he told MPs in response to an urgent question in Commons, tabled by shadow health minister Liz Kendal.

On Monday Panorama revealed new safety alerts had been raised about 19 of the 51 patients who were abused at Winterbourne View but who now live at other care homes.

Not all of the safeguarding alerts issued meant that the patient had been harmed.

Mr Lamb said: "Years and years of public money being spent on putting people into inappropriate settings, often putting them at risk of abuse - this is a national scandal and it has to end."

Mr Lamb said that he was "absolutely determined" that the government's final response "will be robust and clear".

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Cheap colour test picks up HIV

28 October 2012 Last updated at 14:53 ET By James Gallagher Health and science reporter, BBC News

A cheap test which could detect even low levels of viruses and some cancers has been developed by UK researchers.

The colour of a liquid changes to give either a positive or negative result.

The designers from Imperial College London say the device could lead to more widespread testing for HIV and other diseases in parts of the world where other methods are unaffordable.

The prototype, which needs wider testing, is described in the journal Nature Nanotechnology.

The test can be configured to a unique signature of a disease or virus - such as a protein found on the surface of HIV.

If that marker is present it changes the course of a chemical reaction. The final result is blue if the marker is there, red if the marker is not.

The researchers say this allows the results to be detected with "the naked eye".

Prof Molly Stevens told the BBC: "This method should be used when the presence of a target molecule at ultra-low concentration could improve the diagnosis of disease.

"For example, it is important to detect some molecules at ultra-low concentrations to test cancer recurrence after tumour removal.

"It can also help with diagnosing HIV-infected patients whose viral load is too low to be detected with current methods."

Early testing showed the presence of markers of HIV and prostate cancer could be detected. However, trials on a much larger scale will be needed before it could be used clinically.

The researchers expect their design will cost 10 times less than current tests. They say this will be important in countries where the only options are unaffordable.

Fellow researcher Dr Roberto de la Rica said: "This test could be significantly cheaper to administer, which could pave the way for more widespread use of HIV testing in poorer parts of the world."

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