NICE conflicts of interest call doctors claim

Doctors are calling on MPs to investigate potential conflicts of interest at the health spending watchdog NICE.

NICE conflicts of interest call doctors claimIn a letter to the Health Select Committee, they have expressed concern about financial ties to drug companies among experts working for NICE- the National Institute for Curbing Expenditure.

The concerns follow controversy over the recent NICE guideline on statin drugs.

The letter reflects continuing disquiet among some doctors and researchers over the recent decision by NICE to extend the availability of cholesterol-lowering drugs to millions of people at low risk of developing heart disease.

A majority on the NICE panel that recommended this had ties to pharmaceutical companies. Their interests were declared but the letter argues that is not enough to ensure impartiality.

“Transparency is important but accuracy and objectivity should be the gold standard expected of an independent panel,” it says.

The letter argues disclosure of a conflict of interest may even make matters worse because experts may feel “licensed” to emphasise their advice still further.

NICE rules stipulate that members of advisory committees should not have had a personal financial interest in a related company in the last 12 months.

One of the letter signatories, the former Conservative shadow health minister Lord Ian McColl, said this was dubious.

“They could have had millions paid before the 12 months. It really needs to be tightened up.”

Another signatory, a London cardiologist Dr Aseem Malhotra, urged NICE to act.

“I have always had tremendous respect for NICE but their conflicts-of-interest policy clearly needs to be strengthened so that the medical profession and patients can feel fully confident that decisions are made completely independent of personal or industry interests.”

The letter is clear that there is no suggestion of any impropriety, but it says the governance arrangements for conflicts of interest at NICE are “not fit for purpose”.

It proposes the establishment of “more independent panels” to minimise the possibility of conflicts of interest, and calls on the Health Select Committee to consider looking into the issue “as a matter of urgency”. They will discuss the matter later today.

In June, a letter supported by many of the same signatories argued that plans to extend the use of statins should be scrapped. It said NICE had used data which “grossly underestimated” the side-effects.

NICE wants to limit TV watching

Adults and children should consider having TV free days or limiting viewing to no more than two hours a day under new proposals to tackle obesity.

NICE wants to limit TV watchingThe National Institute for Curbing Expenditure (NICE) recommendations also include avoiding drinks with added sugar and limiting takeaways.

The draft guidance- the first on the subject since 2006, is aimed at helping people maintain a healthy weight.

Obesity rates have nearly doubled over the past 10 years in England.

Prof Mike Kelly, director of the Centre for Public Health at NICE, said a healthier diet and being more physically active was important for everyone not just those who were already overweight or obese.

“The general rule for maintaining a healthy weight is that energy intake through food and drink should not exceed energy output from daily activity,” he said.

“We all know we should probably take the stairs rather than the lift, cut down on TV time, eat more healthily and drink less alcohol. But it can be difficult to know the most useful changes that we can make in terms of our weight.”

The guidelines make a number of recommendations that aim to ensure the advice given about maintaining a healthy weight is more specific and based on real evidence.

There are also new recommendations encouraging people to monitor their weight and activity levels, using apps or regular weigh-in sessions.

The draft suggestions include:

  • Walking or cycling to school or work
  • Reducing TV viewing with strategies such as TV-free days or setting a limit of no more than two hours a day in front of the TV screen
  • Cutting down on calorific foods, such as fried food, biscuits, sweets and full-fat cheese
  • Adopting a Mediterranean diet high in vegetables, fruit, beans and pulses, whole grains, fish and olive oil
  • Avoiding drinks sweetened with sugar, including fizzy drinks, sports drinks and squash
  • Limiting the amount of fast food and takeaways
  • Limiting the amount of alcohol consumed, as alcoholic drinks are a source of extra calories

Last month, health leaders called for an emergency taskforce to be set up to tackle childhood obesity in England.

In an open letter to the chief medical officer for England, Prof Dame Sally Davies, they said “an entire generation is being destroyed by a diet of junk food and sugary drinks”.

And last week, the head of NHS England, Simon Stevens, said obesity was “the new smoking” in terms of the impact on health and the cost to the NHS- which Health Direct posted at: Obesity is new smoking says NHS boss

Dementia care patchy- quango finds

The standard of care provided for people with dementia is “patchy”, the National Institute for Curbing Expenditure (NICE) has said. Dementia care patchy- quango findsSome people with the condition were not getting even basic levels of care, it added.

The warning came as NICE unveiled new standards for dementia care in England, covering issues such as housing and access to leisure services.

Care services were playing “catch-up” on dementia, it said.

The guidance is the first to be produced by NICE under its new extended remit.

To date, the organisation has focused on issuing recommendations about NHS treatments and encouraging healthy lifestyles.

But under the shake-up of the NHS, it now has responsibility for providing guidance on care and support provided by the likes of councils and care homes.

NICE’s dementia guidance includes 10 standards it wants the care sector to follow.

One calls for people with dementia to live in housing that meets their needs, while another says they should be given the support they need to access leisure activities.

Others focus on keeping patients involved in community life and ensuring they get access to services such as dentists and opticians.

NICE deputy chief executive Prof Gillian Leng said: “The general picture is that care is patchy.  We know that it is really good in places but it’s not consistent.  My personal view is that we are all playing catch-up because the number of people with dementia has been increasing so dramatically.”

Currently about 670,000 people in England are living with dementia but one in three over the age of 65 are expected to develop the condition.

George McNamara, of the Alzheimer’s Society, said people with the condition were being denied the quality of life they deserved.

“These standards will be a useful tool for the care sector and show what people with dementia and carers should be able to expect,” he said.  “But, as they are not mandatory, it’s a case of ‘wait and see’ as to whether this guidance will drive real change or just sit on the shelf.”

NICE’s system used to decide whether drugs are cost effective is flawed

NICE’s formula which they use to decide whether NHS patients can have access to costly drug treatments is flawed and should be scrapped, according to a European Commission funded study.NICE's system used to decide whether drugs are cost effective is flawedThe National Institute for Curbing Expenditure (NICE) aka the Killer Quango uses a mathematical formula to work out whether it is worth the NHS buying medicines when their cost is judged against their potential benefits.

NICE’s decisions can be controversial because they decide whether patients suffering from potentially fatal illnesses such as cancer receive life saving treatments.

Nice uses a method called quality-adjusted life years (QALY) for assessing the value of new drug treatments in England and Wales.  The formula looks at the cost of using a drug for a year and weighs it against how much a patient’s life can be extended and improved.

If a treatment costs more than £30,000 per QALY – a theoretical unit representing one year in perfect health – it is generally not recommended as cost-effective by Nice.

But researchers from the European Consortium in Healthcare Outcomes concluded that the system failed to reflect variations in views on illness and disability.

The European research surveyed 1,300 respondents in Belgium, France, Italy and the UK, including 301 in the UK.

It concluded that the way people rate medical outcomes varied widely and could not be summed up in a neat medical formula, and suggested that the QALY indicator was an invalid way to make medical decisions, that should be scrapped.

For example, it found 71% of respondents would prefer to live 15 years in a wheelchair than die after ten or five years in a wheelchair. But the remaining 29% said they would prefer to die earlier than spend 15 years in a wheelchair.

Ariel Beresniak, the French doctor and economist leading the study: “Important decisions are being made on the basis of QALY, but it produces the wrong results. This isn’t a scientific way to classify and prioritise the drugs – mathematically, it’s flawed.

“We think it is time to open this debate, particularly as some of the newer European countries are trying to organise their health assessment systems and might be considering QALY.

“Nice has made negative recommendations about many major innovative drugs, based only on arbitrary incremental cost per QALY. Agencies such as Nice should abandon QALY in favour of other approaches.”

The full release with details of results, methodology and background on QALYs is available here:

Preventative breat cancer healthcare- new choice of drugs or mastectomy

Women at high genetic risk of breast cancer could soon have a new treatment option other than double mastectomy – preventive drugs.Preventative breat cancer healthcare- new choice of drugs or mastectomyDraft recommendations from the drugs watchdog in England and Wales, the National Institute for Curbing Expenditure (NICE), say such women should be given the option of taking tamoxifen or another drug called raloxifene for five years to cut their lifetime risk of the disease.

Until now, women facing a future with a strong likelihood that they would one day develop breast cancer have had only two real options – live in hope that it would never actually happen or have both of their breasts removed.

About one in every 100 women over the age of 30 falls into the high-risk category for breast cancer that Emma was in. Because of their family and genetic history, another two in every 100 women are at moderate risk and may also benefit from preventive therapy, experts say.

Prof Gareth Evans, an oncologist at Christie Hospital, says for some of those women, taking tamoxifen could be an alternative to having a preventative mastectomy, or breast removal.

“That surgery can reduce the risk by 90-95%, so it doesn’t eliminate the risk,” he says.

“It’s impossible to remove every last breast cell and depending on whether women keep their nipple or not, and that’s a big decision for some women, the risk may only be reduced by about 90%.

“We think that in about half of women, tamoxifen actually reduces the risk by 70% – if we can actually identify which women get that extra benefit, that may be enough for those very high-risk women to change their minds and say, ‘I’ll go for the tamoxifen instead’.”

Tamoxifen is not suitable for every woman and can cause side-effects, like hot flushes. Research suggests that up to half of women given tamoxifen to stop a breast cancer returning stop taking the drug prematurely.

Women who want to try for a baby would also need to come off the drug for at least three months before trying to conceive.

Hospitals to pay price for postcode lottery failure to innovate

NHS hospital patients across the country will soon be able to see whether their local hospital or health authority is rationing care as part of government plans to eradicate “postcode prescribing” in the NHS.Hospitals to pay price for postcode lottery failure to innovateFrom this autumn, every hospital and commissioning body in England will be forced to start publishing statistics showing how many of its patients are being provided with the latest drugs and treatments recommended by the National Institute for Curbing Expenditure (Nice).

The move will mean that, by next year, every hospital and health trust will be rated using an “innovation scorecard” allowing patients to compare services and treatments offered in different parts of the country.

Those health authorities found to be denying approved treatments are likely to face censure from the Department of Health.

The plans are due to be announced by the head of the NHS, Sir David Nicholson, next month. At first the “scorecard” is likely to be made up of around 20 key treatments and interventions where uptake across the NHS is known to be inconsistent. It is expected to be expanded over time to include all new drugs recommended by Nice for widespread use in the NHS.

Ministers hope that the move will bring an end to the problem of “postcode prescribing” where health authorities deliberately restrict access to approved drugs to save money.

Last year it emerged that about a quarter of primary care trusts were blacklisting more expensive drugs in favour of cheaper generic versions, which are sometimes not as effective. Among those banned in some areas were Lipitor and Crestor, two branded statins for cutting cholesterol in people at raised risk of strokes.

Three weeks ago Sir Michael Rawlins, the chairman of Nice, accused trusts of “messing around with the law”. “They want to use their money for other purposes: I understand that. But the law is the law, and … the law clearly says that when Nice gives a positive view of a drug, patients are entitled to it if their doctors think it is appropriate,” he said.

Announcing the move, the Health minister Paul Burstow, said allowing patients to see where drugs were being restricted would be a key catalyst for change. “Patients have a right to drugs and treatments that have been approved by Nice.

“NHS organisations must make sure the latest Nice-approved treatments are available in their area, and if they are not, then they will now be responsible for explaining why not.

“Being transparent with data like this is the hallmark of a 21st-century NHS. It is a fundamental tool to help healthcare professionals improve care.”

Sir Andrew Dillon, chief executive of Nice, said the organisation has been working with the NHS Information Centre on drawing up a scorecard of around 20 indicators to assess how NHS organisations were adopting Nice appraisals.

He said the intention was to launch the scorecard in September and it would act as a “benchmark on expected levels of uptake” which would be relevant to patients, doctors and commissioners.

“This is a step change in the detail with which we will be able to see how trusts respond to our recommendations,” he said.

“It will be valuable not just to patients but also help hospitals assess how well they’re performing and ensure that best practice is disseminated across the NHS.”

Sir Andrew added that, in the past, there had been numerous barriers to uptake of new drugs – sometimes financial but often organisational.

“We know that changing professional practice can take time. Doctors, although positively orientated, nevertheless take time to be made aware of the benefits of new treatments for patients.

“What we hope is that the scorecard will help rapidly get a consistent response to national guidance.”

Katherine Murphy, chief executive of the Patients Association, said it would be crucial the information be made available in a format that was meaningful to patients. “They must be in a position to hold the NHS to account because at the moment that doesn’t happen. We know the NHS is hopeless at introducing new ideas.”

Clare Gerada, president of the Royal College of GPs, said that, while she supported the aims of the scheme, she was sceptical about how effective a scorecard would be. “Will it be a bureaucratic tickbox or will it be something more sensible?” she asked.


Newborns facing unnecessary delays in treating infections

Some hospitals are causing unnecessary delays in treating newborn babies suffering from infections, the healthcare quango has said.Newborns facing unnecessary delays in treating infectionsThe National Institute for Curbing Expenditure (Nice) has published new guidance after finding variations in the treatment of babies with early onset neonatal infection.

It found delays at some hospitals in recognising and treating sick babies.

Early-onset neonatal infection – within 72 hours of birth – causes the death of one in four babies who are diagnosed, even when they are given antibiotics.

Nice’s recommendations urge medical staff to treat infected babies within an hour of diagnosis and use antibiotics appropriately to avoid the development of bacterial resistance to treatment.

Professor Mark Baker, director of Nice’s Centre for Clinical Practice at Nice , said: “Early-onset neonatal infection can be very serious and, at present, there is much variation in how it is managed, with sometimes unnecessary delays in recognising and treating sick babies.”

“Many babies are receiving antibiotics needlessly, and consequently there is concern that the effectiveness of antibiotics is being reduced because of the development of resistance to them.”

Early-onset neonatal infections, usually caused by organisms passed from mother to baby during birth, include group B Streptococcus (GBS), E.coli, Pseudomonas and Klebsiella.

Infections can develop suddenly and rapidly. Death rates are particularly high in premature babies and low birth weight babies, Nice said.

The infections may also cause babies to develop cortical lesions in the brain, and subsequently cause neuro-developmental delay.

Sue NHS if managers deny approved drugs says NICE

Patients should sue their local health authorities if they deny them drugs deemed cost effective for use on the NHS, the head of the National Institute for Curbing Expenditure (NICE) has said in a excellent example of the pot calling the kettle black.Sue NHS if managers deny approved drugs says NICESir Michael Rawlins, chairman of the killer quango watchdog, said “numerous trusts” were “acting unlawfully” in denying patients Nice approved treatments. Health trusts were wrongly using “delaying tactics” before allowing them, to save money, he said.

Sir Michael urged patients not to stand for such behaviour, saying courts would without doubt side with them.

He made clear his comments in an article for the Health Service Journal about problems many patients were having accessing a Nice-approved treatment, called dexamethasone intravitreal implants, for the common eye condition retinal vein occlusion. Installed every six months, the implants help prevent sight deterioration.

He said: “Quite clearly numerous trusts are acting unlawfully. They are denying patients an innovative and cost-effective treatment, recommended by Nice, that significantly improves their quality of life.

“The reason, of course, is that trusts do not wish to use their resources in this manner. Although they know that are required to make Nice-approved products available, they introduce delaying tactics.”

Disputes between primary care trusts (PCTs) and hospitals over payment meant “many months pass with the arguments going back and forth”, he added.

His advice was that organisations such as the Royal National Institute of Blind People (RNIB) should seek a judicial review in the High Court.

“The court would unquestionably uphold the claim,” he predicted.

However, he added such case would not reach court – the implication being that trusts would quickly back down if threatened with the prospect of costly legal action.

He noted that the NHS Constitution enshrined the patient’s right to Nice-approved drugs “if your doctor says they are clinically appropriate for you”.

The RNIB had found 37 of 125 hospital trusts were either not providing the dexamethasone implants or providing a restricted service.

Sir Michael also said NHS managers should show more allegiance to patients and less to their trusts.

“I want my clinical colleagues to start exercising leadership and ‘whistle-blow’ when their trusts fail to meet their legal obligations,” he said.

Steve Winyard, head of policy at the RNIB, who raised the matter with Sir Michael, commented: “If Nice has done all the detailed work on cost effectiveness then I think it’s inappropriate is for PCTs or hospitals at local level to make decisions that run counter to that.

“Nice doesn’t come to these decisions lightly and it would like to see patients across the county benefit.”

Last autumn it emerged that about a quarter of PCTs were blacklisting more expensive drugs, even if Nice-approved, in favour of cheaper ‘generic’ versions.

In January Andrew Lansley, the Health Secretary, promised to introduce an “effective compliance regime” to end “postcode prescribing” of Nice-approved treatments.

Health authorities often put pressure on doctors not to prescribe certain treatments if there are cheaper alternatives available.

However, health authorities themselves are under intense pressure to use ever more limited resources as efficiently as possible.


Thousands denied IVF because of British red tape restrictions

Thousands of couples in Britain are being denied the chance to become parents because the country has one of the most restrictive policies in Europe when it comes to publicly funding fertility treatment.Thousands denied IVF because of British red tape restrictionsThey were speaking after a study was presented at an IVF conference showing that only Russia and Ireland offer worse access.

At the moment about 13,000 babies are born every year in Britain thanks to IVF and another technique called ICSI, which is mainly used to counter male infertility.

However, the new study indicates that number could be up to three times higher, if our policies matched those of the most generous nations.

Among those with more generous IVF programmes include Slovakia, Montenegro, Czech Republic and Slovenia.

Dr Mark Connolly, an American health economist based at Groningen University in The Netherlands, compared public funding of Fertility treatments and how frequently they was used in 23 European countries in 2008. The UK came third from bottom in terms of reimbursement, and also had among the lowest number of “assisted reproduction technology” cycles per million people.

Europe-wide, he said there was a “highly significant relationship between high levels of public reimbursement and high levels of utilisation”.

For example in Belgium, one of the most generous countries, there were 2,479 cycles per million people. In the UK there were only 825.

Under guidelines issued by the National Institute Curbing Expenditure (Nice), primary care trusts (PCTs) should offer up to three full cycles of IVF – which includes giving hormones that stimulate release of eggs, egg retrieval, test-tube fertilisation, reimplantation of viable embryos and freezing of unused embryos for later use – to infertile women from 23 to 42.

In practice, only a quarter do so, found a group of MPs who looked at provision across England last year. Since then some have tightens restrictions, such as refusing treatment to smokers and the obese, to reduce costs.

Speaking at the annual conference of the European Society for Human Reproduction and Embryology (ESHRE) in Istanbul, Dr Connolly said most English PCTs were “feeble” in their ability to fund three cycles of IVF.

Clare Lewis-Jones, chairman of the National Infertility Awareness Campaign, said: “For thousands of couples here, the dream of having a child of their own remains elusive: many are denied IVF because their PCT or health board is reluctant to fund sufficient treatment.

“We will continue our fight for fair and equitable access to IVF and ICSI on the NHS, a situation that simply does not exist in the UK.  Despite the fact that IVF was pioneered in our country, we are near the bottom of the list in terms of the number of cycles performed.  Those suffering from the disease of infertility have the right to expect the chance to have a healthy baby of their own.”


How to improve your sperm count- new study confounds conventional wisdom

Men trying to improve their sperm count may be able to ditch the healthy living advice- but should think carefully about their underwear, doctors have found.How to improve your sperm count- new study confounds conventional wisdomSmoking, drinking alcohol, using recreational drugs and being overweight are all listed by the National Institute for Curbing Expenditure (NICE) guidelines as factors likely to harm male fertility.

But research has found they make little difference– with one exception. Changing underwear style could improve a man’s chances of having a baby.

“There is no need for men to become monks just because they want to be a dad,” said Allan Pacey, senior lecturer in andrology at the University of Sheffield, who was involved in the study.

“But if they are a fan of tight Y-fronts, then switching underpants to something a bit looser for a few months might be a good idea.”

To make healthy sperm, the testicles need to be a degree or two below body temperature, which is why evolution has seen to it that they hang outside in their own sac, where it’s cooler. Tight Y-fronts risk reversing what millions of years of evolution have achieved.

The researchers from the Universities of Manchester and Sheffield compared some 900 men with low sperm counts with 1,300 who had high sperm counts.

They found drugs, tobacco, alcohol and weight had little effect. But boxer shorts did.

Dr Andrew Povey, from the University of Manchester’s School of Community Based Medicine, said: “This potentially overturns much of the current advice given to men about how they might improve their fertility and suggests that many common lifestyle risks may not be as important as we previously thought.

“Delaying fertility treatment for these couples so that they can make changes to their lifestyles, for which there is little evidence of effectiveness, is unlikely to improve their chances of a conception and, indeed, might be prejudicial for couples with little time left to lose.”

The findings are published in the journal Human Reproduction. The researchers found that the proportion of men who had low numbers of swimming sperm was similar whether they had never been a smoker or were smoking more than 20 cigarettes a day. Similarly, there was little evidence of any risk associated with alcohol consumption.

Infertility was most strongly linked with having had previous testicular surgery, being of black ethnicity or working in a manual occupation.

Professor Nicola Cherry, now at the University of Alberta, Canada, said: “The higher risk we found in manual workers is consistent with earlier findings that chemicals at work could affect sperm and that men should continue to keep work exposures as low as possible.”