Replacement for Professor David Nutt said cannabis should be legalised

A former Oxford academic chosen to replace sacked Professor David Nutt as the head of the government's drugs advisory panel once called for the legalisation of cannabis.

Professor Les Iverson, a retired pharmacologist, has in the past mirrored Professor Nutts comments that cannabis is less harmful than alcohol and tobacco and even called for the drug to be made legal.

He said: "Cannabis should be legalised not just decriminalised because it is comparatively less dangerous than legal drugs alcohol and tobacco."

Professor Iverson played down any potential clashes with Alan Johnson, the Home Secretary, by suggesting the debate had moved on - and that he had changed his mind since his speech at a dinner in 2003 hosted by the Beckley Foundation, a charity in favour of regulating rather than banning drug use.

He said: "I don't remember saying that, it's certainly not my position now. That was a view I had in 2003 and a great deal has happened since then.

"We have now to confront the more potent forms of cannabis. We have the new evidence that arose since 2003 linking cannabis to psychiatric illness.

Prof Iverson, who has sat on the committee for five years, said much more active attention was currently being paid to so-called legal highs such as mephedrone.

"I'm not the drug adviser to the government, I'm a spokesman for a large group of people on the advisory council, only a few of whom are scientists."

In October, Mr Johnson sacked Prof Nutt for "crossing a line" into politics. Prof Nutt, who is setting up a rival think-tank, said he was simply reiterating scientific fact. Five other members on the panel subsequently resigned in protest and have yet to be replaced.

Professor Colin Blakemore, the neuroscientist, said Prof Iverson, a friend and former colleague, was conservative by nature but nevertheless shared the same views as his predecessor.

"I see no reason that Les Iverson's view on ecstasy deviates from the conclusions of the ACMD in that it should be classified as B rather than A.

"Similarly on cannabis that should have remained at C rather than being downgraded."

In the weeks that followed Prof Nutt's sacking, the home secretary tried to smooth over the row by making a number of concessions to his drugs advisers.

Mr Johnson agreed to write to panel members to explain any decisions that went against their advice. He also said he would not prejudge decisions on drug classification ahead of the committee issuing advice.

From:

http://www.telegraph.co.uk/Replacement-for-Professor-David-Nutt-said-cannabis-should-be-legalised.html

Obese patients encouraged to put on weight to qualify for surgery

Access to NHS weight loss operations is inconsistent, unethical and a postcode lottery, says Royal College of Surgeons

Obese patients are being "effectively encouraged" to pile on the pounds to qualify for weight-loss operations on the NHS, the Royal College of Surgeons warns.

The college claims lives are being put at risk as some health trusts require patients to reach higher body mass index (BMI) levels than others before they receive surgical treatments.

The postcode lottery means that access to NHS weight-loss surgery is "inconsistent, unethical and completely dependent on geographical location", according to the college.

Last year 4,300 operations to reduce body weight were carried out on the NHS, but as many as 1 million people could meet the National Institute for Curbing Expenditure (Nice) criteria for being classed as having severe obesity.

Bariatric, or weight-loss, surgery is carried out after diets, drugs and lifestyle-altering interventions are seen to have failed. It is not generally recommended for children or young people.

"Constraints on NHS funding mean that in some areas NHS decision-makers are opting to ignore professional guidelines and are denying patients' access to surgery," the college maintains. "In others, patients who already meet the [Nice] criteria are forced to wait until either they become more obese or develop life-threatening illness like diabetes or stroke."

According to the Nice guidelines, bariatric surgery is recommended for adults with a BMI of more than 40, who have other significant diseases (for example, type 2 diabetes) that could be improved if they lost weight, and who have tried but failed to lose weight using non-surgical techniques.

The college, which is holding a conference on the issue today, says hospitals are assessing patients referred from primary care trusts under different eligibility criteria, resulting in some patients with a BMI of 60 or greater being refused surgery while others with a BMI of 40 or less are undergoing operations.

"Nice guidelines are meant to signal the end of postcode lotteries yet local commissioning groups are choosing not to deliver on obesity surgery," said the college's director of education, Prof Mike Larvin. "In many regions the threshold criteria are being raised to save money in the short term, meaning patients are being denied life-saving and cost-effective treatments, and are effectively encouraged to eat more in order to gain a more risky operation further down the line."

One bariatric surgeon, Peter ­Sedman, said: "There is absolutely no doubt that some patients more needy of surgical treatment than others are being denied it. I will treat the patient, my hospital will offer the service, but unless the patient moves house they will not be referred and if they are, the treatment is subsequently blocked."

David Haslam, chair of the National Obesity Forum, said: "Bariatric surgery is amongst the most clinically effective and cost effective specialities in any field of medicine, preventing premature death and transforming lives, whilst saving vast amounts of money for the NHS and the economy.

"Even the most cynical taxpayer should support bariatric surgery, alongside clinicians, in opposing the unethical and immoral barriers to surgery imposed by NHS purse-string holders."

The college is calling on the Department of Health to ensure all patients have equal access to treatment. It estimates that obesity problems cost the NHS £7.2bn a year.

Alberic Fiennes, president-elect of the British Obesity and Metabolic Surgery Society, said: "We recognise the difficulties faced in dealing with a 'new' disease of epidemic proportions, but to limit surgery to the most severely obese is unfair and short-sighted and against basic professional ethics. It is also contrary to strategies that are standard for diseases that overwhelm resources."

From:

http://www.guardian.co.uk/society/2010/jan/21/obesity-weight-loss-surgery

Patients in England and Wales denied arthritis drug available in Scotland by NICE

Patients in England and Wales are being denied a powerful new arthritis drug on the NHS despite a decision by Scottish health authorities to provide it to sufferers for free by NICE- the drug rationing quango.

The Government’s drugs rationing body, the National Institute for Curbing Expenditure (Nice), has provisionally said that it does not intend to recommend the use of the drug, called Tocilizumab, or Roactemra.

Nice claims that the £9,000 a year drug, for rheumatoid arthritis, has not proved that it is cost effective.

But patients in Scotland are to receive the treatment after it was recommended by the body which regulates drugs on the Scottish NHS, the Scottish Medicines Consortium (SMC).

The move will reopen accusations of medical ‘apartheid’ within Britain.

It follows an outcry after patients in Scotland were given access to expensive cancer drugs denied on the NHS in England and Wales.

Roactemra has been described as a “life changing” drug because it can be taken after other medications have failed, a common problem in the treatment of rheumatoid arthritis.

Patients groups last night said that denying the medication to tens of thousands of patients with the crippling condition in one part of the country was “cruel”.

Ailsa Bosworth, chief executive of the National Rheumatoid Arthritis Society (NRAS), said: “I have heard patients stories that would make you weep.

“People are virtually suicidal because they have nowhere else to go and yet they know that there are other drugs out there that they could have access to but cannot because of Nice.”

She added that it was “ludicrous” that the drug would be available in Scotland “and yet two miles on over the border you can’t get it.”

The drug - the first new arthritis treatment for a decade - is already used in most other European countries, including France and Germany.

It offers another option for patients for whom other treatments have failed or no longer work and is used in combination with a standard anti-inflammatory drug, called methotrexate.

Currently many rheumatoid arthritis patients receive methotrexate as a first-line treatment to ease their symptoms.

In later years they are offered another class of drugs, called anti-TNFs, together with methotrexate, but even combined the effects of the drugs can wear off.

In combination Roactemra has been found to improve the rates of remission of the illness sixfold in comparison with just methotrexate alone.

The SMC - set up in the aftermath of devolution to make decisions about drugs north of the border - has agreed that the drug can be used for patients suffering from moderate to severe forms of the disease for whom other medications no longer work.

Prof John Isaacs, from Newcastle University, said: “This is fantastic news for people in Scotland who suffer from this disabling, lifelong disease.

“However, it also highlights the disparities in accessing treatments between Scotland and the rest of the UK.

“Because Roactemra works in a completely different way to the existing drugs it is likely to be effective in some patients where the other drugs don’t work or have stopped working, providing an extremely important option for these individuals.”

Neil Betteridge, chief executive of Arthritis Care and vice president of the European League against Rheumatism (EULAR), said: "There are a number of treatments for RA currently available but they simply don't work for everyone.

"There are people who are most severely affected by this debilitating condition – living in intense pain, unable to work, often struggling even to walk – who have been failed by existing treatments, and it's for them that tocilizumab could provide real hope.”

He called on Nice to follow the lead of the SMC and approve the drug for use in England and Wales.

Up to 37,000 patients across Britain would be eligible for the drug. But local health care trusts do not have to pay for drugs which have not been approved by Nice.

In December Nice took the unusual step of challenging Roche, the drug’s manufacturers, to provide more evidence of that the drug was cost effective.

A final Nice appraisal of the drug is expected later this year.

Around 646,000 people in Britain are though to suffer form rheumatoid arthritis, in which their own immune systems start to attack their joints.

Herceptin, a £21,000-a-year drug for breast cancer, was initially turned down by Nice but available in Scotland, which has its own health budget.

A climb-down, ordered by Patricia Hewitt, the then health secretary, allowed the drug in England and Wales.

Patients in Scotland also had access to Tarceva, a lung cancer treatment, which costs about £1,700 a month, two years before the rest of the country.

Nice also provoked outcry by turning down Lucentis, a £20,000-a-year treatment available in Scotland for wet age-related macular degeneration, one of the most common causes of blindness, although it later also reversed that decision.

From:

http://www.telegraph.co.uk/health/healthnews/7020499/Patients-in-England-and-Wales-denied-arthritis-drug-available-in-Scotland.html

Fall in clinical trials of drugs through NICE

Investment by drugs companies and access by patients to innovative medicines in the UK are coming under threat, as data show a decline in the number of clinical trials conducted in this country.

Bureaucracy, low recruitment rates and the slow uptake of new drugs are pushing pharmaceutical companies to undertake more research in other countries in Europe and North America, as well as increasingly in low cost developing nations.

In spite of efforts by the labour government to make trials cheaper, faster and easier to conduct, the UK's disproportionately strong historic role in the development of medicines is being undermined. 

Data show a declining role for the UK since the turn of the decade, with its share of global clinical trials falling from 6 per cent in 2002 to only 2 per cent in 2007.

The latest figures from the Department of Health show the number of mid-stage, late-stage and post-approval clinical trials fell from 728 in 2008 to 470 this year, its lowest level in the past decade. Early-stage trials fell to 210, the lowest in five years.

The data were corroborated by figures provided to the Financial Times by Quintiles, one of the world's leading clinical research organisations, which conducts trials for most significant drug companies. These show that the number of patients recruited into mid and late-stage clinical trials in the UK stagnated at 782 last year compared with 749 in 1999. 

By contrast, patient numbers during the same 10-year period almost doubled to 1,283 in France; trebled to 31,617 in the US and to 3,657 in Poland; and quadrupled to 2,117 in the Czech Republic.

Dennis Gillings, chief executive of Quintiles, which has continued to expand early-stage clinical trials in the UK, said: "We would be happy to invest more in the UK, but there's a feeling that the NHS has a negative attitude towards industry and a reluctance to pay for drugs."

The statistics come in spite of rising patient recruitment in some areas, including cancer trials, and a broader range of efforts in conjunction with industry to streamline approvals, reduce costs and encourage National Health Service doctors to participate in research.

The findings come as researchers lead calls for reforms to the EU's clinical trials directive. A consultation on revising the legislation closes in early January. But Kent Woods, head of the Medicines and Healthcare Products Regulatory Agency, the UK body that scrutinises new drugs, said only minor modifications were required to distinguish standards for high-risk and low-risk trials.

From:

http://www.ft.com/cms/s/0/acbd525c-f5ac-11de-90ab-00144feab49a.html?nclick_check=1

Health Direct NHS preview of 2010

Spending will dominate debates over the NHS and health – especially in an election year and the scale of NHS cuts will become apparent as the year progresses.

Already hospitals have been told that they will receive no increase in the amount of money that they are paid per procedure, essentially a real terms cut in the cash they will receive.

Overall, the health service has also been set a goal to make between £15 million and £20 million of efficiency savings over the next four years.

The fact that McKinsey, the management consultancy firm, estimates that to achieve such that a goal would take making 10 per cent of NHS staff redundant and abandoning procedures such as varicose vein operations suggests the scale of the challenge.

Patients' groups will continue to keep a close eye on the labour government’s drugs rationing body NICE in 2010. Over the last year the National Institute for Curbing Expenditure (NICE) began looking more favourably on drugs which prolong life for terminal patients, as it was instructed to do so by Government.

2009 also saw a number of drug companies come forward with innovative deals that allowed the NHS to pay less for some medicines.

But with expensive drugs for cancer and other illnesses coming through the pharmaceutical pipeline at all times patients will continue to monitor how Nice makes decisions about which drugs it will allow on the NHS.

The Government will scale up its Change4Life campaign, which so far has concentrated on children and families, to focus on adult obesity.

Despite data which suggests that rises in childhood obesity could be levelling off, ministers and health planners are still worried about the strain on the NHS if predictions that half of adults could be heavily overweight by 2050 come true.

2010 should be the defining year for the Swine flu pandemic. Will cases continue to drop or will swine flu return either early in the new year or next winter?

Sir Liam Donaldson, the Chief Medical Officer, warns that we cannot be complacent about the threat that the virus still poses and points to pandemic flus in the 1960s in which death rates were higher in the second winter than the first.

The H1N1 vaccine could be the deciding factor, but to what extent remains to be seen.

Nanny state libel laws gag doctor over drug risks

General Electric, one of the world’s biggest corporations, is using the London libel courts to gag a senior radiologist after he raised the alarm over the potentially fatal risks of one of its drugs.

The multinational is suing Henrik Thomsen, a Danish academic, after he described his experiences of one of the company’s drugs as a medical “nightmare”. He said some kidney patients at his hospital contracted a potentially deadly condition after being administered the drug Omniscan.

GE Healthcare, a British subsidiary of General Electric, has run up more than £380,000 in legal costs pursuing Thomsen.

“I believe the lawsuit is an attempt to silence me,” he said last week. “It’s dangerous for the patient if we can’t frankly exchange views.”

The company admits its product has been linked to serious side effects in some patients, but said Thomsen accused the company of suppressing information in a presentation at a scientific congress in Oxford in October 2007.

A summary of Thomsen’s presentation for the High Court writ, provided by GE Healthcare, appears to show that it was an even-handed account of his clinical experience.

When asked by The Sunday Times to highlight any part of the presentation that explicitly stated wrongdoing by GE Healthcare, a spokeswoman for the company was unable to do so. The writ states that the defamation may have been “by way of innuendo”.

His case will trigger a fresh row over the draconian use of Britain’s libel laws to stifle scientific debate and silence critics. Thomsen now refuses to discuss the possible risks of the drug in any UK public forum.

Evan Harris, a former hospital doctor and the Liberal Democrat science spokesman, who is leading the parliamentary campaign to reform the libel laws, said: “It is hard to conceive a stronger public interest than scientists and clinicians being able to discuss freely their concerns about drugs or devices used on patients. Libel laws should not be used in this way.”

More than 48m doses of Omniscan have been given worldwide and it is safe for the vast majority of people. It is one of a number of “contrast agents” containing the potentially toxic metal gadolinium, which are used to enhance images for magnetic resonance imaging scans.

Omniscan and other products have been linked with a skin condition in kidney patients, known as nephrogenic systemic fibrosis. Sufferers can be confined to a wheelchair and may even die from related causes.

Regulators in Europe and the US are now taking action over the potential risk from Omniscan and two similar products.

Five people in Britain have died from possible side effects after being administered Omniscan, according to the Medicines and Healthcare Products Regulatory Agency.

Patients have launched legal actions in America involving more than 170 deaths where it is claimed Omniscan and similar drugs may have been a factor. Safety problems with the drugs have been highlighted in the US by the independent investigative news organisation ProPublica.

Paul Flynn, the Labour MP, said, “It is a scandal that a company should take action against someone acting in the interests of patients.”

GE Healthcare said it had launched a libel action against Thomsen as a “last resort”. It is also suing Thomsen for an article in a medical magazine published in Brussels, but he said his name had been put on an article that he had not written.

From:
http://business.timesonline.co.uk/tol/business/law/article6962865.ece

Labour doesn't want you to have a High Christmas as more legal drugs are banned

More legal high drugs are banned in UK by the nanny state as several drugs known as "legal highs" has come into force.

The substances, including GBL and BZP, become Class C drugs, with a possible two year jail sentence for possession.

Labour ministers moved to classify them after a recommendation from the Advisory Council on the Misuse of Drugs and fears they are a threat to user health.

GBL was linked to the death of medical student Hester Stewart, 21, in Brighton last April. Her mother, Maryon, campaigned nationally for the ban.

So called legal highs are typically man made chemical substances designed to act like banned drugs.

Scientists, officials and police officers have been concerned for several years that GBL, BZP and other so-called "legal highs" have been sold openly across Britain and on the internet, despite evidence that they can be harmful to health.

GBL, which metabolises in the body into the already banned drug GHB, will become a Class C drug carrying maximum jail terms of two years for possession and 14 years for supply.

Piperazines, of which BZP is the most popular, are also being made Class C drugs.

This group of drugs is popular on the club scene as an alternative to ecstasy and amphetamines.

Synthetic cannabis has also been banned and become a Class B drug. Possession of products such as "spice", a herbal mixture laced with psycho-active chemicals, now carries a maximum five-year jail term.

Fifteen anabolic steroids, associated with drug abuse in sport, have also been classified as Class C.

Police chiefs say their response will be proportionate and focused on dealers.

Home Secretary Alan Johnson said the government was committed to raising awareness of the dangers of psychoactive substances through its Frank campaign, but also wanted to send a clear message to those thinking of using the drugs.

"We are cracking down on so-called 'legal highs' which are an emerging threat, particularly to young people," said Mr Johnson.

"That is why we are making a range of these substances illegal from today with ground- breaking legislation which will also ban their related compounds."

Scientists at the Forensic Science Service laboratories have recently discovered that drug dealers in London have been using one of the newly-banned drugs to manufacture fake "crack cocaine".

Piperazines were first developed as a worming agent and are also used in some manufacturing processes. The FSS says "legal highs" based on the chemical have become more prevalent than ecstasy.

Friday's ban is unlikely to be the last. The Advisory Council on the Misuse of Drugs will next year consider a new wave of so-called "legal highs", which are based on a group of chemicals known as cathinones.

However, the recent controversy over the sacking of the council's chairman, Professor David Nutt, and the subsequent resignation of council members in protest, could mean any final recommendations are delayed.

From:

http://news.bbc.co.uk/1/hi/uk/8427439.stm

New drugs available on NHS before NICE appraisal

Patients with rare diseases are to get innovative new drugs on the NHS before they have been through NICE under a new pilot scheme.

The new scheme will allow patients with rare diseases to receive important new drugs which have not been appraised by the NHS rationing body, NICE (National Institute for Curbing Expenditure).

It will allow the makers to build up sufficient evidence on the benefits of the drugs which will then be used by Nice to decide if the medicine is cost effective enough for the NHS.

Currently, it is very difficult to provide enough evidence of a drug's benefits if only small numbers of people take it.

A pilot scheme of the so-called Innovation Pass has been launched by ministers.

The Innovation Pass pilot will be funded from a ring-fenced £25m budget in 2010/11.

Health Minister Mike O’Brien said: “I am extremely pleased to launch this consultation that will help patients with the greatest need to benefit from and get access to exciting new innovative drugs.

“The Innovation Pass pilot will help collect the essential data needed to demonstrate that such drugs, which would not otherwise be available to patients, are making a big difference to their lives."

Andrew Dillon, Chief Executive of Nice, said: "We recognise that for a small number of very promising new treatments, the evidence available may not reveal their full potential benefits for patients.

"Where there is a high risk that a Nice appraisal of a new treatment at the point of its first use in the NHS might underestimate its benefits, providing the opportunity to gather more evidence and making the treatment available before undertaking an appraisal is the right thing to do.

“We’re happy to play our part in making this new arrangement work well, and that it works in the interests of patients and the NHS.”

The Innovation Pass pilot consultation will run for 10 weeks, closing on 8th February 2010. Input and comments are welcome from all groups including stakeholders, industry, the NHS and patient groups.

From:

http://www.telegraph.co.uk/New-drugs-available-on-NHS-before-Nice-appraisal.html

NHS bureaucracy bill soars by £78 million in two years

The number of bureaucrats working for the NHS has soared over the past two years, according to a survey.

The amount spent on employing managers has risen by a quarter, or £78 million, in the past two years, the study shows. NHS Trusts blamed Whitehall targets for the increase.

It comes a day after NICE, the drugs rationing watchdog, refused funding for life prolonging bowel cancer drug Avastin, saying it was not cost effective.

Pulse, a magazine for GPs, found that projected spending on management salaries has increased by 25 per cent between 2007/08 and 2009/10 in primary care trusts, which look after community services. It was up from £312million to £390million.

But the true figure is likely to be far higher, because only a third - 55 - of the 152 trusts responded.

The rise is largely down to trusts taking on more managers, with 15 that provided headcounts saying the number of posts had gone up 14 per cent.

These trusts also reported that the cost per manager had risen by 11 per cent. David Stout, director of the NHS Confederation's PCT Network, said it was "unrealistic" for such increases to continue.

"A lot of this is spending trusts are carrying out in response to what the Department of Health has asked for," he told the Daily Mail.

Conservative health spokesman, Mike Penning said: "It is inevitable the rises must be keeping money away from patient care and the front line.

"Labour ministers must explain why so much more is being spent on management after a reorganisationof PCTs that was intended to produce efficiency savings."

The editor of Pulse, Richard Hoey, added: "What we're seeing exposed here is the bureaucratic machinery that has been put in place to implement Government policy priorities.

"These are policies which look good on paper, but in practice create whole new chains of managerial command."

From:

http://www.telegraph.co.uk/NHS-bureaucracy-bill-soars-by-78-million-in-two-years

Turmoil over NHS records scheme as labour cuts NPfIT to save cash

The world’s biggest civilian IT project was thrown into turmoil yesterday after Alistair Darling, the labour chancellor, implied that it was going to be scrapped.

The chancellor told the BBC’s Andrew Marr Show the £12.7bn NHS IT programme – already running years late – was “something that I think we don’t need to go ahead with just now”.

Treasury officials rushed to explain that the government was looking for “significant savings” of up to perhaps £600m over the medium term by cutting back some features that are less important for patients.

A senior health department official, meanwhile, said bluntly span that “the chancellor mis-spoke” in saying the project to create an electronic medical record would be scrapped.

Details of which elements would go were not clear on Sunday night. But the government would face compensation claims of many hundreds of millions of pounds if it cancelled the programme. Fujitsu, an IT provider, is already in mediation with the health department over its £700m compensation claim after it was fired last year.

Ahead of Wednesday’s pre-Budget report, Gordon Brown will on Monday announce that the government has found another £3bn of “efficiency savings” – in practice, many of them cuts – since the Budget.

In a change of rhetoric, Mr Brown is expected to argue these savings are an “element of our efforts to reduce the [£175bn] deficit”, not just a means of protecting frontline services.

Some 123 quangos will go – including the Foreign Office advisory committee on wine purchasing – with the courts inspectorate merged into an existing inspectorate and several health bodies merged with NICE, the National Institute for Curbing Expenditure.

Full details of quango mergers and abolitions will not be spelt out until next year’s Budget, but they are expected to save an estimated £500m.

Central government’s use of consultants will be halved and the marketing budget cut by 25 per cent, saving £650m. Better use of text messaging and online services should save £665m – for example by reducing missed hospital appointments – according to government estimates.

Many of the proposals, which the prime minister will present as “streamlining government”, mirror those from the Tories, who have promised to slash the use of consultants to cut council tax. They also propose reducing by 24,000 the 80,000 civil servants employed in policymaking, inspection and regulation, and grant assessment over the next Parliament.

The FDA, the top civil servants union, condemned the planned cut in civil service numbers as “crude electioneering” and “irresponsible” just months ahead of a general election.

Mr Darling’s apparent scrapping of the NHS electronic record programme excited both the Conservatives and the Liberal Democrats, the latter calling for it to be “abandoned in its entirety” and Andrew Lansley, the Tory health spokesman, describing it as “another government IT procurement disaster”.

From:

http://www.ft.com/cms/s/0/71d29630-e2a5-11de-b028-00144feab49a.html?nclick_check=1

Nanny state wants NHS to provide free marriage guidance

Couples are to be offered marriage guidance counselling for free on the NHS, in a move which has drawn strong condemnation from patients and doctors' groups.

Couples with relationship problems will be offered free sessions for up to six months, as part of a £270 million programme to increase the provision of "talking therapies" for the public, Andy Burnham, the health secretary, announced.

Doctors and patients' groups said they were "horrified" by the use of NHS resources for relationship advice when patients with cancer and dementia were being denied treatment they desperately needed.

Currently, most people seeking help from services like Relate pay between £45 and £60 per session, meaning the free counselling packages will be worth around £1,000 per couple.

The NHS is expected to have to pay existing marriage guidance services, and newly-trained counsellors to provide the therapy.

Doctors and patients groups last night attacked the recommendation, contained in guidance by the National Institute for Health and Clinical Excellence (NICE). NICE has repeatedly come under fire for decisions to reject life-extending drugs for cancer and treatment to reduce symptoms of dementia.

On Thursday, NICE was accused by charities of "condemning patients" to an early death by rejecting the use of Nexavar, a drug which can extend the lives of liver cancer, arguing that its £9 million annual cost – £3,000 a month per patient – could not be justified.

Nick James, professor of clinical oncology at the Cancer Research UK Institute for Cancer Studies said: "I am horrified, in particular because of the way these decisions are taken without public debate.

"I think most people would say treatment for those who are sick with cancer should be top of our list, and I would really question whether these kinds of efforts to preserve marriages are a matter for the state."

NICE has previously restricted the use of drugs to limit the effects of Alzheimer's, costing £2 a day, while provoking further controversy in May when it ruled in favour of alternative therapies like acupuncture for back pain, despite admitting there was little evidence they worked.

Michael Summers, Vice-President of the Patients Association, urged NICE and the Government to "get their priorities right". If we had the luxury of untold sums of money, maybe we would think about paying for couples counselling," he said.

"As things stand, people are still waiting for urgent treatment, being denied drugs for cancer, and dementia, and it seems inappropriate at the very least to start using public money in this way".

From:

http://www.telegraph.co.uk/health/healthnews/NHS-will-provide-free-marriage-guidance

Women and older people less likely to receive heart attack drugs

Thousands of women and older people who suffer heart attacks are dying unnecessarily because they are not being prescribed the gold standard treatment which could prevent another attack.

One in five people who have had a heart attack in Britain do not receive all four drugs recommended to prevent a second, a study of 60,000 people have found.

NICE guidelines say heart attack patients should be prescribed two blood pressure drugs, a cholesterol lowering statin and aspirin to thin the blood.

However research based on a database of all surviving heart attack patients in England and Wales has found one in 20 people received only one or two drugs.

Women and older people are less likely to receive all four drugs, the study by University of Leicester has found.

Only 29 per cent of people leaving hospital on all four drugs were women. In addition the average age of those on one drug was 82 while the average age of those on four was 67.

Lead author Prof Iain Squire, professor of cardiovascular medicine at University of Leicester and consultant at the Leicester Royal Infirmary, calculated that 2,000 out of the 5,000 deaths over the two year study period had been undertreated and 'could potentially have been avoided'.

He said: "The patients who are most likely to get undertreated are the elderly and females but they get incremental benefit for each drug they take so we should not be withholding these therapies based on age and gender alone."

People aged 65 to 74 were 20 per cent less likely to get all four drugs compared with those under 55; while people aged over 85 were three times less likely to get all four medicines.

The findings, based on an analysis of the national registry called the Myocardial Infarction National Audit Project collected between January 2004 and December 2005, were presented at the European Society of Cardiology Congress in Barcelona.

It is thought doctors believe the drugs are less beneficial and more difficult to use in older people, and that women do not gain as much as men from them.

But the study showed that the survival benefits are similar in women as in men and in the elderly, the research showed.

The chances of surviving for one year after a heart attack increased with the number of drugs prescribed.

When other factors such as age, gender, and other illnesses were taken into account, people on four drugs were 54 per cent more likely to be alive one year later compared with people on just one drug.

Those on three drugs were 42 per cent more likely to be alive 12 months on than people on one drug; and people on two drugs were 27 per cent more likely to survive for one year than patients receiving one drug.

The effect was the same in men and women and the graded benefits of multiple drugs remained evident for patients aged 80 and over, the authors said.

Prof Squire said: "Our data indicate that provision of equitable management in these high-risk groups has the potential to deliver major improvements in prognosis for patients with acute myocardial infarction."

Prof Adam Timmis, co-author and professor of clinical cardiology at the London Chest Hospital, said the majority of people are receiving all four drugs but improvements could still be made.

He said: "If you optimised the use of exisiting drugs and people were all managed appropriately across the country that would have a very large effect on cardiovascular outcomes."

Prof Timmis said the guidelines, complied by the National Institute for Curbing Expenditure, Nice, are clear that there should be no discrimination on the basis of age or gender.

He said: "There is a general feeling that women don't get this [heart attacks]. But we are not dealing with a condition that is rare in women, but there has been this perception."

Prof Peter Weissberg, Medical Director of the British Heart Foundation, said this data was four years old.

He said: "We can pretty reasonably assume we are better now then we were then. We are getting better because we have this audit, hospitals are named and shamed when they are poor performers.

"There is a way to go and, generally speaking, women get a poorer deal in cardiovascular disease. That is improving but still less than perfect."

Around 113,000 people in Britain each year suffer a heart attack and about one in three die before reaching hospital.

From:

http://www.telegraph.co.uk/Women-and-older-people-less-likely-to-receive-heart-attack-drugs

Sentenced to death on the NHS by NICE red tape

Patients with terminal illnesses are being made to die prematurely under an NHS scheme to help end their lives, leading doctors have warned.

In a letter to The Daily Telegraph, a group of experts who care for the terminally ill claim that some patients are being wrongly judged as close to death.

Under NHS guidance introduced across England to help doctors and medical staff deal with dying patients, they can then have fluid and drugs withdrawn and many are put on continuous sedation until they pass away.

But this approach can also mask the signs that their condition is improving, the experts warn.

As a result the scheme is causing a “national crisis” in patient care, the letter states. It has been signed palliative care experts including Professor Peter Millard, Emeritus Professor of Geriatrics, University of London, Dr Peter Hargreaves, a consultant in Palliative Medicine at St Luke’s cancer centre in Guildford, and four others.

“Forecasting death is an inexact science,”they say. Patients are being diagnosed as being close to death “without regard to the fact that the diagnosis could be wrong. As a result a national wave of discontent is building up, as family and friends witness the denial of fluids and food to patients."

The warning comes just a week after a report by the Patients Association estimated that up to one million patients had received poor or cruel care on the NHS.

The scheme, called the Liverpool Care Pathway (LCP), was designed to reduce patient suffering in their final hours.

Developed by Marie Curie, the cancer charity, in a Liverpool hospice it was initially developed for cancer patients but now includes other life threatening conditions.

It was recommended as a model by the National Institute for Curbing Expenditure (Nice), the labour Government’s health scrutiny body, in 2004.

It has been gradually adopted nationwide and more than 300 hospitals, 130 hospices and 560 care homes in England currently use the system.

Under the guidelines the decision to diagnose that a patient is close to death is made by the entire medical team treating them, including a senior doctor.

They look for signs that a patient is approaching their final hours, which can include if patients have lost consciousness or whether they are having difficulty swallowing medication.

Patients can become semi-conscious and confused as a side effect of pain-killing drugs such as morphine if they are also dehydrated, for instance.

When a decision has been made to place a patient on the pathway doctors are then recommended to consider removing medication or invasive procedures, such as intravenous drips, which are no longer of benefit.

If a patient is judged to still be able to eat or drink food and water will still be offered to them, as this is considered nursing care rather than medical intervention.

Dr Hargreaves said that this depended, however, on constant assessment of a patient’s condition.

He added that some patients were being “wrongly” put on the pathway, which created a “self-fulfilling prophecy” that they would die.

He said: “I have been practising palliative medicine for more than 20 years and I am getting more concerned about this “death pathway” that is coming in. It is supposed to let people die with dignity but it can become a self-fulfilling prophecy.

“Patients who are allowed to become dehydrated and then become confused can be wrongly put on this pathway.”

He added: “What they are trying to do is stop people being overtreated as they are dying. It is a very laudable idea. But the concern is that it is tick box medicine that stops people thinking.”

He said that he had personally taken patients off the pathway who went on to live for “significant” amounts of time and warned that many doctors were not checking the progress of patients enough to notice improvement in their condition.

Prof Millard said that it was “worrying” that patients were being “terminally” sedated, using syringe drivers, which continually empty their contents into a patient over the course of 24 hours.

In 2007-08 16.5 per cent of deaths in Britain came about after continuous deep sedation, according to researchers at the Barts and the London School of Medicine and Dentistry, twice as many as in Belgium and the Netherlands.

“If they are sedated it is much harder to see that a patient is getting better,” Prof Millard said.

Katherine Murphy, director of the Patients Association, said: “Even the tiniest things that happen towards the end of a patient’s life can have a huge and lasting affect on patients and their families feelings about their care.

“Guidelines like the LCP can be very helpful but healthcare professionals always need to keep in mind the individual needs of patients. There is no one size fits all approach.”

A spokesman for Marie Curie said: “The letter highlights some complex issues related to care of the dying.

“The Liverpool Care Pathway for the Dying Patient was developed in response to a societal need to transfer best practice of care of the dying from the hospice to other care settings.

“The LCP is not the answer to all the complex elements of this area of health care but we believe it is a step in the right direction.”

The pathway also includes advice on the spiritual care of the patient and their family both before and after the death.

It has also been used in 800 instances outside care homes, hospices and hospitals, including for people who have died in their own homes.

The letter has also been signed by Dr Anthony Cole, the chairman of the Medical Ethics Alliance, Dr David Hill, an anaesthetist, Dowager Lady Salisbury, chairman of the Choose Life campaign and Dr Elizabeth Negus a lecturer in English at Barking University.

From:
http://www.telegraph.co.uk/Sentenced-to-death-on-the-NHS

Swine flu- nanny state criticises naughty professionals who refuse vaccine putting patients at risk

Doctors and nurses are potentially putting patients at risk if they refuse the swine flu vaccine, labour's nanny state has warned.

Nanny state officials said that NHS staff had a duty to take the jab, to ensure they did not pass on the virus to those who were already sick. Even though the vaccine has not met their own NICE drug guidelines.

The warning follows a spate of surveys which suggest that many healthcare workers will refuse the vaccine, despite being on the labour Government's “priority list”.

Up to half of GPs and one in three nurses say that they do not plan to take the vaccine, some because of concerns over safety.

Vivienne Parry, a member of the Joint Committee on Vaccination and Immunisation, (JCVI) who advise ministers on vaccines, said that health professionals should protect “vulnerable patients” from the virus.

She said: “This (protection) aspect does not seem to feature at all in medical staff responses about flu vaccination, which is extremely concerning.

“Indeed the word ‘patient’ hardly seems to figure at all in responses in this and other surveys of healthcare workers, even though 75 per cent of deaths from swine flu are in those with serious underlying medical conditions who are in regular contact with healthcare workers.”

Prof David Salisbury, the nanny states's Department of Health director of immunisation, told GP magazine, which carried out the poll, that frontline health workers had a “duty” to have the vaccine.

“They have a duty to their patients not to infect their patients and they have a duty to their families,” he said.

More than two thirds of GPs who told Pulse magazine that they would turn down the jab believe that it has not undergone enough tests.

Doctors have been warned to look out for possible signs of Guillain Barre Syndrome, a rare neurological condition, which can cause paralysis and even death.

A vaccine used against flu in America in 1976 caused a number of cases of the condition.

However, the World Health Organisation (WHO) insists that the production of vaccines has become much safer since then.

Human trials are currently underway and will be scrutinised by the regulatory authorities before the vaccines will be licensed for use, probably in October.

Earlier this month a poll of almost 1,500 Nursing Times readers revealed that one in three said that they would not have the swine flu vaccine.

Uptake of the seasonal flu vaccine among NHS staff has been traditionally low, and just 16 per cent of all those employed by the health service took the vaccine last year.

Another study published online by the British Medical Journal shows that half of 8,500 healthcare workers in Hong Kong say that they would refuse a swine flu vaccine, because of safety concerns and worries that it would not work very well.

Researchers said that the figures were surprisingly low given the impact the SARS (Severe Acute Respiratory Syndrome) virus had on the area.

However, some experts insisted that the polls did not prove that NHS staff were “irresponsible” or had serious concerns about the safety of the vaccine.

Prof Robert Dingwall, Director of the Institute for Science and Society at the University of Nottingham, said that it was important not to blow the apparent reluctance of healthcare workers to have the vaccine “out of proportion”.

He said: “(These polls) identify a communication challenge for those managing the pandemic but they are not evidence of a crisis of confidence in the vaccine or of professional irresponsibility by health workers."

From:
http://www.telegraph.co.uk/Swine-flu-Doctors-who-refuse-vaccine-putting-patients-at-risk

Cancer drugs fail to win NHS funding killer quango NICE

Four drugs for treating various stages of kidney cancer have been turned down for health service funding in England by NICE, in spite of price cuts by the manufacturers.

The decisions by the National Institute for Curbing Expenditure (NICE) underline that new guidance last year for “end of life” treatments will not produce a wave of new approvals for costly drugs that can extend life but where there is not yet evidence of dramatic results.

This year Nice approved Pfizer’s Sutent as a “first line” treatment for kidney cancer. But the institute has now rejected it as a second line treatment – where an initial therapy has failed – and has turned down rival products from Roche, Bayer and Wyeth for first line use.

It has done so in spite of Pfizer, Roche and Bayer agreeing deals with the Department of Health, which effectively cut the price of the drugs to the National Health Service.

The decisions were described as “a bitter blow” by the patients’ charity the Rarer Cancers Forum, which claimed they “went against the spirit” of last year’s amended guidance giving greater weight to end-of-life care.

Roche, whose product Avastin was rejected, was also furious, saying it was “considering all options”, including legal action. It attacked the decision as “illogical” when its product costs broadly the same as Sutent.

Professor Peter Littlejohns, clinical director of Nice, said that in spite of the revised guidance and price cuts “the benefit [from these drugs] was still too small, set against their cost”.

From:
http://www.ft.com/cms/s/0/10069bfc-91bc-11de-879d-00144feabdc0.html?nclick_check=1

Couples are still being refused IVF treatment in a postcode lottery

Couples are still facing problems getting IVF treatment on the NHS, with some trusts refusing to fund procedures or comply with guidelines, such as a woman’s age.

Regional disparities mean that the same woman can be too old for treatment in one part of the country and too young in another. Two trusts have provided no IVF treatment in the previous two years.

Research suggests that eight out of ten primary care trusts are still failing to follow government recommendations set out in 2004 by the National Institute for Curbing Expenditure (NICE), allowing women three free cycles of IVF.

Other eligibility criteria, such as whether one of the couple has a child from a previous relationship, smoking habits and weight, also vary widely, the study shows.

The study, by Grant Shapps, the Conservative MP for Welwyn Hatfield, who has campaigned for better access to fertility treatment, was based on an 80 per cent response rate from trusts in England. It found that provision was worse than two years ago.

In the East Midlands, every trust offered one full cycle of treatment but, in the South East, 41 per cent did not offer IVF to women aged 23 to 39, as set out in the NICE guidance. Some trusts, such as North Lincolnshire, offered IVF only to women between 37 and 39, whereas at least four trusts have an upper age limit of 37. One in eight was failing to comply with guidelines on a woman’s age.

In the East Midlands, no trust would offer treatment to couples in which one partner had a child but 70 per cent would in the North East. Overall, 54 per cent of trusts excluded couples from IVF if one partner had a child from a previous relationship.

Almost half of all trusts said that they wanted couples to have been in a relationship for more than three years. Others wanted one or two years while some asked only if the relationship was “stable”. While many trusts refused IVF to couples who smoked, some allowed treatment if the man was the smoker.

The 2004 NICE guidance said that the NHS should fund three cycles of IVF for women under 40. John Reid, then the Health Secretary, said that couples would be offered one free IVF cycle by April 2005, with a view to three cycles being offered in the future.

By 2007 this was still not happening. Dawn Primarolo, the Health Minister, wrote to trusts in that year saying that they should be looking to fund three cycles.

Experts have said that the drive to cut the number of multiple births is also being hampered by the lack of access to free IVF. Couples who have the chance of only one cycle on the NHS might wish to have more than one embryo transferred.

The NICE guidance also said that trusts should allow frozen embryos to be transferred as part of one cycle. But very few offered this.

Mr Shapps said that the study, compiled from freedom of information requests, showed that IVF “remains a postcode lottery in this country”. He added: “Budgets are tight and the NHS must set its priorities, but it is wrong to raise expectations in couples who are desperate to start a family only for them to find out later that they won’t get the real help they expected.”

Clare Lewis-Jones, chief executive of the charity Infertility Network UK, said that although there had been an improvement recently in the provision of treatment by some trusts there remained a totally unjustifiable and unfair variation in the criteria used to determine whether couples could have treatment. “This proves that five years on from the issue of the NICE guideline, patients are still facing a postcode lottery when it comes to accessing NHS fertility treatment.”

She urged trusts to accept recommendations laid down in a document, Standardising Access Criteria to NHS Fertility Treatment, produced by Infertility Network UK and funded by the Department of Health.
 

From:
http://www.timesonline.co.uk/tol/life_and_style/health/article6740622.ece

Patients forced to live in agony after NICE refuses to pay for painkilling injections

Tens of thousands with chronic back pain will be forced to live in agony after a decision to slash the number of painkilling injections issued on the NHS by the killer quango, doctors have warned.

The labour Government's drug rationing watchdog says "therapeutic" injections of steroids, such as cortisone, which are used to reduce inflammation, should no longer be offered to patients suffering from persistent lower back pain when the cause is not known.

Instead the National Institute of Health and Clinical Excellence (NICE) is ordering doctors to offer patients remedies like acupuncture and osteopathy.

Specialists fear tens of thousands of people, mainly the elderly and frail, will be left to suffer excruciating levels of pain or pay as much as £500 each for private treatment.

The NHS currently issues more than 60,000 treatments of steroid injections every year. NICE said in its guidance it wants to cut this to just 3,000 treatments a year, a move which would save the NHS £33 million.

But the British Pain Society, which represents specialists in the field, has written to NICE calling for the guidelines to be withdrawn after its members warned that they would lead to many patients having to undergo unnecessary and high-risk spinal surgery.

Dr Christopher Wells, a leading specialist in pain relief medicine and the founder of the NHS' first specialist pain clinic, said it was "entirely unacceptable" that conventional treatments used by thousands of patients would be stopped.

"I don't mind whether some people want to try acupuncture, or osteopathy. What concerns me is that to pay for these treatments, specialist clinics which offer vital services are going to be forced to close, leaving patients in significant pain, with nowhere to go,"

The NICE guidelines admit that evidence was limited for many back pain treatments, including those it recommended. Where scientific proof was lacking, advice was instead taken from its expert group. But specialists are furious that while the group included practitioners of alternative therapies, there was no one with expertise in conventional pain relief medicine to argue against a decision to significantly restrict its use.

Dr Jonathan Richardson, a consultant pain specialist from Bradford Hospitals Trust, is among more than 50 medics who have written to NICE urging the body to reconsider its decision, which was taken in May.

He said: "The consequences of the NICE decision will be devastating for thousands of patients. It will mean more people on opiates, which are addictive, and kill 2,000 a year. It will mean more people having spinal surgery, which is incredibly risky, and has a 50 per cent failure rate."

One in three people are estimated to suffer from lower back pain every year, while one in 15 consult their GP about it. Specialists say therapeutic injections using steroids to reduce inflammation and other injections which can deaden nerve endings, can provide months or even years of respite from pain.

Experts said that if funding was stopped for the injections, many clinics would also struggle to offer other vital services, such as pain management programmes and psychotherapy which is used to manage chronic pain.

Anger among medics has reached such levels that Dr Paul Watson, a physiotherapist who helped draft the guidelines, was last week forced to resign as President of the British Pain Society.

Doctors said he had failed to represent their views when the guidelines were drawn up and refused to support the letter by more than 50 of the group's members which called for the guidelines to be withdrawn.

In response, NICE chairman Professor Sir Michael Rawlins expressed outrage over the vote that forced Dr Watson from his position, describing the actions of the society as "shameful". He accused pain specialists of refusing to accept that there was insufficient scientific evidence to support their practices.

A spokesman for NICE said its guidance did not recommend that injections were stopped for all patients, but only for those who had been in pain for less than a year, where the cause was not known.

Iris Watkins, 80 from Appleton, in Cheshire said her life had been "transformed" by the use of therapeutic injections every two years. The pensioner began to suffer back pain in her 70s. Four years ago, despite physiotherapy treatment and the use of medication, she had reached a stage where she could barely walk.

"It was horrendous, I was spending hours lying on the sofa, or in bed, I couldn't spend a whole evening out. I was referred to a specialist, who decided to give me a set of injections. The difference was tremendous",

Within days, she was able to return to her old life, gardening, caring for her husband Herbert, and enjoying social occasions.

"I just felt fabulous – almost immediately, there was not a twinge. I only had an injection every two years, but it really has transformed my life; if I couldn't have them I would be in despair".

http://www.telegraph.co.uk/health/healthnews/5955840/Patients-forced-to-live-in-agony-after-NHS-refuses-to-pay-for-painkilling-injections.html

NHS to give back pain acupuncture after NICE U Turn

Patients with persistent low back pain should be offered acupuncture, massages or exercises on the NHS, says new NICE guidance.

It is the first time that the National Institute for Curbing Expenditure has explicitly backed the use of complementary therapies.

The rationing watchdog said evidence suggests they help and will be cost effective if doctors stop providing less proven back services like x-rays.

The move was welcomed by some charities and experts but criticised by others.

Low back pain is a very common problem affecting one in three adults in the UK each year, with an estimated 2.5 million people seeking help from their GP.

For many people the pain goes away in days or weeks. But for some, the pain can persist for a long time and become debilitating.

NICE says anyone whose pain persists for more than six weeks and up to a year should be given a choice of several treatments, because the evidence about which works best is uncertain.

Complementary therapies

In addition to painkillers and regular advice to stay active and carry on with normal activities as much as possible, patients, together with their doctor, can decide to opt one of three complementary treatments.

This includes up to eight exercise sessions or 10 sessions of acupuncture over 12 weeks, or a course of manual therapy, which includes up to nine sessions of spinal manipulation, mobilisation or massage.

Professor Peter Littlejohns, NICE said NHS providers now had the opportunity to look at the services they provide and decide what changes are needed.

He said: "There is variation in current clinical practice, so this new NICE guideline means that for the first time we now have the means for a consistent national approach to managing low back pain.

"Importantly, patients whose pain is not improving should have access to a choice of different therapies including acupuncture, structured exercise and manual therapy."

Patients who fail to benefit from their first choice may be offered another of these options, he said.

If that doesn't work, they can try an intensive treatment programme combining exercise and psychological therapy.

He said the costs to the NHS would be minimal - in the order of £77,000 - because they are offset by the savings in terms of reducing future disability and healthcare needs and moving away from treatments with little supportive evidence.

The guidelines, which apply to England and Wales, say doctors should no longer offer spinal x-rays or MRI scans or injections of therapeutic substances into the back for non-specific low back pain.

The Chartered Society of Physiotherapy welcomed the guidelines, as did Dr Dries Hettinga of the charity BackCare.

He said: "This offers a real choice for patients. This guideline will help patients understand what treatment and care can help them with their back pain and shows that there can be a positive outlook for treating this condition."

From:
http://news.bbc.co.uk/1/hi/health/8068427.stm

NICE guidelines on drugs are unfair MPs decide

The methods used by the labour government's killer quango NICE to decide whether the NHS should pay for expensive drug treatments are wasteful and unfair, according to MPs.

A report from the Commons Health Committee recently attacked the way in which the National Institute for Curbing Expenditure (NICE) assesses costly cancer medicines as "both inequitable and an inefficient use of resources".

The MPs' inquiry was sparked by calls for cancer patients to be able to pay out of their own pockets for medicines that Nice advises the NHS not to use, leading to new guidelines issued late last year by Prof Michael Richards, the government's "cancer tsar".

After a series of decisions by Nice to reject new cancer drugs as insufficiently effective either clinically or on cost, Prof Richards called for the National Health Service to make more expensive drugs available.

However, the select committee argued that Nice had in response adopted a threshold for judging whether to approve "end of life drugs" that was too high, depriving the NHS of resources to spend on more cost effective drugs for other illnesses that had a more significant benefit.

It also criticised Nice for moving too slowly in assessing new drugs, and said the agency's guidelines for selecting the types of costly cancer drugs to be reviewed was "too woolly".

The committee questioned the increased threshold adopted by Nice for approving such drugs above the usual £30,000 per quality adjusted life year (Qaly), the measure it uses to assess the benefit a drug brings to a patient. Nice denied that threshold was as high as £70,000.

Kevin Barron, chairman of the committee, denied that the implication of the report was that Nice should reduce its Qaly threshold, arguing instead that it should make greater efforts to free up resources by finding other ways for the NHS to save money.

His committee said it was "extremely disappointed" little progress had been made by the government in following its previous calls for Nice to "disinvest" in obsolete technologies.

Prof Sir Michael Rawlins, chairman of Nice, said: "There is a balance between egalitarianism and utilitarianism. The select committee has fallen into the latter."

He said Nice was reviewing the Qaly, but it was "the only game in town", and that identifying savings for the NHS from older treatments and techniques was a difficult and "subtle" process.

The health select committee also expressed caution over the growing use of "risk sharing" schemes, whereby the government and pharmaceutical companies agree to reimburse some of the costs of medicines that prove less effective than initially believed.

The debate came as the National Audit Office identified one source of savings, estimating that NHS primary care trusts had saved £394m last year through more consistent use of lower cost, generic medicines for some common conditions such as high blood pressure, high cholesterol and gastric problems.

From:
http://www.ft.com/cms/s/0/3d1bce3a-3f57-11de-ae4f-00144feabdc0.html?nclick_check=1

Health Direct points out that NICE's use of the phrases "difficult" and "subtle process" are similar to that of MPs' expenses. A smokescreen for don't ask me uncomfortable questions.

Until NICE publishes what it's Qaly definition and it's scientific analysis guidelines for evaluating drugs actually are- the killer quango will continue to have the disrespect it deserves.

NICE U turn as kidney cancer patients to get Sutent drug on NHS

Terminal kidney cancer patients will receive an expensive drug on the NHS, following a U turn by the labour Government's drugs rationing body.

The National Institute for Curbing Expenditure (Nice) has approved the use of Sutent, which costs around £27,000 a year, in its final decision yesterday.

But the body will turn down three other kidney cancer drugs insisting that they are not "cost effective" for the health service.

Nice sparked outrage in August last year when it initially turned down Sutent, claiming it was too expensive.

At the time patient groups and cancer charities accused the body of condemning sufferers to an "early death".

The drug, which can prolong life for months, is used in the treatment of patients with terminal kidney cancer.

Since its initial draft guidance on the use of the drug Nice has agreed with the labour Government to look more favourably on drugs which prolong life when it makes it decisions.

This, coupled with an offer from Pfizer, the company which makes Sutent, to cut the price, means that the drug will be approved for use on the NHS.

Under the agreement, Pfizer will pay the £3,139 cost of the first six-week cycle of the drug, with the health service paying the rest of the costs.

Three other kidney cancer drugs, Avastin, Nexavar and Torisel, are expected to be rejected because the body has deemed them too expensive for the benefits they provide.

Around 7,000 people are diagnosed with kidney cancer in Britain every year and an estimated 3,600 could be eligible to receive Sutent.

Earlier this year it was announced that the drug, also called sunitinib, would be given to patients in Wales, paid for by the Welsh Executive, even before the Nice announcement.

Prof Robert Hawkins, Cancer Research UK Professor and Director of Medical Oncology at Christie Hospital Manchester, said: "I am delighted that Sutent will be available.

"It will remove a great deal of anxiety and uncertainty for people diagnosed with renal cancer to know that modern, effective treatment is now available to them."

James Whale, from the James Whale Fund for Kidney Cancer, said: "Finally, we have justice for the kidney cancer community. This positive recommendation from Nice will allow thousands of kidney cancer patients in England and Wales access to this life extending treatment.

"The options previously available to us have been limited and are inadequate for the majority of patients. For some, sunitinib is the only hope."

From:
http://www.telegraph.co.uk/health/healthnews/5044196/Kidney-cancer-patients-to-get-expensive-drug-on-NHS.html

Health Direct asks how many people have been condemned to an early death by labour's killer quango whilst it dragged it's feet over spending NHS money?

Rheumatoid arthritis patients beneift from NICE U turn postcode lottery

Faster treatment has been promised for the 20,000 new sufferers of rheumatoid arthritis every year as part of the first nationwide guidance for treating the incurable condition.

The new advice, to be issued by the National Institute for Health and Clinical Excellence (Nice), follows a damning report that found a postcode lottery with wide variations in the way cases of the painful condition were handled.

It also calls for specialist physiotherapy to improve fitness for the 400,000 existing UK sufferers.

Experts said early treatment was key to reducing the effects of the debilitating auto-immune disease in which a person's joints, particularly hands and feet, are attacked by their body's own defences. It affects relatively young people and cannot be cured.

A report last year by think tank The King's Fund found thousands of sufferers were being let down by "unacceptably wide variations" in care by GPs and hospitals, with some patients waiting years for a diagnosis because of a lack of understanding among GPs.

The guidelines will apply throughout England and Wales.

It calls for anyone with suspected symptoms to be referred to a specialist. The referral should be urgent if the small joints of the hands or feet are affected or it has been three months or longer since the onset of symptoms.

Newly-diagnosed patients, which number some 20,000 a year, should be offered a combination of disease modifying antirheumatic drugs as soon as possible, it says.

The 400,000 existing sufferers should have access to physiotherapy to improve their general fitness and learn exercises for enhancing joint flexibility and muscle strength. The guidance also says they should also have access to assessments of the effects the disease – such as pain, fatigue, and inability to work.

Consultant rheumatologist Dr Chris Deighton, who was clinical adviser to the guideline development group, said: "Early diagnosis and referral to a specialist are key recommendations in this guideline – this will help us catch the disease at earlier stage where it may be possible to reduce future damage to the joints with disease-modifying drugs."

The guidance was welcomed by patients' groups. National Rheumatoid Arthritis Society chief executive Ailsa Bosworth said that, if widely implemented, it would help patients get the care they need.

"This guideline will help patients understand what constitutes best practice in managing RA, and realise that putting up with unbearable pain doesn't have to be an option," she said.

Arthritis Care chief executive Neil Betteridge said that Nice's "whole-person" approach to treatment represented a "giant leap" for sufferers but must now be backed with adequate resources.

"This guideline ticks a lot of boxes and includes much that Arthritis Care has long campaigned for. However, it must be backed up by the range of services needed in GPs' surgeries, hospitals, and the wider community," he said.

From:
Faster-access-to-drugs-promised-for-rheumatoid-arthritis-patients-under-new-NHS-advice

Health Direct reveals Labour's drug problem

Health Direct asks what is the problem that labour has with drugs?

First off, when they took office in 1997 they created NICE- the National Institute for Curbing Expenditure.

The spin was that NICE would research and regulate new drugs treatments. In practice this was a clever wheeze to cut NHS costs by limiting access to new life saving treatments.

AKA the postcode lottery. AKA the killer quango.

The creation of nice meant that for the first time since the sixties unelected anonymous people were given the power of life- or death over British subjects.

So opaque were the “rules” governing nice's remit that drug companies had to go to court to find out how they actually evaluate and approve new drugs.

Then in parallel whilst labour were messing around with “mainstream” drugs they flip flopped with recreational drugs. One memont downgrading cannabis then upgrading it, as well as ignoring the scientific evidence of ecstacy.

On Wednesday, August 02, 2006 Health Direct posted: Risks of taking drugs compared- Scientific review of dangers of drugtaking- Drugs, the real deal when Health Direct reproduced the first ranking based upon scientific evidence of harm to both individuals and society. It was devised by government advisers - then ignored by ministers because of its controversial findings.

The analysis was carried out by David Nutt, a senior member of the Advisory Council on the Misuse of Drugs, and Colin Blakemore, the chief executive of the Medical Research Council. Copies of the report have been submitted to the Home Office, which has failed to act on the conclusions.

Since then labour's stance on recreational drugs has not improved, below and tomorrow Health Direct posts a review by the Financial Times:

The Slow Road To A Ban

The emergence of the rave party scene in the 1980s and the circulation in the early 1990s of the Californian pharmacologist Alexander Shulgin's "cookbook" on how to make more than 200 psychoactive substances created the conditions for a new generation of potent products.

When the resulting "designer drugs" began to proliferate in Europe, national authorities saw the need to introduce new mechanisms to speed up cross-border regulation and control.

Currently, the European Monitoring Centre for Drugs and Drug Addiction and Europol, which liaises between police across the EU, consider whether a new drug merits more detailed study. They look at the substance's biological, psychological and behavioural effect on the user; the effect on families, neighbourhoods and communities, and on society at large.

They then may recommend to the European Commission and the European Medicines Agency that a "risk assessment" be launched. If a qualified majority of the European Council agrees, the drug may then be banned and brought within criminal laws in EU member states. The process can take many months from identification to ban.

The UK Drugs Market

Despite the tough criminal penalties for dealers, illegal drugs are available relatively cheaply. The Home Office says cannabis in resin or herbal form typically sells for £10 for an eighth of an ounce - enough for half-a-dozen joints - and the more potent skunk for twice that. Ecstasy sells for £2-£5 per pill, amphetamines for £10 per gramme and cocaine and heroin for £30-£50 for a gramme - enough for four or five lines. Crack cocaine sells at about £65 per gramme.

By contrast, "herbal highs" such as Spice are more expensive, typically selling for £20-£30 in shops and over the internet. One reason may be precisely because they are not banned, so purchasers will pay a premium to stay within the law. Plus, for large manufacturers, there are overheads to cover such as tax that are not borne by criminal dealers.

Legal drugs' slick marketing and packaging may persuade customers that they are less dangerous for their health. But Les King, a Home Office adviser, warns against glib comparisons with their illegal counterparts. "Perhaps Spice is seen as safer," he says, "if only because it comes in a nice package rather than, like cannabis, in a dirty piece of clingfilm."

From:
http://www.ft.com/cms/s/0/3e6b6c44-fa3a-11dd-9daa-000077b07658.html

Killer quango NICE in cancer drug Sutent U Turn

Thousands of kidney cancer patients should soon receive an expensive drug that could prolong their lives on the NHS following an about turn by the labour Government's drugs rationing body NICE.

The National Institute for Curbing Expenditure (Nice) has issued new guidance recommending that patients with the cancer should be given Sutent, or Sunitinib, following a public outcry.

Last year NICE was accused of condemning sufferers to an "early death" when it recommended that the drug was not "cost effective" for the health service.

However, Nice has revised that guidance after taking into account new rules requiring greater funding for expensive drugs that can help terminally ill patients.

Coupled with an offer from the manufacturers, Pfizer, to make the drug cheaper, Nice said that its new draft guidance was that Sutent should be prescribed on the NHS.

Under the deal, Pfizer, will pay the £3,139 cost of the first six-week cycle of the drug, with the NHS picking up the rest of the bill, expected to be just over £30,000 a year.

In a statement, Nice said that it accepted that the drug was a "clinically effective treatment".

The organisation has recommended that it be used for patients whose cancer is advanced or has spread to other parts of their body, and who currently have few other treatment options.

However, it still recommends that three other kidney cancer drugs, Avastin, Nexavar and Torisel, are too expensive for the benefits they offer.

Cancer experts said that the new guidance on Sutent would make an "enormous difference" to patients.

Around 7,000 people are diagnosed with kidney cancer in Britain every year and an estimated 3,600 could be eligible to receive Sutent, which is widely available in countries like Germany and France, and last month given to patients in Wales.

Currently patients with the advanced stage of the disease are offered just one drug, Interferon, to which many sufferers do not respond.

Sutent has been shown to increase survival by several months, and in some cases for up to two years, but does not cure the disease.

Andrew Dillon, the chief executive of Nice said: "Having decided that one of these treatments should be recommended for use in the NHS, we felt that it was in the interests of patients to get that advice out as quickly as possible.

"Although this final recommendation is subject to appeal we very much hope it will form the basis of our guidance to the NHS."

Professor John Wagstaff, from the South West Wales Cancer Institute, said: 'This really fantastic news for people with kidney cancer... (this will) make an enormous difference for patients and for clinicians.'

Dr David Gillen, medical director, Pfizer Limited, said Sutent had become "the new standard of care in the rest of the world" for kidney cancer patients.

"Not only will this decision have immediate benefits for eligible patients today, but will also pave the way for future treatment advances in kidney cancer," he said.

In recent months Nice has agreed payment deals to allow a number of expensive drugs to be prescribed on the NHS.

These include Lucentis, which can improve the sight of sufferers of a degenerative eye condition, Tarceva, for lung cancer, and Revlimid, for a rare type of blood cancer.

Nice has previously faced controversy over its advice that Herceptin, the breast cancer drug, could only be used for advanced cases. Following public pressure and legal battles the drug was allowed for early stages of the disease.

The organisation is currently looking at its advice that Aricept, which costs £2.50 a day, be given only to Alzheimer's patients with advanced stages of the disease.

Final guidance on the use of the four kidney cancer drugs is expected in March.

From:
http://www.telegraph.co.uk/health/healthnews/4449605/Kidney-cancer-patients-should-get-Sutent-on-the-NHS-says-NICE.html

NICEly does it- Financial Times comment

"Probably not. But it's worth a bloody good try."

That was the response of Frank Dobson, then health secretary in Britain's Labour government, to a question in 1999 about whether the new National Institute for Curbing Expenditure (NICE) would work.

Nice is the public body that recommends which treatments the National Health Service can dole out to patients. Mr Dobson sounded sceptical.

But last week the NHS constitution was launched in England (a country that has muddled through for centuries without bothering to set one down for its citizens) and Nice, which has only been around for a decade, is enshrined in it.

In its short life, the institute has made waves, both in the UK and abroad. Assessing the cost-effectiveness of drugs and diagnostic techniques is bound to court controversy. But, even if some disagree with its criteria, Nice has at the very least encouraged a national debate about how healthcare resources should be spent.

It take two to tango, though. And if Nice has brought to the UK (and some might argue to other countries as well) a new rigour in this kind of cost-benefit analysis, it has also forced drug companies to do some hard thinking of their own.

The result has been some innovative pricing of drugs. GlaxoSmithKline, for instance, has said it will bear the initial 12-week cost of a breast cancer drug, after which the NHS will foot the bill. The idea is that by then, the drug's clinical benefit should be pretty clear. An alternative kind of risk-sharing was suggested by Novartis, with its Lucentis drug, which the Swiss drugmaker will pay for if patients need more than a certain number of injections.

At a time when the private sector is getting a thrashing, it's good to reflect on the merits of the public sector. But what's nice about Nice is that it's a public-private partnership that really makes the most of both systems.

From:
http://www.ft.com/cms/s/0/db025c9c-e825-11dd-b2a5-0000779fd2ac.html?nclick_check=1

Health Direct is not surprised that the Financial Times is broadly supportive about the quango NICE, as they review it's cost benefit analysis.

What is ignored though is that it is over four decades since unelected "experts" lost the power to bring about the premature deaths of UK citizens when the judiciary lost the power to hang criminals.

However labour's formation of NICE has recreated the situation whereby unelected officials have the power of life or death over NHS patients by granting NICE the authority to withhold drugs which they deem to be too costly.

NHS to widen drugs range in NICE U Turn

A wider range of costly “end of life” treatments for terminal illness is to be made available on the NHS, the body that recommends which treatments the service should adopt has confirmed.

Sir Michael Rawlins, chairman of the National Institute for Curbing Expenditure (NICE), said it would issue new guidance to its advisory committees which would have the effect of raising the price the NHS should pay for treating some terminal illnesses.

The new guidance will apply only to conditions likely to affect small numbers of patients a year – up to about 7,000 – and who have a life expectancy of two years or less.

Following the row over patients having to “top up” their NHS care by paying for life-extending, but not curative, drugs, Sir Michael said Nice had recognised that “people attach a special importance to extending the lives of [those with] mortal illnesses, even for a few months, and we appreciate these extra weeks and months can be very special”.

As a result, he told the BBC in an interview, its new guidance would “have the effect of extending the threshold range of what we would normally regard as cost-effective”.

Nice has been consulting on the change, which has been warmly welcomed by the pharmaceutical industry.

However, the NHS Confederation, which represents health authoritiesand trusts, has warned that such drugs will come at the expense of other treatments. Primary care trusts, which buy care on patients’ behalf, have fixed budgets, the confederation said in its response. If more is spent on end-of-life care, “then as cash-limited organisations, primary care trusts will need to reduce spending elsewhere”.

“There is some concern that treatments, interventions and services that are more cost-effective, but not subject to Nice guidance, will lose out to pay for the high cost of end-of-life drugs,” it said. The proposals “could lead to less cost-effective medicines being prioritised over those able to provide greater overall benefit”, it said, arguing that it was not entirely clear that society wanted to benefit small numbers of patients in that way.

The confederation said there was also concern “the proposed change could encourage the pharmaceutical industry to focus on end-of-life research, product development and marketing at the expense of other health priorities”.

By contrast, the Association of the British Pharmaceutical Industry welcomed the change, saying it believes that it better reflects “societal preferences in the allocation of scarce resources”. But it warned that proving cost effectiveness, even at the higher threshold, would be “extremely challenging in some cases”, because care at the end of life is often expensive and even the limited improvement in life expectancy that some of these products bring would add to already high costs.

It also questions the justification for the new threshold being limited to treatments likely to affect only 7,000 patients a year who have limited life expectancy.

However, Sir Michael said that to raise the threshold for more common conditions, on which it is easier for the industry to make its money back, would cost the NHS “hundreds of millions of pounds a year”.

From:
http://www.ft.com/cms/s/0/6929870a-d39c-11dd-989e-000077b07658.html

NHS managers’ skill levels criticised by MPs

The National Health Service lacks the leadership and commissioning skills to implement the labour government’s plans for high quality care in the NHS, a cross party committee of MPs warned.

Despite a programme called “world-class commissioning” aimed at boosting the ability of primary care trusts to buy care for their patients, “there are few signs yet” that wide variations in how well PCTs commission care have been addressed. “We doubt that most are currently capable of doing this task successfully,” the Commons health committee said.

Too many managers lacked the analytic and planning skills needed. And the MPs added that it was “striking and depressing” that commissioning was still not given sufficient status within the service, despite its being nearly 20 years since a ­purchaser/provider split was first introduced.

Furthermore, the link between primary care trusts buying care, and doctors doing the same through practice-based commissioning, “remains opaque”, the committee said, with little progress on the latter.

Part of the drive to im­prove quality involves giving a much higher profile to reporting of the outcomes of the care patients receive. But the committee says there is a lack of information about how extensive the financial incentives associated with that will be, how much it will cost to implement, when it will be fully implemented and whether it will give value for money.

The sceptical assessment of the government’s plans came as a leading academic suggested very few extra new cancer drugs were likely to be approved for use by the NHS, despite a change in policy on “end of life” treatments by Nice, the National Institute for Clinical Excellence.

Nice is to give more weight to such treatments in future assessments, and Professor Michael Rawlins, its chairman, has suggested two to three extra drugs may be approved a year as a result.

However, James Raftery, professor of health technology assessment at Southampton university, says the new arrangements “may do little to improve availability of expensive cancer treatments”.

The price of the 14 cancer drugs Nice has recommended against since 1999, either provisionally or finally, is way above the threshold of £30,000 ($44,325) per quality adjusted life year (Qaly) normally needed to gain Nice approval, Prof Raftery says, writing in the British Medical Journal.

For example, for four kidney cancer drugs that Nice is due to reappraise shortly, the cost per Qaly ranged from £72,000 to £171,000 per Qaly.

Even with a big rise in the threshold, his assessment is that “few of the rejected drugs would qualify under the new criteria”. One or two may, Prof Raftery says, where there is lack of any alternative treatment. But much will depend on how Nice interprets that stipulation.

From:
http://www.ft.com/cms/s/0/998e0454-e100-11dd-b0e8-000077b07658.html?nclick_check=1