Watchdog says failure by trusts to comply with alerts is unacceptable by risking patients' lives

Hospitals were accused of putting patients' lives at unnecessary risk after research revealed they were failing to comply with NHS orders designed to prevent deaths from mistakes involving drugs, surgery or equipment.

Information released by the ­Department of Health after a freedom of information request showed that hospitals were not complying with safety alerts issued by the National Patient Safety Agency (NPSA).

The NPSA's chairman, Lord Patel of Dunkeld, told the Guardian that the behaviour of the trusts was unacceptable and endangered the health of patients.

"It's not good enough," he said. "What's the point of us developing these alerts if they don't pay any attention to them? Alerts are produced to reduce risk and hopefully avoid many deaths, so not to implement them to me is alarming. If they aren't implemented then they run the risk of harm occurring and the danger will continue."

The Department of Health research revealed that:

• 104 hospitals and other providers of NHS care in England have not confirmed they have implemented an NPSA alert issued in March 2007 to ensure that ­injectable medicines are used more safely – even though new systems are meant to be in place by March 2010. 

The alert came after 25 patients died and 28 others experienced serious harm in 18 months.

• 25 NHS organisations have not ­confirmed compliance with an NPSA safer-practice notice designed to reduce the risk of patients ­falling out of bed. It was issued after about 90 patients who rolled out of bed on to the floor in ­hospitals, mental health and learning disability units, fractured their neck or femur; 11 of them died.

• 81 hospitals and other care providers had not taken the "required actions" outlined in patient safety alerts covering opioid (painkilling) medicines. The alert was originally issued in July 2008 with a deadline of January 2009; the 81 had not complied by 29 December 2009.

• 10 NHS trusts have not said they have complied with a February 2005 alert on nasogastric feeding tubes, which can sometimes be wrongly placed into the lungs during insertion. Errors involving the feeding tubes caused at least 11 deaths before the alert came out, according to the NPSA.

Patel acknowledged that complying with alerts can be difficult for the NHS. "They can't be implemented overnight because they involve system changes, for example to IT systems or clinical practice. But having said that, the level of implementation is not good enough and needs major improvement," he added.

The research, sought by the patient safety charity Action Against Medical Accidents (AvMA), also reveals that 50 trusts have not showed they have ­followed the NPSA's advice in 2008 on hand hygiene, which is a major source of hospital-acquired infections; 37 have not taken steps set out in 2006 to improve the safety of blood transfusions; 56 did not comply with 2009 advice on reducing the risk of children being injured or killed by parents with mental heath conditions; and six have not implemented a 2008 alert on avoiding patients undergoing brain surgery accidentally having burr holes drilled in the wrong side of their head, as at least 15 did between 2005 and 2008.

Peter Walsh, AvMA's chief executive, said: "The fact that so many NHS bodies are failing to act on potentially life-saving alerts from the NPSA is shocking. It is putting lives at unnecessary risk and adds insult to injury for patients who have been harmed or lost loved ones as a result of NHS lapses in safety."

Lisa Richards-Everton, whose husband, Paul, died in July 2007 after a drugs blunder while he was a cancer patient in Birmingham's Heartlands hospital, said the report was shocking. 

"It shows how the government and the NHS are failing everyone," she said. "The systems that are currently in place are inadequate and urgent changes need to be made. These are people's lives we are talking about; everyone deserves to be safe in hospital. We trust adequate safety measures are in place, but clearly this is not the case."

In addition, a total of 119 trusts did not comply with a 2008 NPSA alert on the risk to patient safety of not using the NHS number as the method of identifying patients nationally across England. That was despite the NPSA declaring that local hospital patient numbering systems involved "real danger to patients of serious harm or death".

The Department of Health revealed which NHS trusts had confirmed they had complied with the 53 patient safety alerts the NPSA issued between 2004 and 2009. University Hospitals Coventry and Warwickshire NHS Trust had not implemented the largest number: 37.

However, after becoming aware that the charity planned to publicise the department's data, the trust recently told the NHS's central alerts system that it had in fact complied with most of the 37. A trust spokesman said that its adherence to NPSA alerts had been examined by the Care Quality Commission (CQC), the NHS watchdog in England. "The CQC found absolutely no issues of concern and gave the trust a clean bill of health," he said.

Lewisham Hospital NHS Trust in south London had not acted upon the joint second highest number of alerts: 31. Joy Ellery, its director of knowledge, governance and communications, said it had delayed notifying the central alerts system because it took the alerts so seriously.

"We are so thorough with implementing safety alerts that until we've complied with them fully, we don't sign them off. We have now signed off a number of the 31 and are down to 18 that haven't been implemented." Asked if 18 was still poor, Ellery replied: "I would like it to be better."

The DH said it expected all NHS trusts to comply with safety alerts and to record and action them. It will issue the health service with a reminder about the need to update the alerts system reliably and as soon as possible, a spokeswoman said.

The new responsibility on all NHS trusts from April to register with the CQC will make mandatory the reporting of threats or potential threats to patient safety, she added.
 

From:

http://www.guardian.co.uk/society/2010/feb/15/hospitals-nhs-patient-safety-orders

Hospital made profit on NHS drugs sold abroad

A Surrey hospital sold millions of pounds worth of NHS medicines abroad during the past year, despite official warnings calling for an end to such arbitrage for fear it could lead to shortages for British patients.

The Royal Surrey County Hospital in Guildford confirmed a report in the Health Service Journal that it had made £300,000 in profit by exporting £4.6m in medicines in the 10 months to January.

The revelations precede a conference convened next month by Mike O'Brien, the health minister, designed to clamp down on such "parallel trade" after pressure by the pharmaceutical industry. They provide a clear example of NHS entities trading for profit, despite a statement by the Department of Health to the Financial Times last week that it was unaware of any particular examples.

The weakness of sterling against the euro has turned the UK into a low priced source of medicines in the past two years, allowing intermediaries to buy them for resale at a higher price elsewhere in Europe, such as Germany.

The UK was formerly a net importer of drugs from lower-priced countries such as Greece, as part of the widespread practice of parallel trade, transferring potential drugs company profits into the hands of intermediary traders.

While individual pharmacies and some drugs wholesalers have long taken part in this cross-border arbitrage, which is legal under European Union law, the government became concerned in recent months at the possible involvement of NHS hospital pharmacies. The chief pharmacist wrote to them last July, calling the practice "irresponsible".

The arbitrage runs the risk of creating medicine shortages in the UK. Officials were particularly concerned because of extra pressure on medical services caused by the flu pandemic. 

Bad weather in recent weeks also caused breaks in the normal drugs supply chain, causing stock shortages that could have threatened patients' lives.

Monitor, the hospital regulator, said it had inspected the Royal Surrey's practices in preparation for its conversion into a foundation trust in December but found no fault with the practice.

"As long as what they are doing is not illegal and doesn't affect their ability to focus on NHS patients, it is not an issue for us," Monitor said. It cited other commercial activities, such as childcare, while saying that car parking had become subject to ministerial  scrutiny.

The hospital said it had discontinued the parallel export of medicines last month in response to negative publicity and when a shift in exchange rates made the practice less lucrative. It said it was satisfied it did not run the risk of forming any medicine shortages for NHS patients.

The Department of Health told the FT last week that it had "received anecdotal evidence of NHS trusts being approached to become involved in such activities but has no concrete evidence that NHS trusts are involved".

The department said that it was "aware of a report that a hospital has considered trading in medicines for short-term financial gain. Such activities are wrong and threaten the medicines supply chain and patient care."

From:

http://www.ft.com/cms/s/0/ecf3b51a-1b62-11df-838f-00144feab49a.html

Doctors are addicted to every drug under the sun

Doctors are addicted to “every drug under the sun” the head of the first ever confidential GP service for health professionals has warned.

In its first year the clinic has treated NHS staff hooked on drugs including heroin, ketamine, a horse tranquilliser, and methadrone, a drug linked to amphetamines, said Dr Clare Gerada, medical director of the Practitioner Health Programme.

The service also uncovered six cases of undiagnosed psychosis, in which sufferers see things or hear voices.

The clinic was set up amid fears many health professionals were treating themselves or avoiding their local GP or hospital because of worries colleagues could learn of their health problems.

Overall, two of the doctors and dentists treated were reported to to the General Medical Council (GMC), because of fears that they could be putting patients in danger.

Another six were encouraged to report themselves to the regulator.

So far the service has operated only in London but there are plans to roll it out across the country, starting initially in Newcastle.

Two thirds of the 184 treated in the first 12 months had mental health problems, while one in three who came to the specialist service had some form of addiction.

Of these 51 were alcoholics and 16 drug addicts.

Dr Gerada said: “We are seeing every drug under the sun. Ketamine, methadrone, amphetamines, heroin, every drug you have ever heard of is coming through the door.”

The service has also treated unexpectedly high numbers of paediatricians, anaesthetists and psychiatrists.

The stress of the jobs, easy access to drugs, and the extra stigma attached to psychiatrists suffering from mental health problems could be reasons for the high demand, Dr Gerada said.

More than 80 per cent of those treated for drug or alcohol addictions were now sober, the first report on the service shows.

Prof Sir Liam Donaldson, the Chief Medical Officer for England, praised the success of the scheme.

“It has uncovered problems that would otherwise not have been seen and the interventions been highly effective,” he said.

From:

http://www.telegraph.co.uk/health/healthnews/Doctors-are-addicted-to-every-drug-under-the-sun

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.

USA is legalising marijuana on the quiet

You know things are shifting in America when Fortune magazine, the bible for business journalism, runs a cover story titled “Is pot already legal?”. 

You also know it when Barack Obama’s Department of Justice publishes a long expected memo signalling that the federal government will no longer raid medical marijuana dispensaries if they are legal under state law. That happened formally last month.

It was not, moreover, a symbolic gesture. Marijuana for medical reasons— to tackle chemotherapy- induced nausea or Aids-related wasting or glaucoma, among other conditions — is now legal in 13 states, including the biggest, California. 

Next year, 13 more states are planning referendums or new laws following suit. Last month a California legislative committee held the first hearings not simply on whether medical marijuana should remain legal, but on whether all marijuana should be decriminalised, full stop. The incentive? The vast amounts of money the bankrupt state could raise by taxing cannabis.

Now look at the polling on the question. In 1970, 84% of Americans supported keeping marijuana illegal. Today, that number has collapsed to 54%. The proportion believing that marijuana should be legal has gone from 18% at the end of the 1960s to 44% today. 

On current trends, a majority of Americans will favour legalisation by the end of Obama’s first term. In the western states, 53% already favour legalising and taxing the stuff. Support for legalisation is strongest among the young — the Obama generation — but has climbed among self-described Republicans as well.

But the reality is already ahead of the polls. Take a trip, so to speak, to Los Angeles today, where one would be forgiven for thinking that marijuana was already legal. There are more than 800 marijuana dispensaries in the city — and an estimated 7,000 in the state of California as a whole (many times more than in Holland).

Getting a doctor’s recommendation for marijuana is easier than getting health insurance — just look at the ads in the papers, where a consultation costs about $200. The dispensaries range from the dime store to elaborate palaces of capitalist taste. Seminars are held for entrepreneurs who want to start a business selling medical cannabis. On display are sophisticated strains that can provide exquisitely tailored effects: some best for countering nausea, some for building appetite, others for going to sleep, others for staying alert or for watching movies or for general relaxation.

The concentration of THC, the active compound, is much higher than in the past. But since no one has ever overdosed on marijuana, it’s difficult to say why that matters. Yes, if someone has a history of mental illness, it’s not that smart to experiment with the cannabinoid receptors in the brain. But it isn’t smart for such people to take any drugs — or too much alcohol — for that matter. For most people, stronger pot merely translates into a need for less of it to get the same effect. 

Too much and you’ll likely nod off — and wake up later with no hangover. If pubs served pot rather than beer, crime rates would plummet.

Americans, for whom the use of marijuana is almost a rite of passage in most colleges, know all this. And at some point they stopped pretending otherwise. The past three presidents smoked marijuana in their earlier days, even if only one has openly written about it. (Obama, when asked the Clinton question — if he had inhaled — responded: “I thought that was the point.”) In an online press conference with his younger supporters, the first question was about whether legalising and taxing pot would be a good thing to help raise revenues. Obama laughed it off. With an annual deficit of more than a trillion dollars, he may not be able to laugh it off much longer.

The key to the shift has been the emphasis on marijuana’s medical properties. Human beings have used marijuana as medicine for millennia. It was once sold in the States by Eli Lilly, the pharmaceutical manufacturer. Allowing this compassionate use for a few soon revealed, accidentally, how harmless it is. It is not chemically addictive, although some mild withdrawal can happen if you are a regular pot-smoker and go cold turkey. 

Its side-effects are minimal compared with those of most authorised drugs for similar conditions. It is far less addictive than tobacco or alcohol. It leads to no measurable degree of antisocial behaviour, as is the case with, say, crystal meth or cocaine or heroin. Many of its users are successful, productive members of society who simply prefer it to alcohol as a relaxant in the evening or as a way to get through cancer treatment.

Denying Aids patients a tool to stay alive tips the balance. I have one friend who would never have been able to tolerate the medications that saved his life without it. That’s pretty persuasive stuff and lots of people have similar first-hand experiences. A gateway drug? Yes, many users of hard drugs smoked pot in the first place. 

But almost all started out with alcohol as well — and that is not illegal.

Of course, nothing is inevitable. The police still police it and hundreds of thousands of Americans — disproportionately black and poor — are in jail for it. Los Angeles’s failure to regulate adequately its hundreds of dispensaries may lead to connections with organised crime that could come back to delegitimise the whole thing.

I give it a couple of years to become a non-issue or to go into reverse. And my bet is that in a decade’s time, the banning of cannabis will seem as strange as the banning of alcohol. In the end, unnecessary prohibition undermines itself. And this time around, there are millions of cancer and HIV patients who are on the side of legalising and some truly desperate branches of government looking to see what they can tax next. In fact, I’ll go further: sooner rather than later, marijuana may be more acceptable than tobacco.

The need for taboos is eternal. But the object of the taboo is always shifting. The age of tobacco may be ending; and the millennium of marijuana may be about to begin.

From:

http://www.timesonline.co.uk/tol/news/world/us_and_americas/article6897958.ece

Breast removal for cancer is postcode lottery, study shows

Women with breast cancer are five times more likely to undergo a mastectomy rather than have less invasive surgery in some parts of the country compared with others, research has shown.

Sufferers living in some parts of the North are far more likely to undergo the major operation, rather than having the "breast conserving" surgery more common elsewhere, according to NHS figures revealing a "postcode lottery" in cancer care.

Statistics showing the ratio of mastectomies to less invasive procedures to treat breast cancer, show that Redcar and Cleveland, in the North East, is the place where patients were most likely to have at least one breast removed.

Those in the London borough of Richmond and Twickenham were the most likely to receive treatment which removed just part of their breast, with radiotherapy used to prevent the spread of tumours.

The statistics show that those living in Wolverhampton, West Midlands, the London borough of Kingston, South Staffordshire and Telford in Shropshire were also more likely to have mastectomies.

Research has found that for many women with breast cancer, either treatment has a similar survival rate, if the tumour is of a size where it can be removed without the whole breast being lost. The chance of drastic surgery was highest in the North. 

Women living in Redcar and Cleveland, in the North East, were five times as likely to have their whole breasts removed, rather than part of them, compared with those living in Richmond and Twickenham.

Those in Ashton, Leigh and Wigan, in the North West, Middlesbrough, in the North East and Bassetlaw in Nottinghamshire were also most likely to have mastectomies.

The new NHS figures, placed in the House of Commons library, show massive variations in practices across the country. Analysis found no relationship between the patterns and rates of survival in different parts of the country.

Experts said it was impossible to know from the data whether the massive discrepancies reflected the choices made by women from different areas, or pressure put on them by surgeons.

Cancer charities urged surgeons working in the areas most likely to carry out mastectomies, to carry out further investigations.

Women with breast cancer should be offered the option of mastectomy, or less invasive surgery backed by radiotherapy. Research has shown that for most women, the survival chances are similar, although those with larger tumours may have no choice but have the more drastic operation.

Meg McArthur, from Macmillan Cancer Support, said: "These variations are really substantial, and they really do require further investigation. In some cases – such as the way a tumour is positioned, women would have no choice but to have a full mastectomy, but that really wouldn't explain the scale of the difference shown here."

She said it was vital that women diagnosed with breast cancer were given full information about the risks and benefits of different treatments.

"I would want all surgeons to look closely at these figures, and for primary care trusts to examine them closely too," Miss McArthur added.

Dr Jane Maher, chief medical officer for Breakthrough Breast Cancer, said it should not be assumed that women in areas most likely to have mastectomies were necessarily being put under pressure to undergo the procedure. Many women given information about the risks and benefits of both procedures chose the more drastic surgery, because they felt more able to put their fears behind them if they took the most extreme option.

From:

http://www.telegraph.co.uk/Breast-removal-for-cancer-is-postcode-lottery-study-shows.html

Cancer research at risk in scramble for care funds

Research into cancer and dementia will come under threat from labour government plans to fund social care, experts warned.

Andy Burnham, the Health Secretary, told The Times that millions of pounds would be “reprioritised” from health research and development to pay the costs of the Social Care Bill..

Money will also be diverted from public health campaigns such as those on swine flu, sexually transmitted diseases and obesity.

The Bill, a key plank of Gordon Brown’s pre-election legislative agenda, has been condemned by Labour peers, scientists and health campaigners. It would guarantee free care at home or other support for up to 400,000 elderly and disabled people from next October, at a cost of £670 million a year.

Mr Burnham, disclosing for the first time how he planned to pay for the proposal, said that £60 million would be diverted from the health service’s research and development (R&D) budget and £50 million from public health promotions.

Further funds will be sought as part of a “major productivity drive”, he said. The NHS is expected to make up to £20 billion in efficiency savings over the next four years. Hospitals could see their income tied to levels of patient satisfaction on matters such as the quality of maternity care.

Scientists warned of the consequences of cutting research budgets, which help to support the clinical trials of new medicines.

Nick Dusic, director of the Campaign for Science and Engineering, said: “This is extremely disturbing as the NHS budget was supposed to be ringfenced to protect long-term investment into the health needs of this country. In any department any raid on the R&D budget is supposed to be discussed first with the Government’s Chief Scientific Adviser. If they’ve breached this process it’s an extremely worrying development that needs to be looked into.”

Health ministers are expected to be interrogated in detail about which elements of the R&D budget should be cut to pay for social care as part of a continuing inquiry by the Lords Science and Technology Committee.

Lord Warner of Brockley, the Labour peer and former Health Minister who last week described the social care proposals as “totally misjudged”, said: “I will be looking at the Bill very carefully to see if my worst fears are confirmed and whether the figures really do add up.”

Mr Burnham defended the Bill from claims that it amounted to “an admiral firing an Exocet into his own flagship”.

From:
http://www.timesonline.co.uk/tol/life_and_style/health/article6930661.ece?token=null&offset=0&page=1

Dramatic postcode lottery for cancer survival rates shock charities

Department of Health figures have shown a wide variation in cancer survival between different parts of the UK with lung cancer patients in Herefordshire three times more likely to die within a year than those in Kensington and Chelsea.

The country's biggest cancer charity has expressed shock at government figures revealing huge variations in patients' chances of surviving from one area of the UK to another. The biggest survival gap was in lung cancer, where Department of Health figures showed patients in Herefordshire were three times more likely to die within a year of diagnosis than those in Kensington and Chelsea. 

In the London borough, 44% of patients survived the first year after diagnosis, compared with only 15% in Herefordshire.

In bowel cancer there was also a big gap in survival – 80% in Telford and Wrekin after one year, but only 58% in Waltham Forest and Hastings and Rother. The gap was less pronounced in breast cancer, with the best rate in Torbay, where 99% survived for one year, compared with 89% in Tower Hamlets.

"There is no excuse for such a big difference between different areas," said Harpal Kumar, chief executive of Cancer Research UK. "It is appalling that someone with lung cancer in Herefordshire should be three times more likely to die within a year than a patient in Kensington, or that a person diagnosed with bowel cancer in Waltham Forest or Hastings should be 22% more likely to die within a year than a patient in Telford. This is the worst kind of postcode lottery."

Very few primary care trusts (PCTs) had survival rates that were as good as other countries in Europe now or even as good as Europe was achieving 10 years ago, which Kumar called "a disgrace".

"We're pleased that the Department of Health have been bold enough to publish these figures," he said. "The NHS now needs to take them very seriously."

One-year survival figures highlight the issues around delayed diagnosis of cancer. That can be partly the responsibility of the GP, who may not see many cancer cases in a year, but is often to do with the reluctance of the patient to seek medical advice when they suspect a problem.

The figures are contained in the Cancer Reform Strategy second annual report from national cancer director Mike Richards, who points out that cancer deaths continue to fall and that prevention efforts, such as the cervical cancer vaccination programme for schoolgirls and better screening, will further help.

Jeremy Hughes, chief executive of Breakthrough Breast Cancer, said the charity shared the concerns. "Although progress has been made in some parts of the country, in others key Cancer Reform Strategy initiatives are still yet to be implemented," he said. "In particular, urgent action must be taken to ensure that digital mammography is in place by the December 2010 deadline and that, as previously committed by the government, all women with breast problems referred by their GP will see a specialist within two weeks by the end of this year."

Here are the PCTs with the best and worst records for dealing with common types of cancer, in terms of the proportion of patients who are still alive one year after diagnosis:

Breast cancer- Worst
Tower Hamlets (89.3pc)
Hillingdon (89.5)
Barking and Dagenham (90.2)
Hastings and Rother (90.3)
West Hertfordshire (90.6)

Breast cancer- Best
Torbay Care Trust (99.0)
Darlington (97.9)
Stockport (97.6)
Warrington (97.6)
Western Cheshire (97.6)

Colorectal cancer- Worst
Hastings and Rother (57.8)
Waltham Forest (57.9)
Tameside and Glossop (61.5)
Derby City (62.6)
Enfield (62.6)

Colorectal cancer- Best
Telford and Wrekin (80.0)
City and Hackney (77.5)
Shropshire County (77.0)
Peterborough (76.7)
Plymouth Teaching (76.6)

Lung cancer- Worst
Herefordshire (15.4)
Milton Keynes (17.5)
Blackpool (18.3)
East and North Hertfordshire (20.3)
Hartlepool (21.1)

Lung cancer- Best
Kensington and Chelsea (43.7)
Hammersmith and Fulham (35.3)
Richmond and Twickenham (35.2)
Islington (34.8)
South Birmingham (34.6)

Health Direct has compiled this post from:

http://www.guardian.co.uk/society/2009/nov/30/cancer-survival-rates-figures
and
http://www.telegraph.co.uk/health/healthnews/6693438/Cancer-survival-rates-best-and-worst-trusts.html

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

Cancer postcode lottery- London patients get three times more funding than those in Leicester

The full extent of Britain's postcode lottery in cancer care has been laid bare by research showing some health trusts are spending three times as much per patient as others.

Huge variations in funding mean that cancer sufferers' chances of being given life-extending drugs, surgery, and specialist care vary wildly from one part of the country to another.

While the average amount spent on a cancer sufferer in some parts of London is almost £15,000 a year, in Leicestershire it is less than £5,000.

Cancer experts said the research, carried out by The Sunday Telegraph, exposed a "grotesque lottery" in which life-and-death decisions were routinely being made by bureaucrats who were "unelected, unaccountable and unqualified" to make the rulings.

The figures obtained by the paper give the most detailed picture so far of the postcode lottery in cancer care.

Data from 150 Primary Care Trusts for 2007/2008 detailing cancer funding was divided by separate NHS records showing the number of cancer sufferers in each area.

Average spending was highest in Tower Hamlets, in East London, where cancer patients were allotted £14,697 for the year.

Those living in the cities of Birmingham, Leeds and Manchester all received average funding of at least £12,500.

Spending was lowest in Leicestershire and Rutland, with just £4,989 allotted to the average patient; about £500 more was spent in Harrow, North London, Hampshire, Northumberland and North Yorkshire.

Last year a study of patients with advanced cancer showed a tripling in the life-expectancy of those given drugs which many PCTs refuse to pay for.

Research on patients treated by University Hospitals Birmingham Foundation Trust compared the fate of 40 given the drugs Sutent and Nexavar for kidney cancer with 40 whose requests for funding were denied.

Those given the drugs survived 22 months, while those denied them lived just seven months, the study found.

Prof Nick James, director of research and development at University Hospital Birmingham, said: "A lot of PCTs are severely restricting access to drugs which can make a substantial difference to survival".

While PCTs across Birmingham had agreed to fund many drugs for cancer patients living within their borders, those living further afield could only secure the same treatment if they won lengthy battles with bureaucracy, Dr James said.

The oncologist and professor of oncology at the University of Birmingham added: "Clinicians and patients in some areas are forced to battle continuously with bodies which are unelected, unaccountable and unqualified".

He said that patients and doctors wasted "hundreds of hours" drafting appeals, writing to MPs and campaigning in the local media in an attempt to be heard by PCTs who often failed to even reply to correspondence.

The research found that PCTs across the country spent an average of £7,807 on cancer patients per year.

Jonathan Waxman, professor of oncology at Imperial College London, accused the labour Government of devising a "grotesque lottery" of local decision-making by PCTs in order to duck the blame for difficult decisions.

He said: "It is an absolutely absurd system, which is exposed by this excellent investigation. These discrepancies in funding are the reason people die.

"Why should how you are treated depend on where you live, and on decisions made by 150 different organisations who don't have specialist knowledge of the patient?"

The study found the gulf between funding allocated in different parts of the country was growing.

Figures analysing spending per head of population showed the highest spending in Leeds, at £157 per head, compared with just £48 per head in the London boroughs of Camden and Newham.

The gap between the PCTs spending the most and those spending the least per head of population (weighted to take account of the health of the local population) increased from £70 to £109 between 2006/2007 and 2007/2008.

Cancer charities expressed alarm at the extent of the differences revealed by the research.

Sarah Woolnough, head of policy at Cancer Research UK, which raises funds to find treatments for cancer, said: "These huge variations in how much PCTs spend are worrying. We urge the Government to ensure that all PCTs deliver an efficient and high quality service for cancer patients in the face of predicted NHS cutbacks".

Mike Hobday, from Macmillan Cancer Support, said: " We know there are some PCTs which say yes to everything, and others which almost always say no, and that is something that we are concerned about.

"Some variation is to be expected, and in fact is necessary to meet the needs of particular populations, but it is really important that those commissioning services examine these findings closely".

Dr Peter Marks, director of public health at NHS Leicestershire County and Rutland, said its local death rates for cancer were significantly lower than in the rest of England, while survival rates for specific cancers were similar, and in some cases better, to those elsewhere.

Shadow Health Secretary Andrew Lansley described the findings as "extremely concerning".

He said: "Britain languishes near the bottom of the table in Europe when it comes to five year cancer survival rates. It's clear that ministers' promises to improve access to cancer drugs and treatments are ringing hollow for many vulnerable patients."

From:
Cancer-lottery-London-patients-get-three-times-more-funding-than-those-in-Leicester

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?

new labour top up rules for cancer drugs creates more red tape as fear of litigation mounts

The labour government is having to rewrite its guidance on implementing cancer czar Mike Richards' recommendations for top up payments.

Trusts have been observing the draft guidance since it was published in November. As it stands, primary care trusts face increased bureaucracy as an unintended consequence.

Cancer clinicians are already expanding the number of requests for exceptional funding sent to PCTs to include "clinically non-exceptional cases".

Traditionally, the exception route was only open to patients with recognised criteria such as an unusual health need where no commissioning policy was in place.

But in a move likely to be followed by other trusts, Mark Wright, Royal Marsden Foundation trust's head of contracts, has written to commissioners saying the trust must now send exceptional case requests even where the patient does not meet exception criteria.

Exhaust all routes

This is to fulfil the requirement to "exhaust" all NHS funding routes before allowing private treatment.

"While the trust does not want to compromise the quality of the existing [exceptional circumstance] process, it is unavoidable that clinically non-exceptional cases may need to be submitted under this guidance," the letter says.

The DH said the line in the guidance about exhausting all reasonable avenues for securing NHS funding was "an important safeguard for patients", but revised guidance, which took into account consultation responses, would be published shortly.

A spokeswoman said: "There is no intention to require clinicians to use exceptional funding procedures where this would be clearly inappropriate."

National clinical director for cancer Mike Richards told HSJ: "During the consultation, comments have been made about this particular point and clearly the DH is now considering that in drawing up the final guidance."

PCT CONCERN OVER CONSTITUTION

Measures in the NHS Constitution to increase transparency will allow patients and their legal teams to crawl over primary care trust decisions and seek judicial review.

Lawyers have raised concerns over the duty for PCTs to demonstrate they followed internal processes to the letter and set out clear reasons when making decisions. The constitution even reminds patients they can seek a judicial review if they believe the NHS has acted unlawfully.

There is also a risk that, as well as patients and lawyers attending exceptional case panel hearings and challenging results, drug companies and patient groups could send round robin letters to PCTs demanding to know their reasons for all funding decisions, before targeting legal action on PCTs with weaker rationales.

Inconsistent decision making

Commissioners fear the twin threats will exacerbate inconsistent decision making.

UK Public Health Commissioning Network chair Daphne Austin said: "Where it breaks down is whether or not [PCTs] can hold their commissioning position… Some PCTs find it hard to say no to patients coming to the individual funding request panel even though it is obvious the patient is not an exception.

"The minute one PCT says yes, the next one gets pressure."

The DH said the constitution was a "declaratory document" and had not been set out in primary legislation, in order to avoid it becoming a lawyers' charter.

From:
hsj.co.uk/news/2009/02/nhs_topup_rules_set_for_rewrite_as_fear_of_litigation_mounts

Health Direct asks, apart from the sheer incompetence of labour's red tape, if the DoH claims that the new expensive NHS constitution lacks teeth, what on earth is the point of it- apart from to increase labour's spin on the NHS?

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 top-up confusion grows after labour's U turn on funding

Campaigners are demanding clarity over whether patients using non drug-based NHS services will be able to "top up" their care.

National clinical director for cancer Mike Richards' review of co-payments allowed patients to pay for drugs that are not funded by the service, as long as private care was given separately from NHS provision.

Charity Age Concern is now calling on the Department of Health to clarify how far its logic may extend to other situations where NHS funds are used to provide care.

Grey areas in current policy include care home residents fearing they will be forced to meet all their bills once they are paid for with continuing care funding. "We can't see how you can say you can top up all these other things and not top up the care home you wish to go to".

There are also questions around new policy areas, such as individual budgets for healthcare.

Age Concern care finance policy adviser Pauline Thompson said the charity had heard of cases where elderly care home residents had been afraid to apply for NHS continuing care funding because they feared they would be forced to move to cheaper homes.

She said care home residents should be allowed to top up health service payments, but that their rights to NHS funding must also be spelled out clearly.

"With current support for the idea of being able to top up, we can't see how you can say you can top up all these other things and not top up the care home you wish to go to.

"But we'd also wish to make absolutely sure that there were some mechanisms in place to ensure that the NHS did pay the going rate."

Direct payments

King's Fund senior policy adviser Anna Dixon said whether patients would expect to top up individual health budgets was likely to depend on whether the Department of Health's pilot scheme allowed for direct payments - as in social care - or was simply a "nominal budget".

People receiving direct payments under the social care system are currently allowed to top up.

"The suggestion at the moment is that they are not going to go down the route of direct payments, which would suggest that it probably won't be possible," she said.

From:
clarify_rules_on_nondrug_topups_campaigners

Health trusts may face bill for top-up refunds after labour's U turn on cancer drugs

Primary care trusts could come under pressure to refund tens of thousands of pounds to patients who have paid for top-up treatment.

One PCT has already refunded more than £23,000 to two patients who paid for care that was later deemed to be the responsibility of the NHS.

Another faces a demand for nearly £60,000 from a patient who initially funded his own treatment with Cetuximab before being accepted by the NHS as an exceptional case. The patient's lawyer told HSJ that if the PCT did not pay up, their fight would go to court, where they hoped to set case law.

PCT network director David Stout warned that in the absence of clear guidance on how to handle retrospective claims, PCTs were likely to come under pressure to follow precedents set by others.

Worcestershire PCT agreed to "compensate" two patients for the cost of NHS care they were forced to pay for while receiving Avastin for bowel cancer. Barbara Moss was awarded £13,658 of her £21,000 treatment bill and Clifford Shore got £10,000 of his £16,000 costs.

A PCT spokeswoman said the PCT had taken legal advice. "We don't believe this will set a precedent across the country; it will be up to individual PCTs to look at cases individually, as we did," she said.

Patient Michael Porter is challenging East and North Hertfordshire PCT to refund £55,900 that he used to pay for Cetuximab. His claim rests on the fact he responded well to the drug and was subsequently accepted as an exceptional case by the PCT.

Swaffields Solicitors principal Simon Swaffield, representing Mr Porter, said: "It's not satisfactory from a health service point of view to just muddle along and if you make enough noise, you might get some money.

"The reality is we've taken Michael's case forward on this footing, very much with a mind to establish liability."

Mr Stout said PCTs were expected to make judgements on whether to reimburse or not "without any real framework within which to work".

"If some PCTs start [reimbursing], I'm sure that ratchets up the pressure on other PCTs to do the same," he said.

He also said that where a patient had secured exceptional case funding on the basis they had proved a drug's efficacy by self-funding initial courses of treatment, this breached the principles of the Richards review of co-payments because it created inequity.

From:
threat_of_retrospective_topup_pay_outs_looms_for_pcts

Doctors will be offered cash incentives to prescribe new medicines

Doctors will be given extra cash when they prescribe newer, more expensive medicines under a pilot scheme aimed at accelerating the UK's slow uptake of new medicines compared with other European countries.

The plan is part of a package agreed by the labour government and the pharmaceutical industry yesterday that aims to reward drugs innovation in exchange for cuts in the price the NHS pays for drugs.

The pharmaceutical price regulation scheme will lead to a 5 per cent reduction in the overall medicines bill over the next five years, starting with a 3.9 per cent cut in February.

But the labour government has pledged to sweeten the scheme with measures to link the price of medicines more closely to the value that they provide.

Companies will for the first time be able to raise prices on medicines already launched if clinical data show they provide a greater benefit than originally believed. Any such increases will be exempt from the overall 5 per cent price cut.

Richard Barker, director general of the Association of the British Pharmaceutical Industry, the trade body, said: "This landmark deal marks a turning point for patients, the NHS and the pharmaceutical industry."

A new process will also be introduced to streamline, accelerate and make systematic the process of renegotiating pricing for medicines initially rejected as not cost effective by the National Institute for Curbing Expenditure (NICE), the medicines advisory body.

This will help the government's attempts to limit the number of expensive new drugs that patients have to pay for because the NHS refuses to fund them.

The Department of Health, in consultation with Nice, has already approved a handful of such "risk-sharing" schemes, whereby drug companies reduce the NHS bill through discounts, free products or reimbursement for patients for whom the medicines do not work.

Incentive payments to doctors- which already exist to stimulate testing for certain diseases and encourage generic prescriptions - could prove controversial, and may also need to be supplemented by additional funding to primary care trusts.

From:
http://www.ft.com/cms/s/0/d38e92b2-b6a4-11dd-89dd-0000779fd18c.html

Medicines shortage fears grow

British patients face the prospect of drug shortages as the falling price of medicines makes it more profitable for pharmacists and wholesalers to sell them abroad.

The weakening of sterling against the euro has reduced British drug prices, compared with levels in other countries. That has fuelled a surge in the legal "grey market" practice of exporting drugs from the UK to more expensive medicine markets elsewhere in Europe - so-called parallel trade.

Supplies could tighten further from January 1, when the labour government's Pharmaceutical Price Regulation Scheme comes into force, imposing a 5 per cent price cut on prescription medicines bought by the National Health Service.

Andrew Hotchkiss, managing director of the UK operations of Eli Lilly, the US-based pharmaceutical company, warned of a "triple whammy" creating supply shortages, with the falling pound, price cuts and both fewer imports and more exports all creating uncertainties that could mean medicines are not available in pharmacies.

"We're worried about patient access," he told the Financial Times.

Britain has traditionally been an importer of medicines via parallel trade.

Wholesalers and many individual pharmacies have licences that allow them legitimately to export medicines from the UK to other countries where they fetch higher prices. Concerns are growing that this may increasingly squeeze supplies to British patients.

Martin Sawer, spokesman for the British Association of Pharmaceutical Wholesalers, whose members distribute medicines from drug companies to pharmacies, said he agreed that there were risks of supply shortages, especially since medicine stocks were likely to run low over the Christmas holidays.

The situation risked being worse than at any time in the past because the introduction of computerised stock control meant pharmacies often held smaller volumes of supplies.

Groups of pharmacies may deliberately order more medicine than they require, selling the remainder at a profit - a practice known as skimming. Prices in other northern European countries are about 10 per cent or more higher than in the UK.

Paul Johnson, UK managing director of IMS Health, the data consultancy, agreed that the UK's share of parallel trade across Europe, traditionally about 30 per cent, had been shrinking since the spring - with faster growth in other higher priced markets. "The UK still has significant parallel imports but they have reduced dramatically in the last few months. And a whole range of products are now being exported. This is a perfect storm."

He estimated that parallel trade accounted for nearly 10 per cent of Europe's total prescription medicine sales and involved purchases from low-cost countries led by Greece, Spain and Portugal, with re-sale into the UK, Germany, Benelux and the Nordic region, where parallel imports accounted for nearly €5bn (£4.2bn) a year.

From:
http://www.ft.com/cms/s/0/82357bc2-b511-11dd-b780-0000779fd18c.html?nclick_check=1

The last nail in the NHS coffin

Top up co-payments are the last nail in the coffin for the NHS as it opens the door to private providers.

On the face of it and from a moral perspective, a decision to allow “top-up” payments for cancer drugs seems the correct course of action to take to curb postcode lotteries for funding cancer drugs. However, this must be seen in the wider context of the future of the NHS and the fundamental principles of “universality” of care.

“Top-up” payments will open the door to the insurance industry and private providers to deliver these treatments. This will become the norm for many new treatments, not only cancer drugs, and will lead to a system of “managed care” much like that in the US where it is the insurers and not doctors who decide who gets treated, where they get treated, how they get treated, who gives the treatment and how much it costs.

The universality of care provided by the NHS has already been eroded (eg, loss of the majority of NHS dentistry and eyecare) and this is the last nail in the coffin. The real tragedy lies in the fact that we should not even be having this debate.

The total NHS drug spend on cancer drugs in England is approximately £1 billlion per year, but, in the British Medical Journal last week, the chief economist of the King’s Fund, Professor John Appleby, stated that the NHS in England is projecting an underspend of £1.7 billion and foundation trusts are reporting cash balances of £2.5 billion.

Furthermore, it is painfully ironic that the huge cost of introducing a market based system to the NHS has actually helped to spark a debate that will lead to further privatisation and fragmentation.

From:
http://www.timesonline.co.uk/tol/comment/letters/article5091892.ece

Health Direct notes that one of the factors behind the current controversy about “top-up” drugs is the absence of any explicit recognition that vital moral issues are involved.

If an old person is trapped under a collapsed building late at night, people do not say: “She has not got long to live anyway, let’s leave it till the morning; it will cost a bomb if we get the cranes and crews out at this time of night.” They are more likely to say: “She is pretty frail; we had better pull out all the stops, and get cracking as soon as possible.”

The weakness of the NICE approach is to assume that life and death decisions about whether the NHS should buy new drugs can be based solely on an economic model. Common humanity comes into it too: even if it may involve paying higher taxes.

Labour U turn on NICE's cancer drugs postcode lottery killing policy

The rule preventing NHS patients from "topping up" their treatment is cruel and vindictive. Under just axed guidelines, anyone paying for drugs with their own money may be deprived of any further free health care.

This is a crude form of blackmail by the state provider that may have been understandable 60 years ago when the NHS was finding its feet but has no place in a modern healthcare system. It is to the credit of Alan Johnson, the Health Secretary, that he has finally acted to remove this barrier to patient choice.

Allowing a co-payment system to develop in healthcare is, however, more than just a humane decision that will allow seriously ill people to purchase life-saving drugs that may be too expensive for the NHS to prescribe. It is also a fundamental step towards diversifying healthcare in a way that will allow a better-funded and more patient-friendly system.

Health insurance companies will now start marketing policies for top-up payments only, as a supplement - not an alternative - to NHS provision, an attractive option to people who cannot afford full private health insurance.

That will help remove the barrier between state and private provision that has proved so restrictive, while opening up new revenue streams. A hybrid, public/private system could then emerge, without sacrificing the cardinal NHS principle that treatment remains free at the point of delivery to all who need it.

From:
http://www.telegraph.co.uk/opinion/main.jhtml?xml=/opinion/2008/11/05/dl0502.xml

Health Direct points out that there is now a three tier NHS service. The top level is private health insurance for NHS services. The middle tier is part payment for drugs and services. With the base rate being access for patients only if whitehall edicts allow doctors to prescribe certain life saving drugs.

Top-up insurance is still essentially a means test - and works contrary to the concept of universal access on equal terms to the NHS at all points of contact.

There is no reward here for those who already self-provide, nor any consideration of what those seeking to claim contribute to our taxes, or to the costs of the NHS.

This is a bit like thanking the person, who has decided to refrain from beating you over the head with a baseball bat.

The magic formula, top up insurance- is routine in France. The plan does not call for genius; rather, its absence calls for rebuke.

I have just one question about this, Alan Johnson is claiming credit for changing this particular rule, but which minister was it who allowed the rule to be set in the first place- Health Direct suspects the bean counter Patricia Hewitt?

Doctors do not back cervical vaccine choice made by labour ministers

The wrong vaccine against cervical cancer has been chosen by the labour Government and doctors would give their own daughters the alternative jab, a prominent doctor has warned.

GP and broadcaster Dr Phil Hammond, said he and most doctors he has spoken to have opted for Gardasil, rather than Cervarix, for their own children as it also protects against 90 per cent of cases of genital warts as well as cervical cancer.

Writing online in the British Medical Journal, he said the issue has been overlooked because genital warts 'never made it to the front cover' of newspapers, but if it were breast cancer instead there would 'marches on Downing Street' to campaign for the choice of vaccine to be made available on the NHS.

There are two different cervical cancer vaccines on the market, Cervarix and Gardasil, which protect against the human papillomavirus which causes the disease.

The Government has chosen to offer Cervarix as part of a national vaccination programme for all girls aged 11 and 12 with a catch up campaign for older girls.

There are over 100 strains of HPV and Cervarix protects against the two which account for most cases of cancer whereas Gardasil works against an additional two strains so protects against other sexually transmitted conditions as well.

Gardasil remains available but only privately even though most other European countries have chosen it for their own national programmes.

Dr Hammond wrote that with 100,000 new cases of genital warts in England each year and condoms only reducing transmission by up to 50 per cent, the far safer option is to vaccinate with Gardasil.

But, although Gardasil is available privately to parents, at a cost of £350 to £400, most will not be able to afford it, he added.

The vaccine choice could be a false economy because of the estimated cost of treating genital warts is £23m a year and vaccinating with Gardasil would have begun to pay off within three to four years, he said.

According to Hammond, who is a vice-president of the Patients Association, with the current cost of treating genital warts estimated to be £23 million, the government's decision may be a false economy. Within three or four years the use of Gardasil would have begun to have a considerable financial payback.

The NHS offers no information about Gardasil, raising serious questions over patient choice.

The Government's vaccine advisors said that if both vaccines were offered to the NHS at the same price then it would recommend using Gardasil because of the extra protection and because Cervarix, made by Sanofi Pasteur, has been chosen it seems the decision has been made on the basis of cost.

Both vaccines are listed as costing £80.50 in the book of licensed medicines but the details of the discount offered by GlaxoSmithKline to the NHS in order to get the contract, remains 'commerically confidential'.

From:
Doctors-do-not-back-cervical-vaccine-choice-made-by-ministers.html

Health Dept prescription medicines pricing shake up descends into chaos

Plans to introduce a new system for setting the price of prescription medicines have been thrown into chaos by the Department of Health, potentially costing the health service tens of millions of Pounds.

A joint memo circulated this week by the department and the Association of the British Pharmaceutical Industry, the trade body, warns that there will now be a delay of at least three months in implementing one part of the arrangement negotiated with industry over the summer.

In spite of having had months to prepare for the new arrangement, which had been due to come into force by the start of next year, the Department of Health has also failed to develop a system to monitor drug prices systematically, which is essential for implementing another part of the new deal.

The moves are fresh blows to relations between the pharmaceutical sector and the government, which sparked industry ire last year when it unilaterally decided to scrap the present Pharmaceutical Pricing Regulation Scheme, which determines how drug prices are set.

One pharmaceutical industry official said the issue was causing a "furore" in the sector and said it would take at least several weeks to clarify the full implications and how to respond.

The memo circulated last week says that industry will not now be expected to cut the price of off-patent branded medicines from January 1, as had been previously agreed, since the department decided it needed to hold a public consultation on the issue.

In the short term, the uncertainty means that the NHS will be sacrificing an estimated £80m in annual savings from price cuts in these so-called branded generics or "loss of exclusivity" medicines.

But the delay also creates uncertainty over how to implement the entire PPRS deal, which gives companies flexibility over how much they charge the NHS for individual medicines, provided there is an overall price cut of 5 per cent in the £8bn annual total.

Under the agreement reached with the pharmaceutical industry this summer, 3.9 per cent of the annual savings were des-igned to come from price reductions on patented medicines, and a further 1.1 per cent from the off-patent brands.

The new deal was supposed to reduce the price of branded generic drugs to 1.5 times the government's reimbursement level set for generic medicines. Generic drug manufacturers fear they may lose out if this ratio is modified as a result of the latest department consultations.

A second aspect of the PPRS raises the possibility of fresh price cuts, on top of the 5 per cent scheduled for the start of this year, if drug prices rise too fast.

From:
http://www.ft.com/cms/s/0/de162cfc-a099-11dd-80a0-000077b07658.html?nclick_check=1

NHS hospitals allowing top up cancer drugs payments

Health Direct has learned that payments to top up NHS care - supposedly banned - are happening at 30 hospitals across the UK.

Professor Mike Richards, the cancer tsar for England, has been holding a review about so called co-payments and will report at the end of this month. The issue is also under review in Wales and Scotland.

But patients are already topping up their NHS care, as hospitals find ways around the current rules.

The current rules say you cannot mix and match between the NHS and private.

You are either all NHS and it is free or you're all private and you pay for everything.

But the details are interesting. The code of practice says a patient cannot be both an NHS patient and private in the same episode of care.

So in Birmingham they have found a way round the ban on top ups.

Separately another consultant at the same hospital writes a private prescription for the drugs that patients wants to keep them alive.

They are supplied at patients' homes by a private company called Healthcare at Home.

They pay the company direct. So the administration of the drugs is viewed as a separate episode of care.

Professor Nick James is the oncologist in Birmingham who designed this model of allowing patients to top up their care.

"Nowhere does it say that an episode of care is from diagnosis to death of your cancer" he said. "So we've just interpreted the rules in a way which is in favour of the patients."

Across the country

What is remarkable is that topping up, something the labour government says is banned, is not just happening in Birmingham.

The company which provides the drugs to Ian says they have contracts with 30 NHS hospitals across the country.

Mike Gordon, chief executive of Healthcare at Home, said: "Top ups are happening today and they'll happen tomorrow. So long as they're done through us not using the auspices of the NHS I see no reason why they shouldn't continue."

A Department of Health spokesperson said: "We know there is variation in how individual Trusts are applying the current guidance, and that is why the Secretary of State asked Professor Mike Richards, National Clinical Director for Cancer, to lead a review into this difficult issue.

"Professor Richards is looking at how a consistent approach across the country might be best achieved."

Shadow Health Secretary Andrew Lansley said: "David Cameron and I have pressed the Health Secretary, Alan Johnson, to enter into a risk sharing scheme for the kidney cancer drug Sutent in order that patients will be able to access this life saving treatment immediately, but nothing has been done."

Norman Lamb, for the Liberal Democrats, said: "We are in an outrageous situation where patients are left in a lottery, dependent on a few hospitals which are bending the rules.

"This case makes the need for reform all the more urgent."

All Ian Jenkins wants is to stay alive as long as possible.

But his story does raise the question, why the need for a high level review of top ups if they are already happening all over the country?

From:
http://news.bbc.co.uk/1/hi/health/7668121.stm

Cervical cancer jab given 'without consent' by nanny state

A mother claims her daughter was injected with the cervical cancer vaccine without her consent.

Parental consent is not required for the Cervarix vaccination, which is being administered to 300,000 girls in an attempt to cut down incidents of the fatal disease.

But girls are supposed to give consent themselves before being given the jab and Debbie Jones, from Orkney, claims her daughter did not do so.

The vaccine counters the effects of the human papilloma virus, which is transmitted through sexual contact later in life, but some parents and religious groups have argued that the life saving injection encourages promiscuity.

Mrs Jones, a Christian, said: "We all discussed it at length as a family. I just didn't feel comfortable with it. I told my daughter that if she really wanted it, she could have it, but she agreed with me.

"I couldn't believe it when she came home and said they'd given it to her anyway. She didn't say yes or no because she was never directly asked. They talked to her then just gave it to her."

Mrs Jones says she believes her daughter should not have the injection because she is too young and suffers from diabetes but health professionals at Stromness Academy went ahead anyway.

Orkney NHS trust said it was launching an investigation.

"We take this complaint extremely seriously and will be investigating fully as a matter of urgency," a spokesman said. "If there are lessons to be learned they will be incorporated into the vaccination programme in Orkney."

The jab is to be given to every 12 and 13 year old girl in a programme it is hoped will save 400 lives a year. A catch-up programme will focus on girls aged 14 to 18 over the next two years.

From:
Cervical-cancer-jab-given-without-consent.html