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.


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.

EU Cuts to trainee surgeons’ hours threaten patient safety: Royal College of Surgeons

Trainee surgeons are under pressure to falsify their working hours and are operating on days off as hospitals struggle to comply with cuts to working hours, the Royal College of Surgeons has said.

Junior doctors should be allowed to opt out of the European Working Time Directive that limits them to a 48-hour working week from August because the effects on patient care will be ‘disastrous’, John Black, president of the College said.

Patients are being put at risk and the quality of their care is under threat as many hospitals are covering up failures to implement new rotas that comply with the directive, the Royal College has warned.

The College is calling for the Government to agree an opt out to safeguard patient safety and highlighted that in America juniors work an 80-hour week and in Germany a 61-hour week has been agreed.

The College also wants the on-call rule to change so sleeping at hospital does not count towards the working hours as it does currently.

Concerns were raised over junior doctors hours as many were working up to 100 hours a week and were making mistakes because they were so tired. Now the working time directive threatens to cut juniors hours so much that they cannot get enough experience to practice safely, it has been argued.

A survey of over a thousand surgeons by the Association of Surgeons in Training (ASiT) found more than half of trainees felt under pressure to falsify their hours.

Nine in ten were regularly exceeding their rostered hours, 85 per cent were coming in on days off to carry out operations and seven out of ten said the reduction of their hours so far has not improved their worklife balance.

ASiT believe 65 hours a week is required to gain the necessary training opportunities and 80 per cent of respondents would support an opt-out of the European Working Time Regulation to protect training.

Only a quarter of junior surgeons felt that the records of their working hours held by their trust’s human resources department accurately reflected their actual hours.

A further survey of almost 500 surgeons found unsafe levels of staffing because there are not enough surgeons available to fill rotas and gaps are appearing.

Over half of those questioned had experienced gaps on their rota. NHS Trusts are now routinely re-employing their own trainee surgeons out of hours as “internal locums” to cover gaps in shifts – with over two thirds of rota gaps filled in this way.

Two thirds of trainees working with rota gaps feel that patient care has suffered as a result.

“This is a worry for today and tomorrow,” said John Black, President of the Royal College of Surgeons. “On the one hand, the immediate effects on patient care in the NHS are potentially disastrous.

“There are simply not the surgeons in the UK to fill the gaps when every doctor’s hours are cut to a 48 hour per week maximum. On the other, trainees are telling the college they cannot gain enough experience to progress on the shortened hours.

The choice for the nation is clear – do we want patients of the future to be treated by a group of highly skilled and experienced surgeons; or be passed around a wider group of lower skilled surgeons with less experience?”

Alastair Henderson, joint director, NHS Employers, said: “Increasing junior surgeons’ hours would be a backward step.

“NHS employers have worked hard to implement the directive and have made good progress. More than half of junior doctors are already compliant and employers are still committed to ensuring that the maximum number of doctors are compliant by August 2009.

“We recognise, however, that there are a small number of services for which compliance may not be possible by August 2009. In those circumstances arrangements which offer a derogation of up to 52 hours work per week for a limited time are being considered, subject to EU approval. In these circumstances there would be rigorous scrutiny of the services affected and these would include plans to achieve compliance as soon as possible.

“We are not aware of any evidence that junior doctors are being asked to falsify their hours. If any doctor is being pressurised or bullied into falsifying their monitoring returns they should raise the issue with their HR department or trade union so that this can be investigated.”


Labour has broken mixed sex wards promise admits Health Secretary Alan Johnson

Labour has failed to end mixed sex NHS hospital wards despite promising to do so for 12 years, the Health Secretary Alan Johnson has admitted.

Mr Johnson told a meeting of senior NHS executives that ministers had “got it wrong” and “sane and rational arguments about why it can’t be done no longer cut it”, a regional health boss claims.

The labour Government promised before the 1997 and 2001 elections to end the practice of male and female patients being forced to share a ward.

Yet another fresh attempt to stop the practice is soon to be launched by ministers, according to the account of the meeting by Graham Eccles, the chief executive of the South East Coast Strategic Health Authority. Mr Johnson is expected to unveil a new initiative on the issue next week.

Last month data from the Conservatives disclosed that about one in seven of hospital trusts still used at least one open plan mixed sex ward. Curtains were still being to segregate patients in some areas, it was discovered.

In an email to colleagues, Mr Eccles wrote: “There is no doubt that the Tories have rattled Labour over their failure to meet the manifest promise of ending mixed sex accommodation.

“[Mr Johnson’s] view is that the [Department for Health] got it wrong in implementing the policy in 1997, again in 2001 but he is going to make sure it is done right in 2009.

“I quote: ‘Sane and rational arguments about why it can’t be done no longer cut it with me, it’s going to happen’.”

Mr Eccles’s memo stated that the Health Secretary will be asking hospitals for their assessment of the issue before April.

It added: “Expect a revised definition on the subject that simply makes it clear that men and women and children and adults will no longer share the same accomodation. Everything is included in that definition, except accident and emergency.”

Andrew Lansley, the shadow health secretary, said: “This is a stark admission of failure from Labour. Frankly it is a scandal that they have done nothing about mixed sex wards except make repeated empty promises.

“What’s worse is that they are only taking action now because Conservatives have exposed their abysmal record and set out real plans for change, with single rooms in hospital for all patients who need them.”


NHS drug shortage looms as Pound plummets

The NHS could face a shortage of drugs because the weak Pound means speculators are targeting UK pharmaceutical supplies for export to more lucrative markets.

Data obtained by HSJ shows there has also been a dramatic slowdown in imports of cut-price branded drugs into the UK.

When the Pound was strong, so-called “parallel traders” could buy drugs in Europe and sell them in the UK at a profit. But there is evidence that these traders are now attempting to buy up UK supplies, repackage them, and export them at a profit to Scandinavia and Germany.

Drug manufacturers and wholesalers have begun rationing the amount of certain drugs each UK pharmacist, GP and hospital dispensary can buy. Pharmacists report that in some cases patients have had to wait days for their drugs.

The change in the market could also lead to higher costs for the NHS as pharmacists attempt to recoup the lost savings.

Parallel traders wanting to import drugs into the UK that were originally manufactured, packaged and priced for sale in another country must apply for a licence from the Medicines and Healthcare products Regulatory Agency. Its latest data shows a 60 per cent drop in the number of applications from November 2007 to November 2008.

British Association of European Pharmaceutical Distributors secretary general Richard Freudenberg told HSJ that was because the fall in the Pound had made a lot of products “unviable for importation”. That is a concern as think tank the Office of Health Economics estimates parallel imports make up 12 per cent of the UK pharmaceutical supply.

Falling profits

Mr Freudenberg said parallel traders were generally only interested in importing drugs where there was a 20 per cent difference between what they paid and what they could sell it for. But the pound has fallen by more than 20 per cent in the last 12 months, wiping out much of that potential profit.

The parallel trade is controversial. There have been claims it has caused drug shortages in countries such as Greece and Spain, which have been targeted by traders wanting to source low-cost drugs.

Martin Sawer, executive director of the British Association of Pharmaceutical Wholesalers, which represents the largest drug distributors in the UK, warned there was a danger the UK could become “the new Greece or the new Spain”.

“There is a lot of evidence of British products in the Scandinavian countries and in Germany,” he said.

A growth in exports from the UK could exacerbate any drug shortages caused by the fall in cheap imports. In the last four months of 2008, the MHRA issued 41 per cent more export certificates than the same period in 2007.

The government’s latest data on pharmaceutical exports to the 14 other strongest EU economies shows they have been growing steadily for the last two years. The biggest monthly increase was between May and June this year when the value of exports surged by 33 per cent from £626m to £832m – a 51 per cent increase on the value of exports in June 2007.

By October 2008, the value of exports was 27 per cent higher than a year earlier.

Supply and demand

Manufacturers and wholesalers have responded by imposing quotas on the volume of drugs UK pharmacies can buy in an attempt to cut off supply to parallel exporters. Individual pharmacies are being monitored for unusually large orders, which might suggest they were selling drugs on into Europe.

The Pharmaceutical Services Negotiating Committee represents pharmacists in contract negotiations with the NHS. Its head of information services Lindsay McClure told HSJ the quotas were so far preventing medicines going out of stock completely, but had meant some patients having to wait “two or three days” if their pharmacist had exceeded their quota and needed to apply for extra supplies.


Your health records- open to all in new labour data disaster

NO2ID and Health Direct has been warning since 2006/7 about the stated intentions of the labour government “to overcome current barriers to information sharing within the public sector”.

Now the Ministry of Justice has launched an extraordinary coup. It is about to convert the Data Protection Act into its exact opposite, a means for any government department to obtain and use any information however it likes- including your supposedly confidential medical records- if you were stupid enough not to protest at your records being digitised.

Hidden in the new Coroners and Justice Bill is one clause (cl.152) amending the Data Protection Act. It would allow ministers to make ‘Information Sharing Orders’, that can alter any Act of Parliament and cancel all rules of confidentiality in order to use information obtained for one purpose to be used for another.

This single clause is as grave a threat to privacy as the entire ID Scheme. Combine it with the index to your life formed by the planned National Identity Register and everything recorded about you anywhere could be accessible to any official body.

The Database State is now a direct threat not a theory.

Quite apart from the powers in the Identity Cards Act, if Information Sharing Orders come to pass, they could (for example) immediately be used to suck up material such as tax records or electoral registers to build an early version of the National Identity Register. But the powers apply to any information, not just official information.

They would permit data trafficking between government agencies and private companies – your medical records are firmly in their sights – and even with foreign governments.


We urge you to write to your MP straight away via – don’t wait. The Bill is being rushed through Parliament, even as we write. It contains a number of controversial provisions, but to the casual reader appears mainly to be about reforming inquests and sentencing.

As it progresses, NO2ID will be publishing more information but it is crucial that every MP realises how dangerous the information sharing clauses in the Coroners and Justice Bill really are. This will only happen if YOU tell them.

*In your own words*, please ask your MP to read Part 8 (clauses 151 – 154) of the Coroners and Justice Bill, and to oppose the massive enabling powers in the “Information sharing” clause. The Bill is due its Second Reading in the Commons on 26th January 2009.

Request them to demand the clause be given proper Parliamentary scrutiny. This is something that will affect every single one of their constituents, unlike the rest of the Bill. There is a grave danger that the labour government will set a timetable that will cut off debate before these proposals – which are at the end of the Bill – are discussed.

With support for the ID scheme crumbling, even in the Home Office’s own skewed polls – the last of which showed a 5% drop- trust in the government’s handling of our personal information is at an all-time low.

A YouGov poll in the Sunday Times on 18th January shows that the public opposes these new powers by a factor of 3 to 1 *against*. 65% of people asked said they give labour government “too much power”, only 19% thought not. The government can’t pretend a popular mandate for what it is doing. And it is a mechanism designed to by-pass parliament in future. It is being done only for the convenience of the bureaucrats.

Please write NOW – – it won’t take long, and we are going to ask you again. But if you don’t start now, our battle is going to be much harder.

Please ALSO pass on or forward this part of the newsletter to friends, family and colleagues who might share your concerns. The more people it reaches, the more we hope will act.

We really can’t afford not to win.

NHS patients to get cash to buy care

Patients with long term medical conditions are to be given cash to buy their care.

The move could encourage more private and not-for-profit providers to enter the market for treatment currently given by the NHS. The cash option is one of a range of “personal health budgets” to be piloted.

The health department estimates that some 3m people – out of the 16m with long-term conditions ranging from multiple sclerosis to chronic pulmonary disease, diabetes and mental illness – may eventually be interested in some sort of personal budget.

The pilots range from a notional budget held by a commissioner, to a budget held by a third party, or a direct cash payment, similar to those already used by some 70,000 social care clients. They were announced as a new health bill was published yesterday by Alan Johnson, the health secretary.

Putting patients in control of their own care will lead to innovation and competition, the department believes, “with patients and care providers seeking novel ways to meet their healthcare needs”.

Direct cash payments will also produce “a transparent pricing system, and a level playing field for alternative providers to enter the market,” the document adds.

The NHS Confederation, which represents health authorities and trusts, welcomed the pilots. But Steve Barnett, its chief executive, said the policy raised big issues and carried risks.

“Should patients be allowed to spend their personal budgets on non cost effective treatments?” he asked. “Should they be allowed to top up their care? And should they keep any underspends for later use?” The department’s document says that if needs are less than expected, those with a budget “may have spare resources to buy services of higher quality, or to meet more marginal needs”.

Unison said the result would be a two-tier health system, with the move “paving the way for top-up payments”. That would undermine the founding principle of the NHS that care should be delivered equally, Karen Jennings, the union’s head of health, said.

Patients who took the cash would be able to buy additional services outside their NHS care plan from the private sector as they can now, the health department said – though they would not be able to buy additional services from the NHS.

The British Medical Association said giving patients cash seemed “further to establish the idea of healthcare as a commodity”, something it believed was “not in patients’ best interests”.

The department’s background paper says there is a risk, “as budgets start being used in non-traditional ways”, that “the public will perceive that the money is being used frivolously”. That has happened in social care with controversy over one client using his cash to buy a football season ticket.

A background document produced by the department admits “we do not know the likely take-up” or which patients would benefit most – hence the pilots.

The bill also legislates to ban the display of tobacco products in shops, with only a plain price list permitted.


NHS constitution is no defence against commercialisation

Responding to the signing of the new labour NHS constitution, Health Direct and the NHS Support Federation is warning that it is too weak to protect the core ideas behind the NHS against the impact of commercialisation.

Labour “Government lawyers have been working long and hard to ensure that the NHS constitution which was launched yesterday cannot be used to stop its commercialisation programme, but it is this precisely which is the greatest threat to the values and principles of the health service.

“The first test for the NHS constitution will come quickly as the plan to extend competition and patient choice will in fact bring greater unfairness, poorer care for some patients and waste public resources.”

The Federation believes that the terms of the constitution are at odds with the impact of government policy. The NHS constitution states that “The NHS is an integrated system of organisations and services bound together by the principles and values now reflected in the Constitution”.

In reality the NHS is becoming more fragmented as more commercial providers are contracted to run NHS services.

However the public cannot use the constitution to defend the core values of the NHS unless it counts in law. The Federation is calling on MPs to look at this aspect as the new Health Bill passes through Parliament.

“The current economic crisis shows that we cannot rely on commercial companies to act in ways which protect the public interest. Yet the labour government is placing commercial values at the heart of the NHS. It is doubtful that the NHS constitution will be any match for the large corporate interests currently looking to run NHS services.”

– Paul Evans, director of the NHS Support Federation

In Friday, June 06, 2008’s post Health Direct repeated the Financial Times’s Editorial and wrote: NHS constitution- another bad labour idea

The key test of any health reform should be whether it will actually improve the quality of care that patients receive.

By any measure, the latest big new idea from Gordon Brown, the British prime minister, fails the test: that, after muddling along without one for 60 years, the National Health Service in England (healthcare is now devolved in Scotland and Wales) should have a constitution.

The very origins of the idea betray its weakness. It was initially dreamt up by Andy Burnham, then a junior health minister, as a means of celebrating the NHS’s 60th anniversary this July.

Why not, he mused, lay out the service’s values and ethos, setting out what patients can expect in terms of rights and responsibilities?

The real motivation, however, was far tawdrier.

Labour hoped that something could be written about the service being tax-funded and largely free at the point of use in language that the Conservative opposition would balk at. Labour would then go into the next election arguing that the NHS was not safe in Tory hands.

The “NHS constitution” which Alan Johnson launched yesterday utterly fails this test.

Please see:

Credit crunch slows number of PFI deals

Fewer deals were signed under the private finance initiative (pfi) last year than at any point since the PFI took off a decade ago, according to an authoritative database.

The credit crunch contributed heavily to just 34 PFI deals being signed last year, after at least 60 deals were signed every year over the past decade, according to Public Private Finance magazine. Hospital deals fell to just seven last year, against 20 in 2007, while just three waste management deals were signed.

The economic conditions also mean big deals such as the £4.5bn M25 widening, the M80 in Scotland and Britain’s biggest waste management project in Greater Manchester are still struggling to raise the money needed, with some practitioners arguing that further government guarantees, or public sector funding, will be necessary.

Analysis of last year’s deals comes as the National Audit Office warned that both central and local government faced potentially massive European Union fines for failing to reduce landfill if a string of PFI waste management schemes were not signed soon.

Fines “could run into several hundred millions of pounds”, the NAO said. Projects currently in procurement “face difficulties in obtaining private finance”, it said, adding some schemes will have to be financed more conventionally.

The Greater Manchester Waste Disposal Authority has already had to agree to find an additional £70m from its own borrowing in order to ensure its £600m waste scheme is fully funded. There are concerns that additional public sector cash may also be needed to finalise the M25 deal.

One leading practitioner said that raising private finance remained “a nightmare” with banks still reluctant to lend.

David Metter, chairman of the PPP Forum, the trade body for the industry, said some additional Treasury guarantee might be needed to get funds flowing into infrastructure projects that the government wanted to see built to combat the downturn.

“The risk to the government of doing that would be small,” he said. “In effect, it would be guaranteeing its own payments for the service charges, or unitary payments that it makes on projects.”

The Treasury declined to discuss the idea of further public sector support, arguing it would take time for the measures it had already taken to take effect.


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”.


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.