Contaminated Blood (Support for Infected and Bereaved Persons) Bill [HL]

Baroness Finlay of Llandaff Excerpts

Friday 22nd October 2010 Lords Chamber

[Baroness Finlay of Llandaff]

My Lords, I rise in support of the noble Lord, Lord Morris of Manchester, who must be admired for his perseverance and loyalty to a group of people who have felt severely wronged. It has been said that the civilisation of a society is reflected in the way in which it looks after its most vulnerable members. I think that the noble Lord has done a great deal to raise the level of civilisation in our society and the way in which we approach people who are vulnerable.

I declare an interest: I work for Velindre NHS Trust, which now incorporates the Welsh Blood Service. I am grateful to Geoff Poole, the director of that service, for having discussed this matter with me prior to this debate.

I take this opportunity to pay tribute to the deceased husband of my noble friend Lady Campbell of Surbiton. Graham was a delightful, charming and intelligent man, who unfortunately had contaminated factor 8. He was responsible for supporting my noble friend at the beginning of her career, which I sincerely believe has been as stellar as it has been because of the love and support that he gave her. When he died, she was completely devastated, as were many of us. In his dying, he was extremely dignified and never bitter.

The tragedy that has happened is one from which lessons must be learnt. Indeed, the noble and learned Lord, Lord Archer, says in the closing paragraph of his report:

“We must now look to the future. We cannot undo the damage done, nor turn back the clock to take a closer view of those past events and decisions”.

I take this opportunity to take a forward look. The Bill is important, but I just wonder whether it might need to take more of a prospective view, particularly where it includes lists of conditions to be considered in blood donations.

This tragedy has highlighted the problem of risk assessment. We do not live in a risk-free society and it is important that we do not fail to recognise risk when it emerges and stares us in the face. The Advisory Committee on the Safety of Blood, Tissues and Organs—SaBTO—was set up three years ago, replacing its predecessor. I ask the Minister to provide assurance that the committee will continue and remain supported, as it has important work to do. It is currently looking at the risk of new variant CJD in relation to blood, tissues and organs. The services out there are waiting to hear its conclusions as new evidence emerges.

I also take this opportunity to say that, in my view, we face an unintended consequence of previous legislation—the Human Tissue Act—which prevented our looking at routine samples from tonsillectomies and splenectomies in an ongoing way to try to find out the true incidence in the population of variant CJD. Without that information, it is harder to know the size of the risk that blood transfusion services face in taking blood from donors, as we do not have a reliable and simple clinical test to look for the presence of variant CJD. It is likely that variant CJD is transmitted in blood transfusion, but we are not sure whether the removal of white cells from blood has decreased the risk as much as the services hope. The removal of white cells should have decreased the risk hugely, but the risk is always there in the clinical scenario, where a patient faces life-threatening haemorrhages—the risk of dying from exsanguination versus the risk of transfusion. Obviously, the risk of using blood and the readiness to do so in the service varies with the clinical condition of the patient, but that balance is considered every day across Britain. We do not know whether blood should now be filtered more vigorously than has been the case because of variant CJD. SaBTO’s ongoing work will, we hope, inform that decision.

Blood services are aware of the theoretical risk, but they just do not know the best way of allocating resources to keep that risk to a minimum. We no longer use imported plasma, we do not accept paid donors and HIV is quickly identified in screening. However, the true safety of blood depends on the way in which the service screens and refers its donors. Men who have had sex with men are excluded for life from being blood donors. The decision has just been made that people with ME are deferred. There is a possibility—it is unproven—that the XMRV virus is associated with ME. The fact that these people are being excluded from being donors does not make the statement that there is a definite association, but it is part of the risk assessment process and I am glad that the risk has been taken seriously and that proportionality was applied when the question emerged. Similarly, when people have travelled abroad, donation is deferred, as things such as dengue fever are not easily detected. Much of our safety depends not on testing the blood that is donated but on the early screening out of donors who may be at risk and on being careful about the blood products that are used.

The use of blood is remarkably safe, but it would not be fair to say that it has zero risk. The major problem now comes from misidentification—either a blood sample wrongly labelled at cross-match or misidentification of the recipient, so that they are given the blood that was cross-matched with somebody else. Another problem is infection in relation to platelets, although the use of single donors for platelets has decreased that risk hugely. Platelets cannot be stored at 4 degrees centigrade; they are stored at 20 to 22 degrees centigrade, so that they still function, but that is an environment in which bacteria can multiply. Indeed, there have been recent deaths of people who, unfortunately, have had bacterial septicaemia. I hope that the Government will support new developments, such as the clotting factors that have been developed for our troops in the battlefield. They are contained in teabags and, when they are put over a bleeding wound, rapidly cause clotting. They may revolutionise our management of trauma. They are expensive and new, but they may turn out to be cost-effective in the long term.

In the balancing act, we also have to consider the costs related to self-salvage of blood. I pay credit to Dr Dafydd Thomas from Morriston Hospital, who has pioneered a lot of this work to significantly decrease exposure to pathogens. As far as factor 8 concentrates go, we hope that they are now virus free, but it should be stated that that relates to all known viruses. When I qualified, HIV did not exist; it was not known. I remember clearly the index cases that started to emerge in the USA, when people did not know what the condition was. We do not know what we will face tomorrow. Looking towards tomorrow, I think that, whatever happens, we need to be vigilant about emerging new diseases, as well as the discovery of viruses of all types which we do not currently know exist but which I am sure we will find are responsible for diseases that we are treating but do not know are infection related.

In these last moments, I turn to compensation. Whenever something has gone wrong, the longer it goes on, the worse it is for those who are bereaved and feel aggrieved. The anger and distress turn to deep, corroding bitterness as time goes on and people feel that they have not been listened to. The sad reality is that no money can replace the life of the person who has died prematurely from a cause that was not expected. In many ways, the only measure that we have in our culture is money, so we look to financial compensation. However, I hope that one of the lessons that will be taken from this whole tragic saga is that things must be dealt with quickly. To become overfocused on money is to lose sight of the deep personal distress of people before they die from the time that they know that something has gone wrong. We must address that with a change in attitude

I support the comment of the noble and learned Lord, Lord Archer, that we must get away from looking to the courts and the legal system to provide us with answers. They are the point of last resort; I would say that they are beyond the point of last resort. Things have probably gone irretrievably wrong by the time they get there.

There are many lessons to be learnt. I wish the noble Lord, Lord Morris, well with his Bill. Some tiny amendments could make it more future proof.

Health: Neurological Conditions

Baroness Finlay of Llandaff Excerpts

Monday 11th October 2010 Lords Chamber

[Baroness Finlay of Llandaff]

My Lords, I am sure that all patients with chronic neurological disease and the allied healthcare professionals who look after them would join me in thanking the noble Baroness, Lady Gardner of Parkes, and congratulating her on securing this important debate. I have to declare my interests as president of the Chartered Society of Physiotherapy, as patron of the Motor Neurone Disease Association, as patron of MS Society Cymru and as a clinician with responsibility for palliative care services in Wales, where we have recently instigated consultant and physiotherapy posts to lead on co-ordination of care for young people’s transition from paediatric to adult services.

As the Every Child Matters report, Transition—Getting it Right for Young People, points out, it is those with neuromuscular conditions who are the worst catered for. They feel as though there is an abyss when they go from children’s to adults’ services. Young adult disability teams are no more expensive than the ad hoc services that they often encounter. This debate is timely because the changes in the NHS present a real risk to the multidisciplinary specialist teams that are key to delivering high-quality care. It is cost-effective care when the teams work well, but given the new commissioning arrangements, I ask the Minister how the Government will ensure that the multidisciplinary teams have the relevant allied healthcare professionals as core members of the specialty team for these patients. These patients in any one diagnostic group with neurological conditions are not in high numbers on a GP’s list. They are not a volume problem in primary care. They have not been subject to government targets and are not at the forefront of commissioners’ minds. They are too dependent to be able to speak up for themselves, and their families are too occupied with care to have the spare time and energy to find out what they should be getting and call for it.

In the short time that I have, let me focus on a specialised area of allied healthcare professionals’ work—the management of failing respiration in patients with progressive neuromuscular disease. As respiration fails, patients do not sleep well, wake with a headache, feel muzzy, function less well and are less likely to work. That is because their lower respiratory effort during sleep means that carbon dioxide levels rise rather than being exhaled, as happens in normal deep breathing. Early non-invasive ventilation at home overnight allows the patient to have good overnight oxygenation, lowers carbon dioxide levels, and the patient wakens refreshed. This means that they can continue to function in society, and that includes working. Indeed, it is no secret that some Members of this House depend on night ventilation and contribute enormously and invaluably every day here in this Chamber.

In acute episodes of respiratory failure, the early intervention of appropriate professional help saves money and lives. Early non-invasive ventilation, or NIV, has better outcomes than intubated ventilation because it has a lower complication rate, particularly a lower infection rate. It is a technique that depends on expert physiotherapy. NIV corrects blood gases, including oxygenation, in about 70 per cent of these patients, so they do not need to go on to be intubated. Intensive care costs about £2,000 a day; 25 days in ITU costs more than the salary, including on-costs, of an allied healthcare professional for a year. It does not make sense not to have them locked in as core members of the team. It is a waste of money not to have them there.

The NICE guideline on NIV for motor neurone disease lists the core members of team as a specialist respiratory physiotherapist, a speech and language therapist and a respiratory physiologist—with others added to the team when needed. They need early contact with patients and they must be core members of the team to establish a baseline and inform patients of what lies ahead. It is often the physio who allows early recognition of symptom deterioration and the functional impacts on activities of daily living. Proactive intervention on advice on seating, limb supports and so on pays for itself over and over again. The physiotherapist can follow up on patients, provide continuity of care and free up consultant time for complex diagnoses. He or she can also allow more time at the point of interaction when people are devastated by a new diagnosis.

The churn that the noble Lord, Lord Alderdice, described occurs just as much with nurses and doctors, so competent teams are absolutely key. A proper team meets regularly, reviews patients together, teaches across the boundaries of the disciplines and develops cross-over skills. However, the psychosocial support of a proper multidisciplinary team is a major part of the specialist role. A Dutch study by van den Berg and colleagues showed that patients seen in an MDT—a multi-disciplinary team—had better aids and appliances, better swallowing support and better quality-of-life scores. The most pronounced differences between them and those with motor neurone disease seen in an ordinary neurology service were in the domains of social functioning and mental health. This was through the better implementation of supportive treatments, better nutrition and better psychosocial support. The Italians found that those seen by specialist teams had 75 per cent fewer acute hospital admissions, and, even if admitted, the length of stay was reduced by a half. The service proved cost-effective to the patients and to the community as a whole. I am quoting from a paper that they published. A Cochrane review of non-invasive ventilation in respiratory failure shows the same benefits of the multi-disciplinary team—fewer infections, better weaning off ventilation, lower mortality and shorter hospital admissions.

I am indebted to the Lane Fox unit at St Thomas’s for allowing me to access its data over the weekend, which support the cost efficacy of a highly specialised centre with a full multidisciplinary team. Such a tertiary centre can link to other units, drive up standards of care and ensure better care delivery nearer to patients’ homes. Even if highly specialised commissioning is done centrally, how will GP consortia know what to commission to ensure cost efficacy from local neurological services? It is at that level that often the really tight multidisciplinary team is not in place. The Motor Neurone Disease Association, in its “Year of Care”, provides excellent information on both the interventions and the costs, but that needs to be taken up at a local level.

Before I finish, perhaps I may turn to the more generalist services. It is the OT and the physio who will get the patient home quickly through improved functioning and appropriate support and aids to avoid pressure sores. Let us not forget that pressure sores can kill patients. It is these professionals who teach families how to support patients safely as they move. It is the physiotherapist who will spot early deterioration in neurological function. For those with stable but severe brain injury, physiotherapy and occupational therapy have led the way in helping people to get back to functioning well in spite of their disability, supported by speech and language therapists, who are in terribly short supply.

For those with a serious disease, nutrition is absolutely key to recovery. Dietetics are complex when patients need assisted feeding. No one should forget the key role of the speech and language therapist in re-establishing communication whenever speech is impaired and in ensuring effective safe swallowing, avoiding aspiration pneumonia. None of these roles can be fully undertaken by healthcare assistants or nurses. They do not have the training to give them the competencies required. However, perhaps I may give a St Bartholomew patient the last word. He wrote in a letter to his consultant at the unit:

“I really can’t overstate the benefit to me of this integrated multidisciplinary approach. It enabled me to play a major part in managing my own condition, with the minimum of time off work. It gave a richer and more thorough diagnosis than could be done by the clinicians working separately and it gave me confidence in the clinical team.

I have subsequently thought about the process from the hospital’s point of view. Some major problems were managed better than I have previously experienced, in fewer appointments and in a shorter time than using the traditional interdepartmental referral process. It has involved specialist clinicians from the outset. I could witness the energy, enthusiasm and collaboration of the clinical team. I can’t help thinking that this is much more cost-effective and economical than the old ways of doing things”.

And indeed it is.

Therefore, I urge the Government to lay out clearly the parameters of a modern service—the minimum required for a service so that the tariff is fixed appropriately. If that is not done, the allied health professionals will be the first to be skimmed off and it will be a false economy. It will rebound with complex admissions that could have been avoided, and let us not forget the cost of those admissions to the NHS.

Food: Regulation and Guidance

Baroness Finlay of Llandaff Excerpts

Thursday 7th October 2010 Lords Chamber

[Baroness Finlay of Llandaff]

My Lords, I am also most grateful to the noble Lord, Lord Whitty, for having secured this debate, particularly this week when we have seen the nation’s passions enflamed by concern for the welfare of children. It is apt and welcome that we have an opportunity to focus on one aspect of welfare, which is that good nutrition feeds our children’s life chances.

One concern is that, although we can all grasp the value of financial benefits in determining a child’s outcome, the specific high currency of a nutritious diet is often undervalued and underexposed. It is particularly worrying—I think that we have a moral imperative now to act—that education about nutrition gets through to all sections of society. That has not happened to date, given that invaluable knowledge about healthy eating has tended to be the property of the privileged and the educated and has not reached those whom it needs to reach. The science of nutrition is extensive and complex, but there are, nevertheless, several key messages that must be common knowledge, not privileged knowledge.

The difficulty of acquiring such knowledge is compounded by some of the bogus claims that are made about food and foodstuffs. I was asked recently, “Is plain chocolate good for you?”. That seems such a ludicrous question, but the trouble was that it was asked in all seriousness by someone who was very ill. There was desperation behind that question. I have seen really bogus nutritional advice given to patients. The worst was to a woman with extensive cancer, who had been told by someone with a nutritional adviser label that parsnips would help her body to fight her cancer. As a result, she was eating more than 1 kg of parsnips a day, to the exclusion of everything else in her diet. When I saw her, she had magnesium toxicity as a result. That was a tragic outcome of the desperation that people can feel at times—they are desperate to do anything—because they associate food with the source of life itself.

Of the different aspects of nutrition, I want to focus on intrauterine nutrition, by which I mean the importance of nutrition before birth. There is evidence that the long-term effects of the way that the foetus is nourished carry on throughout the person’s life. In 2002, Sir Derek Wanless’s report to the Department of Health entitled Securing our Future Health: Taking a Long-Term View, identified low birth weight as a pivotal cause of the vicious cycle of poor health. He recognised that the cycle repeats itself from generation to generation and traps communities in poverty and health inequality. The UK now has the highest rate of low birth weight in western Europe. Our message concerning nutrition’s significance from womb to tomb is clearly not resonating sufficiently.

A wealth of medical research and literature corroborates the impact of intrauterine nutrition. In a literature search in preparation for this debate, out of 904 papers listed on the subject, my eye was caught by one paper that examined the emergence of insulin resistance, visceral obesity and glucose intolerance in adult life. Evidence from the Sansom Institute for Health Research indicates that, in the uterus, the foetus adapts to being starved when it is being undernourished by upregulating insulin receptors so that glucose is driven into cells. That does not occur in the skeletal muscle to the same extent, so that organs and the brain are preferentially fed—a very good survival adaptation for the foetus. After birth, there is a general upregulating, so in the growth catch-up that occurs glucose is generally driven into cells. The problem is that, as it is driven in, it is driven into fat cells, so the fat cells get glucose more quickly than muscle and other organ cells can develop. At that point, the foundations of obesity and the metabolic pathways that are associated with it are laid down.

It may seem obvious that obesity is malnutrition, not simply overnutrition, but I think that that is often forgotten. Glucose is essential to our lives. We cannot survive without it, but all of the nutrients that we take in are important. Statistics on child obesity vary, but there is nothing to dispute the information that childhood obesity is rising in the UK. Childhood obesity is unhealthy in terms of biological damage as well as its emotional impact due to stigmatisation and all its other effects.

In our supermarkets, the choice of food and drinks available is now overwhelming. We have to look at the way in which people shop and buy. Following on from the theme taken up by my noble friend Lord Patel, I shall focus on the use of artificial sweeteners, which so often appeal to the young. Another paper that caught my eye was written by Swithers and Davidson at Purdue, who looked at the effects of artificial sweeteners on calorie intake in rats. They did a clever experiment. They fed half the rats with artificial sweeteners and the other half not and they let them run around eating as much as they wanted. They found that the ones that had consumed artificial sweeteners became more obese. It seems that the artificial sweetener affects the whole physiology of the organism, making the animal want to take in more calories, because they are primed to expect a calorie load. I know that that research was on rats—it would be difficult to do it in our population—but it underlines the importance of research and of good knowledge about the problem that we face with this epidemic of obesity.

The problem for the Government is that they have to communicate risk in a proportionate and sensible manner. I am sure that the noble Lord, Lord Whitty, knows better than most of us the difficulty of trying to communicate risk to the public, allowing people to be risk intelligent while not creating food scares. We all remember the food scare in 1988 about eggs and egg production. Egg production plummeted following the statement that it was infected with salmonella. The risk was minute—less than 200 million to one—but that warning will always be remembered in relation to public statements. Indeed, in my own household, egg consumption at breakfast went from high to zero—not my doing, but because of other members of the family.

Nutritional outcome in our society is inextricably linked to socio-economic outcome. Sir Michael Marmot’s review, Fair Society, Healthy Lives, conducted in 2008, although published only recently, shows clearly the importance of nutrition from the moment of conception, from when we can nourish and nurture every child’s health and opportunity. Sir Michael reports that,

“the foundations for virtually every aspect of human development ... are laid in early childhood. What happens during these early years (starting in the womb) has lifelong effects on many aspects of health and well-being”.

The Food Standards Agency certainly tries hard to communicate accurate information. I was interested in tartrazine, that yellow colouring in food, which fortunately fell out of favour some years ago. However, we have not banned it. In 2008, it was recommended that tartrazine should not be included, as a result of awareness that it is allergenic, is associated with behavioural problems in children and has been implicated in malignancy of the thyroid. The Food Standards Agency called for a voluntary phasing-out of tartrazine along with five other colourings and duly reported the link with hyperactivity. By then, tartrazine had already been banned in Norway, Austria and Germany, but an EU directive overturned that ban in the same year. We are left without it being banned; it is simply recommended against.

The information on the FSA website is helpful. It states that, if you have a child with hyperactivity, you should consider avoiding giving them certain artificial colourings, because this might help to improve their behaviour. It lists six colourings, which have absolutely no nutritional value. However, there is a problem. The colourings are listed either by name or by E number. I am sure that none of us can remember our PIN codes let alone the E numbers for six different food additives when we go shopping for children. These six have to carry a label saying that they may have an adverse effect on activity and attention in children, but it is impossible to read all the print on all the labels—we probably end up just reading the main name. Those who have difficulty with literacy may not be able to assimilate the information in a meaningful way.

Another problem with this brightly coloured food is that children become acclimatised to the notion that food should be brightly coloured; they begin to think that if it does not have food additives it looks dull and unexciting. In that way, we begin to condition the next generation to believe that food that is not psychedelically coloured is of less worth, particularly if the people who are responsible for their care are buying this food for them.

We should not forget the mantra “Every Child Matters”, which is associated with the previous Government, or the importance of education. They touch the humanity of every individual. They are universal sentiments, which cut across all political lines. They point to universal education about the value and importance of nutrition, which is a fundamental contributor to affording equal opportunity and outcome for all. If we do not teach children how food grows, how to shop, how to cook, how to sit at table with others and how to eat well, it is hardly surprising that the cycle of malnutrition continues. If we do not have clear information for the public, put across in a sensible way, it will become increasingly difficult for well meaning parents to know how to shop appropriately for children. People need to be able to avoid being misled by the sensationalist headlines that appear so often in the press and skew shopping habits. It is interesting to talk to shopkeepers, who will sometimes say, “I don’t know why we’ve had a run on such and such this week”. The reason is that the product has probably been associated with a headline or a magazine article.

I suggest to the Government that they consider, in all that they do, the importance of communicating accurately and with sound information, to help people to understand risk. If we do not improve the nutrition of our nation, particularly for women about to conceive and in pregnancy, we will harvest the downside for many generations.

Health: NICE

Baroness Finlay of Llandaff Excerpts

Wednesday 14th July 2010 Lords Chamber

[Earl Howe]

My Lords, I am grateful to my noble friend. It is important for me to state that the Government respect the independent expertise provided by NICE and we think that it should be allowed to continue to issue guidance free from political interference. That is a point of principle. However, we also think that there are failings within the wider system regarding drug pricing and drug access. We are determined to address that but we are clear that NICE plays a vital advisory role.

[Baroness Finlay of Llandaff]

My Lords, how will the Government ensure that the research, which NICE requires to provide the data on which it can make informed decisions, will be supported in the newly reorganised NHS? The NICE document published today, with its review of Alzheimer’s drugs, has as a major recommendation: co-ordination of research to provide good, long-term, end-of-life care studies of the effects of these new drugs in patients.

[Earl Howe]

My Lords, the noble Baroness will have seen in the White Paper the emphasis placed on research. A number of paragraphs in it will be of interest to her, as they emphasise the key role that research and research funding play in the long-term agenda of the NHS and as regards the interests of patients.

NHS: White Paper

Baroness Finlay of Llandaff Excerpts

Monday 12th July 2010 Lords Chamber

[Earl Howe]

My Lords, I agree with my noble friend. There is no doubt scope for reconfiguration but we are not going to prescribe it from Whitehall. The structures that we propose in the White Paper will facilitate reconfiguration in a much more coherent and structured way on a local level because, with the buy-in of patients, local authorities will have a major say in the way in which services are configured, as will GPs, acting in consortia, jointly. The key issue is whether reconfiguration makes sense from a clinical perspective. Politicians are not in the best position to decide that. Having said that, there will be occasions when people will be unable to agree at a local level and we have plans to cater for that situation: ultimately, the Secretary of State will stand as arbiter in such difficult cases. However, in the majority of cases, we see decisions as properly lying at a local level.

[Baroness Finlay of Llandaff]

I have two brief questions. First, in the Statement the Minister referred to outcomes. Given that secondary care sometimes has patients—sadly too often—referred late because of delayed diagnosis in primary care, how is the clinical care of the general practitioner going to be held to account in this system? My second question relates to the Minister’s mention of “any willing provider”. What security will there be to ensure that a provider cannot introduce a loss-leader service with clearly defined boundaries in order to gain a market share, and to prevent complex and difficult cases not covered by that provider being dumped on the NHS? This has been the experience with some private practices where patients are in private hospitals but, when things become too complicated, they are shipped down the road to the local NHS intensive care unit.

[Earl Howe]

My Lords, the noble Baroness identifies two particularly important issues. How will GPs be held to account for the clinical care that they provide? The data emanating from their performance will be transparent and published. The consortia will monitor the performance of each practice. They will identify outliers, whether good or bad, and act accordingly. We do not have those information systems sufficiently in place—I hope that, over the next 18 months or so, there will be time to develop the systems needed for consortia to do this—but it is vital that GPs are held to account for their performance and they will be incentivised in their remuneration to provide high quality.

The noble Baroness made an important point about loss leaders among providers. The NHS commissioning board will license a provider only if it is satisfied that the quality of care delivered by that body is of an adequate standard. I think that the board will look with great care at the practice of introducing loss-leader services and rule out, if there is any doubt at all, quality being compromised in the process.

Health: Spending Cuts

Baroness Finlay of Llandaff Excerpts

Wednesday 30th June 2010 Lords Chamber

[Earl Howe]

My Lords, as I have just indicated, the Department of Health is very fortunate to be protected from cuts in its budget during this Parliament, but at the same time we have a duty to spend every pound wisely and to obtain value for money. The spending review is still ahead of us. The only cuts that I can predict are those to bureaucracy and administration, to enable us to direct more money into front-line healthcare.

[Baroness Finlay of Llandaff]

Will the Minister provide an assurance to those highly specialised secondary care services that are fearful that GP commissioning may be at too small a population level to ensure that those with complex conditions, which may need complex early diagnosis and management, will be adequately managed? I declare an interest as a member of the BMA ARM at the moment.

[Earl Howe]

My Lords, the noble Baroness is right to draw attention to this issue, of which I am very conscious. Where we have commissioning, it is important that the population base for a given condition is sufficient for that commissioning organisation to contend with. With regard to specialised conditions, I am working hard to ensure that the model we propose will take them fully into account.

Health: Primary and Community Care

Baroness Finlay of Llandaff Excerpts

Thursday 24th June 2010 Lords Chamber

[Baroness Finlay of Llandaff]

My Lords, I must declare an interest as a true Dr Finlay. I am a practising clinician; I am president of the Chartered Society of Physiotherapy; I work in palliative medicine; and I have links with many hospices around the UK. I hope that I have made all the declarations before I start.

We are facing change and I am sure that the Minister is inundated with advice and pressures but in the time preceding change, I hope that he will be cautious so that we do not have change while ignoring the potential unintended consequences of such change. One of the difficulties is that often we do not know what we do not know, and in the rush to bring about change we may not do the background research or explore the issues. I want to address the specialist services providing care for patients, the role of the third sector, particularly for terminal and palliative care, and the needs of patients out of hours.

In 2006, in England and Wales there were 503,000 deaths. That figure is anticipated to rise to 586,000 in 2030, which is a massive increase. Only about 20 per cent of patients die at home, so we have to think how the needs of all these patients will be accommodated. With that there has been pressure to move patients out into the community. The need for integrated care pathways for complex conditions increases as high levels of expertise are required to meet patient needs and there are more patients with complex conditions. I am concerned that in trying to save money substitution has been looked at but it is not without its dangers.

Despite a priority of providing care closer to home, the Audit Commission report, More for Less, found little evidence to show that PCTs have been successful in removing care from hospitals. There is little evidence that patients with rare, complex conditions are not prepared to travel to get expert care, because they know that they need accurate diagnosis and a really good management plan. The challenge is: how do we get patients seen by the right person at the right time in the right setting, as well as trying to move care out into the community? That is a stark cultural challenge that needs multiprofessional teams working in managed clinical networks to encourage collaboration and co-operation between primary, community and secondary care. That must also cover other aspects of home care provision, including social care.

The new commissioning arrangements must cross traditional NHS boundaries. The publication by the Royal Colleges of Physicians and General Practitioners, Teams without Walls, identified the need for integrated systems, clinical leadership in commissioning and aligned incentives, underpinned by patient involvement in commissioning systems, especially for those with long-term conditions.

The current problem is that payment-by-results tariffs in their present form incentivise against integrated care. The current tariff-based system encourages hospitals to treat more patients while, simultaneously, GPs are under pressure to refer fewer patients. That creates a tension that can work against the development of integration and against quality in patient care. It works against earlier diagnosis, particularly in recognising rarer and complex conditions. One way to rebalance the disincentive is to introduce payment by pathways or payment by conditions, to ensure that high quality generalist and specialist care have a sustainable future, for the benefit of patients.

Patients must enjoy equitable access to specialists when required. I have just chaired a joint report on allergies for the Royal Colleges of Physicians and Pathologists, and we have found a stark inequity in provision around the country. Specialist resources must be at the heart of any clinical network or community-based service. It is essential that we have services available 24/7. The current five-day provision does not meet patient needs. That service does not respond to the true, seven-day need of those who are really ill, including at night. In Wales, we have moved from five-day to seven-day working by clinical nurse specialists in palliative care, and we have shown in a short space of time a dramatic change, because problems that occur on Saturday will be dealt with on the Saturday or Sunday. By the Monday, it would have been too late to address them.

There are some specialist service needs where integration is essential. There needs to be a one-to-one relationship between the GP, the patient and the specialist in secondary care to ensure patient safety and that people understand the complexity of the patient's background. Repeated handovers do not work well. We know that information is being lost in a kind of conveyor-belt hand-over between clinicians. We need to restore patient safety and quality of care and ensure that the lead clinician has a comprehensive understanding of the patient to reduce complications and near misses, particularly in surgery.

Some things should be done only in places well equipped to do them. An increasing amount of so-called minor surgery has been done in general practice, but there have been some awful situations where melanomas have been removed, the margins have not been adequately marked, the resection was inadequate and the subsequent surgery was much more extensive and expensive than if it had been done in a specialist dermatology surgery centre at the outset. The Anaphylaxis Campaign has sent me horror stories of GPs giving advice to parents about children suspected of having a peanut allergy that was completely inappropriate and would have jeopardised the child’s life, not just their health. It was just as well that the parents phoned the campaign with their anxiety.

There are real problems out there, and there are risks as well as opportunities in moving towards a largely GP-commissioned framework. Academic GP is essential to driving up the standard of evaluation. We need to evaluate patient outcomes in any change. This is not about having a fashion for one model or another; an evidence base must underpin commissioning. As PCTs are divested of their commissioning responsibilities, GP consortia are expected to take up the mantle, but their skills and background knowledge, and even their willingness to do this, are really deficient in some places.

There needs to be a national view on minimum access rates and the provision of highly expert services to avoid a postcode lottery, particularly where there is a low critical mass in a smaller population, otherwise you get a bidding war between GPs and consultants that works against quality. If you do not have adequate dual provision, community-based services will have fewer places to turn to for training specialists for the future, for continuing professional development and for research. Driving that forwards will drive up standards of care in the future, particularly for those with more complex conditions.

I ask the Minister to consider some specific things: that promoting the idea that engaging doctors in the spirit of collaboration is required for successful commissioning; that commercial loss leaders might appear at first sight to be useful but may lose expertise and undermine quality in the long term; that the repudiation of unhealthy forms of competition is essential, as is encouraging jointly commissioned models for integrated health services; that choice for patients means the ability to access specialist scientifically based clinical excellence to diagnose and plan their management, which can then go back for ongoing care in primary care if there are good pathways; and, lastly, that the incentives and disincentives of payments by result need to be rebalanced to bring integrated generalists and specialist care closer to the patient’s home.

I am grateful to the noble Lord, Lord Alderdice, for flagging up the importance of the whole person and the whole family, because the third sector provides that par excellence in hospice care. There is a need to specify minimum levels of service, such as in hospice care, across the UK, and to have centrally agreed three-year contract with an agreement on how the service is delivered locally. At the moment, Marie Curie has to negotiate 200 separate contracts across the UK. That is a waste of time and a duplication of effort when models such as the fire service or the police demonstrate that you could have a national framework with local agreements on implementation.

Hospice grant money has to be negotiated at a local level by small hospices that often do not have much expertise in negotiating with all the different people from whom their patients come. Competitive tendering is punitive to the third sector, because it does not have the resources to tender or the expertise of larger bodies. Punitive contracts in the third sector can really work against them. If they miss a level in their service they may incur a penalty, yet they provide a key service to the NHS.

Commissioning must become outcome-related, as much in hospice care as anywhere else. Currently, it seems to be process-related. It has to be integrated across the whole pathway, and this need to commission across the whole pathway means that the professional competency framework needs to be driven up to promote higher levels of competency. There is a real concern and a danger that private companies will come in and commission against a whole pathway, and one questions why they are needed as an intermediary. The danger is that increased income will go in profits to shareholders and not be reinvested in the not-for-profit third sector that the hospices epitomise.

In summary, there needs to be 24/7 provision, which should be addressed urgently. There is a large shortfall in district nursing. Only 53 per cent of PCTs have 24-hour district nursing, which is grossly inadequate if you are trying to care for critically ill patients at home. There has to be a closer link between health and social care. Care assistants can often be the key people to keeping patients at home.

On incentives, we should remember that healthcare professionals are proud. They want to deliver a good service. If you embed direct patient feedback into the system, as we have in Wales for palliative care using iWantGreatCare, it can become a powerful driver to quality improvement. One team does not want to perform less well than another, but patients need to provide feedback in an anonymised way so that they are not fearful that their comments might antagonise the clinicians looking after them.

There have been unintended outcomes from the current arrangements where financial incentives or punishments drive provision rather than need. Patients feel particularly lost out of hours and it is really important in commissioning healthcare that we get it right. There is a steady stream of horror stories coming through. It is not simple; it is not like shopping for shoes; and I hope that the Minister will think carefully about the unintended consequences of change.

Mid Staffordshire NHS Foundation Trust

Baroness Finlay of Llandaff Excerpts

Wednesday 9th June 2010 Lords Chamber

[Earl Howe]

My Lords, I agree wholeheartedly with my noble friend that in many parts of the NHS we need a culture change—a culture that puts patients first. We need an NHS that listens to patients and responds to their concerns and needs. We must prioritise the people whom the NHS serves and we must listen to the doctors and nurses who work in it. The measures that we are taking today on whistleblowing are important. Last week, we began to publish more transparent data about the NHS so that people can hold their local services to account in a more meaningful way. We are looking also at reducing the number of hospital readmissions, as I am sure my noble friend is aware.

The culture change that is needed will not happen in a hurry and I would not want to give the impression that it is required everywhere in the NHS. Mid Staffordshire was an unusual event, but unless we get to the bottom of why it happened there must be a fear that it may happen again. As we move forward and propose to Parliament changes in the way in which the NHS is regulated and care is commissioned, we must not lay ourselves open to unintended traps. I therefore concur with all that my noble friend said. I think that he will find, as we bring forward our proposals, that the emphasis on transparency, openness and the patient’s voice will do much to address the concerns raised.

[Baroness Finlay of Llandaff]

My Lords, the Minister has spoken about listening to professionals and to patients. Will he give an undertaking that, long before whistleblowing is necessary, there really will be measures in place to support staff who want to raise concerns that changes proposed by management might adversely affect patient outcomes? That requires an empowering of clinicians at the coal face.

Furthermore, as the Government consider changes in the NHS generally, will they not be fooled into thinking that this was a completely isolated event? I fear that there are a lot of other pockets in the NHS that are not right. What emerged from the inquiry were the voices of the patients’ relatives. When they gave evidence, those voices shouted out loud and clear that things were wrong, but they were not adequately heard. I commend—I declare an interest here—the Dying Well Matters programme as part of the Wales 1000 Lives Campaign, which I have been involved in instigating. It routinely seeks stories from relatives and patients before trouble occurs to try to detect those subtle but extremely distressing instances of poor and inadequate care in parts of the service that otherwise might go unnoticed.

[Earl Howe]

My Lords, as ever, the House will listen to the noble Baroness with great attention and respect, knowing that she works in the midst of an important and active part of the NHS. I hope that she is wrong and that the seriousness of the malpractice at Mid Staffordshire is rare, but we have to be vigilant. There could be another instance of a failing trust out there. The House may want to know that the Care Quality Commission has announced the registration status of 378 NHS trusts to provide healthcare services from 1 April. Only 22 of those are registered with conditions, but the CQC has said that those trusts are safe to provide services to patients. No trusts were refused registration, which is an important point.

On the question of openness within trusts, the noble Baroness is right: a culture of openness and willingness to learn from mistakes is essential to a health service that wishes to improve. There is a requirement on hospitals to inform regulators about serious errors, but that requirement does not extend to informing patients, so we are looking at how that can be addressed.

Genomic Medicine: S&T Committee Report

Baroness Finlay of Llandaff Excerpts

Wednesday 9th June 2010 Lords Chamber

[Baroness Finlay of Llandaff]

My Lords, I was fortunate enough to be co-opted on to the inquiry and it has been a great privilege to work alongside so many people from a scientific background, many of whom sit on our Cross Benches. I congratulate my noble friend Lord Patel on his chairing of the committee and on his splendid introduction today.

I wish to speak about stratified or personalised medicine, the area of genomic medicine predicted to hold great potential for healthcare in the near term. It entails matching treatments to specific patients using clinical biomarkers to target treatments effectively by taking account of patient susceptibility to particular drugs or to adverse drug reactions. The Royal College of Pathologists told us that it anticipates that DNA and RNA-based diagnostic approaches,

“will guide more appropriate treatment and avoid ineffective treatment, and will identify some patients who do not need treatment. [They] will be an absolute requirement before the administration of many new treatments, especially new anti-cancer drugs; [and] will increasingly allow the prior prediction of severe adverse [drug] reactions”.

However, doing the test is not enough; it is the clinical context that is crucial. Therefore any thoughts that over-the-counter tests could move things out of the clinical arena are misplaced. Tests can be misleading at best—but they can be worse than that if they are not conducted in a proper clinical context.

My noble friend Lord Patel has already spoken about the cancer treatments that have emerged indicating a likelihood of a response to drugs, particularly Herceptin and Iressa in breast and lung cancer respectively. It is worth noting that such testing has increased about threefold in the past two years.

However, there are problems surrounding, in general, the translation of research on pharmacogenetic tests into applications. At present there is little incentive for the pharmaceutical industry to develop the genomic tests because the business model relies on the consumption of a product—a rather blockbuster approach—to ensure a return on the substantial R&D investment which is needed to bring a drug to the market. However, stratified medicine targets a much smaller patient group and requires the development of accompanying tests, and these tests must be developed in parallel with the therapy itself.

Professor Sir John Bell suggested that,

“the delivery of a new set of genetic tools into the clinic has proved really difficult”.

One reason for this was that diagnostic companies could not be relied on,

“to do what is done in therapeutics, which is to demonstrate clinical utility”.

This was because,

“the cost of a clinical utility programme is such that, at the prices paid for diagnostics, they would never get the money back”.

We therefore recommended flexible pricing models for therapies that rely on the use of pharmacogenetic tests, the protection of intellectual property and the concurrent development and authorisation processes for therapies and diagnostic tests that will assess the clinical utility and validity of genetic and genomic tests within the NHS.

The previous Government’s response stated that the Department of Health had commissioned NICE to develop and manage a single evaluation pathway specifically for diagnostic technologies, with a pilot scheme due to report this summer. A new committee within NICE should ensure health technology assessments look at the clinical utility and validity of diagnostic tests. Can the Minister assure us that these developments are still on course? Can he clarify how the proposed value-based pricing system will allow targeted treatments to be more available, even if at a local level commissioning decisions do not support the necessary infrastructure? There may be a potential tension here between central promises and local sovereignty in decision-making.

This is particularly important when evaluating diagnostic tests. These are inherently more complex to evaluate and yet the funds for doing so are relatively trivial. Commissioners do not know when to invest in expensive testing equipment if its utility and validity has not been assessed, and so silo budgeting acts as a barrier to capital investments, leading to a postcode lottery in diagnostics. Decisions need to be made at a national strategic level, not locally, and it is essential that clinical genetics departments are supported. They should be linked and pivotal to informing studies into the whole commissioning process. Can the Minister confirm that the Department for Business, Innovation and Skills is working with the Department of Health to ensure that intellectual property systems and management of intellectual property rights support diagnostic test development, evaluation and rollout as we recommended?

The research community is collaborating to realise the potential of the NHS for the benefit of all. The network of hospitals in the NHS is ideally placed to link with research bodies. Indeed, the funding bodies are doing just that. This year Cancer Research UK will begin to establish a network of NHS centres using similar genetic techniques to guide treatment decisions. It will be the precursor to treating every NHS cancer patient in a similar way, perhaps in as little as five years. However, other genetic tests have not been integrated properly into healthcare. Our committee heard of the patchiness of testing, as has already been alluded to, for conditions such as diabetes.

There is a lack of clarity over funding streams for the use of such tests as part of treatments within non-genetic specialties, and there are inconsistencies in the ordering of such tests during consultations. As I have said, doing the test alone is not enough; it is the clinical context that is key. Genetic testing is usually in the genetics department’s budget and so is not necessarily more widely available. The cost of testing is increased if the patient has to be referred to be seen in genetics rather than a treating clinician taking responsibility for the whole process. Meanwhile, genetics departments are increasingly taken up with the delineation of single gene disorders as a subset of common complex disorders, and with the co-ordination of care for those with single gene, multi-system complex disease. Genetics departments are already facing potential overload.

To ensure better use of drugs we need a red flag system of automated warnings rolled out to ensure that appropriate tests happen routinely. This will result in a cost saving through stopping inappropriate prescribing and inappropriate testing and avoid adverse reactions.

The area that concerns me most of all is the failure of the Human Tissue Act to promote single gene testing for single gene sudden death disorders that mean that many young lives are lost. For more than 20 years we have been able to perform gene testing in the family and make an early diagnosis in the family of a risk of sudden cardiac death. NICE recommended the testing but at a clinical level it is not readily available.

One problem is that there is no clear definition at post-mortem of “retention” for tissue samples, so, whether or not anything is seen macroscopically, samples are not always sent for DNA testing. If the family is not integrally linked into the process, samples can fall between pathology, genetics and the coroners system, and a diagnostic opportunity for others in the family can be lost. Will the Minister assure me that we will look urgently at this matter so that all patients who die of suspected sudden cardiac death will have tissue removed post-mortem for comprehensive DNA analysis? That will be linked to genetic support. Such testing should be for multiple genes, because it will save lives.

The UK Genetic Testing Network is meant to be undertaking a review of service provision within the NHS to inform a consistent approach for single-gene disorders and single-gene subtypes of common disorders. Does the Minister know when we can expect the Government's comprehensive assessment of this? I realise that it is difficult for a Government who have only just taken over something already in progress.

An extension of genomic medicine is epigenetics; that is, changes in the gene expression caused by mechanisms other than a change in the underlying DNA. The molecular basis of these changes is related to the packaging proteins known collectively as chromatin. The changes are not encoded in the genome sequence so are not generally passed from generation to generation. We are seeing ever more examples of underlying genetic links, such as the link with addiction, where it seems that the serotonin and dopamine in the brain’s reward systems may be linked in some people when other factors come into play with developing addictions. However, it does not mean that everybody with that piece of genetic code will necessarily become an addict.

Understanding these developments provides a “fantastic window” on different types of common diseases, but genetic counselling and genetic support are key if we are going to use any advances appropriately. I must declare an interest: I am at Cardiff University, which has one of only two established MSc courses in genetic counselling in the UK. It is well on its way to becoming an independent discipline.

We need to ensure that genetic testing and services are supported today to ensure that developments are used to best advantage when they appear tomorrow.

Health: Dementia

Baroness Finlay of Llandaff Excerpts

Thursday 3rd June 2010 Lords Chamber

[Earl Howe]

My Lords, the Care Quality Commission is revising its current quality rating system for adult social care and is working closely with the adult social care sector to develop a more user-friendly system that provides people using services with the information they need to make decisions about their care. That is absolutely in tune with the work being done in the department on driving up quality standards in dementia care. Better information for people with dementia and their carers will enable individuals to have a good understanding of their local services, how they compare with other services and the level of quality that they can expect.

[Baroness Finlay of Llandaff]

My Lords, will the Government maintain the e-learning packages developed in palliative care to enhance end-of-life care for people with dementia across health and social care, and will they respect the agreement that those packages should be rolled out in Wales? I declare an interest as the palliative care lead for Wales.

[Earl Howe]

My Lords, it so happens that only yesterday I received a briefing on the e-learning programme, and I am well seized of the value attached to it by the royal colleges in particular as well as many other professional bodies.