Food: Regulation and Guidance
Baroness Finlay of Llandaff Excerpts(14 years, 3 months ago)
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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(14 years, 6 months ago)
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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(14 years, 6 months ago)
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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(14 years, 7 months ago)
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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(14 years, 7 months ago)
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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(14 years, 7 months ago)
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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(14 years, 7 months ago)
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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(14 years, 8 months ago)
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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.