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In all countries the inexorable development of clinical medicine to a large extent drives the demands upon health services. The five chapters of From Cradle to Grave (published 1998) deal with clinical developments between 1948-1998. This section aims to continue the coverage of new and rapidly developing topics. It is based on material in general medical publications. Specialists asked to send me additional, preferably concise, material for inclusion. Paragraphs include National Service Frameworks. For many years government had supported the professions in encouraging good clinical practice; the standard technique was to establish a professional sub-group under the auspices of the Standing Medical Advisory Committee, and then to commend its recommendations (SMAC and SNMAC were abolished in 2005 as no longer necessary). In the seventies both the Conservatives and Labour had issued a range of proposals to improve clinical services, for example Better Services for the Mentally Handicapped (1971). This process was continued with the introduction of national strategies and National Service Frameworks (NSFs) which
NSFs were issued in September 1999 for mental health and for coronary heart disease in March 2000. More followed. In the seventies there were complaints that the total costs of all the good advice coming from government exceeded the funds available. Now there were similar complaints, not least that the amount of data that GPs and hospitals were expected to collect to demonstrate their performance was becoming beyond the capacity of the system to deliver. As the number of NSFs grew, they tended to move away from centrally driven targets towards the identification of good practice. Another new approach was the appointment of senior clinicians to central positions of responsibility from 1999 onwards. Such clinicians had previously been advisors to the Chief Medical Officer and members of the medical staff of the Department of Health had developed close links with professional leaders. But as the Department's Medical Division shrank, Health Directors, or "tsars" were were appointed to drive clinical policies in cancer, heart disease, mental health, older people's services, primary care, children, emergency access and patients' issues. By issuing guidelines, e.g. for the management of high blood pressure, NICE also came to influence clinical practice. Advances in the management of serious acute conditions, such as heart disease and stroke, were influencing the organisation of the NHS. If the best treatment for a heart attack was early coronary angioplasty (an approach commonplace in the USA for ten years), patients needed direct admission to a unit capable of performing this. Similarly, a specialist stroke unit with scanning facilities and clot-busting drugs 24/7 might reduce ultimate dependency. Such units could not be provided in every DGH - they might need a base population of a million, making a case for major regional units equal to the challenge. Reconfiguration of hospital services along these lines was given impetus by the reports from Prof. Lord Darzi of Imperial College Medical School, and the National Advisor on Surgery A report on the future of planned surgery, 'Saws and Scalpels to Lasers and Robots - Advances in Surgery', said that 80% of all surgery should be done locally with the remaining 20% of the more complex cases taking place at specialist centres with access to the highly skilled surgeons and the most up to date technology.
Darzi outlined changes over the previous two decades which had led to a revolution in surgery, with the use of more lasers and keyhole surgery leading to a quicker recovery for patients and less risk of infection. To take advantage of this specialisation the most complex cases needed to be treated by the most skilled surgical teams (surgeons, nurses and anaesthetists). Chronic Diseases Increasingly health services were concerned with chronic diseases rather than the accent on acute illness of previous decades. The pharmaceutical industry was obviously interested in diseases requiring long term medication. Particularly in the USA ‘disease management programmes’, in which health services sometimes contracted the management of some chronic diseases to pharmaceutical companies, were adopted. In theory systematic, integrated evidence-based and long-term care of chronic high cost diseases such as asthma, rheumatoid arthritis and diabetes might be more effective. However, the management of specific diseases by a separate organisation risked the fragmentation of care, as patients with multiple unrelated pathology might be directed to specialised units. World wide there was increasing demand upon doctors and health care systems from the mounting numbers of patients with chronic disease, not only the degenerative ones such as heart disease, diabetes and chest disease, but a wide range of others including chronic uveitis, multiple sclerosis, depression and osteoporosis. Although smoking remained a major problem, rising levels of obesity in children as well as adults was increasingly a threat. Indeed in the US it was suggested that obesity might overtake smoking as the major preventable cause of morbidity and mortality. Drug treatment for chronic conditions became ever more complex as clinical trials of new drugs and regimes were published. Even where the evidence was clear, there were wide and unwarranted variations in clinical practice, even in the best academic centres. Improving the management of chronic disease, (or "managing long term conditions"), and the many admissions for which such diseases were responsible, became a high priority for government, and led to an examination of the methods adopted by US managed care organisations. Many medical routines were originally developed to handle acute illnesses, and were ill suited to chronic disease management. Two new approaches were introduced, disease management and the chronic care model. Disease management was provided by large companies unrelated to doctors' practices, paid by health insurers. They use sophisticated information systems to identify patients with chronic diseases, and establish close communication with them, educating them and their families on self-care, track their progress and intervene if problems seek likely to arise. The chronic care model, in contrast, is based within the doctors' practices, reorganised to create informed patients with self-management skills, and developing multidisciplinary teams to monitor patients at risk. (Casalino JAMA.2005; Evaluation studies were mounted in the USA and pilot projects were established, advised by the US based Evercare, in the hope that surveillance might reduce admission. Doctors and managers might agree goals, identify high risk patients, and establish intensive nurse led outreach. Financial incentives might be introduced, for example to encourage joint working by hospital specialists and primary care. Early pilots did not, however, suggest that intensive fcase management of the vulnerable elderly would reduce emergency admissions substantially. The health service was being overtaken by an increasing number of expensive but clinically effective drugs sometimes "life-style" in nature. Prozac, HRT, and Viagra were examples of pharmaceutical advance that might improve qualities of life to which medicine had previously paid less attention. In January 2001 NICE approved three new drugs for the treatment of mild or moderate Alzheimer's disease. A new anti-obesity drug, Xenical, offered an alternative approach to a common problem by reducing fat absorption; NICE agreed in March 2001 that it could be prescribed under the NHS when patients were motivated to lose weight and obesity was significant and posing a threat to health. In April 2002 NICE recommended the use of bupropion (Zyban) and nicotine replacement therapy (NRT) for smokers who wished to quit. Drug safety The examination of drugs for safety and efficacy in the UK had a long history, back to the thalidomide disaster in the 1960s. Within the European context the European Medicines Evaluation Agency was established to bring together the resources of Community members, and was based in London. In April 2003 the Medicines Control Agency (MCA) was merged with the Medical Devices Agency (MDA) as the Medicines and Healthcare Products Regulatory Agency, (MHRA) In the USA the FDA occupied a similar role. Not all the new drugs proved safe either before or after public release. Unexpected problems emerged. At the clinical trial stage, the testing of a monoclonal antibody TGN1412 led in 2006 to multi-organ failure simultaneously in 6 young men; all survived but some suffered permanent injury. Reporting systems made it possible to spot increased numbers of rare events, such as liver failure. However a raised incidence of a common problem, for example heart attacks, was harder to discover. A new anti-depressive, Paroxetine (Seroxat) seemed to be associated with a raised incidence of suicidal thoughts and suicide. Cox-2 inhibitors were introduced in 1999 for the the treatment of arthritis in the hope that gastro-intestinal side effects would be less common. These drugs received massive publicity, often direct to consumer and combined sales exceeded $5 billion annually. Over a 5 year period, evidence emerged of higher risk of heart attacks and stroke and appeared to be an effect of all drugs in that class. In September 2004 Merck withdrew rofecoxib (Vioxx ) from the market. The belief that the Company had not drawn attention to early indications of problems led to Court actions and substantial awards against Merck. Pfizer also withdrew Celebrex (celecoxib), there being well established alternatives for the treatment of all the approved indications for their use. (Drazen J M, NEJM 17 March 2005) Off-label prescribing The prescription of a medication in a manner different from that approved, was legal, common and often done in the absence of adequate supporting data. Off-label uses have not been formally evaluated, and evidence provided for one clinical situation may not apply to others. Off-label use usually entails the use of drugs for unapproved clinical indications or in unapproved subpopulations (e.g., paroxetine [Paxil] for depression in children). It may originate from a presumed drug class effect, extension to milder forms of an approved indication, extension to related conditions or extension to conditions whose symptoms overlap with those of an approved indication. In general the evidence base for such use, which might be substantial, was often not supported by strong evidence. There are conflicts about off-label use. Payers question the need to pay for products that are not proven. Physicians desire the autonomy to prescribe drugs that match individual patient needs regardless of label. The pharmaceutical industry seeks to enlarge its markets to ensure future profits and sustain drug development. The public wants drugs that are safe, evidence-based, and affordable; but also want the newest therapies. Ask your doctor about... A substantial number of patients consulted their doctors as a result of advertisements that they had seen on TV or in the papers. In 1997 the US Food and Drug Administration (FDA) further relaxed the controls on Direct-to-Consumer Advertising (DTCA) advertisement of prescription drugs. DTCA was a powerful tool, designed to create demand and maximise profits by encouraging patient demand. Bob Dole, the former US vice-president appeared in the US on a TV commercial for erectile dysfunction - paid for by Pfizer. Some drugs now became household names, Viagra, Prozac for depression, Claritin for allergies, Rogaine for baldness and matrix for migraine. DTCA was often inaccurate; from 1997 to 2001, the FDA issued 94 notices of violations, mostly because benefits of the drug were hyped and risks minimised. In 1999 drug companies began ‘public awareness campaigns’ in England. These had little to do with health education, for the material and the advertisements were not about inexpensive diuretics, immunisation or cervical smears, but unsightly rashes and cures for baldness. In 2001 the European Commission proposed changes in EU law to allow DTCA for AIDS/HIV, diabetes, and asthma for a 5-year period, a proposal was categorically rejected by MEPs the following year. New Zealand reviewed DTA and concluded that the benefits did not outweigh the harms; similar views were held in Canada and Australia. Internet increased the availability of public knowledge of pharmaceutical products available and inevitably, there was increased pressure on doctors to prescribe the drugs publicised. The drug industry regarded Internet as an essential part of their DTCA campaigns, and one aimed at people actively searching for information. (e.g. www.emc.vhn.net ) Such developments were slower in Europe, where governments inevitably wished to control drugs budgets. Increasingly drugs were cleared for over the counter (OTC) sale by a pharmacist, as was simvastatin 2004. Candidates for OTC were usually drugs for non-chronic conditions that patients could easily self-diagnose, with a low potential for harm from widespread availability. Three factors motivated OTC, the patient self-help movement, the desire to minimise costs to the public purse, and the belief by the company that this was profitable. Little time was lost in advertising simvastatin to the public once it ceased to be a prescription drug. Factors affecting premature death.
To reduce the death rates further now involved changing individual behaviour for the key problems were circulatory diseases, cancer, and injury and poisoning. Some trends were upwards, for example deaths from liver cirrhosis in young people, probably related to alcohol consumption, in both men and women. Smoking rates had fallen over the past twenty years in most groups but the fall was less in the lower social classes than in the higher and health education had had little impact on working class women. Labour had pledged to end the advertising of tobacco, but this was delayed amid claims that financial interests had influenced the decision (the Eccleston affair and Formula 1 racing). A White Paper, Smoking Kills, set out a series of modest measures in the hope of re-establishing a downward trend. Economists (in the Department of Health) had difficulty in assessing the balance between spending on health promotion and health care services. There was some resistance to rigorous application of cost-effectiveness frameworks to favoured interventions. Nevertheless a range of preventive programs that seemed cost effective included universal 'flu vaccination for the over 65s, statin therapy to middle-aged people with coronary heart disease or who were at high risk, screening for Chlamydia infection, nicotine replacement for smokers wishing to stop, and increased support for counselling smokers. In general these were implemented. Public Health Reports A mind-numbing series of reports appeared. They were lengthy, repetitive and because of the compromises necessary to avoid trenching on private liberty, were more radical than some wished, and less prescriptive than others would have them. The Acheson Inquiry (1998) Labour commissioned an inquiry into inequalities in health, conducted by Sir Donald Acheson, an unusual choice as he had been CMO at the time when The Health of the Nation was prepared under the previous administration. The inquiry team, composed of scientists but no economist, based their recommendations on published evidence. Because of evidence that the poor generally lived shorter unhealthy lives, the key recommendations involved a wholesale redistribution of wealth. The difference between the mortality rates of Social classes IV and I for stroke, heart disease, accidents and suicide were, if anything, widening. Unlike the recommendations of the Black Report (1980), Acheson’s 1998 wide ranging recommendations were not costed. Sir Donald wanted to see the package implemented as a whole. ‘The inquiry had not looked at cost effectiveness’, he said, ‘affordability is not a matter for scientists but politicians…’ Some recommendations were vague, for example the need to take ‘measures to prevent suicide among young people’ or ‘policies to reduce fear of crime and violence’. Sir Donald had asked an evaluation group to look at the quality of the evidence it used to reach its conclusions, and support its recommendations. For most of these there proved to be no high quality controlled studies showing that the recommendations would improve health - there were few randomised-controlled trials available – but hard evidence of effectiveness has seldom underpinned changes in health policy. Indeed the widely held view that the extent of inequality of income in a society correlated with the health of the population was undermined by more recent studies, for at least in the US education was a powerful predictor of mortality, far more than income inequality (BMJ 2002;324: 1-2) Saving Lives - our healthier nation This was a review of 1992 Health of the Nation initiative that found that its strategy had failed to change spending priorities and had made no significant impact on health authorities, trusts or GPs. In 1999 Labour published a revised programme as a Green Paper, Our Healthier Nation, then a White Paper, Saving Lives - our healthier nation. This aimed to improve the health of everyone, particularly the worst off, taking into account the social, economic and environmental factors affecting health. It reduced the number of health improvement targets to four and re-iterated the contributions to health both of social, economic and environmental factors, and the individual decisions taken by individuals and their families. The document expressed aspirations, and tended to say what government could do - and not what it would do. The role of the Health Visitors would be strengthened, and educational programmes would be introduced, for examine sessions at school to help children to avoid accidents. The new policy was not substantially different from the old one, though the goal was now to improve the health of the worst off in particular. In July 2003 Tackling Health Inequalities - A Programme for Action set out a three-year plan on health inequalities. It aimed to meet the 2010 national health inequalities target on life expectancy (by geographical area) and infant mortality (by social class) and was organised around four themes, supporting families, mothers and children to break the inter-generational cycle of health, engaging communities and individuals, to ensure relevance, responsiveness and sustainability, preventing illness and providing effective treatment and care and dealing with the long term underlying causes of health inequalities. In his first report to the Treasury, largely concerned with financial matters, Derek Wanless had provided 3 different scenarios based on different levels of involvement of the public in relation to their health. Economic analysts within the Department of Health had a substantial input to these scenarios. In April 2003 he was asked to provide an update on the challenges involved, focusing on prevention and the wider determinants of health. Two issues emerged again, regulation versus patient education, and local versus national projects. He issued a report on population health trends in December 2003 and his final document, Securing Good Health for the Whole Population, appeared in February 2004. It provided little assistance in policy making, while criticizing policy, service frameworks and targets in smoking and obesity. Wanless thought the costs of the health service would be massively less if there was "full engagement" - i.e. energetic and effective action by all concerned, including individual members of the population. Wanless drew attention to the problems of smoking, lack of activity and obesity, while failing to make clear what the costs would be incurred if individuals avoided life-style induced illnesses, and died later of something else instead. Report summary - recommendations Key points included
Shortly after the report appeared the Secretary of State opened consultation in the run up to a further White Paper on the health of the nation, asking what individuals and organisations thought would be most effective in changing behaviour, health inequalities and organisational responses to improve people's health. Increasingly the role of the individual was emphasized in the making of healthy lifestyle choices. Published in November 2004, the principles were said to be informed choice (with the protection of those too young to choose, and ways of ensuring that one person's choice did not harm others), tailoring proposals to the reality of individual lives, and working together. Among a myriad of actions to make the NHS a health promoting organisation, Choosing Health proposed
There would be a ban on smoking in most public places such as pubs and restaurants, and in February 2006 the House of Commons on a free vote went further, for a near total prohibition. There would be restriction of TV advertising before 9 p.m. of high calorie junk foods and provision within primary care health of education on lifestyle. The plan was criticized because of many of the proposals were already being pursued - there was little new about patient education - the timescales were long and reliance was sometimes placed on self-regulation by industry. PCTs in the more deprived areas would, however, receive extra money to pilot such initiatives as health trainers, local people advising others on healthy living. But the financial crisis of the NHS in 2006 led many PCTs to use money intended for Choosing Health to reduce the deficits that government said was their highest priority, and in his annual report for 2005 the CMO regretted the low priority given to spending on public health services, compared with clinical ones. Government's role in public health However Government increasingly realised that the problems with obesity, alcohol abuse and smoking were more about lifestyle than public health. In many cases government was not able to persuade people to change personal behaviour. Speaking in Nottingham on Public Health on 26th July 2006, the Prime Minister, Tony Blair, said that the role of government was to enable and help people to act with responsibility. Referring to the problem of obesity, smoking levels, drinking habits and diabetes, the he pointed out that "these individual actions lead to collective costs." The Health Development Agency The Health Development Agency (HDA) was established in April 2000, the successor to the Health Education Council (1969-1987) and the Health Education Authority (1987-2000). It was a Special Health Authority like its immediate predecessor and was merged with NICE in 2004. The HDA's role was
It worked alongside professionals "to get evidence into practice" advising and supporting policy makers and practitioners. It had a staff of approximately 120 and an annual budget of £10 million. Organisation of public health The changes in the organisational structure of the NHS created problems for public health, as the organisations seldom matched local authority boundaries. Until 2001 most worked in Health Authorities – the “purchaser” or “commissioner” side. Some worked as epidemiologists in hospital trusts. Each Authority had a Director of Public Health sometimes with other roles such as Director of Health Strategy and usually with support from other consultants and trainees. As regions were abolished and regional outposts were integrated into the Department of Health, Regional Directors of Public Health became civil servants with all that that entails. "Observatories" were created was to report on the problems at regional level by the analysis of statistical data. In parallel non-medical staff concerned with public health, e.g. health visitors, health educators and environmental officers, became eligible for membership of the Faculty of Public Health Medicine and the government decided that the post of Director of Public Health did not require a medical qualification. April 2002 completed the move to Primary Care Trusts, exacerbating the problems of public health as a discipline. Primary Care Trusts were essentially built upon general practitioner registered populations rather than a defined geographical area, and the large number of PCTs each of comparatively small size, posed problems for public health. Later, an attempt was made to align many PCTs with local authority boundaries. Eexpectations of what public health should be doing also included activities the scientific bases of which were uncertain. 9 Regional Public Health Groups were ultimately formed to match the strategic health authorities and were part of the Department of Health, co-located in each of Immunisation was one of the success stories of the NHS and high levels of immunisation were maintained. Aside from the professional committees advising the Department, Dr David Salisbury oversaw the programme for 20 years or more and was largely responsible for its success. In 2000-01 about 94.5% of children had been immunised against diphtheria, tetanus and polio by their second birthday, and about 94% of 2 year olds had been immunised against Haemophilus influenzae b, 94% against pertussis and 87% against measles, mumps and rubella. Over the previous ten years meningitis as a result of meningococcal infection had steadily increased. More cases were associated with septicaemia and more children and teenagers were dying. A newly emergent strain, meningococcal group C, was responsible for much of the increase and, in 1998/9, a new vaccine for this strain was introduced into the routine childhood programme and in 2002 for everybody under the age of 25. In 2001 there were 79 confirmed cases of meningitis C and three deaths compared with 551 cases and 47 deaths in 1999, before the vaccine was introduced. Routine infant immunisation against Haemophilus influenzae, introduced in 1992, also continued to prove successful. In 2001 an annual meningitis vaccination campaign to immunise travellers to the annual Hajj Muslim pilgrimage to Mecca, estimated at 50,000, dramatically cut the number cases from 45 cases in 2000 to just 6 with no deaths following the campaign in 2002. A specific vaccine incorporating the W135 strain prevalent in Saudi Arabia was used. Rates for Measles, Mumps and Rubella (MMR) immunisation fell following a paper by Andrew Wakefield and colleagues in The Lancet in 1998. This suggested a linkage between the combined vaccine and some cases of autism. The media took up the scare story and neither repeated studies suggesting that the vaccine was safe nor government campaigns alleviated anxieties. There was a fall in uptake to below 80%. Outbreaks of measles followed, with 740 cases in 2006 and 971 in 2007 and the first deaths since 1992 . In 2004 an author's conflict of interest emerged, undermining further the initial report. Late in the day, the media changed sides and supported immunisation. Other anxieties were raised about the mercury content of some vaccines. In 2002 a vaccine against chickenpox became available, but where it would fit in to the normal programme of vaccination was not decided. In August 2004 the routine programme for children was modified, and a single vaccine against five diseases was introduced., diphtheria (D), tetanus (T), pertussis (a new acellular whooping cough vaccine), polio (inactivated polio vaccine in place of the live oral vaccine), Hib – (haemophilus influenzae type b) The 2008 schedule for children was as below (source DH website)
Infectious Disease and its surveillance Following 9/11 and the use of anthrax through the mail in 2001 in the USA (with many cases of skin infection and several deaths from pulmonary anthrax), the possibility of similar attacks in the UK, led the government to issue guidance to GPs and responsible bodies throughout the country. The NHS and the emergency services were primed to plan and organise for bioterrorist emergences. For anthrax, the brunt of the problem fell on the CDC in Atlanta, Georgia that was deeply involved in examining the outbreaks, and learning more about the epidemiology of a previously rare condition. The US government placed a major contract for ciprofloxacin an appropriate antibiotic. Concern that smallpox might be used by terrorists led by US and the UK government to order supplies of vaccine and to issue contingency plans for on the containment of local outbreaks, and mass vaccination. The Communicable Disease Surveillance Centre (and its successor the Health Protection Agency) continued to survey the hazards of infectious disease and European health ministers planned to strengthen and extend the EU's communicable diseases network so that it could be used in the event of bioterrorist attacks as well as the threat posed to health by world-wide mobility of people, infections, food and products. One such threat, emerging in 2004/5, was the possibility that avian influenza might change genetically so that humans might be infected. This led to world-wide consultation, and the stockpiling of anti-virals and vaccines. Citing the global threat of infectious diseases to health, prosperity and national security, the Chief Medical Officer of the Department of Health proposed in January 2002 a strategy he considered would improve the current system of preventing, investigation and controlling the threat of infectious diseases threats, and health protection more widely - Getting ahead of the curve. A new Health Protection Agency (HPA) would combine the existing functions of the Public Health Laboratory Service and three other national bodies (the National Radiological Protection Board, the Centre for Applied Microbiology and Research, and the National Focus for Chemical Incidents) to integrate the approach to protecting the public against infectious diseases as well as chemical and radiological hazards. There would be a national expert panel to assess the threat from new and emerging infectious diseases. Local PHLS laboratories would be taken over by the NHS, the Agency having local health protection services, working with the NHS and local authorities, to prevent, investigate and control infectious diseases as well as chemical and radiological hazards. The PHLS board believed that the proposals would break up a managed national system, leading to fragmentation. In August 2002 Sir William Stewart, formerly of the Microbiological Research Authority, was chosen to chair the Agency, and the PHLS was ordered to transfer their laboratories to NHS trusts by April 2003 when the HPA was established. 42 Local Health Protection Teams were formed.. Each team had a leader, specialists in communicable disease, nurses, and other staff with health protection skills. Teams had access to expert advice on chemical and radiological issues, health emergency planning, and communications and the HPA published a five year strategy. The national networks had long linked together number of surveillance institutes. The London based CDSC, for example, acts as the hub of the operation to track developments linked to legionellosis and salmonellosis infection with Escherichia coli O157, and the Institut de Veille Sanitaire in Paris is performing the same role for tuberculosis and HIV and AIDS. DNA fingerprinting is a powerful tool for identifying people. Such advances were now applied fingerprint germs, to show their family relationships; to look at their evolution; to track the spread of germs and identify where they came from; or to fingerprint them to prove that a particular strain of the germ was the culprit of a particular outbreak. (Other techniques, e.g. phage typing, had been in use since the 1950s). Infectious diseases Tuberculosis was an increasing a global health problem. The worsening situation was due to the breakdown in health services, the spread of HIV infection and the emergence of multi-drug resistant tuberculosis (resistance to two key first line drugs, rifampicin and isoniazid.) XDR tuberculosis (extensively drug resistant because there was also resistance to at least three of the six classes of second-line agents) was almost untreatable and the first British case (in a Somali) was admitted to a Scottish hospital in 2008. Annual notifications in England were steady at roughly 6,000 although the number in London was rising steadily. Around seven out of every ten people with TB came from an ethnic minority group, and two-thirds of people with TB were born abroad. 6% were multi-drug resistant. In 2001 an outbreak in a Leicester school, though contained, demonstrated the need to maintain an effective tuberculosis services, and to be aware of the global problems presented by the disease. A campaign was launched in 2004 to target high risk groups and mobile radiography units were brought back into use. Britain's biggest as yet outbreak of Legionnaire's disease occurred in July and August 2002 in Barrow-in-Furness, when a cloud of infected steam from an inadequately maintained air-conditioning unit passed over the town centre. There were 7 deaths and a total of 179 cases. In February 2003 an unusual form of pneumonia was recognised. The severe acute respiratory syndrome (SARS) was responsible for the first pandemic of the 21st century. Initially of unknown origin, it was soon found to be due to a new coronavirus. Within months after its emergence in Guangdong Province in mainland China, it had affected more than 8000 patients and caused 774 deaths in 26 countries on five continents. It illustrated the potential of air travel and globalization for the dissemination of a new infectious disease and the need for a coordinated global response to contain such disease threats. The risk of an influenza pandemic led the government to stock up on an antiviral drug in 2005. Food born infection continued to cause of concern. A survey of 70 general practices produced an estimate of 9 million cases annually, most of which were never seen by a GP. Campylobacter was the most common bacterial isolate, but in the majority of cases, none of the main food poisoning organisms was identified. Milk born coliform infection in Cumbria received national attention. In 2002 Norwalk-like virus gastroenteritis affected a number of large cruise ships. Until 2002 the UK had the luxury of being free from rabies. That year the first case of indigenously acquired rabies occurred in over 100 years. A naturalist and bat handler died from European bat rabies, since when infection has been verified in bats in various parts of England. People bitten or scratched by a bat now had a small risk of developing. rabies. Hospital infection, particularly with MRSA and Clostridium difficile, was an increasing problem, and one attracting public and political attention. The Department of Health demanded that all hospitals were "deep cleaned", for example with steam cleaning. Bacteria are adept at developing drug resistance and this ever-increasing problem led to alarm. The Standing Medical Advisory Committee (SMAC) reported upon it in 1998 - The Path of Least Resistance. SMAC believed that up to 75% of antibiotic use was of questionable value, yet there seemed to be inevitability to the problem. Society demanded easy answers and there was increasing use of broad-spectrum antibiotics. People might be treated inappropriately or too long; antibiotics were used on fruit-trees and salmon farms. The most vulnerable members of society were often crowded together. There are worldwide pressures for greater efficiency in health systems with higher bed occupancies, and stretched nursing and medical care, and particularly high hospital bed occupancy in the UK. With patients waiting admission from A & E, people with infected wounds might be admitted to wards wards which should have been kept bacteriologically clean. In the 19th Century hospital infection was worst in the busiest hospital, and history was repeating itself. Yet the essentials of control are well known, reducing antibiotic use, improving hygienic measures and hospital cleanliness. Staphylococcus resistance had been a problem in the 1950s-1960s, then becoming far less troublesome. In the eighties infection by methicillin resistant Staphylococcus aureus (MRSA) began to increase once more, and by 2000 roughly a third of strains isolated in hospitals were resistant. Some now showed resistance to the only remaining antibiotic, vancomycin. The number of patients from whom MRSA had been isolated had multiplied more than ten fold over ten years. The National Audit Office reported in 1999/2000 that dirty hands and unsanitary conditions in hospitals caused 5,000 deaths a year and over 100,000 inpatients became seriously ill with infections, costing the NHS £1 billion a year. A follow-up report in 2004 showed only patchy progress. Voluntary surveillance of hospital-acquired infection had long been undertaken; government made it mandatory in April 2001 and launched initiatives to attempt to improve hospital hygiene and lower infection rates. By 2006 Clostridium difficile was rivalling MRSA as a cause of hospital acquired infection, and death in hospital and the Healthcare Commission publicised large outbreaks at the Maidstone Tunbridge Wells Trust, whose chief executive resigned. A problem of poor hygiene and the over-use of antibiotics, elderly patients were particularly at risk. Until the 1980s a steady stream of new antibacterials had become available. The 1980s saw little new investment in them, but that began to change. The continuing emergence of resistance strains established the need, and three approaches were followed, the modification of existing agents, genomic approaches and vaccine development. Agents such as the fluoroquinolones, active against anaerobes and streptococci, began to appear. In January 2001 Zyvox, a new antibiotic for the treatment of resistant organisms including MRSA was approved for hospital use. With a multiplicity of antibiotics, and ever increasing microbial resistance, accurate information on antibiotics and their proper use became essential. A free peer-reviewed database was provided on the Internet by Johns Hopkins, Baltimore. AIDS and sexually transmitted diseases
In 1999, it became policy in England to offer HIV testing to all pregnant women. It was in the inner cities, with their multi-racial populations, that the incidence of maternal infection was at its highest. In 2000 heterosexual sex became, in England, the leading cause of new infections. Since the epidemic began in the early 1980s in the UK about 15,000 deaths were known to have occurred. In a tragedy that attracted little attention, over 1,000 haemophiliacs contracted HIV from therapy, of whom 600 died. I In 2006 there were an estimated 73,000 persons of all ages living with HIV in the UK, perhaps a third of whom were unaware of their infection. An estimated 7,800 were newly diagnosed with HIV in 2006; Two fifths of newly diagnosed persons probably acquired their infection in the UK, of whom approximately two thirds were men who have sex with men. The number of people living with diagnosed HIV rose each year due to increased numbers of new diagnoses and decreasing deaths due to antiretroviral therapies. Most in the UK who acquired infection heterosexually were not infected in this country. More than three quarters were recorded as having acquired infection abroad with almost two thirds of the total in Africa, the majority in East Africa though the impact of the HIV epidemics in southern and western Africa was growing. Sixty percent of new cases were in London, and a fifth of these were in Lambeth, Southwark and Lewisham, more than half of these in ethnic minority populations. The patients might be on student visas, seeking asylum, or less commonly treatment not available in their own countries. Increasingly HIV was drug resistant, 27% of new cases in 2000, compared with 14% in 1994. In 2003 there were 7,000 new cases of HIV, up 20% in a year. 70% were in heterosexual African migrants and 1% of the population were black Africans; this group constituted 32% of all HIV cases in the UK. Now it became important to act, political correctness aside. While most of these infections had probably been contracted abroad, it had to be treated as a health problem, not an immigration one. There were only two approaches to the epidemic, preventing new HIV infections and anti-retroviral treatment to those needing it. The consensus view was that in the treatment of established HIV infection initial therapy should include a combination of three potent anti-viral drugs; there might prove to be a case for four. In 2007 three new agents were developed for the management of drug resistant virus, two new classes of anti-HIV drugs - entry inhibitors and integrase inhibitors - and a second generation of non-nucleoside reverse transcriptase inhibitors (NNRTIs). There was new hope for patients in "deep salvage" who were resistant to currently available drugs. For the third world, new low cost drug regimes, administering zidovudine in pregnancy, offered a chance of reducing the infection of the foetus by the mother by some 80%; more intensive treatment from 28 weeks of pregnancy was even more successful. But though drug companies might offer special deals, funds were hard to find in the third world and "dismal" was a charitable way of describing the treatment-coverage rates in many countries. The problem was compounded by the unwillingness of some fundamentalist churches to talk about condom use.
Until 1998, the number of cases of infectious syphilis remained stable among both sexes in England, but then rose six fold between 1998 and 2002 (from 132 to 1232). Outbreaks were often localised, and might have different characteristics, for example predominantly among men sleeping with men, or commercial sex work and crack cocaine use. Cases of chlamydia had been rising since 1993, partly as a result of improving awareness and diagnosis. Cases rose from 53221 in 1999 to 81680 in 2002. The highest incidence per 100,000 was in black ethnic groups. Chlamydia became the most common sexually transmitted infection seen in clinics Although chlamydial infection could later lead to pelvic inflammatory disease it frequently has no symptoms and passed undiagnosed, and it is likely that these figures still represent as little as a tenth of the real number of infections. Following pilot trials in which approximately 1 in 10 were found to be infected, a national chlamydia screening programme for women aged 16-24 using sexual health services was proposed, and ten centres were established for the next phase. BSE The Labour government established a judicial review of the handling of BSE, chaired by Lord Phillips, which reported in October 2000. Twenty eight Ministers, civil servants and scientists were criticized in the Report. A culture of inter-departmental dispute between the Ministry of Agriculture and the Department of Health, and unnecessary secrecy, was exposed. The public assurances of safety, given at the most senior level, had been revealed as flawed at the time they were given. The then Chief Veterinary Officer Keith Meldrum, and the then Chief Medical Officer, Sir Donald Acheson, were accused in the Report as glossing over potential health risks. ‘Safe’ seemed to mean different things to the public and to government officials. Senior Conservatives immediately accepted responsibility for the crisis and a government compensation scheme was introduced. There were continuing cases of new variant Creutzfeldt-Jakob disease (vCJD), 10 in 1996, 10 in 1997, 18 in 1998, 15 in 1999, 28 in 2000 and by November 2007 a total of 166 confirmed and probable cases throughout the UK with 162 deaths had been reported. The numbers were beginning to decline. Though infection in cattle was most marked in the UK, it was also reported in France and Germany, and human vCJD was found in France. Molecular strain typing and transmission studies confirmed that vCJD and cattle BSE were caused by the same prion strain. A cluster of five cases in a single small village, Queniborough, provided useful information. All patients had lived in the village between 1980 and 1991, and died between 1998 and 2000, providing some indication of the incubation period in their cases. Traditional butchery practices in small abattoirs at that time seemed the probable cause. The possibility of a substantial epidemic in coming years remained in the absence of firm evidence of when the infective agent entered the food chain. To begin with nobody knew if vCJD was transmitted by blood products, but in 1998 it was decided not to use UK blood plasma, and instead to import this from the US. Whole blood was also treated to remove white blood cells. In 2002 Life Resources Inc., a US firm, was purchased by the Department of Health to secure the long term supplies needed by the NHS. Of those known to have vCJD at least nine had been blood donors so there was a small risk of infection from transfused blood; in December 2003 a case of vCJD was reported in a patient who had previously received blood from a donor incubating the disease and two more followed, the third in 2006. In April 2004 people who had received blood transfusions were stopped from being blood donors and in July a second possibly transfusion related case was reported. Blood donated by a small number of people who went on to develop vCJD was traced. Some people had received direct one to one transfusion of whole blood from these donors and they were contacted and told about the risk that the might face, and plasma from the same donors used to manufacture products such as clotting agents was also traced, and recipients contacted. Some 6,000 people were involved. The development of a better method of identification of infection in its earlier stages, by tonsil biopsy, opened the possibility of population screening to determine the incidence of infection. A study of 12,500 specimens of tonsils and appendix removed at operation showed 3 cases of the prion responsible for vCJD, suggesting that perhaps three thousand people carried the infection. New guidelines in January 2001suggested that disposable surgical instruments should be used in operations such as appendicectomy and tonsillectomy in spite of the cost. Shortly after operative difficulties, and possibly deaths, followed their use and they were withdrawn. Compensation became available to people who had been infected with Hepatitis C from blood transfusions, developing liver cirrhosis, after the hazard was recognised, but before the introduction of routine screening in April 1991 - lump sum payments of £20,000. John Reid extended this to cover a wider range of people infected as a result of being given blood products by the NHS. In October 2001 compensation was also offered to victims of vCJD and their families. Screening The National Screening Committee, established in 1996, was one of the bodies attempting to introduced evidence into medical protocols. In its first report in 1998 it identified almost 300 screening programmes, many at a research stage and nearly 100 in practice. Only four met stringent criteria for both quality and evidence of effectiveness, breast and cervical screening, and neonatal blood spot screening for phenyl-ketonuria and hypothyroidism. Earlier considered harmless, there was a growing body of evidence that screening could harm people, particularly because of false-positive and false-negative results. To Wilson’s earlier criteria (see From Cradle to Grave) was added a new one, that there should be evidence from high quality randomised controlled trials that programmes were effective in reducing mortality or morbidity. In 2003 it was agreed to work towards a national screening programme for bowel cancer, the second most common cancer in men and women and this would be introduced with the testing of stools for blood in the over sixties in 2006. Further trials would be undertaken for an alternative method common in the USA, flexible sigmoidoscopy. "Multi-phasic screening" as a form of health check, had been popularized in the USA in the sixties. Now a new form of "screening" emerged there, with the introduction of whole body spiral CAT and MRI scanning. Mobile units might offer cardiac, thoracic or abdominal scans. Other organisations provided Doppler ultrasound investigations to the worried well. There were, of course, some positive findings - for example young men with an operable but clinically silent cancer. Such procedures might take only a few minutes and cost $200 each, not an impracticable sum. Complementary, or alternative, medicine remained in public demand. The main common factor seemed to be the time and patience of practitioners of alternative medicine, commodities in short supply in the NHS. The Prince of Wales, like many of the Royal family, was a longstanding advocate for these therapies, or at least for research into their effectiveness. In November 2000 a sub-committee of the House of Lords Select Committee on Science and Technology, chaired by Lord Walton, reported that there was scant evidence that alternative remedies worked. Yet the public spent £1.6 billion annually and 50,000 practitioners were treating some 5 million patients. Only osteopathy, chiropractic and acupuncture were backed by scientific evidence. The evidence for herbal medicine was mixed, and that for homeopathy was anecdotal. The subcommittee was particularly concerned about dangerous and inaccurate information that appeared in some media articles, and on internet. Better regulation of practitioners, and control of misleading product labelling, were needed. In December 2001 the Department of Health expressed a willingness to consider the provision of some forms of complementary medicine within the NHS, subject to evidence of its effectiveness. Almost certainly such evidence would be a long time coming. How, in any case, could one regulate and examine people in an ever changing and expanding number of alleged disciplines, most of which had the scientific background of snake-oil salesmen.? In 2004 the Department of Health provided £900,000 to The Prince of Wales’s Foundation for Integrated Health to support the Foundation’s work in developing "robust systems of regulation for the main complementary healthcare professions" and published a guide, available online, to help people understand the main alternative therapies available. The guide avoided the obvious question, "does it work?" In 2006 the Prince of Wales addressed the WHO, urging delegates to embrace alternative therapies in the fight against serious disease. Leading doctors spoke out against his campaign, and a group wrote to the chief executives of all acute and primary care trusts, urging them to stop paying for unproven or disproved alternative medicine at the expense of more conventional treatments.(HSJ25 May 2006) Clinical specialties When faced with an emergency, patients require reliable and appropriate attention fast. For example falls in the elderly may require hospital admission because of a fractured hip, but in many cases there is no serious damage and it is important to provide social care and adapt the house to reduce the chance of a further fall in the future. Emergency mental health care might also be appropriate. Emergency Care Networks (ECNs) were proposed to draw together ambulance services, A and E Departments, primary care and social care. New types of personnel emerged, e.g. nurse practitioners, community paramedics, and emergency care practitioners. Changes in general practice out of hour arrangements and the increasing role of NHS Direct made it important to redesign accident and emergency departments. The annual number of patients steady increased, supplemented by those attending walk-in centres and minor injury centres. Sir George Alberti, 'emergency access czar', and previously President of the Royal College of Surgeons, oversaw a review of Accident and Emergency Services, a target was established for the percentage of patients seen within 4 hours, and systems were reviewed to try to reduce the time taken by each stage of a patient's visit. For example "see and treat" was encouraged, a a senior doctor or emergency nurse practitioner being the first to review each arrival. Increasingly genetic medicine was showing the potential to identify people at risk of serious disease, for example some forms of breast and bowel cancer. Genetic blueprints of individuals could show the risks that they might run in later life. Academic centres had evolved into regional centres serving populations of 2 - 6 million. Clinical and laboratory services worked closely together, and developed "hub and spoke" systems with clinics in district hospitals. They provided access to the latest developments, clinical diagnosis, laboratory (DNA and chromosomal) diagnosis, genetic counselling and the care of extended families long term. In 2001 Alan Milburn invested £30 million in genetic services and to create a national policy on clinical genetics, the government announced a forthcoming paper on genetics. In June 2003 the White Paper Our inheritance, our future - realising the potential of genetics in the NHS was published. It painted a vision of a future health service offering personalised care based upon a person's genetic profile. It promised increased spending on research, on the development of clinical services in primary care and the hospitals, and more education and training programmes.
Research proposals were sought and funded to examine how information about a patient's genes might be used to tailor treatment to individual need, perhaps reducing the incidence of adverse drug reactions, or targeting patients most likely to respond well. Awareness that demand for services might exceed resources also led to the establishment by the Department of Health of the Genetics Commissioning Advisory Group, to develop ways to evaluate and set priorities for genetic technologies within the NHS. It was proposed to establish two 'National Reference Laboratories' to help the NHS keep abreast of new genetic testing methods and discoveries. The Human Genetics Commission (HGC) was created in 1999 to provide the Government with strategic advice on human genetics. Ministers asked the Commission to look at the wider social and ethical issues involved in the use of genetic data in insurance. The Commission was concerned that the results of genetic tests might be used by insurance companies to the detriment of the population were examined by the Department of Health's Genetics and Insurance Committee (GAIC). In October 2000 the committee agreed that to allow insurers in the UK to use genetic test results for assessing the risk of Huntingdon's disease. The Gene Therapy Advisory Committee (GTAC) was also established to advise on the ethical acceptability of proposals for gene therapy research on humans taking account of the scientific merits and the potential benefits and risks, and to advise on developments in gene therapy research. The lengthy hunt for the structure of the human genome accelerated as commercial interests united with the international programme led by the American National Institutes of Health. A draft structure for the entire genome was announced in June 2000 and the virtually complete mapping of the human genome was completed in April 2003, two years ahead of schedule. Breakthroughs in basic science sometimes feed through to major advances in clinical medicine as did microbiology at the end of the 19th century, and later imaging and immunology. Genetics is fundamentally concerned with the cause of disease. Some diseases are wholly genetic in origin, for example cystic fibrosis. Others are largely environmental, for example asbestosis. But many common conditions are a combination, for example coronary heart disease and asthma. Knowledge of the human genome seemed likely to underpin a further advance in clinical care. The development of pre-implantation genetic diagnosis (PGD) offered the possibility of ensuring that a new born child was not a carrier of some genetically determined diseases. In 2004, the Human Fertilisation and Embryology Authority (HFEA) that regulates the storage of eggs, sperm and embryos and reviews new developments in treatment and research, agreed to the use of PGD for assessing the risk of familial adenomatous polyposis. By 2006, in the USA, with a credit card and a few clicks of their computer mouse, consumers could organise a test for the BRCA1 or BRCA2 gene mutation or any of hundreds of other diagnostic assays, with or without involving their physician. Direct-to-consumer marketing of genetic testing and other laboratory services had arrived. Genetics offered the possibility of early identification of those people likely to become ill because some disorders of adult life are preceded by a prolonged presymptomatic period, for example vascular disease and diabetes, even though environmental and dietetic factors may play a larger role. This opened the possibility of predicting and preventing disease, instead of diagnosing and treating it at a later stage. Genetics also provided an insight into the cause of many diseases at a molecular level, making the transition from merely describing a disease to understanding its mechanism. Diseases previously thought of as one, could be separated into categories with a different origin - and therefore treatment. For example a computer algorithm designed to seek out those breast tumours that had the most similar genetic profiles, and cluster them together, revealed that 98 cancers fell into two main groups that could be recognised on the basis of the activity of 70 genes. A woman who possessed a “poor” 70-gene signature would be 15 times more likely to suffer a recurrence within five years than a woman who had a “good” genetic signature and the second group might possibly be spared aggressive chemotherapy with all its side effects. The possibility also existed of developing drugs with an appropriate therapeutic action. Genetics provided the pharmaceutical industry with a wealth of new targets against which to design drugs; suddenly the industry went from famine to feast’. In primary care as much as in the hospital service, an increasing number of conditions could now be seen in a genetic context.
Radiology and diagnostic imaging Imaging technology was increasingly central to accurate diagnosis, but was costly. The NHS, with its tradition of cost containment and late adoption of technology lagged behind western Europe. Digital radiographic systems continued to improve and images could be rotated, enlarged and manipulated in other ways, helping clinicians diagnose conditions more quickly and accurately. The filmless hospital was commonplace by the end of the decade The Department of Health’s Picture Archiving and Communications System (PACS) increasingly enabled images to be stored and mailed electronically rather than printed on film and filed manually, although professionals across the NHS might or might not be able to obtain images online from other units. . Computed tomography was developing rapidly. In the late eighties the rotation of the x ray source was combined with continuous movements of the table on which the patient was placed. Because the tube was rotating while the subject moved smoothly through the scanner, the x ray beam described a spiral pathway. This meant more rapid scans, closer spaced scans, and a scan within a single breath-hold, giving three-dimensional images. Images were better providing new applications for the imaging technique. For example, the colon could be viewed in exquisite detail. Next, multi-slice scanners were introduced with not one row of detectors, but up to eight. Image acquisition was even faster and a larger area could be covered. The newer scanners were inevitably more expensive, but there was a danger of rising radiation dosages. Magnetic Resonance Imaging was developed to be a rapid imaging tool for the whole body. Its ability to reveal skeletal spread of cancers, sometimes when no primary tumour had been found, made it particularly useful because radiation was avoided. Positron Emission Tomography (PET) was recognised as important for the accurate diagnosis of some cancers, and a national plan to increase its availability was launched. In 2000, Nutt and Townsend working first in Geneva and later in Pittsburgh, combined computerized tomography scanners (CAT) with positron emission tomography. The result was a single machine that could simultaneously image anatomical structure, for example cancerous tumours, and metabolic processes, reducing the time for a diagnosis and reducing patient discomfort. Conformational radiotherapy, which enabled accurate dosage to be given to precisely the required field even if it was irregular in shape, enabled higher doses to be given with less tissue damage and, hopefully, better outcomes. "Intensity modulated radiotherapy" enabled different doses to be administered to different parts of a tumour. Electron beam imaging was also under development. Progressive development of imaging systems also aided the development of minimal access surgery. Image-guided surgery used imaging systems during a surgical procedure to assist its performance. Magnetic resonance imaging was the best technique, but it had not been practical because the machines had been fully enclosed. The first truly open scanner was installed in Boston in 1994, but in 1999 one was installed at St. Mary's Paddington. Surgeons had full access to any part of the patient's body, while simultaneously that part was scanned. Endoscopic views could be combined with MRI images, and important structures could be identified and safeguarded during surgery. Surgeons and surgery figured frequently in the medical issues covered by the media. Sir Barry Jackson, when President of the Royal College of Surgeons, was frequently seen on TV, providing quiet and thoughtful comment on cases of clinical misadventure, for example Bristol. Cosmetic surgery was becoming a growth industry, and in some circles an obsession. Both in the UK and the US the demand was growing rapidly. In 2001, over 13,400 patients were registered as having had a breast implant. The most common reason was cosmetic augmentation (77% of total). The NHS was providing, if anything, less of a service and therefore less training for young surgeons, the private sector mushroomed. Professionally, the main controversy was who should be regarded as qualified and competent to carry out plastic surgery, for some of those operating were clearly lacking appropriate skills. The use of botulinum toxin (botox) to reduce wrinkles was popular; in the US it was approved by the Food and Drugs Administration for the removal of wrinkles and Botox parties were commonplace. In the UK |