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At the ESCD congress held in Manchester in 2016, a session was organized to encourage more dialogue between clinicians with expertise in skin sensitization and toxicologists seeking to provide effective risk assessment to prevent human health issues. That session focused on the remaining uncertainties regarding the induction and regulation of skin sensitization in humans, and the opportunities and challenges associated with the refinement and improvement of risk assessment methodologies. This short article, prompted by those discussions, debates what the authors regard as being among the most important and most intriguing uncertainties about skin sensitization and allergic contact dermatitis in humans, and the most significant opportunities for improving risk assessment. The aim has been to provide a basis for mapping out the areas that might benefit from a closer alignment between the relevant clinical community and toxicologists charged with the responsibility of ensuring that skin sensitization risks are understood and managed.

Although the development of successful vaccines against coronaviruses may be achieved, for some individuals the immune response that they stimulate may prove to be insufficient for effective host defence. The principle that a relatively strong contact allergen will have an enhancing effect on sensitisation to a less potent contact allergen if they are co‐administered, may not at first appear relevant to this issue. However, this augmentation effect is thought to be due to the sharing of common or complementary pathways. Here we consider briefly aspects of the shared and complementary pathways between skin sensitisation induced by exposure to a contact allergen and the immune response to viruses, with particular reference to Covid‐19. This relationship leads us to explore whether this principle, which we name here as ‘cooperative immune augmentation’ may extend to include viral vaccination. We consider evidence that even relatively weak contact allergens, used in vaccines for other purposes, can show enhanced sensitisation, which is in keeping with a cooperative augmentation principle. Finally, we consider how the potent contact allergen diphenylcyclopropenone could be employed safely as an enhancer of vaccine responses. This article is protected by copyright. All rights reserved.

Inflexible use of evidence hierarchies confuses practitioners and irritates researchers. So how can we improve the way we assess research?

An index of quality is a measurement like any other, whether it is assessing a website, as in today's BMJ ,1 a clinical trial used in a meta-analysis,2 or the quality of a life experienced by a patient.3 As with all measurements, we have to decide whether it measures what we want it to measure, and how well. The simplest measurements, such as length and distance, can be validated by an objective criterion. The earliest criteria must have been biological: the length of a pace, a foot, a thumb. The obvious problem, that the criterion varies from person to person, was eventually solved by establishing a fundamental unit and defining all others in terms of it. Other measurements can then be defined in terms of a fundamental unit. To define a unit of weight we find a handy substance which appears the same everywhere, such as water. The unit of weight is then the weight of a volume of water specified in the basic unit of length, such as 100 …

Current UK regulations deny free treatment for HIV to illegal immigrants and failed asylum seekers. Is this policy resulting in unjustifiable harm to infants who are born to infected mothers?

The government hopes that getting patients' views on their priorities for primary care will ensure support for its plans. It is likely to find patients care more about quality of care than structural or financial reform

For the past two decades coronary artery bypass grafting has been the standard treatment for patients with severe multivessel ischaemic heart disease.1 In the past few years, however, it has been increasingly challenged by percutaneous coronary intervention. Indeed, in many parts of the developed world percutaneous coronary intervention is done twice as often as coronary artery bypass grafting. Why has this change in practice occurred? I believe that it is not evidence based, does not represent best value for money, and that patients are not appropriately informed of its limitations. Coronary artery bypass grafting is probably the most intensively studied surgical procedure, with follow up data extending over 20 years.2 It is highly effective in relieving the symptoms of ischaemic heart disease and improving life expectancy in patients with certain anatomical patterns of disease; these benefits are magnified in patients with more severe disease and with impaired left ventricular function.1 Furthermore, coronary artery bypass grafting is remarkably safe. Improvements in medical, anaesthetic, and surgical management have ensured that hospital mortality has remained around 2% over the past decade despite the treatment being used in older and sicker patients.3 On the other hand, …

One day when Pooh Bear had nothing else to do, he thought he would do something, so he went round to Piglet's house to see what Piglet was doing. It was snowing as he stumped over the white forest track, and he expected to find Piglet warming his toes in front of the fire, but to his surprise he saw that the door was open, and the more he looked inside the more Piglet wasn't there.1.

Activist groups have been successful in promoting research and better treatment for people with HIV infection, but they can also stop trials if their views are not considered Methods to prevent HIV infection are one of the most urgent global public health needs.1 One novel method in clinical trials is pre-exposure prophylaxis with the antiretroviral drug tenofovir. The trials have, however, been criticised by activist groups, citing human rights, ethical concerns, and a lack of community involvement.2 This opposition and media coverage has stopped two trials in Cambodia and Cameroon and threatens the stability of planned and recruiting trials among intravenous drug users in Thailand and other developing nations. The issues raised by activists, academics, and the research community highlight the poor communication between these stakeholders and the need for mutual understanding of values. The differences threaten to undermine the progress of prevention trials and ultimately affect the most important stakeholders, those who are at risk.3 This protest at the 2004 International AIDS Society Conference helped stop the Cambodian tenofovir trialCredit: STR/AFP/GETTY IMAGES ### Cambodia The first randomised trial planned to assess the safety and efficacy of prophylactic tenofovir was in Phnom Penh, Cambodia. The study, funded by the US National Institutes of Health and the Bill and Melinda Gates Foundation, planned to recruit 960 sex workers and was led by researchers from the United States and Australia.3 In July 2004, activists mounted the first large demonstration against the trial at the Gilead booth at the International AIDS Society conference in Bangkok, a protest that captured the world's media attention.4 This protest, as well as local remonstration to the Ministry of Health in Cambodia, resulted in the Cambodian prime minister closing the trial before recruitment. The government has provided no official reasons for its decision. The primary …

Globally, we are producing more food than the population needs. Subsidising overproduction in Europe is affecting the health of people in both Africa and Europe Being overweight is becoming the norm rather than the exception in most developed countries, and obesity is a serious health problem worldwide.1 Many people see obesity as a lifestyle issue. However, behavioural interventions to prevent obesity in both adults and children have generally been ineffective,2 indicating strong influences beyond individual control. Considerable resources are currently invested in developing drugs to prevent and treat obesity. However, from a societal perspective, prevention of obesity through diet and physical activity should be given priority for both economic and ethical reasons.1 3 Chopra and DarntonHill recently suggested that we need a global strategy on food similar to the Framework Convention on Tobacco Control.4 Their suggested actions are mainly aimed at reducing demand for food. But we argue it is equally important to tackle the oversupply of food, driven by agricultural subsidies. The societal changes causing the worldwide increase in body mass index include mass production of heavily marketed, energy dense foods, globalisation of trade and taste, technological developments in the workplace, a sedentary lifestyle, and the reduction in active transport.5 6Improvements in agricultural productivity over the past decades have facilitated a massive increase in dietary energy intake. Actually, the main problem for the agricultural sector in many developed countries is overproduction.7 Several studies have suggested that overproduction of food followed by excessive consumption is the prime cause of the increase in body mass index in the United States and elsewhere.8 9 Continued subsidy to stimulate production of food through agricultural policy is therefore paradoxical. Obesity and associated noncommunicable diseases cause costs for health care and lost productivity, and overproduction in agriculture …

Rural African communities, especially those that are nomadic, often have poor access to health care. Collaboration with other services could help improve coverage Livestock contribute to the livelihood of at least 70% of the worlds' rural poor.1 In arid and semi-arid ecosystems of sub-Saharan Africa, livestock holders (mobile or settled pastoralists and agro-pastoralists) use vast grazing lands and residuals of crops that otherwise could not be used productively2 Yet, they are marginalised from development processes and vulnerable to exclusion from health services because of their geographical, social, and cultural environment. The weak infrastructure and quality of service in both the public health and veterinary sectors are closely related to resource constraints, especially lack of qualified staff.3 4 Therefore, professionals from the World Health Organisation and UN Food and Agriculture Organisation have suggested that public health and veterinary services should share resources.5 6 Few experiences of joint delivery of services to pastoral communities have been documented.7 We describe the implementation and effects of a joint project in Chad Veterinary services have a crucial role in controlling highly contagious diseases and zoonotic infections, which have implications for human health as well as that of livestock. However, in many contexts veterinary services could also contribute to the provision of essential public health interventions. This is particularly important in areas with unacceptably low health service coverage, as is often the case in rural settings of low income countries. One example of collaboration between public health and veterinary services is in providing child vaccination, one of the most cost effective health interventions, in developing countries.8 In southern Sudan, the Expanded Programme on Immunization shared cold chain equipment with the veterinary service,7 and the International Red Cross has implemented vaccination campaigns using veterinarians' vehicles (B Peterhans, personal communication). Similar …

Assessment of the cost effectiveness of interventions designed to achieve the millennium development goals for health is complex. The methods must be capable of showing the efficiency with which current and possible new resources are used, and incorporating interactions between concurrent interventions and the effect of expanding coverage on unit costs.1 They should also allow valid comparisons across a wide range of interventions. Here we describe how the standardised cost effectiveness methods used in the World Health Organization's Choosing Interventions that are Cost Effective (CHOICE) project have tackled these issues. The analysis was performed for 14 regions classified by WHO according to their epidemiological grouping (table A on bmj.com). The regional results (except if not relevant to the disease area, for example, malaria) are available at www.who.int/choice, but the papers in this series give details for just two regions: Afr-E, which includes countries in sub-Saharan Africa with high child mortality and very high adult mortality, and Sear-D, which comprises countries in South East Asia with high child and adult mortality.2–6 The term intervention is defined to include any preventive, promotive, curative, or rehabilitative action that improves health. Interventions are analysed individually and then in combinations or packages that could be undertaken together (box 1), taking into account interactions in costs or effectiveness, or both. Interventions were chosen for analysis either because they are commonly used or because disease control experts have advocated their introduction. In each case, some evidence was needed that the intervention could be effective. The list is not exhaustive, and excluding an intervention does not imply it is cost ineffective. All interventions and combinations are assessed assuming they are implemented for 10 years starting in 2000, the year the Millennium Declaration was signed. Good policy making would then require a reassessment of …

This article is the last in a series examining the cost effectiveness of strategies to achieve the millennium development goals for health

How can policy makers decide which of five treatments is the best? Standard meta-analysis provides little help but evidence based decisions are possible

Current calls for the removal of user fees respond to evidence of their regressive impacts and their role in enhancing social exclusion—but removal must be carefully managed because this action may have negative impacts on the wider health system User fees are once again a topic of hot policy debate in Africa. They were introduced relatively recently in many countries (box 1), but the current call is for their removal, particularly at primary care level.2 As analysts who have consistently argued against user fees, we broadly support this call. However, we recognise that this action cannot be introduced overnight and, if weakly implemented, may exacerbate the problems facing African health systems. We outline both why we believe African countries should move away from user fees, and what actions should accompany their removal to ensure that this policy change strengthens rather than undermines healthcare provision. Our suggestions are based on the experience of countries such as South Africa and Uganda that have already removed some or all fees, as well as wider experience of policy change. User fees are the most regressive form of healthcare financing available; they contribute to the unaffordable cost burdens imposed on poor households; and they represent one facet of the social exclusion experienced by these households. Out of pocket payments (which include user fees at public sector facilities) are more regressive than any other method of financing health care, capturing a higher proportion of income among poor households than wealthier ones.3 Thus, simply on the basis of the equity principle that those with the greatest ability to pay should make appropriately larger contributions, out of pocket payments are the least desirable way of financing health services. At primary care level, fees are relatively low. None the less, such fees can encourage inappropriate self treatment …

Over half of adults infected with HIV in Africa are female—but poverty and social structures still prevent many women from protecting themselves The United Nations millennium development goals have set out specific targets for 2015, including commitments to reduce extreme poverty, increase women's empowerment, and reverse the spread of the HIV pandemic. In this respect, they clearly recognise what has been called the triple threat facing Africa: poverty, gender inequalities, and HIV and AIDS.1 Tackling these issues is clearly difficult, and many people have greeted these goals with a sense of scepticism and even futility. We describe why tackling poverty and gender inequalities is central to controlling the HIV pandemic in Africa and suggest how it might be achieved. Two years ago, the UN secretary general Kofi Annan declared that “AIDS has a woman's face.”2 Echoing this statement, the Joint United Nations Programme on HIV and AIDS (UNAIDS) has highlighted women, girls, and HIV and AIDS as the theme for their most recent World AIDS Day campaign. Today, women account for nearly half the 40 million people living with HIV worldwide. In sub-Saharan Africa, 57% of adults with HIV are women, and young women aged 15 to 24 are more than three times as likely to be infected as young men.3 Contradictory analyses of Uganda's success in tackling HIV and AIDS have sparked debates over the relative prevention merits of promoting condoms, sexual fidelity, or abstinence. The United States has increased its funding for abstinence-only strategies, while the Catholic Church has questioned the efficacy of condoms, raising concerns about the influence of ideological or religious perspectives in shaping global priorities for prevention.4 Yet a larger question remains. Regardless of their point of emphasis, why are HIV prevention efforts continuing to fail women and girls? The prevention …

Low cost and effective drugs, such as magnesium sulphate, need to be included in initiatives to improve access to essential medicines in Africa Ensuring the availability of effective drugs for priority health problems remains a key public health issue in many African countries.1 Market deficiencies in ensuring drug development for “neglected” diseases affecting developing countries are well described,2 3 w1 and several global initiatives are attempting to tackle this.4 w2 Even when low cost, effective treatments exist, however, drug availability for many common health problems remains poor in many settings, limiting progress towards achieving the millennium development goals.5 One such health problem is the management of pre-eclampsia and eclampsia, important causes of maternal and infant morbidity and mortality. Over 63 000 women die annually after eclamptic convulsions, with 99% of these deaths occurring in low and middle income countries.6 7 w3 Evidence is strong for the effectiveness of magnesium sulphate in treating and preventing eclampsia.8–10 w4 w5 Magnesium sulphate costs $0.35 (£0.19; €0.29) per ampoule (40 ml of 10% magnesium sulphate; Central Medical Stores, Mozambique, April 2005) and has appeared on the World Health Organization's essential medicines list since 1996.11 It is of great concern that this effective and low cost drug is still unavailable in many countries.12 13 w6 w7 We describe problems with the registration, approval, acquisition, and distribution of magnesium sulphate, and hence its availability to clinicians, in Mozambique and Zimbabwe, two countries with high maternal mortality ratios (table).14–16 We draw on a range of sources, including a bibliographical review of policies concerning magnesium sulphate over the past 25 years and qualitative data collected as part of a case study of policy making and procurement for magnesium sulphate in the two countries (box …

Strengthening healthcare systems has been identified as central to Africa achieving global and regional development targets, including the millennium development goals. Lola Dare and Anne Reeler present case studies on issues that can contribute to improved integration and lead to better performance of health systems in Africa As Africa attempts to achieve ambitious millennium development goals, many critical challenges confront healthcare systems. In advancing towards these goals, African countries need to review and reform their healthcare delivery systems, and they need to devise innovative approaches to deal with daunting problems.1 2 Development of healthcare systems and improvement in health outcomes, based on investment in programmes focusing on specific diseases, continues to fragment health systems, leaving the basic infrastructure weak and incapable of delivering equitable, broad based services. There has been much discussion about integrating the primary, secondary, and tertiary tiers of the health system (the “front page”) but inadequate attention has been paid to identifying and strengthening the actions that are required to deliver the basic package of care (the “back office”) at each level of care. Low income countries in Africa face the daunting challenge of improving the performance of their healthcare systems, upgrading their health services to a level that will enable them to deliver services that are effective, efficient, and equitable. They need to build up capacity in a systematic manner, but financial and other constraints make it impossible for them to reproduce exactly the models from affluent developed countries. This paper identifies the main components of the back office that need to be developed and integrated to improve the performance of health systems and strengthen the delivery of healthcare services (box 1), and includes examples of the issues that arise. The physical components of the back office include the infrastructure and capital equipment. The needs …

Accusations of malpractice often end in the courts, damaging the doctor-patient relationship and encouraging defensive practice. In Mexico, an alternative system based on arbitration and conciliation has been effective

Using genetic variants as a proxy for modifiable environmental factors that are associated with disease can circumvent some of the problems of observational studies Epidemiologists look for modifiable causes of common diseases to improve population health. However, epidemiological studies may identify spurious “causes.” For example, the epidemiological findings that hormone replacement therapy protects against coronary heart disease,w1β carotene prevents lung cancer,w2and vitamin E and vitamin C reduce risk of cardiovascular diseasew3have all been refuted by randomised controlled trials and have raised concerns about the value of epidemiological studies.1 The misleading findings were probably due to confounding by behavioural, physiological, and socioeconomic factors related both to exposures and to disease end points.2 3 One solution to these problems is mendelian randomisation.4 5 Mendelian randomisation is a recent development in genetic epidemiology6 7 based on Mendel's second law that inheritance of one trait is independent of inheritance of other traits. It uses common genetic polymorphisms that are known to influence exposure patterns (such as propensity to drink alcohol) or have effects equivalent to those produced by modifiable exposures (such as raised blood cholesterol concentration). Associations between genetic variants and outcome are not generally confounded by behavioural or environmental exposures. This means that observational studies of genetic variants have similar properties to intention to treat analyses in randomised controlled trials (fig 1). Comparison of design of mendelian randomisation studies and randomised controlled trials The simplest way of appreciating the potential of mendelian randomisation is to consider applications of the underlying principles. The inferences that can be drawn from mendelian randomisation studies depend on the different ways in which genetic variants can proxy for environmentally modifiable exposures. ### Understanding effects of health related behaviours In observational studies, alcohol consumption is related to many known and unknown confounding factors; ill health …

Inequalities in health between rich and poor areas of Britain widened in the 1980s and 1990s, and the current government has repeatedly expressed its intention to reduce these inequalities. In this article, however, the authors report that inequalities in life expectancy have continued to widen, alongside widening inequalities in income and wealth, and argue that more potent and redistributive policies are needed

Decisions about the need for ethical review should be based on the morality of all actions rather than arbitrary distinctions between audit and research Ethical considerations should apply to all medical practice, but many people act as if they apply only to research. For example, all research studies have to be scrutinised by an ethics committee (institutional review board in the United States), but most ethics committees specifically exclude audit studies from their remit. Similarly, journal editors and funding agencies will require evidence of ethical review before accepting research for publication or funding but do not require this for audit studies. Consequently, the distinction between audit and research can have important implications, and the temptation to label research as audit is considerable.1 Unfortunately, the distinction is at best difficult. This article reviews the distinction between audit and research, and the nature of ethics. Research and audit have many similarities. They both start with a question, both expect the answer to change or influence clinical practice, both require formal data collection on patients, and both depend on using an appropriate method and design to reach sound conclusions. The standards expected of audit in terms of design, data collection, and analysis should be at least as high as for research, if only because audit potentially leads to change more often than research does and often much greater change. It is also clear that both audit and research differ from normal clinical practice because clinical practice rarely achieves a high standard of data collection and analysis. The major bureaucratic distinction drawn between audit and research is that research investigates what should be done, whereas audit investigates whether it is being done (and if not, why not).2 Guidance on making the distinction between audit and research is available,3 4 but the …

Disasters such as the recent tsunami, which derail development can no longer be viewed as short term blips from which society readily recovers The headline concern for the tsunami victims, living and dead, will be with us for a few weeks; by contrast, their need for assistance and reform will stretch over decades. Huge sums have been pledged in aid and a bold commitment made to build an Indian Ocean tsunami warning system. But, if past is precedent, only a fraction of recent pledges will materialise and the already overdue warning system will remain a pipe dream for the affected communities. The headlines rightly applaud the compassionate outpouring of the public around the world but fail to question the logic of promoting one-off giving from individuals rather than sustained involvement by governments. Disasters are part of normality, and if we are to have a longlasting effect we need to rethink the way aid is delivered and invest in development to help minimise the effects of natural phenomena. The pledging of $5bn (£2.6bn, €3.8bn) for survivors of the tsunami only three weeks after the event, is an impressive expression of global concern. The track record of delivering on such commitments, however, is anything but reassuring (table 1). Pledges fail to materialise for a host of reasons, some rational but some indefensible. Countries affected by disaster may have difficulty in absorbing huge aid flows quickly. Disasters destroy the infrastructure vital to delivering aid. Many of the civil servants, technicians, and local leaders who would normally carry out rehabilitation work may be killed in the disaster, as they were in the Rwandan genocide and the tsunami. View this table: Table 1 Disparity between pledging and delivery of aid after disasters Donors may attach conditions that make contributions difficult to use. These conditions may reflect a policy agenda (such …

The DOTS (“directly observed treatment, short course”) strategy has been successfully used in developing countries to provide effective control of tuberculosis. Field workers in Malawi are promoting the same approach for HIV infection through the expansion of highly active antiretroviral therapy

The potential benefits of linking tuberculosis control programmes with interventions to reduce smoking and indoor air pollution make research to improve our understanding of their relation a high priority

Although evidence for the effectiveness of evidence based medicine has accumulated, there is still little evidence on what are the most effective methods of teaching it.

The scarcity of resources in poorer countries means that ensuring health care is evidence based is particularly important. A group of workers active in the field describe their experiences of trying to do just that

Increasing numbers of countries are considering cost effectiveness in decisions about which drugs to make available for prescription. How do the different approaches work and is it time for standardisation?

Chronic conditions require careful management in patients who develop a life limiting illness. Doctors need to consider both the physical and psychological effects of treatment

Obesity seems to be perpetuated by a series of vicious cycles, which, in combination with increasingly obesogenic environments, accelerate weight gain and represent a major challenge for weight management

Economic evaluations in health and medicine usually ignore the possibility of future advances in treatment. But when technological innovation is rapid such considerations can have major implications

Commercial tests for herpes simplex virus are now widely available, and some experts have advocated screening. But can screening be ethical when false positive results occur, many infected people are asymptomatic, and no cure is available?

The current system of verifying and quantifying adverse reactions to new drugs is too disparate. Epidemiological studies for testing a hypothesis have a part to play in protecting the public from the harmful effects of new drugs

Understanding your study group is key to getting a good response to a questionnaire; dealing with the resulting mass of data is another challenge The first step in producing good questionnaire research is getting the right questionnaire.1 However, even the best questionnaire will not get adequate results if it is not used properly. This article outlines how to pilot your questionnaire, distribute and administer it; and get it returned, analysed, and written up for publication. It is intended to supplement published guidance on questionnaire research, three quarters of which focuses on content and design.2 Questionnaires tend to fail because participants don't understand them, can't complete them, get bored or offended by them, or dislike how they look. Although friends and colleagues can help check spelling, grammar, and layout, they cannot reliably predict the emotional reactions or comprehension difficulties of other groups. Whether you have constructed your own questionnaire or are using an existing instrument, always pilot it on participants who are representative of your definitive sample. You need to build in protected time for this phase and get approval from an ethics committee.3 During piloting, take detailed notes on how participants react to both the general format of your instrument and the specific questions. How long do people take to complete it? Do any questions need to be repeated or explained? How do participants indicate that they have arrived at an answer? Do they show confusion or surprise at a particular response—if so, why? Short, abrupt questions may unintentionally provoke short, abrupt answers. Piloting will provide a guide for rephrasing questions to invite a richer response (box 1). ![][1] #### Box 1: Patient preference is preferable I worked on a sexual health study where we initially planned to present the questionnaire on a computer, since we had read people were supposedly more comfortable “talking” to … [1]: /embed/graphic-1.gif

Media vilification of paediatricians acting in cases of alleged child abuse has resulted in widespread confusion about research data and threatens the systems to protect vulnerable children. How should we move forward?

Much new evidence has emerged on the importance of blood pressure as a risk factor for cardiovascular disease; the importance of lifestyle measures for the prevention and treatment of hypertension; the efficacy and safety of different drug classes; management of hypertension in groups at higher risk, including people with diabetes; the importance of assessing the total risk of cardiovascular disease; and additional benefits associated with the use of statins. Concern remains that national surveys continue to show substantial underdiagnosis, undertreatment, and poor rates of blood pressure control in the United Kingdom.1 A key reason for this is the predominant use of monotherapy by most doctors.1 To improve this suboptimal treatment, the British Hypertension Society recommends a treatment algorithm based on the AB/CD rule.2 Treatment of blood pressure alone will leave many hypertensive patients at unacceptably high risk of cardiovascular complications and death. This guideline reinforces the view that doctors should not focus solely on blood pressure but must also formally assess total risk of cardiovascular disease and use multifactorial interventions, including statins and aspirin, to reduce it. Most management of blood pressure and risk of cardiovascular disease will take place in primary care, and these guidelines are intended for general practitioners, practice nurses, and generalists in hospital practice. Detailed advice on implementation and the implications of the national service frameworks and the general medical services contract are contained in the full document (http://www.bhsoc.org/).3 These guidelines have been prepared by the guidelines working party of the British Hypertension Society on behalf of the society. The working party reviewed new data that have become available since the previous guidelines were published4 and amended the recommendations accordingly. Drafts of the full document were improved by consultation with …

The United States wants to increase senior citizens' access to prescription drugs at a time when spending on drugs is soaring. Is a national list of essential medicines the answer? Many elderly people in the United States have no insurance cover for prescription drugs. Currently, one in four elderly people in the United States limit their drug use because of cost.1 The US Congress recently passed a bill that partially subsidises prescriptions for elderly and disabled people while promoting their use of private health insurance plans. Previous efforts to provide drug benefits to this population have been unsuccessful, however, largely because it would be hugely expensive. One way to extend access to drugs while containing costs is to establish a limited or essential list of medicines. This article discusses the benefits of such an approach and barriers to implementation. One of the reasons that US drug spending is rising rapidly2 is shifting demographics. The group aged over 65 is one of the fastest growing parts of the population. This group tends to be more chronically ill and require more drugs. Another reason for the increase is the influx into the market of newer, more expensive drugs for many diseases. The proliferation of direct to consumer advertising may also be contributing to the rise in drug spending.2 The United States allows adverts in the broadcast media that encourage patients to talk to their doctors about trying brand name medicines. More money was spent in the year 2000 on direct to consumer advertising of the anti-arthritic drug Vioxx (rofecoxib) than was spent on advertising Pepsi, Budweiser beer, or Nike's top shoes.3 But pharmaceutical company spending on consumer advertising is only a small proportion of the promotional budget, most of which is still targeted at physicians.4 The industry …

A new classification system for adverse drug reactions based on time course and susceptibility as well as dose responsiveness should improve drug development and management of adverse reactions

In this article on the public perception of risks Paul Bellaby considers three examples of risks to children in the UK–an insignificant risk (autism caused by MMR vaccine), a real but probably small risk (vCJD from BSE), and a real and demonstrably larger risk (injuries from road crashes) and contrasts the perceptions of the risks by parents Science cannot prove a negative, but, where their children are concerned, parents want to be assured that risk is zero. Would establishing a comprehensive “Richter scale” of risks remove that misunderstanding? If not, then what accounts for miscommunication of risk and how might it be overcome? In this article I try to provide answers by considering public perception of three risks, each of a different order, all involving children: In 1998 Wakefield was the first to make the claim that autism and the MMR vaccine are linked.1 It is based on a dozen clinical cases of gastrointestinal disorders with which developmental regression seemed to be linked. They arose in previously normal children. His team found that eight of the 12 parents attributed the onset to the MMR vaccination. On a population level, diagnoses of autism increased rapidly from 1988, when MMR was introduced, and through the 1990s, not only in Britain but also in North America. Yet epidemiological studies have found no link between increasing numbers of diagnoses of autism and the introduction of MMR vaccine.2 3 The weight of scientific opinion is that the risk is insignificant. By contrast, there is both laboratory and epidemiological evidence for the transmission of BSE from cattle to humans. Consumption …

Effective communication of risk can improve both individual and national health, and there has been substantial investment in such communication. Has this yielded the anticipated improvements in health?

Each year about 0.5% of the total population in Botswana, Ethiopia, Tanzania, Uganda, and Zimbabwe die from HIV/AIDS or cancer. The members of a WHO project to improve palliative care in these countries discuss their work. The greatest needs of terminally ill patients were for adequate pain relief, accessible and affordable drugs, and financial support to counter the loss of income of both patient and family caregiver. Special emphasis should be given to home based palliative care provided by trained family and community caregivers to counteract the severe shortage of professional healthcare workers

Many health problems require international action, but getting governments to agree on strategies for prevention or treatment is difficult. By making use of scientific evidence on the effects of tobacco, the member states of WHO have negotiated their first global health treaty. If the treaty can be implemented effectively, it could act as a possible model for tackling other health issues When Dr Gro Harlem Brundtland became director general of the World Health Organization in 1998, she clearly stated that the tobacco epidemic should be tackled by an international collective action and that WHO should take a leadership role.1 In 1999, WHO started work on the WHO Framework Convention on Tobacco Control, which was endorsed by member states on 21 May 2003. It is the first time WHO has used its constitutional authority in global public health to develop a legal instrument aimed at improving population health. The initiation and negotiation of the framework convention was based strongly on the accumulation of scientific evidence.2 We review the development and scientific basis of the convention and discuss its implications and the potential of international collective action against threats to global public health. The structural basis for framework conventions is to use an incremental process in making law. It begins with a framework convention that establishes a general consensus on the relevant facts and the system of governance for an issue. This is followed by the development of more specific commitments and institutional arrangements in subsequent protocols.3 However, depending on the political will, framework conventions can also include quite specific provisions. In the case of the WHO Framework Convention on Tobacco Control, the powerful political momentum behind the treaty has ensured that several detailed provisions have been incorporated into the final text.4 The framework convention is the first …

Despite worldwide efforts to prevent HIV infection, the number of people affected continues to rise. The authors of this article argue that a commonsense approach based on simple country by country analyses could improve the situation

The rapid spread of HIV in sub-Saharan Africa is one of the greatest failures in the history of public health. Given our detailed understanding of HIV and the natural course of AIDS, the virus should have been controllable. Yet in some African countries 20% of people aged over 15 are HIV positive and 70% of them will eventually die from AIDS.1 India shares some of the same risk factors as Africa, including a similar pattern of health expenditure, an uneven health infrastructure, and prevalent high risk sexual behaviours (table A, bmj.com).2 By 2010 the number of HIV infections in India is predicted to rise from 4 million to 20–25 million1–3 We discuss 10 important lessons from Africa that could limit the spread of HIV in India. The views expressed in this paper are based on current literature reviews, economic analyses of the Berkeley International Group (http://big.berkeley.edu/), and extensive personal experience working on HIV, reproductive health, programme management, and international finance. HIV infection begins in the core groups of commercial sex workers, intravenous drug users, and men who have sex with men (table B, bmj.com). Mathematical models show both the benefits of early intervention and the importance of focusing on these core groups.4–7 India remains a traditional society: its laws forbidding homosexuality derive from British legislation in the 19th century,8 and the sex industry relies on bribing the police to operate. The high risk groups are outside the political, social, and economic mainstream. Leaders must overcome prejudice and be prepared to include these groups in designing well funded programmes. Poverty is a major contributor to the spread of HIV and thus considered an important focus for preventive programmes. However, the prevalence of HIV can double within high risk groups in six …

Many medical journals have a substantial income from pharmaceutical companies from the purchasing of advertising and reprints and the sponsoring of supplements. Is this funding corrupting journals?

In 1981 an influential Japanese study showed an association between passive smoking and lung cancer. This article documents the tobacco industry's attempts to refute this study by producing a credible alternative study In 1981 Japanese investigator Takeshi Hirayama published a cohort study examining the association of passive smoking and lung cancer among non-smoking wives of smokers in Japan.1 The study concluded that wives of heavy smokers had up to twice the risk of developing lung cancer as wives of non-smokers and that the risk was dose related. The Hirayama study was influential because it launched an extraordinary amount of critical debate 2 3 and has been one of the most frequently cited studies in regulatory proceedings, 4 5 risk assessments,6 and the media.7 The tobacco industry has used a variety of tactics to maintain scientific debate about whether secondhand smoke has any harmful effects. 5 6 8–14 We identify and analyse internal tobacco industry documents that describe the industry's response to the Hirayama study. #### Summary points The tobacco industry generated a study, the “Japanese spousal study,” in an attempt to refute the findings of a 1981 cohort study showing an association between secondhand exposure to tobacco smoke and lung cancer Internal tobacco industry documents describe how the tobacco industry considered multiple strategies to conceal its involvement in the Japanese spousal study The tobacco industry considered funding the study through the Center for Indoor Air Research, a research organisation supported by the tobacco industry, in order to hide industry involvement The parties involved in conducting the study included a tobacco industry scientist, a tobacco industry consultant, an industry law firm, and two Japanese investigators. The consultant was the sole author of the final publication We retrieved documents from the Legacy Tobacco Documents Library (www.legacy.library.ucsf.edu/) and tobacco industry websites …