The ethics of HIV research in developing nations

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo-control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta-ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.     

Developing drugs for the developing world: an economic,legal, moral,and political dilemma

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of economic, social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on (1) the prospects for a reasonable profit and (2) the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry's efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying.     

United States patent prior art rules and the neem controversy: a case of subject-matter imperialism?

A recent United States patent covering an improvement to the naturally-occurring pesticide in neem tree seed oil might have been rejected as 'obvious' if United States patent law recognized certain forms of prior inventive activity on a par with similar activity occurring within the United States' borders. But the US only recognizes prior 'knowledge, use or invention' as blocking a claim to a patent when those activities take place within US borders, or are evidenced by publications accessible in the US, or, more commonly, by foreign patents. Neither of these last forms of tangible 'prior art' is likely to be available to block patents on biodiversity inventions – most notably because of the fact that most developing nations do not allow patents on pharmaceutical or agricultural inventions, categories subsuming most biodiversity-related advances. Although the United States patent only has direct force within the United States, it is nonetheless highly significant to this global dispute, since the United States and other developed nations stand to be the major markets for the end-products of neem. This paper argues that the border-drawing distinctions in US patent law are archaic, counter to stated policy directives and are disproportionately influencing the developing world's stance towards GATT and its intellectual property rights provisions.     

IMPROVING GLOBAL HEALTH: COUNTING REASONS WHY

This paper examines cumulative ethical and self-interested reasons why wealthy developed nations should be motivated to do more to improve health care in developing countries. Egalitarian and human rights reasons why wealthy nations should do more to improve global health are that doing so would (1) promote equality of opportunity, (2) improve the situation of the worst-off, (3) promote respect of the human right to have one's most basic needs met, and (4) reduce undeserved inequalities in well-being. Utilitarian reasons for improving global health are that this would (5) promote the greater good of humankind, and (6) achieve enormous benefits while requiring only small sacrifices. Libertarian reasons are that this would (7) amend historical injustices and (8) meet the obligation to amend injustices that developed world countries have contributed to. Self-interested reasons why wealthy nations should do more to improve global health are that doing so would (9) reduce the threat of infectious diseases to developed countries, (10) promote developed countries' economic interests, and (11) promote global security. All of these reasons count, and together they add up to make an overwhelmingly powerful case for change. Those opposed to wealthy government funding of developing world health improvement would most likely appeal, implicitly or explicitly, to the idea that coercive taxation for redistributive purposes would violate the right of an individual to keep his hard-earned income. The idea that this reason not to improve global health should outweigh the combination of rights and values embodied in the eleven reasons enumerated above, however, is implausibly extreme, morally repugnant and perhaps imprudent.     

Putting placebo‐controlled trials in developing countries to the interpersonal justifiability test

This paper considers the ethics of placebo‐controlled trials in developing countries, where a treatment already exists but is not available due to the low local standard of care. Such trials would not be permitted in more developed nations where a higher standard of care is available. I argue that there are moral intuitions against such trials, but a further intuition that if the trials were aimed at producing treatment options for the developing world, that would be more permissible than if the trials were designed with the benefit of rich world people in mind. An approach based upon GA Cohen's work on interpersonal justifiability is suggested to allow us to explain these intuitions. Cohen's framework shows that these trials are ethically problematic because the inequality in healthcare provision between developing and developed nations that allows them to take place is at least partly the pharmaceutical corporations’ fault. Following Cohen's argument, this means the trials are non‐comprehensively justified. This allows for a more complete explanation of our intuitions than to consider such trials as cases of exploitation, because intuitions on the ethicacy of research can vary even when the exploitation relation remains the same. It is then established that there is good empirical evidence to believe that pharmaceutical corporations do fail the interpersonal justifiability test. The policy implications of this judgement are then considered, and it is suggested that the framework might be equally applicable to examining the permissibility of research conducted on vulnerable people within more developed nations.     

Population aging and international development: addressing competing claims of distributive justice

To date, bioethics and health policy scholarship has given little consideration to questions of aging and intergenerational justice in the developing world. Demographic changes are precipitating rapid population aging in developing nations, however, and ethical issues regarding older people's claim to scarce healthcare resources must be addressed. This paper posits that the traditional arguments about generational justice and age-based rationing of healthcare resources, which were developed primarily in more industrialized nations, fail to adequately address the unique challenges facing older persons in developing nations. Existing philosophical approaches to age-based resource allocation underemphasize the importance of older persons for developing countries and fail to adequately consider the rights and interests of older persons in these settings. Ultimately, the paper concludes that the most appropriate framework for thinking about generational justice in developing nations is a rights-based approach that allows for the interests of all age groups, including the oldest, to be considered in the determination of health resource allocation.     

The Development of Nematology on a World Basis

Nematology on a world basis has experienced phenomenal growth during the last 25 years. Major influences responsible for this growth are discussed. Education of nematologists has been most evident in only a few developed nations. Some developing countries are now beginning to train nationals as nematologists. Research programs in developed countries are more intensive than in developing nations, largely because of available resources and priorities given to solving nematological problems. Developed nations have been able to take advantage of technological advances almost immediately, whereas in developing nations the lack of resources and constraints imposed by certain social or political conditions has made this difficult. Indications are that emphasis in training nematologists in developed countries may have reached a plateau, while in developing nations provisions for training and research are on the increase.     

Questionable Gate-keeping: Scientific Evidence for Complementary and Alternative Medicines (CAM): Response to Malcolm Parker

The more popular complementary and alternative medicine (CAM) has become, the more often it is demanded that the integration of CAM should be limited to those approaches that are scientifically proven to be effective. This paper argues that this demand is ethically and philosophically questionable. The clinical legitimacy being gained by CAM and its increasing informal integration should instead caution against upholding the biomedical framework and evidence-based medicine as conditions of acceptance. Patients’ positive experiences with CAM deserve a truly scientific exploration of non-biomedical conceptualizations of health and illness. It is also problematic to request scientific evidence when there is proven resistance against CAM in research institutions, under-funding and a lack of suitable research methodologies. This is even more so, when much conventional medicine is not practiced with the same level of evidence as demanded from CAM.     

Bioethics and practical justice in the post‐COVID‐19 era

The ethical concept of justice, as it relates to the development and deployment of innovative health technologies, commands the fair and equitable distribution of burdens and benefits. In bioethics, specific guidance on practical strategies for achieving what this concept of justice demands are somewhat elusive. Drawing on issues of justice arising or likely to arise in the context of the search for a vaccine or cure for COVID‐19, this paper argues for a focus on the concept of “practical justice” in post‐pandemic bioethics work. To illustrate the value and promise of this concept, the paper reflects on an approach to achieving practical justice in health biotechnology research that is grounded in a commitment to offer technical assistance to developing and under‐resourced nations.     

Systemic Negligence: Why It Is Morally Important for Developing World Bioethics

In the context of clinical and non‐clinical biomedical practices, negligence is usually understood as a lapse of a specific professional duty by a healthcare worker or by a medical facility. This paper tries to delineate systemic negligence as another kind of negligence in the context of health systems, particularly in developing countries, that needs to be recognized and addressed. Systemic negligence is not just a mere collection of stray incidences of medical errors and system failures in a health system, but is proposed in this paper as a more pervasive kind of neglect. Several non‐medical factors, such as lack of social and political will, also contribute to it and hence is more difficult to address in a health system. This paper argues that recognizing systemic negligence and including it research agenda have special moral importance for researchers in developing world bioethics, public health ethics and for health activists in the developing world. For, it can be a potent health system barrier, and can seriously impair efforts to ensure patient safety, particularly in the weaker health systems. As it erodes accountability in a health system, addressing it is also important for the twin goals of ensuring patient safety and improving health system performance. Above all, it needs to be addressed because the tolerance of its persistence in a health system seems to undervalue health as a social good.     

Leveraging genetic ancestry to study health disparities

Research to understand human genomic variation and its implications in health has great potential to contribute in the reduction of health disparities. Biological anthropology can play important roles in genomics and health disparities research using a biocultural approach. This paper argues that racial/ethnic categories should not be used as a surrogate for sociocultural factors or global genomic clusters in biomedical research or clinical settings, because of the high genetic heterogeneity that exists within traditional racial/ethnic groups. Genetic ancestry is used to show variation in ancestral genomic contributions to recently admixed populations in the United States, such as African Americans and Hispanic/Latino Americans. Genetic ancestry estimates are also used to examine the relationship between ancestry-related biological and sociocultural factors affecting health disparities. To localize areas of genomes that contribute to health disparities, admixture mapping and genome-wide association studies (GWAS) are often used. Recent GWAS have identified many genetic variants that are highly differentiated among human populations that are associated with disease risk. Some of these are population-specific variants. Many of these variants may impact disease risk and help explain a portion of the difference in disease burden among racial/ethnic groups. Genetic ancestry is also of particular interest in precision medicine and disparities in drug efficacy and outcomes. By using genetic ancestry, we can learn about potential biological differences that may contribute to the heterogeneity observed across self-reported racial groups.     

The Unknown Role of Mental Health in Global Development

In this paper, the author contrasts the substantial impact of mental health problems on global disability with the limited attention and resources these problems receive. The author discusses possible reasons for the disparity: Compared to physical disorders, mental health problems are considered less important, perhaps due to lower priority of disorders that primarily cause dysfunction rather than mortality, and skepticism that mental disorders are treatable in low-resource countries. He argues that achieving improved global health and development requires addressing problems causing disability, particularly mental health problems among populations in which the common mental disorders are frequent due to deprivation, war, and disasters. The author contends that services addressing the common mental disorders could be made widely and relatively cheaply accessible if provided by non-professional workers at the community level.     

Ethics of clinical research in the developing world

Many commentators believe that all clinical-trial participants must receive a level of care equivalent to the world's best. Using HIV/AIDS research as an example, we show how this 'Uniform Care Requirement' can undermine biomedical research aimed at improving global health, and then we point towards a more rational and balanced approach to ethical assessment.     

Justice in international clinical research

Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines.     

Moral agency,moral worth and the question of double standards in medical research in developing countries

International regulations governing medical research, healthcare and medical practice, are, obviously, meant to be guidelines and not detailed procedural rules of thumb that can be applied unreflectively without any danger of doing moral wrong. Moreover, such regulations are meant to apply internationally, and no set of straight-jacketed rules of thumb can conceivably apply to all societies and communities of the world, extremely diverse and differently situated as they are. The mark of a good international guideline or regulation, in my view, is that it should provide a clear principle of action that applies equally to all global communities and societies without seeking to foist the particular or momentary moral dilemmas, quandaries, obsessions and preoccupations of some on all. In this paper, I propose to argue that, because moral obligations are obligations only from the point of view of a particular moral agent, we should avoid making the peculiar problems of any particular moral agent(s) the obsessive concern of all moral agents, and that we need, in particular, to make appropriate distinctions between the ethics of developed world research in the developing world, collaborative or cooperative research between the developed and developing worlds, developed world research in the developed world and developing world research in the developing world. A consequence of looking at things this way is that, while it should be clear that there are ethical concerns, imperatives and obligations at all levels, different standards may and, in fact, cannot but be applied in different contexts at different levels, without resorting to the use of double standards, which can never be morally justified. Finally, I venture to propose a formula for a solemn pledge of moral integrity and noble intent, from the perspective of the agent, that is to say, the investigator, sponsor and funder of any research, to complement and balance the widely accepted informed consent requirement, from the perspective of the patient, the subject of any biomedical research.     

Past and future trends in cancer and biomedical research: a comparison between Egypt and the World using PubMed-indexed publications

ABSTRACT: BACKGROUND: PubMed is a free web literature search service that contains almost 21 millions of abstracts and publications with almost 5 million user queries daily. The purposes of the study were to compare trends in PubMed-indexed cancer and biomedical publications from Egypt to that of the world and to predict future publication volumes. METHODS: The PubMed was searched for the biomedical publications between 1991 and 2010 (publications dates). Affiliation was then limited to Egypt. Further limitation was applied to cancer, human and animal publications. Poisson regression model was used for prediction of future number of publications between 2011 and 2020. RESULTS: Cancer publications contributed 23% to biomedical publications both for Egypt and the world. Egyptian biomedical and cancer publications contributed about 0.13% to their world counterparts. This contribution was more than doubled over the study period. Egyptian and world's publications increased from year to year with rapid rise starting the year 2003. Egyptian as well as world's human cancer publications showed the highest increases. Egyptian publications had some peculiarities; they showed some drop at the years 1994 and 2002 and apart from the decline in the animal: human ratio with time, all Egyptian publications in the period 1991-2000 were significantly more than those in 2001-2010 (P<0.05 for all). By 2020, Egyptian biomedical and cancer publications will increase by 158.7% and 280% relative to 2010 to constitute 0.34% and 0.17% of total PubMed publications, respectively. CONCLUSIONS: The Egyptian contribution to world's biomedical and cancer publications needs significant improvements through research strategic planning, setting national research priorities, adequate funding and researchers' training.     

Comforting the (exile) afflicted in Croatia--around and beyond the analytical approaches of critical medical anthropology

Recently, there has been a growing recognition that any research conducted with those that suffer should definitely be critical of the continuing policy of group equalizing, either in relation to ones ethnicity or any other salient parameter. However, it is seldom that this critical knowledge is applied from "outsiders" when a negation and re-evaluation of history, especially concerning the medical systems and their historical development within nations and populations, is used. The propositions within this paper are given on the basis of knowledge gained in the course of a long-term study dedicated to the exiled in Croatia, and are tightly linked to theoretical perspectives of critical medical anthropology, yet exceed its limits. Critical medical anthropologists deeply engage in ongoing debates that stress how there needs to be more understanding of the necessity to study the wider social context of any population we approach and analyze. However, the knowledge about wider social contexts is unachievable without the new grounds of dialogue being created between professionals and researchers of all disciplines and equally--regardless whether they are "insiders" or "outsiders" to the problem in focus. The knowledge about developments in developing countries, and especially of countries in post-war transition cannot be solely built on strategies of globality and theoretical explorations disconnected from people and their experiences on ground, especially when they concern the delicate issues of social and health care. Hopingly, the given examples in this paper will add to dialogues of corrective kind that should be raised more often.     

Linking bioprospecting with sustainable development and conservation: the Panama case

The limited international resources for economic aid and conservation can only mitigate poverty and losses of biodiversity. Hence, developing nations must establish the capacity to resolve their problems. Additionally, policy-makers and donors need to obtain scientific input on issues such as global change and ecosystem services. We propose that for nations rich in biodiversity, ecosystem services derived from bioprospecting, or drug discovery, could contribute to economic development. In the case where unstudied samples are shipped abroad for research, the chances of obtaining royalties are infinitesimally small. Therefore developing nations will only realize benefits from bioprospecting through in-country research on their own biodiversity. Policy-makers and donors have failed to appreciate the value of this approach. In order to provide an example of the inherent links between conservation and sustainable economic development, we initiated a drug discovery effort in Panama that emphasizes local benefit. As much of the drug discovery process as possible is conducted in Panamanian laboratories, providing jobs dependent on intact biodiversity and enhancing local research and training. In short, research, plus the spin-offs from research, provide immediate and long-lasting benefits to Panama. The connection between conservation and development has been highlighted in publicity about the project in Panama’s urban media. This provides a constructive alternative to the perception the among the urban populace that economic development inevitably competes with conservation. In summary, our program uses biodiversity to promote human health as well as to support research capacity, economic development and conservation within Panama. The program provides an example of the widely recognized but little developed concept of bioprospecting research as an ecosystem service.     

"Taming tradition": medicalized female genital practices in western Kenya

This article considers the question of female genital practices at the hands of health workers in western Kenya. Recent articles in Medical Anthropology Quarterly have critically engaged with the biomedical arguments condemning such practices. This article studies the case of medicalized circumcision in which biomedical concerns over health risks have become incorporated in their vernacular practice. Although some suggest that medicalization may provide a harm-reduction strategy to the abandonment of the practice, research in one region challenges this suggestion. It argues that changing and conflicting ideologies of gender and sexuality have led young women to seek their own meaning through medicalized practice. Moreover, attributing this practice to financial motivations of health workers overlooks the way in which these "moral agents" must be situated within their social and cultural universe. Together, these insights challenge the view that medicine can remain neutral in the mediation of tradition.     

Schools for health: Focus on health, education and the school-age child

Mortality in children under five years old has been dramatically reduced through successful programmes of immunization and control of diarrhoeal diseases. UNICEF estimates that some 90% of children in developing regions now survive to reach school age. These survivors face new and continuing threats to their health, which can affect their physical development and may also prevent them taking full advantage of their only opportunity for formal education. The physical and mental growth of the 1000 million school-age children today will influence how the world is shaped for coming generations. Yet the health problems of this age group have received little attention. Recognizing the importance of this age group, a workshop funded by the Edna McConnell Clark Foundation was held 10-13 November 1994 in Fort Mitchell, Kentucky, USA, to review what is known about the health of school-age children, what is or can be done to improve their health, and what steps must be taken to find ways to improve the health and educational achievement of this important segment of the world's population. Don Bundy and Helen Guyatt here report on the workshop, which had three major conclusions: (1) the school-age children of developing countries face health problems that remain neglected and poorly understood; (2) an important research need is to develop simpler means of monitoring the health status of school-age children and evaluating the impact of public health interventions in this age group; and (3) two strategies are available to address this public health problem. The first is to develop further and test programmes that appear, from available evidence and pilot studies, to offer effective means of improving the health of this age group at reasonable cost, and to be sustainable; and the second is, over a longer term, to develop the capacity within countries to assess the health problems of school-age children and devise cost-effective strategies to address these problems. This report attempts, in brief form, to survey what is known about the health status of school-age children, to discuss the possible benefits to health and learning that accrue from health interventions, and to suggest some avenues currently available for both research and application.