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The World Health Organization estimated that in 1999 roughly one-third of the world's population lacked access to essential medicines that would have saved or improved their lives. Our analysis focuses on how pharmaceutical product patents restrict access to essential medicines in developing countries. It is well established that pharmaceutical product patents provide little incentive for pharmaceutical companies to develop new medicines designed to treat diseases prevalent in developing countries or to market in developing countries those patented medicines developed to treat diseases prevalent in developed countries. Economists have developed theoretical models showing that these incentives could be changed if (1) developing countries provided intellectual property protection for new pharmaceutical innovations and (2) an international regulatory framework were established to facilitate pharmaceutical companies setting lower prices in developing countries and higher prices in developed countries for patented medicines. We develop an index of property rights in pharmaceutical innovations covering 129 countries from 1960 to 2005. It shows that in 1960 only a handful of countries provided significant protection for pharmaceutical innovations, but by 2005 over 95 percent of countries in our sample provided significant statutory protections. However, an international framework to allow pharmaceutical companies to price discriminate has not been put in place. We conclude that international price discrimination mechanisms, compulsory patent licenses, and regional patent buyouts are not viable mechanisms for providing access to essential medicines to patients in developing countries. Global patent buyouts are more likely to achieve this goal, as they are not founded on an impractical separation of pharmaceutical markets in developing and developed countries and they provide critical incentives to develop new essential medicines.

Much of the discussion surrounding the antivaccine movement focuses on the decision of parents to not vaccinate their children and the resulting danger posed to others. However, the primary risk is borne by the child left unvaccinated. Although living in a developed country with high vaccination rates provides a certain amount of protection through population immunity, the unvaccinated child is still exposed to a considerably greater risk of preventable diseases than one who is vaccinated. I explore the tension between parental choice and the child’s right to be free of preventable diseases. The chapter’s goal is twofold: to advocate for moving from a dyadic framework – considering the interests of the parents against those of the state – to a triadic one, in which the interests of the child are given as much weight as those of the parent and the state; and to discuss which protections are available, and how they can be improved. Specific legal tools available to protect that child are examined, including tort liability of the parents to the child, whether and to what degree criminal law has a role, under what circumstances parental choice should be overridden, and the role of school immunization requirements in protecting the individual child.

This study analyzes the rise of genome instability in the life sciences and traces the problematic of instability as it relates to the sociology of health. Genome instability is the study of how genomes change and become variable between generations and within organisms over the life span. Genome instability reflects a significant departure from the Platonic genome imagined during the Human Genome Project. The aim of this chapter is to explain and analyze research on copy number variation and somatic mosaicism to consider the implications of these sciences for sociologists interested in genomics.

This chapter draws on two multi-sited ethnographies of contemporary biomedical science and literature in the sociology of health, science, and biomedicine to document a shift in thinking about the genome from fixed and universal to highly variable and influenced by time and context.

Genomic instability has become a framework for addressing how genomes change and become variable between generations and within organisms over the life span. Instability is a useful framework for analyzing changes in the life sciences in the post-genomic era.

Genome instability requires life scientists to address how differences both within and between individuals articulate with shifting disease categories and classifications. For sociologists, these findings have implications for studies of identity, sociality, and clinical experience.

This is the first sociological analysis of genomic instability. It identifies practical and conceptual implications of genomic instability for life scientists and helps sociologists delineate new approaches to the study of genomics in the post-genomic era.

This chapter reviews factors responsible for climate change, impacts of the change on animal health, zoonotic diseases, and their linkage with One-Health program.

This chapter is based on the available literature related to climate change and its effect on animal health and production from different points. The causes and change forcers of climate change, direct and indirect effects of the change on animal health management, host–pathogen–vector interaction, and zoonotic diseases are included. Inter-linkage between climate change and One-Health program are also assessed.

Beside natural causes of climatic change, greenhouse gases are increasing due to human activities, causing global climate changes which have direct and indirect animal health and production performance impacts. The direct impacts are increased ambient temperature, floods, and droughts, while the indirect are reduced availability of water and food. The change and effect also promote diseases spread, increase survival and availability of the pathogen and its intermediate vector host, responsible for distribution and prevalence of tremendous zoonotic, infectious, and vector-borne diseases. The adverse effect on the biodiversity, distribution of animals and micro flora, genetic makeup of microbials which may lead to emerging and re-emerging disease and their outbreaks make the strong linkage between climate change and One-Health.

Global climate change is receiving increasing international attention where international organizations are increasing their focus on tackling the health impacts. Thus, there is a need for parallel mitigation of climate change and animal diseases in a global form.

Most research on climate change is limited to environmental protection, however this chapter provides a nexus between climate change, animal health, livestock production, and the One-Health program for better livelihood.

This chapter proposes an optimized innovative information technology as a means for achieving operational functionalities of real-time portable electronic health records, system interoperability, longitudinal health-risks research cohort and surveillance of adverse events infrastructure, and clinical, genome regions – disease and interventional prevention infrastructure. In application to the Dod-VA (Department of Defense and Veteran's Administration) health information systems, the proposed modernization can be carried out as an “add-on” expansion (estimated at $288 million in constant dollars) or as a “stand-alone” innovative information technology system (estimated at $489.7 million), and either solution will prototype an infrastructure for nation-wide health information systems interoperability, portable real-time electronic health records (EHRs), adverse events surveillance, and interventional prevention based on targeted single nucleotide polymorphisms (SNPs) discovery.

Big Data analysis is one of the key challenges to the provision of health care to emerge in the last few years. This challenge has been spearheaded by the huge interest in the “4Ps” of health care (predictive, preventive, personalized, and participatory). Big Data offers striking development opportunities in health care and life sciences. Healthcare research is already using Big Data to analyze the spatial distribution of diseases such as diabetes mellitus at detailed geographic levels. Big Data is also being used to assess location-specific risk factors based on data of health insurance claims. Other studies in systems medicine utilize bioinformatics approaches to human biology which necessitate Big Data statistical analysis and medical informatics tools. Big Data is also being used to develop electronic algorithms to forecast clinical events in real time, with the intent to improve patient outcomes and thus reduce costs.

Yet, this Big Data era also poses critically difficult ethical challenges, since it is breaking down the traditional divisions between what belongs to public and private domains in health care and health research. Big Data in health care raises complex ethical concerns due to use of huge datasets obtained from different sources for varying reasons. The clinical translation of this Big Data is thus resulting in key ethical and epistemological challenges for those who use these data to generate new knowledge and the clinicians who eventually apply it to improve patient care.

Underlying this challenge is the fact that patient consent often cannot be collected for the use of individuals’ personal data which then forms part of this Big Data. There is also the added dichotomy of healthcare providers which use such Big Data in attempts to reduce healthcare costs, and the negative impact this may have on the individual with respect to privacy issues and potential discrimination.

Big Data thus challenges societal norms of privacy and consent. Many questions are being raised on how these huge masses of data can be managed into valuable information and meaningful knowledge, while still maintaining ethical norms. Maintaining ethical integrity may lack behind in such a fast-changing sphere of knowledge. There is also an urgent need for international cooperation and standards when considering the ethical implications of the use of Big Data-intensive information.

This chapter will consider some of the main ethical aspects of this fast-developing field in the provision of health care, health research, and public health. It will use examples to concretize the discussion, such as the ethical aspects of the applications of Big Data obtained from clinical trials, and the use of Big Data obtained from the increasing popularity of health mobile apps and social media sites.

This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.