A Bioethics Tool for the Implementation of Global Principles by the Pharmaceutical Industry

Due to scandals of scientific misconduct, a climate of mistrust of science exists amongst the general public. This becomes of concern when we acknowledge that it is difficult for science and technology to flourish without broad societal trust. The pharmaceutical industry has often felt the brunt of such mistrust and has suffered many reputational setbacks over the past several years. Such reputational decline has a strong moral dimension, as it stems from issues such as the questionable conduct of clinical trials, pricing schemas, and access to medicines for low- or middle-income countries. The end product of such issues is the public not viewing pharmaceutical and biotechnology companies favorably. Since pharmaceutical and biotechnology companies are intrinsically tied to health and human flourishing, an ethical framework to aid in resolving both the ethical issues facing the industry and the resulting reputation it yields on both the industry as a whole and individual companies, could certainly be valuable. The central supposition of this dissertation is that additional work needs to be done in the area of pharmaceutical ethics and corporate social responsibility. Currently, no specifically global bioethics tool exists to implement ethics principles into the business practices of pharmaceutical and biotechnology companies, which constitutes a glaring gap in the implementation of ethics principles. This dissertation thus aims to do the following: (i) clarify the ethical grounding of pharmaceutical corporate social responsibility, and (ii) develop a global bioethics tool that can be utilized by the pharmaceutical industry as a manner to aid in implementing global ethics principles. The global bioethics tool seeks to implement a global ethical framework on the basis of performance indicators and best practices, with a long-term goal of helping society regain its trust in the pharmaceutical industry. While there are numerous bioethical guidelines available, it is argued that the UNESCO Universal Declaration on Bioethics and Human Rights, as a global ethics document with the backing of the global community, can be utilized to create such a tool by which to measure the ethical practices of pharmaceutical and biotechnology companies

Approaching Organ Transplant in Islam from a Multidimensional Framework

The subject of organ transplant has been highly contested within Islam. Though the majority of Muslims now accept the validity of the practice from both live and deceased donors, this is by no means a universal consensus. In particular Islamic contexts, the subject of organ transplant remains a major subject of debate. Intertwined with the debate of organ transplant is the sensitive and complex issue of what constitutes death. Bioethical decision-making in Islam takes place within a multi-dimensional framework of authorities and themes. With no central authoritative body for the Islamic community, general consensus on bioethical matters is difficult to locate. The central thesis of this article is that because Islamic bioethics takes place within a multidimensional framework, there remains no common consensus on the question of organ transplant. Though a majority of Muslims have accepted the practice, others continue to find it haram, or forbidden

Does the Distinctiveness of Palliative Care Research Require Distinct Ethical Guidelines?

Palliative and end of life care is changing, becoming more widespread and improving for patients. Yet, the current literature in the field suggests that the evidence for palliative and end of life care is somewhat limited. Research on treatment decisions, family care, and advance directions are just a few of the areas that need rigorous research efforts. Palliative care research is essential in order to continue providing effective treatments to those suffering in the last stages of life. Indeed, the goal of good palliative care research is to relieve suffering and to improve quality of life. Similar to any other field, palliative care programs must develop on a research base, and patient care will suffer if it is not backed by sound research. However, weighted against this need are some who maintain that the ethical and practical challenges of palliative care research are unique and insurmountable. This analysis considers if distinct ethical guidelines are needed for palliative care research

Rowan Community Health Center’s Ask First Model: Building Authentic & Impactful Community Relationships by Asking a Simple Question

Spring of 2017, Rowan University School of Osteopathic Medicine’s student-run free clinic, the Rowan Community Health Center, launched an outreach initiative named the Unity Project. This is an ongoing initiative aimed at fostering relationships with Camden, New Jersey organizations to both educate community members about our clinic services and collaborate on improving Camden’s health. The objective of the Unity Project is to work towards affecting long-term change by forming authentic and impactful relationships with organizations that are already participating in meaningful community work. In order to achieve such a goal, we needed to overcome the traditional model of medical school outreach, which we feel is often short-term and limited. When reaching out to potential community partners, we realized an absence in the crucial first steps of establishing a relationship. We filled this void by simply asking what the organization’s need is. Thus, moving forward, when the Unity Project contacted organizations, we asked how we could help rather than offer suggestions. We termed this method the ‘Ask First’ approach and to this date, we have been observing a successful outcome. We are currently partnered with 38 organizations and are continually growing. The Unity Project has provided a variety of services that ultimately benefit the target populations these organizations are serving. Collaborating with our membered organizations in this way enables us to establish a trusting relationship and work towards bridging the gap between a community in need and a medical organization willing to help by asking a simple, albeit, powerful question

In defense of xenotransplantation research: Because of, not in spite of, animal welfare concerns

It is envisioned that one day xenotransplantation will bring about a future where transplantable organs can be safely and efficiently grown in transgenic pigs to help meet the global organ shortage. While recent advances have brought this future closer, worries remain about whether it will be beneficial overall. The unique challenges and risks posed to humans that arise from transplanting across the species barrier, in addition to the costs borne by non-human animals, has led some to question the value of xenotransplantation altogether. In response, we defend the value of xenotransplantation research, because it can satisfy stringent welfare conditions on the permissibility of animal research and use. Along the way, we respond to the alleged concerns, and conclude that they do not currently warrant a cessation or a curtailing of xenotransplantation research

Xenotransplantation: A historical–ethical account of viewpoints

Formal clinical trials of pig-to-human organ transplant—known as xenotransplantation—may begin this decade, with the first trials likely to consist of either adult renal transplants or pediatric cardiac transplant patients. Xenotransplantation as a systematic scientific study only reaches back to the latter half of the 20th century, with episodic xenotransplantation events occurring prior to that. As the science of xenotransplantation has progressed in the 20th and 21st centuries, the public's knowledge of the potential therapy has also increased. With this, there have been shifting ethical stances toward xenotransplantation in key areas, such as religious and public viewpoints towards xenotransplantation, animal rights, and public health concerns. This review provides a historical–ethical account of xenotransplantation and details if or how viewpoints have shifted over time

IL-25 regulates Th17 function in autoimmune inflammation

Interleukin (IL)-25 is a member of the IL-17 family of cytokines. However, unlike the other members of this family, IL-25 promotes T helper (Th) 2 responses. We now show that IL-25 also regulates the development of autoimmune inflammation mediated by IL-17–producing T cells. We have generated IL-25–deficient (il25−/−) mice and found that they are highly susceptible to experimental autoimmune encephalomyelitis (EAE). The accelerated disease in the il25−/− mice is associated with an increase of IL-23 in the periphery and a subsequent increase in the number of inflammatory IL-17–, IFNγ-, and TNF-producing T cells that invade the central nervous system. Neutralization of IL-17 but not IFNγ in il25−/− mice prevented EAE, suggesting that IL-17 is a major disease-promoting factor. IL-25 treatment at several time points during a relapse-remitting model or chronic model of EAE completely suppressed disease. IL-25 treatment induced elevated production of IL-13, which is required for suppression of Th17 responses by direct inhibition of IL-23, IL-1β, and IL-6 expression in activated dendritic cells. Thus, IL-25 and IL-17, being members of the same cytokine family, play opposing roles in the pathogenesis of organ-specific autoimmunity

From microarray to biology: an integrated experimental, statistical and in silico analysis of how the extracellular matrix modulates the phenotype of cancer cells

A statistically robust and biologically-based approach for analysis of microarray data is described that integrates independent biological knowledge and data with a global F-test for finding genes of interest that minimizes the need for replicates when used for hypothesis generation. First, each microarray is normalized to its noise level around zero. The microarray dataset is then globally adjusted by robust linear regression. Second, genes of interest that capture significant responses to experimental conditions are selected by finding those that express significantly higher variance than those expressing only technical variability. Clustering expression data and identifying expression-independent properties of genes of interest including upstream transcriptional regulatory elements (TREs), ontologies and networks or pathways organizes the data into a biologically meaningful system. We demonstrate that when the number of genes of interest is inconveniently large, identifying a subset of "beacon genes" representing the largest changes will identify pathways or networks altered by biological manipulation. The entire dataset is then used to complete the picture outlined by the "beacon genes." This allow construction of a structured model of a system that can generate biologically testable hypotheses. We illustrate this approach by comparing cells cultured on plastic or an extracellular matrix which organizes a dataset of over 2,000 genes of interest from a genome wide scan of transcription. The resulting model was confirmed by comparing the predicted pattern of TREs with experimental determination of active transcription factors