Pharmaceutical firms seek to fulfill their responsibilities to stakeholders by developing drugs that treat diseases. We evaluate the social and financial costs of developing new drugs relative to the realized benefits and find the industry falls short of its potential. This is primarily due to legislation-mandated reliance on animal test results in early stages of the drug development process, leading to a mere 10 percent success rate for new drugs entering human clinical trials. We cite hundreds of biomedical studies from (...) journals including Nature, Science, and the Journal of the American Medical Association to show animal modeling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs. Legislation still requires animal testing prior to human testing even though the pharmaceutical sector has better options that were unavailable when animal modeling was first mandated. We propose that the U.S. Food and Drug Administration and Congress should work together to abolish regulations and policies that require animal use. Doing so will benefit pharmaceutical industry stakeholders, including patients whose health depends on drugs and the many people who rely on the financial well-being of pharmaceutical firms. (shrink)

The Institutional Animal Care and Use Committee is entrusted with assessing the ethics of proposed projects prior to approval of animal research. The role of the IACUC is detailed in legislation and binding rules, which are in turn inspired by the Three Rs: the principles of Replacement, Reduction, and Refinement. However, these principles are poorly defined. Although this provides the IACUC leeway in assessing a proposed project, it also affords little guidance. Our goal is to provide procedural and philosophical clarity (...) to the IACUC without mandating a particular outcome. To do this, we analyze the underlying logic of the Three Rs and conclude that the Three Rs accord animals moral standing, though not necessarily “rights” in the philosophical sense. We suggest that the Rs are hierarchical, such that Replacement, which can totally eliminate harm, should be considered prior to Reduction, which decreases the number of animals harmed, with Refinement being considered last. We also identify the need for a hitherto implicit fourth R: Reject, which allows the IACUC to refuse permission for a project which does not promise sufficient benefit to offset the pain and distress likely to be caused by the proposed research. (shrink)

The primary aim of biomedical research is to discover and develop new knowledge to advance human medicine. Frequently a ‘mouse model’ is taken to be a necessary step towards understanding a disease, biological mechanism or intervention. We argue for caution with respect to the mouse model: theoretical reasons, meta-analyses of empirical data, and viable alternatives all support a more restricted use of animals in laboratories than is current practice. On its own terms, a utilitarian scientific justification for using animals in (...) biomedical research converges more closely with welfarist claims than is usually recognised. (shrink)

The requirement that animals be used in research and testing in order to protect humans was formalized in the Nuremberg Code and subsequent national and international laws, codes, and declarations. We review the history of these requirements and contrast what was known via science about animal models then with what is known now. We further analyze the predictive value of animal models when used as test subjects for human response to drugs and disease. We explore the use of animals for (...) models in toxicity testing as an example of the problem with using animal models. We conclude that the requirements for animal testing found in the Nuremberg Code were based on scientifically outdated principles, compromised by people with a vested interest in animal experimentation, serve no useful function, increase the cost of drug development, and prevent otherwise safe and efficacious drugs and therapies from being implemented. (shrink)

Respice...prospice: Philosophy, ethics and the character of medical care for the future.

We argue that the recommendations made by the Institute of Medicine’s 2011 report, Chimpanzees in Biomedical and Behavioral Research : Assessing the Necessity, are methodologically and ethically confused. We argue that a proper understanding of evolution and complexity theory in terms of the science and ethics of using chimpanzees in biomedical research would have had led the committee to recommend not merely limiting but eliminating the use of chimpanzees in biomedical research. Specifically, we argue that a proper understanding of the (...) difference between the gross level of examination of species and examinations on finer levels can shed light on important methodological and ethical inconsistencies leading to ignorance of potentially unethical practices and policies regarding the use of animals in scientific research. (shrink)

Abstract:Neuroscience affords knowledge that can be leveraged in the ontological valuation of individuals, groups, and species. Sociocultural sentiments, norms, and mores may impede embracing such knowledge to revise moral attitudes, ethics, and policies. We argue that the practices of neuroethics will be valuable in that they ground ethico-legal discourse in (1) naturalistic philosophy; (2) the current epistemological capital of neuroscience; (3) the issues, problems, and solutions arising in and from neuroscientific research and its applications; and 4) the use of neurocentric (...) criteria—such as painience—to define and resolve ethical decisions regarding attitudes toward and treatment of nonhuman animals. (shrink)

Biomedical research today can be generally classified as human-based or nonhuman animal-based, each with separate and distinct review boards that must approve research protocols. Researchers wishing to work with humans or human tissues have become frustrated by the required burdensome approval panel, the Institutional Review Board. However, scientists have found it is much easier to work with the animal-based research review board, the Institutional Animal Care and Use Committee. Consequently, animals are used for investigations even when scientists believe these studies (...) should be performed with humans or human tissue. This situation deserves attention from society and more specifically the animal protection and patient advocate communities, as neither patients nor animals are well served by the present situation. (shrink)

Dear Editor,The April 2014 issue of Theoretical Medicine and Bioethics [1] presented eight essays regarding the use of nonhuman animals in biomedical research. While I appreciate the essays concerning contemporary research—which were well written and offered new thinking from the fields of ethics and ethology—I believe the journal, via the topics and the authors chosen, failed to communicate the most important fact regarding the current science pertinent to the use of nonhuman animals in research.The foundational reason for using chimpanzees and (...) other animals in research is their predictive value for human response to drugs and disease. This was alluded to by several of the authors when they discussed the necessity of using nonhuman animals. For example, Smith writes: “A common assumption in the selection of nonhuman animal subjects for research and the approval of research is that, if the risks of a procedure are too great for humans, and if there is a so-called scientific necessity, .. (shrink)

BackgroundCurrent policies regulating the use of animals for scientific purposes are based on balancing between potential gain of knowledge and suffering of animals used in experimentation. The balancing process is complicated, on the one hand by plurality of views on our duties towards animals, and on the other hand by more recent discussions on uncertainty in the probability of reaching the final aim of the research and problems of translational failure.MethodsThe study combines ethical analysis based on a literature review with (...) neuropsychiatry-related preclinical research as a case study.ResultsBased on the analysis and the case study we show that neuropsychiatry-related preclinical research is an especially interesting case from an ethical perspective. The 3R principles are used to minimize the negative consequences for the animals used in research. However, neuropsychiatric research is characterized by specific challenges in assessing the probability of success of reaching the final aim, due to our limited mechanistic knowledge of human neuropsychiatric illness. Consequently, the translational value of the currently used animal models may be difficult to prove, which undermines the validity of these models and complicated the ethical assessment.ConclusionsWe conclude that a combined approach that deals with both science and the ethical dimensions is necessary to address the problems of validity and translation in neuropsychiatry-related preclinical research. We suggest this approach to comprise first, improved experimental methods, e.g. by using systematic reviews, second, a more patients-based approach that leads to models that reflect interindividual variation better, and third, more interdisciplinary cooperation. (shrink)