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Cancerous Contradictions: The Mis-Regulation Of Human Carcinogens Based On Animal Data, Andrew Knight, Jarrod Bailey, Jonathan Balcombe 2016 Animal Consultants International

Cancerous Contradictions: The Mis-Regulation Of Human Carcinogens Based On Animal Data, Andrew Knight, Jarrod Bailey, Jonathan Balcombe

Jarrod Bailey, Ph.D.

The regulation of human exposures to potential carcinogens constitutes society’s most important use of animal carcinogenicity data. However, for environmental contaminants of greatest U.S. concern, we found that in most cases (58.1%; 93/160) the U.S. Environmental Protection Agency (EPA) considered the animal data inadequate to support a classification of probable human carcinogen or noncarcinogen.

The World Health Organisation’s International Agency for Research on Cancer (IARC) is a leading international authority on carcinogenicity assessments. For chemicals lacking human exposure data (the great majority), IARC classifications of identical chemicals were significantly more conservative than EPA classifications ...


Animal Carcinogenicity Studies: 3. Alternatives To The Bioassay, Andrew Knight, Jarrod Bailey, Jonathan Balcombe 2016 Animal Consultants International

Animal Carcinogenicity Studies: 3. Alternatives To The Bioassay, Andrew Knight, Jarrod Bailey, Jonathan Balcombe

Jarrod Bailey, Ph.D.

Conventional animal carcinogenicity tests take around three years to design, conduct and interpret. Consequently, only a tiny fraction of the thousands of industrial chemicals currently in use have been tested for carcinogenicity. Despite the costs of hundreds of millions of dollars and millions of skilled personnel hours, as well as millions of animal lives, several investigations have revealed that animal carcinogenicity data lack human specificity (i.e. the ability to identify human non-carcinogens), which severely limits the human predictivity of the bioassay. This is due to the scientific inadequacies of many carcinogenicity bioassays, and numerous serious biological obstacles, which render ...


Animal Carcinogenicity Studies: 1. Poor Human Predictivity, Andrew Knight, Jarrod Bailey, Jonathan Balcombe 2016 Animal Consultants International

Animal Carcinogenicity Studies: 1. Poor Human Predictivity, Andrew Knight, Jarrod Bailey, Jonathan Balcombe

Jarrod Bailey, Ph.D.

The regulation of human exposure to potentially carcinogenic chemicals constitutes society’s most important use of animal carcinogenicity data. Environmental contaminants of greatest concern within the USA are listed in the Environmental Protection Agency’s (EPA’s) Integrated Risk Information System (IRIS) chemicals database. However, of the 160 IRIS chemicals lacking even limited human exposure data but possessing animal data that had received a human carcinogenicity assessment by 1 January 2004, we found that in most cases (58.1%; 93/160), the EPA considered animal carcinogenicity data inadequate to support a classification of probable human carcinogen or non-carcinogen. For the ...


An Assessment Of The Role Of Chimpanzees In Aids Vaccine Research, Jarrod Bailey 2016 New England Anti-Vivisection Society

An Assessment Of The Role Of Chimpanzees In Aids Vaccine Research, Jarrod Bailey

Jarrod Bailey, Ph.D.

Prior to Simian Immunodeficiency Virus (SIV)-infected macaques becoming the ‘model of choice’ in the 1990s, chimpanzees were widely used in AIDS vaccine research and testing. Faced with the continued failure to develop an effective human vaccine, some scientists are calling for a return to their widespread use. To assess the past and potential future contribution of chimpanzees to AIDS vaccine development, databases and published literature were systematically searched to compare the results of AIDS vaccine trials in chimpanzees with those of human clinical trials, and to determine whether the chimpanzee trials were predictive of the human response. Protective and ...


Developmental Toxicity Testing: Protecting Future Generations?, Jarrod Bailey 2016 Physicians Committee for Responsible Medicine

Developmental Toxicity Testing: Protecting Future Generations?, Jarrod Bailey

Jarrod Bailey, Ph.D.

A recent editorial is discussed, which implied that animal-based developmental and reproductive toxicology tests will continue to be crucial, that the thalidomide disaster could have been prevented by more animal testing, and that tests on juvenile animals would help to protect children (as developing adults) from the adverse effects of pharmaceuticals. It is argued that animal tests in these scientific areas do not provide reliable data that are predictive for human responses and, even if they did, the tests are too expensive and time-consuming for application to the very large number of substances that need to be tested. It is ...


An Analysis Of The Use Of Animal Models In Predicting Human Toxicology And Drug Safety, Jarrod Bailey, Michelle Thew, Michael Balls 2016 British Union for the Abolition of Vivisection

An Analysis Of The Use Of Animal Models In Predicting Human Toxicology And Drug Safety, Jarrod Bailey, Michelle Thew, Michael Balls

Jarrod Bailey, Ph.D.

Animal use continues to be central to preclinical drug development, in spite of a lack of its demonstrable validity. The current nadir of new drug approvals and the drying-up of pipelines may be a direct consequence of this. To estimate the evidential weight given by animal data to the probability that a new drug may be toxic to humans, we have calculated Likelihood Ratios (LRs) for an extensive data set of 2,366 drugs, for which both animal and human data are available, including tissue-level effects and MedDRA Level 1–4 biomedical observations. This was done for three preclinical species ...


Non-Human Primates In Neuroscience Research: The Case Against Its Scientific Necessity, Jarrod Bailey, Katy Taylor 2016 Cruelty Free International

Non-Human Primates In Neuroscience Research: The Case Against Its Scientific Necessity, Jarrod Bailey, Katy Taylor

Jarrod Bailey, Ph.D.

Public opposition to non-human primate (NHP) experiments is significant, yet those who defend them cite minimal harm to NHPs and substantial human benefit. Here we review these claims of benefit, specifically in neuroscience, and show that: a) there is a default assumption of their human relevance and benefit, rather than robust evidence; b) their human relevance and essential contribution and necessity are wholly overstated; c) the contribution and capacity of non-animal investigative methods are greatly understated; and d) confounding issues, such as species differences and the effects of stress and anaesthesia, are usually overlooked. This is the case in NHP ...


Monkey-Based Research On Human Disease: The Implications Of Genetic Differences, Jarrod Bailey 2016 New England Anti-Vivisection Society

Monkey-Based Research On Human Disease: The Implications Of Genetic Differences, Jarrod Bailey

Jarrod Bailey, Ph.D.

Assertions that the use of monkeys to investigate human diseases is valid scientifically are frequently based on a reported 90–93% genetic similarity between the species. Critical analyses of the relevance of monkey studies to human biology, however, indicate that this genetic similarity does not result in sufficient physiological similarity for monkeys to constitute good models for research, and that monkey data do not translate well to progress in clinical practice for humans. Salient examples include the failure of new drugs in clinical trials, the highly different infectivity and pathology of SIV/HIV, and poor extrapolation of research on Alzheimer ...


Predicting Human Drug Toxicity And Safety Via Animal Tests: Can Any One Species Predict Drug Toxicity In Any Other, And Do Monkeys Help?, Jarrod Bailey, Michelle Thew, Michael Balls 2016 Cruelty Free International

Predicting Human Drug Toxicity And Safety Via Animal Tests: Can Any One Species Predict Drug Toxicity In Any Other, And Do Monkeys Help?, Jarrod Bailey, Michelle Thew, Michael Balls

Jarrod Bailey, Ph.D.

Animals are still widely used in drug development and safety tests, despite evidence for their lack of predictive value. In this regard, we recently showed, by producing Likelihood Ratios (LRs) for an extensive data set of over 3,000 drugs with both animal and human data, that the absence of toxicity in animals provides little or virtually no evidential weight that adverse drug reactions will also be absent in humans. While our analyses suggest that the presence of toxicity in one species may sometimes add evidential weight for risk of toxicity in another, the LRs are extremely inconsistent, varying substantially ...


An Examination Of Chimpanzee Use In Human Cancer Research, Jarrod Bailey 2016 New England Anti-Vivisection Society

An Examination Of Chimpanzee Use In Human Cancer Research, Jarrod Bailey

Jarrod Bailey, Ph.D.

Advocates of chimpanzee research claim the genetic similarity of humans and chimpanzees make them an indispensable research tool to combat human diseases. Given that cancer is a leading cause of human death worldwide, one might expect that if chimpanzees were needed for, or were productive in, cancer research, then they would have been widely used. This comprehensive literature analysis reveals that chimpanzees have scarcely been used in any form of cancer research, and that chimpanzee tumours are extremely rare and biologically different from human cancers. Often, chimpanzee citations described peripheral use of chimpanzee cells and genetic material in predominantly human ...


An Analysis Of The Use Of Dogs In Predicting Human Toxicology And Drug Safety, Jarrod Bailey, Michelle Thew, Michael Balls 2016 British Union for the Abolition of Vivisection

An Analysis Of The Use Of Dogs In Predicting Human Toxicology And Drug Safety, Jarrod Bailey, Michelle Thew, Michael Balls

Jarrod Bailey, Ph.D.

Dogs remain the main non-rodent species in preclinical drug development. Despite the current dearth of new drug approvals and meagre pipelines, this continues, with little supportive evidence of its value or necessity. To estimate the evidential weight provided by canine data to the probability that a new drug may be toxic to humans, we have calculated Likelihood Ratios (LRs) for an extensive dataset of 2,366 drugs with both animal and human data, including tissue-level effects and Medical Dictionary for Regulatory Activities (MedDRA) Level 1–4 biomedical observations. The resulting LRs show that the absence of toxicity in dogs provides ...


Lessons From Chimpanzee-Based Research On Human Disease: The Implications Of Genetic Differences, Jarrod Bailey 2016 New England Anti-Vivisection Society

Lessons From Chimpanzee-Based Research On Human Disease: The Implications Of Genetic Differences, Jarrod Bailey

Jarrod Bailey, Ph.D.

Assertions that the use of chimpanzees to investigate human diseases is valid scientifically are frequently based on a reported 98–99% genetic similarity between the species. Critical analyses of the relevance of chimpanzee studies to human biology, however, indicate that this genetic similarity does not result in sufficient physiological similarity for the chimpanzee to constitute a good model for research, and furthermore, that chimpanzee data do not translate well to progress in clinical practice for humans. Leading examples include the minimal citations of chimpanzee research that is relevant to human medicine, the highly different pathology of HIV/AIDS and hepatitis ...


Animal Carcinogenicity Studies: Implications For The Reach System, Andrew Knight, Jarrod Bailey, Jonathan Balcombe 2016 Animal Consultants International

Animal Carcinogenicity Studies: Implications For The Reach System, Andrew Knight, Jarrod Bailey, Jonathan Balcombe

Jarrod Bailey, Ph.D.

The 2001 European Commission proposal for the Registration, Evaluation and Authorisation of Chemicals (REACH) aims to improve public and environmental health by assessing the toxicity of, and restricting exposure to, potentially toxic chemicals. The greatest benefits are expected to accrue from decreased cancer incidences. Hence the accurate identification of chemical carcinogens must be a top priority for the REACH system. Due to a paucity of human clinical data, the identification of potential human carcinogens has conventionally relied on animal tests. However, our survey of the US Environmental Protection Agency’s (EPA’s) toxic chemicals database revealed that, for a majority ...


Animal Carcinogenicity Studies: 2. Obstacles To Extrapolation Of Data To Humans, Andrew Knight, Jarrod Bailey, Jonathan Balcombe 2016 Animal Consultants International

Animal Carcinogenicity Studies: 2. Obstacles To Extrapolation Of Data To Humans, Andrew Knight, Jarrod Bailey, Jonathan Balcombe

Jarrod Bailey, Ph.D.

Due to limited human exposure data, risk classification and the consequent regulation of exposure to potential carcinogens has conventionally relied mainly upon animal tests. However, several investigations have revealed animal carcinogenicity data to be lacking in human predictivity. To investigate the reasons for this, we surveyed 160 chemicals possessing animal but not human exposure data within the US Environmental Protection Agency chemicals database, but which had received human carcinogenicity assessments by 1 January 2004. We discovered the use of a wide variety of species, with rodents predominating, and of a wide variety of routes of administration, and that there were ...


Ethical Issues In The Use Of Animals In Biomedical And Psychopharmocological Research, John P. Gluck, Jordan Bell 2016 University of New Mexico

Ethical Issues In The Use Of Animals In Biomedical And Psychopharmocological Research, John P. Gluck, Jordan Bell

John P. Gluck, Ph.D.

Rationale: The ethical debate concerning the use of animals in biomedical and pharmacological research continues to be replete with misunderstandings about whether animals have moral standing. Objectives: This article briefly reviews the central ethical positions and their relationship to the basic parameters of research regulation from an international perspective. The issues associated with the validation of animal models will then be discussed. Finally, suggestions for empirical ethics research will be presented. Methods: Recent literature reviews were accessed and analyzed. Results: This review summarizes the pertinent ethical and research literature. Conclusions: In summary, regardless of the ethical perspective one favors, there ...


Rethinking The Ethics Of Research Involving Nonhuman Animals: Introduction, Tom L. Beauchamp, Hope Ferdowsian, John P. Gluck 2016 Georgetown University

Rethinking The Ethics Of Research Involving Nonhuman Animals: Introduction, Tom L. Beauchamp, Hope Ferdowsian, John P. Gluck

John P. Gluck, Ph.D.

No abstract provided.


Animals In Biomedical Research: The Undermining Effect Of The Rhetoric Of The Besieged, John P. Gluck, Steven R. Kubacki 2016 University of New Mexico

Animals In Biomedical Research: The Undermining Effect Of The Rhetoric Of The Besieged, John P. Gluck, Steven R. Kubacki

John P. Gluck, Ph.D.

It is correctly asserted that the intensity of the current debate over the use of animals in biomedical research is unprecedented. The extent of expressed animosity and distrust has stunned many researchers. In response, researchers have tended to take a strategic defensive posture, which involves the assertation of several abstract positions that serve to obstruct resolution of the debate. Those abstractions include the notions that the animal protection movement is trivial and purely anti-intellectual in scope, that all science is good (and some especially so), and the belief that an ethical consensus can never really be reached between the parties.


Moving Beyond The Welfare Standard Of Psychological Well-Being For Nonhuman Primates: The Case Of Chimpanzees, John P. Gluck 2016 University of New Mexico

Moving Beyond The Welfare Standard Of Psychological Well-Being For Nonhuman Primates: The Case Of Chimpanzees, John P. Gluck

John P. Gluck, Ph.D.

Since 1985, the US Animal Welfare Act and Public Health Service policy have required that researchers using nonhuman primates in biomedical and behavioral research develop a plan ‘‘for a physical environment adequate to promote the psychological well-being of primates.’’ In pursuing this charge, housing attributes such as social companionship, opportunities to express species-typical behavior, suitable space for expanded locomotor activity, and nonstressful relationships with laboratory personnel are dimensions that have dominated the discussion. Regulators were careful not to direct a specific set of prescriptions (i.e., engineering standards) for the attainment of these goals, but to leave the design of ...


Institutional Animal Care And Use Committees: A Flawed Paradigm Or Work In Progress?, John P. Gluck, F. Barbara Orlans 2016 University of New Mexico

Institutional Animal Care And Use Committees: A Flawed Paradigm Or Work In Progress?, John P. Gluck, F. Barbara Orlans

John P. Gluck, Ph.D.

In his challenging article, Steneck (1997) criticized the creation of the Institutional Animal Care and Use Committee (IACUC) system established by the 1985 amendments to the Animal Welfare Act. He saw the IACUC review and approval of biomedical and behavioral research with animals as an unnecessary "reassignment" of duties from existing animal care programs to IACUC committees. He argued that the committees are unable to do the work expected of them for basically three reasons: (a) the membership lacks the expertise in matters relevant to animal research and care, (b) there exists an inherent and disabling conflict of interest, and ...


Harry F. Harlow And Animal Research: Reflection On The Ethical Paradox, John P. Gluck 2016 University of New Mexico

Harry F. Harlow And Animal Research: Reflection On The Ethical Paradox, John P. Gluck

John P. Gluck, Ph.D.

With respect to the ethical debate about the treatment of animals in biomedical and behavioral research, Harry F. Harlow represents a paradox. On the one hand, his work on monkey cognition and social development fostered a view of the animals as having rich subjective lives filled with intention and emotion. On the other, he has been criticized for the conduct of research that seemed to ignore the ethical implications of his own discoveries. The basis of this contradiction is discussed and propositions for current research practice are presented.


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