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Bailey J.,British Union for the Abolition of Vivisection BUAV
ATLA Alternatives to Laboratory Animals | Year: 2014

We are in total agreement with the ABPI that "informed debate amongst key stakeholders" is important. However, this should include animal protection groups, in addition to their suggested partnership between "the pharmaceutical industry, academia and the regulatory authorities." Unfortunately, as we have tried to explain, we believe that the ABPI authors have been too eager to play down the importance of our study. Far from being constructive, their critique is overly critical to the point of being unhelpful. Criticism must be fair and robust. When it has a weak scientific basis, it is unacceptable, especially when it is used as a basis to persist with the status quo, for which there is weak supportive evidence. Source


Bailey J.,British Union for the Abolition of Vivisection BUAV | Thew M.,British Union for the Abolition of Vivisection BUAV | Balls M.,Fund for the Replacement of Animals in Medical Experiments FRAME
ATLA Alternatives to Laboratory Animals | Year: 2013

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 virtually no evidence that adverse drug reactions (ADRs) will also be absent in humans. While the LRs suggest that the presence of toxic effects in dogs can provide considerable evidential weight for a risk of potential ADRs in humans, this is highly inconsistent, varying by over two orders of magnitude for different classes of compounds and their effects. Our results therefore have important implications for the value of the dog in predicting human toxicity, and suggest that alternative methods are urgently required. Source


Bailey J.,British Union for the Abolition of Vivisection BUAV | Thew M.,British Union for the Abolition of Vivisection BUAV | Balls M.,Fund for the Replacement of Animals in Medical Experiments FRAME
ATLA Alternatives to Laboratory Animals | Year: 2014

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 (rat, mouse and rabbit), to augment our previously-published analysis of canine data. In common with our dog analysis, the resulting LRs show: a) that the absence of toxicity in the animal provides little or virtually no evidential weight that adverse drug reactions (ADRs) will also be absent in humans; and b) that, while the presence of toxicity in these species can add considerable evidential weight for human risk, the LRs are extremely inconsistent, varying by over two orders of magnitude for different classes of compounds and their effects. Therefore, our results for these additional preclinical species have important implications for their use in predicting human toxicity, and suggest that alternative methods are urgently required. © 2014 ATLA Alternatives to Laboratory Animals. Source


Taylor K.,British Union for the Abolition of Vivisection BUAV | Balls M.,C o BUAV
ATLA Alternatives to Laboratory Animals | Year: 2014

In December 2013, a group of experts produced a report on the management of an animal unit at Imperial College London, following a BUAV investigation that found evidence of systematic failures in the care and monitoring of animals used in procedures there. The Brown Report looked at four areas: the animal welfare and ethical review body (AWERB); the operation of the unit; training; and overall culture. The report made 33 recommendations to improve practices at Imperial College, many of which were relevant to other institutions. In this report, we identify the recommendations that are applicable to all animal facilities, and redraft them as a checklist with supporting information to assist those reviewing their animal care policies. We support the Brown Report's recommendation that institutions should have a vision statement and an action plan, as well as a 'champion' for the Three Rs. We encourage all institutions that use animals to, as a first step, review the performance of their animal units against this checklist. Source

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