michael balls

/Tag:michael balls

To Be Credible, Success in “Reducing the Use of Animals in Scientific Research” Must Involve the Use of Fewer Animals

Michael Balls

Much worthy effort on the Three Rs is under way in the UK, but its promise of a reduction in laboratory animal use will only be credible and laudable when the number of procedures and animals are progressively and permanently reduced.
You need to register (for free) to download this article. Please log in/register here.

Animal Experimentation and Alternatives: Time to Say Goodbye to the Three Rs and Hello to Humanity?

Michael Balls

The time has come to plan for a future where the Three Rs will have served their purpose, animal experimentation will have been consigned to history, and humane biomedical science in research, testing and education will have become the norm, for the benefit of humans and animals alike.

This article is currently only available in full to paid subscribers. Click here to subscribe, or you will need to log in/register to buy and download this article

Wider Recommendations for Institutions made in the Brown Report Following the BUAV Investigation into the Use of Animals at Imperial College London

Katy Taylor and Michael Balls

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.

This article is currently only available in full to paid subscribers. Click here to subscribe or you will need to log in/register to buy and download this article

Comment – Four papers on the OECD Health Effects Test Guidelines

Michael Balls and Robert D. Combes
Angela Auletta
John E. Doe, Richard W. Lewis and Philip A. Botham
Barry Phillips

 

This post combines four papers:
The OECD Health Effects Test Guidelines: A Challenge to the Sincerity of Commitment to the Three Rs by Michael Balls and Robert D. Combes
An Assessment of Some Recommendations Made Concerning the OECD Health Effects Test Guidelines by Angela Auletta
Comments on A Scientific and Animal Welfare Assessment of the OECD Health Effects Test Guidelines for the Safety Testing of Chemicals Under the European Union REACH System by John E. Doe, Richard W. Lewis and Philip A. Botham
and
OECD Test Guidelines are Tools, not Blueprints, for Chemical Safety Assessment by Barry Phillips

You need to register (for free) to download this article. Please log in/register here.

Editorial

Michael Balls

Animal Experimentation: Transparency and Openness Mean Little, Unless Accompanied by Honesty and Accountability. Delivery Plans, and Declarations and Concordats on transparency and openness, are all very well, but what will they really achieve with respect to the Three Rs?
You need to register (for free) to download this article. Please log in/register here.

Editorial: Openness on Animal Research: The Gauntlet has been Thrown Down

Michael Balls

The delivery of the UK Government's and Concordat's commitments to greater openness on animal research is eagerly awaited. Meanwhile, the questions raised by two studies on the use of animal tests to predict the toxic effects of drugs in humans should be answered. Procedures applied to protected laboratory animals, which may cause them pain, suffering, distress and or lasting harm, are only morally acceptable, and should only be legally permissible, if they are scientifically justifiable.
You need to register (for free) to download this article. Please log in/register here.

An Analysis of the Use of Animal Models in Predicting Human Toxicology and Drug Safety

Jarrod Bailey, Michelle Thew and Michael Balls

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.

This article is currently only available in full to paid subscribers. Click here to subscribe, or you will need to log in/register to buy and download this article

The Three Rs — Opportunities for Improving Animal Welfare and the Quality of Scientific Research

Robert D. Combes and Michael Balls

In 2013, an undercover investigation by the BUAV raised serious concerns about the use, treatment and care of laboratory animals involved in regulated procedures at Imperial College, London. This led to an inquiry, set up by the college, which found deficiencies in the local ethical review process and a general lack of focus on the implementation of the Three Rs (Replacement, Refinement and Reduction). The Three Rs concept is the foundation of UK and EU legislation, but surveys of the published literature show that lack of its adoption is widespread. In spite of numerous guidelines, publications and publicity material extolling the benefits of the Three Rs to both animals and science, as well as substantial advances in the development, validation, and deployment of mechanistically-based non-animal methods, many scientists prefer to use traditional animal-based approaches. In addition, such scientists tend to pay less attention than they should to strategic planning, experimental design and the choice of appropriate statistical procedures. They are often unaware of the existence of replacement test methods to address all or some of their objectives, and are reluctant to develop and use new replacement methods. We explore some possible reasons for these shortcomings. We summarise the welfare and scientific effects of each of the Three Rs, and argue that: a) there is an urgent need for evidence to be made readily accessible to prospective licensees, which directly demonstrates the beneficial effects on animal welfare of the implementation of the Three Rs, separately and in combination, and the direct link this has with the quality of the scientific data obtained; b) a detailed systematic review of this evidence should be undertaken to augment the inadequate content of the prescribed Module 5 licensee training offered currently in the UK; c) such training (including that suggested in new EU-wide proposals) should be much more comprehensive, with stronger emphasis on the Three Rs, all parts of the syllabus should be fully examined, and there should be no exemptions from Module 5 training; and d) as the responsible Government department in the UK, the Home Office should take measures to tighten up its guidance for local ethical review, and its system of inspection of designated establishments, to obviate the justification for future undercover investigations.

This article is currently only available in full to paid subscribers. Click here to subscribe, or you will need to log in/register to buy and download this article

Applying the Three Rs to Animal Experimentation and Animal Testing: Are We Merely Drifting or Lying at Anchor?

Michael Balls and Robert Combes

This issue of ATLA (34 [1], 2006) contains a number of very important items, which can be seen as encouraging or discouraging, depending on one’s hopes and ambitions with respect to alternatives.
You need to register (for free) to download this article. Please log in/register here.