Recently FRAME and the Kennel Club co-authored an open letter to The Rt Hon Greg Clark, MP, Secretary of State for Communities and Local Government, in which we expressed our disappointment at the decision to grant planning permission for establishment of a dog breeding centre in East Yorkshire. We asked “why is breeding of dogs on this site considered necessary and in the national interest?” (see: http://www.frame.org.uk/frame-and-the-kennel-club-ask-for-a-u-turn-on-beagle-breeding-centre).
Some people have interpreted FRAME’s stance as a move away from our traditional, middle ground viewpoint, but we stand by the action, which is still very much in line with the position we have always taken.
It has been argued that the proposed breeding centre is designed to remove the need to fly puppies into the UK to be used in medical and veterinary research. If such is the case, then logical next questions are: what medical and veterinary research and what value does this provide? We consider that these are awfully important details.
FRAME continues to be a proud “Three Rs” organisation, calling for the replacement of animal procedures by scientifically valid alternative methods whenever possible; but it also accepts reduction and refinement of well justified animal procedures, for example in the development of vaccines against debilitating animal infectious diseases.
However, we cannot support continued extensive use of dogs to support human safety assessment of chemicals, because the results they provide are of only limited value for predicting many of the human toxicities caused by prescription drugs (see: http://www.sciencedirect.com/science/article/pii/S0273230000913990). Toxicity studies undertaken in dogs and other preclinical species are especially ineffective at predicting whether drugs can be used safely in large human populations. Many hundreds of licensed drugs have the potential to cause unpredictable and infrequent toxicities in certain susceptible human patients when tested in late clinical trials and post-licensing.
These idiosyncratic human drug toxicities are one very important reason why development of new drugs is now such an inefficient and expensive process. In fact, they are a leading cause of failed drug registration and of withdrawal from use of licensed drugs. They are unrelated to the known pharmacological effects of the drugs and may affect the liver, skin, cardiovascular and other organ systems, plus cause a variety of allergic reactions (see: http://www.annualreviews.org/doi/abs/10.1146/annurev.med.58.072905.160823). Although the incidence of idiosyncratic toxicities caused by individual drugs is low, they pose a far from trivial problem because the consequences can be serious illness or even death, and because they are caused by so many different drugs.
Since the current animal-centric methods used to predict human drug safety are ineffective at predicting idiosyncratic toxicities, new and better methods are needed urgently. The pharmaceutical industry has recognised the need to address this issue and has made substantial investments. Promising progress has been made in use of human tissue-derived cells to distinguish between safe drugs and drugs that can cause idiosyncratic human toxicities. For example, see: http://jpet.aspetjournals.org/content/352/2/281.abstract; http://pubs.acs.org/doi/abs/10.1021/tx300091x). FRAME’s Scientific Director Dr Gerry Kenna was a lead investigator on both these studies, while employed in the pharmaceutical industry as a toxicologist.
However, much more needs to be done. FRAME is calling once again on the UK government and other funding bodies to give this topic a much higher funding priority. We also reiterate that the debate on the pros and cons of the new proposed dog breeding facility must not deflect attention away from the need to provide scientists with improved non-animal research methods, plus awareness and training in how best to use them.