Animal Experimentation - An Industry in Disarray

Throughout the years, animal experimentation has been a polarising issue – concern about the rights of, and cruelty to animals has been countered by arguments about necessity for medical progress – with seemingly authoritative doctors and medical researchers, whom few of us lay people would dare challenge, telling us that such animal experimentation is crucial. Our perception sometimes also influenced by the White Coat Effect where a significant portion of the population believes unquestionably in the views of the medical community.

In more recent years, our perceptions have changed a little, as those advocating for animals do so also on scientific grounds – arguing that the vast and intricate biological differences between humans and other animals render animals inappropriate models from which to extrapolate test data to humans with sufficient accuracy.  Such concerns, now acknowledged by many in the research community themselves, are backed up by systematic reviews and meta analyses.  Scientific literature now frequently raises questions about the reliability and predictive value of animal testing in research for humans.[1],[2] Systematic reviews continue to show that animal experiments are not sufficiently predictive of human outcomes and can be dangerously misleading.[3]

Now there seems to be a new wave of doubt hanging over the industry – articles published in the prestigious British Medical Journal questioning the way in which animals are used and the research reported. The editorial[4]published 11 January 2018 begins:

“New drug development is underpinned by animal research, but is the animal evidence base fit for purpose? A collection of articles published in The BMJ this week suggest not. They conclude that the preclinical foundations of clinical research are shaky and in urgent need of reform.”

According to Medical Xpress, “the [BMJ] investigation and linked expert commentaries highlight the "pick and mix" approach to animal research, and raise wider questions about lack of oversight and transparency, unaccountable regulatory decision making, and lack of clarity about what data are required when deciding to move from animal (preclinical) studies to human (clinical) trials.”

It seems the particular drug in question in this article - MVA85A, a vaccine developed by researchers at Oxford University to boost the effectiveness of the BCG vaccine[5]and provide extra protection against tuberculosis – showed success in animal tests but failed to be effective in South African infants.

“[A]n independent systematic review in 2015 concluded that the results of the animal studies had been overstated.”

However it has also been revealed that a later study in monkeys “should have raised doubts about the effectiveness of MVA85A.” “Yet several months after the monkey study ended, it appears that these results were not included in information submitted to regulators for approval and funding of human trials of MVA85A.”

What we can conclude from this is that the predictive value of animals as models for human research is indeed hit and miss and not very effective at all. Researchers seem to pick and choose which results will best suit their funding applications.

Ever more frequently now, the research community is exposed as being not quite as credible as people have been led to believe, and perhaps the “White Coat Effect” is indeed waning.  Maybe it’s timely to revisit the systematic reviews and place the scientific arguments against using animals as models for human disease squarely on the table for debate, because we do not want publications of flawed research.  We want genuine cures, and at this rate we are simply wasting precious resources on an industry in disarray.

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[1]Bailey J et al. (2014) An Analysis of the Use of Animal Models in Predicting Human Toxicology and Drug Safety. ATLA 42, 181-199.

[2]Hartung T. (2013) Look Back in Anger – What Clinical Studies Tell Us About Preclinical Work. ALTEX 30, 275-291

[3]Greek R, Menache A (2013) Systematic Reviews of Animal Models: Methodology versus Epistemology. Int. J. Med. Sci. Vol. 10: 206-221.

[4] BMJ 2018;360:k124

[5] Bacillus Calmette–Guérin vaccine is a vaccine primarily used against tuberculosis