Replacing Lab Animals with Human Relevant Test Methods

Background

One of our key goals is to campaign to replace the use of animals in laboratory testing with 21st century human relevant test methods. Animal experiments are based on outdated, 75 year old legislation which has not kept up with the advances in modern technology. The only thing preventing pharmaceutical companies from moving to human relevant test methods is a lack of political will to work with the regulatory bodies to update the regulations.

The use of animals is currently a legal requirement, based on national and international regulations. These regulatory requirements can be traced back to the Doctors’ Trial at Nuremberg at the end of the Second World War, 1946 (1).

“In 2004, the FDA estimated that 92 percent of drugs that pass preclinical tests, including “pivotal” animal tests, fail to proceed to the market. More recent analysis suggests that, despite efforts to improve the predictability of animal testing, the failure rate has actually increased and is now closer to 96 percent. The main causes of failure are lack of effectiveness and safety problems that were not predicted by animal tests” (2).

In addition, “Over the recent years, there has been an increasing recognition of the weaknesses that pervade our current system of basic and preclinical research. This has been highlighted empirically in preclinical research by the inability to replicate the majority of findings presented in high-profile journals. The estimates for irreproducibility based on these empirical observations range from 75% to 90%. These estimates fit remarkably well with estimates of 85% for the proportion of biomedical research that is wasted at large”(3)

In view of this embarrassing state of affairs, several attempts have been made by research teams to improve the quality of animal studies, including the updated ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) (4).  These attempts to improve the methodology of animal studies betray a remarkable ignorance of complexity science and evolutionary biology. No matter how good the methodology, animal models cannot predict human outcome with respect to drug development and disease, as demonstrated above and further explained in the following references. (5,6,7)

Not only is the continued use of animals responsible for an enormous amount of avoidable animal suffering but it is also responsible for a significant incidence of human adverse drug reactions (8). This is not surprising in view of our current knowledge of inter and even intra-species differences, based on genomics, complexity theory and evolutionary biology (9).

The following paragraph makes the connection between animal testing and shareholder expectations:

Pharmaceutical firms seek to fulfil their responsibilities to stakeholders by developing drugs that treat diseases. We evaluate the social and financial costs of developing new drugs relative to the realized benefits and find the industry falls short of its potential. This is primarily due to legislation-mandated reliance on animal test results in early stages of the drug development process, leading to a mere 10 percent success rate for new drugs entering human clinical trials. We cite hundreds of biomedical studies from journals including Nature, Science, and the Journal of the American Medical Association to show animal modelling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs.” (10).

The pharmaceutical industry is best placed to make the paradigm change needed to replace outdated and unreliable animal tests with human relevant test methods, including human 3D cell culture, organs on chips, pharmacogenomics, and similar 21st century technologies that were previously unavailable.

Only the pharmaceutical industry has the resources to scientifically validate human based test methods and steer them through the regulatory framework.

We would argue that the only reason that animal testing has evaded the rigors of evidence based science for so long is that the public and indeed, shareholders, are completely unaware of the fact that currently available human based test methods are far more predictive of human outcome than animal tests.

We can choose between the use of human data that is relevant and reliable for human medicine, or the use of animal data that is clearly irrelevant and unreliable for human medicine. The scientific evidence against animal testing is now overwhelming. What is now required is a political will on the part of the pharmaceutical industry to make change happen, in consultation with regulatory agencies and the International Conference on Harmonization (ICH).

The development, manufacture and mass marketing of the COVID-19 vaccine was achieved in just 10 months instead of the normal 10 to 15 years. The pharmaceutical industry has already had 75 years in which to replace animal tests. Now is the time to invest some of the profits made from the COVID-19 vaccine and to replace animal tests with human based methodologies that are currently available. This is an excellent opportunity for the Wellcome Trust to take the lead on this crucial issue by being proactive.


Watch Dr Andre Menache’s Videos

AIA Director, Dr Andre Menache BSc(Hons)  BVSc Dip ECAWBM (AWSEL) MRCVS, who is a expert in this field, has explained the subject of replacing laboratory animals with 21st century human relevant test methods in two videos which can be watched here:


Watch Dr Andre Menache’s Webinars

Dr Andre Menache BSc(Hons)  BVSc Dip ECAWBM (AWSEL) MRCVS has also given two webinars on the subject of replacing laboratory animals with 21st century human relevant test methods. These can we viewed here.


What AIA is Doing
Supporting Animal Free Research

We are supporting Animal Free Research UK through the Cobbe/Schweizter Universal Kinship Fund to search for cures to human diseases using human relevant test methods that do not involve animals.

Letter Writing Campaigns

On 10th July 2021 Dr Andre Menache wrote an open letter to the Chief Executives of AstraZeneca and Glaxosmithkline urging them to use non animal testing methods. His letter can be read here.

On 1 September 2021, Dr Menache wrote a response to the UK government’s reply to Peter Egan’s petition to include lab animals in the Animal Welfare Act. His letter can be read here.

On 24th October 2021 Dr Menache wrote open letters to 24 overseas embassies in the UK calling for a global ban on biohazard research. His letter can be read here.

On 26th January 2022, Dr Menache wrote an open letter to the Wellcome Trust encouraging them to invest in replacing animals with human relevant test methods. His letter can be read here.

We are still awaiting the responses from these letters.


References:

https://bmcmedethics.biomedcentral.com/articles/10.1186/1472-6939-13-16

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4594046/

https://www.ahajournals.org/doi/full/10.1161/circresaha.114.303819

https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3000410

https://pubmed.ncbi.nlm.nih.gov/23372426/

https://pubmed.ncbi.nlm.nih.gov/22963674/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223056/

https://pubmed.ncbi.nlm.nih.gov/9555760/

https://pubmed.ncbi.nlm.nih.gov/29783296/

https://philpapers.org/rec/KRAHSA-3

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