Open Letter to the Wellcome Trust to Replace Animal Experiments with Human Relevant Test Methods

On 26th January 2022, AIA Director Dr Andre Menache and AIA President Dr Richard Ryder wrote an open letter to Sir Jeremy Farrar OBE FMedSci FRS, Director of The Wellcome Trust requesting that the Trust invests in replacing outdated animal experiments with 21st century human relevant test methods. Animal experiments are based on outdated, 75 year old legislation which has not kept up with the advances in modern technology.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 Wellcome Trust has reportedly made huge profits recently which AIA believes should be invested in bringing about these changes.

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Animal Interfaith Alliance

Faiths Working Together for Animals

Sir Jeremy Farrar OBE FMedSci FRS

Director Wellcome Trust

Gibbs Building
215 Euston Road
London NW1 2BE

OPEN LETTER

26th January 2022

Dear Sir Jeremy, 

We, the Animal Interfaith Alliance, a group of 17 faith-based animal advocacy organizations (listed below), write to you in your capacity as Director of the Wellcome Trust to ask you to engage in a genuine dialogue concerning some of the corporate practices of the Trust.

We appeal first and foremost to your corporate social responsibility, generally defined as the self-regulation of a business model that helps an institution be socially and morally accountable to itself, its stakeholders and the public.  

The Wellcome Trust is by far the biggest charity in Britain with £36.3 billion in net assets and was created by Sir Henry Wellcome in 1936 to improve health by supporting scientific research and the study of medicine.

The specific issue we wish to raise is the use of animals used to develop and test new pharmaceutical products intended for human use. We are aware that 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⁾.

Science has moved forward since then by 75 years, but the laws have not yet caught up with the science. The result of this legal inertia is a continued reliance on outdated and unreliable animal testing, which can be summed up in the following paragraph:

“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.

We are sure you will agree that this would represent a win-win situation for the Wellcome Trust, for human health and for animal welfare.

We look forward to hearing from you.

Yours sincerely,

Dr Andre Menache BSc(Hons)  BVSc Dip ECAWBM (AWSEL) MRCVS

Director                                                          

Dr Richard D. Ryder  PhD (Cantab) MA AFBPsS FZS

President

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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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Member Organisations (in alphabetical order):- 

The Anglican Society for the Welfare of Animals

Animals in Islam

Bhagvatinandji Education and Health Trust

Catholic Concern for Animals

Christian Vegetarians and Vegans UK

The Christian Vegetarian Association US

Dharma Voices for Animals

The Institute of Jainology

The International Ahimsa Organisation 

The Jewish Vegetarian Society

The Mahavir Trust

The Oshwal Association of the UK

Pan-Orthodox Concern for Animals

Quaker Concern for Animals

The Romeera Foundation

The Sadhu Vaswani Centre

The Young Jains

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Registered office: 56 Cole Lane, Ivybridge, Devon, PL21 0PN                                        Company number: 8958588

President: Dr Richard Ryder Vice President: Dr Deborah Jones      Website: www.animal-interfaith-alliance.com

Patrons: Rev. Christa Blanke, Rabbi Prof. Dan Cohn-Sherbok, Kay, Duchess of Hamilton, Joyce D’Silva, Faizan Jaleel, Satish Kumar, Nitin Mehta MBE, Fr Simon Nellist, Dr Alpesh Patel, Dr Matthieu Ricard, Anant Shah OBE, Ajit Singh MBE, Charanjit Singh, Mohammad Safa, Dr Will Tuttle, Rabbi Jonathan Wittenberg.

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