In Rat Trap, our Research Director, Dr Pandora Pound ends the debate about animal research once and for all. She shows that, far from being a necessary evil, it is one of the most important and urgent scientific issues of our time.
Animal research harms patients and holds back medical progress. Superior technologies based on human biology could transform medicine if not for the iron grip of animal research.
Rat Trap is dynamite! It blows the lid off decades of dogma.
Read it, share it, and help speed the revolution that will benefit us all
If you need a free e-copy, please let us know: info@safermedicines.org
On November 11th 2025, the UK Government published its long-awaited strategy, ‘Replacing animals in science’. Addressing both regulatory and ‘discovery’ research, it includes a range of measures to help embed non-animal methods across the research system and commits to targets for phasing out a number of outdated animal tests. With substantial funding, a ministerial committee and cross departmental working to ensure delivery, as well as key performance indicators to monitor progress in delivering objectives, the roadmap signals a shift in UK animal research policy, with the government recognising that the benefits of the strategy include scientific advances as well as economic impact.
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The film ‘How to make drugs and feel great about everything’, by director Journey Wade-Hak and co-producer / writer Keegan Kuhn covers what will be familiar ground to many – the translational failure of preclinical animal studies, the adverse effects of approved drugs, the reproducibility crisis, the suffering of animals in laboratories and the new approaches based on human biology that we should be using instead. These are not easy issues to discuss, but this film about the drug development process manages to do so brilliantly. Somehow it succeeds in getting all the important scientific points across, yet with a light touch, while the excellent visuals and one-liners draw in the viewer without diminishing the gravity of what is being considered. (Upon discovering that ‘over 14000 FDA approved drugs have been recalled in the last ten years’, for instance, Journey notes that this is a level of failure not otherwise seen outside of his Tinder profile.)
When considering the use of animals in research intended to have relevance for human health, the time may come when we look back and realise that animal experiments have been a huge and costly distraction, a path we might have done better to completely avoid.
If indeed we have taken the wrong turning, our task now is not to replace animal experiments; after all, there is little point in replacing a distraction. No, the task is to get back onto the correct path, which – if we are interested in human health – is research focused on humans and human biology.
Decades of experience show that – at least within academia, where basic and applied animal research is conducted – replacement isn’t working anyway. This is hardly surprising, since replacement requires animal researchers to voluntarily relinquish everything they have been working for and replace it with technologies they may be unfamiliar with and have no incentive to use. Within academia, it is more or less up to individual research teams to choose their own research topics and methodologies, so if the incentives, support or infrastructure for switching from animal to human biology-based approaches are not there, it will not be in their interests to do so. The regulatory sphere, however, is more tightly controlled: here non-animal tests for specific requirements exist, as well as greater economic and political incentives.
When animal researchers working within academia are asked why they don’t substitute their animal experiments with human biology-based approaches, they report that replacement simply isn’t a realistic option, that it is impossible to implement without disturbing the flow of their research. So, what is the ‘flow of research’? In the context of academic animal research at least, it is the flow of securing funding, publications and scientific careers – the flow of scientific capital, in other words. I write about the need to attend to scientific capital in a paper recently published in NAMs journal. In this paper, I also touch upon the concept of displacement, suggesting it is more in tune with an emphasis on phasing out animal research, whereas replacement, with its implication that there is something that needs to be replaced, continues to assert the primacy of animal research. Towards the end of a talk I wish I had come across when writing that paper, Nico Muller suggests that while replacement focuses on substituting existing animal experiments, displacement might focus on preventing more animals from entering the research pipeline in the first place. It’s a helpful distinction.
We erroneously placed our trust in animal experiments – a case of misplacement. But perhaps our trust in replacement is also misplaced. If we want to get firmly onto the path of human relevant research then we need to avoid the distraction of animal experiments and use human biology-based methods to answer questions about humans. That’s not replacing animal experiments, it’s avoiding them because they’re not relevant to human health.
For more discussion on phasing out animal experiments and how this might occur, watch Nico Muller’s talk and/ or read my paper, which provides a sociological perspective on the issue: https://www.sciencedirect.com/science/article/pii/S3050620425000521
In our new paper, Safer Medicines Trust Research Director, Pandora Pound, explores whether a sociological perspective can help explain why animal research persists within academia despite the availability of scientifically superior, non-animal methodologies (NAMs) – and whether it can expedite a transition away from animal experiments.
Drawing on the theoretical framework of French sociologist Pierre Bourdieu, she explains how animal research maintains its dominance through ‘symbolic capital’ — the rewards and recognition scientists acquire for publishing papers and obtaining funding — and how shifting to NAMs may place this capital at risk. She highlights the relationship between the animal research field and the ‘field of power’ (government, regulators, funders), suggesting this may be delaying the pace of change, and arguing that we need to be alert to the ways in which current power relationships may be perpetuating access to capital for animal researchers and denying it to NAMs scientists.
The paper emphasises that transitioning to NAMs is not just about having the right technologies available, it’s about tackling the academic system of rewards and disincentives, it’s about examining the balance of power and how it works to promote animal research, and it’s about changing what counts as capital within academia, so that scientists are rewarded, not for publishing ‘high-impact’ papers and acquiring prestigious grants, but for conducting scientifically robust, ethical science that will actually make a difference to people’s lives.
An essential read for those working on the transition. Find it here: https://lnkd.in/efXAXJvz
It is wonderful that the government is currently working on a roadmap to phase out animal testing. But if it does not include specific targets and clear timelines, it will not alter the status quo, which is deeply entrenched and resistant to change.
Sign this petition to call for an ambitious and detailed UK roadmap for the phase-out of animal research and testing. This is a once-in-a-lifetime opportunity – we must make sure it really delivers!
Recent developments in the US have taken us all by surprise, not only because they were unanticipated, but also due to their breadth and ambition. First the Food and Drug Administration (FDA) declared its plans to replace the use of animals with human-based approaches in the development of monoclonal antibody therapies and other drugs,1 then the Environmental Protection Agency (EPA) stated that it planned to reinstate a deadline to eliminate the use of mammals in testing by 2035,2 and the National Institutes of Health (NIH) announced the formation of a new department dedicated to expanding human-based science and reducing animal use3.
This was followed by a statement from the US Navy that it will end its research on cats and dogs.4 The most recent announcement, during a workshop held by the FDA and the NIH, was that all new NIH funding opportunities will henceforth incorporate language encouraging consideration of non-animal, new approach methodologies (NAMs) and that proposals exclusively for animal models will no longer be funded.5So, how are the US organisations that promote and advocate for animal research responding to these developments? (more…)
A cultural shift
Much has been written about Nicole Kleinstreuer’s announcement in the joint workshop between the FDA and the National Institutes for Health (NIH), namely that all new NIH funding opportunities will henceforth incorporate language encouraging consideration of NAMs and that proposals exclusively for animal models will no longer be funded.
This is wonderful news, but there were even more things to cheer in this workshop, held on July 7th, on the topic of reducing animal testing. For one, Kleinstreuer, who is Acting Deputy Director for Program Coordination, Planning, and Strategic Initiatives at NIH, noted that the first priority of the NIH is to improve population health, but this could not be done using outdated animal-based models. The NIH is investing in NAMs, she said, so that the best science possible is employed to improve public health protection. Second, she spoke inspiringly about the importance of creating long-lasting transformation: ‘We’re not just investing in NAMs’, she said, ‘we’re creating the policy, infrastructure, and partnerships that make that sustainable adoption possible. So, we’re not just shutting down animal labs overnight, we are actually developing long term solutions that ensure there are no new animal labs that open up in their place.’ Third, she noted that NAMs are not ‘side projects’, but ‘foundational’, so that NIH funded research becomes rooted in human relevance. And fourth, referring to plans announced earlier in the year to provide training for reviewers and regulators, she emphasised, ‘These are not just administrative tasks, they are cultural shifts.’ All in all, she described a systems-based approach to transition, focusing on phasing out animal use as well as phasing in NAMs, to ensure lasting cultural, as well as scientific, transformation of the NIH into an institution that prioritises human biology-based research.
And Kleinstreuer was not the only one. I never thought I would hear such enthusiasm about ending animal experiments from an FDA Commissioner, but Commissioner Makary was on fire. He noted that one of his main goals – one of the first he acted on within weeks of gaining office – is to reduce animal testing and said he was struck by how much consensus there was on the topic. Speaking of reducing animal use he said: ‘For one it can help deliver cures and meaningful treatments faster, to the public. Number two it can reduce R&D costs and potentially even translate into lower drug prices, which is an important agenda item for this administration. It can also encourage more innovation. It reduces the capital requirements for new drug development, and finally it’s more humane and more ethical for animals. God did not make animals on planet Earth for us to abuse and torture. And so we have to respect animals and this workshop is aimed at reducing animal testing in every way we can, while safeguarding the public with medications.’
To hear such words issuing from the FDA and NIH is remarkable and signals a clear cultural shift within the US. Imagine similar statements from the UK’s Medicines and Healthcare products Regulatory Agency, or from the UK’s Medical Research Council or Biotechnology and Biological Sciences Research Council. We can only hope that our government is aware of and emboldened by these awe-inspiring developments as it moves forward with its strategy to reduce the use of animals in scientific research.
Watch the inspirational workshop here: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-nih-workshop-reducing-animal-testing-07072025
May 20th every year marks Clinical Trials Day, to recognise the day in 1747 when James Lind, a ship’s surgeon in the British Royal Navy initiated what is considered to be one of the first ever clinical trials to study the effects of different treatments on scurvy (vitamin C deficiency) using control groups. Lind made the connection between the benefits of citrus fruits and reduction of scurvy after carrying out a clinical trial in 12 people, only two of whom received the citrus fruits. The principle of using human-relevant data to predict and treat human disease is represented in the pioneering work performed by Lind. (more…)
It all began on 10th April, when the US Food and Drug Administration (FDA) announced its intention to take ‘a groundbreaking step to advance public health’ by using ‘more effective, human-relevant methods’ to replace the use of animals in the development of monoclonal antibody therapies and other drugs.
Instead of using animals, the FDA will use a range of approaches, including AI-based computational modelling, human organ models and real-world human data. This, the agency says, will speed up and reduce the costs of drug development as well as improve drug safety. FDA Commissioner Martin Makary, who has only been in office since 25th March 2025, says the new approach ‘is a win-win for public health and ethics,’ noting that ‘Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root.’ (more…)
We have just had our latest paper published, in JRSM Open. A little different from our usual studies, this one is about the safety of a scheme run by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The Early Access to Medicines Scheme (EAMS) was established in 2014 to provide access to medicines that don’t yet have a marketing authorisation for UK patients with life threatening or seriously debilitating conditions. Sounds good? We were interested to see whether, ten years on, it is benefiting patients. Strangely though, we discovered that patients have not been asked for their views, nor have any reviews of the scheme considered the perspective of patients, the people for whom it was ostensibly set up. Instead, we found that reviews focused on the benefits of the scheme to pharmaceutical companies – such as early guidance from the regulator and access to patient populations – and to the UK economy.
Our analysis focuses on 48 submissions to the scheme, relating to 48 indications (mostly cancer) and 32 individual drugs. Unfortunately, we found that the quality of evidence used by pharmaceutical companies to support their submissions was poor, with most studies using surrogate and/or survival outcomes and only 7% using double-blind, placebo controlled randomised trials. Even more worryingly, almost half the expedited drugs had elevated rates of suspected adverse reaction reports according to the pharmacovigilance data we examined. Shockingly, given the paucity and quality of evidence upon which most expedited drugs are approved, the MHRA does not even demand post-approval clinical trials to check whether the promised benefits actually exist.
Perhaps we should not be surprised about this. During her time at the MHRA, Dame June Raine, its Chief Executive Officer, has changed the culture of the agency from one that sees its responsibility as scrutinising pharmaceutical company data on behalf of the public, to one that makes it as easy as possible for companies to market their products. And she is quite open about this. In 2022 she gave a talk at Oxford entitled, ‘From Watchdog to Enabler’ and in 2020 she proclaimed to the House of Commons Science and Technology Committee and the Health and Social Care Committee, ‘The agency, which is an independent regulator, but formerly seen perhaps as a watchdog, should now become an enabler …’. (Q780)
Can a regulator make it as easy as possible for companies to market their products and at the same time protect the public health? Read our paper here: https://journals.sagepub.com/doi/10.1177/20542704251317916
We are very pleased to share our recently published paper in Frontiers in Drug Discovery on How complex in vitro models are addressing the challenges of predicting drug-induced liver injury.
Predicting which drugs might have the potential to cause drug-induced liver injury (DILI) is highly complex and the current methods, 2D cell-based models and animal tests, are not sensitive enough to prevent some costly failures in clinical trials or to avoid all patient safety concerns for DILI post-market. Animal-based methods are hampered by important species differences in metabolism and adaptive immunity compared to humans and the standard 2D in vitro approaches have limited metabolic functionality and complexity. The Alliance for Human Relevant Science hosted a workshop at the Royal Society, London entitled Drug-Induced Liver Injury (DILI): Can Human-Focused Testing Improve Clinical Translation? The conclusion was that complex in vitro models (CIVMs) provide a significant step forward in the safety testing paradigm. This perspective article, written by Dr. Katy Taylor and Alliance members representing collaboration across academia and industry, provides a ‘state of play’ on liver CIVMs with recommendations for how to encourage their greater uptake by the pharmaceutical industry.
Full citation: Taylor, K, Ram, R, Ewart, L, Goldring, C, Russomanno, G, Aithal, GP, Kostrezewski, T, Bauch, C, Wilkinson, JM, Modi, S, Kenna, JG, Bailey, J. Perspective: How complex in vitro models are addressing the challenges of predicting drug-induced liver injury. Front. Drug Discov. 5 – 2025.
Read the full paper here
In the move to transition away from animal research and towards New Approach Methodologies (NAMs), the emphasis tends to be on developing and validating NAMs, as if their availability alone will create the necessary momentum for transition.
But transition science tells us that things aren’t that simple and that in fact there needs to be at least equal emphasis on phasing out old technologies. In the case of animal research, one way of doing this might be to call a halt to animal studies that have clearly failed to generate any clinical benefits (stroke, brain injury, Alzheimer’s disease spring to mind). Another might be to immediately cease funding and approving studies that are clearly unnecessary, unscientific and unethical.
It was with the latter in mind that we read Animal Free Science Advocacy’s recent post about an Australian study published last month, which reported on an animal model of non-fatal strangulation (Sun et al 2025). Unbelievably, this model was developed to throw light on the injuries women can suffer at the hands of sexual partners (‘intimate partner violence’). The scientists assigned 6–7-week-old female rats to either control, brain injury, strangulation, or brain injury plus strangulation groups. Brain injuries were inflicted by using pneumatic pressure to propel a 50mg weight against the rats’ heads and strangulation was mimicked by suspending a 680g weight across the rats’ trachea for 90 seconds. Following a period of assessment the animals were killed and their brains examined. The results of this study? Strangulation plus brain injury presents differently to brain injury alone, exacerbating functional deficits, neuropathophysiology, and blood biomarkers.
