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
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.
