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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.)

Continue reading “How to make drugs and feel great about everything. First Spark Media. September 2025”

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

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? Continue reading “How are US organisations that promote animal research responding to recent developments?”

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 7^th, 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 20^th 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. Continue reading “On Clinical Trials Day – May 20 2025”

It all began on 10^th 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 25^th 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.’ Continue reading “Astonishing April!”

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.

Continue reading “Two wrongs do not make a right: animal models of physical and sexual abuse”

A proposal to use the cosmetic animal testing bans as a legislative framework to advance safety standards in other areas, including medicines.

Our Scientific Consultant, Rebecca Ram, is also a Scientific Consultant to the Lush Prize team at the Ethical Consumer Research Association, for whom she has written this new report. It is a comprehensive but concise summary of the progress made in developing non-animal, human-relevant new approach methods (NAMs) for ensuring the safety of cosmetics.

Safer Medicines Trust does not normally comment on cosmetics testing – but this report show how the animal testing bans drove a sea change in innovation of human-relevant methods, and were ‘a unique move that cemented the cosmetics industry’s place as a propeller for innovation in the field of safety testing.’

If you have been confused by the convoluted saga of the on-off bans on cosmetics animal testing – this is a great summary of the whole timeline. Most importantly, it shows how public pressure drove this tremendous change, which could serve as a blueprint for other sectors to follow. The UK could seize this opportunity to become the global leader in animal-free innovation, to the benefit of human and environmental health, as well as the economy.

Safer Medicines Trust is part of the Coalition to Illuminate and Address Animal Methods Bias, otherwise known as COLAAB, so we were delighted when COLAAB was recently recognised for its important work with a Lush Prize in the category of Major Science Collaboration!

COLAAB is an international coalition of researchers and advocates from a range of organisations, charities and universities worldwide. It was formed in 2022 following a workshop to discuss how the bias towards using animal methods plays out within scientific publishing. Workshop attendees from publishing, academia, industry, government, and non-governmental organisations discussed this phenomenon and the impact it could have on scientists’ research and their careers. Two years later, COLAAB held another workshop, this one to explore the issue of bias in reviews of academic funding proposals.

There has long been anecdotal evidence of a bias towards using animals within academia. But what COLAAB has done is two things. First, and importantly, it has named the phenomenon. Being able to talk about ‘animal methods bias’ makes the issue much easier to discuss and helps people recognise it and – crucially – challenge it when it arises. Second, the coalition is collecting empirical evidence about how this bias plays out and how it affects scientists’ ability to get their studies published if they do not use animals. Not content with anecdote, COLAAB has conducted two surveys of scientists’ experiences of animal methods bias in academic publishing. The first was an initial foray into this field and the second, which should be published later this year, is a much larger survey, together with an analysis of biomedical publications. Further research is planned, including a qualitative study of the experiences of PhD students and early career researchers, and – hopefully – an investigation into animal methods bias within biomedical funding.

It’s wonderful that Lush Prize has recognised the importance of this collaboration. Congratulations to everyone involved!

For our first blog of 2024, we summarise five key messages from Safer Medicines Trust’s landmark new book, Rat Trap by Dr. Pandora Pound which we are delighted has been shortlisted for a 2024 Lush Prize in ‘Public Awareness’.

1. A lack of translation from ‘bench to bedside’ has existed for decades and there are many opportunities that can and must be embraced for change. Better treatments for diseases such as Alzheimer’s, stroke and cancer are long overdue. Knowledge obtained from animal studies cannot be reliably applied to humans.
2.  Science is at a turning point with the development of more powerful, human-relevant methods to investigate disease and drug discovery; for example in vitro assays , which have advanced from the origins of basic cell cultures through to ‘state of the art’ 3D organoids (‘mini organs’) and microphysiological systems (‘organs on chips’), as well  as advanced in silico models, which have evolved from simpler analyses to advanced deep learning models, incorporating artificial intelligence (A.I.) and the use of ‘big data’.
3. No single method provides a solution. Instead, new approaches must be combined in different and ‘bespoke’ ways to answer specific research questions and build evidence. These new approaches can be used in tandem with existing clinical approaches and clinical data, which at present are vastly underused.
4. The regulations governing animal research and pharmaceutical drugs require overhaul to accommodate the transition that is needed towards human-relevant science. Achieving a future with better drug safety and effective treatments depends on it. Regulatory action must be driven by government mandate. There is no specific legal requirement to test on animals, but long-standing guidelines and attitudes maintain a collective expectation that animals must be used.
5. It is time to break with tradition and embrace the human in disease research and drug discovery. Funding must be diverted away from animal research and towards human biology-based approaches as a matter of priority.  The issue of animal research affects all of us. Our health and safety are at stake. This is not just about animals – the effect on patients has been overlooked for far too long.

See more reviews and information on Rat Trap – the spark for a revolution in science – here
as well as media coverage of the book and interviews with Dr. Pandora Pound

It can be bought direct from the publisher Troubador here
Or from online bookshops, including Amazon here

World Patient Safety Day is grounded in the most fundamental principle of medicine – first do no harm 

“Medication Safety” is the theme for World Patient Safety Day 2022.

Safer Medicines Trust is a patient safety charity whose mission is to improve the safety of medicines, so we very much support calls for “Medication Without Harm”.

The World Health Organisation (WHO) quite rightly wants to reduce medication harm, which accounts for 50% of the overall preventable harm in medical care. US$ 42 billion of global total health expenditure worldwide can be avoided if medication errors are prevented.

However, the WHO does not address the fact that correctly-administered medicines also cause massive and ever-increasing harm, through adverse drug reactions (ADRs) which are not due to any errors or unsafe practices.

Our focus, at Safer Medicines Trust, is on the intrinsic safety of the medicines themselves, rather than on ‘downstream’ factors such as prescribing errors. ADRs kill more than 10,000 people in the UK each year, 100,000 in the US and 200,000 in the EU.

Clearly, our safety tests are failing – but why? A major reason is our reliance on animal tests as the ultimate arbiter of medication safety before proceeding to clinical (human) trials. The evidence is now overwhelming that animals cannot reliably predict drug safety for humans. This is borne out by the fact that 9 out of 10 drugs prove unsafe or ineffective in clinical trials, after appearing to be safe and effective in animal tests.

Thankfully, a wealth of new methods based on human biology is now available and is transforming our ability to understand disease and develop new medicines. Human-relevant tests can predict subtle or rare side effects that even human clinical trials cannot. Human-relevant science offers a golden opportunity to save money, create wealth and improve public health.

So why are we still relying on animal tests? As a new paper entitled A History of Regulatory Animal Testing: What Can We Learn? makes clear, moving away from animal testing is limited not by scientific possibilities, but by historical precedents and persistent beliefs that animal tests will prevent future tragedies. The thalidomide tragedy shocked the world and led to new laws requiring ‘proof of safety’ in animals, despite the irony that it was thalidomide’s near-total safety in animals that helped to cause the tragedy and would not have prevented it. No amount of animal testing can eliminate the risks inherent in introducing new drugs to the market. But regulations based on the state of the art of science and technology 60 years ago have not been updated to reflect the seismic technological advances that now offer a quantum leap forward in our ability to perform meaningful risk assessment.

It is time for governments to insist that medicines are tested by the most up-to-date and relevant methods. Outdated regulations cost lives: patients are being injured and killed because regulations have not kept pace with revolutions in science. Regulatory agencies the world over have been captured (and funded) by the pharmaceutical industry, which they are supposed to regulate, with the net effect that profits take precedence over patients.

In a recent egregious example, both Pfizer-BioNTech and Moderna submitted their omicron-specific covid boosters to the US regulator, the FDA, on the basis of tests in mice – and the FDA approved them, with no human data whatsoever! The US Government has bought 171million doses for $5bn, before seeing any evidence that they will be either safe or effective.

Dr Paul Offit, director of the Vaccine Education Centre at Children’s Hospital of Philadelphia and member of the FDA’s vaccine advisory committee (VRBPAC), says: “Right now they are saying that we should trust mouse data and I don’t think that should ever be true. I don’t think you should ever ask tens of millions of people to get a vaccine based on mouse data.”

This example illustrates the two biggest problems in pharmaceutical medicine: 1) the use of animal data to secure approval for products by claiming they are safe and effective in animals, when their safety and effectiveness in humans is unproven; 2) pervasive conflicts of interest, which prevent regulatory oversight in the interests of the public.

We must move safety testing into the sunlight and into the 21st century, for all our sakes.