News

An open letter to:

International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
The International Coalition of Medicines Regulatory Authorities
European Medicines Agency
European Directorate for the Quality of Medicines and Healthcare
European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)
Home Office
Department of Health and Social Care
Department for Business, Energy & Industrial Strategy
Medicines & Healthcare products Regulatory Agency
National Institute for Health and Care Excellence (NICE)

We are calling for a change of mindset and a clear timetable for regulatory change to enable accelerated development of medicines which are likely to be safer, more effective and cheaper, without the use of animals. Investment in human relevant science offers a golden opportunity to revitalise medical research, save money, create wealth and improve public health.

We find ourselves in a time of global health emergency, one that will challenge our healthcare, social fabric and economy for years to come. Hard choices today have been borne out of great and immediate need. Yet there are patterns emerging in the scientific response that will have far reaching consequences for how we progress medical science in the future.

Continue reading “A CALL TO ACCELERATE HUMAN-FOCUSSED MEDICAL RESEARCH”

Hosted by the Physicians Committee for Responsible Medicine, in conjunction with US Congresswoman Lucille Roybal-Allard, our Pharmaceutical Director, Dr Gerry Kenna, recently spoke on why “Human-relevant models are needed to understand and treat human COVID-19 disease” at PCRM’s Congressional hearing “Confronting COVID-19: A Briefing on Prioritizing Human-Based Research”. A recording of the event is here and Dr Kenna’s slides are here.

by Kathy Archibald, Chair, Safer Medicines Trust

Coronavirus: we’ve never had a better opportunity to harness the power of human relevant approaches

Unprecedented research efforts are underway across the world to combat the covid-19 pandemic. Much of this work involves testing potential treatments or vaccines in various animal species, both for safety and effectiveness. What is the likelihood that these animal studies will help us to find a vaccine or treatment within the ambitious timescale of 12 to 18 months?

Continue reading…

On November 6 2019, Merel Ritskes-Hoitinga, Professor of Evidence-Based Laboratory Animal Science at SYRCLE (Systematic Review Center for Laboratory (animal) Experimentation www.syrcle.nl) in the Netherlands, was appointed Officer in the Order of Orange-Nassau, a civil and military Dutch order of chivalry open to “everyone who has earned special merits for society”. This honour, bestowed upon Professor Ritskes-Hoitinga following her inspirational inaugural lecture at the University (transcript here), comes after 30 years of improving the quality of animal research in the Netherlands and elsewhere, and dedicating herself to developing systematic review* methodology in the field of preclinical research.

Continue reading “Delivering better evidence with non animal studies – video of Prof. Ritskes-Hoitinga’s talk now available here”

Our latest newsletter contains brief summaries of our recent publications and some thoughts on progress towards more widespread use of human relevant technologies: what are the major barriers and ways to overcome them. Read it here and if you would like free hard copies, just let us know how many: email info@safermedicines.org or call 0300 302 0521

As a member of the Alliance for Human Relevant Science, Safer Medicines Trust calls for a fresh approach to biomedical research and drug discovery.

New approach methodologies (NAMs) that are human relevant have the potential to improve the efficiency of drug research and development and to deliver safer, cheaper and more effective medicines to patients.

In the new White paper ‘Accelerating the Growth of Human Relevant Life Sciences in the United Kingdom’, the Alliance calls for support from the Government to assist businesses in the transition to NAMs by providing supportive infrastructure, strategic funding, education, collaboration between industries and regulatory engagement.

There is an opportunity for the UK to be a world leader in developing and evaluating NAMs. Investment in human relevant methods is good for both business and public health.

Read the White Paper summary document
Read the full paper

This new study by Pandora Pound and Rebecca Ram from Safer Medicines, published in BMJ Open Science, analyses the opinions of scientists who conduct animal studies of stroke. At present there is only one drug available for patients with acute stroke, a ‘clot buster’ called Alteplase (and this drug was not directly dependent upon animal research for its development). Alteplase can only be given to a minority of stroke patients, half of whom will not benefit from it, so there is an urgent need for effective treatments in this area. Given the failure to develop treatments for acute stroke despite decades of animal research in this field, the study aimed to explore scientists’ views about the way forward.

We found that scientists conducting animal studies of stroke agreed that the field was in crisis, and many robustly criticised the science in this area. When it came to identifying the causes of this crisis, most scientists focused on the poor quality of animal studies. Similarly, when it came to solutions, most proposed improving the quality of animal studies in the hope that this would ultimately translate into benefits for stroke patients. A small number of researchers proposed using human in vitro methods alongside animal studies and one proposed using human focused methods instead of animal studies. Although there is evidence then, that a minority of scientists are beginning to consider human focused approaches, our study indicates a strong resistance to relinquishing the use of animal models in stroke research, despite decades of their failure to produce any benefits for stroke patients.
Read the paper in full here

A systematic review is a way of systematically bringing together the findings from research studies in a particular field and this paper is about the appropriate use of systematic reviews in the field of animal studies. Some researchers suggest that systematic reviews of animal studies conducted prior to human trials (i.e. prospective systematic reviews of animal studies) would allow scientists to scrutinise data on the safety and efficacy from animal studies, helping them decide whether or not human trials should proceed. However Pandora Pound from Safer Medicines Trust, together with Merel Ritskes-Hoitinga from Radboud University in the Netherlands, argue that while prospective systematic reviews can make the evidence obtained from animal studies more transparent, individual studies in animals are not necessarily able to reliably predict the safety and efficacy of an intervention when trialled in humans, and so systematic reviews of these individual studies would likewise fail to offer reliable predictions of safety and efficacy. As a result they would not be able to reliably safeguard humans participating in clinical trials. The authors also note that animal and human studies are often conducted concurrently, which not only makes prospective systematic reviews of animal studies impossible, but suggests that animal studies do not inform human studies in the expected way. They argue that it is time to review expectations of what animal studies can deliver and focus instead on investigating how clinical knowledge is actually produced. Read the full paper here

The open access journal ‘Animals’ is running a Special Issue guest edited by Pandora Pound of Safer Medicines. The topic for the Special Issue is ‘Are Animal Models Needed to Discover, Develop and Test Pharmaceutical Drugs for Humans in the 21st Century?’ Original manuscripts that address this question are invited for the Special Issue. The deadline is May 15th 2020. More information can be found here: http://www.mdpi.com/journal/animals/special_issues/animal_models_2020

Background to call for papers
Despite many decades of research, much of which has focused on studies in animals, humans continue to suffer from diseases and illnesses for which there are no cures or treatments. It is now clear that insights provided by animal studies do not often translate to humans, explaining the very high failure rate observed when new medicines are evaluated in human clinical trials. In addition, there is increasing evidence that animal studies are frequently conducted so poorly that no clear conclusions may be drawn from them. Some claim that if only the quality of animal studies was improved, and animal models were made to more faithfully capture the relevant human disease, then these models would begin to translate and deliver clinical benefits. Others argue that research focusing on humans is necessary to gain a better understanding of human disease and to develop safe and effective drug treatments.These scientists point to developments in human biology during the last decade that have yielded in vitro and in silico techniques capable of providing novel insights into human disease mechanisms, as well as human-relevant disease models for developing and testing drug treatments for humans. A key question is whether there is value in refining animal models, or whether these should be relinquished in favour of new, human-focused research approaches.

Dr Azra Raza, Professor of Medicine at Columbia University in New York, international authority on leukaemia, and Science Adviser to Safer Medicines Trust, has written a remarkable and highly recommended new book published in October 2019: The First Cell: And the human costs of pursuing cancer to the last

In amongst highly moving stories of her patients, including her own husband, Dr Raza explains why the global cancer research effort should make two major changes of direction:

1) to focus on prevention and early detection, to find the first malignant cell instead of attacking late-stage disease; and

2) to focus research exclusively on humans and their tissues, rather than on mice, rats and other futile animal models.

To that end, she has founded the First Cell Center, to study her tissue repository of more than 60,000 samples collected from her patients over the past 35 years.

Many articles and interviews are available from https://azraraza.com. This video: Early Footprint and this news article: Here’s why we’re losing the war on cancer, according to this doctor are a great place to start, along with this powerful and moving 13-minute TEDx Talk from 2014.

By Dr Jan Turner

Today is the inaugural #WorldPatientSafetyDay, the objective of which is to raise global awareness about patient safety and encourage global solidarity and action. So, from my perspective as Director of the Safer Medicines Trust, I would like to raise the subject of the safety of patients taking medicines. Continue reading “Why is patient safety compromised in the development of new medicines?”

In response to: Drug discovery and preclinical drug development – have animal studies really failed?

By Pandora Pound and Merel Ritskes-Hoitinga

Response: Let’s work together to explore the evidence base for all preclinical research methodologies

Hear our Director Dr Jan Turner speak about barriers and progress to adoption of human relevant in vitro models in drug discovery at the Advances in Cell and Tissue Culture conference in Cardiff, June 2019

See our Pharmaceutical Director, Dr Gerry Kenna, present on the prediction of human hazard using in vitro data at the British Toxicological Society (BTS) Annual Congress, Cambridge UK, 17th April 2019.

Watch the 30 minute presentation here

Open Access (free) E-book, also available to buy in hard copy from scholarly publisher Brill

In this important new book, 51 authors critically review current animal use in science, present new and innovative non-animal approaches to address urgent scientific questions, and offer a roadmap towards an animal-free world of science.

Edited by Drs Kathrin Herrmann and Kimberley Jayne

Featuring a chapter by Kathy Archibald, Tamara Drake and Dr Robert Coleman, entitled: Replacing Animal Tests to Improve Safety for Humans

Watch a 30 minute presentation of the chapter, from the recent London Book Launch Conference, by Dr Jan Turner

Researchers, academics and representatives from the pharmaceutical industry and advocacy groups have joined together to call for a significant and urgent shift to prioritise predictive, human-based nonclinical tests.

Drug Discovery Today has published the call from participants of the Nonclinical Innovation and Patient Safety Initiative, including Dr Gerry Kenna of Safer Medicines Trust.

Read the Open Access paper

We are deeply saddened by the death of Paul Flynn MP. It was a great honour for us to have his support as a Patron. He was a politician of courage and conviction and a fearsomely talented communicator, which made him a powerful advocate for causes he cared passionately about, including social justice and improving the safety of medicines. He was a towering figure in the House of Commons and in his beloved Welsh homeland and will be greatly missed.

Dr Gerry Kenna, our Pharmaceutical Director, spoke at the second WIST Congress in Germany on October 27th 2018

•  View 30 minute talk
• View slides
• View programme
• Read all abstracts and view all talks in English and German

We are delighted to announce the appointment of Dr Jan Turner as our new Director. She brings with her a wealth of experience in developing and promoting human-relevant in vitro technologies, including directing validation studies and influencing organisations such as the FDA to introduce such technologies into the early safety testing of drugs.

After completing her BSc in Biochemistry & Pharmacology, followed by a PhD and postdoctoral research in Genetic Toxicology, Dr Turner worked for Amersham Biosciences, subsequently GE Healthcare Life Sciences. Her roles included Development Scientist, Project Leader, Global Product Manager and Product Management Operations Leader. For the past 18 months she has been Senior Product Manager at BBI Solutions, directing global cross-functional teams and driving adoption of innovative technologies.

Jan is passionate about human-focused biomedical research and we look forward to her leadership in making medicines safer by accelerating the transition from animal-based to human-relevant drug development and testing. She says:

“I am thrilled to join Safer Medicines Trust and to work with so many talented and inspirational people towards our shared vision of a future where safe and effective treatments for patients will be delivered by scientifically valid, human-focused research.”

Kathy Archibald, our founder and Director for the past 14 years, remains the Chair of Trustees and will continue to manage Supporter Communications as the charity moves from strength to strength. She says:

“We are excited to welcome Jan to lead our team at this important time. I believe our expert team and the many visionary scientists and others with whom we collaborate will help to realise a future where better science will improve our health and save lives.”