“The future of medicines regulation in the UK” was the subject of a recent Westminster Health Forum meeting at which our Director, Dr Jan Turner described why innovation and the development of methods to ensure safe and effective medicines, is imperative for the UK. The talk drew on a previous meeting in July 2020 where Jan also spoke but included some reflections this time on lessons learned from the COVID pandemic which may be exploited to develop safer medicine, and post-Brexit opportunities for the UK regulatory body MHRA to support the approval and inclusion of human relevant methods into medicines testing. Dr Turner’s slides are available here..
Safer Medicines Trust was a partner in a world-first comparative study led by the US Evidence-based Toxicology Collaboration (EBTC) and the Norwegian Institute of Public Health.
The collaboration conducted a comprehensive comparison of the in vivo (animal and human) and in vitro tests currently available to assess drug safety and compared their findings against ‘real world data’ on adverse drug reactions. They focused on two diabetes drugs: troglitazone (Rezulin), which was withdrawn from the market due to severe and fatal liver toxicity and rosiglitazone (Avandia), which remains on the market in the US.
Neither drug indicated a strong hazard signal in either preclinical animal studies or human trials. In contrast, in vitro data (using human cells and tissues) found that Rezulin exhibited strong signals for off-target effects on the liver, while Avandia did not.
This world-first comparative approach found that preclinical animal and clinical human trials – despite being mandatory – did not predict Rezulin’s potential to cause harm. Tests on human cells and tissues could have clearly revealed the hazard, which caused hundreds of liver injuries and killed at least 63 people. Sophisticated human-relevant technologies now offer a new paradigm for preventing adverse drug reactions and saving patients’ lives.
View the open access publication in Nature Scientific Reports here: www.nature.com/articles/s41598-021-85708-2
Our research consultant Dr Pandora Pound recently guest edited a special issue of the journal ‘Animals’ entitled “Are Animal Models Needed to Discover, Develop and Test Pharmaceutical Drugs for Humans in the 21st Century?” The key question she posed is whether there is value in refining animal models for medical research, or whether these should be relinquished in favour of new, human-focused research approaches. The seven open access, scientific papers that attempt to address this question, including Dr Pound’s editorial, can be found below.
A new All-Party Parliamentary Group for Human Relevant Sciences held its first AGM on Tuesday 6th October 2020, with the aim of accelerating the development and uptake of human relevant life sciences in the UK.
The APPG will be a discussion forum for politicians, the human relevant life sciences sector, third sector groups, scientists and stakeholders to promote new approach methodologies that provide unique insights into human biology, transform our ability to understand human disease and can develop effective new medicines more quickly and without the use of animals.
Speaking at the launch, the APPG’s Chair and Safer Medicines Trust Patron, Labour MP Grahame Morris, said, “I am delighted to Chair the new All-Party Parliamentary Group on Human Relevant Science. The COVID-19 pandemic has demonstrated that the current approach to developing new treatments is simply not fast enough to meet humanity’s needs. We urgently need a moonshot to transition to new approach methodologies which promise to deliver safer and more effective medicines, more quickly and at less cost.”
APPG Vice Chair and Safer Medicines Trust Patron, Conservative MP Sir David Amess said, “I am thrilled to be Vice Chair of the new All-Party Parliamentary Group on Human Relevant Science. With the cancellation of the Autumn Budget, the Government now has more time to think about what it can do to provide much-needed financial support to boost growth in the human relevant life sciences sector and enable the UK to remain an innovative science superpower.
“As the country seeks a COVID-19 vaccine, this is the perfect time for parliamentarians to take seriously the growing evidence in favour of the pioneering human relevant medical research techniques that are replacing the outdated use of animals.”
For more information on the APPG, please contact us at 0300 302 0521 or email info@SaferMedicines.org