Nature Scientific Reports 18 March 2021
UK patient safety charity Safer Medicines Trust was a partner in a groundbreaking international 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 They focused on two diabetes drugs: troglitazone (Rezulin), which was withdrawn from the market due to severe and fatal liver toxicity and rosiglitazone (Avandia), which remains on the market in the US.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 troglitazone exhibited strong signals for off-target effects on the liver, while rosiglitazone did not.
This world-first comparative approach found that preclinical animal and clinical human trials – despite being mandatory – did not predict troglitazone’s potential to cause harm. Human-based tests 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.
Rebecca Ram, scientific consultant to Safer Medicines Trust and one of the report’s authors, says:
“The government and the pharmaceutical industry must act now to employ the new human-based technologies which could slash the 10,000 deaths from adverse drug reactions in the UK every year.”
Dr Katya Tsaioun, director of EBTC at Johns Hopkins University and corresponding author of the study, says:
“Patients need safer affordable medicines delivered in their lifetime. The pharmaceutical industry is in crisis, with empty pipelines and skyrocketing costs. Focusing on human biology is the route to developing safer medicines faster and with lower total development costs.”
ENDS
Contacts: UK – Rebecca Ram 07719 382822 / rebecca@safermedicines.org
US – Katya Tsaioun PhD +1-410-456-2032 / Ktsaiou1@jhu.edu
Notes: The open access publication appeared in Nature Scientific Reports on March 18 and may be viewed here: www.nature.com/articles/s41598-021-85708-2
See this press release here: https://safermedicines.org/for-immediate-release-tests-on-human-cells-and-tissues-predict-dangerous-drug-side-effects-where-animal-tests-and-even-human-trials-fail/
About Safer Medicines Trust: Safer Medicines Trust is a patient safety charity whose mission is to change the way medicines are tested, to a system based on human biology: the only way to ensure safety for patients. Our scientists have extensive expertise in drug discovery and development. We have hosted international conferences at the Royal Society and the House of Lords, showing the benefits to drug safety and medical progress offered by a focus on human, rather than animal biology. We are a founder member of the Alliance for Human Relevant Science
About EBTC: EBTC is an international collaboration of research, regulatory and industry leaders, united in their vision to improve public health outcomes and reduce human impact on the environment by bringing evidence-based approaches to chemical safety sciences. By facilitating the modernization of the toxicological toolbox, reinvigorating the safety sciences, and integrating evidence-based approaches into decision-making, we hope that all interested parties – including stakeholders in government, industry, academia, and the general public – will be able to have more confidence and trust in the processes by which scientific evidence is assessed when addressing questions related to the safety of chemicals to human health and the environment.
