News

Groundbreaking international study published in Nature Scientific Reports

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 They focused on two diabetes drugs: troglitazone (Rezulin), which was withdrawn from the market due to severe and fatal liver toxicity and rosiglitazone (Avandia), which remains on the market in the US.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

Share
Follow Us

Latest Blog Posts

Presentation: Ending animal testing to advance human relevant research via New Approach Methodologies’

By Rebecca Ram I was pleased to be invited to give a presentation on the issues concerning use of animals in research at a recent workshop hosted by Advocates for Animals, the UK’s first legal organisation devoted to animal protection. The theme of the workshop was “Animal experiments; the law, the framework and the alternatives”. […]

Safer Medicines Trust at the 11th World Congress on Alternatives (WC11) 

Scientific consultant Rebecca Ram presented during a virtual session as part of the ‘YOU-WC11’ mentoring programme. The session theme was ‘Challenges and Opportunities for Expanding the 3Rs’’ and was particularly aimed at early career scientists. The session was further divided to discuss two topics; ‘Dropping an R: Is it Time to Retire Refinement?‘ featuring Charu Chandrasekera of […]