2014 Public Lecture

2014 Public Lecture

About the speaker:

Thomas HartungThomas Hartung, Chair for Evidence-based Toxicology, Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing, Baltimore, USA

Thomas Hartung has devoted his career to promoting a paradigm shift in toxicity testing to improve public health, via a strong evidence base. As the previous Director of the European Centre for the Validation of Alternative Methods of the European Commission (2002-2008), Thomas was involved in the implementation of the European REACH legislation and the ban on animal testing for cosmetics. Through this EU leadership, and as the current Director of the Center for Alternatives to Animal Testing, he assumed a key role in promoting the 2007 NRC vision document “Toxicity Testing in the 21st Century – a vision and a strategy” and the success in the translation of concepts for evidence-based medicine to toxicology. This aims for systematic assessment of the quality of all tools for regulatory toxicology, and the development of new approaches based on annotated pathways of toxicity.

To the field of animal alternatives for experimentation and testing, Thomas brings a broad background in clinical and experimental pharmacology and toxicology, documented in more than 350 publications. Thomas has been the recipient of many awards including the 2009 Russell & Burch award of the Humane Society of the US, the 2010 Agilent Thought Leader award, and the 2006 US Society of Toxicology Enhancement of Animal Welfare Award.

RSPCA Public Lecture 2014:
Safe drugs and products without animal testing?

Every year, about $3 billion is spent worldwide on animal tests to ensure the safety of consumer products—including drugs, chemicals, food, and cosmetics. While pesticides and drugs are extensively tested, food additives are mostly not, and the testing of cosmetics is even banned in some parts of the world. But what are these tests worth when a common, relatively safe drug like aspirin fails most of them? What does it tell us that 23 of 31 tested ingredients in coffee produce cancer in rats (other than humans are not 70 kg rats)? How many business and regulatory decisions are made on this flawed data? How many potentially useful or even life-saving drugs never made it to the clinics?

Over the last two decades a biotech revolution has taken place, which has delivered the proof-of-principle that we can do things differently. Roughly fifty alternative methods have been internationally validated and are increasingly used to establish product safety. The current alternative methods are used mainly to test for acute and local effects (such as skin sensitivity and eye irritation), but they serve as door-openers for a new era in regulatory science.

Exciting technical advances underlie the next generation of safety tests. New technologies can visualise and pinpoint what is happening when substances harm a tissue on a molecular level. Major advances include the development of miniature ‘organs-on-chips’ to test drugs and ‘virtual experiments”’ using computer modelling. Testing strategies which integrate a variety of tools may ultimately replace animal experiments entirely.

The emergence of new scientific tools for creating safer products (including ‘green’ toxicology for the design of the next generation of non-toxic substances) also allows quicker and less-costly development and manufacturing. Of course, it is crucial that the new methods maintain high safety standards. Despite the culture of validation that clings to what many believe is excessive regulation, the acceleration of technologies is forcing us to develop new methods of quality assurance, from the establishment of best practices, to systematic reviews and meta-analyses inspired by Evidence-based Medicine (EBM). A new regulatory science has emerged—one that is evidence-based, humane, and predictive for human risk.