Difficulties with Animal Models and Alternative Approaches: Moving Toward New Forms of Testing

Putting Lessons Learned from SOT Scientific Sessions into Practice

Before I proceed with my report on the 2017 Workshop Session "Safety or Prediction? What is the Future of Regulatory Toxicity Testing," it would be appropriate to state my Conflict of Interest (COI) and bias, which is a concept I first picked up from the SOT Roundtable Session the previous day. In "Bias and Conflict of Interest in Conducting Research and Risk Assessment: Perspectives from Academia, Government, Industry, and Others," each speaker voiced not only if they had a COI, but a bias as well. Prior to that session, I had never attended a scientific session where speakers actively voiced their biases—consequently, the idea was new and impactful to me.

To continue in the spirit of education and application, my COI is that I work for Physicians Committee for Responsible Medicine (PCRM), whose mission is to reduce and replace the use of animals in biomedical research and toxicity testing. However, the words expressed in this post are my own and not necessarily the thoughts or views of PCRM. My bias is I believe, along with a large and growing body within the scientific community, that we can provide ethical, more human-relevant, and financially responsible toxicity testing using alternative approaches to animal testing.

One Scientist's Views on the State of Alternative Methods

Due to my own COI and bias, one presentation in particular from the 2017 Workshop Session "Safety or Prediction? What is the Future of Regulatory Toxicity Testing" stood out to me: Thomas Hartung, MD, PhD, Johns Hopkins Bloomberg School of Public Health, gave a phenomenal presentation titled "Systems Toxicology: The Final Goal of the Emerging New Approach Methods." I laughed, learned, and literally cried.

From Dr. Hartung’s very first slide, he had my full attention. He opened speaking out in solidarity of his colleague who was denied travel to the US because of his country of birth, which subsequently meant he was not able to attend SOT. In my opinion, Dr. Hartung subtly and respectfully preached about social responsibility, which received a warm applause from the audience.

He then segued into the problems animal studies have presented concerning predictivity of toxicity testing. He stated that although he is not of the camp that totally denies if animal testing has made our world a safer place, he strongly reiterates that animal predictive models leave room for improvement. He also recognizes that alternative methods, such as in vitro studies, have room for improvement in their current state, but are surely better on the ethical side.

Dr. Hartung and his colleagues have advanced this concept through their mini-brain project, which is an organo-typic cell culture that has simple brain function capabilities. Additionally, these organotype models are high-throughput and information rich. Dr. Hartung and associates are expanding this research with opportunities for human mini-brain research that can target specific populations.

Technologies like the mini-brain are driving a new type of toxicology testing, and in the process, opening up innovation and the need to manage big data. Just the same way the animal model paradigm is riddled with limitations and uncertainties, so are alternative tests. However, the scientific community has accepted the current paradigm of toxicology tests and, thus, can collectively move towards a different type of toxicity testing. Dr. Hartung appropriately concluded with a quote by John Maynard Keynes, “The difficulty lies not in the new ideas, but escaping from the old ones.”

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