The scientific community is divided over the use of animals in scientific research. Proponents say animal testing contributes to lifesaving cures and treatments and science at some level still needs the full system. Opponents say animal testing is inhumane and not physiologically relevant to humans. Several in vitro and in silico approaches better mimic human physiology with equivalent or better accuracy. The question is: Are we ready to establish a new gold standard and demonstrate confidence in nonanimal research methods (NAMs)? The Roundtable Session “Are Animal Studies Still the ‘Gold Standard’ for Validating New Approach Methods?” during the 2022 SOT Annual Meeting debated if animal studies should still be continued to address scientific questions.
The first speaker of the session, Dr. Matt Bailey from the National Association for Biomedical Research, advocated for the use of animals in biomedical research. According to Dr. Bailey, many of the revolutionary therapies such as blood transfusions, vaccines, insulin, and antibiotics were developed using animal data. Additionally, roughly 84% of the Nobel Prizes in Physiology and Medicine are awarded to animal-based research. Moreover, using animals for biomedical research benefits not only humans but animals, too. Federal organizations have started to take alternatives seriously, but we cannot negate the total narrative of the importance of animals in basic science research. So, if we ask ourselves whether to completely replace animal testing with NAMs, the answer is most likely not. NAMs can be used as an early screening tool, thus reducing the number of experiments that are meant to fail in the initial stage, but claiming to replace the use of animals is a bridge too far.
The next speaker, Dr. Helena Hogberg from NIEHS/NTP, advocated for the use of NAMs and for establishing a new gold standard in biomedical research. Dr. Hogberg argued that 90% of drugs fail in clinical trials and the reproducibility of animal data is not 100% due to species-specific differences. Dr. Hogberg also discussed several drugs that are now withdrawn from the market due to adverse side effects in humans but did not show toxicity in animal models. In several instances, the toxicity of the drug was predicted using NAMs but not using an animal model. As an avid supporter of NAMs, Dr. Hogberg asked the scientific community to show confidence in NAMs and wear that confidence proudly.
The final speaker of the session, Dr. Szezpan Baran from VeriSIM Life Inc., opposed the use of animals in research. Dr. Baran emphasized that the “age of animals” is now over and emerging NAMs platforms such as organ-on-chip and organoids have demonstrated tremendous ability to recapitulate human physiology and disease states.
The final and the most interesting section of the session was the panel discussion moderated by Dr. A. Wallace Hayes. All the speakers questioned what type of data is needed to qualify for alternative approaches. There is no consensus among regulatory scientists over the use of animals; therefore, the use of animals in research is a critical issue in moving forward. The biggest questions are: If we do not have animal data, are we ready to make the decision? Are we ready to go to clinical trials without going through safety and efficacy studies in animals? Also, how confident we are with safety and animal efficacy studies that are not 100% human relevant?
This blog was prepared by an SOT Reporter and represents the views of the author. SOT Reporters are SOT members who volunteer to write about sessions and events in which they participate during the SOT Annual Meeting and ToxExpo. SOT does not propose or endorse any position by posting this article. If you are interested in participating in the SOT Reporter program in the future, please email Giuliana Macaluso.
On-demand recordings of all Featured and Scientific Sessions delivered during the 2022 SOT Annual Meeting and ToxExpo will be available to meeting registrants in the SOT Event App and Online Planner after their conclusion, through July 31, 2022.