Better Patient Outcomes: NIH Must Go Beyond Animal Research

By Catharine E. Krebs, Ph.D.

At one point or another, each of us is touched by the disease, whether it’s your aunt with dementia, your neighbor with cancer or your brother with COVID-19. Medical research is the basis of advances that keep you and your loved ones healthy. We all have a stake in research being the best it can be.

The National Institutes of Health (NIH) is the world’s largest funder of medical research, with an annual budget of just under $43 billion in 2021. But NIH-funded research largely relies on animal experiments: About half of NIH-funded grants have an animal component, resulting in the use of as many as 100 million dogs, cats, monkeys, mice, rats, and other animals in labs Americans every year. A research enterprise that depends on animals is far from the best it can be.

Due to species differences in anatomy, physiology, lifespan, and disease characteristics, animal experiments do not reliably inform patient outcomes. Analyzes of many disease areas, from Alzheimer’s disease to cancer to sepsis, show that the results of animal testing don’t translate well to humans. Animal experiments are also an inefficient use of funding. New drugs can take 15 years and cost $2 billion to develop, but fail 95% of the time after passing extensive animal testing. The United States has invested more than $10 billion in Alzheimer’s disease research alone over the past 10 years, but, in part because of failed attempts to model the disease in animals, there is no still no clearly effective treatments to demonstrate. The reality is that Americans are inundated with drugs that don’t work and expect miracles.

The NIH itself increasingly recognizes the serious scientific and ethical problems associated with animal research; but instead of prioritizing non-animal approaches, the agency continues to double down on trying to improve and expand existing animal research. In 2019, a special task force was formed to provide the NIH with recommendations to improve rigor, transparency, and translatability in animal research. Among the motivations for the formation of this group is the major crisis of translatability of biomedical research described above: the inability of preclinical research in animals to successfully justify, design and inform human clinical trials.

However, on June 11, 2021, the task force presented its final report, which contained a bewildering slew of recommendations to improve and expand animal research. Instead of calling for a reduction in the number of animals used, the group recommended increasing the number of animals to improve study design and statistical capabilities. Instead of investing in non-animal models that are more relevant to humans, the working group recommended trying to improve the relevance and use of animals. Ultimately, the task force failed to recognize how the unreliable and often secretive reporting of animal numbers by institutions and investigators contributes to a lack of accountability and public trust.

To truly overcome the barriers to translatability, the NIH must radically move away from the use of animals and begin investing heavily in human-specific research: approaches that use human cells, tissues, and data to better understand how diseases arise and why some people are more at risk than others, and to develop more effective treatment strategies for patients and communities.

Human-specific non-animal models, such as tissue chips and organoids, use patient-derived cells to replicate the structure and function of human tissues in 3D. Not only do these approaches model human physiology, disease states, and clinical responses to drugs more closely than animals, but they also offer key advantages over comparable animal-based systems, such as microenvironmental monitoring, longitudinal monitoring , high throughput experimentation and patient care. specific modeling, all in a shorter time and with fewer resources and ethical burdens. Such models are currently available for a wide range of diseases, tissue types, and even multi-organ systems, but funding for these approaches is still massively overshadowed by funding for animal-based models. In addition to improving translatability, the focus on human-specific research at NIH would reduce the number of animals used in research, a principle to which the US government and the American public are committed.

The NIH said a major barrier to achieving more translatable research will be “addressing cultural incentives to maintain the status quo.” That’s true, but we need to be clear about what the biggest problem with the status quo really is. It’s not that animal research lacks characteristics like rigor, reproducibility, and validity, it’s the NIH’s reliance on the use of animals and its general reluctance to stray from that paradigm.

No number of nonhuman animal research reforms will increase translatability enough for animal research to be fruitful or meaningful. The NIH must accept its own culture of continually prioritizing animal-based methods over more ethical and translatable non-animal methods. Only then will the agency address the scientific status quo that serves patients and animals so poorly.

This guest essay was written by Catharine E. Krebs, Ph.D., a research fellow with the Physicians Committee for Responsible Medicine, a national organization of physicians and laypeople promoting preventive medicine, conducting clinical research, and encouraging higher standards of ethics and effectiveness in medical research and training.

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