It’s estimated that more than 50 million mice, rats, dogs, cats, monkeys, rabbits and other animals endure experiments in U.S. laboratories each year. The sheer scale of this animal suffering is hard to imagine, but thanks to new commitments to phase out animal testing and prioritize replacing animals in research, things could soon drastically change.
We were thrilled when, earlier this week, the National Institutes of Health announced its intent to “prioritize human-based research technologies,” stating that “this human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments.” This will include the creation of a new office that will act as a hub to ensure coordination and implementation of efforts within and across agencies.
This is something worth celebrating: NIH is the world’s largest funder of biomedical research, with an annual $48 billion budget, so a shift in NIH’s funding priorities from research on animals to human-based technologies can have an immediate and significant impact on reducing the use of animals. NIH’s announcement amounts to an acknowledgment of the limited effectiveness of using animals to study and test treatments for human diseases such as Alzheimer’s and cancers. Its statement follows closely on the heels of similar announcements by the Food and Drug Administration and the Environmental Protection Agency.
These announcements make it clear that there is a dramatic paradigm shift underway for biomedical research and safety testing, one that we have been advocating for decades, here in the U.S. and around the globe.
The concept of alternatives to the use of animals first emerged in the early 20th century, but its clearest expression came with the development of an overarching rubric, the 3Rs (replacement, reduction and refinement), forged by scientists working with humane organizations in the late 1950s. By the 1980s, the 3Rs rubric had gained greater traction, and the worldwide influence of a revitalized animal protection movement helped to bring it onto the agenda of scientists, corporate leaders, regulators, legislators and philanthropists.
Now scientists can use advanced computational models to simulate human disease and drug interactions; human cell-based “micro-physiological systems” like organoids and organ chips to model human disease; and other sources of real-world information about human health to further medical progress. These modern, non-animal technologies are increasingly allowing scientists to address previously untestable hypotheses, accelerate the timeline for implementation, improve public health outcomes and deliver lifesaving treatments. They are helping health scientists to break free from an obsolete cycle of creating artificial disease models through genetic, surgical or other manipulations of animals to study human diseases—a process that NIH acknowledges is flawed “due to differences in anatomy, physiology, lifespan, and disease characteristics.”
Last year, NIH launched the Complement Animal Research in Experimentation program, an ambitious and multifaceted initiative to speed the development, standardization, validation, and use of human-based non-animal methods with a dedicated budget of approximately $400 million over ten years. We are pleased to be a partner in one component of this effort. And we are approaching this work pragmatically and collaboratively, to ensure that problems around reporting standards and data sharing can be resolved.
From one administration to another, over several decades now, we have been advocating for coordinated strategies across the federal government for transparency, translational science (which involves converting the results of biomedical research into direct clinical benefits to humans), and implementation of new approaches to replace the use of animals in research and testing over the longer term.
Our work toward this transformation in the U.S. includes:
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our backing of the Health Research Extension Act of 1985 and the NIH Revitalization Act of1993.
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our support for limiting new animal testing in the High Production Volume Chemical Program at the EPA which also provided dedicated federal funding for the first time for non-animal methods (1999).
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our support for passage of the Interagency Coordinating Committee on the Validation of Alternative Methods Authorization Act of 2000 to ensure better coordination of non-animal methods use across federal agencies.
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our contributions to the 2007 National Academies report, Toxicity Testing in the 21st Century, which helped to kickstart many government programs on non-animal methods.
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our successful lobbying for the first-ever call to end animal testing requirements in the Frank R. Lautenberg Chemical Safety for the 21st Century Act (2016).
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our formal legal petition pressing the FDA to clarify that animal testing is not legally required and to prioritize non-animal approaches (2024).
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our successful lobbying, year after year, in support of a federal shift toward research, development, scientific assessment and implementation of non-animal methods at the NIH, the EPA and the FDA.
Our work in this area doesn’t stop at U.S. borders. Since 2015 we have convened a series of international workshops to facilitate dialogue and collaborative policymaking through the Biomedical Research for the 21st Century (BioMed21) Collaboration. By bringing together government and private funding bodies, leading research universities and disease institutes, scientific journal editors, pharmaceutical companies, animal and patient advocacy organizations and other parties, our BioMed21 workshops are helping to build trust and a common understanding around the promise of human-based methods to address public health needs without harming animals. Our recent workshops in Europe, India and Brazil attracted dozens of high-level officials and thought leaders, including a representative from NIH, and galvanized support for: discussions to include non-animal methods in a new European Life Science Strategy this year; the launch of three new funding opportunities specific to non-animal methods by India’s Department of Biotechnology and the Indian Council of Medical Research, and a consortium to create a non-animal methods funding roadmap for India; and potential new opportunities for funding for non-animal methods in biomedical research under Brazil’s forthcoming 10-year science strategy.
NIH’s commitments are exceptional, but to carry them out with genuine impact will require broad collaboration among agencies, international and public-private partners, as well as substantial, sustained funding, worldwide. Advances in this space—such as the lung-on-a-chip technology, pioneered by Harvard University’s Wyss Institute in 2010 and highlighted in NIH’s press release on its plans—have required the support and funding of government agencies and the engagement of philanthropy-funded science hubs. So, while these new announcements about federal commitments are welcome, the Trump administration and others that follow will need to sustain momentum in this area with proper funding allocations.
What is good for animals can be inextricably linked to what is good for humans, and in this case, there is strong global support for bringing animal use in the laboratory to an end. Now it becomes a matter of creating the permanent systemic changes needed to bring that vision of a better world to life.
Sara Amundson is president of Humane World Action Fund.
