The halls of Congress are currently weighing the future of biomedical research funding. As that debate unfolds, one question deserves more scrutiny than it is getting: what happens to rare disease patients if we eliminate the research tools that make their treatments possible? And what happens to American scientific leadership if we regulate those tools out of existence while our chief geopolitical rival races to fill the void?
The push to ban or severely restrict animal testing has grown louder in recent years, and some of those arguments carry merit in narrow contexts. However, when advocates and legislators apply that pressure broadly, without accounting for the patients who rely on treatments that have no other scientific pathway, they risk trading a moral talking point for a medical catastrophe — and handing China a strategic windfall in the process.
There are more than 10,000 known rare diseases, and approximately 95 percent have no FDA-approved treatment. The patients who do have options — children with Spinal Muscular Atrophy (SMA), patients with Duchenne Muscular Dystrophy, infants with Pompe disease — owe those breakthroughs to federal research infrastructure that utilizes animal research to answer questions that could not have been addressed any other way.
The development of Spinraza (nusinersen), the first approved treatment for SMA, hinged on pharmacokinetic and safety studies in non-human primates that confirmed the drug could effectively target the spinal cord. Similarly, Zolgensma (onasemnogene abeparvovec), a groundbreaking gene therapy approved by the FDA in 2019 for SMA Type 1, required biodistribution and toxicology studies to ensure its viral vector was safe before ever administered to a human infant. These are not bureaucratic hurdles, they are the bedrock of the science.
Proponents of ending animal research point to breakthroughs like organs-on-a-chip, human organoids, and AI-assisted drug screening as replacements. These technologies are genuinely exciting, and the Cure Coalition supports robust federal investment in accelerating their development. But excitement is not equivalence, and promise is not substitute for validation.
Rare diseases are frequently systemic. They do not attack one organ, they afflict the whole body. Current organ-on-a-chip platforms remain limited in their ability to model multi-organ crosstalk and systemic immune responses inherent in rare diseases. For conditions involving the human brain and immune complexity, non-human primates remain the only model with sufficient biological fidelity. Consider that the macaque model of Parkinson's disease provided the foundation for validating deep brain stimulation — a breakthrough that has since improved the quality of life for an estimated 160,000 patients worldwide.
There is also a critical geopolitical issue that opponents of this research have yet to answer: if the United States restricts or eliminates non-human primate biomedical research, where does that innovation go?
The answer, increasingly, is China — and that reality should alarm every member of Congress regardless of their position on animal welfare.
The genetic engineering of large animals such as pigs, monkeys, and dogs faces scant regulation in China, while regulators in the U.S. and Europe mandate rigorous ethical reviews, rendering similar research involving large animals almost impossible. Beijing is not ignoring this advantage — it is aggressively leaning into it. China has built eight major animal research centers since 2010 and now maintains tens of thousands of animals in these facilities, making it one of the biggest suppliers of lab animals in the world. In 2023 alone, the Chinese government funneled an estimated $3 billion into biotech, with its sales of cell and gene therapies projected to reach $2 billion by 2033.
The results are already visible in the competitive landscape. In 2019, China's share of new molecules licensed to major pharmaceutical companies was zero percent. By 2024, it had surged to 31 percent. The National Security Commission on Emerging Biotechnology put it bluntly in its April 2025 report: "Our window to act is closing. We need a two-track strategy: make America innovate faster, and slow China down." And that warning was issued before the full weight of recent NIH funding disruptions was felt.
Restricting the animal research models that underpin America's rare disease pipeline does not eliminate the science. It merely outsources it to an adversary with fewer ethical constraints, less transparency, and a stated national goal of biotech dominance. That is not a more humane solution, it is simply a less visible one.
We recognize the urgency of modernizing the drug development process and the imperative to reduce unnecessary animal testing. We are not asking Congress to grant animal research a blank check, but as this discussion evolves, it is critical that it is conducted with the same honesty, transparency, and precision we demand from the science itself.
That means honestly distinguishing between research applications where alternatives are genuinely viable and those where they are not. It means transparently recognizing the current and near-term complementary relationship between animal models and emerging alternatives. It means fully funding the 3Rs framework — Replace, Reduce, Refine — first articulated by Russell and Burch in The Principles of Humane Experimental Technique (1959) — so that the transition to next-generation methods is accelerated responsibly. And it means ensuring that NIH rare disease research programs are not collateral damage in a broader ideological debate that has little to do with the patients they serve.
Weakening America's biomedical research infrastructure does not make animals safer. Instead, it threatens to leave rare disease patients without hope while making China’s biomedical research and development industry stronger. Congress must be clear-eyed about these geopolitical and humanitarian consequences — and act accordingly.
Cara Kingan is the executive director of the Cure Coalition. She began her career in medicine, with a background in laboratory research, pharmaceuticals, clinical and surgical practice, and public health. She has published written works, counseled on insurance processing, and piloted new-to-market medical devices.
