Curbing Animal Testing

I hope this happens soon as in few months: 

Animal testing is a relic from a bygone era but still promoted fervently by interest groups and government agencies as the “gold standard” in experimental sciences for predicting response in people. That is even though — in drug development, for instance — animals are notoriously poor predictors of drug safety and efficacy in humans. To this end, exclusive reliance on animal testing translates into irrecuperable delays in the development of medicines, missed opportunities due to misguided regulatory principles, and exorbitant costs ultimately passed onto consumers.

A jarring 90-95% of experimental drugs fail in clinical trials after acceptable outcomes data in animals are used to justify their advancement for testing on humans. Moreover, scores of potentially life-saving drugs are prematurely abandoned once they confer no benefits to animals, exacerbating an already inefficient animal-centric drug discovery paradigm. Failed oncology trials alone are estimated to cost $50-$60 billion annually. Most new-generation therapies (e.g., cell therapy, immunotherapy) are by design human-specific, and testing on animals is a fool’s errand.

Through decisive actions, DOGE could in principle curb unreliable testing on animals in favor of prioritizing technology-driven, human-relevant alternatives. By doing so, it would — in a singular swoop — reduce waste across federal contracts and grants, promote modern drug development, lower healthcare and prescription drugs cost, bolster national competitiveness, improve environmental health and safety testing, and modernize practices within all health and regulatory agencies.

Francis S. Collins, the longest-serving former director of the National Institutes of Health, wrote in the journal Nature a decade ago that “preclinical research, especially work that uses animal models, seems to be the area that is currently most susceptible to reproducibility issues.” Consistently, 89% of preclinical studies, most of which involve animals, cannot be reproduced!

Reducing the dependency on the key variable (i.e., animal models) associated the most with irreproducibility (e.g., the failure to translate results from the laboratory to the clinic) is one sensible approach to limit fiscal waste in medical research and, more broadly, healthcare.

The cost of developing a single new drug is a stupefying $2 billion with an average development time of 10-15 years from target identification in the laboratory to market release, not factoring in withdrawals or recalls. Poor reliability of animal models in the drug discovery workflow compounds sky-high research and development costs to disincentivize investment in many disease domains. Case in point, 95% of the 7000-plus rare diseases that affect 25-30 million Americans have not a single FDA approved drug to treat them.

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Yet to this day, inexplicable delays in implementing the FDA Modernization Act 2.0 (FDAMA 2.0) are causing significant regulatory confusion among drug sponsors. The failure to act on the part of the FDA, the regulatory agency chiefly responsible for implementing this policy mandate, is in turn a good example of government discordancy, if not malfeasance.

In 2023, a bipartisan group of Senators, led by Rand Paul, R-Ky., and Cory Booker, D-N.J., sent a letter to the FDA demanding an explanation for the stultification and an implementation timeline of the enacted law. When no progress materialized, alarmed lawmakers introduced in February of 2024 the FDA Modernization Act 3.0 (FDAMA 3.0) in the U.S. House of Representatives, H.R. 7248  (and later in the U.S. Senate, S. 5046) to assure FDAMA 2.0 implementation and accomplish further improvements.