DOGE is Poised to Revolutionize Biomedicine by Curbing Animal Testing

The intent of the new administration to create the Department of Government Efficiency (DOGE) and reduce federal spending by more than a trillion dollars is an eye-catching goal. While it is not the first time that a new administration has promised major cuts to spending — only to see those efforts crash and burn — this plan might jibe with an emerging realization that there are inefficiencies baked into our nation’s drug development programs. The underlying flaw: an unwarranted faith in animal testing to model human response in health and disease.

Animals are poor and misleading predictors of drug response in humans

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.

DOGE represents a historic opportunity to improve research and reduce waste

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.

FDA Modernization Act 2.0 and 3.0 will markedly facilitate the mission of DOGE   

Regrettably, little has been done by government watchdogs to address the grossly wasteful spending on animal testing. On the contrary, spending on animal testing, including funding high-end facilities and housing infrastructures (reviewed here), is uncontrollable. The use of animals in research is estimated to have reached nearly 200 million annually, with the United States being in the top three countries by number of animals used, along with China and Japan.

Should DOGE take on the task of weaning America from the reliance on animal testing in modeling human response, the consequences could be historic vis-à-vis trimming waste and bolstering efficiency in the biomedical discovery space. This shall benefit all Americans. Of note, such an undertaking will be facilitated by the existence of the FDA Modernization Act 2.0 (FDAMA 2.0), a U.S. law shepherded to passage by the Center for a Humane Economy in 2022. This important policy reform has garnered strong bipartisan Support and shined the spotlight on the complex issues of reliability and relevance in biomedical investigations, specifically the futility of animal testing.

FDAMA 2.0 lifted the mandate on requiring animal testing on drugs in preclinical research prior to advancing to clinical trials if modern 21^st century tools can be used instead. Some of the modern tools that now outperform animal testing in many applications include human-based organoids, organ-chips, advanced human cell models and AI methodologies (reviewed here).

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.

Simultaneous improvement in multiple sectors of our economy is within reach

The failure of the FDA to implement a law Congress passed without dissent is inexcusable. It is an alarming erosion in the core tenats of responsible governance. To put it bluntly, such bootlessness makes a mockery of the earnest and time-consuming legislative process and undermines the efforts of democratically elected lawmakers and everyone else involved. The new public-health team by President Trump should seize this opportunity and shake up the working of the FDA and its parent agency.

Organizations like the Center for a Humane Economy and Animal Wellness Action that championed FDAMA 2.0 alongside their partners across industry, academia, and nonprofit organizations have shown no abatement in their advocacy efforts thus far and will not until the full, clear, and indivisible implementation of FDAMA 2.0 is accomplished. By all indications, a revised FDAMA 3.0 bill will pass in the Senate in 2024 by unanimous consent. The FDAMA 3.0 bill under consideration requires the FDA to align its regulations with the new statute under FDAMA 2.0.

Rarely could tackling a single challenge present that many opportunities for simultaneous improvement in multiple sectors of our economy. Yet in this instance, the single, multifactorial issue of animal testing is a prime example of wasteful and entrenched practices that DOGE is precisely created to eliminate.

Related Content:

• Ferrero and Agropur Commit to Ending Cruel Animal Testing
• Five Major Companies End Support for Animal Testing at Food Research Institute
• Changing Views on Animal Testing in America
• Animal Testing Company to Pay $35 Million in Historic Resolution After Rescue of 4,000 Beagles
• The Story of a Woman Who Turned an Animal Testing Lab into a Rehab Sanctuary

Easy Ways to Help the Planet:

• Eat Less Meat: Download Food Monster, the largest plant-based Recipe app on the App Store, to help reduce your environmental footprint, save animals and get healthy. You can also buy a hard or soft copy of our favorite vegan cookbooks.
• Adopt-a-Pet: Visit WildWatchers, a watchdog platform specifically designed for animal, earth, and wildlife warriors to actively give back, rescue, and protect animals and the planet.
• Reduce Your Fast Fashion Footprint: Take initiative by standing up against fast fashion Pollution and supporting sustainable and circular brands like Tiny Rescue that raise awareness around important issues through recycled zero-waste clothing designed to be returned and remade over and over again.
• Support Independent Media: Being publicly funded gives us a greater chance to continue providing you with high-quality content. Please consider supporting us by donating!
• Sign a Petition: Your voice matters! Help turn petitions into victories by signing the latest list of must-sign petitions to help people, animals, and the planet.
• Stay Informed: Keep up with the latest news and important stories involving animals, the environment, sustainable living, food, health, and human interest topics by subscribing to our newsletter!
• Do What You Can: Reduce waste, plant trees, eat local, travel responsibly, reuse stuff, say no to single-use plastics, recycle, vote smart, switch to cold water laundry, divest from fossil fuels, save water, shop wisely, Donate if you can, grow your food, volunteer, conserve energy, compost, and don’t forget about the microplastics and microbeads lurking in common household and personal care products!