Animal Testing Enthusiasts Want to Double Down on Experimenting on Monkeys Even As Innovation Obviates the Need

You’ve heard of a strategic oil reserve. Even a grain reserve. But how about a monkey reserve?

If it comes to pass, it won’t be a barrel of laughs for the monkeys, to be sure. Considering that primate research has been a dismal failure in translating to treatments for humans, suggesting such an initiative runs away from advancing 21st century science. And a nation that halted its use of chimpanzees in invasive experiments would be well-suited to consult the taxonomic tree and kick the tires when it comes to animal welfare science. They are, in their capacity to suffer, like humans and chimps.

Non-Human Primates Aren’t Good Models of Human Disease

Decades of research on non-human primates, bred and housed to be used for diseases like HIV/AIDS and Hepatitis C, didn’t lead to treatments or vaccines. Out of 85 potential AIDS vaccines that were tested in 197 human trials, only seven reached Phase III trials, and not one vaccine was successful after passing muster in chimpanzees.

When the National Academy of Medicine opined that experimentation on chimpanzees was unnecessary and the National Institutes of Health (NIH) determined that chimpanzee experiments “rarely accelerated new discoveries or the advancement of human health for infectious disease,” the monkeys of choice for research for vaccines focused on “Old World Monkeys” such as rhesus and cynomolgus macaques, and African green monkeys.

Data from monkey experiments for SARS and MERS were shown to beunreproducible with inconsistent results. The Centers for Disease Control and Prevention, the United States Army Medical Research Institute of Infectious Diseases, the National Institute of Allergy and Infectious Diseases, and others reported contradictory results with at least two strains of SARS-CoV.

Despite documented problems with non-human primate models of human SARS infection, the research continued with SARS-CoV-2, resulting in the deaths and shortage of monkeys used in experiments that don’t often yield human-relevant results. Animals such as monkeys, mice, and hamsters tend to develop milder disease symptoms than humans, if they get sick at all, making it hard to test new medicines. Given these problems with human translation, the use of nonhuman primates in SARS-CoV-2 vaccine and therapeutic testing is troubling.

Innovations in technology went a long way in producing the vaccines for SARS-CoV-2 now being administered throughout the world. The value of non-human primate models in this effort is unclear and unproven. Pfizer and Moderna realized that mRNA vaccines work very different in animals compared to humans, thus they eliminated many animal efficacy studies and opted to go directly into humans clinical trials. Data from hundreds of thousands of humans in clinical trials gave FDA, from a safety vantagepoint, the confidence to issue an “Emergency Use Authorization” for these vaccines.

There is a coordinated effort to use 21st century science in the battle against SARS-CoV-2 using nonanimal technologies. For example, the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICETM) has joined other government agencies and global partners to apply advanced nonanimal technologies for COVID-19 research. This working group includes drug and device developers, microphysiological system developers, regulators, founding members of the National Center for Advancing Translational Science, the National Institute for Allergy and Infectious Diseases, and the US Department of Defense.

Use of Human Biology–based Nonclinical Test Methods Must Be Allowed in FDA Regulatory Submissions

Our drug development paradigm is archaic and dysfunctional. We have a “shortage” of monkeys only because of regulatory requirements to run through the animals even in the absence of their usefulness in assuring safety or the effectiveness of vaccines. What’s needed is not for drug developers to churn through more monkeys, but to embrace the idea that they’ll use the best scientific means of safety and efficacy testing. The data show that 95 percent of drugs fail in human clinical trials after they pass muster in animals.

Human-relevant cell-based assays, organs-on-a-chip, human-on-a-chip (microphysiological systems), and sophisticated computer modeling have been developed to more accurately predict human response to new drugs, yet the Federal Food Drug & Cosmetics Act (FFDCA) does not officially acknowledge these superior test methods. The FFDCA and FDA regulations specifically require the use of animals, to the exclusion of human biology-based nonclinical methods. These breakthrough discoveries can’t help if they don’t leave the lab.

Fortunately, instead of turning to decades-old technology that has shown limited value, the pandemic has forced people to think differently and use modern, human-relevant technology that has contributed to the development of effective and safe vaccines and treatments. The global organs-on-chips market is expected to grow from $20.53 million in 2020 to $84.09 million in 2025.

Recently, Israeli scientists at Hebrew University created a cancer drug using a “human simulator chip”, completely circumventing animal tests. This demonstrates that the use of modern, human-relevant technology can lead to faster, safer outcomes. Getting a drug to the point of clinical trials normally takes at least four to six years, hundreds of animals and costs millions of dollars, denying treatments to patients and leaving a trail of beleaguered animals in its wake. Investing in human biology is the pathway forward.

The “Stockpile” Exists , But Has Been Squandered on Needless Experiments, Abuse and Neglect in National Primate Research Centers

A “national stockpile” of non-human primates already exists. The NIH National Primate Research Centers (NPRC) were established by Congress in the 1960s to “provide scientists with specialized resources to conduct research with nonhuman primates.” The facilities operate with continuing controversy. For example, the Oregon National Primate Research Center (ONPRC) has a disturbing record of violations of the Animal Welfare Act since its inception. The NIH has provided over $100 million in grants over the past five years for ONPRC to conduct mostly needless and redundant research on these highly intelligent animals. With that public funding comes responsibilities for proper animal care.

The ONPRC has committed at least a dozen violations of the AWA over the past few years due to its inexcusable mistreatment of primates. Many of those violations were considered “critical violations” by the USDA. One incident occurred in August 2020 when a technician neglected to remove two rhesus macaques from their cage before placing the cages in a high temperature cage-washing machine. One monkey died in the machine, while the second needed to be euthanized because of injuries sustained.

Compounding these acts of negligence and even cruelty, the studies carried out are largely repetitive and appear to offer little prospect of advancing work to advance human health. For example, NIH has been funding virtually the same, recurring research related to stress and alcoholism for the past 20 years to the tune of over $8 million dollars at ONPRC alone. The project leader for these ongoing, redundant studies, was approved for another $2.4 million in the fall of 2020 to spend the next five years studying the impact of chronic drinking on COIVD-19 morbidity.

Fortunately, a bill (HR 1744) recently introduced in the U.S. House of Representatives seeks to establish a National Center for Alternatives at the NIH specifically to develop, promote and fund alternatives to animal research and testing. This Center would provide incentives to use nonanimal methods and provide funding for that type of research and testing. The establishment of this Center would be a major step forward in moving the archaic research system to human-relevant methods.

Funding these modern test methods instead of wasting funds on repetitive, unproductive animal research must become a top priority to advance science for meaningful change for humankind. We cannot persist in driving a constant loop where we run through animals, get non-predictive results, and then make up for it by relying on the results of human clinical trials. Every segment of society relies on innovation to improve. Why not in drug development science?

Click here to take action and support updates to archaic, unreliable FDA animal testing requirements for human drugs.