FDA Modernization Act Will Be a Boon for Domesticated and Wild Animals
Last year, deeply disturbing images and descriptions of ghastly tests on beagles for drug development — intentionally infecting them with parasites to test a vaccine in one experiment and cutting their vocal cords to reduce decibel levels because beagles vocalize pain in a separate laboratory exercise — reminded Americans about the painful cost of animal testing to the dogs we invite into our homes and our hearts.
But it’s not just domesticated animals – such as mice, rats, rabbits, and dogs – who are widely used in testing for new drugs. There are also extraordinary numbers of wild animals thrust into this world of pain and terror.
From 2000 to 2020, wildlife traffickers imported approximately 482,000 primates to the U.S. for laboratory use. Primates are wild animals, whether captured and removed from their wild habitat, or bred for research. Monkeys evolved to live in highly social groups of other monkeys and range over large areas. They can survive as many as 40 years in the wild.
A concern for wildlife protection is just one more reason for citizens to demand that Congress pass the FDA Modernization Act, led by Senators Rand Paul, R-Ky., and Cory Booker, D-N.J., and by Reps. Vern Buchan, R-Fla., and Elaine Luria, D-Va. Their bills, S. 2952 and H.R. 2565, seek to eliminate a Depression-era statutory mandate for animal testing for any new drug development protocol and, instead, allow the best scientific methods to be put to use for safety and efficacy testing.
Because of antiquated FDA requirements for animal testing for all new drugs and vaccines, primates are thrust into a life of captivity and permanently housed in cages to prevent violent interactions among strong and agile animals with sharp teeth. They are injected with dangerous and experimental drugs, and forced to endure pain, suffering, and isolation.
In 2019, laboratories held nearly 69,000 non-human primates in cages and used them in research in the United States, and many of those animals were used for drug development protocols. Yet, the history of their use has not proved productive. 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. For example: 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. In short, years of research and the sacrificing of chimpanzees and other primates yielded little of value for the human condition, diverting resources from other more promising pathways and racking up a major opportunity cost.
In 2015, the National Academy of Medicine determined 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,” paving the way for a ban on the use of chimpanzees in invasive experiments in the United States. While that was a long overdue and welcome action, it did not solve the problem of painful testing on primates. Laboratory scientists pivoted to monkeys as a substitute, with rhesus, cynomolgus macaques, and African green monkeys bearing the brunt of additional testing.
Data from monkey experiments for SARS and Middle East Respiratory Syndrome (MERS) did not prove valuable. Yet laboratory scientists doubled down on primate use for SARS-CoV-2, with so many of the animals used that a shortage in the primate resulted. 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.
Especially as compared to testing methods grounded on human biology, animal testing does not deliver on its promise of helping screen drugs for safety risks or for effective palliatives or cures. Innovations in technology went a long way in producing the vaccines for SARS-CoV-2 now being administered throughout the world. Pfizer and Moderna realized that mRNA vaccines work very different in animals compared to humans, and they delayed 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 non-animal 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 Department of Defense.
The FDA Modernization Act does not seek to settle the debate over animal testing, but to apply the widely accepted view that where alternative methods exist, they should be used. It’s not a controversial notion, and it’s enshrined in the broad accept of the “3Rs” approach – Reduction, Refinement, and Replacement — developed more than a half century ago by Drs. William Russell and Rex Burch.
In recent decades, almost all major research organizations, pharmaceutical companies, academic institutions, and even government agencies have embraced the principle. The FDA Modernization allows the government and pharmaceutical companies to act on their pledges. Without a lifting of the animal-testing requirement, the Three Rs approach is just rhetoric, not reality. Primates, beagles, and millions of animals will continue to suffer for a broken drug development paradigm that is a throwback to the first half of the 20th century.
Wayne Pacelle is a New York Times bestselling author and President of Animal Wellness Action and the Center for a Humane Economy.
Tamara Drake is the Director of Research and Regulatory Policy for the Center for a Humane Economy.
Capuchin monkey image credit: Jo-Anne McArthur / NEAVS / We Animals Media