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Laboratory Testing Industry Doubles Down on Monkey Breeding, Even as Congress Directs Phase Down of Archaic Animal Models
Key lawmakers from both parties seek to build on FDA Modernization Act with 3.0 version
to accelerate movement toward 21st-century human-biology-based testing methods.
By Tamara Drake, Zaher Nahle, and Wayne Pacelle
We will never forget the plight of the beagles mistreated by Envigo.
It didn’t take an eagle eye or beagle nose to sniff out abuses at the Virginia-based dog breeding facility. After a 2022 investigation by PETA into its practice of selling beagles for invasive experiments, Envigo was hit by the U.S. Department of Agriculture with more than 70 animal welfare violations. Dead puppies, decomposed bodies, complete inattention to animals in varying states of illness. Just a single veterinarian had the task of caring for 5,000 dogs. The U.S. Department of Justice, in the end, shut it down and worked with non-government organizations to adopt out the gentle, compliant, floppy-eared beagles.
The good news is, the dogs had the best kind of whiplash. First, abused at a breeding facility and slated for invasive, cruel experiments. Then, hustled into rescue vans, with their trauma becoming ever more distant in the rearview mirror, bound for homes where they’d be treated as sisters and brothers rather than tools for testing.
With Congress enacting the FDA Modernization Act 2.0 at the close of 2022, we were poised to turn the page on the era of unyielding, archaic, and inhumane animal testing, along with the breeding and collecting of animals that precede invasive procedures. But the FDA, breeding labs, and too many in the scientific establishment are still working from reflexive muscle memory when it comes to animal testing. Animal testing is what they know, and they are firmly gripping their old instruments of pain.
This reluctance to look ahead not only keeps animals at risk, but it delays the prospect of delivering safer, more effective drugs at a lower cost and a faster pace to patients.
A group of bi-partisan members of Congress is leading an effort to tell the FDA to do its job, and the bill needs your support. Please send an email to your legislators by filling out the form below. [[link removed]]
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Trafficking of Primates from Asia to the U.S. for Use in Labs
A new company with a euphemistic name, Safer Human Medicine, started construction of a nonhuman primate breeding facility in Bainbridge, Ga. Its 200-acre complex is slated to house 30,000 primates for use in labs, and the individual running SHM is Jim Harkness. He’s the same executive who ran the house of horrors at Envigo. Same person, old gig, new victims.
The individual running SHM is Jim Harkness. He’s the same executive who ran the house of horrors at Envigo. Same person, old gig, new victims.
Part of the explanation for the idea: China cut off primate exports bound for U.S. labs after COVID-19 and concerns about further spread of zoonotic disease. U.S. laboratories, even though they now have the option to use 21st-century human-biology-based testing methods, panicked and declared “a national monkey shortage.” They decided to double down on primate use and figure out a new supply chain.
It didn’t start well for them. Charles River Labs, a big name in the field, decided to get monkeys from Cambodia. It turns out they were importing wild-caught [[link removed]] , endangered primates from the southeast Asian nation. A U.S. Department of Justice subpoena followed, highlighting illegal trafficking of endangered long-tailed cynomolgus macaques. The DOJ indicted eight Cambodians [[link removed]] at the center of a separate smuggling ring.
Inotiv, the parent company of Envigo, also supplies primates to pharmaceutical research companies and contract testing labs doing drug-development work. The company, which itself houses about 9,000 monkeys for sale to labs, also received a subpoena from the DOJ regarding receipt of endangered primates.
With its international trafficking options limited, the lab-breeding industry turned to domestic breeding strategies. They felt the pull of big money in the primate trade. Pre-pandemic, primates went for $7,000-$9,000 per animal. They’re now priced at $50,000 apiece.
Monkey Farms in Georgia and Texas
City leaders in Bainbridge, within Decatur County in Georgia, also had jobs and revenues in mind when it promised tax breaks and other financial incentives to Safer Human Medicine to build a monkey-breeding facility starting in 2023. With a 20-year tax abatement scheme worth at least $58 million, the plan was to become the monkey-breeding capital of the United States, breeding 30,000 monkeys in a town of 15,000 people.
But the city fathers hadn’t taken the temperature of the electorate. There was a citizen revolt, and it was well warranted. This monkey factory farm will hurt property values in the community and overwhelm neighbors with waste from the complex. With so many animal inhabitants, disease is also a threat, with 75 percent of novel infections originating in transmission from animals to humans.
After much agitation, Decatur County commissioners voted to withdraw the previously approved tax breaks. Lawsuits ensued. Moreover, the Georgia Department of Natural Resources found that the Bainbridge Decatur County Development Authority had violated its rules on land disturbance. The project isn’t dead, but it’s on life support as members of the community rebel against the monkey metropolis within their small town.
A second attempt to build a primate farm in Texas is also languishing. Charles River Laboratories bought more than 500 acres of land in Brazoria County last March to open a facility to house more than 43,000 monkeys. This plan didn’t even get out of the gate. Brazoria County Commissioners Court passed a resolution asking federal and state agencies to deny the company permits to bring the animals to their corner of Texas. Charles River has since put its plans on hold.
Getting On with the Transition to Human-Biology-Based Testing
The current animal-centered paradigm of drug development—whether it’s primates, beagles, or other animals—yields a crushing 90-95 percent failure in clinical trials of the experimental drugs. That means that when drugs pass muster in years of animal tests, 9 of 10 fail when they reach the human clinical trial phase. In what kind of business do we accept that rate of failure?
In enacting the FDA Modernization Act 2.0, Congress called out the failure rate and said we can do better. We are already seeing major shifts in how the delivery of treatments for patients in need is accomplished, moving toward personalized or precision medicine. Here, animal models will have no real value since other species will not capture biological variation among humans.
Forward-looking scientists understand that nonclinical tests or studies using human cells and tissues can better gauge biological variation among the human population. These human-biology-based testing methods have the potential to serve as “clinical trials in a lab” and to test a drug’s safety and effectiveness for individual patients. This is the near future of biomedical science, and animal testing has little of value for this new paradigm.
Even though labs have been running through millions of beagles, primates, and other animals through the years, we have limited treatments for a range of diseases. Primates showed very mild clinical symptoms in response to SARS-CoV-2, rendering them unreliable as research models for COVID-19. In fact, vaccine development for COVID-19 was cut from years to months as a result of an emergency action by the federal government to lift the requirement for testing on animals prior to administration of the experimental vaccine in humans.
With a system that relied on animal models, we have no cures for major diseases, such as Parkinson’s, multiple sclerosis, Alzheimer’s, congestive heart failure, stroke, pancreatic cancer, brain tumors, amyotrophic lateral sclerosis, and psychiatric disorders like schizophrenia, depression, and more.
For HIV/AIDS and Hepatitis C, it’s the same story. 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. The failure rate for vaccines for HIV/AIDS is 100 percent, yet nonhuman primates are still the model of choice for safety and efficacy.
Rather than expanding the breeding of primates for cruel, costly, and suspect use, it’s time to turn to 21st-century science. Throwing more money at animal-breeding facilities makes little sense.
The FDA Modernization Act 3.0
In early February, lawmakers from both parties are demanding a new way. Led by U.S. Representatives Buddy Carter, R-Ga., Nanette Barragán, D-Cal., Diana Harshbarger, R-Tenn., Rosa DeLauro, D-Conn., and Vern Buchanan, R-Fla., they introduced the FDA Modernization Act 3.0 [[link removed]] in the U.S. House. That bill was the focus of a U.S. House hearing today. And when enacted, that bill, H.R. 7248, will direct the FDA to create a credible qualification program of non-animal testing methods, establishing a vehicle for using these methods in the regulatory process for gaining approval for experimental drugs. FDAMA 3.0 will also require FDA to align its regulations with the new statute under the FDA Modernization Act 2.0, which eliminated a Depression-era mandate that all new drugs and vaccines be tested on animals before human clinical trials.
The bill reflects Congressional frustration with the FDA. Indeed, more than a year after the FDAMA 2.0 was signed into law, there’s been little effort by the agency to implement it. With that agency mindset on display, you can understand why the lab-animal-breeding business is still clinging to the idea of building massive monkey farms in the South for decades to come of commerce in live animals.
The obstinacy of the FDA stands in stark contrast to the expectations, let alone excitement, that ensued following the signing of the new law in late December 2022. Since then, more than 460 worldwide publications, including news articles, commentaries, scientific reviews, and primary papers, have been published, underscoring the transformative nature of the FDAMA 2.0 and its mighty importance. It should have been a matter of self-interest and best practice: Improving the safety and effectiveness of drugs, in addition to delivering lower-priced drugs in a timely way, is the core mission of the agency.
But it’s a bureaucracy at work. The FDA response is intolerable, as a matter of animal health but also human health and wellness. It’s indefensible to keep relying on animal models that do not translate to the human condition. We have innovative, human-relevant models that can and must be embraced to break this logjam. The FDA Modernization Act 3.0 will move this process forward in a meaningful way.
As a proud agency with a crucial mission, it’s time for the FDA to heed their call.
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