Beagle shown in laboratory cage.

While Heartwarming and Important, Beagle Rescue Will Result in 4,000 Other Beagles Sacrificed in Experiments Unless It’s Paired with FDA Modernization Act

It is just and right that the U.S. Department of Justice (DOJ), in response to a PETA investigation, ordered the release of more than 4,000 beagles from Envigo, a contract-breeding facility in Virginia supplying dogs to laboratories. When the DOJ investigated the outfit and then filed criminal pleadings in the case, government lawyers noted that the breeding facility “is failing to meet the minimum standards for handling and housing the beagles” and “allowed beagles to die from malnutrition, treatable and preventable conditions … .” There were 300 puppies found dead from “unknown causes” in a six-month period and an additional 173 beagles dead in such a state of decomposition that forensic work was impossible.

It is particularly heartwarming news that the beagles — coveted in academic, government, and pharmaceutical laboratories for their pliant, sweet dispositions — are headed to safehouses. There, they will know human kindness rather than mercilessness and the misuse of human power. As someone owned by a floppy-eared 13-year-old beagle rescue, I cannot tolerate the thought of their torment. Because so many others share that instinct, shelters around the country will have no problem adopting these lucky newborns and breeding moms.

It’s important though that would-be beagle owners and just about everybody else understand that while the rescue is game-changing for those beagles, it may have the perverse effect of resulting in the torment of 4,000 newly produced beagles conscripted to fill the void by the Envigo action.

There is one breeding facility in New York with 23,000 beagles, and like all the other contract-breeding facilities, its nefarious work is uninterrupted by the kerfuffle in Virginia and the adoptions happening from Portland, Maine, to Portland, Oregon. In fact, the well-warranted shutdown of Envigo, and the very appropriate and welcome rescue of the beagles, is a market opportunity for the other contract-breeding labs. Beagle production and sales will expand at the other breeding facilities because at this point, given current statutory and regulatory requirements, demand for beagles is inelastic. 

To be sure, this is not a criticism of anyone — not the DOJ, private animal welfare investigators, or adopters. This is a reality check. And it is a strategic assessment of what additional steps are needed to achieve our shared goal to move away from beagles and other animals in testing.

The Federal Food, Drug and Cosmetics Act of 1938 mandates animal testing for all new drug development protocols. The number of investigational drugs isn’t diminishing anytime soon, and that means that the number of animals required for testing won’t either, regardless of this rescue.

Only A New National Policy on Animal Testing Will Remedy The Problem

There are 59,000 dogs used every year in lab experiments in the United States, mainly for drug testing. The Envigo beagles removed from the laboratory pipeline represent about 7 percent of dogs used in tests. The other contract breeding facilities will fill that gap without any difficulty.

Add to the toll about 68,000 primates used in these laboratory tests annually. And there are almost certainly 1 million other animals used a year in these same labs. The amount of animal use is colossal in drug development.

The DOJ action against Envigo was pathbreaking, but it was a first-ever action on this scale and it is unlikely to be replicated. In short, we cannot rescue our way out of the problem of mass use of beagles and other mammals in laboratories for new drugs.

The only pathway that will change the equation is passing the FDA Modernization Act, which has momentum and bipartisan support in Congress. That legislation, S. 2952 by Senators Rand Paul, R-Ky., and Cory Booker, D-N.J., and H.R. 2565, by Reps. Vern Buchanan, R-Fla., and Elaine Luria, D-Va., eliminates a mandate for animal testing for all new drug development protocols. When the FDA accepts non-animal testing data, we will see thousands of beagles spared and no corresponding surge in the use of other animals elsewhere. We’ll see an across-the-board reduction in the use of dogs, primates, rabbits, mice, and other creatures.

Animal Testing Does Not Forecast Human Reaction to Drugs

While we know that dogs feel pain and fear like humans do, bitter experience and reams of data tell us that dogs and other mammals are not good subjects for modeling human disease. An analysis of the most comprehensive quantitative database of publicly available animal toxicity studies suggests that drugs that pass muster in animal tests fail in human clinical trials 90-to-95 percent of the time.

The mistreatment of beagles, wild primates, and a wide range of other species is the hidden backstory for our drug development programs.

The good news, though, is that almost all major research organizations, pharmaceutical companies, academic institutions, and even government agencies have embraced the broadly accepted construct of the “3 Rs” approach — Reduction, Refinement, and Replacement — to animal testing.

The FDA Modernization Act will itself test the companies to see if they make good on their public pledges. Where alternative methods exist, they should be used, and the entire sector subscribes to this thinking in word.

Leaders of U.S. House Committee on Energy and Commerce have added the FDA Modernization Act as a “rider” to a broader legislative package to reauthorize the Food and Drug Administration (FDA) user-fee agreements, and the Senate HELP Committee has also approved our bill as a rider, though the full Senate has not yet to act on the package.

Because animal testing is more costly, slower, and less reliable than alternative methods, the bill will have the effect of easing suffering and averting death for millions of people and nonhuman animals. 

The legal action against Envigo reminds us that the suffering of animals starts long before the animals reach the labs. It also reminds us that until we change the law, we are just moving the deck chairs on the Titanic when it comes to our compassionate concern for beagles and other animals.

Amending that Depression-era law in a smart way offers the prospect of ushering in desperately needed cultural and scientific changes at the FDA and within the entire drug development sector, and enduring safety for tens of thousands of beagles.