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Spokane, Washington  Est. May 19, 1883

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Wayne Pacelle and Tamara Drake: Beagle abuse exposes flaws in drug research

By Wayne Pacelle and Tamara Drake

In May the U.S. Department of Justice detailed a long list of Animal Welfare Act violations occurring at the nation’s second largest supplier of animals to laboratories – in this case, the abuse of beagles. Kudos to PETA for throwing back the curtain on an obscure supplier of laboratory animals called Envigo and exposing their abuses through a comprehensive investigation.

While behavioral science tells us with certainty that beagles and other dogs conscripted into the laboratory animal trade feel pain and fear like humans do, it also tells us they are not good “models” when it comes to human disease. An analysis of the most comprehensive quantitative database of publicly available animal toxicity studies suggests that dogs are highly inconsistent predictors of toxic responses in humans.

The mistreatment of beagles, wild primates and a wide range of other species is the hidden backstory for our flawed drug development paradigm. The Federal Food, Drug and Cosmetics Act of 1938 mandates animal testing for every new drug development protocol, translating into the use perhaps of millions of animals a year. The existing drug “safety” framework isn’t protecting us all that well; adverse reactions to drugs – which go through the animal tests – are the fourth leading cause of death in the U.S.

In its recent law enforcement action against Envigo, federal authorities seized 145 dogs and puppies experiencing “acute distress.” And they are just some of the survivors. According to the pleadings from DOJ, “Envigo 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 173 beagle puppies dead and in such a state of decomposition that forensic work was impossible.

At the facility, Envigo employed one veterinarian for 5,000 dogs, making comprehensive care an impossibility. Think of a single doctor treating 5,000 patients at a hospital. As a business and medical practice, it just doesn’t come close to an acceptable work-to-task ratio.

The good news is not only the merciful intervention by federal law enforcement, but also a parallel effort in Congress to reboot the current drug development paradigm. By lifting archaic regulatory requirements for animal tests and allowing scientists to use the best testing strategy in new drug and vaccine development, the FDA Modernization Act, which got a key push from Congresswoman Cathy McMorris Rodgers, R-Wash., will assure that patients get lifesaving drugs and vaccines faster and at lower cost. 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. Rep. McMorris Rodgers is the top Republican on the powerful House Energy and Commerce Committee.

In recent decades, almost all major research organizations, pharmaceutical companies, academic institutions, and even government agencies have embraced the “3Rs” approach – Reduction, Refinement, and Replacement – to animal testing. The FDA Modernization will finally allow the government and pharmaceutical companies to make good on their pledges to replace animals with nonanimal test methods where they are available.

With McMorris Rodgers in the lead, Democrat and Republican leaders in House and Senate health committees have agreed to include the FDA Modernization Act as a “rider” to a broader legislative package to reauthorize the Food and Drug Administration (FDA) user-fee agreements. We cannot have progress for animals in the realm of drug development until the Federal Food, Drug and Cosmetics Act of 1938 is changed.

We can only imagine the fear, pain and suffering endured by animals in laboratories for FDA-mandated tests. Now we know that the suffering starts in the contract breeding facilities and long before the animals reach the labs. We must enact and enforce national policies to usher in 21st century science and to make animal testing the exception rather than the rule.

Wayne Pacelle, a two-time New York Times best-selling author, is president of Animal Wellness Action in Washington, D.C. Tamara Drake is director of research and regulatory affairs for the Center for a Humane Economy in Ashland, Oregon.