By Wayne Pacelle and Tamara Drake
In May, the US Department of Justice detailed a long list of animal welfare violations, large and small, that occurred at a contract breeding lab in Cumberland, Va., run by Envigo, the second-largest supplier of animals in the country’s laboratories.
Kudos to People for the Ethical Treatment of Animals (PETA) for lifting the curtain on this obscure lab animal supplier and exposing these abuses through a thorough investigation.
While behavioral science tells us with certainty that beagles and other dogs enlisted in the lab animal trade experience pain and fear like humans, it also tells us that they are not good “models” in matter of 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 abuse of beagles, wild primates and a wide range of other species is the hidden backstory of our drug development programs. The Federal Food, Drug, and Cosmetic Act of 1938 mandates animal testing for every new drug development protocol, perhaps resulting in the use of millions of animals per year.
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In its recent law enforcement action, federal authorities seized 145 dogs and puppies in “acute distress.” And they are just some of the survivors. According to the DOJ’s pleadings, “Envigo fails to meet minimum standards for handling and housing beagles” and “allowed beagles to die of malnourished, treatable and preventable conditions…”.
At the facility, Envigo employed one veterinarian for every 5,000 dogs, making comprehensive care impossible. Think of a Starbucks store with 5,000 personalized drinks and a barista. As a business practice, this simply does not come close to an acceptable work-to-task ratio.
The U.S. complaint cited dozens of issues, including a beagle with a ruptured uterus, 300 puppies found dead of “unknown causes” over a six-month period, and 173 beagle puppies dead and in such condition. decomposition that forensic work was impossible.
The good news is not just the merciful intervention of federal law enforcement, but also a parallel congressional effort to jump-start the current drug development paradigm. By lifting archaic regulatory requirements for animal testing and allowing scientists to use the best testing strategy in the development of new drugs and vaccines, the FDA Modernization Act, pushed by the pharmacist and congresswoman Diana Harshbarger, R-Tennessee, will ensure patients get lifesaving drugs. and vaccines more quickly and at lower cost. Because animal testing is more expensive, slower and less reliable than alternative methods, the bill will have the effect of alleviating the suffering and preventing the death of millions of people and non-human animals.
Over the past few decades, nearly every major research organization, pharmaceutical company, academic institution, and even government agency has embraced the “3Rs”—reduce, refine, and replace—approach to animal testing. The FDA Modernization Act will finally allow the government and drug companies to deliver on their promises to replace animals with non-animal testing methods where they are available.
Democratic and Republican leaders of the House and Senate health committees have agreed to include the FDA Modernization Act as a ‘jumper’ in a broader legislative package to reauthorize fee agreements of use of the Food and Drug Administration (FDA).
Last week was a big step forward, as the House passed this reform package with our FDA Modernization Act intact, HR 7667, by a majority vote of 392 to 28. Senate action will be the next.
We cannot make progress for animals in drug development until the Federal Food, Drug, and Cosmetic Act of 1938 is amended. This legislation will ripple from contract testing labs to private Pfizer and Merck labs to testing facilities at the National Institutes of Health and other federal health agencies. It offers the prospect of ushering in a cultural shift at the FDA and in the pharmaceutical industry so that 21st century science is developed and put into practice.
We can only imagine the fear, pain and suffering endured by animals in labs for FDA mandated testing. We now know that suffering begins in contract breeding facilities and long before animals reach labs. We must adopt and enforce national policies to usher in 21st century science and make animal testing the exception rather than the rule.
Two-time New York Times bestselling author Wayne Pacelle is president of Animal Wellness Action. Tamara Drake is director of research and regulatory affairs for the Center for a Humane Economy.