Last month, the US Department of Justice detailed a long list of animal welfare violations large and small that occurred at a contract breeding lab in Virginia run by Envigo, the second-largest supplier of animals to the labs. from the country. Kudos to People for the Ethical Treatment of Animals for lifting the curtain and exposing this abuse through a thorough investigation.
While scientists tell us that beagles and other dogs in the lab animal trade experience pain and fear like humans, they also tell us that they are not good “models” for 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.
In their recent law enforcement action, federal authorities seized 145 dogs and puppies in “acute distress.” 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 hospital with 5,000 patients and one doctor. As a medical and business practice, this simply does not come close to an acceptable work-to-task ratio.
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, co-sponsored by U.S. Representative Elaine Luria, D-Virginia Beach, will ensure patients get life-saving drugs and vaccines faster and cheaper. 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 an addendum to a broader legislative package to reauthorize user fee agreements. United States Food and Drug Administration.
We cannot make progress for animals in drug development until the Federal Food, Drug, and Cosmetic Act of 1938 is amended. This legislation will trickle down from contract testing labs to private labs from Pfizer and Merck, to testing facilities at the National Institutes of Health and other federal health agencies. It offers the prospect of ushering in scientific and cultural change at the FDA 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.
Wayne Pacelletwo-time New York Times best-selling author, is president of Washington, D.C.-based Animal Wellness Action Tamara Drake is director of research and regulatory affairs for the Center for a Humane Economy, based in Ashland, Oregon.