Animal Testing to be a Thing of thePast

Animal Testing May Be on the Decline

A combination of factors, ranging from increased technological capacity to a burgeoning drug pipeline to increased sensitivity appear to be forcing the medical development industry away from its long-term reliance on animal testing, according to landmark reports issued by the U.S. and other governments recently.

“In June of 2007, the National Academy of Sciences released a report called ‘Toxicology Testing in the 21st Century,’ and it ended up saying that animal studies din’t necessarily give you correct results, and that we should begin to look at the use of human cells in culture,” said Dr. Alan Goldberg, MD, PhD, Director of the Center for Alternatives to Animal Testing at Johns Hopkins University.

“Then in February of this year, the EPA and the NIH signed a memorandum of understanding to indicate they would be working together to generate the high-throughput, in vitro data identified in the National Academy report,” Goldberg said. Elias Zerhouni reportedly said that the report heralded the beginning of the end of animal testing.

“That is a landmark report,” said Samantha Dozier, Ph.D. an advisor on medical testing issues with People for the Ethical Treatment of Animals (PETA). “The notion has just begun to permeate regulatory agencies. The EPA just released a draft of their nanomaterials testing plan. The first tier of this plan uses non-animal test methods,” added Dozier.

Regulatory Clarity

While the agencies that regulate medical device development may not specifically mandate animal testing of devices prior to human use approval, FDA’S prior statements have not been as helpful in eliminating the practice, she said. “According to the Office of Device Evaluation, ‘The FDA’s office has no policy requiring animal tests in devices to demonstrate functional performance,’” Dozier said. “The problem is, the agency operates on an informal guidance system, the preferences they state in their guidances always make strong recommendations, and they won’t approve your device unless you’ve done all the recommended tests,” she explained.

The federal agencies may be following the lead of other organizations like the Organization for Economic Cooperation and Development, a 30-member organization of which the U.S. is a member, which validates test methods, or the European Commission on the Validation of Alternate Methods.

The agencies have found that new methods suffice to test devices and drugs without recourse to harmful animal testing. “They’ve found that the Ames test for bacterial reverse mutation can replace animal genotoxicity testing, according to OECD Guideline 471. The in vitro chromosomal aberration test is OECD Test Guideline 473, and Guideline 428 supports a tissue culture skin irritation test for penetration or absorption,” Dozier continued. Another sufficient replacement is the artificial cerebral aneurysm model, which is growing in popularity, she noted.