A year ago, the prospect of making a substantial reduction in the amount of animals tested for research purposes looked bleak for Martin Stephens, VP for animal research issues at the Humane Society of the United States (Washington).

That bleak outlook was wholly understandable, considering the long history of research in which animals have been killed in numbers too large to be accurately estimated often after being tortured in a variety of ways, to find cures for human diseases, in a culture putting the primary value on human life over animals.

But a new five-year plan by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), a committee of National Institute of Environmental Health Sciences (NIEHS) along with a new federal push to look for alternatives is giving a new sense of hope that animal experimentation may be significantly reduced within the next 10 years.

"These are heady times for those of us who are looking for alternatives to animal testing," Stephens told Medical Device Daily. "There seems to be a paradigm shift approaching us."

The 60-page report gives a detailed look at endpoints and goals that ICCVAM is trying to reach and how it plans to disseminate its findings to companies to encourage their use of alternatives for testing research endpoints, positive or negative, toxicities and adverse events of medical devices, drugs and cosmetics.

William Stokes, DVM, director of the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and a member of the ICCVAM committee, said that the plan "should not be considered as a document that spells official end of animal testing, but it should be viewed as a "step in the right direction" that will lead to a significant reduction in the animals tested in some research. In particular, the report provides recommendation for safer in vitro test methods that can replace some animal test methods or can reduce the pain and stress the animal experiences.

The plan was developed over a 12-month period with opportunities for public input, including a town meeting held in June 2006.

ICCVAM targets four areas of that it lists as priorities for reducing animal testing: ocular, biologics, dermal toxicity and acute toxicity. The highest priority for reduction is ocular tests in which animals are routinely disfigured and blinded to monitor the effects of eye irritants and pharmaceuticals.

Following are some of the procedures outlined in the report:

• The five-year plan was distributed to the various federal agencies that oversee companies that use animal testing (such as the FDA's Center for Device and Radiological Health branch of the FDA).

• Each federal agency will determine whether the test methods are acceptable for their respective programs.

• The agencies must then respond to ICCVAM recommendations within 180 days after receiving them.

• Those agencies would then adopt portions of the plan relevant to their industries.

But herein lies a rather large challenge for the committee, according to Stokes. The plan has no legislative teeth to back it up, leaving everything up to the company.

"Just because [the plan] gets adopted by a federal agency doesn't mean the company has to adhere to the plan," Stokes told MDD. "While agencies say they endorse this method, the responsibility is in the company and their animal care and use committee" [ACUC]"

This is a contention that many critics of the ICCVAM have raised concerning the plan.

In a recent Washington Post article, opposition to the plan and the recommended procedures was leveled at the committee by calling it "broken" and unable to give validation to alternative methods quickly enough.

There has been much criticism that Europe does a far better job at eradicating state animal testing because it has developed legislation mandating the use of non-animal tests, in comparison to what in the U.S. are only "recommendations" such as this plan ultimately is.

But a key factor that the committee hopes will grab the attention of companies doing animal testing is cost what it takes out of their corporate pockets to maintain and manage animals. Thus, Stephens points out that animal testing "is a slow and expensive process."

According to the website of Harlan Bioproducts for Science, maintaining just one guinea pig throughout a 90-day period costs close to $254. That amount is made up of immunization shots, bleed tests and maintenance, including $15 to dispose of the animal.

Most skin irritant tests call for at least 30 guinea pigs tested at a single time, thus multiplying the costs.

"It's just not cost effective to have some of these tests," Stokes told MDD.

And he additionally points to a lack of validity for testing using animals, saying "in the end it's not certain that some of the results derived from the test [using animals] relate to people."

That's one of the problems that the ICCVAM report points out how some of the aspects of animal testing just aren't as accurate as some non animal models.

Some argue that it costs too much to invest in alternatives that haven't yet been validated which leaves ICCVAM in the position of arguing for the advancements in more cost-effective non-animal tests.

Stokes said there will be further meetings to ensure that everyone is on the same page, but ultimately public awareness about the issue must come from company compliance.

But what this finalized study and the recent concern regarding animal testing will mean over time remains to be seen. Stephens still is optimistic that one day it will end, but as far as an end in sight, well, that picture is a bit fuzzy.

"I don't think we're going to see the end of animal experimentation or research in our lifetimes," said Stephens, who is in his 50s. "There is a lot of promise now, and [the National Humane Society's] job is to see that the work is done to get closer to that goal."