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Alternatives to Monoclonal Antibody Production (Proceedings)

NIH Denies AAVS' Request for a Ban on Animal Use in the Production of Monoclonal Antibodies

DeWayne H. Walker, DVM
by Lisa Libowitz, Altweb Editor

On April 23, the American Anti-Vivisection Society submitted a petition to the National Institutes of Health and the U.S. Department of Agriculture, asking them to prohibit the use of animals to produce monoclonal antibodies (MABs). On Sept. 25, at a workshop on MAB production, both agencies responded publicly by denying AAVS request.

AAVS launched its Antibodies Without Animals campaign last spring after a European panel of scientists concluded that reasonable alternatives exist to the use of animals, primarily mice, in the production of MABs. The European Centre for the Validation of Alternative Methods has recommended that the entire European Union adopt a ban. Currently, Germany, Switzerland and The Netherlands prohibit the use of animals in MAB production.

The NIH cannot approve such a ban, however, said Dr. Louis R. Sibal, Director of the NIH Office of Laboratory Animal Research. In a 24-page response to the petition, Sibal said the NIH had given "serious consideration" to the request, but believed that it did not have the power to "prescribe or proscribe" methods of research.

At the workshop, "Alternatives in Monoclonal Antibody Production," Sibal said, "It is very unusual for the NIH to receive such a petition." He said the NIH, in considering the petition, had surveyed a large number of U.S. scientists who had used and produced MABs. "All were very supportive of in vitro methods," he said, but added that many scientists complained that in vitro methods sometimes failed to produce MABs entirely or with the activity required.

Therefore, he said, the NIH decided it could not ban the use of animals.

Dr. John McArdle, AAVS Science Adviser and Director of the Alternatives Research and Development Foundation, said his organization did not see a ban as interfering with a scientist's intellectual freedom. "We do not see this as a scientific design issue. There are one or more alternatives that are acceptable now."

The petition also asked the NIH to "confirm the validity and reliability of alternative methods of MAB production," "encourage acceptance of alternative methods by the scientific community by initiating an education and outreach program," and "initiate a training program at NIH to train scientists in the use of alternatives."

Sibal responded by saying that the NIH currently does all of those things. Core facilities at 13 NIH centers and institutes around the country produce MABs using in vitro methods, he said. Those core facilities, he explained, "create, produce, characterize and subsidize MAB production--and offer training."

Dr. Jerry D. DePoyster, Veterinary Medical Officer for the USDA, stated that, by regulation, the USDA does not include rats and mice in its oversight of animal welfare--and would not be changing its list of regulated animals at this time.

"We do expect our field personnel to make sure an alternatives search has been done--if it is a regulated animal," he said, explaining that occasionally MABs are produced using regulated animals such as rabbits. "And any time there is an alternative available, it should be employed. It is just good sense. And it's the law."

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