12 October, 2004

Monkey Shortage Threatens Germwar Vaccine Testing, Some Researchers Warn

By Zack Phillips, CQ Staff

"The effort to develop countermeasures to biological terrorism, many scientists say, faces a looming problem on the horizon: a critical shortage of monkeys needed for testing.

Three years after the anthrax attacks that killed five people and injured dozens of others, many involved in biodefense research say the country does not have a large enough supply of non-human primates for the kind of massive research effort that would be needed in the aftermath of another bioterrorist attack.

"Today it is an area of concern," said Michael J. Hopmeier, a special adviser to the U.S. Surgeon General, the Pentagon's Defense Advanced Research Projects Agency (DARPA) and other government agencies. "In the near future, it's going to be a significant problem."

Testing vaccines to defend against bio-terror agents - such as anthrax, smallpox and even monkeypox - is too dangerous for human subjects. DARPA, long a leader in over-the-horizon scientific projects, is working to construct synthetic systems to duplicate human organs and immunology for such tests, but they are still far from producing results needed now, researchers say.

Thus the development of countermeasures to biological agents, many scientists say, rests largely on the shoulders of the monkey, the animal whose biology most closely resembles that of humans.

A rule developed by the Food and Drug Administration (FDA) in 2002 allows the approval of new drugs and products based solely on animal studies, in cases where clinical trials in humans are unethical or unsafe.

Biodefense researchers say they have enough monkeys for current projects. But many say no contingency stock is available to supply the kind of immediate and unexpected push for a new inoculation necessary in the wake of a bioterrorist attack.

"To me, we don't have any surge capacity," said C.J. Peters, director for biodefense at the University of Texas Medical Branch Center for Biodefense and Emerging Infectious Diseases."
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--WP

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