Chimp Research Lab Under FDA Scrutiny

A controversial primate research center has committed hundreds of laboratory irregularities, according to an inspection conducted this summer by the U.S. Food and Drug Administration (FDA). The Coulston Foundation, a nonprofit research laboratory in Alamogordo, New Mexico, had dozens of record-keeping infractions and unapproved changes in experimental protocol, according to an internal FDA document released today by animal activists.

The largest chimpanzee facility in the United States, the Coulston Foundation is a private breeding and research facility which conducts research into AIDS, spinal cord injury, and vaccine development. Much of its support comes from the National Institutes of Health, but it also contracts with pharmaceutical and medical device companies to test new products.

Using the Freedom of Information Act, the advocacy group In Defense of Animals (IDA), based in Mill Valley, California, obtained a report from an inspection by the FDA. The 31-page document details violations in record-keeping requirements, including data and observations recorded on "scrap paper" unattached to any notebook, and the use of "deteriorated or outdated reagents and solutions." The FDA investigator also reported missing data on animal conditions and found that required samples of tissue and urine were not collected.

IDA says the document highlights sloppy science at the Coulston Foundation. "It's far more than just record keeping," maintains IDA's Eric Kleiman. "If a protocol calls for tissue samples to be taken and they're not, that could damage the whole study." James McCormack of the FDA's Bioresearch Monitoring Program said he could not comment on the report because the investigation is still under way. According to FDA regulations, violation of FDA rules could result in punishments ranging from a warning letter to disqualification of the facility.

Coulston Foundation spokesperson Don McKinney says the lab has responded to the report with "foundation-wide changes" in record-keeping procedures. "We always take these things very seriously," he says. He does not believe the infractions would jeopardize the validity of the three studies.

But the FDA frowns upon even minor deviations in experiments when they review a product application, says virologist and immunologist Krishna Murthy of the Southwestern Foundation for Biomedical Research, who has served as principal investigator on several primate studies subject to FDA approval. "Any time FDA raises concerns ... it's a pretty serious matter," he says. The agency's final report should be issued in the next few months.

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