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10 November 1999

FDA INSPECTORS SLAM SCIENCE CONDUCTED AT COULSTON LAB
By In Defense of Animals, ida@idausa.org

Scathing 31-Page Report Documents Over 270 Violations of FDA GLP Regulations on Just 3 Studies Reviewed by Agency

Data Integrity, Human Safety Called Into Question

Alamogordo, NM (November 2, 1999) - A scathing 31-page inspection report by a team of Food and Drug Administration (FDA) investigators calls into question the validity of every study ever conducted at The Coulston Foundation, In Defense of Animals, a national animal protection organization, charged today. The August 1999 inspection
(see entire report at http://www.idausa.org/Campaigns/fdaviolations)
which documents over 270 violations of the FDA's Good Laboratory Practice (GLP) regulations on three studies -- all involving negligent chimpanzee deaths -- was issued after IDA filed formal complaints with FDA charging widespread GLP violations at the New Mexico primate testing lab. All tests for drugs or medical devices must adhere to GLP regulations in order to be approved by the FDA for consumer use.

"After reading this devastating report, we find it hard to believe that any private company or public agency -- including the National Institutes of Health - would test any product designed for human use at TCF," said IDA president Elliot Katz, DVM. "We believe the gravity of the violations documented by FDA calls into question the data integrity of every study ever conducted at the lab, especially considering that FDA found over 270 violations on just the 3 studies reviewed. How many more hundreds, or thousands, of violations would FDA have found had it inspected all TCF studies? The human safety implications of these findings are extremely serious and far-reaching."

According to the FDA, GLP regulations and inspections exist to ensure the quality and integrity of data, and the rights and welfare of human subjects. The FDA inspectors cited TCF study directors for failing to have Standard Operating Procedures (SOPs) to ensure quality and integrity of data; failing to ensure that all experimental data are accurately recorded and verified; failing to follow protocols; failing to ensure that GLP regulations were followed; and amending protocols without proper approval. In one study, misplaced raw data was not even used in a research report.

TCF was also cited for keeping critical laboratory records on scrap paper, erasure of original observations, handwritten notes conflicting with computer generated dates, records missing entirely for two of the three studies, records containing conflicting data with no explanation for discrepancies, removal of archived records from archives, and numerous lab notes, observations, calculations not signed or dated. In one case, TCF told inspectors that certain records were in the records vault. When the documents were not located in the vault, TCF then claimed that the records were sent to the sponsor, but the lab could produce no record of shipment to support this claim.

Many of the GLP violations related to multiple failures to follow protocols. These included pathologists unavailable to take required tissue samples; failure to take required blood and urine; failure to conduct physical and neurological exams or monitor blood pressure, body temperature and food intake of test subjects. Protocols were altered without approval, amendments contradicted each other, and SOPs were deviated from repeatedly. In addition, TCF repeatedly failed to assure that basic physical examinations of chimpanzees took place prior to, and during, testing.

Some GLP violations also constituted grave violations of the Animal Welfare Act. For example, TCF allowed chimpanzees involved in a drug study to experience weight loss so severe that it killed one of them. The chimpanzees showed both decreased appetite and diarrhea, but TCF took no action and left the chimpanzees on the drug study while documenting their life-threatening weight loss. The dead chimpanzee lost 29% of his body weight in a period of weeks, while another lost 23% in less than one month, and another 18% in two weeks. This would be analogous to a human weighing 175 pounds losing 50 pounds, 40 pounds and 32 pounds, respectively, in two to four weeks. Obtaining valid scientific data under these conditions would be virtually impossible.

One of the three studies singled out for criticism was the controversial and invasive spinal protocol on chimpanzees sponsored by Spinal Dynamics Corp. (206-275-2715), a start-up medical device company based in Mercer Island, Washington. The violations cited by FDA relating to this study are so severe as to fatally compromise any data attained from it, IDA said. Further details on these specific violations can be found in IDA's 3-page Summary of the FDA inspection.

"This spinal protocol has been touted by TCF as one of just two banner studies conducted at the lab," Katz observed (see http://www.coulston.org/page1.html). "If TCF points with pride to an experiment that has been so shoddily conducted that it would almost certainly be rejected by the FDA, what does that say about the quality and integrity of the rest of the testing conducted at TCF?"

"This stunning FDA inspection report should be the death knell for this abysmal laboratory," Katz stated. "Is there any federal law governing animal research that TCF has not violated?"

The FDA is not the first federal agency of which TCF has run afoul. Also in August 1999, TCF signed a settlement decree with the U.S. Department of Agriculture requiring the lab to divest 300 of its 650 chimpanzees and to submit to unprecedented oversight by outside animal care and fiscal monitors. The decree settled unprecedented multiple sets of formal USDA charges against the lab for violations of the Animal Welfare Act related to negligent chimpanzee deaths, inadequate veterinary care and deficient research oversight. Last February, NIH also placed formal restrictions on TCF's animal use, based largely on inadequate veterinary staffing.

"This stunning FDA report, combined with USDA's unprecedented findings, now show beyond any doubt that U.S. taxpayers have been bilked of more than the $20 million given to TCF since 1993, as well as TCF's current $1 million+ annual subsidy," concluded Katz. "How can NIH bureaucrats possibly be allowed to continue sending our hard-earned tax dollars to prop up a private laboratory with such an abysmal record regarding data integrity, human safety and animal welfare? We intend to make NIH answer to Congress and the American people."

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