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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