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Stop Animal Exploitation NOW!
S. A. E. N.
"Exposing the truth to wipe out animal experimentation"

Articles and Reports

Official Letter of Complaint to Dr. Elias A. Zerhouni, Director NIH about SWFBR's Treatment of Primates


Stop Animal Exploitation NOW!
1081-B St. Rt. 28 PMB 280
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saen@saenonline.org
513-575-5517

 

Dr Elias A Zerhouni, Director                        2/6/08
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892

Dr. Zerhouni,

I am writing to you today in reference to documentation regarding several research projects currently underway at the Southwest Foundation for Biomedical Research (SWFBR) in San Antonio. The National Institutes of Health currently funds several grants at this facility including involving baboons:

1

5R01NS047755-03

WILLIAMS, JEFF

Baboon Model for Genetics of Human Generalized Epilepsy

2

5R01RR013199-08

BRENT, LINDA

Baboon Model for the Study of Primate Maternal Behavior

3

5R01MH065462-05

ROGERS, JEFFREY

Genetics of Monoamine Endophenotypes and Mental Health

4

5P01HL028972-249003

CAREY, KENNETH

CORE--VETERINARY SERVICES

5

5P01HL028972-240009

RAINWATER, DAVID

Lipoproteins, oxidataive damage, and responses to diet

6

5P01HL028972-24

VANDEBERG, JOHN

DIET AND GENOTYPE IN PRIMATE ATHEROSCLEROSIS

7

5P01HL028972-240011

COMUZZIE, ANTHONY

PLEIOTROPIC EFFECTS ON OBESITY AND LIPOPROTEINS

8

5P01HL028972-249007

DYKE, BENNETT

CORE--DATA MANAGEMENT AND COMPUTING

9

5R01AI018867-18

LOVERDE, PHILIP

Toward a Molecularly-Defined Vaccine for Schistosomiasis

10

5P01HL028972-240010

VANDEBERG, JOHN

GENE MAPPING, STRUCTURE AND EXPRESSION

11

5R01AI065697-02

VANDEBERG, JOHN

TB Vaccine Development in Nonhuman Primate Model

I have recently obtained documentation from the United States Department of Agriculture which reveals that that this facility was cited on 4/3/07 for the performance of an unapproved surgical procedure on a primate. This procedure was a necropsy and tissue harvest that went terribly wrong because the baboon was not euthanized before the procedure was begun. The USDA inspector justifiably chastised the SWFBR staff:

“Euthanasia means the humane destruction of an animal accomplished by a method that produces rapid unconsciousness and subsequent death without evidence of pain or distress. The euthanasia of one baboon was not accomplished as described above as it was not dead prior to the start of the necropsy procedure.”

SWFBR is also cited in this inspection for the performance of multiple survival surgeries on a primate without approval from the USDA, another unapproved procedure. In fact, the citation on this date is a repeat citation of an infraction that originally occurred on 7/13/06. (See attached inspection reports)

These situations led to multiple violations of the Animal Welfare Act (2.31 (c)(3), 2.31 (c)(4), 2.31 (d)(1)(ii), 2.31(d)(1)(x), 2.31 (e)(3), 2.31(d)(1)(xi), 2.33(b), etc see attached USDA inspection reports dated 4/3/07, 11/28/06, 7/13/06.

This situation led to multiple issues regarding compliance with NIH guidelines including:

1. Failure to adhere to PHS Policy and the Animal Welfare Act
2. Conducting procedures without IACUC approval
3. Failure to promptly report AWA and PHS violations to OLAW

All of these issues are directly addressed by the USDA inspection report.

Pursuant to NIH policy, we ask that the NIH take appropriate disciplinary action including: 1) demanding full repayment of the grant money spent during the period of noncompliance; 2) prohibiting the offender from ever receiving another NIH grant; 3) revoking Southwest Foundation for Biomedical Research’s Office of Laboratory Animal Welfare (OLAW) accreditation; and 4) further investigating Southwest Foundation for Biomedical Research for further noncompliance with animal welfare laws during the entire funding period of the grant(s) in question. Additionally, I believe that it is will be important to examine all primate protocols at this facility for similar violations.

Full institutional compliance with all Public Health Service (PHS) and USDA regulations is “an absolute requirement” of PHS Policy IV.C.1.a. g. and is required for the retention of OLAW Assurance approval. Furthermore, using PHS and USDA classifications, the above incidents of noncompliance must be classified as “serious deficiencies,” as they all constitute a threat to the health and safety of animals at Southwest Foundation for Biomedical Research.

As you are aware, the provisions outlined in NOT-OD-07-044 specify the following:

The Office of Management and Budget Cost Principles and the NIH Grants Policy Statement (NIHGPS) do not permit charges to grant awards for the conduct of animal activities during periods of time that the terms and conditions of the NIHGPS are not upheld. Specific situations under which charges are not allowable are as follows:

1. The conduct of animal activities in the absence of a valid Assurance on file with OLAW.
2. The conduct of animal activities in the absence of valid IACUC approval of the activity. Absence of IACUC approval includes failure to obtain IACUC approval, expiration, or suspension of IACUC approval.

The aforementioned incidents of noncompliance at the Southwest Foundation for Biomedical Research laboratory satisfy the latter criteria and I request that funds spent during the period of noncompliance be returned.

I respectfully request that you respond to this correspondence within 5 business days.
 

Sincerely,


Michael A. Budkie, A.H.T.,
Executive Director, SAEN

cc: Axel Wolff

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