October 25, 2001

Mr. Jerry Montoya, Executive Director
New Mexico Board of Pharmacy
1650 University Northeast, Suite #400 B
Albuquerque, New Mexico 87102

Dear Mr. Montoya:

On April 20, 2001 Animal Protection of New Mexico (APNM) contacted the New Mexico Board of Pharmacy (Board) requesting records on file for The Coulston Foundation (TCF).  You provided the requested records on August 9, 2001 and thank you very much.

Our review of the records has raised serious concerns about the veracity of the information provided to the Board by TCF in order to renew its annual animal control clinic and controlled substance applications.  It appears to APNM that the lab has failed to acknowledge disciplinary actions taken or pending against TCF by federal agencies and a US District Court’s finding that TCF created a hostile work environment and sexually harassed female employees.

By this letter and attachments, APNM informs the Board that TCF has been continually investigated by federal agencies beginning in 1995 and is still under investigation by both the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA).

Following is a summary of the complaints and enforcement actions against TCF by FIVE separate federal agencies, an internationally recognized laboratory accreditation organization, and a federal district court.

July 1995: The United States Department of Agriculture (USDA) formally charged TCF for multiple violations of federal animal welfare laws.  The violations resulted in the negligent deaths of primates at TCF.

April23, 1997: The Environmental Protection Agency (EPA) filed a formal complaint (FIFRA-H-08) against TCF predecessor, Coulston Products, Inc., an Easton, Pennsylvania-based company then owned by Frederick Coulston.  The complaint was for multiple and serious violations of Good Laboratory Practice Standards (GLPs) under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  Although the complaint was filed against Coulston Products,

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Inc., the actual laboratory where the violations occurred is White Sands Research Center in Alamogordo, New Mexico –the same facility (and the same employees) on La Velle Road now known as The Coulston Foundation.  White Sands Research, Inc. merged into TCF in 1994.    GLPs exist to guarantee data integrity and, ultimately, to protect human health.  Some of the GLPS violations—on Coulston’s own product—include:  • failing to document a description of all the circumstances that may have affected the quality or integrity of the data submitted to EPA; • failing to document a description of the circumstance that resulted in the testing of a dose that was only 45.7% of the intended test dose; • failing to properly document any changes or revisions to the test protocol; • failing to record data properly during measurements of test substances; • submitting a false compliance statement to EPA; and, •  failing to ensure that raw data was handled properly.  On October 14, 1997, Coulston Products settled the EPA complaint by agreeing to pay  a $12,000 fine and promising to comply with “the requirements set forth in FIFRA and its regulations.”  Frederick Coulston-- “Chairman of the Board and CEO” of Coulston Products, Inc., signed the consent order.

February 1998: The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) inspected TCF.  Following this on-site

inspection, AAALAC refused to accredit the lab.  Among the drug program deficiencies sited by AAALAC as reasons for refusing accreditation (appendix one) were the following:

·Protocol 972709 failed to list any analgesic drugs (page 2);

·Public health Service Assurance annual reports indicated that the semi-annual inspections had occurred on exactly the same calendar days for the past three years, in spite of the fact that these dates sometimes fell on weekends (page 3); 

·The location of ketamine HCl, which might be needed for weekend treatments, in Building 1204, HAFB, was unknown to some of the veterinary staff (page 4);

·There was a lack of consistency and adequacy of herpes virus B treatment kits (page 5);

·Analgesics used for non-human primates were limited to primarily over the counter preparations and one prescription drug.  In conversations with Dr. Walden it was apparent that additional analgesics were utilized that were not listed in the Program Description (page 18);

· …in the Macaque Quarantine Building 1820, expired Flagyl (1997) and epinephrine (1/98) were observed.  In building 100, Dakins solution was out of date and suture material that expired in the 1980s were present.  The coded “dot” system used in some areas was not uniformly used and thus could lead to inaccurate monitoring of the drug inventory (page 19).

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March 19, 1998: The USDA formally charged the lab (appendix two) for multiple violations of federal animal welfare laws, which resulted in the negligent deaths of two primates.  The complaint charged that TCF failed “to establish and maintain programs of adequate veterinary care by group sedating chimpanzees (chimpanzee Jello died) and by failing to treat chimpanzee Echo for shock and to stabilize him before surgical treatment (chimpanzee Echo died).

April 22, 1998: A jury in Federal District Court, Las Cruces, found TCF, as well as individual defendants employed by TCF, had “subjected (plaintiff) to a hostile environment of sexual harassment.”  The jury awarded the plaintiff $30,000.  A Memorandum Opinion and Order dated June 30, 1998 (appendix three) stated: “ A reasonable jury could conclude that the sexual harassment by Craig Coulston (son of the lab’s owner) was so pervasive, open and obvious that Defendants had constructive notice of Mr. Coulston’s harassment yet failed to take proper remedial action.”

February 9, 1999: The USDA formally charged TCF with multiple violations of federal animal welfare laws (appendix four).  The complaint amended the March 19, 1998 complaint to incorporate the negligent deaths of three more chimpanzees-- Holly, Terrance and Muffin.  The USDA said TCF again “failed to establish and maintain a program of adequate veterinary care by not making itself and its veterinarians aware of the known side effects and complications of pharmaceutical compounds being tested, resulting in the unnecessary deaths of three chimpanzees…”

February 22, 1999: The National Institutes of Health’s Office for Protection from Research Risks (now called the Office of Lab Animal Welfare) restricted TCF’s Animal Welfare Assurance (appendix five).  The NIH stated: “Based on the continuing concerns about the number of veterinarians and their credentials available to provide veterinary care to chimpanzees and other non-human primates at the CF, and the major changes in other aspects of the CF program of animal care and use, OPRR is placing the Animal Welfare Assurance for the CF (#A3858-01) into a restricted status.”  Among other provisions, the restriction required the lab to hire an adequate number (seven) of “fully qualified” veterinarians (TCF has never complied with this requirement).

August 24, 1999: Coulston signed a Consent Decision and Order with the USDA (AWA Docket No. 98-0014, appendix six).  Among other provisions, Coulston agreed to: • comply with federal animal welfare laws; • maintain disease control and prevention programs, euthanasia programs and adequate veterinary care programs under supervision of a doctor of veterinary medicine; • submit to unprecedented oversight of its animal program and financial status by an external review team; • employ and adequate number of veterinarians; • cease breeding chimpanzees absent resources for the long

term care of their offspring; and, divest of 300 chimpanzees by January 2,

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2002.  A $100,000 fine was held in abeyance pending TCF’s compliance with the Order.  Almost immediately, TCF violated the Order by continuing to breed chimpanzees, which the USDA discovered several months later (USDA inspection report, appendix six).

December 22, 1999: The Food and Drug Administration issued TCF a warning letter (appendix seven) based on an on-site investigation of the lab conducted between July 26 and August 19, 1999.  The FDA concluded “that the conditions are serious violations of GLP regulations…(and) unless these deficiencies are corrected, we would consider future studies conducted at your facility to be seriously flawed.”  The FDA directed that “Prior to the initiation of any further new non-clinical laboratory studies, the observed GLP deficiencies must be corrected and you should request from the FDA Denver District Office that your laboratory be re-inspected.” 

Although TCF had been inspected by the FDA just two month’s prior, the Animal Control Clinic Application (appendix seven) signed October 11, 1999 by TCF veterinarian Gregory Heisey fails to disclose to the Board the results of the FDA investigation.  The December 22, 1999 FDA Warning Letter clearly states:  “During the inspection (July 26-August 19, 1999) our investigators observed a number of deviations from the GLP regulations.  The deficiencies were listed on a Form FDA 483 (appendix seven), which was discussed with and presented to you at the conclusion of the inspection.”

February 2000: To comply with the terms of the August 24, 1999 Consent Decision and Order, TCF invited AAALAC conducted another on-site inspection, which was completed in February 2000.  AAALAC issued its report and recommendations (appendix eight) on April 28, 2000, again refusing to accredit TCF.  The report stated that: “the evaluation team identified issues…mandatory…for correction, in the same programmatic and facilities areas indicated in the 1998 AAALAC report.  The…team was of the opinion that resource shortages were sufficiently significant to preclude the current program from meeting the requirements of accreditation.  Of further concern was (TCF President) Dr. Renquist’s resignation from TCF shortly after the evaluation.”  The report identifies numerous violations of federal regulations, including: • failure of TCF to notify members of its IACUC of the FDA’s findings that TCF was not in compliance with FDA regulations; • unsatisfactory institutional arrangements for veterinary care; unsatisfactory personnel qualifications and training; and unsatisfactory hazard identification and risk assessment, including the failure by TCF to include non-chemical hazards on the institutional list.  In addition, AAALAC noted (page 13): “…the complete separation of the experimental procedures from the husbandry procedures in most instances resulted in lack of knowledge/understanding by animal care personnel as to research procedures/drugs being used.”

November 2, 2000: The Occupational Safety and Health Administration

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(OSHA) cited TCF for more than a dozen “serious” violations of worker safety laws (appendix nine) and fined the lab $7,100.  Among the charges was a cluster of violations regarding Coulston’s failure to assure the safety of its employees exposed to HIV/SIV, HBV, HCV and Cercopithecine herpesvirus l (B virus), including failure to train the employees in the use of respirators (and their limitations), failure to determine if the employees were physically able to perform the work and use the equipment, failure to periodically (for instance, annually) to review the respirator user’s medical status, and failure to fit test the respirators.  “On or about April 3, 1998 and again on July 7, 1999 Coulston employees received contaminated needle sticks from needles

contaminated by HIV positive chimpanzees.” (Note: Such a scenario led to the death of a young woman at Yerkes Primate Center several years ago).

Yet, on the October 12, 2000 Controlled Substance Renewal Application, (appendix nine) TCF veterinarian Greg Heisey states that there are NO “pending disciplinary actions(s) and/or ongoing investigations against the applicant (TCF) by any licensing authority or law enforcement agency.”

From November 27-December 8, 2000, the FDA conducted another inspection of TCF (appendix ten) and found that TCF had initiated and conducted new GLP studies in violation of the FDA warning letter requesting that no further new non-clinical laboratory studies be initiated prior to correction of all deficiencies noted during the previous FDA inspection (7/26/99 – 8/19/99). 

Despite the USDA Consent Decision and Order in effect, the receipt of an FDA warning letter, AAALAC’s findings of multiple program and staffing inadequacies, and OSHA’s citation and fine, TCF on its October 12, 2000 Controlled Substance Renewal Application also failed to disclose to the Board pending disciplinary actions by either the USDA or the FDA.  Instead, TCF stated that there were NO pending disciplinary action(s) and/or ongoing investigations against the lab by any licensing authority or law enforcement agency (question #3, Controlled Substance renewal Application, signed by Greg Heisey, 10/12/00)

July 12, 2001: The USDA again filed charges (AWA Docket No. 01-0044) (appendix 11) against TCF related to the deaths of chimpanzee Ray (8/16/01) from an alleged “fungal infection” and chimpanzee Donna (10/27/99), who died after carrying a dead fetus in her womb for almost two months. Once again, the USDA alleged that TCF “has failed to establish and maintain programs of adequate veterinary care…”

July 2001: The National Institutes of Health cancelled TCF’s Animal Welfare Assurance, making the lab ineligible for further federal research funds.

In view of TCF’s record of violations, fines, misrepresentations and the

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ongoing investigations by the USDA and the FDA, APNM requests that the New Mexico Board of Pharmacy conduct a full investigation of TCF’s mis- representations to the Board on its applications and withhold any new permits until the Board’s inquiry is concluded.

Sincerely,

Harriette F. Roller

Development Director