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Complaint Regarding Sole-Sourcing to former NIH Official Dr. Lou Sibal

September 28, 2000

VIA FAX (27 pages) and EMAIL

(2 separate FAXes; 1st is the 20-page Complaint, 2nd is the 7-page April 1999 site visit/audit)


Ms. Karen Riggs
National Library of Medicine
Office of Acquisitions Management
Building 38A, Room B1N17
8600 Rockville Pike
Bethesda, Maryland 20894


301-402-8169 (FAX)

karen_riggs@nlm.nih.gov

RE: Complaint Regarding Sole-Sourcing to former NIH Official Dr. Lou Sibal for SOL NLM 00-212/UHP, "Professional Support Services for Onsite Monitoring of the Colony of Chimpanzees (Pan Troglodytes)"



Dear Ms. Riggs:

Please consider this a formal complaint filed by In Defense of Animals (IDA), an international animal protection group based in Mill Valley, California, regarding the sole-sourcing to former NIH official Dr. Lou Sibal of the above-referenced contract SOL NLM 00-212/UHP. We believe that Dr. Sibal’s long record of obfuscations and misrepresentations to both members of Congress and the taxpaying public regarding The Coulston Foundation (TCF) — which currently cares for the chimpanzees mentioned in the above-referenced contract — mandates that he be disqualified from receiving this contract.

We also believe that Dr. Sibal’s central involvement in the NIH’s actions regarding TCF while he was at the NIH constitutes a clear conflict of interest that should also disqualify him from receiving this contract. We have included voluminous examples of Dr. Sibal’s central involvement towards the end of this complaint, based on documents IDA obtained through FOIA. Indeed, Dr. Sibal was the Project Officer until December 31, 1999 on the very contract for "onsite monitoring" of the chimpanzees at TCF that the NIH is now sole-sourcing to him. Moreover, this contract is mandated by Section 5 of the August 24, 1999 consent decree between TCF and the USDA, which outlines the responsibilities of the "INDEPENDENT compliance review officials." Given Dr. Sibal’s documented record of misrepresentation and obfuscation as a high NIH official regarding the situation at TCF, coupled with his intimate working relationship with current NIH officials who have also repeatedly misled the public and Congress about the situation at TCF, we believe it is impossible to consider Dr. Sibal free of a severe conflict of interest, and "independent" in any meaningful sense, as required by the consent decree.

For well over one year before his retirement from the NIH on December 31, 1999, Dr. Sibal was centrally involved in the NIH’s actions (or inactions) regarding TCF. According to NIH records obtained by IDA under the Freedom of Information Act (FOIA), Dr. Sibal was cc’d on virtually every correspondence dealing with TCF that originated from the NIH Office of Director (OD); the Office for Protection for Research Risks (OPRR); the National Center for Research Resources (NCRR); other NIH institutes and offices; and, of course, from Dr. Sibal himself. Dr. Sibal also attended numerous NIH meetings regarding TCF, including several in which he made presentations regarding the situation at the facility. Again, we have included many examples, including direct quotations from various emails and correspondence, towards the end of this complaint.

As we will document in this complaint, Dr. Sibal’s intimate knowledge of the TRUE situation at TCF stands in stark contrast to the blatant misrepresentations and obfuscations that Dr. Sibal chose to provide — repeatedly — to both members of Congress and the taxpaying public. If, as we believe, Dr. Sibal never honestly reported the true conditions AS HE KNEW THEM to members of Congress and the taxpaying public, how can you, as the contracting officer, possibly expect that he will now honestly report those conditions as required by the above-referenced contract? If he can’t report honestly to the funding public and to members of Congress about the very conditions that are the subject of this proposed contract, how can you possibly expect him to report honestly about the situation at TCF now, which would in our opinion be in direct contravention of not only his former colleagues at the NIH, who have repeatedly misled the public and Congress, but also his own misrepresentations to Congress and the public? Especially if those reports would be subject to FOIA, as they certainly are?

We believe that this is especially questionable in light of the fact that such honest reporting would be available under FOIA, and would not only undercut the misrepresentations regarding the TCF situation made publicly by his former colleagues at the NIH, with whom Dr. Sibal worked very closely on the TCF situation, but also directly contradict Dr. Sibal’s own, repeated misrepresentations to both members of Congress and the taxpaying public regarding TCF. In other words, if Dr.. Sibal were to honesty report on the conditions at TCF, as required by this contract -- which in our opinion he has never done publicly -- he would have to directly contradict his own misleading statements as contained in his repeated letters, statements, etc. to both Congress and the public.

In this complaint, IDA will also discuss other reasons why we believe Dr. Sibal should not be awarded this contract. These include questions about his qualifications; his failure to provide complete information as Chair of the Interagency Animal Models Committee regarding a proposed NIDDK-funded project at TCF; what we believe is his failure to fulfill the responsibilities of FOIA and the August 24, 1999 consent decision between TCF and Coulston to settle multiple formal charges against TCF for multiple violations of the Animal Welfare Act that calls for release through FOIA of the "independent compliance review officials" reports; and other reasons that we will elaborate on in this complaint.

Please be advised that we will be quoting numerous documents in this complaint, many of which are internal NIH documents obtained by IDA through FOIA. We will be happy to provide copies of any such documents upon request.

1. CONFLICT OF INTEREST

As we stated above, Dr. Sibal was for many years an official with the NIH’s Office of Director. He directed the Office of Laboratory Animal Research and was Chair of the Interagency Animal Models Committee (the IAMC is supposed to provide an extra layer of peer review for PHS-funded chimpanzee experiments. Without IAMC approval, PHS-funded chimpanzee experiments cannot be started). Dr. Sibal was, until his retirement from the NIH on December 31, 1999, the Project Officer on the very contract that the NIH is now attempting to sole-source to him. We believe that that alone constitutes a clear conflict of interest. It is also very important to note that this contract is mandated as part of the August 24, 1999 consent decree between the USDA and TCF — and Section 5 outlines the duties of the "INDEPENDENT compliance review officials."

Most importantly, Dr. Sibal was centrally involved in the NIH’s actions, inactions, meetings, correspondence, etc. relating to TCF (multiple excerpts provided towards the end of this complaint). It was Dr. Sibal who blatantly misrepresented the findings of an April 1999 NIH site visit/audit — which Dr. Sibal attended — to both members of Congress and the taxpaying public (we will explain in detail his misrepresentations later in this complaint). In his letter, sent to numerous members of Congress and the public, Dr. Sibal essentially said that the conditions at TCF were fine; that the NIH was providing proper oversight; misrepresented the NIH’s oversight action of restricting TCF’s Animal Welfare Assurance; and minimized the unprecedented U.S. Department of Agriculture (USDA) formal charges and findings against TCF regarding multiple, repeated and grave violations of the Animal Welfare Act relating to inadequate veterinary care and inadequate research oversight involving the deaths of at least five chimpanzees, as well as numerous physical plant and sanitary violations. It should be noted that adequate veterinary care and adequate research oversight (IACUC) review are the cornerstones of compliance with all animal welfare laws.

It is also important to note that Dr. Sibal wrote this blatantly misleading letter after attending a meeting of various USDA and NIH officials on March 16, 1999 (in fact, Dr. Sibal gave a presentation). At this meeting, according to handwritten notes, Dr. Nelson Garnett of the NIH’s Office for Protection from Research Risks (OPRR), which is supposed to ensure compliance with animal welfare laws at PHS-funded facilities such as TCF, stated his office’s "Great concern about long-term situation/animals at serious risk" at TCF. Garnett also stated that his office's concerns "parallel USDA[‘s]" (USDA APHIS Deputy Administrator Dr. William R. DeHaven was also at the meeting); that TCF had "inadequate IACUC [Institutional Animal Care and Use Committee] review" and an inadequate "level of veterinary care." As stated above, a properly functioning IACUC, and adequate veterinary care and staffing, are the cornerstones of compliance with all federal animal welfare laws. Representatives from NCRR (Director Judith Vaitukaitis, Deputy Director Louise Ramm, Director of Comparative Medicine John Strandberg) and the NIH's Office of Director (Sibal) were also present at the meeting.

Given this documented history of blatant misrepresentation — and remember that Dr. Sibal was cc’d by other NIH officials on virtually every email, correspondence, etc. relating to TCF since at least November 1998 — how could Dr. Sibal possibly state, repeatedly, as a high NIH official, that everything was essentially fine at TCF, but then turn around and report the true conditions at TCF, as required by the above-referenced contract, only ten months after departing the NIH office where he repeatedly said everything was essentially fine at TCF? Would it not be impossible for Dr. Sibal to write ANYTHING negative about TCF without calling into serious question his own actions as a high NIH official who repeatedly stated that, essentially, everything was fine at TCF? Would that not constitute a disavowal of his own actions — in essence, calling himself a dissembler — as well as a disavowal of the actions, public statements, etc. of the NIH colleagues with whom he had worked so closely for so many years?

Such colleagues would include Dr. John Strandberg, who made blatantly misleading statements in the May 15, 2000 Washington Post about the conditions at TCF, e.g., that TCF’s continuing violations were simply public relations problems, and that the USDA’s unprecedented findings regarding inadequate veterinary care and inadequate research oversight involving the deaths of at least 12 chimpanzees were instead mere record-keeping and wall-surface deficiencies. These statements were so misleading that three days later, on May 18, 2000, Rep. James Greenwood (R-PA) introduced the Post article into the official record during a hearing where Dr. Strandberg testified, and challenged Dr. Strandberg to defend not only his statements in the Post, but also the NIH’s statements about the conditions at TCF and the findings of the USDA (and remember, just a year earlier, OPRR’s Dr. Garnett had stated during the March 16, 1999 meeting that his office’s concerns paralleled USDA’s). However, Dr. Strandberg even refused to concede that the USDA had documented inhumane conditions and violations of the Animal Welfare Act at TCF. After Strandberg refused to identify what caused the USDA’s concerns at TCF, Rep. Greenwood responded that "Well, they [USDA] considered it a violation of the Animal Welfare Act. That's pretty obvious what their concerns were over."

To put it bluntly: If, as we believe the record clearly shows, Dr. Sibal repeatedly states as a high NIH official that everything is essentially fine at TCF, what is he going to report as the "INDEPENDENT" compliance review official mandated by the August 24, 1999 consent decree between the USDA and TCF — that the situation at TCF has "gone to pot" in the ten months since he left the NIH? That he totally disavows his own misleading statements while he was at the NIH, and also totally disavows the misleading statements of close ex-colleagues such as Dr. Strandberg? Indeed, it was Sibal who was centrally involved in the NIH’s debacle of "oversight" of TCF — "oversight" that led to the situation at TCF deteriorating so badly that the unprecedented August 24, 1999 USDA consent decree, and the "INDEPENDENT compliance review official," were needed in the first place. In other words, Dr. Sibal played no small role at the NIH in the necessity of creating the very position that the NIH is now attempting to sole-source to him.

In addition, this is supposed to be a contract for an "INDEPENDENT compliance review official," not one for a former high NIH official only ten months removed from his NIH position whom we believe covered up the NIH’s malfeasance regarding TCF, and, in our opinion, would simply continue his record of obfuscation and misrepresentation, if only to (1) justify his own misleading actions as a high NIH official, and (2) to support the continued misleading actions of his close ex-colleagues at the NIH, such as Dr. Strandberg.

2. QUALIFICATIONS

It is true, as stated in the NLM’s September 14, 2000 Commerce Business Daily Notice, that Dr. Sibal has experiencing conducting site visits. But we believe that the true question should be, Does Dr. Sibal have experience reporting TRUTHFULLY about the findings of those visits? If one goes by the statements he made, repeatedly, to members of Congress and the taxpaying public regarding the April 1999 NIH site visit/audit at the very facility that is the subject of this proposed sole-sourced contract — a site visit in which he participated — then we believe that the answer is a resounding "no."

Moreover, to the best of our knowledge, Dr. Sibal is a Ph.D., not a DVM or VMD. He is not a veterinarian. He, to the best of our knowledge, is not accredited by the American College of Laboratory Animal Medicine (ACLAM). He, to the best of our knowledge, has no clinical chimpanzee experience. He, to the best of our knowledge, has never operated a large chimpanzee colony. He, to the best of our knowledge, has never worked at a large chimpanzee colony. He, to the best of our knowledge, has no experience regarding the accounting or financial resources aspects of operating a large chimpanzee colony. To the best of our knowledge, he has never served on an IACUC at a large chimpanzee colony — and may never have served on an IACUC anywhere. This is a contract for onsite monitoring of the largest chimpanzee colony in the world, to meet the legal obligations of the August 24, 1999 USDA consent decree for an "INDEPENDENT compliance review official." According to Section 5 of the decree, the review official’s responsibilities include having "full access to all facilities, IACUC meetings and relevant records necessary to ensure compliance with the AWA and to evaluate the financial status of [TCF] with respect to matters under APHIS jurisdiction...."

Given these legally mandated responsibilities, and Dr. Sibal’s total lack of experience in these vital areas, we believe that he is simply not qualified to meet the requirements of this contract.

3. MISREPRESENTATIONS ABOUT THE COULSTON FOUNDATION

A. The April 1999 NIH Site Visit/Audit

We have repeatedly mentioned how Dr. Sibal blatantly misrepresented the findings of the NIH’s April 1999 site visit/audit of TCF, as well as the conditions at TCF and the unprecedented findings of the USDA. We will now detail some of those misrepresentations.

In a letter dated September 20, 1999 — almost one month after the August 24, 1999 consent decree between the USDA and TCF that settled the March 1998 and February 1999 formal charges against TCF — Dr. Sibal wrote to Ms. Marcia Davis of Colorado Springs, Colorado that "Although the USDA has filed several charges against the CF, the issues have not yet been resolved and no final action has been taken." This is simply untrue. The August 24, 1999 consent decree settled the charges Dr. Sibal mentions, and was indeed the final action regarding those charges. The unprecedented consent decree required TCF to, among other things, divest 300 chimpanzees by January 2002; restrict chimpanzee breeding; comply with the Animal Welfare Act; appoint both an "INDEPENDENT compliance review official" and an external review team; and provide adequate veterinary care and staffing. This language is essentially the same as the blatantly misleading letters that Dr. Sibal repeatedly sent to both members of Congress and the taxpaying public before the consent decree was signed.

However, the most egregious misrepresentations involve the findings of the April 1999 site visit/audit, in which Dr. Sibal participated; the conditions at TCF (with which Dr. Sibal was intimately familiar, as evidenced by numerous emails and meetings he attended, including the March 16, 1999 meeting referenced above); the USDA’s unprecedented findings; and Dr. Sibal’s explanation of the restriction OPRR placed on TCF’s Animal Welfare Assurance.

Before we begin, we would like to provide a partial listing of some of the members of Congress Dr. Sibal sent his blatantly misleading letter to: Rep. Peter King (R-NY), May 7, 1999 and May 5, 1999; Sen. John McCain (R-AZ), May 21, 1999; Rep. Carolyn McCarthy (D-NY), May 26, 1999; Rep. Michael R. McNulty (D-NY), June 21, 1999; Ms. Lucy Locher, Ms. Linda Clark, Ms. Lana Luhm, Ms. Bernice Martz, Mr. Pat Rankin, Ms. Lois Laita, Mr. David Conley on behalf of Senator Herbert Kohl (D-WI), July 30, 1999; Rep. Bob Riley (R-AL), June 22, 1999; Rep. Lynn Rivers (D-MI), September 3, 1999; Sen. John Breaux (D-LA), October 22, 1999; Rep. Steve Buyer (R-IN), August 16, 1999; Sen. Robert Byrd (D-WV), May 6, 1999; Sen. Ben Nighthorse Campbell (R-CO), May 13, 1999; Rep. Peter Deutsch (R-FL), May 5, 1999; Sen. Richard Durbin (D-IL), May 26, 1999; Sen. Phil Gramm (R-TX), May 11, 1999; Sen. Charles Grassley (R-IA), July 30, 1999; Sen. Chuck Hagel (R-NE), May 5, 1999; Sen. Thomas Harkin (D-IA), June 8, 1999; Rep. Wally Herger (D-CA), June 18, 1999; Sen. Paul Sarbanes (D-MD), October 1, 1999; Sen. Bob Smith (R-NH), May 21, 1999; Sen. Arlen Specter (R-PA), June 23, 1999; and Rep. Anthony Weiner (D-NY), October 1, 1999.

Note that some of these letters are dated after the August 24, 1999 consent decree was signed by TCF and the USDA, but that Sibal continued to send out the false information about the charges not being settled, in addition to the blatantly misleading information we are about to discuss.

According to Dr. Sibal — and remember, he sent this to numerous members of Congress and the taxpaying public — "In addition, because of public concern for the welfare of these valuable animals [the chimpanzees at TCF that the NIH wants to sole-source the monitoring of to Sibal], the NIH sent a team of senior scientists and veterinarians to the CF in April 1999. The group found the facilities acceptable; the animals appeared to be in good physical condition and were receiving proper care and treatment by an attentive animal care staff."

We are attaching the full site visit and audit in Adobe Acrobat "pdf" format in the emailed version of this complaint (please advise if you have problems opening the attachment; we are FAXing it with our FAX’d version of this complaint). We urge you to read IN THEIR ENTIRETY both the site visit and audit and come to your own conclusions as to whether or not Dr. Sibal misrepresented the findings of this visit, and the general conditions at TCF. We will now demonstrate some of the highlights of Dr. Sibal’s blatant misrepresentation, and suppression of evidence, regarding this site visit that he himself participated in. It is also vital to keep in mind that Dr. Sibal had additional evidence about the conditions at TCF — e.g., the March 16, 1999 meeting in which OPRR’s Dr. Nelson Garnett said that his office’s concerns paralleled USDA’s; that TCF had inadequate IACUC review and questionable levels of veterinary care; and this his office had great concern about the long-term situation, and that the animals were at serious risk — and MUCH other material, which is located further into this complaint. At this same meeting, the USDA’s Dr. DeHaven related that TCF CEO Dr. Fred Coulston had told him that "no major company wants to do work with us" because of the USDA charges, indicating financial distress. Other internal NIH indicate that Dr. Sibal knew that then-TCF vice president and Chief Financial Officer Dr. Ali Javadian had contacted NIH-funded researcher Patricia Fultz, stating his concerns that TCF could not adequately care for the chimpanzees, and that animal care employees were leaving for lower-paying but more secure positions, also putting the animals at risk. TCF’s financial situation will be discussed later — but Dr. Sibal was privy to that devastating information as well.

Although Dr. Sibal claims that the chimpanzees were receiving proper care, he neglects to mention the devastating finding from this site visit, which he attended. Like the USDA, NIH auditors also found TCF’s veterinary care to be "problematic," with the three full-time veterinarians being "very junior with no formal training in primate medicine, and may be inadequate for the job at hand." As stated above, adequate veterinary care — by veterinarians, not animal care staff (which constitutes caretakers, technicians, etc.) — is one of the cornerstones of adequate care and compliance with animal welfare laws. Why did not Dr. Sibal mention this devastating finding about TCF’s "very junior" veterinary staff and its "problematic" veterinary care? It should be noted that these three "very junior" primate veterinarians have all since left TCF — TWO OF THE THREE DURING THE TIME THAT DR. SIBAL WAS STILL EMPLOYED BY THE NIH — and have been replaced by veterinarians who apparently have even LESS clinical chimpanzee experience than the ones NIH itself described as "very junior with no formal training in primate medicine, and may be inadequate for the job at hand." If these vets were inadequate for the job at hand, what would veterinarians with even less clinical chimpanzee experience be? In fact, since 1994, 16 veterinarians with over 60 years of combined clinical chimpanzee experience have left TCF.

In 1999, the NIH told Speaker Hastert essentially the same thing from Dr. Sibal’s letter: that the April 1999 NIH site visit found that "In general, the facilities were acceptable at all sites.... All of the animals appeared to be in good physical condition...and were receiving good care by an attentive animal care staff." It appears from email excerpts below that Dr. Sibal was involved in providing Congress information about the situation at TCF. This statement misrepresents the findings of the NIH site visitors recounted above; it ignores the formal USDA charges that were filed just two months prior, in February 1999, for inadequate veterinary care and multiple research oversight violations resulting in what the USDA called the "unnecessary" deaths of three chimpanzees; and it contradicts the scathing findings of the AAALAC site visit team, which in February 1998 found fundamental, facility-wide deficiencies at TCF in the cornerstones of compliance with animal welfare laws — veterinary care and staffing, and IACUC review and functioning, as well as physical plant and workplace safety deficiencies.

The violations found by AAALAC were so severe that it mandated that AAALAC reject TCF’s application to become AAALAC-accredited. And it is also very important to note that AAALAC uses as its major accreditation criterion the NIH Guide for the Care and Use of Laboratory Animals (the heart of the PHS Policy on the Humane Care and Use of Laboratory Animals) — the very same Guide that the NIH is supposed to use to enforce the PHS Policy, which Dr. Sibal mentions in his letter when he speaks of what a good job of oversight the NIH was doing.

As stated above, Dr. Sibal’s letter also carefully omits reference to TCF’s veterinary staffing, which this same NIH site visit described as "problematic" and lacking both experience and training, and which the USDA had THREE TIMES before this April 1999 site visit — in the March 1998 formal charges, a December 1998 inspection report (which found that TCF had only 2.5 clinical vets to care for over 600 chimpanzees and 300 monkeys), and the February 1999 third set of formal charges — found that TCF had failed to provide the adequate veterinary care mandated by the Animal Welfare Act. The agency also cited TCF for this same violation in a December 1999 USDA inspection, ALL DURING DR. SIBAL’S TENURE AT THE NIH. The NIH and Dr. Sibal knew that TCF’s veterinary staffing and care were deficient and at the heart of the laboratory’s animal care problems, along with its "dire" financial situation. But neither members of Congress nor the taxpaying public would ever know that from Dr. Sibal’s blatantly misleading letter.

Dr. Sibal also conveniently neglects to mention the devastating comments made by the NIH site visit report regarding TCF management, which is ultimately responsible for complying with federal animal welfare laws; ensuring adequate IACUC review; retaining an adequate veterinary staff; knowing the facilities and what problems need to be addressed; etc. The site visit states that TCF president Dr. Ronald Couch is "evasive" and unfamiliar with the facilities. Another NIH internal email stated that Dr. Couch had also misrepresented TCF’s financial status to the CDC (TCF had a contract with the CDC for NHANES testing) in April 1999, while another email, from November 1998, stated that Dr. Couch had told NCRR officials that the rumor of $500,000 in unpaid bills was essentially none of the agency’s business (NCRR was a major funder of TCF under the Chimpanzee Breeding and Research Program), and that the layoffs of approximately 20 TCF employees were not indicative of any financial distress, but were simply ordinary corporate downsizing.

The April 1999 NIH site visit also made scathing remarks regarding TCF CEO Dr. Fred Coulston’s lack of veracity, stating that Dr. Coulston had made "many contradictory statements," and that he had told varying stories regarding TCF’s financial status to the USDA and various NIH offices. Other internal NIH documents stated that Dr. Coulston’s rosy financial assertions made to NCRR stood in stark contrast to the findings of the April 1999 site visit/audit, and that Dr. Coulston had denied saying to the USDA that TCF was in deep financial distress — with only enough money for two or three more payrolls — despite stating this in the presence of not only Dr. DeHaven, but also two USDA attorneys. A May 18, 1999 letter from NCRR to Dr. Coulston further illustrates this "credibility gap": "...we at NCRR continue to be concerned about the Coulston Foundation’s financial stability. The documentation provided by staff of the Foundation reflecting the very precarious financial status of the organization conflicts with the positive and optimistic reports that you continue to provide about the current and future financial status of the Foundation."

The USDA, AAALAC and the FDA have echoed the NIH’s internal concerns about TCF’s management. In fact, according to internal documents, in 1997 AND 1999, TCF was so uncooperative during official USDA investigations that the USDA was forced to draw up subpoenas for records it is clearly and incontrovertibly entitled to under the Animal Welfare Act. As Dr. William R. DeHaven said in a June 3, 1999 email sent to various NIH officials, INCLUDING SIBAL, "I can only assume the real reason for [TCF’s] reluctance [to turn over the records] has to do with turning over damaging evidence."

The February 1998 AAALAC site visit team also found fundamental problems with TCF management, criticizing them for hiring inexperienced veterinarians with no one with the adequate training, experience or longevity to train them; for inadequate responses to the USDA; for failing to ensure proper IACUC functioning; and for physical plant and safety violations.

In addition, in August 1999, the FDA found over 270 violations of Good Laboratory Practice (GLP) regulations, and found violations of the Animal Welfare Act of which the USDA had not even been aware. The FDA found fundamental problems with all three elements of GLP compliance — Management, Study Directors and Quality Assurance — and in December 1999 issued a rare Warning Letter, finding the conditions at TCF to be "serious violations" having "wide spread consequences" for data integrity and human safety. The FDA also ordered TCF to halt any new GLP studies until these "serious violations" were corrected. AGAIN, ALL OF THIS HAPPENED DURING DR. SIBAL’S TENURE AT THE NIH, BUT WE HAVE NO KNOWLEDGE OF HIS EVER MENTIONING THESE GRAVE FDA GLP VIOLATIONS TO MEMBERS OF CONGRESS OR THE PUBLIC, WHICH ALSO INCLUDED VIOLATIONS OF THE ANIMAL WELFARE ACT OF WHICH THE USDA HAD NOT EVEN BEEN AWARE, INVOLVING THE DEATH OF AT LEAST ONE CHIMPANZEE. In what we believe are clear violations of the Animal Welfare Act related to IACUC and inadequate veterinary care, the FDA documented a study in which one chimpanzee died after losing 29 per cent of his body weight in less than a month, while others became sickened after losing 23 per cent, 18 per cent and 18 per cent in a similar period of time (the USDA had not previously known of this study involving the fatal weight loss).

THE FDA ALSO CONFIRMED MANY OF THE USDA’S FINDINGS REGARDING INADEQUATE RESEARCH OVERSIGHT. BUT, AGAIN, WE HAVE NO KNOWLEDGE OF DR. SIBAL’S EVER MENTIONING THESE GRAVE GLP AND AWA VIOLATIONS TO MEMBERS OF CONGRESS OR THE TAXPAYING PUBLIC THAT PAID HIS SALARY, AND WILL PAY FOR THE CONTRACT THAT THE NIH IS ATTEMPTING TO SOLE-SOURCE TO HIM. All that IDA is aware of from Dr. Sibal is his blatantly misleading letter, sent to numerous members of Congress and the taxpaying public, regarding the April 1999 site visit/audit.

Why did not Dr. Sibal explain to members of Congress and the taxpaying public that the NIH itself found that TCF President Couch was "evasive" and unfamiliar with the facilities, and that TCF CEO Coulston had made "many contradictory statements," with varying stories to the USDA and NIH offices about TCF’s financial stability? Or that the USDA was forced to draw up subpoenas for records it was legally entitled to because TCF management was so uncooperative during official USDA investigations relating to violations of the Animal Welfare Act? If TCF senior management is not truthful, and blatantly uncooperative during official federal investigations into allegations of animal welfare violations, how can they be trusted to comply with the very animal welfare laws they have repeatedly broken, or to tell the truth about the conditions at the facility, or, in Couch’s case, to even know the conditions at the facility, in order to address problems? Such problems with the truth go the very heart of the chimpanzees’ welfare — but by omitting this devastating information, Dr. Sibal again blatantly misrepresented the site visit findings.

One of the most egregious misrepresentations made by Sibal to members of Congress and the taxpaying public regards TCF’s dire financial situation. The NIH has, to date, funneled over $1.7 million in taxpayer funds to TCF despite being aware of the lab’s financial, managerial and animal care problems, specifically to "prop up" TCF after the April 1999 NIH site visit/audit found that TCF, a private lab, was on the verge of bankruptcy. The auditors found that TCF had $800,000 in unpaid bills, causing some vendors not honoring new orders from TCF; $2.6 million in outstanding loans; projected that over the next 12 months, it would bring in, at most, only one-third of the monthly cash flow needed to keep it solvent; and was on the verge of bankruptcy. CEO Fred Coulston, who had sunk $6.8 million of his own money into TCF, could no longer personally pay the $200,000 monthly payroll, and "did not appear to have faced the reality of his dire financial situation." Auditors found it unlikely that, based on TCF’s current cash flow, that TCF "could operate much more than two or three months longer." In various documents, the NIH describes TCF’s financial situation as "very precarious," "severe," "grim," and "dire," with remaining staff being paid paycheck to paycheck. TCF’s then-vice-president and Chief Financial Officer Ali Javadian expressed concern that if TCF filed bankruptcy, no sponsor would deal with them. But even bankruptcy was not an option, since "under a bankruptcy filing, an organizational plan and operating capital is required to continue operations. CF has no realistic expectation of an influx of operating capital."

Javadian had earlier told NIH-funded researcher Patricia Fultz that he was concerned about TCF’s ability to care for its chimpanzees. He had also stated that because of TCF’s uncertain financial status, employees were leaving for lower-paying but more secure jobs — including those involved in animal care. The April 1999 site visit report states, "As a result of the uncertain financial status of the Foundation, a number of staff have departed in order to find more secure work." In March 1999, Coulston told the USDA that TCF was experiencing severe financial difficulties, and had only enough money left to meet one or two payrolls. An April 1, 1999 letter from NCRR to TCF states that Dr. Coulston had told the USDA that TCF "was having severe financial difficulties." This was confirmed in a March 2, 1999 email, in which NCRR’s John Strandberg stated that the USDA Western Sector Director Robert Gibbens had noted, "There is a concern in the USDA about the financial solvency of the CF." Gibbens went on to note that "there was little use of Coulston animals at this time with only (1) a spinal study using 5-6 chimpanzees and (2) a toxicity study using 2 macaques (out of nearly 300)." Indeed, during the April 1999 site visit, Dr. Coulston was asking the NIH for additional money as he attempted to obtain support for an additional 100 chimpanzees; the audit reports Dr. Coulston’s request in light of TCF’s need for "immediate additional [financial] support."

Within two months of this site visit, on June 11, 1999, the NIH awarded over $300,000 in its first "supplemental award" in order to avert TCF’s bankruptcy. To date, these supplemental "prop-up" awards have exceeded $1.7 million in taxpayer funds for this private lab. In the June 11, 1999 supplemental award, the NIH wrote that "This supplemental award...provides additional funds in accordance with the grantee’s letter of request dated May 24, 1999," and that the agency (NCRR) was placing very strict conditions on the use of the money by TCF because of "the serious financial problems being experienced by the Coulston Foundation and questions about the financial stability of the organization...." Yet, once again, Dr. Sibal’s misleading letter mentions not one word about TCF’s dire financial situation, nor the apparent misuse of millions of dollars in taxpayer funds (explained further below).

Why is TCF’s dire financial condition important? Perhaps NCRR Deputy Director Dr. Louise Ramm, whom then-NIH Director Dr. Harold Varmus had specifically "tasked" to deal with the TCF situation, said it best, in a March 3, 1999 letter: "If CF is in financial difficulty...it may pose an imminent threat to the welfare of all these animals, whether supported by the NIH or not." Ramm cc’d this letter to Sibal. This is a clear indication (and we have others from internal NIH documents) of how TCF’s financial condition has direct relevance to compliance with federal animal welfare laws, and to the welfare of the "valuable animals" that Sibal’s misleading letter mentions in his attempts to address the legitimate interest of members of Congress and the public. Other examples include an April 9, 1999 document obtained from NCRR entitled "The Coulston Foundation: a serious situation," which states that "Through several sources, the NIH was alerted the week of March 29 that the CF was having major financial problems and that the staff at the CF were concerned about the possible impact on the animals in their care....The Foundation is having severe financial problems. At this time, staff are being paid paycheck to paycheck. Staff are leaving to take more stable, even if low paying, positions....According to Dr. Coulston, private sources of funds have become quite limited." An NIH document entitled "New Mexico 1999" states, "March 29: Phone call to Ali Javadian requesting information on status of chimpanzees. He expressed great concern about the situation noting lack of funds and loss of animal care staff because of inability to pay them." An April 1, 1999 letter from NCRR states that Dr. Coulston had told the USDA that TCF "was having severe financial difficulties." This was confirmed in a March 2, 1999 email, in which NCRR’s John Strandberg stated that the USDA Western Sector Director Robert Gibbens had noted, "There is a concern in the USDA about the financial solvency of the CF." Gibbens went on to note that "there was little use of Coulston animals at this time with only (1) a spinal study using 5-6 chimpanzees and (2) a toxicity study using 2 macaques (out of nearly 300)."

Dr. Sibal’s letter also fails to mention the gravity of the USDA charges — or even what the charges were about. He mentions them only in passing, and does not explain what they relate to. The USDA only rarely files formal charges against research facilities. Under the Animal Welfare Act, the USDA does not have the authority to suspend a research facility’s registration. The most serious step the agency can take against a registered research facility is to file formal charges. We believe that the rarity of USDA’s taking such serious action against registered research facilities can give some indication as to how egregious TCF’s record truly is; but a member of Congress or the public would never know that from reading Dr. Sibal’s letter.

From 1992 through February 11, 1999, USDA filed 341 formal complaints under the AWA. Of those 341, only 19 were filed against registered research facilities (the USDA also has authority over animal dealers, exhibitors, etc.). 3 of those 19 were filed against TCF.

From March 19, 1998 through February 11, 1999, USDA filed 28 complaints under the AWA. Of those 28, USDA only filed three formal complaints against registered research facilities. USDA filed two of those three — 67 per cent — against TCF.

What the USDA formally charged TCF with is even more eye-opening. In March 1998, the USDA filed its unprecedented second set of formal charges for the negligent deaths of two chimpanzees; failing to provide adequate veterinary care, failing to provide adequate post-procedural observation, failing to adequately prepare a chimpanzee for surgery, performing an extensive surgery under inappropriate conditions, negligently failing to ensure that a chimpanzee was fasted prior to sedation, negligently group-anesthetizing chimpanzees, and numerous physical plant and sanitary violations. In February 1999, the USDA again formally charged TCF with failing to provide adequate veterinary care by failing to make itself and its veterinarians aware of known side-effects and complications of drugs being tested, thereby causing the "unnecessary" deaths of three chimpanzees, as well as multiple and repeated IACUC violations relating to these three deaths. In a press release on the February 1999 charges, USDA Undersecretary Mike Dunn said that the agency had "grave concerns regarding the circumstances under which several chimps have died at the Coulston Foundation." But a member of Congress or the public would never know the unprecedented severity of the formal charges against TCF from Dr. Sibal’s letter — let alone the repeated violations documented in USDA inspection reports, which included a December 1998 inspection that again found failure to provide adequate veterinary care (with only 2.5 veterinarians) and a December 1999 inspection that also found failure to provide adequate veterinary care, this time involving the deaths of four more chimpanzees.

Dr. Sibal’s letter also misrepresents the restriction that OPRR placed on TCF’s Animal Welfare Assurance in February 1999. Dr. Sibal goes into some of the requirements of the restriction — e.g., immediate notification of staff changes and changes in the animal care and use program — but fails to mention by far the most important part of the restriction — namely, that TCF was required to hire seven "fully qualified" veterinarians. In its restriction letter of February 22, 1999, OPRR detailed named the then-veterinary staff members, then described their credentials, their experience, their licensing status, their clinical competency testing status (where applicable), their experience with chimpanzees, and the failure to provide information relating to their experience in managing a large environmental enrichment program for nonhuman primates. After describing in great detail the credentials, experience, etc. of TCF’s veterinary staff, OPRR announced that "Based on the continuing concerns about the number of veterinarians and their credentials available to provide veterinary care to chimpanzees and other nonhuman 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" (emphasis in original). According to NIH spokesperson Donald Ralbovsky, quoted in the March 9, 1999 Albuquerque Journal, NIH OPRR "places only a handful of restrictions on the funding agreements it maintains with several thousand research institutions nationwide."

OPRR’s restriction came only two months after the USDA’s December 1998 inspection report showed that TCF had only 2.5 veterinarians, and that it needed to hire 3-5 more to meet animal care needs and comply with the Animal Welfare Act at the facility. Incredibly, TCF’s then-Directory of Veterinary Sciences, and other unnamed TCF officials, agreed with this devastating indictment of TCF’s entire animal care and use program. But where is any mention by Sibal that TCF’s veterinary staffing was so deficient that OPRR was ordering the facility to hire seven "fully qualified" veterinarians? Where is any mention that OPRR itself was restricting TCF’s assurance based on "the continuing concerns about the number of veterinarians and their credentials available to provide veterinary care to chimpanzees and other nonhuman primates at the CF, and the major changes in other aspects of the CF program of animal care and use?" It is nowhere in Dr. Sibal’s misleading letter — just as it fails to mention that the vaunted April 1999 site visit — two months after OPRR’s restriction was put in place — found that TCF’s veterinary care was "problematic," with the three primate vets being "very junior" with no formal training in lab animal medicine, and that they may be inadequate for the task at hand.

Dr. Sibal’s letter also conveniently neglects to mention TCF’s apparent misuse of millions of taxpayer dollars meant for the lifetime care of specific chimpanzees. The April 1999 site visit auditors quote then-TCF Chief Financial Officer Dr. Ali Javadian as saying that TCF had "expended" these millions of dollars in endowment funds. According to a November 1998 NIH email, TCF management had earlier told the NCRR it was none of the agency’s business how TCF uses these millions of dollars in taxpayer-funded chimpanzee endowments. After the site visit that Dr. Sibal so glowingly reports, his colleagues in the NIH Office of Director paint a very different picture in internal emails obtained by IDA through FOIA. Various OD staffers described the TCF situation as "explosive" and "VERY explosive." One April 1999 OD staffer email stated, "This one has the potential to be a nasty oversight issue, particularly with the endowment funds apparently having been spent for other purposes. This could be another NIH management problem if they think that we have not been diligent in our oversight of contracts." As stated above, the NIH was so concerned about TCF that then-NIH Director Harold Varmus specifically "tasked" the deputy director of NCRR to deal with the situation.

But, according to Dr. Sibal, no "nasty oversight issue" exists — he relays OPRR’s claim that TCF has promptly corrected deficiencies in the past, and then, as described above, fails to mention the most important parts of OPRR’s oversight efforts — the restriction — and its finding of a woefully deficient, woefully understaffed, woefully under-credentialed veterinary staff. An adequately staffed, trained and experienced veterinary staff is one of the cornerstones of compliance with animal welfare laws and the welfare of these "valuable animals" that the NIH now wants to sole-source to Sibal to monitor.

B. The February 1999 NIH Response to December 1998 Inquiry From Rep. Carolyn Maloney (D-NY)

In December 1998, Rep. Carolyn Maloney (D-NY) wrote to NIH, asking for the agency’s explanation of its oversight of TCF. According to internal NIH emails obtained through FOIA, Dr. Sibal was apparently involved in the drafting of this response; he was cc’d regarding the Maloney response (excerpts later in this complaint). However, the final response to Rep. Maloney was also blatantly misleading. For example, it claimed that the USDA had the authority to suspend funding at TCF (the implication being that if the situation were so bad, then the USDA would suspend funding, and the NIH would support such a choice); however, according to APHIS Deputy Administrator Dr. William R. DeHaven, USDA has no such authority, and cannot suspend funding to TCF. Indeed, as stated above, the USDA’s authority under the Animal Welfare Act is extremely limited. It cannot suspend a research facility’s registration; indeed, the most serious step it can take is to file charges, which it has done in unprecedented fashion regarding TCF.

However, another misrepresentation is far more egregious, and again illustrates not only the NIH’s duplicity regarding TCF, but we believe also calls into serious question Dr. Sibal’s fitness to be awarded this contract. Dr. Sibal was cc’d this draft response, as detailed in the excerpts towards the end of this complaint. NIH’s ultimate response to Maloney stated that in 1994, NIH site visitors had recommended that TCF achieve AAALAC accreditation in 3-5 years, but then told Rep. Maloney that "Subsequent site visits have indicated continuing progress has been made toward that goal." THE NIH TOLD THIS TO A MEMBER OF CONGRESS AFTER AAALAC HAD ALREADY REJECTED TCF’S ACCREDITATION APPLICATION MORE THAN EIGHT MONTHS BEFORE, IN JUNE 1998! To make matters worse, it appears that TCF’s rejection by AAALAC was common knowledge at the NIH — and, again, in a February email sent to Sibal, NIAID official Randy Elkins stated that TCF not only had been rejected by the Association for Assessment and Accreditation of Laboratory Animal Care ("AAALAC"), but also it was Elkins’ opinion, based on a source at TCF, that (1) TCF would never become accredited, and (2) that Dr. Coulston did not support the AAALAC accreditation process. As Elkins writes, "Good morning, Lou,....The Coulston Foundation is not AAALAC accredited and will not be. They hired a board-certified laboratory animal veterinarian 2 years ago to facilitate the accreditation process for them but he departed Coulston in the last year. My source at Coulston said that Dr. Coulston does not support the AAALAC process or have the funds available for facility modification necessary for AAALAC accreditation identified in a site visit last spring."

Not only is this a blatant misrepresentation to a member of Congress, but it is also important because AAALAC evaluates laboratories for compliance with the NIH Guide for the Care and Use of Laboratory Animals. It is this Guide that the NIH is supposed to use to enforce animal welfare laws, and to ensure a lab's eligibility for Public Health Service funds. AAALAC's rejection of TCF means that the lab is not in compliance with the Guide. Where is that in Dr. Sibal’s misleading letter on the April 1999 site visit, or the response to Rep. Maloney? If the email came to Sibal after the response was sent to Rep. Maloney, why did not Sibal send a correction or an update to Rep. Maloney, on a matter of such importance to compliance with the PHS Policy that the NIH is supposed to enforce — and which Sibal mentions in his misleading letter on the April 1999 site visit? However, an email dated 2/16/99 from Tawanda Abdelmouti of NCI, which was also cc’d to Sibal, asked for comments on the Maloney letter by "COB February 17, 1999." THIS CLEARLY INDICATES THAT THE MALONEY LETTER WENT OUT AT LEAST SEVEN DAYS AFTER SIBAL RECEIVED THE 2/10/99 EMAIL FROM RANDY ELKINS IN WHICH ELKINS STATED THAT TCF HAD BEEN REJECTED BY AAALAC, AND THAT IT WAS HIS OPINION THAT TCF WOULD NOT ACHIEVE ACCREDITATION. Why, for that matters, were updates — regarding USDA actions, USDA inspections, the FDA’s devastating findings, etc. — apparently not sent to members of Congress or the public, but simply the same, stale, misleading letter from Sibal?

4. FAILURE TO ADDRESS TCF’S DOCUMENTED ANIMAL CARE RECORD DURING PEER REVIEW PROCESS

As stated above, when he was at the NIH, Sibal chaired the NIH’s Interagency Animal Models Committee, which is supposed to review and approve all protocols on chimpanzees that are funded by NIH dollars. On August 26, 1998, the committee met to discuss, among other things, a grant application to study a prostate disorder on chimpanzees at TCF (Dr. Mitchell Steiner, PI). In advance of the meeting, IDA had submitted voluminous information documenting TCF’s seriously deficient animal care record, which at the time included two sets of formal USDA charges for multiple violations of the Animal Welfare Act related to negligent chimpanzee and monkey deaths. Also, at the time of the meeting, TCF was again under "official" USDA investigation for more chimpanzee deaths, which eventually led to the February 1999 third set of formal charges for the negligent deaths of three chimpanzees, failure to provide adequate veterinary care, and numerous IACUC violations relating to the deaths.

The minutes of this meeting, obtained by IDA through FOIA, show that Sibal made serious misrepresentations about TCF’s record. According to the minutes, "Dr. Sibal pointed out that the project would involve a subcontract with the Coulston Foundation (CF). The animal protection organization, In Defense of Animals, has written to the NIDDK [the NIH agency funding the study] alleging numerous violations of Federal law by the Foundation. However, the OPRR has reviewed the CF facilities and has worked with the Foundation to correct the deficiencies identified. At this time, there is no bar against NIH funding studies at CF."

Sibal’s carefully-crafted language, which acknowledges deficiencies but implies that they have been corrected, is deceiving, particularly since he fails entirely to mention the USDA charges and the fact that TCF was once again under "official" investigation by USDA. IT SHOULD BE NOTED THAT PHS POLICY ON THE HUMANE CARE AND USE OF LABORATORY ANIMALS INCORPORATES COMPLIANCE WITH THE ANIMAL WELFARE ACT.

The USDA is the federal agency that is charged with enforcing the federal Animal Welfare Act. NIH policy requires all grantees to comply with the Animal Welfare Act. The fact that serious charges for AWA violations were still pending against TCF, and that the USDA was "officially" investigating TCF for more violations involving yet more negligent chimpanzee deaths, would explicitly suggest that deficiencies in TCF’s animal care program were ongoing. This certainly should have been of interest to the Interagency Animal Models Committee, which is supposed to ensure the welfare of chimpanzees used in NIH-funded studies. And it most certainly should have been of interest to the Chair of the Committee, Dr. Sibal. But, according to the minutes, it is as if the USDA charges did not even exist.

It should be noted just how serious the act of USDA’s simply initiating an "official" investigation is, let alone the multiple levels of scrutiny and departmental review that must be satisfied before the USDA takes the extremely rare step of filing formal charges against a research facility. It should also be noted that at the time of this meeting, every single "official" USDA investigation eventually led to formal charges — and the investigation that was ongoing at the time of this meeting was no exception, as it resulted in the February 1999 formal charges.

The USDA only makes an investigation "official" after a preliminary inquiry finds enough evidence of Animal Welfare Act violations sufficient to warrant a full-blown, "official" inquiry. All five previous "official" investigations of TCF at the time of the August 1998 meeting had led to formal USDA charges. It should also be noted that USDA only files formal charges after a thorough investigation, which involves multiple levels of departmental review — from Investigative and Enforcement Services (IES), USDA’s investigative arm, which conducts the investigation, gathers evidence, obtains documents, affidavits, staff interviews, etc.; the USDA Regional Office; the USDA Office of General Counsel; and the APHIS Administrator. USDA will file formal charges only if the agency believes it has enough evidence to support the complaint in a legal proceeding before an administrative law judge.

5. TOTAL DISREGARD FOR FOIA AND THE AUGUST 24, 1999 CONSENT DECREE REGARDING RELEASE OF INDEPENDENT COMPLIANCE REVIEW OFFICIAL REPORTS

According to Section 5 of the August 24, 1999 consent decree between TCF and USDA dealing with the "INDEPENDENT compliance review official," the reports of the official "...shall not be released in whole or in part except in accordance with the Freedom of Information Act, 5 U.S.C. Section 552, et seq. The Coulston Foundation will be given the opportunity to review and redact confidential information in accordance with the Freedom of Information Act." Clearly, this states that such reports will be available through FOIA.

However, in a document dated 10/27/99, Sibal writes to Coulston regarding the appointment of Dr. Dave Johnson to "provide on-site monitoring of the overall activities of the Coulston Foundation" — the very same contract that the NIH is attempting now to sole-source to the project officer of this contract through December 31, 1999 — Sibal. His status as project officer is confirmed by an August 16, 1999 memo from you, Karen Riggs, to Dr. Sibal, identifying him as the "Project Officer." It is also consistent with what Sibal writes later in this letter "Since Dr. Johnson will report directly to me at the NIH, ALL OFFICIAL COMMUNICATIONS WILL, OF COURSE, REMAIN CONFIDENTIAL" (emphasis added). This statement clearly indicates a violation of the spirit if not the letter of FOIA, as well as the clear conditions of the August 24, 1999 consent decree. "Of course" remain confidential? Johnson was a publicly funded contractor performing a publicly funded activity that is well-recognized to be in the public interest — e.g., ensuring compliance with laws relating to animal welfare, data integrity and human safety. Dr. Sibal’s comment is even more disturbing if one considers the possibility of his being awarded this contract — his saying that "all official communications will, OF COURSE, remain confidential" calls into serious question what is more important to Sibal: maintaining confidentiality for Coulston of his findings, or the honesty and veracity of his monitoring? What does this say about what he might fail to report to maintain TCF’s confidentiality — which would be a violation of the very contract attempting to be sole-sourced to him by his friends at the NIH — knowing that such reports are, by law (FOIA and the consent decree), to be made available through FOIA?

6. MORE EVIDENCE OF SIBAL’S CENTRAL ROLE DURING HIS TENURE AT NIH REGARDING NIH ACTIONS, DECISION, CORRESPONDENCE, EMAILS, MEETINGS, RESPONSES TO CONGRESS RELATING TO TCF

As stated above, Dr. Sibal was cc’d on virtually everything dealing with TCF, at least from November 1998 on (which is how far back IDA’s FOIA records mostly go). He was also actively involved in making presentations, providing information to both Congress and the public, etc. Sibal was apparently part of the oversight team that allowed the situation at TCF to deteriorate so badly that it necessitated the creation of the very position, "INDEPENDENT compliance review official," that the NIH is now attempting to sole-source to Sibal. Some examples of just how central Sibal’s role was in the NIH’s debacle of "oversight" of TCF can be seen in some of the following emails obtained through FOIA: A "New Mexico 1999" summary lists various Sibal-related actions, including several USDA emails: "4/1: Copy of email from USDA to OPRR reporting the deaths of three chimpanzees...." "4/1: Conversation with Denise SoFranko (of USDA) to arrange meeting in Alamogordo on April 6...." "4/5: Telephone call from Ron DeHaven (USDA) reporting a call he had received from Fred Coulston on Friday, April 2....In this conversation (Ron has extensive notes) Coulston denied ever telling the USDA that the Foundation was in serious financial trouble despite the statements which Coulston had made to DeHaven on his D.C. visit in the presence of two attorneys."

Sibal emails on 8/2/99 to NCRR’s John Strandberg, "re: USDA settlement agreement," "I just called Ron [DeHaven of USDA] as you suggested. The agreement was sent Friday. He is expecting to hear from Coulston’s lawyer today. So far, not signed, but Ron will keep us informed. He is sending me a copy of the revised agreement." Also on 8/2, Harper from NCRR emails Sibal and suggests that he call DeHaven for status report on settlement. Earlier, Sibal emails Harper, "Dr. Baldwin [Office of Director] would like to know if Coulston has signed the agreement with the USDA?" In a 7/9/99 email from Baldwin to Sibal of "High Importance" regarding Coulston conversation with USDA, "week of July 12, is that a possibility for a meeting with Coulston, USDA needs to know," while a 5/6/99 email from Ramm to Baldwin and Sibal relates that Ramm had just spoken with USDA’s DeHaven, and that USDA would be increasing inspections, and also would be filing a motion for hearing; "however, Ron [DeHaven] is interested in arranging a meeting or telephone conference call with NIH/USDA/Coulston to put on the table that USDA is willing to negotiate with him and settle the case, and to discuss future plans for CF. He would like NIH to arrange the meeting since he thinks Coulston will balk if USDA is the only focus." And in yet another email cc’d to Sibal, NCRR’s Ramm writes on 6/21/99 email to various NCRR and OD officials, including Sibal, regarding "our favorite topic." This document also has copies of previous emails, dated 6/18/99 and 6/14/99, discussing USDA actions, meetings, etc., which were also cc’d to Sibal.

It is clear from FOIAs obtained from many NIH agencies that Lou Sibal was long a central player in the NIH’s debacle of "oversight" regarding The Coulston Foundation. IF SIBAL FAILED TO PROVIDE HONEST OVERSIGHT WHEN HE WAS AT THE NIH, WHY IS HE EVEN BEING CONSIDERED FOR THIS CONTRACT? Indeed, it appears that OPRR, NCRR and NIH Office of Director staffers involved in the Coulston situation regularly cc’d Sibal. Sibal’s central role is perhaps exemplified by several emails. These include a 4/23/99 email from Wendy Baldwin, Deputy Director of the Office of Extramural Research in the Office of Director’s Office. Baldwin has been intimately involved with the Coulston situation. She writes, "RE: Coulston Fdn., High Importance,...this is very explosive." A 4/19/99 email from Baldwin to Sibal, RE: "Coulston Laboratory Financial Worries, Confidential." Another document, "New Mexico 1999," includes a summary of events regarding Coulston. It mentions the 3/16/99 meeting in which Sibal spoke to various USDA and NIH officials. It mentions that on 3/16/99, Sibal reports on Air Force transfer of chimpanzees to Coulston; on 3/17, conversation with Lou Sibal regarding the FDA breeding contract with Coulston expiring, Air Force chimpanzee divestiture, LEMSIP chimpanzees, etc. On 3/18, Sibal and John Strandberg met with Air Force contractor, who turned over documents related to the Air Force chimpanzee divestiture to Coulston.

In 2/19/99 typed notes from NCRR’s Deputy Director Louise Ramm: "related CF updates (which you probably already know from Lou): On 2/10/99, John Strandberg received a phone call from Nelson Garnett relaying information from Ron DeHaven (USDA) that Chris Staley...was no longer at Coulston. Both Garnett and NCRR subsequently questioned Coulston. In NCRR’s conversation with CF, CF asked that we permit the reduction in Staley’s time to 50%." Next, Ramm talks about an email received by Sibal regarding Coulston’s lack of AAALAC accreditation NIAID official Randy Elkins (discussed above).

A 2/11/99 email from Sibal to Ramm, Strandberg, "FW: Chimps — a head’s up," Baldwin had emailed to Sibal, with "High Importance," "lou, you might want to clue Louise [Ramm] in that I have sent this, OK? thanks, wendy [baldwin]." Baldwin is referring to an email she wrote to the head of NIAID, Anthony Fauci, again with "High importance," regarding "serious concerns" regarding Coulston Foundation.... "I would caution that it is very important for you to get the latest information from me or Louse if you are thinking of renewing that agreement [regarding the FDA chimpanzee breeding contract, in which NIAID gained access to Coulston-bred chimpanzees]." This again shows Sibal’s central role. The same is true for a 2/10/99 email from NIAID official Randy Elkins to Sibal regarding Coulston's lack of AAALAC accreditation, Coulston’s rejection by AAALAC of the facility’s application for accreditation, and the opinion that Coulston would never obtain AAALAC accreditation. The email also discussed the expiration of the FDA chimpanzee breeding contract. This not only has direct relevance to NIH oversight, but begs the question, Why is this NIAID official writing to Sibal? Because Sibal had a central role in oversight of the Coulston situation at the NIH.

Another email, dated 1/28/99 from NCI to various NIH officials, including Sibal, involves NIH’s response to questions raised by Rep. Carolyn Maloney regarding Coulston. As discussed above, this shows that Sibal was "in the loop" regarding the blatantly misleading response to Rep. Maloney. Another email, dated 1/7/99 from Gary Ellis of the OD was also cc’d to Sibal, and dealt with "RE: Maloney letter — action." It also discusses a 1/6/99 meeting about the letter and thanks those for attending — this, too, was cc’d to Sibal. This goes on to say that "...OPRR may need more time to provide input for question G. NCRR AND LOU SIBAL HAD VOLUNTEERED TO WORK WITH OPRR ON THIS."

Another email, dated 1/21/99 from Ramm, and cc’d to Sibal, also deals with the "Maloney letter." On 1/6/99, Sibal FAX’d to Stephen Potkay of OPRR excerpts of the Maloney letter. Another email, dated 2/16/99 from Tawanda Abdelmouti of NCI, was also cc’d to Sibal, and asked for comments on the Maloney letter by "COB February 17, 1999." THIS CLEARLY INDICATES THAT THE MALONEY LETTER WENT OUT AFTER SIBAL RECEIVED THE 2/10/99 EMAIL FROM RANDY ELKINS IN WHICH HE STATED THAT TCF HAD BEEN REJECTED BY AAALAC, AND THAT IT WAS HIS OPINION THAT TCF WOULD NOT ACHIEVE ACCREDITATION.

A 12/18/98 email also shows Sibal’s central role: NCRR’s Ramm writes to NCRR Director Vaitukaitis "when I met with Wendy or Lou." Another email on the same date, from Sibal to Ramm, states "[Lanman’s] suggestion was to conduct an administrative site visit on the basis that NCRR (being responsible for the developing the NIH Chimp Plan) needs to meet with Coulston to discuss future plans....He asked me for a copy of Cong. Maloney’s package so he could review some of the charges; he will get back to me. I can explain more when I see you." This shows Sibal’s central involvement in both the devastating site visit and the misleading response to Rep. Maloney.

In a 3/8/99 email from Ramm to Strandberg, Ramm writes "Lou Sibal called to let me know that he mentioned to Wendy that Fred Coulston will be in town on Weds to speak with Nelson Garnett and USDA. Wendy suggested that, of course, I should meet with him."

An important 6/16/99 letter to Coulston from Harper (of NCRR) and Strandberg discusses the supplemental awards, says that NIH cannot maintain this level of funding for Coulston, and goes into the use of the funds by Coulston in the supplemental award dated 6/11/99. This important letter was cc’d to Sibal, indicating (again) not only Sibal’s central role in the Coulston situation, but also the fact that he was routinely cc’d by officials in the Office of Director, NCRR and OPRR. Indeed, a 5/19/99 email from Strandberg to various NIH officials, including Sibal, on Coulston reports "a little bit of a crisis."

Sibal’s central role in the NIH on-site monitoring contract — the one he is currently attempting to become sole-sourced on -- can also be seen in a 7/29/99, email from Sibal to Ramm, RE: oversight contract for compliance official. Earlier, on 7/28, Sibal had written to Ramm, "I will be working with Peter Alterman, RE: the Coulston oversight contract."

According to handwritten notes obtained from NCRR, Sibal spoke at a 3/16/99 meeting of various NIH and USDA officials regarding Coulston. Sibal’s remarks are clearly indicated in the handwritten notes, and related to this important interagency meeting in which he himself spoke, and which he himself was listed on the agenda as speaking about "Office of Director concerns and perspective" (which again confirms Sibal’s central role in the NIH’s "oversight" of the entire Coulston situation).

According to a 4/9/99 email from Heffernan of NCRR to Sibal and an OPRR official, re: Coulston Fdn. Meeting, "A meeting has been scheduled to discuss the Coulston Foundation this Monday, 4/12, 9:00-11:00 AM in 31/B13." This was emailed to various NCRR, Office of Director and OPRR officials.

Another email, dated 5/7/99, regarded a meeting of 25 NIH officials regarding TCF. IDA received an agenda and sign-in sheet listing the 25 officials who attended this meeting. Who was on the agenda as a speaker at this meeting of 25 NIH officials, including now-Acting Director Kirchstein? Lou Sibal. This, again, was an important meeting related to TCF, in which he himself spoke, and which he himself was listed on the agenda.

In a 4/22/99 email from NCRR’s Joellen Harper cc’d to Sibal, regarding NIH funding of Coulston as well as attaching the 4/99 site visit/audit, Harper writes, "I spoke with Lou Sibal in OER about your question. He has received a number of Congressional inquiries about Coulston, so he indicated that I should refer you to him for information about the allegations." Again, this shows Sibal’s central role, not only in NIH policy, but also dissemination of information to both Congress and the public — information that we have shown is blatantly misleading.

7. CONCLUSION

With this complaint, we believe that we have demonstrated beyond any doubt that Dr. Lou Sibal should not be awarded this contract based on his documented record of misrepresentation, his lack of qualifications, his conflict of interest and total lack of independence, his failure to provide information about TCF’s animal care record to the IAMC, his failure to understand the responsibilities inherent in FOIA and the August 24, 1999 consent decree, his central role in the debacle of "oversight" at the NIH regarding TCF, and the many other questions raised herein. We believe that your responsibilities to ensure the proper stewardship of taxpayer funds, let alone the welfare of the chimpanzees at TCF — which is supposed to be the purpose of this on-site monitoring program — mandate that the NIH not be allowed to reward one of its cronies for his part in covering up the NIH’s own malfeasance and its utter failure to provide even a semblance of oversight — WHICH IS THE VERY PURPOSE OF THIS CONTRACT — as well as Sibal’s own obfuscations and misrepresentations regarding TCF.

Thank you for your consideration. We look forward to your response.

Sincerely,

Elliot M. Katz, DVM
President

Enclosures (7 pages — April 1999 NIH site visit/audit)


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