September 6, 2015 Office of Laboratory Animal Welfare (OLAW) National Institutes of Health RKL 2, Suite 360, MSC 7982 6705 Rockledge Drive Bethesda, MD 20892-7982 Dear Dr. Wolff: ‘This communication is formal notice of significant animal welfare concerns at the University of Texas Medical Branch/Galveston National Laboratory in Galveston, ™ Iwas the Attending Veterinarian at this facility from March 1, 2013 through June 9, 2015. The complaints in this memo are based upon my official responsibilities outlined in the Animal Welfare Act during this time frame. {have read the National institute far Allergy and Infectious Disease Audit report concerning the recent site visit in February 2015 to assess the ability of the GNL to conduct contract work. | have followed with great interest in the news media the response to the report by the GNL. | am in position to contribute significant additional information concerning the animal welfare issues found during the site visit. Officials from UTMB deny any animal welfare issues of concern, They have claimed the monkeys infected with the Marburg virus were expected to die and that there was no expressed expectation of increased overnight monitoring in the contract. This statement is a gross public relations fabrication. It is implicitly understood by any institution with a PHS Assurance Letter and facilities registered with USDA the institution must adheve to all rules, regulations and laws governing animal research. It does not matter the expectation be written in the contract with a funding agency. The project of the NIAID audit was limited to 12 monkeys infected with the Marburg virus. The animal use protocol approved by the UTMB IACUE specifically asks a very simple question. 1s death an endpoint? This is not a narrative answerSeptember 6, 2015 ‘Office of Laboratory Animal Welfare (OLAW) National Institutes of Health RKL 2, Suite 360, MSC 7982 6705 Rockledge Drive Bethesda, MD 20892-7982 Dear Dr. Wolff: ‘This communication is formal notice of significant animal welfare concerns at the University of Texas Medical Branch/Galveston National Laboratory in Galveston, ™ Iwas the Attending Veterinarian at this feeility from March 2, 2013 through June 4, 2015. The complaints in this memo are based upon my official responsi outlined in the Animal Welfare Act during this time frame. tes | have read the National institute far Allergy and Infectious Disease Audit report concerning the recent site visit in February 2015 to assess the ability of the GNL to conduct contract work. Ihave followed with great interest in the news media the response to the report by the GNL. | amin position to contribute significant additional information concerning the animal welfare issues found during the site visit. Officials from UTMB deny any animal welfare issues of concern, They have claimed the monkeys infected with the Marburg virus were expected to die and that there was no expressed expectation of increased overnight monitoring in the contract. This statement is a gross public relations fabrication. It is implicitly understood by any institution with a PHS Assurance Letter and facilities registered with USDA the institution must adheye to all rules, regulations and laws governing animal research. It does not matter the expectation be written in the contract with a funding agency. The project of the NIAID audit was limited to 12 monkeys infected with the Marburg vitus. The animal use protocol approved by the UTMB IACUC specifically asks a very simple question. Is death an endpoint? This is not a narrative answerthe scientist chacks yes or no. The protocol was checked no. The protocol further gives a behavioral scoring table to determine when the animal will be humanely euthanized to reduce pain and distress. The expected outcome given the Marburg virus is lethat is no-animal will be allowed to die but humane intervention will occur prior to death. Allowing these animals to die directly increased the pain and distress to the monkeys. Failure to euthanize these animals was a violation of § CFR section 2.33(2){y) (Animals that would otherwise experience severe or chronic pain or distress that cariadt he reflieved will be poinfessly euthanized at the end of the procedure or, if appropriate, during the procedure.). The NiAID audit found that 75% of the animals were found dead and not euthanized! Since the expected outcome was euthanasia the animals found dead must be considered an “unexpected or adverse outcome”. Unexpected outcomes must be reported to the AV, FACUC and the 10 by regulation. As the AV and asa member of the IACUC I was never informed of any monkey death(s). This is a violation of The Guide gighth Edition, pg 28, “Because of the potential for unexpected outcomes that may affect animal well-being when highly novel variables are intraduced, more frequent monitering of animals may be required.” Ifinformed | would have requested the protocol be stopped and a review instituted to find a more consistent method of monitering other than a behavior scoring system. Behavioral scoring systems have been shown to be a poor inditator of pain, distress and death at several scientific laboratory animal meetings. There are several methods that shauld have been considered and instituted. This was a violation of Policy 12 {Consideration of Alternatives te Painful/Distressful Procedures The Animal Weifare Act (AWA) regutations require principal investigators to consider altematives te procedures that may couse more than momentary or slight pain or distress to the animals and provide a written narrative of the methods used and sources consulted ta determine the ovaitability of afternatives, inchating refinements, ceduetions, and replacements.) The study director for the contract is Jason Comer. Or Comer is the Vice Chair of the IACUC, He had an absolute responsibility te report the unexpected outcome.The biocontainment veterinarian directly responsible for the veterinary care is Curtis Klages. He additionally had an obligation to report When the NIAID report was received at UTMB with the animal welfare concerns. The AV and the |ACUC were not allowed to know the cantents. | became aware of the repart when Dr, Klages mentioned there was a NIAD report accusing UTM8 of inadequate veterinary care. 1 took the information | had been told to the IACUC Chair, Ron Tilton. Dr. Tilton told me he had conversation with the Chief Scientific Officer, Dv. Niesel and the Director of Compliance, Toby Boing and demanded the audit be investigated by the IACUC, His demands were denied and he was not allowed to reac the audit report. This constitutes direct interference by upper administration in the ability of the AV or the IACUC te insure animal welfare. | only read the NIAID report when it was released in the media, These actions were a violation of 9 CFR ({2) The research facility must provide the attending veterinarian with sufficient oad appropriate authority ta ensure that adequate veteriaery care is provided at all times and that he or she is able to oversee the adequacy of all aspects of wnimal care ond use: for all animats (Sect. 2.33(a}{2)}. While the NIAID audits scathing in regardste animal welfare. | have significant reason to believe this was not the exception, butthe rule, During my tenure as AV, TMB performed similar research on morkeys involving Ebola and other lethal pathogens. 1 met frequently with Dr. K'ages. The animal program conducted rounds three times per week concentrating on clinical eases, The only clinical case Dr. Klages ever reported was hair loss in three training enonkeys that were singly housed. He never reported a single monkey death in rounds or in a IACUC meeting. It is impossible to have conducted research on hundreds of monkeys and never have a clinical case or an unexpected outcome. When challenged he claimed aft animals were euthanized in a timely fashion. This was violation of 9 CFR ({3) Daily observation of all animols to assess their health and weil-being. Daily observation of the animals may be accomplished by someone other than the attending veterinarian, provided that a mechanisin of direct aad frequent communication is established 50 that timely and accurate information en problems of snimol health, behavior, and well-being is conveyed to the attending veterinarian (Sect. 2.33 (833).All attempts to discipfine Dr. Klages were not supported the 10: All of the non-human primate [ACUC pretocols were basically clones and stated death was nat an endpoint and the animals would be euthanized. itis my professional opinion that the NIAID audit is the smoking gun indi¢ating a much larger problem concerning the animal welfare in the GNI. My efforts to gain factual information abeut the GNE was never supported by the upper administration. | was threatened to be fired and reprimanded for requesting and meeting with the President of UTMB to express concerns about the animal program and oversight. [ was fired for asking to talk with the Vice Provost to express these same concerns. These actions were a violation of $ CFR The research facility must provide the attending veterinarian with sufficient and apprapriate authority to ensure that adequote veterinary core is provided at all times and that he or she is able to oversee the adequacy of al! aspects of animal care and use for all animats (Sect. 2.33/e}{2). Since leaving UTMB J have reached out to the Chair of the IACUC to assist in an IACUC probe of active collusion berween Dr. Klages and the investigators in the GNL to conceal animal welfare issues. My attempts to work through the IACUC have been ignored. The Institutional Official at UTM is Toni D'Agostino. She has a direct conilict of interest, She oversees the regulatory studies inthe GNL. This is the group performing the contract for NIAID. The conflict places her in the oversight role of herself! UTMB has had five AVs in the last 13 years. all have been well qualified professionals. None have been allowed tg canduct the duties described in the animal welfare act. This should be considered an institutional pattern of non- compliance. All of the IACUC protocols including the NIAID contract were assigned by the JACUC chair for review to the biocontainment veterinarian, Dr. Klages. UTM6 had several veterinarians more experienced with relevant experience such as sepsis and primates. The input fram the Attending Veterinarian would have discouraged the use of a behavior scoring system as a predictor af death and would haveoffered alternative methods. This practice by the IACUC was a violation of 9 CFR. HL IACUC Review of Activities Involving Animals (Section 2.31 {d}} (iv) That procedures that may cause more thon momentary or slight pain or distress da the animals will: (8) require involvement and consultation with the attending veterinarian during planning of the activity (Sect, 2.32 (AN 1}{iv}i8}). This never occurred on any protocols fram the GNL As the Attending Veterinarian of record during zhese events, | wouid like to state the animal care and use program and the IACUC have a dichotomy of care and oversight for the animal program for the GNL and the rest of the campus. The veterinary care and |ACUC oversight for the majority ef the research animals and protocols is vigorous. The IACUC routinely is informed of animal deaths and non- compliance. The actions of the LACUC is punitive for very minor infractions and hold both the investigators and animal care sta‘ to overly strict standards but the ENL is exempt from this oversight. Proof of this was provided in the NIAID report. The fact that monkey deaths were only discovered by the AV and the |ACUC from the NIAID audit Is evidence of this dichotomy. This is a vidiotion of 9 CFR, Section 2.33 - Attending Veterinarian and Adequate Veterinary Care and the Guide page 34 (Based en risks to animals and their handlers, other study oreas say require more or less frequent inspections. Exomples of effective monitoring strategies include: regular review of adverse or unexpected experimental outcomes affecting the animals). In the case of these animals the risk to animal handlers could be held te @ minimum through the use of electronic monitoring methods so more frequent monitoring was required. Although the GNLis equipped with cameras to monitor the animals they were seldom if ever used. The GNE through the actions af the biocontainment veterinarian fosters a hostile work environment decreasing the care and oversight of the animals. As the Attending Veterinarian I received complaints from four clinical veterinarians stating they did not want to work in the environment created by Dr. Klages. Two: of the four were prevented becoming ABSL4 certified due to Dr. Klages failure to support their efforts. The other two did not want to enter the GNL due to negative interactions with Or. Klages. | received similar complaints from four animal health technicians. & formal Human Resources complaint was filed fromadministrative staff concerning hostile werk environment created by Dr. Klages. UTM Human Resources policy requires an investigation and action reported to the employees within 90 days. No investigation was conducted, This hostile work environment decreased morale and had a negative impact upon animal care and welfare. As the Attending Veterinarian, | informed the IO but did net receive: support to correct this problem. This is a vielation of 9 CFR§ 2.33 - Attending veterinarian and adequate veterinary care. (2) Each research facility shalt assure that the ottending veterinarian has appropriate authority to ensure the provision of edequote veterinary care and to oversee the adequacy of other aspects of animal care and use. My conclusion of the lack authority provided to the Attending Veterinarian plus the fact that no monkey deaths or clinical cases were ever presented to me or the n between the GNL investigators and the biccentainment veterinarian to subvert both the intent of the AWA and PHS policy for both adequate veterinary care and IACLIC oversight. JACUC was active collu: after reading the NIAID repart | find their findings consistent with my observations during my tenure as the Attending Veterinarian. The claim that UTME were held to GLP standard is absurd. The standards listed in the NIAID report are “reasonable man” standards. | will be willing to assist in any investigation conducted by your agency: