Ray L. Watts, M.D, President Board of Trustees, 11/13/18

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1 Ray L. Watts, M.D, President Board of Trustees, 11/13/18 Office of the President University of Alabama System The University of Alabama at Birmingham C/O Sid Trant, nd Ave South Secretary of the Board of Trustees Birmingham, AL Via Via CC: Matt Calderone, DEPUTY BOARD SECRETARY Via President Watts, Trustees, I am contacting you today because a specific Principal Investigator at the University of Alabama, Birmingham (UAB), has demonstrated a pattern of violating federal regulations regarding the use of animals in biomedical research. The malfeasance perpetrated by this Principal Investigator led to the suspension of a protocol, and the paralysis of multiple animals due to the performance of highly invasive procedures which had not been approved by the UAB Institutional Animal Care and Use Committee (IACUC). UAB correspondence with the Office of Laboratory Animal Welfare of the National Institutes of Health has delineated a long list of issues which indicate both negligence and malfeasance which led to the suspension of this project. This correspondence (dated 3/28/18) discloses the scenario which revealed these serious incidents: "This is a final report describing a deviation from PHS policy and the actions taken to reduce the chance of repeat or continued non-compliance by the individual/individuals involved. Procedures were performed without Institutional Animal Care and Use Committee (IACUC) approval. Animal Resource Personnel (ARP) discovered two mice exhibiting paralysis of the rear legs. ARP personnel confirmed with the IACUC office that the procedure to induce paralysis was not approved." The idea that UAB staff would intentionally induce paralysis in animals, in procedures which were not approved, is simply shocking. Not only is this a totally cruel and unnecessary process, the fact that this was done without ACUC approval indicates that this UAB PI ignores standard research practices, and believes that they are essentially above the law. This person has succeeded in significantly damaging the scientific reputation of UAB. "The University of Alabama at Birmingham IACUC board met on Wednesday February 28, 2018, and discussed the noncompliance associated with performing two separate procedures where active immunization with myelin-derived proteins were performed on a total of 48 mice without IACUC approval." The idea that four dozen animals were subjected to partial paralysis for nothing is entirely heinous and unforgivable B State Route 28 #280 Milford, OH

2 "The quorum decision of voting members and corrective actions are as follows: 1. Immediate suspension of all animal research activities for a period of 3 months. 2. Destruction of all tissues and samples collected from the animals that were part of the unapproved experiments. Directed to not use any of the data generated from those experiments in any way. 3. Management of investigator's mouse colony during suspension is to be provided by individuals selected by the primary department chair, and must not include any individuals from investigator's staff. 4. Retraining of the PI and staff conducted and coordinated through the IACUC office." The fact that all tissues and samples were destroyed means that these animals truly suffered and died for absolutely nothing. These conditions also bring to mind several questions. How is it that UAB staff was allowed to begin a research project without adequate training? They should not require RE-training, they should have been trained properly in the first place! And if these UAB staff persons simply chose to flaunt the authority of UAB's research administration, as is apparently the case, then the penalty which they served is nowhere near sufficient. A temporary suspension is not adequate. These renegades should never be permitted to utilize animals again! If this were the only incident of research malfeasance at UAB, that would be a less serious concern. However, UAB correspondence demonstrates that this is clearly not the case. This incident is only the latest in a long pattern of unapproved procedures. UAB correspondence discusses an incident which was reported on 8/31/17 in which involved: "Administration of an unapproved agent" On 7/25/17, Animal Resources Program (ARP) personnel discovered a cage of 3 rats that had been administered an Adeno-associated Viral (AAV) vector that was not described in the protocol to which the animal was assigned." In other words, this is another incident in which UAB staff performed a procedure which was not part of an approved protocol. Further UAB correspondence discusses another troublesome incident which was reported on 1/26/17: "Performance of an unapproved procedure: On 12/22/16 Animal Resources Program (ARP) personnel discovered a rat that had undergone an ovariectomy that was not described in the protocol to which the animal was assigned." Another UAB PI who flouted the authority of the IACUC with impunity. Yet another incident was reported late in 2016: "Performance of an unapproved procedure. A special diet (high fat) was administered to approximately 42 mice for 3 months without prior IACUC approval." It is becoming abundantly clear that UAB research staff apparently believe they can perform whatever procedures they like, whenever they like, without having knowledge of their own protocols, or approval from the UAB IACUC. This is an indictment not only of UAB research staff but also of UAB research administration.

3 How many more unapproved procedures have been performed but never discovered because ARP staff didn't happen to walk in on them or find the animals victimized in these procedures? But these issues with unapproved procedures are not the only issues in UAB labs. Apparently UAB staff is also not capable of performing basic animal husbandry. A report from November 2017 discusses horrific animal deaths: "Failure to provide adequate care to assure health and comfort of animals used for biomedical purposes: Animal Resource Personnel (ARP) discovered three cages of mice (16 mice total) deceased. On October 25, 2017, the IACUC determined that Animal Resource Personnel neglected to recognize these three cages of mice were without water even though documentation at the room level indicated the care technician had checked the cages. The IACUC recommend that the care technician and their supervisor be retrained... " These staff should not be retrained, they should be terminated. This is not something minor. It isn't that the cages weren't cleaned quite often enough, or a box on a form wasn't checked. These 16 animals died of thirst, an extremely unpleasant death. And what does this say about the competence of UAB staff? What else is being missed? So, we have multiple incidents of either intentional performance of unapproved procedures, or multiple incidents of research staff being totally unfamiliar with the very research projects they are charged with performing. And on top of that, UAB staff is so utterly incompetent that they can't remember to give animals water, and don't notice that these animals are in distress until they have died. This is a total and utter failure to perform experimentation in accordance with federal regulations by multiple Principle Investigators and a total failure to supervise these PIs by the UAB IACUC. The severity of the compliance issues and the lack of adequate supervision by the IACUC clearly indicate that major systemic issues exist. In the presence of these projects, I cannot imagine that other UAB projects are fully compliant with federal regulations. It is highly likely that the failures of other PIs have simply not yet been discovered. This situation has not only wasted what could have been scientific funding, and likely denied animals even the most basic level of humane treatment, it has also clearly resulted in experimental behavior that can be called anything BUT science. The multiple and deliberate failures to perform experimentation in a way that would bear any resemblance to science, as well as the intentional performance of unapproved painful procedures by multiple UAB PIs should never have happened, and should not be allowed to take place in the future. Not only are animals lives at stake, but the credibility and reputation of the University of Alabama is on the line. Therefore, I am calling upon your offices to take administrative action to launch an independent investigation to determine if even more incidents of non-compliance have occurred in relation to other projects, as well as ascertaining how and why these aforementioned failures occurred. However, the willful disregard for federal regulations as well as the authority of UAB research administration, the IACUC, and the welfare of the animals used in this project collectively require a much more serious penalty then temporary suspension of the project. If you are to restore the credibility of UAB research you must: 1. Permanently terminate all animal protocols associated with the PI who intentionally paralyzed animals without IACUC approval. Any projects performed by this PI are forever questionable and must not move forward. 2. Prohibit the publication of the results of this research, because since the protocol was not followed, the data is meaningless. It is clear that the IACUC considers the data which had been obtained to be corrupted because it was ordered to be destroyed.

4 3. Return all funding received for this project to the funding source. 4. Immediately terminate all staff connected to the incident in which 16 animals died of thirst. 5. Launch an independent investigation into the entire animal experimentation program at UAB. I will await action from your office, and expect to receive a reply within five (5) business days. Sincerely, Attachment: University of Alabama Correspondence Michael A. Budkie, A.H.T., Executive Director, SAEN

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