Re: Use of Live Pigs for Emergency Medicine Residency Training at the University of South Carolina School of Medicine

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1 Aug. 25, 2016 Elizabeth Goldentyer, D.V.M. Regional Director USDA/APHIS/AC Eastern Region 920 Main Campus Drive, Suite 200 Raleigh, NC Submitted by Re: Use of Live Pigs for Emergency Medicine Residency Training at the University of South Carolina School of Medicine Dear Dr. Goldentyer: The Physicians Committee for Responsible Medicine requests that the Animal and Plant Health Inspection Service (APHIS) investigate the use of live animals for training at the University of South Carolina (USC) School of Medicine in Columbia. USC uses live pigs to teach procedures to emergency medicine residents, despite the widespread availability and implementation of educationally superior nonanimal training methods. Based on documents obtained by the Physicians Committee under South Carolina s Freedom of Information Act, USC uses live animals to teach emergency medicine residents up to 10 procedures, including: Anterolateral thoracotomy (an incision in the left side of the chest and spreading of the ribs in order to access the heart or lung) Chest tube placement (an incision between the ribs followed by the insertion of a tube into the chest cavity to drain air, blood, or other fluids) Cricothyroidotomy/surgical airway (an incision in the throat and the insertion of a breathing tube) Direct cardiac compression (accessing the heart via a thoracotomy, then squeezing the heart to restore circulation) Pericardiotomy (opening of the sac surrounding the heart to remove fluid) Resuscitative thoracotomy (an incision with spreading of the ribs, or splitting of the breastbone, in order to access the heart for control of bleeding and surgical repair) Animal use is at odds with the current standards of practice in emergency medicine training in the United States. According to an ongoing Physicians Committee survey, 141 of 160 surveyed emergency medicine programs (88 percent) including prominent regional programs at the Medical University of South Carolina, Duke University, Wake Forest University, Carolinas Medical Center in Charlotte, Emory University, and the Medical College of Georgia

2 exclusively use nonanimal methods to teach residents. Also, the other USC campus, in Greenville, uses only human-based methods to train emergency medicine residents. Under the Animal Welfare Act, USC meets the statutory definition of a research facility and is therefore required to comply with the Animal Welfare Act. As part of this required compliance, any use of live animals for research, testing, or training must be approved by the University of South Carolina Institutional Animal Care and Use Committee (IACUC). USC is registered with the U.S. Department of Agriculture under cert. no. 56-R The Physicians Committee believes that inadequate oversight by the USC IACUC is responsible for the approval and scheduled use of live animals in USC s emergency medicine residency program. The specific regulatory violations are: 1. Justification of Animal Use is Subjective and Insufficient Because Alternatives Exist Section 2143 of the Animal Welfare Act and CFR Title 9, Section 2.31(d)(1)(i, ii) of the Animal Welfare Act s implementing regulations require that the principal investigator (PI) including course instructors consider alternatives to procedures that may cause more than momentary or slight pain or distress to any animal used for research or educational purposes. In addition, the PI must provide a written narrative description of the methods and sources used to determine that alternatives were not available. The content of this narrative is detailed in the APHIS Animal Care Policy Manual (2011), which states in Policy 12: If a database search or other source identifies a bona fide alternative method (one that could be used to accomplish the goals of the animal use proposal), the IACUC may and should ask the PI to explain why an alternative that had been found was not used. We believe that the PI did not meet this requirement because justification of animal use for emergency medicine residency training is not possible in view of the validation and widespread implementation of purpose-designed nonanimal training methods. Having not provided objective evidence to support animal use in view of numerous acknowledged validated and implemented alternatives, this requirement of the AWA was not met. A proper alternatives search would have revealed nonanimal methods for the training of all procedures currently taught at USC using live pigs. All emergency medicine procedures can be taught using human-based medical simulation, partial task trainers, and cadavers. Over the last 12 years, animal use among surveyed emergency medicine residency programs has declined from 86 percent (Custalow 2004, published survey) to 12 percent (19 of 160 responding programs); see Addendum I. With advances in technology, as well as ethical considerations, there has been a shift in paradigm and a majority of programs are now exclusively employing nonanimal training methods. For a summary of current peer-reviewed publications and reviews pertaining to emergency medicine training methodologies, see Addendum II. On page three of the protocol, the PI states: These surgical procedures cannot be mastered by computer simulation, simulation labs, or mannequins, nor is it appropriate to practice on patients, especially where the procedures are non-elective emergency procedures, usually lifesaving. The PI provides no evidence to support his claim that these procedures cannot be mastered by nonanimal training methods.

3 Further, the PI states on page 13 of the protocol: The market place has not been able to meet the challenge of producing high fidelity tissue models. This contrasts sharply with a study conducted by U.S. Air Force Maj. Andrew Hall, M.D., which found in 2014 that post-training self-efficacy scores demonstrated no statistical difference between live animals and simulators for three critical emergency procedures. 1 In a letter to the editor published in Military Medicine that same year, Maj. Hall concluded: We have entered into an age where artificial simulator models are at least equivalent to, if not superior to, animal models. 2 In an attempt to exemplify his qualifications, the PI mentions on page nine of the protocol that he has over twenty three years of teaching ATLS (Advanced Trauma Life Support) procedures using this species. It should be noted that the use of live animals for ATLS training is no longer standard practice. As of Jan. 1, 2015, the U.S. Department of Defense ended the use of animals for ATLS training, concluding that sufficient simulation models [are] available to meet medical education and training needs. 3 In addition, 99 percent of ATLS programs in the United States and Canada (285 of 287) surveyed by the Physicians Committee use only nonanimal training methods, including the University of South Carolina. The PI's experience using live animals for ATLS courses and training emergency medicine residents has little relevance, since the vast majority of similar programs employ exclusively nonanimal training methods. Also of note is that, according to the protocol, four residents are assigned per pig, which results in unrealistic teaching of surgical airway. When performing this time-sensitive procedure, familiarity with anatomical landmarks is critical. As explained in a 2006 U.S. Army training video in which surgical airway is performed on an anesthetized goat: Only one student will be able to actually perform a true surgical [airway]. The rest of the students will have to go down the trachea and go through the cartilaginous rings. 4 Thus, the first surgical airway is the only true procedure, with each subsequent procedure being performed in a slightly different location on the neck than it would be in real-life situation. Simulators could replace animal use for this procedure while allowing for trainees to hone their craft though repetitive practice. The replaceable tissues on simulators provide each resident with a first cut experience. A validated and widely implemented example of these human-based methods includes Simulab s TraumaMan System, a realistic anatomical human body simulator with lifelike skin, subcutaneous fat, and muscle. The TraumaMan System can be used to replace USC s use of pigs in numerous procedures, including chest tube placement, surgical airway, and venous cutdown. The TraumaMan System is used by the majority of ATLS programs to teach some of the same skills for which USC is using animals. In addition, the Emergency Thoracotomy simulator from Operative Experience, Inc., can be used to teach almost all of the procedures for which the school is using pigs including resuscitative and anterolateral thoracotomy, pericardiotomy, direct cardiac compression, and cardiac wound repair. In Addendum III, you will find an extensive list of nonanimal training methods available to replace animal use in USC s emergency medicine procedural training lab. 1 Hall A., Riojas R., Sharon D. Comparison of self-efficacy and its improvement after artificial simulator or live animal model emergency procedure training. Military Medicine. 2014; 179(3): Hall A. Letter to the Editor. Military Medicine. 2014; 179(7): Woodson, J. Determination for the use of Animals in Medical Education and Training. 15 May United States of America. Department of the Army. Headquarters, United States Army Medical Command. Tactical Combat Medical Care Surgical Skills Lab Update

4 Lastly, USC already has a state-of-the-art simulation center the Palmetto Health USC School of Medicine Simulation Center which offers a full range of high-fidelity mannequins and partial task trainers. If fully utilized, the center could provide the simulation capabilities to replace the use of animals in USC s emergency medicine residency. 2. The Use of Pigs for Emergency Medicine Training is Not Unavoidable The Animal Welfare Act also requires that activities involving animals be designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research. 9 C.F.R. 2.31(e)(4). We believe that this requirement was not met by the PI because of the widespread availability of validated simulators and the fact that 88 percent of surveyed emergency medicine programs in the United States do not use animals. This clearly documents that such use of live pigs is not unavoidable. 3. The University of South Carolina at Columbia IACUC is Failing to Properly Oversee Animal Use Section 2143 of the Animal Welfare Act and Title 9, Section 2.31(d)(1)(i, ii) of the Animal Welfare Act s implementing regulations require that the IACUC enforce the requirements described in items 1 and 2 above and thereby determine that the proposed activities are in accordance with the Animal Welfare Act and CFR Title 9, Section 2.31(d). Further, the APHIS Animal Care Policy Manual (2011) Policy 12 places the burden of alternatives justification on the IACUC as well as the PI by stating: The IACUC, in fact, can withhold approval of the study proposal if the Committee is not satisfied with the procedures the principal investigator plans to use in his study. We believe that these requirements were not met by the USC IACUC because the animal use protocol was approved despite the violations described in items 1 and 2 above. Thus, the Physicians Committee alleges inadequate institutional oversight by the USC IACUC. Accordingly, the Physicians Committee requests that APHIS investigate this matter to find the University of South Carolina School of Medicine in violation of the Animal Welfare Act and its implementing regulations as detailed above, and to implement correction and appropriate penalties. Thank you for your attention. Sincerely, John J. Pippin, M.D., F.A.C.C. Director of Academic Affairs Phone and facsimile: JPippin@pcrm.org

5 Leslie Rudloff Senior Counsel Phone: Marjorie Chorness, M.D. Greer, S.C. Geeta Nangia, M.D. Simpsonville, S.C. Addendums I. Animal Use in Allopathic and Osteopathic Emergency Medicine Residency Programs in the United States: An Ongoing Survey II. Emergency Medicine Training References: Research and Reviews III. Human-based Training Methods to Replace the Use of Live Animals in the University of South Carolina s Surgical Skills Laboratory