Usda Complaint Re Wustl (Usda Cert. No. 43-R-0008) - 4-17-13

7/28/2019 Usda Complaint Re Wustl (Usda Cert. No. 43-R-0008) - 4-17-13

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April 17, 2013

Robert Gibbens, D.V.M.

Regional Director

USDA/APHIS/AC Western Region2150 Centre Ave.

Building B, Mailstop 3W11

Fort Collins, CO 80526-8117

Via e-mail:[email protected]

Dear Dr. Gibbens,

Thank you in advance for your time. I am writing on behalf of PETA and our

more than 3 million members and supporters to request an investigation intoapparent serious violations of the Animal Welfare Act (AWA) by Washington

University in St. Louis (WUSTL) (Western Region USDA Customer No. 1444,

USDA Certificate No. 43-R-0008). New video footage obtained by PETA,filmed on March 7, 2013, depicts live cats being used for intubation training

exercises in WUSTLs Pediatric Advanced Life Support (PALS) course, which is

held in conjunction with St. Louis Childrens Hospital. This video, which youmay view by visiting

http://www.petapreview.com/4preview/footage_supporting_petas_april_18_2013

_complaint_to_usda.asp, supports the following alleged AWA non-compliances.

I. Failure to Minimize Pain, Distress, Harm and Discomfort to AnimalsThe AWA regulations require that WUSTL minimize discomfort, distress, and

pain to the animals during experimental procedures [9 C.F.R.2.31(c)(8d)(1)(i)], handle animals in a manner that does not cause trauma,

physical harm, or unnecessary discomfort [9 C.F.R. 2.38(f)(1)], and provide a

description of procedures designed to assure that discomfort and pain to animalswill be limited to that which is unavoidable for the conduct of scientifically

valuable research. [9 C.F.R. 2.31(e)(4)].

During video time mark 00:06 00:26, a PALS course participant asks WUSTL

veterinarian Mike Talcott how often the cats are used for intubation training.

Talcott replies, About three years. And we use them for about four times a year.

Four times a year we intubate them less than 15 times per lab. During video

time mark 00:27 00:31, Talcott tells a PALS course participant, Yes theres atime where we have, you know, maybe some [vocal] cord edema in the cats due

to as many as 15 intubations performed on each animal per training session.

Research on repeated intubations in animals by faculty at Delawares Alfred I.

duPont Hospital for Children shows that, Repeated intubation alone results in
mailto:[email protected]:[email protected]:[email protected]://www.petapreview.com/4preview/footage_supporting_petas_april_18_2013_complaint_to_usda.asphttp://www.petapreview.com/4preview/footage_supporting_petas_april_18_2013_complaint_to_usda.asphttp://www.petapreview.com/4preview/footage_supporting_petas_april_18_2013_complaint_to_usda.asphttp://www.petapreview.com/4preview/footage_supporting_petas_april_18_2013_complaint_to_usda.asphttp://www.petapreview.com/4preview/footage_supporting_petas_april_18_2013_complaint_to_usda.aspmailto:[email protected]


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significant tracheal trauma and systemic inflammation.1

One highly-cited study conducted at the

Uniformed Services University of the Health Sciences found that 29 percent of animals used forintubation training showed trauma to the larynx or trachea after 5 intubation attempts and 100 percent of

animals who were intubated 10 times or more experienced trauma.2

Another recent paper by faculty at

Naval Medical Center-Portsmouth suggested that no more than 10 intubations be performed on eachanimal before risking serious trauma to the airway.3

Talcotts admission that cats in WUSTLs PALS course suffer from [vocal] cord edema and that catsendure as many as 15 intubations per session confirms that WUSTL is grossly exceeding the established

veterinary medical practice limits for safely performing intubations without injury, and these injuries arenot unavoidable for the conduct of scientifically valuable research. Such a high number of intubationsand confirmed injury to the animals indicates that WUSTL is allegedly violating AWA regulations for

minimizing pain, distress, harm and discomfort to animals.

II . Failure to Provide Adequate Anesthesia to Animals During Painful ProceduresThe AWA regulations state, Procedures that may cause more than momentary or slight pain or distress

to the animals will [b]e performed with appropriate sedatives, analgesics or anesthetics [9 C.F.R.

2.31(d)(1)(iv)(A)].

During video time mark 00:42 00:50, a PALS course participant who had completed the cat intubation

session states, They had to give Jessie [a cat used in the WUSTL PALS course] more ketamine becauseI was messing with him so much. During video time mark 00:51 01:00, one PALS course participant

asks a trainee, Was he [Jessie] waking up for you? A PALS course participant replies mmmhmm

(indicating yes) and another PALS course participant states, they gave him [Jessie] more ketamine

The acknowledgement that at least one cat was waking up during a potentially painful intubation

procedure indicates that WUSTL provided inadequate anesthesia to the animal, in apparent violation of

the AWAs requirement that animals receive proper anesthesia during painful procedures.

II I. Failure to Consider Alternatives and J ustify Use of CatsThe AWA regulations require that WUSTL faculty must have considered alternatives to the use ofanimals in painful procedures and provided a written narrative description of the methods and sources

used to determine that alternatives were not available." [9 C.F.R. 2.31(d)(1)(ii)]. USDA Policy 12

goes onto explain, Regardless of the alternatives sources(s) used, the written narrative should includeadequate information for the IACUC to assess that a reasonable and good faith effort was made to

determine the availability of alternatives or alternative methods. 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

1 A. Oshodi et al., Airway Injury Resulting From Repeated Endotracheal Intubation: Possible Prevention Strategies,Pediatric Critical Care Medicine(2011) 12.1: e34-39.2 D. Powell et al., Use of the Ferret as a Model for Pediatric Endotracheal Intubation Training, Lab AnimSci (1991) 41.1:86893 S. Kircheret al, Minimizing Trauma to the Upper Airway: A Ferret Model of Neonatal Intubation,J AmAssoc Lab AnimSci (2009) 48.6: 780-4.


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use proposal), the IACUC may and should ask the PI to explain why an alternative that had been found

was not used.4

It is literally impossible for WUSTL faculty to demonstrate that non-animal alternatives cannot meet the

requirements of the PALS training course since the courses developer and sponsor, the American HeartAssociation (AHA), has clearly stated that, The AHA does not endorse the use of live animals for

PALS training. The use of lifelike training manikins for PALS courses is the standard accepted norm.

[T]he AHA recommends thatany hands-on intubation training for the AHA PALS course be performedon lifelike human manikins.

5When asked recently to explain why it has taken position, the AHAs

Director of Training Center Operations and Quality stated, We do not endorse or require the use of

animals during the AHA-PALS training because of advances and availability of simulationmannequins. These mannequins provide the opportunity to practice all the necessary skills required for

successful completion of an AHA PALS course.6

Indeed, there is absolutely no evidence available to show that using animals improves intubationproficiency. WUSTL is the only one of the more than 1,000 PALS facilities that PETA knows of that

uses animals for intubation training. Clearly, alternatives to the use of animals for completing this

training course are available and the preferred standard nationwide.

The AWA regulations also require that WUSTL provide a reasonable rationale for the

appropriateness of the species to be used during the PALS course; yet, the use of cats for intubationtraining in the PALS course has been criticized in the scientific literature.

Cindy Taitco-developer of the PALS course and a flight nurse, medical educator and president of the

Center for Healthcare Education, an AHA training centerhas written extensively on the drawbacks ofanimal use and benefits of simulation for neonatal and pediatric intubation training. She describes the

anatomical differences that make cats poor substitutes for human infants, stating: Kittens and ferrets

have proportionately longer tongues than human infants that are one and a half times the length of theirmouth. Further differences include more profuse salivation, dome-shaped arytenoid cartilage, and

comparatively larger epiglottises and smaller anterior larynxes .... [T]here is no anatomical specificity

between the maxillofacial or oropharyngeal features of animals and humans. The bottom line is thatthere is no need to traumatize and harm animals to teach [intubation], especially when highly effective

non-animal methods are the accepted standard of practice and readily available to instructors.7

As such WUSTL is allegedly violating the AWA regulations since it cannot reasonably determine that

alternatives to animal use in PALS training are not available, nor can WUSTL provide a reasonable

rationale for using cats despite their obvious anatomical differences from human infants.

Request for USDA InvestigationWe urge you to undertake a full investigation into WUSTLs use of live animals in the PALS course and

any underlying issues that such an investigation might expose. If noncompliance is found, we urge you

4 USDA, Policy #12: Consideration of Alternatives to Painful/Distressful Procedures, 25 Mar. 2011

.5 American Heart Association, Letter to PETA, 3 Feb. 2009.6 American Heart Association, E-mail to PETA, 18 Mar. 2013.7 C. Tait.
http://www.aphis.usda.gov/animal_welfare/policy.php?policy=12http://www.aphis.usda.gov/animal_welfare/policy.php?policy=12http://www.aphis.usda.gov/animal_welfare/policy.php?policy=12http://www.aphis.usda.gov/animal_welfare/policy.php?policy=12


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to take swift and decisive action that includes citing WUSTL for violations of the AWA as well as

levying all appropriate fines against the facility.

You can contact me directly by telephone at 757-962-8325 or by e-mail [email protected]. Thank

you for investigating these serious issues, and we look forward to your response.

Sincerely yours,

Shalin G. Gala

Laboratory Methods Specialist

Laboratory Investigations Department
mailto:[email protected]:[email protected]:[email protected]:[email protected]


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Enclosures:

American Heart Association, Letter to PETA, 3 Feb. 2009

American Heart Association, Message from AHA ECC Programs: Use of Live Animals inPALS Courses, 27 Jan. 2009

PETA Correspondence with American Heart Association ending 18 Mar. 2013


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February 3, 2009

lan SmithResearch AssociateLaboratory Investigations DepartmentPeople for the Ethical Treatment of Animals501 Front StreetNorfolk, VA 23510Dear Mr. Smith:

American Heart / American StrokeAssociation AssociationLearn and Live

National Center7272 Greenville Avenue Dallas, Texas 75231-4596

Tel 214.373.6300 americanheart.org

Thank you for sharing your concerns with us regarding the American HeartAssociation's (AHA) policy against using animals in the Pediatric Advanced LifeSupport (PALS) course. Please allow me to address your specific concerns.The AHA does not endorse the use of live animals for PALS training. The use oflifelike training manikins for PALS courses is the standard accepted norm.In addition, endotracheal intubation is not required to successfully pass the PALScourse. Therefore, the need for hands-on intubation training is limited within eachcourse. The skill may be practiced by providers who are authorized to performintubation in their profession, but the AHA recommends that any hands-onintubation training for the AHA PALS course be performed on lifelike humanmanikins.We routinely send email reminders to our training network of instructors about ourpolicies, including our policy on the use of animals in training. Additionally, we haveposted this policy on our Instructor Network, an internal intranet site for ourinstructors.We appreciate your request to strengthen the language of our PALS manuals. Allof our course materials are on a five-year cycle that coincides with the release ofour new Guidelines for CPR & Emergency Cardiovascular Care. Thus, anyupdates to our materials will occur between fall 2010 and 2011.Again, thank you for your interest in this issue.Sincerely,

Robert O'Connor, M.D., MPHChair, Emergency Cardiovascular Care Committee

Cc: Dr. Michael Savre


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From: Robin Crawford [mailto:[email protected]]Sent: Tuesday, January 27, 2009 1:59 PMTo: AHA Instructor NetworkSubject: Message from AHA ECC Programs: PETA inquiries re: use of live animals in PALScourses

Dear PALS Training Centers,

Over the course of the last six months, PETA (People for the Ethical Treatment of Animals) has

been targeting AHAs ECC Training Centers nationwide to determine if they use live animals in

training courses, specifically in Pediatric Advanced Life Support (PALS). AHA has responded to

inquiries from PETA with the following messages outlining our position on use of live animalsin PALS courses:

The AHA does not require or endorse the use of live animals in any of its trainingcourses.

It is an independent decision for training centers to use live animals for PALS training. Indoing so, they could be targeted by PETA and will be responsible for responding on

behalf of their own business/organization.

If a training site decides to use live animals to supplement the required instruction in aPALS course, the use of live animals must be identified as not being a part of AHAscourse, must not be a requirement for successful course completion, and training sites

must identify to the students that use of live animals is not a requirement of the AHA to

participate in or to complete the PALS course.

If you have any questions about the AHAs position on this issue, please send an email [email protected].

Sincerely,

ECC Programs

___________________________

American Heart Association, ECC ProgramsNational Center

7272 Greenville AvenueDallas , TX [email protected]
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]


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From: Timothy Williams [mailto:[email protected]]Sent: Monday, March 18, 2013 1:02 PMTo: Justin GoodmanCc: Matthew BannisterSubject: RE: Question from PETA

Mr. Goodman,

We do not endorse or require the use of animals during the AHA-PALS training because ofadvances and availability of simulation mannequins. These mannequins provide the opportunity

to practice all the necessary skills required for successful completion of an AHA PALS course.

Regards,

Timothy E. WilliamsDirector of Training Center Operations and Quality

--------------------------------------------------------------From: Justin Goodman [mailto:[email protected]]Sent: Thursday, March 14, 2013 11:28 AMTo: Timothy WilliamsCc: Matthew BannisterSubject: Question from PETA

Mr. Williams,

I hope all is well. I would like to ask one clarifying question regarding AHA policy:

SLCH has insisted to the public and media that the reason AHA does not endorse animal use inPALS is solely because of the cost associated with it. As far as I know, AHA has never stated

this. Further, this explanation seems off-base since not only does AHA not require animal use in

the course, but AHA prohibits it and exclusively recommends that any hands-on intubation

training for the AHA PALS course be performed on lifelike human manikins.

Can you tell me if the AHAs position on animal use in PALS is solely based on economics, or

the fact that the use of animals is unnecessary to meet course objectives?

Thank you very much, in advance.

Justin

Justin Goodman, M.A.Director

Laboratory Investigations Department

People for the Ethical Treatment of Animals

860-882-2492 |[email protected]
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]

Documents

Usda Complaint Re Wustl (Usda Cert. No. 43-R-0008) - 4-17-13