AAVPT Newsletter, Vol 20, No 1, February 2001

From The President

An organization stands on the work of those who have guided it before and with that in mind I begin this letter by recognizing those leaders, and in particular the most recent set of officers. AAVPT is deeply appreciative of the work that Scott Brown has performed, not only as President, but also for his work for the organization in preceding years. Debbie Kochevar did an exemplary job as Secretary-Treasurer and I am especially appreciative of her work in establishing the new AAVPT web page at www.aavpt.org. Mark Papich, Dawn Boothe, Carol Davis and Jack Oliver as councilors that have finished their terms in the last two years also deserve our sincere gratitude. Our new officers are Ted Whittem as President-elect/Program Chair and Carol Davis as Secretary-Treasurer. Steve Sundlof and Debbie Kochevar are our newest councilors, filling out the Executive Council with Marilyn Martinez, Jeff Wilcke, Jane Owens Clark, and Tomas Martin-Jiménez. I'm sure I speak for all the officers and councilors in saying that we are gratified and humbled by the trust the membership has placed in us.

I am a firm believer in organized veterinary medicine and I feel that the AAVPT still has a vital role to play in veterinary medicine and the discipline of pharmacology. Without such organizations we become much too introverted in our perspectives and, just as importantly, we lose the voice as a group of concerned pharmacologists to best change policies and approaches that otherwise might not be dealt with. As for specific agenda items during my term that I would like to see addressed, I believe that we need to do a better job of sharing our expertise and teaching resources to make for better graduate and veterinary student training programs and will work toward that end. My biggest concern however, is what appears to be a shrinking membership. We recently purged our rolls of delinquent members and, while this was indeed appropriate as these members represented a drain in terms of mailings and other resources, it begs the question of why these individuals have chosen not to remain members of AAVPT. Others have noted the same observation that I have made in that the core membership of AAVPT is increasingly becoming the same as ACVCP. While I welcome this continued joint relationship, we must offer programs and services that are appealing to the nonclinical pharmacologist, inclusive of academia, regulatory and industry.

In order to address the needs of all of our members it is imperative that the membership communicate those needs. While I believe that our recent symposium was a great success, I found it disappointing that leading up to the meeting the program committee heard from only two members as to suggested topics. We need more participation from the membership if we are to make this organization what YOU would have it be. If you have a theme or even an individual topic you'd like to see presented at subsequent meetings please let Ted, as the new Program Chair, know of it. Likewise, please communicate to any officer the services and agenda items that you would like to see incorporated into AAVPT.

I look forward to the next two years as your president. If there is anything I can do to better meet your needs as an AAVPT member I hope you will not hesitate to contact me.

Best wishes,

Cory Langston

President, AAVPT

(langston@cvm.msstate.edu)

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As the newly elected Secretary-Treasurer, I would like to take this opportunity to make a personal statement before I get to my report. I want to take this opportunity to thank Debbie Kochevar for her outstanding contribution to the AAVPT as our Secretary-Treasurer for the last three years. She has done an outstanding job. The office of Secretary-Treasurer has many duties (all of which I am about to discover!) that are critical to the operation of the organization. Debbie carried out these duties in outstanding fashion and has left the affairs of the office in great shape. In addition to her normal duties the council had several additional projects requiring an enormous amount of effort on her part. She oversaw the transfer of our website and has worked hard, along with our new webmaster (Susan Cook) to get the site up and going. I am sure everyone who has visited the site is pleased with the results. In addition to this, the council made several changes to the bylaws and requested a more formal budget procedure be put into place. All this required much of her time. These tasks have been completed and all of us, both officers and members, should reap the benefit of her effort. Debbie leaves the office in fine shape and I know I will benefit personally from all her effort as I go forward as the new Secretary-Treasurer. I wanted to take this opportunity to thank her for her contribution to the organization.

I hope everyone had a good time at the Denver meeting and had a safe and hassle-free return home. The AAVPT council meeting convened on Tuesday, May 22, 2001, at the AAVPT 12^th Biennial Symposium in Denver and the general business meeting was held on May 23, 2001, prior to the banquet and award ceremony. The Secretary-Treasurer’s (Kochevar) report detailed at the meeting put our current membership at 137 Fellows, 30 Associate Fellows, 8 Student Members and 38 Distinguished or Emeritus Fellows. We welcome seven Fellows (upgrades: Robert Hunter, Sanja Modrić, Tomas Martin-Jiménez, Virginia Fajt; new: Michele Doucet, Cynthia Kollias-Baker, Ron Johnson), one new Associate Fellow (Gina Michels) and two new Student Members (Maya Scott, Kylie Kavanagh) added to the membership rolls. Several members converted their memberships to Emeritus status due to retirements. We would like to thank all members who have paid their dues, and, especially, the following members who have contributed to the AAVPT awards fund: W. Kay, S. Sundlof, S. Longhofer, J. Oliver, D. Boothe, W. Lance, J.O. Clark, V. Langston, M. Papich, C. Sawyer, C. Lanusse, G. Coppoc, J. Weissinger, M. Greenberg, D. Gingerich, T. Clark, A. Jernigan, AVMA (for Current Topics in Drug Therapy contributions), Elanco Lilly, Pharmacia Animal Health, Alpharma, Bayer, Fort Dodge and Schering-Plough. As reported at the meeting, there are several members with dues outstanding. I would remind our members who have not paid their dues for 2001 to please send their payment to me. Second notices will be mailed in the near future.

The treasury summary report showed a balance of $14,086.98 as of June 1, 2001. Debbie and I are in the process of transferring the funds and records from Texas to Illinois and the final transfer will not be completed until she has the opportunity to conduct a final audit. This audit will wait until she gets a final invoice from JVPT publisher and a final budget report for the symposium. To date we have 49 paid subscriptions with 12 AAVPT members receiving complimentary subscriptions for editorial board service. Journal subscriptions were $74 for 2000-2001. Complimentary subscriptions for selected developing countries (n=19) were requested from Blackwell for 1999-2000; however, these subscriptions were never activated (perhaps due to confusion due to a change in personnel at Blackwell). The council is evaluating the current policy of sending out these issues.

Costs for the web site included site and domain hosting ($20/month), web page layout and design ($25/hr), web database programming ($45/hr). To date costs awaiting billing amount to approximately $700. This covers cost of redesign, extensive work to mount and clean up the membership database and an on-line member survey (S. Brown). The database is now in a form that will allow all incoming Secretary-Treasurers to work easily and electronically with membership data that is centralized and accessible from the web.

The election results are as follows. All 13 changes to the Constitution and Bylaws were approved (10 unanimously, 3 by an overwhelming majority). The new officers and councilors elected to a 3-year term (2001-2004) are: President-elect is Ted Whittem, Secretary-Treasurer is Carol Davis and Councilors are Stephen Sundlof and Deborah Kochevar.

I look forward to serving as your Secretary-Treasurer. Please contact me concerning any questions or any AAVPT business. Debbie and I will be in a transition mode for the next couple of months, but between the two of us we should be able to answer any questions. Hopefully, the transition between outgoing and incoming Secretary-Treasurer will be “smo-o-o-th as silk.” Have a good summer and please remember to notify me of any changes in mailing, phone, fax or email information so we can keep the entries current in the directory.

The Animal Health Association, COMISA, which represents the global industry, has changed its name to the International Federation for Animal Health (IFAH). This was to reflect a new and strengthened organizational structure which will work more effectively with other associations to address the increasing international challenges that affect the industry. The priorities for the coming year will include:

- monitoring the activities of international regulatory bodies and representing the interest and positions of the animal health industry therein;

The Animal Health Institute reported from a recent survey of manufacturers that most antibiotics are used to treat and prevent disease in animals. The survey found that 20.5 million pounds of antibiotics were sold for use in animals in 1999. Of the 20.5 million pounds, 17.7 were used for treatment and prevention of disease and 2.8 were used for improving feed efficiency and enhancing growth.

CVM Plans Second Antimicrobial Risk Assessment

CVM, in continuing its review of the potential risk to humans of the use of antimicrobials in food animals, has completed a feasibility study for a second risk assessment, and has decided to proceed with the study.

For the study, CVM will be conducting a quantitative risk assessment on the human health impact of the development of the streptogramin (quinupristin/dalfopristin [QD]) resistant Enterococcus faecium in humans associated with the use of streptogramins (specifically, virginiamycin) in food-producing animals.

The drug Synercid(tm), a streptogramin (QD), was approved in September 1999 for use in humans to treat vancomycin-resistant E. faecium infections, as well as other gram-positive bacterial tissue infections. Virginiamycin has been used for therapeutic and growth promotion purposes or similar purposes for several years in chickens, swine, cattle and turkeys.

CVM initiated a feasibility study to determine whether sufficient data exist to support a quantitative model or if additional data need to be generated. CVM originally announced the plan to develop the risk assessment in April 2000. At that time, it requested comments on the plan, and asked for the submission of relevant scientific data and information. This feasibility study has been completed, and CVM has determined that there are sufficient data either available or forthcoming to support a quantitative risk assessment of the human health impact from the use of virginiamycin in food-producing animals. Because some of the data needed for the risk assessment are currently under development, CVM will not be able to complete the risk assessment for a year or more.

The first risk assessment, completed last year, modeled the human health impact of fluoroquinolone resistant Campylobacter infections associated with the consumption of chicken. It demonstrated the extent of the adverse impact of fluoroquinolone use in poultry on human health.

CVM Has New Risk Assessment Specialist

H. Gregg Claycamp, Ph.D., CHP, has joined CVM as the Senior Advisor for Risk Assessment. Dr. Claycamp will help develop the antimicrobial risk assessment policy for CVM. He will also serve as the senior scientist for CVM's Office of New Animal Drug Evaluation (ONADE) in all other risk assessment issues.

Dr. Claycamp comes to CVM from the University of Pittsburgh, Graduate School of Public Health, where he was a Professor in the Department of Environmental and Occupational Health. At the University of Pittsburgh, Dr. Claycamp directed the graduate programs in the Risk Assessment and Radiation Health while maintaining an active research and teaching career. His research has included international studies in radiation risk assessment, chemical hazard identification, environmental exposures and basic studies on radiation or chemically induced DNA damage in both microbes and animal cells. Dr. Claycamp has developed novel applications of artificial intelligence for diverse problems in human health risk assessment.

CVM Makes Pathogen Load Report Available

CVM has made available on its Website a review of published literature on the effect of using antimicrobials in food-producing animals on pathogen load. CVM contracted with Exponent of Alexandria, VA, to conduct the review.

The report's title is, "Effect of the use of antimicrobials in food-producing animals on pathogen load: Systematic review of the published literature." It is available under the section on "Antimicrobial Resistance" on the CVM Website. Also, requests for paper copies of this document may be submitted to: the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855. Please send a self-addressed adhesive label to assist in processing the request.

In November 1998, FDA's CVM published in the Federal Register a notice of availability for the draft guidance document entitled "Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals" (Guidance for Industry #78). In this guidance document, CVM stated that the Agency intended to consider the potential human health impact of the microbial effects associated with all uses of all classes of antimicrobial new animal drugs intended for use in food-producing animals. The guidance said that in order to assess this impact, it may be necessary to evaluate the following two separate, but related aspects: 1) the rate and extent of development of antimicrobial drug resistant enteric bacteria formed in the animal's intestinal tract following exposure to the antimicrobial new animal drug (resistance); and 2) changes in the number of enteric bacteria in the animal's intestinal tract that cause human illness (pathogen load).

CVM held a public scientific workshop in February 2000 on pre-approval studies in antimicrobial resistance and pathogen load. The purpose of this workshop was to discuss the appropriate designs for pre-approval studies to evaluate the potential microbial effects associated with the use of antimicrobial drugs in food-producing animals. At the workshop, CVM received numerous comments questioning the relevance of conducting studies to try to assess the impact of drug effects on pathogen load.

CVM officials said they recognize that scientific information in this area is limited and acknowledged the concerns raised at the workshop. Therefore, in an attempt to gather additional information on the topic, CVM contracted with Exponent to conduct this literature review.

The International Conference on Antimicrobial Agents in Veterinary Medicine (AAVM) will be held in Helsinki, Finland, August 4-8, 2002. Topics including clinical use of antimicrobial agents, antibiotic use in farm animals and companion or racing animals, extralabel use, pharmacokinetics and residues of antimicrobials will be presented. Abstracts will be due April 1, 2002. For more information, visit http://www.aavm2002.com.

A position announcement for qualified veterinary pharmacologists in FDA/CVM issued May 14, 2001. Skills should include knowledge of biopharmaceutics and pharmacokinetic principles, ability to communicate in writing and orally and ability to interpret computer modeling of pharmacokinetic data. Contact FDA/CVM (Elaine Walker, phone (301) 827-4262) for more information.

Assistant Professor of Pharmacology and Toxicology, Michigan State University: applications are invited for an annual year, tenure-track position at the Assistant Professor level. The successful candidate should have a DVM and PhD (preferably in Pharmacology) or equivalent degrees and several years of postdoctoral experience. The applicant will be expected to direct an extramurally-funded research program; participate with research teams in directing, consulting and/or executing clinical research programs; coordinate/organize and participate in teaching in the introductory course in pharmacology to Veterinary Medical students; supervise a 4^th-year clerkship in clinical pharmacology; participate in graduate training. Applicants should submit a curriculum vitae, a statement of research and teaching interests and names and addresses of three references. Electronic submission to hummeld@msu.edu is encouraged (use MS Word 2000 or Corel WordPerfect 6/7/8); paper applications may be sent to: Dr. Patricia E. Ganey, Chair, Search Committee, Department of Pharmacology and Toxicology, Michigan State University, B440 Life Sciences Building, East Lansing, MI 48824-1317 (website: http://www.phmtox.msu.edu). Complete applications must be received by October 15, 2001.

The Newsletter is published three times a year by the American Academy of Veterinary Pharmacology and Therapeutics, at the Pharmacia Animal Health. Please kindly address all correspondence to: Scott Anthony Brown, DVM, PhD, 7926-190-45, Pharmacia Animal Health, 7000 Portage Road, Kalamazoo, MI 49001, U.S.A., phone 616.833.2412, FAX 616.833.3295, or e-mail scott.a.brown@pharmacia.com.