Volume 17, Number 1                                       February 1998


From The President

ssuming that you have all survived El Nino to this point, I wish you a happy and prosperous 1998.
I also wish to acknowledge the special effort of Scott Brown who organized the AAVPT Special Symposium on the "Role of Veterinary Therapeutics in Bacterial Resistance Development" in near record time to provide an open public forum for the discussion of very important issues affecting veterinarians and the pharmaceutical and livestock industries (see later in this newsletter). A number of other interesting programs are either scheduled or being developed for the year ahead. I especially encourage you to attend the AAVPT Biennial Symposium organized by Rick Vulliet on "Quantitative Approaches to Veterinary Therapeutics" to be held June 14-18 in Monterey, California. Need I remind you of the proximity to San Francisco, Yosemite, Napa Valley.............?

    A number of nominations have been made for the various AAVPT awards and are currently being processed. The recipients will be recognized at a special awards ceremony in conjunction with the Biennial Symposium. These individuals, through their attainment of excellence in various aspects of veterinary pharmacology, have done much to further the good reputation of the AAVPT as a dynamic professional association.This is the last newsletter prior to the annual business meeting of the AAVPT at the Biennial Symposium. Should you wish to provide items for the agenda, please contact myself, Secretary Ann Jernigan or one of the AAVPT Councilors. The question of an AAVPT dues increase will be on the agenda for discussion.

- Gary Koritz

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AAVPT Secretary-Treasurer's Report

irst, I would like to invite everyone to the AAVPT Biennial Symposium to be held at Asilomar Conference Center near Monterey from June 14 to June 19. Rick Vulliet and his committee have lined up a very exciting program. Please make sure to attend the AAVPT Business Meeting on June 18 in the morning. The exact time and place will be listed in the Symposium Program. Since we will be discussing and voting on some very important items (dues and JVPT subscriptions), I encourage everyone to attend.

Second, please join me in congratulating our newest AAVPT members. Elected as AAVPT Fellows are Calvin Walker, Michael Stegemann, Jane Owens, Joseph Bertone, Steven Fox, Carolyn Kilroy, Marilyn Martinez, Kemmy Mizinga, and Alastair Cribb. New Student Members are Eden Bermingham, Albert Boeckh, and Sarah Anne Louise Jones. The addresses and telephone numbers for these new members are listed below.

The vote to change the Constitution and Bylaws was successful. These changes now make the position of Comptroller, to manage the financial assets of the Academy, official.

Next, I appreciate the good response on dues payments. So far, 90 people have paid their dues, but 95 people still need to send dues to me. Remember, dues are $35 for Fellows, $20 for Associate Fellows, and $10 for Student Members. Importantly, please send your new or renewed subscription for the Journal of Veterinary Physiology and Pharmacology - only $60 this year - to me as soon as possible. Please Note - those members renewing subscriptions will not receive any issues until the subscription fee is received; this is a new policy from the publisher, Blackwell Scientific. So please don't delay, send in your renewal today. So far, 35 people have started or renewed subscriptions.

The finances for AAVPT are stable. The current checking account balance is $8233.71, and this varies as more dues checks are received. The major payments for this year will be to Blackwell for JVPT.

We have received $300 in contributions for the Awards fund. This fund supports the teaching, research, service, and student awards which the AAVPT presents. Please consider adding a contribution for the Awards fund to your dues check.

We have been busy boxing up the Proceedings from previous AAVPT Symposia to send to the 19 people that AAVPT supports for JVPT subscriptions. This has led me to the realization that for most Symposia, we have many, many extra copies. Please contact me if you would like a copy of the Proceedings from a previous Symposium. A nominal $5 charge per Proceedings covers shipping costs. The AAVPT also needs to make a decision about what to do with the many remaining copies. Do people have additional addresses of people who could not otherwise receive them? There really are too many books (hundreds) to continue to store long term.

New AAVPT Members

Calvin C. Walker, DVM, PhD
U.S. Food and Drug Administration
P.O. Box 25087
Denver, CO 80225-0087
303-236-3062
FAX 303-236-3100
craw@ecentral.com

Michael Stegemann, DVM
c/o Bayer Corp. Animal Health
Merriam, KS 66202
913-268-2062
FAX 913-268-2541
MICHAEL.STEGEMAN.B@BAYER.com

Jane G. Owens, DVM, PhD
Pfizer Central Research
Dept. AHSM, Box 820
Groton, CT 06340
860-441-1754
FAX 860-441-0750
Jane_G_Owens@pfizer.groton.com

Joseph J. Bertone, DVM, MS
HFV-114
7500 Standish Place
Rockville, MD 20855
301-594-1692
FAX: same
Jbertone@bangate.fda.gov

Steven Fox, MS, DVM, MBA, PhD
8352 Crystalwood Dr.
Dallas, TX 75249
214-296-7717
FAX 214-296-2877
sfoxk9doc@aol.com

Carolyn R. Kilroy, DVM, PhD
Pfizer
Eastern Point Rd
Groton, CT 06340
860-715-5165
kilroyc@pfizer.com

Marilyn N. Martinez, PhD
7500 Standish Place
Rockville, MD 20855
301-594-1698
FAX 301-594-2298
MMARTIN1@BANGATE.FDA.GOV

Kemmy M. Mizinga, PhD
Physiology & Pharmacology Dept.
School of Veterinary Medicine
Tuskegee University
Tuskegee, AL 36088
334-727-8793
FAX 334-727-8177
mizinga@acd.tusk.edu

Alastair Cribb, DVM, PhD
Atlantic Veterinary College
550 University AVe
Charlottetown, PEI CANADA C1A 4P3
902-566-0661
FAX 902-566-0832
acribb@upei.ca

Eden Bermingham, DVM
101 D Terrace Dr.
Cary, NC 27511
919-467-4860
ecbermin@unity.ncsu.edu

Albert Boeckh, DVM
Clinical Pharmacology Lab
Veterinary Teaching Hospital
Texas A&M University
College Station, TX 77843-4457
409-845-9184

Sarah Anne Louise Jones, DVM
Texas A&M University
Department of Veterinary Physiology and Pharmacology
College Station, TX 77843
409-845-2351

- Ann Jernigan

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AAVPT Program Committee Update

he AAVPT Special Symposium on "The Role of Veterinary Therapeutics in Bacterial Resistance Development: Animal and Public Health Perspectives" was held on 19-21 January 1998 in College Park, Maryland. One-hundred sixty-two registrants and 27 speakers and moderators comprised the meeting attendance, with representation from the United States as well as six foreign countries. Organizations represented included animal producer groups, veterinary practitioner and specialty associations, veterinary pharmacology, veterinary microbiology, public health, congressional committees, and consumer interest groups. United States governmental agencies represented included FDA/CVM, United States Department of Agriculture (USDA), Centers for Disease Control and Prevention (CDC), and General Accounting Office (GAO). The Task Force report is currently in progress is is scheduled to be published in the 15 April issue of the Journal of the American Veterinary Medical Association. This is only the initial step in a campaign to foster prudent use of antimicrobials that the Program Committee will be proposing within the coming weeks. For many reasons, not the least of which being financial, the campaign must be a collective effort from many organizations within veterinary medicine and animal agriculture.

Day-long sessions, cosponsored by the AAVPT and the ACVCP, are now finalized for the 1998 Annual Forum of the American College of Veterianry Internal Medicine (22-25 May in San Diego, with the AAVPT and ACVCP session scheduled for 22 May)) and the Annual Meeting of the American Veterinary Medical Association (25-30 July in Baltimore, with the AAVPT/ACVCP sponsored session scheduled for 26 July). The title of the session at both meetings is "Evaluation of Efficacy of Pharmaceuticals and Nutriceuticals."

Last, but certainly not least, plan on attending the AAVPT Biennial Symposium, 14-18 June, 1998 in Monterey, California. Interest builds as we draw closer to the meeting, and the venue promises to provide an excellent atmosphere for scientific interchange and collegiality. See Dr. Vulliet's update elsewhere in the newsletter.

- Scott Brown

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News From the Pharmaceutical Industry

he Animal Health Institute (AHI) is a trade association that consists primarily of research-based companies involved in the development and manufacture of animal health products (pharmaceuticals, vaccines, and feed additives).

These firms make more than 80% of the animal health products used yearly in the United States. In 1996, these member firms had sales of approximately $3.3 billion, with pharmaceuticals representing $2.3 billion. The growth in the pharmaceutical market was fueled by new products to treat pets, as well as for beef cattle. These companies spent $388 million of R & D, of which, 58% was on pharmaceuticals and 19% on biologicals.

AHI's key goals and objectives are as follows;

1. Increase Product Availability

  • Work with the Center for Veterinary Medicine to implement the Animal Drug Availability Act and Veterinary Feed Directive regulations.
  • Explore the new direct-to-consumer advertising rules for animal drugs.
  • Discourage expansion of government user fees to animal products.
  • Monitor the new export provisions.

2. Coalition Building

  • Develop partnerships with companion animal groups
  • Maintain the Coalition for Animal Health that supported the Animal Drug Availability Act.

3. International Opportunities

  • Complete Veterinary International Cooperation on Harmonization efforts.
  • Advance animal drug food standards (setting of MRL's) before Codex.

4. Maintain an Efficient, Effective Trade Association

  • Increase membership through affiliates
  • Move AHI headquarters from Alexandria VA to Washington DC.

For further information pertaining to AHI activities, please visit their on-line Internet site at: <http://www.ahi.org>.

- David F. Kowalczyk

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Education Committee Activities

Upcoming AAVPT Symposium Workshop

The Education Committee has been asked to prepare a workshop on computers in veterinary education to be held in conjunction with the AAVPT Symposium being coordinated by Dr. Richard Vulliet. The workshop is scheduled for Tuesday, June 16. I would appreciate receiving proposals/offers for participation in this workshop. It would be very helpful if I could have these by Sunday, 15 March, so we can finalize what we are able to do and to determine what resources might be needed. Examples of problem-oriented learning applications (with or without computers) would be very appealing to many. Depending on the response, we may have more than the presentation that I plan to make.

Please include your E-mail address so I can communicate easily with you, and send comments and suggestions at one of the following: E-mail <coppoc@purdue.edu> (preferred mode of communication); FAX (765) 494-0781; or by "snail mail" to Dr. Gordon L. Coppoc, School of Veterinary Medicine, Purdue University, West Lafayette, IN 47907-1246.

Suggestions for Committee Activities

I would appreciate receiving suggestions for projects related to education in the DVM (or related degree) curriculum that can be supported by the AAVPT, as well as the names of persons who might be interested in working on these. I believe that with the dynamic changes in communications that are being enabled by the development of the Internet, we might undertake some very interesting projects. We could even help each other with Web-site development by reviewing sites and making suggestions for improvement. I'll step out on a limb and request feedback on my own site that I use in teaching pharmacology to veterinary and medical students. Please visit my site at the following address: <http://www.vet.purdue.edu/bms/courses/index.htm>, and send your comments and suggestions to me, preferably by E-mail, at <coppoc@purdue.edu>.

AAVPT's Internet Web-Site

An AAVPT Web site has been created, and it is gradually growing. It contains announcements of programs, AAVPT officers, recent AAVPT Newsletters, a statement of principles of the organization, etc. It is not yet beautiful, but is functional. It will soon contain the current edition of the AAVPT Directory. I would like to expand it by adding a list of sites that you view as important to veterinary pharmacology and therapeutics. Please help by sending me lists of sites that you have found useful, as well as your critique of the site. The address for our AAVPT site is: <http://www.vet.purdue.edu/bms/aavpt/index.htm>. Please send suggestions, contributions and comments to me, again preferably by E-mail, at: <coppoc@purdue.edu>.

- Gordon L. Coppoc

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News From Washington

CVM Seeks New Director for Its Office of New Animal Drug Evaluation

VM has announced that Dr. Robert Livingston, who has been Director of the Office of New Animal Drug Evaluation (ONADE), has stepped down from that position. Dr. Livingston's new responsibilities will focus on international drug harmonization issues and particularly on the Codex Alimentarius Commission (Codex) meetings. Codex is an international body that establishes food safety standards under the joint auspices of the United Nations World Health Organization (WHO) and Food and Agriculture Organization ((FAO). (Dr. Livingston chairs the U.S. Delegation to the Codex Committee on Residues of Veterinary Drugs in Foods.)

Dr. Andrew Beaulieu, ONADE Deputy Director for Therapeutic and Production Drug Review and Dr. Margaret Miller, ONADE Deputy Director for Human Food Safety and Consultative Services, will serve consecutive 90-day details as Acting Director, ONADE. CVM has begun a nationwide recruiting effort to fill the position on a permanent basis.

Comments on the Prohibition of Extra-label Use of Fluoroquinolone and Glycopeptide Antibiotics in Food-Producing Animals Available

Analysis of the comments on its prohibition of the extra-label use of fluoroquinolone and glycopeptide antibiotics in food animals is being made available by CVM from CVM's Internet Home Page (http://www.cvm.fda.gov) or by calling or writing CVM's Communications Staff at FDA/CVM, HFV-12, 7500 Standish Place, Rockville, MD 20855; telephone 301/594-1755.

Although under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), licensed veterinarians are allowed to prescribe extra-label uses of approved animal and human drugs in animals, AMDUCA provides authority for FDA to prohibit such uses when it deems such use may result in a risk to public health. When such an order of prohibition is issued, AMDUCA regulations require an opportunity for public comment on the order. However, such an order of prohibition automatically becomes effective 90 days after publication unless FDA revokes or modifies the order. In this case, FDA did not revoke or modify the order and it became effective on August 20, 1997.

FDA Requests Comments on Draft Guidance Document for Professional Flexible Labeling

FDA has announced the availability for comment of draft guidance on "Professional Flexible Labeling of Antimicrobial Drugs." The document is intended to provide specific guidance on the development of professional flexible labeling (PFL) for therapeutic veterinary prescription and veterinary feed directive (VFD) antimicrobial drugs. The draft guidance document is being made available for comment only. Such guidance will not become effective until comments have been received and analyzed and the guidance amended as appropriate. Copies of the document can be obtained from CVM's Internet Home Page or by contacting CVM at the address or phone number listed above. Members of the AAVPT are encouraged to obtain a copy of and comment on this very important guidance document.

Drug Approvals for 1997

CVM announced 102 new animal drug related approvals for Fiscal Year 1997 (FY `97), up from 80 for FY `96. Six of the approvals were for drugs not previously approved for use in animals (new chemical entities): Carprofen (Pfizer, Propofol (Mallinckrodt), Fomepizole (Orphan Medical), Selegiline HCl (Deprenyl Animal Health), and Orbifloxacin (Schering Plough), all for use in dogs, and Eprinomectin (Merck) for use in cattle. Thirty-seven of the approvals were for generic animal drugs. Other approvals were for use in new species, new production classes, new formulations, new indications, etc.

- Richard Teske

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Academic Position Available


Assistant/Associate Professor of Pharmacology

he Department of Physiology and Pharmacology, College of VeterinaryMedicine, Auburn University, is seeking applicants for a full-time, tenure-track position. The successful candidate will share responsibility for pharmacology instruction to veterinary and graduate students. The candidate will be expected to develop an independent research program. Applicants must have the Ph.D., postdoctoral experience is desirable, and a Doctor of Veterinary Medicine (or equivalent) is preferred. Applicants are invited to submit a letter of application, curriculum vitae, statement of research goals, and names of at least three references. Applications will be reviewed beginning January 16, 1998 and will be accepted until a candidateis selected. Applications should be sent to: Dr. Robert J. Kemppainen,Chair, Pharmacology Search Committee, 212 Greene Hall, Department of Physiology and Pharmacology, College of Veterinary Medicine, Auburn University, Auburn, AL 36849 (Telephone: 334-844-4425, FAX: 334-844-5388, Email: kempprj@vetmed.auburn.edu).

Auburn University is an affirmative action and an equal opportunity employer. Women and minorities are encouraged to apply.

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Eleventh Biennial Symposium

he Eleventh Biennial Symposium of the AAVPT will be held at the Asilomar Conference Center on the Monterey Peninsula in California from June 14-18, 1998. Entitled "Quantitative Approaches to Veterinary Therapeutics," the symposium will combine recent advances in pharmacokinetics and pharmacodynamics with newer approaches to veterinary therapeutics. The meeting will feature morning and evening sessions, with afternoons free to explore surrounding areas. Poster presentations are encouraged from everyone attending, and these sessions will be held from 4:00 p.m. to 6:00 p.m., with complimentary wine and cheese being served. .

The Asilomar Conference Center, located on the beach at the north entrance of California's famous "17-mile drive," is part of the California State Park System, and it features rustic lodges, nature walks, etc. This will be an excellent meeting for your family to accompany you, since there are so many interesting things to see and do in this beautiful area. When making your travel plans, be certain also to include a visit to San Francisco, and to tour the Bay area's "Wine Country."

The advance-registration fee is $175, whereas registration at the door will cost $225. Please register early, and let us know what else we can do to encourage your attendance. If you have not already done so, please circle June 14-18 on your calendar today.

- Rick Vulliet

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AAVPT to be represented at the U.S. Pharmacopeial Convention

n January 27, 1998, the Officers and Trustees of the U.S. Pharmacopeia (USP) voted unanimously to invite the AAVPT to appoint a member to the U.S. Pharmacopeial Convention (USPC). The AAVPT would be one of the Conventions' member organizations representing national and state professional and scientific ortanizations.

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A.A.V.P.T. Newsletter Staff

Editor: Carl E. Aronson

Correspondents
Industry:
David F. Kowalczyk
Washington: Richard H. Teske
J.V.P.T.: Arthur L. Aronson
Education: Gordon L. Coppoc

The Newsletter is published three times a year by the American Academy of Veterinary Pharmacology and Therapeutics, at the University of Pennsylvania School of Veterinary Medicine. Please address all correspondence to: Dr. Carl E. Aronson, Department of Chemistry, 215 Stokes Hall, Haverford College, 370 Lancaster Avenue, Haverford, PA 19041-1392 [Telephone: (610) 896-1357; FAX: (610) 896-4904; E-Mail: <aronsonc@vet.upenn.edu>].

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NOTE: pagination and some formatting of the "HTML" version is not the same as for the printed version distributed because of differences in versions of Corel Word Perfect used to create the Newsletter. Content of the two versions is the same other than this footnote. glc 3/22/98