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Volume 20, Number 3 |
November 2001 |
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From the President
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AAVPT Newsletter |
Scott Brown |
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Comptroller |
Dan Gingerich |
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Drug Availability and Food Safety Committee |
Arthur Craigmill |
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Education Committee |
Mark Papich |
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Journal of Veterinary Pharmacology & Therapeutics Editorial Board |
Jim Riviere |
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Membership and Bylaws: Bylaws Sub-Committee |
Scott Brown |
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Membership and Bylaws: Membership Sub-Committee |
Marilyn Martinez |
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Program Committee |
Ted Whittem |
As I mentioned in the previous newsletter, I am particularly excited about the potential of AAVPT, through our Education Committee, to provide a variety of tools for our membership to aid in the training of veterinary students, graduate students, clinical pharmacology residents, and perhaps their own CE. Mark Papich is preparing a survey to determine the needs of our members in this area, so please let him know if you would like to serve on the Education Committee or if you have specific ideas you would like to see pursued.
The need to increase our membership by providing services not available elsewhere was a key topic of discussion during an Executive Council (EC) conference call last month. In addition to enhancing education tools, suggestions included such things as providing free JVPT subscriptions to graduate students, an uploadable literature database of all JVPT tables of content including abstracts, and establishing a veterinary pharmacology listserve. One particular suggestion that is being considered by the EC is to propose a change in the constitution to establish a new nonvoting membership category for individuals who are interested in the discipline but may not have the credentials or experience to qualify for associate fellow status. Ways to streamline the membership application process are also being considered.
I encourage you to become involved in any of the committees listed above. I particularly need volunteers for three positions for which I have not yet found replacements for chairs that have stepped down after many years of service. These are the Awards Committee, formerly chaired by Gary Koritz, the Budget and Finance Committee, formerly chaired by Gene White, and the Archivist and Historian, for which Carl Aronson was a keystone for many years. Relative to this latter position, Carl tells me that the National Library of Medicine (NLM) physically stores the material. The archivist serves primarily as the liaison to transfer our materials to the NLM. If you are interested in any of these positions please contact me.
The EC is also considering creating a position paper on the proper management of anthrax exposure in pets. More specifically, several members have expressed concern about the widespread use in humans of ciprofloxacin to treat an organism known to be susceptible to other antibiotics. The position paper would offer guidance as to the need for prophylactic antibiotic treatment in pets and, if used, what constitutes a rational selection.
I wish you and yours the best for the upcoming holiday season and a happy new year!
Best wishes,
Cory Langston
President, AAVPT
Secretary-Treasurer
ReportGreetings from Illinois. I hope everyone had a great summer. The weather here has been magnificent, making it very difficult to get into a holiday mood. But, we take one day at a time around here. I am fully prepared to wake up tomorrow and see either thick ice or several inches of snow on the ground. The transition of funds and records has been completed and a new account has been opened here in Illinois. The treasury shows a balance of $14,689.62 as of November 11, 2001. To date we have 49 paid subscriptions with 12 AAVPT members receiving complimentary subscriptions for editorial board service. We currently have 214 members (139 Fellows, 3 Distinguished Fellows, 32 Emeritus Fellows, 31 Associate Fellows, and 9 student members). We have consolidated all our symposia proceedings and are maintaining four original copies of each symposium in our archives. Unfortunately, we do not have any copies of the first two symposia - the one held at LSU (1978) and the one at Philadelphia (1980). If any of you have a copy of either of these proceedings and would be willing to donate them to our archive, please give me a call (217-359-0661). I would really like to get at least one copy for our archives. Debbie Kochevar continues as our website liaison and will work with our new webmaster (Brett Rose) at Texas A&M. The website is a work-in-progress. There are several ideas being considered as to what features we might like to add to the site. We encourage you to send us your suggestions. There is a place on the website for your comments and we encourage you to send us suggestions, comments or corrections. I am currently working on the dues announcement for 2002 and will mail them out before the end of the year. As reported at the meeting, there are several members with dues outstanding for 2001. Notification of unpaid balance were not mailed out this summer so I am planning on including a reminder to those who, according to our records, have not paid their 2001 dues. I would ask members who have an outstanding balance to include their 2001 dues along with their 2002 dues. When you receive your announcement, please look it over carefully and if there is any question about your dues status, contact me immediately so we can clear things up. In addition to your dues, I would ask you to include any changes you would like to make to your directory listing on the dues form. Remember to let us know if you have any change in your mailing, phone, fax or email information. Please check the website to verify your current information. If there are any errors, please let me know. I look forward to serving as your Secretary-Treasurer and I encourage you to contact me concerning any questions or any AAVPT business. I want to extend my best wishes to everyone for a happy and joyous holiday season and hope everyone has a Happy New Year.
-Carol Davis (cdavis@shout.net).
Planning for the 2003 biennial Forum is just starting. It is proposed to hold the Symposium on 3rd and 4th June 2003, immediately preceding the ACVIM Forum which itself is to be held in Charlotte, NC, June 4 - 7, 2003. Council is currently seeking AAVPT members who wish to join the Programs Committee. A theme has been proposed for the Symposium; "The Cutting Edge".
People who wish to nominate for the Program Committee or who wish to recommend speakers and speaker topics, should contact Ted Whittem. mailto:tedw@jurox.com.au.
The AAVPT/ACVCP Annual Scientific Symposium and Annual Meeting will be once again held in conjunction with the ACVIM Annual Forum, this year to be held in Dallas May 29-June 1. The AAVPT/ACVCP morning session this year will focus on clinical trial design, regulation, implementation, and evaluation. The afternoon session will include therapeutic discussions about parvovirus, parasitology, oncology, and pain and inflammation. We will be welcoming Drs. Smothers, Oeller, Heit, Wang, Otto, Blagburn, Vail, and Martinez to the podium for their insights in these areas. Please plan on attending not only the AAVPT/ACVCP sessions, but other parts of the ACVIM Forum as well.
The College is pleased to announce that the following colleagues successfully completed ACVCP credentialing and examination requirements and have been certified as Diplomates.:
Dr. Albert Boeckh
Dr. Kurt Grimm
Dr. Gina Michels
The addition of these Diplomates brings the total membership of the ACVCP to 36.
A scientific program, co-sponsored by the ACVCP and AAVPT, was presented in conjunction with the ACVIM Forum and AAVPT Biennial Symposium in May of this year. Topics focused on antimicrobial therapy and therapy of special patient groups. Sessions were very interesting and well attended. The Scientific Program Committees of the ACVCP and AAVPT, chaired by Drs. Terry Clark and Ted Whittem, respectively, are in the process of developing the 2002 program, which will focus on clinical trail design and new therapeutic strategies resulting from well-controlled clinical trials.
-Cyril Clarke
Clarke@okstate.edu
News
From the Pharmaceutical IndustryThe Animal Health Institute (trade association of animal pharmaceutical companies) reported that animal health product sales in the US for 2000 totaled $4.21 billion dollars which was down slightly from the previous year. Among AHI member companies, sales for products used in livestock and poultry totaled $1.8 billion while sales for companion animal health products totaled $1.5 billion. AHI companies spent $418 million, or 12 percent of total sales, on research and development which was up from $409 million in 1999. Of the $418 million R/D expenditures, 87 percent went toward innovative research and the rest went toward defensive research.
At a recent meeting Dr. Sundlof of the Center for Veterinary Medicine addressed the issue of drug review delays that have been occurring over the last few years. He stressed a "back-to-basics" approach as a key strategy to reinvigorate the agency's drug approval process. In order to do so, CVM will cut back on staff development, quality assurance, development of guidance documents and SOPs.
- Dave Kowalczyk
The
Washington SceneFINAL GUIDANCE AVAILABLE ON FUMONISIN LEVELS IN HUMAN FOOD AND
ANIMAL FEEDS
FDA announced the availability of a final guidance document entitled
"Guidance for Industry: Fumonisin Levels in Human Foods and Animal
Feeds" in the November 9, 2001, Federal Register. The purpose of the
guidance is to identify for the industry fumonisin levels that FDA
considers adequate to protect human and animal health and that are
achievable in human foods and animal feeds with the use of good
agricultural and good manufacturing practices.
FDA considers this guidance to be a prudent public health measure during the development of a long-term risk management policy and program by the agency for the control of fumonisins in human foods and animal feeds. The Agency is also announcing the availability of the final supporting documents entitled "Background Paper in Support of Fumonisin Levels in Corn and Corn Products Intended for Human Consumption," and "Background Paper in Support of Fumonisin Levels in Animal Feed."
FDA SEEKING COMMENTS ON IMPORT TOLERANCES
The Food and Drug Administration (FDA) is soliciting comments on
issues related to the implementation of the import tolerances provision of
the Animal Drug Availability Act of 1996 (ADAA).
The ADAA authorizes FDA to establish drug residue tolerances (import tolerances) for imported food products of animal origin for drugs that are used in other countries, but that are unapproved new animal drugs in the U.S.
Food products of animal origin that are in compliance with the import tolerances will not be considered adulterated under the Federal Food, Drug, and Cosmetic Act (FFDCA) and may be imported into the U.S.
In the August 10, 2001, Federal Register FDA published an advance notice of proposed rulemaking (ANPRM) on the import tolerance issue. FDA's Center for Veterinary Medicine (CVM) plans to hold a public advisory committee meeting on import tolerances. The meeting, which was originally scheduled for September, has been rescheduled to January 22-24, 2002. CVM intends to consider the comments made at the meeting and in response to this ANPRM in writing the proposed regulation. Written or electronic comments on the ANPRM should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The deadline for comments is expected to be in February. Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments. Comments should reference Docket No. 01N-0284.
UPDATE ON LIVESTOCK CLONING
FDA's Center for Veterinary Medicine (CVM) has received numerous
inquiries about livestock cloning, and in July it issued a general
statement to address those questions.
CVM is reviewing the type of cloning process known as somatic cell nuclear transfer (also known as somatic cell clones or NT clones). "Dolly the Sheep" is the most famous animal produced in this manner. But the technology also has been applied to rodents, cattle, swine, and other species. It involves removing the nucleus of a cell from an adult animal that will be copied and inserting it into an animal egg whose nucleus has been removed. The resulting embryo is implanted into a surrogate mother that carries the fetus to term. In evaluating animal cloning, CVM's first priority is to examine the safety of food products (e.g., meat, milk, eggs) from animals developed through somatic cell cloning but are otherwise unmodified. CVM is also considering the safety of animals and their progeny.
Last fall, CVM contracted with the National Academy of Sciences (NAS) to conduct an independent, scientific peer review of available safety data on cloned animals and the food derived from them. This review, including the safety of cloning to the animals and environment as well as any food derived from the animals, will help CVM decide how these animals should be regulated, including whether there may be circumstances in which CVM ordinarily would not need to exert its authority.
CVM has contacted companies known to be developing cloned animals to inform them that the Center is considering this issue, and to encourage their contributions to the NAS review. Until it has scientific information on safety, the Center has been asking the companies not to introduce these cloned animals, their progeny, or their food products (such as milk or eggs) into the human or animal food supply. CVM has asked the companies to participate in the NAS public meeting, and to be prepared to supply scientific information they have collected on the safety of cloned animals.
DR. TOLLEFSON PROMOTED TO REAR ADMIRAL
Dr. Linda Tollefson, FDA/Center for Veterinary Medicine (CVM) Deputy
Director, was promoted to Assistant Surgeon General (Rear Admiral) on
August 1, 2001. Dr. Tollefson is the first female veterinarian in the U.S.
Public Health Service Commissioned Corps to reach the O-7 (Rear Admiral)
rank.
As the CVM Deputy Director, Rear Admiral (RADM) Tollefson is responsible for all public health programs and international activities. A primary focus of the Center's mission is human food safety, through assessing the safety and effectiveness of drugs used in animals intended for human consumption. RADM Tollefson is also responsible for the management and coordination of all Center projects under the National Food Safety Initiative. The Food Safety Initiative is designed to reduce the incidence of foodborne disease through extensive collaboration among the U.S. Federal food safety agencies, State governments and private organizations.
RADM Tollefson is one of the founders of the National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS). NARMS monitors development of resistance in zoonotic enteric pathogens isolated from human and animal clinical specimens, from carcasses of food-producing animals at slaughter, and from retail food. NARMS was established in 1996 as a collaboration among several Federal agencies in response to concerns associated with the approval of antibiotics for use in food animals that are important for human medical therapy. The data generated from NARMS and follow-up outbreak investigations are used by several Departments and multiple agencies and are vital to the mission of the Public Health Service and to the health of the entire population.
RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES
FDA's Center for Veterinary Medicine (CVM) has assembled data from the
inspections that have been conducted AND whose final inspection report has
been submitted to CVM (i.e., "inspected/reported") as of October
26, 2001.
As of October 26, 2001, CVM had received inspection reports covering inspections (both initial inspections and re-inspections) of 10,018 different firms. The majority of these inspections (around 80%) were conducted by State officials under contract to FDA and the remainder by FDA officials.
Totals (as of October 26, 2001): ?Number of firms whose initial inspection has been reported to CVM -- 10,018 ?Number of firms handling materials prohibited for use in ruminant feed -- 2,501 (25% of those firms inspected/reported) ?Of the 2,501 firms handling prohibited materials, at their most recent inspection (could have been an initial or a follow-up inspection): ?204 (8%) had products that were not labeled as required ?116 (5%) did not have adequate systems to prevent co-mingling ?106 (4%) did not adequately follow record keeping regulations ?333 (13%) firms were found to be out of compliance (some firms were out of compliance with more than one aspect of the rule. These 333 firms will be re-inspected in the near future.)
Re-inspections: When firms are found to be out of compliance with the feed ban rule, FDA lists them for a re-inspection. As of October 26, 2001, reports of 1,719 re-inspections have been submitted to CVM. On re-inspection of these 1,719 firms, 108 (6%) were found still to be out of compliance with this rule. Firms previously found to be not in compliance have corrected problems through a variety of ways, including further training of employees about the rule, developing systems to prevent co-mingling, re-labeling their products properly, and adhering to record keeping regulations. Other firms have achieved compliance by eliminating prohibited materials from their operations.
- Jon Scheid, FDA-CVM
2002 Joint AAPS, AAVPT, CRS Workshop
Collaboration in the Research and Development of Veterinary
Pharmaceuticals, The American Association of Pharmaceutical Scientists,
the American Academy of Veterinary Pharmacology and Therapeutics, and the
Controlled Release Society will present a joint workshop in May, 2002. The
program was proved by AAPS and supports the programming efforts of the
AAPS Animal Health Focus Group. Goals of the workshop are:
The meeting will be a 2.5 day meeting in the Chicago area and will bring together speakers from both the pharmaceutical sciences and veterinary pharmacology disciplines. Pharmaceutical scientists will discuss basic formulations, pharmaceutical technology and principles of controlled release technologies used to develop drug delivery systems used in animals. Veterinary pharmacologies will discuss various aspects of comparative pharmacology relating to drug disposition in animals. Printed announcements of the meeting (location, time and speakers) are presently being prepared and will be sent to AAVPT members and other organizations in early January 2002. The meeting is scheduled for early May, 2002. Mark your calendars. We hope many of you will attend. If you have any questions you can call Carol Davis, 217-359-0661 or by e-mail at cdavis@shout.net.
The 2002 FDA Science Forum will be held 20-21 February 2002
at the Washington Convention Center in Washington, DC. The Forum,
entitled "FDA: Building a Multidisciplinary Foundation", will
include such topics as bioengineered foods, botanicals, bioterrorism,
antibiotic resistance, children's health issues, tissue engineering,
genomics, and bovine spongiform encephalopathy. The first day will focus
on the role of research and review in the formulation of the FDA's public
health policies. The second day will include principles of public health
surveillance and how surveillance relates to current scientific issues,
both domestically and globally. For more information, please visit FDA's
webpage (www.fda.gov) or
by contacting Dr. Suzanne Fitzpatrick at sfitzpat@oc.fda.gov,
or at 301/827-4591. Online registration is available at www.aoac.org.
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.
Your Journal of Veterinary Pharmacology and Therapeutics is receiving and publishing manuscripts at about the same rate as last year. We continue to look for review articles to bolster our readership. I am happy to report that the journal will now be cosponsored by Chapter of Veterinary Pharmacology of the Australian College of Veterinary Sciences in addition to AAVPT, ACVCP, EAVPT and the ACVPT. In the long run, this action will increase the impact of our journal. In a similar vein our publisher, Blackwell Publishing, is working closely with the International Network for the Availability of Scientific publications (INASP), to provide reduced rate online access to 600 leading peer-reviewed journals including JVPT, initially, to six countries in sub-Saharan Africa. The funding is provided by partnerships between INASP, development programs such as ENRECA (Danida) and Sida:SAREC and the universities, so that access to the journal content is free for the participating libraries and researchers. The business of journal publishing continues to evolve in this world of e-media, and Blackwell is actively involved in assuring that their journals are represented. As far as the old print standby, look for a new look next year as the publisher changes cover design.
Editor: Scott Anthony Brown Correspondents:
Industry: David F. Kowalczyk
Washington: Jon Scheid
J.V.P.T.: Jim Riviere
Program: Ted Whittem

The Newsletter is published three times a year by the American Academy of Veterinary Pharmacology and Therapeutics, at Pharmacia Animal Health. Please kindly address all correspondence to:
Scott Anthony Brown, DVM, PhD
7926-190-045, Pharmacia Animal Health
7000 Portage Road
Kalamazoo, MI 49001
USA
Phone: 616.833.2412
FAX 616.833.3295
e-mail scott.a.brown@pharmacia.com.
Copyright, 2001, AAVPT