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U.S. Department of Health and Human Services

Animal & Veterinary

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SWINE MYCOPLASMAL WORKSHOP HELD

by LCDR Princess R. Campbell, DVM
FDA Veterinarian Newsletter 2002 Volume XVI, No III

The Division of Therapeutic Drugs for Food Animals, in the Office of New Animal Drug Evaluation, Center for Veterinary Medicine (CVM) held a Swine Mycoplasmal Workshop following the annual conference of the American Association for Swine Veterinarians (AASV), on March 6 and 7, 2002. The workshop was an information gathering forum with attendees from academia, the pharmaceutical industry, and veterinarians, and producers involved in swine production. Dr. Naba Das representing CVM presented the opening remarks followed by the President of the AASV, Dr. Lisa Tokach, who welcomed the FDA's efforts to involve outside experts in this collaborative effort. The two-day event featured speakers representing the top experts in the field. The speakers included Drs. Brad Thacker (Associate Professor in the Department of Veterinary Diagnostic & Production Animal Medicine, Iowa State University), Monte McCaw (Associate Professor of Swine Medicine, North Carolina State University, College of Veterinary Medicine), Eric Bush (epidemiologist, USDA Centers for Epidemiology and Animal Health), Kent Schwartz (Adjunct Assistant Professor of Department of Veterinary Diagnostic & Production Animal Medicine, Iowa State University), Chris Minion (Associate Professor in the Department of Veterinary Microbiology and Preventive Medicine, Iowa State University), Eileen Thacker (Assistant Professor in the Department of Veterinary Microbiology and Preventive Medicine, Iowa State University), Carlos Pijoan (Professor in the Department of Clinical & Population Sciences, University of Minnesota College of Veterinary Medicine), John Kolb (Boehringer Ingelheim Vetmedica, Inc.), John Korslund (hog producer and veterinarian, Indiana), Bill Hollis (swine practitioner, Illinois), and James Bradford (Pharmacia Animal Health).

The discussion was confined to the effects of Mycoplasma hyopneumoniae in swine respiratory disease. The presentations reflected each speaker's area of expertise and views on this topic. Both Drs. Brad Thacker and Monte McCaw spoke on disease presentation on the farm, while Dr. Eric Bush spoke on the epidemiology of the disease from the NAHMS perspective. Dr. Eileen Thacker addressed the effect the organism had on the immune system and discussed a research induced infection model being developed at Iowa State University. Dr. John Kolb presented immunological considerations, Dr. Kent Schwartz addressed diagnosis from pathological signs, and Dr. Carlos Pijoan presented some new diagnostic tools for the disease. Dr. Chris Minion gave a very interesting talk on the genome sequencing for M. hyopneumoniae. Dr. John Korslund expounded on the economic effect of the disease. Dr. Bill Hollis gave a practitioner's perspective and Dr. James Bradford discussed the only drug approved for reduction in the severity of M. hyopneumoniae in the United States. He discussed all the data his company generated for substantial evidence of effectiveness for the approval.

Dr. Gillian Comyn was CVM's chairperson for the committee that produced the workshop. Dr. Janice Derr and Dr. Cindy Burnsteel of CVM gave presentations on Statistical Considerations and Substantial Evidence of Drug Effectiveness, respectively. Other committee members from CVM not previously mentioned that assisted in the preparation and actual presentation of the workshop are Dr. Nabil Anis, Dr. Princess Campbell, Ms. Irma Carpenter, Dr. Janis Messenheimer, Dr. Julia Punderson, Dr. Susan Storey, and Dr. Michelle Stull. The task remains for the Division of Therapeutic Drugs for Food Animals along with the Biometrics Team to assimilate the information and knowledge gained at this beneficial workshop with the goal of determining the information needed to support substantial evidence of effectiveness for a drug against M. hyopneumoniae.

Dr. Campbell is a veterinary medical officer in CVM's Division of Therapeutic Drugs for Food Animals.