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MRLS ELISA Testing -- A Regulatory Revolution World Racing Rules on Equine Medications

Thomas Tobin
Biographical Sketch 

Thomas Tobin (TT), Veterinarian, Dublin, 1964, Pharmacologist, MSc, Guelph,1966, PhD Medical Center,  University of Toronto, 1970, Instructor>Associate Professor, Michigan State University, 1970-1974.  From 1975- date, Equine Pharmacology, Therapeutics and Toxicology (EPTT) program at the University of Kentucky.  In 1979 organized the Third Int. Symp. on Equine Medication Control, in 1980 became a Diplomate of the America Board of Toxicology, DABT. http://www.ca.uky.edu/gluck/index.htm.  In 1981 authored/published Drugs and the Performance Horse, a 450 page text.  In 1983 testified before Congress on the “Corrupt Horse Racing Practices Act”; activity on this bill thereafter ceased. 

In 1985 TT began the research that introduced ELISA testing to horse racing. Commercialization of this technology led to the creation of the first UK spin-off company, WTT  ELISA TESTS, later sold to Neogen Corp (www.neogen.com).  Neogen Lexington now employs 150 plus, brings in $80M plus/year to Lexington and the ELISA IP yields a significant UK royalty, www.EconDev.uky.edu. A number of these ELISA tests have now been adapted for human hair testing, www.omegalabs.net/.   

In 1988 TT became Director of the UK Graduate Center for Toxicology, brought in an $800K NIEHS Training Grant and developed minority programs.  By 1993 core faculty and student admissions were up three-fold, extramural funding had increased from 0 to $800K per year and new courses on “Ethics in scientific research” and “Risk assessment” had been developed.  When the National Research Council reviewed Kentucky doctoral programs in 1993, only the Graduate Center for Toxicology was rated “extremely effective”.

            In 1994, TT organized and published an international workshop, “Testing for Therapeutic Medications, Environmental and Dietary Substances in Racing Horses,” that brought 70 international industry leaders to Lexington.  In 1995, TT and colleagues organized “The Commission Veterinarian/Equine Medical Director:  A Short Course”.  In 1995, TT and colleagues founded the Testing Integrity Program (TIP), a national drug testing Quality Assurance Program (www.testingintegrityprogram.org/).  In 1995 TT was named “Man of the Year” by the National Horsemen's Benevolent and Protective Association. 

            In 1996, TT and David Granstrom investigated new therapeutic approaches to Equine Protozoal Myelitis (EPM), rapidly establishing the therapeutic efficacy of Diclazuril and Toltrazuril.  A patent in this area was granted (US patent #5,883,095, 1999) and licensed to Bayer Animal Health; in July 2001, Bayer Marquis® (Bayer DVM.com – Marquis® ) became the first FDA-approved treatment for EPM. More recently, diclazuril as Protazil® has been brought to market under this same patent by Merck Animal Health.

            In 1998 the industry focused on Clenbuterol.  A series of LC-MS-MS based studies led to the publication of a highly sensitive serum test for Clenbuterol, allowing much more sensitive and reliable regulatory control of therapeutic medications than previously. In 1998 TT also organized and published a Testing Integrity Program [TIP] seminar on furosemide. 

            In 2000, at the direction of the Kentucky Racing Commission (KRC), TT developed a series of nationally accredited continuing education short courses for practitioners and regulatory veterinarians in Kentucky and surrounding states.  Six such short courses were offered. 

      In May  2001, TT chaired the Toxicology Working Group investigating the 2001 Mare Reproductive Loss Syndrome (MRLS) and his group temporarily redirected to work on MRLS.  Within three weeks the Eastern Tent Caterpillar was identified as a/the central factor in MRLS.  Work in 2002 clearly linked MRLS to the Eastern Tent Caterpillar;  in July 2002 TT proposed that the pathogenesis of MRLS followed a biologically unique probabilistic septic penetrating setal emboli model.  In August 2002, TT and David Powell organized the first workshop on the Mare Reproductive Loss Syndrome, published in May 2003. In 2003, MRLS was shown to follow a unique probabilistic mathematical model, Accelerated Failure Time Analysis, and the biologically unique pathogenesis for MRLS based on septic penetrating and embolic setal fragments  (www.jarvm.com/articles/ Vol2Iss2/ TOBINJARVMVol2No2.pdf) was formally communicated and the copyright registered (US Copyright# TXU1111484). 

      In 2003 the program contributed to the writing of the first National HBPA Proposed Policy on Drug Testing and Therapeutic Medication (http://hbpa.org/resources/MedicationPolicy.pdf) and focused on developing fully validated quantitative analytical methods for agents abused in racing horses.  In 2003 it was decided that it would be in the best interests of the racing industry in Kentucky for the program to accredit, and the process of becoming A2LA accredited was initiated.  In 2004, following election of a Republican governor, the program redirected to address therapeutics and toxicology, with an emphasis on diagnostics, prophylaxis and therapeutics for equines.

 In 2005 the program began synthesizing a series of certified reference standards and stable isotope internal standards for therapeutic medications, based on earlier thresholds research pioneered by the program, and currently in the process of being licensed.  In July 2006 US Patent # 7,074,843 for a novel veterinary sedative and tranquilizer was awarded and a unique pathogenesis for oligofructan associated equine laminitis was proposed. 

More recently work on certified reference standards and stable isotope internal standards for use in quantitative forensic work in equine medication control continues.  The program has generated research support from the Kentucky Science and Engineering Foundation [KSEF] the Racing Medication and Testing Consortium [RMTC] and National and local Horsemen’s Benevolent and Protective Association organizations [HBPAs] the Kentucky Equine Drug Research Council and other equine groups in support of the creation and commercial availability of appropriate reference standards for use in racing chemistry.  The research/intellectual property goal is to create and provide certified reference standards and stable isotope internal standards for the 50 or so therapeutic medications used in horses in training, and whose use is regulated by quantitative forensic chemistry.  This work is being carried out in association with Frontier BioPharm Inc. of Richmond Kentucky [www.FrontierBiopharm.com] and the Lexington division of Neogen Corporation Inc. [www.neogen.com].

Medications for which certified reference standards and stable isotope, usually deuterated, internal standards have been developed and are have been or are being brought to market include phenylbutazone, flunixin, ketoprofen, methocarbamol, guafenesin, clenbuterol, procaine and furosemide.  Additionally, a number of certified reference standards for drug metabolite fragments/regulatory analytes include unlabeled and deuterated 3-hydroxylidocaine, 3-hydroxymepivacaine, hydroxyethyl promazine sulfoxide, carboxyDetomidine and Hydroxydetomidine, with approximately 5 corticosteroid therapeutic medications scheduled for stable isotope reference standard development.   

In 2008 the third edition of the National Horsemen's Benevolent and Protective Association Policy on Drug Testing and Therapeutic Medication Regulation was assembled by the program in cooperation with Mr. Kent Stirling, Chairman of the National HBPA Medication Committee and Executive Director of the Florida Horsemen's Benevolent and Protective Association.   In 2009 Mr. Kent Stirling and TT were jointly awarded the 2008 National Horsemen's Benevolent and Protective Association Industry Service Award. In  March 2011 the first of a sequence of  metabolites/regulatory analytes/deuterated standards certified reference standards were  licensed to Frontier BioPharm. In February 2012 the fourth edition of the HBPA medication book,  now entitled “World Rules for Equine Drug Testing and Therapeutic Medication Regulation” was published and the first certified reference standard for myo-Inositol TrisPyroPhosphate [ITPP] was released through the Frontier Biopharm LLC licensing agreement. 

In 2012 a University of Kentucky Intellectual Property involving novel therapeutic approaches to parasitic disease was licensed for patenting and commercialization to VC Equine Research, Inc. A provisional patent was filed by VC Equine. In 2104 the utility patent made possible by this Intellectual Property disclosure was filed on August 4th, 2014: US Utility Patent E-filing, Filing, Oz, H and Tobin T “Novel Compositions & Methods for Preventing & Treating Apicomplexan Related Disease” utility patent application E-filed August 4th, 2014, EFS ID: 19771622, Application Number: 14451337 International Application Number: n/a Confirmation Number: 496.