Update on Update on Medication IssuesMedication Issues

Dan FickDan Fick

Racing Medication & Testing Racing Medication & Testing ConsortiumConsortium

Mission of RMTCMission of RMTC

Formed in 2002 as a 501 (c) (3) Formed in 2002 as a 501 (c) (3) charitable organizationcharitable organization

To develop, promote and help coordinate, To develop, promote and help coordinate, at the national level, policies, research at the national level, policies, research and educational programs that seek to:and educational programs that seek to:

– ensure ensure fairness and integrityfairness and integrity of racing of racing– ensure the ensure the health and safetyhealth and safety of of

racehorses and participants racehorses and participants – protect the protect the interestsinterests of the racing of the racing

publicpublic

Participation Organizations Participation Organizations on the Board of Directorson the Board of Directors

AAEPAAEP AQHAAQHA Arabian Jockey ClubArabian Jockey Club Breeders’ CupBreeders’ Cup California TB TrainersCalifornia TB Trainers Churchill Downs Churchill Downs Del Mar Del Mar Hambletonian SocietyHambletonian Society Harness Tracks of Harness Tracks of

America     America     Jockeys’ GuildJockeys’ Guild KeenelandKeeneland Kentucky TB Kentucky TB

AssociationAssociation Magna EntertainmentMagna Entertainment

National HBPA National HBPA National National

SteeplechaseSteeplechase NTRANTRA NYRANYRA Oak TreeOak Tree RCIRCI THATHA The Jockey ClubThe Jockey Club TOBATOBA TB Owners of TB Owners of

CaliforniaCalifornia TRATRA TRPBTRPB USTAUSTA

TopicsTopics

PenaltiesPenalties LasixLasix NSAIDNSAID Anabolic SteroidsAnabolic Steroids CorticosteroidsCorticosteroids International HarmonizationInternational Harmonization Drug Testing InitiativeDrug Testing Initiative SecuritySecurity

Penalties and the Penalties and the Model RulesModel RulesOld Version:Old Version:

– Penalties were based on RCI Class of the Penalties were based on RCI Class of the drug.drug.

– Classification based on pharmacology of Classification based on pharmacology of drug. drug.

– Penalties had large ranges for number of Penalties had large ranges for number of suspension days and amount of fines.suspension days and amount of fines.

– No guidance on how treat multiple No guidance on how treat multiple violations and extenuating circumstances, violations and extenuating circumstances, either mitigating or aggravating.either mitigating or aggravating.

Penalties and the Penalties and the Model RulesModel RulesReasons for change:Reasons for change:

– Consideration should be whether the Consideration should be whether the drug is appropriate to see in a racehorse drug is appropriate to see in a racehorse on race day.on race day.

– Penalties should increase with intent, Penalties should increase with intent, severity and repeat violations.severity and repeat violations.

– Other licensees should participate in the Other licensees should participate in the penalty phase especially repeat violators.penalty phase especially repeat violators.

– We need to define possible mitigating We need to define possible mitigating and aggravating circumstances.and aggravating circumstances.

Extenuating Extenuating CircumstancesCircumstances Past record of trainer, veterinarian Past record of trainer, veterinarian

and owner in drug cases.and owner in drug cases. Potential of drug(s) to influence a Potential of drug(s) to influence a

horse’s racing performance.horse’s racing performance. Legal availability of the drugLegal availability of the drug Whether there is reason to believe the Whether there is reason to believe the

responsible party knew of the responsible party knew of the administration of the drug or administration of the drug or intentionally administered the drug. intentionally administered the drug.

Steps taken by the trainer to Steps taken by the trainer to safeguard the horse.safeguard the horse.

Extenuating Extenuating CircumstancesCircumstances

Probability of environmental contamination Probability of environmental contamination or inadvertent exposure due to human drug or inadvertent exposure due to human drug use.use.

Purse of the racePurse of the race

Whether the drug found was one for which Whether the drug found was one for which the horse was receiving a treatment as the horse was receiving a treatment as determined by the Medication Report determined by the Medication Report Form.Form.

Whether there is any suspicious betting Whether there is any suspicious betting pattern in the race.pattern in the race.

Whether the licensed trainer was acting Whether the licensed trainer was acting under the advice of a licensed veterinarian.under the advice of a licensed veterinarian.

Penalties and the Penalties and the Model RulesModel Rules

Flunixin Flunixin (Banamine)(Banamine)– RCI Class 4RCI Class 4– NSAIDNSAID– FDA-approved for FDA-approved for

the horsethe horse– Many studies in Many studies in

the scientific the scientific literature in the literature in the horsehorse

– Regulated by ruleRegulated by rule

MeloxicamMeloxicam– RCI Class 4RCI Class 4– NSAIDNSAID– Not FDA-approved Not FDA-approved

for the horsefor the horse– No scientific No scientific

studies in the studies in the horsehorse

– Not regulated by Not regulated by rulerule

So, the question is why would someone use Meloxicam instead of Flunixin?

Penalties and the Penalties and the Model RulesModel RulesNew Version:New Version:

– All RCI Drugs All RCI Drugs categorizedcategorized into A, B, C or D into A, B, C or D groups.groups.

– Each drug was slotted based on criteria:Each drug was slotted based on criteria:

1.1. FDA approval…1FDA approval…1stst for horse, 2 for horse, 2ndnd for any reason? for any reason?

2.2. Potential to enhance race day performance?Potential to enhance race day performance?

3.3. Legitimate therapeutic application?Legitimate therapeutic application?

4.4. Identified as necessary by RCI Regulatory Identified as necessary by RCI Regulatory Veterinarian Committee?Veterinarian Committee?

5.5. Does an alternative exist?Does an alternative exist?

6.6. What is the current RCI Classification?What is the current RCI Classification?

Penalties and the Penalties and the Model RulesModel RulesDiclofenac (Surpass)Diclofenac (Surpass)1.1. FDA-approved? Yes, for FDA-approved? Yes, for

the horsethe horse2.2. Performance? MinimalPerformance? Minimal3.3. Legitimate therapeutic Legitimate therapeutic

application? Yes, as a application? Yes, as a topical anti-topical anti-inflammatoryinflammatory

4.4. Identified as necessary? Identified as necessary? YesYes

5.5. Does an alternative Does an alternative exist? Noexist? No

6.6. Current RCI Class? 4Current RCI Class? 4

Penalty Class “C”Penalty Class “C”$500 fine & loss of $500 fine & loss of

pursepurse

MeloxicamMeloxicam1.1. FDA-approved? No for FDA-approved? No for

horse, yes for humanhorse, yes for human2.2. Performance? YesPerformance? Yes3.3. Legitimate therapeutic Legitimate therapeutic

application? No, no application? No, no researchresearch

4.4. Identified as necessary? Identified as necessary? NoNo

5.5. Does an alternative exist? Does an alternative exist? Yes…Flunixin, Bute, Yes…Flunixin, Bute, KetoprofenKetoprofen

6.6. Current RCI Class? 4Current RCI Class? 4

Penalty Class “B”Penalty Class “B”15 day suspension, 15 day suspension,

$1000 fine & loss of $1000 fine & loss of pursepurse

Penalties and the Penalties and the Model RulesModel RulesOther Aspects:Other Aspects:

– Ability to penalize veterinarian to same Ability to penalize veterinarian to same extent as trainer if culpability can be proven.extent as trainer if culpability can be proven.

– Licensed owners to be notified of any Licensed owners to be notified of any hearings as a result of a violation.hearings as a result of a violation.

– Penalties for owner and horse potentially.Penalties for owner and horse potentially.– Flexibility to let the penalty fit the Flexibility to let the penalty fit the

circumstances of the case…not circumstances of the case…not uniform uniform penaltiespenalties but a but a uniform approach to uniform approach to penalties.penalties.

– RCI Model Rules: http://ag.arizona.edu/rtip/ RCI Model Rules: http://ag.arizona.edu/rtip/

Furosemide Furosemide (Salix/Lasix)(Salix/Lasix) 90+% of horses suffer from some degree of 90+% of horses suffer from some degree of

EIPH, estimated that industry cost of EIPH EIPH, estimated that industry cost of EIPH approaches $100 million dollars.approaches $100 million dollars.

Working theory is that increase in Working theory is that increase in circulating red blood cells during exercise circulating red blood cells during exercise increases pressure in capillaries and vessels increases pressure in capillaries and vessels of lung.of lung.

Furosemide thought to lower blood Furosemide thought to lower blood pressure in lungs by reducing fluid pressure in lungs by reducing fluid component of blood.component of blood.

Published science was not seen by many as Published science was not seen by many as definitive on whether this is the case or not.definitive on whether this is the case or not.

Furosemide Furosemide (Salix/Lasix)(Salix/Lasix)

Lasix PerceptionsLasix Perceptions– We are breeding We are breeding

generations of generations of bleeders.bleeders.

– Lasix masks the Lasix masks the presence of other presence of other drugs.drugs.

– Lasix is somehow Lasix is somehow linked to linked to soundness issues.soundness issues.

Furosemide Furosemide (Salix/Lasix)(Salix/Lasix)South African Study (2008):South African Study (2008):

– Double-blind study using horses that had never Double-blind study using horses that had never received Lasix before a race. received Lasix before a race.

– Raced twice under same exact conditions two Raced twice under same exact conditions two weeks apart – jockey, post, distance, competition, weeks apart – jockey, post, distance, competition, purse. purse.

– Horses receiving saline instead of Lasix had Horses receiving saline instead of Lasix had increased severity of EIPH.increased severity of EIPH.

– 67.5% of horses that bled when receiving saline 67.5% of horses that bled when receiving saline had improved EIPH severity scores (1-4) by one.had improved EIPH severity scores (1-4) by one.

– Conclusion…EIPH incidence and severity was Conclusion…EIPH incidence and severity was improved by pre-race administration of Lasix.improved by pre-race administration of Lasix.

– Cost: $1,000,000+Cost: $1,000,000+

NSAIDSNSAIDS

One of three – Phenylbutazone, Flunixin, One of three – Phenylbutazone, Flunixin, Ketoprofen – can be administered at 24 hours Ketoprofen – can be administered at 24 hours before post time of the race. before post time of the race.

Must be administered with single IV injectionMust be administered with single IV injection Recommended Threshold concentration used Recommended Threshold concentration used

to enforce the Model Rule:to enforce the Model Rule:– 20 ng/ml for Flunixin20 ng/ml for Flunixin– 10 ng/ml for Ketoprofen10 ng/ml for Ketoprofen– 5 mcg/ml for Phenylbutazone5 mcg/ml for Phenylbutazone

Research studies had indicated analgesic Research studies had indicated analgesic effect entirely gone by 24 hours after IV effect entirely gone by 24 hours after IV injection.injection.

NSAIDSNSAIDS Most regulatory veterinarians believe the 24-hour Most regulatory veterinarians believe the 24-hour

administration impacts their ability to perform pre-administration impacts their ability to perform pre-race exams at 4-10 hours before the race.race exams at 4-10 hours before the race.

Research study results are mixed on this time frame.Research study results are mixed on this time frame.

Some states lax in enforcement of 24-hours – 6PM.Some states lax in enforcement of 24-hours – 6PM.

Blood samples recently collected in CA & KY at the Blood samples recently collected in CA & KY at the time of the pre-race exam show levels significantly time of the pre-race exam show levels significantly above threshold limits.above threshold limits.

At RCI April Convention RMTC Board will consider At RCI April Convention RMTC Board will consider recommendations for 48-hour rule (Canada), and/or recommendations for 48-hour rule (Canada), and/or reducing Bute threshold to 2 mcg/ml.reducing Bute threshold to 2 mcg/ml.

Anabolic SteroidsAnabolic Steroids Model rule has been in place now for 6-18 Model rule has been in place now for 6-18

months depending on jurisdiction.months depending on jurisdiction. Rule has basically eliminated the use of Rule has basically eliminated the use of

the usual anabolic steroids in racing and the usual anabolic steroids in racing and training.training.

Chemists reporting no detectable anabolic Chemists reporting no detectable anabolic agents in post-race samples.agents in post-race samples.

Revised Model Rule with plasma Revised Model Rule with plasma thresholds proposed to RCI – limit of thresholds proposed to RCI – limit of detection 25pg/ml.detection 25pg/ml.

Labs with proper instrumentation will Labs with proper instrumentation will likely switch to plasma testing with LC/MS.likely switch to plasma testing with LC/MS.

Anabolic Steroids Anabolic Steroids IssuesIssues The program gelding with high The program gelding with high

testosteronetestosterone– Recommend a HCG Challenge Test to Recommend a HCG Challenge Test to

determine whether residual testicular determine whether residual testicular tissue.tissue.

– If “positive” horse is classified for If “positive” horse is classified for regulatory purposes as a “rig” and kept as regulatory purposes as a “rig” and kept as a gelding for program.a gelding for program.

– ““Rig” notation is sent to lab with Rig” notation is sent to lab with subsequent samples which are excused subsequent samples which are excused from testosterone testing.from testosterone testing.

HermaphroditesHermaphrodites– One Standardbred mare on east coast One Standardbred mare on east coast

throws fillies with internal male sex organs.throws fillies with internal male sex organs.

Anabolic steroids Anabolic steroids

Starting to see Starting to see “replacement” “replacement” substances begin substances begin to be a problem:to be a problem:

– High-dose High-dose Mexican Mexican ClenbuterolClenbuterol

– RactopamineRactopamine– EthylestrenolEthylestrenol– FactrelFactrel

CorticosteroidsCorticosteroids

RCI Class 4 Substances - Anti-inflammatoryRCI Class 4 Substances - Anti-inflammatory

Very diverse group of drugs; wide number of Very diverse group of drugs; wide number of uses.uses.

Difficult to test; complicated by multiple routes Difficult to test; complicated by multiple routes of administration.of administration.

Intra-articular administrations within 72 hours – Intra-articular administrations within 72 hours – waiting to see if horse draws into race.waiting to see if horse draws into race.

Many states choose to use testing budget Many states choose to use testing budget elsewhere mostly due to Class 4 status.elsewhere mostly due to Class 4 status.

Abuse, particularly inter-articular is significant Abuse, particularly inter-articular is significant especially in claiming and Quarter Horses.especially in claiming and Quarter Horses.

CorticosteroidsCorticosteroids

Pennsylvania has adopted a 7-day ban on Pennsylvania has adopted a 7-day ban on intra-articular injections.intra-articular injections.

New York has a 5-day ban.New York has a 5-day ban.

AAEP is considering 5-10 day recommendation.AAEP is considering 5-10 day recommendation.

Questions as to whether these rules can be Questions as to whether these rules can be enforced with current testing methodologies.enforced with current testing methodologies.

RMTC is requesting proposals on RMTC is requesting proposals on corticosteroid research on pharmacokinetics, corticosteroid research on pharmacokinetics, withdrawal times and dynamic markers.withdrawal times and dynamic markers.

International International HarmonizationHarmonization Joint meeting of RMTC & IFHA Joint meeting of RMTC & IFHA

Advisory Council on Prohibited Advisory Council on Prohibited Substances in April 2009 at RCI.Substances in April 2009 at RCI.

RMTC signed a non-disclosure RMTC signed a non-disclosure agreement with EHSLC.agreement with EHSLC.

USA attendance for first time ever USA attendance for first time ever at EHSLC meeting in Newmarket in at EHSLC meeting in Newmarket in July 2009.July 2009.

We have a much better We have a much better understanding of each others understanding of each others approaches and issues.approaches and issues.

International International HarmonizationHarmonization

USA, IFHA and EHSLC sharing priority USA, IFHA and EHSLC sharing priority lists for administration studies and lists for administration studies and resulting data produced.resulting data produced.

Interest from EHSLC & IFHA on Interest from EHSLC & IFHA on cooperative research on administration cooperative research on administration studies in multiple jurisdictions.studies in multiple jurisdictions.

USA & IFHA meeting at March ICRAV in USA & IFHA meeting at March ICRAV in NZ and EHSLC meeting in July in NZ and EHSLC meeting in July in Ireland.Ireland.

Dispelling perception that USA racing is Dispelling perception that USA racing is over medicated and international racing over medicated and international racing is drug free.is drug free.

Drug Testing Drug Testing InitiativesInitiativesPost-race testing in the United States:Post-race testing in the United States: Currently 18 laboratories conducting testing in Currently 18 laboratories conducting testing in

USA.USA. Only six labs are ISO 17025 accreditedOnly six labs are ISO 17025 accredited

– 30% of samples were tested by an accredited lab in 2008.30% of samples were tested by an accredited lab in 2008. 2008 RMTC Lab Survey: Funding and methodology 2008 RMTC Lab Survey: Funding and methodology

are dramatically different state-to-state.are dramatically different state-to-state. No uniform industry standards for USA testing labs.No uniform industry standards for USA testing labs. Animal selection strategies has not changed in Animal selection strategies has not changed in

years.years. Financially limited industry quality assurance Financially limited industry quality assurance

programs until 2009.programs until 2009.

Drug Testing Drug Testing InitiativesInitiatives

DTI Task Force of leading chemists with RMTC DTI Task Force of leading chemists with RMTC & RCI representatives formed in September & RCI representatives formed in September 2008.2008.

Goal: “Design the best system for USA Drug Goal: “Design the best system for USA Drug Testing irrespective of funding and politics.”Testing irrespective of funding and politics.”

Utilized laboratory standards developed by the Utilized laboratory standards developed by the World Anti-Doping Association (WADA) and World Anti-Doping Association (WADA) and AORC ILAC-G7 where applicable working AORC ILAC-G7 where applicable working towards the development of a performance-towards the development of a performance-based system.based system.

Other related topics discussed…next generation Other related topics discussed…next generation of lab directors, sample selection, frozen of lab directors, sample selection, frozen samples, harmonization nationally and samples, harmonization nationally and internationally.internationally.

Drug Testing Drug Testing InitiativesInitiativesCreation of Industry Standards for Labs:Creation of Industry Standards for Labs: Edited version of WADA Lab Accreditation Edited version of WADA Lab Accreditation

Program has been completed by DTI Task Force.Program has been completed by DTI Task Force.– Uniform Lab Standards was the first step.Uniform Lab Standards was the first step.– Equine Quality Assurance Program is next by July 1.Equine Quality Assurance Program is next by July 1.– EQAP and laboratory accreditation required in state EQAP and laboratory accreditation required in state

racing commission drug testing RFP’s by 2012?racing commission drug testing RFP’s by 2012?– 10% of laboratory budgets are mandated to be 10% of laboratory budgets are mandated to be

directed towards research.directed towards research. Current QAP program (TIP) expanded for 2009-Current QAP program (TIP) expanded for 2009-

2010 by RMTC to prepare for transition to 32010 by RMTC to prepare for transition to 3rdrd party EQAP.party EQAP.

Drug Testing Drug Testing InitiativesInitiativesCreation of Industry Standards for LabsCreation of Industry Standards for Labs States/industry now has a document to States/industry now has a document to

“sell” to legislatures in order to provide “sell” to legislatures in order to provide funding for drug testing laboratories to funding for drug testing laboratories to meet DTI standards. (NY) meet DTI standards. (NY)

Industry will also need funding for the Industry will also need funding for the industry organization that takes on the role industry organization that takes on the role of WADA.of WADA.

RMTC is currently the “place-holder”. RMTC is currently the “place-holder”. Could be a perfect fit for concept of a Could be a perfect fit for concept of a

national interstate racing regulatory national interstate racing regulatory compact.compact.

Drug Testing Drug Testing InitiativesInitiatives

Post-doctoral and grad student Post-doctoral and grad student recruitment:recruitment:

Laboratory directors are aging…who replaces them?Laboratory directors are aging…who replaces them? Those with research programs that are racing Those with research programs that are racing

related could do more with capable students.related could do more with capable students. Developing a comprehensive program to target Developing a comprehensive program to target

individuals with pharmacology/veterinary/chemistry individuals with pharmacology/veterinary/chemistry backgrounds to place in research positions and will backgrounds to place in research positions and will also utilize racing laboratories and possibly U of A also utilize racing laboratories and possibly U of A RTIP for broader racing education.RTIP for broader racing education.

Initial cost: $150,000 per year for two positions Initial cost: $150,000 per year for two positions RMTC has pledged $75,000 per year.RMTC has pledged $75,000 per year.

Drug Testing Drug Testing InitiativesInitiatives Sample CollectionSample Collection

– Is testing winners the most efficient use Is testing winners the most efficient use of testing dollars?of testing dollars?

– 1991 McKinsey Report recommended 1991 McKinsey Report recommended testing 50% of winners and specials testing 50% of winners and specials based on odds and finish.based on odds and finish.

– Possibility of collection without testing.Possibility of collection without testing. Frozen Sample & Retro-Testing ProgramFrozen Sample & Retro-Testing Program

– Possible deterrent effect and useful for Possible deterrent effect and useful for intelligence information.intelligence information.

– Program funded by The Jockey Club for Program funded by The Jockey Club for 2009-2010 with RMTC as administrator 2009-2010 with RMTC as administrator (UC-Davis).(UC-Davis).

Big Event Security Big Event Security TeamTeam TRPB/SIS & RMTC joint ventureTRPB/SIS & RMTC joint venture Team of investigators at major racing Team of investigators at major racing

eventsevents 2005 Kentucky Derby was 12005 Kentucky Derby was 1stst event. event. All breeds: Little Brown Jug & Los AlamitosAll breeds: Little Brown Jug & Los Alamitos Three years BET was at 25+ major events.Three years BET was at 25+ major events. Many horsemen appreciated increased Many horsemen appreciated increased

security.security. RMTC support discontinued in 2008 as not RMTC support discontinued in 2008 as not

part of RMTC mission.part of RMTC mission.

Security ManualSecurity Manual

TRPB/SIS & RMTC joint effortTRPB/SIS & RMTC joint effort Detailed instructions for Detailed instructions for

security personnel training.security personnel training. Power point presentationPower point presentation DVDDVD Distributed to all racetracks in Distributed to all racetracks in

2007.2007. Needs to be updated.Needs to be updated.

Barn Area Security Barn Area Security TRPB Security Assessment ProgramTRPB Security Assessment Program RMTC joint effort in 2006-2008RMTC joint effort in 2006-2008 Stable Area Security Assessment ProtocolsStable Area Security Assessment Protocols Offered free to TRA and USTA tracksOffered free to TRA and USTA tracks Very limited participationVery limited participation NTRA Safety & Integrity Alliance Track NTRA Safety & Integrity Alliance Track

Certification RequirementCertification Requirement AAEP Racing Task Force recommendation: AAEP Racing Task Force recommendation:

“More backstretch security”“More backstretch security” Racetrack Chaplain as a resource. Racetrack Chaplain as a resource.

Consultation and Consultation and Contraband TestingContraband Testing

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