Transcript Dr. Scot Waterman`s presentation to the Ontario Racing Commission

Drug Control in Horse
Racing in the U.S.
Scot Waterman, DVM
Executive Director
Racing Medication & Testing Consortium
U.S. Regulatory Framework
U.S. Regulatory Framework
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State statute enables a state agency to govern
pari-mutuel wagering
Commission has power to write, enforce and
adjudicate rules…executive, quasi-judicial,
quasi-legislative
Commissioners are usually appointed by the
governor
No US federal government counterpart to the
CPMA
U.S. Regulatory Framework
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Makeup of commission varies state-by-state
– Some states do not allow those involved in the
industry day-to-day to serve as commissioners
– Number of commissioners (as low as 1, as high as 13)
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Funding for operations varies state-by-state
– Majority of states funded through general funds but
some based on revenue sources from handle
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Rulemaking process varies state-by-state
– NJ, NY, CA from start to finish process can take over
one year. Some states also have regulations encoded
in statute…need to involve legislature to change
U.S. Regulatory Framework—
Challenges
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Commission only quasi-legislative
– Generally some state legislature oversight which
creates another potential hurdle for model rules
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Commission only quasi-judicial
– Violations appealed to state court which
historically have reduced significant penalties
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Commission budgets always at risk
Local politics more important than national
politics
Racing Medication &
Testing Consortium
RMTC History
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Formation:
– Began with the AAEP Medication Summit,
December 2001
– Summit designed to determine level of consensus
on uniform medication policy
– All organization that participated in original
meeting are still involved nine years later
– Organization has moved beyond rule uniformity as
a singular goal
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Incorporated as a 501 (c) (3) charitable
organization since 2003
RMTC Board
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Horsemen—THA, HBPA, CTT
Tracks-Magna, Churchill, Oak Tree, Del Mar, HTA,
TRA, NYRA, Keeneland
Owners/Breeders—TOBA, TOC, KTA
Veterinarians—AAEP
Security—TRPB
Regulatory Association—RCI
Breed Registries/Other—AQHA, The Jockey Club,
NTRA, USTA, Hambeltonian Society, Arabian Jockey
Club
Jockeys—Jockey’s Guild
Goals and Objectives
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Uniform medication rules
Uniform testing procedures and laboratory
accreditation
Uniform thresholds and withdrawal guidelines for
therapeutic medications
Unbiased source of information on medication issues
for state racing commissions
Develop intelligence on new threats to integrity
Better communication regarding medication issues
RMTC Goals and Objectives
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Generally successful in the development of
model medication policies and
encouragement of adoption at state level
– Large board viewed as an “industry consensus”
once language is completed
– Have been able to overcome some of the parochial
issues as state level
– Able represent RMTC in person at state
commission meetings when requested
– Development of a network of individuals within
commissions to assist in the adoption process
RMTC Goals and Objectives
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US closer to uniformity than ever before
Challenges still remain:
– Penalties
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Difficult to get stewards/commissions to depart from
status quo
– How to make smaller states relevant, part of
process
– Commissions that want to look tougher than
anyone else
– Grinding process, impatient industry
RMTC Pharmacokinetic
Program
Uniform thresholds and
withdrawal times
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First step…create a priority list of drugs
for study:
– AAEP was asked to put together a committee
of veterinarians to identify “most essential”
therapeutic medications
– List was then prioritized based on the number
of positive tests caused in the USA over a five
year period and survey results of practitioners
Uniform thresholds and
withdrawal times
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Second step…fund administration studies
on each drug at relevant doses
– FDA formula used for drug residues in milk
used to calculate threshold at a given
withdrawal period
– Minimum of twenty horses used for each
study to reduce the k factor of the formula
– Withdrawal time based on end of
pharmacologic activity when known
Study Design
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Test substance
– Blood primary
– Urine secondary
Laboratory methods
– LC-MS at lowest attainable limit of detection (LOD) using
latest instrumentation and methodology
Drug Administrations
– Drugs were administered IV as single dose except for select
drugs
– Blood and urine samples were collected at specific times after
drug administration – samples were sent to testing
laboratories for analysis
– “Cheater doses” studied when intelligence on
dose/route/time is available
University of Florida Equine
Performance Laboratory
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Director
– Pat Colahan, DVM
Horses
– Breeds
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Thoroughbred
Standardbred (specific studies)
– Gender
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Geldings and mares
– Age
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3-10 years
– Fitness
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Trained on treadmill and fitness assessed periodically
Equine Performance
Laboratory
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Training and Fitness Assessment
– Exercised 3 times per week on high-speed treadmill
 Trot for 0.6 km at 4.0 m/s, gallop for 2 km at 8 m/s, and
trot for 0.6 km at 4 m/s
 Treadmill horizontal on Monday and inclined 6 degrees
on Wednesday and Friday
– Incremental Exercise Test to Exhaustion
 Warm up on the treadmill at 4 m/s for 5 min before the
start of the test; exercise for 1 min each at 9, 10, 11, 12, 13
and 14 m/s until they are unable to maintain the speed.
 Blood samples collected for lactate and pH
– Require lactate > 20 mM and pH <6.95
Equine Performance
Laboratory
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Sample collections
– Blood – individual
venipuncture into lithium
heparin tubes – plasma
harvested and stored at –
70 °C
– Urine – collected by free
catch method – urine
aliquotted and stored at –
70 °C
Sample distribution
– Samples are sent by
overnight courier to
participating laboratories
Process for sample analysis
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ISO 17025 accredited laboratories used
Instrumentation is LC-MS or LC-MS-MS.
Develop and validate methods for each
analyte before testing experimental samples.
Schedule sample collection for a drug study
after the proposed method has been suitably
validated and approved for use in the study.
Withdrawal Times Research
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Priority Group 1
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Acepromazine
Butorphanol
Detomidine
Glycopyrrolate
Lidocaine
Mepivacaine
Methocarbamol
Pyrilamine
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Priority Group 2
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Boldenone
Dantrolene
Firocoxib
Fluphenazine
Hydroxyzine
Nandrolone
Stanozolol
Testosterone
Glycopyrrolate Example
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Quaternary amine
Anti-cholinergic
FDA approved as a pre-anesthetic but used in
racing as a respiratory “aid” due to
bronchodilatory effect and reduction in airway
secretions
Rapidly eliminated making detection more
difficult
20-horse administration using 1 mg/horse IV
and 10 mg/horse orally (n=6)
Plasma Threshold
Time, hours
24
Threshold concentration based on
99/95 Tolerance Interval
3.5 pg/mL
48
2.0 pg/mL
72
0.5 pg/mL
96
0.33 pg/mL
Firocoxib Example
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Non-Steroidal Anti-Inflammatory Drug
FDA-approved for use in the horse as an oral
paste
Drug has an exceptionally long half life
Clinical effects compare favorably to
phenylbutazone with fewer side effects
20-horse administration using 0.1 mg/kg
orally for 7 days
Merial funded the research
Firocoxib threshold
considerations
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Plasma concentrations after a single dose are less
than those after a multiple dosing regimen.
Clinical effects are likely during a single dose
administration.
Therefore, a threshold must be able to detect
single dose administration.
A threshold of 20-50 ng/mL would detect race day
administration of a single dose.
The withdrawal period after a multiple dosing
regimen using a threshold of 40 ng/mL is one
week.
Uniform thresholds and
withdrawal times
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Other recommendations:
– Methocarbamol threshold of 1 ng/ml in plasma, withdrawal
guideline of 48 hours based on single 15 mg/kg IV dose
– Anabolic steroid screening and confirmatory limits
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Drugs complete by our next Board meeting
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Acepromazine
Detomidine
Lidocaine
Mepivacaine
Pyrilamine
SOPs and method validation data will be made
available to all labs free of charge
General Industry Challenges
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Funding for RMTC to continue research
Funding from states for commissions to increase
spending on testing, investigatory capabilities,
adjudication
“Silver bullet” thinking on complex issues
Dealing with issues that may be strictly based on
perception and misinformation
Culture of medication use
Competition for horses which encourages overnight
extras instead of condition book races
RMTC: Contact Us
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www.rmtcnet.com