Transcript Drug testing: what’s coming in the next mellinium

Update on Medication
Issues
Dan Fick
Racing Medication & Testing Consortium
Mission of RMTC
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Formed in 2002 as a 501 (c) (3) charitable
organization
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To develop, promote and help coordinate, at the
national level, policies, research and educational
programs that seek to:
– ensure fairness and integrity of racing
– ensure the health and safety of racehorses and
participants
– protect the interests of the racing public
Participation Organizations
on the Board of Directors
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AAEP
AQHA
Arabian Jockey Club
Breeders’ Cup
California TB Trainers
Churchill Downs
Del Mar
Hambletonian Society
Harness Tracks of America
Jockeys’ Guild
Keeneland
Kentucky TB Association
Magna Entertainment
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National HBPA
National Steeplechase
NTRA
NYRA
Oak Tree
RCI
THA
The Jockey Club
TOBA
TB Owners of California
TRA
TRPB
USTA
Topics
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Penalties
Lasix
NSAID
Anabolic Steroids
Corticosteroids
International Harmonization
Drug Testing Initiative
Security
Penalties and the Model Rules
Old Version:
– Penalties were based on RCI Class of the drug.
– Classification based on pharmacology of drug.
– Penalties had large ranges for number of
suspension days and amount of fines.
– No guidance on how treat multiple violations
and extenuating circumstances, either
mitigating or aggravating.
Penalties and the Model Rules
Reasons for change:
– Consideration should be whether the drug is
appropriate to see in a racehorse on race day.
– Penalties should increase with intent, severity
and repeat violations.
– Other licensees should participate in the
penalty phase especially repeat violators.
– We need to define possible mitigating and
aggravating circumstances.
Extenuating Circumstances
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Past record of trainer, veterinarian and owner in
drug cases.
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Potential of drug(s) to influence a horse’s racing
performance.
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Legal availability of the drug
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Whether there is reason to believe the responsible
party knew of the administration of the drug or
intentionally administered the drug.
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Steps taken by the trainer to safeguard the horse.
Extenuating Circumstances
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Probability of environmental contamination or
inadvertent exposure due to human drug use.
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Purse of the race
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Whether the drug found was one for which the horse
was receiving a treatment as determined by the
Medication Report Form.
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Whether there is any suspicious betting pattern in the
race.
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Whether the licensed trainer was acting under the
advice of a licensed veterinarian.
Penalties and the Model Rules
Flunixin (Banamine)
– RCI Class 4
– NSAID
– FDA-approved for
the horse
– Many studies in the
scientific literature in
the horse
– Regulated by rule
Meloxicam
– RCI Class 4
– NSAID
– Not FDA-approved
for the horse
– No scientific studies
in the horse
– Not regulated by rule
So, the question is why would someone
use Meloxicam instead of Flunixin?
Penalties and the Model Rules
New Version:
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All RCI Drugs categorized into A, B, C or D groups.
Each drug was slotted based on criteria:
1. FDA approval…1st for horse, 2nd for any reason?
2. Potential to enhance race day performance?
3. Legitimate therapeutic application?
4. Identified as necessary by RCI Regulatory
Veterinarian Committee?
5. Does an alternative exist?
6. What is the current RCI Classification?
Penalties and the Model Rules
Diclofenac (Surpass)
Meloxicam
1. FDA-approved? Yes, for
the horse
2. Performance? Minimal
3. Legitimate therapeutic
application? Yes, as a
topical anti-inflammatory
4. Identified as necessary?
Yes
5. Does an alternative exist?
No
6. Current RCI Class? 4
1. FDA-approved? No for
horse, yes for human
2. Performance? Yes
3. Legitimate therapeutic
application? No, no
research
4. Identified as necessary? No
5. Does an alternative exist?
Yes…Flunixin, Bute,
Ketoprofen
6. Current RCI Class? 4
Penalty Class “C”
$500 fine & loss of purse
Penalty Class “B”
15 day suspension, $1000
fine & loss of purse
Penalties and the Model Rules
Other Aspects:
– Ability to penalize veterinarian to same extent
as trainer if culpability can be proven.
– Licensed owners to be notified of any hearings
as a result of a violation.
– Penalties for owner and horse potentially.
– Flexibility to let the penalty fit the
circumstances of the case…not uniform
penalties but a uniform approach to penalties.
– RCI Model Rules: http://ag.arizona.edu/rtip/
Furosemide (Salix/Lasix)
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90+% of horses suffer from some degree of
EIPH, estimated that industry cost of EIPH
approaches $100 million dollars.
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Working theory is that increase in circulating
red blood cells during exercise increases
pressure in capillaries and vessels of lung.
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Furosemide thought to lower blood pressure
in lungs by reducing fluid component of
blood.
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Published science was not seen by many as
definitive on whether this is the case or not.
Furosemide (Salix/Lasix)
Lasix Perceptions
– We are breeding
generations of
bleeders.
– Lasix masks the
presence of other
drugs.
– Lasix is somehow
linked to soundness
issues.
Furosemide (Salix/Lasix)
South African Study (2008):
– Double-blind study using horses that had never
received Lasix before a race.
– Raced twice under same exact conditions two weeks
apart – jockey, post, distance, competition, purse.
– Horses receiving saline instead of Lasix had
increased severity of EIPH.
– 67.5% of horses that bled when receiving saline had
improved EIPH severity scores (1-4) by one.
– Conclusion…EIPH incidence and severity was
improved by pre-race administration of Lasix.
– Cost: $1,000,000+
NSAIDS
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One of three – Phenylbutazone, Flunixin,
Ketoprofen – can be administered at 24 hours
before post time of the race.
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Must be administered with single IV injection
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Recommended Threshold concentration used
to enforce the Model Rule:
– 20 ng/ml for Flunixin
– 10 ng/ml for Ketoprofen
– 5 mcg/ml for Phenylbutazone
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Research studies had indicated analgesic effect
entirely gone by 24 hours after IV injection.
NSAIDS
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Most regulatory veterinarians believe the 24-hour
administration impacts their ability to perform prerace exams at 4-10 hours before the race.
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Research study results are mixed on this time frame.
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Some states lax in enforcement of 24-hours – 6PM.
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Blood samples recently collected in CA & KY at the
time of the pre-race exam show levels significantly
above threshold limits.
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At RCI April Convention RMTC Board will consider
recommendations for 48-hour rule (Canada), and/or
reducing Bute threshold to 2 mcg/ml.
Anabolic Steroids
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Model rule has been in place now for 6-18
months depending on jurisdiction.
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Rule has basically eliminated the use of the
usual anabolic steroids in racing and training.
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Chemists reporting no detectable anabolic
agents in post-race samples.
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Revised Model Rule with plasma thresholds
proposed to RCI – limit of detection 25pg/ml.
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Labs with proper instrumentation will likely
switch to plasma testing with LC/MS.
Anabolic Steroids Issues
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The program gelding with high testosterone
– Recommend a HCG Challenge Test to determine
whether residual testicular tissue.
– If “positive” horse is classified for regulatory
purposes as a “rig” and kept as a gelding for
program.
– “Rig” notation is sent to lab with subsequent
samples which are excused from testosterone
testing.
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Hermaphrodites
– One Standardbred mare on east coast throws fillies
with internal male sex organs.
Anabolic steroids
Starting to see
“replacement”
substances begin to
be a problem:
– High-dose Mexican
Clenbuterol
– Ractopamine
– Ethylestrenol
– Factrel
Corticosteroids
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RCI Class 4 Substances - Anti-inflammatory
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Very diverse group of drugs; wide number of uses.
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Difficult to test; complicated by multiple routes of
administration.
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Intra-articular administrations within 72 hours –
waiting to see if horse draws into race.
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Many states choose to use testing budget
elsewhere mostly due to Class 4 status.
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Abuse, particularly inter-articular is significant
especially in claiming and Quarter Horses.
Corticosteroids
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Pennsylvania has adopted a 7-day ban on
intra-articular injections.
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New York has a 5-day ban.
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AAEP is considering 5-10 day recommendation.
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Questions as to whether these rules can be
enforced with current testing methodologies.
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RMTC is requesting proposals on corticosteroid
research on pharmacokinetics, withdrawal times
and dynamic markers.
International Harmonization
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Joint meeting of RMTC & IFHA Advisory
Council on Prohibited Substances in April
2009 at RCI.
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RMTC signed a non-disclosure agreement
with EHSLC.
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USA attendance for first time ever at EHSLC
meeting in Newmarket in July 2009.
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We have a much better understanding of each
others approaches and issues.
International Harmonization
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USA, IFHA and EHSLC sharing priority lists
for administration studies and resulting data
produced.
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Interest from EHSLC & IFHA on cooperative
research on administration studies in multiple
jurisdictions.
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USA & IFHA meeting at March ICRAV in NZ
and EHSLC meeting in July in Ireland.
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Dispelling perception that USA racing is over
medicated and international racing is drug free.
Drug Testing Initiatives
Post-race testing in the United States:
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Currently 18 laboratories conducting testing in USA.
Only six labs are ISO 17025 accredited
– 30% of samples were tested by an accredited lab in 2008.
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2008 RMTC Lab Survey: Funding and methodology
are dramatically different state-to-state.
No uniform industry standards for USA testing labs.
Animal selection strategies has not changed in years.
Financially limited industry quality assurance
programs until 2009.
Drug Testing Initiatives
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DTI Task Force of leading chemists with RMTC
& RCI representatives formed in September 2008.
Goal: “Design the best system for USA Drug
Testing irrespective of funding and politics.”
Utilized laboratory standards developed by the
World Anti-Doping Association (WADA) and
AORC ILAC-G7 where applicable working
towards the development of a performance-based
system.
Other related topics discussed…next generation of
lab directors, sample selection, frozen samples,
harmonization nationally and internationally.
Drug Testing Initiatives
Creation of Industry Standards for Labs:
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Edited version of WADA Lab Accreditation Program
has been completed by DTI Task Force.
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Uniform Lab Standards was the first step.
Equine Quality Assurance Program is next by July 1.
EQAP and laboratory accreditation required in state
racing commission drug testing RFP’s by 2012?
10% of laboratory budgets are mandated to be
directed towards research.
Current QAP program (TIP) expanded for 2009-2010
by RMTC to prepare for transition to 3rd party EQAP.
Drug Testing Initiatives
Creation of Industry Standards for Labs
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States/industry now has a document to “sell”
to legislatures in order to provide funding for
drug testing laboratories to meet DTI
standards. (NY)
Industry will also need funding for the
industry organization that takes on the role of
WADA.
RMTC is currently the “place-holder”.
Could be a perfect fit for concept of a national
interstate racing regulatory compact.
Drug Testing Initiatives
Post-doctoral and grad student recruitment:
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Laboratory directors are aging…who replaces them?
Those with research programs that are racing related
could do more with capable students.
Developing a comprehensive program to target
individuals with pharmacology/veterinary/chemistry
backgrounds to place in research positions and will
also utilize racing laboratories and possibly U of A
RTIP for broader racing education.
Initial cost: $150,000 per year for two positions
RMTC has pledged $75,000 per year.
Drug Testing Initiatives
 Sample Collection
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Is testing winners the most efficient use of
testing dollars?
1991 McKinsey Report recommended testing
50% of winners and specials based on odds
and finish.
Possibility of collection without testing.
 Frozen Sample & Retro-Testing Program
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Possible deterrent effect and useful for
intelligence information.
Program funded by The Jockey Club for
2009-2010 with RMTC as administrator
(UC-Davis).
Big Event Security Team
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TRPB/SIS & RMTC joint venture
Team of investigators at major racing events
2005 Kentucky Derby was 1st event.
All breeds: Little Brown Jug & Los Alamitos
Three years BET was at 25+ major events.
Many horsemen appreciated increased security.
RMTC support discontinued in 2008 as not part
of RMTC mission.
Security Manual
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TRPB/SIS & RMTC joint effort
Detailed instructions for security
personnel training.
Power point presentation
DVD
Distributed to all racetracks in 2007.
Needs to be updated.
Barn Area Security
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TRPB Security Assessment Program
RMTC joint effort in 2006-2008
Stable Area Security Assessment Protocols
Offered free to TRA and USTA tracks
Very limited participation
NTRA Safety & Integrity Alliance Track
Certification Requirement
AAEP Racing Task Force recommendation:
“More backstretch security”
Racetrack Chaplain as a resource.
Consultation and Contraband Testing
RMTC
821 Corporate Drive
Lexington, KY 40503
[email protected]
(859) 224-2844
www.rmtcnet.com