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

Drug Control in Horse
Racing in the U.S.
Scot Waterman, DVM
Executive Director
Racing Medication & Testing Consortium
Terminology
Testing Basics
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Every winner of every race in the US goes to
the test barn
Depending on the state, one or two additional
horses may be selected for testing
Typically both urine and blood samples are
drawn at the test barn
Samples are tagged with a unique identifier
and sealed to begin a chain of custody
Definitions
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Screening test- rapid and sensitive,
specificity not crucial. A sample with a
positive screening test would be said
to be “suspicious”
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Confirmation test- sensitive and
specific, if the result is positive the
presence of a forbidden substance is
said to be confirmed.
Definitions
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Limit of Detection—the lowest
concentration of a drug that can be detected
by a particular laboratory method.
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Limit of Quantitation—the lowest
concentration of a drug that can be reliably
quantified by a particular laboratory method.
Generally higher than the LOD.
Definitions
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Withdrawal Time – the time period that must
elapse from the time of administration of the
last dose of a drug formulation until the drug
concentration decreases below some
concentration in urine and/or blood.
– That concentration may be the LOD, the LOQ, or
some predetermined concentration.
– Factors affecting withdrawal time include dose,
route of administration, formulation, number of
doses administered, accuracy and precision of the
assay, and within-horse and between-horse
variability among other factors
Definitions
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Regulatory Limit
– When a drug and/or its metabolites are found in
the urine or blood at a concentration that is at or
below the regulatory limit, no administrative action
is taken.
– Also called a “threshold” or “decision level”
– European terminology = “screening limit”
– Can be a LOD, LOQ, arbitrary, based on data from
administration studies
Definitions
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Zero Tolerance—somewhat of a myth
since no testing methodology can detect
down to a concentration of zero.
– Usually suggests that the laboratory calls
positive any concentration of drug that is
detected
– Entirely dependent on the method being
used though
Zero tolerance?
Screening
Method
Thin Layer
Chromatography
ELISA
Limit of
Detection
~100 ng/ml
Detection
Time
~24 hours
~1 ng/ml
~72-96 hours
Mass Spectral
Methods
~25 pg/ml
~7-30 days
Zero tolerance?
Screening
Method
Sample
contains
150 ng/ml
Sample
contains
50 ng/ml
Sample
contains
50 pg/ml
State A Thin Layer
Positive
Chromatography
Negative Negative
State B ELISA
Positive
Positive
Negative
State C Mass Spectral
Methods
Positive
Positive
Positive
Definitions
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Hay, oats and water—there is really no
definition since the phrase means
different things to different people.
– No drug administration on raceday?
– No detectable concentrations of drugs on
raceday? Since we can’t detect down to zero
whose definition of “detectable” is used
– No drugs ever?
Hay, Oats and Water
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Keene Dangerfield, The Blood-Horse, 1979:
“One things I will say is that people who are
talking about going back to racing on hay,
oats and water don’t know what they are
talking about. We’ve never raced on hay, oats
and water…Today we simply are able to find
out what they are medicating them with.”
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
Reason…the industry asked for it to eliminate
bookmaking competition, state wanted to
control since gambling is a vice
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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Funding, funding, funding
Horsemen/practicing veterinarians have too
much influence in some states
U.S. Regulatory Framework—
What actually happens
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RMTC develops a model rule on a therapeutic medication
RCI Model Rules Committee and Board of Directors
approve model rule
The adoption of the model rule will be more restrictive
than what is allowed under state “A” current rule
State “A” begins adoption process
RMTC and sometimes RCI show up at a public
commission hearing and present rationale
Local horsemen and veterinarians say adoption of rule will
hurt racing in state “A”
You are the commissioner…who do you listen to? The guy
from out of town or the local guys who say racing in your
state will suffer?
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
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
Improved security measures
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
Model Rules V. 2005
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Permitted Therapeutics:
– IV administration of furosemide 4 hours
prior to post
– Anti-ulcer medications permitted 24 hours
prior to post
– One of three NSAIDS – Bute, Banamine &
Ketoprofen – 24 hours prior to post
Prohibited Practices
– ESWT restrictions
– Possession of blood doping agents
Salix/NSAID Adoption Progress
Language adopted
Language in the process of being adopted
Process require legislative action
Process has not been started
No horse racing or harness racing commission
Androgenic Anabolic Steroids
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Unregulated in US (except Iowa) up until 2007
Model rule developed proactively by RMTC in
2007
Rule set thresholds for 4 anabolic steroids and
prohibits presence of any others
Adopted the international thresholds for
endogenous anabolic steroids
Thresholds for stanozolol and nandrolone
based on the LOD using GC/MS in urine
(best science at the time)
AAS Adoption Progress
Language adopted
Language in the process of being adopted
Process pending completed administration studies
Process has not been started
No horse racing or harness racing commission
RMTC Goals and Objectives
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Industry closer to uniformity than ever before
Very few in industry thought RMTC would be this
successful in driving uniformity
Organizations involved standing behind rules
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
RMTC Goals and Objectives
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Improving Communication Efforts—Successful
– Industry
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Presence at conferences and organizational board meeting
Respected source of information for industry trades
Withdrawal times database on website
Regular newsletters, annual report
– Wagering Public
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Regular spot on Steve Byk show on Sirius
Educational materials on website
Database of positive tests with explanation of drug in
development
Source for mainstream press
RMTC Goals and Objectives
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Development of Uniform Withdrawal Times and
Thresholds—Too Early To Tell
– Accomplished:
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Identified drugs with legitimate therapeutic uses
Prioritized drugs into five groups based on number of
violations over 5 year period
Collected previous science on each drug
– Ongoing:
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Administration of each drug at relevant doses to 20 horses for
maximum statistical power
Analyze drug concentrations and determine withdrawal time
Ultimate goal: uniform withdrawal time with a
corresponding concentration of drug which regulates
the withdrawal time
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
Dexamethasone
Fluphenazine
Hydroxyzine
Nandrolone
Stanozolol
Testosterone
RMTC Goals and Objectives
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Challenges:
– Has taken much longer than anticipated
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Good science takes time but frustrating since we wanted
answers yesterday
No dedicated laboratory to analyze the significant
number of samples generated
Discrepancies in data between labs due to methodology
differences
– How do we determine desired withdrawal time?
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Pharmacodynamic markers
Best educated guess
– How to present data to reach goal of uniformity
RMTC Goals and Objectives
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Uniform Testing Procedures—Too Early To
Tell
– Post-race testing in the United States:
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Currently 18 laboratories conducting testing in US…too
many labs chasing too few dollars
Only 5 labs ISO 17025 accredited
– 30% of samples were tested by an accredited lab in ‘08
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Funding is state-by-state and many times is under state
procurement laws which reward low bidder or is
statutorily directed
No industry standards for US testing labs
Not enough attention being paid to sample collection
strategies
Number of Horses Selected Per Race
4.5
4
3.5
2.5
2
1.5
1
0.5
State
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ID
AZ
IL
W
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PA
O
K
NE
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KS
IN
CA
TX
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0
NY
Horses
3
Laboratory Budget By State
$4,500,000.00
$4,000,000.00
$3,500,000.00
$3,000,000.00
$2,500,000.00
$2,000,000.00
$1,500,000.00
$1,000,000.00
$500,000.00
W
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ID
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CO
DE
W
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NH
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IL
NY
PA
$-
Per Sample Testing Costs (Combined Blood and Urine)
$200.00
$180.00
$160.00
$140.00
$120.00
$100.00
$80.00
$60.00
$40.00
$20.00
$IL
KY
VA OH DE
IA
ME WV
TX
OR
IN
KS
AZ
NE CO ND WA
RMTC
Drug Testing Initiatives
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Task Force formed in September 2008
First meeting…design the best system for US Drug
Testing irrespective of funding and political
concerns
Consensus that we should utilize laboratory
standards developed by the World Anti-Doping
Association where applicable and work towards the
development of a performance-based system
Other related topics discussed…next generation of
lab directors, sample selection strategies and the
use of frozen samples
RMTC
Drug Testing Initiatives
Creation of Industry Standards for Labs:
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Edited version of the Lab Standards document
created by the World Anti-Doping Association
has been developed by the committee
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Standards rely on ISO 17025 accreditation as the first
step
An external proficiency program is then conducted
Labs failing proficiency cannot conduct testing
A percentage of the laboratory budget is mandated to
be directed towards research
Working on a truly external quality assessment
program for testing laboratories…hope to have in
place during Q2 in 2010
RMTC
Drug Testing Initiatives
Creation of Industry Standards for Labs
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Result will create the first set of industry
standards for post-race testing labs in US
Result will create the first ever external QAP in
the US
States/industry will have a document to “sell” in
order to provide incremental funding for lab to
meet standards
Will need funding for the industry organization
that takes on the role of WADA
RMTC
Drug Testing Initiatives
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Possible outcomes
– Incremental funding by states in order to
allow their labs to meet the standards
– Reduction/consolidation of testing labs
due to inability to meet standards and/or
failure in proficiency
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If implemented will lead to greater
uniformity in laboratory procedures and
methodologies
General Industry Challenges
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Funding for RMTC to continue research
Funding from state 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
Indirect issues that affect medication use
RMTC: Contact Us
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www.rmtcnet.com