Microsoft word - indiana letter november 2013_final

821 CORPORATE DRIVE · LEXINGTON, KY 40503 · PHONE: 859-224-2844 · FAX: 859-296-3033 · WWW.RMTCNET.COM
November 25, 2013
Joe Gorajec
Executive Director
Indiana Horse Racing Commission
1302 N. Meridian Street, Suite 175
Indianapolis, IN 46202
Dr. Angela Demaree
Equine Medical Director
Indiana Horse Racing Commission
1302 N. Meridian Street, Suite 175
Indianapolis, IN 46202
Mr. Gorajec and Dr. Demaree:
Thank you for your inquiry regarding the National Uniform Medication Program. RMTC is happy to respond
to the concerns raised in the Indiana Horsemen’s Benevolent and Protective Association’s (IHBPA) letter.
The RMTC welcomes the opportunity to explain the program and to resolve any concerns about it.
The National Uniform Medication Program is the result of a decade or more of work in the areas of medication
policies, laboratory testing, and increased penalties for multiple medication violators. The medication policies
proposed for the National Uniform Medication Program have been reviewed at the national level by multiple
industry stakeholders including the National HBPA and other horsemen’s groups. These policies represent an
attempt to reach long awaited uniformity in the horse racing industry.
Approved Medication Schedule
The Controlled Therapeutic Medication schedule is a list of medications which are allowed to be present in
test samples on race day if they are present at concentrations less than the applicable threshold. This list is the
result of many hundreds of thousands of dollars of research funded by the RMTC as well as other industry
groups. The IHBPA raises a number of issues regarding the providence and composition of this list. For
clarity’s sake, RMTC will address each issue in turn.
Issue #1
The IHBPA initially raised concerns regarding limiting the list to 24 therapeutic medications in lieu of a 51
medication list first developed in 2001. The characterization of the initial list of 51 medications by the HBPA
as approved therapeutic substances is specious at best. The original genesis of the 51 medication list was a
survey of practicing veterinarians compiled by RMTC. This list is the compilation of responses by 78
veterinarians surveyed. Those veterinarians were asked to list all medications that they used in 2001.
The original reason for producing the list was not to create an "end all/be all" for therapeutic medications. The goal was simply to prioritize the administration studies based on the drugs practitioners relied on the most at that time as well as which ones caused the most violations. Looking, however, at the list provided by the IHBPA, there are several medications that are not appropriate for approval of thresholds in 2013. For brevity’s sake, I will attempt to group these medications. Anabolic Steroids The IHBPA’s list includes boldenone, nandrolone, testosterone, and stanozolol. The first three are endogenous anabolic steroids with existing thresholds in the RCI regulations designed to reflect naturally occurring concentrations of these substances in the horse. Stanozolol is only available as a compounded pharmacy product giving rise to concerns regarding concentration of drug and purity of the active ingredient. As such the RMTC board unanimously voted to remove a regulatory threshold for this substance. Medications Lacking Efficacy Several of the medications on the list are not efficacious in the horse. Specifically, research completed in Dr. Tobin’s laboratory has shown that oral pyrilamine and isoxsuprine lack efficacy due to poor oral bioavailability as a result of a high first pass effect.i Long Term Tranquilizers The IHBPA’s list includes fluphenazine and reserpine. These drugs are long-acting tranquilizers that can have substantial central nervous system effects for up to 30 days. These were considered and quickly rejected due to the safety and welfare concerns associated with training horses at speed and racing horses on long term tranquilizers. Adjunct Bleeder Medications The IHBPA’s list includes two drugs that have been characterized as adjunct bleeder medications for use with furosemide. However, there is significant evidence that adjunct bleeder medications are not efficacious. Moreover, the Association of Racing Commissioner’s International (RCI) has determined that the only appropriate race-day medication is furosemide. Consequently, use of any adjunct bleeder medication on race day is prohibited. Other Concerning Medications A number of drugs with significant pharmacologic effects were reviewed but not included in the controlled therapeutic medication list. They are as follows: 1. Hydroxyzine – an antihistamine drug with significant side effects (tranquilization); cetirizine, an active metabolite of hydroxyzine without these side effects, is being considered for inclusion as an orally effective antihistamine as an alternative to hydroxyzine; 2. Trichlormethiazide – a weak diuretic which the AAEP has advised is normally administered at 24 hours in combination with dexamethasone. But now that dexamethasone cannot be used at 24 hours, AAEP veterinarians indicated no interest in pursuing a threshold for it; 3. Atropine – has significant cardiovascular and respiratory system effects associated with its use – ocular use is appropriate but would require significant time off as the eye is dilated for several weeks after use; 4. Buscopan – smooth muscle relaxant, usually used in cases of colic; 5. Beclomethasone – inhaled corticosteroid that is not FDA approved for use in the horse, limited research completed on this medication in horses; 6. Cromolyn – mast cell stabilizer that is not FDA approved for use in the horse, questions regarding 7. Pentoxifylline – vasodilator usually used in laminitic horses; 8. Phenytoin – anti-epileptic medication in humans – not FDA approved for use in the horse; 9. Diazepam – a benzodiazepine drug that is used for induction to surgery; 10. Dipyrone – not permitted by the FDA for any use in the United States. Other Medications Finally, there are a group of medications that either are being considered or could be considered for inclusion in the list. They are as follows: 1. Albuterol – currently undergoing review for possible inclusion on the list with a threshold that would permit use closer to race time than that permitted for clenbuterol. Anticipate having a proposal before the RMTC board in late 2013/early 2014; 2. Isoflupredone – currently completing research for this medication. Anticipate having a proposal before the RMTC board in late 2013/early 2014; 3. Ranitidine – administration study in progress for this medication; 4. Cimetidine – administration study in progress for this medication; 5. Cetirizine – administration study to be completed for this medication in early 2014; 6. Altrenogest – while not on the original list of 51, this drug is being considered for an administration
Issue #2
The current list of 24 medications has been reviewed by the AAEP Racetrack Veterinarians subcommittee.
Current research efforts reflect their input into the list. We consider them an “independent panel of nationally
respected racetrack veterinarians.”
Issue #3
As for a concern regarding cost, while it was not a primary concern, we are in the process of administration
studies for ranitidine and cimetidine. The focus of the group choosing medications was to look to those drugs
that had significant research reflecting their safety and efficacy in the horse. Therefore, preference has been
given to those drugs and medications approved by the FDA for use in the horse. Additional considerations
were to give priority to those that had the fewest side effects that could affect racing integrity.
Issue #4
The list has been in place for less than 6 months. In that time we have initiated research projects for at least 5
additional medications. These projects are expensive and our budget will not allow for expenditures in this
area. If there are concerns regarding the speed of this work, we invite the IHBPA to contribute funds to assist
with completion of the projects.
Issue #5
The existence of controlled therapeutic medications does not affect the ability of a veterinarian to use any
other appropriate therapeutic medication. Any appropriate therapeutic medication may be administered to
horses on the backside of a race track. The only difference between these drugs and the controlled therapeutic
medications is they cannot be present in a horse’s system at detectable concentrations on race day. Moreover,
the RMTC will not provide any information to practitioners regarding appropriate withdrawal times, doses,
and routes for these substances.
Issue #6
This allegation is unsupported. Simply put, this regulation does not discourage the development of new drugs.
Instead it encourages drug companies to work with RMTC and horse racing commissions on appropriate and
responsible use of medications. Moreover, as there is a preference for medications approved for use in the
horse by the FDA, it will, if anything, encourage companies to perform this extra research so that their
products will be considered for inclusion on the list of controlled therapeutic substances.
Issue #7
The penalties for all medications are at the discretion of the stewards – the same system that currently exists.
The Multiple Medication Violation Penalty System (MMV) assigns points clearly to each RCI Penalty Class
of medications.
Issue #8
This allegation is patently false. All substances on the list of 24 have significant scientific research supporting
the threshold and withdrawal guidelines. Moreover, the research for these has been vetted by private
veterinarians, regulatory veterinarians, analytical chemists, laboratory directors, and veterinary
pharmacologists and toxicologists. While the supporting data have not been made public for some of these
thresholds, summary reports have been available to the regulatory community prior to adoption of each
threshold. As for the list provided by the IHBPA, it is also incorrect. Please see the attached list of research
by controlled therapeutic medication.
Issue #9
The RMTC has, at the request of RCI, provided technical assistance on a National HBPA proposal regarding
environmental, endogenous, and dietary substances. These are being presented to RCI by the HBPA in
December.
Multiple Medication Violation (MMV) Penalty
The MMV is a system that is designed to address the serious issue of repeat drug and medication regulation
violators. Very few individuals will ever be subjected to penalties as a result of multiple medication
violations. Those few individuals with multiple violations are, however, responsible for forming the negative
public perception of medication and horse racing.
The IHBPA raises a myriad of issues regarding the MMV. These issues are identical to those raised by the
National HBPA before the RCI. Each of these issues was discussed and considered by the regulators prior to
enacting the current regulation. The IHBPA’s proposal would in essence eviscerate the MMV – by allowing
trainers more violations in a shorter period of time and have their suspensions run concurrently with any
suspension for the underlying punishment.
To address a few points specifically, however, the IHBPA would like all violations occurring within a period
of time prior to notification to be considered as one for the purpose of MMV. This would require medication
violations such as dermorphin to be treated as a single violation regardless of the number of positive findings.
The IHBPA states that it would not object to Class A violations being treated separately – but even this
provision would allow a trainer to have multiple stanozolol positives and require the stewards treat them as
one violation. Giving stewards the discretion to treat these violations separately does not alter the discretion
they currently have under the rule. The IHBPA states that this is not uniform – it would be just as uniform to
treat each medication violation as separate for the MMV. Removing discretion here is not appropriate.
The IHBPA wants to place the responsibility for expunging records for multiple medication violations on the
individual racing commissions. It is unrealistic to require commissions to track the multitude of licensed
trainers under their jurisdiction – when it is appropriate for a trainer, who is most familiar with his or her own
record, to track these points and request an expungement.
I hope this information is of assistance as you review the National Uniform Medication Program. I am happy
to speak with you at any time regarding these issues or any other questions you may have. Please feel free to
contact me at your convenience. Thank you.
i Dirikolu, L., et.al, Pyrilamine in the horse: detection and pharmacokinetics of pyrilamine and its major urinary
metabolite O-desmethylpyrilamine, J. Vet. Pharacol. Ther., 32(1): 66-78 (2009); Harkins, J.D., et.al, Absence of
detectable pharmacological effects after oral administration of isoxsuprine, Equine Vet. J., 30(4): 294-99 (1998).
Harkins JD, Mundy GD, Stanley S, Woods WE, Sams RA, Richardson DR, Grambow SC, Tobin T,.Absence of
detectable pharmacological effects after oral administration of isoxsuprine. Equine Vet J. 1998 Jul;30(4):294-9.

Source: http://www.horseracingreform.org/Pdfs/IndianaLetterNovember2013FINAL.pdf