HIWU’s Scollay: New Medication Rules ‘Your New Bible’

Despite all the legal jockeying these past few weeks and months, the Horseracing Integrity and Safety Act's (HISA) anti-doping and medication control program still appears set for launch on Jan. 1 in the vast majority of states that conduct pari-mutuel wagering.

This means on the first day of 2023, thousands of trainers, veterinarians and other backstretch workers must grapple with a new set of rules guiding how and when to administer a set of everyday medications–the list of which can be found here–to avoid falling foul of a post-race and out-of-competition positive.

Is there much of a difference between the Association of Racing Commissioners International (ACRI)'s current therapeutic medication schedule and that as outlined by the Horseracing Integrity and Welfare Unit (HIWU)?

Turns out there is–one that, in short, boils down to the differences between the current world of withdrawal guidelines and thresholds, and the looming system of detection times and screening limits.

“There is a substantial difference and if the terms are used interchangeably, there is a profound risk of a medication violation,” warned Mary Scollay, chief of science at HIWU, established by Drug Free Sport International.

Some of the key points as Jan. 1 looms large:

 

  • Detection times do not necessarily provide an accurate medication withdrawal guide;

 

  • New screening limits will require different administration protocols;

 

  • There will be no enforcement “grace period” for stakeholders to adjust.

 

  • This different medication schedule will require adjustments well before Jan. 1;

 

Withdrawal Guidelines vs. Detection Times

Traditionally, withdrawal guidelines are based on administration studies with a “statistically derived margin of safety built in,” said Scollay.

“The idea is that if you follow the administration protocol described in the study–dose, route of administration–and you comply with the withdrawal guidance,” said Scollay, “you should have a high degree of confidence that you will not have a medication violation.”

In other words, withdrawal guidelines provide a reliable cut-off point to administer a medication to avoid post-race positives.

This is in contrast to detection times under HISA, calculated through studies on a group of horses administered a certain medication.

These horses are then tested to determine the earliest time the drug is eliminated from all the horses' systems–a level below either the lowest concentration identified by the laboratory or below a defined screening limit.

This means that detection times “do not have any margin of safety calculated in,” warned Scollay. “It is the starting point for determining a withdrawal interval. So, the burden for establishing an appropriate withdrawal interval for medication now lies exclusively with the horses' connections.”

In any of these given studies, for example, the horses may metabolize drugs at different speeds–and potentially quicker than a racehorse given the same drug at the same dose.

Studies with a very small cohort of horses–like hydroxyzine, with a detection time of 96 hours from a study with only two horses–provide another reason why detection times can provide a very thin margin of error.

Imagine a study testing a doorframe set at six feet, explained one regulatory veterinarian. If the study participants are all under six foot, no problem. But what about all the six-foot plus individuals not studied?

For practicing veterinarians accustomed to concrete withdrawal times, therefore, this constitutes a sea-change in the way medications can be safely prescribed and administered to avoid costly post-race positives.

“There's no easy answer to this,” admitted Scollay. “I fully understand what a philosophical change this is, and yes, I understand that the vets can feel like they're flying blind right now.”

Aim of Schedule

Aside from a select few substances–like electrolytes, orally administered vitamins and anti-ulcer medications which can be administered up to 24-hours before a race–there is a mandatory 48-hour restricted administration time for all controlled medications.

For a number of these routine controlled medications, the dosage, withdrawal time and stipulated threshold in the current ARCI schedule are the same as the dosage, detection time and screening limits outlined by HIWU.

But where these differ, the differences might be subtle, easily over-looked. The ARCI's phenylbutazone threshold is 0.3 micrograms per millimeter, but is 0.2 micrograms per millimeter under HISA, for example–a small change with significant implications when it comes to its use in the days prior to a race. What's more, Scollay is unable to provide veterinarians and horsemen with specific withdrawal numbers. “HIWU and HISA are not in a position to provide withdrawal guidance,” she said. “I cannot say, 'I think you're going to be fine if you back out to 82 hours.'”

Things can get even trickier when HIWU provides zero dosage, detection time and screening limit guidance on a drug listed on the controlled medication list. But that doesn't necessarily mean veterinarians and trainers are indeed “flying blind.”

The corticosteroid betamethasone has no dosage or detection time listed, but it comes with a Restricted Administration Time (RAT) to race of 14 days (7 days for a work).

The Non-steroidal anti-inflammatory drug (NSAID) diclofenac–commonly found in a topical ointment to treat swelling and inflammation–similarly has no listed dosage and detection time.

As Scollay explains, that's because the process of calculating elimination times in an ointment–and therefore, one routinely applied in wildly different amounts to different parts of the body–is extremely difficult.

But this underscores, she said, the overarching aim of the new medication schedule–to foster a more conservative approach to veterinary medicine.

If diclofenac is used to treat a problematic joint, said Scollay, “from my perspective, once you've got that joint quieted down, I think you'd still want to assess that horse's response to treatment and assess the horse's recovery by breezing him.

“And so, you're not talking about ceasing treatment on a specific joint that has been inflamed and problematic going into a race in three days.”

In other words, if a topical diclofenac ointment is being used to treat certain musculoskeletal problems, then racing probably shouldn't be on the horse's imminent agenda, said Scollay.

Clearance Testing

More broadly, there's a very rough rule-of-thumb when it comes to calculating withdrawal times. One is that a short detection time is typically indicative of fast elimination from the system, said Scollay.

“But if something takes 96 hours to clear, I would be more conservative because I know it clears slowly,” said Scollay, speculating that “if I add just 24 hours onto that, I may not have allowed enough time for it to clear.”

But perhaps the most accurate guide for veterinarians and trainers concerned about a positive test, said Scollay, would be to conduct “clearance testing” well before race-day–a service provided through HIWU.

“We'll collect the sample from the horse, and then send it to the laboratory that's doing the testing. The trainer would have to provide information about the treatment, the drug, the dose, the frequency–when it was halted,” said Scollay.

It's not a free service, however.

“I don't know what that fee is yet,” Scollay added. “That would be paid for by the horse's connections.”

Importantly, the new controlled medication rules are primarily germane to post-race testing, not HISA's out-of-competition testing program, which is largely focused on banned substances.

That said, the new rules prohibit the presence of more than one NSAID or corticosteroid in both post-race and post-work samples–a prohibition designed to nix the practice of “stacking.”

HIWU's new common controlled medication list provides secondary detection times for three common NSAIDS, to help avoid a stacking offense.

Enforcement

Though the new drug rules might prove a marked change from the current status-quo, don't expect an enforcement grace period for stakeholders to acclimatize to their new regulatory expectations.

“The regulations don't provide for it,” said Scollay, categorically.

So, what are some of the implications for a positive of a controlled substance? An outline of the sanctions can be found here.

The majority of post-race positives are for everyday therapeutic medications–like phenylbutazone, a class C controlled drug, a first time positive for which would result in a fine of up to $500 and the automatic disqualification of the horse.

Which leads to another question: Who will be held responsible in the event of a positive?

The ultimate-insurer rule places the burden of responsibility on the shoulders of the trainer. But in the language of the law, there appears to be room for the veterinarian (and perhaps others) to be similarly held culpable.

As Scollay describes it, such a scenario would be case-specific. “The facts of the case would have to determine who else might be complicit,” she said. “To be fair, if it's an overage of a medication one would say, 'well, the vet didn't administer that without the trainer's knowledge and consent.'”

And so, when should veterinarians, trainers and others start applying these new controlled medication rules?

Given the 14-day stand down on all intra-articular injections–along with a 15-day detection time for the NSAID firocoxib–Scollay recommends familiarization with, and application of, the new rules as soon as possible, to avoid regulatory consequences come Jan. 1.

In other words, if trainers and veterinarians are deciding on withdrawal decisions after a horse is entered to race after Jan. 1, “they've waited too long,” said Scollay.

“I think more important is for veterinarians and trainers to review the document together and develop a shared approach to interpreting detection times,” she said. “And there is no time like the present for that.”

Education

Between now and Jan. 1, HIWU will apparently be releasing educational materials aimed towards regulatory and practicing veterinarians, and the trainers themselves.

Another intended event, said Scollay, is a webinar with a noted European veterinarian to explain how detection times and screening limits translate in Europe, where they've been in effect for much longer. Scollay was unable to provide details about then that might be, however.

The Racing Medication and Testing Consortium (RMTC) can act as an information intermediary, said Scollay, who added that industry stakeholders can contact her directly with any drug-related questions.

She also recommends printing off HIWU's controlled medication list—once again linked to here–before laminating and pinning it to the barn wall.

“I've been using the 'L' word every chance I can get. Laminate it, put it on your clipboard. Give them to your staff. That's your new bible,” Scollay said.

“There's no easy answer to this other than be more conservative and be more cautious of medication than you have been,” she said. “And ask yourself, 'does this horse really need it?'”

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Lazarus on HISA Anti-Doping and Medication Control

Bit by bit, the pieces of the puzzle are slotting into place for the Anti-Doping and Medication Control (ADMC) component of the Horseracing Integrity and Safety Act, set to go into effect at the start of next year.

Last month, that program was designated an agency to officially run it–namely Drug Free Sports International, an organization that has helped administer drug testing programs to a slew of major human sports leagues.

Then, last week, the draft ADMC rules were for put out public comment. These draft rules can be found here.

Adolpho Birch, Chair of HISA's ADMC Committee, concurrently issued a letter outlining the primary changes to the revised ADMC rules as compared to the draft rules previously issued, when the United States Anti-Doping Agency's (USADA) appeared set to become HISA's enforcement agency.

In the letter, Birch points out that possible sanctions for controlled therapeutic medication violations have been reduced, to make a clearer distinction between medication offenses where banned substances are administered, and those when controlled therapeutic substances have been given.

Furthermore, in the event of a positive test result and a request for a B sample analysis, someone from the enforcement agency itself will choose the laboratory, which may be a different laboratory from the one that did the initial analysis.

Tuesday morning, HISA CEO Lisa Lazarus held a media Q&A to discuss the draft ADMC rules further. The following is a summary of her comments.

Responsible Persons

Lazarus provided interesting context to the reasons underpinning the need for trainers and owners to maintain daily treatment records for the horses in their care, a basic outline for which can be found here.

The registration system designates a responsible person for each horse. And that in turn places the burden on the responsible trainer or owner to make sure that they keep detailed records and documentation–essentially, run a “tight ship,” as Lazarus put it.

In the event of a medication violation, therefore, the HISA Authority can request these documents and records, “and those records can become part of the case,” said Lazarus.

In relation to this, Lazarus also expanded on HISA's “whereabouts” program, which essentially ensures that all horses under HISA's remit are accounted for at all times.

In the first phase of the whereabouts program, set to go into effect early next year, responsible persons are required to submit a whereabouts filing if they remove a horse from a racetrack or registered facility.

In other words, said Lazarus, “If you take a horse to a private facility or a private farm, you have to notify us.” And there are possible penalties for non-compliance, including potential fines for failure to submit a whereabouts filing.

However, failure to produce a horse for drug testing results in a presumptive two-year violation (pending a hearing), irrespective of any test result.

“If you take a horse off a public racetrack where we know where the horse is, you don't tell us where the horse is with the whereabouts filing, we look for the horse, we reach out to the Covered Person–we're going to have access to all of this through our database–and they don't produce [the horse] immediately for testing, then, it's a presumptive two-year penalty,” said Lazarus.

Ultimately, said Lazarus, the plan is for a system in place that identifies the whereabouts of any covered horse at any time.

“But one of the things we want to understand and see is whether or not we can really just mine that data from existing resources without putting a paperwork burden on participants,” she said.

Case Management

Before diving into this section, there are some important nomenclature changes to note, as compared to the previous draft rules' use of “primary” and “secondary” substances.

Under these revised draft rules, “prohibited substances” is an umbrella term for anything that shouldn't be in a horse on race day. Banned substances refers to doping substances, while controlled medications are essentially therapeutic substances.

A list of banned and controlled substances, along with possible sanctions in the event of a positive test result, can be found here.

Lazarus provided a snap-shot of the case management process.

In the event a horse tests positive for a banned substance like a steroid, an anabolic agent or a growth hormone, the responsible person is immediately suspended until a hearing takes place.

“The presumption is that this is a two-year sanction,” said Lazarus.

However, that two-year sanction can be reduced if the responsible person can show “no fault or no significant fault,” said Lazarus, adding how any penalty reduction is predicated upon the responsible person proving how the substance got into the horse's system in the first place.

“So, for example, if you're in a situation of a steroid [positive] and you want to argue that somebody gave the horse a steroid without your knowledge, you have to actually prove that [scenario] to the confidence and satisfaction of the hearing panel,” said Lazarus, who also explained how there will be potential four-year bans in the event of “aggravating circumstances” like trafficking, evading sample collection and tampering with samples.

Public Disclosure of Test Results

Under USADA's version of the ADMC program, one rather controversial component concerned how A samples results weren't necessarily going to be automatically disclosed to the public.

But Lazarus pointed to a change of tune, with A sample results now indeed set to be made available online.

“You'll know the covered person, covered horse, and the substance that was detected in the sample,” she said. “You'll be able to follow the case essentially as it goes through the various steps. [For example,] if there's a hearing to lift a suspension that'll be recorded, the decision will be recorded,” she added.

Shortened Adjudication Timelines

The timeline to hear and adjudicate cases will be “incredibly reduced” when compared to the current model at the individual state level, said Lazarus.

After a hearing, for example, the arbitrator will have to issue a decision within 14 days. In the appeals process, defendants have 30 days to file an appeal to the charges, and then, a hearing must happen within 60 days after initial notice.

When asked if the tightened system provides adequate time for defendants to mount a fair defense–especially in complex cases–Lazarus said that cases will be adjudicated on an individual basis, with wriggle room given in “exceptional circumstances” so as not to compromise due process.

That said, the truncated timeline–along with any provisional suspension in the event of a banned substance violation–could also act as an incentivizing lever, said Lazarus.

“If you're dealing with a two-year penalty and it's a banned substance, you're going to be suspended during the case processing scheduling period, and so they're probably going to be very motivated to have it heard quickly as well, so, it also protects the participants,” she said.

Registration Numbers

According to Lazarus, nearly half the horses and covered persons who need to be registered by July 1 have done so. However, racing offices will soon provide a “can't race flag” if a horse that is entered to race is not registered with HISA, she said.

This is intended more as a prompt, said Lazarus, as it won't necessarily affect the horse's eligibility to race, just as long as that horse is, indeed, registered by July 1.

Drug Testing

The actual ADMC testing program is still being developed, said Lazarus, and so, specifics are thin.

That said, in the past various officials have suggested that under HISA, all winners won't necessarily be tested post-race–something of a departure from the current model.

Lazarus indicated, however, that indeed, the post-race drug testing net could still accommodate all winners.

“We're trying to balance a robust testing program that has a deterrent effect with the intelligence-based advantages you get from looking at intelligence metrics,” said Lazarus.

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Hall Of Fame Trainer Fighting Testosterone Positive For Harness Racing Champion

Perfect Sting, named 3-year-old male pacing champion of 2021 by the U.S. Harness Writers Association when Dan Patch Award winners were announced on Dec. 20, was subsequently found to have failed a drug test from the $148,332 Pennsylvania Sire Stakes at The Meadows that took place six months earlier.

The ruling, published  at the United States Trotting Association website on Dec. 31 and reported at HarnessLink.com, stated that Perfect Sting tested positive for testosterone at a level of 3,765 pg/ml. A split sample subsequently confirmed the finding at a level of 3,635/pg/ml.

Trainer Joseph Holloway has been suspended 15 days from Jan. 17, 2022, through Jan. 31, 2022, and fined $500. Perfect Sting, who was elevated to first place in the Pennsylania Sire Stakes via disqualification of the original first-place finisher, has been disqualified from his win, with $74,166 in purse money ordered returned and redistributed.

Perfect Sting, also the champion 2-year-old pacer in 2020, was harness racing's richest performer in 2021 (prior to this ruling). Holloway, a member of the Harness Racing Museum Hall of Fame, was recipient of the Dan Patch Good Guy Award in 2021.

Holloway, who has appealed the ruling, contends Perfect Sting was never given testosterone, according to a report in HarnessLink.com. Instead, he suggests, the testosterone level of Perfect Sting – an intact horse – may have spiked naturally through proximity to an in-heat mare or other reason. Levels for testosterone for females and gelded males are more predictable than full colts and stallions.

“Stallions can have seasonal highs and lows for testosterone levels,” said Dr. Mary Scollay, executive director and chief operating officer of the Racing Medication and Testing Consortium. “That's why RMTC does not recommend a threshold level for testosterone.”

Pennsylvania may be the only racing state that has a threshold level for testosterone for intact male horses, apparently set at 3,000 pg/ml.

Holloway told HarnessLink.com he has sent hair samples from Perfect Sting to a laboratory in the United Kingdom that he said “can tell whether the testosterone at that time was given to him, or  it is just natural in his system at such a high level.”

Read more at HarnessLink.com

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The Friday Show Presented By Woodbine: Colorado Test Barn Caper

One way to beat a bad drug test is for the split sample to disappear. At least that's the working theory behind a break-in at the test barn at Arapahoe Park in Aurora, Colo.

Natalie Voss, editor-in-chief for the Paulick Report, joins publisher Ray Paulick in this week's edition of the Friday Show to recount the Colorado test barn caper that Voss wrote about earlier this week, including security lapses and missteps investigators appeared to make along the way.

While Arapahoe is not a major racing circuit, Voss points out several things racing officials around the country can learn from this unusual crime in the Centennial State.

Bloodstock editor Joe Nevills reviews the performance of this week's Woodbine Star of the Week, the 5-year-old mare Mutamakina, who led a 1-2 finish for trainer Christophe Clement in the Oct. 17 renewal of the Grade 1 E.P. Taylor Stakes at the Toronto, Ontario, track, giving jockey Dylan Davis his first career G1 victory.

Watch this week's Friday Show, presented by Woodbine, below:

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