As HISA Medication Program Nears Launch, Key Points Raised

This past year, the Horseracing Integrity and Safety Act (HISA) has encountered more legal scrutiny than Leona Helmsley's last will and testament. But as of writing, no court action prevents the law's anti-doping and medication control (ADMC) program from going into effect on March 27 in all but three states—Texas, West Virginia and Louisiana—pending Federal Trade Commission approval.

To prepare for launch, Mary Scollay, the Horseracing Integrity & Welfare Unit's (HIWU) chief of science, has been racking up frequent flier points on a whistle-stop tour of the country's horsemen's groups. On Monday it was Southern California's turn, when she addressed a full court of trainers, veterinarians and other interested parties in Santa Anita's Baldwin Terrace.

Lisa Lazarus, the chief executive officer for the HISA Authority, and Ben Mosier, HIWU's executive director, also addressed the media on Monday to discuss some of the broader looming changes.

The following is a round-up of a handful of key points shared in the above public presentations, from an interview TDN conducted with Scollay early Monday and through follow-up questions sent to HISA and HIWU.

For a full rundown of the impending rules, go to HIWU's website here and HISA's website here.

Voluntary Agreements, 2023 Fees

No states have so far officially signed voluntary agreements with HIWU to implement the ADMC program. “But we are in communication with all HISA-governed jurisdictions and will be prepared to implement the program on March 27,” wrote HISA spokesperson, Mandy Minger.

When it comes to the 2023 fee assessments, HISA has not yet invoiced states or tracks these assessments, said Minger. The following states, however, have already officially announced they won't pay the 2023 assessment (placing the financial burden onto the relevant tracks): Ohio, Oklahoma, Arizona, New York and Iowa.

Banned Substances, Bisphosphonates

Drugs are classified in two buckets, controlled and banned substances.

Controlled substances are those permitted for use within specific windows. A full inventory of these drugs can be found here. Banned substances are those prohibited at all times. A full list of these substances can be found here.

The list of banned drugs is fairly rote, but includes some substances of note, according to Scollay, such as isoxsuprine (which can increase blood flow), sarapin (a plant extract that deadens nerves), ammonium chloride (a salt), and carbazochrome (an anti-bleeding medication otherwise known as Kentucky Red).

Also banned under HISA are bisphosophonates, a controversial group of drugs—with brand names like Tildren and Osphos—used in older horses to tackle issues like navicular disease.

Though major U.S. sales companies have taken different steps to prohibit the off-label use of bisphosphonates in horses that go through their rings, some fear these drugs are still administered to young horses, including those coming from abroad.

A problematic feature of bisphosphonates is that they can remain in a horse's system for many years, making this a potentially slippery drug to track as horses pass through multiple hands.

This issue caused much consternation among the stakeholders at Santa Anita Monday, not least because a horse that tests positive for bisphosphonates under HISA faces a possible lifetime ban, said Scollay. The trainer also faces a possible two-year suspension for a first-time banned substance violation.

Further complicating matters is how a horse administered a bisphosphonate won't necessarily test positive for the drug consistently over time, explained Scollay.

“You can see ebbs and flows in bisphosphonates,” said Scollay. A likely positive test result occurs “when their bone remodels and you get activity for [the bisphosphonate] to be released into the blood,” Scollay added.

When purchasing a horse, is there something the buyer can do to shield themselves from possible later recrimination?

“As a condition of sale, I would have the seller attest that the horse has never been treated [with a bisphosphonate] so you have got the ability to turn that horse back and get your money back,” Scollay told the Santa Anita crowd. “It's a civil legal situation, but I think there are ways to protect yourself if needs be.”

Horses already in the racing pipeline may have been administered bisphosphonates in the past without their current connections' knowledge. With that in mind, one stakeholder asked Scollay if HISA's investigative body has the authority to go back over the horse's full medical history, in the event of a positive bisphosphonate test.

Though a young racehorse remains beyond HISA's legal purview until the time of its first official workout, HISA does have subpoena authority, explained Scollay. Ultimately though, as the HISA law is written, the burden of responsibility, she stressed, is placed on the trainer and owner's shoulders.

Note: In response to follow-up questions, HIWU said it was expected to be releasing educational materials about bisphosphonates in the near future.

Detection Times vs. Withdrawal Times

One of the key distinctions between now and March 27 is that HIWU is eschewing the current use of thresholds and withdrawal times for a medication schedule based on detection times.

What's the difference? Scollay—who broke it down in detail for the TDN last year—explains withdrawal guidelines as based on administration studies with a “statistically derived margin of safety” built in.

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

Rather than a statistically safe guideline, detection times are calculated through studies on a group of horses administered a certain medication to see the earliest time it is eliminated from all the horses' systems-a level below either the lowest concentration identified by the laboratory or below a defined screening limit.

Because horses can metabolize drugs at different speeds—and because of the sometimes small number of horses studied—detection times can provide an unreliable guide for withdrawing a medication from a horse's system to avoid an adverse test finding.

“Withdrawal times have a margin of safety built in. Detection times do not,” Scollay summarized, earlier on Monday. In other words, “withdrawal intervals should always be longer than the detection time.”

The question is: By how much?

HIWU does not have the authority to issue withdrawal guidance, explained Scollay. But she mentioned a veterinary pharmacologist called Pierre-Louis Toutain who suggests the following general rule of thumb. “His conclusion was that a conservative minimizing risk move is to take the detection time and multiply it by a factor of between 1.4 and 2.0,” said Scollay.

Help may soon be on its way, however.

Scollay said that the Racing Medication and Testing Consortium (RMTC) is in the process of calculating withdrawal times for commonly used medications on the controlled substances list, guidance anticipated to be issued well before March 27.

Standdown Times

That said, HIWU has established some important standdown times, including a restricted administration time for controlled medications 48 hours prior to a horse's scheduled post-time.

However, some substances are permitted up to 24 hours of a horse's post time. The full list—found here—includes orally administered vitamins, anti-ulcer medications, and certain antimicrobials.

To curtail “stacking” of non-steroidal anti-inflammatory drug (NSAIDS)—the use of multiple drugs simultaneously for increased effect—the detection of more than one NSAID is prohibited in a post-race sample, and in a post-workout sample including a vets' list workout.

Though all NSAIDS are prohibited within 48 hours, some of them will have withdrawal times beyond the 48-hour cut-off.

Intraarticular injections have an automatic 14-day standdown before a race and a vets' list workout. Scollay stressed that certain intraarticular injections—like those into the hocks and stifles—may need more than 14 days to clear. Intraarticular injections are restricted to seven-days before a routine work.

Polyacrylamide hydrogels (joint treatments like Arthramid and Noltex) have a 180-day stand down.

Read more on these mandatory standdown times here.

Testing

Come March 27, all industry participants will start with a clean state, their prior adjudicatory histories erased completely. That said, for some the new testing system will require no small amount of extra veterinary vigilance, especially during training.

Under HISA, there will be four main testing categories. Post-race. Post-workout. A vets' list workout. And an out-of-competition (OOC) test. Click here for an overview of the system.

Different categories of test permit and prohibit different medications. In OOC testing, for instance, only banned substances are prohibited, while a vets' list workout is treated like a post-race test. A catch-all: Lasix is controlled only in post-race samples.

Importantly, a positive finding from any of these tests can be pursued as a rule violation, said Scollay. A big sea change for many.

Historically, a positive test following a vets' list work, for example, simply resulted in the horse remaining on the list. Under HISA, however, a post vets' list workout positive can result in consequences to the trainer in the form of a fine or a suspension.

At Monday's meeting, Scollay addressed what had been an industry sticking point concerning access to private property. Rather than afford HIWU representatives blanket access to private facilities for OOC sampling, responsible parties must instead present the horse for testing as required.

“People think we're going to storm the court. That's not the case,” Scollay told the Santa Anita crowd. “You've just got to make sure we have access to the horse when we want to get testing done.”

Lasix

Come March 27, Lasix will be uniformly prohibited for use in 2YO races and stakes. For these horses, Lasix has a 48-hour restricted administration time at a 1mg/kg IV dose.

For horses still permitted Lasix on race-day, it cannot be administered within four hours before post-time.

A furosemide advisory committee has also been formed, charged with piecing together a study on the efficacy of Lasix usage, executing the study, then ultimately reporting their recommendations to the HISA Authority.

Compounded Medications

During Monday's presentation, Scollay raised an issue that has recently bedeviled California's backstretch veterinary community—compounded medications.

Scollay confirmed that compounded products are permitted under HISA as long as they comport with the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA).

“Compounding is a grey and fuzzy area, it confuses a lot of people—it confuses regulators,” said Scollay. Which is why HIWU is working on producing a compounding handbook.

There is a general no-no, however, when it comes to compounded drugs: “Convenience or cost control, neither is accepted by the FDA as justification for compounding,” said Scollay.

“So,” she added, “when someone puts fenbendazole and omeprazole into the same paste tube because it's easier to give one dose than two separate doses, that's convenience. That is not adequate justification for compounding.”

Clearance Testing

A trainer or a veterinarian can request from HIWU clearance testing of a horse to see if a specific medication is eliminated from its system in time to enter a race without triggering a violation.

This is not a free service. Proposed costs, however, have yet to be determined.

If clearance testing is conducted post workout, Scollay “strongly advised” that Lasix is not given within three hours of the work.

“If that horse is producing a dilute urine as a result of the Lasix, the relative concentration of whatever is in that urine is going to be lower,” she added. “You want valid results on your clearance test.”

Laboratories

While the Texas A&M Veterinary Medical Diagnostic Laboratory is not scheduled to make up HIWU's drug testing furniture, HIWU is still in the process of finalizing contracts with other RMTC-accredited laboratories to perform the testing come March 27.

Given the looming deadline, why haven't these contracts already been signed?

“I'm not party to those negotiations for the most part,” answered Scollay, prior to Monday's meeting at Santa Anita. “In general what I can say is, each lab' situation is unique,” she said, pointing to the multiple parties that weigh into these negotiations, and different testing capabilities between laboratories. “It's not a one-size fits all.”

Scollay added, however, that she has zeroed in on a “core group of analytes”—more than 320 of them—and has established a uniform set of performance specifications for each, which are different to screening limits and thresholds.

Each laboratory that eventually forms part of HIWU's testing network, Scollay added, “will be expected to meet those performance specifications.”

Results

HIWU's results management processes are broadly outlined here and for medication violations here.

HIWU is not required to make A sample findings public once that finding has been reported back to them.

Rather, HIWU is only required to publicly disclose the resolution of a potential violation within 20 days of a final decision, within 20 days of a resolution between HIWU and the covered person, or within 20 days of the withdrawal of a charge by HIWU.

“HIWU will not publish a resolution/final decision if it may compromise an ongoing investigation,” wrote HIWU spokesperson, Alexa Ravit.

The “resolution” will be published on HIWU's website and will include standard information like the name of the parties involved and any associated horses, the rule or rules violated, and the consequences imposed.

“Please note that it is not required to publicly disclose a violation if the Covered Person who has been found to have committed a violation is a minor,” wrote Ravit.

HIWU will also report select testing statistics on the HIWU website on a regular basis, wrote Ravit. What will that include?

“Examples of test statistics that could be published are the number and types of tests conducted in a given period,” Ravit responded.