A Diabetes Drug’s Outsized, Contested Role in Horse Racing’s Anti-Doping Crusade

Trainer Mike Lauer is now a month past serving what he believes was an unjust 75-day suspension because a Thoroughbred under his care at Horseshoe Indianapolis tested positive last summer for metformin, a drug used to treat diabetes in people. With more 20 million patients taking it, metformin ranks as the nation's third-most-prescribed human medicine, according to the consumer healthcare website Healthgrades.

Before Lauer's case made it to an official arbitration hearing, the 72-year-old conditioner with five decades of licensure was able to present enough evidence to the Horseracing Integrity and Welfare Unit (HIWU) for the agency to conclude that the likely source of the metformin was “unintentional contamination” by a groom who had ingested his doctor-ordered blood sugar-regulating tablet at lunch, then touched the mouth of Mowins (Mohaymen) while fitting the gelding with a bit and bridle for an Aug. 5 race.

But even though that negotiated HIWU resolution stated that “Mr. Lauer's degree of fault is in the light range” and that he “fulfilled his personal responsibility to be knowledgeable of the Anti-Doping and Medication Control Program and to inform all personnel associated with the care, treatment, training, or racing of his Covered Horses,” the evidence was only enough to reduce–not eliminate–Lauer's potential penalties of a two-year suspension and $25,000 fine, which are HIWU's standard sanctions for banned substances.

The “banned” category is the most serious class of drug offences under Horseracing Integrity and Safety Act (HISA) rules. Those substances are considered the most harmful and egregious, and are never supposed to show up in tests on any covered Thoroughbred.

Lauer and his wife, Penny, detailed to TDN how they spent $45,838 over a five-month span trying to clear Lauer's name and keep his training business afloat while fighting the ruling, which ended up with a $2,600 fine in addition to the 2 1/2-month suspension.

But, the Lauers said, they can't calculate the direct costs of the logistical headaches they endured while trying to temporarily disperse a 50-horse racing stable among five new trainers for the time that Mike was ineligible to compete.

Nor, the Lauers added, does the financial outlay take into account the lost income from Mike's being unable to ply his trade, purse money from two of Mowins's races that had to be forfeited, or the credibility blow the ruling inflicted upon the outfit's reputation.

They also aren't sure that their groom was even the correct source of the metformin positive, even though the groom came forward and volunteered the timetable of events that Mike Lauer agreed to when signing his “case resolution without a hearing/final decision” document.

Lauer told HIWU investigators that he, too, takes metformin as prescribed by a doctor, although he said he had not touched Mowins anywhere near the gelding's face in the week before the positive test. The Lauers also said they paid $1,100 to have testing done on the Shelbyville, Indiana, water source that supplies the track's stable area, and it revealed traces of metformin.

Mowins | Coady

As a trainer since 1976 with an 11.7% win rate from 9,988 starts that is not suggestive of performance-enhancing drug use, Lauer's stock in 2023 was spread across three divisions stabled in Kentucky, Ohio and Indiana, and his entrants ranged from a horse who ran third in the GI Man o' War S. at Belmont Park to lower-end claimers who routinely competed at Belterra Park.

Lauer has only three previous medication violations listed against him on The Jockey Club's online rulings database. All were for penalty category C (the lowest level of severity) infractions that occurred in races in 2009 and 2018 (twice). They resulted in fines of $250, $1,000, and $1,500 as per then-in-effect racing commission standards in Kentucky and Indiana, plus a 10-day suspension for the latter positive because it was his second violation within a one-year period.

Lauer said he's doing the best he can to put HIWU's bureaucratic rodeo behind him while focusing forward now that he's permitted to train again. But it seems every time he tries to clear his mind of the ordeal, some little reminder of it pops up to skewer him anew.

Like a couple weeks back when Lauer was attending a horse auction, and an industry acquaintance approached him and said by way of greeting, “Well, I see they caught ya!”

Lauer ignored the wiseguy's remark. Still, the stigma of it stung.

“You get little cracks like that,” Lauer said. “But we lost clients. We lost a ton of money, and I mean a ton. And we went through a ton of aggravation. My life's not back to normal, and I don't know when it will be.”

Penny Lauer, a part-owner of Mowins, the gelding whose urinalysis came back positive for metformin after he ran third at 21-1 odds in an allowance sprint, put it this way:

“Just the fact that Mike's name was plastered all over having a positive test, people take that info and run with it. Everybody thinks you're cheating. We had to change so many things [for horses owned by Penny and other longtime clients] to be able to run, and pay people that we wouldn't normally had to pay if Mike was able [to train]. We did nothing wrong, yet took a big hit for it. Metformin is not cheating. We didn't put it there. It was just there.”

Penny Lauer continued: “There are so many people that touch and care for a horse every day, and even more people on a race day, that a trainer, no matter how much care you take with safe protocol, it is impossible to even know what you come into contact with.

“If you want to believe what HIWU laid out regarding the probability of where this metformin came from, we are talking about possibly a dusting from a pill, on the hands of the groom that transferred it to the bit that the groom put in the horse's mouth, and the horse eventually peed out, and [was] not [detected in tests of] blood,” Penny Lauer said.

“And you think this actually made a difference in the performance of this horse?” Penny Lauer asked rhetorically. “Ridiculous!”

And confusing. The Lauers said that even after hiring an attorney and having their own back-and-forths with HIWU, plus a pre-conference call with an arbitrator, and after speaking to scores of veterinarians, stewards, and racing commission officials in an effort to seek supporting information to bolster their case, they still don't have a clear understanding of why metformin is considered a purported performance-enhancer.

Nor do the Lauers know why the diabetes drug's presence in a horse carries such draconian penalties.

They also said they have no clue as to why the five positive tests for metformin since HIWU took over the sport's drug testing in May 2023 have resulted in widely varying outcomes.

In October, two trainers–Javier Morzan of the mid-Atlantic region and the New Mexico-based Guadalupe Munoz, Jr.–had metformin charges against them withdrawn after an internal HIWU review of its six accredited laboratories discovered different limits of detection in blood for metformin, a problem that HIWU officials said has since rectified by harmonizing those detection values across all labs.

In November, Angel J. Castillo Sanchez, a conditioner based in the mid-Atlantic, resolved a metformin positive in one of his trainees by signing an “admission of rule violation and acceptance of consequences” agreement with HIWU that resulted in an 18-month suspension and $12,500 fine.

In December, Anthony Farrior, the leading trainer at Charles Town, had charges from a metformin positive triggered at Laurel Park dropped. He had requested testing of the split sample, but HIWU determined the specimen's volume was “insufficient for analysis,” so the complaint was withdrawn.

Another metformin positive from June has yet to be resolved by HIWU. Trainer Jonathan Wong remains under provisional suspension in a case involving a test from a maiden-breaking filly at Indiana Grand.

Jonathan Wong | Benoit

Wong, too, faces up to a two-year suspension and a $25,000 fine. He has publicly disclosed that he has a valid metformin prescription to control his own diabetes. Despite being out of work since July 2 while his case makes its way through the system, Wong told TDN back in August he had “zero problems” with the concept of HISA, and that its oversight was “much needed.”

But, added Wong, “when you're completely not awarded any opportunities from day one until your hearing, that's pretty much being charged as guilty until proven innocent. I feel like I've been locked up and had the key thrown away.”

Perspective is Everything

Widening the lens, the metformin positives can be grouped into a broader issue that involves other drugs ingested by people whose residues sometimes show up in equine drug tests. Some of those substances, like methamphetamines and cocaine, are drugs of human abuse with a low likelihood of having been intentionally administered to enhance a horse's performance. But because of their illegal and dangerous nature, they are in the “banned” category.

For example, there are currently five pending methamphetamine violations awaiting adjudication by HIWU. Five others have already been ruled upon, all from horses in the stable of Prairie Meadows trainer Dick Clark, who admitted the violations and accepted the consequences of being ruled off for 90 months and a $62,500 fine, the largest penalties on record since the inception of HIWU.

Lauer told TDN he believes HIWU is going after easier human-drug contamination targets rather than rooting out true horse dopers. His belief is that anxiety over getting caught for something that is essentially out of one's control is causing innocent horse trainers to get out of the business.

“I wish HIWU would catch somebody,” Lauer said. “All they're catching is [the equivalent of] parking tickets. That's all they're passing out, and they're just crucifying trainers for things like metformin and meth.”

TDN emailed Lisa Lazarus, the chief executive officer for the HISA Authority, asking if she'd answer several overarching questions: Is this the way HIWU and HISA are really supposed to work? Are the Authority and HIWU comfortable with the idea that trainers–even some who were initially supportive of HISA–are expressing legitimate fear over getting their lives derailed by accidental contaminations?

Lazarus agreed to a phone interview to discuss the situation. Over the course of about 35 minutes one morning last week, she gave her perspectives on metformin, inadvertent contamination cases, and the evolution of her agency.

Opponents of HISA might not like some of what she said. But give Lazarus credit: This sort of back-and-forth dialogue about real-life concerns over medication control policies had been notoriously difficult for TDN (and other media outlets) to engage in with racing commission personnel prior HIWU's advent, back when those agencies controlled the nation's drug testing under state-by-state rules.

(Disclaimer: Because Lauer opted not to give permission for Lazarus to speak to TDN about any aspects of his case that haven't already been made public via HISA and HIWU documents, Lazarus was unable to go too deeply into specifics about Lauer's negotiated settlement.)

And before Lazarus would tackle any general questions, she wanted to get a few points on the record for perspective and background. She asserted that HISA and HIWU are not tone-deaf to industry complaints, and she said there is evidence to show that the agencies have been proposing new policies when they realize the original ones aren't working the way they were intended to.

Those changes, Lazarus said, have included altering how provisional suspensions for likely inadvertent contaminations get reported, providing ombudsman assistance and pro-bono legal resources for trainers who can't afford to hire a lawyer, and a renewed focus on getting racetracks to clean up receiving barns and other common areas where horses might be subject to environmental contamination.

Lisa Lazarus | The Jockey Club photo

Lazarus also stressed that while catching alleged cheaters and keeping them from getting an illegal edge is a main concern for HISA and HIWU, the agencies are also mandated to focus on horse welfare, which drives some of the reasoning on how substances that are generally considered human drugs of abuse are handled.

“Somebody who's on meth shouldn't be walking a 1,200-pound animal around the backside,” Lazarus said, underscoring the obvious safety hazard that scenario presents.

“Horses shouldn't have to be exposed to drugs that the trainers and grooms are taking,” Lazarus explained. “There should be some degree of care, even if it's not obviously anywhere near the culpability of an intentional administration to get a performance advantage.

“Trainers tell me all the time that they treat their horses better than they treat their children,” Lazarus said. “Well, you wouldn't let your child be exposed to meth. And so it's a professionalization that we're trying to achieve and we think is important.”

Lazarus continued: “I don't doubt that you have trainers that share with you the concerns that you've raised. And we try to be really responsive to those and to show empathy and engage, and where we need to make changes, we do.

“But I've also had so many trainers call me and say that for the first time, they feel like they have a chance when they compete, that they don't feel like they have to use substances or compete with somebody else's pharmacy,” Lazarus said.

“I've also heard anecdotally that there are a number of horsemen that had artificially high win percentages that have now been normalized,” Lazarus said.

“The most objective thing in the universe, in my view, is you take a sample from the horse, it goes to the lab, and it comes back positive or negative,” Lazarus said, defending HIWU's methodology.

“There's no subjectivity in that. There's no judgment. We can only be governed by that,” Lazarus said. “Otherwise you get into this–what I think was a problem with the state racing commissions–'Who's a good guy/who's a bad guy? He had a clean record/He didn't have a clean record.'

“We can't operate like that, because you lose all credibility,” Lazarus said. “You're not objective. One of the best things about HIWU is that they're a totally objective organization. They don't have local relationships. They don't know, most of the time, who these trainers are. The sample, the positive test, is always adjudicated the same way.”

The Fault Continuum

Still, Lazarus said, HISA and HIWU have recognized that changes are needed with regard to human-drug positives that are likely caused by contamination, and she said the agencies have responded by proposing fault-based rule changes that are expected to be approved by the Federal Trade Commission (FTC). At the same time, Lazarus added, HIWU is holding off on adjudicating exposure cases for human drugs of abuse until the FTC makes a decision on the proposed rule tweaks.

“In that sense, trainers have been able to benefit from what we expect to be these new relaxed rules without having to wait for the FTC to approve them,” Lazarus said. “We're going to continue to try to bring in ideas like that, to lessen the burden [on trainers] and to help us really identify what needs to be addressed and to take care of what doesn't need to be addressed…

“Our new system is all about fault,” Lazarus continued at a different point in the interview. “And when you have a high degree of fault, you'll have a higher penalty. When you have a low degree of fault you'll have a much lower penalty.”

But while those changes will, in theory, mitigate positive tests from illegal street drugs like methamphetamines and cocaine, the new standards won't apply to a commonly prescribed diabetes pill like metformin.

Why not?

“We look at [metformin] as a potential risk, so we don't put it in that category,” Lazarus said. “We do have intelligence that metformin is being used intentionally to enhance performance.”

HISA and HIWU aren't obligated to disclose the exact nature of such intelligence. That would be akin to handing over their enforcement playbook to alleged dopers, the reasoning goes.

When asked specifically what metformin might do to make a horse run faster, Lazarus said she believed it might be able to improve endurance. She later had a HISA staffer email supporting information that stated metformin “does impact glucose metabolism, so it could have an effect on overall performance.”

Those views aren't widely shared by everybody, though, and published research on metformin's alleged role as a performance-enhancer (in either humans or horses) is not definitive.

In human athletics, metformin is not prohibited by either the World Anti-Doping Agency or the  United States Anti-Doping Agency. Anecdotally, some bodybuilders take it because they believe it helps them appear more “cut” in terms of reduced body fat, which has led to misperceptions that it can build muscle. Other broad claims contend that metformin can reduce inflammation or provide anti-aging benefits in people.

In U.S. horse racing, metformin has been listed as a Class 2/Penalty Category B drug under the Association of Racing Commissioners International (ARCI) classification system since 2018.

A mid-level designation, Class 2 drugs are defined by ARCI as substances “that have a high potential to affect performance, but less of a potential than drugs in Class 1. These drugs are 1) not generally accepted as therapeutic agents in racing horses, or 2) they are therapeutic agents that have a high potential for abuse.”

But are the positive tests for metformin being triggered more by coincidental contaminations or by intentional administrations?

The winter 2023-24 issue of The Horsemen's Journal contained a “Fact or Fiction” article that touched on veterinary perspectives of the five recent HIWU positives for metformin.

The article stated that “Metformin is so ubiquitous in the environment that it can be found in drinking water whenever it is looked for, including at the racetrack [Horseshoe Indianapolis] where two of the violations were found. Metformin use is so common in humans that many studies have been conducted to determine if it has an effect on athletic performance, and the overall conclusion of those studies is that the only measurable effect is increased perception of exertion. This effect would detract from performance rather than enhance it.”

Lazarus said that HIWU's methodologies for metformin testing are designed to screen out accidental contaminations and to differentiate them from intentional administration.

“I'm not saying that every horse that tests positive for metformin is an intentional abuse,” Lazarus explained. “Obviously, there are very innocent explanations, and there are explanations where that fault continuum should be in the [trainer's] favor. I'm just saying that there are situations where it is being used to enhance performance, and that's where we have to be more careful about it than we might have to with meth or cocaine…

“The level at which the laboratories have agreed to call metformin a positive, in their view, sort of rules out inadvertent exposures,” Lazarus said. “It doesn't necessarily rule out someone putting their hand in the horse's mouth after they take metformin. But it's intended to really limit it to either a gross negligence or an intentional situation…

“Mr. Lauer's [test on Mowins] wasn't one of them, because it was obviously above [the limit for a positive],” Lazarus said.

Lazarus dismissed the contention that metformin in a water supply can cause a violation.

“It's not possible to get a positive test through metformin in the water,” Lazarus said. “The [testing] level that we have excludes the possibility.”

That's why achieving harmonization on testing levels at laboratories is so crucial for HISA and HIWU, Lazarus said.

“We're harmonized on more than 300 [substance levels] right now,” Lazarus said. “But obviously, some substances that are prohibited have never been detected. So they have to be detected first for the labs to agree on a level of detection. So there is some degree of that that is always going to be ongoing, as science tries to catch up with the very small percentage of the industry than might be trying to use substances nefariously for gain. There's always a risk that those folks are sometimes a little bit ahead of the labs…

“However, because the system is based on fault, if you do come, like Mr. Lauer did, with an explanation, and that explanation is credited, then obviously you are going to get a more lenient sanction,” Lazarus said.

“So in [Lauer's] case, his suspension was 2 1/2 months out of a potential of 24 months,” Lazarus said. “And his fine was about 10% of the maximum fine. So that just shows how HIWU viewed his fault on that continuum.”

'Happy' or 'Hell'?

Lauer steadfastly believes he was wronged by HIWU and HISA, while Lazarus firmly asserts the systems at those agencies worked exactly the way they were intended to.

Surely, there must be a middle-ground perspective. TDN sought out Alan Foreman, who is widely recognized as one of the nation's leading racing law and equine attorneys, to see what he had to say on the subject.

In September 2023, Foreman, the chairman and chief executive officer of the Thoroughbred Horsemen's Association, agreed to serve as an impartial go-between, or ombudsman, on behalf of HISA, HIWU, and horsemen. In this role, he provides confidential advice and assistance at no cost to trainers, owners and other HISA-covered persons, while communicating feedback to the agencies about how they can improve their programs. When Foreman took the job, he pledged to donate all compensation paid by both sides to the Thoroughbred Aftercare Alliance.

Alan Foreman | Horsephotos

This means Foreman is usually the first person trainers contact when HIWU notifies them of an alleged infraction. Lauer sought him out, and he said they spoke for several hours when Lauer first learned of the ruling against him. But in keeping with his obligations as an ombudsman, Foreman told TDN he would not be able to discuss Lauer's case in detail because of confidentiality requirements.

However, one of the first general points Foreman made about Lauer's case that he said should be heartening to horsemen is that Lauer was able to resolve his charge without having to go through with the full-blown hearing process.

“Up until now, it's required a trainer to go through the expense and the difficulty of prevailing in an arbitration,” Foreman said.

“There are changes in the pipeline,” Foreman said. “We've been discussing this and pushing for these changes for some time. There is a change presently that has been submitted by HISA to the FTC with respect to the drugs of illicit human use that would give to HIWU the discretion to resolve those cases, and they can do so by concluding that it is more likely than not that the positive was the result of contamination. 'Inadvertent exposure' is the term I like to use, as opposed to an intentional administration.

“So if HIWU is satisfied that the positive test was not the result of an intentional administration, the penalty is now reduced to a maximum of 60 days, and that can be mitigated down based on facts and circumstances. And assuming the FTC approves these changes, that would allow HISA and HIWU to resolve this with the trainer short of having to go to arbitration,” Foreman said.

“It would be handled similarly to the way racing commissions handled them before HISA and HIWU went into effect,” Foreman said. “And that was a part of the system that was not broken, and did not need fixing. I think there was satisfaction that the racing commissions were correctly handling those kinds of cases. And the handling was, if a positive test was reported, obviously the horse was disqualified because it had a drug in its system. But the trainer penalty was substantially mitigated.

“In many jurisdictions, the trainer was not penalized,” Foreman said. “The disqualification of the horse was deemed to be a sufficient penalty. Some jurisdictions may have imposed a fine or a short suspension. But nothing like the drastic penalties that are being imposed now, which can be career-ending [for] something that a trainer probably could not have prevented.”

Foreman continued: “This area of contamination seems to be the most vexing area. My own personal observation, at least based upon the calls that I get, is that the number of banned substance violations has substantially decreased. I'm not seeing that many, at least [for] those where trainers are calling me, or I need to refer people out to attorneys. That seems to have calmed down. What has surprised me [is] I thought that there would be a large number of positive tests in the controlled substance area, the therapeutic medications, because we were going to screening limits, because we were going to international standards.

“We were, in many respects, backing out the withdrawal time, or the time within which a drug should be administered to a horse, to 72 hours, as opposed to previously, with the non-steroidals, we had gone from 24 to 48 hours. But that hasn't materialized. There have not been a substantial number–at least compared to prior [findings from] HISA and HIWU–of positives as a result of the new system. Which to me is a very positive indication for the industry,” Foreman said.

“The horsemen have been adjusting to the new system, and it's working,” Foreman said. “That doesn't mean that horsemen aren't scared to death when they see these contamination violations and they're concerned about what is happening to these trainers. At least we're attempting to get that under control. And when I say we, I'm certainly trying to do it on behalf of the industry. I don't work for HISA. I don't work for HIWU. But they have been listening. I think they've been coming to grips with the problems they created here. I think they're hearing the outcry from the industry and they are adapting to it…

“So slowly but surely, changes are taking place,” Foreman summed up. “That's what I've been advocating for.”

Lazarus, in her separate interview, corroborated Foreman's observation that the banned substance violations are decreasing.

“When we first launched the program, about 40% of the positives were for banned substances, what we would categorize as doping,” Lazarus said. “That has completely dropped, [so] I think that has had a genuinely important impact. There are also a number of investigations that are ongoing that I believe are going to have a very positive impact.

“[HIWU is] only seven months in, so I need a little bit more time to bring some of these things to fruition,” Lazarus said. “But I really believe that this is a strong, fair, balanced, effective program. And we're going to have to continually tweak and evaluate and be open to feedback. But I think overall, I am very happy with where we've stood on that balance.”

However, when asked if she concurred with Foreman that the contamination positives were the “most vexing” part of the system, Lazarus had a different take.

“I think what happens a lot is when one horseman gets concerned about something, and they speak about it on the backside, it becomes almost like an epidemic of concern,” Lazarus said. “And so that is probably the most difficult thing for us to deal with generally, is some of the misinformation, and some of the, kind of, 'fear-mongering' that I think is sometimes intended by our detractors.

“I think when we're at the year mark, there's going to be a fair amount of comfort with where we are,” Lazarus said. “I think if you ask any trainer, they will tell you that on the [controlled] medication side our program is fair and balanced and working. I haven't heard a single complaint about the medication program. The adjustment is the severity and the different system on the doping side. And I think that's important for the evolution of the industry and for us to get to a point where we're protecting the clean trainers.

“That's what it's all about, right? Protecting the trainers who are competing fairly, and also who have systems in place to avoid some of the mismanagement of medication or inadvertent exposure,” Lazarus said. “We're going to get better at that, and I think over time trainers are going to feel more comfortable with what they have in place and that the risks to them are very low, and that if they do have an inadvertent exposure, that we'll treat it fairly.”

As a way of wrapping up the conversation, TDN proposed an analogy to Lazarus: Would it be fair and accurate to say that in any large enforcement endeavor like an anti-doping control program, there are going to be growing pains as the system gets rolled out, and even if the agencies make corrections along the way, it's inevitable that there are going to be some trainers–like Mike Lauer–who end up being collateral damage as the result of HISA and HIWU's evolving methods of enforcement?

Lazarus didn't buy that line of reasoning.

“I don't consider him 'collateral damage,'” Lazarus said. “I think he actually received very fair sanctions under the circumstances. Under the previous state racing commissions, fault was never a consideration. It was a pure, strict liability thing [and] the consequences were extreme without any opportunity to defend….

“Mr. Lauer settled his case. That was his choice. He did not have to do that, but he decided to settle his case, and that was the resolution that he was happy to accept,” Lazarus said.

“Happy” is not how Lauer would describe the ending to his five-month ordeal with HISA and HIWU.

“Hell” was the adjective he chose.

“They were going to drag me out,” Lauer said, noting that even though his case never reached an actual hearing, he still got invoiced $13,700 for having initiated the arbitration process.

After submitting all his supporting documentation by the first weekend of December, Lauer said the attorney for HIWU “wanted to try and make a deal, and if we couldn't, he was going to ask for more time to submit his brief so the hearing [date] would have to be reset.”

Lauer said HIWU's initial offer of a $4,000 fine and 120-day suspension was “not acceptable” to him. The next offer was the $2,600 fine and 75 days with time served, which was to end his suspension by Dec 25, 2023.

Essentially, Lauer said, he accepted that settlement just to get his life back.

“My attorney said this is the best deal you're going to get without going to the hearing and a possible appeal and all that,” Lauer said. “Plus the money, and the extra time, and you have no idea if you're going to win or lose.”

Now that he's back in action, what's Lauer's takeaway message for other trainers who might find themselves in the crosshairs of HISA and HIWU over a metformin positive?

“Their whole operation is very intimidating,” Lauer said. “And it's aimed to be intimidating.”

The post A Diabetes Drug’s Outsized, Contested Role in Horse Racing’s Anti-Doping Crusade appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

Source of original post

Weekly Stewards And Commissions Rulings, Dec. 12-18

Every week, the TDN posts a roundup of the relevant Horseracing Integrity and Safety Act (HISA) related rulings from around the country.

Among the key rulings from the last seven days is the saga surrounding Tankinator, a horse at the centre of two positfives within 17 days.

On Oct. 21, Tankinator finished 6th at Delaware Park. Tankinator was claimed out of Webster Gayle's barn that day before running again on Nov. 7 for Bonnie Lucas at Parx Racing. Tankinator was pulled up and vanned off in that race. It's unclear whether Tankinator was euthanized.

In pending rulings posted on the Horseracing Integrity and Welfare Unit's (HIWU) website, the 5-year-old gelding's post-race sample after his Oct. 21 appearance tested positive for the corticosteroid Dexamethasone, a controlled drug commonly used as an anti-inflammatory.

Tankinator's post-race sample after his Nov. 7 run tested positive for Xylazine, a controlled drug that can be used to sedate or tranquilize horses.

According to a HIWU spokesperson, the notice for the first positive test was sent out after the horse ran again on Nov. 7, as the post-claim owner would not have had the option to void the claim through HISA without being aware of the first positive test. Gayle and the post-claim owner were alerted to the dexamethasone positive at the same time, the spokesperson added.

In a separate case, trainer Michael Lauer was handed down a two and ½ month suspension after his horse, Mowins, had tested positive for the diabetes drug, Metformin, after finishing third at Horseshoe Indianapolis on Aug. 5. He was also fined $2,600. Lauer's suspension began on Oct. 12.

HISA lists Metformin as a banned drug, meaning it comes with a possible two-year suspension.

According to the case resolution posted on HIWU's website, the groom looking after Mowins had a prescription for Metformin, which he took twice daily. The day of the race, the groom, Jorge Ceballos, took the medication during lunch, before preparing Mowins for the race, “which included putting the bridle in Mowins' mouth,” according to the case resolution.

HIWU agreed that “Mr. Lauer was able to establish the source of Metformin by a balance of probability was unintentional contamination by Mr. Ceballos during his pre-race grooming preparations,” according to the case resolution.

Trainers Jeffrey Englehart and A. Ferris Allen were each issued seven-day suspensions and $1,000 fines for Phenylbutazone positives. Phenylbutazone is a Class C controlled medication. For both trainers, the sanctions handed down constituted their second Class C substance violations under HISA.

NEW HISA/HIWU STEWARDS RULINGS
The following rulings were reported on HISA's “rulings” portal and through the Horseracing Integrity and Welfare Unit's (HIWU) “pending” and “resolved” cases portals.

Resolved ADMC Violations
Date: 11/05/2023
Licensee: Anthony Farrior, trainer
Penalty: No penalty. Equine anti-doping charges withdrawn. B Sample volume insufficient for analysis.
Explainer: For the presence of Metformin-a banned substance-in a sample taken from Geothermal, who raced at Laurel Park on 11/5/23. This was a possible violation of Rule 3212-Presence of a Banned Substance and/or its Metabolites or Markers.
Read more on the story here.

Date: 10/28/2023
Licensee: Tony Lello, trainer
Penalty: A fine of $500; imposition of 1.5 Penalty Points. Admission.
Explainer: For the presence of Methocarbamol-Controlled Medication (Class C)-in a sample taken from Reel Em In. This was a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 10/25/2023
Licensee: Joe Pizzurro, trainer
Penalty: A fine of $500; imposition of 1.5 Penalty Points. Final decision by HIWU.
Explainer: For the presence of Phenylbutazone-Controlled Medication (Class C)-in a sample taken from Atlantic Firestorm. This is a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 09/28/2023
Licensee: Terry Eoff, trainer
Penalty: Disqualification of Covered Horse's Race results, including forfeiture of all purses and other compensation, prizes, trophies, points, and rankings and repayment or surrender (as applicable); a fine of $500; imposition of 1.5 Penalty Points. Admission.
Explainer: For the presence of Methocarbomal-Controlled Medications (Class C)-in a sample taken from Kentucky Dawn, who finished second at Remington Park on 9/28/23. This was a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 09/01/2023
Licensee: A. Ferris Allen, trainer
Penalty: 7-day period of Ineligibility, beginning on December 13, 2023; Disqualification of Covered Horse's Race results, including forfeiture of all purses and other compensation, prizes, trophies, points, and rankings and repayment or surrender (as applicable); a fine of $1,000; imposition of 1.5 Penalty Points. Admission.
Explainer: For the presence of Phenylbutazone-Controlled Medication (Class C)-in a sample taken from Aristocratic, who finished second at Colonial Downs at 9/1/23. This was a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 08/05/2023
Licensee: Michael Lauer, trainer
Penalty: Two and ½ month (i.e., 75-day) period of Ineligibility for Covered Person, beginning on October 12, 2023; 60-day period of Ineligibility for Covered Horse, beginning on August 31, 2023 (already served); Disqualification of Covered Horse's Race results obtained on 08/05/23 and 08/23/23, including forfeiture of all purses and other compensation, prizes, trophies, points, and rankings and repayment or surrender (as applicable); a fine of $2,600. Final decision of HIWU, and admission.
Explainer: For the presence of Metformin-a banned substance-in a sample taken from Mowins who finished third at Horseshoe Indianapolis on 8/5/23. This was a possible violation of Rule 3212-Presence of a Banned Substance and/or its Metabolites or Markers.

Date: 07/17/2023
Licensee: Jeffrey Englehart, trainer
Penalty: 7-day period of Ineligibility, beginning on December 13, 2023; Disqualification of Covered Horse's Race results, including forfeiture of all purses and other compensation, prizes, trophies, points, and rankings and repayment or surrender (as applicable); a fine of $1,000; imposition of 1.5 Penalty Points. Admission.
Explainer: For the presence of Phenylbutazone-Controlled Medication (Class C)-in a sample taken from Graywing, who finished fourth at Finger Lakes on 7/17/23. This is a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers.

Pending ADMC Violations
Date: 11/29/2023
Licensee: Lacey Gaudet, trainer
Penalty: Pending
Alleged violation: Medication violation
Explainer: A possible violation of Rule 3314-Use or Attempted Use of a Controlled Medication Substance or a Controlled Medication Method-on the horse, Graceful Union. This is also a possible violation of Rule 4222-Intra-Articular Injections Within Seven (7) Days of Timed and Reported Workout.

Date: 11/25/2023
Licensee: Peter Walder, trainer
Penalty: Pending
Alleged violation: Medication violation
Explainer: A possible violation of Rule 3314-Use or Attempted Use of a Controlled Medication Substance or a Controlled Medication Method-on the horse, Hello Jack. This is also a possible violation of Rule 4222-Intra-Articular Injections Within Seven (7) Days of Timed and Reported Workout.

Date: 11/14/2023
Licensee: Robert Lucas, trainer
Penalty: Pending
Alleged violation: Medication violation
Explainer: For the presence of Dexamethasone-Controlled Medication (Class C)-in a sample taken from Shake N Fries. This is a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 11/13/2023
Licensee: Librado Barocio, trainer
Penalty: Pending
Alleged violation: Medication violation
Explainer: For the presence of Phenylbutazone-Controlled Medication (Class C)-in a sample taken from Sugar Fish. This is a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 11/13/2023
Licensee: Librado Barocio, trainer
Penalty: Pending
Alleged violation: Medication violation
Explainer: For the presence of Phenylbutazone-Controlled Medication (Class C)-in a sample taken from Barristan the Bold. This is a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 11/13/2023
Licensee: Ron Rozell, trainer
Penalty: Pending
Alleged violation: Medication violation
Explainer: For the presence of Pemoline-a banned substance-in a sample taken from Bavaria. This was a possible violation of Rule 3212-Presence of a Banned Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 11/08/2023
Licensee: Ilmar Loaiza, trainer
Penalty: Pending
Alleged violation: Medication violation
Explainer: For the presence of Dexamethasone-Controlled Medication (Class C)-in a sample taken from Roseinthesky, who finished second at Finger Lakes on 11/8/23. This is a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 11/07/2023
Licensee: Bonnie Lucas, trainer
Penalty: Pending
Alleged violation: Medication violation
Explainer: For the presence of Xylazine-Controlled Medication (Class B)-in a sample taken from Tankinator, who was pulled up and vanned off in a race at Parx Racing on 11/7/23. This is a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 10/21/2023
Licensee: Webster Gayle, trainer
Penalty: Pending
Alleged violation: Medication violation
Explainer: For the presence of Dexamethasone-Controlled Medication (Class B)-in a sample taken from Tankinator, who finished sixth at Delaware Park on 10/21/23. This is a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Date: 09/21/2023
Licensee: Bret Calhoun, trainer
Penalty: Pending
Alleged violation: Medication violation
Explainer: For the presence of Diclofenac-Controlled Medication (Class C)-in a sample taken from Ain't Broke, who won at Churchill Downs on 09/21/23. This is a possible violation of Rule 3312-Presence of Controlled Medication Substance and/or its Metabolites or Markers (Post-Race/Vets' List).

Violations of Crop Rule
One important note: HISA's whip use limit is restricted to six strikes during a race.

Los Alamitos
Diego Herrera – violation date Dec 16; $250 fine, one-day suspension, 2 strikes over limit
Giovanni Franco – violation date Dec 16; $250 fine, one-day suspension, 1 strike over limit
Kyle Frey – violation date Dec 17; $250 fine, one-day suspension, 1 strike over limit

OTHER KEY RULINGS
The TDN also publishes a roundup of key official rulings from the primary tracks within the four major racing jurisdictions of California, New York, Florida and Kentucky.

Here's a primer on how each of these jurisdictions adjudicates different offenses, what they make public (or not) and where.

New York
Track: Aqueduct
Date: 12/14/2023
Licensee: Manuel Franco, jockey
Penalty: Three-day suspension
Violation: Careless riding
Explainer: For having waived his right to an appeal Jockey Mr. Manuel Franco is hereby suspended for three (3) NYRA racing days January 1st 2024, January 4th 2024, January 5th 2024 inclusive. This for careless riding during the running of the 6th race at Aqueduct Racetrack on December 9th 2023.

Track: Aqueduct
Date: 12/18/2023
Licensee: Junior Alvarado, jockey
Penalty: Three-day suspension
Violation: Careless riding
Explainer: For having waived his right to an appeal Jockey Mr. Junior Alvarado is hereby suspended three (3) NYRA racing days January 1st 2024, January 4th 2024, January 5th 2024 inclusive. This for careless riding during the running of the 9th race at Aqueduct Racetrack on December 16th 2023.

The post Weekly Stewards And Commissions Rulings, Dec. 12-18 appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

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Drug Testing Under HISA: When Uniformity and Variability Collide

From an altitude of 10,000 feet, the Horseracing Integrity and Safety Act (HISA)'s mandated goal is a simple two-pronged affair. Uniformity in welfare and safety. Uniformity in drug testing.

Over the past few months, the Horseracing Integrity and Welfare Unit (HIWU)–HISA's enforcement arm–has made several announcements that have peeled the curtain back on just how difficult the second part of that equation will be to accomplish.

Internal reviews of the six HIWU-contracted laboratories uncovered different limits of detection in blood for diabetes drug Metformin and for benzoylecgonine (BZE), a metabolite of cocaine. In the case of Metformin, all the positives originated from just the one lab.

After dropping several cases against trainers for Metformin and BZE positives, HIWU explained that it had subsequently harmonized its “testing sensitivity” in blood across the six labs for these two substances, and that it would repeat the harmonization process for other drugs, including banned substances of which there are listed well over a thousand.

“There are an awful lot of substances out there that we need to sort through, and we won't sort through them until they're actually identified by a laboratory,” said HIWU chief of science, Mary Scollay, at a recent HISA town hall. “But we are committed to harmonizing across laboratories in fairness to stakeholders.”

Scollay then added this coda: “It's important to realize that the lack of harmonization across laboratories has existed for decades.”

For those who have watched drug testing evolve in the sport over the years, Scollay's words hardly came as a shot from the dark. One of the key drivers of federal regulation of horse racing was to eliminate the crap-shoot nature of drug testing under a state-by-state system.

But under HISA, why haven't these differences been ironed out?

The answer involves a bracing plunge into the opaque waters of drug testing, where clear answers can be as easy to retrieve as Excalibur from its stone, and where arcane terminology is used interchangeably depending upon the person talking.

But it turns out that a variety of issues–from different testing equipment to different testing methodologies to different sets of staff interpreting the results–have all played a part in leading the sport to where it finds itself now.

HIWU has “testing specifications” for more than 300 “core” analytes–most of them controlled medications but some banned substances–to which all HIWU-contracted laboratories are required to test.

“Beyond those analytes, HIWU has asked each laboratory to utilize the broadest scope of analysis available to them,” wrote Scollay, in response to a list of questions.

Outside of those 300 or so core analytes, therefore, testing variability from facility to facility means the six HIWU-contracted labs are screening for different numbers of substances, and have varying abilities to screen for the same substances, according to drug testing experts. In other words, the same sample sent to two different laboratories could result in two different sets of results.

Furthermore, as HIWU–which was built by Drug Free Sports International–continues to work through a laborious “lab harmonization” process, what are the implications for the horsemen and women facing potentially life-changing sanctions for banned substance violations? And how can stakeholders be assured that newly established harmonized limits adequately factor in the risk of inadvertent contamination, especially those banned substances ubiquitously used by humans?

“It would be one thing if this was just a fine and a ten-days [ban],” said Cynthia Cole, former director of the University of Florida's (UF) laboratory. No contractual agreement was reached between the UF lab and HISA. In different equine anti-doping cases, Cole has both provided testimony for HIWU, and prepared opinions for trainers defending themselves.

“But these bans, these are career ending for people,” Cole added. “I just feel really strongly that the bar should be very high, and that there should be no doubt that there was a violation.”

 

History

“Incredulity and disbelief ran neck and neck, but outrage outstripped them both at Santa Anita Saturday as horsemen reacted angrily to the latest drug scandal to rock thoroughbred racing.”

The above paragraph, which reads as though plucked from a story from recent years, instead originates from a 1989 LA Times article, when a spate of cocaine positives had entangled several trainers, including leading lights like Wayne Lukas and Laz Barrera.

The reason given for the sudden rash of cocaine positives? That Truesdail Laboratories, the drug testing laboratory used at the time by the California Horse Racing Board (CHRB), had started to use more sophisticated equipment to analyze the samples.

According to one official at the time, the “improvements in testing” had suddenly increased the sensitivity of the equipment “10-fold.”

In other words, new state-of-the-art instruments were detecting substances in blood and urine at previously unachievable levels. Some said at the time the levels were so small as to be inconsequential–a refrain that has turned into a steady drumbeat in the intervening years.

“The increased sensitivity in drug testing has resulted in a number of things being called positives that never would have been called before,” said Eric Hamelback, chief executive officer of the National Horsemen's Benevolent and Protective Association, speaking at the 2019 National HBPA Convention.

The same drumbeat has reverberated around other equine sports, as well.

Nearly 20 years ago, one Irish veterinarian who had administered a “mild sedative” to the high-level show jumper, Landliebe, one-month prior to a failed drug test subsequently issued a public statement evoking “amazement” that traces of the drug could still be found in a horse's system after that time.

On a practical front, drug testing has evolved in an attempt to keep up with an ever more sophisticated array of performance enhancing drugs and doping methods. In human sports at least, regulators don't appear to be winning that war, for there remains quite a lag-time between new drugs coming onto the scene and reliable ways to test for them.

But advances in testing sensitivity has also had the effect of widening the gap between possibility and practice from one lab to the next. For it turns out there exists a complicated set of issues that weigh into testing variability between facilities.

The instruments used to analyze samples, the way tests are prepared for sampling, the types of tests run, the substances being tested for, staffing expertise, ongoing research into the detection of emerging substances and a slew of other issues all play a part.

 

Just Why Are Labs Different?

In pre-HISA days, individual state commissions contracted their drug testing programs out to individual laboratories. And though most states followed the Association of Racing Commissioners International's (ARCI) model rules, it still left a lot of contractual wriggle room around things like the scope and type of testing performed, what specific matrices–blood or urine, for example–were being tested, and so on.

At the end of the day, however, the relative accuracy and breadth of each drug testing program can–like so many things in life–be distilled down to money. Funding for the drug testing program, for one. And funding to keep the laboratories at the cutting edge of science.

“In a lot of cases, the determining factor in those contracts was price, with the low bidder winning the work,” said Richard Sams, an expert in racing chemistry and toxicology. Sams is also a former lab director currently advising several defendants in cases against HIWU.

“Low-bidding often meant limited testing, and oftentimes, not very high quality testing,” Sams added.

Take Joe Gorajec's term as executive director of the Indiana Horse Racing Commission. Back in 2015, he organized for blood samples taken from harness and Quarter horses to be sent to the California-based Truesdail Laboratory–the Commission's official lab at the time-and to two audit laboratories: LGC in Kentucky, and Industrial Laboratories in Colorado.

Gorajec's actions led to the Indiana racing commission severing ties with Truesdail after it failed to detect in three samples high levels of commonly used corticosteroids that the other two laboratories detected.

Under HISA, of course, the regulatory dynamic in drug testing has changed. But horse racing has swapped out a patchwork quilt of different rules for a patchwork quilt of different labs.

Though a single entity now contracts out a set of testing requirements to six different laboratories, the fact that no two labs are created equal remains a thorn in the side of testing uniformity. And experts single out two primary reasons why.

One concerns the instruments used to analyze the samples. In a recent presentation at the Global Symposium on Racing in Arizona, Scollay compared the situation to the use of different ovens from kitchen to kitchen.

This is where the specter of poor funding continues to loom large. “Some of the laboratories have brand new instruments–state of the art,” said Cole. “Other laboratories, not so much.”

Historically well-funded laboratories like UC Davis's “Maddy Lab” in California and the University of Kentucky's Equine Analytical Chemistry Laboratory have “a lot of new equipment and a lot of very well-trained chemists and technicians,” said Cole.

When it comes to HIWU-contracted laboratories like the Ohio Department of Agriculture's Analytical Toxicology Laboratory, and the Animal Forensic Toxicology Laboratory at the University of Illinois-Chicago, “these are smaller laboratories with generally older equipment,” Cole said.

“Over the years, they've adapted to what they've been asked to do, and they've developed their own methods of testing and confirmation methods, and they're not the same,” said Cole.

To get a gauge on just how crucial funding can be, a top-of-range liquid chromatography-mass spectrometry system can retail around the $750k mark. And these machines can have a shelf-life of only around a decade, give or take a few years, due to ongoing technological advances.

The other key area concerns drug testing extraction methods. This is the process by which the substance or analyte is removed from the blood or urine to be examined under an instrument like a mass spectrometer.

There are all sorts of different extraction processes for different analytes, and each of these processes can be “substantially different” depending on the lab, Sams said.

“The fraction of the drug that's present in the sample that gets removed by the process can vary considerably from one lab to the next,” said Sams.

Horse racing is far from the only sport confronting these sorts of problems. Just take this 2022 paper, in which three Norwegian researchers focus on the World Anti-Doping Agency (WADA)'s approach to drug testing in human athletics.

“Some laboratories are capable of detecting lower concentrations of prohibited substances than other laboratories, simply because the laboratories may use different equipment and/or test methods,” the researchers write.

 

HIWU'S Approach

If lab variability has been a decades-long problem ensnaring all professional sports, not just horse racing, why has it become a lightning rod under HISA?

One of HISA's most compelling selling points has been the advent of a level playing field comprising the same drug testing rules and a stable of accredited laboratories “testing for the same banned and controlled medicines at the same level,” as HISA CEO, Lisa Lazarus, put it in September of this year.

But for the reasons already identified, the goal of a completely fair drug testing playing field for all participants–no matter their location in the country and no matter where a sample is sent-is a major challenge when dealing with multiple laboratories.

The more labs needing to be unified in their capabilities, equipment and approaches, the more complex and expensive the problem.

For U.S. horse racing, the crux of this issue primarily surrounds HISA's lengthy list of banned substances–those substances, in other words, beyond the more than 300 core analytes that HIWU's six labs can test for reliably.

Banned substances are not supposed to be detected in a horse's system at any point, racing or training. As such, violations for these substances come with the heaviest penalties under HISA, including a potential two-year ban for the trainer. No trifling matter, therefore.

Unlike most controlled substances under HISA–those with set thresholds and screening limits–banned substances under HISA are being tested to limits of detection, which is the lowest concentration of a substance that can be identified by a laboratory. And different labs can have different limits of detection for the same substances. That's if they're testing for them at all.

As Cole puts it, “I think the really difficult issue has come up with the banned substances, which is where they basically have said, 'if it's there at all, it should be called.' That's been a problem because you can have a laboratory that's very, very good at finding [a banned substance], and then another lab where their ability to detect [a banned substance] isn't as good.”

When asked about this aspect of the drug testing program, Lazarus wrote in emailed answers to questions that “it is important to remember that all samples at any given racetrack go to the same Laboratory,” so lab variability is not a problem within the same “races and meets.”

It's unclear just how many banned substances for which HIWU has set harmonized limits of detection. Nor will the specific limits be made public, once established.

“HISA/HIWU cannot comment on the number of Banned Substances that have a harmonized Limit of Detection,” wrote Scollay. “Since Banned Substances should never be in a horse, laboratory testing specifications for them are not published.”

Another key question is this: Exactly how many substances is each lab routinely screening for?

According to one state regulator–who asked to remain anonymous–the most proficient HIWU-contracted laboratories are screening for around double the number of substances as some other HIWU-contracted labs.

Scollay didn't deny the claim, but explained how beyond the more than the 300 “core” analytes, “HIWU cannot speak to the overall capabilities of each lab.” She added, however, that a key part of the harmonization process is the “collaboration and sharing of information” between labs.

 

Human Drugs

Which leads to the issue of those banned substances which are commonly found in everyday life, like legitimately prescribed human drugs.

What process is the agency using to ensure that the harmonized limits of detection weigh the possibility of intentional misuse of a banned drug in a racehorse against the threat of inadvertent contamination?

In her written responses, Scollay explained that the agency uses any or all of the following criteria to set “relevant, effective, and achievable” harmonized limits of detection in banned drugs:

Dr. Mary Scollay | The Jockey Club

1–A survey of the laboratories to determine their current capabilities to detect the substance.

2–Conducting a review of the science surrounding the substance to determine illicit use in human and equine sports, or its effects in other mammalian species.

3–Assessing the threat level of the substance. “I.e., the potential for that substance to be present in the horse's environment beyond the control of the trainer,” Scollay wrote.

 

Scollay wrote that HISA and HIWU also consult the international community on testing specifications, “and consider their controls on Banned Substances and Controlled Medications that are not regulated by Screening Limits or Thresholds.”

A feature of the new regulatory environment is the potential for trainers to be provisionally suspended for banned drug positives while they await a hearing.

In Jonathon Wong's case, for example, the trainer has been provisionally suspended for at least 170 days for a June 1 Metformin positive.

What happens if one of the six HIWU-contracted labs detects a new banned substance without a harmonized limit of detection? How will the cases be handled while the harmonization process takes place?

“The actions taken will depend on the specific circumstances of the case with an emphasis on fairness to all racing participants,” wrote Scollay.

 

International Community

International regulators like the British Horseracing Authority avoid the issue of lab variability by using only using one primary facility to test their samples in their jurisdiction.

But how do other international jurisdictions handle substances with no established international threshold, residue or screening limits?

In Europe, at least, the answer sounds familiar.

The European Horserace Scientific Liaison Committee (EHSLC) considers some substances to be prohibited-at-all-times, as is the case with anabolic steroids and other anabolic agents. For these substances, European laboratories generally work to the lowest concentrations their confirmatory analysis procedures allow.

But the EHSLC also maintains an evolving list of substances that have “target sensitivities”–in other words, agreed-upon screening concentrations similar in effect to HIWU's “harmonized limits of detection,” said Clive Pearce, an internationally renowned animal sports medication and doping control expert.

To generate this list, the EHSLC's veterinarians, analytical chemists, pharmacologists, and racing administrators work together to select substances whose presence in a racehorse's blood or urine sample would be of particular concern.

What are these concerns? That such substances are, for example, unlicensed veterinary products, routinely used human medicines, or environmental and plant-based contaminants, Pearce explained.

The “sensitivities” agreed upon for each substance reflect the concentrations considered to have the potential to affect a racehorse's performance or to compromise its welfare.

More broadly, for all substances subject to the EHSLC's process for achieving drug screening harmonization, the most important consideration is that all its laboratories are able to routinely deliver the same level of detection, said Pearce.

According to Pearce, the list of substances with “target sensitivities”–drug substances and their major metabolites in both blood plasma and urine–total about 150.

At the symposium in Arizona, Scollay explained that there are now new “open lines of communication” between HIWU and the EHSLC.

Why can't the EHSLC simply share all relevant information on substances with “target sensitivities” with HIWU, therefore? It turns out it's not that simple.

“The international community's research and laboratory testing specifications are confidential,” Scollay wrote. “International jurisdictions limit their information dissemination due to potentially compromising their own anti-doping and medication control programs.”

Other experts consulted for this story were more specific. They explained that the litigious nature of U.S. horse racing can make international jurisdictions wary of sharing with their American counterparts sensitive information that might be publicly divulged during a case.

If all boats can't be lifted by readily shared information across international borders, how else then to make the program here better, quicker?

 

Solutions

Gorajec is all in on federal oversight of racing. He played an instrumental part in getting HISA passed in Washington. But he said he has his reservations about the current drug testing program.

“This shouldn't be an issue at this juncture,” said Gorajec, highlighting the documented problems associated with uniformly detecting BZE, the cocaine metabolite long on regulators' radars. “They had a couple, three years to get their arms around this. Cocaine has been around for decades.”

HIWU-contracted labs must be accredited with an international standards organization and with the Racing Medication and Testing Consortium (RMTC), the latter of which handles an external quality assurance program, which includes single- and double-blind testing of the six labs.

HIWU officials are also putting together another accreditation program to “build on the foundations” of the international and RMTC accreditation systems as the agency “moves testing laboratories towards harmonization of methodologies and sensitivities across the spectrum of Prohibited Substances.”

What would help, Gorajec said, would be to significantly raise accreditation standards to whittle down the number of HIWU-contracted labs to just the most proficient. “That should have already been done,” he said.

When asked about Gorajec's comments, Lazarus wrote that HIWU will evaluate the contracted laboratories on a regular basis, “and if a Laboratory does not meet HIWU's performance criteria, it will not be continued in the program.”

Cole suggested for HIWU to establish an oversight committee-possibly populated by a chemist, a veterinary pharmacologist and an industry figure-to review new or unusual findings and make recommendations as to whether they should be pursued.

“They are trying to fix the plane while it is in the air,” said Cole, about the work HIWU officials are doing to fix the problem of lab variability. “But they are trying.”

According to Ed Martin, president of the Association of Racing Commissioners International (ARCI)–another key industry figure not shy of voicing his concerns and frustrations with the federal law–HIWU should convene a long meeting between the various lab directors with the sole purpose of reaching an agreement as to what the “point of regulatory action” is on a list of some of the more commonly called substances.

“It would seem to me, the best way to insulate themselves from legal challenges would be to get that done sooner rather than later,” Martin added.

In response to Martin's suggestion, Scollay wrote that HIWU conducts weekly meetings with the directors of its contracted laboratories.

“There have been multiple discussions regarding strategies to achieve harmonization,” she wrote. “All the directors are committed to this goal, but all parties recognize that time is needed to reach it. In short, meetings are already happening on a weekly basis.”

When asked about her overall thoughts as to the harmonization process, Lazarus wrote that she was “absolutely thrilled” at the progress made in the time given.

“The discrepancies amongst states under the prior system were significant, so to be where we are at such an early stage is a major benefit to the industry,” wrote Lazarus. “I am also proud of the transparency and adjustments HIWU has made when a non-harmonized analyte is identified. These adjustments have all been to the benefit of horsemen. Prior to HISA, this level of transparency did not exist at the Laboratory level.”

As racing continues to grapple with the practical and legal conundrums posed by lab variability, stakeholders can seek cold comfort from the fact they are not alone.

The Norwegian researchers critical of WADA's drug testing program zero in on the testing of “so-called non-threshold substances” for accusations of subjectivity.  “These tests lack objective and quantifiable decision limits that undisputedly resolve whether test results should be interpreted as positive or negative,” they write.

The lack of “clearly defined criteria for doping tests,” the researchers added, “carries a great risk of punishing innocent athletes and undermines the fight against doping in international sports.”

Sound familiar?

 

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HIWU Withdraws Farrior Suspension

Just one week after the Horseracing Welfare and Integrity Unit (HIWU) issued a public disclosure on its website that top Mid-Atlantic trainer Anthony Farrior had a horse test positive for the banned substance Metformin, Farrior's attorney Drew Mollica said that he has been informed by HIWU that the charges have been dropped.

“The system worked and we are happy to clear his good name and his reputation,” Mollica said.

Mollica said HIWU's decision came about after a review of the split sample, which was requested by Mollica and Farrior. Mollica said there were “issues” with the split sample, also known as the B sample.

“Pursuant to the procedures available we sought verification of the alleged positive by requesting a B sample,” Mollica said. “Due to issues with the B sample and pursuant to the rules, HIWU withdrew the charges. There were issues with the B sample that precluded them from prosecuting.”

Farrior faced a suspension of up to two years. When HIWU took over the role of drug testing and handing out penalties for infractions on May 22, trainers who had an alleged positive for a banned substance were issued provisional suspensions that went into effect immediately. It has since changed its rules and allows trainers to put off their suspensions until the results of the B sample have come back.

“The fact that he was not summarily or provisionally suspended is a testament to the effort HIWU has made to seek some level of justice and we look forward to more modifications going forward to protect the innocent,” Mollica said.

Metformin, is used in humans to combat Type II diabetes, but is not FDA approved for horses. In October, HIWU announced that following an internal review, it had discovered that not all of its participating laboratories had applied the same limit of detection in analyzing samples for the presence of drug. HIWU said it met with the six laboratories it works with to establish uniform limits of detection for the Metformin.

Farrior, who has been training since 2011, has 840 winners from 3,725 starters. He is currently the leading trainer at Charles Town with 136 wins on the meet.

The post HIWU Withdraws Farrior Suspension appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

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