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Baffert/KHRC Appeal Day 4: Ointment or Injection?

The debate over whether or not Medina Spirit's 2021 GI Kentucky Derby disqualification for betamethasone was the result of an injection or the application of an ointment was a focal point in the fourth day of testimony at Bob Baffert's appeal before a Kentucky Horse Racing Commission (KHRC) hearing officer in Frankfort, Kentucky, on Thursday.

That argument has percolated for the better part of 16 months in various hearing and courtroom settings. It is now being brought up again in front of the KHRC hearing officer to adjudicate the Hall-of-Fame trainer's attempt to expunge from his record a 90-day suspension (that Baffert has already served) for the infraction. The appeal also seeks to reverse the KHRC's disqualification of Medina Spirit from the Derby.

Back in December, Baffert's legal team stated that third-party testing on the colt's urine “definitively confirmed” and had “scientifically proven” that the type of betamethasone that showed up in Medina Spirit's post-race positive test is the type that comes from a topical ointment and not via an intra-articular injection.

The distinction is important because Baffert believes the proper resolution of the betamethasone overage hinges on how it was administered to Medina Spirit. He has claimed Kentucky's medication rules only apply to the injectable form of that drug.

But the KHRC has maintained that a positive finding is a positive finding, and that it doesn't matter how the Class C medication entered Medina Spirit's system.

Baffert has claimed that Medina Spirit was treated with the betamethasone-containing ointment Otomax as late as Apr. 30 (the day before his Derby win) to help deal with a skin lesion, and he has denied that the colt's joints were ever treated with the injectable form of that drug.

Ron Flatter of Horse Racing Nation (HRN) provided key points of Thursday's proceedings. His reporting is summarized below by TDN.

Flatter wrote that Jennifer Wolsing, the KHRC's general counsel, said she had two depositions to back up her contention that Medina Spirit could have been injected with betamethasone.

Dr. Scott Stanley, the director of the equine testing laboratory at the University of Kentucky, testified as a witness for the KHRC.

According to HRN, Stanley was questioned about the third-party testing by Dr. George Maylin, director of the New York State Equine Drug Testing lab. Last summer, Baffert's attorneys got a court order to allow outside testing on the Medina Spirit samples.

Flatter wrote that “Maylin concluded last fall that the medication 'resulted from the topical administration of Otomax and not an injection of betamethasone.'”

Testifying eight months later on Aug. 25, Stanley criticized the process by which Maylin tested the Medina Spirit urine sample and offered technical reasons why it was flawed, HRN reported.

“I don't agree with…Dr. Maylin's conclusion that says the data definitively shows the topical administration of betamethasone…. I don't believe that the data definitely concludes that,” HRN quoted Stanley as testifying.

Yet under cross-examination by the Baffert side, Stanley also said, “I do not have any evidence that Medina Spirit was injected with any product,” HRN reported.

Dr. Mary Scollay, the current executive director of the Racing Medication and Testing Consortium (and previously the KHRC's equine medical director), testified at the request of the KHRC.

HRN reported that Scollay said there was no record of a diagnosis when Baffert's veterinarian, Dr. Vince Baker, recommended that Otomax to be applied to Medina Spirit in April 2021. Nor was there any record provided on dosage and frequency.

“Otomax is FDA-approved for use in dogs,” Scollay said, according to HRN. “I would hesitate to describe Medina Spirit as a dog. That would be most unfair.”

Flatter wrote that, “Under cross-examination, Brewster attacked Scollay's credentials for lacking backside experience, saying that Baker has had a great deal of experience in stable work. And he recounted when, in a deposition, Scollay said anyone wanting more expertise on Otomax should ask a veterinarian who works on the backside.”

After a scheduled weekday off on Friday, the hearing resumes on Monday, with Tuesday the agreed-upon date both parties are targeting for finishing the proceedings. (See coverage of previous days here, here, and here.)

Hearing officers hired by racing commissions typically take months to issue a written report and recommended findings.

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Getting Down to the Science of It All In Medina Spirit DQ Appeal

FRANKFORT, KY – After a brief private meeting between attorneys and the hearing officer to discuss “confidentiality” matters, the Kentucky Horse Racing Commission's hearing addressing trainer Bob Baffert's appeal continued, slowly but surely, on Wednesday in Frankfort, KY.

While Tuesday's session focused on the KHRC's medication rules, along with those established by the industry's Racing Medication and Testing Consortium (RMTC) and the model rules of the Association of Racing Commissioners International (ARCI), the center of interest Wednesday was the corticosteroid betamethasone itself.

The day started off with Dr. Heather Knych, a professor of clinical veterinary pharmacology and head of the pharmacology section at the K.L. Maddy Equine Analytical Pharmacology Laboratory at the School of Veterinary Medicine at the University California, Davis. She provided her testimony via Zoom (from California) as an expert witness.

Called to the stand (virtually) by KHRC general counsel Jennifer Wolsing, Knych spoke to her area of specialty in equine pharmacology, with special interests specifically in studying drug metabolism, anti-inflammatory drugs, pain management and emerging threats. Knych explained that she has studied the effects of drugs on performance horses for nearly 15 years and has had several studies focused on corticosteroids published.

Wolsing asked Knych to explain what betamethasone is, what the effects of it are, and made note of the longevity of its effects in a genomic sense. Along that line of questioning, the KHRC's Medication Classification Schedule was pulled up as an exhibit, as Knych was asked if she agreed with betamethasone being listed as a Class C medication.

“I agree with its classification as a Class C medication. Based on the description, it's an FDA approved drug, it's a therapeutic agent and it has moderate potential to affect performance. [It] could potentially mask a lameness or injury and fits nicely with the other medications in this category,” said Knych, who also serves on the RMTC's Scientific Advisory Committee.

When asked if the administration of the drug matters in terms of measuring its impact, she replied, “I don't think it matters. The drug is the drug. Once it gets in the system, that's what we're looking at, [what it does] once it gets in the body and its effect.”

Diving deeper into the specifics of betamethasone and corticosteroids in general, Knych discussed the effects of various cortisol levels, how that is measured, and the overall picture when it comes to how the concentration of a drug in the horse's system correlates directly with the effects of the drug. Wolsing presented various published studies on the topics at hand during this time, including some that Knych was involved with herself. Some of the studies focused on betamethasone, while others centered around the effects of dexamethasone, a comparable drug that is also listed as a Class C medication.

When asked if the health and safety of the horse is part of the focus in equine pharmacology work, Knych said, “The primary reason corticosteroids are so tightly regulated is to eliminate the potential to affect performance, the potential to mask [things such as] lameness.”

Knych also acknowledged that there is potential of masking underlying health issues when using higher amounts of betamethasone.

However, when it came to the findings from the studies presented, Knych did say, “We don't know the end pharmacological effect of betamethasone in the horse.” She also said there have been no studies done specifically on the effects of betamethasone in horses when administered as a topical ointment.

During this time, Wolsing cited the KHRC's case with trainer Graham Motion in 2015, involving a stewards' ruling after a horse he trained that raced was found with too much methocarbamol in its system, to show that the commission has a right to regulate in situations where there is gray scientific area with regard to medication. Craig Robertson, an attorney for Baffert, argued against its relevance when discussing the systemic effects of corticosteroids.

Motion claimed he followed the RMTC guidelines for withdrawal but was still flagged, which is a similar claim from Baffert in terms of what happened with Medina Spirit's post-race result that revealed a betamethasone overage, which ultimately resulted in the colt's disqualification from his victory in the 2021 GI Kentucky Derby.

Robertson, who was part of the KHRC case involving Motion in 2015, believed the case was being mischaracterized and stated, “The case says that you have to have a rational scientific basis for what you do.”

Wolsing also asked Knych if the route of administration of the drug has any bearing on the effect of the drug once it is in the horse's system. She replied, “No. It depends on what the concentration of the drug is regardless. I'm talking about the concentrations at the end, when we still see suppression of cortisol.”

In one of her final inquiries, Wolsing stated, “Medina Spirit was administered approximately 45 milligrams of Otomax from a bottle over a period of about Apr. 9 and going through Apr. 30, the day before the [2021] Derby.” She followed up asking Knych what the impact of that would be on the horse.

“I don't think we can say one way or another. We don't have the science to say one way or another,” she replied.

Her response was met with audible satisfaction from Baffert's legal team, who took over from there, as they continued to argue that the KHRC's medication rules lack detail and scientific backing, specifically when it comes to administering betamethasone in the form of a topical ointment.

The cross-examination of Knych, conducted by Baffert's attorney Joe DeAngelis, delved into the inexactness of the science in the studies of and testing for betamethasone, along with how long it takes for betamethasone to leave a horse's system–intended to enforce that the 14-day withdrawal period established by the KHRC was unreliable.

The RMTC's Controlled Therapeutic Substances Monograph Series was also brought up, as DeAngelis asked if Knych recalled discussing or hearing any discussion about the ethics and safety of topical use of betamethasone. She said she hadn't. When asked if there had been any recommendation from the RMTC specifically on a stand-down period for topical use of corticosteroids, Knych replied, “No.”

DeAngelis also referenced RMTC's Position Statement on Corticosteroids, a study published in 2013, which showed that the use of topical corticosteroids was known to RMTC at the time the findings were published.

When asked if she approved of the 14-day stand-down period, Knych replied, “Yes,” and admitted she did not recall any discussion of recommending it to be longer.

Knych's time as a witness, which lasted nearly 3 1/2 hours, ended with some final questions from Wolsing and a few remaining questions for the sake of clarification from DeAngelis.

Wolsing asked, “Could a much higher concentration affect a horse's health and safety?”

“Potentially yes, but what those levels are, I don't think we necessarily know that yet,” said Knych.

After a 45-minute lunch break, members of the media were asked to leave the conference room as lawyers met behind closed doors to discuss what hearing officer Clay Patrick, a Frankfort attorney, called “proprietary information.”

The hearing addressing Baffert's appeal to get his already served 90-day suspension and a $7,500 fine removed from his record, along with reinstating Medina Spirit's victory in last year's Kentucky Derby, continues Thursday at 9 a.m. and is expected to roll over into next week, starting Monday, Aug. 29.

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Baffert Takes Stand in Day One of ’21 Derby DQ Appeal

Trainer Bob Baffert spent 2 1/2 hours on the witness stand testifying at a Kentucky Horse Racing Commission (KHRC) appeal hearing Monday.

Baffert's intent by filing the appeal is to clear from his record a 90-day suspension he has already served while also reversing the KHRC's disqualification of Medina Spirit from the 2021 GI Kentucky Derby.

Those penalties were the result of the Baffert-trained colt returning a positive for betamethasone after crossing the finish wire first in America's most historic and important horse race.

Beyond the already-served suspension (which ran from early April through early July) and a pending KHRC fine for $7,500 (that is also being appealed), Medina's Spirit's betamethasone overage also triggered separate banishments and sanctions from racing at the Churchill Downs, Inc. (CDI) portfolio of racetracks, plus at the New York Racing Association tracks.

Baffert has either fought or is in the process of fighting both of those sanctions in court, but right now he is precluded from having a trainee in the 2023 Derby because of CDI's actions against him (as part of a two-year ban, CDI had also denied Derby participation to the Hall-of-Fame trainer in 2022).

Monday's hearing rekindled many of the same pro-and-con arguments that have been repeatedly articulated by both sides over the past 16 months in various courtroom and hearing settings.

This latest KHRC hearing process could last the entire week.

Horse Racing Nation (HRN) published live updates of the Aug. 22 proceedings in Frankfort, Kentucky.

HRN reported that Jennifer Wolsing, general counsel for the KHRC, framed the case in straightforward terms during her opening statement.

“This is a very simple case,” she stated. “Betamethasone is a class C medication which has been prohibited in Kentucky.”

Clark Brewster, who represents Baffert, countered with his own opening statement that focused on disputing the KHRC's claim that there was an applicable “limit of detection” rule while also disputing the KHRC's assertions that Baffert had a pattern of medication rulings against him.

HRN also reported that, “Brewster also sought to discredit Industrial Labs, which returned the positive test on Medina Spirit, suggesting that the company needed to come back with positive tests to stay in business.”

Brewster also claimed there was a difference between injecting betamethasone (which Baffert has denied) and using it topically as an ointment like Otomax (which is Baffert's explanation of how the drug got into Medina Spirit), according to HRN.

“I won't say it was a mistake [to give Medina Spirit an ointment the day before the Derby],” Baffert was quoted as saying in HRN. “If you use an ointment to humanely heal a rash, it's not a mistake.”

At one point during testimony, Wolsing questioned Baffert's knowledge about medication rules in Kentucky, and asked Baffert to read aloud the ingredient list for Otomax, which includes betamethasone valerate.

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Is Kentucky’s Claiming Outflux A Real Or Perceived Problem

The Week In Review, by T.D. Thornton

Does Kentucky need to do something to stop the outflux of horses leaving the state after being claimed? And will any attempt at corrective action by rewriting regulations result in unintended consequences that could create their own problems?

Those questions were up for debate last week when the Kentucky Horse Racing Commission (KHRC)'s rule committee met to kick around ideas that could surface in a near-future proposal.

Commissioner Frank Jones, Jr., the rules committee chair, said that last year 779 Thoroughbreds were claimed out of Kentucky races. Of that number, 412 made their next start outside of the state.

“It's diluting the inventory of horses that we have,” Jones said.

“The claiming rule is a very, very intricate and difficult thing to wholesale [amend],” Jones said, adding that by his recollection over the decades, “this claiming rule has probably been changed about six times.”

But, Jones added, “You put the lid on the pot; the pot keeps boiling” with new issues.

One suggestion was to mandate that an outfit had to have started a horse at the race meet in question prior to being allowed to drop a claim slip for another horse at that track.

But Commissioner Greg Harbut was quick to point out that a problem with that methodology is that larger stables with many starters would have an edge over smaller outfits with only a horse or two.

“I believe that would give certain individuals a distinct advantage over other stables,” Harbut said, alluding to the likelihood that a sizable outfit might be able to achieve getting starters in on the first day of a meet, while smaller-scale owners and trainers are at the mercy of the condition book to determine when their individual horses might get in.

Harbut instead suggested that the rule tweak could be re-phrased to make it so that licensees who are stabled in Kentucky get preference at the claim box.

“I think if they're licensed and stabled here, it does show an intent to support Kentucky racing. I think that's all that we are looking for,” Harbut said.

Jones said that while a “residency” idea might have some traction, regulators have to tread carefully. Previous attempts at rulemaking to force claimed horses to stay in Kentucky for a longer period of time are “when we run into possible anti-trust” challenges, Jones said.

Jones also added that a residency rule might not be able to stop Kentucky trainers who claim horses for out-of-state outfits for a fee.

“Some people that are claiming horses in Kentucky, [then] you look up in 30 or 40 days and the same horse is entered in someone else's name,” in Indiana or in another nearby state, Jones said.

“There are some trainers who will claim horses for a $500 fee [and] it's been like that for at least the last five or 10 years,” Jones said.

“You will always have individuals that are going to skirt around the rules,” Harbut acknowledged, noting that regulations alone won't stop “individuals that still want to be aggressive” about claiming.

“The ownership landscape has changed in the last five to seven years,” Harbut explained. “A lot of entities are teaming together, not only in racing, but at horse sales and other things of that nature.”

Commissioner Bill May suggested that the committee step back and take in the overall landscape prior to recommending any changes.

“Is it a big enough issue that we need to actually memorialize it in the regs?” May asked. “We don't need to get in the business of writing a reg for every scenario that comes along, because we're never going to be able to address every issue.”

May continued: “I don't have the answer to whether or not [the claiming outflux] is a big problem. But if it's not a big issue, if it's only going to affect one or two people, I'm not sure it's worth fooling with. But if it's going to affect a multitude of people, then it needs to be addressed.”

Harbut brought up a related point: How many of those claimed horses eventually returned to Kentucky after briefly leaving the circuit?

Jones didn't believe that stat that had been compiled within the report he had been referencing.

“The reason I ask is that I know at the end of the racing season here in Kentucky, we no longer run dirt or turf, so a lot of those trainers that support Kentucky year-round go off to other jurisdictions such as Oaklawn, Fair Grounds, [where they] have the option of running on dirt or turf,” Harbut said.

“They, in turn, bring those horses back to Kentucky,” Harbut said.

Harbut said he would like better understanding of that seasonal give-and-take aspect of the claimed horse outflux before moving forward with any rules rewrite. The committee took no action on formally adopting any changes to the existing claiming rules.

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