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Route of Administration Argument Continues in Day 5 of Derby DQ Appeal

The Kentucky Horse Racing Commission's hearing to address Bob Baffert's appeal came to a crossroad early in its fifth session on Monday in Frankfort, Kentucky following a three-day break over the weekend. After the KHRC closed their case at the start of the session, the appellants began their case by calling for a partial directive verdict in their favor based on their claim that the KHRC never proved how Medina Spirit (Protonico) received the betamethasone that led to his positive test and subsequent disqualification from his 2021 GI Kentucky Derby victory.

“Although we heard the testimony of a veterinary pharmacologist and three analytical chemists, none of the KHRC experts testified that Medina Spirit received an intra-articular injection of betamethasone within 14 days of the race or ever,” said Baffert attorney Joe DeAngelis.

The route of administration that was used when Medina Spirit received the betamethasone has already been a thoroughly-debated point since Baffert first filed the appeal to clear from his record a 90-day suspension (which he has already served earlier this year) and reverse Medina Spirit's disqualification. While Baffert's team of attorneys have said there is no evidence that Medina Spirit received betamethasone via injection and that he instead received the medication topically to treat a skin lesion, the KHRC argues that the route of administration does not matter as betamethasone is a Class C, prohibited substance in any form.

The attorneys volleyed back and forth on this subject, but ultimately hearing officer Clay Patrick opted to deny the partial directive verdict motion and proceed with further witnesses.

While Baffert was present in court for the hearing last week, he was not present in the hearing room on Monday. He is set to appear back as a witness on Tuesday via Zoom, along with Medina Spirit's owner Amr Zedan.

Over a seven hour span on Monday, three scientific experts took to the stand, all virtually, to discuss the details of Medina Spirit's test result findings.

The first witness of the day was Dr. George Maylin, the director of the New York State Equine Drug Testing Lab which was responsible for the court-approved outside testing of Medina Spirit's urine sample last summer. Taking the stand virtually, Maylin's questioning was frequently interrupted due to technical difficulties, but it went on for over two hours.

Baffert attorney Craig Robertson asked Maylin about the procedure used to test Medina Spirit's sample and the results that were found. Maylin reported that the substances found included betamethasone 17-valerate, clotrimazole and a metabolite of clotrimazole. He concluded that all three were components of the topical ointment Otomax. Later asked by Robertson if the injectable form of betamethasone contains clotrimazole, Maylin replied, “Not that I'm aware of.”

Maylin was cross-examined by Jennifer Wolsing, general counsel for the KHRC. Wolsing's questioning focused in on the fact that betamethasone acetate and betamethasone phosphate, which would be found in an illegal injection of betamethasone, were not directly tested for.

“Had there been more urine and more time, more could have been done,” Maylin said. “But the judge wanted an answer in a hurry.”

When the examination was redirected to Robertson at the end of Maylin's time on the witness stand, Maylin concluded that he was confident in the test results and that he believed there was no injected betamethasone in Medina Spirit's system.

After a break for lunch, the Baffert team brought Tom Lomangino to the witness stand. Lomangino has previously served as the Director of the Maryland Racing Commission Laboratory and the Director of USEF Equine Drug Testing and Research Laboratory.

Lomangino worked under Maylin for a brief stint at Cornell University and categorized Maylin as, “Very dedicated. Consummate technician. Good person to work for.”

Brewster asked Lomangino about the Standard Operating Procedures (S.O.P.) that were used for the original testing conducted by Industrial Laboratories of Colorado. When asked if he believed that the original test followed these procedures, Lomangino said, “No. I read something that said the analyst guessed…What we're talking about here is analytical chemistry. You're going to have certified reference material of the exact compound you're trying to find and you're going to compare that to the unknown.”

Lomangino's time on the witness stand went into the details of the S.O.P. for both the initial test through Industrial Laboratories and the second test conducted by the University of California, Davis. Lomangino said he was not confident that S.O.P were followed for either test.

While Wolsing's cross-examination went into Lomangino's qualification as a lab technician and started a deep dive interpreting the graphs from Medina Spirit's UC Davis test, the examination was cut short due to a medical appointment Lomangino had to attend. He will return to the witness stand tomorrow.

The last witness of the day was Dr. Steven Barker, the former head of the laboratory that tests horse samples in Louisiana. Barker was supportive of the results Maylin discussed earlier in the day.

“Let's keep something in mind,” he said. “Dr. Maylin was asked to do the analysis from three different companies. He did not have an existing method before any of the three. He was asked to, in a very short time, develop an analysis for betamethasone valerate, clotrimazole and gentamicin. Those are not typically monitored in equine horse samples…There's nothing routine about this.”

Barker also criticized Dr. Scott Stanley, who, in his testimony last Thursday, said he did not believe that Medina Spirit got betamethasone from a topical ointment.

“Dr. Stanley made a number of egregious errors in interpreting the data and results,” Barker said.

Robertson later asked if Barker had an opinion as to whether the findings reported by the KHRC were the result of an ointment or an injection.

“The evidence clearly shows that it was as prescribed by the veterinarian,” Barker replied. “It was a topical administration of Otomax that contained the [betamethasone] valerate, clotrimazole, and the clotrimazole metabolite. Yes, this had to have been–with the levels in the urine and with the other facts–from a topical administration.”

With the possibility of the hearing meeting its end on Tuesday, the upcoming session is expected to see virtual appearances by Baffert and Zedan, along with Baffert's veterinarian Dr. Vince Baker. From there, Patrick can arrive at his ruling that the KHRC may accept or reject. Hearing officers hired by racing commissions typically take months to issue a written report and recommended findings.

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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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KHRC Rules the Focus On Day 2 of Medina Spirit DQ Appeal

A deeper dive into the Kentucky Horse Racing Commission's rules defining what medications are considered prohibited versus those that are considered therapeutic and the standards for out-of-competition testing in relation to betamethasone as opposed to post-race testing were the hot topics during day two of the Kentucky Horse Racing Commission's hearing addressing trainer Bob Baffert's appeal Tuesday.

Baffert filed the appeal to clear from his record a 90-day suspension he already served this spring, along with reversing Medina Spirit (Protonico)'s disqualification from his victory in the 2021 GI Kentucky Derby.

Both were the result of the Baffert trainee testing positive for betamethasone after winning the first leg of last year's Triple Crown, which led to the stewards' February ruling which disqualified the horse, cost owner Zedan Racing Stables the $1.86-million purse, and served Baffert his suspension (which ran from April through early July) and a $7,500 fine.

The day started off with Kentucky chief steward Barbara Borden taking the witness stand, where she stayed nearly four and a half hours while providing testimony, as Baffert's team argued that since the betamethasone was administered as an ointment rather than injected, it did not violate any regulations. However, the KHRC maintained that any systematic presence of betamethasone, regardless of how it was received, is prohibited on race day.

Borden took to the stand at 9 a.m., where she began answering questions from KHRC general counsel Jennifer Wolsing, setting the foundation for further inquiry with a review of Gamine (Into Mischief)'s disqualification from her third-place finish in the 2020 GI Kentucky Oaks following her post-race blood test that revealed the presence of betamethasone. Along with Gamine's disqualification, Baffert was fined $1,500.

From there, Borden responded to questions specifically regarding what transpired following the confirmation of Medina Spirit's betamethasone overage in the 2021 Kentucky Derby.

“I'm not happy when there's any medication violation. I felt like the process we were gonna go through…there was going to be a lot of publicity, [it would be] bad for racing in general, [and] would possibly be drawn out like it has been,” she responded when asked by Wolsing what her reaction to the positive test result was.

When asked if her decision in the final ruling was influenced at all by factors such as the media, the cases with Churchill Downs and the New York Racing Association, or Gerard O'Brien–Borden's significant other of 30 years that is a seasonal employee of Turfway Park (which is owned by Churchill Downs)–Borden was firm in her answer, “no.”

She reaffirmed that the stewards' decision was based on Baffert's four offenses in the 365-day period, including Gamine and Medina Spirit's overages of betamethasone in Kentucky–both considered Class C violations–and the overages of lidocaine found in the post-race samples of Charlatan (Speightstown) and Gamine after each won on 2020 GI Arkansas Derby Day, which are considered Class B violations.

“We did consider everything that was presented to us and ultimately this was our unanimous decision,” she said.

Also, during Wolsing's time taking testimony from Borden, she presented results of a review of positives for betamethasone that noted since the threshold change on Aug. 25, 2020, there were only two positives, and both were in Baffert horses: Gamine and Medina Spirit.

Over an objection by Baffert's attorney Clark Brewster, Wolsing presented a 2016 case regarding a betamethasone positive that involved trainer Tom Amoss, where he explained that he believed it came from application of an ointment. Though the case was dealt with under old rules, the case was presented to draw a parallel to the Baffert case, as Borden said the administration of the betamethasone was irrelevant then and Amoss was sanctioned and the horse that tested positive was disqualified.

The case of Kentucky-based trainer Carlos Lopez, who was suspended a total of 180 days following four violations within a year-period in 2014 and 2015, was also brought up as a parallel to Baffert's case.

In the final moments of Wolsing's cross-examination of the witness, Wolsing asked Borden if the ruling handed down to Baffert by the stewards for his four offenses in that year period was a penalization that she'd stand behind today. Borden was quick to respond, “Yes.”

After a brief break, Brewster began his questioning of Borden, focusing intently on the line drawn between what is considered a therapeutic medication and what is a prohibited medication, specifically in the case of the topical ointment Otomax, which contains betamethasone. Though she acknowledged that it is used therapeutically, Borden said that betamethasone is prohibited completely in a post-race sample, meaning it cannot be present in the horse's system at any level on race day.

Brewster also focused on Kentucky's out-of-competition rules, which center around out-of-competition testing's focus on finding substances that are never allowed in the horse, but does allow betamethasone as a therapeutic use, since those tests are not administered on race day.

Borden was adamant to point out that these rules only applied to out-of-competition testing, not testing completed on the day of a race, which strictly prohibits betamethasone.

Later on, Brewster questioned Borden about the Kentucky rules that offer different guidance of various medications based on method of administration, while also citing the differences in rules for non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids (which is the category betamethasone falls under), as both are considered Class C medications.

He also cited the lack of detail that came with the 14-day stand down period, which was added in August 2020, and emphasized that it appeared to be “advisory” rather than firm. Brewster also noted the lack of limit or threshold listed, along with the absence of a stop or start time for the stand down period.

“There is no reference at all in a stand down definition that it is regulated by a lab test, is there?” he asked Borden.

“Not in this definition,” she replied.

Later in the day, Kentucky equine medical director Bruce Howard took to the witness stand, where he explained how the out-of-competition testing was handled prior to the 2021 Kentucky Derby, how testing was handled on race day, and what the process of collecting and sending out the post-race samples was like.

“We tested every horse in the Derby, even some that didn't draw in,” said Howard, when asked about the out-of-competition testing conducted.

It was during this time that Howard shared that pre-race testing of Medina Spirit, conducted Apr. 18, did not reveal any detection of betamethasone.

“I was a little surprised we didn't find it,” said Howard. “If it was being applied every day, I would've expected we'd still see it.”

When asked about his reaction to Medina Spirit's betamethasone positive in his post-race sample following his Derby victory by attorney Luke Morgan, representing the KHRC, Howard said, “I hate it when we have this happen. It leads to a lot of problems, obviously. My wish every year is for a good, safe, clean race.”

In terms of substances in the Kentucky rules that do not list a threshold for, Howard made it clear that they are not allowed at any level in the horse on race day, which follows guidance from the industry's Racing Medication and Testing Consortium and the model rules of the Association of Racing Commissioners International.

“Moving these drugs away from race day would give us a clearer picture when we did our race day exams,” Howard said, in response to a question about the stand down period rule change. “If there is a systemic level of corticosteroids or NSAIDs or any of these kinds of drugs, it doesn't matter how it gets in. Anything that can cause a systemic level in a horse concerns us.”

Rounding out the day's session, Brewster questioned Howard on the absence of betamethasone from the list of medications with detection thresholds, also citing a lack of matrix.

“If the medication is not listed with a threshold, it is a limit of detection drug,” replied Howard.

Brewster also brought up whether trainers were properly notified that there was a rule change, which established a zero tolerance of betamethasone, arguing they were not. Howard referenced the guidance from national and international bodies that study medication in racing, also pointing out that he offered his contact information for anyone who had questions concerning the new rule.

Howard ended his time on the stand, and the day's session, answering a few final questions presented by Morgan.

When asked if the route of administration of a drug mattered in terms of a positive finding of a banned substance on race day, Howard firmly replied, “No.”

The hearing in Frankfort, Ky., continues for a third full day beginning at 9 a.m. Wednesday and will move along with morning and afternoon sessions Thursday. If the hearing is not done by Thursday afternoon, it will resume next Monday.

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