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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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Racing Medication and Testing Consortium to Fund Postdoctoral Fellowship

The Racing Medication & Testing Consortium (RMTC) has announced that it will fund the research proposal, “Detection of Bisphosphonates Using Metabolomics,” submitted by Dr. Bethany Keen at the University of Pennsylvania's Equine Testing and Research Laboratory. Dr. Keen's research to date has been conducted in Australia and focused on equine anti-doping, analytical chemistry, and statistics.

Metabolomics is an emerging field in doping control and represents a novel testing approach that identifies cellular effects unique to a class of drugs rather than identifying the specific molecule responsible for those effects.

“The RMTC is proud to support the professional development of young scientists who are the future of our drug testing and research programs,” said Alex Waldrop, RMTC Board Chair. “It is particularly rewarding to be able to fund Dr. Keen as she will be under the supervision and tutelage of Dr. Mary Robinson whose own post-doctoral training program was funded by the RMTC over 10 years ago.”

“The recruitment and retention of motivated, highly trained personnel and support of competitive research programs are critical to anti-doping, medication control, and racing safety programs,” said Dr. Mary Scollay, Executive Director and Chief Operating Officer. “The racing industry has a responsibility to solicit qualified individuals, support their advanced training, provide incentives for relevant research programs, and foster productivity in research laboratories.”

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RMTC Announces Post-Doctorate Fellowship Program

Edited Press Release

Racing Medication and Testing Consortium (RMTC) has announced their support of post-doctoral training by funding a Fellowship Program beginning in 2022.

The need for establishing such a program is two-fold:

To promote a sustained research program with a core focus on anti-doping, to include topics related to drug testing, development of new analytical methods with application to racing chemistry, pharmacokinetics/pharmacodynamics, forensic toxicology, or other related disciplines. The future of horseracing's anti-doping programs requires mentoring young scientists to become researchers, racing laboratory directors, and industry leaders. Innovation and application of newer, more sophisticated technological advancements will come from those young scientists.

To establish a mechanism to identify, recruit, and retain young scientists and encourage their research pursuits relevant to horse racing's need for a rigorous anti-doping program and the promotion of enhanced safety for racehorses.

“The recruitment and retention of motivated, highly trained personnel and support competitive research programs are critical to anti-doping, medication control, and racing safety programs, said Dr. Mary Scollay, Executive Director and Chief Operating Officer. “The racing industry has a responsibility to solicit qualified individuals, support their advanced training, provide incentives for relevant research programs, and foster productivity in research laboratories.”

Relevant fields of study have historically included veterinary pharmacology, veterinary or human toxicology, and analytical chemistry. More recently other disciplines, including genetics, biophysics, and immunology have become relevant to anti-doping. Scientists trained in these disciplines are encouraged to apply for the Fellowships.

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New York State Gaming Commission: Paulick Commentary On Lack Of Medication Positives At NYRA Tracks Purposefully Misleading

The following letter was submitted by Robert Williams, executive director of the New York State Gaming Commission.

I am writing in response to your October 18, 2021 column “View from The Eighth Pole: Of Rulings and Squeaky Clean Racing.” I feel the obligation to object to your sarcastic characterization, which creates a purposefully inaccurate picture of the efficacy of drug testing in New York.

You wrote that you could “only find one ruling for a medication violation in all of 2021 at New York Racing Association tracks … [and] zero positive tests in the New York State Gaming Commission rulings database in 2020 and zero positives in 2019 for NYRA tracks.” See https://www.paulickreport.com/news/ray-s-paddock/view-from-the-eighth- pole-of-rulings-and-squeaky-clean-racing/.

Limiting your data examination to such a narrow band suggests an intention to cast aspersions on the efficacy of the New York drug testing.

First, your analysis suggests New York does not have race day drug positives. If you banded your data over a more useful period – 10 years – you would have found 541 race day positives at all New York tracks. Second, examining only race day positives at New York Racing Association (NYRA) tracks (Aqueduct Racetrack, Belmont Park and Saratoga Race Course) during such 10-year look-back, you would have identified over 100 drug positives. Third, intentionally limiting your data set to NYRA racetracks enables you to purposefully ignore the seven Standardbred and other Thoroughbred racetracks in operation. The arithmetic illustrates over the last 10 years there have been over 160 race day positives at New York Thoroughbred tracks and over 370 race day positives at New York Standardbred tracks.

It is obvious to the most casual reader your intention was to mislead people in believing there has been one race day drug positive in two years. Your narrative disregards readily available data, misleading readers into believing that the New York Equine Drug Testing and Research Program (Laboratory) is either inept or negligent in its responsibilities.

I take great offense at your gratuitous shot at Laboratory director George Maylin, DVM, PhD. Even the most casual follower of equine drug testing is aware that Dr. Maylin developed many of the forensic equine drug testing techniques used worldwide. He has performed groundbreaking work in determining the presence of drugs that may affect the performance of equine athletes, including recently developing screening tests for:

• IOX-2, a new class of drugs that increases the body's own erythropoietin gene to produce more red blood cells. It accomplishes the same response as the administration of erythropoietin, or EPO. It is a performance enhancing drug and a gene doper.
• Clenpenterol, a beta-2 agonist with pharmacologic properties like clenbuterol which is not approved for use in horses.
• AH 7921, an experimental synthetic opioid with pharmacologic properties similar to morphine-like drugs, which is not approved in the United States for use in horses or humans.
• Kratom (mitragyna speciosa), a natural plant that contains the psychoactive alkaloid mitragynine that has opium-like analgesic effects and coca-like stimulant effects.
• Yellow Rocket (barbarea vulgaris), a plant that contains the alkaloid barbarin, which is used to metabolize bararin to aminorex, a central nervous system stimulant.
• Glaucine, an alkaloid with anti-inflammatory, antitussive, bronchodilator and central nervous system effects.

All of these research discoveries have been shared with other drug testing laboratories around the world and have been widely reported by the racing press.

While I am certain you are aware the Laboratory is one of only nine in the United States that have been fully-accredited by the Racing Medication & Testing Consortium (RMTC), you may not be aware what is necessary to obtain and maintain certification. The accreditation process begins with a document review of the laboratory's processes by an independent auditor with specific experience in horse racing laboratory operations. Once the documentation is reviewed, the laboratory must also submit to a multi-day site inspection by another independent assessor. As part of the accreditation requirements, laboratories are required to participate in an external quality assurance program that determines if laboratories have the capabilities required to detect substances of concern at the concentrations that are mandated by the RMTC model rule recommendations. All participating laboratories must also be ISO 17025-accredited to even apply.

To maintain RMTC accreditation, a laboratory must maintain its ISO 17025-accreditation and annually pass RMTC proficiency sample testing. Additionally, the Horseracing Testing Laboratory Committee of the RMTC also conducts a review of the Laboratory's funded research and internal laboratory development. This calendar year the HTLC found the Laboratory in good standing. In fact, since granting the New York Drug Testing and Research Program has remained in good standing for all its accreditations.

Your column also casts aspersions on Dr. Maylin's credibility, positing that the lack of recent positives at NYRA racetracks might be due to his using different criteria than laboratories in other racing states. You further state that “Maybe the [New York Laboratory] isn't very good.”

A quick look at the annual numbers finds race day positives in 2020 – a VERY anomalous year given the 40 percent reduction in racing dates conducted – for clenbuterol, flunixin, guaifenesin, methocarbamol, methylprednisolone, and phenylbutazone. In 2019 there were positives for adrenochrome monosemicarbazone, clenbuterol, clenpenterol, dexamethasone, flumethasone, flunixin, furosemide, guaifenesin, IOX-2, isoflupredone, methocarbamol, methylprednisolone, phenylbutazone, phenytoin, and propantheline.

Your commentary failed to note any of the above, I guess because it didn't fit your narrative about the lack of medication violations.

New York has been successful in identifying and punishing those who seek to cheat, but we understand that those with the propensity to use unlawful or illegal drugs persist. We appreciate the dedication and diligence of Dr. Maylin and the dozens of employees of the New York Equine Drug Testing and Research Program who are committed to ensuring the integrity of horse racing and protecting equine athletes participating in the sport.

Unfortunately, the Paulick Report prevents reader comments which limits our ability to directly shed light on your misstatements. I am hopeful, however, that this letter gets widespread attention so people can better understand your bias.

(Response from Ray Paulick: The Oct. 19 commentary accurately stated that only one drug positive has been prosecuted at New York Racing Association tracks in 2019, 2020 and 2021. I stand by the article as written.)

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