This explanation is questionable from a clinical pharmacology standpoint. Metformin for human use is a film coated tablet (coated with a polymer). Unless the individual taking the tablet crushes or chews it (and puts a finger in the mouth), handling the film coated tablet does not transfer metformin to the hands. Additionally, published data shows that the amount of metformin absorbed from an oral dose in a horse ranges from 3.9-7.1% (fed vs fasted state) which is minuscule. Finally, the suggested dose of metformin in horses for approved use is 15 mg/kg (7.5 grams in a 500 kg horse) versus a usual 500 mg dose in a human. Thus, horse exposure from a human dose (by rubbing the face) or even putting a finger/hand in the horse's mouth would be quite a stretch of science.

This story is not the only one that TDN readers have seen over time. We have been subjected to stories of a horse with detectable betamethasone in his blood supposedly not from an intraarticular injection but due to use of a topical product, a horse with dextromethorphan in the blood due to a groom using a cough syrup and urinating in the stall and many other stories. These explanations stretch the science of clinical pharmacology to unreasonable levels.

I'd like to offer my human-based clinical pharmacology expertise to HISA/HIWU to “solve” these human-based inaccurate explanations in terms of horse exposures to banned drugs, gratis.

Horse racing is a great sport with a long tradition. Unfortunately, stories of horses having banned substances (no matter how low the exposure) is a negative for a sport where interest at least in the USA is declining and groups like PETA show up to protest at large racing venues putting more negative attention to the sport. But, worst of all, use of banned substances is bad for the horses and aren't the horses our primary interest/concern?

Sincerely,
Joseph S. Bertino Jr., PharmD, FCP, FCCP
Guilderland, New York

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The post read: “I have instructed my attorneys to dismiss the appeal related to the disqualification of Medina Spirit in the 2021 Kentucky Derby. Zedan Racing owner, Amr Zedan, and I have decided that it is best to positively focus on the present and future that our great sport offers. We thank the KHRC (Kentucky Horse Racing Commission) and Churchill Downs for listening and considering our point of view and we are grateful for the changes and clarity that HISA brings to our sport.”

Ever since Medina Spirit was disqualified over the positive for the medication betamethasone, Baffert and Zedan have tried to have the disqualification overturned. Their primary argument was that the medication got into the horse's system through a topical cream used to combat skin rashes. Baffert and Zedan's lawyers would eventually build more than two years of court cases and administrative appeals around the contention that the betamethasone that showed up in Medina Spirit's post-race positive test was the type that came from a permissible topical ointment and not via some other restricted means, like an intra-articular injection.

In September, Zedan and Baffert filed a petition for a judicial review of the Kentucky Horse Racing Commissions's disqualification of the colt from his win in the 2021 Kentucky Derby. The petition was filed in Franklin Circuit Court in Kentucky and also includes a protest over Baffert's suspension in Kentucky.  Zedan and Baffert claim in the petition that the “laboratory limit of detection” used to identify betamethasone in Medina Spirit “is contrary to the plain terms of KHRC regulations and is void as arbitrary and capricious.”

They also argued that KHRC's exercise of rule making and adjudicatory powers is illegal and that the penalties against Zedan “are unconstitutional, arbitrary and capricious.”

One month earlier, the Kentucky Horse Racing Commission (KHRC) closed the 27-month regulatory saga involving Medina Spirit's Kentucky Derby drug disqualification by unanimously voting to deny appeals by trainer Baffert and Zedan Racing Stables while accepting a hearing officer's recommended order that the penalties originally imposed by the Churchill Downs stewards be affirmed in their entirety. From there, Zedan and Baffert began to try to win their case through the courts.

“The KHRC did what it does best–rubber stamped its own foregone conclusion. I will discuss with Mr. Baffert, but believe it is highly likely the matter is appealed so that it can finally be presented to an impartial Court,” Baffert attorney W. Craig Robertson III said at the time.

It was not clear Monday why Zedan and Baffert apparently changed their minds and decided to drop their case.

It is possible that their dropping the case was a peace offering in what has been an ugly battle between Churchill Downs and Zedan and Baffert that at times took on a personal tone. Churchill first banned Baffert from the 2022 and 2023 Derby. In a surprising move, Churchill announced in July that the Baffert ban was being extended until at least Dec. 31, 2024.

“Mr. Baffert continues to peddle a false narrative concerning the failed drug test of Medina Spirit,” Churchill said at the time in a statement.

Churchill also recently announced that any horse trained by someone banned by the track (Baffert is believed to be the only one under such a suspension) will be ineligible to compete in the Derby if still in that trainers barn as of Jan. 29.

Throughout the dispute, there was widespread speculation that Churchill's harsh treatment of Baffert was in response to the lawsuits. With those lawsuits now having been dropped, it will be interesting to see how Churchill reacts and what doors might open for Baffert and his owners.

Following the news that the case had been dropped, Churchill Downs officials said that the development would have no bearing on Baffert's current status. “Today's dismissal of appeal does not change the current suspension or deadline to transfer horses for the upcoming 150th Kentucky Derby,” read a statement forwarded by Churchill's Darren Rogers.

pic.twitter.com/5RUsOSHMjD

— Bob Baffert (@BobBaffert) January 22, 2024

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The 47-page report was made public via press release by the Kentucky Public Protection Cabinet early on the Friday evening of the long Memorial Day holiday weekend. Its issuance comes 765 days after Medina Spirit crossed the finish wire first in the 147th Derby but subsequently tested positive for betamethasone in a KHRC post-race drug screening.

The recommendation, which must be considered and voted upon by the full KHRC board at a later date, upholds Medina Spirit's DQ, a 90-day suspension that Baffert has already served but wanted expunged from his record, and a $7,500 fine imposed upon the Hall-of-Fame trainer. Acceptance of the report's findings by the KHRC would affirm Mandaloun (Into Mischief) as the official winner of the 2021 Derby.

“The Hearing Officer finds and concludes that the KHRC has shown that the stewards' decision was made on reliable, substantive evidence that the horse, Medina Spirit, was administered and carried the prohibited substance, betamethasone,” hearing officer Eden Stephens wrote.

“The plain language of the KHRC's betamethasone regulations is clear: betamethasone is prohibited in a post-race sample,” Stephens wrote.

The debate over whether or not Medina Spirit's betamethasone finding was the result of an injection or the application of an ointment to treat a skin condition had been a focal point of testimony during six days of appeal hearings in August 2022.

“Parties agree the KHRC has the burden of proof but differ framing the question of what needs to be proven,” Stephens wrote. “KHRC argues it must establish a prima facie case that Medina Spirit [tested positive for a prohibited drug]. Appellants believe this case is solely premised on whether the use of a topical ointment, Otomax, for a clinically diagnosed skin infection on a racehorse, constitutes a violation of any clearly expressed and unambiguous rule…” Stephens wrote.

“At the running of the 147th Kentucky Derby on May 1, 2021, no KHRC regulation set forth an 'established concentration level' under which betamethasone is allowed in a post-race sample. Therefore, a laboratory finding of betamethasone in a post-race sample establishes a prima facie case that a trainer violated the KHRC's medication regulations,” Stephens wrote.

“Appellants contend that 810 KAR 8:010 Section 4 permits the administration of betamethasone ointment; therefore, a betamethasone positive arising due to an ointment administration is not a violation. This interpretation improperly conflates the KHRC's regulations governing medication administration with the regulations governing medication levels in post-race samples,” Stephens wrote.

“The KHRC's regulations do not state that any route of administration excuses a post-race betamethasone positive,” Stephens wrote.

“Additionally, the KHRC has a longstanding, uninterrupted history of treating all medications without thresholds as limit-of-detection medications and of finding that the administration route leading to a medication positive is irrelevant,” Stephens wrote.

“Betamethasone is a Class C drug. Its presence in a horse's post-race sample is prohibited by the KHRC, regardless of method of administration. Betamethasone has the potential to influence performance, as well as health and safety, in equine athletes,” Stephens wrote.

“Finally, the Stewards' Rulings in this case were restrained and reasonable. The stewards could have imposed a five-year suspension and $50,000 fine. Instead, they suspended Mr. Baffert for 90 days and fined him $7,500,” Stephens wrote.

The press release outlined the next steps in the process.

“Both parties can file exceptions to the recommended order should either party believe the hearing officer made an incorrect finding of fact or conclusion of law. The matter will then be referred to the KHRC to issue a Final Order,” the release stated.

“A Final Order may be appealed to Circuit Court within 30 days of issuance of the Final Order.  If no appeal is filed within 30 days, the case will end,” the release stated.

A Saturday morning voicemail message seeking comment from Baffert's attorney, Clark Brewster, did not yield a reply prior to deadline for this story.

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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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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'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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The report has been sent to a three-person panel that has been convened to consider whether or not Baffert should be penalized by NYRA. Each side will have seven days to respond to the report. After the seven days, the panel will have 10 days to make a final decision.

The panel consists of attorney John Carusone Jr., New York Thoroughbred Horsemen's Association Executive Director Will Alempijevic and Humberto Chavez, who heads the New York Racetrack Chaplaincy of America program.

On May 17, NYRA suspended Baffert, but had to drop the ban when a federal judge ruled that NYRA could not take such steps without first holding a hearing for Baffert or for anyone else the racing organization sought to suspend. Because of its affiliation with the state of New York, NYRA, unlike privately owned tracks like Churchill Downs, does not necessarily have the right to ban someone without due process. Churchill's two-year ban of Baffert is currently in place.

The hearing commenced in January with NYRA attorney Henry Greenberg stating that Baffert had taken a “wrecking ball” to the sport's integrity because of his record of repeated drug violations. NYRA charged that during a 14-month span, Baffert-trained horses tested positive for prohibited medications seven times. The most high-profile offense occurred in the 2021 GI Kentucky Derby in which Medina Spirit (Protonico) tested positive for betamethasone.

In asking the hearing officer to recommend a suspension for Baffert, NYRA said that his conduct was detrimental to the best interests of racing, the health and safety of the horses and NYRA business operations.

NYRA released Sherwood's 54-page report Tuesday.

This story will be updated.

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The Apr. 15 ruling did, however, note that the judges' order was not a ruling on the merits of the arguments related to Baffert's 90-day suspension and $7,500 fine or Zedan's being stripped of both his Derby-winning status and Medina Spirit's share of the purse.

On Mar. 21, a Franklin Circuit Court judge initially denied the trainer and owner's request to force the KHRC to impose any sort of stay on those sanctions. Baffert and Zedan then decided to kick the Franklin court's denial up to the higher Court of Appeals on Mar. 24. When the appeals court judge ruled against the “emergency” request Apr. 1, Baffert and Zedan asked for further court intervention via requests for interlocutory relief and a chance to make oral arguments on their own behalf.

Separately, the KHRC had also filed to dismiss the entire proceeding, but that motion was also denied within the same three-judge ruling (which effectively stopped the case from going forward anyway with the denial of Baffert and Zedan's request for interlocutory relief).

“[T]he circuit court did not err in determining that the equities of the situation mitigate against injunctive relief,” the three-

judge order stated. “We echo the circuit court's assessment that 'it is imperative to ensure public confidence in the Commonwealth's signature industry'…

“[T]he penalties the Stewards assessed upon Baffert may ultimately be reversed [but] Baffert's interest in staying enforcement of the Stewards' Ruling does not necessarily trump the public interest in the integrity of Thoroughbred horse racing and the safety of the horses,” the Apr. 15 order continued.

Baffert is now two weeks into his 90-day suspension, which is being appealed at the KHRC level. Depending on timing, the suspension could very well run its course before that administrative process gets underway or even results in a decision.

The Hall-of-Fame trainer's legal team had previously argued in court filings that “Baffert's income from racing is almost entirely linked to a horse's performance in a given race. There is simply no way to conclusively determine how his horses would have performed in the races taking place during his suspension. Missing out on the prestigious Triple Crown races (and many others) in 2022 is irreparable harm to a trainer like Baffert as the opportunity to compete in them can never be regained and the lost opportunity is not subject to remuneration.”

The three-judge Apr. 15 ruling dissected Baffert and Zedan's motions as follows:

“Neither Movants' motion for emergency relief, disposed of by this Court's April 1, 2022, Order, nor their motion for interlocutory relief, advances any specific argument as to 1) how or why Movant Zedan Racing Stables, Inc., will suffer irreparable harm from the circuit court's denial of a temporary injunction; or 2) what particular interim relief Zedan Racing Stables, Inc., seeks from this Court…

“In the April 1, 2022 Order, the Court pointed out that the motions, as they pertain to Zedan Racing Stables, Inc., are lacking in these respects…. Despite the Court's drawing attention to these omissions, Zedan Racing Stables, Inc., has not filed a motion for leave to supplement the motion for interlocutory relief, nor has Amr F. Zedan moved to intervene herein. In light of this failure to act, the Court denies the motion for…relief as it pertains to Zedan Racing Stables, Inc., and will consider the motion with respect to Baffert only.”

The order continued: “The circuit court's March 21, 2022, order addressed two separate claims made by Baffert [but] the statutory procedure under [Kentucky state law] is a complete and adequate remedy in itself, thus undermining any claim that Baffert could have properly sought a temporary injunction in the circuit court…

“This Court lacks a sufficiently developed record to assess Baffert's contentions of error,” the Apr. 15 order summed up. “Furthermore, because we have concluded the circuit court did not abuse its discretion in finding that Baffert failed to show he would suffer irreparable injury in the absence of injunctive relief, resolving the question whether Baffert has shown a substantial question on the merits is not necessary to our decision today.”

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Why are there different forms (salts) of betamethasone (in this case acetate and valerate)?

Many drugs do not dissolve well in water, so other molecules are added to them so that they can dissolve in water in order to make useful dosage forms. Sometimes these other molecules are added to the drug to make them last longer in the animal when injected into something like a joint, that is, dissolve very slowly (think of a slow-release drug). Often, the betamethasone used to inject into a joint has two forms, one that is already dissolved to act sooner and one that remains in the joint and delivers [the] drug more slowly. For use on the skin, betamethasone valerate is used and can be absorbed into the animal. Betamethasone from any of these salts is the same in the animal's body; it's a potent drug used to reduce inflammation and pain and its effect is long lasting in any form.

What happens to these other molecules added to betamethasone?

The body removes these extra molecules added leaving the main drug (in this case betamethasone) to do its work. For betamethasone valerate in an ointment, some of it will be absorbed and the amount depends on the integrity of the area it is being applied to. The valerate added to betamethasone would be found in the urine along with some betamethasone valerate. For betamethasone acetate, the acetate is removed and used in the body to make other things so finding it in the urine would be quite unusual.

How does a drug like betamethasone work to reduce inflammation and pain?

Inflammation occurs due to the animal's immune system working and its reaction to an injury. The drug acts to calm down the immune system to produce its effect. Betamethasone in any salt form does not work immediately when injected in a vein, a joint, or applied as an ointment. This effect takes time to occur (at least a few hours after the animal gets the drug). Even when the drug is completely gone from the body, the effect remains for some time (hours or days) because it takes the immune system time to gear back up (and hopefully the injury is healed). So that means even if small amounts or no drug is found in the blood, the effect on inflammation and pain lingers after a dose.

Do we know the relationship of the amount found in the blood and the drugs' effect on reducing inflammation and pain?

Absolutely not, we do not know how much drug in the blood is needed to get the effect to reduce inflammation and pain. Measurement of the drug in blood is not a good indicator of the dose of the drug used or when the drug was given; it simply tells us that the animal has received the drug. This is the reason that there is such a long time between injection of the drug into a joint and when a horse can race “clean” as set up in the rules of a racing commission.

What can measurement of drug in the blood tell us?

Measurement of drug in blood can tell us how much total drug can be found in the blood of the horse but not how much total drug is in the body of the horse. For Medina Spirit, a measurement of 21 pg/mL in the blood was found the day he won the 2021 Kentucky Derby. The average blood volume of a horse is 54.5 liters (54,500 mL or 12.3 gallons). So, if you multiply 21 pg/mL x 54,500mL of blood, you get 1.14 micrograms total in the blood. The usual dose injected into a joint in a horse is 9 mg (9,000 micrograms), and since the betamethasone acetate used is designed to dissolve slowly, we would suspect that there could be more drug remaining in the joint than what is reflected in the blood.

So, what does this all mean? 

Well first, betamethasone is betamethasone, it doesn't matter how it got into an animal (injection, ointment, etc.), it is active in reducing inflammation and pain. Next, finding low amounts of the drug in the blood does not tell us when the drug was last given. It does tell us that an exposure has occurred and may be ongoing. Since the drug effect is long lasting (and lasts even after the drug concentration is low or no longer measurable in the blood), a significant effect on inflammation and pain may still be occurring. Finding betamethasone valerate in the urine is not unexpected when betamethasone valerate is used as an ointment [as] some is absorbed. When using betamethasone acetate injection, finding no acetate in the urine is expected because the body uses the acetate that is shaved off the betamethasone to make other things.

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Because of overlapping uses of the term “appeal,” it has grown difficult to keep track of the status of what has now escalated to Baffert and owner Amr Zedan's intertwined administrative and legal cases against the Kentucky Horse Racing Commission (KHRC).

At the commission level, Baffert and Zedan have already appealed the KHRC's penalties (the suspension and a $7,500 fine for Baffert, plus the forfeiture of Zedan's purse winnings from the Derby) that were handed down Feb. 21 in the wake of now-deceased Medina Spirit's betamethasone positive in last year's Derby.

But when a routine request to stay those penalties (pending the outcome of the commission-level appeal) was denied by the KHRC Feb. 25, Baffert and Zedan took the matter to Franklin Circuit Court Feb. 28.

A Franklin Circuit Court judge Mar. 21 rejected Baffert and Zedan's plea for a stay or temporary injunction to keep the penalties from going into effect, so the trainer and owner bumped up their request to the next legal level, the Court of Appeals, Mar. 24.

On Mar. 25, the Court of Appeals judge raised the out-of-the-blue issue of whether the underlying Franklin Court appeal originated in the correct venue in the first place.

As Downey reported, the question drills down to: Should the case have originally been heard in Jefferson County (specifically Louisville, where the Derby itself is run), Fayette County (Lexington, where the KHRC's offices are headquartered), or Franklin County (Frankfort, where the Kentucky Public Protection Cabinet, the KHRC's parent organization, is housed)?

Even if Baffert prevails in this Court of Appeals attempt, he is still barred from having horses qualify for and run in the Derby based on a separate, private-party prohibition issued by the gaming corporation that owns Churchill Downs.

But Baffert is also fighting that banishment in federal court even while contingently transferring his Derby contenders to other trainers so they can try and earn qualifying points and enter the Derby.

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