Tag: betamethasone

Letter to the Editor: Detection of Banned Drugs in Horses

As a Clinical Pharmacologist (human) and an avid horse player, I have grown tired of these instances of biologic samples from horses having banned substances found and the “interesting” explanations as to how the exposure happened. One recent example was a story of a horse in which three samples of blood had metformin (a drug used to treat type II diabetes in humans) detected. The explanation was that a groom and later the trainer was taking metformin and “touched the horse's face.”

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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Baffert, Zedan Drop Appeal of Medina Spirit Disqualification

Trainer Bob Baffert took to X late Monday afternoon to report that he has told his legal team to drop the appeal to the result of the 2021 GI Kentucky Derby, from which Zedan Racing Stable's Medina Spirit (Protonico) was disqualified for a betamethasone positive.

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.

 

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Hearing Officer Affirms Medina Spirit Derby DQ And Baffert Penalties

The hearing officer assigned to oversee trainer Bob Baffert and owner Zedan Racing Stables' appeal of penalties related to the drug disqualification of 2021 GI Kentucky Derby winner Medina Spirit (Protonico) has issued a recommended order to the Kentucky Horse Racing Commission (KHRC) that the underlying stewards' rulings be affirmed in their entirety.

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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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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