Letter to the Editor: Joseph S. Bertino, Jr., PharmD, FCP, FCCP

I am writing to try to clear up some of the confusion concerning the science around betamethasone as it pertains to its use in racehorses. I am a (human) clinical pharmacologist and the Editor-in-Chief of the Journal of Clinical Pharmacology.

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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Bettor Suing Baffert Leaving the Racing Game

Michael Beychok has been one of the most visible horseplayers in the sport for a while. He's a winner of the National Handicapping Championship, a horseplayer advocate and a public handicapper for the New Orleans Times-Picayune who has spent the better part of his life betting on the horses. Just not for much longer.

Beychok, who is the leading figure in a class-action lawsuit filed by gamblers who say they would have made money on the 2021 GI Kentucky Derby had it not been won by Medina Spirit (Protonico), says he has grown so disillusioned by the sport that he will stop betting on a regular basis after attending this year's National Handicapping Championship. His future bets will be limited to the handful of times he attends live racing.

“I'm just fed up with the drug cheating,” he said. “I'm fed up with the takeout. I'm fed up that we apparently can't get into a position to implement new and better drug testing. I have more outlets now to gamble. I live in Louisiana, which was a state, up until last year, where the only thing available was horse racing. Now, there is daily fantasy sports, which I enjoy, and the takeout is much, much better. Soon we will have on-line sports betting. I am a consumer. I have just found better products.”

Beychok made headlines last year when filing a suit against Baffert, contending that he would have made more than $50,000 on the Derby had the race been won by Mandaloun (Into Mischief). Mandaloun finished second behind the Baffert-trained Medina Spirit, who tested positive for the banned race-day medication betamethasone. He wants the court to rule that Baffert must compensate gamblers involved in the suit who would have cashed if Medina Spirit did not win.

“My first motivation was as a gambler,” he said. “I was kind of pissed off when it was announced he was positive for a banned race-day drug. Looking back on what had happened in the past with some of Baffert's positives in major races, I just knew that nothing was going to happen. I felt I had to do something because I didn't think anyone else would. I decided I wasn't going to take it anymore. I was going to do something not only for myself but for the more than 250 other bettors who have joined our class action. We're tired of being defrauded by Bob Baffert. In big races, his horses keep turning up positive.”

Beychok insists this isn't about the money.

“Any money that I get from this lawsuit, I'm donating to Thoroughbred aftercare,” he said. “I'm not putting a penny of this money into my pocket. Hopefully, I do get paid. But what I'm trying to do is to raise the point that we cannot, in a game of chance, on a game of gambling, let anybody, be it Bob Baffert, Jason Servis, Jorge Navarro, defraud us as bettors.”

Baffert's legal team has fought back and is seeking to have Beychok's suit thrown out. In a court filing last week, Baffert said Beychok's allegations were libelous and called his actions a matter of a “tinfoil conspiratorial premise.”

“That was for public consumption,” Beychok said. “That's all. I just laughed at it. The judge will look at the law and decide if applies in this case or if it doesn't.”

Beychok said he's not surprised that Baffert is putting up a good fight.

“Bob Baffert is very good at this and he has a very good PR machine,” he said. “He's good at it because he had to do it so many times over the last 15 years when his horses have tested positive. He's got to come up with an excuse, a PR campaign. He's good at this stuff and so are his lawyers.”

Beychok said he would like to see Baffert issue a mea culpa.

“My hope for this game that I do love is that he does what Lance Armstrong did,” Beychok said. “At some point, he needs to come clean and tell the truth. That might preserve some of his legacy.”

While about to step back, Beychok said he's willing to give horse racing another chance, that is if there are meaningful changes.

“I hope it changes because I love the game and the people in it,” he said. “I hope everything changes and I can say I am back. If I ever feel like this is a fair game I will come back.”

 

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Santa Anita Releases Baffert Statement

Following Wednesday's announcement from Churchill Downs Inc. that Hall of Fame trainer Bob Baffert would be banned for two years, Santa Anita released the following statement:

“Santa Anita Park is committed to integrity, accountability and fairness in our sport. As it stands, the Kentucky Horse Racing Commission (KHRC)–which is the governing body for horse racing in Kentucky–has not released all of the information nor has it offered a ruling on this matter. We will continue to await action by the KHRC and will make a decision once their regulatory process is complete.”

Santa Anita is Baffert's home track and where the majority of his stable is based. He will be unable to enter horses in races or occupy stalls at any Churchill-owned tracks, which include Fair Grounds and Arlington Park, due to the split sample from Medina Spirit (Protonico)'s first-place finish in the May 1 GI Kentucky Derby returning positive for betamethasone, a prohibited substance in Kentucky.

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Churchill Suspends Baffert For Two Years After Medina Spirit’s Split is Positive

According to Craig Robertson, the lawyer representing Bob Baffert, a second-post race test has confirmed that Medina Spirit (Protonico) tested positive for the prohibited corticosteroid betamethasone, which could lead to the horse being disqualified from this year's GI Kentucky Derby. In response, Churchill Downs Inc. banned Baffert for two years.

“In response to the inquiries, this will acknowledge that the Medina Spirit split sample confirmed the finding of betamethasone at 25 picograms,” Robertson said in a statement. “There is other testing that is being conducted, including DNA testing. We expect this additional testing to confirm that the presence of the betamethasone was from the topical ointment, Otomax, and not an injection. At the end of the day, we anticipate this case to be about the treatment of Medina Spirit's skin rash with Otomax. We will have nothing further to say until the additional testing is complete.”

As of the deadline for this story, the Kentucky Racing Commission had yet to make any statements regarding Medina Spirit and the Betamethasone positive and neither had it confirmed that Medina Spirit has failed any drug tests. However, Churchill Downs took action of its own Wednesday, suspending the trainer until the conclusion of the spring meet in 2023. If Baffert cannot compete in the 2022 and 2023 Kentucky Derby many prominent owners may choose to give their horses to other trainers.

Churchill issued a statement Wednesday, which read, in part: “The suspension prohibits Baffert, or any trainer directly or indirectly employed by Bob Baffert Racing Stables, from entering horses in races or applying for stall occupancy at all CDI-owned racetracks. This decision follows the confirmation by attorneys representing Bob Baffert of the presence of betamethasone, a prohibited race-day substance, in Medina Spirit's bloodstream on the day of the 147th running of the Kentucky Derby in violation of the Commonwealth of Kentucky's equine medication protocols and CDI's terms and conditions for racing.”

Churchill Downs CEO Bill Carstanjen made it clear that the company has no tolerance for anybody whose action might compromise the integrity of the sport.

“CDI has consistently advocated for strict medication regulations so that we can confidently ensure that horses are fit to race and the races are conducted fairly,” Carstanjen said. “Reckless practices and substance violations that jeopardize the safety of our equine and human athletes or compromise the integrity of our sport are not acceptable and as a company we must take measures to demonstrate that they will not be tolerated. Mr. Baffert's record of testing failures threatens public confidence in thoroughbred racing and the reputation of the Kentucky Derby. Given these repeated failures over the last year, including the increasingly extraordinary explanations, we firmly believe that asserting our rights to impose these measures is our duty and responsibility.”

CDI said that it was reserving the right to extend Baffert's suspension if there are additional violations in any racing jurisdiction.

NYRA suspended Baffert for an undetermined period starting May 17 and they announced that the ban would stay in place until further notice.

“On May 17, the New York Racing Association, Inc. announced the temporary suspension of Bob Baffert from entering horses in races and occupying stall space at Belmont Park, Saratoga Race Course and Aqueduct Racetrack,” NYRA spokesman Pat McKenna said. “That suspension remains in effect and NYRA will make a determination regarding the length and terms of Mr. Baffert's suspension at the appropriate time and based on information generated by the ongoing investigation in Kentucky.”

After the news broke that the horse had tested positive following the Derby, trainer Bob Baffert and owner Amr Zedan requested that a second sample be sent to a laboratory, hoping that it would not show any traces of the prohibited medication.

If Medina Spirit is disqualified, the official winner of the Derby will be Mandaloun (Into Mischief). In 1968, Dancer's Image was disqualified from the Kentucky Derby after tests revealed the presence of phenylbutazone in his system and Forward Pass was declared the winner.

Once the racing commission makes it official that Medina Spirit has failed both tests, a hearing will be held before Churchill Downs stewards. If they decide that Medina Spirit must be disqualified then the Baffert team will have the option of appealing the case to the Kentucky Racing Commission. Should it decide to uphold the disqualification and penalties given to Baffert by the stewards, the next move from the Baffert team would likely be to appeal to the courts and to seek a stay pending the outcome of the case.

It took four years for the Dancer's Image case to work its way through the court system. He was not officially disqualified until 1972.

Baffert did not respond to a text from the TDN. When reached by phone, Zedan said he had no comment and referred questions to his attorney, Clark Brewster.

Brewster said he was confident that the original results of the Kentucky Derby would hold up and that Baffert would be exonerated. Baffert has said that Medina Spirit was treated with Otomax, an ointment that contains betamethasone and is used to treat dermatitis. For that reason, Brewster will make the case that the drug positive was nothing more than a case of inadvertent contamination. He said that the Medina Spirit team will request additional tests in an effort to prove that Medina Spirit was in fact treated with Otomax, which would indicate, he said, that the horse was not injected with the medication and that there were no attempts to use the medication as a performance-enhancer.

“Bob Baffert wins the Derby and within days is pilloried. People are on social media saying he is a cheat,” Brewster said. “The upshot of this is that they all believe this was an injectable into the joint and he's trying to get a horse in that might have some joint issues or pain. That's nonsense.  If it can be proven that it simply was salve for eczema and used on a portion of his hip, which I think we can document…And it's not just Bob saying that, it would be proven scientifically. Reasonable people with some of facts will reach the same conclusion. The Horse Racing Integrity act? I love it. Let's make the rules uniform for everybody. But if you reject the science and use Draconian decision making, then it's bad for everybody. It's like rejecting climate change. When you are at a picogram level you have to use common sense and when you show the method of how it got into the horses's system, that is relevant and important for any decision making. I am very confident that reasonable people with the same facts will reach a reasonable conclusion, which means victory for Bob.”

PETA issued a statement Tuesday in which it called for Baffert to be permanently banned from the sport.

“Bettors who've been cheated by putting money down on the rigged Kentucky Derby may contact PETA or attorneys who are filing class-action lawsuits, but the other victim here is Medina Spirit,” said PETA Senior Vice President Kathy Guillermo. “He should be thoroughly examined by independent veterinarians to find out why he was administered a powerful medication and whether it was through injections to his joints rather than with a topical cream. The racing industry must at last stop buying Baffert's nonsensical excuses and kick him out for good.”

The Animal Wellness Action called for Churchill Downs to permanently ban Baffert from participating in the Derby.

Though the Kentucky Racing Commission has yet to take any official action against Baffert, he has been banned indefinitely by Churchill Downs and the New York Racing Association. The Stronach Group, which operates Santa Anita, Baffert's home track, has not taken any action against him, but may have been waiting for the split sample to come back. Should he be suspended by the Kentucky Racing Commission, all other state racing commissions will have to honor that suspension.

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