New York: Newly-Amended Clenbuterol Rule Goes Into Effect June 2

The New York State Gaming Commission (NYSGC) voted Monday to amend its rules for the use of clenbuterol in New York State to follow the model proposed by the Racing Medication and Testing Consortium (RMTC). These rules will go into effect state-wide, including at all three New York Racing Association, Inc. (NYRA) tracks – Belmont Park, Saratoga Race Course and Aqueduct Racetrack – as of June 2.

The full text of the rules for the NYSGC's amendment for the use of clenbuterol in thoroughbred racing [Rule 4043.12(b)(6)] can be found at https://www.gaming.ny.gov/proposedrules.php.

As a reminder, as of January 1, the use of Furosemide (Lasix) is prohibited within 48 hours of all stakes races conducted at NYRA tracks, including the Belmont Stakes.

In April of 2019, NYRA led the formation of a coalition of leading racing organizations founded to address race day medication in a uniform and consistent way throughout the sport. The initiative commenced on January 1, 2020, with NYRA prohibiting Lasix in all 2-year-old races at the three NYRA tracks.

Live racing at the 48-day Belmont Park spring/summer meet continues Thursday with a nine-race card. First post is 3:05 p.m. Eastern.

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NY Aligns Clenbuterol Policy With RMTC’s

The New York State Gaming Commission (NYSGC) uninimoulsy voted to adopt two Thoroughbred-related medication rule changes at its May 17 meeting, although the exact timetable for implementation was not discussed.

Pending official adoption of the new rule, clenbuterol use in Thoroughbred racing will be regulated so it follows the model rule proposal of the Racing Medication and Testing Consortium (RMTC).

“Clenbuterol, a drug that is ordinarily used in horses as a bronchodilator to treat horses with lower airway disease, also causes a horse's body to build more muscle and reduce its fat content and has the potential to enhance performance,” NYSGC general counsel Edmund Burns wrote in a brief included in the informational packet for Monday's meeting.

Burns wrote that the newly amended NYSGC rules “would require the attending veterinarian to receive written approval [from] the Commission of a clenbuterol treatment plan for an identified horse prior to the start of such treatment. The proposal would also require that all clenbuterol administrations be reported to the Commission at the time of administration.

“The proposal would also require horses treated with clenbuterol to be placed on the veterinarian's list and not be removed until a workout for a regulatory veterinarian is performed and the horse is found to be negative for clenbuterol in blood and urine.

“In addition, horses on the veterinarian's list for clenbuterol use would be required to submit to periodic tests while on such list to ensure that no more clenbuterol is administered to the horse than necessary to complete the pre-approved treatment

regimen and to ensure that muscle-building and fat-reducing effects have dissipated before the horse is removed from the veterinarian's list,” Burns wrote.

A second rule conforms the NYSGC rules on thresholds for controlled therapeutic medications to national model rules of the Association of Racing Commissioners International, Inc. (ARCI).

“ARCI modified the model rule thresholds for three drugs (detomidine, omeprazole and xylazine) based on developing research,” Burns wrote. “ARCI also added to the list of thresholds amounts for another four routine therapeutic medications, three of which are antihistamines (cetirizine, cimetidine and ranitidine) and one of which is a muscle relaxant used in anesthetic protocols (guaifensin). The thresholds are consistent with New York's existing restricted time periods. Trainers who comply with such restricted time periods will be assured of not violating such thresholds.”

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Stewards Hand Groom Suspension Related To Compounded Clenbuterol, No Action Taken Against Trainer

A Jan. 29 suspension of Danny Gibson, a licensed groom at Fair Grounds in New Orleans, La., may have gone largely unnoticed by many, but it was part of a larger case involving a compounded drug. The week before stewards suspended Gibson for the remainder of the 2020-21 meet, the track's senior director of racing, Jason Boulet, was approached by a trainer who remains unidentified – both to the stewards and to the commission. The trainer, who does not stable at Fair Grounds, told Boulet he was approached by Gibson, who has worked as both a groom and hotwalker, and asked whether he wanted to purchase two items. Gibson showed him a bridle and a liquid in a white plastic bottle which contained clenbuterol, according to its labeling.

The trainer paid $150 for the items but then began to have second thoughts, wondering whether he could face consequences for buying them. The trainer brought the items to Boulet and identified Gibson.

When questioned by the stewards, Gibson admitted he had stolen both objects from tack rooms in other barns. The bridle came from the barn of Brendan Walsh, and the medication came from the barn of Chris Hartman. A stewards hearing was conducted and the ruling against Gibson was issued.

The plastic bottle did not bear the standard blue and white labeling of the FDA-approved form of clenbuterol sold as Ventipulmin Syrup, which can run close to $300 for a 330-milliliter bottle. Instead, it had one small sticker on it with the contact information for a Dr. Michael Stevens out of Edmond, Okla. The sticker included instructions for use, and the patient name “Smoking Memo.” It appeared that the bottle contained a compounded substance.

Compounded drugs are not approved by the Food and Drug Administration, and there are limited circumstances in which a drug may be legally compounded. Accepted circumstances include making a drug with a different route of administration (flavoring a medication for easier dosing, for example), providing emergency supply during a supply chain compromise, or making the drug in a different concentration from its mass manufactured version.

Louisiana has a rule on the books about compounded drugs. Title 35, Chapter 17 Section 1707 of the state's administrative code reads, “Any substance or material for human or animal use, ingestion, or injection, or for testing purposes that is not formally approved by the United States Food and Drug Administration is prohibited.”

The rule does not outline possible penalties or detail whether stewards may take mitigating circumstances into effect when considering a potential violation of section 1707.

When questioned by stewards, Hartman explained that the medication had been prescribed for an unnamed offspring of Smoking Memo while the horse was training in Oklahoma. The horse had suffered a knee injury necessitating a lay-off and subsequently been loaded on a trailer along with Fair Grounds shippers, along with all its equipment and the bottle. The horse was offloaded along the route to the racetrack, but the bottle was left on the van and ended up in Hartman's tack room, according to the trainer, who has made 73 starts at the track's current meet and is 15th in the trainer standings.

According to stewards' notes obtained by public record request, the stewards did not make further inquiries of Hartman and did not conduct any searches of his barn or person to verify whether any other compounded drugs were present. As of March 5, they indicated they considered the matter closed and planned no further inquiries.

Subsequent testing on the bottle by the Louisiana State University's Equine Medication Surveillance Laboratory indicated that there were no other drugs detected in the bottle besides clenbuterol. While the bottle was not labeled with a concentration, the strength of FDA-approved Ventipulmin is 72.5 micrograms per milliliter. LSU's testing showed the sample in the Gibson case contained a similar, if slightly higher concentration of about 85 micrograms per milliliter.

Churchill Downs, Inc., which owns Fair Grounds, conducted its own investigation into the incident. Dr. Will Farmer, equine medical director for CDI, indicated the ownership group had evicted Gibson from the Fair Grounds property and placed him on a no-entry list for all CDI properties. With regard to Hartman, Farmer said the track would defer to the stewards' decision not to pursue further action.

“Fair Grounds Race Course is fully committed to the safety of our human and equine athletes and the integrity of our sport,” read a statement from Farmer. “We are aware of the Louisiana Racing Commission's findings of a questionably compounded product that was uncovered on our backside and believe this activity jeopardizes the wellbeing of the horses and fairness in our sport and should not be tolerated. We have long advocated for strict regulations with respect to the use of medications to ensure that competitors are fit to race and the races are conducted fairly and with transparency.

“Circumstances like this are among the many reasons we herald the recently-passed Horseracing Integrity and Safety Act which will serve as a vehicle to establish and implement uniform medication rules and operational standards that will codify the culture of safety and integrity of which we are so firmly committed.”

Multiple calls to Hartman for comment were unreturned at press time.

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Is Florida Clenbuterol Positive An Open Or Shut Case?

Another real-life story from the pages of “Only In Florida.”

On Aug. 11, 2020, the Division of Pari-Mutuel Wagering (DPMW) filed a complaint against trainer Peter R. Walder after the state's testing laboratory at the University of Florida detected 74.5 picograms of clenbuterol in the post-race blood sample of Crea's Bklyn Law, winner of the 11th race at Gulfstream Park in Hallandale Beach, Fla., on July 11.

The lab notified DPMW director Louis Trombetta on July 28. Typically, a case will then get assigned to an attorney within the Florida Department of Business and Professional Regulation, a complaint is filed and a state investigator is directed to serve the trainer with the complaint.

Under Florida law, the state has 90 days from the date the alleged violation occurred to begin prosecution. If the state has not begun to prosecute the case within 90 days, it's dropped. According to Florida Statute 550.2415 (4), “Service of an administrative complaint marks the commencement of administrative action.”

Walder said he was never served with the complaint because he was out of state when process servers began to visit his stable at Gulfstream Park last summer.

“A detective came to my barn a few times and my assistant told them, 'He's in Saratoga.'” Walder said. “They called and said they need to see me, that they need to give me some papers.”

Officials could have hired a process server in New York to serve Walder with the complaint, but apparently never did.

“They knew where I was,” Walder said. “I was at my barn every day in Saratoga, barn 15. Do you think I'm going to go running to them so they can serve me?”

At one point, Walder said, an investigator “tried handing something to my assistant (at Gulfstream Park), but that wasn't me.”

As the clock starting winding down to the 90-day cutoff, Walder added, officials became more agitated. “One guy cursed out my assistant, calling him a liar and saying I was hiding somewhere in the barn. They couldn't find me because I wasn't there, but it's not like I was hiding.”

On Oct. 8, Walder said, while at Monmouth Park in New Jersey, he contacted a state official in Florida and said he would be returning to Gulfstream Park that weekend. The following day, Friday, Oct 9, was the 90th day after the alleged July 11 violation. By Saturday, Oct. 10, the case would have to be closed.

Or would it?

Patrick R. Fargason, deputy communications director for the Florida Department of Business and Professional Regulation, said the Crea's Bklyn Law case remains open, despite Walder's insistence that he has not been served with the complaint.

“The administrative complaint in this case was effectively served,” Fargason wrote in an email, without further explanation.

That's news to Walder.

“I've never signed anything,” he said. “The law states that they have to give (the complaint) to the trainer. By their letter of the law, the 90 days is up.”

Walder has another clenbuterol complaint, this one filed on Feb. 5 for Resident, who was found to have 246 picograms of the bronchodilator in a urine sample taken after the horse won the seventh race on Dec. 27, 2020, at Gulfstream Park.

Attorney Bradford Beilly is handling that case for Walder and said he has requested a split sample after the complaint was served within 90 days of the alleged violation.

Walder, who's won the last seven races at Gulfstream Park in which he's had a runner, said he stopped using clenbuterol at the end of 2020. Gulfstream instituted house rules prior to the championship meet that began Dec. 2 requiring a prescription for its use and a negative drug test prior to being entered to race for any horse administered the drug.

“I don't use it anymore,” Walder said. “You can't get it from the manufacturer anymore and I refuse to use the compounded stuff.”

Walder said some will try to connect his win streak with clenbuterol. He insists that is not the case, that he's always been a streaky trainer and has gone through both long slumps and hot spells. Walder said he's one of a handful of trainers who “aggressively” play the claiming game. “I'm getting good rides and have patient owners and great help,” he said. “You can't do anything without good help.”

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