Kentucky, New York Move Toward Tougher Restrictions On Clenbuterol

Trainers in several states could soon contend with tougher restrictions on the administration of clenbuterol, a bronchodilator prescribed for respiratory issues which veterinarians say can be misused. At a Dec. 1 meeting of the Kentucky Equine Drug Research Council (EDRC), committee members passed a proposed rule change for the drug which would move administration time from 14 days pre-race to 21 days pre-race, with a requirement the horse be tested for the substance before being cleared to run.

Clenbuterol is a beta-2 agonist which is known as an effective solution for horses battling respiratory ailments — a particularly common problem in racetrack barns which often have poor ventilation. Like other beta-2 agonists, however, it can also decrease body fat and increase muscle mass, particularly by converting slow twitch muscle to fast twitch muscle when used repeatedly.

At a September meeting of the EDRC, Kentucky Horse Racing Commission equine medical director Dr. Bruce Howard revealed that nearly 100 percent of Kentucky-based horses from trainers currently under federal indictment showed signs of clenbuterol administration when they were hair tested. Howard has also seen instances of veterinarians prescribing the drug to every horse in the barn.

The measure to move back the drug's administration time was not without debate. Dr. Andy Roberts, member of the EDRC and longtime Standardbred veterinarian, raised concerns about the harness population's ability to treat horses for illness under a 21-day withdrawal.

“I don't want to diminish the concerns about clenbuterol, because I think it's not illegitimate to want to control its administration to legitimate therapeutic purposes, however I think the Standardbreds are taking it quite strongly in the shorts in this because our horses race every week,” said Roberts. “There's almost no opportunity to put horses on clenbuterol already. Several other states already recognize this and have shorter withdrawals on clenbuterol.”

Roberts asked Howard whether out-of-competition testing at Red Mile had detected any clenbuterol use thus far, and Howard said it had not.

“That's because you've taken the drug out of my hands on a therapeutic basis,” said Roberts, who also maintained that the repartitioning effect of clenbuterol on muscle lasts for 11 days. “Passing rules based on speculation that somebody else is doing something — and I say this specifically from a Standardbred point of view because these horses are in to go often enough that you have already severely limited my ability to use this drug properly. People would rather leave horses sick and end up with pleural pneumonia than treat them with clenbuterol. That means we are over-regulating it.”

The 21-day window is based on the limit of detection by drug testing laboratories tasked with finding clenbuterol in a horse's urine sample. Blood and urine tests would be used to clear a horse to race after clenbuterol administration. Hair samples would show clenbuterol administration for up to six to twelve months after administration, but are highly variable depending on hair growth rates.

All EDRC committee members except Roberts voted for the increased restriction.

The vote comes a day after commissioners in New York expressed an interest in restricting clenbuterol use there, too. The Daily Racing Form reported the New York State Gaming Commission voted to require veterinarians to seek permission from the equine medical director before administering the drug, and that horses receiving clenbuterol must pass drug tests showing it has cleared the system before being permitted to run. That is similar to rule language being considered in other Mid-Atlantic states. In Canada, clenbuterol administration was pushed out to 28 days pre-race earlier this year. The American Quarter Horse Association announced a zero tolerance policy on clenbuterol in 2014, which has subsequently been picked up by several states where Quarter Horse racing is a central part of the calendar.

Experts have raised concerns about the potential for clenbuterol abuse for years, but the drug has made more headlines this year, as influential trainers like Mark Casse have called it one of the “most abused drug in our industry.”

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Clenbuterol Concerns Raised At Kentucky Equine Drug Research Council Meeting

The Kentucky Equine Drug Research Council (EDRC) is considering additional restrictions on clenbuterol use in the state after hair testing reveals widespread use in horses placed on the veterinarian's list after this year's federal indictments.

Dr. Bruce Howard, equine medical director for the Kentucky Horse Racing Commission, revealed at an EDRC meeting Sept. 11 that “a near 100 percent rate” of horses based in Kentucky had shown signs of clenbuterol administration on hair testing. Further, treatment sheets submitted to the KHRC as part of veterinary reporting regulations have shown instances of veterinarians prescribing the drug to entire stables.

“The KHRC office has received concerns from numerous trainers and owners who feel that clenbuterol is being misused,” said Howard, who pointed out California, Maryland, Canada, and Florida all have or are validating rules for a longer withdrawal time than Kentucky's.

Clenbuterol is a beta-2 agonist drug most commonly prescribed as a bronchodilator for horses dealing with breathing issues. As a beta-2 agonist however, it also has the side effect of repartitioning — converting slow-twitch muscle fibers to fast-twitch muscle fibers, which has a similar result to an anabolic steroid.

Currently, Kentucky regulations state clenbuterol may not be given closer than 14 days pre-race. Howard suggested pushing the timeframe back to 21 days pre-race and requiring blood and urine tests after a reported administration before the horse could return to the entry box.

But Standardbred representatives at the meeting, which was held by video conference, raised objections. Because harness horses race so frequently, they claim the 14-day timeline already makes it difficult for veterinarians to prescribe the drug to Standardbreds. Widening the gap further will exacerbate the problem.

“People will refuse appropriate treatment of their horses because of the long withdrawal period,” said council member Dr. Andy Roberts, referring to Standardbred horsemen. “It is not abused in the Standardbred sport to speak of. We have a four-day withdrawal period in the state of Ohio and you don't see horses shipping in from Ohio and just knocking people's heads in. It's really not an issue.

“I think the discussion on this drug has long been a case of people feeling like they're getting beat by somebody else when they're using this drug and I don't think there's any scientific fact that details that. As a matter of fact, the repartitioning effect, when you take the drug away, is very quickly reversed.”

Howard pointed out his intention by suggesting a longer withdrawal time was not to remove veterinarians' ability to treat horses, only to encourage responsible use.

Dr. Naveed Chowhan, chair of the EDRC, questioned whether the committee could recommend separate regulation for the breeds to the commission. Council member Dr. Jim Morehead indicated he thought this was a dangerous precedent to set.

The matter has been tabled for now.

Also at Friday's meeting, the council heard a presentation from ReCellerate, the makers of Equiflow aerosol mist. Equiflow is a non-drug biologic which is supposed to help repair damage from severe incidents of exercise-induced pulmonary hemorrhage (EIPH) and reduce incidents of bleeding without the use of Lasix. The substance, which is administered as an inhalant, is concentrated protein serum harvested from stem cell collection from donor horses.

ReCellerate representatives sought to get permission from the EDRC and KHRC to allow veterinarians to prescribe the substance to active racehorses in controlled conditions to get a better sense of its efficacy. The product is in the process of getting approval as a drug by the Food and Drug Administration (FDA); use of any non-FDA approved substance in a competing horse is required by rule to be approved by the commission.

Council members were interested in Equiflow's initally-promising results, but some voiced concerns about the challenges of getting a biologic product approved by the FDA as a drug, since it's derived from different donor horses at different times in different collections. ReCellerate representatives assured the council that along with safety and efficacy, uniformity was part of the FDA's rubric for approval.

The council also heard an update on plans for Kentucky to participate in a multi-state study on Lasix use as the state has begun its first year of a partial raceday Lasix phaseout. Initial study plans are in the works to collect video scopes on horses running with raceday and non-raceday Lasix, as well as blood samples to look for inflammatory biomarkers that could be related to EIPH incidents. Drs. Will Farmer, equine medical director for Churchill Downs Inc. and Stuart Brown, equine safety director for Keeneland, indicated the study plans are not yet ready for submission to the EDRC as part of a funding request, as organizers are still working out what the cost would be to each participating entity. The current study design would compare scopes and samples from Maryland, Kentucky, California, Louisiana, Pennsylvania, New Jersey, and Delaware.

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