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Kentucky Regulators Express Concern About Fluphenazine And Its Considerable Staying Power

Members of the Kentucky Equine Drug Research Council voted Friday to withdraw existing guidance for racetrack practitioners about the use of fluphenazine after officials became aware that the drug can linger in a horse's body much longer than once thought.

Fluphenazine is used as an anti-psychotic drug in humans and a long-term sedative in horses. Under Kentucky's current guidance, it's considered a Class B drug, meaning it's considered to have a potential to influence racehorses' performance, but not as much potential as those drugs in Class A. Fluphenazine is an oil-based drug and is typically given subcutaneously, meaning under the skin.

Current guidance advises veterinarians to withdraw the drug seven days before a race. Dr. Bruce Howard, equine medical director for the Kentucky Horse Racing Commission, said he got a call from a practicing veterinarian a few months ago asking whether that guidance was correct, which prompted him to do a deep dive into the data available about fluphenazine use in horses.

What he discovered was that the seven day withdrawal suggestion on the books in Kentucky had been in place since 2004, before the advent of instrumentation testing for drugs in post-race samples. The ELISA kit method that was being used at that time was considerably less sensitive than current methods.

(Learn more about drug testing methods and why they matter in this 2014 Paulick Report feature.)

Howard found two unpublished studies, each consisting of only three horses, which claimed the drug could persist “for weeks” in the horse, while a conversation with California officials suggested it may even linger in a horse's system “for months.” That's because, in part, it has a very long half life, meaning the amount of time it takes for the total amount of the drug in the body to be reduced by 50%. While the half life for many drugs can be measured in hours, Howard's findings suggest that of fluphenazine could be 6.8 to 9.6 days. It's also possible that after an initial decrease in drug levels, fluphenazine concentrations might paradoxically increase again about 15 days after dosing.

Other racing groups have suggested that the drug be stopped for 45 to 60 days before racing, or possibly even longer.

“It appears to me from this information that the seven day withdrawal is really inadequate,” said Howard. “I don't think there's a credible study to make a withdrawal recommendation at this time.”

Instead, Howard suggests that trainers request a blood test on horses that have previously had fluphenazine before entering a race to verify whether they're under the required threshold in Kentucky. This could prove especially challenging in situations where a horse may have received the drug at the start of the year, gone to sale as a 2-year-old, and returned with an eye toward making a first start in April or May, as new connections may not know whether the drug had been given or not. In those scenarios, Howard said that a record of a treatment could serve as a “mitigating circumstance” for a trainer who had followed the seven-day guidance before the commission rescinded the guideline.

Fortunately, Howard said there have been no fluphenazine violations in Kentucky since 2009 and several veterinary members of the council agreed they don't think it's commonly used anymore for a variety of reasons.

The council agreed unanimously to rescind the seven-day guidance, on the condition Howard send additional warnings to practicing veterinarians about the issue.

The removal of the rule outlining the seven day guidance will now advance to the full Kentucky Horse Racing Commission for a vote before continuing through the legislature for final approval.

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Funds Granted For Follow-Up Study On Catastrophic Racehorse Injuries

Catastrophic injuries in Thoroughbred racehorses is a top concern for the industry and for its fans. That sentiment is shared by researchers at the University of Kentucky's College of Agriculture, Food and Environment, who are working to learn more about changes happening at the cellular level that might indicate an injury is present before it becomes career- or life-ending.

According to Allen Page, staff scientist and veterinarian at UK's Gluck Equine Research Center, a recently completed study submitted for review shows it is possible to identify several early markers for horses at risk of catastrophic injury, possibly allowing for intervention before those injuries happen.

In this initial study, Page and his colleagues analyzed blood samples from more than 1,000 Thoroughbred racehorses. The samples, collected by participating racing jurisdictions from across the country, have come from both catastrophically injured and non-injured horses in a quest to better understand if there are any red flags in horses that suffer a catastrophic injury.

Previous research showed that many catastrophic injuries occur in limbs with underlying and pre-existing damage, leading to the theory that these injuries occur when damage accumulation exceeds the healing capacity of the affected bones over time. As a result, researchers think it is likely there may be markers of this damage that can be detected prior to an injury.

The identification of protein biomarkers for these types of injuries has been explored in previous research with limited success. As a result, the group opted to focus on quantifying messenger RNA gene transcripts or markers, knowing that the results would likely be much more sensitive than measuring proteins.

“We are definitely encouraged by our findings in the initial study. Out of the 21 markers we measured, three of them show real promise as being able to predict injury,” Page said. “Since the ultimate hope is to develop a screening tool that can be used pre-race to identify horses at increased risk for injury, we anticipate adding multiple other markers with our new study that is just getting started.”

As part of their new study, Page and his colleagues plan to utilize RNA-sequencing, a relatively new technology, to expand their search to the approximately 22,000 protein-coding genes horses have. This will dramatically increase the likelihood that they will be able to identify additional markers for horses at risk of injury. They plan to do this by using the large number of samples that have already been collected, further leveraging their initial study and decreasing the amount of time it will take to complete their new study.

The new study has been funded by the Kentucky Horse Racing Commission's Equine Drug Research Council, which also funded the three-year initial study.

“A lot of the credit for these projects goes to the KHRC and the Equine Drug Research Council. Their willingness to fund our projects is really a testament to their interest in supporting innovative and novel ideas geared towards improving the safety and well-being of horses and riders,” Page said.

“I am pleased that the EDRC is able to continue to provide support for this important study and that Dr. Page is able to continue his work on finding ways to protect our equine athletes,” said David Horohov, chair of the UK Department of Veterinary Science.

Joining Page in the research from UK's Gluck Center are Horohov, Emma Adam, assistant professor, research and industry liaison, James MacLeod, John S. and Elizabeth A. Knight chair, and Ted Kalbfleisch, associate professor.

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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