Judge Wingate issued a written decision on June 16 regarding plans for the remaining urine sample of Kentucky Derby first place finisher Medina Spirit. The decision follows a June 11 hearing in Franklin County Circuit Court, in which Judge Wingate determined that the legal team for Medina Spirit's connections will be permitted to do extra testing on a urine sample (the “split sample”) taken from the colt after the Kentucky Derby and held by the KHRC.

The case is based on the finding of betamethasone in a post-race sample of Medina Spirit, collected immediately after the colt crossed the wire first in the Kentucky Derby.

Counsel for Medina Spirit's trainer Bob Baffert and owner Zedan Stables filed a civil suit against the Kentucky Horse Racing Commission on June 7 demanding their right to test the split urine sample, which sat undisturbed in the commission's freezer. Remnants of the original biologic samples were initially sent to be tested for those ingredients, but they were reportedly damaged before arrival at the plaintiffs' choice of labs.

Judge Wingate ordered June 16 that the remaining urine sample be flown to the plaintiffs' choice of lab for testing, the New York Equine Drug Testing and Research Laboratory, that two KHRC representatives travel with the sample, and that plaintiffs fund the flight. Upon arrival, the KHRC was to retain 5 milliliters of the sample, while the remainder was to be tested for clotrimazole, gentamicin, and betamethasone valerate.

On July 14, the sample was flown to New York accompanied by Dr. Clara Fenger and Tom Huckabee, representing Baffert and Medina Spirit's owner, Amr Zedan, as well as by KHRC executive director Marc Guilfoil and equine medical director Dr. Bruce Howard.

The July 19 filing by the KHRC alleges that the urine sample was split into four milliliter and 19 milliliter segments, with the New York lab to retain the larger segment for testing. Program director Dr. George Maylin attempted to then retain the remnants of the original urine sample, which was contaminated during shipment, claiming he was unaware that the court order required those remnants be turned over to the KHRC.

When the remnants were turned over to KHRC representatives, the filing alleges that the urine tube contained only one to two milliliters of “bloody fluid,” a broken serum separator tube, and another tube with serum that had been saved — all presented at room temperature instead of frozen. Guifoil and Howard report that Dr. Maylin said most of the sample had been used up in testing, but would not indicate what testing was performed.

“We will be formally responding to the Court,” Baffert's attorney, Craig Robertson, told the Courier-Journal. “The statements contained in the KHRC's status report are inaccurate. We have intentionally had no direct communication with the New York lab, so we are unaware of any testing or the results. This will be detailed in our response.”

Read more at the Courier-Journal.

Additional stories about Baffert's Kentucky Derby positive and ensuing legal battles can be found here.

The post KHRC Alleges ‘Lack Of Candor And Contemptuous Conduct’ By New York Lab, Baffert Attorneys appeared first on Horse Racing News | Paulick Report.

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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.

The post Kentucky Regulators Express Concern About Fluphenazine And Its Considerable Staying Power appeared first on Horse Racing News | Paulick Report.

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Dr. Bruce Howard, equine medical director for the Kentucky Horse Racing Commission, said Bayly has gotten commitments from at least eight entities to help collect data that can be used in the study. Across those entities there are three different furosemide withdrawal time regulations on the books: four hours pre-race, 24 hours pre-race, and 48 hours pre-race. Bayly will hope to have at least 60 or possibly more horses sampled from each set of conditions.

“We feel this study is integral part of understanding EIPH evaluating the impact changes in furosemide administration may have,” said Howard.

Bayly may expand the number of horses studied to improve the strength of data.

Howard is hopeful the data could help provide the commission with useful comparisons to other jurisdictions. Earlier this year, Kentucky enacted the first step of a partial phaseout of furosemide, backing up pre-race administration time to 24 hours for 2-year-olds.

Howard said Keeneland began scoping 2-year-olds post-race at its July meet and has continued to do so in October, and Churchill Downs had expressed interest in gathering similar data. This proposal will provide the funds for those efforts to become part of a bigger scientific picture.

Earlier this year, the Maryland Jockey Club and Maryland Thoroughbred Horsemen's Association announced a similar survey of 2-year-olds racing there beginning Aug. 7. The cut-off time for furosemide administration for 2-year-olds in Maryland is now 48 hours pre-race.

The post Equine Drug Research Council Approves Funding For Study On EIPH appeared first on Horse Racing News | Paulick Report.

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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.

The post Clenbuterol Concerns Raised At Kentucky Equine Drug Research Council Meeting appeared first on Horse Racing News | Paulick Report.

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According to bloodhorse.com, the committee declined to take action to stop the regulations, allowing the new rules to take effect immediately.

“Eighty-nine percent of the 2-year-olds showed no evidence of blood in their airways and only two out of the 47 scoped showed anything more than a trace of blood,” Dr. Howard said, referring to a week-long study at Keeneland during the summer meet.

The Lasix ban will extend to all graded stakes races in 2021.

Earlier this year, the Kentucky Horsemen's Benevolent and Protective Association filed suit against the tracks that first implemented the new regulations. The suit is ongoing.

Additional rules included in the new KHRC regulations include: a pushback of non-steroidal anti-inflammatories (NSAIDs) from 24 hours to 48 hours before post time, a rule against stacking NSAIDs, a pushback of intra-articular corticosteroids to 14 days prior to race day, a rule requiring trainers or owners to submit 14 days' worth of a horse's medical records to the commission prior to race day, elimination of bisphosphonates in racing and in horses younger than 4 years old, and a rule requiring a horse be examined by an attending veterinarian in addition to a commission veterinarian pre-race.

Read more at bloodhorse.com.

The post Kentucky: Lasix, New Medication Rules Take Effect As Legislative Committee Declines Action appeared first on Horse Racing News | Paulick Report.

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The committee did not hold a vote, a procedure that produced the same results as if had voted to approve the regulations.

Tuesday’s hearing was the latest in what has been a contentious battle between pro and anti-Lasix forces in Kentucky, a fight that may now be over as the committee has the final say on racing regulations in the state.

The Kentucky tracks are among a number of racing jurisdictions that have taken steps to cut back on the use of the controversial drug that is used to control bleeding.

Led by the Kentucky HBPA and the National HBPA, the pro-Lasix forces expressed their displeasure with how the meeting was handled. Each side was allowed only one witness. Dr. Clara Fenger, who spoke on behalf of the horsemen, said she was told that each side was allowed to have three speakers. She also said her testimony was cut off before she had a chance to read her entire statement.

“This was a done deal and we had no shot,” Fenger said. “We knew that going in.”

Committee member Damon Thayer, who is the majority floor leader, said there was nothing unusual about the number of people who were permitted to speak.

“Both sides had equal time to present their case, including the racing commission and a representative of the HBPA and some veterinarians,” Thayer said. “Their complaints are much ado about nothing. This was just the final obligatory step in a long process that has included two meetings of the equine drug research council, meetings of the Kentucky Horse Racing Commission and public comments periods that every regulation has to go through. There’s really nothing to that complaint. This is the process that every regulation goes through and there was nothing abnormal about it.”

Fenger, a practicing vet in Central Kentucky, said that any steps to cut back on the use of Lasix would be detrimental to the overall health of the horse.

“The banning of the therapeutic medication, Lasix, is one of the most dangerous proposals ever concocted by our racing commissioners,” she said. “Two horses perished from exercise induced pulmonary hemorrhage in Kentucky since the KHRC has begun posting these deaths on their website. Banning Lasix in any group of horses will guarantee a higher number of such deaths.”

Dr. Bruce Howard, the equine medical director for the Kentucky Horse Racing Commission, was the lone speaker allowed to talk on behalf of the proposed new medication rules.

“By adopting this compromise and moving away from the use of race day furosemide we can come into alignment with the rest of the racing world and help lessen the negative public perception that exists surrounding medication issues in racing,” Howard said. “We will minimize the argument that furosemide enhances performance by causing fluid elimination which reduces a horses weight by an estimated 10 to 20 pounds.”

Howard added that there have been 60 2-year-old races run so far this year in Kentucky without Lasix and that out of 532 starters only one had been observed bleeding from the nostrils after the race.

“This is a compromise between those who want to eliminate Lasix all together and those who want to keep the status quo,” Thayer said. “I think it is a good compromise, by eliminating Lasix use in 2 year-old-races and stakes races. It’s a good starting point for other states to consider and I am happy that Kentucky is leading the way. As the great Lasix debate rages I’d like to think this is a good middle ground.”

Lasix was not the only medication dealt with in the new regulations. New rules include a ban on bisphosphonate use in horses under 4-years-old; non-steroidal anti-inflammatories (NSAIDs), may be given no closer than 48 hours pre-race instead of 24; the race day use of electronic therapeutics has been banned; trainers must make veterinary records available if they are asked for by racing officials.

The post Kentucky Legislative Committee Approves Partial Lasix Ban appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

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