This follows news last week that the Horseracing Integrity and Safety Authority (HISA) and Horseracing Integrity and Welfare Unit (HIWU) have opened an investigation into the UK Laboratory's performance, and that the agencies were cooperating with the university's own investigation into the matter.

The university is also conducting an ongoing personnel investigation relating to former lab director Scott Stanley and that “Dr. Stanley was not permitted to be in direct communication with the other staff at the laboratory,” HISA and HIWU wrote in a joint statement last week.

According to Stanley, he stepped down as the UK Lab's director at the beginning of March and has been reassigned within the university. Blood-Horse reported that he had been “removed” from the position.

HIWU stopped sending samples to the UK Lab on Feb. 16. Prior to that, the laboratory had been one of six drug testing facilities used under HISA's Anti-Doping and Medication Control (ADMC) program. According to the RMTC's Hardy, his organization alerted the University of Kentucky to the RMTC's laboratory accreditation suspension on Mar. 11.

When asked what specific developments had prompted the RMTC to take this action, Hardy pointed to the RMTC's laboratory code of standards, section 2.4.9.2.

The document outlines 10 possible considerations that may prompt the RMTC to suspend its accreditation of a laboratory:

• Accreditation suspensions by international lab oversight bodies.
• Failure to take appropriate corrective action after unsatisfactory performance either in routine Analytical Testing or in proficiency testing.
• Failure to comply with any of the requirements or standards listed in an international laboratory accreditation cooperation document.
• Failure to cooperate with the RMTC or the relevant State Horse Racing Authority in providing requested documentation.
• Lack of compliance with the RMTC Laboratory Code of Ethics.
• Major changes in key staff without proper and timely notification to RMTC.
• Failure to cooperate in any RMTC enquiry in relation to the activities of the Laboratory.
• Non-compliances identified from laboratory on-site assessments.
• Loss of financial and administrative support jeopardizing the quality and/or viability of the Laboratory.
• Material breach of contractual obligation to a State Horse Racing Authority.

Hardy declined to elaborate on the nature and severity of the issues identified by the RMTC with operations at the UK Lab. Hardy wrote, however, that “the Horserace Testing Laboratory Committee (HTLC) will, upon receipt, review the laboratory's response and associated corrective actions. Accreditation will not be restored until the laboratory is in full compliance with the Code.”

According to the RMTC's code of standards, the “period and terms” of the suspension shall be proportionate to the “seriousness of the non-compliance(s) or lack of performance and the need to ensure accurate and reliable drug testing of Horses.”

The RMTC can suspend accreditation for a period of up to six months, according to the code of standards, during which time any problems must be “corrected, documented and reported” to the RMTC at least six weeks before the end of the suspension period.

“Delay in submitting the proper corrective actions may lead to an extension of the Suspension period,” the code of standards explains. If the problems are not rectified, laboratory accreditation will be revoked, the document states, “unless an extension, not to exceed two (2) months, is granted by the RMTC.”

In a brief phone interview with the TDN, Hardy added that the RMTC has been “very pleased with the response and communication with executive staff at the University of Kentucky regarding the laboratory and have been assured that they are proactively seeking to redeem those requirements.”

Since Feb. 16, all samples collected in Kentucky and Florida that previously would have been analyzed by the UK Lab have been redirected to Industrial Laboratories in Colorado.

The TDN has reached out to the University of Kentucky for comment. The story will be updated as necessary.

According to a HIWU spokesperson, both agencies were “not party” to the RMTC's decision to suspend its accreditation of the UK Lab.

“Pending implementation of the HISA Equine Analytical Laboratory (HEAL) accreditation standards, a laboratory must be accredited by the RMTC to be eligible for consideration as one of the ADMC Program labs,” the HIWU spokesperson wrote.

Lab accreditation is only one prong of the RMTC, which is also involved in the research, education and advocacy of horse racing's anti-doping and medication control programs.

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“Following this review, which was conducted in collaboration with the laboratories, it was determined that not all applied the same Limit of Detection in analyzing samples for the presence of Metformin. HIWU has since met with all six laboratories to establish an updated, uniform Limit of Detection,” according to the HIWU statement.

Furthermore, “there are efforts to harmonize testing sensitivity across the laboratories through an external quality assurance program that includes single- and double-blind quality assurance samples and a passed sample exchange program,” according to the HIWU statement.

“Additionally, substances will continue to be reviewed on a case-by-case basis to ensure that all laboratories contracted by HIWU report uniform results for the same substances present at the same levels in different samples,” the statement reads.

All HIWU-contracted laboratories contracted are accredited by the Racing Medication & Testing Consortium.

According to HIWU, HISA's Equine Analytical Laboratory Accreditation standards are currently in development, and HIWU expects the process to continue through 2024.

Because of this flaw in testing uniformity, HIWU has lifted the provisional suspensions it had initially imposed on trainers Guadalupe Munoz Elizondo and Javier Morzan for metformin positives.

The agency wrote that it will also be withdrawing the Equine Anti-Doping Charge letters against Elizondo and Morzan “due to their Covered Horses testing positive for Metformin at levels in blood that would not have been reported as Adverse Analytical Findings under the updated Limit of Detection.”

Elizondo trainee, Quinton's Charmer (Quinton's Gold), tested positive for metformin, a common type 2 diabetes drug in humans, in a sample taken June 11 this year.

The Morzan-trained Lady Liv (Bal A Bali) tested positive for metformin after finishing third at Delaware Park June 24.

Elizondo and Morzan were two of five trainers this past week who have seen their provisional suspensions lifted by HIWU. Besides the metformin cases, two were for cocaine positives, and one was for the diuretic hydrochlorothiazide.

On Tuesday, Michelle Pujals, HIWU general counsel, sent Elizondo a letter explaining the decision behind lifting the provisional suspension.

In the letter, Pujals wrote that “HIWU has determined that there was variability across laboratories with respect to Limit of Detection for this Banned Substance, and, in order to eliminate inconsistency in enforcement based on interlaboratory capabilities, HIWU is determining whether this finding will be pursued as an Adverse Analytical Finding.”

On Wednesday, TDN submitted to HIWU a list of questions about the contents of the letter, including further explanations on what was meant by “variability across laboratories,” and “inconsistency in enforcement based on interlaboratory capabilities.”

TDN will follow-up with HIWU about the remaining questions unanswered by Thursday's statement.

There remain three trainers with pending hearings for metformin positives whose provisional suspensions have not been lifted by HIWU. They are Jonathan Wong, Angel Sanchez and Michael Lauer.

In Thursday's statement, HIWU wrote that the review of and update to the metformin limit of detection in blood represents “progress from previous state-based regulatory structures in which laboratories historically operated independently of each other, resulting in substances being controlled differently depending on the laboratory conducting the testing.”

The statement adds that “HISA's national structure enables HIWU to oversee all testing across the country and facilitate uniform enforcement of the ADMC rules. HIWU is committed to the harmonization of its laboratories and continues to work with them to reach this goal.”

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In his new position, Hardy will be responsible for the management of the RMTC's Laboratory Accreditation and External Quality Assurance Program in conjunction with the new Horseracing Integrity and Welfare Unit and will also administer the RMTC's Scientific Advisory Committee (SAC) process, manage the organization's monitoring of emerging threats to the integrity of racing, and oversee the process of reviewing applications received for all RMTC-funded post-doctoral fellowships and research proposals.

“We are very pleased to have Dr. Hardy on board in a full-time capacity,” RMTC Chair Alex Waldrop said. “The Board of Directors has determined that the work of the RMTC and its scientific advisory committee continue to be uniquely relevant to the horseracing industry's efforts to fairly and safely regulate the use of therapeutic medications and aggressively detect and deter the use of prohibited substances. In this regard, Dr. Hardy is the right person to lead these important efforts going forward.”

Also during its recent meeting, the RMTC Board approved the development, organization, and financial support of a Racing Industry Veterinary Student Externship Program in response to the supply and demand concerns associated with available equine-specific veterinarians to meet the racing industry needs. This program will provide a shared experience for veterinary students with racetrack practitioners and regulatory veterinarians with the objective to promote and provide exposure to and networking opportunities in equine veterinary medicine within the racing industry to prospective veterinarians.

“The success of the racing industry is dependent on the recruitment, availability, and retention of motivated attending and regulatory veterinary professionals to oversee the safety and welfare of its participants,” Hardy said. “The RMTC will join other equine industry organizations taking an active role in promoting careers in equine veterinary medicine.”

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This means on the first day of 2023, thousands of trainers, veterinarians and other backstretch workers must grapple with a new set of rules guiding how and when to administer a set of everyday medications–the list of which can be found here–to avoid falling foul of a post-race and out-of-competition positive.

Is there much of a difference between the Association of Racing Commissioners International (ACRI)'s current therapeutic medication schedule and that as outlined by the Horseracing Integrity and Welfare Unit (HIWU)?

Turns out there is–one that, in short, boils down to the differences between the current world of withdrawal guidelines and thresholds, and the looming system of detection times and screening limits.

“There is a substantial difference and if the terms are used interchangeably, there is a profound risk of a medication violation,” warned Mary Scollay, chief of science at HIWU, established by Drug Free Sport International.

Some of the key points as Jan. 1 looms large:

• Detection times do not necessarily provide an accurate medication withdrawal guide;

• New screening limits will require different administration protocols;

• There will be no enforcement “grace period” for stakeholders to adjust.

• This different medication schedule will require adjustments well before Jan. 1;

Withdrawal Guidelines vs. Detection Times

Traditionally, withdrawal guidelines are based on administration studies with a “statistically derived margin of safety built in,” said Scollay.

“The idea is that if you follow the administration protocol described in the study–dose, route of administration–and you comply with the withdrawal guidance,” said Scollay, “you should have a high degree of confidence that you will not have a medication violation.”

In other words, withdrawal guidelines provide a reliable cut-off point to administer a medication to avoid post-race positives.

This is in contrast to detection times under HISA, calculated through studies on a group of horses administered a certain medication.

These horses are then tested to determine the earliest time the drug is eliminated from all the horses' systems–a level below either the lowest concentration identified by the laboratory or below a defined screening limit.

This means that detection times “do not have any margin of safety calculated in,” warned Scollay. “It is the starting point for determining a withdrawal interval. So, the burden for establishing an appropriate withdrawal interval for medication now lies exclusively with the horses' connections.”

In any of these given studies, for example, the horses may metabolize drugs at different speeds–and potentially quicker than a racehorse given the same drug at the same dose.

Studies with a very small cohort of horses–like hydroxyzine, with a detection time of 96 hours from a study with only two horses–provide another reason why detection times can provide a very thin margin of error.

Imagine a study testing a doorframe set at six feet, explained one regulatory veterinarian. If the study participants are all under six foot, no problem. But what about all the six-foot plus individuals not studied?

For practicing veterinarians accustomed to concrete withdrawal times, therefore, this constitutes a sea-change in the way medications can be safely prescribed and administered to avoid costly post-race positives.

“There's no easy answer to this,” admitted Scollay. “I fully understand what a philosophical change this is, and yes, I understand that the vets can feel like they're flying blind right now.”

Aim of Schedule

Aside from a select few substances–like electrolytes, orally administered vitamins and anti-ulcer medications which can be administered up to 24-hours before a race–there is a mandatory 48-hour restricted administration time for all controlled medications.

For a number of these routine controlled medications, the dosage, withdrawal time and stipulated threshold in the current ARCI schedule are the same as the dosage, detection time and screening limits outlined by HIWU.

But where these differ, the differences might be subtle, easily over-looked. The ARCI's phenylbutazone threshold is 0.3 micrograms per millimeter, but is 0.2 micrograms per millimeter under HISA, for example–a small change with significant implications when it comes to its use in the days prior to a race. What's more, Scollay is unable to provide veterinarians and horsemen with specific withdrawal numbers. “HIWU and HISA are not in a position to provide withdrawal guidance,” she said. “I cannot say, 'I think you're going to be fine if you back out to 82 hours.'”

Things can get even trickier when HIWU provides zero dosage, detection time and screening limit guidance on a drug listed on the controlled medication list. But that doesn't necessarily mean veterinarians and trainers are indeed “flying blind.”

The corticosteroid betamethasone has no dosage or detection time listed, but it comes with a Restricted Administration Time (RAT) to race of 14 days (7 days for a work).

The Non-steroidal anti-inflammatory drug (NSAID) diclofenac–commonly found in a topical ointment to treat swelling and inflammation–similarly has no listed dosage and detection time.

As Scollay explains, that's because the process of calculating elimination times in an ointment–and therefore, one routinely applied in wildly different amounts to different parts of the body–is extremely difficult.

But this underscores, she said, the overarching aim of the new medication schedule–to foster a more conservative approach to veterinary medicine.

If diclofenac is used to treat a problematic joint, said Scollay, “from my perspective, once you've got that joint quieted down, I think you'd still want to assess that horse's response to treatment and assess the horse's recovery by breezing him.

“And so, you're not talking about ceasing treatment on a specific joint that has been inflamed and problematic going into a race in three days.”

In other words, if a topical diclofenac ointment is being used to treat certain musculoskeletal problems, then racing probably shouldn't be on the horse's imminent agenda, said Scollay.

Clearance Testing

More broadly, there's a very rough rule-of-thumb when it comes to calculating withdrawal times. One is that a short detection time is typically indicative of fast elimination from the system, said Scollay.

“But if something takes 96 hours to clear, I would be more conservative because I know it clears slowly,” said Scollay, speculating that “if I add just 24 hours onto that, I may not have allowed enough time for it to clear.”

But perhaps the most accurate guide for veterinarians and trainers concerned about a positive test, said Scollay, would be to conduct “clearance testing” well before race-day–a service provided through HIWU.

“We'll collect the sample from the horse, and then send it to the laboratory that's doing the testing. The trainer would have to provide information about the treatment, the drug, the dose, the frequency–when it was halted,” said Scollay.

It's not a free service, however.

“I don't know what that fee is yet,” Scollay added. “That would be paid for by the horse's connections.”

Importantly, the new controlled medication rules are primarily germane to post-race testing, not HISA's out-of-competition testing program, which is largely focused on banned substances.

That said, the new rules prohibit the presence of more than one NSAID or corticosteroid in both post-race and post-work samples–a prohibition designed to nix the practice of “stacking.”

HIWU's new common controlled medication list provides secondary detection times for three common NSAIDS, to help avoid a stacking offense.

Enforcement

Though the new drug rules might prove a marked change from the current status-quo, don't expect an enforcement grace period for stakeholders to acclimatize to their new regulatory expectations.

“The regulations don't provide for it,” said Scollay, categorically.

So, what are some of the implications for a positive of a controlled substance? An outline of the sanctions can be found here.

The majority of post-race positives are for everyday therapeutic medications–like phenylbutazone, a class C controlled drug, a first time positive for which would result in a fine of up to $500 and the automatic disqualification of the horse.

Which leads to another question: Who will be held responsible in the event of a positive?

The ultimate-insurer rule places the burden of responsibility on the shoulders of the trainer. But in the language of the law, there appears to be room for the veterinarian (and perhaps others) to be similarly held culpable.

As Scollay describes it, such a scenario would be case-specific. “The facts of the case would have to determine who else might be complicit,” she said. “To be fair, if it's an overage of a medication one would say, 'well, the vet didn't administer that without the trainer's knowledge and consent.'”

And so, when should veterinarians, trainers and others start applying these new controlled medication rules?

Given the 14-day stand down on all intra-articular injections–along with a 15-day detection time for the NSAID firocoxib–Scollay recommends familiarization with, and application of, the new rules as soon as possible, to avoid regulatory consequences come Jan. 1.

In other words, if trainers and veterinarians are deciding on withdrawal decisions after a horse is entered to race after Jan. 1, “they've waited too long,” said Scollay.

“I think more important is for veterinarians and trainers to review the document together and develop a shared approach to interpreting detection times,” she said. “And there is no time like the present for that.”

Education

Between now and Jan. 1, HIWU will apparently be releasing educational materials aimed towards regulatory and practicing veterinarians, and the trainers themselves.

Another intended event, said Scollay, is a webinar with a noted European veterinarian to explain how detection times and screening limits translate in Europe, where they've been in effect for much longer. Scollay was unable to provide details about then that might be, however.

The Racing Medication and Testing Consortium (RMTC) can act as an information intermediary, said Scollay, who added that industry stakeholders can contact her directly with any drug-related questions.

She also recommends printing off HIWU's controlled medication list—once again linked to here–before laminating and pinning it to the barn wall.

“I've been using the 'L' word every chance I can get. Laminate it, put it on your clipboard. Give them to your staff. That's your new bible,” Scollay said.

“There's no easy answer to this other than be more conservative and be more cautious of medication than you have been,” she said. “And ask yourself, 'does this horse really need it?'”

The post HIWU’s Scollay: New Medication Rules ‘Your New Bible’ appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

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I am writing in response to your October 18, 2021 column “View from The Eighth Pole: Of Rulings and Squeaky Clean Racing.” I feel the obligation to object to your sarcastic characterization, which creates a purposefully inaccurate picture of the efficacy of drug testing in New York.

You wrote that you could “only find one ruling for a medication violation in all of 2021 at New York Racing Association tracks … [and] zero positive tests in the New York State Gaming Commission rulings database in 2020 and zero positives in 2019 for NYRA tracks.” See https://www.paulickreport.com/news/ray-s-paddock/view-from-the-eighth- pole-of-rulings-and-squeaky-clean-racing/.

Limiting your data examination to such a narrow band suggests an intention to cast aspersions on the efficacy of the New York drug testing.

First, your analysis suggests New York does not have race day drug positives. If you banded your data over a more useful period – 10 years – you would have found 541 race day positives at all New York tracks. Second, examining only race day positives at New York Racing Association (NYRA) tracks (Aqueduct Racetrack, Belmont Park and Saratoga Race Course) during such 10-year look-back, you would have identified over 100 drug positives. Third, intentionally limiting your data set to NYRA racetracks enables you to purposefully ignore the seven Standardbred and other Thoroughbred racetracks in operation. The arithmetic illustrates over the last 10 years there have been over 160 race day positives at New York Thoroughbred tracks and over 370 race day positives at New York Standardbred tracks.

It is obvious to the most casual reader your intention was to mislead people in believing there has been one race day drug positive in two years. Your narrative disregards readily available data, misleading readers into believing that the New York Equine Drug Testing and Research Program (Laboratory) is either inept or negligent in its responsibilities.

I take great offense at your gratuitous shot at Laboratory director George Maylin, DVM, PhD. Even the most casual follower of equine drug testing is aware that Dr. Maylin developed many of the forensic equine drug testing techniques used worldwide. He has performed groundbreaking work in determining the presence of drugs that may affect the performance of equine athletes, including recently developing screening tests for:

• • IOX-2, a new class of drugs that increases the body's own erythropoietin gene to produce more red blood cells. It accomplishes the same response as the administration of erythropoietin, or EPO. It is a performance enhancing drug and a gene doper.
• • Clenpenterol, a beta-2 agonist with pharmacologic properties like clenbuterol which is not approved for use in horses.
• • AH 7921, an experimental synthetic opioid with pharmacologic properties similar to morphine-like drugs, which is not approved in the United States for use in horses or humans.
• • Kratom (mitragyna speciosa), a natural plant that contains the psychoactive alkaloid mitragynine that has opium-like analgesic effects and coca-like stimulant effects.
• • Yellow Rocket (barbarea vulgaris), a plant that contains the alkaloid barbarin, which is used to metabolize bararin to aminorex, a central nervous system stimulant.
• • Glaucine, an alkaloid with anti-inflammatory, antitussive, bronchodilator and central nervous system effects.

All of these research discoveries have been shared with other drug testing laboratories around the world and have been widely reported by the racing press.

While I am certain you are aware the Laboratory is one of only nine in the United States that have been fully-accredited by the Racing Medication & Testing Consortium (RMTC), you may not be aware what is necessary to obtain and maintain certification. The accreditation process begins with a document review of the laboratory's processes by an independent auditor with specific experience in horse racing laboratory operations. Once the documentation is reviewed, the laboratory must also submit to a multi-day site inspection by another independent assessor. As part of the accreditation requirements, laboratories are required to participate in an external quality assurance program that determines if laboratories have the capabilities required to detect substances of concern at the concentrations that are mandated by the RMTC model rule recommendations. All participating laboratories must also be ISO 17025-accredited to even apply.

To maintain RMTC accreditation, a laboratory must maintain its ISO 17025-accreditation and annually pass RMTC proficiency sample testing. Additionally, the Horseracing Testing Laboratory Committee of the RMTC also conducts a review of the Laboratory's funded research and internal laboratory development. This calendar year the HTLC found the Laboratory in good standing. In fact, since granting the New York Drug Testing and Research Program has remained in good standing for all its accreditations.

Your column also casts aspersions on Dr. Maylin's credibility, positing that the lack of recent positives at NYRA racetracks might be due to his using different criteria than laboratories in other racing states. You further state that “Maybe the [New York Laboratory] isn't very good.”

A quick look at the annual numbers finds race day positives in 2020 – a VERY anomalous year given the 40 percent reduction in racing dates conducted – for clenbuterol, flunixin, guaifenesin, methocarbamol, methylprednisolone, and phenylbutazone. In 2019 there were positives for adrenochrome monosemicarbazone, clenbuterol, clenpenterol, dexamethasone, flumethasone, flunixin, furosemide, guaifenesin, IOX-2, isoflupredone, methocarbamol, methylprednisolone, phenylbutazone, phenytoin, and propantheline.

Your commentary failed to note any of the above, I guess because it didn't fit your narrative about the lack of medication violations.

New York has been successful in identifying and punishing those who seek to cheat, but we understand that those with the propensity to use unlawful or illegal drugs persist. We appreciate the dedication and diligence of Dr. Maylin and the dozens of employees of the New York Equine Drug Testing and Research Program who are committed to ensuring the integrity of horse racing and protecting equine athletes participating in the sport.

Unfortunately, the Paulick Report prevents reader comments which limits our ability to directly shed light on your misstatements. I am hopeful, however, that this letter gets widespread attention so people can better understand your bias.

(Response from Ray Paulick: The Oct. 19 commentary accurately stated that only one drug positive has been prosecuted at New York Racing Association tracks in 2019, 2020 and 2021. I stand by the article as written.)

The post New York State Gaming Commission: Paulick Commentary On Lack Of Medication Positives At NYRA Tracks Purposefully Misleading appeared first on Horse Racing News | Paulick Report.

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In fact, just last week, the feds disclosed intriguing documentation about SGF-1000, the adulterated and misbranded purportedly performance-enhancing drug (PED) that was an elixir of choice for now-barred trainer Jorge Navarro, who admitted to injecting it into his horses when he pled guilty in August to one felony drug count. SGF-1000 allegedly also served as “juice” for fellow ruled-off conditioner Jason Servis, but he's still fighting his felony doping charges, even after being implicated by other defendants and allegedly being caught on intercepted phone calls discussing his wide-ranging use of PEDs.

The new intel about SGF-1000 arrived Nov. 15 in the form of a sentencing report for Kegley submitted by the government in advance of his Jan. 6 appearance in United States District Court (Southern District of New York), when he will learn his potential prison fate.

Both Kegley and Rhein are facing maximum three-year terms of incarceration. Rhein's sentencing is Jan. 5, and his report from the government is due Nov. 24.

Kegley is the former sales director for MediVet Equine, the Kentucky-based company that marketed and sold SGF-1000. Rhein is a now-suspended veterinarian formerly based at Belmont Park who has admitted that he and Servis were “leaders and organizers” of a network of associates who performed criminal actions related to doping. The feds also allegedly have Rhein taped on an intercepted phone call bragging that he sold “assloads” of SGF-1000 to racetrackers.

Soon after the arrests of 27 defendants on Mar. 9, 2020, we learned about Servis's alleged conversations with Rhein from June 2019 in which the trainer expressed fears that his purportedly doped MGISW Maximum Security would trigger a positive for SGF-1000. Rhein assured him Max wouldn't, because “they don't even have a test for it in America.”

And this past September, when prosecutors released a separate trove of wiretapped evidence, it was further disclosed that MediVet later in 2019 allegedly attempted to trick the Racing Medication and Testing Consortium (RMTC) into delisting SGF-1000 as a prohibited substance.

The government's sentencing submission from Nov. 15 fills in some previously unknown blanks about how SGF-1000 was marketed, pitched, and positioned during this time frame to maximize sales and avoid scrutiny.

$200 a bottle…but it worked

By the time SGF-1000 had landed in the crosshairs of federal prosecutors in early 2019, MediVet had already “reaped millions of dollars in revenue,” the court document stated. Part of the reason the company was able to rake in enormous profits had to do with bypassing the costs of the rigorous drug approval and registration process required by the Food and Drug Administration (FDA).

“Unlike legitimate drug manufacturers, MediVet spent no funds on studies to demonstrate to the FDA the safety and efficacy of SGF-1000,” the submission stated.

Working in tandem, Kegley and Rhein “both extolled the performance-enhancing benefits of the drug to racehorse trainers.”

Up until the spring of 2019, marketing material for SGF-1000 was routinely provided to purchasers and was readily available on MediVet's website. According to the government, its sellers emphasized “the potent effects of SGF-1000,” which were supposedly derived from “an innovative formulation consisting of Regenerative Proteins, Cytokines, Peptides, potent Growth Factors and Signaling Molecules derived from Ovine Placental Extract.”

The submission further stated that SGF-1000 was explained to trainers as being similar to a vasodilator that would “increase stamina, performance, and overall health.” The materials even listed the growth factors that were purportedly found in SGF-1000, including fibroblast growth factor and hepatocyte growth factor.

“Of course, many jurisdictions prohibited the use of such growth factors on racehorses, particularly where the growth factors are component parts of drugs that are not approved by the FDA, and administered solely to improve a horse's recovery and race performance,” the submission stated.

“Despite the advertised effects of, and ingredients in SGF-1000, the drug's appeal was rooted in the fact that it was undetectable in a horse's system through standard drug screens used in the racing industry, which Rhein repeatedly touted when discussing the drug,” the document continued.

The feds also alleged that despite what Kegley, Rhein, and other MediVet representatives claimed when they were parroting the company's marketing materials, no one pushing the product really had any accurate idea of what was in it.

“Notably, Kegley and his coconspirators did not know the precise contents of SGF-1000 until at least in or about August 2019–years after MediVet had started marketing and selling the drug,” the submission stated. “But [they] believed that no matter the component parts of the drug, it would enhance a horse's performance.”

So too, apparently did trainers. That's why they shelled out $200 a bottle for SGF-1000.

After Servis phoned Rhein on June 5, 2019, to allegedly tell him that Maximum Security had received a dose of SGF-1000 right before an unannounced drug test, “Rhein grew concerned regarding the potential for regulatory scrutiny of SGF-1000, and shared this concern with others at MediVet,” the sentencing submission stated.

The filing continued: “A few weeks later, on July 9, 2019,  Rhein and others affiliated with MediVet convened a conference call in which they discussed the potential for increased scrutiny of the drug. During that call, a participant mentioned that the federal government had prosecuted a racehorse trainer, Murray Rojas, for doping horses, citing it as an example of a case where drug use on racehorses had been pursued by governmental authorities beyond state racing commissions.

“Following the drumbeat of events indicating heightened suspicion of SGF-1000, Rhein and Kegley strategized regarding the best way to divert people's attention away from SGF-1000.

Rather than cease their sales of that drug, Kegley and Rhein instead discussed how they could tweak the labeling of SGF-1000, so as to make it appear innocuous,” the sentencing submission stated.

“You're right, it might help to re-brand it,” the feds allegedly recorded Kegley saying on a wiretap. “We won't mention the word 'growth factor' in any way shape or form…. We can even put on the box, you know, 'dietary supplement for equine.' That way it's not–no one even has to question if it's FDA-approved or not. It's strictly a supplement.”

RMTC Trickery

By the summer of 2019, the push was on at MediVet to try and convince the RMTC that this “supplement” was so harmless that it should be delisted as a banned substance.

“On August 8, 2019, a MediVet representative received a report from Industrial Laboratories reflecting a negative finding (at that time) for certain growth factors,” the court document stated.

Yet that same test did detect, among other prohibited substances, “low levels of acepromazine, levamisole, detomidine, pyrilamine, lidocaine, MEGX, xylazine, and caffeine.”

MediVet's reaction to this disturbing news?

According to the sentencing submission, it was “to request that the negative and positive findings be split into two separate reports. On Sept. 10, 2019, MediVet, through counsel, conveyed the negative findings to the RMTC, while withholding the positive findings.”

Around the same time, MediVet was feeling heat from regulators in New York who were zeroing in on SGF-1000 as an allegedly abused PED.

“In September 2019, MediVet's sales of SGF-1000 hit a significant hurdle,” the sentencing submission stated. “The New York Gaming Commission issued a notice in which it reiterated its longstanding prohibition against the use of growth factors and growth hormones on racehorses, but also specifically named SGF-1000 as a prohibited drug of the type that contained growth hormone or growth factors.”

Yet still, the court document explained, “Kegley and Rhein continued to market and sell SGF-1000” while MediVet “altered the promotional material for SGF-1000 to divert attention and mislead anyone who was unfamiliar with the prior marketing materials description of SGF-1000.”

So whereas the packaging and label for SGF-1000 in July 2019 described it as consisting of “regenerative placental proteins” and being “made in Australia,” by October the drug's description “had been altered to remove any reference to Australia, and was instead described as a 'homeopathic placental extract.'”

Yet by Oct. 14, 2019, MediVet had already learned “that a subsequent test of SGF-1000 did result in findings reflecting the presence of a specific growth factor,” the document stated.

And by the time Kegley and Rhein were arrested five months later, “the website for SGF-1000 had been scrubbed clean, removing any reference to growth factors, and much of the description regarding SGF-1000” itself.

“In short, even after Kegley and others at MediVet had reason to pause and take stock of the illegality of SGF-1000, they nonetheless continued to sell the drug,” the submission stated.

“With full knowledge that SGF-1000 was banned in New York, that a racehorse trainer had been criminally charged for doping, and that law enforcement was beginning to scrutinize the use of SGF-1000 specifically…Kegley and Rhein worked together and with others to deceptively label that drug, and to continue to sell the drug to those in the racehorse industry seeking a competitive advantage,” the document stated.

“Given the proliferation of websites that offer potent PEDs to those in the racehorse industry, similar to that operated by MediVet, a significant sentence is warranted to send a strong signal to others thinking of engaging in such criminality that there will be consequences for their crimes.

“Many actors in the racehorse industry have grown indifferent to, and dismissive of, the notion of obtaining illegal drugs to dope racehorses for profit, and assume that no serious ramifications will follow if they are ever caught,” the submission summed up.

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With 18 hours of lectures and labs, in addition to interactive and hands-on sessions, the theme will be 'Infectious Disease and Movement of Horses.'

Internationally recognized experts including Peter Timoney FRCVS, PhD (University of Kentucky); David Horohov, PhD (University of Kentucky); Maureen Long, DVM, PhD, DACVIM (University of Florida); and Laurie Beard, DVM, DACVIM (Kansas State University) will be featured. The conference provides training directly related to the duties and responsibilities of the racing regulatory veterinarian in protecting the health and welfare of racehorses and supporting the integrity of competition.

“To have become established as an international source of quality education for these specialist veterinarians in such a short period of time validates the work of so many in assembling these events,” said RMTC Executive Director Dr. Mary Scollay. “We are grateful to all our stakeholder sponsors who invest in our regulatory veterinarians–and the safety and integrity of our sport–by supporting this program.”

Visit RMTCnet.com for more information.

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“To have become established as an international source of quality education for these specialist veterinarians in such a short period of time validates the work of so many in assembling these events,” said RMTC Executive Director Dr. Mary Scollay. “We are grateful to all our stakeholder sponsors who invest in our regulatory veterinarians–and the safety and integrity of our sport–by supporting this program.”

Visit RMTCnet.com for more information.

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RMTC laboratory accreditation is earned through a rigorous review process by independent experts of the laboratory's protocols, staffing, and facilities. Candidate laboratories must also perform successfully in analyzing external quality assurance samples.

The UK-EACL joins the eight other RMTC-accredited laboratories, whose testing covers more than 92 percent of all pari-mutuel races in the United States.

“The RMTC commends Dr. Stanley, his staff, and the University of Kentucky for undertaking the accreditation process and for their ongoing commitment to promoting the safety and integrity of horse racing,” said RMTC Chairman Alex Waldrop.

“We are proud of this milestone, which attests to the high standards set by Dr. Stanley, and it is gratifying to know this lab is positioned to serve the broader industry in the best way possible,” said Dr. Nancy Cox, dean of the University of Kentucky College of Agriculture, Food and Environment.

The RMTC is a 501(c) 3 organization comprised of 23 industry stakeholder organizations with a shared commitment to engage in research, education, and advocacy for science-based initiatives that promote the health and safety of the racehorse and the integrity of competition. More information can be found at RMTCnet.com.

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Dr. Dionne Benson, chief veterinary officer for The Stronach Group and former executive director of the Racing Medication and Testing Consortium, presented a continuing education seminar for trainers in July to help them distinguish the different categories a drug may fall into and to determine if the product they're looking at is illegal.

When dealing with prescription (sometimes called “legend”) drugs, the first approved version of a new drug is called a pioneer drug. This is a substance that has been legally recognized by the Food and Drug Administration as a new animal drug and has been subjected to considerable testing to demonstrate its safety and efficacy, as well as the purity of its manufacturing process and the stability or shelf life of the drug. They also must show that the manufacturing process is consistent, and the concentration and purity of the drug doesn't change from batch to batch. Pioneer drugs also must show considerable research to validate their suggested doses and uses, and must meet rigorous requirements regarding their package labeling and advertising to be sure consumers are being presented with accurate and complete information.

The FDA approval process for new drugs is long, arduous, and expensive, so to give drug makers an incentive to go through it, they are permitted temporary patents on new substances. This means that for a limited number of years, the company that went through the approval process will be the only one that can legally produce the drug, allowing them to better recoup some of their expenditures in the approval process.

A generic medication is subject to all the same requirements regarding safety and efficacy, and may only be legally produced when the patent on the pioneer version of the drug has expired.

Both types of medications are also subject to adverse event reporting, so there is a public record of any negative side effects or bad reactions to a given drug or batch of drugs and those events can be investigated.

Compounded drugs aren't subject to any of that federal oversight.

Compounding may only be legally done in certain narrow parameters. A compounding pharmacy may only make a drug in response to a prescription a veterinarian has written to treat a specific condition in a specific animal, and it should only take place when there is no legend drug (either a pioneer or a generic) available to serve the patient's needs. Compounders can legally add flavoring to drugs to make them easier to administer, or take a drug traditionally offered in one form like a paste and make it into another, like a powder. In some limited circumstances, a compounder may legally mix two medications to reduce the amount of needle sticks a horse has to endure. In none of those situations should a compounder have large amounts of pre-formulated compounds sitting on the shelf awaiting an order – that, in the eyes of the FDA, is manufacturing. If an FDA-approved drug is no longer being manufactured or is on back order though, a compounder may make small batches of it but should not be in the business of mass manufacture.

“Compounded medications are legal under some circumstances,” said Benson. “Your vets use them every day and in the large majority of those cases they're using them appropriately.”

Benson has seen a number of examples of illegal compounds floating around the track however – sometimes sold online and sometimes peddled by sales reps.

One of the biggest areas of confusion seems to be what constitutes a generic drug. Compounded omeprazole products are a favorite of compounding pharmacies to produce in bulk, in part because horsemen are always looking for cheaper alternatives to the pioneer drug. But Benson said the patent on Gastrogard and Ulcergard, the pioneer form of the drug, hasn't run out yet, so all those “knock off” versions which people may think of as “generics” are actually illegal.

Compounders are also fond of getting around this restriction by combining omeprazole with another ulcer drug like ranitidine, with the result often being priced more cheaply than pioneer omeprazole.

“The funny thing about that one is if you're combining omeprazole and ranitidine you're actually deactivating one of them,” said Benson.

Omeprazole works by reducing acid secretion, while ranitidine works by neutralizing acid. You don't need both, and they tend to be used in different types of ulcer cases.

Of course, Benson said, it's true that the FDA isn't likely to show up at your barn and ask to examine your prescription bottles (although, the federal case demonstrates they will take an interest in racing now and then). So why should horsemen worry about the technicalities of drug production?

Benson said that the illegal compounds she has seen often come along with safety concerns. Compounders mass producing a legend drug and selling it as a “generic” version aren't having their products tested like approved generic drug manufacturers, and testing by the RMTC suggests the amount of active ingredient in these illegal substances can be wildly mismatched to what's on the label. Benson recalled one bottle of clenbuterol that had ten times the labeled concentration of the drug, which was “getting into toxic ranges.” Another test of a triamcinolone bottle found it contained just .01 percent of its labeled concentration.

Another trouble with unauthorized mass manufacturers of prescription drugs is that there's no assurance of consistency from batch to batch of the medication, so just because a horseman has given a drug from a pharmacy once with no issue doesn't mean the next batch will be the same.

Many of these illegal substances can also be missing key safety information on their packaging. Benson cited Gastrotec, an omeprazole/misoprostol product which she said is still in circulation, despite FDA warnings about it.

“What's terrifying about this medication is the misoprostol,” she said, pointing out that drug is half of the abortion cocktail used in humans. “In veterinary school, you can't touch this stuff without gloves. All the women on the backside, they're given this to give to the horse, and what's the first thing we do? We put the tube in our mouth to pull off the cap and give it to the horse.”

There was no warning about these human health risks on the boxes or tubes of Gastrotec, Benson said.

Benson said she believes trainers have a responsibility to educate themselves about what is and isn't permissible in the drug-making world. Just acquiring a product from a sales representative or a veterinarian isn't a guarantee it is legal.

“Oftentimes we assume whatever the doctor or veterinarian says is right,” she said. “We don't want to make them mad; we just go along with it. But realistically it's your license on the line. Very rarely does a vet get called into a hearing or have to call an owner when a horse dies.”

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