Lab Harmonization Two Years Into HIWU

[Wandering Eyes]

It has been two years since the launch of the Horseracing Integrity and Safety Act's (HISA) anti-doping and medication control program.

During that time, one of the struggles federal officials have been open about is getting all the laboratories onto the same page in terms of drug-testing approaches and methodologies, after decades of different state commissions requiring of their contracted laboratories a range of standards.

In this regard, U.S. horse racing is years behind its counterparts in human athletics, which seriously grappled with the same issues around the turn of the millennium–and is still wrestling with them today, as advances in doping and drug testing evolve.

To get a status update on where things stand with lab harmonization, the TDN recently spoke with Horseracing Integrity and Welfare Unit (HIWU) chief of science Dr. Mary Scollay, and with Racing Medication and Testing Consortium (RMTC) executive director, Michael Hardy.

HEAL Program

Earlier this year, HIWU put the new HISA Equine Analytical Laboratory (HEAL) accreditation program into action, with the RMTC still in charge of issuing single and double-blind tests that gauge the labs' performances.

“We are paying them to oversee that program because it is incredibly labor intensive,” said Scollay, about the RMTC's ongoing involvement.

In a single-blind test, a substance has been added to a sample and the lab is required simply to identify it. The single-blind sample is known to the lab (but not of course the substance).

In a double-blind test, a substance has been added to a sample that is included as part of the routine sample flow, and the labs have no idea which of them is the culprit. Single-blinds offer a much easier bar to clear than double-blinds.

Prior to the launch of HEAL, a set of 10 single blind samples were sent out by the RMTC biannually. Under HEAL, this has been ramped up in frequency, with at least two single-blind samples distributed every other month.

“What it allows us to do is not wait six months to ask a question that we want to be answered by the labs. It allows us to be more responsive and more nimble if we have a question,” said Scollay.

Double-blinds are also now sent out roughly every two months, said Scollay.

“We had started a double-blind program when I was with the RMTC,” said Scollay, who before joining HIWU was RMTC's executive director and chief operating officer for three years.

“But it was early days and there were lots of challenges associated with the double-blind program prior to implementation,” she added. “There are lots of ways a sample can degrade or otherwise change that can affect the concentrations detected by the laboratory, and those changes can occur outside the laboratory's control.”

Has HIWU encountered any problems with its labs since the advent of the HEAL program? “We have encountered some matters that after investigation were rapidly resolved, and not evidence of any kind of fatal flaw in the laboratory,” said Scollay.

Chicago Lab

Last September, the RMTC temporarily suspended its accreditation of the University of Illinois Chicago's (UIC) Analytical Forensic Toxicology Laboratory.

When asked later that month what precipitated the suspension, Scollay explained it was for “multiple violations of their code of standards,” and that “there were several external quality assurance samples that were failed.”

The specifics of the problems at the lab remain fuzzy.

After the initial interim suspension was extended, the RMTC's Horseracing Testing Laboratory Committee (HTLC) met at the end of January and ultimately decided to revoke the lab's accreditation altogether, said Hardy.

The revocation, said Hardy, was due in large part to the lab's “repeated failure to take appropriate corrective action given due time by the HTLC to do so, and inability to demonstrate their compliance with the RMTC's code of standards to ensure quality of test results.”

Prior to the advent of HISA's ADMC program, the lab processed samples for Illinois and Oregon, said Hardy. Under HISA, the lab did A sample testing for Illinois, and B sample confirmation testing for other states as directed by HIWU.

Scollay said she doesn't believe the accreditation issues that have bedeviled the Chicago lab will impact any positive cases processed through the facility.

“When we became aware [of the problems at the Chicago lab], we obviously reviewed all the findings that were reported by that laboratory and determined there were no deficiencies in the science that they performed for us,” said Scollay. “The cases we put forward had solid data and we didn't feel the need to withdraw any of them.”

Kentucky Lab

The RMTC initially suspended its accreditation of the University of Kentucky Equine Analytical Chemistry Laboratory (UK-EACL) following news that the Horseracing Integrity and Welfare Unit (HIWU) had stopped sending samples to the lab due to “concerns with the performance” of the facility.

A September report jointly-issued by HIWU and HISA cited multiple failures on the part of the lab and the lab director, Scott Stanley, including “intentional misrepresentations” of positive tests as negative, “persistent delays” and “unprofessional behavior.” Stanley strongly refutes the findings of the report.

In an October statement issued by his attorney, Stanley said the report's claims are made without evidence. “The report offers no concrete documentation–no email records, timelines, or verified communications–leaving the allegations vague and unsupported. Nevertheless, the press has accepted these accusations without scrutiny or fact-checking, painting an incomplete and misleading picture,” the attorney wrote.

Under a major restructuring since, the Kentucky lab is no longer affiliated with the university. It's now under the ownership of Eagle Diagnostics with a newly branded title: the Equine Integrity and Anti-Doping Sciences (EQIAS) Lab.

According to Scollay, the EQIAS lab, under the directorship of Travis Mays–formerly with Texas A&M University–has submitted application for HEAL accreditation.

“The materials that they submitted are under overview by our lab experts group. They have started that work but it's a tremendous volume of materials that they're reviewing,” said Scollay, who added that “realistically,” the new EQIAS lab could receive probationary HEAL accreditation within sixty to ninety days.

Pennsylvania

After an unusually high number of total carbon dioxide (TCO2) cases emerged out of the Pennsylvania Equine Toxicology and Research Laboratory (PETRL), the facility was required to upgrade its TCO2 testing equipment, bringing it up to par with the other labs. Several TCO2 positives processed by the lab were dropped.

More recently, an internal adjudication panel dismissed a Flunixin positive against trainer Christophe Clement that had been processed by the Pennsylvania lab.

The panel agreed “by a balance of probability” with the trainer's legal team, which had identified “sufficient possible problems and deficiencies in the testing that cast some doubt about the scientific reliability of the testing that resulted in the [adverse analytical finding].”

When asked if this recent decision was indicative of ongoing problems with the Pennsylvania lab, Scollay contended that the panel had sided with an expert brought forward by the defense team who lacked expertise in horse racing drug testing.

“They applied a set of standards based on their area expertise which is irrelevant to what our labs are required to do by [International Laboratory Accreditation Cooperation] G7 standards,” said Scollay. “We believe the actual facts contravene the conclusion of the hearing officer.”

When asked if HIWU might be in trouble if other defense teams take the same legal approach, Scollay said that was a question for their legal team.

Sarah Andrew

Metformin

Last June, HISA announced that it was deferring all interim suspensions involving the common diabetes treatment metformin until the RMTC's Scientific Advisory Committee (SAC) had conducted a review of the available science relating to the drug.

This review, which includes multiple administration studies, remains ongoing, said Hardy.

“Once all that information is put together and reviewed by the SAC, that information and any recommendation that comes out of the review will be presented to HISA,” said Hardy.

Why has the review taken so long (it was initially earmarked for conclusion by the end of last year)? “Science,” said Hardy, who said that studies of this kind often throw up new questions that need answering.

“Frankly, when you undertake a review like this, there are a lot more questions than answers, right?” he said. “The best way to come up with the answers is to do more research and study, which in our case, we had the opportunity and the funding to pursue administration studies which provides the most accurate information to make any kind of recommendation.”

General Lab Harmonization

In the early months of the ADMC program, metformin was one of the substances that HIWU officials had to develop testing specifications for. It joined more than 300 core analytes for which HIWU had such uniform testing standards.

Some 18 months later, Scollay said that list of core analytes is largely the same.

“What we do have are different laboratories doing population surveillance for analytics that aren't on that list but potentially of interest,” she said.

“We've got the canary in the coal mine looking for things. And if they show up or there starts to be evidence for them, then yes, there will be a meeting, we'll talk about methodology, we'll say 'this is being added to the list of core analytics, we want you testing in both matrices or we want to be able to test for this in hair,'” said Scollay.

In terms of lab variability, the equation is a simple one: the fewer the facilities, the less chance for differences. If Kentucky's EQIAS lab returns to the fold, then HIWU will be back up to using five facilities. Is this a manageable number?

“An ideal is probably three laboratories, simply because if you get down to too few, the tail starts wagging the dog,” said Scollay. “But I'm not going to say five is suboptimal. Five can be hugely successful, and that is largely dependent upon collaboration, cooperation, communication and willingness to be part of the team.”

 

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