HIWU Lab Update: Tight Lips And Ongoing Investigations

Over a month ago, the Horseracing Integrity and Welfare Unit (HIWU) and the University of Kentucky issued their respective reports into multiple alleged management and operational failures at the university's Equine Analytical Chemistry Laboratory (UK-EACL) under the leadership of its former director, Scott Stanley.

Earlier this month, Stanley issued a response through his attorney. He categorically denied falsifying results and claimed many of the allegations leveled against him were made without evidence. At the same time, Stanley criticized the logistical challenges of running a lab under HIWU's regulatory oversight, including from the implementation of a new information management system, the increased workload, and ongoing resource limitations.

Events surrounding the UK lab have occurred simultaneously with issues at other laboratories contracted by HIWU to process collected samples. This includes the Illinois Chicago Analytical Forensic Toxicology Laboratory's loss of accreditation, and a review of uniform TCO2 testing standards among HIWU's existing stable of labs.

The following is an update on the status of these ongoing reviews and investigations, and other related drug testing matters.

Deadlines for Reaccreditation?

Michael Hardy is executive director of the Racing Medication and Testing Consortium (RMTC).

Hardy said the RMTC's six-member Horserace Testing Laboratory Committee is still working with the UK and UIC laboratories in their attempts to regain RMTC accreditation, which is necessary if they are to once again perform work for HIWU.

In the UK lab's case, the deadline for a final decision is the end of November, the beginning of December, said Hardy.

In UIC's case, the RMTC's 60-day suspension period ends near the beginning of November.

Far less is known about why the UIC lab lost its RMTC accreditation, compared to the UK situation.

In a recent TDN Q&A with Dr. Mary Scollay and Ben Mosier, HIWU's chief of science and executive director respectively, they explained the laboratory had failed several external quality assurance samples, and that samples processed by the lab were undergoing review by the agency.

Hardy declined to provide further details about the lab's loss of accreditation due to the ongoing nature of the suspension. He intimated it unlikely the RMTC would make public any report into the problems at the UIC lab after the suspension period ends.

Hardy added, however, that he has been “pleased with the level of cooperation” by both the UK and UIC labs to become fully compliant with the RMTC.

Will HIWU use these labs again if they regain RMTC accreditation?

When asked if HIWU would once again use both laboratories if they achieved interim RMTC accreditation, a HIWU spokesperson wrote that decision would require further consideration by HIWU and approval from the respective commissions.

“HISA Equine Analytical Laboratory (HEAL) accreditation will be going into effect on January 1, 2025. Thus, to become a Program laboratory next year, UK-EACL and the UIC Lab would need to apply for and then be granted probationary HEAL accreditation,” the spokesperson added.

Further details about UK EPO testing

There are essentially two broad testing components, screening and confirmation. HIWU claims the UK lab under Stanley did not perform EPO testing on HIWU's samples because the equipment used for EPO screening testing was “inoperable, and the lab did not have a validated method for confirmation of EPO.

The lab was supposed to be screening 10% of the samples it received for EPO.

According to UK spokesperson Whitney Siddiqi, the facility was equipped to perform EPO screening for EPO at the beginning of Stanley's tenure as lab director. He joined the university in 2019.

But the “immunoassay plate reader” used to perform the EPO screening broke in the fall of 2022, wrote Siddiqi. “As best as we can determine, it was likely damaged in the move to the new laboratory, which was around fall of 2022,” Siddiqi wrote.

“Additionally, the individual who was trained to run the assay left the program. From that point on the lab was not conducting any EPO testing because Dr. Stanley chose not to repair broken equipment and fill the vacant staff position,” Siddiqi wrote.

According to Siddiqi, the lab “never had the capability to conduct confirmation EPO testing.”

Do UK's problems extend before HIWU?

Prior to HISA's anti-doping and medication control (ADMC) program going into effect in May of 2023, the UK lab performed testing for the Kentucky Horse Racing Commission (KHRC), starting Dec. 30, 2021.

The TDN sent the KHRC a series of questions, including what is being done to verify the integrity of the samples processed by the lab prior to HISA's ADMC going into effect, and what samples still remain from that period for such a review.

Jamie Eads, KHRC president and CEO responded–through KHRC interim general counsel Travers Manley–that the Kentucky Horse Racing and Gaming Corporation (KHRGC) is currently conducting its own investigation of the work performed by the UK lab.

“The University is cooperating with the investigation. We cannot comment further at this time as it is an open investigation,” Eads wrote.

According to the service contracts between KHRC and the UK lab, however, it seems as though any review of the Thoroughbred samples processed by the lab prior to the ADMC program going into effect would be fairly limited.

According to the contract service contract for the period July 1, 2022 to June 30, 2024, the lab kept a maximum of 6,000 samples at any one time for retroactive testing.

For that period, the laboratory retained untested and negative (passed) blood and urine samples only for six months. But it also retained failed blood and/or urine samples in a frozen condition indefinitely.

However, “the KHRC's Executive Director or Equine Medical Director may authorize disposal after final adjudication of the administrative case associated with the samples,” according to the contract.

One thing to note about HIWU's allegations: The four samples that HIWU had to correct–two cleared samples that were found positive and vice versa–all pertained to relatively minor Class B and C controlled substances, like phenylbutazone.

Breeders' Cup

The 2022 Breeders' Cup was held at Keeneland, and all race-day samples related to that event were processed by the UK lab.

Analysis of all samples collected under the Breeders' Cup's out-of-competition testing program in the months leading up to that event, however, “was conducted by the UC Davis lab,” wrote Breeders' Cup vice president of communications, Claire Crosby.

The TDN asked the Breeders' Cup similar questions to the Kentucky racing commission about what is being done to verify the integrity of the samples collected in 2022.

Crosby wrote that “we have been in contact with the [Kentucky Horse Racing and Gaming Corporation] KHRGC in the wake of the release of HISA and the University of Kentucky's investigative reports on UK-EACL, and the KHRGC is conducting its own investigation into the matter. At this time, Breeders' Cup is not aware of any issues with samples from the 2022 World Championships and we remain in touch with the KHRGC pending the results of its investigation.”

When asked about the ongoing investigations involving the Kentucky racing commission and Breeders' Cup, the UK's Siddiqi wrote there is “no evidence at this time to suggest that other samples or testing were compromised beyond the small number of tests mentioned in both our report and HIWU's report.”

Siddiqi added, “we have cooperated with all requests from clients for information about samples processed by the lab and will continue to assist any current or former client of the lab in investigating the integrity of their results. Our audit review is ongoing.”

Pennsylvania Equine Toxicology and Research Laboratory

At the end of August, HIWU said that it had granted a temporary stay of enforcement to connections in six pending total carbon dioxide (TCO2) cases, all of which are out of Pennsylvania, in order to conduct a review of TCO2 analysis at the Pennsylvania Equine Toxicology and Research Laboratory.

In the recent Q&A, Scollay and Mosier said there was “no evidence for error, aberration or inconsistent analytical approach” with the Pennsylvania lab's TCO2 testing.

They added that HIWU was “investigating and undertaking some experiments on our end across the laboratories to determine if there is non-conformity across the laboratories, what the significance of it is, and to the extent that it might exist, how to remedy it.”

When asked for a status update, a HIWU spokesperson wrote that the agency's review of laboratory procedures regarding TCO2 testing remains ongoing.

“HIWU will notify affected individuals with pending cases of the review's findings before any potential public comment on the matter,” the spokesperson added.

RMTC's Metformin Study

The human diabetes drug metformin has played an out-sized role in the federal organization's anti-doping crusade.

Back in June, HISA announced that it was deferring all interim suspensions involving metformin until the RMTC's Scientific Advisory Committee had conducted a review of the available science relating to metformin.

Hardy said that research–which includes administration studies–is ongoing. The RMTC, he added, “expects to have information to report, any recommendations that it may or may not have, in the coming months.”