HIWU: Efforts to Harmonize Laboratory “Testing Sensitivity” Underway

Sarah Andrew

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In a statement Thursday, the Horseracing Integrity and Welfare Unit (HIWU)–the enforcement arm of the Horseracing Integrity and Safety Act (HISA)–said that an internal review of the six accredited laboratories used by the agency had unearthed different limits of detection in blood for metformin, a banned substance at all times under HISA.

“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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