Indiana Ousts Widely-Used Drug Testing Lab For ‘Continued Failure To Detect Substances’

by | 05.19.2015 | 12:30pm
Irvine, Calif.-based Truesdail Laboratories plans to appeal Indiana's decision to stop using the lab for equine drug testing

Officials at Truesdail Laboratories in Irvine, Calif., said they plan to contest a May 12 decision by the Indiana Horse Racing Commission to terminate the company's equine drug testing contract after Truesdail failed to detect high levels of commonly used corticosteroids in three samples taken from harness horses competing at Hoosier Park in late March and early April.

Truesdail conducts drug testing for racing in Arkansas, Delaware, Idaho, Maryland, Massachusetts, Nebraska, Nevada, New Jersey, Oregon, Puerto Rico, Washington, West Virginia and Wyoming. That includes testing for such prestigious races as last Saturday's Preakness Stakes at Pimlico.

The firing of Truesdail was a byproduct of a quality assurance program that went into place this year under the leadership of Indiana Horse Racing Commission executive director Joe Gorajec. On randomly selected racing programs, blood samples taken from harness horses at Hoosier Park and Thoroughbreds and Quarter horses at Indiana Grand were sent to three laboratories: Truesdail, the official lab (which also received urine samples) and two audit laboratories –  LGC in Lexington, Ky., and Industrial Laboratories in Wheat Ridge, Colo.

The first problem arose on April 9, when Industrial reported a finding of 597 picograms per milliliter of Isoflupredone, nearly six times higher than the Indiana Horse Racing Commission's threshold of 100 pg/ml. That threshold level is the same as the model rules adopted by the Association of Racing Commissioners International (RCI) on the recommendation of the Racing Medication and Testing Consortium (RMTC). LGC also confirmed the sample as positive for Isoflupredone, at a level of 465 pg/ml.

Truesdail reported the sample clear of any drugs above the threshold.

One week later, after another sample was reported clear by Truesdail, Industrial reported a finding of Betamethasone at 22 pg/ml, more than twice the Indiana and RCI threshold level of 10. LGC also found a violation for Betamethasone at 28.6 pg/ml.

On the same date, April 16, Truesdail failed to find Betamethasone in a third sample that Industrial detected at 62 pg/ml and LGC detected at 84.7 pg/ml – the latter more than eight times the permitted level.

As part of Truesdail's contract with Indiana, the laboratory was given an opportunity to re-test the samples for which there were conflicting results.

On April 13, after the discovery of Isoflupretone by Industrial Laboratories in a sample that was cleared by Truesdail, Holly Newell, deputy counsel for the Indiana Horse Racing Commission, wrote to Dr. Norman Hester, Truesdail's chief science officer, in an e-mail obtained by the Paulick Report: “The Indiana Horse Racing Commission is in receipt of Truesdail's April 9, 2015, Drug Tests Report, which cleared samples taken from March 27, 2015, at Hoosier Park. Please be advised that we have a report from our audit laboratory that indicates a finding in Sample Number 123003 from March 27, 2015.

“Please review this sample, and submit an amended finding, if necessary, by 2 p.m. (EST) on Wednesday, April 15, 2015. If your finding remains the same, please confirm that by the same time and date as well.”

On April 14, Hester responded:

“Julie (racing chemist Julie Hagihara)and I and our staff reexamined our screening data for Sample Number 123003 shortly after receiving your e-mail. Our documentation indicated that we had detected flunixin in this sample when we tested it. As we noted in our proposal, when we test the blood samples we run positive control samples along with the track samples that have been spiked with drugs at the threshold levels for that drug. Thus we had data for a sample spiked at 20ng/ml to compare with the data from 123003.  The screening data indicated the peak area for flunixin was about half that of the 20ng/ml spiked sample. Since this is well below threshold we did not send the sample on for further confirmation testing.

“After receiving your e-mail, I asked one of our chemists to run a full confirmation test on the sample with a multipoint calibration, positive and negative controls etc. This quantitative confirmation, ran in duplicate, confirmed the presence of flunixin at values of 11.6ng/ml and 11.7ng/ml. Thus we have three determinations that indicate the flunixin level is sample 123003 is well below threshold and should not be reported in a violation letter.

“If we have a misunderstanding of what you want reported as a finding please clarify.

“Our analysts have reviewed again all screening data of serum by UHPLC/HRMS and all screening data of urine by IA and UHPLC/HRMS and found nothing else to report. If Industrial has found a drug other than flunixin, please identify the drug and we will evaluate our screening protocols to see why it was not detected and take corrective actions.

“At this point, we see no reason to issue any revised reports.”

Newell wrote a similar e-mail to Hester after both Industrial and LGC detected high levels of Betamethasone in the two samples that Truesdail said were clear.

Hester responded: “I had my chemists re look at the two samples and the data indicated both samples to be suspect for the antibiotic sulfamethazine. In the past our clients have not wanted us to report trace levels of sufa druga (sic). We estimate the levels for both samples to be less than 1ng/ml. I guess we need a policy decision on these types of compounds…”

Both Isoflupredone and Betamethasone, Class 4 drugs under RCI model rules, are commonly used as joint injections. They are on the list of 26 controlled therapeutic medications in the RCI's National Uniform Mediation Rules.

drug testing test tubesIn other words, these were commonly used drugs detected at levels as high as eight times Indiana's permitted levels as recommended by the RCI. And even after being given a second chance to detect them, Truesdail failed. None of the cases involved could be prosecuted by Indiana stewards, because the findings of medication violations had to come from the official lab – not a secondary or audit lab.

In her Contract Termination letter to Dr. Anthony Fontana, technical director of Truesdail, Newell wrote that “Truesdail is in breach of the contract. … Truesdail's continued failure to detect substances in post-race samples, even after a review of the specific sample number, has been significantly detrimental to the prosecution of at least three trainers for medication violations. Truesdail has continuously failed to provide services that meet IHRC specifications for equine drug testing.”

Truesdail, when questioned by the Paulick Report about why it was unable to detect the medication violations in the three samples, issued the following statement: “We initiated a root cause investigation and corrective action per ISO 17025 requirements. The process identified the root cause of the issue and it has subsequently been corrected. We are confident in our ability to screen and confirm these drugs at current RMTC threshold levels.”

To prevent further failures, the Truesdail statement added, “We have made adjustments to our sample preparation procedure.”

Truesdail was selected as the official laboratory for Indiana by the state's Department of Administration based on both financial and performance metrics. In 2014, a contract with LGC was terminated by the Indiana Horse Racing Commission because of a backlog that prevented timely reports on post-race samples.

Truesdail has received accreditation from the Racing Medication and Testing Consortium, but the organization's executive director, Dr. Dionne Benson, said: “The RMTC Accreditation Code does allow for breach of an agreement with any commission to affect a laboratory's accreditation status.  We are in the process of gathering facts regarding the situation.  Until the Horseracing Testing Laboratory Committee (HTLC) is able to review the facts from both parties involved, we are not in a position to take action on any laboratory's accreditation status.  The RMTC and HTLC take these allegations seriously and intend to review all of the facts that are presented to us and will act in accordance with the Code taking any action that is warranted.”

At least one state regulator has expressed concern over the termination.

“It's not good news,” said John Wayne, executive director of the Delaware Thoroughbred Racing Commission, which earlier this year selected Truesdail as its official lab. “I called Norm Hester and went through an agenda of questions I had for him about the two drugs and how they missed them. He said they shouldn't have missed them and assured me they have taken corrective action and is going to give us the very best service.

“We were excited to select (Truesdail) as our lab and be on the same page as Maryland and New Jersey, thinking it would be good for the horsemen,” Wayne added. “That remains to be seen. We've got some quality assurance steps we are going to take as well – we're going to send live samples to another lab.

“You want to have a comfort level,” said Wayne. “You want the RMTC accreditation to mean something. We have faith in RMTC and the fact the laboratory is trying to do the best it can.”

Indiana, meanwhile, has shifted its testing to Industrial Laboratories in Colorado, one of the audit labs that detected the drugs that Truesdail missed.

“We've kept the Department of Administration fully apprised and they are supportive of our need to change laboratories,” said Gorajek, the Indiana commission's executive director.

In a statement made to the Paulick Report, Truesdail said the horse racing industry should not lose faith in the lab's testing capabilities.

“Truesdail has maintained and is committed to maintain both ISO 17025 and RMTC accreditations. In addition to our accreditations, we are also a member of the AORC (Association of Official Racing Chemists) and RMTC Scientific Advisory Committee. As such we are subject to annual audits and proficiency testing evaluations. We have followed all of our accrediting body's guidelines in response to this issue.”

Hanging in the balance is the integrity of clean horse racing, from the sport's biggest events like the Preakness, Arkansas Derby and Haskell Invitational to the small county fairs of Nevada.

Indiana Horse Racing Commission's termination letter to Truesdail Laboratories and supporting documents.

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