Maylin Deposition May Lay Groundwork For Commission To Question Medina Spirit/Otomax Theory – Horse Racing News

Maylin Deposition May Lay Groundwork For Commission To Question Medina Spirit/Otomax Theory – Horse Racing News

The legal teams for trainer Bob Baffert and owner Amr Zedan have given much credence to what they’ve said is new science as they’ve built their narrative around the positive betamethasone test from Medina Spirit after the 2021 Kentucky Derby. But the impact that science could have on the appeal is unclear.

Dr. George Maylin, director of New York’s Equine Drug Testing and Research Laboratory, was deposed in the appeal case on June 10 as the Kentucky Horse Racing Commission tried to learn more about the testing he conducted on Medina Spirit’s split sample.

The appeal hearing is scheduled to begin in the case on Aug. 22.

The Paulick Report recently acquired a copy of the transcript of Maylin’s deposition via public information act request. When depositions are conducted in this context, each side of the legal case makes available the experts and witnesses they expect to call during the upcoming proceeding so opposing attorneys can gain a sense of what to expect during the hearing. While KHRC staff and stewards were deposed primarily by attorneys for Baffert and Zedan, Maylin was primarily deposed by KHRC’s counsel. This means that we’ve had a look at one side’s handling of each witness.

You can find our previous reporting on other evidence and depositions in the case here.

An editorial note: Some readers asked, after publication of the piece linked above, why we’re still reporting on this case. For one thing, the appeal is ongoing and is expected to drag on for some time. For another, the narrative about the circumstances surrounding Medina Spirit’s positive test and the commission’s subsequent investigation has, to this point, largely been driven by the attorneys for Baffert and Zedan. The stewards’ hearing took place behind closed doors, and so far the public has had only small glimpses of the commission’s view in a limited number of public hearings in motions related to the requested stay of suspension. While the commission is still not making public statements or comments, it is now, after the ruling of the stewards, subject to some types of public information act requests. Taking a look at the way both sides are deposing experts and what they’re discussing in correspondence can shed light on the state’s perspective in a way we haven’t seen before.

Here are a few things we learned from Maylin’s deposition:

–It took a lot to get Maylin to agree to a deposition. Emails reveal that KHRC attorney Jennifer Wolsing was in touch with Maylin’s counsel as far back as March, trying to arrange a deposition ahead of the appeals hearing.

Joseph Faraldo, attorney for Maylin, expressed the laboratory director’s reluctance to participate in an in-person interview and for a while, would only agree to a Zoom interview. Maylin is 80 and Faraldo said he had serious concerns about the prospect of being deposed in person due to fears about COVID-19. After two months of back-and-forth, Wolsing had apparently had enough of that explanation.

“We are aware that Dr. Maylin is reluctant to engage in an in-person deposition due to alleged COVID concerns,” she wrote in early May. “However, our previous experience with Dr. Maylin indicates that he is comfortable with meeting people for extended periods of time, even without any COVID precautions. When the KHRC brought Medina Spirit’s urine sample to New York in 2021, Dr. Maylin met with four people for 60 to 90 minutes without masks or social distancing. Some of his conversations with KHRC staff on that date included very close, face-to-face discussions and document review. He also drove one of our employees to and from the airport in his car, again without masks or social distancing.”

Nonetheless, Wolsing said the commission would agree to a Zoom deposition, which was eventually held in June.

–There was a lot of confusion about Maylin’s official role in the case. In his deposition, Maylin does not frame himself as a member of either side in the case, even though his test results would appear to be beneficial to Baffert. He said that after Baffert’s announcement that the horse’s betamethasone test could be traced to the administration of Otomax, Maylin decided to investigate whether this was possible all on his own, in late May 2021. It was later that Maylin said Dr. Clara Fenger contacted him and suggested that he be the one to do additional testing on the remainder of Medina Spirit’s urine sample.

Faraldo said in an April email that he had been “laboring under the assumption that Dr. Maylin was retained as an expert on behalf of Bob Baffert” but before the KHRC attorneys, Maylin indicated he had not been paid a dime by Baffert or Zedan. The expense of his research and the testing of the urine, which he estimated came to $10,000 or less, was absorbed by “the New York Racing and Wagering Board,” the former name for the modern-day New York State Gaming Commission, which regulates racing in New York.

The reason it matters whether Maylin is a paid witness or not is that it subjects him to different requirements of disclosure of his research materials. Since he said Baffert did not pay for the work he did, Maylin also asserted he could not be forced to provide all of the results of research because this would risk his ability to publish it in a scientific journal down the road. Accordingly, he turned over a huge volume of results sheets from the testing he did on Medina Spirit’s urine, but has only provided his own summary of the research he did studying whether non-injection administrations of betamethasone could result in a positive test.

–Maylin’s research sample is very small so far – so small he says the work he has done can’t be published yet. Maylin said he administered Otomax to just two horses, but it turns out with one of them, researchers smeared the product in the horse’s mouth, trying to mimic what may happen if a horse had Otomax on a skin lesion and subsequently licked the area – something that hasn’t been suggested in the Medina Spirit case, as his skin lesions were limited to one hindquarter in the days just before the Derby.

As it turns out, Maylin’s researchers only applied the substance topically to one horse. In that case, Maylin said Otomax was applied every day for four days to an area on the hindquarters of a mare. The skin was not damaged prior to application, and the mare’s hair was not clipped. Maylin said the mare had a one-gram tube applied a day for four days. (Otomax doesn’t appear to be available commercially in one-gram containers.) Maylin said components of Otomax, including clotrimazole and betamethasone valerate, were found in urine samples collected from both horses 24 hours after administration.

Of course, these conditions aren’t exactly the same as what Medina Spirit encountered. According to Baffert, he was getting Otomax daily from April 9 until the day before the Derby. The areas of the colt’s skin that had healing lesions would have been broken, with less hair in those spots, which could impact absorption. Veterinary records do not indicate the size of the containers of Otomax Baffert’s staff were given, and it’s unlikely the amount applied to the horse was exactly the same each day.

Maylin acknowledged that two horses isn’t going to be a large enough sample size for a peer-reviewed journal to publish this work. He estimated he will need at least eight samples. When asked when that research could be done, Maylin emphasized that his lab’s primary directive was testing and said he hoped to have eight samples collected June 2023. He said he had no idea where he would submit such a study for publication.

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–Depending on who you ask, there may be some question about whether Maylin’s testing really did enough to establish there are two components of Otomax in Medina Spirit’s urine sample. Wolsing spent some time asking Maylin about the signal to noise ratio he used when setting up testing equipment.

Signal to noise ratio, or S/N, is a numerical value used to determine the lower limit of detection (LOD), a measure of a mass spectrometer’s sensitivity as it looks for a given compound, like betamethasone valerate, in a sample. The ratio is intended to assure that there is more ‘signal’ (the compound of interest, like betamethasone valerate) than ‘instrument noise’ in the test results. Maylin testified that the industry standard S/N should be at least 3:1 to claim the presence of a given drug.

But under questioning from Wolsing, Maylin admitted that the S/N for some of the tests he performed for betamethasone valerate fell below the 3:1 standard, suggesting he didn’t find detect a sufficiently strong signal from the substance compared to the “background noise” in the colt’s urine.

Elsewhere in the deposition, Wolsing confronted Maylin about similar data for clotrimazole, the antifungal component of Otomax that Zedan’s attorneys claimed Maylin had also identified in Medina Spirit’s sample. Some of the data turned over by Maylin showed that the apparent concentrations of clotrimazole he found were very close to the apparent concentrations in the negative control sample he also tested.

Maylin emphasized that his task was to see whether he could find any components of Otomax, not to quantify how much of each were present and that his testing methodology was appropriate for that task.

All of this could lay part of the groundwork for the KHRC’s scientific experts to claim that Maylin’s testing of Medina Spirit’s sample did not meet industry (Association of Official Analytical Chemists) or other widely accepted forensic toxicology standards to identify either of the two key ingredients in Otomax.

–Maylin claimed his initial interest in the case was preventing a similar post-race positive after the Belmont. Of course, Medina Spirit didn’t end up running in the 2021 Belmont Stakes, but Maylin said “the New York Racing and Wagering Board” was aware of his research and that there was some concern about whether a repeat situation could occur in New York.

“They were – they were aware of the study because of implications of this horse racing in the Belmont Stakes and what we would do to try to preclude the folly that you folks are dealing with,” Maylin said.
“To preclude the folly that we are dealing with, is that what you said?” asked Wolsing.
“Yeah.”
“What folly are you referring to there, Doctor?”
“The horse was treated with Otomax and allowed to run.”
“And you’re saying it was folly to allow the horse to run after it had been treated with Otomax?”
“The answer is yes.”

Maylin went on to say that had the horse gone to New York, he would have been tested out-of-competition and not been allowed to run.

Out-of-competition testing in most places isn’t designed to look for the presence of therapeutic drugs, but rather to catch the use of banned drugs like EPO or anabolic agents.

New York’s regulation on out-of-competition testing states that “A race-day prohibition or restriction of a substance by a commission rule is not applicable to an out-of-competition test unless there is an attempt to race the horse in a manner that violates such rule.”

–Maylin said hypothetically, it’s possible the horse could have received both topical Otomax and betamethasone in an injection. Although Maylin believes his results establish that Medina Spirit was given Otomax, he could not say this eliminated the possibility the horse had been exposed to betamethasone via injection. Both exposures could have taken place, he said, and there would be no way to tell from the testing he did.

Maylin did not test for so-called ‘free betamethasone’ meaning betamethasone that didn’t have the valerate ester attached to its molecule. The valerate ester is what enables it to be absorbed topically in drugs like Otomax. When the drug enters the horse’s body, the valerate is cleaved off, and plain old betamethasone is what circulates through the bloodstream and tissues. This also happens with betamethasone phosphate and betamethasone acetate, the two injectable forms of the drug – all of it ends up as free betamethasone by the time it gets to the tissues. When asked why he didn’t look for free betamethasone, Maylin said that was not on the list of substances in Judge Thomas Wingate’s order from Franklin Circuit Court guiding the release of excess urine sample to the New York lab.