Q&A: Mary Scollay on Drug Testing Protocols & Baffert Otomax Explanation

Since Sunday morning, horse racing has largely been a one-issue sport. That morning, of course, trainer Bob Baffert announced that GI Kentucky Derby winner Medina Spirit (Protonico) had tested positive for 21 picograms per milliliter of betamethasone in a post-race sample.

Betamethasone is a regulated corticosteroid commonly used in horse racing as an intra-articular joint injection. In Kentucky as of last year, a detection of betamethasone at any level is deemed a violation. The previous threshold was 10 picograms per milliliter. A split sample will now go for confirmation testing.

On Tuesday morning, Baffert released a statement explaining that following the GI Runhappy Santa Anita Derby, Medina Spirit had developed dermatitis on his hind end and that his veterinarian had recommended daily use of an anti-fungal ointment called Otomax.

“Yesterday, I was informed that one of the substances in Otomax is betamethasone,” the statement reads. “I have been told by equine pharmacology experts that this could explain the test results.”

Prior to Tuesday's announcement, Baffert had conducted a series of national interviews in which he maintained his innocence and insisted that he and his team have never administered betamethasone to Medina Spirit. During these interviews, Baffert cast serious doubts on drug testing protocols currently in use in horse racing, arguing how, among other things, the hyper-sensitivity of modern testing technologies leaves horses susceptible to positives through cross-contamination.

In Tuesday's statement, Baffert repeated those accusations, arguing that “horse racing must address its regulatory problem when it comes to substances which can innocuously find their way into a horse's system at the picogram (which is a trillionth of a gram) level.”

To discuss some of the issues that Baffert has raised in his interviews, the TDN spoke with Mary Scollay, executive director and chief operating officer of the Racing Medication and Testing Consortium (RMTC). Scollay was recently appointed to the Anti-Doping and Medication Control Standing Committee arm of the Horseracing integrity and Safety Authority.

The TDN spoke with Scollay both prior to, and after, Baffert released his statement Tuesday. In her first interview, Scollay raised the possibility that the positive could be the result of exposure through use of a topical product that contains betamethasone.

The two interviews have been spliced into the following, which has been edited for brevity and clarity.

In his statement, Baffert claims that the positive finding could be the result of use of a betamethasone-containing anti-fungal ointment called Otomax, which was used to treat dermatitis. Does this seem plausible?

It's plausible–the horse was exposed to betamethasone, so, that's beyond where we were a day ago when the horse had never been exposed to betamethasone.

In the scenario you presented in our first interview, the horse who tested positive for betamethasone after topical treatment of an ointment had also ingested the ointment. A scenario of double exposure. Would the levels of betamethasone detected in Medina Spirit also have required him to have ingested the topical ointment?

No way to know. I don't know that there's any pharmacokinetic data on concentrations of betamethasone following topical treatment. And again–because I never make anything easy, right–that would depend on the condition of the skin, too. Intact skin would likely absorb less into the blood stream than inflamed skin, or an open wound where there's more direct contact between the blood and the blood vessels and the medication.

The skin's a pretty good barrier–it's intended to prevent you from absorbing lots of stuff. If you could absorb lots of toxins and noxious substances through your skin, you'd be in trouble. Intact skin is a fairly effective barrier, so, again this is where an assessment of the horse's physical condition would be helpful. I don't know. Was the skin disease noted by the commission veterinarians in any of their contact with the horse? Don't know.

To be fair, it's not part of your routine inspection to lift the tail and look underneath. But, if the horse is jogging away from you and it's got irritated skin on the perineum, that's not something you'd notice–perhaps.

How common is Otomax?

It's a very common veterinary drug–I've used it on my Cocker Spaniels for years because they're inclined to get ear infections, and it is very useful in treating ear infections. It has a lot of use in small animal medicine. It wouldn't surprise me if it is used in equine veterinary medicine for different types of skin disease, especially the diagnosis of fungal diseases which has been referenced here, because some of the other topical medications of corticosteroids don't have an anti-fungal component, and Otomax does.

So, from what you're saying, Otomax could be a fairly ubiquitous medication on the backstretch. If so, why hasn't there been a rash–pardon the pun–of prior betamethasone positives subsequent to Otomax usage?

I don't know if it is commonly used [on the backstretch]. It wouldn't surprise me. It has extensive use in small animal medicine, and I would say that this is where I am most familiar with it as a client. You'd have to talk to practitioners on the backside to see how extensively they use it or if they carry it in their practice. A lot of topical medications come down to personal preference of the practitioner.

Again, I don't know the frequency with which it's used on the backside–nor do I know how it's used in proximity to a race. Are other people using it but withdrawing use of it within 72 hours? Because horses get bathed often, I would not expect there to be much carry over from day-to-day in terms of what's on the surface of the skin. You'd have to apply it a couple times a day–I think in this case, they said they were applying it once a day.

But again, what's the skin condition on which it's used? If it's on the girth or an area where the tack is inclined to rub, you probably are not planning on running the horse until it's resolved because that chaffing and discomfort could cause the horse to not provide maximum effort as it's uncomfortable. So, maybe most of its use is outside the context of a race, and so, it's not an issue.

These are questions I can't answer because I'm not on the backside prescribing it, and I would think if you want more information on the use of Otomax, you need to talk to some veterinarians who are attending to racehorses on a daily basis.

Taken from interview prior to Tuesday's statement:

Baffert has claimed that he's the victim of a systemic drug testing problem within the industry, and seems to have suggested he might be the subject of more deliberate efforts to tarnish his name. How likely is it that a sample was tampered with or that a testing error, deliberate or otherwise, was made?

I'm going to say highly improbable–very, very slim. There are multiple people in the test barn at any one time, and there are multiple people in the sample processing area at any one time. So, the thought that somebody would be able to successfully introduce something into a blood or urine sample without being detected, that I think is most unlikely.

Secondly, sort of as an aside, the RMTC has what's called an external quality assurance program where a couple of times a year we send sets of samples to each laboratory, and we pay another laboratory–one that's certified to do this–to put specific concentrations of substances into these blood and urine samples.

We may instruct 0.5 micrograms of [phenylbutazone, or bute] in a blood sample. Well, that requires very precise measurements and instrumentation–it's not like you just take a drop of injectable bute and plunk it into the test tube and say, 'there it is.' Doing something like that would result in extraordinarily high concentrations that would raise eyebrows and lead people to question the validity of the sample right there and then.

To tamper a sample with the addition of 21 picograms per milliliter? Say there's 6 milliliters of serum in that tube–what's that, 126 picograms of betamethasone? That's not easy to do. It's just not. There would be a large margin of error.

One of the first things you'd do if you saw a sample that high is look at the urine sample, and if there wasn't a corresponding concentration in the urine, you'd say, 'well, something's wrong here, this is not an accurate representation of what's in the horse. We need to notify the commission and decide how best to proceed.'

So, it would require two samples to be tampered with, and tampered with in such a way that concentrations of the substance present in such a way that would be complementary of each. And that to me would be tremendously difficult.

Baffert has also suggested that the finding could be a result of inadvertent cross-contamination. In a two-part TDN series last year, you voiced scepticism about the likelihood in certain circumstances of a positive being legitimately attributable to environmental contamination. What do you think of the likelihood of cross contamination in this case?

It still seems to me highly improbable. I mean, this horse, as I understand it, lived and was managed in Southern California until it came here for the Kentucky Derby. So, it's my understanding that in both circumstances, the stalls were under control of the trainer.

He has advised that this horse was never treated with betamethasone, so, I'm assuming that no betamethasone was introduced into the horse's stall in California through urine or feces or whatever. And it's also my understanding that the stalls at Churchill are unoccupied until the horses return in the spring. So, that's fresh bedding that's put down–again, it's hard for me to imagine that there was sufficient exposure in those stalls to result in a detection.

It is absolutely clear that there are substances that can be detected when you do swabs on the wall or you analyze clumps of dirt from the floor of the stall. But, again, you put clean bedding over those. The horse who is urinating over the bedding is reported never to have been treated [with betamethasone]. So, if the concentrations that had been detected in the flooring–you'd have to paw through and gnaw with your teeth in order to get some up to eat–were present in the milligram or nanogram concentrations, how much of that dirt would the horse have to eat in order to have a detectable concentration in its blood? To me the math doesn't add up.

Now, there are other ways unintended exposure can occur. We have dealt with a situation with a topical product that contains both antibiotics and betamethasone. It's used to treat wounds, and apparently, a horse had been treated topically with it, and the horse also seemed to like to lick its wounds. So, there was double exposure there through the wound as well as ingestion of the betamethasone. We attributed the finding to that level of exposure–we did not determine that the horse had been injected or that there was any nefarious activity. But the horse was exposed two ways. Clearly that was not an intended exposure.

There are certainly ways that unintended exposure can occur. But you're going to have a hard time convincing me a horse has licked enough of a stall wall to ingest a sufficient amount of betamethasone to result in a detectable finding.

Are there other ways betamethasone be found in the sample? Could it be a metabolite, for example, derived from another substance?

No, I don't believe so. I believe betamethasone is a unique medication, unique molecule. It is very similar to dexamethasone. It is the same molecular weight as dexamethasone, but the labs are able to discern the difference between the two. And again, when they report a finding for dexamethasone or betamethasone, they have unequivocally identified that molecule to the exclusion of all others.

Twenty-one picograms of betamethasone is described by some as insignificant. Can what appears such a relatively small amount of betamethasone be a performance enhancer?

You sort of ask two questions there, and so, I need to answer them separately.

First of all, we're not talking about the sum total of 21 picograms in the entire horse's body, it's 21 picograms per milliliter of blood. The horse has an awful amount of blood, probably in excess of 50,000 milliliters. That also doesn't measure the medication that has left the blood stream and entered the tissue. So, it's not 21 picograms in the entire horse–it's 21 picograms in one milliliter of blood. That's a different math problem right there.

Secondly, picogram is a measurement of weight and not potency. And so, my best way to explain this is to compare a pound of celery to a pound of Godiva chocolate. They both weigh a pound, so they have the same weight measurement, but in terms of potency–and let's say that's caloric content–they are hugely different, right? So, when you talk about a picogram of something, all you're really talking about is a measurement of weight.

Betamethasone is a potent corticosteroid administered at fairly low doses–nine milligrams or less in a single joint. Compare that to phenylbutazone which is a nonsteroidal anti-inflammatory. It's not a particularly potent drug–it's administered in gram doses. And so, we don't worry about picogram doses of phenylbutazone. We regulate phenylbutazone at the microgram level, which is one-millionth of a gram, and that's again because the drug disperses throughout the entire body.

So, you have to consider the potency of the drug, and because betamethasone is administered in low milligram doses, picogram concentrations are highly relevant.

Now, do I know what effect 21 picograms has on a horse? No, I do not. But I do know that, based on the administration studies that were funded by the RMTC, 21 picograms is consistent with the intra-articular administration of nine milligrams into a single fetlock joint at less than 72 hours prior to sampling.

Now, I'm not saying the horse in question received an intra-articular injection of betamethasone. It's clear that at the moment, no one knows how it got into the horse, and I'm not suggesting otherwise. I'm just saying that drug at that dose by that route of administration would result in that concentration within administration at less than 72 hours to a race.

Our regulation of corticosteroids is really based on racing safety and equine welfare. When I think of performance enhancing drugs, I think of EPO, doping, amphetamines, that sort of thing. The classic hop that we talk about. Whereas corticosteroids could allow a horse that is unsound to feel better and race better than he otherwise would. And so, that's a safety and welfare concern. I don't consider that to be a performance enhancing problem.

At the end of April, the Kentucky Horse Racing Commission formally agreed to end its contract with Industrial Laboratories in Wheat Ridge, Colorado, and begin using instead the University of Kentucky Equine Analytical Chemistry Laboratory as its official testing institution. The switch is expected to occur in June. Is this something that concerns you about the validity of the findings?

Absolutely not. When I worked for the commission, we were extremely satisfied with the service from Industrial Laboratories, and I don't think the switch has anything to do with dissatisfaction or lack of confidence in the services provided. I think the decision was based on local availability and supporting the home team, as it were.

I think the commission will continue to use Industrial Laboratories for split samples and maintain a good working relationship with the lab because they did their work well, and Petra Hartmann, who oversees the equine racing and testing component end of the program has been immensely helpful to the commission all along.