by Paulick Report Staff
Dr. Mary Scollay, Dr. Rick Arthur, and Dr. Lynn Hovda submitted the following letter to the Paulick Report voicing their support of the RCI’s recent decision to establish rules on compounded medications in horse racing:
The Association of Racing Commissioners International (RCI) recently announced they have given approval to a Model regulatory policy that would establish rules on compounded drugs in horse racing. We support the RCI’s position on compounded drugs. The intent of the proposed Model Rule is to provide racing commissions with the authority to act, rather than their relying on other relevant federal or state agencies for enforcement. If the language appears imprecise to some veterinarians, it is because federal or state law and regulations lack specificity. We recommended racing commissions duplicate those agencies’ regulations rather than draft their own regulations that could potentially overreach state and federal laws.
Historically, the FDA, DEA, and other federal and state agencies have been reluctant or unable to respond to complaints from racing regulatory agencies. This has resulted in a significant regulatory void that has been exploited by individuals or companies producing illegally compounded substances or illegal new animal drugs. In our opinion this has jeopardized the safety of horses, jockeys, and drivers, not to mention the integrity of the competition. Absent pari-mutuel regulations that address illegally compounded medications, racing commissions have been unable to appropriately respond to the threat posed by these substances. In most cases, the ‘violation’–if one is even determined to have occurred–ends up being a related charge such as “possession of improperly labelled medications” which typically carries a minimal fine.
The proposed Model Rule will not impact the ethical racetrack practitioner. We understand the need for equine veterinarians to use many compounded drugs for legitimate horse health purposes and support their ability to do so. The RCI’s proposed compounding regulation Model Rule does, in fact, provide a means for a racing commission to approve a substance, in consideration of the health needs of the racehorse, that would otherwise be determined to be not permitted, per FDA regulations. What the Model Rule will do is allow a racing commission to take meaningful action when, for example, compounded clenbuterol (at 10x the concentration of the FDA approved Ventipulmin™) is administered to, and kills, horses. Just as importantly, a search of the internet locates websites such as www.horseprerace.com, among others, that clearly demonstrates the problem racing commissions are facing with compounded drugs. Completely inappropriate drugs can be readily obtained from a number of these sources which are designed to evade regulation. Many of these sites distribute unapproved new animal drugs–lacking any kind of evidence for safety, efficacy, purity, sterility, or stability– to veterinarians and laypersons alike. They are clearly marketed to persons intending- and there is no other word for it-to cheat. These substances, bearing enticing names such as Blast-Off Red, Game Changer, Purple Pain and Tourniquet, are in reality, complete unknowns intended to be injected or otherwise administered to horses immediately prior to racing. The risks posed to the horse and horse racing integrity cannot be overstated.
Some compounding pharmacies offer clones or knock-offs of FDA approved drugs. It is well documented that many of these products do not carry the same concentration as the commercially available product and represent substantial risk of a medication violation. In some cases compounded products, bearing labels listing only permitted substances, have contained prohibited substances and resulted in medication violations and substantial penalties to unwitting horsemen and veterinarians. The use of these products is not without risk and should not be considered when FDA approved products are available.
Gastrotec, currently sold over the counter and aggressively marketed through credible trade e-zines, is a good example of a compounded medication with many issues. The product label indicates it contains omeprazole and misoprostol. While both medications individually have FDA approval for use in one or more species, the combination of the two does not. The name implies gastric protection–so the assertion of efficacy (absent any FDA trials) represents another problem. There is likely an issue with the omeprazole component as it is doubtful that the FDA approved product is used in the production of this combination drug. But the biggest concern is associated with the misoprostol. It is a prescription medication and cannot legally be sold over the counter. It is also one of the two drugs used in combination by human physicians to induce medical abortions. When prescribed for humans, it contains a Black Box warning that begins…”If you are pregnant or may become pregnant…” The equine product label advises caution with respect to use in pregnant mares, but contains NO warning about human exposure. There is substantial danger here in addition to numerous unknowns. Absent the proposed Model Rule, the only way this product could be regulated is if 1) the FDA gets involved–which is unlikely or 2) a positive drug test results from its administration. (The detection of misoprostol and/ or omeprazole–both Penalty Class D substances—would likely result in a written warning. It is doubtful that the actual source of the misoprostol and omeprazole would be investigated or addressed.) This product may be just fine. But it may not. We don’t know, and neither does anyone else.
Racing Commissions need the authority to act in addressing illegally compounded substances. Waiting for the FDA, DEA, state pharmacy boards or any other non-racing regulatory or law enforcement agency simply will not work. It is like waiting for Godot.
Mary Scollay, DVM
Rick Arthur, DVM
Lynn Hovda, DVM