Ohio veterinarian Dr. Scott Shell has been suspended for two years and fined $25,000 for administering 228 injections of a product named Hemo-15 to 37 horses from May 29 through Oct. 19, 2023.
Under the sanctions from the Horseracing Integrity and Welfare Unit, the enforcement arm of the Horseracing Integrity and Safety Authority, he also is required to pay an additional $10,000 to cover arbitration costs.
Hemo-15 is a compound sold overseas that contains more than 16 ingredients, including an iron salt (ammonium ferric citrate) and cobalt gluconate, which are touted for their alleged effects on erythropoiesis—the process of producing red blood cells. The compound has not been approved by the U.S. Food and Drug Administration nor has any product that contains all the ingredients found in Hemo-15 been approved by the FDA, according to the arbitration report on this case produced by the JAMS Resolution Center in New York.
The report also noted that Hemo-15 is not recognized by any federal agency for veterinary or human use.
Shell, a veterinarian for 37 years whose practice is concentrated in northeast Ohio, maintained during his hearing that Hemo-15 is not listed as a banned substance by HISA rules. He also said that it is a vitamin or nutritional supplement and so does not require FDA approval. Shell said he reviewed HISA's banned substance list and relied on a presentation from Dr. Mary Scollay, HIWU's chief of science, at Mahoning Valley Race Track during which she said that vitamins, because they do not require FDA approval, are not a banned substance under HISA's rules.
During testimony it was noted that Scollay never told anyone that Hemo-15 was "a vitamin" and she also noted that any vitamin mineral substance sold as a drug that makes a claim to treat a specific condition is considered a banned substance.
Dr. Joseph Bertone, a former professor of equine medicine at the College of Veterinary Medicine, Western University of Health Sciences, and at one time an FDA veterinary medical officer, testified on Shell's behalf that Hemo-15 was in his opinion a legal substance that has been given to horses for decades, primarily to stimulate appetite or to aid with anemia. Vitamins are not used to diagnose or treat any medical condition, they are used instead because they are beneficial to overall well-being, Bertone testified.
Shell did confirm that he understood that non-approved substances are prohibited from use and that administering such banned substances violates HISA's Anti-Doping and Medication Control rules.
The arbitrator ultimately sided with the testimony of Dr. Lara Maxwell, a professor of pharmacology at Oklahoma State University's College of Veterinary Medicine, who testified Hemo-15 is an "unapproved animal drug" and meets the definition of a non-approved, and therefore banned, substance under ADMC rules.
Maxwell noted that foreign versions of Hemo-15 are registered as pharmaceutical agents and sold with standard drug labels and that the FDA has directly expressed concerns about the use of injectable vitamins, including establishing their classification as "unapproved animal drugs."
The arbitrator also found Shell demonstrated significant fault for his violations because he had access to HISA's educational materials, attended a workshop conducted by Scollay but did not ask any questions about whether Hemo-15 was a banned substance, did not follow up with any HIWU or HISA official about compliance, and paid little attention to the label on the product stating: "this is a compounded drug. Not an FDA approved or indexed drug."
Shell did self-report his use of Hemo-15 and continued to report its administration on the HISA Portal after his initial filing May 29, 2023. The arbitrator stated it was concerning that no action was taken against Shell for almost six months.
The report notes that there was no indication that Shell intended to cheat and that he sincerely believed he was using a legal substance. Shell has never been sanctioned or suspended prior to 2023.
"Dr. Shell would have taken some comfort from the fact that his reporting of the administration of Hemo-15 did not draw any immediate concern from HISA or HIWU," the report stated.
