Veterinarian Shell from Ohio sentenced to fine and two years probation

Ohio veterinarian Dr. Scott Shell was suspended for two years and fined $25,000 for administering 228 injections of a product called Hemo-15 to 37 horses from May 29 to October 19, 2023.

Due to sanctions imposed by the Horseracing Integrity and Welfare Unit, the enforcement arm of the Horseracing Integrity and Safety Authority, he must also pay an additional $10,000 to cover arbitration costs.

Hemo-15 is a drug sold overseas that contains more than 16 ingredients, including an iron salt (ferrous ammonium citrate) and cobalt gluconate, touted for their alleged effects on erythropoiesis – the process of forming red blood cells. The drug has not been approved by the U.S. Food and Drug Administration, nor has any product containing all of the ingredients in Hemo-15 been approved by the FDA, according to the arbitration report on the case from the JAMS Resolution Center in New York.

The report also noted that Hemo-15 is not approved by any federal agency for veterinary or human use.

Shell, a veterinarian for 37 years whose practice focuses on northeast Ohio, insisted during his hearing that Hemo-15 is not listed as a banned substance under HISA rules. He also said it is a vitamin or dietary supplement and therefore does not require FDA approval. Shell said he reviewed the HISA list of banned substances, relying on a presentation by Dr. Mary Scollay, HIWU’s chief scientific officer, who Mahoning Valley Racetrack She said that vitamins are not banned substances under HISA rules because they do not require FDA approval.

During testimony, it was pointed out that Scollay never told anyone that Hemo-15 was “a vitamin.” She also pointed out that any vitamin or mineral sold as a drug that claims to treat a specific disease is considered a controlled substance.

Dr. Joseph Bertone, a former professor of equine medicine at the College of Veterinary Medicine at Western University of Health Sciences and a former FDA veterinary surgeon, testified on behalf of Shell that he believes Hemo-15 is a legal substance that has been given to horses for decades, primarily to stimulate appetite or help with anemia. Vitamins are not used to diagnose or treat disease, but because they have a positive effect on general well-being, Bertone testified.

Shell confirmed that it was aware that the use of unauthorized substances was prohibited and that the administration of such prohibited substances constituted a breach of HISA’s anti-doping and drug control regulations.

The arbitrator ultimately agreed with the testimony of Dr. Lara Maxwell, a professor of pharmacology at Oklahoma State University School of Veterinary Medicine, who testified that Hemo-15 was an “unapproved veterinary drug” and met the definition of an unapproved and therefore banned substance under the ADMC rules.

Maxwell noted that foreign versions of Hemo-15 are registered as active pharmaceutical ingredients and sold with standard drug labels, and that the FDA has directly expressed its concerns about the use of injectable vitamins, including noting their classification as “unapproved animal drugs.”

The arbitrator also found that Shell was substantially at fault for its violations because Shell had access to HISA’s training materials, attended a workshop led by Scollay, but did not ask questions about whether Hemo-15 was a banned substance, did not inquire with any HIWU or HISA official about compliance, and paid little attention to the label on the product, which stated, “This is a compounded drug. Not an FDA-approved or indicated drug.”

Shell self-reported its use of Hemo-15 and continued to report the administration on the HISA portal even after its first report on May 29, 2023. The arbitrator stated that it was concerning that no action had been taken against Shell for nearly six months.

The report finds that there was no evidence that Shell intended to defraud and that it seriously believed it was using a legal substance. Shell was never sanctioned or suspended before 2023.

“Dr. Shell would surely have taken comfort in the fact that his reporting of Hemo-15 administration at HISA or HIWU did not cause immediate concern,” the report said.