As U.S. District Judge J. Paul Oetken prepares to sentence former pharmacist Scott Mangini on Sept. 10 as part of the federal anti-doping probe that yielded more than two dozen arrests in March 2020, documents filed by prosecutors depict an operation churning out dangerous products while ignoring and avoiding regulators' attempts to shut it down.
Mangini had worked at various times in partnership with co-defendant Scott Robinson, who earlier this year was sentenced to 18 months in federal prison for drug adulteration and misbranding conspiracy.
In a letter to Judge Oetken, Mangini explains that he worked in human pharmacy at the start of his career, and also owned and trained harness horses on the side. While living in Florida, Mangini kept his horses at the South Florida Training Center in Lake Worth, and took over there as farm manager when the previous manager died. It was there he met Robinson, who was already in the business of selling what he called “horse supplements.” The two worked together under the banner of Horse Gold, then split off when Mangini launched Ergogenic Labs. Mangini supplied custom-made compounded drugs to Robinson and also sold them directly to consumers himself, under the online banners of RacehorseMeds or HorsePreRace.
Mangini depicts himself as a hard-working, hands-on horseman who was primarily interested in creating more affordable versions of recognized therapeutic drugs. His attorneys point to his loss of a young filly to equine protozoal myeloencephalitis (EPM) as the inspiration for his progression from human to equine pharmacy. Nearly a quarter of the sales of Mangini's business were for some form of omeprazole paste, while various forms of pentosan accounted for 13 percent, and EPM medications another 4.6 percent, according to documents from defense counsel.
Still, Mangini's attorneys admit, he did not apply to the Food and Drug Administration to become an authorized commercial manufacturer of these products and made them outside of federal oversight. He also falsified prescriptions to justify the compounding of some of those drugs – including “an omeprazole paste that could be used as an injectable product.” Mangini said he was offering owners “an easy, low-cost option” to get drugs like omeprazole. The FDA-approved versions cost between $30 and $36 per tube, while Mangini sold it for $9.99. The price difference was apparently attractive to “a broad cross section of animal hospitals, clinics, humane societies, animal rescues, and veterinarians and included entities that treated not just horses, but also dogs, goats, llamas, alpacas, lambs, and livestock.”
“Your honor, I am extremely sorry for breaking the law,” Mangini wrote to Oetken. “My passion in life has been to always help people and animals and hopefully I have explained that to you. I tried to justify my need to earn income based on my financial situation at the time along with using the excuse that I was simply helping horses, trainers, and owners. These laws are made for a reason and there is no excuse to break the law no matter what you believe or tell yourself.”
Mangini's attorneys requested he be given a sentence of six months' home confinement.
“The products he made were safe,” Mangini's attorneys wrote. “They contained the active ingredients that were promised and advertised. And the products he sold are well-recognized as a reliable part of care for animals, including horses.”
But prosecutors say even that omeprazole paste wasn't as benign as Mangini would have the judge believe. In February 2020, an unnamed individual filed a complaint with the Food and Drug Administration about a shipment of they drug they gave to their horse.
“I ordered omeprazole oral paste from www.racehorsemeds.com and instead the syringe containing paste for a 30 days supply actually contained DMSO, which causes birth defects in humans and serious side effects to horses,” the complaint read. “It was mislabeled, placing me and my horse at risk for life threatening injuries. The owner … has been cited before. SHUT HIM DOWN BEFORE HE KILLS SOMEONE!
“I will be filing a civil federal lawsuit, but the FDA should be doing more to protect the public. This guy is not a vet or a legitimate pharmacy.”
The complainant, according to prosecutors, gave her horse the paste and saw it rapidly decline, dropping weight and ultimately requiring hospitalization.
No federal suits were filed against Mangini subsequent to the early 2020 FDA complaint.
HorsePreRace had already received a warning letter in 2014 informing the company it needed to seek approval for the paste as a new animal drug, based on its assertions that the paste worked like approved omeprazole. Further, the FDA stated it had tested the omeprazole paste sold via HorsePreRace and found it contained only 68.1 percent of the omeprazole advertised on the label.
The person who filed the complaint wasn't the only one noticing problems with Mangini's products. As documented in the Robinson case, the two men exchanged frequent texts about customer complaints, including people reporting bugs in boxes of medication and inside injectable products. Robinson told Mangini in 2015 he had received “a bad photo of pentosan” with “shit floating in it” and “mold inside,” to which Mangini advised he ”just replace it,” blaming the quality on the customer.
“Vitamin c is exploding” Robinson informed Mangini in 2014 via text message, referring to a product quality concern.
“That's common on all of them,” Mangini replied.
It remains unclear exactly what Robinson meant.
Robinson also warned Mangini about horses who were “infected and blowing” after getting shots of “poly p” and a mare who became depressed and unable to move after getting her first injection of a pentosan product. Another customer reported two horses that were unable to walk, appearing heavily sedated for 36 hours after getting a pentosan injection, and a third said their horse had experienced a stiff neck, which their treating veterinarian suspected was caused by “some impurity in the branch.”
“Ur not turning ur inventory as fast,” Mangini texted Robinson upon hearing these complaints about pentosan. “So bottles sitting longer which makes them more susceptible – only thing I can think of but these people also to blame too.
“These Momo's [sic] have no clue on injecting.”
It was around this time Ergogenic Lab, where Mangini was making the items being sold online, received a dismal inspection from Florida's Department of Health. The compounding pharmacy had no working sink, so employees who were making sterile injectable solutions were washing their hands in a bucket. The prescription counter and floors were covered in layers of dust and unidentified powder, and one inspector said the floor was so dirty he was able to scrawl the initials 'DOH' on the floor with an alcohol swab. Ingredients, many of which Mangini imported from Wuhan, China, were mislabeled or unlabeled. The state restricted the pharmacy's licenses, and it eventually closed down. But that didn't stop Mangini.
“After receiving this report and agreeing to restrictions on his license, Mangini did not seek to reform,” the prosecutors' report read. “Instead, with little interruption, he transplanted his operations to a new location, transferred certain staff, hired new staff, and continued supplying others with adulterated and misbranded drugs (in many cases, with the exact same adulterated and misbranded drugs he had sold previously.) In other words, Mangini was undeterred.”
It's also worth noting, according to prosecutors, that Mangini's catalogue was not limited to omeprazole or EPM products. His websites also peddled injectable prescription drugs available without prescriptions, as well as proprietary products with names like Blast Off Red, Numb It, Plug It, Purple Pain, Green Speed, White Lightning, and other formulas. Those products did not come with ingredient lists but did come with claims that they “will not test” and included instructions that they should be administered four to six hours before competition – a clear violation of racing regulations in most jurisdictions. Blast Off Red was described to customers as “an extremely potent blood builder injection” while Blast Off Extreme was said to “increase the force of heart muscle contraction, thereby increasing blood flow and oxygen to the muscles in race horses, greyhound, dogs, and camels.”
Further, prosecutors revealed that RaceHorseMeds was also selling its own version of a bisphosphonate. In 2015, Dechra filed a civil lawsuit against the company in U.S. District Court in Kansas claiming patent infringement, trademark infringement, false designation, unfair competition and false advertising. Dechra is one of two companies with FDA approval to make and sell bisphosphonates for use in horses in the United States. Dechra's version, clodronate, is sold under the trade make Osphos. Dechra discovered that RaceHorseMeds was selling OsteoPhos, which was described on its website as having “the same mechanism of action as Osphos.” After Dechra emailed the company warning it of possible patent and trademark infringements, the product's name changed to OzPhoz Explosion and the reference to Osphos was removed from the description.
Ultimately, Dechra dismissed the civil case largely because it could not figure out where RaceHorseMeds was actually located or how to properly serve the principals with documents. Its website claimed RaceHorseMeds was a Panamanian company with operations in the United States and Canada. A return mailing label from one of its products listed a Kearney, Neb., address which turned out to be invaiid.
(This publication launched an investigation to try uncovering the real ownership and location of RaceHorseMeds and HorsePreRace in 2016. The resulting story was attached as an exhibit to the prosecutors' sentencing report.)
In fact, prosecutors say, Mangini and others worked very hard to make sure they were difficult to reach for this kind of correspondence. According to them, Mangini and others hired a 1099 contractor to handle outgoing shipping for them, so any mailed orders would be traced to the contractor and not the websites' owners. They misrepresented the company's location on its website and set up a corporation in the name of a co-conspirator to make it appear as though that person, and not Mangini, was the operator RaceHorseMeds.
Prosecutors are requesting a five-year prison sentence, which is the maximum allowed by law for the charge at hand.
The post ‘Shut Him Down Before He Kills Someone’: Documents Paint Unsettling Picture On Eve Of Pharmacist’s Sentencing appeared first on Horse Racing News | Paulick Report.
