Maryland Horsemen Navigate New Corticosteroid Guidelines In Wake Of Lab Switch

At a virtual meeting on Sept. 28, Maryland horsemen tried to understand what the newest change in corticosteroid testing in the state will mean for them. The Maryland Racing Commission last week approved a motion to remove testing thresholds for five different corticosteroids and begin using the laboratory's limit of detection for all five drugs.

While that sounds like a big change, experts on the call said it's mostly intended to bring testing into line with the regulations the commission approved in 2019.

In the wake of the Santa Anita fatality spike of 2018-19, The Stronach Group and the California Horse Racing Board determined that backing out the last acceptable administration for intra-articular corticosteroids and other drugs was beneficial to equine safety, because it reduced the likelihood that the drugs could cloud a veterinarian's assessment of a horse pre-race and also the chance for a horse with an underlying problem to continue running. In 2019, with this background in mind, Maryland adopted Association of Racing Commissioners International (ARCI) model rules backing up the administration of intra-articular corticosteroids including prednisolone, betamethasone, isoflupredone and triamcinolone, from seven days pre-race to 14 days pre-race.

The problem, officials say, is that the testing laboratory contracted at that time — Truesdail Laboratories of Irvine, Calif., — did not change the threshold they used to determine whether a sample was positive for corticosteroids or not. From that regulation change in 2019 until April 2021 when the contract expired, it was illegal to give the drugs in the joint closer than 14 days pre-race, but the only way the commission could have caught someone was through surveillance, or if they turned in a treatment sheet showing an administration in the prohibited timeframe. Testing was only going to pick up an administration within one week.

(This wasn't the first or only issue racing jurisdictions discovered with Truesdail, which in 2015 was the subject of a quality control audit by the Indiana Horse Racing Commission which found that seven positive tests were missed over a 26-day period.)

When Industrial Laboratories of Wheat Ridge, Colo., began testing for Maryland, it implemented a threshold that would catch corticosteroids at 14 days. The lab also implemented thresholds to match the 72-hour withdrawal requirement given for intramuscular or intravenous administration of dexamethasone, which is also a corticosteroid.

That's when there were a handful of high-profile positives, including one from trainer Claudio Gonzalez. Gonzalez and others told the commission they had been giving dexamethasone inside the 72-hour window but at a lower dose and had previously had no trouble with positives.

The trouble with using a threshold, according to Racing Medication and Testing Consortium executive director Dr. Mary Scollay and The Stronach Group's equine medical director Dr. Dionne Benson, is people get focused on the threshold itself. (And some trainers like Gonzalez figure out how to beat thresholds by giving lesser doses closer in to races.) What regulators are hoping trainers will begin doing instead is following withdrawal guidelines.

“It quite frankly is the best and only way to regulate these drugs,” said Alan Foreman, chairman of the Thoroughbred Horsemen's Association.

By removing thresholds, track officials and the commission believe they can more precisely recognize when someone has violated administration rules. Now, these corticosteroids will be tested at the limit of laboratory detection — which the laboratory generally does not want to publish. All the public knows is that limit of detection is greater than 0. British data suggests that the safest timeframe for IV or IM dexamethasone administration in a “limit of detection” scenario is five days. Scollay stressed that it isn't illegal for trainers to give that drug through either IV or IM injection at 72 hours, but that could come with an increased risk of a positive test. It's also true, however, that different labs have different limits of detection, and that should be worrying to horsemen who travel.

“You should not, with confidence, cross state lines and say I was giving it at 72 hours in Maryland and I'm going to be ok in California doing it the same way, because chances are you may not,” she said. “Their limit of detection may be lower … that's where the five-day guidance comes in. It gives you that added safety for labs that may have a lower limit of detection.”

Intra-articular corticosteroid injections are regulated by date of administration, not lab results, though lab results can help regulators catch someone breaking the rules on those.

According to Benson, these changes will go into effect Nov. 2. At that point, the lab will begin reporting whatever corticosteroids it can see in a sample.

“The risk [of a positive test] is no different than it has been,” said veterinarian Dr. Tom Bowman, who chairs the Equine Safety Health and Welfare Advisory Committee of the Maryland Racing Commission. “The level of awareness [is] — you now know that five days out is safer than three days.”

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At Long Last, We Know (Kind Of) What Was In Those Products Sold By The Indicted Pharmacist

For years, testing experts and regulators had looked at websites like RacehorseMeds and HorsePreRace and wondered about some of their most dramatically named products. Blood Building Explosion; White Lightning; Ice Explosion; Purple Pain – items with marketing as bright and attention-catching as the vibrant colors of the liquid inside the bottles had been a source of fascination for some time. Products that promised to “light one up” and that they “will not test” had no ingredients list, let alone a breakdown showing strengths of their active ingredients.

In her time at the Racing Medication and Testing Consortium, Dr. Mary Scollay said she had acquired bottles of these and other products from the two sites that later became part of the focus of FBI investigators. Rigorous testing had yielded mostly inactive ingredients, sugars, or harmless amino acids. Still, she had always wondered whether the makers of the substances were including some new, sinister form of performance enhancer that simply evaded even top-shelf testing.

Now, we know more about the instructions given to staff mixing up products at the direction of former pharmacist Scott Mangini, who had business involvement with both websites at various times. (Mangini was one of more than two dozen people indicted in March 2020 on drug adulteration and misbranding charges stemming from an alleged series of illegal doping rings in Thoroughbred and Standardbred racing.)

One of the final items filed by prosecutors just before Mangini's sentencing on Sept. 10 included a cache of documents seized in FBI searches related to the investigation of RacehorseMeds and HorsePreRace. Included in the public filing was a series of formulas for some of the products sold by RacehorseMeds, as well as a series of invoices for orders of product ingredients sent from a supplier based in Wuhan, China. (There was also a set of billing records for RacehorseMeds, but that was filed under seal so is inaccessible to media or the public.)

We asked Scollay and former HFL Sport Science laboratory director Dr. Rick Sams to take a look at those records and help us understand what they mean about the products sold on these sites.

Harmless, or not?

Many of the substances listed on these (and other, similar websites) were clearly intended to appear as cheaper, knock-off versions of prescription drugs already in FDA-approved mass manufacture. Usually, those shared the same names as the prescription products (clenbuterol, omeprazole, flunixin, etc.) but were offered to lay people with no requirement they be licensed veterinarians. Those substances had their own problems, but it was at least clear what was supposed to be in them.

The mysterious substances with proprietary names had been more intriguing for regulators. Formulas revealed that many of them contained nothing different from more innocuously-named oral supplements – vitamins like pyridoxine (B6) and thiamine (B1), minerals like iron and copper salts, and amino acids like L-tryptophan. Many of these things can be found naturally in feed or hay, and Scollay says there's no evidence that feeding extra of many of those ingredients produces any appreciable effect in a horse's health, let alone performance. A product named  Horse Power turns out to contain ATP, vitamins, amino acids, and di-isopropylamine dihydrochloride. It's true that they would not test, but it wouldn't be because they were magically hidden by masking agents; rather, they aren't usually tested for post-race because those substances are probably present in most horses being fed balanced diets.

Under the cloak of “proprietary formulas,” the websites managed to charge much more for those pedestrian ingredients than what they would have cost horsemen who knew what they were buying. Red Explosion Blood Builder, for example, is still listed for sale online for $35 for a 10-milliliter bottle, but according to its formulation it only contained .002 grams of B12, water, and a couple of stabilizers. The B12, according to shipping records, was purchased for $8 per gram. A mark-up is just good business of course, but injectable B12 is available from legitimate, FDA-approved mass manufacturers for less than $6 for a 100-milliliter bottle.

Besides being expensive, some of the products may not have actually been capable of being absorbed by horses' bodies, according to the formulas in the court filing. A product called TQ Explosion contained calcium levulinate, thiamine, tryptophan, and GABA.

“Calcium levulinate is a source of calcium,” said Sams. “Thiamine is a vitamin. Tryptophan is an essential amino acid. GABA is gamma aminobutyric acid and is prohibited. This product is made up in sterile water for injection instead of 0.9% sodium chloride so it may not be isotonic.”

The inclusion of salts is usually made in injectable formulas to ensure the solution is appropriately passed through the bloodstream. Blood cells are isotonic, meaning they naturally contain some salts. Pure water is naturally drawn in by salty solution, so exposure to pure water could make red blood cells swell and burst – that's why most IVs are run with saline and not sterile water. Leaving out any kind of salt probably didn't make the product risky to the horse, according to Sams, but it does mean it probably didn't get delivered throughout the body in any sort of useful way.

Sometimes, the proprietary formulas left our expert sources scratching their heads as to what the makers thought they were accomplishing. The frighteningly-named Allergy Explosion turns out to contain only formic acid.

“Formic acid is the substance that causes the stinging sensation in ant bites,” said Sams. “I don't think that injecting it in a horse is inhumane, but may lead the trainer to believe that it is doing something to excite the horse.”

Another product called Ozone contained nothing but food grade hydrogen peroxide in water. The “food grade” designation is unsettling to laboratory experts because it means the ingredient has not been created with sufficient purity to be safe for use in medication, let alone an injectable formula.

“Although hydrogen peroxide injections of people have been reported, it is not an approved therapy,” said Sams. “I wondered about the source of the hydrogen peroxide and its strength and purity as well as its stability in the injection vial and whether the peroxide interacted with the vial septum. All of these need to be addressed and answered before the product can be assumed to be safe for administration to horses. Mangini's company did not report conducting any of these studies.”

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A few of the proprietary products may have kicked up a few interesting results on Google had their ingredient lists been made available at the time of purchase, but were probably still bunk.

“As I recall, the Purple Pain was to be administered intravenously, so while there is evidence that ammonium sulfate will interrupt nerve conduction—when injected adjacent to a nerve—there's nothing to suggest that systemic administration would have any effect on pain,” said Scollay. “There is some speculative stuff about L-isoleucine and d-phenylalanine [both found in a formula called Adrenal Cortex] exerting analgesic effects, most of the credible sites said there was no legitimate evidence for that claim.”

Just because it seems like a lot of this stuff didn't work didn't mean it was a harmless waste of money for the trainers who may have been buying it. While it's not uncommon for legitimate pharmacies and pharmaceutical companies to import ingredients from China and elsewhere, there are varying standards to which those products can be held. Shipping receipts seized from Mangini showed that many of the ingredients he purchased were lacking a USP designation after their names. USP stands for United States Pharmacopeia, which is an organization that sets quality, purity, strength, and identity standards for raw ingredients. Imported ingredients with this designation have been verified to meet USP standards.

Several products were listed on shipping receipts as being less than 100% in purity – a no-no for reputable compounders to put in injectable products.

“The 98% pure claims make my skin crawl.  That other 2% can be a killer—literally,” said Scollay.

Not only were many ingredients lacking this seal of approval, Scollay and Sams point out there were a few which contained dyes or colorings to make them appear an appealing color that would match the marketing name given to them. Blast Off Yellow contained yellow food coloring which, of course, isn't intended to be injected into the veins of an animal. It remains unknown what, if any, side effects this could have.

There also isn't a lot of detail provided in the instruction sheets on filtration, which would be a key step in making an injectable formula, though it's possible there were additional instructions on filtration provided in documentation not attached to prosecutors' exhibits. We do know that sanitary conditions in Mangini's facility were lacking – state health inspectors discovered his pharmacy had no working sink for people to wash their hands before compounding drugs and the areas where drugs were made were filthy. They also found that there were no quality assurance tests taking place to check for sterility or endotoxin contamination of products like this one.

Read more about Mangini's pharmacy in this 2016 report.

Then there were the instructions to make ITTP, which is supposed to be expensive to produce, even for much more technically advanced laboratories than Scott Mangini's. Scollay couldn't decide whether the instructions for making that product were more “hilarious or horrifying.”

“Take a bottle of water under the hood, open it,” read the single page of instructions. “Pour 100 ml into one beaker, 100 ml into another. Put 10 g of calcium ball things in one beaker, put 37.5 ittp in the other. Ph the ittp to 7.5. Pour them back into the bottle that has remained under the hood. Shake, it's great. No filter. Yay we are done.”

“I'll say 'c'—all of the above,” said Scollay when considering how she viewed those instructions. “In case there would be any question about the credibility of the laboratory, or how seriously it undertook its tasks—this certainly doesn't read like the business model of a good guy just trying to make good medicine more affordable.  Unless the good guys were the writers at the National Lampoon.”

The heavy hitters

There were substances in the shipping receipts that gave Sams pause. There were some that were intended to be knockoffs of legitimate drugs, and others that were more sinister.

“The products containing dexamethasone, omeprazole, clenbuterol, flunixin, phenylbutazone, and toltrazuril are all generic knockoffs of prescription products,” Sams said. “The FDA requires generic products to be manufactured in FDA-approved facilities according to Good Manufacturing Practices standards. Mangini's operation could not have met these standards. Furthermore, the preparation of knockoff products in bulk as he was doing does not meet the definition of “compounding”.

“The remaining products contain clearly prohibited and performance-enhancing substances such as selective androgen receptor modulating drugs (SARMs) and others. I include injectable clenbuterol in this group because it is not an approved drug in the U.S. Although all of these substances are prohibited in horse racing, they are not DEA controlled substances so no DEA violations occurred.”

Given the manufacturing conditions in Mangini's lab, Sams said veterinarians and trainers could not have relied on the labeled concentrations to be accurate enough to comply with testing thresholds established by state commissions – because those thresholds were created based on the FDA approved versions of the drugs.

The SARMs that attracted the most attention from prosecutors went into a product called Ostarine MK-2866 Oral Solution. Its label promised “Ostarine MK-2866 is in the class of Selective Androgen Receptor Modulators or SARMs. SARMs offer the benefits of traditional anabolic adrogenic steroids such as testosterone, including increased muscle mass, fat loss, and bone density.”

The label also indicated the drug had a 24-hour half life, which would give a user information about how to evade testing.
“Ostarine is extensively metabolized so administration studies had to be performed in order to identify metabolites to facilitate its detection in blood and urine because orally administered ostarine is subject to substantial first-pass effects,” said Sams. “This is a drug of ongoing concern in racing and, in my opinion, is one of the more egregious violations in the Mangini document.”

Other invoices include “Cardanine,” which appears to be a misspelled version of cardarine and Antibolicum LGD4033, which is also a type of SARMs drug. They also reveal the shipment of ITPP, a prohibited substance believed to increase the oxygen-carrying ability of red blood cells. Di-isopropyl diacetate, or pangamic acid, is also among the orders and is also a prohibited substance.

Scollay thought it notable that several products – both knockoffs and proprietary formulas seemed to be reliant on the inclusion of a common thyroid drug.

“Interesting that the Light Explosion and Green Speed contain levothyroxine as their primary ingredient—just in case anyone didn't think it was being used to impact performance,” she said.

L-thyroxine is sold under various trade names, including Thyro-L and Levo-Powder, and was the subject of much concern several years ago, when California regulators discovered that trainer Bob Baffert was giving the substance to all his horses as a feed additive, whether or not they'd been diagnosed with thyroid problems. It remained a topic of concern due to its association with cobalt administration.

Read previous reporting about l-thyroxine here.

Mangini's response

To the extent Mangini responded to some of these issues in court, he maintained that the majority of his sales came from knockoffs of existing drugs like omeprazole (which he was warned by the FDA to stop mass manufacturing). Ostarine, he said, accounted for .5% of his overall sales. Blood Building Explosion, which contained cobalt, was .4% of sales, while Horse Power was .65% of sales.

At sentencing, prosecutors pointed out that the only reference they have to verify Mangini's account of his sales are the records he kept.

“This is not a company that has produced anything remotely like a wholesome breakdown of its finances,” remarked U.S. Attorney Andrew Adams.

Regardless of Mangini's assertion that he didn't actually sell many of the problematic products on offer, Adams pointed out that each bottle of Blood Building Explosion contained many doses, so even the sale of dozens of bottles really resulted in hundreds of doses going into horses pre-race.

For his part, Mangini and his attorney said the former pharmacist was mostly “hurt” by the suggestion that his products were intended to corrupt the industry he loved so much.

“It was wrong to have this internet site and run the pharmacy the way he ran it,” said Mangini's attorney, William Harrington. “He's pled guilty to that. But to suggest that what he's really been doing was to create dozens of products to abuse animals, I just don't support that.”

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Mangini Sentenced To 18 Months In Federal Prison For Role In Drug Misbranding Case

Former pharmacist Scott Mangini, who helped develop the products sold on RacehorseMeds and HorsePreRace, was sentenced to 18 months in federal prison on Sept. 10. U.S. District Judge J. Paul Oetken also ruled that Mangini would be on supervised release for three years after he completes his prison sentence.

Judge Oetken originally determined that Mangini would surrender himself to begin his sentence in October, but upon request from his attorney to let him spend the holidays with his family, moved his surrender date to January.

Mangini pleaded guilty to one count of conspiracy to unlawfully distribute adulterated and misbranded drugs with the intent to defraud and mislead. His prison sentence is the same as that of Scott Robinson, his co-conspirator who was sentenced in March 2021.

The indictments of Mangini and Robinson were made public at the same time as those against a number of prominent trainers, assistants, and veterinarians in the racing industry, all of whom prosecutors say were involved in the sale, distribution and use of illegal drugs to enhance the performance of racehorses.

Mangini's attorneys had requested a sentence of six months' home confinement, while prosecutors requested the maximum allowable sentence for the offense of 60 months in prison.

“I find the fact of imprisonment is more important than the length of the imprisonment,” said Oetken in rendering his decision. He cited his legal obligations to impose a sentence that would serve as an effective deterrent to others while not being harsher than necessary to do so.

Both men were ordered to forfeit over $8 million, which investigators say is the value of the illegal products that the two sold during the time in question. Attorneys revealed that in 20 months, sales records from RacehorseMeds indicated there were over 27,600 sales made by the company. The government is in possession of some sales records, but those have not been made publicly available.

Read more about new details of the case as revealed in sentencing documents filed in recent days in this story from Sept. 9.

There was considerable debate between attorneys before the sentencing about the characterization of Mangini's behavior in the pre-sentencing reports which will remain on his record. Mangini's counsel maintained that the majority of sales through his companies were for illegally compounded, “knock-off” versions of therapeutic prescription drugs and while not approved or appropriately prescribed, this made it unfair to call his behavior abusive towards animals. Prosecutors pointed to injectable products formulated by Mangini with names like Blast Off Red and Blast Off Extreme, which were advertised to behave as mimetics for epogen and other performance-enhancing drugs.

Mangini's attorneys said that most of those products did not behave as performance-enhancers and were instead dietary supplements because they did not have the same effects as the products they claimed to mimic. Oetken questioned whether this amounted to fraud on the part of the people marketing the drugs, which seemed problematic also. Ultimately though, he made clear that the nature of the drugs themselves was less important to him than the fact they were misbranded.

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“The performance-enhancing aspect of the case is not really, I think, relevant to sentencing. It may be relevant to press releases and reputations and things like that. You made a good point that it may not be most of what's been sold on these website, but the fact is there were still problems. It was a shoddily-run pharmacy,” said Oetken, describing the problems Mangini's facility had with safety and sterility, as well as his efforts to conceal his association with the websites. “All of that is related to the effort to evade regulation from state and federal authorities and that's what I'm focused on for sentencing.”

An emotional Mangini spoke during the proceedings, begging Oetken not to send him away from his wife and stepson.

“I thought I could help all kinds of horses and owners and trainers,” said Mangini. “I didn't know it was illegal.

“Now that I look back, I destroyed my life and I have no one to blame but myself. I am living with the consequences of my actions. I've ended my career as a pharmacist and I can't work with horses again…Since my arrest, I've tried to be better. I admitted that I violated the FDA rules. I met with the government every time they wanted and truly told them the truth. I admitted I broke the law. I am filled with regret and remorse. I am sorry.”

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‘Shut Him Down Before He Kills Someone’: Documents Paint Unsettling Picture On Eve Of Pharmacist’s Sentencing

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.

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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.

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