A plain brown package arrived at the doorstep of Dr. Mary Scollay, equine medical director for the Kentucky Horse Racing Commission. There was no return address label. No packing slip. According to what she had read online, the small vial inside containing a dark red liquid was “a proprietary formula that is an extremely potent blood builder.” It was “extremely fast acting” and “best given the day before an event.” It also “would not test.”
Scollay had placed the order on HorsePreRace.com at the request of an international racing authority that wanted to do some testing on the product. A little wary of putting her own name on the mailing list for a website peddling blood builders, she ordered the injectable substance under her husband's name, but was never asked to produce a veterinary license number.
If you believe everything you read on the Internet, a few clicks can take away your horse's arthritic joint pain, open his airways, increase his muscle mass, buoy his mood, and put him lengths ahead of where he might have finished without a little help. Product descriptions from online retailer RaceHorseMeds.com boast that its wares (including the unsettlingly-named “Explosion Product Line”) “will light one up,” “are stimulants” and “will not test.” Many have instructions suggesting the products be injected several times over the course of the last 24 hours before a performance for maximum impact.
What's in those bottles, exactly?
Tests of these supplements performed at the request of racing commissioners or the Racing Medication and Testing Consortium reveal varying levels of truth in labeling. Some supplement bottles appear to more or less divulge what the product contains (a requirement for drugs approved by the Food and Drug Administration) while others remain as opaque as possible. One backstretch veterinarian heard the fluorescent-colored injectable liquids were usually sterile water and food coloring.
As it turns out, many of the would-be performance enhancers trend more toward snake oil than frog juice.
“When we test these, we find amino acids. We find sugar. We find preservatives. But we don't find anything that would actually have an impact on the horse,” said Dr. Dionne Benson, executive director of the RMTC.
The vast majority of the substances marketed by HorsePreRace, RacehorseMeds, and others are comprised of amino acids, according to their labels. Amino acids are naturally occurring compounds that are the most basic building blocks of the human or animal body, forming cells, tissues, and neurotransmitters, among other things. Humans and animals acquire amino acids largely from their diets. In other words, a supplement made of amino acids will do much the same thing for a horse as simply feeding him. Essential amino acids only go to work when all of them are present in the right balance, so supplementing one or two is likely ineffective. Excess amounts of one or two amino acids are released, unused, in waste.
Benson acknowledges there are naturally occurring compounds that could make a horse run faster, though these amino acid supplements are likely not going to do the trick. It's true, Benson said, that amino acids won't produce a positive test, since laboratories don't have baselines for amino acids, but that doesn't mean putting these products into horses is harmless.
“First of all the question is, with any of these sites, does [the product] contain what they say it contains? And even if it contains what they say it contains, does it do what they say it does?” she asked. “And even if that's all true, is there anything else in there that we need to worry about?”
Benson and other regulators suspect the products sold on sites like RacehorseMeds and HorsePreRace are being compounded in batches. Without government oversight, however, there's no way to know the credentials of the person mixing the latest batch, or how consistently batches of the products are made. So, when it comes to identifying what's in them, an analysis run on the bottle of Blast Off Red that Scollay ordered may bear no resemblance to what's in the next shipment of the same product. There's also no way to know what contaminants or impurities may have worked their way into the solution, and there's no way to know whether manufacturers are replacing one active ingredient with a performance enhancer to produce a convincing impact.
Trainer Roy Sedlacek found this out the hard way when he was suspended five years for a positive test for a synthetic opioid. He told regulators the product he thought he purchased was ITPP, a different performance-enhancing substance that was not found. (Actual ITPP, Benson said, is extremely difficult and expensive to produce and would have run into the seven figures for an equine dose, based on costs of academic research of the drug on mice.)
“A lot of trainers, not all trainers, but a lot of trainers, have a protocol for their barn, not a protocol for a horse,” said Benson. “Every horse gets these three things leading up to a race. Instead of going through and saying this horse needs this because it medically needs it, we say this horse needs it because it's going to race. And racing is not a medical condition.”
Is this even legal?
HorsePreRace and others are careful to refer to their products as animal supplements, which is not a recognized product category by the Food and Drug Administration. Instead, the FDA has historically opted to regulate animal supplements inconsistently either as feed or as drugs, which requires examination of the labeling and marketing for each individual product. The production of either animal feed or drugs without approval from the FDA is illegal.
The FDA can object to the sale of compounded versions of prescription drugs sold by online retailers without prescriptions. In 2014, the agency issued a warning letter to Simon Jones of HorsePreRace, demanding that the website stop selling a list of so-called supplements “intended for use in the mitigation, treatment, or prevention of disease in animals, which makes them drugs.” Several, including omeprazole oral paste, flunixin, and toltrazuril paste, bear identical names to prescription drugs, though no prescription was required to order them. Furthermore, the FDA charged, HorsePreRace was mislabeling its products — a tube of omeprazole tested by the agency contained just 68.1 percent of the omeprazole claimed on the tube. Mislabeling of drugs is also considered a violation of the Federal Food, Drug, and Cosmetic Act.
Those kinds of discrepancies with would-be prescriptions aren't unusual; a study of randomly-selected compounded drugs tested by the Missouri Board of Pharmacy found that about 20 percent of the products tested contained a drastically different amount (between 0 and 450 percent) of the active ingredient from what was advertised on their packaging. A University of California-Davis study found compounded clenbuterol that contained ten times its advertised concentration. A sample of triamcinolone acetal discovered in Minnesota boasted 6 mg/ml of the active ingredient on its bottle, but turned out to contain only .00828 mg/ml.
As far as regulatory officials are concerned, possession of most of the HorsePreRace website's products, whether supplements or compounded copies of prescription drugs, would constitute a violation of racing rules in many states. Most jurisdictions prohibit any non-veterinarian to possess hypodermic needles or injectable products on the grounds. Many of the supplements on RacehorseMeds and HorsePreRace instruct users to give injections within hours of a performance, which is also illegal.
Duncan Patterson, chairman of the Delaware Thoroughbred Commission and of Racing Commissioners International's drug testing standards and practices committee, said that in his experience, most of these products are found in the possession of trainers rather than veterinarians. In some states, such as Indiana, a veterinarian's possession of a substance that does not meet certain labeling requirements (such as expiration date, patient name, and duration of treatment) could constitute a violation, too. Patterson said Delaware officials will open mail addressed to trainers, looking for prohibited substances, and perform surprise searches of offices and veterinary trucks. Discoveries are relatively rare.
Who's behind the keyboard?
If questionable contents and high-risk possession aren't worrisome enough for potential customers of web-based pharmacies, a quick search into the companies' identities should be. Attempts to name the proprietors of HorsePreRace and RacehorseMeds (their terms of service agreements imply they are or once were different tails in the same viper's nest, although one associate denied any connection) lead the searcher down an online rabbit hole with more questions than answers.
The FDA warning letter to HorsePreRace was issued to a Mr. Simon Jones of 635 N. Orange Avenue in Orlando, Fla. The invalid mailing address would appear to occupy part of the parking lot of the Orlando Sentinel, where newsroom reporters told the Paulick Report they had never heard of the business. One of many phone numbers associated with HorsePreRace was at one time used in a telephone scam run by an entity called Centex Resources SA, in which a caller tried to convince people to buy into oil and gas investments but never delivered. Centex was alleged to be based out of Panama, where HorsePreRace and RacehorseMeds claim their websites are hosted, but the government of Panama said Centex was not authorized to operate there, and in fact, had no offices in Panama. Instead, the mailing address for HorsePreRace appears to be one obtained through a virtual office address system. (IP addresses for both sites suggest they originate in the United States).
Further examination into the ownership of RacehorseMeds leads to the physical address for the South Florida Trotting Center, where domain owner Frank Stefanizzi can be reached. Stefanizzi has spent his career in the harness racing industry as a sometimes-trainer/owner, sometimes-groom, according to his license applications. Requests by Stefanizzi for licensure in New York and Florida in 2010 were denied when he falsified information on his application by failing to disclose a lengthy history of arrests. When reached by the Paulick Report, Stefanizzi said he owns 99 percent of RacehorseMeds, which he founded with a pharmacist, and that the company is based in the United States. When queried about the origin of the products, the interview was discontinued due to a “poor connection.”
The other identity associated with RacehorseMeds is Patrick Zarrelli, also known by his chosen moniker “Kid Chronic.” In addition to his duties as a website builder and public relations manager, Zarrelli is a self-declared reputation manager via his company Dependable Website Management and admitted to doing search engine optimization work for RacehorseMeds.
“Consumers and those using search engines rarely look past the first page of search results,” reads Zarrelli's sales pitch for his reputation management services. “In web marketing, it is considered a fantastic success to appear on the first page of Google. The second page of results and beyond may as well not even exist. If your company's results are strewn with poor reviews, you can fight back by placing numbers of positive reviews all over the front page.
“Combative management takes steps to fight back against poor reviews by flooding the internet with positive reviews of your company. Even though negative statements cannot be erased, we can make them almost impossible to find, buried under glowing positivity and reviews that will bring customers flocking to you. We'll push those negative results straight from the first page of search results into places that no one will ever look.”
Email queries and phone messages to both companies about whether a veterinary license was required to order products or querying the ‘Ask a Veterinarian' section of RacehorseMeds were unreturned.
It would seem the owners of HorsePreRace are hoping their identities and qualifications for selling equine drugs will also be nearly impossible to find.
How do authorities deal with this?
The advantage of remaining anonymous, as the proprietors of websites like these must realize, is that it's harder for over-taxed state and federal agencies to catch drug and “supplement” sellers red-handed. Officials with the Kentucky Board of Pharmacy expressed concern that the two websites were marketing prescription drugs to state residents while neither was registered with LegitScript, an online pharmacy verification service approved by the National Association of Boards of Pharmacy. (Online retailers selling prescriptions across state lines are usually required to be registered with the states in which they do business, and those registrations may involve inspection requirements.) However, the boards' authority can only go so far.
“Since the Board is only an administrative agency, we could assist the Attorney General's office,” said Steve Hart, spokesman for the Kentucky Board of Pharmacy. “This should be investigated as a criminal case by statute.”
In cases like these, Hart said, authorities need access to forensic computer experts to unmask, and then charge, proprietors with the sale of unauthorized prescription drugs.
“We found that these pharmacies can be literally anywhere,” said Hart, who noted that Caribbean and Asian countries are common hosts.
As for the “supplements” sold by HorsePreRace and others, the FDA acknowledged in a veterinarian newsletter that a lot of products run afoul of the letter of the law but aren't likely to be checked.
“Most of these types of products on the market would be considered unapproved and unsafe food additives or new animal drugs based on current intended uses. While these products are technically in violation of the law, they are of low enforcement priority except for when public or animal health concerns arise,” read a regulatory update on animal dietary supplements published in a 2002 FDA newsletter.
These days, the agency acknowledges it has no over-arching policy on how to handle substances sold as illegal drugs.
“FDA action on unapproved drugs or illegal drugs is taken on a case-by-case basis,” said FDA spokesman Jason Strachman Miller. “Enforcement action may include, among other things, seizure of violative products and injunction and/or criminal prosecution against those marketing violative products.”
Even when the FDA did take action against HorsePreRace in 2014 for its sale of omeprazole, flunixin, and other drugs sold without prescriptions, little appeared to change. The warning letters issued by the agency demanded the company notify the FDA within 15 days about its plans to bring its products into compliance. One year later, an FDA spokesperson told the Paulick Report there had been no follow-up communication from either side at that point. Strachman Miller said that the FDA does not comment on the existence or nonexistence of ongoing investigations, including any possible follow-up from the FDA to HorsePreRace.
The U.S. Anti-Doping Agency has dealt with similar so-called supplements alleging performance-enhancing powers in human sport. USADA provides educational materials urging athletes to consult with dietitians or trainers before starting the use of a supplement, and maintains a list of “high risk” substances that contain prohibited substances. The agency also works with the federal government to identify products that could cause problems.
“We have a joint testing program with the Uniformed Services University (Department of Defense) and together we select products that we receive questions about from either military personnel or athletes and if we suspect them to contain prohibited substances, we test them. If they're found to contain these substances, we then add them to our high risk list,” said Dr. Amy Eichner, special advisor on drugs and substances for USADA. “We share any and all information with our federal partners.”
When it comes to racing regulators, the prospect of wrangling state boards, law enforcement, attorneys, and the FDA to stop these products at their source seems far-fetched. One regulator said repeated attempts to alert the state board and FDA about new products masquerading as performance enhancing supplements were met with disinterest. Others said they left such coordination to the RMTC and are instead focused on using the tools that are available to them: penalties for possession, and keeping veterinarians out of stalls on race day. Kentucky's racing commission reported a noticeable improvement in trace amounts of substances, both identifiable and unidentifiable, after enacting its third-party Lasix administration rule, suggesting the regulation may have cut down on the use of products like Blast Off Extreme on race day.
“I think that the pre-racing of horses on race day is one of racing's dirty little secrets that goes on unabated in a large number of jurisdictions,” said Joe Gorajec, former executive director of the Indiana Horse Racing Commission. “I think that the third-party Lasix rule is a good starting point … the penalty is half the equation. If a significant penalty isn't there, people are going to take a shot.”
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