Finally, we know what's in the products sold by the (somewhat) convicted pharmacist-Horse Racing News | Polyk Report

2021-12-08 11:33:10 By : Mr. Hailong Ding

For years, testing experts and regulators have been checking websites such as RacehorseMeds and HorsePreRace and want to know some of their most compelling products. Blood Building Explosion; White Lightning; Ice Burst; Purple Pain-The bright color of the liquid in the bottle is an item with marketing significance, which has been fascinating for some time. Products that promise to "light up" and "will not be tested" have no ingredient list, let alone a breakdown of the strength of their active ingredients.

During the Racing Drug and Testing Consortium, Dr. Mary Scollay said that she obtained bottles of these and other products from these two locations, which later became the focus of FBI investigators. Rigorous testing produced mostly inactive ingredients, sugars or harmless amino acids. Nevertheless, she has always wondered whether the manufacturers of these substances include some new and sinister performance enhancers that can even evade top-of-the-line testing.

Now, we learn more about the instructions for mixing products to employees under the guidance of former pharmacist Scott Mangini, who has had business dealings with these two websites many times. (Mangini is one of more than two dozen people accused of drug adulteration and mislabeling due to a series of illegal doping loops in thoroughbred and standard stallion races in March 2020.)

The last document that prosecutors submitted before the Mangini sentence on September 10 included a cache of documents related to the RacehorseMeds and HorsePreRace investigations seized during the FBI search. The public documents include a series of formulas for some of the products sold by RacehorseMeds, as well as a series of product ingredient order invoices from suppliers in Wuhan, China. (RacehorseMeds also has a set of billing records, but the records are sealed and archived, so they cannot be accessed by the media or the public.)

We asked Scollay and former HFL Sports Science Laboratory Director Dr. Rick Sams to review these records and help us understand what they mean for the products sold on these sites.

Many of the substances listed on these (and other similar websites) are clearly intended to appear as cheaper counterfeit versions of prescription drugs already approved by the FDA in mass production. Usually, those products with the same name as the prescription products (clenbuterol, omeprazole, flunixin, etc.), but provided to non-professionals, do not require them to be a licensed veterinarian. These substances have their own problems, but at least it is clear what they should be.

Mysterious substances with proprietary names are more attractive to regulators. The formula shows that many of them are no different from more harmless oral supplements-vitamins such as pyridoxine (B6) and thiamine (B1), minerals such as iron and copper salts, and amino acids such as L-tryptophan . Many of these things can be found naturally in feed or hay, and Scollay said there is no evidence that additional feeding of many of these ingredients will have any noticeable effect on the horse’s health, let alone performance. A product called Horse Power is certified to contain ATP, vitamins, amino acids and diisopropylamine dihydrochloride. They do not do the test, but it will not be because they are magically hidden by the masking agent; on the contrary, they are usually not tested after the race because these substances may be present in most horses fed a balanced diet.

Under the guise of "proprietary formulas," these sites managed to charge these pedestrian ingredients far more than riders who knew what they were buying. For example, Red Explosion Blood Builder is still sold online for $35 a 10 ml bottle, but according to its formula, it only contains 0.002 grams of B12, water and some stabilizers. According to shipping records, the purchase price of B12 is $8 per gram. Of course, the price increase is just a good thing, but injectable B12 is available from a legal, FDA-approved large-scale manufacturer, and the price is less than $6 per 100 ml bottle.

According to the formula in the court documents, in addition to being expensive, some products may not actually be absorbed by the horse's body. A product called TQ Explosion contains calcium levulinate, thiamine, tryptophan and GABA.

"Calcium levulinate is a source of calcium," Sams said. "Thiamine is a vitamin. Tryptophan is an essential amino acid. GABA is gamma aminobutyric acid and is banned. This product is made with sterile water for injection instead of 0.9% sodium chloride, so it may It's not isotonic."

Salt is usually added to injectable formulations to ensure proper passage of the solution through the bloodstream. Blood cells are isotonic, which means they naturally contain some salt. Pure water is naturally inhaled by the salt solution, so contact with pure water will swell and rupture red blood cells-this is why most intravenous injections use saline instead of sterile water. According to Sams, not using any kind of salt may not make the product a risk to horses, but it does mean that it may not be delivered to the body in any useful way.

Sometimes, proprietary formulas leave our expert sources confused and wonder what the manufacturer thinks they are accomplishing. The terrible allergy explosion turned out to contain only formic acid.

"Formic acid is the substance that causes the stinging sensation of ant bites," Sams said. "I don't think it is inhumane to inject it into a horse, but it might convince the trainer that it is doing something to motivate the horse."

Another product called ozone contains only food-grade hydrogen peroxide in the water. The name "food grade" disturbs laboratory experts because it means the ingredient is not pure enough to be used safely in medicines, let alone injectable formulations.

"Although hydrogen peroxide injections have been reported in people, it is not an approved therapy," Sams said. "I want to know the source of hydrogen peroxide, its strength and purity, as well as its stability in the injection bottle, and whether the peroxide interacts with the vial septum. Before assuming that the product is safe for use in horses, all this Both need to be addressed and answered. Mangini’s company has not reported conducting any of these studies."

If the ingredient list is provided at the time of purchase, some proprietary products may produce some interesting results on Google, but may still be rubbish.

"I remember that purple pain was given intravenously, so although there is evidence that ammonium sulfate interrupts nerve conduction-when injected near a nerve-there is no indication that systemic administration will have any effect on pain," said Scole. "There are some speculations about the analgesic effects of L-isoleucine and d-phenylalanine [both in a formula called adrenal cortex], and most credible websites say that there is no legal evidence to support it. This argument."

Just because it seems that many of these things don’t work, it doesn’t mean it’s a harmless waste for trainers who may have bought it. Although it is not uncommon for legal pharmacies and pharmaceutical companies to import raw materials from China and elsewhere, the standards for these products vary. The transportation receipt seized from Mangini showed that many of the raw materials he purchased did not have the USP logo after the name. USP stands for United States Pharmacopoeia, which is an organization that establishes quality, purity, strength, and identity standards for raw materials. The imported ingredients with this name have been verified to meet USP standards.

Some products are listed on the shipping receipt as having a purity of less than 100%-for reputable compound manufacturers, the use of injectable products is prohibited.

"The 98% purity requirement makes my skin crawl. The other 2% may be killers-literally," Scole said.

Not only do many ingredients lack this seal of approval, Scollay and Sams point out that some ingredients contain dyes or pigments that make them look attractive and match the marketing name given to them. Blast Off Yellow contains yellow food coloring. Of course, it is not intended to be injected into the veins of animals. It is not clear what side effects (if any) this might have.

The filter instruction form also does not provide many details, which will be a key step in the preparation of the injectable formulation, although additional filter instructions may be provided in documents that are not attached to the prosecutor’s evidence. We do know that Mangini’s facilities lack sanitation — the state health inspector found that his pharmacy does not have a working sink for people to wash their hands before dispensing, and the area where the medicine is made is dirty. They also found that no quality assurance tests were performed to check the sterility or endotoxin contamination of such products.

Read more about Mangini Pharmacy in this 2016 report.

Then there are instructions for manufacturing ITTP. Even for laboratories that are much more technologically advanced than Scott Mangini's, ITTP should be expensive to produce. Scollay was unable to determine whether the instructions for making the product were more "funny or scarier."

"Take a bottle of water under the hood and open it," read the one-page instructions. "Pour 100 ml into one beaker, and 100 ml into the other beaker. One beaker puts 10 grams of calcium balls and the other puts 37.5 ittp. Ph ittp to 7.5. Pour them back and leave them in the engine In the bottle under the cap. Shake it, great. There is no filter. Yes, we are done."

"I would say'c'-all of the above," Scollay said as she considered how she views these instructions. "If there is any doubt about the credibility of the laboratory, or how serious the task it undertakes-it is certainly not like a business model where a good person is just trying to make good medicine cheaper. Unless the good person is a screenwriter of a national satire."

Something in the shipping receipt caused Sams to stop. Some are designed to counterfeit legal drugs, while others are more sinister.

"Products containing dexamethasone, omeprazole, clenbuterol, flunixin, butyl benzene, and toltrazuril are all counterfeit prescription products," Sams said. “The FDA requires generic drugs to be produced in FDA-approved facilities in accordance with Good Manufacturing Practice standards. Mangini’s operations cannot meet these standards. Moreover, his current batch preparation of counterfeit products does not meet the definition of “mix and match”.

"The rest of the products contain substances that are clearly banned and performance-enhancing, such as selective androgen receptor modulating drugs (SARM), etc. I will include clenbuterol injections in this group because it is not an approved drug in the United States despite all these Substances are banned in horse racing, but they are not DEA controlled substances, so there is no violation of DEA."

Taking into account the manufacturing conditions in the Mangini laboratory, Sams said that veterinarians and trainers cannot rely on the concentration of the markers to be accurate enough to meet the test thresholds set by the state committee-because these thresholds were created based on the FDA-approved version of the drug.

SARM, which received the most attention from prosecutors, entered a product called Ostarine MK-2866 oral solution. Its label promises "Ostarine MK-2866 belongs to the selective androgen receptor modulator or SARM class. SARM has the benefits of traditional anabolic androgenic steroids (such as testosterone), including increasing muscle mass, reducing fat and bone density."

The label also states that the drug has a half-life of 24 hours, which will provide users with information on how to evade detection. "Ostarine is widely metabolized, so dosing studies must be conducted to identify metabolites to facilitate their detection in blood and urine, because oral ostarine can produce a significant first pass effect," Sams said. "This is a drug that the racing community continues to pay attention to. In my opinion, this is one of the most serious violations in the Mangini file."

Other invoices include "Cardanine", which appears to be a misspelled version of cardarine and Antibolicum LGD4033, which is also a SARMs drug. They also revealed the shipment of ITPP, a prohibited substance believed to increase the oxygen-carrying capacity of red blood cells. Diisopropyl diacetate or pantothenic acid are also in the order and are also prohibited substances.

Scollay thinks it is worth noting that some products-including counterfeit products and proprietary formulations-seem to rely on the inclusion of a common thyroid drug.

"Interestingly, Light Explosion and Green Speed ​​contain levothyroxine as their main ingredient-just in case someone thinks it won't be used to affect performance," she said.

L-thyroxine is sold under various trade names, including Thyro-L and Levo-Powder, and became a subject of much concern a few years ago when California regulators discovered that trainer Bob Baffert would This substance is fed to all his horses as a feed additive, regardless of whether they have been diagnosed with thyroid problems. Since it is related to cobalt management, it is still a topic of concern.

Read previous reports on l-thyroxine here.

In terms of Mangini's response to some of these issues in court, he insisted that most of his sales came from counterfeit products of existing drugs such as omeprazole (the FDA warned him to stop mass production). He said that Ostarine accounted for 0.5% of his total sales. The explosion of blood buildings containing cobalt accounted for 0.4% of sales, while horsepower accounted for 0.65% of sales.

When the sentence was pronounced, the prosecutor pointed out that the only reference they needed to verify Mangini’s sales was the records he kept.

US Attorney Andrew Adams said: "This company will not produce anything similar to its financial collapse."

Although Mangini claimed that he did not actually sell many problematic products, Adams pointed out that every bottle of Blood Building Explosion contains a lot of doses, so even if dozens of bottles are sold, it does cause hundreds of doses to enter the horse. Before the game.

As far as he is concerned, Mangini and his lawyers stated that the former pharmacist was “injured” mainly by hints that his products were designed to disrupt an industry he loves so much.

"It is wrong to own this website and run the pharmacy the way he runs it," said William Harrington, Mangini's lawyer. "He pleaded guilty. But to imply that what he is really doing is creating dozens of products to abuse animals, I just don't support it."

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