Thursday, November 14, 2013

MUST READ!! Texas Compounder Draws Industry Scrutiny By Frank Angst, @BH_FAngst Updated: Wednesday, November 13, 2013 8:22 PM Posted: Wednesday, November 13, 2013 5:43 PM


Until a few days ago, the website for the Weatherford Compounding Pharmacy in Weatherford, Texas, had prominently displayed seals from the Texas State Board of Pharmacy and the Department of Health and Human Services. 
A sentence on the professional-looking site, located next to the image of horses racing to the finish line, notes that Weatherford will "work with your veterinarian to supply quality medicinal compounds specifically formulated for your animals." That accurately describes one of the missions of compounding pharmacies.
When placed on hold, phone callers to the compounding pharmacy owned by Joe Landers, a former horse breeder in Weatherford, are greeted with an introduction to the company over a pleasant sounding country tune.
But racing regulators and industry leaders in Texas and beyond are reporting a less pleasant side of Weatherford. They know the compounder as the manufacturer of mysterious products with names that suggest performance-enhancing effects: Equine Growth Hormone, Game Changer, Exacta, and Race Ready, to name a few.


Prominent regulators and racing leaders believe Weatherford Compounding Pharmacy is the biggest problem compounder among several that are either manufacturing substances designed to provide illegal performance-enhancing and painkilling effects while skirting enforcement, or marketing their substances as such. Either way, it's a problem.

Days after Bloodhorse.com asked Weatherford owner Landers what the compounder had done to earn the seals from the Texas Pharmacy Board and the Department of Health and Human Services on its website, those seals disappeared from the bottom of the site's homepage.

Compounded Problems
In September regulators in New Mexico confiscated Weatherford products, as well as similar substances from other compounders, at a Ruidoso Downs Quarter Horse meet and sent them to the Racing Medication and Testing Consortium, which represents 24 industry stakeholders on medication and testing issues. RMTC Executive Director Dionne Benson said the RMTC is testing 19 such products taken at Ruidoso—more than half of which are from Weatherford—to determine the exact ingredients.
In a sport working through groups like The Jockey Club and Mid-Atlantic Uniform Medication Program to limit medications to a short list of specific therapeutic drugs while banning all other substances, the RMTC has tried to identify such compounded substances that could range from harmless amino acids and vitamins to serious painkillers and performance enhancers.
While some amino acids may be innocuous, Benson noted that with the right mix of amino acids, it is possible for a compounder to formulate dermorphin, the powerful painkiller known as "frog juice."
This year the RMTC has found two compounded substances to be outside of racing's rules. In July it issued a notice that Purple Pain and TB-500 would be treated as the highest level of medication violations and result in the most severe sanctions as recommended by the Association of Racing Commissioners International. Purple Pain is marketed as, "the most powerful pain shot on the market today," while TB-500 boasts muscle-building qualities.
As the owner of a company that markets the performance-enhancing powers of its substances but wants regulators to believe they are completely within the rules, Landers said Weatherford products will pass testing. That includes even a product named Tourniquet, which he claims curtails exercise-induced pulmonary hemorrhage.
"I hope they do test them because unless somebody tampered with them, they're going to find nothing," Landers said. "There's not been a horse yet that's had a bad test on Race Ready. There's not been a horse yet that's had a bad test on Tourniquet. If there was, this would have surfaced a long time ago."
After saying his products would hold up to testing, Landers then said they are needed by rule-abiding horsemen to compete with crooked trainers using illegal drugs he said are arriving in the U.S. from Mexico that are "far, far, far ahead of the racing commissions—far ahead of them."
There are legitimate uses for compounding pharmacies in U.S. racing—making therapeutic products no longer manufactured by drug manufacturers and creating products for horses with specific needs—but an explosion of compounded products in recent years that, at the least, market themselves as performance-enhancers or powerful painkillers and, at worst, provide such results while evading detection, have regulators and testing labs wary.
Growing ProblemSeveral compounders are receiving scrutiny. Regulators mentioned a compounding lab near Fonner Park as one of concern, as well as the Internet site HorsePreRace.com. California Horse Racing Board equine medical director Rick Arthur said earlier this year the CHRB sanctioned Rapid Equine Solutions in Pennsylvania. Arthur said the Weatherford products have not been seen in his state but he will not provide the benefit of the doubt to any trainer found possessing them.
"I would take it as a sign that whoever has that product bears close scrutiny," Arthur said.
Dr. Scott Stanley, a chemist and lab director at the University of California-Davis Kenneth L. Maddy laboratory, said on a weekly basis—if not daily—his lab receives for testing from regulators an inappropriate pharmaceutical prepared by a compounder.
Landers said the RMTC should focus its attention on veterinarians and their use of products, not the manufacturer of the substances.
"We have a license to sell medicine and that's what we do. They have a license to buy medicine, and they have a license to use it on the track. It's their decision how it's to be used; and the trainer," Landers said. "It has nothing to do with me; nothing."
Landers, who is not a pharmacist, argues his company is only filling a need.
"I guess I'm having a hard time understanding why these people want to go look at the compounders. Compounders ain't got Jack Doodle to do with it," Landers said. "The veterinarians are the ones that are purchasing it, bringing it on to the backside, and they're the ones that are using it. If they think it's a problem, don't take it back there...
"Anything we make, it's at the request of veterinarians and how they want to put them together, and what they want to do. The owners, the trainers, and the veterinarians are the ones that control what goes into their horse, not the pharmacy. We don't go in there and give them anything."
Regulators at Quarter Horse and Thoroughbred meets in the Southwest report Weatherford representatives may not be administering their substances but they actively market their products on the backstretch. Ken Quirk, state veterinarian for the Texas Racing Commission, said Weatherford and Landers have his attention.
"We certainly believe that he's a bad actor," Quirk said. "There is significant concern about his activity."
Quirk said compounders aiming to sell illegal products or operate in a gray legal area have become problematic. He has seen products like Purple Pain marketed as having the same amino acids as dermorphin while evading tests.
"They market to people suggesting that their product cannot be tested for and that it enhances performance," Quirk said. "There's a lot of that going on."
Quirk has attempted to enforce racing commission rules regarding the substances but he also has gone to the Texas Department of Public Safety, the Texas State Board of Pharmacy, and the Texas State Board of Medical Examiners for help. Quirk and others have requested federal intervention. But to this point, little has been done.

Many of these regulators either do not have specific powers to regulate compounders or, in the case of horse racing's problems, rank far behind bigger issues. Last year dozens of people died during a fungal meningitis outbreak linked to a Massachusetts compounder.
"It seems like they have so many things on their plate that I'm not sure it's a priority for them," Quirk said. "I guess these guys figure they have bigger fish to fry than a veterinary compounder."
American Quarter Horse Association executive director of racing Trey Buck was at Ruidoso when the 19 compounded substances were confiscated. He has seen Weatherford salesmen getting their message out at Remington Park. He noted that at least one Weatherford product included instructions that would require breaking the rules of racing.
"When you put something on a label that says it should be administered four hours before a race, when the only thing you can give on race day is Lasix, right there they're promoting breaking rules," Buck said. "And if they don't know that, they should before they go selling these products."
For now, Quirk is continuing his efforts that include trying to shame veterinarians into not supporting these types of compounded, gray-area products.
"We don't need it," Quirk said. "It would be nice if there were a way to address it."
The Racing Medication and Testing Consortium is testing several substances from the Weatherford Compounding Pharmacy.
Game Changer
Photo: Courtesy RMTC
Game Changer

Equine Growth Hormone
Photo: Courtesy RMTC
Equine Growth Hormone

Exacta
Photo: Courtesy RMTC
Exacta

Race Ready
Photo: Courtesy RMTC
Race Ready

Clenbuterol
Photo: Courtesy RMTC
Clenbuterol

Equine Monster
Photo: Courtesy RMTC
Equine Monster

Touniquet
Photo: Courtesy RMTC
Touniquet

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