Polo-horse deaths fuel controversy

WELLINGTON, FLA. — The death of 21 polo horses just prior to the start of the U.S. Open Polo match in April continues to unleash a flurry of questions without answers.

A number of Florida state agencies, as well as the U.S. Food & Drug Administration, are still investigating.

The agencies are looking at whether action should be taken against the veterinarian who ordered a compounded injectible vitamin supplement, the Argentine veterinarian who administered it or the compounding pharmacy that admitted it mixed the drug incorrectly.

"We're simply looking at the totality of the incident," says Terence McElroy, spokesman with the Florida Department of Agriculture and Consumer Services.

"We know what the horses died of; now we want to know how they came to be administered and what transpired."

The incident also has brought the issue of compounding to the forefront and has the U.S. Polo Association examining its protocols regarding horse safety and welfare.

Paul Wollenman, DVM, of the Palm Beach Equine Clinic and occasional veterinarian for the International Polo Club Palm Beach, planned on being a spectator at the event April 19. Instead, he watched as several horses being unloaded from their trailers began staggering and walking blindly.

He went over to the attending veterinarian and asked whether he needed help.

The men began putting in intravenous catheters and administering steroids, drugs for shock and sedatives for the horses that were becoming violent.

"I asked if he knew what we were treating, and he said all they had were vitamins," Wollenman says. "They did start stabilizing, but then their gums started getting pink and they were going down, down and down. I thought we were going to save them."

Some of the horses went into cardiac arrest right there. One survived long enough to be transported to Wollenman's hospital five minutes away, but it was euthanized about six hours later.

Dr. James Belden, the veterinarian alleged to have ordered the compounded substitute for Biodyl, an injectable approved for use in many countries but not in the United States, was also at the track that day, according to Wollenman.

"I know he was there beside me battling to keep every horse alive," Wollenman says.

Belden was advised by his attorney, Dan Bachi of Sellars, Marion, Bachi in West Palm Beach, Fla., not to speak with the media.

Deadly dose

Franck's Pharmacy of Ocala, Fla., issued a statement shortly after the deaths that "the strength of an ingredient in the medication was incorrect."

The Venezuelan Lechuza Caracas Polo team released this statement:

"Much attention has been given to Biodyl, an injectable vitamin supplement that is manufactured in France and is used worldwide in horses competing in strenuous competitions such as polo. Biodyl is not the issue in this instance. A Florida-licensed veterinarian wrote a prescription for a compounded substitute vitamin supplement for Biodyl containing vitamin B, potassium, magnesium and selenium. This compound was prepared in the state of Florida by a compounding pharmacy. Only the horses treated with the compound became sick and died within three hours of treatment. The horses that were not treated remain healthy and normal."

Florida State Veterinarian Thomas J. Holt reported that an overdose of selenium was the probable cause of death.

Holt stated that the animals had "significantly increased selenium levels" in samples tested. He reported that the findings obtained at the department's Animal Disease Diagnostic Laboratory in Kissimmee were confirmed by independent testing conducted at the University of Florida's College of Veterinary Medicine in Gainesville, the University of California-Davis Animal Health and Food Safety lab and at testing facilities at Cornell University in Ithaca, N.Y.

"B-12, selenium, magnesium, a potassium supplement — these are basically innocuous vitamins," Wollenman says, adding that this incident was the first he ever heard of involving this injectable supplement.

While veterinarians in his field sometimes use compounds, it is not prevalent, he says.

"Some products are no longer manufactured because the drug companies are no longer interested in producing them, so there is sometimes a need," he says.

"Typically, we only have four to five items compounded."

Wollenman had nothing but praise for Franck's Pharmacy, saying he had used the pharmacy both before and after the incident. The 35-year veterinarian knows that compounding is on many minds now, though.

"It's been simmering back there at state conventions, national conventions for the past few years," he says. "I'm sure it's going to be shoved to the forefront now. But any time you mix drug "A" and "B" in a syringe, you're compounding."

Compounding the problem

Western U professor of equine medicine Joe Bertone, DVM, MS, Dipl. ACVIM, says a compounding pharmacy is essential to veterinary medicine, but it has to be used appropriately.

"The problem is that, although there are regulations, no one enforces them," he says.

"What the FDA and state pharmacy boards enforce for animal compounding pharmacies is minimal at best. I have been involved in several situations where the FDA wants to come in and do something, but the state or local courts can stop that effort, and it is unlikely that the FDA will continue the argument. Often the FDA does little because of costs and time."

The American Veterinary Medical Association (AVMA) policy on compounding urges veterinarians to seek out a compounding pharmacy that is accredited by an independent accreditation body, such as the Pharmacy Compounding Accreditation Board (PCAB).

Bertone sees the problem as veterinarians just being too comfortable using compounded drugs.

"When problems occur with compounded drugs, invariably the problem could have been avoided and almost invariably the risk was unacceptable," he says.

"It's questionable that the sometimes necessary risk in using compounded drugs was worth the benefit from what was used in the horses in Florida."

The question should be whether the risk outweighs the benefit. That question should have been asked before using selenium intravenously, Bertone says.

Most veterinarians believe there is a need for compounding medications, especially for those not FDA approved for use in animals. But the incident brings up a number of regulatory issues.

If in fact an Argentine veterinarian not licensed in the United States administered the drug, which was ordered for him by a Florida-licensed veterinarian, other issues arise.

"Was the Argentine veterinarian practicing without a license?" Bertone asks. "Did the U.S. veterinarian have a valid veterinary-client relationship?"

The way the drug was obtained in this incident is fairly common in the world of polo, Wollenman says.

"None of the barns I do work for employ Argentine vets, but they don't hang a shingle out and practice on everybody, either," he says.

"I think that it is legal. They need to rely on someone they can work with. The right hand needs to know what the left hand is doing. Everybody cries a little bit about it, but if you were going to a foreign country and taking a U.S. team, you would want a U.S. veterinarian."

The investigation likely will take several more weeks, according to McElroy.

"This was a terrible accident, a terrible tragedy, but it happened as a public tragedy," Wollenman says. "Good things tend to come out of bad things. The polo association is evaluating its drug policy as a result. Hopefully, we learn something and we pay a little more attention to compounding and how things get made."