The U.S. Food and Drug Administration’s stance on medical devices for equines is well documented. But when a veterinarian gets into the field of practice, they have to make educated decisions about their own procedures and treatments.
“I think that practicing veterinarians have a bit of a love/hate relationship with the whole entire pharmaceutical approval system,” said Richard Markell, DVM, of Ranch & Coast Equine Practice in Encinitas, Calif. Markell has practiced on top dressage and hunter/jumper horses for decades and is an accredited Federation Equestre Internationale veterinarian.
“The approval process for medications in this country is set up so that we protect our horses [and humans] from unlicensed products that have wild claims and are not beneficial or safe. There are some really great things about how you get drugs approved in this country and the consumer and patient protection it provides is immensely valuable. I’m pro-drug approval; I think it’s important for the safety of our patients without a doubt,” Markell continued.
“The frustrating thing, though, is that the system has necessarily and unfortunately been a victim to a lot of protocols that get in the way of allowing great medications to be approved. My friends who practice in other parts of the world have their hands on quite a few medications that are beneficial and effective and have been well proven for safety and efficacy in other countries, but we can’t seem to get them here. If a drug is licensed and approved in another country, just because it’s not FDA-approved in the United States doesn’t mean it’s not a good medicine.”
One such product is pentosan polysulfate sodium, which is a licensed and approved product in Australia (and several other countries) named Pentosan. U.S. veterinarians use Pentosan either in a compounded form, or as the veterinary device PentAussie. A study done at the Orthopaedic Research Center of Colorado State University concluded that pentosan polysulfate had a beneficial therapeutic effect on joint disease.
In 2011, Matrix Animal Health LLC announced the launch of PentAussie Equine, a pentosan polysulfate and N-acetyl glucosamine formulation that is being manufactured in the United States and marketed as a veterinary device, as a post-surgical joint lavage. “I have done research and happen to know that [PentAussie] is the exact same product that is manufactured in Australia as Pentosan, and that it is manufactured to the same standards as Pentosan in Australia. It is the product that’s been licensed and approved in Australia,” Markell said. It is possible for a veterinarian to apply for a temporary import permit from the FDA for the Australian product for specific patients (just as many have done for for the drug Tildren).
“I’m comfortable with my patients using that product. I use it on my wife, Kristen’s, horse—that may be the ultimate trust for a veterinarian. However, I cannot say that for other medical devices being used as drugs,” said Markell.
Markell said it’s a fine line that veterinarians face in practice. “If we wait for everything to be licensed and approved and properly jumping through the hoops, we’re missing out on literally hundreds of beneficial treatments that we could be offering our patients. No great advances were made without creative, forward thinking, in any field.
“However, those that are creative and thoughtful and innovative sometimes step over the line and start doing crazy things and using medications and treatments that aren’t safe and approved and that’s not good either,” he said.
Innovation and progress have to find a balance with regulation. “I consider myself ethical and respected,” Markell said. “I look at the value of the horses I deal with and on average, they’re worth half a million dollars, so I’m conservative, careful, and cautious about my choices in caring for them. I agree with the process, but I think we have to be careful that it doesn’t limit our progress forward.
“The FDA approval process started so that we don't use snake oil. But a product that’s licensed and approved in another country and has legitimate, solid research behind it isn’t snake oil,” he said.
Markell acknowledged that using veterinary devices as drugs is, by the letter of the FDA rules, wrong. And he does not recommend the pharmaceutical use of devices such as Chondroprotec and polyglycan. “Just because a lot of people use them and haven’t had serious problems doesn’t mean it’s a smart thing to do,” he said. “I see people skiing without a helmet and they luckily don’t get hurt, but I wouldn’t. Why take the chance?"
He advises horse owners to be educated and involved in the medication decisions they make for their horses. “If a veterinarian wants to use certain drugs, ask them why. If they say simply because it’s cheaper, then it’s up to you and the veterinarian to decide if it’s worth the cost savings to use something that’s not a proven safe, reliable product.
“Using a non-approved drug instead of an approved drug just because it’s cheaper isn’t a good reason. Clients have to be thoughtful of the questions they ask their veterinarian. And veterinarians have to be thoughtful and cautious of the information they give their clients,” said Markell.
“Every day in my practice, I constantly think about ‘What is the best thing I can do for my patients? How can I make my horses healthier? That’s my job.’ If using medications that I genuinely believe, based on legitimate research and licensure in other countries, is part of that, as long as my client is informed and understands and it is medically sound advice, I’m interested in that. That’s how I run my practice. But I’m very cautious about it because it’s a slippery slope with important legal and ethical questions. As well, it opens myself to questions from clients regarding products that do not meet that standard.”
He said that every veterinarian has to decide where he stands on each individual medication or product. “If you stand on the side of licensed and approved only, you’re safe, but you may be missing some really effective treatments,” he said. “If you stand too far on the side of using anything regardless of licensure and approval, now you’re on the dangerous side and could be using things that are not proven effective or safe. The middle ground is when you’re reasonable and thoughtful and honest with yourself and how you use it, and the client is thoroughly understands and is informed about the product and the risks and benefits.”