The days of shady salesmen hawking miracle potions like colic drench and spavin cures with questionable ingredients are long in the past. Or are they?
Two hundred years ago, veterinarians would treat lameness with a topical mixture of ammonia, turpentine, alcohol and camphor. Today, they use sophisticated blends of drugs via intra-articular, intravenous and intramuscular injections; present-day veterinarians have access to diagnostic tools, surgeries, drugs and treatments that their colleagues couldn’t even imagine 50 years ago. Thanks to these advances, horse owners are able to prolong their horses’ soundness and lives longer then ever.
But the torrent of innovation has also resulted in some ethical dilemmas for veterinarians. A few shortcuts taken in the race to discover the newest, most effective and most affordable treatment of joint disease have complicated the decisions veterinarians and horse owners face.
Not only have compounded drugs become an issue, but the use of substances that are technically defined as “medical devices” as drugs has become popular. Some veterinarians are using substances labeled as semen extender and joint lavage as pharmaceuticals—injected into joints, veins and muscles—to combat joint disease.
The U.S. Food and Drug Administration defines human medical devices and veterinary devices as products that affect the structure of the body without the use of chemical action or metabolism. Things like syringes, radiograph machines, and surgical implements are medical devices, which do not undergo the same rigorous testing, approval and regulation that the FDA applies to drugs.
“The biggest issue is how a lot of the companies have used labeling a product as a veterinary device to skirt FDA approval, in which they would have had to prove that their product works and that its safe and effective. They’ve found a loophole,” said Joe Bertone, DVM, a professor at Western University of Health Sciences College of Veterinary Medicine and adjunct professor at California Polytechnic Institute (Calif.) and a former Veterinary Medical Officer with the FDA Center for Veterinary Medicine.
“What we have to do is realize that in terms of veterinary medicine, in some ways we’re back to the 1800s, and everybody should be suspicious of what comes in a bottle if its not FDA-approved,” said Bertone.
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When Is A Device A Drug?
A quick Google search reveals the websites of multiple equine veterinary clinics in the United States clearly promoting the use of medical and veterinary devices such as MAP-5, polyglycan, ChondroProtec and PentAussie as joint therapies in injected drug form.
• MAP-5 is a veterinary device composed of hyaluronate sodium manufactured and labeled as a substance to enhance the collection and cryopreservation of embryos and semen. But it is also being used via intra-articular and intravenous injections as joint therapy. Hyaluronate sodium is also the main ingredient of the FDA-approved drug Legend.
• Polyglycan, a veterinary device, contains hyaluronic acid, sodium chondroitin sulfate and N-acetyl-D-glucosamine. It is labeled as a post-surgical lavage for synovial compartments, i.e., it is intended to replace synovial fluid lost during surgery. But it is also being administered intravenously and intra-articularly as joint therapy.
• ChondroProtec (polysulfated glycosaminoglycan) is a human medical and veterinary device labeled for topical application on wounds such as skin lesions, burns, or surgical incisions. But it is being injected intra-muscularly as a joint therapy. Polysulfated glycosaminoglycan is also contained in the FDA-approved drug Adequan.
• PentAussie (pentosan polysulfate sodium and N-acetyl-glucosamine) is a veterinary device also labeled as a post-surgical joint lavage. It contains the same drugs found in the Australian joint therapy drug Pentosan, which is not FDA-approved in the United States but is approved and licensed in Australia. PentAussie is being used intramuscularly and intra-articularly.
If a substance is injected into the horse’s vein or muscle, then it is metabolized by the horse’s body and is therefore, by the FDA’s definition, a drug. In addition, if it is injected into a joint, it affects the joint in a chemical manner, and is, again, by definition a drug.
The Case Of CompoundingThe use of compounded forms of FDA-approved and non-FDA-approved drugs is also attracting attention in veterinary medicine. The Chronicle of the Horse published a comprehensive article about compounded drugs in the Nov. 6, 2009 issue.
The FDA even released a newsletter to veterinarians that clarified the issue: “The key difference between an animal device and an animal drug is how the product works. If it relies on a chemical action occurring in or on the animal’s body to work, the product is a drug, not a device. If it needs to be metabolized by the animal’s body to work, the product is a drug, not a device.
“Unlike animal drugs, animal devices do not have to be approved by FDA before they can be marketed.”