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January 23, 2013

Are We Returning To The Wild West Of Veterinary Medicine?

Injecting a substance labeled as a veterinary device into the horse intramuscularly is actually using that device as a drug, which is illegal and unethical. Photo by iStock

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.

If you enjoy this article and would like to read more, consider subscribing to the Chronicle. This article appeared in the March 26 & April 2, 2012 issue, which was the Spring Horse Care Issue. 

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 Compounding

The 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.”

In others words, no outside authority is ensuring the quality and safety of veterinary devices. Using a medical device as a drug is NOT off-label or extra-label use. Off-label or extra-label use is when veterinarians are allowed to use drugs that are not FDA-approved for equine medicine. Off-label use applies only if those drugs are FDA-approved for use in another species or for a different disease or route of administration. Since human medical and veterinary devices have not undergone FDA drug approval, their use is not considered valid off-label or extra-label use.

Simply put, “It’s against the law to use a medical device as a drug,” said Bertone. “You should never use a medical device as a drug. You’re using something that is very substandard.”

Some horsemen refer to Chondroprotec as “generic Adequan” and MAP-5 as “generic Legend,” but this is incorrect. Technically, the FDA recognizes generic drugs if they’re identical in composition, safety, efficacy, and concentration to the name brand drug and manufactured after the name-brand drug’s patent has expired. And true generic drugs undergo the same FDA testing and approval as the name-brand approved drugs. These medical devices have not proven themselves to be identical to the name-brand, FDA-approved drugs, nor have the undergone the FDA approval process.

In an address he gave at the 2004 American Association of Equine Practitioners Convention, Wayne McIlwraith, BVSc, PhD, DSc, FRCVS, DMV, Dipl. ACVS, the director of Colorado State University’s Gail Holmes Equine Orthopaedic Research Center, discussed Chrondroprotec in particular.

“It has been commonly represented as generic Adequan, but it is not,” he said. “This is both illegal and unethical. The fact that the company calls the product Chondroprotec [which implies cartilage protection] and packages it in a container-closure system that is identical to that used for an injectable product is an extreme example of misrepresentation.”

You Get What You Pay For

What does an FDA-approved drug have that a veterinary device doesn’t? In a word, regulation.

During the FDA approval process, a drug is studied intensely to determine its stability, efficacy, sterility and consistency. The facilities of FDA-approved drug manufacturers are inspected and monitored. The base ingredients of an approved drug are evaluated for purity and consistency.

The manufacturer of a veterinary device does not have to submit a pre-market approval application to the FDA, their product does not undergo any testing for efficacy, stability, or sterility, and their manufacturing locations do not have to be registered with nor inspected by the FDA.

According to the FDA specifications about veterinary device regulation, “It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled.”

The process of FDA approval is expensive, and so are quality ingredients. “FDA approval is actually peanuts in cost versus what it takes to buy a chemical in a form that you know exactly what that chemical is,” said Bertone. “The biggest problem is meeting the specifications of a drug, and that means it’s not contaminated, it’s the strength it’s supposed to be, and it’s stable. It’s so difficult to meet that standard, but it makes sense that it’s supposed to meet that standard.”

FDA-approved drugs have not only proven their efficacy, safety, sterility and consistency of concentration of the drug, but they are also monitored after release to the market.

 “There’s lots of oversight for an FDA-approved medication,” said James Morehead, DVM, of Equine Medical Associates PSC in Lexington, Ky., who has served on the AAEP’s Professional Conduct and Ethics Committee. “There are much higher quality standards applied than if you just come up with a drug.”

The FDA has a reporting process in place for approved medications—veterinarians are required to report adverse effects such as an infection in a post-injected joint. Adverse effects from veterinary devices have no central reporting process. In the case of an adverse reaction to the use of a veterinary device as a drug, the treating veterinarian is on shaky ground liability-wise. 

“If I use an FDA-approved product on a horse and there’s an adverse reaction, I have a company backing me up. You, as the horse owner, have a company backing you up. You’ve got lots of people on your side trying to resolve this adverse reaction,” Morehead said.

If a veterinarian uses a veterinary device as a drug, which is in violation of FDA regulations and against AAEP recommendations, they assume more of the liability risk.

“Our professional liability insurance trust is there to defend us and they do so no matter what is going on,” said Morehead. “But you can imagine they have some issue with it if I, as a veterinarian, am out practicing illegally. What the insurance carrier would like is for all of us to practice at the top of the level all the time, and strive to do the best job that can be done. And obey the law.”

But an adverse affect doesn’t have to be as dramatic as an infected joint or a death. If the medication simply isn’t effective, that’s also an adverse effect, a silent one. “The hardest thing to show is that a drug doesn’t work. When we talk about adverse responses, like injecting something into a joint and having it explode, those are actually the really rare adverse responses,” Bertone said.

“The worse case, and the most common, is when the patient is not improving because of lack of efficacy of the treatment. That’s a lot harder to point at than a horse that has a dramatic reaction.”

An Erosion Of The Authority

Avoiding the FDA approval process and FDA regulation of base ingredients allows the manufacturers of veterinary devices to market their products at less cost than an FDA-approved drug.

“I’ve spoken to veterinarians who say ‘I use them because of the cost,’ to which I reply ‘But then don’t you wonder what’s actually in it? Why don’t you just buy a bottle of water from me for $20 and say it’s a wonder drug,’” said Bertone. “That’s the problem with all of this. The drug companies spend a lot of money to develop these [FDA-approved] products, and then they find out there’s nobody to protect them.”

“If these companies can bring devices to market without bothering with FDA approval and sell plenty of the stuff, then eventually FDA approval will break down and we’re left with the Wild West,” said Joe Davis, DVM of Piedmont Equine Practice in The Plains, Va., an FEI-accredited veterinarian

“If that happens, when someone comes to my office and says to me, ‘This is a new drug; its the greatest thing,’ I can’t rely on the FDA approval process to inform me about the drug. I might have to say ‘Do I trust this company?’ How would I learn to trust that company? I would have to learn that by giving the drug to clients’ horses and discovering the adverse effects myself. I don’t want to do that.”

The bypassing of FDA approval has deeper effects as well. If some companies are circumventing FDA approval by producing veterinary devices that are being used by veterinarians as drugs in competition with FDA-approved drugs, “A pharmaceutical company’s motivation level to bring products to the market is diminished,” said Morehead.

“I think that all of us in this industry—not just veterinarians but all of the horse-owning public—need to think long and hard about that because whether you like pharmaceutical companies or not, we rely on them in the human and veterinary market. That may not be the biggest issue we see this year or next year, but at some point, we’ll all see repercussions from that as pharmaceutical companies elect not to bring new products to the market,” Morehead continued.

On The Honor System

For the moment, the FDA has chosen to adopt an “enforcement discretion” policy on the pharmaceutical use of veterinary devices, even though it violates their rules.

“The FDA regulates many important issues. For example, our food supply is more important than this issue, and the monitoring of such is also, so certain things get priority,” said Morehead. “If horse production was for producing food, it would also be far higher on the priority list. But they’re not, so horses are a lower priority in the eyes of the FDA.”

So, it’s up to the veterinary community to self-police. And veterinarians are frequently under quite a bit of pressure from clients to find an effective, yet cheaper, treatment. And if their friend had good success with a veterinary device, the client might ask for the same.

“You have to decide if you’re going to do the best for your client and for the patient,” said Bertone. “It’s about the ethics of doing the right thing for your client. I don’t care if the FDA decides to do anything to enforce their rules about this. I doubt they will. But it’s about what my profession dictates to me is ethical behavior in delivering services to my client.

“It’s so important for the veterinarian to educate the client about all the facts and the risks,” Bertone continued.

Read more about a practicing veterinarian's decision-making process regarding medical devices.

A white paper produced by the Biological and Therapeutic Agents Committee of the AAEP in July 2010 stated that “it is the AAEP’s position that if there are FDA-approved products available and formulated in the appropriate dosage for the disease indication of the patient, those products should be used in preference to a medical device used as a pharmaceutical.” And that “It is unethical for a veterinarian to promote or represent a medical device as equivalent to an approved pharmaceutical product.”

There are a multitude of resources available online for horse owners seeking to educate themselves about their horses’ care and medications. “When you’re talking to your individual veterinarian in the privacy of your own barn aisle, that’s one conversation,” said Tom Daniel, DVM, of Southern Pines Equine Associates (N.C.).

“But if you really want to see what the profession as a whole thinks about that issue, go to the American Association of Equine Practitioners website and read up on it. Don’t be afraid to challenge your veterinarian’s position if it stands at odds with his professional organization’s stance.”

 
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