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Reconciling the Facts on Separation Anxiety in Pets

It's been said for years now that, as a society, we're overmedicated, and the numbers seem to support that contention. According to the latest statistics, more than 50 million people around the world have taken Prozac, for example, to help ease their symptoms of depression, obsessive compulsive disorder, bulimia nervosa, and other ailments.

Believe me when I say I'm not suggesting that depression isn't a serious illness, or that those who suffer from it shouldn't take prescription drugs. No, what I have a problem with is that now, we're prescribing anti-depressants for our pets, too. Lilly created a doggie version of their best-selling Prozac and called it Reconcile; it's meant to treat separation anxiety. And if you look at the labeling information, the empirical formulas for Prozac and Reconcile are identical; it's the same drug, fluoxetine.

And according to the Reconcile Web site (www.reconcile.com), 10.7 million dogs in the United States suffer from separation anxiety, with nearly 60 percent of cases going undiagnosed.

That raises an interesting question, of course, which is this: If approximately six million dogs were suffering from undiagnosed separation anxiety, wouldn't their humans know about it? Really, a mental illness so serious that a powerful drug should be prescribed for it, and six million families aren't aware that their pooch has a problem?

Skeptic that I am, I decided to look into the business of doggie Prozac, and found myself appalled, once again, at what a giant corporation will do in the name of profits.

Prozac has been around for twenty years now, and Reconcile for less than two. Yet despite numerous reports of moderate to severe side effects from Prozac, it is still heavily prescribed for adults and children.

How severe are the side effects of Prozac? According to the FDA fact sheet for the drug, they include "anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania" in both adults and children. Worse, however, is the fact that the drug makers were forced to add what's known as a "black box warning" to the product because the above symptoms were leading in some cases to, well, suicide.

Aside from the obvious problems with a drug meant to treat depression actually leading to suicidal thoughts and behavior, that drug was causing a host of other problems as well. Besides the ones mentioned, other frequent side effects were ear pain, "taste perversion," and even tinnitus. There was also a pesky little rash problem, which led to other, more serious problems, as you can see in this quote from another section of the fact sheet: "Since the introduction of Prozac, systemic events, possibly related to vasculitis and including lupus-like syndrome, have developed in patients with rash. Although these events are rare, they may be serious, involving the lung, kidney, or liver. Death has been reported to occur in association with these systemic events." Looks like if the suicidal thoughts don't get you, the rash will.

And then, since the drug was obviously such a winner, Lilly, through its animal "health" sector, Elanco, decided to make a version for our dogs. Not that dogs hadn't received fluoxetine before that; as Prozac was undergoing its pre-approval testing, it was indeed tested on dogs. In one study, of the six dogs purposely overdosed with oral fluoxetine, five experienced grand mal seizures. The study notes that "the lowest plasma concentration at which a seizure occurred was only twice the maximum plasma concentration seen in humans taking 80 mg/day, chronically." In other words, it doesn't take all that much, really, to induce seizures, and grand mal seizures, the worst kind, at that.

Lilly did other studies on dogs in order to receive the FDA approval to market Reconcile, one of which gave the drug to only 117 dogs, three of which experienced seizures (one fatally). Another study on the toxicity of the drug included five beagles, three of which either died or were euthanized in the first six months of the study.

Yet Reconcile was approved by the FDA in April of 2007, and Lilly began marketing it. They set up a Web site devoted to the product, and peppered it with cute photos of endearing dogs and puppies, most of whom appear to have just torn up part of your furniture and are looking decidedly regretful. Yet if you scroll down a bit, you find this: Adverse reactions in dogs given Reconcile included "seizures, weight loss, lethargy, depression, decreased appetite, vomiting, tremor, diarrhea, restlessness, otitis externa, disorientation, incoordination, constipation, excessive salivation." A safe product for dogs, indeed. And in fact, the labeling information for Reconcile says it's not meant for dogs with epilepsy or a history of seizures: "Seizures may occur in dogs treated with Reconcile chewable tablets, even in dogs without a history of epilepsy or seizures."

But surely the company tested it thoroughly, right? Apparently not. Still on the Reconcile site, we find this: "The effectiveness and clinical safety of Reconcile chewable tablets for long-term use (i.e. for more than 8 weeks) has not been evaluated." Which would seem to imply a time limit for the drug of up to eight weeks, but no longer. Why, then, does the site go on to say, "It can take time to see improvement in your pet's behaviors. If you don't see immediate improvement, continue with Reconcile for as long as your veterinarian has indicated. Don't give up! It is important that you continue the medication as prescribed."

Let's see if we have this straight, then. If your vet tells you to keep drugging your dog, keep it up; after all, your vet has your dog's best interests at heart, even though the drug hasn't been evaluated in dogs for more than eight weeks. If your vet says keep using it, then keep using it. Don't give up!

Could it be, perhaps, that your veterinarian sees some benefit from prescribing Reconcile for your dog? Let's look at what the company has done for veterinarians. Again, from the company: "Lilly Companion Animal Health is excited to offer you the new Reconcile™ Professional Education & Training (PET) Program. Funded by Lilly and free of charge to you, the Reconcile™ PET Program will provide you with the knowledge you desire on canine separation anxiety and prepare you to work with pet owners dealing with this distressing disorder." Those vets who do decide to join forces with Lilly can fill out a simple form and, as the company says, start earning "unique incentives and rewards today." Unfortunately, the part of the Lilly site reserved for veterinarians is very private, so what those incentives and rewards are, we can only guess.

According to Lilly's 2007 Annual Report, their animal health products sales worldwide were up 14 percent over 2006, and as you'll remember, it was in April 2007 that Lilly received FDA approval to market Reconcile. The annual report goes on to say "Animal health product sales in the U.S. increased 18 percent, driven by increased demand, the acquisition of Ivy Animal Health, and new companion-animal product launches."

To drive this increased demand, Lilly does such things as, well, bribe vets to recommend their product. Compendium is a journal of veterinary medicine research, and in January 2008 it carried a column called "Separation Anxiety in Dogs," by one Barbara L. Sherman, a Ph.D. and doctor of veterinary medicine at North Carolina State University. What is striking about this column , which you can access at (http://www.veterinarytherapeutics.com/Media/PublicationsArticle/PV_30_01_27_0.pdf), is that the author's writing is nearly identical to that in the Reconcile Web site, particularly the parts about separation anxiety eroding the human-animal bond and leading to possible euthanization. Also striking is the disclaimer at the bottom of the first page of the article: "Dr. Sherman discloses that she has received financial support from Lilly Companion Animal Health"

In fact, it's no surprise that Lilly must buy the positive word of mouth of experts; much of what the company has said about its product has been somewhat overstated. In June 2007, not long after Reconcile was approved for marketing, the Division of Surveillance of the FDA's Center for Veterinary Medicine sent a warning letter to Elanco for suggesting that "the product is more effective than has been demonstrated." The company was warned to change its marketing materials and Web site copy. What did Elanco do that was illegal? They neglected to mention in the original materials that behavior modification alone worked nearly as well as their drug.

And that, surely, is the heart of this matter. Of course, true separation anxiety is a serious problem, but how many dogs are being prescribed an incredibly powerful drug because their humans simply want the easy way out?

Knowing that it's primarily the training that will help a dog overcome its separation anxiety, Lilly developed the BOND program, which stands for Be positive, Only reward calm behavior, No more drama when coming and going, and Develop the dog's independence. And in fact, on the BOND training section of the site (http://www.reconcile.com/bond-training/), we see this: "This process may take a week or more, depending on the individual dog."

So wait, the training alone will fix your dog's problem in as little as a week? Then why as many as eight weeks, or even more, on the drug? And why push the drug when test data submitted for Reconcile by Elanco said this: "Administration of Reconcile chewable tablets did not result in considerable improvement in SA [separation anxiety] behaviors when administered without behavior modification. Therefore, because this study did not confirm the effectiveness of Reconcile chewable tablets, this study will be used for safety purposes only."

Why? Get out your calculator: 10.7 million dogs in this country alone with separation anxiety, at about $50 per month, the midpoint of most prices online (although I haven't checked with any vets on what they charge, which may conceivably be higher), for a 30-day supply, depending on the size of your dog. Double that for the recommended two-month course of treatment (unless, of course, your vet tells you not to give up!). Bottom line for Lilly? Potentially, over one billion dollars. And for the veterinarians that prescribe it, well, they get your dog in to the office more frequently for assessments, not to mention whatever kickbacks they get from Lilly.

Oh, and the clinic assistants get their goodies, too, if they go through the training modules that will help them decide your pet has separation anxiety and will benefit from treatment. Lilly offers them "Unique incentives and rewards, such as insulated lunch coolers, totes and more, upon completion of each learning module."

Why push the drug? For the usual reason: money. And for another reason. As this recent article in the New York Times (http://www.nytimes.com/2008/07/13/magazine/13pets-t.html?pagewanted=5&em) notes, some vets admit their human clients don't follow the directions about the training aspect of the dog's treatment because, as one says, "They just want the magic pill."

And as long as we continue to bring home new pets, lavish them with attention for the first few months, and then routinely leave alone in the house, or, worse, locked into one small area, for half a day or longer, we shouldn't really be that surprised when the animal becomes anxious or destructive. As the author of the Times article says, "If I were locked inside the bathroom all day, I'd swallow the shampoo, too."

Which, when you think about it, might be better than swallowing the medication. Even Elanco/Lilly knows that it's the training that works, and that's why every piece of marketing material stresses the need for behavior modification in conjunction with the drug. It's the training, the one-on-one interaction between human and dog, that alleviates the separation anxiety. The scientists know it, the company knows it, the animal behaviorists know it.

Now you know it, too. But what none of us knows, and never will, is this: If Prozac for people can cause thoughts of suicide and even worse depression, what is it doing to your dog? The animals we've committed to our care can't tell us when they're miserable, and the veterinarians won't tell us that the expensive drug they're pushing on us may be causing that misery. And that's the saddest part of this whole experiment: We'll never really know what the drug is doing to our beloved pets.

Because, unlike the human subjects in the Prozac studies, our dogs can't tell us.

For further reading:

The Reconcile site: www.reconcile.com

The FDA labeling for Prozac: http://www.fda.gov/cder/foi/label/2006/018936s076lbl.pdf

"Big Pharma Chases Dogs and Cats" at http://pubs.acs.org/cen/business/85/8526bus2.html

The FDA's document on the studies done on Reconcile: http://www.fda.gov/cvm/FOI/141-272o011907.pdf

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