Are your Pets being Sold-Out by Big Pharma?
According to last Tuesday’s Wall Street Journal, pets who rely on drugs approved for people are likely to suffer now that nearly 200 of these are in short supply, according to the American Society of Health-System Pharmacists.
So you understand, only a fraction of the drugs veterinarians use on animals are actually approved for use in veterinary settings. That’s mostly because it’s expensive to get drugs approved for specific uses in specific species (as the FDA requires for each individual drug). Luckily, the federal government makes exceptions for what’s called "extra-label" drug use.
This means that when a critical mass of veterinarians have deemed a certain drug for a certain species, at a certain dosage, useful in the treatment of a certain disease, then this drug is legally acceptable to implement, despite the fact that it’s not gone through the onerous approval process. This kind of drug use is referred to as "off-label" pharmaceutical therapy.
This is also how veterinarians have come to rely on human preparations of so many drugs in our daily lives. So it is that when humans suffer drug shortages, we experience them even more acutely. After all, people come first when it comes to distributing drugs.
But lately, there have also been shortages of some animal-specific drugs.
According to the article,
The only FDA-approved drug to kill adult heartworms in dogs, Immiticide, is currently unavailable for weeks or months due to a manufacturing issue.
So, okay, it’s not enough that upwards of 200 human drugs are largely unavailable to us, now our own dedicated animal drug manufacturers are leaving us in the lurch. Still, it’s the human drugs we mostly rely on. And –– predictably, perhaps –– we’re last in line to gain access to these drugs. Which only makes sense.
But here’s the big question: Why has this been happening?
According to the Institute for Safe Medication Practices, which last year called the shortages of key human drugs "unprecedented," drugs become scarce for a variety of reasons, including the unavailability of raw ingredients, FDA-enforcement actions that halt production, voluntary recalls, poor inventory ordering, a change in product formulation and even rumors of an impending shortage, which can cause hoarding.
Ah, hoarding ... it happens in all circles. But should you be worried for your pets?
Mostly? ... Not so much. After all, more than 99 percent of the drugs we lack are those not approved in vet medicine because they’re not terribly common. The downside is that these drugs we lack are those veterinarians use in times of serious crisis. Consider:
Vets reported shortages of doxorubicin, a chemo drug used to treat different cancers in humans and pets, and of another oncology drug, mechlorethamine hydrochloride (brand name Mustargen). The latter is a "rescue" therapy for lymphoma used when other drugs don't work in people and pets. "When it's not available, that limits the little bag of tricks" to reach into, says Kristine Burgess, a veterinary oncologist at the Foster Hospital for Small Animals at Tufts University's Cummings School of Veterinary Medicine. Not offering it "is denying your pet a really good drug.
So sad that so many pets are going without. And yet, it’s even MORE sad to hear that all of us are missing out.
Given the table I’ve set, here’s the inevitable question: What is it about modern manufacturing processes that these behemothic pharmaceutical companies haven’t yet come to understand about producing chemicals and biologicals on a global scale? How can it be that they’ve gone so inept at keeping pace with basic supply and demand?
Call me cynical, but somehow it seems to me as if there are certain industries who’ve recently proved they’re not best built for globalization and oligopoly — especially when they’ve obviously not lived up to their blustery promises of greater efficiency and seamless supply. If anything, our reliance on their ginormity and outsized global reach has proven overblown and altogether unfounded.
So it is that we sit and wait for our drugs. While our patients die ... and big pharma plays its ticker-tape game of thrones.
Dr. Patty Khuly
Pic of the day: iStockPhoto