Last month, our features editor and bimonthly columnist, Randall C Willis, penned a commentary titled “I am not an animal,” in which he took to task the zeal with which some companies share data about preclinical successes with animal models, getting public hopes up for cures way too early.
This month, I’d like to turn that on its head a bit. What if you are an animal? Specifically, where does the target market for drugs intersect with regard to humans and animals?
This comes from an email that’s been sitting in my files winking at me for months, from business intelligence provider GBI Research, which supplies a fair amount of the material we use in the “Market News” section.
Citing research from a spring report they released, titled “Human Drugs For Veterinary Use—Current Trends and Future Commercial Prospects for Crossover Drugs,” the folks at GBI noted that significant unmet needs within veterinary care, including a lack of drugs for senior animals and underdeveloped research in areas such as veterinary oncology—as well as a scarcity of novel drugs, diagnostic aids, treatment monitoring and vaccines—are attracting more and more veterinarians to the idea of treating animals such as dogs, cats and horses by prescribing drugs intended for human use.
Not surprisingly, the most significant drivers of extralabel drug use in animals are financial. GBI noted in its report that unlike the market for human therapeutics, clinics that treat animals are not just involved in diagnosis and treatment but also have the ability to dispense pet medications. As the firm states in a news release about the report, consumers cannot purchase the prescribed medications from a pharmacy of their choice, where there would be access to low-priced generic drugs, and human treatments may be a viable alternative.
“A blockbuster drug in human health generates revenues in excess of $1 billion, whereas the animal health market’s highest-selling drugs achieve $50 [million] to $100 million, with around 85 percent of animal sales reaching less than $1 million,” noted Deekshita Allavarapu, an analyst for GBI. “In this way, many manufacturers of veterinary drugs are looking for products already licensed for human use to fill their pipelines.”
There are legal, ethical and safety issues to consider, but they mostly related to the veterinary side rather than the pharma side, such as the fact that while mammalian species share many basic similarities in terms of responses to drugs, responses may differ in notable ways for animals due to differences in biology. Also, if a human drug is prescribed despite the presence of a veterinary-approved alternative due to affordability issues, a veterinarian could face legal issues.
“Despite such problems, the intersection between human and veterinary medicine is a very important and emerging area that GBI Research believes will receive more focus in the years to come,” Allavarapu said. “For example, specially designed clinical trials are currently being run in which pets can be enrolled alongside human patients.”
How do I feel about this? Well, as long as the animals aren’t in the same room as the human clinical trial patients, I don’t see many problems—as long as we also steer clear of prescribing new classes of human antibiotics to them. As much as I love Fido, Fluffy and the rest, we have few enough new antibiotics and too many resistant microorganisms. The FDA just finally got around to banning a bunch of antibacterials from soap because they have no proven value in such uses and could help promote antibiotic resistance. Let’s not go down the wrong path with the animals and end up compromising human health in the process.