Sick call of the wild

FDA Consumer, July-August, 1998 by Paula Kurtzweil

Minor Players

"Minor" may be a misnomer because these animals are prevalent throughout the United States. More than a million of them alone live in zoos and sanctuaries throughout the country. They represent just about every species, too, says Jane Ballentine, public affairs director for the American Zoo and Aquarium Association. "The scope is international," she says. "You name it, somebody has probably got it."

All wildlife, though abundant in rural and some urban areas, falls in the minor category, as do farm-raised fish (aqua-culture). And many U.S. households--about 13 million in 1996, according to the American Veterinary Medical Association--have pets that fall into the minor species category. These pets number about 80 million, according to the AVMA.

Still, the drug market for minor species is limited because, while there is a wide variety of species, the number of animals within each is small and the number for which veterinary services are sought is even smaller. As a result, many veterinary drug companies don't seek drug approval because they fear they won't recoup the cost of developing and testing the drug once it's on the market. "It's just not worth it for the drug company," FDA's Wilmot says.

For instance, between October 1996 and September 1997, FDA approved nearly 80 drugs for the seven major species and only one for a minor species.

Off-Label Use

The 1994 Animal Medicinal Drug Use Clarification Act helped ease the drug scarcity by giving veterinarians the legal right to use approved human and animal drugs in "extra-label," or "off-label," uses. This means that under certain circumstances veterinarians can use approved drugs in other species, for other diseases and conditions, or at different dosage levels from those listed in drug labeling.

For example, Bush has used a penicillin product approved for horses, dogs and cattle to treat a zebra with an infected hoof. Nick Kapustin, D.V.M., senior veterinarian at the Indianapolis Zoo, says human insulin is used to treat diabetes in apes, and he frequently uses an antibiotic approved only for horses "across the board on a variety of species," including kangaroos, wallabies, birds, and many amphibians.

Avery Bennett, D.V.M., an assistant professor of wildlife and zoological medicine at the University of Florida and a veterinary surgeon, says he uses a children's cough syrup and a children's antibiotic in liquid form to treat infections in birds.

And at the National Zoo in Washington, D.C., veterinarians give the giant panda Hsing Hsing an anti-inflammatory medicine, Rimadyl (carprofen), approved for use in dogs, for Hsing Hsing's arthritis.

"If we could no longer use drugs off label, I'd quit the business," Bennett says.

While the 1994 act has extended veterinarians' drug choices, many, including FDA, believe it isn't the solution to the drug scarcity. Problems that still exist, according to FDA, are:

* inability to get drugs to minor species that don't have access to veterinary care. Under the law, only veterinarians can administer off-label drugs to minor species.