Home | Forum | Search
When Wild Animals Get Sick: Drugs : Part 2
by Food and Drug Administration (FDA)

(Page 2 of 2)

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 (aquaculture). 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.
  • inability of veterinarians to prescribe medicated feed "off label." Off-label use of drugs to medicate feed is prohibited under the act. But for many minor species, such as birds and fish, feed offers the most effective route for administering drugs.
  • reluctance of some veterinarians to prescribe drugs for off-label use because of liability concerns
  • risk of unsafe and ineffective drugs in animals for which the drugs or their uses have not been approved
  • risk posed by drug reformulations created as part of off-label use
  • increased risk of drug resistance in animals because of repeated use of one drug.

The problems are compounded by an increasing animal population. Because of better veterinary care, zoo animals are living longer, and, as a result, veterinarians are seeing more animals with diseases typical of older age — for example, heart disease, cancer, arthritis, and cataracts.

Also, specialty and exotic pets are becoming more popular. Between 1991 and 1996, an AVMA survey found that the number of households with pets of a minor species — especially ferrets, reptiles and fish — grew 65 percent.

Other reasons FDA and veterinary experts would like to see more applications for minor species' drugs are:

  • to meet the expected increase in consumption of fish and seafood from aquaculture (the production of fish and shellfish for food in a closely managed habitat). In the United States, there are only a handful of approved drugs on the market for food fish. According to the AVMA's Aquaculture and Seafood Advisory Committee, the lack of drugs for aquatic species is one reason the United States lags behind the rest of the world in aquaculture production.
  • to provide contraception to solve overpopulation problems, such as for deer in urban areas. Currently, there are no contraceptive medicines approved for any animal, although there are some that delay the mating period.
  • to protect endangered species from extinction. Bill Lance, D.V.M., Ph.D., founder and president of Wildlife Pharmaceuticals in Fort Collins, Colo., says: "If you lost an animal 30 years ago, it was not a problem. Today, it's a problem. These animals are very valuable. [Veterinarians] can't afford to use [just] any drug on them."

Proposal Benefits

Though some of the expected proposals may take years to implement, Wilmot and other veterinary experts believe they are necessary for ensuring public health. With more drug options, they say, veterinarians will find it easier to reduce pain and suffering by treating diseases in animals of minor species. And the approved labeling will provide more complete information on proper dosing and possible side effects.

"It will give veterinarians a handle on what the drug can do and how it works," Wilmot says.

Veterinarians like Bush at the Conservation Center believe that humans have a role in animal health. "Just as we feed them and clean them, we're obligated to provide their medical care," he says.

"Effective treatments are not just for zoo animals," he adds. "We also need them for animals in the free-living situation, where our intervention can help ward off diseases. We're responsible for these animals' health care, [as well]."

Previous: When Wild Animals Get Sick: Drugs


About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.

Related Topics
Alternative Medicine
Antibiotics
Vaccination
Articles & Books
Ensuring Drugs Are Safe and Effective : User Fees, Clinical Data
Since the Prescription Drug User Fee Act (PDUFA) was passed in 1992, more than 700 drugs and biologics have come to the market, including new medicines to treat cancer, AIDS, cardiovascular disease, and life-threatening infections.
Imported Drugs Safety: Benefits of a Closed System
Drugs sold in the United States also must have proper labeling that conforms with the FDA's requirements, and must be made in accordance with good manufacturing practices. As part of the FDA's high standards, drugs can only be manufactured at plants
Imported Drugs Safety : Re-Importation, Personal Use, Canada
The FD&C Act also states that prescription drugs made in the United States and exported to a foreign country can only be re-imported by the drug's original manufacturer. Even when original manufacturers re-import drugs, the drugs must be real

© 2008 eNotAlone.com