Vioxx Debate Echoed in Battle Over Dog Drugs

"This is really the same thing we saw with dangerous drugs being given to people, but maybe even more unfair because pet owners had no idea these pills could be so harmful," said Herman, who two years ago helped start a Web site dedicated to reporting on adverse drug reactions in dogs http://-- http://www.dogsadversereactions.com -- after his miniature schnauzer died after being given Deramaxx.

"If our vet had only told us what danger signs to look for, maybe we could have acted sooner and she wouldn't have had to die the miserable death she did," he said. "We know from our Web site that hundreds or thousands of dogs are dying from their medications, and that most of their owners never even knew there was a danger."

Herman's complaint is one that David Stansfield, director of professional relations for Novartis Animal Health, the maker of Deramaxx, says he understands.

He said the company tells veterinarians not only to inform pet owners of possible side effects -- especially stomach problems with anti-inflammatory drugs such as Deramaxx -- but also to conduct blood and sometimes urine tests before the drug is prescribed. Those tests can be expensive, however, and are not routinely done.

Stephen Sundlof, director of the Center for Veterinary Medicine, said the agency believes that pet owners need better information about possible adverse reactions from the drugs their pets are given. But the agency cannot require veterinarians to give out the consumer information drug companies provide, he said.

"Some drugs are not as safe as we would like them to be," Sundlof said. "We hear a lot from dog owners who lost a loved pet, and we pay a lot of attention to that. But these drugs appear to be doing a lot of good for a lot of animals, too."

Stansfield said that when it comes to treating chronic and acute canine pain, the new medicines are a major step forward. His company has worked hard to improve its reporting of adverse events, he said, because it understands that the benefits come with risks.

FDA's Hampshire, who worked on the Deramaxx and ProHeart 6 cases before losing her position last year, said, "Whatever problems we face with drugs in the human world are magnified in the animal world. There's no pharmacist involved, and so there's no monitoring of prescriptions. And, of course, the patient can't talk and tell you he doesn't feel right."

Hampshire remains concerned about her agency's response to reports of serious side effects. She likens her experience to that of two other FDA whistle-blowers whose concerns about human drugs were not being properly addressed -- safety officers David Graham (Vioxx) and Andrew Mosholder (antidepressants).

"Nobody wanted to believe I was just doing my job; they wanted to think I was off on my own agenda," said Hampshire, who last month won the U.S. Public Health Service's award for veterinarian of the year. "I think a lot of people [in the agency] didn't want to hear what I was saying."

Because veterinarians dispense animal drugs themselves, their role is at the center of the debate. The FDA's Sundlof and Novartis's Stansfield said their organizations are working with veterinary groups to encourage practitioners to do more to warn clients about possible side effects, and that many vets are responding.

But many veterinarians resist efforts to force them to share drug information sheets -- provided by the companies and endorsed by the FDA -- with pet owners. Elizabeth Curry-Galvin, interim director of the scientific activities division of the American Veterinary Medical Association, said vets are trained to discuss possible drug side effects with pet owners, and her organization thinks most do so. She said the association opposes efforts to require vets to give out the drugmakers' information because "it's just not the be-all and end-all of the communication that's needed."

Bills that would require distribution of the sheets have been introduced in South Carolina and Pennsylvania. The South Carolina measure was defeated in 2004, but the Pennsylvania legislation, sponsored by state Sen. Michael J. Stack, is pending.

Because of his experience with Deramaxx and later what he considers foot-dragging by the state veterinary medicine board, Herman is pushing hard for a consumer's seat on that board.

"Drugs are needlessly injuring and killing hundreds of dogs every year," he said, "and some of us are really upset about that."