By Marc Kaufman
Washington Post Staff Writer
Friday, May 12, 2006
The drug came on the market four years ago after being tested in a healthy, young population, although it was intended for use by the old and sick. The manufacturer aggressively advertised it and ultimately made claims deemed by regulators to be beyond what testing had established.
When reports of illness and death linked to the drug surfaced not long after it went on the market, the company was slow to report the problems to the Food and Drug Administration. The agency eventually did issue a reprimand and a formal warning letter, but two years later the drug is still being sold, and some consumers complain that too little is being done to warn pet owners of its dangers.
The medication is Deramaxx, and it's the center of another drug controversy. But this medication isn't for people. It's for dogs.
An anti-inflammatory closely related to the human painkiller Vioxx, which was taken off the market in 2004 and is now the subject of thousands of lawsuits against Merck & Co., Deramaxx has helped relieve many canine aches and pains. But in an echo of the national debate over the dangerous side effects of some popular human drugs, Deramaxx has also proved at times to be deadly.
Before the early 1990s, most drugs given to pets were human medications that appeared to help animals as well. But with dogs in particular living longer and being treated increasingly as members of the family, the demand for better drugs has grown, along with the public's willingness to pay for them. Most companies that now develop and sell pet drugs are subsidiaries or divisions of the major brand-name drug companies, and they must seek FDA approval to market their products much as they do with drugs intended for people.
Deramaxx is not the only drug to run into trouble in the burgeoning world of animal medicine. The widely used ProHeart 6 heartworm treatment was the subject of controversy several years ago and was withdrawn from the market in 2004 following reports that healthy dogs were becoming sick and dying after getting a shot of the preventive medicine.
In both cases, the deadly side effects led to formal -- but by many accounts ineffective -- government and industry efforts to warn veterinarians and dog owners of the drugs' risks.
In 1999, 300 pet owners filed a lawsuit against Pfizer Inc., alleging that its early dog arthritis medicine Rimadyl had seriously harmed their pets. Pfizer settled in 2003, saying it had done nothing wrong but wanted to avoid costly litigation. Each plaintiff was given $1,000.
The ProHeart 6 case also led to allegations that its manufacturer, Wyeth, had sought to discredit the FDA official overseeing the investigation -- a pattern seen with FDA officials who questioned the safety of human drugs.
Victoria Hampshire, the agency official at the center of the ProHeart 6 controversy, was taken off the case and later became a whistle-blower. Her difficulties were documented on the Senate floor last winter by Sen. Charles E. Grassley (R-Iowa). Wyeth maintains that it simply gave the FDA potentially troubling information it found on a Web site about a possible conflict of interest involving Hampshire. The agency cleared her after an investigation, and ProHeart 6 remains off the market.
Hampshire says she became increasingly alarmed after receiving reports of hundreds of dogs dying soon after receiving the heartworm shots, just as more than 350 reports of deaths linked to Deramaxx have come into the FDA's Center for Veterinary Medicine. As with adverse reactions in people, the number of reported cases is generally believed to represent less than 10 percent of the true total.
Hampshire, who now works in a different FDA division, said she learned about many cases from distraught pet owners such as Demitry Herman, a manager with Lehigh Electric in Allentown, Pa.
"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."