Vioxx Debate Echoed in Battle Over Dog Drugs
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 The widely used ProHeart 6 heartworm treatment was the subject of controversy several years ago and was withdrawn from the market in 2004 following reports that healthy dogs were becoming sick and dying after getting a shot of the preventive medicine.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.