In the past you may have seen television commercials showing previously lame dogs jumping and running about like young puppies. These commercials were promoting Rimadyl, a drug introduced in 1997 by Pfizer Chemical for the treatment of hip dysplasia and arthritis in dogs. What the commercials carefully avoided was any mention of the side effects of Rimadyl in dogs.
Today it’s no longer possible to see those commercials because the advertising was halted by Pfizer for good reasons. As a dog owner, we are indebted to dogs like Montana, a six-year-old Siberian husky who had stiff legs. Montana was prescribed Rimadyl by his veterinarian and at first the drug appeared to work well. But then Montana lost his appetite, wobbled when he walked, and finally was unable to walk at all. He began vomiting and had seizures; eventually his owner was forced to put him to sleep. An autopsy was performed which showed the presence of liver damage that could only be associated with a harmful drug reaction.
Drugs for pets are big business in the United States, as well as in many other countries where pet animals are valued. It is estimated that world-wide, the sale of these drugs total more than 3-1/2 Billion dollars annually. Rimadyl is one of the bestselling drugs included in this estimate.
Rimadyl has been prescribed for more than four million dogs in the United States alone, and has earned Pfizer tens of millions of dollars. After introducing the drug, the company ran full-page magazine ads and a public-relations campaign that resulted in 1,785 print stories, 856 radio reports and more than 200 television news reports of the benefits of Rimadyl. What dog owner whose beloved pet was suffering from arthritis or hip dysplasia wouldn’t want such a “miracle drug” for their pet?
But Rimadyl has also resulted in many debates and intense arguments between veterinarians and pet owners who were furious that they were not warned of the risks of giving their pets Rimadyl.
After Montana’s owner contacted Pfizer and the Food and Drug Administration to complain about the early and untimely death of her dog, Pfizer offered to pay her $440 in what they called “a gesture of good will.” Today we can be thankful that Montana’s owner was insulted by Pfizer’s offer and their lawyers’ stipulation that she tell no one about the payment (or bribe as some would call it). She refused to sign any of Pfizer’s proffered documents and would not accept any money. She felt it was an affront both to her and to the memory of Montana to absolve Pfizer of any blame.
As additional reports of serious reactions and the deaths of many dogs started pouring into the FDA, the agency recommended that Pfizer list “death” as a possible side effect in a warning letter to veterinarians and also place a warning on the drug labels. Pfizer indicated this “would be devastating to the product” and after much stalling, eventually was forced to put the word “death” on Rimadyl’s labels and notify all veterinarians in writing.
The strongest blow to Pfizer’s inappropriate labeling and advertising was the FDA’s requirement that they mention the same warning on their television ads. When given an ultimatum about their commercials mentioning “death” or else pulling the ads, Pfizer chose to stop all television ads for Rimadyl. Although this came too late to save the life of Montana, he and his owner should be credited with bringing pressure to bear on the FDA and Pfizer and forcing them to begin warning of the possible serious side effects of Rimadyl.
Since the introduction of Rimadyl in 1997, the FDA has received reports of more than 1,000 dogs that died or had to be put to sleep, and 7,000 more that had serious adverse reactions after taking the drug.
Despite these serious side effects, the FDA has not ordered the removal of Rimadyl from the marketplace. The FDA requires safety and efficacy testing for animal drugs just as it does for human drugs. However, animal drug tests are conducted with a much smaller number of test subjects. Pfizer used about 500 dogs in their trials of Rimadyl, which is less than one fifth the number of subjects used in most human-drug trials. During Pfizer’s Rimadyl trials, some dogs developed unusual liver-function readings and one young beagle tested on a high dose of the drug died.
Neither the FDA or Pfizer found these effects alarming, and the drug was subsequently approved. A consumer group has mounted a campaign against Pfizer called BARKS, which stands for ”Be Aware of Rimadyl’s Known Side-effects.” Hopefully this organization will be able to influence more dog owners to carefully consider very seriously whether or not to have Rimadyl prescribed for their pet dog.