Rimadyl – Most Arthritic Dogs Do Very Well Except Ones That Die
Most Arthritic Dogs Do Very Well On Rimadyl, Except Ones That Die
Article Courtesy of Chris Adams Staff Reporter of THE WALL STREET JOURNAL
March 13, 2000
You might call it a made-for-TV drug. Approved for human
use in the U.S. but not marketed that way, an arthritis medicine called Rimadyl
languished for nearly 10 years in developmental limbo, then emerged in a
surprising new form: Instead of a human drug, it was now a drug for arthritic
dogs. And it became a hit.
With the aid of slick commercials featuring
once-lame dogs bounding happily about, Rimadyl changed the way veterinarians
treated dogs. “Clients would walk in and say, ‘What about this Rimadyl?’ ” says
George Siemering, who practices in Springfield, Va.
Video Below - Rimadyl Lawsuit Boulder Couple Settles Lawsuit Over Death Of Dog March 27, 2013 – denver.cbslocal.com
Today, those TV spots
are gone. The reason has to do with dogs like Montana.
six-year-old Siberian husky with stiff back legs, Montana hobbled out of a vet’s
office in Brooklyn, N.Y., six months ago accompanied by his human, Angela
Giglio, and a supply of Rimadyl pills. At first, the drug appeared to work. But
then Montana lost his appetite. He went limp, wobbling instead of walking.
Finally he didn’t walk at all. He ate leaves, vomited, had seizures and,
eventually, was put to sleep. An autopsy showed the sort of liver damage
associated with a bad drug reaction.
Pet drugs are big business — an
estimated $3 billion world-wide — and Rimadyl is one of the bestsellers. It has
been given to more than four million dogs in the U.S. and more abroad, brought
Pfizer Inc. tens of millions of dollars in sales, and pleased many veterinarians
and dog owners. But the drug has also stirred a controversy, with other pet
owners complaining that nobody warned them of its risks.
Ms. Giglio, is among them. After she informed Pfizer and the Food and Drug
administration of her relatively youthful dog’s death, Pfizer offered her $440
“as a gesture of good will” and to cover part of the medical costs. Insulted by
the offer and a stipulation that she agree to tell no one about the payment
except her tax preparer, she refused to sign and didn’t take the money. “There’s
just no way in my conscience or heart I can release them from blame,” she says.
After reports of bad reactions and deaths started streaming in to the FDA,
the agency suggested that Pfizer mention “death” as a possible side effect in a
warning letter to vets, on labels and in TV ads. Pfizer eventually did use the
word with vets and on labels, but when given an ultimatum about the commercials
— mention “death” in the audio or end the ads — Pfizer chose to drop them.
Pfizer’s director of animal-products technical services, Edward W. Kanara,
says that when reports started coming in, “we acted extremely promptly based on
the information we had.” Pfizer points out that reported adverse events involve
less than 1% of treated dogs.
Since Rimadyl’s 1997 launch, the FDA has
received reports of about 1,000 dogs that died or were put to sleep and 7,000
more that had bad reactions after taking the drug, records and official
estimates indicate. The FDA says such events are significantly underreported.
While the numbers include cases “possibly” related to Rimadyl, it is hard to
be sure. Many dogs given the arthritis drug are older, and few are autopsied
after they die. Pfizer says it analyzed cases of Rimadyl treated dogs that died
in 1998 and found a link to Rimadyl to be “likely” in 12% of cases and “not
likely” in 22%; it says there was too little information for a judgment about
Despite these problems, the FDA says
Rimadyl deserves to be on the market, provided vets take the proper precautions.
These include advising dog owners what bad reactions to watch for and
periodically doing liver-function or other lab tests.
Within a few weeks,
Pfizer will begin affixing a safety sheet directly to packages of Rimadyl pills.
It is the first time either FDA officials or Pfizer can recall such a step being
taken in the world of animal drugs.
Rimadyl — generically carprofen — is
an anti-inflammatory medicine. Developer Roche Laboratories expected to market
it for people in 1988 and received FDA approval, but shelved the plan after
concluding the market for such drugs was too crowded. In addition, some outside
experts expressed concerns; a commentary in a pharmaceutical journal noted
unusual liver-function readings in 14% to 20% of test subjects and opined that
“until additional data on carprofen are available, older compounds should
probably be tried initially.”
The idea of switching the product to the
animal-drug track soon arose. A couple of corporate transactions later, it ended
up in the hands of Pfizer’s animal-drug unit.
There, it was treated to
the kind of sophisticated marketing Pfizer does well. A survey of 885 dog owners
was done. Besides shedding light on favorite dog names (Jake, Ginger, Lady), the
poll revealed that one-fifth of dog owners would be willing to spend “whatever
it took” to buy an aging dog an extra year or two of life. No fewer than 53%
agreed that “my dog is a better companion than other members of my family.”
The FDA requires safety and efficacy testing for animal drugs just as for
human ones, but animal-drug tests are smaller. Pfizer says about 500 dogs got
Rimadyl in various trials, which is no more than a fifth of the number of
subjects in comparable human-drug trials. Some dogs showed unusual
liver-function readings and one young beagle on a high dose died, but for the
most part, the FDA and Pfizer didn’t find side effects alarming. The drug was
approved for an early-1997 launch.
That same year, the FDA made it easier
to market drugs directly to consumers on TV. Soon, Pfizer was running
commercials in which a once-stiff yellow Labrador retriever named Lady bounded
over a fallen tree as she fetched tennis balls beside a lake. In another ad, a
dog leapt through a window and slid down a banister.
There were also
full-page magazine ads and a public-relations campaign, whose results, the PR
firm later said, included 1,785 print stories, 856 radio reports and 245 TV news
reports “generating 25.5 million positive impressions on the product.”
Early on, vets were floored by the drug’s effects. “The results in some cases
have been pretty darn close to miraculous,” says David Whitten of the Hilldale
Veterinary Hospital in Southfield, Mich. “I’m using this drug on my own dog. It
has been effective. But as with all medications, side effects are certainly a
The First Complaints
Indeed, within months of the
launch, vets at Colorado State University in Fort Collins noticed troubling
reactions. Labrador retrievers seemed particularly affected. Since the safety
studies for Rimadyl had emphasized testing on young beagles, Pfizer went back to
conduct another, small test just on Labs; it says that test showed no particular
Bill Keller, an FDA veterinary-medicine official, notes that
“any time you take a product from the investigation and put it into actual
practice, you’re going to see things you didn’t expect.” But reports about
Rimadyl came in by the hundreds. The FDA had received just over 3,000
animal-drug bad-reaction reports in 1996, the year before Rimadyl’s launch; in
1998, the drug’s first full year, Rimadyl alone produced more than that many.
They swamped the FDA’s tiny Center for Veterinary Medicine in Rockville, Md.
Pfizer was scrambling as well. “Basically, their response,” says Dr. Keller,
“was ‘Tell us what you want us to do. We love the fact that it’s selling so
well, but we don’t know what to do with all these adverse reactions.’ ”
The FDA and Pfizer discussed a “Dear Doctor” letter to be sent to vets. FDA
records show the agency found parts of an early Pfizer draft “unacceptable as
they are promotional in tone… .” It was revised.
The records also show
Pfizer disagreed with the FDA’s suggestion that the letter cite “death” as a
possible side effect. To get the letter out, the FDA told Pfizer it was
“agreeing to your exclusion of the ‘death’ syndrome from the letter at this
time. However, we will revisit the ‘death’ syndrome issue and other potential
side effects for possible inclusion in labeling at a later date.” So the term
didn’t appear in the first warning Pfizer sent, in mid-1997.
Meanwhile, dog owners were asking for Rimadyl. “It was their
advertising that sold me on the drug,” says Michelle Walsh, a Phoenix woman who
says her miniature schnauzer was given it and later died.
Not that vets
needed much convincing. They saw clear benefits from the drug. On top of that,
they could get points from Pfizer for each Rimadyl purchase they made; points
were redeemable for PalmPilots, Zip drives for PCs and other equipment.
Although Pfizer’s letter told vets to explain to owners the signs of a bad
reaction to Rimadyl, such as vomiting, lethargy or diarrhea, it is evident that
a great many didn’t. The FDA’s Dr. Keller says, “There are a lot of
veterinarians who don’t think they need to take the time, or who forget, or for
whatever reason are not providing animal owners with this information.”
Donna Allen, whose chow-mix, Maggie, started on Rimadyl last summer, says, “All
my vet did was give me this little bag of pills, with no information.” She says
Maggie “didn’t want to take it, but I made her.”
After four weeks, Maggie
began to vomit violently, Ms. Allen says. The dog vanished from their home
outside Birmingham, Ala., and later was found lying in a ditch. Ms. Allen loaded
her into a truck and sped 35 miles to a veterinary clinic, but the five-year-old
dog died. Her vet wouldn’t implicate Rimadyl in the death until Ms. Allen urged
him to send the dog’s internal organs to the University of Illinois vet school,
where an examination showed liver toxicity.
Maggie was buried under a
marker adorned with the figure of an angel. And Ms. Allen took to the streets,
delivering a letter to all the vets in the area urging them to “understand that
Rimadyl helps certain dogs, but it is poison to other dogs.”
As the complaints poured in, the FDA told Pfizer it would have to revisit
the label issue. Pfizer had referred to “fatal outcomes” on the label as a
possible effect of the drug class to which Rimadyl belonged, but not
specifically of this drug. Now the agency asked that Pfizer cite “death”
prominently as a possible side effect of the drug. Describing the back and forth
with Pfizer, the FDA’s Dr. Keller says, “They did it. They weren’t enthusiastic
about it, but they have always been cooperative. And that’s part of the nature
of the game we play with industry.”
But the FDA also wanted the word
“death” in the audio of commercials. Pfizer indicated this “would be devastating
to the product,” FDA minutes of a February 1999 meeting show. A company
spokesman says that “putting ‘death’ on a 30-second commercial and in proper
context was something we didn’t think was possible.” Rather than do so, it
eventually pulled the commercials.
Pfizer says it now will do traditional
marketing to vets, making sure they know the proper way to use the drug. Another
“Dear Doctor” letter will soon go out, and the company will start attaching a
safety sheet to pill packages.
Pfizer acknowledges it has a perception
problem with some dog owners; a consumer group, for instance, has mounted a
campaign dubbed BARKS, for Be Aware of Rimadyl’s Known Side-effects. The company
is contacting dog owners who have told their stories on the Internet, and it is
offering to pay medical and diagnostic expenses for some dogs who may have been
harmed by Rimadyl.
But Pfizer stands firmly behind the value of the drug,
of which it says sales have continued to grow. Most vets also remain strongly
behind Rimadyl. Owners, too, generally say they think the drug is important —
they just want to know the risks.
Atlantan Roger Williams gave his
mixed-breed terrier, William, Rimadyl for more than a year and believes it
contributed to the dog’s death. “But if I had to do it all over, I would give my
dog Rimadyl again,” he says. “The difference is I would have known what to
expect. Without Rimadyl, William was miserable. And what’s the point of living
another three years if you’re miserable?”
NOTE: If you’re anything like
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medications given on a regular basis by conventional veterinarians for the
treatment of illnesses/diseases of our precious pets. An excellent natural
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Agility, which is formulated by
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safe alternative with no side effects. Steroids and NSAID’s (non-steroidal
anti-inflammatory drugs) can have medical disadvantages such as pancreatic
disease, diabetes and liver disease to name a few. For complete product details,
If you prefer a glucosamine formula in liquid form, we highly
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