July/August 2010 - Dogs Naturally Magazine

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 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. “
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 problem.""
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 problem.
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 labelling at a later date."" So the term
didn't appear in the first warning Pfizer sent, in mid-1997.
www.dogsnaturallymagazine.com July/August 2010 | 35