Vioxx
Debate Echoed in Battle Over Dog Drugs
By
Marc Kaufman Washington Post Staff Writer
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 its the center
of another drug controversy. But this medication isnt for people. Its 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 publics willingness to pay
for them. Most companies that now develop and sell pet drugs are subsidiaries or
divisions of the major brandname 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withdrawn from the market in 2004 following reports that healthy dogs were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 Pro-Heart 6 controversy, was taken off the case
and later became a whistleblower. Her difficulties were documented on the Senate
floor last winter by Sen. Charles E. Grassley (RIowa). 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 FDAs 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 - 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 wouldnt 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.
Hermans 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.
FDAs 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. Theres no pharmacist involved, and so theres no monitoring of
prescriptions. And, of course, the patient cant talk and tell you he doesnt
feel right.
Hampshire remains concerned about
her agencys 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 Services
award for veterinarian of the year. I think a lot of people [in the agency]
didnt want to hear what I was saying.
Because
veterinarians dispense animal drugs themselves, their role is at the center of
the debate. The FDAs Sundlof and Novartiss 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 its just not the
be-all and end-all of the communication thats 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 consumers 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. WWW.DOGSADVERSEREACTIONS.COM
Kasi died shortly after taking ProHeart 6 heartworm medication. Owner
Staci Walker sued Wyeth.
