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In a message dated 5/12/2006 7:33:02 A.M. Eastern Daylight Time,
LptimmTruckin writes:

Hi!

Please click on the following link to read the item:
_http://daily.washpost.com/Repository/ml.asp?Issue=WPost/2006/05/12&ID=Ar00105
&Mo\
de=HTML_
(http://daily.washpost.com/Repository/ml.asp?Issue=WPost/2006/05/12&ID=Ar00105
&Mode=HTML)

(_http://daily.washpost.com/Repository/ml.asp?Issue=WPost/2006/05/12&ID=Ar0010
5&Mode=HTML_
(http://daily.washpost.com/Repository/ml.asp?Issue=WPost/2006/05/12&ID=Ar00105&M\
ode=HTML) )



Laurryn~
"Got Dogs?"

Laurryn:

We all need to express our thanks to Marc Kaufman ( _kaufmanm@..._
(mailto:kaufmanm@...) ) of the Washington Post Staff for his
excellent article -

See:
_http://daily.washpost.com/Repository/getFiles.asp?Style=OliveXLib:ArticleToMail\
&Type=text/html&Path=WPost/2006/05/12&ID=Ar00105_
(http://daily.washpost.com/Repository/getFiles.asp?Style=OliveXLib:ArticleToMail\
&Type=text/html&Pa
th=WPost/2006/05/12&ID=Ar00105)


Jean Townsend - Johns Island, SC
(Always for George - Always for the Rimadyl Dogs)
B. A. R. K. S.
(Be Aware of Rimadyl's Known Side-effects)
_http://hometown.aol.com/luswinton/myhomepage/memorial.html_
(http://hometown.aol.com/luswinton/myhomepage/memorial.html)

QUOTE:
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 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 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 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.

“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 wouldn’t 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.”

Herman’s 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.

FDA’s 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. There’s no pharmacist
involved, and so there’s no monitoring of prescriptions. And, of course, the
patient
can’t talk and tell you he doesn’t feel right.”

Hampshire remains concerned about her agency’s 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 Service’s award for veterinarian of the year. “I think a lot of
people
[in the agency] didn’t want to hear what I was saying.”

Because veterinarians dispense animal drugs themselves, their role is at the
center of the debate. The FDA’s Sundlof and Novartis’s 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 “it’s just not the be-all
and
end-all of the communication that’s 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
consumer’s 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.”
(picture of Kasi removed from this e-mail as attachments are not allowed on
doghealth2.)

_WWW.DOGSADVERSEREACTIONS.COM_ (http://www.DOGSADVERSEREACTIONS.COM) Kasi
died shortly after taking ProHeart 6 heartworm medication. Owner Staci Walker
sued Wyeth.
END QUOTE






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