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Is it possible that YOUR VET could be a Pfizer DALE VET?

Thanks to Laurryn for providing the link to this article.

Jean
(Always for George - Always for the Rimadyl Dogs)
http://hometown.aol.com/luswinton/myhomepage/memorial.html

In a message dated 6/2/2006 5:49:17 A.M. Eastern Daylight Time,
LptimmTruckin writes:

_http://www.presspublications.com/pages/stories/mstories03.asp_
(http://www.presspublications.com/pages/stories/mstories03.asp)
(Ohio) Press Publications:


* Opinion
Extra-label use of drugs tricky for vets


By Melissa Burden
Special to The Press
Veterinarians commonly administer or prescribe drugs in ways unapproved by
the Food and Drug Administration’s Center for Veterinary Medicine (CVM) to
treat a variety of conditions and diseases. The FDA, the government agency
responsible for overseeing drug safety, allows the widespread practice because
it
does not want to interfere with medical decision-making.
Indeed, drugs used extra-label or “off-label,” have saved the lives of many
pets, particularly when there are no alternatives for treatment of severe and
chronic illnesses.
Veterinarians can use drugs extra-label when the health of an animal is
threatened, or suffering or death may result from failure to treat, according
to
Linda Grassie, communications director at the FDA. The agency explicitly
prohibits drug manufacturers from promoting or recommending the extra-label use
of drugs or medical devices. In doing so, the FDA wants to keep companies from
skirting requirements to test the safety and efficiency of a drug before it
goes to market.
But in practice, what is promotion and widespread discussion of extra-label
use of drugs among vets can be unclear.
“Whena pharmaceutical company that is the `sponsor’ of an approved animal
drug `instructs’veterinarians in the extra-label use of their products, the
legality of such instruction depends on a number of factors,” said Grassie.
“
In general, FDA does not intend to interfere with bona fide continuing medical
education (CME) of veterinary practitioners. However, continuing medical
education events are frequently paid for by drug sponsors. The information
being
provided can easily cross the line between `education’ and `promotion.’
When drug sponsors promote use of their FDA approved products for indications
or
dosages that are not part of the approval, this tends to violate the Federal
Food, Drug, and Cosmetic Act.”
Veterinarians at the Sylvania Veterinary Hospital, on Holland-Sylvania Road,
say the extra-label use of Domitor (medetomidine) a potent sedative, was
widely discussed at CME seminars held by Pfizer, which manufactures the drug.
Domitor, according to the label, can be used to sedate dogs for short
procedures, such as teeth cleaning and minor surgeries not requiring muscle
relaxation.
The facility, which provides round the clock care, routinely uses Domitor on
dogs after surgery, an extra-label use.
Dr. Robert Esplin and Dr. Ross Mahowald, veterinarians at the hospital, said
discussion of the drug’s extra-label use occurred at two seminars funded by
the drug giant as part of its DALE (Domitor Antisedan Local Expert) program.
Mahowald was among 400 veterinarians invited by Pfizer to go on an
all-expense paid trip to Chicago to attend the seminars, said Esplin, who
occasionally
appears on Channel 13's "Ask the Expert," segment and "Ask Dr. Bob" on radio
station Star 105 FM. Pfizer chooses vets already using the drug at a "high
rate" for the DALE program, according to Pfizer.
“We had very limited material on Domitor before I went to the seminar,”
Mahowald said. "We discussed how Domitor was used, different methods, and how
it
is used in different species.”
Agent of Pfizer
Vets in the DALE program sign one year contracts with Pfizer, who expects
them to schedule seminars for area veterinarians to discuss the “new uses" of
Domitor, Mahowald said. Pfizer pays DALEs for each seminar they hold.
Mahowald called discussion of extra-label use of Domitor at the seminars “a
matter of semantics.”
“I believe discussion is the same as recommendation,” said Mahowald. “When
I signed the contract, I am acting as a representative of Pfizer and I am able
to discuss off-label use with other vets.”
Barry Poole, of the FDA, said drug companies, and their representatives,
cannot recommend or promote a drug for any indication unapproved by the FDA,
“
either in writing or by word of mouth.”
“You can’t recommend off-label,” he said. “That is promoting. That’s
what
the law says.”
S. Kristina Wahlstrom, DVM, MS, group director, U.S. Companion Animal
Veterinary Operations for Pfizer, said the company does not recommend
extra-label
use of Domitor at DALE seminars.
Pfizer, she agreed, signs DALEs to become "agents" of the drug company upon
completion of the seminars, but “they are under the same regulations we are,
in that they cannot promote the extra-label use of Domitor.”
DALEs can tell other vets about Domitor's extra-label uses, but only if they
are asked, per FDA regulations, she said.
“If someone asks them about an extra-label use, they have to tell the vet
that what they're considering doing with the drug is extra-label,” she said.
“
The DALE can then give the vet the information, if they have it, on the
specific extra-label use. DALEs then have to remind the vet again that it is an
extra-label use.”
Robert Fauteux, public relations representative at Pfizer, also said Pfizer
does not recommend extra-label use of Domitor.
DALEs, as agents of Pfizer, are "obligated to comply with the regulations
that govern Pfizer employees," he said.
Veterinarians who attend DALE seminars are paid for their travel, lodging
and meals. Additionally, they receive $500 in honoraria to compensate for their
time, said Fauteux.
Safety is an issue when drug companies promote the extra-label use of drugs,
said Grassie.
“We do not have evidence of the safety and effectiveness of the drug for the
unapproved indication,” she said. Extra-label promotion, “may mislead a
medical or veterinary practitioner to use a product inappropriately” for an
extra-label use.
Domitor, according to its label, is contraindicated in dogs with underlying
health conditions, including liver, heart and kidney disease, respiratory
disorders, fatigue, dogs that are in shock, or are severely debilitated.
Special
care is recommended when treating very young animals, debilitated older
animals, coughing dogs, or dogs in poor general condition, says the label.
Clinical trials of Domitor, approved by the FDA in 1996, concluded that it
is mostly safe and effective so long as it's used "according to the label."
Sylvania Veterinary Hospital, according to Mahowald, routinely uses Domitor
on dogs after surgery to keep them sedated and quiet, an extra-label use.
Esplin and Mahowald still support the DALE program. Mahowald's contract with
Pfizer expired, though he would not hesitate to hold future seminars on the
drug.
"Extra label use allows us the flexibility to include the drug in multiple
protocols,” Mahowald said.
Esplin agreed. “I have used it enough that I am comfortable and confident to
use it in a lot of scenarios.”
Facts on label
A drug’s label “is the first source of important facts for veterinarians,"
Dr. Victoria Hampshire, former adverse drug events coordinator in the office
of surveillance and compliance in the FDA's Center for Veterinary Medicine,
said in a Jan. 15, 2004 article in the Journal of American Veterinary Medical
Association (JAVMA).
“The label is the result of considerable scientific regulatory review before
CVM approves the drug,” she said.
“Product precautions, contraindications, safety information, and warnings
should identify animal patients that are not good candidates for the
medication,
” she said.
But Wahlstrom leaves it to veterinarians to conduct a risk/benefit
assessment of an animal before the drug is used.
The drug industry for years has been under fire for promoting extra-label
use of human drugs, which reportedly expands their profit margin.
Promotional activities of drug companies and others are substantially
motivated by profit and market expansion, William B. Schultz, former deputy
commissioner for policy and drug administration in the U.S. Department of
Health and
Human Services, said before a Senate committee in 1996.
"If drug companies were allowed to freely promote extra-label uses, there
would be no incentive to conduct or fund the necessary scientific research and
to present data to FDA to verify the safety and efficacy of those
extra-label uses," said Schultz.
The FDA can take a number of enforcement actions against drug companies,
ranging from sending a warning letter, to injunctions, and even criminal
prosecution, according to Grassie.
The Sylvania Veterinary Hospital promotes Mahowald as a DALE on its website,
and touts the “several new ways we will be able to use Domitor."
“We have used this drug for many years," says the website. Mahowald,
described as "a local expert" on the use of Domitor, "will be conducting
several
seminars for other local veterinarians and their staff."
Since becoming a DALE, Mahowald has yet to hold a seminar, but held a
lecture for the facility’s staff concerning new uses of the drug.
Two seminars for local vets had been scheduled, he said, but were canceled
by Pfizer's area representative.
Pfizer awarded four veterinarians with trips to Hawaii in May, 2004, to
attend a national dermatology conference. A veterinarian at Sylvania Veterinary
Hospital was among the winners, according to the facility's website.
Features editor Tammy Wilhelm contributed to this report
To comment on this story, email _mic@..._
(mailto:mic@...) .
(Also, posted with permission:
_http://www.dogsadversereactions.com/extralabel.html_
(http://www.dogsadversereactions.com/extralabel.html) )



Laurryn~
"Got Dogs?"




_www.DogsAdverseReactions.com_ (http://www.dogsadversereactions.com/)


To SAY nothing......... to DO nothing......... STOPS nothing.......



UN-known risks are UN-acceptable






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