See Dr. Jean Dodd's response to this scientifically illiterate woman's
statement:
RABIES CHALLENGE FUND
c/o HEMOPET
11561 Salinaz Avenue
Garden Grove, CA 92843
714-891-2022; Fax 714-891-2123
www. rabieschallengefund.org
June 14, 2010
The Honorable Curt Hagman
California State Assembly
Re: CA Assembly Bill AB2000
State Capitol, Room 4116
Sacramento, CA 95814
Sent by e-mail to _saulo.londono@gmail.com_
(mailto:saulo.londono@gmail.com)
Dear Assembly Member Hagman:
I learned today from your staff person, Saulo Londono, that the California
Department of Public Health (CDPH) has officially opposed your sponsored
bill AB 2000. This decision by the CDPH is a huge step backwards for
veterinary health care professionals, like myself, who need to be able to
justify
exemption from rabies vaccine boosters on a case-by-case basis. Your bill
AB 2000 would permit a safe alternative for dogs whose illnesses were
caused by a rabies vaccine, as well as those too sick to tolerate the
rabies
vaccine because of terminal cancer, kidney/liver failure, grand mal
seizures,
and other chronic diseases.
The CDPH letter of June 8, 2010 states that “there is no scientific
evidence that rabies vaccines are associated with severe or a high rate of
vaccination reactions.” This statement is just false. The letter goes on
to
state that “Modern rabies vaccines are safe and effective”, and that “A
recent study published by the U.S. Department of Agriculture (USDA) found
that
rabies vaccines used for dogs —- do not result in a high frequency or
unexpected pattern of adverse events.” On the contrary, this same cited
study
found:
Rabies Vaccines and the USDA/CVB
Rabies vaccines are the most common group of biological products
identified in adverse event reports received by the USDA’s Center for
Veterinary
Biologics (CVB). Currently, 14 rabies vaccines are labeled for use in
dogs.
Before licensure, a product must be shown to be safe through a combination
of safety evaluations. The field safety trial is the most comprehensive
evaluation and has the objective of assessing the safety of the product in
its
target population under the conditions of its intended use. However, safety
studies before licensure may not detect all safety concerns for a number
of reasons, as follows: insufficient number of animals for low frequency
events, insufficient duration of observation, sensitivities of
subpopulations
(e.g. breed, reproductive status, and unintended species), or interactions
with concomitantly administered products.
Reporting Adverse Vaccine Reaction to Manufacturer and the Government
There is no mandatory reporting of adverse reactions in veterinary
medicine. The 2007 World Small Animal Veterinary Association (WSAVA)
Vaccine
Guidelines states that there is: “gross under-reporting of
vaccine-associated
adverse events which impedes knowledge of the ongoing safety of these
products.” WSAVA 2007 Vaccine Guidelines _http://www.wsava.org/SAC.htm_
(http://www.wsava.org/SAC.htm)
Despite the serious under-reporting of vaccine-associated adverse
reactions, the 2008 Report from the USDA’s CVB [JAVMA 232:1000-1002, 2008],
states
that between April 1, 2004 and March 31, 2007, they “requested
manufacturers of rabies vaccines to provide adverse event report summaries
for
theirproducts. During this period, nearly 10,000 adverse event reports
(all animal
species) were received by manufacturers of rabies vaccines. Approximately
65% of the manufacturer’s reports involved dogs.”
The USDA/CVB 2008 Report further states that “Rabies vaccines are the most
common group of biological products identified in adverse event reports
received by the CVB.” During the 3-year period covered in this report,
the
CVB received 246 adverse event reports for dogs in which a rabies vaccine
was identified as one of the products administered.
The following clinical terms were listed “to describe possibly related
adverse events in dogs vaccinated against rabies “ and reported to the
USDA/CVB between April 1, 2004-March 31, 2007. For 217 adverse event
reports – the
clinical term is followed by the % of dogs affected:
Vomiting-28.1%; facial swelling-26.3%; injection site swelling or
lump-19.4%; lethargy-12%; urticaria-10.1%; circulatory shock-8.3%;
injection site
pain-7.4%; pruritus-7.4%; injection site alopecia or hair loss-6.9%;
death-5.5%; lack of consciousness-5.5; diarrhea-4.6%; hypersensitivity (not
specified)-4.6%; fever-4.1%;, anaphylaxis-2.8%; ataxia-2.8%; lameness-2.8%;
general signs of pain-2.3%; hyperactivity-2.3%; injection site scab or
crust-2.3%;, muscle tremor-2.3%; tachycardia-2.3%; and
thrombocytopenia-2.3%.
The overall adverse report rate for rabies vaccines was determined to be
8.3 reports/100,000 doses sold. Adverse events considered possibly related
to vaccination included acute hypersensitivity (59%); local reactions
(27%); systemic reactions, which refers to short-term lethargy, fever,
general
pain, anorexia, or behavioral changes, with or without gastrointestinal
disturbances starting within 3 days after vaccination (9%); autoimmune
disorders (3%); and other (2%).
While there may be no contraindications listed on the label for canine
rabies vaccines, the labeling instructions on vaccine products clearly
instruct veterinarians to only vaccinate healthy dogs. I submit that the
dogs for
which medically justified exemptions from rabies boosters are sought are
not healthy.
The CDPH “believes that passage of AB 2000 could increase the risk to the
public health by allowing dogs to be exempted from current rabies
vaccination requirements.” This statement lacks credibility, as the number
of dogs
eligible for exemptions statewide would be small and such exemptions
require that a primary care veterinarian justify them on a case-by-case
basis.
To deny these animals the opportunity to avoid serious or even fatal
adverse events from rabies vaccines just encourages pet owners to break the
law
to save their pets from harm. They would then join the approximate 50% of
pet owners in our State that fail to vaccinate their dogs at all. It is
those that flaunt the law and never comply that we should seek out, rather
than penalizing the few unfortunate pets and owners whose dogs cannot
tolerate rabies boosters.
Finally, the CDPH letter states “ Standard veterinary immunization
protocols already exist to prevent vaccine adverse reactions.” I know of
no such
standard protocols, and further, one often cannot predict which animals
will react adversely without a prior history of reaction or family
predisposition.
Sincerely,
W. Jean Dodds, DVM
Co -Trustee, _Rabies Challenge Fund Charitable Trust_
(http://rabieschallengefund.org/) ;
President, _Hemopet_ (http://hemopet.org/)
The Rabies Challenge Fund is a 501(c)(3) charitable organization [Fed.
EIN # 84-6390682]
Hemopet, dba Pet Life-Line, is a 501(c)(3) charitable organization [Fed.
EIN # 95-4063237]
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