The following is Dr. W. Jean Dodds' letter of support for "Molly's Bill", AB 2000, and her refutation of the California Department of Public Health's opposition:
PERMISSION GRANTED TO CROSS-POST
June 14, 2010
The Honorable Curt Hagman
California State Assembly
State Capitol, Room 4116
Sacramento, CA 95814
Re: CA Assembly Bill AB2000
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,
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 their products. 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;
President, Hemopet
