ROMI's Website

PART #9: 

UPDATE Re: Washington State Veterinary Board of Governors

01/12/05

The February 2005 Veterinary Board of Governors Meeting has been cancelled.

The next meeting is scheduled for April 11, 2005 in Kent beginning at 9:00 a.m.

Janelle C. Teachman, Program Manager
Veterinary Board of Governors
Department of Health, HPQA Section Three
P. O. Box 47868
Olympia, WA 98504-7868
(360) 236-4876
Fax: (360) 664-9077
E-mail:  janelle.teachman@doh.wa.gov

"The Department of Health works to protect and improve the health of the people of Washington State"

 1/24/05

"Packaging - RIMADYL Chewable Tablets are scored and contain 25 mg, 75 mg or 100 mg of carprofen per caplet or tablet. Each Chewable Tablet size is packaged in bottles containing 7, 14, 30, 60 or 180 tablets. "

 

and,  "Always provide a Client Information Sheet with prescription. " 

"There are a spectrum of lesions some of which may be related . . . the large intestinal mural lesions suggest penetrating foreign body although a variety of other scenarios are feasible.  This lesion potentially could have been multicentric histologically, and consequences of this type of lesion could result in hepatic changes, and even pulmonary and multicentric inflammation via toxemia/septicemia.  This is of course speculative." 

GIVEN that I was charged by DVM Hammond/Five Corners [verbally] for 'a whole lot of ice', how much 'decomposition' would have occurred when the preliminary report was written/dated 4/26/05 ? ROMI was euthanized on 4/25/04 and in the responses made by DVM Hammond/Five Corners to the Better Business Bureau [previously supplied] that DVM Hammond offered that she could "attest" to ROMI's body having been picked up/transported by 3:00 p.m. on 4/25/04, that same day.  Was ROMI even transported to DVM Murnane/Phoenix Central Laboratory?  Or is it just possible that ROMI's body was otherwise 'disposed of' and the necropsy report written with the purpose of destroying the evidence of the cause of ROMI's death?  

 

IF PROPER/ADEQUATE REFRIGERATION HAD BEEN DONE both prior to the alleged necropsy being performed [per their notes in the DVM Hammond/Five Corners records regarding the preservation requirements] and during the time-frame(s) the alleged necropsy took place, why then was there so much alleged "autolysis" [decomposition] which then became the excuse/explanation for an inability to definitely state anything regarding the alleged 'findings'? 

 

On page 2 of the DVM Murnane/Central Phoenix Laboratory necropsy report, where it begins the "final report", dated 4/29/04, the statement is made: "Tissues exhibit moderate to more often extensive autolysis significantly impeding evaluation (postmortem condition is downgraded to poor)." and "autolysis" is repeated a number of times in the "Microscopic" section as being the explanation/excuse for the alleged inability to arrive at any definitive diagnosis: "Examination of virtually all organs/tissues is impeded and description and diagnoses are as such tentative."  It would appear that DVM Murnane/Central Phoenix Laboratory also did not provide adequate refrigeration for ROMI's necropsy, again assuming that an actual necropsy even took place.

 

I previously provided the WA Vet Board with the information regarding the alleged 'location' of ROMI's body from both DVM Hammond/Five Corners and DVM Murnane/Phoenix Central Laboratory in which I was given a "choice" that was obviously designed to eliminate any possibility of a 2nd necropsy and DNA identification of ALL of ROMI's remains and based upon that "choice" I hereby allege that BOTH DVM Hammond/Five Corners and DVM Murnane/Phoenix Central Laboratory have "worked in concert" to cover up the true cause of ROMI's death and to continue to fail to provide any evidence that a necropsy was even actually performed. I additionally allege that it's more likely than not that the 'body only' being offered to me [without any of the parts allegedly preserved or access to any of the alleged histology slides] or a choice of 'cremation' may well not even have been ROMI's.  If everything regarding the necropsy was 'legitimate', why is nothing of use for a 2nd necropsy and DNA identification available? Exactly what is being hidden here?   

 2/18/05

below is a true copy of Part #11 filed with the WA Vet Board to be added to the complaint:

NEW ALLEGATION: A WILLFUL disregard of basic animal health & safety resulting in ROMI's horrific death due to not only the inappropriate/illegal prescribing/dispensing of the RIMADYL, but potentially ALSO due to and/or contributed to by "vaccinosis" compromising her immune system and DVM Williams/BVH doing all of these actions at the same office visit time and without any potential for her to have any recovery time because he did all of this at one office visit, and failing to provide any sort of warning/cautionary information to me as to either there being any risks/dangers regarding vaccinations and failing to provide any information as to possible symptoms of an adverse vaccine reaction (what should be looked for), and after my reporting ROMI's symptoms/condition to DVM Williams/BVH, he provided nothing in the way of either supportive care and/or even any information regarding supportive care other than "just watch her", "push fluids" and "let me know how she does" after I refused to give her any more RIMADYL, as had been advised/insisted upon by DVM Williams/BVH.

• I took ROMI into DVM Williams/BVH for the purpose of having her toenails clipped back [note that no information regarding that appears on the DVM Williams records despite DVM Williams having gotten down on the floor and spending at least 15 minutes trimming back her nails - Exhibits #1 and #2] and in response to a reminder card that ROMI's rabies shot was due;
• DVM Williams/BVH gave ROMI a rabies vaccination [Exhibit #2], according to the label provided in his records, of "Imrab 3TF", which is made by Merial.  While I understand that the rabies vaccination is required by "law", I was not given a rabies "tag" or any "certificate" as had been done in the past.  The manufacturer, Merial, specifically states on their label [which I never saw and was never provided any risk/danger information regarding by DVM Williams/BVH] that is it to be given to "healthy" animals only [see Exhibit #132 below] and that there ARE risks/dangers of adverse reactions to rabies vaccines.
• It would appear that it is the USDA, rather than the FDA/CVM, that deals with all vaccines and they have their own and separate location for reporting adverse events [http://www.aphis.usda.gov/vs/cvb/ic/adverseeventreport.htm], which they define as being: "An adverse event is any undesirable occurrence after the use of an immunobiological product, including illness or reaction, whether or not the event was caused by the product."  According to the USDA, there are potential risks/dangers associated with the administration of all vaccines [see Exhibit #133 below], none of which DVM Williams/BVH informed me of, nor did DVM Williams/BVH ever advise me of the symptoms/indications of an adverse reaction (what to be on the lookout for in the event of an adverse reaction.)  The symptoms ROMI was displaying after getting 1) rabies vaccination, 2) the other vaccination, and 3) the RIMADYL, were called into DVM Williams/BVH, are consistent with an adverse vaccine reaction, as well as a RIMADYL reaction, and are documented by his own records, but at NO time did DVM Williams/BVH offer anything other than to state to "keep an eye on her", "push fluids" and "let me know how she does".  The administration of the rabies vaccine, while required by law, would have had the potential of creating STRIKE #1 against ROMI's immune system.
• At the SAME veterinarian visit on 4/13/04 [Exhibit #2], DVM Williams/BVH administered Pfizer's vaccination, "VANGUARD Plus 5", which may not have even been necessary given her age, "lifestyle" and vaccination history per DVM Williams/BVH's own records, and was certainly not required by "law". Once again, the symptoms ROMI was displaying were called into DVM Williams/BVH, are consistent with a vaccine reaction, as well as a RIMADYL reaction, and are documented by his own records, and which additionally could have provided STRIKE #2 to ROMI's immune system per Exhibit #132 outlining the alleged controversial information contained in Exhibits #130 and #131 [below], and again, without any information and/or warnings about possible risks, side-effects and/or symptoms to be on the lookout for and the same lack of interest/concern when I called in and told him of her symptoms.  NOTE: According to Pfizer at: http://www.pfizerah.com/product_overview.asp?drug=V5&country=US&lang=EN&species=CN: "Precautions: As with many vaccines, anaphylaxis may occur after use." 
• And, according to the Merck Veterinary Manual at: http://www.merckvetmanual.com/mvm/index.jsp?cfile=htm/bc/60203.htm&word=anaphylaxis, "(Generalized anaphylactic reactions) Anaphylactic shock occurs in sensitized animals after parenteral injection of vaccines or drugs . . . In people and most domestic animals, lungs are the primary target organ and the portal-mesenteric vasculature is secondary; this is reversed in dogs. Mast cell degranulation in the pulmonary vasculature causes constriction of bronchial airways or pulmonary veins and pooling of blood in the pulmonary vascular bed, which results in severe respiratory distress. Mast cell degranulation in the portosystemic vasculature causes venous dilatation and pooling of blood in the intestines and liver, with resultant shock, agitation, colic, nausea, vomiting and diarrhea, hypersalivation, dyspnea, cyanosis, and in severe cases, death. "  
• And, at the SAME veterinarian visit on 4/13/04 [Exhibit #2], DVM Williams gave a single RIMADYL chewable tablet to ROMI, himself, along with prescribing/dispensing RIMADYL in his own container, which he claimed "was safe" and "would fix her right up" and that ROMI would "consider them [the tablets] as treats", without any of the product information that is supposed to accompany the product and be given to the client/pet owner per both the manufacturer, Pfizer, and the FDA/CVM [previously provided in this complaint], thereby causing STRIKE #3 to ROMI's immune system [previously provided in the e-mail dated 1/24/05 in the FDA/CVM listing of symptoms/conditions known to be csused by and/or associated with RIMADYL].  
• BECAUSE of all of the previously submitted and well-documented shenanigans/manipulations by the DVM Hammond/Five Corners group and the DVM Murnane/Phoenix Central Lab group regarding ROMI's alleged necropsy, it is obvious now that it will NEVER BE KNOWN what and/or what-all caused and/or contributed to ROMI's horrific death, as the alleged "bits and pieces/frozen carcass" per the necropsy report have not been and are still not available for a 2nd necropsy and DNA identification by an unbiased and qualified veterinarian/pathologist. 
• But, there is no doubt that ROMI died a horrific and agonizing death after receiving the "triple whammy" treatment(s) from DVM Williams/BVH which are documented within his own records.

EXHIBIT #131:

 

CHANGING VACCINE PROTOCOLS

 

W. Jean Dodds, DVM
938 Stanford Street
Santa Monica, CA 90403
(310) 828-4804; FAX (310) 828-8251

 

The challenge to produce effective and safe vaccines for the prevalent infectious diseases of humans and animals has become increasingly difficult. In veterinary medicine, evidence  implicating vaccines in triggering immune-mediated and other chronic disorders (vaccinosis) is compelling.  While some of these problems have been traced to contaminated or poorly attenuated batches of vaccine that revert to virulence, others apparently reflect the host=s genetic predisposition to react adversely upon receiving the single (monovalent) or multiple antigen “combo” (polyvalent) products given routinely to animals. Animals of certain susceptible breeds or families appear to be at increased risk for severe and lingering adverse reactions to vaccines. 

 

The onset of adverse reactions to conventional vaccinations (or other inciting drugs, chemicals, or infectious agents) can be an immediate hypersensitivity or anaphylactic reaction, or can occur acutely (24-48 hours afterwards), or later on (10-45 days) in a delayed type immune response often caused by immune-complex formation. Typical signs of adverse immune reactions include fever, stiffness, sore joints and abdominal tenderness, susceptibility to infections, central and peripheral nervous system disorders or inflammation, collapse with autoagglutinated red blood cells and jaundice, or generalized pinpoint hemorrhages or bruises. 

 

Liver enzymes may be markedly elevated, and liver or kidney failure may accompany bone marrow suppression.  Furthermore, recent vaccination of genetically susceptible breeds has been associated with transient seizures in puppies and adult dogs, as well as a variety of autoimmune diseases including those affecting the blood, endocrine organs, joints, skin and mucosa, central nervous system, eyes, muscles, liver, kidneys, and bowel.   It is postulated that an underlying genetic predisposition to these conditions places other littermates and close relatives at increased risk. Vaccination of pet and research dogs with polyvalent vaccines containing rabies virus or rabies vaccine alone was recently shown to induce production of antithyroglobulin autoantibodies, a provocative and important finding with implications for the subsequent development of hypothyroidism (Scott-Moncrieff et al, 2002). 

 

Vaccination also can overwhelm the immunocompromised or even healthy host that is repeatedly challenged with other environmental stimuli and is genetically predisposed to react adversely upon viral exposure. The recently weaned young puppy or kitten entering a new environment is at greater risk here, as its relatively immature immune system can be temporarily or more permanently harmed. Consequences in later life may be the increased susceptibility to chronic debilitating diseases.

 

As combination vaccines contain antigens other than those of the clinically important infectious disease agents, some may be unnecessary; and their use may increase the risk of adverse reactions. With the exception of  a  recently introduced  mutivalent Leptospira spp. vaccine, the other leptospirosis vaccines afford little protection against the clinically important fields strains of leptospirosis, and the antibodies they elicit typically last only a few months. Other vaccines, such as for Lyme disease, may not be needed, because the disease is limited to certain geographical areas. Annual revaccination for rabies is required by some states even though there are USDA licensed rabies vaccine with a 3-year duration. Thus, the overall risk-benefit ratio of using certain vaccines or multiple antigen vaccines given simultaneously and repeatedly should be reexamined. It must be recognized, however, that we have the luxury of asking such questions today only because the risk of disease has been effectively reduced by the widespread use of vaccination programs.

Given this troublesome situation, what are the experts saying about these issues? In 1995, a landmark review commentary focused the attention of the veterinary profession on the advisability of current vaccine practices. Are we overvaccinating companion animals, and if so, what is the appropriate periodicity of  booster  vaccines ?  Discussion of this provocative topic has generally lead to other questions about the duration of immunity conferred by the currently licensed vaccine components.         

In response to questions posed in the first part of this article, veterinary vaccinologists have recommended new protocols for dogs and cats. These include: 1) giving the puppy or kitten vaccine series followed by a booster at one year of age; 2) administering further boosters in a combination vaccine every three years or as split components alternating every other year until; 3) the pet reaches geriatric age, at which time booster vaccination is likely to be unnecessary and may be unadvisable for those with aging or immunologic disorders.  In the intervening years between booster vaccinations, and in the case of geriatric pets, circulating humoral immunity can be evaluated by measuring serum vaccine antibody titers as an indication of the presence of Aimmune memory@. Titers do not distinguish between immunity generated by vaccination and/or exposure to the disease, although the magnitude of immunity produced just by vaccination is usually lower (see Tables).

 

Except where vaccination is required by law, all animals, but especially those dogs or close relatives that previously experienced an adverse reaction to vaccination can have serum antibody titers measured annually instead of revaccination. If adequate titers are found,  the animal should not need revaccination until some future date.  Rechecking antibody titers can be performed annually,  thereafter, or  can be offered as an alternative to pet owners who prefer not to follow the conventional practice of annual boosters. Reliable serologic vaccine titering is available from several university and commercial laboratories and the cost is reasonable (Twark and Dodds, 2000; Lappin et al, 2002; Paul et al, 2003; Moore and Glickman, 2004).

 

Relatively little has been published about the duration of immunity following vaccination, although new data are beginning to appear for both dogs and cats.   
Our recent study (Twark and Dodds, 2000), evaluated 1441 dogs for CPV antibody titer and 1379 dogs for CDV antibody titer. Of these, 95.1 % were judged to have adequate CPV titers, and nearly all (97.6 %) had adequate CDV titers. Vaccine histories were available for 444 dogs (CPV) and 433 dogs (CDV). Only 43 dogs had been vaccinated within the previous year, with the majority of dogs (268 or 60%) having received a booster vaccination 1-2 years beforehand. On the basis of our data, we concluded that annual revaccination is unnecessary. Similar findings and conclusions have been published recently for dogs in New Zealand (Kyle et al, 2002), and cats (Scott and Geissinger, 1999; Lappin et al, 2002).  Comprehensive studies of the duration of serologic response to five viral vaccine antigens in dogs and three viral vaccine antigens in cats were recently published  by researchers at Pfizer Animal Health ( Mouzin et al, 2004).  

When an adequate immune memory has already been established, there is little reason to introduce unnecessary antigen, adjuvant, and preservatives by administering booster vaccines.  By titering annually, one can assess whether a given animal=s humoral immune response has fallen below levels of adequate immune memory. In that event, an appropriate vaccine booster can be administered.

References
Dodds WJ. More bumps on the vaccine road.  Adv Vet Med  41:715-732, 1999.
Dodds WJ.  Vaccination protocols for dogs predisposed to vaccine reactions. J Am An Hosp Assoc 38: 1-4, 2001.
Hogenesch H, Azcona-Olivera J, Scott-Moncreiff C, et al.  Vaccine-induced autoimmunity in the dog. Adv Vet Med  41: 733-744, 1999.
Hustead  DR, Carpenter T, Sawyer DC, et al. Vaccination issues of concern to practitioners. J Am Vet Med Assoc  214: 1000-1002, 1999.
Kyle AHM, Squires RA, Davies PR. Serologic status and response to vaccination against canine distemper (CDV) and canine parvovirus (CPV) of dogs vaccinated at different intervals. J Sm An Pract, June 2002.
Lappin  MR, Andrews J, Simpson D, et al. Use of serologic tests to predict resistance to feline herpesvirus 1, feline calicivirus, and feline parvovirus infection in cats. J Am Vet Med Assoc 220: 38-42, 2002.
McGaw DL, Thompson M, Tate, D, et al. Serum distemper virus and parvovirus antibody titers among dogs brought to a veterinary hospital for revaccination. J Am Vet Med Assoc 213: 72-75, 1998.
Moore  GE, Glickman LT. A perspective on vaccine guidelines and titer tests for dogs. J Am Vet Med Assoc 224: 200-203. 2004.
Mouzin DE, Lorenzen M J, Haworth, et al. Duration of serologic response to five viral antigens in dogs. J Am Vet Med Assoc 224: 55-60, 2004.
Mouzin DE, Lorenzen M J, Haworth, et al. Duration of serologic response to three viral antigens in cats. J Am Vet Med Assoc 224: 61-66, 2004.
Paul MA.  Credibility in the face of controversy.  Am An Hosp Assoc Trends Magazine XIV(2):19-21, 1998.
Paul MA (chair) et al. Report of the AAHA Canine Vaccine Task Force: 2003 canine vaccine guidelines, recommendations, and supporting literature. AAHA, April 2003, 28 pp.

Schultz RD.  Current and future canine and feline vaccination programs.  Vet Med 93:233-254, 1998.
Schultz RD, Ford RB, Olsen J, Scott F.  Titer testing and vaccination: a new look at traditional practices. Vet Med, 97: 1-13, 2002 (insert).
Scott FW, Geissinger CM. Long-term immunity in cats vaccinated with an inactivated trivalent vaccine. Am J Vet Res 60: 652-658, 1999.
Scott-Moncrieff JC, Azcona-Olivera J, Glickman NW, et al.  Evaluation of antithyroglobulin antibodies after routine vaccination in pet and research dogs. J Am Vet Med Assoc 221: 515-521, 2002.
Smith CA.  Are we vaccinating too much?  J Am Vet Med Assoc  207:421-425, 1995.
Tizard  I, Ni Y.  Use of serologic testing to assess immune status of companion animals. J Am Vet Med Assoc 213: 54-60, 1998.
Twark L, Dodds WJ. Clinical application of serum parvovirus and distemper virus antibody titers for determining revaccination strategies in healthy dogs. J Am Vet Med Assoc 217:1021-1024, 2000.
Table 1. “Core” Vaccines *
              Dog        Cat
                            Distemper           Feline Parvovirus
                    Adenovirus                      Herpesvirus
                    Parvovirus           Calicivirus
                    Rabies           Rabies
   _______________________________________
   * Vaccines that every dog and cat should have

 

Table 2.  Adverse Reaction Risks for Vaccines  *

 

  “There is less risk associated with taking a blood sample
  for a titer test than giving an unnecessary vaccination.”
  _______________________________________________
  * Veterinary Medicine, February, 2002.

 

Table 3. Titer Testing and Vaccination *

 

        “While difficult to prove, risks associated with overvaccination
          are an increasing concern among veterinarians. These experts
          say antibody titer testing may prove to be a valuable tool in
          determining your patients’ vaccination needs.”
         _____________________________________________________
         * Veterinary Medicine, February, 2002.

 

Table 4. Vaccine Titer Testing  *

 

  “Research shows that once an animal’s titer stabilizes,
   it is likely to remain constant for many years.”
 _____________________________________________     
  * Veterinary Medicine, February, 2002.     

========================================================

EXHIBIT #132:

 

from: http://merialusa.naccvp.com/view.php?prodnum=1111104

MERIAL LTD.
3239 SATELLITE BLVD., DULUTH, GA, 30096

Telephone:		888-637-4251
Website:		www.merial.com

---

Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert.

---

IMRAB^® 3 TF

Merial

Rabies Vaccine

Killed Virus

DESCRIPTION: IMRAB^® 3 TF contains the same virus strain that is used in the Pasteur Merieux Connaught human vaccine. The virus is grown in a stable cell line, inactivated, and mixed with a safe and potent adjuvant. Safety and immunogenicity of this product have been demonstrated by vaccination and challenge tests in susceptible animals.

INDICATIONS: IMRAB^® 3 TF is recommended for the vaccination of healthy cats, dogs, and ferrets 12 weeks of age and older for prevention of disease due to rabies virus.

DOSAGE: Aseptically inject 1 mL (1 dose) subcutaneously or intramuscularly into healthy cats or dogs. Revaccinate 1 year later, then every 3 years. Inject 1 mL (1 dose) subcutaneously in healthy ferrets. Revaccinate ferrets annually.

PRECAUTIONS: Store at 2-7ºC (35-45ºF). Do not freeze. Shake well before using. Do not use chemicals to sterilize syringes and needles. Contains gentamicin as a preservative. This product does not contain thimerosal. A transient local reaction may occur at the injection site following subcutaneous administration. Some reports suggest that in cats, the administration of certain veterinary biologicals may induce the development of injection site fibrosarcomas. In rare instances, administration of vaccines may cause lethargy, fever, and inflammatory or hypersensitivity types of reactions. Treatment may include antihistamines, anti-inflammatories, and/or epinephrine.

1-888-Merial-1 (1-888-637-4251)

Contains	Prod. No
50 Doses 5 x 1 Dose (1 mL)	2311-50	RM960R1

Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert. NAC No.: 11111040

=====================================================

EXHIBIT #133:

from: http://www.aphis.usda.gov/vs/cvb/ic/vaccinovigilance.htm

1. What is an immunobiologic?

An immunobiologic product (also known as a biological product) is one which modulates the immune system for the prevention, treatment, or diagnosis of disease. Veterinary immunobiologics used to prevent disease include vaccines or toxoids which stimulate an animal to produce antibodies against specific organisms or substances. This is termed active immunization. Passive immunization may be obtained from antibody-containing products such as serum derivatives; they may be used to treat disease. Immunological reactions are increasingly used as the basis of test kits for the diagnosis of disease.

2. How is an immunobiologic produced?

The immunologically active ingredients in an immunobiologic may be either antigens or antibodies. Antigens are derived from killed or attenuated live disease organisms such as viruses and bacteria. Antibodies may be derived from the blood or milk of donor animals who are often immunized against specific antigens. Other components of immunobiologics include the fluid suspension medium, preservatives or antibiotics, stabilizers, and adjuvants, which are substances which enhance the immune reaction. Licensed manufacturers of animal immunobiologics are regularly inspected to verify that production is done in accordance with approved procedures. Products intended for use in animals must be tested for purity, safety, and potency before they may be marketed. As a further check on the manufacturer's quality control, the USDA regularly tests randomly selected lots of all products in its own laboratory.

3. What is the purpose of postmarketing surveillance?

Postmarketing surveillance of veterinary immunobiologics has two main functions. One is to serve as an alert system for detecting the possibility that a product may not be performing as intended. An alert is triggered when information has been received which implicates a product as the cause of events which appear to be unusual in nature or frequency. The immediate response to an alert is an evaluation of the possibility the product is defective. The alert may be confirmed, rejected, or more information may be sought. Confirmation of an alert could trigger an intervention. Fortunately, this is a rare occurrence. Postmarketing surveillance also provides an essential source of descriptive baseline information about the behavior of a vaccine or other immunobiologic when it is used under everyday field conditions. This type of information is a valuable reference in guiding our expectations and comparing situations which appear unusual. Temporal or geographical trends may become apparent.

4. What is an adverse event?

An adverse event is any undesirable occurrence after the use of an immunobiological product, including illness or reaction, whether or not the event was caused by the product.

5. What adverse events may possibly occur after the use of immunobiologics?

Some animals, like people, may be uncomfortable or lethargic the day they are vaccinated. More serious adverse events are a less common possibility. Immune (hypersensitivity) reactions are infrequent but possible after exposure to any immunobiologic as well as many other substances. Acute anaphylaxis with immediate collapse is a dramatic reaction that may happen shortly after vaccination. It is important to observe an animal for at least an hour after vaccination, so that it may be treated if necessary. Other reactions that have been observed within a day of vaccination include loss of appetite, fever, facial swelling, hives, nasal or ocular discharge, respiratory distress, vomiting, or diarrhea. Events occurring a day to two weeks after vaccination include similar events as well as stiffness, local inflammation, and systemic illness which may or may not be based on an immune reaction. If you have any concerns about the health of an animal after the use of an immunobiologic, consult your veterinarian promptly. Your veterinarian is also an important source of guidance about the proper administration of immunobiologics. Not all properly vaccinated animals will be immune to disease under all circumstances. Many factors affect the response of a particular animal to vaccination and the chance that it will subsequently succumb to disease. Such factors include the animal's immune competency, its health at the time of vaccination, stress, environment, and the virulence of the pathogen. Even under optimal conditions, antigens vary widely in the strength and duration of the disease protection they confer. A vaccine may be licensed for the prevention of disease if, in a clinical challenge trial, 80% of the vaccinates were free of the disease. Otherwise, the vaccine may be licensed as an aid in the prevention of the disease.

6. How frequently do adverse events occur?

Good estimates of the rates of various types of adverse events after the use of veterinary immunobiologics are not readily available. The information we have is based on voluntary spontaneous reports to manufacturers and the USDA. While it may be possible to calculate a reporting rate, the relationship between a reporting rate, and an incidence rate is not clear. This relationship may vary by type and severity of event, species, manufacturer, and even from one month to the next. Under appropriate conditions, a reporting rate may sometimes be used to estimate minimum incidence, and for certain comparisons.

7. What happens when an adverse event is reported?

The mission of the USDA is to ensure that animal immunobiologics are in compliance with the Virus-Serum-Toxin Act. Reports are assessed for the possibility of a product deficiency. When necessary, testing is performed or additional information sought. The USDA is, however, unable to make diagnoses or recommendations specific to individual cases. Some of the manufacturers do provide such services. Receipt of a report by the USDA does not necessarily imply that the product caused an adverse event, or even that a particular event actually occurred.

8. How can I report an adverse event?

Veterinary Immunobiologics are regulated by the United States Department of Agriculture, Center for Veterinary Biologics (USDA, CVB) under the Virus-Serum-Toxin Act. The CVB maintains Pharmacovigilance. An adverse event report enters this program through several channels.

Adverse events may be reported to the:

• Manufacturer. Many biologics manufacturers maintain veterinary services departments to handle such reports and may also offer diagnostic advice, treatment recommendations, and guidance on product use.
  

• Center for Veterinary Biologics. Once an adverse event has been reported to the manufacturer, the CVB may be contacted by submission of the electronic Adverse Event Report Form. A PDF version of this form may be downloaded and submitted by FAX to (515) 232-7120 or by mail to the CVB. Adverse events may also be reported by calling the CVB at (800) 752-6255, if necessary.
  
  Veterinary drugs, medicated feeds, and animals devices are regulated by the Food and Drug Administration, Center for Veterinary Medicine (FDA, CVM) under the Food, Drug and Cosmetic Act. The CVM recommends that you first contact the manufacturers to report an adverse event. To contact the CVM directly, call (888) FDA-VETS.

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2/25/05

 

Lee Zavala, Investigator

State of Washington

Department of Health

Board of Governors

 

NOTE: e-Mail copy sent to: Darlene.Tiffany@DOH.WA.GOV to be added/included with the complaint file/materials previously submitted in this matter. 

 

Re:     Case #: 2004-04-0008 VT    

        Lawrence Williams/Burien Veterinary Hospital

        Hammond/Meyer/Baty/Five Corners Veterinary Hospital

        Murnane/Jewett/Phoenix Central Lab

 

Dear Mr. Zavala and Ms. Tiffany:

 

Please acknowledge your receipt of:

 

1. ADD-ON #10: NEW EVIDENCE/ALLEGATIONS and                  SUPPLEMENTAL INFORMATION sent to you 2/18/05.

 

2. ADD-ON #11: NEW EVIDENCE/ALLEGATIONS and                  SUPPLEMENTAL INFORMATION/EXHIBITS for same sent to you 2/23/05.

 

Thank you.

 

Ginger Sanchez

e-Mail [ONLY]: GingerLSanchez@aol.com

 

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Subject:	RE: RECEIPT REQUEST
Date:	2/25/05 1:13:46 P.M. Pacific Standard Time
From:	Lee.Zavala@doh.wa.gov
Reply To: To: GingerLSanchez@aol.com CC: BCC: Sent on:
Sent from the Internet (Details)
Internet Address Card Attached

Greetings Ms. Sanchez,

This e-mail is to acknowledge receipt of your e-mail messages. Please be advise I've talked to the Program Manager regarding your additional information and I have forwarded all the messages.  My portion of the investigation is closed and the Board of Vet Governors now have the case in their hands. I have asked that these additional e-mails be included in the case file.  It is my understanding that the messages will be added to the file. 

 

Thanks and best regards,

Lee Zavala, Health Care Investigator
Investigation Service Unit     MS: TB-33A
20435 72nd Avenue South, Suite 200
Kent, WA. 98032
Phone: (253) 395-6711 FAX: (253) 395-6724
E-mail:  lee.zavala@doh.wa.gov

---

Subject:	Re: RECEIPT REQUEST
Date:	2/25/05 1:50:47 P.M. Pacific Standard Time
From:	Ginger L Sanchez
Reply To: To: Lee.Zavala@doh.wa.gov

2/25/05

 

Lee Zavala, Health Care Investigator
Investigation Service Unit     MS: TB-33A

Hi, Mr. Zavala:

 

Thank you for acknowledging receipt of the last two e-mails and especially for letting me know that the investigation portion of the case has now been closed and that the last two e-mails will be added/included with the case file.

 

I am assuming that with your portion of the case now ended, that you either have or will be providing the Board with a summary/report of your findings.  Are you allowed to tell me whether a copy of such summary/report would be available to me, and if so "when" and what must I do to request it?

 

I want to thank you for the professional attention you gave this matter and for all of your cooperation with the copying projects.  I also want to apologize to you personally for the tremendous amount of e-mails generated by me. 

 

I'll look forward to hearing from you regarding the status of your summary/report.

 

Sincerely, 

 

Ginger Sanchez

e-Mail [ONLY]: GingerLSanchez@aol.com

---

2/26/05

And, 10 months after ROMI's needless/senseless and horrific death, I now listen to the sounds of silence while the Washington State, Veterinary Board of Governors has the complete case.

---

In a message dated 3/15/05 2:17:13 P.M. Pacific Standard Time, Janelle.Teachman@DOH.WA.GOV writes:

03/15/05

 

Ms. Sanchez,

 

The investigative report and all the information you provided to our office has been forwarded to a board member for review.  Once the board member has had a chance to thoroughly review all documentation, the case will be presented to the Veterinary Board for a decision.  You will be notified in writing when a decision has been made.  A copy of the entire file will be available once the case has been closed.

 

Janelle

* * * * * * *

From: GingerLSanchez@aol.com [mailto:GingerLSanchez@aol.com]
Sent: Tuesday, March 15, 2005 1:48 PM
To: vrippie@pdc.wa.gov
Cc: janelle.teachman@doh.wa.gov; lee.zavala@doh.wa.gov
Subject: Re: Information/Records Request

Dear Ms. Rippie:  THANK YOU for your very  speedy reply - I'll be waiting to hear from Ms. Teachman !

 

Ginger Sanchez

e-Mail [ONLY]: GingerLSnchez@aol.com

* * * * * * *

 

In a message dated 3/15/05 1:39:18 P.M. Pacific Standard Time, vrippie@pdc.wa.gov writes:

Dear Ms. Sanchez:

By copy of this reply, I am forwarding your letter to Janelle Teachman, Department of Health.  It is my understanding that she will know the answer to your question (or at least have better information than I about who can assist you).

The Public Disclosure Commission's mission relates to providing public access to financial information about campaigns, lobbying and the personal financial affairs of state officials and candidates.  However, given this agency's name, it is certainly understandable why you contacted us for assistance.

I hope Ms. Teachman is able to help you.

Vicki Rippie

 -----Original Message-----
From: GingerLSanchez@aol.com [mailto:GingerLSanchez@aol.com]
Sent: Tuesday, March 15, 2005 11:19 AM
To: Vicki Rippie
Subject: Information/Records Request

3/15/05

State of Washington

Public Disclosure Commission 

711 Capitol Way #206 - PO Box 40908
Olympia, WA 98504-0908

I currently have a State of Washington, Veterinary Board of Governors complaint pending, #2004-04-0008 VT, which was originally filed on 4/28/04.

It is my understanding that the "investigative phase" of this complaint was closed and a report was made by the Investigator, Mr. Lee Zavala.

What must I do or whom must I contact in order to obtain a copy of the investigation report?

Ginger Sanchez

CONTACT:  e-Mail [ONLY]: GingerLSanchez@aol.com

 

---

In a message dated 3/24/05 4:08:39 P.M. Pacific Standard Time, Janelle.Teachman@DOH.WA.GOV writes:

03/24/05

The April 11th and June 6th Veterinary Board of Governors meetings have been cancelled.

The next scheduled meeting will be on August 1st in Kent.

5/09/05: per website on their form: http://governor.wa.gov/contact/govemail.htm

The SILENCE deepens!

May my beloved partner ROMI rest in peace  - no matter wherever her bits and pieces/frozen carcass are being held hostage.

                            

[What's in YOUR "urn"?]

 

Copyright: 2004 Ginger Sanchez. All Rights Reserved.

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