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Critter Fixer Pet Hospital 5703 Louetta Spring, Texas 77379 281-370-3262 October 22, 2002
Dear Ms Pearson, My complaint, filed with this Office of the Attorney General of Texas, and the Texas State Board of Veterinary Medical Examiners, alleges fraud and theft by deception on the part of the Veterinarians of Texas in the marketing of vaccines for dogs and cats. The following is a brief review of pertinent literature I submit to support my complaint. The duration of immunity for Rabies vaccine, Canine distemper vaccine, Canine Parvovirus vaccine, Feline Panleukopenia vaccine, Feline Rhinotracheitis, feline Calicivirus, have all been demonstrated to be a minimum of 7 years by serology and challenge studies. Schultz, Ronald D, Duration of Immunity to Canine Vaccines: What We Know and What We Don't Know, Proceedings - Canine Infectious Diseases: From Clinics to Molecular Pathogenesis, Ithaca, NY, 1999, 22. Minimum Duration of Immunity (DOI) for Canine Vaccines:
Fishman B & Scarnell J, Persistence of protection against infectious canine hepatis virus, Vet Rec, 99, 509. 1976. Schultz, Ronald D., "Are we vaccinating too much?" JAVMA, No. 4, August 15, 1995, pg. 421. Canine distemper and adenovirus 2 vaccines both provide lifelong immunity. (Schultz) We see good titers to calici and panleukopenia for 2 to 4 years in cats. (Scott) There is the mistaken assumption that if we recommend annual re-vaccination a greater percentage of the population will be vaccinated. It doesn't do any good to over vaccianate one segment of the population and not vaccinate the rest. (Macey) Scott FW, Geissinger C, Long-term immunity in cats vaccinated with an inactivated trivalent vaccine, Am J Vet Res, 60(5): 652-8, May 1999. 7.5 years DOI by challenge Lappin M R, Andrews J, Simpson D, Jensen WA, Use of serologic tests to predict resistance to Feline Herpesvirus 1, Feline Calcivirus, and Feline Parvovirus infection in cats, J AVMA, 220(1): 38-42, Jan 1, 2002 3 years DOI by challenge. With modified live virus vaccines like canine parvovirus, canine distemper and feline panleukopenia, calicivirus, and rhinotracheitis the virus in the vaccine must replicate to stimulate the immune system. In a patient that has been previously immunized, antibodies from the previous vaccine will block the replication of the new vaccinal virus. Antibody titers are not significantly boosted. Memory cell populations are not expanded. The immune status of the patient is not enhanced. After the second rabies vaccination, readministration of rabies vaccine does not enhance the immune statis of the patient at one or two year intervals. We do not know the interval at which re-administration of vaccines will enhance the immunity of a significant percentage of the pet population, but it is certainly not at one or two year intervals. Tizard Ian, Yawei N, Use of serologic testing to assess immune status of companion animals, JAVMA, vol 213, No 1, July 1, 1998. Modified live vaccines rely on the replication of the agent to trigger a protective immune response. When an animal has maternal or endogenous antibodies at the time of vaccination, the vaccine agent may be neutralized before it can replicate. . It may not be possible to stimulate an additional immune response in that animal. HogenenEsch Harm, Dunham Anisa D, Scott-Moncrieff Catharine, Glickman Larry, DeBoer Douglas J, Effect of vaccination on serum concentrations of total and antigen-specific immunoglobulin E in dogs, AJVR, Vol 63, No. 4, April 2002, pg 611-616. Dogs were injected with rabies vaccine at 16 weeks of age and then annually. Vaccination had no effect on serum concentrations of IgA, IgG and IgM for rabies as measured at 2 and 3 years of age. There were no significant differences in the concentration of IgA and IgM at 2 years and 3 years of age. Gorham, J.R., "Duration of vaccination immunity and the influence on subsequent prophylaxis" JAVMA 149:699-704; 1966. Larson L J, Sawchuck S, Bonds M D, Schultz RD, Comparison of Antibody Titers Among Dogs Vaccinated, One, Two, Three Years Previously, Proceedings of 80th Meeting of the Conference of Research Workers in Animal Diseases, CRWD, Chicago, IL, 1999. Wolf, Alice M., Vaccinations-What's right? What's not? Compendium on Continuing Education, Schering-Plough Animal Health, 1999, pg. 32. In studies Schultz performed at the Univ. of Wisconsin, 106 dogs vaccinated within the previous 1 to 4 years, were each given a canine parvovirus booster vaccination. Only one of the 106 dogs showed a significant increase in serum antibody titer following the booster. These results show that revaccination does not enhance antibody levels or improve immunity because the vaccine virus is neutralized before it can reach the memory T and B cells. The immunity provided by previous vaccination not only protects against the virulent disease but also prevents response to revaccination. Wolf Alice, Vaccines of the Present and Future, Proceedings of the World Animal Veterinary Congress, Vancouver 2001. The recommendation for annual re-vaccination is a practice that was officially started in 1978. This recommendation was made without any scientific validation of the need to booster immunity so frequently. In fact the presence of good humoral antibody levels blocks the anamnestic response to vaccine boosters just as maternal antibody blocks the response in some young animals. Schultz, Ronald D., "Current and future canine and feline vaccination programs", Veterinary Medicine, March 1998, pg. 243. The patient receives no benefit and may be placed at serious risk when an unnecessary vaccine is given. Few or no scientific studies have demonstrated a need for cats or dogs to be revaccinated. Annual vaccination for diseases caused by CDV, CPV2, FPLP and FeLV has not been shown to provide a level of immunity any different from the immunity in an animal vaccinated and immunized at an early age and challenged years later. We have found that annual revaccination with the vaccines that provide long-term immunity provides no demonstrable benefit. Schultz, Ronald D, The Vaccine Controversy: What Vaccines Do Cats and Dogs Really Need and How Often Do They Need To Be Vaccinated? Department of Pathobiological Sciences, School of Veterinary Medicine, University of Wisconsin-Madison. There was never a scientific study performed to show that CDV, CAV, CPV, or rabies virus needs to be given annually to be effective, or that if they are given annually they are more effective. There is data available for the dog and cat to show that modified live CDV, CAV, and CPV given seven years previously and killed PLP, FeCV, and FeHV given seven years previously provided the same immunity as if these products had been given one year prior to challenge with virulent organisms. Phillips, Tom R. and Schultz, Ronald D, "Canine and Feline Vaccines", Current Veterinary Therapy XI, ed. Kirk and Bonagura, pg. 202, 205, WB Saunders Co, Philadelphia, PA 1992. Almost without exception there is no immunologic requirement for annual re-vaccination. Immunity to viruses persists for years or for the life of the animal. Furthermore re-vaccination with most viral vaccines fails to stimulate the anamnestic response as a result of interference by existing antibody. The practice of annual vaccination in our opinion should be considered of questionable efficacy. Klingborg Donald, Principles of Vaccination, AVMA Council on Biologic and Therapeutic Agents, Policy on Biologics, April 2002. The one- year re-vaccination frequency recommendation found on many vaccine labels is based on historical precedent, and not on scientific data. Re-vaccination of patients with sufficient immunity does not add measurably to their disease resistance, and may increase their risk of adverse post vaccination events. Schultz, Ronald D., "Are we vaccinating too much?" JAVMA, no. 4, August 15, 1995, pg. 421. Dr Schultz said "The client is paying for something with no effect or the potential for an adverse reaction." Dogs over 6 weeks of age do not develop disease from canine corona virus. Schultz, Ronald D., "Are we vaccinating too much?" JAVMA, No. 4, August 15, 1995, pg. 421. Schultz, Ronald D., "Current and future canine and feline vaccination programs", Veterinary Medicine, March 1998, pg. 251. Wolf, Alice M., Vaccinations-what's right? What's not? Compendium on CE, Schering-Plough Animal Health, 1999, pg. 32,33. Paul, Michael A., Vaccinations-what's right? What's not? Compendium on CE, Schering-Plough Animal Health, 1999, pg. 32,33. In Texas, there are an average of twelve cases per year of Leptospirosis in dogs testing positive at the Texas Veterinary Medical Diagnostic Lab. It is estimated by the Texas Department of Health that there are 6 million dogs in Texas. *(Antec samples are all sent to the TVMDL, Idexx samples are sent to Michigan, consequently Texas results are not available.) Angulo, A. B. DVM, MS, PhD, ACVM, Texas Veterinary Medical Diagnostic Lab, College Station, Texas, Personal phone conferences 1998, 1999, 2000, 2001. Tizard, Ian R. Veterinary Immunology an Introduction, 6th Ed, Saunders 2000 pg ix It serves no useful purpose to exaggerate the importance of an infection in order to sell vaccines. Antibody Titers Titers don't take into effect cell mediated immunity, which is the most important aspect of disease protection for a number of diseases. Titers they don't asses the ability of memory cells, B and T lymphocytes, which can live up to 20 years or more, to regenerate an immune response. You can have a negative titer and if the pet is exposed, memory cells can respond within hours to regenerate enough antibodies for protective immunity. 2000 Report of American Association of Feline Practitioners and Academy of Feline Medicine Advisory Panel on Feline Vaccines, pg. 15 & 16. Tizard Ian, Yawei N, Use of serologic testing to assess immune status of companion animals, JAVMA, vol 213, No 1, July 1, 1998. Wolf, Alice M., Vaccinations-what's right? What's not? Compendium on CE, Schering-Plough Animal Health, 1999, pg. 32,33. Wolf Alice M, Just the Facts About Vaccs: Frequently Asked Questions About Current Vaccination Recommendations and Practice Guidelines, Proceedings from the North American Veterinary Conference, 13, 1999, pg 681. Klingborg Donald, Principles of Vaccination, AVMA Council on Biologic and Therapeutic Agents, Policy on Biologics, April 2002. Lappin M R, Andrews J, Simpson D, Jensen WA, Use of serologic tests to predict resistance to Feline Herpesvirus 1, Feline Calcivirus, and Feline Parvovirus infection in cats, J AVMA, 220(1):38-42, Jan 1, 2002 Legal Aspects: Standard of Care, Informed Consent 2000 Report of American Association of Feline Practitioners and Academy of Feline Medicine Advisory Panel on Feline Vaccines, pg. 11 & 12. If in a court of law, the quality of care provided by a practitioner is being called into question, the practitioner's action will likely be compared to the prevailing "standard of care". Although many Veterinarians will, for various reasons resist and delay the adoption of new protocols they should know that adherence to old protocols may, in the light of new knowledge, not protect them as .conformity to custom is not in itself an exercise of care as a mater of law. (30Am Jur2nd Evidence: 1123). Questions about the Veterinarians actions will focus on the following types of inquiry: Did the animal need the vaccine? Was it administered at the proper interval? Did the client give informed consent? The current informed consent standard is "the reasonable patient standard." Under this standard, the scope of disclosure is not measured by the physician's standards, but rather by the patient's needs and whether the information is material to the patient's decision. Would a person in the client's position, if given the information a reasonable person would use to make an intelligent decision, decide to accept or reject the vaccination? Under this standard a Veterinarian should disclose the nature of the condition, the risk of vaccination vs the benefit, and reasonable alternatives to vaccination. Failure to specifically obtain informed consent could in itself be negligent, and result in liability. In the U.S. licensed vaccines are subject to the Virus, Serum, and Toxin Act (VSTA) of 1913. The USDA and not the FDA regulates use of animal vaccines. In 1996 in the U.S. Supreme Court Case; Lynbrook Farms vs Smith Kline Beacham the court upheld the contention that VSTA pre-empts all remedies, and in effect eliminates vaccine manufacturers as defendants in all cases. The Veterinarian bears all liability for professional negligence and breach of warranty. There are no federal regulations concerning the after the sale (by manufacturers) use of animal vaccines by Veterinarians. The Animal Medicinal Drug use Clarification Act (AMDUCA) gives Veterinarians "discretionary" use of vaccines. The Texas State Board of Veterinary Medical Examiners is empowered and obligated to take decisive action on this complaint.
Subchapter D Board Powers and Duties 801.151 Rules b) The board may adopt rules of professional conduct appropriate to establish and maintain a high standard of integrity, skills, and practice in the veterinary medicine profession. c) The board shall adopt rules to: 1) protect the public; 801.402 Grounds for Dismissal or Disciplinary Action: A person is subject to denial of a license or disciplinary action if the person: 4) engages in dishonest or illegal practices in, or connected with, the practice of Veterinary Medicine; 6) engages in practices or conduct that violates the board's rules of professional conduct; 10) commits fraud in connection with the application or reporting of a test of animal disease. 12) performs or prescribes unnecessary or unauthorized treatment. The Texas Veterinary Practice Act; Rules of Professional Conduct specifies that: 573.26 Licensed Veterinarians shall conduct their practices with honesty, integrity, and fair dealing with clients in time and services rendered, and in the amount charged for services, facilities, appliances and drugs. and ethically with the public. Sincerely, Dr Robert L Rogers
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