Christie Keith who is one of the authors of the Pet Connection Blog has written an excellent piece on the controversy surrounding Jean Dodds, DVM, RFC and PETA.
Christie says: "The argument over the use of animals in medical research is a heated one, and I’ve hesitated to raise it here for that reason. But two days ago, a letter Dr. Dodds wrote responding to criticism by PETA, in which she defends the study and insists she is working hard to conduct it humanely, started making the rounds of the dog lists, and the fallout has been shocking to me."
Read more at the Pet Connection Blog: Dr. Dodds, the Rabies Challenge Fund & PETA
Friday, July 18, 2008
Monday, July 14, 2008
PETA Targets Rabies Challenge Fund
Since April, PETA has been targeting The Rabies Challenge Fund, which seeks to save the lives of thousands of dogs and ensure the well-being of millions of others by funding research with the goal of extending state-mandated rabies vaccination boosters from 3 to 5, and then hopefully 7 years.
Remember than no vaccine manufacturer will undertake long-term duration of immunity studies on rabies vaccine "because of the cost." So the Rabies Challenge Fund is privately funded. PETA would like to discredit The Rabies Challenge Fund with prospective donors saying it will inhumanely treat dogs to accomplish its goals. This premise is specious and hypocritical.
Below is a copy of Dr. Dodds' response to PETA'S allegations, her responses are in red. Beneath that is information compiled by Kris Christine which may help you understand why this research is necessary.
Jean [W. Jean Dodds, DVM]
Please see the series of e-mails and my responses to PETA. You'll see that I did answer each letter in good faith in a timely manner and not as alleged by Dr. Dozier. Additional information and responses are below.
By the way, perhaps the current PETA people are unaware that over the years I've provided PETA --- upon their request -- pro-bono extensive review and scientific opinion about the research records obtained under FOIA concerning certain inhumane, invasive primate research experiments. I've been roundly criticized by my peers for this activity, as you can well imagine ! I'm the Past -President of the Scientist's Center for Animal Welfare and a 20 + year member of AVAR -- the Association of Veterinarians for Animal Rights -- which has now joined HSUS; among other long standing activities in the humane community [40 + years].
Here at last are my responses to the further comments on the RCF protocol and PETA's allegations. Under separate cover, I'm forwarding you the actual letters I sent the 2 people at PETA upon their initial and repeat inquiries. You'll see that I answered them immediately and forthrightly.
***
PETA:
Thank you for your email regarding the Rabies Challenge Fund (RCF). Please be aware that we attempted to correspond with W. Jean Dodds (co-trustee and veterinarian responsible for the RCF) for a number of weeks in April and May of this year. During that time, we tried to clarify a number of issues surrounding the RCF experiments, yet we received nothing of substance in response to our questions.
We have repeatedly asked the study organizers:
1. To supply a copy of the protocol so that we (and other experts who collaborate with PETA) might help redesign the study so that dogs are not killed at the end of the study, and so that the study might be done in the most humane way possible).
Dr. Dodds: Did that in an attachment to my first response to PETA.
PETA:
2. The number of dogs to be used as part of the two concurrent studies, how far along the study had progressed (have the dogs been purchased from a laboratory animal supplier, have they been vaccinated, are they already housed in the RCF facilities, etc.).
Dr. Dodds: Answered that too. The study began last fall, as described.
PETA:
3. What efforts RCF had made to avoid killing all of the dogs they are using in their study. Dr.
Dr. Dodds: Ron Schultz has undertaken informal dialog with USDA senior officials , in his capacity as advisor to the vaccine industry and regulatory body. He has decades of experience in the field and attends meetings with these folks regularly. At this point, we have not made progress in changing their views, BUT, he and I together are planning to present a more formal proposal to them. We have 4 + years to accomplish what we view as an important need to change the regulations as currently written for endpoint challenge testing -- before anything involving challenge of these healthy dogs [vaccinates and controls] with rabies virus has to take place according to the current regulatory protocol.
PETA:
In Dodd’s last response, (the third letter without substantive information) , she told us she did not have the information we were seeking and referred our questions to another scientist responsible for the study – Ronald Schultz. We never received any response from Schultz.
Dr. Dodds: Dr. Schultz is a very busy Department Chairman, teacher, and world respected vaccinology scientist. I do not know if he directly answered any remaining questions PETA raised -- certainly we have nothing to hide here.
PETA:
It is interesting that the Rabies Challenge Fund folks are now saying they will attempt to make changes to the protocol after the experiments have begun on the dogs (even though it is highly unlikely the USDA will agree to that since the experiments have already begun). So it is still likely that many dogs will die and many will die excruciating deaths.
Dr. Dodds:Nonsense. This has nothing whatsoever to do with the fact that the study has begun, because no procedures related to challenge with rabies virus will take place for 4 + years. We have the interim years to dialog with the federal authorities, based upon Dr. Schultz's expertise, and hope to amend the CFR regulatory requirements for the end phase of their protocol.
All the vaccinates should be healthy and survive challenge. Even if we're forced by the USDA to follow the current challenge protocol at the end of the 5 and 7 year studies, there will be no excruciating deaths among the control dogs, because at the very first evidence of malaise and illness they will be sacrificed. The existing data on rabies challenge trials that were completed for each currently licensed rabies vaccine tells us what to expect as far as the number of days before any sign of illness in the challenged control dogs shows up. Remember, this is a fatal mammalian disease, so animal caretakers in these facilities will be ever vigilant to spot the first signs of malaise and illness.
PETA:
As far as we can tell, RCF has made no attempts to date to get a serological protocol approved [i.e, titer testing commonly offered at many vet offices to accurately detect the concentration of rabies antibodies at any interval post-vaccination] .
Dr. Dodds: That is not true; most rabies titers done in the county today are to satisfy export requirements for animals moving to rabies-free countries. Relatively few clinical vets check rabies titers for purposes of getting exemption waivers as justified only on a case-by-case basis, and requiring approval by local public health regulatory authorities. In fact most vets don't even realize that such tests can be done.
PETA: The experiments being conducted by RCF are purely elective.
Dr. Dodds: Also not true.
PETA: Why not design a tenable serological protocol that can be approved by USDA?
DR. DODDS: They have always deigned such methodology and every year the US State and Territorial Public Health Officials unequivocally state that rabies titer serology is unacceptable and unreliable -- this year's reiteration was published in a May 2008 issue of the JAVMA.
PETA: A serological method would allow data to be collected from volunteers rather than dogs stuck in a laboratory.
Dr. Dodds: No , it will not suffice . I don't know whether the PETA people are completely naive here, or knowingly suggesting something to mislead their supporters into thinking that we've not thought of or tried to get such testing allowed. Why were none of these efforts made before PETA began to shine a spotlight on the myriad of problems with RCF’s plans? This presumption without evidence to support their contention is perhaps arrogant. These alternative suggestions have been made for years by myself, Dr. Schultz and others; they have been the subject of seminars, publications, and teaching handouts to both the profession and the public.
PETA: With regards to RCF's statement that PETA should be working on this issue, we are indeed working on non-animal protocols for vaccine testing at both the USDA and the FDA. PETA has spent more than three quarters of a million dollars in recent years to develop non-animal testing methods. We're very happy to put our money where our mouth is!
Dr. Dodds: IF that's true; we applaud the effort !
PETA: Despite repeated requests, the RCF folks have refused to provide details including:
• the actual number of dogs involved in each study. The USDA gives only the minimum number of dogs that they must have data for at the culmination of the study, so logically RCF must use more dogs than the USDA’s minimum of 70. However, RCF has not answered even this simple question.
Dr. Dodds: No we only need a few extra animals [should a few become ill during the length of the study for some unforeseen natural disease] , and we will not use more from both humane and cost issues.
PETA:
• the conditions and socialization for the dogs. Dodds referred PETA to USDA’s protocol for this information. USDA’s protocol does not specify that dogs should be socialized, group housed, or that they should receive toys or even a bed.
Dr. Dodds: The existing USDA CFR protocol is outdated in that regard, and the law has not been updated, BUT, as we and PETA all realize, all current research protocols are governed by the USDA Animal Welfare Act and the NIH Guide for the Care and Use of Laboratory Animals for all institutions that receive federal research monies. These regulations require socialization and exercise and specify the animal housing conditions. So, this point is moot and they're certainly are well aware of the current federal and state rules that apply.
PETA:
• how and when the dogs would be killed. RCF referred PETA to the USDA protocol for this information. USDA’s protocol stipulates that even vaccinated dogs are to be killed and their brains examined.
Dr. Dodds: At the end of the 5 and 7 year studies, the current regulations do so state, but see above for our plans to get some amendments accepted in the interim years.
PETA: This is in direct contradiction RCF’s current claim that it will adopt out the dogs who don't die.
Dr. Dodds: No one in an official capacity for the RCF or any one else purporting to represent us, to my knowledge, has ever said that. It would create a huge liability issue.
PETA: RCF makes it appear that dogs will be killed at the first signs of rabies. Rabies is painful and its symptoms can begin quietly. Dogs will likely die of painful complications related to paralysis and inability to breathe.
Dr. Dodds: Not true; the end point will be recognized long before this end stage of paralysis.
PETA: No one is disputing how the immune system works and that dogs are most likely being over-vaccinated in many ways. However, much more good could have come from an effort to change the way rabies vaccine efficacy is tested rather than to use more than $1 million to kill beagles.
Dr. Dodds: This is just inflammatory rhetoric.
To paraphrase PETA's president, "A dog is a dog is a dog is a dog." It is unfortunate the RCF chose to use crude and cruel methods in its attempts to help other dogs." It seems there are critical differences here, and I stand with PETA and again demand the issues raised by PETA be addressed AND FOLLOWED.
Sincerely,
Below is a copy of Dr. Dodds' previous responses to two other PETA members who have contacted her with concerns.
Unfortunately, this information from PETA is terribly misleading. See below. We've tried to have a dialog with PETA about their RCF concerns and so hope that they now understand what we're doing and why. We appreciate your concern about the way in which we must conduct the RCF Research Study. Please allow me to explain the regulatory requirements we must follow as specified by the Code of Federal Requirements, USDA , Title 9, part 113.209. We cannot get a new rabies vaccine licensed by the government with the extended booster periods of 5 and eventually 7 years unless we strictly follow these regulatory requirements. The protocol is not up to us .
The Rabies Challenge Fund is designed to prove to UDSA authorities that dogs only need two booster rabies vaccines in their lifetime. This would significantly reduce the tragedies outlined below, save countless animal pain and suffering, and still protect the public health.
The public has little understanding of how all vaccines must be tested through USDA -specified trials before they are licensed for veterinary use. Every currently licensed rabies vaccine has been required to successfully complete these specified trials; and these vaccines as you know are required by law.
Only purebred beagles raised in a dog breeding facility run by veterinarians are involved in our project. This a large USDA licensed facility maintained in strict compliance with animal care and use requirements. The dogs live in large pens and are housed together in small groups for socialization and exercise. Further socialization is provided by their caretakers.
Today, we have a formidable uphill battle compounded by inertia in trying to change outdated rabies regulations to reflect what is truly needed to protect animals and people from contracting rabies. The federal government is just not interested in promoting a uniform requirement throughout the country that rabies booster vaccinations be given every three years. A few individual states and locales still insist on mandating annual rabies boosters when these vaccines are licensed for three years by the USDA. The recent media furor over the annual rabies booster mandate by the city of Wichita, KS is but one example.
While this travesty continues under the rubric of state's rights, countless companion animals suffer from being required to receive rabies boosters even when they're terminally ill, debilitated, very old or have a record of prior serious adverse reaction to vaccination. This usually occurs when veterinarians either don't believe that adverse events occur or are likely, or they use the excuse that they're merely following the law. This situation is further complicated when local or state authorities will not accept waivers of booster requirement even with a veterinary letter of justification and/or a rabies antibody titer beyond the 1:5 titer level deemed by CDC to be adequate for people. Just today, a distraught caregiver was faced with having to revaccinate a middle aged dog with prior history of collapse after rabies vaccine. The dog's rabies antibody titer was 1: 3125, six hundred times that required for people, and yet the local authorities refused to grant a waiver.
These all too common occurrences have resulted in an increasing number of people simply breaking the law and not vaccinating their dogs at all. However, IF these dogs injure someone, even accidentally, and they're quarantined without evidence of an in-date rabies vaccination, the public health authorities have the right to require surety and direct that the animal be killed; his/her head is then examined for rabies. One such tragedy where a family was not given the chance to appeal on behalf of their dog is in litigation as we speak.
Then, there are the heartbreaking adverse reactions and deaths that occur when animals are forced to be given rabies boosters in lieu of waivers, when justified, and the dog seizures uncontrollably and dies in the caregiver's arms. Such a case also happened this past week.
Best wishes. With reverence for all life. Jean
More information on this subject from Dr. Dodds below responding to another PETA Member's inquiry. None of the research dogs will be allowed to develop full-blown rabies (see below).
1. Question: How many dogs actually suffer, per year, to make purposely killing 70 pure bread beagles acceptable?
Dr. Dodds' Reply: It has been estimated that the adverse reaction rate of a serious nature to rabies vaccinations is in the order of 0.38- 0. 50 % , with another 1-3% of vaccinates experiencing less severe reactions. of the millions of dogs that must be vaccinated by law annually.
2. Question: How long does the dog suffer with obvious rabies before he is humanely euthanized?
Dr. Dodds' Reply: Not at all ; as soon as any relevant sign is noted with round-the-clock coverage --- at the end of the 5 and 7 year trials -- when all the dogs must be challenged with rabies virus, they are humanely sacrificed. We expect that all the non-vaccinated dogs will become ill, and that vaccinates will survive. BUT, as all these dogs will be just housed in large family style group pens, cared for and socialized for the entire trial period, without any exposure challenge to rabies virus until the end of the study, we have at least 4 years of their routine husbandry and care in which to dialog with the responsible USDA authorities to ask them to consider an alternative endpoint to the trial -- for example, allowing us to run rabies vaccine serology titers as proof of adequate protection from rabies rather than an actual live rabies virus challenge. Dr. Schultz and I are both personally committed to work towards changing the current requirements before the end of the trials.
3. Question: What makes you believe that if an owner does not vaccinate their dog every three years because of the reaction the dog may have to the vaccination, that that same owner WILL get the dog vaccinated every five years?
Dr. Dodds' Reply: We don't, but, if the law is changed , then a dog will only need one more booster in midlife and none in old age - a bigger issue if they're frail or ill. Also, remember that some states and locales within states still mandate annual rabies boosters ! In Wichita, KS and Cheyenne, WY a huge recent blitz of officials challenging their ignorant position of annual rabies vaccination resulted in the city ordinances being changed for the future. Much of this effort was spearheaded by Kris Christine and the RCF. ..
Question: As we all know, there’s a fine line between scientific experiments that are worthwhile for the benefits of those in the future and there are those experiments that are more harmful than what will benefit anyone in the long run! I am a firm believer that the end must justify the means and I, at this point, am not convinced that the ends of this experiment justifies the means, mainly due to the fact that I’m unsure as to how many animals, per year, truly suffer from five vaccinations in their lifetimes, rather than just three !
Dr. Dodds' Answer: Rabies vaccine is the strongest of all vaccines available today, and so elicits the highest likelihood of adverse events , including death. I deal with these tragedies almost every day from all over North America -- as does Dr. Schultz.
Actually, this is what does and will happen -- once a rabies vaccine is licensed for 5 years, a puppy would receive 2 initial doses, and then one more dose 5 years after the second one. IF we can show that a rabies vaccine can be effective and licensed for 7 years, then the dog will require one more vaccine 7 years after the second one. As it now stands, dogs are required to get a rabies booster either annually or every three years after the second one -- depending on the applicable state or local laws, and so when these privately cared for dogs become older and ill or frail - even with life-threatening diseases, most states and locales refuse to grant exemptions from rabies boosters even with justification provided by the primary care veterinarian and/or a high level of rabies antibody titer.
Were the states to extend their rabies booster requirements without USDA Title 9, part 113.209 challenge studies, accept rabies titers in lieu of vaccination, or recognize the 1992 French rabies challenge study results demonstrating a minimum 5 year duration of immunity, this research would not be necessary. The Rabies Challenge Fund seeks to save the lives of thousands of dogs and millions of others from suffering vaccinal adverse reactions.
If the USDA does not change their vaccine licensing requirements upon which all state rabies immunizations laws are currently based, Title 9 Part 113.209, by the time the first challenge is conducted in 4 1/2 years, then 35 of the dogs will be required to be euthanized and their brain tissue tested for rabies according to USDA's standard. Dr. Dodds and Dr. Schultz are committed to trying to get the USDA to change that requirement, and we're all very much hoping that they will be successful.
The Journal of the American Veterinary Medical Association has published a report in its April 1, 2008 issue, Vol. 232, No. 7, entitled: Postmarketing Surveillance of Rabies Vaccines for Dogs to Evaluate Safety and Efficacy."
Despite the extreme under-reporting of vaccinal adverse reactions, this report states on the second page that between April 1, 2004 and March 31, 2007, the Center for Veterinary Biologics, "nearly 10,000 adverse event reports (all animal species) were received by manufacturers of rabies vaccines.... ......Approximat ely 65% of the manufacturer' s reports involved dogs."
The report further states on the second page that: "Rabies vaccines are the most common group of biological products identified in adverse event reports received by the CVB," and they give the following description of the adverse reaction 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%.
Veterinarians are not required by law to report adverse reactions to vaccines, to which the World Small Animal Veterinary Association stated in their 2007 Vaccine Guidelines that there is: "gross under-reporting of vaccine-associated adverse events which impedes knowledge of the ongoing safety of these products," and in an article entitled, A New Approach to Reporting Medication and Device Adverse Effects and Product Problems, (JAMA - June 2, 1993. Vol.269, No.21. p.2785) Dr. David Kessler, former head of the Food & Drug Administration, reported that "only about 1% of serious events are reported to the FDA."
In light of the 10,000 adverse reactions to the rabies vaccine in the JAVMA report, 65% of which were in dogs, the estimated 1% reporting of "serious" events by the former head of the FDA means that the actual number of dogs that had adverse reactions to the vaccine would be more like 650,000 -- applying the 5.5% figure given by the CVB resulting in death indicates that 3,750 died over the same 3 year period (1,250 a year or 6,250 over the course of 5 years, or 8,750 over the course of 7 years).
-----
If PETA is truly concerned about dogs' lives, they will channel their concerns constructively and launch a massive petition to the USDA to get them to change their vaccine-licensing standards. Every member of The Rabies Challenge Fund team would applaud such a movement.
Dog owners who would like to see PETA petition the USDA to change their Code of Federal Requirements , Title 9, part 113.209 , please contact PETA's policy advisor, Samantha Dozier at samanthapeta@ hotmail.com 757-622-7382 and let her know how you feel.
Pet owners interested in learning more about PETA might want to read the following articles: April 28, 2008 Newsweek article entitled PETA and Euthanasia by Jeneen Interlandi http://www.newsweek .com/id/134549 "Since 1998 PETA has killed more than 17,000 animals, nearly 85 percent of all those it has rescued. "
Channel 3 News in Kentucky May 7, 2008: http://www.ky3. com/news/ trends/?feed= bim&id=18743839 OVER 90 PERCENT PUT TO DEATH "WASHINGTON -- An official report filed by People for The Ethical Treatment of Animals (PETA) with the Virginia government shows that the organization put to death more than 90 percent of the dogs, cats, and other pets it took in for adoption during 2007. "
Remember than no vaccine manufacturer will undertake long-term duration of immunity studies on rabies vaccine "because of the cost." So the Rabies Challenge Fund is privately funded. PETA would like to discredit The Rabies Challenge Fund with prospective donors saying it will inhumanely treat dogs to accomplish its goals. This premise is specious and hypocritical.
Below is a copy of Dr. Dodds' response to PETA'S allegations, her responses are in red. Beneath that is information compiled by Kris Christine which may help you understand why this research is necessary.
Jean [W. Jean Dodds, DVM]
Please see the series of e-mails and my responses to PETA. You'll see that I did answer each letter in good faith in a timely manner and not as alleged by Dr. Dozier. Additional information and responses are below.
By the way, perhaps the current PETA people are unaware that over the years I've provided PETA --- upon their request -- pro-bono extensive review and scientific opinion about the research records obtained under FOIA concerning certain inhumane, invasive primate research experiments. I've been roundly criticized by my peers for this activity, as you can well imagine ! I'm the Past -President of the Scientist's Center for Animal Welfare and a 20 + year member of AVAR -- the Association of Veterinarians for Animal Rights -- which has now joined HSUS; among other long standing activities in the humane community [40 + years].
Here at last are my responses to the further comments on the RCF protocol and PETA's allegations. Under separate cover, I'm forwarding you the actual letters I sent the 2 people at PETA upon their initial and repeat inquiries. You'll see that I answered them immediately and forthrightly.
***
PETA:
Thank you for your email regarding the Rabies Challenge Fund (RCF). Please be aware that we attempted to correspond with W. Jean Dodds (co-trustee and veterinarian responsible for the RCF) for a number of weeks in April and May of this year. During that time, we tried to clarify a number of issues surrounding the RCF experiments, yet we received nothing of substance in response to our questions.
We have repeatedly asked the study organizers:
1. To supply a copy of the protocol so that we (and other experts who collaborate with PETA) might help redesign the study so that dogs are not killed at the end of the study, and so that the study might be done in the most humane way possible).
Dr. Dodds: Did that in an attachment to my first response to PETA.
PETA:
2. The number of dogs to be used as part of the two concurrent studies, how far along the study had progressed (have the dogs been purchased from a laboratory animal supplier, have they been vaccinated, are they already housed in the RCF facilities, etc.).
Dr. Dodds: Answered that too. The study began last fall, as described.
PETA:
3. What efforts RCF had made to avoid killing all of the dogs they are using in their study. Dr.
Dr. Dodds: Ron Schultz has undertaken informal dialog with USDA senior officials , in his capacity as advisor to the vaccine industry and regulatory body. He has decades of experience in the field and attends meetings with these folks regularly. At this point, we have not made progress in changing their views, BUT, he and I together are planning to present a more formal proposal to them. We have 4 + years to accomplish what we view as an important need to change the regulations as currently written for endpoint challenge testing -- before anything involving challenge of these healthy dogs [vaccinates and controls] with rabies virus has to take place according to the current regulatory protocol.
PETA:
In Dodd’s last response, (the third letter without substantive information) , she told us she did not have the information we were seeking and referred our questions to another scientist responsible for the study – Ronald Schultz. We never received any response from Schultz.
Dr. Dodds: Dr. Schultz is a very busy Department Chairman, teacher, and world respected vaccinology scientist. I do not know if he directly answered any remaining questions PETA raised -- certainly we have nothing to hide here.
PETA:
It is interesting that the Rabies Challenge Fund folks are now saying they will attempt to make changes to the protocol after the experiments have begun on the dogs (even though it is highly unlikely the USDA will agree to that since the experiments have already begun). So it is still likely that many dogs will die and many will die excruciating deaths.
Dr. Dodds:Nonsense. This has nothing whatsoever to do with the fact that the study has begun, because no procedures related to challenge with rabies virus will take place for 4 + years. We have the interim years to dialog with the federal authorities, based upon Dr. Schultz's expertise, and hope to amend the CFR regulatory requirements for the end phase of their protocol.
All the vaccinates should be healthy and survive challenge. Even if we're forced by the USDA to follow the current challenge protocol at the end of the 5 and 7 year studies, there will be no excruciating deaths among the control dogs, because at the very first evidence of malaise and illness they will be sacrificed. The existing data on rabies challenge trials that were completed for each currently licensed rabies vaccine tells us what to expect as far as the number of days before any sign of illness in the challenged control dogs shows up. Remember, this is a fatal mammalian disease, so animal caretakers in these facilities will be ever vigilant to spot the first signs of malaise and illness.
PETA:
As far as we can tell, RCF has made no attempts to date to get a serological protocol approved [i.e, titer testing commonly offered at many vet offices to accurately detect the concentration of rabies antibodies at any interval post-vaccination] .
Dr. Dodds: That is not true; most rabies titers done in the county today are to satisfy export requirements for animals moving to rabies-free countries. Relatively few clinical vets check rabies titers for purposes of getting exemption waivers as justified only on a case-by-case basis, and requiring approval by local public health regulatory authorities. In fact most vets don't even realize that such tests can be done.
PETA: The experiments being conducted by RCF are purely elective.
Dr. Dodds: Also not true.
PETA: Why not design a tenable serological protocol that can be approved by USDA?
DR. DODDS: They have always deigned such methodology and every year the US State and Territorial Public Health Officials unequivocally state that rabies titer serology is unacceptable and unreliable -- this year's reiteration was published in a May 2008 issue of the JAVMA.
PETA: A serological method would allow data to be collected from volunteers rather than dogs stuck in a laboratory.
Dr. Dodds: No , it will not suffice . I don't know whether the PETA people are completely naive here, or knowingly suggesting something to mislead their supporters into thinking that we've not thought of or tried to get such testing allowed. Why were none of these efforts made before PETA began to shine a spotlight on the myriad of problems with RCF’s plans? This presumption without evidence to support their contention is perhaps arrogant. These alternative suggestions have been made for years by myself, Dr. Schultz and others; they have been the subject of seminars, publications, and teaching handouts to both the profession and the public.
PETA: With regards to RCF's statement that PETA should be working on this issue, we are indeed working on non-animal protocols for vaccine testing at both the USDA and the FDA. PETA has spent more than three quarters of a million dollars in recent years to develop non-animal testing methods. We're very happy to put our money where our mouth is!
Dr. Dodds: IF that's true; we applaud the effort !
PETA: Despite repeated requests, the RCF folks have refused to provide details including:
• the actual number of dogs involved in each study. The USDA gives only the minimum number of dogs that they must have data for at the culmination of the study, so logically RCF must use more dogs than the USDA’s minimum of 70. However, RCF has not answered even this simple question.
Dr. Dodds: No we only need a few extra animals [should a few become ill during the length of the study for some unforeseen natural disease] , and we will not use more from both humane and cost issues.
PETA:
• the conditions and socialization for the dogs. Dodds referred PETA to USDA’s protocol for this information. USDA’s protocol does not specify that dogs should be socialized, group housed, or that they should receive toys or even a bed.
Dr. Dodds: The existing USDA CFR protocol is outdated in that regard, and the law has not been updated, BUT, as we and PETA all realize, all current research protocols are governed by the USDA Animal Welfare Act and the NIH Guide for the Care and Use of Laboratory Animals for all institutions that receive federal research monies. These regulations require socialization and exercise and specify the animal housing conditions. So, this point is moot and they're certainly are well aware of the current federal and state rules that apply.
PETA:
• how and when the dogs would be killed. RCF referred PETA to the USDA protocol for this information. USDA’s protocol stipulates that even vaccinated dogs are to be killed and their brains examined.
Dr. Dodds: At the end of the 5 and 7 year studies, the current regulations do so state, but see above for our plans to get some amendments accepted in the interim years.
PETA: This is in direct contradiction RCF’s current claim that it will adopt out the dogs who don't die.
Dr. Dodds: No one in an official capacity for the RCF or any one else purporting to represent us, to my knowledge, has ever said that. It would create a huge liability issue.
PETA: RCF makes it appear that dogs will be killed at the first signs of rabies. Rabies is painful and its symptoms can begin quietly. Dogs will likely die of painful complications related to paralysis and inability to breathe.
Dr. Dodds: Not true; the end point will be recognized long before this end stage of paralysis.
PETA: No one is disputing how the immune system works and that dogs are most likely being over-vaccinated in many ways. However, much more good could have come from an effort to change the way rabies vaccine efficacy is tested rather than to use more than $1 million to kill beagles.
Dr. Dodds: This is just inflammatory rhetoric.
To paraphrase PETA's president, "A dog is a dog is a dog is a dog." It is unfortunate the RCF chose to use crude and cruel methods in its attempts to help other dogs." It seems there are critical differences here, and I stand with PETA and again demand the issues raised by PETA be addressed AND FOLLOWED.
Sincerely,
Below is a copy of Dr. Dodds' previous responses to two other PETA members who have contacted her with concerns.
Unfortunately, this information from PETA is terribly misleading. See below. We've tried to have a dialog with PETA about their RCF concerns and so hope that they now understand what we're doing and why. We appreciate your concern about the way in which we must conduct the RCF Research Study. Please allow me to explain the regulatory requirements we must follow as specified by the Code of Federal Requirements, USDA , Title 9, part 113.209. We cannot get a new rabies vaccine licensed by the government with the extended booster periods of 5 and eventually 7 years unless we strictly follow these regulatory requirements. The protocol is not up to us .
The Rabies Challenge Fund is designed to prove to UDSA authorities that dogs only need two booster rabies vaccines in their lifetime. This would significantly reduce the tragedies outlined below, save countless animal pain and suffering, and still protect the public health.
The public has little understanding of how all vaccines must be tested through USDA -specified trials before they are licensed for veterinary use. Every currently licensed rabies vaccine has been required to successfully complete these specified trials; and these vaccines as you know are required by law.
Only purebred beagles raised in a dog breeding facility run by veterinarians are involved in our project. This a large USDA licensed facility maintained in strict compliance with animal care and use requirements. The dogs live in large pens and are housed together in small groups for socialization and exercise. Further socialization is provided by their caretakers.
Today, we have a formidable uphill battle compounded by inertia in trying to change outdated rabies regulations to reflect what is truly needed to protect animals and people from contracting rabies. The federal government is just not interested in promoting a uniform requirement throughout the country that rabies booster vaccinations be given every three years. A few individual states and locales still insist on mandating annual rabies boosters when these vaccines are licensed for three years by the USDA. The recent media furor over the annual rabies booster mandate by the city of Wichita, KS is but one example.
While this travesty continues under the rubric of state's rights, countless companion animals suffer from being required to receive rabies boosters even when they're terminally ill, debilitated, very old or have a record of prior serious adverse reaction to vaccination. This usually occurs when veterinarians either don't believe that adverse events occur or are likely, or they use the excuse that they're merely following the law. This situation is further complicated when local or state authorities will not accept waivers of booster requirement even with a veterinary letter of justification and/or a rabies antibody titer beyond the 1:5 titer level deemed by CDC to be adequate for people. Just today, a distraught caregiver was faced with having to revaccinate a middle aged dog with prior history of collapse after rabies vaccine. The dog's rabies antibody titer was 1: 3125, six hundred times that required for people, and yet the local authorities refused to grant a waiver.
These all too common occurrences have resulted in an increasing number of people simply breaking the law and not vaccinating their dogs at all. However, IF these dogs injure someone, even accidentally, and they're quarantined without evidence of an in-date rabies vaccination, the public health authorities have the right to require surety and direct that the animal be killed; his/her head is then examined for rabies. One such tragedy where a family was not given the chance to appeal on behalf of their dog is in litigation as we speak.
Then, there are the heartbreaking adverse reactions and deaths that occur when animals are forced to be given rabies boosters in lieu of waivers, when justified, and the dog seizures uncontrollably and dies in the caregiver's arms. Such a case also happened this past week.
Best wishes. With reverence for all life. Jean
More information on this subject from Dr. Dodds below responding to another PETA Member's inquiry. None of the research dogs will be allowed to develop full-blown rabies (see below).
1. Question: How many dogs actually suffer, per year, to make purposely killing 70 pure bread beagles acceptable?
Dr. Dodds' Reply: It has been estimated that the adverse reaction rate of a serious nature to rabies vaccinations is in the order of 0.38- 0. 50 % , with another 1-3% of vaccinates experiencing less severe reactions. of the millions of dogs that must be vaccinated by law annually.
2. Question: How long does the dog suffer with obvious rabies before he is humanely euthanized?
Dr. Dodds' Reply: Not at all ; as soon as any relevant sign is noted with round-the-clock coverage --- at the end of the 5 and 7 year trials -- when all the dogs must be challenged with rabies virus, they are humanely sacrificed. We expect that all the non-vaccinated dogs will become ill, and that vaccinates will survive. BUT, as all these dogs will be just housed in large family style group pens, cared for and socialized for the entire trial period, without any exposure challenge to rabies virus until the end of the study, we have at least 4 years of their routine husbandry and care in which to dialog with the responsible USDA authorities to ask them to consider an alternative endpoint to the trial -- for example, allowing us to run rabies vaccine serology titers as proof of adequate protection from rabies rather than an actual live rabies virus challenge. Dr. Schultz and I are both personally committed to work towards changing the current requirements before the end of the trials.
3. Question: What makes you believe that if an owner does not vaccinate their dog every three years because of the reaction the dog may have to the vaccination, that that same owner WILL get the dog vaccinated every five years?
Dr. Dodds' Reply: We don't, but, if the law is changed , then a dog will only need one more booster in midlife and none in old age - a bigger issue if they're frail or ill. Also, remember that some states and locales within states still mandate annual rabies boosters ! In Wichita, KS and Cheyenne, WY a huge recent blitz of officials challenging their ignorant position of annual rabies vaccination resulted in the city ordinances being changed for the future. Much of this effort was spearheaded by Kris Christine and the RCF. ..
Question: As we all know, there’s a fine line between scientific experiments that are worthwhile for the benefits of those in the future and there are those experiments that are more harmful than what will benefit anyone in the long run! I am a firm believer that the end must justify the means and I, at this point, am not convinced that the ends of this experiment justifies the means, mainly due to the fact that I’m unsure as to how many animals, per year, truly suffer from five vaccinations in their lifetimes, rather than just three !
Dr. Dodds' Answer: Rabies vaccine is the strongest of all vaccines available today, and so elicits the highest likelihood of adverse events , including death. I deal with these tragedies almost every day from all over North America -- as does Dr. Schultz.
Actually, this is what does and will happen -- once a rabies vaccine is licensed for 5 years, a puppy would receive 2 initial doses, and then one more dose 5 years after the second one. IF we can show that a rabies vaccine can be effective and licensed for 7 years, then the dog will require one more vaccine 7 years after the second one. As it now stands, dogs are required to get a rabies booster either annually or every three years after the second one -- depending on the applicable state or local laws, and so when these privately cared for dogs become older and ill or frail - even with life-threatening diseases, most states and locales refuse to grant exemptions from rabies boosters even with justification provided by the primary care veterinarian and/or a high level of rabies antibody titer.
Were the states to extend their rabies booster requirements without USDA Title 9, part 113.209 challenge studies, accept rabies titers in lieu of vaccination, or recognize the 1992 French rabies challenge study results demonstrating a minimum 5 year duration of immunity, this research would not be necessary. The Rabies Challenge Fund seeks to save the lives of thousands of dogs and millions of others from suffering vaccinal adverse reactions.
If the USDA does not change their vaccine licensing requirements upon which all state rabies immunizations laws are currently based, Title 9 Part 113.209, by the time the first challenge is conducted in 4 1/2 years, then 35 of the dogs will be required to be euthanized and their brain tissue tested for rabies according to USDA's standard. Dr. Dodds and Dr. Schultz are committed to trying to get the USDA to change that requirement, and we're all very much hoping that they will be successful.
The Journal of the American Veterinary Medical Association has published a report in its April 1, 2008 issue, Vol. 232, No. 7, entitled: Postmarketing Surveillance of Rabies Vaccines for Dogs to Evaluate Safety and Efficacy."
Despite the extreme under-reporting of vaccinal adverse reactions, this report states on the second page that between April 1, 2004 and March 31, 2007, the Center for Veterinary Biologics, "nearly 10,000 adverse event reports (all animal species) were received by manufacturers of rabies vaccines.... ......Approximat ely 65% of the manufacturer' s reports involved dogs."
The report further states on the second page that: "Rabies vaccines are the most common group of biological products identified in adverse event reports received by the CVB," and they give the following description of the adverse reaction 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%.
Veterinarians are not required by law to report adverse reactions to vaccines, to which the World Small Animal Veterinary Association stated in their 2007 Vaccine Guidelines that there is: "gross under-reporting of vaccine-associated adverse events which impedes knowledge of the ongoing safety of these products," and in an article entitled, A New Approach to Reporting Medication and Device Adverse Effects and Product Problems, (JAMA - June 2, 1993. Vol.269, No.21. p.2785) Dr. David Kessler, former head of the Food & Drug Administration, reported that "only about 1% of serious events are reported to the FDA."
In light of the 10,000 adverse reactions to the rabies vaccine in the JAVMA report, 65% of which were in dogs, the estimated 1% reporting of "serious" events by the former head of the FDA means that the actual number of dogs that had adverse reactions to the vaccine would be more like 650,000 -- applying the 5.5% figure given by the CVB resulting in death indicates that 3,750 died over the same 3 year period (1,250 a year or 6,250 over the course of 5 years, or 8,750 over the course of 7 years).
-----
If PETA is truly concerned about dogs' lives, they will channel their concerns constructively and launch a massive petition to the USDA to get them to change their vaccine-licensing standards. Every member of The Rabies Challenge Fund team would applaud such a movement.
Dog owners who would like to see PETA petition the USDA to change their Code of Federal Requirements , Title 9, part 113.209 , please contact PETA's policy advisor, Samantha Dozier at samanthapeta@ hotmail.com 757-622-7382 and let her know how you feel.
Pet owners interested in learning more about PETA might want to read the following articles: April 28, 2008 Newsweek article entitled PETA and Euthanasia by Jeneen Interlandi http://www.newsweek .com/id/134549 "Since 1998 PETA has killed more than 17,000 animals, nearly 85 percent of all those it has rescued. "
Channel 3 News in Kentucky May 7, 2008: http://www.ky3. com/news/ trends/?feed= bim&id=18743839 OVER 90 PERCENT PUT TO DEATH "WASHINGTON -- An official report filed by People for The Ethical Treatment of Animals (PETA) with the Virginia government shows that the organization put to death more than 90 percent of the dogs, cats, and other pets it took in for adoption during 2007. "
Wednesday, June 25, 2008
Deadly Reaction to Comfortis Heartworm Preventative
PERMISSION GRANTED TO CROSS POST
June 24, 2008
COMFORTIS® and ivermectin interaction Safety Warning Notification
Today the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) is announcing that it has received reports of adverse reactions in dogs receiving the drug Comfortis® (spinosad) concurrently with high, extra-label doses of the drug ivermectin. The clinical signs of these adverse reactions are consistent with ivermectin toxicity.
Comfortis® (spinosad), manufactured by Elanco Animal Health, a division of Eli Lilly and Company, is a monthly oral, chewable tablet used for the prevention and treatment of flea infestations on dogs. Veterinarians who use high, extra-label doses of ivermectin to treat dogs with non-responsive demodectic mange and other conditions should be aware that some dogs have developed signs of ivermectin toxicity when ivermectin is used concurrently with Comfortis® (spinosad).
CVM and Elanco Animal Health are advising veterinarians that dogs receiving extra-label doses of ivermectin should not receive concurrent treatment with Comfortis® (spinosad).
CVM is working with Elanco Animal Health as they address this issue. Additional information regarding this safety warning can be obtained on the Elanco Animal Health website.
Lilly Companion Animal Health Technical Bulletin: Spinosad and the Extra-Label Use of High Dose Ivermectin for the Treatment of Generalized Demodicosis in Dogs - http://elms.xh1.lilly.com/10788_03_tech_Bulletin.pdf 
Friday, June 6, 2008
Deadly ProHeart® 6 Heartworm Prevention in the Market Again
Rabies vaccine is not the only miscreant in the adverse reactions that negatively affect our dogs and cats.
FDA and Fort Dodge are bringing the heartworm preventative ProHeart® 6 back on the market after it was voluntarily withdrawn by Fort Dodge in 2004 due to “serious, life-threatening adverse reactions. These include loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death.”
Reports of adverse reactions and death in dogs injected with this heartworm preventative began in 2002. It was implicated in the death of untold hundreds of dogs before it was pulled in 2004.
For a manufacturer and the FDA, "hundreds of dogs" is not statistically important enough to ban the product entirely. It's the "untold" stories that demand more investigation.
Now it's back with no change in formulation but only revised warning language on the label (which pet owners will never see.)
"ProHeart® 6 is generally well tolerated. Do not use in sick, debilitated or underweight animals, animals with a history of weight loss, or within one month of vaccination. Use with caution in dogs with pre-existing allergic disease. A small percentage of dogs showed mild, transient swelling or itching at the injection site. While rare, allergic, digestive, hematological, or neurological reactions may occur. In addition, death has been reported. ProHeart 6 is available only through a restricted distribution program. Only veterinarians enrolled in this program can receive and administer ProHeart 6. In addition, ProHeart 6 must only be administered to clients whose owners have been advised of the risks of ProHeart 6 and sign an Owner Consent Form. To obtain additional information including a copy of the product labeling, visit the website at www.proheart6dvm. com or call 1-800-533-8536."
If you you would like to be in touch with others whose dogs have experienced adverse reactions to ProHeart® 6, contact these people:
FDA and Fort Dodge are bringing the heartworm preventative ProHeart® 6 back on the market after it was voluntarily withdrawn by Fort Dodge in 2004 due to “serious, life-threatening adverse reactions. These include loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death.”
Reports of adverse reactions and death in dogs injected with this heartworm preventative began in 2002. It was implicated in the death of untold hundreds of dogs before it was pulled in 2004.
An independent website has been created that posts reports of adverse side effects to the ProHeart6 shot. It is updated regularly and can be reached via this link: ProHeartInformation.
For a manufacturer and the FDA, "hundreds of dogs" is not statistically important enough to ban the product entirely. It's the "untold" stories that demand more investigation.
Now it's back with no change in formulation but only revised warning language on the label (which pet owners will never see.)
"ProHeart® 6 is generally well tolerated. Do not use in sick, debilitated or underweight animals, animals with a history of weight loss, or within one month of vaccination. Use with caution in dogs with pre-existing allergic disease. A small percentage of dogs showed mild, transient swelling or itching at the injection site. While rare, allergic, digestive, hematological, or neurological reactions may occur. In addition, death has been reported. ProHeart 6 is available only through a restricted distribution program. Only veterinarians enrolled in this program can receive and administer ProHeart 6. In addition, ProHeart 6 must only be administered to clients whose owners have been advised of the risks of ProHeart 6 and sign an Owner Consent Form. To obtain additional information including a copy of the product labeling, visit the website at www.proheart6dvm. com or call 1-800-533-8536."
Way to go, Fort Dodge. Don't fix the problem; cover your ass.
It is extremely important, if you suspect your dog has had an adverse reaction to ProHeart® 6, that you report both to Fort Dodge Animal Health and to the FDA. The toll-free number for Fort Dodge is: 1.800.533-8536 . You can file a report with the FDA by telephone at: 1-888-332-8387 (or 1-888-FDA-VETS)
or:
You may also report an adverse drug experience using a form that is available on the FDA website. Access to the form is at
Just print out the form, complete it and mail it. It is two-sided and postpaid.
If you you would like to be in touch with others whose dogs have experienced adverse reactions to ProHeart® 6, contact these people:
- Myra Kirkland, MKirkland@carolina.rr.com
- Janice Storey, jstorey1@swbell.net
- You may also wish to join the "doghealth2" E-mail list, which has ongoing discussions about canine medications and health. doghealth2@yahoogroups.com
Friday, May 30, 2008
Rabies Vaccine Kills Poodle in Boston
Channel 5 WCVB Boston Woman: Rabies Shot Killed my Poodle May 28, 2008
http://www.thebostonchannel.com:80/news/16410586/detail.html?rss=bos&taf=bos
When a Boston woman's 12 year old poodle died within hours of receiving a rabies "booster" vaccination, the veterinarians interviewed by the TV station covering the story concluded: rabies vaccine is necessary to protect the public. Better safe than sorry.
In 1992, Michel F. Aubert, a French research scientist proved that a dog or cat with at least 2 rabies inoculations has a less than 1 in 8 million chance of contracting rabies if exposed. You by contrast have
a better than 1 in 600,000 chance of being struck by lightning in a thunderstorm.
Furthermore, the Animal Veterinary Medical Association agreed in 2003 that there is no medical necessity for re-administration of the rabies vaccine.
So either the veterinarians the station interviewed are years behind their peers on the current knowledge of vaccinology or they are using the reporters lack of specialized expertise in this area to protect their practice income at the expense of our pets.
By virtue of its age, proximity of exposure and the administration of rabies vaccine multiple times in its life, this poodle should have been exempt from further inoculations against the rabies virus.
Yet this dog owner and consumers in all but 7 states are forced by antiquated rabies control and prevention
ordinances to buy a product with no benefit and the potential for a great deal of damage, even death.
Educating ourselves, our friends and family, elected officials and holding veterinarians accountable for perpetuating fear and outdated information is the only hope for reform.
http://www.thebostonchannel.com:80/news/16410586/detail.html?rss=bos&taf=bos
When a Boston woman's 12 year old poodle died within hours of receiving a rabies "booster" vaccination, the veterinarians interviewed by the TV station covering the story concluded: rabies vaccine is necessary to protect the public. Better safe than sorry.
In 1992, Michel F. Aubert, a French research scientist proved that a dog or cat with at least 2 rabies inoculations has a less than 1 in 8 million chance of contracting rabies if exposed. You by contrast have
a better than 1 in 600,000 chance of being struck by lightning in a thunderstorm.
Furthermore, the Animal Veterinary Medical Association agreed in 2003 that there is no medical necessity for re-administration of the rabies vaccine.
So either the veterinarians the station interviewed are years behind their peers on the current knowledge of vaccinology or they are using the reporters lack of specialized expertise in this area to protect their practice income at the expense of our pets.
By virtue of its age, proximity of exposure and the administration of rabies vaccine multiple times in its life, this poodle should have been exempt from further inoculations against the rabies virus.
Yet this dog owner and consumers in all but 7 states are forced by antiquated rabies control and prevention
ordinances to buy a product with no benefit and the potential for a great deal of damage, even death.
Educating ourselves, our friends and family, elected officials and holding veterinarians accountable for perpetuating fear and outdated information is the only hope for reform.
Please call or e-mail the station, WCVB-TV, 781-449-0260 and ask them to do a follow-up story. E-mail Susan Griffin at sgriffin@hearst.com. Also, it would be helpful if you could forward this to your network and ask them to do the same! Any media coverage in the states bodes well for all states, so please send an e-mail or make a quick call.
Tuesday, April 29, 2008
Cheyenne WY Extends Rabies Vaccine Interval to 3 Years
The e-mail below, shared with permission from the recipient, from the President of the Cheyenne City Council, Don Pierson, was received 4/29/08 by the lead activist in Wyoming, Karon Volk:
"Hello Mrs. Volk: Just a follow up to let you know that the Mayor and I are working together and have instructed the city attorney to prepare an ordinance or a resolution to take care of the 1 year vs 3 year problem. All the research I have found says that to require our city residents to get the vaccination for their pets every year is unnecessary.I will let you know when it will be ready for introduction and would hope that you would like to attend our meetings and testify about the situation. Let me know if there is anything else I can do at this time about this situation. Thanks for all your info you provided and your concern."
Once again, you are helping to bring about great changes for dogs with your active participation on rabies laws -- THANK YOU!!!
"Hello Mrs. Volk: Just a follow up to let you know that the Mayor and I are working together and have instructed the city attorney to prepare an ordinance or a resolution to take care of the 1 year vs 3 year problem. All the research I have found says that to require our city residents to get the vaccination for their pets every year is unnecessary.I will let you know when it will be ready for introduction and would hope that you would like to attend our meetings and testify about the situation. Let me know if there is anything else I can do at this time about this situation. Thanks for all your info you provided and your concern."
Once again, you are helping to bring about great changes for dogs with your active participation on rabies laws -- THANK YOU!!!
Regards, Kris Christine
Sunday, April 27, 2008
2008 Report on Rabies Vaccine Adverse Reactions in Dogs
PERMISSION GRANTED TO CROSS-POST THIS MESSAGE
The Journal of the American Veterinary Medical Association has just
published a report in its April 1, 2008 issue, Vol. 232, No. 7,
entitled:
"Postmarketing Surveillance of Rabies Vaccines for Dogs to Evaluate
Safety and Efficacy."
Despite the extreme under-reporting of vaccinal adverse reactions,
this report states on the second page that between April 1, 2004 and
March 31, 2007, the Center for Veterinary Biologics, "nearly 10,000
adverse event reports (all animal species) were received by
manufacturers of rabies vaccines.... ......Approximat ely 65% of the
manufacturer' s reports, involved dogs."
The report further states on the second page that: "Rabies vaccines
are the most common group of biological products identified in
adverse event reports received by the CVB," and they give the
following description of the adverse reaction 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%.
Veterinarians are not required by law to report adverse reactions to
vaccines, to which the World Small Animal Veterinary Association
stated in their 2007 Vaccine Guidelines that there is: "gross under-
reporting of vaccine-associated adverse events which impedes
knowledge of the ongoing safety of these products,"
And in an article entitled, A New Approach to Reporting Medication
and Device Adverse Effects and Product Problems, (JAMA - June 2,
1993. Vol.269, No.21. p.2785) Dr. David Kessler, former head of the
Food & Drug Administration, reported that "only about 1% of serious
events are reported to the FDA."
In light of the 10,000 adverse reactions to the rabies vaccine in the
JAVMA report, 65% of which were in dogs, the estimated 1% reporting
of "serious" events by the former head of the FDA means that the
actual number of dogs that had adverse reactions to the vaccine would
be more like 650,000!!!!!
World Small Animal Veterinary Association 2007 Vaccine Guidelines
http://www.wsava. org/SAC.htm Scroll down to Vaccine Guidelines 2007
(PDF)
A New Approach to Reporting Medication and Device Adverse Effects and
Product Problems
http://www.vaccinat ionnews.com/ Adverse_Reaction s/VAERS/credible _estima
tes.htm Scroll down to David Kessler statement in JAMA - June 2,
1993,vol.269, No.21, p.2785
The Journal of the American Veterinary Medical Association has just
published a report in its April 1, 2008 issue, Vol. 232, No. 7,
entitled:
"Postmarketing Surveillance of Rabies Vaccines for Dogs to Evaluate
Safety and Efficacy."
Despite the extreme under-reporting of vaccinal adverse reactions,
this report states on the second page that between April 1, 2004 and
March 31, 2007, the Center for Veterinary Biologics, "nearly 10,000
adverse event reports (all animal species) were received by
manufacturers of rabies vaccines.... ......Approximat ely 65% of the
manufacturer' s reports, involved dogs."
The report further states on the second page that: "Rabies vaccines
are the most common group of biological products identified in
adverse event reports received by the CVB," and they give the
following description of the adverse reaction 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%.
Veterinarians are not required by law to report adverse reactions to
vaccines, to which the World Small Animal Veterinary Association
stated in their 2007 Vaccine Guidelines that there is: "gross under-
reporting of vaccine-associated adverse events which impedes
knowledge of the ongoing safety of these products,"
And in an article entitled, A New Approach to Reporting Medication
and Device Adverse Effects and Product Problems, (JAMA - June 2,
1993. Vol.269, No.21. p.2785) Dr. David Kessler, former head of the
Food & Drug Administration, reported that "only about 1% of serious
events are reported to the FDA."
In light of the 10,000 adverse reactions to the rabies vaccine in the
JAVMA report, 65% of which were in dogs, the estimated 1% reporting
of "serious" events by the former head of the FDA means that the
actual number of dogs that had adverse reactions to the vaccine would
be more like 650,000!!!!!
World Small Animal Veterinary Association 2007 Vaccine Guidelines
http://www.wsava. org/SAC.htm Scroll down to Vaccine Guidelines 2007
(PDF)
A New Approach to Reporting Medication and Device Adverse Effects and
Product Problems
http://www.vaccinat ionnews.com/ Adverse_Reaction s/VAERS/credible _estima
tes.htm Scroll down to David Kessler statement in JAMA - June 2,
1993,vol.269, No.21, p.2785
Monday, April 14, 2008
Update: Wyoming's Rabies Laws
To update you on efforts to change Wyoming's rabies laws, on Saturday April 12, 2008, an article entitled Changes to vaccine ordinance unlikely published in the Wyoming News. ]http://www.wyomingnews.com/articles/2008/04/13/news/19local_04-13-08.txt
Below is a copy of a letter to the editor sent to the paper this morning.
What You Can Do To Help
1.) Contact Cheyenne Mayor Jack Spiker mayor@cheyennecity.org Phone: (307) 637-6200; Fax: (307)637-6378
2.) Leave a comment on the newspaper article at http://www.wyomingnews.com/articles/2008/04/13/news/19local_04-13-08.txt
3.) Write a letter to the editor of the Wyoming News (Scott Smith) ssmith@wyomingnews.com Fax: 307-633-3189
PERMISSION GRANTED TO CROSS-POST THIS MESSAGE
April 14, 2008
To the Editor:
There are a number of issues in the April 12, 2008 article entitled Changes to Vaccine Ordinance Unlikely that need to be addressed.
The state veterinarian, Dr. Walter Cook, seems to be unaware that the national organization of which he is supposed to be a member, the Center for Disease Control’s CDC, National Association of State Public Health Veterinarians (NASPHV), currently recommends a 3 year rabies vaccination protocol in their 2008 Compendium of Animal Rabies Prevention and Control and has done so since at least 2001. The American Veterinary Medical Association also endorses the NASPHV’s 3 year rabies immunization protocol.
Contrary to Dr. Cook’s statement, veterinarians are not required to report adverse reactions to vaccines and the World Small Animal Veterinary Association (WSAVA) stated in 2007 there is “gross under-reporting of vaccine-associated adverse events which impedes knowledge of the ongoing safety of these products.” In an article entitled, A New Approach to Reporting Medication and Device Adverse Effects and Product Problems, (JAMA - June 2, 1993. Vol.269, No.21) Dr. David Kessler, former head of the Food & Drug Administration, reported that "only about 1% of serious events are reported to the FDA."
Studies demonstrating long-term (more than 3 years) duration of immunity for the canine rabies vaccine have already been published. In 1992, a French research team led by Michel Aubert published the results of a rabies challenge study in Scientific Technical Review (Rev. sci.tech. Off. int. Epiz.) 1992, 11 (3), 735-760 in which they demonstrated that dogs were immune to a rabies challenge 5 years after vaccination. The serological studies of Dr. Ronald Schultz of the University of Wisconsin School of Veterinary Medicine showed that dogs had antibody titers counts at levels known to confer immunity to rabies 7 years after vaccination, the results of which have been incorporated into the 2003, 2006 American Animal Hospital Association’s Canine Vaccine Guidelines as well as WSAVA’s 2007 Vaccine Guidelines.
Because the rabies vaccine is the most potent of the veterinary vaccines and associated with significant adverse reactions, it should not be given more often than is necessary to maintain immunity. Adverse reactions such as autoimmune diseases affecting the thyroid, joints, blood, eyes, skin, kidney, liver, bowel and central nervous system; anaphylactic shock; aggression; seizures; epilepsy; and fibrosarcomas at injection sites are linked to rabies vaccinations.
Rabies is a “killed” vaccine and contains adjuvants to enhance the immunological response. Mercury (Thimersol) is commonly found as a preservative in killed, adjuvanted veterinary vaccines such as Rabies, Leptospira, and Lyme. The combination of mercury with adjuvant components (aluminum hydroxide, aluminum phosphate) are of considerable concern because of the reactive properties of aluminum, when in contact with mercury. Reactivity with aluminum is so acute that mercury may not be packed in checked or carry-on baggage on commercial airplanes, and there is currently a petition to Congress Petition to Congress, Removal of Aluminum Additive in Vaccines Resolution and Petition, citing as cause for removing aluminum in human vaccines that: "The combination of mercury plus aluminum is far worse than the sum of the two toxicities added together. The synergistic toxicity could be increased to unknown levels."
In 1999, the World Health Organization " classified veterinary vaccine adjuvants as Class III/IV carcinogens with Class IV being the highest risk," and the results of a study published in the August 2003 Journal of Veterinary Medicine documenting fibrosarcomas at the presumed injection sites of rabies vaccines stated, “In both dogs and cats, the development of necrotizing panniculitis at sites of rabies vaccine administration was first observed by Hendrick & Dunagan (1992).” According to the 2003 American Animal Hospital Association’s Canine Vaccine Guidelines, "...killed vaccines are much more likely to cause hypersensitivity reactions (e.g., immune-mediated disease)."
A clarification on the Postmarketing Surveillance of Rabies Vaccines for Dogs to Evaluate Safety and Efficacy referenced in the story. Only the 246 adverse reactions to the rabies vaccine reported directly to the Center for Veterinary Biologics by the public, veterinarians, and pet owners had 72% of the dogs receiving other vaccines or drugs at the same time as the rabies shot. That is not stated to be the case further on in the report where they discuss the 10,000 adverse reactions reported by the rabies vaccine manufacturers, 65% of which were in dogs.
If the 6,500 of canine adverse rabies vaccine reactions reported by the vaccine manufacturers represents "only about 1% of serious events are reported to the FDA,” then that would translate into 650,000 if all reactions were reported.
Cheyenne Mayor Jack Spiker and State Public Health Veterinarian, Dr. Cook, should be guided by the recommendations of the CDC’s National Association of State Public Health Veterinarians and the American Veterinary Medical Association to determine the state’s and city’s rabies immunization protocols rather than seeking the advice of local animal shelters and veterinary practitioners to determine appropriate protocols.
Kris L. Christine
Founder, Co-Trustee
THE RABIES CHALLENGE FUND
Thursday, March 27, 2008
Wyoming Tribune-Eagle: Vaccine overkill?
Vaccine overkill?
By Baylie Davis
bdavis@wyomingnews.com
CHEYENNE -- Even though city residents might have the option of getting rabies vaccines for their pets that last three years, according to city ordinance, the vaccine has to be administered every year.
There are two types of vaccines available. The only difference between them is how long they’ve been proven effective, Wyoming State Veterinarian Walter Cook said.
A one-year vaccine might be the same formula as the three-year vaccine, but it may or may not work as long, he said.
Depending on what the dog owner asks for and what the veterinarian has available, pets can be vaccinated with either type.
But even if the animal gets the three-year vaccine, the city requires that rabies tags be updated every year, which means a new shot every year.
Cook said the state will recognize the three-year vaccination, but local jurisdictions are allowed to make their own rules.
In Cheyenne, a yearly update is required; in the county, the tags must be updated based on “current veterinary standards,” said Paula Cook, Cheyenne and Laramie County animal control supervisor. That means a three-year vaccine is current for three years outside of Cheyenne.
Paula Cook said ensuring accountability is one reason for requiring a yearly update in Cheyenne. It’s a lot harder to keep track of vaccine records for three years than for one year, and it’s harder to determine if they’re current, she said.
The bottom line, Cheyenne Animal Shelter Executive Director Rick Collord said, is there are two schools of thought among experts: one, that requiring yearly vaccinations is overkill; the other that requiring yearly vaccines is safer and more reliable.
Collord said he tends to agree with the latter, after having been through a rabies outbreak in Texas.
“My main concern is that we don’t get a rabies outbreak,” he said, adding that requiring a yearly vaccination means people are less likely to forget about it.
For people who can remember to do the vaccination every three years, however, the yearly requirement might feel excessive. But for those who have trouble remembering to follow even a yearly schedule, a three-year schedule might be even harder.
Frontier Veterinary Center head veterinary technician Amanda Adsit said using the three-year vaccine is “sort of like insurance” because they have a few clients who don’t follow the yearly schedule, despite the ordinance. This way, they know the dogs are protected for three years, even though they may get fined by the city for out-of-date tags.
The cost of yearly visits is one concern of pet owners at Frontier, Adsit said.
The vaccine itself only costs $16 there, but an office visit costs $46, and other vaccines can increase the price also. Plus, it isn’t always convenient to make an appointment, coax Fido into the backseat, hold him down when he sees the cats in the office and then hold him down some more when it’s time for the needle.
Some people are pretty vocal about their frustration with having to come in every year, even though they get a three-year vaccine at Frontier, Adsit said.
Another concern pet owners have is whether their dogs could get sick from getting a vaccine every year that is meant to last for three years.
Walter Cook said there is no danger of that. In fact, dogs that have been exposed to other animals with rabies will often be given another vaccination, even if theirs is current, just to make sure they don’t get sick.
Having a tag with the animal’s current veterinarian on it also is valuable if the dog gets lost, hit by a car or needs to be taken to a vet quickly, Paula Cook and Dr. Christopher Church, a veterinarian at the Cheyenne Pet Clinic, added.
Not having current tags “wastes precious time” in getting the animal taken care of, Paula Cook said.
Although she said she felt the one-year ordinance was reasonable, Paula Cook added that if the law would allow it, she doesn’t see any problem with three-year vaccines having tags that last three years.
“What the law says and what we can do are two different things,” she said.
Walter Cook recommends that curious pet owners ask about the vaccine that their dog will receive. The type, whether three-year or one-year, can be found on the label of the vaccine itself.
Mayor Jack Spiker said the issue of how often vaccinations are necessary has come up several times in the City Council, and that he didn’t have a good answer for why the city requires a yearly vaccination.
“I would take a lead from the animal shelter folks,” he said. “If we had a recommendation from the animal shelter and the board, we’d certainly amend our ordinance to reflect that.”
Action Alert: Stop Overvaccinating in Wichita
petition overview | letter
Petition to change City of Wichita’s rabies vaccinations requirements from annually to tri-ann
Target:
Dog Owners in Wichita, KS City Limits
Whereas major veterinary schools and the American Animal Hospital Association recommend that most major canine vaccines should be given once every three years
http://www.thepetitionsite.com/1/Stop-Over-Vaccination-in-Wichita
Subscribe to:
Posts (Atom)
