|Kris L. Christine
Joined: 01 Feb 2008
Location: THE RABIES CHALLENGE FUND
|Posted: 07/16/08, 6:09 am Post subject: PETA attack on Rabies Challenge Fund -- Fund Response
|PETA Attack on Rabies Challenge Fund, Rabies Challenge Fund Response
PERMISSION GRANTED TO CROSS-POST
PETA launched a public attack on The Rabies Challenge Fund in April this year, the allegations of which have appeared on various dog discussion boards and chat lists. For those of you who may have seen those posts, below is an updated copy of Dr. Dodds' response to PETA'S allegations-- her responses are in red. Beneath that is information I compiled which may help dog owners understand why this research is necessary.
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.
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.
Jean (W. Jean Dodds, DVM)
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). Did that in an attachment to my first response to 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.). Answered that too. The study began last fall, as described.
3. What efforts RCF had made to avoid killing all of the dogs they are using in their study. Dr. 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.
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. Please read my direct correspondence here. We never received any response from Schultz. 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.
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). 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. So it is still likely that many dogs will die and many will die excruciating deaths. Absolutely untrue; 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.
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]. 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. The experiments being conducted by RCF are purely elective. Also not true. Why not design a tenable serological protocol that can be approved by USDA? 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. A serological method would allow data to be collected from volunteers rather than dogs stuck in a laboratory. 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.
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! IF that's true; we applaud the effort !
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. 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. However, RCF has not answered even this simple question.
• 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. 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.
• 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. 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. This is in direct contradiction RCF’s current claim that it will adopt out the dogs who don't die.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.
RCF makes it appear that dogs will be killed at the first signs of rabies. Rabies is painful and its symptoms can begin quietly. See above. Dogs will likely die of painful complications related to paralysis and inability to breathe. Not true; the end point will be recognized long before this end stage of paralysis.
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. 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 is also unfortunate that PETA chooses to paint our good will for the benefit of millions in this light.
It seems there are critical differences here, and I stand with PETA and again demand (hey -- how about a request rather than demand here ?) the issues raised by PETA be addressed AND FOLLOWED.
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.
The following information was compiled by Kris L. Christine:
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.
Looking specifically at the number of dogs for whom "death" is an adverse reaction to rabies shots within days (not taking into account those which develop cancers and other disorders over the course of several weeks or months) of vaccination, 1,250 dogs a year could be saved if the challenge studies are successful and states adopt the extended booster protocols.
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..........Approximately 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).
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.. 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 firstname.lastname@example.org 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. "
Kris L. Christine
THE RABIES CHALLENGE FUND