Rabies Challenge Fund Meets First Year Goal

http://www.mainelincolncountynews.com/index.cfm?ID=26297

Kris Christine of Alna is surely proof of the adage that one person's determination and passion can make a difference. First, in 2004, she launched a successful campaign to change the canine rabies vaccination laws in the state, which were vague enough to allow vaccinations to occur every year as opposed to the every three years most states have on the books, and vaccine manufacturers recommend as well.

But, in the course of her research, she found information on studies indicating a possible longer immunity, up to seven years, from a canine rabies shot. So, in 2005 she started The Rabies Challenge Fund to raise money for the necessary challenge studies to be conducted to prove the preliminary research. And the fund has just reached its first-year goal of $177,000.

"It's a testament to how much people love their pets," Christine said, "because most of the money came from the public – from pet owners as well as dog associations and kennels. It came from a grass roots effort, not from professional veterinary medical organizations, except for the American Holistic Veterinarian Medical Association."

The challenge studies would not be able to go forward, however, Christine adds, if it weren't for the generous contribution of time and expertise by two leading veterinary vaccine researchers, Dr. W. Jean Dodds of Hemopet in California, who is co-trustee of the fund with Christine, and Dr. Ronald Shultz of the University of Wisconsin School of Veterinary Medicine.

"This is one of the most important projects in veterinary medicine. It will benefit all dogs by providing evidence that protection from rabies vaccination lasts at least five years, thereby avoiding unnecessary revaccination with its attendant risk of debilitating adverse reactions," Dodds said. "And it's the first time in my 43 years of involvement in veterinary issues that what started as a grassroots effort to change an outmoded regulation affecting animals will be addressed scientifically by an acknowledged expert to benefit all canines in the future."

Adverse reactions to rabies vaccination can include 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.

The studies, of concurrent five and seven years, in accordance with FDA vaccine licensing standards, will be conducted by Shultz at the University of Wisconsin. Annual budget goals of $150,000 for the studies have to be met in the future. Current rabies immunization laws in the United States are not based upon long-term duration of immunity studies, Christine pointed out.

Schultz stated, "Showing that a vaccine for rabies can provide five or preferably seven years of immunity would have great significance not only in controlling rabies but more importantly in reducing the adverse vaccine reactions that can occur in dogs and cats after vaccination."

More information on The Rabies Challenge Fund can be found at www.RabiesChallengeFund.org.
====================

The US is free of canine rabies


Rabies Vaccine May Save Some Pain


Veterinarians Urged to Shift Away from Annual, Grouped Vaccinations - Adverse Effects Cited


Podcast interview with Dodds & Christine


How Often Does He REALLY Need A Rabies Shot?


Are We Overvaccinating our Dogs?

Maine Today blog on RCF


Other related podcasts

Anyone wishing to have a copy of the 1992 French challenge study data from a research team led by Michel Aubert in which dogs were demonstrated to be immune to a rabies challenge 5 years after vaccination,
or
Vascellari's study which documented cancerous tumors in dogs at presumed injection sites of rabies vaccine, please e-mail me at
ledgespring@ lincoln.midcoast .com

Regards,
Kris L. Christine
Founder, Co-Trustee
The Rabies Challenge Fund
*****************************
Edit 07-15-08
PETA has been abusing the RCF for their challenge to ultimataly save the lives of many animals and prevent unnecessary health risks for countless others. The government refuses to accept scientific studies that have been done outside the US since the pharmaceutical industry holds so much power and wealth. They don't want to lose their cash cow, no matter how many health problems are generated as a result. And PETA claims to be for the animals, but one has to question their true motives and desires. Here is information that has been sent as official responses to the PETA attacks:

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.

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.

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.

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 samanthapeta@... 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. "