The Science
An entire ovary in the process of being analyzed.
_PNG.png)
A closer view of the same ovary; follicle evaluation in progress.
Greater magnification, with follicle evaluation in progress.
Dear Friends of 600,
It is my honor to present our
Spay and Neuter Cookie Overview and Update.
As you know, our science-centered mission is to
significantly reduce animal suffering by developing safe,
non-profit, permanent one-dose birth control food
for stray dogs and cats.
Our approach is to modify known ingredients so
that they will safely sterilize a stray without surgery.
The first birth control food we are developing are the
Spay and Neuter Cookies.
They are being designed to be species- and gender-specific,
and we expect the first Cookie that will be
completed will be for female dogs.
Our Pilot Pups
When we rescue a stray, in addition to caring for her
or him, we also feed her or him a single trial Cookie.
Once a rescued stray has eaten a single trial Cookie,
she or he becomes an official Pilot Pup.
We also cover the associated costs such as veterinary
care, food, housing, transportation, adoption -- and
we add a hefty dose of love and affection.
Trial Cookies
Each trial Cookie contains a combination of key
ingredients and trial formulations -- often as many
as 15 or more variables go into a single Cookie,
such as the varying temperatures at
which they are prepared and the length of time
they are heated, all of which we are evaluating.
At this stage of development, each trial formulation
(trial Cookie) must be made by one or more
scientists and made by hand one at a time.
The work is labor-intensive and each trial
formulation is unique and can cost thousands
of dollars and take months to prepare -- and
many formulations need to be evaluated.
Once the final formulation is completed,
our goal is to be able to produce it in bulk
for under $5 per Cookie.
In our work, the welfare of the Pilot Pup comes
first, before the science. We take precautions
and go out of our way to ensure that each trial
Cookie is as safe as possible, based on using
ingredients and amounts that we already know
to be safe.
For the safety of the Pilot Pup, to study
variations in formulas, we only increase key
ingredients by very small, controlled amounts,
one tiny step at a time.
This is a significant factor in why it is taking
so long to perfect the formulas.
In contrast, a for-profit drug company
would not typically follow our one tiny step
at a time approach; instead they would
increase the dose as high as possible
and as fast as possible, to cut costs.
Some of us humans at 600 have eaten
trial Cookies ourselves, myself included.
Thus far there have been no negative side effects
for animals or people. We suspect a key reason
for the lack of negative side effects is that the
Cookie is designed as a rare “only one dose
over a lifetime” product, unlike traditional
birth control products that are ingested daily.
Evidence also shows, thus far, that eating multiple
doses (of the ingredients of the Cookies) does
not harm the animal.
After the Pilot Pup eats the single trial Cookie,
the Pup usually stays at the veterinary clinic for
a few days to ensure that he or she is in good health.
As soon as they get the green light from the
veterinarian, they go home to their foster or
permanent home.
If a home is not readily available, the Pup stays
at the veterinary clinic or in a doggy day care
center until a home is found.
Approximately one month after eating the trial
Cookie, the Pilot Pup comes back to the veterinary
clinic, the veterinarian performs a spay or neuter
surgery and the Pup goes home again.
In a standard spay or neuter surgery, the
veterinarian discards any tissue that is removed,
such as the ovaries or testes.
In our case, the veterinarians keep these
now-treated tissues, and we provide them to other
specialists to histologically process
them physically, chemically and digitally
for microscopic examination.
Once the slides are digitized, we have them
microscopically examined by other specialists.
The Science
Dear Friends of 600,
It is my honor to present
our Spay and Neuter Cookie
Overview and Update.
As you know,
our science-centered mission
is to significantly reduce
animal suffering
by developing safe,
non-profit, permanent
one-dose birth control food
for stray dogs and cats.
Our approach is to modify
known ingredients so that
they will safely sterilize
a stray without surgery.
The first birth control food we
are developing are the
Spay and Neuter Cookies.
They are being designed to be
species- and gender-specific,
and we expect the first
Cookie that will be completed
will be for female dogs.
Our Pilot Pups
When we rescue a stray,
in addition to caring for her
or him, we also feed her
or him a single trial Cookie.
Once a rescued stray has eaten
a single trial Cookie, she or he
becomes an official Pilot Pup.
We also cover the associated
costs such as veterinary care,
food, housing, transportation,
adoption -- and we add a
hefty dose of love and affection.
Trial Cookies
Each trial Cookie contains a
combination of key ingredients
and trial formulations.
Often as many as 15 or more
variables go into a single Cookie,
such as the varying temperatures
at which they are prepared and
the length of time they are heated,
all of which we are evaluating.
At this stage of development,
each trial formulation (trial Cookie)
must be made by one or more
scientists and made by hand
one at a time.
The work is labor-intensive and
each trial formulation is unique
and can cost thousands of dollars
and take months to prepare --
and many formulations
need to be evaluated.
Once the final formulation
is completed, our goal is to
be able to produce it in bulk
for under $5 per Cookie.
In our work, the welfare of the
Pilot Pup comes first,
before the science.
We take precautions and
go out of our way to ensure
that each trial Cookie is as safe
as possible, based on using
ingredients and amounts
that we already know to be safe.
For the safety of the Pilot Pup,
to study variations in formulas,
we only increase key ingredients
by very small, controlled amounts,
one tiny step at a time.
This is a significant factor in why
it is taking so long to perfect
the formulas.
In contrast, a for-profit drug
company would not typically follow
our one tiny step at a time
approach; instead they would
increase the dose as high
as possible and as fast
as possible, to cut costs.
Some of us humans at 600
have eaten trial Cookies
ourselves, myself included.
Thus far there have been no
negative side effects for
animals or people.
We suspect a key reason for
the lack of negative side effects
is that the Cookie is designed
as a rare “only one dose over
a lifetime” product, unlike
other birth control products
that are ingested daily.
Evidence also shows thus far
that eating multiple doses
(of the ingredients of the Cookies)
does not harm the animal.
After the Pilot Pup eats the single
trial Cookie, the Pup usually stays
at the veterinary clinic for a few
days to ensure that he or she
is in good health.
As soon as they get the green light
from the veterinarian, they go
home to their foster
or permanent home.
If a home is not readily available,
the Pup stays at the veterinary
clinic or in a doggy day care
center until a home is found.
Approximately one month
after eating the trial Cookie,
the Pilot Pup comes back to
the veterinary clinic,
the veterinarian performs
a spay or neuter surgery,
and the Pup goes home again.
In a standard spay or neuter
surgery, the veterinarian discards
any tissue that is removed,
such as the ovaries or testes.
In our case, the veterinarians
keep these now-treated tissues,
and we provide them to other
specialists to histologically process
them physically, chemically and
digitally for microscopic examination.
Once the slides are digitized,
we have them microscopically
examined by other specialists.
This examination is a painstaking process, and
it allows us to determine if the Pilot Pup is sterile
as a result of eating the single trial Cookie.
This in turn allows us to learn if
the trial formulation worked.
How do we know if the Cookie worked?
It’s a long and important answer.
These are the basics of what we refer to as the count,
our nickname for the percentage of various types of
ovarian reproductive follicles that are impaired.
The more follicles that are impaired (the higher
the count) the better, and the closer the dog is
to being infertile.
For example, a high count occurs naturally through
aging in humans and dogs -- which is why elderly
humans and dogs naturally become infertile.
What is the magic number
that produces infertility?
According to the scientific
community, the answer is
unknown.
At this time the answer is not clear when it comes to dogs, cats,
or humans.
What is known is that in humans,
for example, it is common for
an adult female in her sixties
to be infertile yet still have a considerable number of
normal follicles.
This is good news for dogs
and cats, because it means
that if a human female
can be sterile even though
not all of her follicles are
impaired (she has less than
a 100% count), the same
can be true for dogs and
cats, who have reproductive
systems very similar
to humans.
Our ability going forward
to reliably produce a high
yet less than 100% count
should be much easier
than producing a 100%
count -- all of which is
good for the animals.
When will we discover
the winning formula and
how much will it cost?
As with most scientific
endeavors, no one can
answer this question
with certainty – just as
no one can predict the
future with certainty.
A team of scientists
formulated projections
for the time and cost
that would be required
to complete the work,
including the studies
needed to submit the data
to the FDA and initiate
the FDA approval process
so that the product can be
used in the U.S.
They reached the following conclusion:
With a budget of $3 million
per year for 3 years,
the Cookie could be
developed within those
3 years, including the
studies needed to initiate
the FDA approval process.
These funds would go
toward hiring scientists,
allowing them to devote
themselves full-time
to the project.
As you know, we are not
waiting for the $3 million.
Our plan is to continue
our research and
development to find
the winning formula
-- without applying
for FDA approval
at this time.
Instead, our work is
being performed at a
grassroots level:
Scientists are retained
individually and paid
on a limited hourly basis,
and much is done
outside of the U.S.
Instead of waiting for
FDA-level funding, we
intend to continue
at the grassroots level,
find the winning formula
-- and put it to work
in field trials in parts of
the world where the need
is the greatest and where
the suffering is the
most severe.
Despite the obstacles,
we are pushing forward
to make the Spay and
Neuter Cookie a reality.
At this time, we are actively pursuing opportunities to carry out the work humanely, cost-effectively, and with the best scientists and technology available in the U.S.
In the meantime,
I cannot thank you enough
for your support.
Our scientists review, analyze and quantify these
follicles under a microscope, and one of the things
we’re trying to do is cause as many of these follicles
as possible to become impaired -- without harming
the animal, of course.
Our scientists then provide us with a report
on each tissue, including the percentage of
impaired follicles.
A count of 20% means 20% of a certain type of
follicle were found to be impaired.
Again, the higher the count the better, and the
closer the dog is to being infertile.
Conducting accurate counts is not easy, and we
send the same digital slides to various specialists
in order to secure second and third opinions.
Thus far, three of our best cumulative counts
(the counts for all follicle types found to be
impaired, combined) have been 41%, 45% and 69%.
In short, these are surprisingly high numbers
and good news for the animals.
Some additional good news:
Three of our best individual counts
(the counts for individual types of follicles)
are higher than the cumulative counts.
The best news is that each of these results
have come from their own single trial Cookie
formulation -- produced on a minuscule budget,
with scientists working on our behalf
in their spare time.
At this point, our budget is around $270,000.
What is the magic number that produces infertility?
According to the scientific community,
the answer is unknown.
At this time the answer is not clear
when it comes to dogs, cats, or humans.
What is known is that in humans, for example,
it is common for an adult female in her sixties
to be infertile yet still have a considerable
number of normal follicles.
This is good news for dogs and cats, because it
means that if a human female can be sterile
even though not all of her follicles are impaired
(she has less than a 100% count), the same can
be true for dogs and cats, who have reproductive
systems very similar to humans.
Our ability, going forward, to reliably produce a
high yet less than 100% count should be much
easier than producing a 100% count
-- all of which is good for the animals.
When will we discover the winning formula
and how much will it cost?
As with most scientific endeavors,
no one can answer this question with certainty
-- just as no one can predict the future with certainty.
A team of scientists formulated projections
for the time and cost that would be required
to complete the work, including the studies
needed to submit the data to the FDA and initiate
the FDA approval process so that the product
can be used in the U.S.
They reached the following conclusion:
With a budget of $3 million per year for 3 years,
the Cookie could be developed within those
3 years, including the studies needed to initiate
the FDA approval process.
These funds would go toward hiring scientists,
allowing them to devote themselves full-time
to the project.
As you know, we are not waiting for the $3 million.
Our plan is to continue our research and
development to find the winning formula
-- without applying for FDA approval at this time.
Instead, our work is being performed at a grassroots level:
Scientists are retained individually and paid on a
limited hourly basis, and much is done outside of the U.S.
Instead of waiting for FDA-level funding, we intend to
continue at the grassroots level, find the winning formula
-- and put it to work in field trials in parts of the world
where the need is the greatest and where the suffering
is the most severe.
Despite the obstacles, we are pushing forward
to make the Spay and Neuter Cookie a reality.
At this time, we are actively pursuing opportunities to carry out the work humanely, cost-effectively, and with the best scientists and technology available in the U.S.
In the meantime, I cannot thank you enough for your support.
This examination is a painstaking
process, and it allows us to
determine if the Pilot Pup is
sterile as a result of eating
the single trial Cookie.
This in turn allows us to learn
if the trial formulation worked.
How do we know
if the Cookie worked?
It’s a long and important answer.
These are the basics of what we
refer to as the count, our
nickname for the percentage of
various types of ovarian
reproductive follicles that
are impaired.
The more follicles that are
impaired (the higher the count)
the better, and the closer the dog
is to being infertile.
For example, a high count occurs
naturally through aging,
in humans and dogs -- which
is why elderly humans and dogs
naturally become infertile.
Thank you for caring.
A count of 20% means 20%
of a certain type of follicle
were found to be impaired.
Again, the higher the count
the better, and the closer
the dog is to being infertile.
Conducting accurate counts
is not easy, and we send the
same digital slides to various
specialists in order to secure
second and third opinions.
Thus far, three of our best
cumulative counts
(the counts for all follicle types
found to be impaired, combined)
have been 41%, 45% and 69%.
In short, these are surprisingly
high numbers and good news
for the animals.
Some additional good news:
Three of our best individual
counts (the counts for individual
types of follicles) are higher
than the cumulative counts.
The best news is that each
of these results have come
from their own single trial
Cookie formulation -- produced
on a minuscule budget,
with scientists working
on our behalf in their spare time.
At this point, our entire budget,
including our research and
development, for this year
is expected to be approximately
$270,000.
Alex Pacheco
600 Million Stray Dogs Need You
Founder
Animal Rights Hall of Fame
Inductee
Adopt A Pet
Co-Founder
PETA Co-Founder
Chairman (1980-2000)
Sea Shepherd
Crew Member of the Year
Peace Abbey
Courage of Conscience Award
Our scientists review, analyze and
quantify these follicles under a
microscope, and one of the things
we’re trying to do is cause as many
of these follicles as possible to
become impaired -- without
harming the animal, of course.
Our scientists then provide us
with a report on each tissue,
including the percentage
of impaired follicles.
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Out of 1.8 million nonprofits,
600 Million Stray Dogs Need You
has been awarded the prestigious
Gold status of accountability
by GuideStar, "the nation's premier
nonprofit database."