The Science
An entire ovary in the process of being analyzed.
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 2019
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.
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.
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.
On 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.
In the meantime, I cannot thank you enough for your support.
Thank you for caring.
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
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