No product, no scientists, nothing else that makes sense
POMPANO BEACH, Florida––The pseudo-science in a “Spay and Neuter Cookie Science Update and Overview” fundraising appeal emailed by “600 Million Stray Dogs Need You” founder Alex Pacheco to potential donors on December 19, 2018 began in the first sentence beneath the headline.
Pacheco has raised more than $1.3 million since 2009, according to IRS Form 990 filings, on the unfulfilled promise to be “developing safe, non-profit, permanent lasting one-dose birth control food for stray dogs and cats.” He has as yet no tangible product to show for the use of the money.
Further, Pacheco has had no scientists in relevant fields verifiably working for or with him since the Arizona rodent control product developer SenesTech severed relations with him, after just four months, in April 2011.
On December 22, 2018, about 24 hours after ANIMALS 24-7 first posted “Pseudo-science & the Alex Pacheco “Spay & Neuter” Cookie,” Pacheco in an emailed appeal following up on his “Spay and Neuter Cookie Science Update and Overview” included a brief introduction to “one of our scientists: Dr. Rajay Kumar,” who holds “degrees from MIT and the University of Southern California,” and is said to be an “ethical research scientist specializing in nanotechnology,” a field wholly unrelated to contraceptive development.
According to Kumar’s LinkedIn page, he heads Riot Shield Games, a one-person online game development company.
His degrees are in electrical engineering and technology commercialization, with no evident background in any aspect of biology or biochemistry.
Neither has Pacheco ever postulated any credible scientific approach to his proposition that there is a way to develop a “permanent lasting one-dose birth control food for stray dogs and cats” in the form of a “Spay and Neuter Cookie,” which will not harm the animals and could win regulatory approval.
Pacheco’s December 19, 2018 “Science Update” opened by asserting that he is “modifying known ingredients such as calcium chloride, zinc, vinylcyclohexene and others so that they (in a single dose) will safely sterilize a stray, without surgery.”
Gastrointestinal tract doesn’t lead to gonads
The pseudo-science in the claim begins with the reality that calcium chloride and zinc are the chief ingredients in several chemosterilants developed by various others over the past 30 years for injection into the testicles of male animals to block the release of sperm.
Neither calcium chloride nor zinc could be put into a “Spay and Neuter Cookie” to any useful effect because an ingestible product, passing through the gastro-intestinal tract of an animal, could not deliver either calcium chloride, zinc, or any other mineral into the animal’s sperm ducts. The plumbing simply does not run in that direction.
Vinylcyclohexene is a carcinogenic chemical with known damaging effects on the human reproductive system, used experimentally to model human menopause in laboratory mice.
Developer ended relationship
SenesTech in 2006 tested a product based on vinylcyclohexene, called ChemSpay, in dogs, funded by the Alliance for Contraception of Cats & Dogs, but the experiment was unsuccessful.
In December 2010 SenesTech announced that it would be working with Pacheco and “600 Million Stray Dogs need you,” but in April 2011 advised Alliance for Contraception of Cats & Dogs executive director Joyce Briggs that “neither ‘600 Million’ nor Mr. Pacheco have any claim, right, title, license or interest in our ChemSpay product or any other [SenesTech] product.”
Because vinylcyclohexene is a carcinogen, meaning that exposure could potentially cause cancer in humans, ChemSpay would in any event have been extremely difficult to register for use in dogs and cats.
Continued Pacheco in his December 19, 2018 appeal, reasserting previous claims, “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.”
But while Pacheco thereby acknowledged not having any “Spay and Neuter Cookies” that are “completed,” whatever he might mean by that, he also claimed to be feeding “incomplete” versions of “Spay and Neuter Cookies” to male dogs.
“When we rescue a stray,” Pacheco said, “we also feed her or him a single trial Cookie.”
Claimed Pacheco, “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.”
Heating the first two of the substances Pacheco mentioned to cookie-baking temperatures––calcium chloride and zinc––would not likely have any effect on their contraceptive properties, even if those properties could be imparted to a dog or cat in cookie form.
Heating vinylcyclohexene is part of the process of manufacturing some plastic products.
Pacheco, PETA, & missing ballots
But Pacheco in his December 19, 2018 appeal is addressing donors, not chemists––and probably mostly donors who remember when he was for a time one of the media stars of the animal rights movement, after joining Ingrid Newkirk in cofounding People for the Ethical Treatment of Animals in 1981.
Less well-remembered is that Pacheco, while still with PETA, was also associated from 1988 to 1996 with the New England Anti-Vivisection Society, but was ousted by legal action after claiming to have been elected president by a membership vote in which ballots believed to have favored an opponent mysteriously disappeared.
Pacheco parted company with PETA soon after litigation resulting from the NEAVS leadership dispute was settled.
“Made by hand”
Continued Pacheco in his December 19, 2018 appeal, “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.”
Pacheco did not suggest any reason why this might be. ANIMALS 24-7, however, in a quick web search found two commercial cookie baking companies who advertise also that their products are “made by hand.”
Actual scientific chemical and pharmaceutical product development and testing usually involves making the substance under study in batches, to be tried with multiple test subjects in controlled comparative evaluations.
“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,” Pacheco added. “Once the final formulation is completed, our goal is to be able to produce it in bulk for under $5 per Cookie.”
Readers familiar with developments in producing cell-cultured meat might at this point have recognized some apparently borrowed rhetoric.
Indeed, cell-cultured meat and leather have so far been produced only in very small quantities, but for a self-evident reason: producing cell-cultured meat is largely a process of scaling up techniques already commonly practiced in petri dishes at the cellular level.
Growing enough cloned cells to have viable product samples does take time. Most of the work underway to bring cell-cultured meat and leather to market involves perfecting and expediting the scaling-up process.
Calcium chloride, zinc, vinylcyclohexene, and dog cookie ingredients, by contrast, are readily available in industrial quantity.
Eating trial cookies
Pacheco in his December 19, 2018 appeal went on to mention that “a for-profit drug company would not typically follow our one tiny step at a time approach.”
This is true, but either a for-profit or nonprofit drug developer would actually be working toward making a viable product accessible within a reasonable time frame.
“Some of us humans at 600 have eaten trial Cookies ourselves, myself included,” Pacheco claimed, as he often has.
“Thus far there have been no negative side effects for animals or people. We suspect,” Pacheco said, “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.”
Off the shelf
But assuming Pacheco has actually made and eaten some “Spay and Neuter Cookies,” another reason for “no negative side effects” might be simply that the cookies don’t contain any ingredient with properties that might not be found in cookies off a store shelf.
Calcium chloride, for instance, is among the most common ingredients in commercially manufactured baked goods. Zinc mineral supplements are sold at any drug store.
Making cookies with nuts
“Approximately one month after eating the trial Cookie,” Pacheco said, each animal goes through a conventional spay/neuter surgery, after which the excised gonadal tissue is kept “for microscopic examination.”
All of this, however, is just the standard procedure used in researching any contraceptive product, as described in hundreds of publications by dozens of scientists.
The December 19, 2018 “Spay and Neuter Cookie Science Update and Overview” segued at that point into an 11-sentence summary of a testing protocol for a product that would interfere with the development of ovarian follicles.
The description resembled SenesTech descriptions of ChemSpay and the SenesTech rodent control product ContraPest.
$3 million a year for three years
After that came the pitch for money.
“A team of scientists formulated projections for the time and cost that would be required to complete the work,” Pacheco said, without naming the scientists, “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.”
No doubt Pacheco would like to be taking in $3 million a year from hopeful donors.
Your name could be right there with NylaBone!
But Pacheco is “not waiting for the $3 million per year funding to arrive,” he admitted, and does not plan to be “applying for FDA approval.”
Instead, Pacheco claimed, “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.,” meaning that it is beyond verification through U.S. accountability requirements.
However, Pacheco hopefully concluded, “If someone were to win the lottery and provide the tax-deductible $3 million per year funding themselves, the Cookie could also be named after them!”
Echoing false hopes of decades past
Of note, much of Pacheco’s pitch to donors over the years, including in the appeal of December 19, 2018, has resembled the rhetoric that the Upjohn and Carnation companies used from 1975 to 1985 in repeatedly announcing that they hoped to soon market a contraceptive dog food using a hormonal drug called mibolerone.
Many older donors may remember the false hopes those announcements raised, especially through “golly gee” summaries ballyhooed by supermarket tabloid newspapers, that something like a “spay/neuter cookie” might soon become available.
Some older donors may also be susceptible to conspiracy theories about why this never happened.
Why mibolerone never became a cookie
But there was no conspiracy. Mibolerone products were kept off the market for 15 years by regulatory concern that mibolerone chemically resembles RU-486, the active ingredient of the so-called “abortion pill.”
The U.S. Food & Drug Administration finally authorized the manufacture and marketing of RU-486 in September 2000. Mibolerone products in liquid form are now available by prescription, as they long have been in northern Europe, and are used to some extent to suppress estrus in racing greyhounds, sled dogs, some show dogs, and zoo animals.
But mibolerone requires frequent dosing and has only short-term contraceptive effects, meaning it is used effectively only with captive animals, not with free-roaming dogs and cats, nor even with pets who may escape outdoors.
That mibolerone could ever have been used in any form resembling “Spay and Neuter Cookies” was never more than a tabloid supposition.
Contradictory claims in IRS Form 990
The most recent “600 Million Stray Dogs Need You” filing of IRS Form 990, for 2016, was filed in February 2018. It shows on page one that “600 Million Stray Dogs Need You” had total contributions and grants in 2016 of $319,476, against total expenses of $272,637.
But the attached Schedule G, “Supplemental Information Regarding Fundraising or Gaming Activities, stated that “600 Million Stray Dogs Need You” had gross revenue from gaming activities of $646,600, less $216,444 in prize money and non-cash prizes distributed. Presumably this should have produced a net of $430,156.
Instead, “600 Million Stray Dogs Need You” claimed “Other direct expenses” of $749,640, not otherwise described.
Who got the money?
The IRS Form 990 on page 2 claimed $256,735 in non-itemized program expenses, one of which was for $123,004, but claimed only $222.010 in program expense on page 10 in the “Statement of Functional Expenses.”
Included in the “Statement of Functional Expenses” was a line item mention of $123,004 in “R&D program support,” with no indication of what this consisted of or who got the money.
Even if the $123,004 is presumed to have been spent in some manner to develop a “Spay and Neuter Cookie,” however, for example in an unregistered lab in a garage somewhere, evading Animal Welfare Act reporting requirements by using dogs from a friendly local rescue instead of from a Class B dealer, the expenditure would only be about a third of the total declared expenses of the organization.
Related board members paid, but have “no business relationship”?
The “Statement of Compensation of Officers, Directors, Trustees, Key Employees, Highest Compensated Employees, and Independent Contractors” shows that Pacheco was paid $32,500. A Mary Pacheco, his mother’s name, was paid $6,510.
Schedule O says, “2 members of board of directors are related; Mary Pacheco and Alex Pacheco; no business relationship.”
The “600 Million Stray Dogs Need You” filing of IRS Form 990 is, in short, very difficult to make sense of by comparing line items.
In this it resembles all previous available “600 Million Stray Dogs Need You” IRS Form 990 filings.