600 Million Stray Dogs Need You
About our position statements
ACC&D’s mission is to advance non-surgical fertility control to effectively and humanely reduce the number of unwanted cats and dogs. We also have interest and expertise in subjects that complement this mission, including modeling of free-roaming cat and dog populations and methods of identifying non-surgically sterilized animals. When news, organizations, and research related to our field arise, ACC&D plays an important role in interpreting new science and claims. We are an independent organization with no financial ties to any company or product sales, and we have found that our role as a watchdog, and our commitment to data and sound science, are as essential as our efforts to advocate for and advance non-surgical options.
600 Million Stray Dogs Need You (600 Million), founded by PETA co-founder Alex Pacheco, claims to be developing “spay and neuter cookies” for dogs and cats. ACC&D is often asked about the work and claims of 600 Million, and here we’ll summarize what we know (and do not know) about this organization and its activities.
In general, we are highly skeptical of this organization’s claims and use of funds. We sincerely hope that the work (or lack thereof) of this organization does not tarnish the field of non-surgical fertility control for dogs and cats and the high-quality research being conducted, largely with financial support from the Michelson Prize & Grants in Reproductive Biology.
After several years of online fundraising, in September 2012, Mr. Pacheco and then-Scientific Director, Dr. Jeffrey Young, announced that clinical trials had begun on a “cookie” for dogs, and today the organization frequently solicits donations to continue conducting the research. The organization has demonstrated a lack of transparency, data, and results, plus a history of providing misleading information on the status of its progress and partnerships.
In December 2018, for the first time, 600 Million revealed some details about its approach for studying its “cookies.” It also provided more information about the “Pilot Pups” being used in its research. Based on information in the fundraising appeals, the active ingredients that the organization are studying are highly questionable, and its research methodology flawed. Moreover, its approach to obtaining research subjects—having its volunteers “rescue” “stray” dogs—raises serious ethical questions. Further details are in the December 2018 update, below.
To be sure, ACC&D appreciates the organization’s vision of managing free-roaming and feral populations more effectively and humanely through use of non-surgical tools. However, facts matter. 600 Million claims that it is working to develop a product that: 1) can sterilize a dog in a single dose, consumed orally, but will not have adverse effects if multiple are consumed; 2) will be safe if consumed by non-target animals (which would presumably include wildlife and humans); and 3) will be approved by the U.S. Food and Drug Administration (FDA).
Even assuming high-quality, ethical research, there are multiple reasons why reality cannot match the organization’s goals. Among them:
Mammals have many similarities in their reproductive systems. There is not yet a known way to create an oral contraceptive that works only in dogs, or only in cats. Thus a product designed to be consumed orally would place non-target species at risk, humans included. The risk would be exacerbated with the target population of “stray” animals that are the focus of 600 Million’s fundraising appeals.
A sterilant must be very potent to permanently sterilize in a single dose and has never before been achieved. In addition, an oral product is systemic, meaning it will reach many more parts of a dog or cat’s body than, say, an intratesticular sterilant that is injected directly into the testicles. This could yield adverse side effects. Consuming multiple doses could increase the risk.
With an oral sterilant for free-roaming animals, it would be very difficult to ensure that an individual animal receives the proper dose.
The FDA regulates most veterinary drugs. The FDA carefully evaluates safety and efficacy as part of a highly scientific review process. The issues noted above—and many others—would likely prevent FDA approval, which means that a product could not be sold commercially in the U.S. Regulatory approval to permit such a product would be a major challenge in other countries as well.
ACC&D values scientific advancement, collaboration, and integrity. We have reached out to 600 Million personnel on multiple occasions, including inviting them to attend and present at ACC&D’s 5th International Symposium on Non-Surgical Contraceptive Methods of Pet Population Control. They declined. We encourage 600 Million to share better documented scientific information to support the progress they claim in their fundraising appeals. Based on past history with the organization, we are skeptical that their claims will match reality.
ACC&D has released periodic updates on 600 Million Stray Dogs, provided below. We invite you to read them; please note their date, however, and the fact that we cannot guarantee the information contained within is up to date.
December 2018: Holiday donation appeal provides research "details"
Research details are finally revealed and raise as many questions as answers
There is a shift in 600 Million’s approach in that fundraising emails for the first time provide some “data” about the “research” being conducted. None of what is described makes much sense, and some details are quite concerning.
In one letter, Mr. Pacheco describes that his team is focusing first on female dogs and working with calcium chloride, zinc, and vinylcyclohexene, all of which are unlikely active ingredients for an oral sterilant, according to experts, based on safety, efficacy, and/or potential for regulatory approval.
Zinc gluconate and calcium chloride are indeed key ingredients in intratesticular injectable sterilants—Zeuterin, approved by the FDA for male dogs, has the active ingredient zinc gluconate, and calcium chloride in ethyl alcohol is being researched for male dogs and cats. However, both of these chemicals have an effect as sclerosing agents, essentially causing scar tissue that prevents production of sperm. To do this, they have to be injected into the testicles.
Vinylcyclohexene may have its origins in a brief partnership that Mr. Pacheco had with the company SenesTech, when it was evaluating the potential of compound called ChemSpay (with a similarly named but different active ingredient) as a sterilant for dogs. According to Dr. Loretta P. Mayer, Co-Founder and CEO of SenesTech, whose company severed the relationship with Mr. Pacheco, “There is no evidence that vinylcyclohexene could become a sterilant for dogs and cats, nor that it could receive FDA approval. We limit our partners to those committed to excellence in science, animal welfare, the sharing of peer reviewed data, and meeting the high standards of our regulatory agencies."
Pacheco asserts that after approximately one month after treatment, a dog is spayed or neutered. He includes photos of ovaries from allegedly treated bitches, with a discussion of how specialists examine the ovaries microscopically to determine the number of ovarian follicles that are impaired. Unfortunately, the photos do not appear to show the ovarian follicles that Mr. Pacheco describes. Furthermore, dogs would need to be mated as the final determination of infertility, which is not possible given that the dog has at this point been surgically sterilized.
A second fundraising appeal showcases “Miss Sunny, top of her Graduating Class of Pilot Pups!” Mr. Pacheco reports that the now-healthy dog, photographed while hardware shopping, was “almost dead,” a “bag of bones,” and “covered with mange” just two months prior. She was “rescued by a volunteer” and “clearly she used to be someone’s companion.” It is difficult to believe that a starving dog with mange—or ticks, as the letter later describes—be put through an experimental treatment, and recover so rapidly.
If she did in fact go from dying to thriving in such a short time, the scenario is also highly problematic on both scientific and ethical fronts. First, it means that volunteers are taking potentially owned animals from communities in undisclosed locations to enroll in a research study. Second, given the alleged timing, the team would be studying a sterilant in a malnourished, immunocompromised dog, which could skew results and recklessly further endanger the dog’s health.
Additional information is available in the article "Pseudo-science & the Alex Pacheco 'Spay & Neuter' Cookie," written by Merritt Clifton for Animals 24-7.
April 2017: Questionable expenses unearthed
Two Organizations Investigate 600 Million Stray Dogs Need You's 990s
Recently, independently of ACC&D, animal news organization Animals 24/7 and animal rights organization Showing Animals Respect & Kindness (SHARK) investigated the scientific claims and allocation of funds from 600 Million. Animals 24/7 published articles on November 3, 2016 and April 25, 2017. The latter article focused on a video produced by SHARK to expose organizations that defraud donors to animal causes.
Both Animals 24/7 and SHARK focused on questionable aspects of 600 Million’s use of funds, specifically raising over $1 million since 2011 while providing no evidence of the legitimacy of its project. In doing so, they rely on IRS Form 990s (recent years are available here). SHARK notes that $40,000 and $20,000 were spent on “formula clinical trials” in Central America in 2011 and 2012, but there was no subsequent funding for this activity in this location, and no indication of who received the money and what that person(s) did with it. Expenditures of more than $48,000 and $54,000 on “volunteers recruiting”/“volunteers recruiting members” in 2014 and 2015, respectively, was also cited as questionable. In 2015, 600 Million also spent $250,280 on gaming expenses. SHARK tried unsuccessfully to obtain more information from 600 Million to explain these and other questionable expenditures, hence bringing the issue into the public eye.
In the interest of transparency and honest use of funds, and the reputation of non-surgical fertility control for companion animals, ACC&D appreciates that other entities are looking into the suspicious expenditures and activities of 600 Million.
January 2013: 600 Million ramps up fundraising and promises of progress
Wish we could get more excited
We have recently been contacted about the aggressive year-end fundraising and updated website the non-profit 600 Million Stray Dogs Need You (600 Million).
When 600 Million, founded by PETA co-founder Alex Pacheco, announced two years ago that it had found a birth control pill that causes sterility and is completely safe and effective, it sounded like a dream come true. Unfortunately, it was just a dream. The partnership announced in December 2010 with a company doing research toward this goal, SenesTech, was severed by April 2011; the researchers pulled out as it was revealed that the science was far less advanced than the story the non-profit was telling the public.
Less than two years later 600 Million reports to have a new approach to achieve something very difficult to do: create life-long contraception using an oral formula and with no off-target health effects. 600 Million claims that it is now “in clinical trials” with birth control dog food that causes permanent sterility. The website describes its first formula for female dogs requiring seven doses over seven days for sterilization, and their focus to reduce that to a single dose. The organization continues by saying that with sufficient funds it could accomplish this in 18 months. For cats: “If we had the funds we would hire a chemist today to concentrate on our cat formula, and the clinical trials for cats could begin in as little as four months.” Pacheco further writes that “none of the large national organizations will support this work, for reasons beyond my comprehension,” yet declines to outline the science behind his claims.
ACC&D encourages 600 Million to share scientific information to support the progress they claim in their fundraising appeals. We also encourage the organization to join other researchers in submitting their findings to be considered for presentations at ACC&D’s 5th International Symposium on Non-Surgical Contraceptive Methods of Pet Population Control in June 2013. This is the premiere event for key players interested in advancing this field to convene, collaborate, and learn from one another. We will be pleased and excited if 600 Million can bring forward any data showing they have found a new and promising approach to dog and cat sterilization. So far, we have no submissions from 600 Million to share news of a breakthrough at the symposium.
April 2011: Update On "Super Birth Control Pill"
SenesTech severs ties with 600 Million Stray Dogs Need You
On April 4, 2011, SenesTech notified ACC&D that it severed ties with 600 Million Stray Dogs Need You (600 Million) and its founder, Alex Pacheco, and that “neither 600 Million nor Mr. Pacheco have any claim, right, title, license or interest in our ChemSpay™ product or any other [SenesTech] product.” (Although the separation is official, content on the 600 Million website still seems to refer to this technology in fundraising appeals.)
On December 22, 2010, ACC&D responded to claims being made by 600 Million and its then partner, SenesTech, about their non-surgical sterilant technology, ChemSpay. At that time, we expressed our concerns about the unfounded statements being made, especially by 600 Million, about the effectiveness and safety of ChemSpay. The treatment was being presented as proven and ready to be submitted for regulatory approval, but no data were presented to support those claims. Even lead SenesTech researcher Dr. Loretta Mayer conceded that the technology is still at an early stage for use in dogs.
Today, Dr. Mayer remains hopeful about ChemSpay and plans to continue work to advance this technology for dogs. In a recent interview for The Bark magazine, Dr. Mayer stated, “This isn’t a pill sitting on my desk: this is a technology based on scientific fact that we believe can be developed.We believe that anything that decreases eggs in the ovary of one mammal can also deplete them in another mammal, but that is an academic argument that hasn’t been tested yet.”
In communication with ACC&D, Dr. Mayer says she hopes to share new data from SenesTech with ACC&D. ACC&D will continue to track progress with ChemSpay and will share updates as they become available.
December 2010: The science (lags) behind the story...
Data supporting claims of a “super birth control pill” leaves much to be desired
Animal advocates around the world are eager for safe, effective, affordable, non-surgical methods to prevent the births of unwanted puppies. And when 600 Million Stray Dogs Need You (600 Million) announced early this year that it had found a birth control pill that causes sterility and is completely safe and effective, it sounded like a dream come true. So is it true, or just a dream? ACC&D President Joyce Briggs attended a briefing held by 600 Million in Los Angeles on December 2, 2010, eager to find that this dog sterilization pill was indeed a reality. Unfortunately, it appears that the scientific data lags far behind the story being told by 600 Million.
ACC&D first learned of this approach, called ChemSpay and developed by a company called SenesTech, in 2004. We were intrigued by published data from studies in mice, which showed that several weeks or more of daily treatments caused sterility, and by the company’s suggestion that this technology might also work in dogs and cats. Results that SenesTech shared in 2007 from studies in a small number of dogs (supported in part by funding from ACC&D) were less promising, bringing to light some significant hurdles to demonstrating safety and efficacy. In 2008, SenesTech’s research turned back to birth control for mice and rats, which are responsible for the devastation of rice crops around the world, though the researchers planned to return to work in dogs in the future. ACC&D remained interested in this technology, while recognizing that it was still in the very early stages of development and that success in rodents would not necessarily translate to dogs and cats.
Now ChemSpay for dogs is back in the limelight, thanks to a partnership between the nonprofit organization 600 Million and SenesTech. But while 600 Million is quick to make specific promises that this technology works in dogs (and that, when work is completed, a single treatment will be effective), the scientific data shared to date do not support these statements. At the briefing, previously published results from studies in mice were described, but although over 270 dogs are said to have been included in studies, only a few examples were given of effects on dog ovaries, with little detail about dose, route of administration, number of doses used, or even number of dogs tested. ABC Los Angeles, which attended the December 2 briefing and interviewed the researchers, reported that three or four oral doses sterilized just 20 percent of the dogs in one study.
“Although we were hopeful that new data would be introduced at the briefing showing that Chemspay, given either as an injection or a pill, sterilized dogs, we were disappointed that there was no documentation of any significant achievements beyond what was shared with us in 2007,” commented ACC&D President Joyce Briggs. Even Dr. Loretta Mayer, lead researcher working on the ChemSpay project, conceded that the technology is still at an early stage for use in dogs. But communications from 600 Million suggest that the technology is ready to be submitted for regulatory approval.
In addition to a shortage of data showing the technology works, there are also key unanswered questions about safety. SenesTech asserted at the briefing that since the targeted reproductive pathways are conserved across all mammalian species, this chemical will certainly sterilize female dogs as it does mice. However, oddly, they also stated that the chemical does not have any effects in primates and is completely safe for humans (also mammals). The chemical in Chemspay is 4-vinylcyclohexene diepoxide (VCD), used widely in manufacturing products such as tires, polyesters, and epoxy resins. Other work with VCD showed that it does in fact impact fertility in monkeys,¹ although subsequent work was not been able to replicate this result.² VCD has also been shown to be a dermal carcinogen in mice and rats after multiple applications to the skin,³ which raises questions about safety in other species. Given such findings, much work will be needed to substantiate the claims being made that this compound is safe and effective for use in dogs and that it will have no impact on women handling it.
The invitation to the briefing noted that that “Cheetah, one of the first dogs in the world to be sterilized without surgery, [would] be available for visits.” Dr. Mayer shared that Cheetah was treated nearly six years ago with multiple injection treatments of ChemSpay and then surgically had her ovaries removed to examine the effects of the treatment. Yet, those results showed 67 percent depletion of primordial follicles, with no data to show sterility. Cheetah is sterile now, since her ovaries were removed after treatment.
ACC&D is committed to basing our communications and actions on sound science. Our Board of Directors and Scientific Advisory Board include experts in animal welfare, animal health, veterinary medicine (including dog and cat reproduction), international dog and cat population control, regulatory requirements for animal health products, and public health. “We believe it's critical that stakeholders in this work are provided with accurate information and a realistic picture of the most promising paths toward more humane and effective methods of controlling unwanted cat and dog populations,” writes ACC&D board chair Linda Rhodes, VMD, PhD, who specializes in the regulatory submission and review process for animal health products. “We’re concerned to see these statements being made about this technology unsupported by facts and data. Based on what has been shared publicly, there is still a long way to go to prove that this approach is as safe and effective as claimed by 600 Million and SenesTech. ACC&D will seek clarification and new information about this technology, and will share important updates.”
ACC&D hopes to see technologies advance that can provide safe and effective sterilization for dogs as well as cats. We look forward to seeing more data to demonstrate that this chemical may become a new tool for those working to humanely control pet populations everywhere, and we encourage 600 Million and SenesTech to share that data with the public as they ask for donations. While there are many unanswered questions here, what is not in doubt is the critical need for faster, easier, less expensive and less invasive methods for sterilizing cats and dogs and preventing unwanted litters.
The Alliance for Contraception in Cats & Dogs (ACC&D) is a nonprofit animal welfare organization founded in 2000 based in the U.S. but with global scope. Our mission is to expedite the successful introduction of methods to non-surgically sterilize dogs and cats and to support the distribution and promotion of these products to humanely control cat and dog populations worldwide. ACC&D’s efforts are supported by over 120 Organizational Partners, including animal welfare, animal health, and public health organizations from around the world.
Amppt SE, et al. Destruction of primordial ovarian follicles in adult cynomolgus macaques after exposure to 4-vinyl cyclohexene diepoxide: a nonhuman primate model of the menopausal transition. Fertility and Sterility 86(4): supplement 1210-16, 2006.
"Flagstaff firm inks deal with Australia for rodent-control test." Arizona Biosciences News/Flinn Foundation, June 18, 2008. http://www.flinn.org/news/756.
Maronpot RR. Ovarian toxicity and carcinogenicity in eight recent National Toxicology Program studies, Environmental Health Perspectives 73:125-30, 1987.