So-Called “Puppy Mills” Are Not All As Bad As We Think, Pioneering Research Suggests
Candace Croney joined the faculty at Purdue University in 2011, thinking her job would focus on the welfare of livestock and poultry in Indiana. With bachelor's, master's, and doctoral degrees in animal sciences, her work until then had centered on sheep, cattle, and pigs. She'd even had the esteemed animal behaviorist Temple Grandin help shape her master's research project.
Croney's research has become the first of its kind in the world—and it's challenging our understanding of how dog breeding is being done.
Then came an email from a new colleague asking Croney to discuss animal welfare with some of Indiana's commercial dog breeders, the kind who produce large quantities of puppies for sale in pet stores.
"I didn't even know the term commercial breeders," Croney says. "I'd heard the term 'puppy millers.' That's pretty much what I knew."
She went to the first few kennels and braced herself for an upsetting experience. She's a dog lover who has fostered shelter mutts and owned one, and she'd seen the stories: large-scale breeders being called cruel and evil, lawmakers trying to ban the sale of commercially bred puppies, and constant encouragement to rescue a dog instead of paying into a greedy, heartless "puppy mill" industry.
But when she got to the kennels, she was surprised. While she encountered a number of things she didn't like about the infrastructure at the older facilities—a lack of ventilation, a lot of noise, bad smells—most of the dogs themselves were clean. The majority didn't have physical problems. No open sores. No battered bodies. Nothing like what she'd seen online.
But still, the way the dogs acted gave her pause.
"Things were, in many regards, better than I thought they would be," Croney says. "Google told me the dogs would be physically a mess, and they weren't, but behaviorally, things were jumping out at me."
While she did note that some of the breeders had play yards for their pups, a number of the dogs feared new people and things like leashes because they hadn't been exposed to enough of them. Some of the dogs also seemed to lack adequate toys, activities, and games to keep them mentally and physically stimulated.
But she was there strictly as a representative of the university to ask questions and offer feedback, no more or less. A few times, she says, she felt like the breeders wanted her to endorse what they were doing, "and I immediately got my back up about that. I did not want my name used to validate things that I could tell I didn't agree with. It was uncomfortable from that perspective."
After sharing the animal-welfare information her colleague had requested, Croney figured that was that. She never expected to be in a commercial kennel again. But six months later, her phone rang. Some of the people she'd met were involved in legislative lobbying, and they were trying to write welfare standards for Indiana's commercial breeders to follow.
In the continuing battle over what is, and is not, a "puppy mill," they wanted somebody with a strong research background to set a baseline standard, somebody who would actually bring objectivity to the breeder-activist conflict without being on one side or the other.
In other words, they wanted Croney's help to figure out not only appropriate enclosure sizes, but also requirements for socialization and enrichment activities—stimulation she knew the dogs desperately needed.
"I thought, crap, how am I not going to help?" she recalls. "And they said, 'Well how long will that take? A couple of weeks? A month?'"
Dr. Croney with Theo, whom she calls "a beloved family member of our research team."
(Photo credit: Purdue University/Vincent Walter)
Six years later, Croney's research remains ongoing. It has become the first of its kind in the world—and it's challenging our understanding of how dog breeding is being done, and how it could and should be done for years to come.
How We Got Here
Americans have been breeding pet dogs in large-scale kennels since World War II. The federal standard that regulates those kennels is the Animal Welfare Act, which President Johnson signed into law in 1966. Back then, people thought it was OK to treat dogs a lot differently than they do today. The law has been updated, but it still allows a dog the size of a Beagle to be kept in a cage the size of a dishwasher all day, every day because for some dogs, when the law was written, having a cage that size meant an improvement in living conditions.
Countless commercial breeders, who are regularly inspected under the Animal Welfare Act, have long believed that as long as they followed the law, they were doing things right. And they've seen sales for their puppies go up and up over the years. About 38 percent of U.S. households now own one or more dogs, the highest rate since the American Veterinary Medical Association began measuring the statistic in 1982.
Consumers now demand eight million dogs per year, which has reinforced breeders' beliefs that despite what activists shout at protests, the breeders are actually running businesses the public supports. As one Ohio commercial breeder—long decried by activists as a "puppy mill" owner—told The Washington Post in 2016, "This is a customer-driven industry. If we weren't satisfying the customer, we'd starve to death. I've never seen prices like the ones we're seeing now, in my whole career."
That breeder, though, is also among leading industry voices who say they understand that public perception of what's acceptable and what's not in a breeding kennel has changed. Regardless of what the laws are, they say, kennels must change along with the public's wishes if the commercial breeding industry is going to survive. The question is how, exactly, to move from the past to the future, at a time when demands for change have reached a fever pitch.
"The Animal Welfare Act, that was gospel. It meant you were taking care of dogs," says Bob Vetere, former head of the American Pet Products Association and now chairman of the Pet Leadership Council. "That was, what, 40 years ago? Things have evolved. People understand much more since then—and back then, there were maybe 20 million dogs in the country. Now, there's 90 million. It's that dramatic. People love their dogs, and everybody is going to get one."
Vetere became an early supporter of Croney's research, which, unbelievably, became the first ever to focus on what it actually means to run a good commercial breeding kennel. At the start of her research, Croney found that the scientific literature underpinning many existing laws and opinions was not just lacking, but outright nonexistent.
"We kept finding it over and over," she says of the literature gaps, citing common but uninformed beliefs about appropriate kennel size as just one example. "I can't find any research about how much space they're supposed to have. People said, 'Yeah, we had a meeting and a bunch of people made some recommendations.'"
She started filling in the research gaps with her team at Purdue, building relationships with dog breeders until she had more than 100 kennels letting her methodically figure out what was actually working for the dogs.
"The measurable successes in animal welfare over the past 50 years began from a foundation in science."
Creating Standards from Scratch
Other industry players soon took notice. One was Ed Sayres, who had served as CEO of the ASPCA for nearly a decade before turning his attention to lobbying efforts regarding the "puppy mill" issue. He recognized that what Croney was doing for commercial breeding mirrored the early work researchers started a half-century ago in the effort that led to better shelters all across America today.
"The measurable successes in animal welfare over the past 50 years began from a foundation in science," Sayres says. "Whether it was the transition to more humane euthanasia methods or how to manage dog and cat overpopulation, we found success from rigorous examination of facts and emerging science."
Sayres, Vetere, and others began pushing for the industry to support Croney's work, moving the goalposts beyond Indiana to the entire United States.
"If you don't have commercial breeding, you have people importing dogs from overseas with no restrictions, or farming in their backyards to make money," Vetere says. "You need commercial breeders with standards—and that's what Candace is trying to create, those standards."
Croney ended up with a $900,000 grant from three industry organizations: the World Pet Association, Pet Food Institute, and the Pet Industry Joint Advisory Council. With their support, she created a nationwide program called Canine Care Certified, like a Good Housekeeping Seal of Approval for a kennel. The program focuses on outcome-based standards, meaning she looks at what the dogs tell her about how well they are doing through their health and behavior. For the most part, beyond baseline requirements, the program lets a breeder achieve those goals in whatever ways work for the dogs.
The approach is different from many legislative efforts, with laws stating a cage must be made three feet larger to be considered humane. Instead, Croney walks through kennels with breeders and points out, for instance, which puppies in a litter seem to be shy or fearful, and then teaches the breeders how to give those puppies better socialization. She helps the breeders find ways to introduce dogs to strangers and objects like umbrellas that may not be part of regular kennel life, but will need to become familiar when the breeding dog retires and gets adopted into a home as a pet. She helps breeders understand that dogs need mental as well as physical stimulation, whether it comes from playing with balls and toys or running up and down slides.
The breeders can't learn fast enough, Croney says, and she remains stunned at how they constantly ask for more information—an attitude that made her stop using the term "puppy mill" to describe them at all.
"Now, full disclosure: Given that all of these kennels had volunteered, the odds were that we were seeing a skewed population, and that it skewed positive," she says. "But if you read what was in the media at the time, we shouldn't have been able to find any. We're told that all these kennels are terrible. Clearly, it was possible to get a positive outcome."
To Buy or Not to Buy?
Today, she says, she's shocked at how quickly some of the kennels have improved. Facilities that appalled her at first sight now have dogs greeting people with wagging tails.
"Not only would I get a dog from them, but would I put my dog there in that kennel temporarily? Yeah, I would."
"The most horrifying thing I learned was that some of these people weren't doing what I'd like to see, not because they didn't care or only wanted money, but because nobody had ever told them," she says. "As it turned out, they didn't know any different, and no one would help them."
For Americans who want to know whether it's OK to get a commercially bred puppy, Croney says she thinks about her own dogs. When she started working with the breeders, there were plenty of kennels that, she says, she would not have wanted to patronize. But now she's changing her mind about more and more of them.
"I'm just speaking as somebody who loves dogs and wants to make sure I'm not subsidizing anything inhumane or cruel," she says. "Not only would I get a dog from them, but would I put my dog there in that kennel temporarily? Yeah, I would."
She says the most important thing is for consumers to find out how a pup was raised, and how the pup's parents were raised. As with most industries, commercial breeders run the gamut, from barely legal to above and beyond.
Not everyone agrees with Croney's take on the situation, or with her approach to improving commercial breeding kennels. In its publication "Puppy Mills and the Animal Welfare Act," the Humane Society of the United States writes that while Croney's Canine Care Certified program supports "common areas of agreement" with animal-welfare lobbyists, her work has been funded by the pet industry—suggesting that it's impure—and a voluntary program is not enough to incentivize breeders to improve.
New laws, the Humane Society states, must be enacted to impose change: "Many commercial dog breeding operators will not raise their standards voluntarily, and even if they were to agree to do so it is not clear whether there would be any independent mechanism for enforcement or transparency for the public's sake. ... The logical conclusion is that improved standards must be codified."
Croney says that type of attitude has long created resentment between breeders and animal-welfare activists, as opposed to actual kennel improvements. Both sides have a point; for years, there have been examples of bottom-of-the-barrel kennels that changed their ways or shut down only after regulators smacked them with violations, or after lawmakers raised operating standards in ways that required improvements for the kennels to remain legally in business.
At the same time, though, powerful organizations including the Humane Society—which had revenue of more than $165 million in 2018 alone—have routinely pushed for bans on stores that sell commercially bred puppies, and have decried "puppy mills" in marketing and fund-raising literature, without offering financial grants or educational programs to kennels that are willing to improve.
Croney believes that the reflexive demonization of all commercial breeders is a mistake. Change is more effective, she says, when breeders "want to do better, want to learn, want to grow, and you treat them as advocates and allies in doing something good for animal welfare, as opposed to treating them like they're your enemies."
"If you're watching undercover videos about people treating animals in bad ways, I'm telling you, change is happening."
She adds that anyone who says all commercial breeders are "puppy mills" needs to take a look at the kennels she's seen and the changes her work has brought—and is continuing to bring.
"The ones we work with are working really, really hard to improve and open their doors so that if somebody wants to get a dog from them, they can be assured that those dogs were treated with a level of care and compassion that wasn't there five or 10 years ago, but that is there now and will be better in a year and will be much better in five years," she says. "If you're watching undercover videos about people treating animals in bad ways, I'm telling you, change is happening. It is so much better than people realize, and it continues to get even better yet."
Breakthrough therapies are breaking patients' banks. Key changes could improve access, experts say.
CSL Behring’s new gene therapy for hemophilia, Hemgenix, costs $3.5 million for one treatment, but helps the body create substances that allow blood to clot. It appears to be a cure, eliminating the need for other treatments for many years at least.
Likewise, Novartis’s Kymriah mobilizes the body’s immune system to fight B-cell lymphoma, but at a cost $475,000. For patients who respond, it seems to offer years of life without the cancer progressing.
These single-treatment therapies are at the forefront of a new, bold era of medicine. Unfortunately, they also come with new, bold prices that leave insurers and patients wondering whether they can afford treatment and, if they can, whether the high costs are worthwhile.
“Most pharmaceutical leaders are there to improve and save people’s lives,” says Jeremy Levin, chairman and CEO of Ovid Therapeutics, and immediate past chairman of the Biotechnology Innovation Organization. If the therapeutics they develop are too expensive for payers to authorize, patients aren’t helped.
“The right to receive care and the right of pharmaceuticals developers to profit should never be at odds,” Levin stresses. And yet, sometimes they are.
Leigh Turner, executive director of the bioethics program, University of California, Irvine, notes this same tension between drug developers that are “seeking to maximize profits by charging as much as the market will bear for cell and gene therapy products and other medical interventions, and payers trying to control costs while also attempting to provide access to medical products with promising safety and efficacy profiles.”
Why Payers Balk
Health insurers can become skittish around extremely high prices, yet these therapies often accompany significant overall savings. For perspective, the estimated annual treatment cost for hemophilia exceeds $300,000. With Hemgenix, payers would break even after about 12 years.
But, in 12 years, will the patient still have that insurer? Therein lies the rub. U.S. payers, are used to a “pay-as-you-go” model, in which the lifetime costs of therapies typically are shared by multiple payers over many years, as patients change jobs. Single treatment therapeutics eliminate that cost-sharing ability.
"As long as formularies are based on profits to middlemen…Americans’ healthcare costs will continue to skyrocket,” says Patricia Goldsmith, the CEO of CancerCare.
“There is a phenomenally complex, bureaucratic reimbursement system that has grown, layer upon layer, during several decades,” Levin says. As medicine has innovated, payment systems haven’t kept up.
Therefore, biopharma companies begin working with insurance companies and their pharmacy benefit managers (PBMs), which act on an insurer’s behalf to decide which drugs to cover and by how much, early in the drug approval process. Their goal is to make sophisticated new drugs available while still earning a return on their investment.
New Payment Models
Pay-for-performance is one increasingly popular strategy, Turner says. “These models typically link payments to evidence generation and clinically significant outcomes.”
A biotech company called bluebird bio, for example, offers value-based pricing for Zynteglo, a $2.8 million possible cure for the rare blood disorder known as beta thalassaemia. It generally eliminates patients’ need for blood transfusions. The company is so sure it works that it will refund 80 percent of the cost of the therapy if patients need blood transfusions related to that condition within five years of being treated with Zynteglo.
In his February 2023 State of the Union speech, President Biden proposed three pilot programs to reduce drug costs. One of them, the Cell and Gene Therapy Access Model calls on the federal Centers for Medicare & Medicaid Services to establish outcomes-based agreements with manufacturers for certain cell and gene therapies.
A mortgage-style payment system is another, albeit rare, approach. Amortized payments spread the cost of treatments over decades, and let people change employers without losing their healthcare benefits.
Only about 14 percent of all drugs that enter clinical trials are approved by the FDA. Pharma companies, therefore, have an exigent need to earn a profit.
The new payment models that are being discussed aren’t solutions to high prices, says Bill Kramer, senior advisor for health policy at Purchaser Business Group on Health (PBGH), a nonprofit that seeks to lower health care costs. He points out that innovative pricing models, although well-intended, may distract from the real problem of high prices. They are attempts to “soften the blow. The best thing would be to charge a reasonable price to begin with,” he says.
Instead, he proposes making better use of research on cost and clinical effectiveness. The Institute for Clinical and Economic Review (ICER) conducts such research in the U.S., determining whether the benefits of specific drugs justify their proposed prices. ICER is an independent non-profit research institute. Its reports typically assess the degrees of improvement new therapies offer and suggest prices that would reflect that. “Publicizing that data is very important,” Kramer says. “Their results aren’t used to the extent they could and should be.” Pharmaceutical companies tend to price their therapies higher than ICER’s recommendations.
Drug Development Costs Soar
Drug developers have long pointed to the onerous costs of drug development as a reason for high prices.
A 2020 study found the average cost to bring a drug to market exceeded $1.1 billion, while other studies have estimated overall costs as high as $2.6 billion. The development timeframe is about 10 years. That’s because modern therapeutics target precise mechanisms to create better outcomes, but also have high failure rates. Only about 14 percent of all drugs that enter clinical trials are approved by the FDA. Pharma companies, therefore, have an exigent need to earn a profit.
Skewed Incentives Increase Costs
Pricing isn’t solely at the discretion of pharma companies, though. “What patients end up paying has much more to do with their PBMs than the actual price of the drug,” Patricia Goldsmith, CEO, CancerCare, says. Transparency is vital.
PBMs control patients’ access to therapies at three levels, through price negotiations, pricing tiers and pharmacy management.
When negotiating with drug manufacturers, Goldsmith says, “PBMs exchange a preferred spot on a formulary (the insurer’s or healthcare provider’s list of acceptable drugs) for cash-base rebates.” Unfortunately, 25 percent of the time, those rebates are not passed to insurers, according to the PBGH report.
Then, PBMs use pricing tiers to steer patients and physicians to certain drugs. For example, Kramer says, “Sometimes PBMs put a high-cost brand name drug in a preferred tier and a lower-cost competitor in a less preferred, higher-cost tier.” As the PBGH report elaborates, “(PBMs) are incentivized to include the highest-priced drugs…since both manufacturing rebates, as well as the administrative fees they charge…are calculated as a percentage of the drug’s price.
Finally, by steering patients to certain pharmacies, PBMs coordinate patients’ access to treatments, control patients’ out-of-pocket costs and receive management fees from the pharmacies.
Therefore, Goldsmith says, “As long as formularies are based on profits to middlemen…Americans’ healthcare costs will continue to skyrocket.”
Transparency into drug pricing will help curb costs, as will new payment strategies. What will make the most impact, however, may well be the development of a new reimbursement system designed to handle dramatic, breakthrough drugs. As Kramer says, “We need a better system to identify drugs that offer dramatic improvements in clinical care.”
Each afternoon, kids walk through my neighborhood, on their way back home from school, and almost all of them are walking alone, staring down at their phones. It's a troubling site. This daily parade of the zombie children just can’t bode well for the future.
That’s one reason I felt like Gaia Bernstein’s new book was talking directly to me. A law professor at Seton Hall, Gaia makes a strong argument that people are so addicted to tech at this point, we need some big, system level changes to social media platforms and other addictive technologies, instead of just blaming the individual and expecting them to fix these issues.
Gaia’s book is called Unwired: Gaining Control Over Addictive Technologies. It’s fascinating and I had a chance to talk with her about it for today’s podcast. At its heart, our conversation is really about how and whether we can maintain control over our thoughts and actions, even when some powerful forces are pushing in the other direction.
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We discuss the idea that, in certain situations, maybe it's not reasonable to expect that we’ll be able to enjoy personal freedom and autonomy. We also talk about how to be a good parent when it sometimes seems like our kids prefer to be raised by their iPads; so-called educational video games that actually don’t have anything to do with education; the root causes of tech addictions for people of all ages; and what kinds of changes we should be supporting.
Gaia is Seton’s Hall’s Technology, Privacy and Policy Professor of Law, as well as Co-Director of the Institute for Privacy Protection, and Co-Director of the Gibbons Institute of Law Science and Technology. She’s the founding director of the Institute for Privacy Protection. She created and spearheaded the Institute’s nationally recognized Outreach Program, which educated parents and students about technology overuse and privacy.
Professor Bernstein's scholarship has been published in leading law reviews including the law reviews of Vanderbilt, Boston College, Boston University, and U.C. Davis. Her work has been selected to the Stanford-Yale Junior Faculty Forum and received extensive media coverage. Gaia joined Seton Hall's faculty in 2004. Before that, she was a fellow at the Engelberg Center of Innovation Law & Policy and at the Information Law Institute of the New York University School of Law. She holds a J.S.D. from the New York University School of Law, an LL.M. from Harvard Law School, and a J.D. from Boston University.
Gaia’s work on this topic is groundbreaking I hope you’ll listen to the conversation and then consider pre-ordering her new book. It comes out on March 28.