Goat No. 11765 spent the last few days of her life foraging on a hillside near Shandon, a pretty town on the central coast of California. On the morning of May 2, 2012, she was placed in a truck and moved to a pen for goats in poor health. A few hours later, a Department of Agriculture inspector watched her struggle in the afternoon heat and, before the accompanying veterinarian could put her down, the goat died.
Many other goats in the area give milk, but the herd to which No. 11765 belonged provides antibodies, which are crucial for biomedical research—they can mark cells, pull specific proteins from a slurry of tissue, or deliver a radioactive payload directly to a tumor. To harvest antibodies from an animal, technicians inject it with a target protein and, because its immune system wants to control or eliminate what it doesn’t recognize, it produces sticky molecules that latch onto unwelcome foreign bodies. Technicians can then take the animal’s blood and extract these antibodies.
Santa Cruz Biotechnology, which owned Goat No. 11675, is the second-largest vendor in the billion-dollar antibody market. Its extensive catalogue is in high demand: according to a 2012 survey by The Scientist, fifty-three per cent of labs work with antibodies acquired from the company. But this production comes at a cost. According to U.S.D.A. inspection reports, Goat No. 11765 was not the only animal owned by Santa Cruz Biotech to meet a grim fate. Years of problematic reports, including issues ranging from documentation troubles to animals in extreme distress, led the U.S.D.A. to file an enforcement action, in 2012, accusing Santa Cruz Biotechnology of willful violation of the Animal Welfare Act; a hearing was recently set for July.
Santa Cruz Biotech is owned by John and Brenda Stephenson, who have spent the past fifteen years acquiring forty-four thousand hilly acres along California’s central coast, in hopes of restoring the historic San Juan Ranch to its former peak of nearly sixty thousand acres. The sloping pastures are dotted with sleek, award-winning show horses and champion Gelbvieh cattle. Down the road, they keep ten thousand goats and six thousand rabbits to generate their product.
Santa Cruz Biotechnology’s string of troubles with the U.S.D.A. began in the mid-aughts, when the company paid forty-six hundred dollars in fines for twenty-three citations received between 2003 and 2005. According to a blog post in Nature, agency inspectors found that Santa Cruz Biotech was improperly euthanizing the animals and harvesting antibodies from a thousand rabbits, despite telling the Department of Agriculture that it had just eighty. A 2007 inspection, the first of the seven included in the U.S.D.A. complaint, resulted in a citation for poor veterinary care.
Between 2010 and 2013, inspectors noted problems during almost every inspection. The July, 2010, report included a goat with a coyote bite that received no treatment for pain; a lame goat lying in a feeder, unable to reach its food; and a sick goat lying prone, in the sun, on a ninety-degree day. (The U.S.D.A. would not comment on the case, but it generally inspects research institutions once or twice a year; reports indicate that fourteen inspections took place at Santa Cruz Biotech between 2010 and 2012.) In its initial defense against the U.S.D.A. enforcement action, the company denied the allegations and said, in response to the July, 2010, episode, “Unfortunately, the inspector did not observe the animal voluntarily walking to the outdoor pen to lie down in the sun, and we believe, the inspector drew a false conclusion that SCBT personnel placed the animal directly in the outdoor pen.”
A report from April 19, 2012, describes a goat whose shin was so badly broken that the leg below it was hanging loose. According to the goat’s medical record—which was provided to the inspector five days after the inspection—its cast had fallen off two days earlier, and the only treatment was a dose of Banamine, a veterinary painkiller. The company initially explained that the medical records had not been available to the inspector because, as the result of a computer problem, they were all handwritten, and “not sufficiently collated.” That same day, an inspector recorded Santa Cruz Biotechnology and San Juan Ranch’s senior veterinarian complaining bitterly about overwork and understaffing. She told the inspectors that she was in charge of all of the ranch’s thousands of animals, as well as the Stephensons’ catalogue of animal supplies. (Citing the ongoing case, Santa Cruz Biotech declined to comment regarding the specifics of the animals’ care.)
The last investigation cited in the U.S.D.A. complaint was conducted in May, 2012; it was then that Goat No. 11765 died. Though it had been moved to a pen for sick animals earlier that morning, no vital signs were taken, no veterinarian was contacted, and the only note on its medical record said “poor condition Start Tx thin.” The inspector noted that the goat was of a healthy weight. A state lab later performed a necropsy, which showed that the probable cause of death was a strain of pneumonia that would likely have been treated effectively by antibiotics. The company defended itself by saying that three independent parties had noted that Goat No. 11765 was not in poor condition. “Unfortunately, in a population of any size, death may occur suddenly and unexpectedly for a variety of reasons that cannot always be predicted, prevented or cured,” the company said.
Since May 2012, eight inspections have occurred, and each one noted a new or recurring violation. Almost three weeks after the final inspection covered by the enforcement action, and about a month before the U.S.D.A. complaint was filed, an inspector reported a goat with a rattlesnake bite to its face. Though it had been treated in April, 2012, its mouth hung open for the entirety of the inspection. Medical records indicated the goat had lost almost a quarter of its body weight since the bite, likely due to its inability to eat normally. Six other goats were in varying levels of poor condition, and had not received proper veterinary care. One had wounded legs and received no pain treatment, while others had hair falling out in patches or were thin enough to cause alarm.
The inspection that has received the most attention was reported in Nature, in January, 2013. Eight hundred and forty-one goats were kept in a secret barn that had been in use for at least two and a half years, without ever having been reported to or inspected by the U.S.D.A.’s Animal and Plant Health Inspection Service. Eric Kleiman, a researcher with the Animal Welfare Institute, told me, “In my experience, what they were cited for—which the Nature article led with—about deliberately misleading A.P.H.I.S. for over two and a half years, including management, about the existence of an entire site—that’s the worst thing I’ve ever heard happening with a U.S.D.A. violation … and I’ve been doing this for twenty years.” In an e-mail to me, the company’s lawyer wrote, “Santa Cruz takes U.S.D.A. oversight and enforcement very seriously and directs its utmost efforts to compliance with the applicable laws and regulations.”
The U.S.D.A. offered to settle the case—the only one it has filed against a research facility in the past three years—but the company chose to fight. Santa Cruz Biotech’s lawyer wrote to me that the company “has strong defenses that will be addressed in the litigation.” The initial legal response to the suit offers a hint about those defenses: when accused of drawing blood more frequently than the once-weekly limit, the response quotes Webster’s Ninth New Collegiate Dictionary and points out that a seven-day cycle runs from Sunday through Saturday. Therefore, the two blood draws—one on Thursday, one the following Wednesday—were during separate weeks, and “in keeping with the spirit of the approved Protocols.”
Court records show that a hearing has been scheduled for between July 14th and 18th of this year. A long wait between a violation and legal action is common for Animal Welfare Act enforcement. “The U.S.D.A. has admitted in internal audits that it does a poor job enforcing the A.W.A.,” said Chris Berry, a lawyer for the Animal Legal Defense Fund, which sued Santa Cruz Biotech on behalf of the animal-rights group Stop Animal Exploitation Now. “Basically, regulated entities see enforcement actions and fines as just the cost of doing business, and not as a real deterrent to violating the Animal Welfare Act.” (S.A.E.N. sued Santa Cruz Biotech under California anti-cruelty laws. The Santa Cruz Superior Court ruled that the federal U.S.D.A. court was a more appropriate venue for hearing the matter; S.A.E.N. has appealed the decision.)
Some scientific-research animals have another line of legal protection, from an entirely different part of the government. The National Institutes of Health, the biggest single source of biological-research funding in the world, follows the Public Health Service’s strict animal-welfare regulations, which are significantly stiffer than those of the Animal Welfare Act, regulating everything from cage size to the number of required on-call vets. (The Animal Welfare Act requires only that veterinary care be “adequate.”) If labs or subcontractors don’t follow the guidelines while making antibodies for a given set of experiments, they risk losing government funding.
However, if an antibody is not custom-produced for a specific project—if it’s purchased from a catalogue such as Santa Cruz Biotech’s—P.H.S. regulations don’t protect those animals. According to a spokesperson for the Office of Laboratory Animal Welfare, “antibodies sitting on a vendor’s shelf—created independently by the vendor for retail as a broadly available laboratory reagent—may have many sources, some non-animal, and their production is not a research activity but a commercial endeavor.”
Although Santa Cruz Biotech is registered as a research facility under the U.S.D.A. regulations, it is certainly a commercial endeavor. “Everything is about cost savings,” said Denise McGrath, who worked with antibodies at the company’s lab in Santa Cruz from 2006 to 2010. “If you went to management with your concerns about quality control, it would come down from on high that it wasn’t a priority.” In an e-mail to me, a lawyer for the company quoted John Stephenson as saying, “We also devote considerable energy, time, and resources to the care and welfare of all of our animals.”
One of the company’s obvious priorities is expansion. In the past few years, it has opened an online veterinary pharmacy, whose offerings include a growing line of supplements, and has begun marketing its products in Shanghai. A former employee, who worked in the company’s main lab from 2009 to 2012, told me that he believed John Stephenson’s goal is to make Santa Cruz Biotechnology “the Walmart of biotech.”
A number of researchers who work with antibodies told me that they’d never heard of Santa Cruz Biotechnology’s U.S.D.A. troubles. Matt Scott, a developmental biologist at Stanford, said that he had read the Nature article and asked his lab to avoid buying Santa Cruz Biotech products. “I don’t think what’s going on is widely known in the scientific community,” he said. “If it was more widely known, it would have an impact. Biologists care about animals and the land, and don’t want to take part in something where either of those is hurt.”
When I asked Scott why he had requested that his lab avoid Santa Cruz Biotech products, he seemed almost hurt. “Most of us are in this field because of a childhood fascination with nature and biology and the wonders of it,” he said. “If we can get as good or better products from somebody else, why not support other companies?”
Cat Ferguson is a science writer based in California.
Photograph by Alex Webb/Magnum.
