A lab that uses animals for research has been the subject of a series of critical reports by inspectors from the United States Department of Agriculture (USDA).
The lab is called ProSci Inc., a $10 million-a-year Poway biotech business specializing in antibody production. While its office is in Poway, it keeps its lab animals in corrals, pens, cages, and barns in Ramona, according to business records. The company creates antibodies for researchers, including those in academia, the private sector, and the government.
Antibodies are naturally found in humans and animals and are produced by the immune system to help fight disease. Standard practices for creating antibodies in animals start with them being injected with a mild toxin or antigen, spurring the immune system to target the toxin or antigen and subsequently develop a mixture of antibodies. The lab later withdraws the antibodies that have been created from the animals’ bloodstream.
There is a growing chorus of researchers and academics who claim creating antibodies from animals’ blood, first done in 1901, is outmoded science and often cruel to the animals.
The treatment of animals is what’s at the heart of the USDA inspections of ProSci. Among the animals ProSci works with are rabbits, llamas, goats and cattle.
NBC 7 Investigates reviewed inspection reports, from 2015 up to the current year, with several experts in animal care and research, all of whom expressed alarm at what they saw in the reports.
Among them was Kathleen Conlee, an expert on animal research issues at the Humane Society of the United States.
Her initial response was that she “was shocked at the range of problems at the facility.”
In a series of responses to our questions the company told us whenever there is a problem, they address it immediately, taking corrective action as called for.
Echoing Conlee’s concerns was Dr. Ingrid Taylor, a veterinarian for 12 years as well as a researcher for People for the Ethical Treatment of Animals (PETA). She too reviewed the USDA inspection reports.
PETA has filed a complaint with the San Diego County Sheriff's Department claiming the lab's policies and procedures should be investigated under California's animal cruelty laws.
“I’m extremely concerned as a veterinarian about the deplorable living conditions and the conditions in which these animals are being kept,” she said.
For example, in a July 15, 2015 report, she notes there is a reference to rabbits exhibiting what’s called head tilt and a description of thick yellow discharge coming from their eyes.
Said Dr. Taylor, “Conditions like head tilts and eye discharge could indicate respiratory infections, bacterial infections, parasitic infections, traumas, and abscesses."
The veterinarian also notes that photographs from a 2015 and a 2016 inspection show how closely confined the rabbits are in wire cages.
“The cages are only large enough for them to be able to turn around and lay down in them,” she said.
One inspection report says the three-square-foot cages are a minimum size requirement. In March 2016, Inspectors found larger rabbits in cages too small for their bodies. Dr. Taylor says the cramming can lead to spinal deformities.
The photos from the 2015 and 2016 inspections show all of the rabbit cages have wire floors.
Said Taylor, “they form painful sores and ulcers on their feet. They can also develop fractured toes and toenails from getting caught in the wire flooring.”
Dr. Sari Kanfer with the Exotic Animal Veterinary Center in Pasadena has focused her work on exotic pets, primarily rabbits, for 18 years. Kanfer reviewed the documents and drew the same conclusion about the rabbits’ confinement in the cages that the USDA had identified in a March 2016 inspection report.
“It's basically like being in solitary confinement in jail. And you know even in jail, convicts will get some time out in the yard.”
These experts say this is not the worst of it.
Conlee from the Humane Society said, “they collect the blood from the animals and they weren't even putting limits on how much blood was collected from the animals.”
In September 2016, an inspector noted “the amount of blood drawn may exceed what is safe” and in June of last year, inspectors found dried blood on the back of rabbits ears which indicated, our experts tell us, the bleeding continued after blood draws.
“Antibody procedures (are) inherently a painful and stressful procedure,” Conlee told us. “They could minimize it to the extent possible. I do not believe that's happening at this facility”
Dr. Kanfer added, “I think the worst thing of all is thinking of these animals living in chronic pain and chronic suffering. That's what bothered me the most.”
ProSci challenged that assertion, telling us in a statement that “humane animal treatment is a top priority. We hire, train, and supervise our employees specifically with animal welfare in mind and we also have external veterinarians continuously evaluate the health and wellbeing of our animals.”
Back in 2015, the USDA issued what our experts say is rare for the agency -- a “warning of violations” to ProSci labs for inadequate veterinary care. This was after a series of inspections of breeding and the main barn housing for its 900 to 1,300 New Zealand White Rabbits and other animals. While the agency provided public documents when requested, they were unwilling to comment further on any of the details in the reports.
NBC 7 Investigates reviewed the Animal Welfare Assurance report for ProSci, showing a list of requirements required of the company under the Animal Welfare Act. The documents provide some insights into the workings of the lab. It is signed off by Yu Geng, MD, the company’s CEO and president. The lab promises to provide humane care in the use of their laboratory animals.
The company also promised a veterinarian would provide “review of the care and maintenance procedures” four times a year contributing “between 4-8 hours of his time per quarter.” This equates to, at the most, 32 hours a year of an outside veterinarian oversight for monitoring animals’ health and the work of employees involved with the care and handling of the animals.
In responding to our requests for an interview and more information regarding the reports, ProSci’s President Yu said the lab has since addressed the problems with increased staff training and hiring of new veterinarians.
The company’s previous vet has left ProSci, and the company will not tell us why. NBC 7 Investigates reached out to the veterinarian who left ProSci at an animal clinic in the East County where he works but he hasn’t returned our calls.
ProSci sent NBC7 Investigates what’s called a “pre-inspection” report from August of last year, not available to the public. ProSci said it demonstrates how it is fully complying with the Animal Welfare Act.
The USDA website revealed that this particular type of “pre-inspection” is done at the request of the lab.
Unlike earlier inspections, ProSci knew when the USDA was coming to the lab and what the inspectors would be looking at. This is the only USDA inspection at the ProSci facilities where no problems were reported.
This past February, a USDA inspection found new problems. ProSci said USDA inspectors found “minor issues” including unlabeled medication, medical bottle had debris in the area where a needle is inserted, excess accumulations of excreta, veterinary care was not appropriate, watering bowls contain excreta, animal enclosures not maintained in good repair and not cleaned adequately or often enough.
The lab said these issues were immediately addressed “with procedures in place to correct any inspection issues.”
Looking at the February inspection report, Dr. Taylor disagrees, saying these “minor issues” aren’t minor when ineffective cleaning and sanitation exposes the animals to disease.
“They still weren't doing the proper sanitation and cleaning of the actual barn and cleaning up the feces from the floor,” Dr. Taylor said.
In reference to all of the USDA inspection reports of ProSci since 2015, Conlee said, “I think it's important to point out that these are minimum standards. Minimum standards that they are failing.”
The lab declined our request for an on-camera interview and would not allow us to see the animal cages or holding pens.
ProSci said it provides “humane animal treatment,” which it says is a “top priority”. It also points out that its license has not been revoked, which confirms the problems aren’t that serious, it says.
Not necessarily so, says the U.S. Humane Society's Vice President Kathleen Conlee.
“We don't know if there's an investigation underway but we certainly hope that there is,” she said.
NBC 7 Investigates found the only real consequences from USDA violations like these are fines or a company’s license being revoked. ProSci has not been fined, nor have they had their license revoked.
We have no evidence of an investigation underway by the agency.
The USDA declined to discuss any of the ProSci reports. NBC 7 Investigates found only one instance where the agency severely punished an antibodies lab for the mistreatment of its animals.
Taking a broader point of view on this topic, NBC 7 Investigates found recent studies reveal problems with the animal antibody research field as a whole that wasn’t known for years. There are viable alternatives to using animals when creating antibodies, according to Dr. Stefan Dubel, a biotechnology professor at the Technical University in Braunschweig, Germany.
“It’s just not technically necessary anymore,” Dubel said.
The professor says science has a replacement -- creating antibodies from cell cultures as opposed to animals’ blood. But it’s not widely understood. Dubel said researchers are more comfortable with the systems they have used for twenty or thirty years, they have to be convinced the newer methods have value.
Another motivation to use alternative methods is seen in the results of numerous studies done by the professor and others. The results show a high error rate for creating antibodies when using animal blood. In Dr. Dubel’s investigation, he found an error rate of about one-third among the 800 antibodies tested. Larger studies have discovered the same thing.
A company in Carlsbad was involved in another research project with similar results.
Dubel says the problems associated with using animal-generated antibodies has been overlooked for years.
“It’s an interesting phenomenon which comes directly from the way we publish scientific research,” he said.
He tells us that scientists only report successes, not when antibodies fail during research. There is no way of tracking how often the antibodies fail during research projects, he said.
According to a recent review of the problem, it’s costing $800 million in wasted research efforts worldwide, $350 million in the United States. The professor believes these factors are going to lead to a major shift in how antibodies are created for research.
“I think the quality argument will convince more and more people and also save the animals,” Dubel said.