What Happens When Animal Testing Isn't Internally Monitored? Not Much.
BY CRAIG MALISOW
USDA inspectors are supposed to conduct yearly visits of facilities that use animals for research. But facilities are also supposed to monitor their treatment of animals through the use of a so-called institutional animal care and use committee. These committees oversee a facility's experiments on animals to ensure that researchers are complying with the Animal Welfare Act. The USDA's guidelines for who sits on a committee are pretty loose — all the administration requires is a minimum of three members appointed by a facility's CEO. One must be a veterinarian, and one must not otherwise be affiliated with the facility.
These people, whoever they are, are in charge of making sure a facility abides by the minimal requirements of the Animal Welfare Act, which generally states that lab animals should not be subjected to undue pain. (If the lead researcher can prove it is scientifically justified, the committee can grant an exemption.) Institutional animal care and use committees are also required to review, at least every six months, a facility's "program for humane care and use of animals," as well as conduct inspections, according to the USDA.
USDA records at two Texas facilities show what can happen when an IACUC fails to do its job.
On January 13, 2015, a USDA veterinarian inspecting a Sugar Land drug research company and research dog supplier called Stillmeadow observed some behavior among a few dogs that concerned her.
Dog 4243, an individually housed adult brown and white beagle, "was observed exhibiting a continuous circling behavior to the left." The vet noted that "this repetitive behavior can have behavioral or physical origins."
The dog's medical record showed that it had exhibited the same behavior back in April 2012, and had ceased the behavior once it was placed in group housing in May 2012. But there were no records indicating why the dog was no longer in group housing — there were no records since May 2012 detailing the dog's behavior, period. Before the end of the inspection, the dog was placed back in group housing.
The vet also noticed that an adult female brown and white hound mix "was observed to have thickened pink skin with concurrent hair loss and small crusted lesions in both flank areas at the front of the rear legs. Multiple small, red, circular raised lesions were visible on the abdomen in an area where the hair is naturally sparse."
The dog's records indicated that she had been "diagnosed and treated for allergic dermatitis in September and October 2014 [which had been] resolved with treatment," but the USDA inspector wrote that both dogs' behavior and condition "should be communicated to and addressed accordingly by the attending veterinarian."
This was something Stillmeadow seemed to have a problem with. In February 2015, the USDA fined the company $3,071 for failing to provide dental care to two beagles suffering from "swollen gums and severe brown and tan hard material attached to the upper canine and cheek teeth."
A Stillmeadow representative declined to comment for this story, so it's difficult to find out the full extent of how Stillmeadow uses its dogs.
According to its website, Stillmeadow was founded in 1975 and encompasses three buildings with more than 75,000 square feet of laboratory and "support space." It provides safety studies on medications for dogs — e.g., tick and flea treatments and dental treatments — as well as pharmaceutical testing and EPA-mandated toxicity tests for pesticides. Until April 2015, when its license was canceled, Stillmeadow also sold dogs. (According to records obtained by the Humane Society of the U.S., Stillmeadow sold more than 100 beagles to Texas A&M in 2010-2011.)
Per USDA guidelines, Stillmeadow's deficiencies should have been noticed and corrected, if not by Stillmeadow staff, then by the facility's institutional animal care and use committee.
But Stillmeadow had had trouble with its IACUC in the past. A USDA inspector noted in 2012 that Stillmeadow did not meet the bare minimum of laboratory animal research because it failed to "give a rationale for involving animals" and for "the appropriateness of the species and numbers of animals to be used" in an unidentified experiment. (The "animals" on hand during the inspection were 13 adult dogs and three adult cats.)
The inspector noted that a study proposal submitted to Stillmeadow's IACUC failed "to give a description of procedures designed to assure that discomfort and pain to animals will be limited ... Management needs to comply with the Animal Welfare Act and Animal Welfare Regulations."
Another Texas research facility that has had trouble with its institutional animal care and use committee is Sharp Veterinary Research in Vernon, where the inspector noted in 2011 that "three of the five members of the IACUC are the three primary investigators for all protocols. This constitutes a conflict of interest."
Sharp, which appears to test on dogs for pet medications only and not for human pharmaceuticals, had experienced "a significant number of unexplained deaths" — 17 dogs and 15 cats in the year before the report. The record-keeping was lacking; all the inspector was able to figure out was this: "Cause of death noted in the dog records was either 'died pneumonia' or 'culled.'"
Some of the dogs were given medication, but the records didn't say what it was. The overall lack of diagnostics and shoddy care subjected the cats and dogs to "unnecessary pain and suffering," according to the report.
The USDA last visited Sharp Veterinary Research in August 2014, at which time the inspector noted that the facility's IACUC had not been inspecting the facility every six months as required. The report also noted that while the facility's own policy required a weekly visit by a veterinarian, this hadn't been done "in at least a month."
Marvin Sharp, the head of the facility, did not respond to calls seeking comment.
But the IACUC problems at these two facilities were not flukes: The USDA's Office of Inspector General's 2014 audit found an alarming lack of oversight among IACUCs. Its inspectors cited 531 of 1,117 research facilities between 2009 and 2011 for "inadequate protocol reviews and monitoring." Some violations included a failure to find "alternatives for painful procedures" and the approval of protocols that failed to include "descriptions of procedures designed to assure that pain to animals would be limited to that which is unavoidable."
Inspectors also found instances in which researchers had deviated from protocols, including "doubling the number of implants" — be they catheters, needles or electrical shockers — "in an animal" and "using more animals than authorized by the protocol." Some deviations seemed to spring from laziness, as at a facility in Maryland where researchers "dropped chili pepper flakes into the eyes of an animal to induce tearing," even though the protocol "called for carefully placing a few flakes on the cheek below the animal's eye."
Get the ICYMI: Today's Top Stories Newsletter Our daily newsletter delivers quick clicks to keep you in the know
Catch up on the day's news and stay informed with our daily digest of the most popular news, music, food and arts stories in Dallas, delivered to your inbox Monday through Friday.