The Humane Society of the United States alleged in November that the experiments conducted on six dogs in March, witnessed by an undercover investigator, were frivolous and driven by profit.
According to a research protocol obtained by The Chronicle, researchers were attempting to develop an antimicrobial coating that would prevent infection from colonizing dental implants, an issue that arises in about 10 percent of cases.
Dr. Christopher Cutler, the chairman of the Department of Periodontics at GRU and interim associate dean for research at the dental school, said this is a pioneering approach to solving a serious medical issue and had to be tested in animals before human clinical trials could begin.
The research protocol for this experiment was first approved in 2010 by the Institutional Animal Care and Use Committee, a group of faculty and community members required by federal law to approve all animal testing. The protocol was renewed for another three years in June, three months after the experiment witnessed by the Humane Society, internal memos obtained by The Chronicle show.
Cutler declined to say how many times the experiment had been performed on dogs since 2010.
Cutler said the IACUC is charged with screening all studies to “make sure that these animals are not subjected to this therapy in vain.” The members have the opportunity to pose questions to researchers and get more information before approving a protocol.
The newspaper obtained a copy of the minutes to the IACUC’s 2010 and 2013 meetings where these experiments were approved, but the university redacted almost every word, making it impossible to tell whether this discussion between the IACUC and researchers took place.
GRU officials have not determined how they will address another concern raised by the Humane Society – the fact that the school purchases animals from Class B dealers. These dealers obtain animals from sources such as shelters, “free to good home” ads and strays, and sell them to labs. Class A dealers breed animals purposely for research.
The National Institutes of Health, the largest source of public funding in the U.S., will discontinue funding projects that use animals from Class B dealers in 2015.
Cutler and Senior Vice President for Research Mark Hamrick said university officials are discussing this issue and will decide how to proceed “soon.”
IN THE DENTAL EXPERIMENT conducted on dogs in March, implants with the antimicrobial coating were to be placed in six hound dogs along with an already approved implant for comparison. Eight weeks after the surgery, the dogs were euthanized so the implants could be examined. Dogs are used because their jaw sizes and teeth allow for a better comparison to humans, and the type of disease and bone loss they experience is very similar to what humans would experience, Cutler said.
“I think it is fair to say that we would welcome in the future a better model for use in less sentient animals,” he said. “I think everyone would like to get completely away from animal research, but it is so important to medical research. Every major breakthrough in terms of medical devices, in terms of cancer drugs, has first been tested in animals because
of the complexity of the biological systems.”
Cutler said researchers across the world are trying to develop such a technology that will prevent infection and acknowledged there is a commercial gain to be made.
This particular experiment was privately rather than publicly funded, but school officials were not willing to disclose the source.
“You think about every major medical advancement in either medical devices or pharmaceuticals, there has to be support behind it, financial support with the understanding that some ultimately is going to the shareholders,” Cutler said.
However, he said the main goal was to prevent implants from infection and failure. He said that while most people think of implants as cosmetic, they serve an important functional purpose – without teeth for chewing hard, fibrous foods, diet is limited to soft foods, which can lead to nutritional deficiencies and digestive problems.
Any infection in the mouth can also turn invasive and enter the bloodstream, attaching to heart lining or valves and cause a serious infection called endocarditis.
A meta-analysis published last month in the Journal of Periodontology found that less serious infections occur 63 percent of the time with implants and a more serious peri-implantitis occurs with 9.6 percent of implants.
Cutler said the next step for his researchers would be to seek approval so clinical trials in humans could begin, but he did not know whether that process had begun. He could not disclose where the researchers were in the process but said he wasn’t aware of any additional tests.
“I am sure that at other institutions, not only in the United States but worldwide, there are ongoing research projects that are testing these antimicrobial coatings. But to my knowledge this is not an ongoing project here,” he said.