NIH says it will need more than a year to develop new policies to allow chimpanzees in biomedical research “only under stringent conditions,” as suggested by the Institute of Medicine (IOM) and National Research Council of the National Academies.
An IOM 12-member ad hoc committee prepared a report called Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity, calling for changes to usage rules pertaining to chimps. In that report, the institute positioned itself as all but opposed to future chimp research. “While the chimpanzee has been a valuable animal model in past research, most current use of chimpanzees for biomedical research is unnecessary,” IOM concluded in its report. “The present trajectory indicates a decreasing scientific need for chimpanzee studies due to the emergence of nonchimpanzee models and technologies.”
According to the IOM report, 110 NIH-sponsored projects between 2001 and 2010 involved chimpanzee research. Of those 110, 44 projects were for research on hepatitis; comparative genomics accounted for 13 projects; 11 were for neuroscience research; nine were for AIDS/HIV studies; and seven were for behavioral research. The remaining projects funded studies in areas such as malaria and respiratory syncytial virus as well as projects supporting chimpanzee colonies.
Now, NIH is tasked with creating new policies and has set an April 10 deadline for public comment. These will be passed along to NIH’s Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research. “NIH anticipates that the Working Group will present its final report during an open session of the Council of Councils in early 2013,” the council has noted. “After the council considers the Working Group’s report and recommendations, the NIH will subsequently open a 60-day public comment period on the report and recommendations.”
Effectively, NIH will hold off on awarding grant funds for research projects using chimpanzees for more than a year while those recommendations are being finalized, the agency told GEN.
Policies to Be Developed
The nine-member working group was established and its members appointed last month. They are charged with developing a plan to implement IOM’s guiding principles and criteria and advising NIH about which studies will meet those tighter rules and about how to shut down studies that do not comply with IOM.
Additionally, the working group will advise NIH on the size and placement of active and inactive populations of NIH-owned or -supported chimpanzees. The IOM report noted that 937 chimpanzees were housed at five facilities as of October 2011.
Perhaps most importantly, the working group will develop a process for reviewing whether future use of chimpanzees in NIH-supported research is scientifically necessary and consistent with IOM’s principles. The institute stopped short of endorsing a ban on future chimpanzee research, though.
IOM contended that “development of nonchimpanzee models requires continued support by the NIH” and that “a new, emerging, or re-emerging disease or disorder may present challenges to treatment, prevention, and/or control that defy nonchimpanzee models and technologies and therefore may require the future use of the chimpanzee.”
IOM recommended continued use of chimps in research that satisfied three conditions:
- The knowledge gained from the research “must be necessary to advance the public’s health.”
- The research cannot be ethically performed on human subjects, and no other research model exists by which the knowledge could be obtained.
- Animals used in research must be maintained either in ethologically appropriate physical and social environments or in natural habitats.
IOM pointed to mAb therapies and prophylactic HCV vaccines as two areas where continued use of chimpanzees may be needed. “Specifically, the committee could not reach agreement on whether a preclinical challenge study using the chimpanzee model was necessary and if or how much the chimpanzee model would accelerate or improve prophylactic HCV vaccine development,” the report stated.
“By endorsing the continuation of vital research that requires chimpanzees, NIH Director Francis Collins encourages us to continue creative efforts to design critical studies aimed at developing vaccines for hepatitis C and other diseases that affect millions of people worldwide,” John L. VandeBerg, Ph.D., director, Southwest National Primate Research Center (SNPRC), said in a statement to IOM and NIH.
SNPRC is hosted within the Texas Biomedical Research Institute. SNPRC is home to approximately 3,000 nonhuman primates including 150 chimpanzees, Texas Biomed spokesman Joe Carey told GEN.
Texas Biomed and other groups supporting research on chimpanzees contend that chimps are the only animals besides humans that are susceptible to infection with hepatitis B and hepatitis C viruses. Unlike humans, however, chimpanzees do not develop symptoms from these infections. Research with chimpanzees at Texas Biomed was instrumental in developing a successful vaccine for hepatitis B, now given to school-age children worldwide, and the institute hopes to develop a similarly successful vaccine for hepatitis C.
Committee members opposed to using chimpanzees argued that rodent and other alternative models can provide sufficient immunogenicity and safety data to proceed to human efficacy trials without the need for studies in chimpanzees. They also said that chimpanzee data does not always predict vaccine toxicity or efficacy in humans and that the chimpanzee model is often complicated by the lack of sufficient quantity needed to generate statistically significant results.
“The likelihood and length of any possible delay in vaccine development caused by foregoing chimpanzee research is difficult to assess, and human trials are required whether or not research proceeds using the chimpanzee during the course of vaccine development,” IOM stated in its report. The institute panelists agreed that human trials of candidate vaccines could be designed and performed ethically with or without data from chimpanzee research.
Kathleen Conlee, senior director, animal research issues for the Human Society of the United States (HSUS), which opposes the use of chimps in biomedical research, told GEN the IOM report highlighted the fact that “alternatives to chimpanzee use are the answer going forward—not only in regards to chimpanzee welfare but in regards to more effective science, for economic and scientific reasons.” During the 2011 federal fiscal year, only 53 active projects sponsored by NIH used chimpanzees in research.
HSUS has joined six groups in asking the U.S. Fish and Wildlife Service (FWS) to change the designation of captive chimps from “threatened” to “endangered,” which would mean they would be protected under the Endangered Species Act. FWS launched a review of the status of chimps last September following the groups’ petition. Current law distinguishes between captive chimps and wild chimps, which are protected as endangered species.
Opponents of chimp research have also urged Congress to pass the Great Ape Protection and Cost Savings Act of 2011 (HR 1513 and S 810). The bill would phase out invasive research on chimps and other great apes as well as use of Federal funding for such research. Additionally, it would ban the breeding and transporting of great apes for research. The measure would also require the provision of lifetime care of great apes owned or controlled by the federal government “in a suitable sanctuary through the permanent retirement of the apes.”
The House bill has 161 co-sponsors, and the Senate bill has 14. However, no action has been taken since the measure was introduced a year ago in April. Similar measures failed in 2008, 2009, and 2010. With Congress embroiled in the budget and other issues, bill supporters in the animal protection community will have to overcome the usual election year inertia to get the chimp-protection bill back on track.
In the meantime, NIH will be developing policy to discourage but not necessarily ban using chimpanzees in research. It remains to be seen how that would be reconciled with FWS, where a redefinition of captive chimps could preclude their use in research. The answer will likely emerge in about a year.