Date: Dec. 15, 2011
FOR IMMEDIATE RELEASE
IOM Report Recommends Stringent Limits On Use Of Chimpanzees in Biomedical and Behavioral Research
NIH also should limit the use of chimpanzees in behavioral research to studies that provide otherwise unattainable insights into normal and abnormal behavior, mental health, emotion, or cognition, the report says. NIH should require these studies to be performed only on acquiescent animals using techniques that are minimally invasive and are applied in a manner that minimizes pain and distress. Animals used in either biomedical or behavioral studies must be maintained in appropriate physical and social environments or in natural habitats, the report adds.
"The report's recommendations answer the need for a uniform set of criteria for assessing the scientific necessity of chimpanzees in biomedical, comparative genomics, and behavioral research," said committee chair Jeffrey Kahn, senior faculty member, Johns Hopkins Berman Institute of Bioethics,
Advances in the development of other research tools and methods, including cell-based tests and other animal models, have rendered chimpanzees largely nonessential as research subjects, the committee noted. It acknowledged two possible ongoing uses: the development of a limited number of monoclonal antibody therapies already in the pipeline, and development of a vaccine that would prevent infection by hepatitis C virus (HCV).
New methods such as recombinant technologies can replace the chimpanzee in efforts to develop monoclonal antibodies. While industry and academic laboratories are in the process of adopting these alternate approaches, there may be a few therapies in development that require continued use of chimpanzees to keep progress from stalling and slowing patients' access to needed new treatments. These cases should be assessed to ensure that they meet the criteria outlined in this report, and NIH should continue to support the development of and access to alternatives to make future use of chimpanzees unnecessary.
The committee did not reach a consensus decision on whether chimpanzees are essential to the development of a prophylactic HCV vaccine and if or how much the use of chimpanzees would accelerate or improve this work. Roughly 3.2 million Americans are chronically infected with HCV, and about 17,000 new infections occur each year in the
Chimpanzees and humans are the only two species that are susceptible to HCV infection, and no other suitable animal models currently exist to test a prophylactic vaccine. However, chimpanzees' immune systems clear HCV from their bodies more effectively, and they are less likely to develop liver damage. The committee members agreed that it would be possible and ethical to test a prophylactic vaccine candidate in humans without prior testing in chimpanzees, provided that it was first shown to be safe and to stimulate an immune response in other animals. However, the committee was evenly split on the necessity of testing various HCV vaccine candidates in chimpanzees before proceeding to human trials.
Research to develop a therapeutic HCV vaccine — one that would be given to people already infected with HCV to boost their immune systems' ability to clear the virus — and antiviral drugs for patients with chronic HCV infection can be performed without use of chimpanzees, the committee agreed. These products can be more readily and rapidly tested in people, and new drugs and therapeutic vaccine candidates are moving forward without the use of chimpanzees.
The committee would not close the door on the possibility that chimpanzees may be needed in future research to develop treatments or preventive tools against as yet unknown diseases or disorders. It is impossible to say in advance whether other animal models or research tools will always serve effectively and quickly enough in the face of a novel health threat.
The report's recommendations focus on the scientific necessity of the chimpanzee as a research subject, but also take ethical issues into account. Chimpanzees' genetic closeness to humans and their similar biological and behavioral characteristics not only make chimpanzees a uniquely valuable species for certain types of research but also demand greater justification for conducting research with them, the committee said.
The study was mandated by Congress and sponsored by the National Institutes of Health. Established in 1970 under the charter of the National Academy of Sciences, the
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Board on Health Sciences Policy
Committee on the Use of Chimpanzees in Biomedical and Behavioral Research
Jeffrey P. Kahn, M.P.H., Ph.D. (chair)
Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy
Berman Institute of Bioethics
John G. Bartlett, M.D.
Professor of Medicine
H. Russell Bernard, Ph.D.
Department of Anthropology
Floyd E. Bloom, M.D.
Molecular and Integrative Neuroscience Department
The Scripps Research Institute
Warner C. Greene, M.D., Ph.D.
Director and Senior Investigator
Gladstone Institute of Virology and Immunology;
Nick and Sue Hellmann Distinguished Professor of Translational Medicine; and
Professor of Medicine, Microbiology, and Immunology
Diane E. Griffin, M.D., Ph.D.
Distinguished University Service Professor, and
Alfred and Jill Sommer Chair
W. Harry Feinstone Department of Molecular Microbiology and Immunology
Edward E. Harlow Jr., Ph.D.
Jay R. Kaplan, Ph.D.
Professor of Pathology and Anthropology
Department of Comparative Medicine
Margaret S. Landi, D.V.M.
Vice President of Global Laboratory Animal Sciences, and
Chief of Animal Welfare
Frederick A. Murphy, D.V.M., Ph.D.
Department of Pathology
Robert Sapolsky, Ph.D.
John A. and Cynthia Fry Gunn Professor of Biological Sciences, Neurology and Neurological Sciences
Sharon Terry, M.A.
President and CEO
Bruce M. Altevogt, Ph.D.