Mr. Chairman and Members of the Committee, I am Dr. John Strandberg, Director of the Comparative Medicine area of the National Center for Research Resources at the National Institutes of Health (NIH). I joined NIH in 1998 from Johns Hopkins University School of Medicine where I directed the comparative medicine program. One of my priorities on arriving at NIH was to develop a trans-NIH plan to address how to optimize the care and use of chimpanzees in federally funded biomedical research. I welcome the opportunity to speak with you today about the contributions chimpanzees make in selected areas of biomedical research and why this research is important to the public and its health. In addition, I will address NIH’s continuing efforts to ensure that chimpanzees used in biomedical research receive humane treatment and monitoring.

Let me assure you that NIH takes very seriously its responsibility for the health and welfare of research animals of all types and that of the people that care for them, whether directly through an intramural program or in partnership with extramural organizations.

Animal-based research continues to be a highly productive and valuable approach to solving human health problems. We have discovered the means of controlling devastating and debilitating diseases using vaccines developed and tested in animals. The polio vaccine is one of many examples that might be cited; this vaccine was developed using monkeys, and the safety testing of vaccines was done in monkeys for many years. Animal models have provided critical information in the development of treatments for cardiovascular diseases, such as hypertension and cardiac arrhythmias. Significant challenges, however, remain in the fields of organ transplantation, inherited diseases, and infectious diseases, including HIV and hepatitis C. Animal-based research will continue to play an important role in meeting the scientific and public health challenges that lie ahead.

Although there are striking similarities between the physiological systems of humans and various species of other animals, there is no single animal species that is appropriate for the study of all diseases. For example, much of what we know about the immune system has come from studies with mice, and much of what we know about the cardiovascular system has come from studies using dogs. There are numerous instances in which only nonhuman primates and man’s most closely related species, the chimpanzee, can provide the solutions to important human diseases. Recent examples of these include the development of a vaccine against hepatitis B virus. Ongoing efforts are trying to develop vaccines for other infectious diseases, such as hepatitis C (HCV) and respiratory syncytial virus (RSV), the most common cause of respiratory tract infections (pneumonia and bronchiolitis) in infants and young children. Both infections cause significant morbidity and mortality in this country.

Chimpanzees are the only animal, other than man, that can be infected with human immunodeficiency virus (HIV). For this reason, it was hoped that they could provide information on the progression from HIV infection to AIDS and in the development of treatments and vaccines. However, despite the fact that chimpanzees become persistently infected with HIV, we found that the development of clinical AIDS occurs in chimpanzees late or not at all.

Studies using chimpanzees have produced a cohort of several hundred animals that have been exposed to viruses, with many persistently infected with hepatitis C and HIV. These chimpanzees have unique health care requirements and pose hazards to their caretakers, to other unexposed animals in their colonies, and to the public. Thus, we believe that their care must be provided by individuals with knowledge and expertise specific to their medical histories.

The NIH currently has title to approximately 600 chimpanzees. There are approximately 1,600 chimpanzees in this country that have participated in biomedical research. However, not all these chimpanzees fall under the purview of the Public Health Service as some have participated in research conducted in the private sector, principally by the pharmaceutical industry. We estimate that approximately 500 chimpanzees that have been used in research have been exposed to or are chronically infected with agents transmissible to humans.

Chimpanzees are highly sophisticated animals with housing requirements reflecting their mental abilities, physical strength, and inter-animal interactions. Their housing requirements are extensive, specialized, and costly. Construction of new facilities therefore often takes considerable time and resources.

The NIH has always monitored the use and humane treatment of chimpanzees in biomedical research which it sponsors, because chimpanzees constitute a valuable and scarce research resource. In response to the AIDS epidemic, the Chimpanzee Biomedical Research Program was established in 1986. However, researchers found that the chimpanzee model was not capable of answering some research questions, and by the 1990's, concerns were raised about the apparent surplus of chimpanzees. In response to a request from the NIH, a National Academy of Sciences (NAS) panel reviewed this issue and produced a series of recommendations. These recommendations form the basis of the Chimpanzee Management Program (ChiMP) that has been implemented by the National Center for Research Resources at NIH. The ChiMP includes an advisory body of independent research scientists to discuss and resolve issues related to chimpanzees that have participated in biomedical research. This advisory group is composed of scientists from outside the NIH with expertise in animal behavior, veterinary medicine, and genetics. The group advises the NIH on many issues, including the development of programs for long-term care of chimps and their use in research.

Also, in accordance with the NAS panel recommendations, the NIH has implemented: (1) a breeding moratorium on NIH-supported chimpanzees (which the NIH actually began two years before the report was issued), and (2) a policy that rules out euthanasia as a method of population control. The NAS panel proposed a core population of 1000 federally owned chimpanzees to meet research needs. That number seems to be a bit high today, given limitations of the chimpanzee model in AIDS research, and is under consideration by the ChiMP advisory group. To provide high-quality care while conserving resources, the NIH will consolidate its five existing chimpanzee facilities into two sites. At the beginning of the next fiscal year, we expect to make the awards to the entities that will operate these two facilities. These sites are critical to the placement and humane care of chimpanzees that have participated in research. Successful applicants will have proven expertise in long term housing and humane care of chimpanzees in biomedical research. In addition, a five-year grant was funded in March 2000 to provide an improved database of all chimpanzees that have participated in research. This will allow us to track animals more efficiently over time and to plan for resources needed.

In addition to long-term care and housing needs for the chimpanzees, the NIH must consider biomedical researchers’ need to monitor animals that have been the subject of research in the past. Follow-up is needed to gain further information from the research in which they participated. Much of the data needed can be gathered through minimally-invasive procedures, such as blood draws and urine collection. In addition, we would also want to conduct post-mortem examinations of those that die.

No one can tell what the future will bring. At some future point in time, a scientist might discover a treatment that could potentially eradicate all HIV from infected individuals, develop a candidate hepatitis C vaccine, or discover a means of eradicating persistent hepatitis infection. It would be very unfortunate if we did not have access to animals with long-term infections to assess new treatments and vaccines. Not only would this be poor stewardship of our Federal investment in these animals, it could have a substantial negative impact on the health of humans and chimpanzees.

Thus, NIH cannot support proposed legislation that would require it to establish sanctuaries for chimpanzees and would make the animals permanently unavailable for study or monitoring. The NIH, however, would be pleased to work with the Congress to enhance the existing network of long-term care facilities for chimpanzees used in biomedical research, which will allow such animals to remain the subject of scientific inquiry should a future need arise. In recognition of this need, the NIH has taken the initiative to enlarge and improve housing facilities for NIH-supported chimpanzees at two chimpanzee facilities. These activities will serve as the basis for responding to the NAS recommendations as well as our mutual concerns about the health and welfare of chimpanzees used in research.

The continuing use of chimpanzees in NIH-sponsored biomedical research is subject to extensive oversight at the level of the Office of the Director. The Interagency Animal Models Committee reviews all federally supported research protocols that propose using chimpanzees to promote the conservation and care of chimpanzees when this species is the best or possibly the only model for conducting the research.

And, as noted above, the NCRR’s ChiMP plan is in place. But sometimes there are situations that require immediate attention. The NIH recognizes the need for vigilance, flexibility, and action when problems present themselves. This is the case with the Coulston Foundation. The Coulston Foundation is the largest chimpanzee facility in the world, with approximately 600 animals. The NIH has provided support to ensure the humane care and feeding of the animals through closely monitored administrative supplements to cover additional expenses within the scope of the existing grant. Since February 22, 1999, the Coulston Foundation has received supplements of $399,946 from the National Center for Research Resources (NCRR) and $700,000 from other NIH components.

The NIH is aware of shortcomings at the Coulston Foundation and has worked closely with the USDA and the Coulston Foundation to identify, mitigate, and correct identified problems. Furthermore, the NIH has conducted regular site visits. I recently participated in a site visit and witnessed no evidence of significant hazards to the chimpanzees. The NIH will, of course, continue to monitor the Coulston Foundation facility.

The NIH has recently taken title to 288 chimpanzees at the Coulston Foundation, all of which participated in biomedical research and are infected with HIV and/or hepatitis C, to ensure their continued care and well-being. At the same time, the NIH has announced through the Commerce Business Daily that we will issue a Request for Proposals (RFP) for the operation and maintenance of a long term care facility for these animals. Like all other NIH solicitations, this will involve a competitive process. Applications will be solicited and subject to peer review. An award will be made to the most highly qualified applicant, with expertise in both care of chimpanzees that have participated in research and in administrative and financial operations necessary to run a stable organization to care for those animals. We expect to award that new contract at the end of the summer when the cooperative agreement with the Coulston Foundation expires. The applicants will need to demonstrate expertise in caring for HIV and hepatitis C infected chimpanzees as well as financial stability and administrative acumen in managing and operating a long term care facility for chimpanzees.

In summary, the NIH recognizes that both good research ethics and responsible stewardship of public funds require us to attend to the humane care of chimpanzees currently or formerly used in biomedical research. We will continue to use our resources and leadership to promote the health and welfare of chimpanzees used in such research, and to ensure that the highest level of continuing humane care is provided to those chimpanzees for which we are responsible.

Thank you for giving NIH the opportunity to testify on this important topic. I would be pleased to answer any questions that you may have at this time. Thank you.