Animal Experimentation Issues

PCRM Position Paper on Animal Research

Adopted by the PCRM Board of Directors on June 4, 2004

The primary purpose of medical research is to promote human health, and the most direct research methods focus on the study of human populations, individuals, and tissues. Animal research has been used as an alternative method when the study of humans is deemed impractical or unethical, or when animal biology is of primary interest, and animals are frequently used in biological and medical research, in the testing of drugs and commercial products, and in educational exercises in the sciences. While the number of animals used in the United States is not known, estimates range into several tens of millions annually.

Ethical concerns are raised by the use of animals in experimental studies, particularly when they are subjected to painful procedures or toxic exposures. These concerns are accentuated by recent studies showing marked stress responses in animals undergoing routine laboratory procedures. For example, routine handling, venipuncture, and gavage (the administration of test compounds through an oral tube) elicit striking elevations in pulse, blood pressure, and steroid hormone release that can persist for an hour or more after the event. Similarly, routine features of the laboratory environment—isolation, confinement, social disruption, noise, and restrictions on physical movement—have been shown to be noxious for animals. Together, these bodies of evidence indicate that even routine experiments that appear to be minimally invasive can be highly stressful for the animal subjects, and this finding applies to commonly used rodent species as well as larger and less frequently used animals. Stress effects are relevant to humane concerns as well as to the interpretation of scientific findings. Research on immune function, endocrine and cardiovascular disorders, neoplasms, developmental defects, and psychological phenomena are particularly vulnerable to stress effects.

Promoting Nonanimal Methods

Ethical concerns have propelled the exploration of methods that replace animal use. However, such methods may also have scientific advantages related to cost or applicability to human disease. For example, toxicologists seeking more accurate or reliable methods have turned to cellular screening tests for many applications and have realized substantial savings in the process. Trauma training, once conducted almost universally using animals, is now commonly taught with simulators that are cheaper and are designed to more closely mimic critical aspects of patient care.

It is incumbent on scientists and institutions using animals for research, testing, or educational purposes to actively investigate and implement alternatives. The federal Animal Welfare Act regulations require that research personnel be trained in methods of searching for alternatives to animal use, and the NIH Guide for the Care and Use of Laboratory Animals encourages efforts to develop and use scientifically valid alternatives to animal research. There are three broad scenarios for doing so:

1. In some cases, alternatives are readily available. For example, nonanimal methods in medical education have already been implemented for a wide variety of applications at many medical schools, but are not yet in use at all institutions.

2. In other cases, nonanimal methods may not be apparent. In such cases, development of suitable alternative means should be a high priority. For example, many laboratories produce monoclonal antibodies for research or diagnostic purposes by placing antibody-producing cells in the abdomen of animals, often causing significant pain and distress as the cells produce large amounts of fluid (ascites). While antibodies can also be produced by cellular techniques, there are major technical challenges in so doing for some cell lines.

Pharmaceutical testing presents challenges for the replacement of animal tests. At the present time, the Food and Drug Administration does not allow the marketing of new pharmaceutical products without animal testing. While animal tests leave much to be desired as means of identifying drug-related risks, no alternative test methods are yet acceptable to the FDA for many toxicology endpoints.

In these cases, the most appropriate course of action is neither to assume that nonanimal methods will be easily produced nor to be resigned to the continued use of animals. Rather, it is incumbent on investigators and research-supporting institutions to make the replacement of animals a priority.

3. For many applications, the replacement of animal use occurs most appropriately, not through a specific alternative method, but by a substantially different approach to the clinical problem at hand. For example, some research centers are assessing the toxic effects of recreational psychoactive drugs by testing them on animals. Another strategy relies on assessing their effects through noninvasive neurological and psychometric testing on humans who have been using such compounds voluntarily.

The Role of Divergent Viewpoints, Discussion, and Debate

To address the ethical and practical issues raised by animal research, scientists and research-sponsoring institutions benefit from information sharing, discussion, and debate representing a wide variety of opinions. Governmental bodies in the U.S. (e.g., the Environmental Protection Agency) and abroad dealing with animal testing issues have implemented policies that ensure that animal welfare advocates and scientists advocating for alternatives to animal tests are represented on scientific and regulatory panels.

In recent years, it has become clear that viewpoints vary greatly on this issue and are highly mutable as new information comes forward. It is helpful to recognize that, generally speaking, implementing nonanimal methods is neither a simple matter nor a theoretical impossibility.

In 1990, the AMA registered its objection to what it saw as PCRM’s stance on animal research. In the years since that action, the scientific climate has changed substantially and PCRM has implemented many progressive programs addressing the need for alternatives to animal use. In cooperation with physicians at Harvard University and the Massachusetts General Hospital, PCRM has developed educational materials demonstrating clinical alternatives to animal use in medical instruction, and progress in implementing alternatives has been documented in surveys published by PCRM physicians in the Journal of Medical Education and Academic Medicine. PCRM toxicologists serve on scientific panels for the Environmental Protection Agency and on the Board of Directors of the Toxicology Excellence for Risk Assessment. PCRM physicians have published invited papers on animal research issues in Scientific American and Lancet Oncology. Working with outside scientists, PCRM is developing a new laboratory technique for assaying insulin that provides alternatives to the ascites method for producing monoclonal antibodies and to the use of fetal calf serum for in-vitro cellular growth. PCRM is now a grantee institution of the National Institutes of Health, through the National Institute of Diabetes and Digestive and Kidney Disorders, for its research on nutrition and diabetes conducted in cooperation with the George Washington University and the University of Toronto.

We believe it would be helpful to address the AMA’s concerns with the goal of promoting a better dialogue and tolerance of varying viewpoints. The AMA’s objection had three parts:

First, the AMA felt that PCRM was in some way “implying that physicians who support the use of animals in biomedical research are irresponsible….” By this policy statement, we clarify that, in any area in which ethics and values are involved, particularly a controversial area, such as the use of animals in research, a wide variety of opinions is to be expected and, indeed, welcomed. PCRM does not deem any particular viewpoint “irresponsible.” On the contrary, PCRM actively works with individuals and organizations involved in research, testing, and education who hold widely divergent views with the aim of advancing common goals.

Second, the AMA faulted PCRM for “misrepresenting the critical role animals play in research and teaching….” By this policy statement, we clarify that, while animal welfare considerations mandate the replacement of animals, we recognize that there are areas for which alternatives have not yet been developed or have not yet gained acceptance by regulatory bodies. The impediments to their development and acceptance relate to both technical difficulties and attitudinal issues. In the course of scientific inquiry, many investigators have credited the use of animals with the elucidation of key points, and it remains a matter of conjecture as to whether the same discoveries could have been accomplished by other means. In contrast, the use of animals in education has undergone dramatic changes in the past decade. Most medical schools have eliminated the use of animals from their curricula, and instructional methods at other educational levels have also evolved in the face of changing technologies. A reasonable viewpoint, we believe, is for investigators and institutions using animals to explore and implement nonanimal methods with all due haste and without limit, recognizing that in some cases the practical challenges inherent in doing so are considerable.

Third, the AMA held that PCRM erred in “obscuring the overwhelming support for such research which exists among practicing physicians in the United States.” While we are unaware of any past actions by PCRM that had the effect of obscuring physicians’ opinions, we find that physicians’ support for animal use varies depending on the application involved. Research focused on the treatment of disease has considerable support, while product testing, animal use in medical education, surgical training for nonphysicians, psychological experiments, and many other areas of animal use are highly controversial, both among physicians and the lay public.

Conclusions

The process of replacing animals in research, testing, and education is supported by studies showing that routine laboratory procedures and typical laboratory environments are more stressful for animals than is commonly appreciated. Nonetheless, the challenges of replacing animals are often considerable, raising major scientific, economic, and regulatory issues.

The exploration and implementation of nonanimal methods should be a priority for investigators and research institutions and should take advantage of a wide variety of viewpoints to ensure progress toward scientific, human health, and animal protection goals.

Media Center | Health | Research | About PCRM | Catalog | Join Us | Search | Site Index | Home

The site does not provide medical or legal advice. This Web site is for information purposes only.
Full Disclaimer | Privacy Policy