Overview

In the U.S. there are over 1200 facilities registered with the U.S. Department of Agriculture as "active" in the conduct of animal research. While many of these facilities are privately funded pharmaceutical and biotechnology firms, many more are universities and other institutions that are the beneficiaries of public funding. The lion's share of public funding for medical research in this country is provided by the National Institutes of Health (NIH).

More than a decade ago, the famed investigative journalist Jack Anderson wrote, "the NIH gives away more than $5 billion a year on research. Whether that money is well spent is anybody's guess. For the most part, NIH blindly trusts that the money went for credible research." (Washington Post, April 11, 1988). Subsequent Congressional hearings on scientific fraud and misconduct laid bare the woeful lack of oversight provided to research by NIH.

Today, while the NIH's budget has literally quadrupled, improved mechanisms for oversight have not been implemented. The victims of this lax system for research are many: the taxpayers who fund research of questionable validity and value; the patients who are involved in clinical studies; and the animals, an estimated 18.5 million of whom are used annually in biomedical experiments.

What follows is a brief overview of the laws, regulations and institutional structures regulating the conduct of research on animals.

Animal Welfare Act

In 1966, "Concentration Camps for Dogs," a Life Magazine expose on the conditions at dog dealer kennels, sparked public outrage and led to the passage of the federal Animal Welfare Act (7 USC, 2131-2156). The Animal Welfare Act (AWA) sets forth minimum standards of care for animals used in research and other forms of commerce. These standards relate to specifics such as sanitation, housing, ventilation, transportation and the provision of adequate veterinary care. With regard to research, the AWA specifies that pain and distress must be minimized in experimental procedures.

It further specifies that alternatives to the use of animals be considered by the principle investigator. It does not, however, restrict any procedures or conditions to which an animal can be subject during the course of an experiment.

And while the AWA states that no animal can be used in more than one major operative experiment with recovery, it allows exceptions that render this provision essentially meaningless.

The AWA does not govern the care and use of rodents, birds and farm animals, because those species were specifically exempted from regulations promulgated under the AWA by the U.S. Department of Agriculture (USDA). Unfortunately,
these species represent approximately 80 percent of all animals used in research.

In October 2000, the USDA agreed to include mice, rats and birds under the AWA in response to a legal petition submitted by animal advocates. Later that month, however, Senator Thad Cochran (R-MS) successfully included a provision in the Agriculture appropriations bill that blocked funding for USDA's efforts to write regulations to include these species under the AWA. Thus the status of these animals, deemed "non-animals" by government bureaucracy, remains in limbo.

The USDA's Animal and Plant Health Inspection Service/Animal Care division is responsible for enforcing the AWA. It does so by conducting routine unannounced inspections and by initiating investigations into continuing non-compliance with the AWA.

The USDA has been routinely found by its own Inspector General (IG) to have failed to adequately enforce the AWA. In three audits issued in 1992, 1994 and 1996, the IG found the USDA's Animal and Plant Health Inspection Service fails to make inspections with reliable frequency, lets violations go uncorrected for too long and imposes penalties only if violators agree to pay. The penalties are so low, the 1994 audit states, that licensees consider them "part of the cost of doing business."

Chronic understaffing has played a role in the USDA's poor performance, but so too has a bureaucratic coziness with the industries that the agency is supposed to regulate. The USDA has historically been reluctant to challenge research institutions, and has pursued only the most egregious and highly publicized violations by research facilities. For example, In Defense of Animals estimates that between 1992 through March 2001, the USDA filed 417 formal complaints under the AWA. Of those 417, only 21 were filed against registered research facilities. (Source: USDA website) Most of those complaints were settled with little more than slaps on the wrist when offending facilities agreed to pay a fine and promise to cease and desist violating the Animal Welfare Act.

Unfortunately, even when the USDA does take action, its authority to stop violations of the Act is limited. Unlike with dog dealers, the USDA has no authority to revoke the licenses of research facilities that do not comply with federal animal welfare laws. This loophole in the Act allows facilities like The Coulston Foundation, a New Mexico primate-testing laboratory that has been formally charged an unprecedented four times by the USDA for AWA violations (most involving negligent chimpanzee deaths), to continue to operate.

Public Health Service Policy for the Care and Use of Laboratory Animals

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory animals sets forth the requirements for all research, training, testing, and related activities involving animals that are supported or conducted by agencies of the PHS, including the National Institutes of Health (NIH). The Office of Laboratory Animal Welfare (OLAW) is responsible for enforcing this policy at the NIH. By law (Health Research Extension Act of 1985, Public Law 99-158) this agency is required to disqualify any institution that chronically violates PHS policy from receipt of PHS funds. In practice, the agency relies on a meaningless policy of "institutional self-regulation," and has a well-documented history of inactivity and whitewashing of allegations of non-compliance against research institutions.

OLAW was formerly known as the Office of Protection from Research Risks (OPRR). In addition to animal research oversight, OPRR was also responsible for overseeing human based research, relying on a similar policy of institutional self-regulation to do so. In 1999, an expert panel found protections for human research subjects to be inadequate and oversight of human-based research to be entirely lacking. As a result, responsibility for oversight of human based research was moved away from the NIH (which was deemed to have a conflict of interest in providing such oversight) and placed under the auspices of a newly created office in the Department of Health and Human Services. The agency's oversight of animal research, although similarly plagued with conflicts and laxities, was not examined. Responsibility for this important activity remained with the NIH and its newly renamed OLAW office.

Institutional Animals Care and Use Committees

Amendments to the Animal Welfare Act (Public Law 99-198), passed in 1985, mandated the establishment of Institutional Animal Care and Use Committees, or IACUC's, at all federally funded research institutions utilizing animals.

By law, IACUC's are supposed to: 1) review animal research protocols to determine if the appropriate animal model and appropriate numbers of animals have been chosen, and if personnel are properly trained and knowledgeable in the proper use of anesthesia, analgesia and euthanasia, 2) ensure that no alternatives to using animals are available, 3) ensure that all animal care and use at the facility is in compliance with the Animal Welfare Act and PHS Policy on the Care and Use of Laboratory Animals (if PHS funds are involved), 4) conduct semi-annual, unannounced inspections of facilities to ensure the humane care, treatment and transport of animals, and 5) support the attending veterinarian, making sure he or she has access to all animal facilities, and aiding the veterinarian in training of personnel and review of protocols and facilities.

Members of the IACUC are predominantly scientists who use animals and veterinarians who work with them. By law, each IACUC must include one "non-affiliated" member who is supposed to represent the concerns of the community.

On paper, IACUC's are the lynchpin of animal welfare enforcement. In practice, however, IACUC's are little more than rubberstamps, with researchers approving each other's protocols. The public member is frequently chosen for his or her willingness to go along. Those who do raise questions and object to experimental procedures are outnumbered; several have been harassed and intimidated off the committees.

A study published in Science magazine on July 27, 20001 confirmed the low reliability of IACUC reviews of animal experiments. Funded by the National Science Foundation, the three-year study found that approval decisions made by university animal use committees in the United States are unreliable when it comes to experimental procedures involving animals.

Privately, conscientious members of IACUC's have confided about the pressures they face from investigators expecting total academic freedom, and from administrations wanting to bring in grant dollars. This pressure leads to approval of protocols with little scientific merit as well as those with questionable animal use. At New York University, the IACUC approved Ron Wood's crack-smoking experiments even though, in the words of one IACUC member, everything Wood was studying on monkeys had already been well documented in humans. The IACUC also approved a protocol allowing water deprivation of monkeys for 18 hours/day. The approval was made over the objections of several members and under stiff pressure from the administration. (Wood's annual grant of $500,000 brought in excess of $300,000 annually to NYU for "overhead" administrative costs).

The NIH relies explicitly on IACUC's to ensure compliance with federal animal welfare laws and policies. However, when IACUC's have been documented to be failing to uphold their legally mandated duties, the NIH has taken no action. For example, since 1998, the USDA has cited the University of California at San Francisco repeatedly for oversight failings. According to inspection reports, the UCSF IACUC has failed, among other things, to ensure that 1) alternatives to animals are adequately explored; 2) pain and distress are minimized through the appropriate use of anesthesia and analgesia; 3) researchers adhere to approved procedures; and 4) all personnel working with animals are adequately trained and qualified. Yet, the NIH has taken no against this institution; its federal research funding, totaling over $290 million annually, continues uninterrupted.

Between 1995 and 2000, the IACUC at The Coulston Foundation was found by the USDA and by the Association for Assessment and Accreditation of Laboratory Animal Care International to be even worse. Yet the NIH only belatedly disqualified the lab from receipt of federal research funds in June 2001, years after the foundation was first documented to be violating animal welfare laws. Prior to June 2001, the NIH had given the foundation in excess of $20 million, including $3.1 million in "supplemental awards" granted solely as a public bailout of this failing private corporation. During that time period, the foundation's IACUC was basically non-functioning and the lab continually violated the Animal Welfare Act.

Conclusion

Although research institutions are quick to claim that they adhere to numerous federal laws protecting animals in laboratories, in reality, oversight of animal research is minimal. A policy of institutional self-regulation ensures that research institutions go virtually unchecked in terms of animal welfare violations. The only exception to this rule has been when whistleblowers have courageously come forward to expose wrongdoing. In many cases, however, animal welfare whistleblowers have suffered severe retaliation for their actions. Unfortunately, although Congress stressed the importance of whistleblowers in upholding laws to protect laboratory animals, the Animal Welfare Act offers only weak and unenforceable protections for individuals who expose wrongdoing.