TESTIMONY OF STEVEN L. LEARY, D.V.M.

PRESENTING ON BEHALF OF

THE NATIONAL ASSOCIATION FOR BIOMEDICAL RESEARCH

BEFORE THE

HOUSE COMMITTEE ON AGRICUTLURE

SUBCOMMITTEE ON LIVESTOCK, DAIRY AND POULTRY

May 8, 2007

Mr. Chairman and members of the Subcommittee,

Thank you for allowing me to testify today and for conducting this
hearing on animal welfare. I am Dr. Steven L. Leary, Assistant Vice
Chancellor for Veterinary Affairs at Washington University. I am
testifying today on behalf of the National Association for Biomedical
Research (NABR). NABR is the only national, nonprofit organization
dedicated solely to advocating sound public policy that recognizes the
vital role of humane animal use in biomedical research, higher education
and product safety testing. Founded in 1979, NABR provides the unified
voice for the scientific community on legislative and regulatory matters
affecting laboratory animal research. NABR's membership is comprised of
more than 300 public and private universities, medical and veterinary
schools, teaching hospitals, voluntary health agencies, professional
societies, pharmaceutical and biotechnology companies, and other animal
research-related firms.

Animal research has played a vital role in virtually every major medical
advance of the last century -- for both human and animal health. From
antibiotics to blood transfusions, from dialysis to organ
transplantation, from vaccinations to chemotherapy, bypass surgery and
joint replacement, practically every present-day protocol for the
prevention, treatment, cure and control of disease, pain and suffering
is based on knowledge attained through research with animals. Ample
proof of the success of animal research can be found in the vast body of
Nobel Prize winning work in physiology and medicine. Seven out of the
last 10 Nobel Prizes in medicine and 68 awarded since 1901 have relied,
at least in part, on animal research.

**Thanks to animal research**

Thanks to animal research, many diseases that once killed millions of
people every year are either treatable or have been eradicated
altogether. Immunizations against polio, diphtheria, mumps, rubella and
hepatitis save countless lives and the survival rates from many major
diseases, such as cancer and AIDS, are at an all time high thanks to the
discovery of new drugs, medical devices and surgical procedures.
According to the American Cancer Society, the "War on Cancer" has seen
24 significant biomedical advances made in the past 30 years. None of
them could have occurred without animal research. Eight of the
discoveries required the use of living animals and virtually all of
those that did not use animals relied on information gained from earlier
animal studies. Six of the discoveries were recognized with a Nobel
Prize, among them: the bone marrow transplantation technique (E. Donnall
Thomas, M.D.); cloning of the first gene (Paul Berg, Ph.D.) and
discovery of proto-oncogenes in normal DNA showing that a normal cell
could have latent cancer genes (J. Michael Bishop, M.D. and Harold
Varmus, M.D.).

Animal research for animal health has also resulted in many remarkable
life-saving and life-extending treatments for cats, dogs, farm animals,
wildlife and endangered species. Pacemakers, artificial joints, organ
transplants, decreased arthritic pain and vaccines for rabies,
distemper, parvo virus, infectious hepatitis, anthrax, tetanus and
feline leukemia contribute to longer, happier and healthier lives for
animals. New treatments for glaucoma, heart disease, cancer and hip
dysplasia can save, extend or enhance the life of a beloved pet and
exciting new reproductive techniques are helping to preserve and protect
threatened species.

**The public understands the need for animal research**

Key findings from a recent national public opinion survey on animal
research found overwhelming support of animal research. In fact, 81%
agree with medical and scientific research using laboratory animals if
they believe it will help alleviate suffering from a serious disease.

**Animal research is a requirement**

Research on animals is in many cases an obligation that prevents humans
from being used as medical "guinea pigs." According to the Nuremburg
Code, drawn up after World War II as a result of Nazi atrocities, any
research on humans \"should be designed and based on the results of
animal experimentation.\" The Declaration of Helsinki, adopted in 1964
by the 18th World Medical Assembly and revised in 1975, also states that
medical research on human subjects \"should be based on adequately
performed laboratory and animal experimentation.\" As well, the Food and
Drug Administration expressly requires that laboratory animal tests be
conducted both for prescription drugs and over-the-counter drugs before
these products can be tested further in humans.

**The regulations are thorough and effective**\
Responsible regulation is a very important component of oversight to
instill public confidence in animal research. Congress already has
provided the mechanism for the assurances of proper care and treatment
of laboratory animals with the 1966 enactment of the Animal Welfare Act.
Over time and multiple subsequent amendments, Congress has expanded and
refined the regulatory framework of the Act based on both public demand
and continued advances in laboratory animal medicine. For example, the
1985 amendments to the Animal Welfare Act required the establishment of
the Institutional Animal Care and Use Committee (IACUC) which is
required in every registered research facility. Some of the highlights
of these sweeping amendments strengthened standards of animal care by
requiring training for personnel, expanded requirements to promote
psychological well-being of non-human primates and exercise for dogs.
They also created a national information service, the USDA's Animal
Welfare Information Center, which provides information on best practices
in laboratory animal research. Every research facility in the country
receives at least one unannounced USDA inspection annually.

Although the USDA is the federal agency charged with enforcement of the
Animal Welfare Act, other federal agencies also play an important role
in oversight of animal research. In fact, any research institution
working with or receiving funds from the National Institutes of Health
(NIH), the Food and Drug Administration (FDA), or the Centers for
Disease Control and Prevention (CDC) must comply with the Public Health
Service (PHS) Policy on Humane Care and Use of Laboratory Animals, when
using live vertebrate animals. The IACUC, which is taken very seriously
by each research institution, is an internal committee that is charged
with reviewing, approving, and monitoring research protocols. An IACUC
is comprised of a minimum of five members consisting of a veterinarian,
a practicing scientist using animals, a non-scientist, an individual not
affiliated with the institution, and other individuals as designated by
the institution. IACUC approval for a proposed research project must be
acquired before any government funds can be secured. IACUCs require a
major commitment from those who serve, but they have proved to be very
effective in acting as a safeguard to insure that the research proposed
is meritorious, uses the fewest number of animals to obtain
statistically sound research results and the lowest species possible to
answer the research question being asked.

**Efforts to ensure animal welfare go beyond the regulations**

Many institutions have gone above and beyond what is required of them by
the law. Ninety-nine of the top 100 NIH awardee institutions, all US and
many international locations of all PhRMA members, all large and most
medium-sized biotech companies, all NIH, DOD and VA intramural research
programs, have voluntarily sought accreditation with the Association for
Assessment and Accreditation of Laboratory Animal Care International
(AAALAC International). In order to receive AAALAC accreditation,
institutions must follow thorough guidelines set forth by the "*Guide
for the Care and Use of Laboratory Animals*" published by the National
Research Council. Many institutions also voluntarily seek training
certification from the American Association for Laboratory Animal
Science (AALAS) for laboratory animal care staff to ensure the proper
handling and care of animals in research. Good care of laboratory
animals is not only a moral and ethical responsibility but is essential
for valid results. An unsanitary lab, poor diet or stressed animals all
hinder the scientific process.

In addition, a number of non-animal procedures and tests have been
developed to supplement animal research. Computer modeling, in vitro
testing, genetic research, and post marketing drug surveillance all
serve as valuable adjuncts to basic animal research. As part of the
evolution of scientific research and an increased understanding of the
complex biology of the vertebrate animal, new techniques are developed
and validated. But there still is no replacement for animal research.
Researchers do place a high priority on "The Three Rs" -- reduction,
replacement and refinement. Here in the US, our research communities are
committed to supporting techniques that: reduce the number of animals
used, replace animals with other models wherever possible, and refine
tests to ensure the most humane conditions possible.

**Conclusion**

We are all challenged with that delicate balance of insuring the public
trust and the highest standard of care for laboratory animals with a
regulatory mandate that still allows the freedom of inquiry so important
to medical discovery. We who are directly involved with animal research
share this challenge and concern. In fact, it is that very concern which
has drawn many of us to choose careers in veterinary medicine or medical
research. We, too, have family members who contract diseases. We, too,
have pets that become ill. For these reasons, we are dedicated to
finding ways to cure both human and animal ailments. In the words of the
esteemed Dr. Michael E. DeBakey, chancellor emeritus of the Baylor
College of Medicine and Director of the DeBakey Heart Center: "These
scientists, veterinarians, physicians, surgeons and others who do
research in animal labs are as much concerned about the care of the
animals as anyone can be. Their respect for the dignity of life and
compassion for the sick and disabled, in fact, is what motivated them to
search for ways of relieving the pain and suffering caused by diseases."

Thank you, Mr. Chairman and members of the Subcommittee, for the
opportunity to testify before you today. I look forward to answering any
questions you may have.