TESTIMONY OF STEVEN L. LEARY, D.V.M.NABR, like essentially every special interest group focussed on maintaining the flow of public funds into private coffers, makes false claims intended to sway uninformed lawmakers. They commonly present false or erroneous claims under the guise of historical fact or current regulatory reality.
PRESENTING ON BEHALF OF
THE NATIONAL ASSOCIATION FOR BIOMEDICAL RESEARCH
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.
Even Dr. Leary's claim regarding the uniquness of NABR spins the facts. (See for instance Americans for Medical Progress.)
Let's look at his proclaimed facts in no particular order:
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 ...In fact, the Animal Welfare Act is quite clear:
Definition - Committee: means the Institutional Animal Care and Use Committee (IACUC) established under section 13(b) of the Act. It shall consist of at least three members...Given that the IACUC is the keystone of the Act, the fact that Dr. Leary is wrong about this very basic fact should make us wonder whether he has gotten other basic things wrong.
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...In fact, the only serious evaluation of the IACUC system has found exactly the opposite. The current definitive evaluation of the IACUC system is Plous S, Herzog H. Animal research. Reliability of protocol reviews for animal research. Science. 2001 Jul 27;293(5530):608-9, excerpted here:
Over the past 20 years, the reliability of scientific peer-review judgments has been a topic of frequent debate and scrutiny. However, one area of peer review that has not received much empirical investigation is the system that protects animal subjects from research risks. At most research institutions, studies involving animal subjects must be approved by an Institutional Animal Care and Use Committee (IACUC)....Dr. Leary:
...[W]e conducted a study of randomly selected IACUCs from U.S. universities and colleges. Seventy committees were drawn from a master list of 916 IACUCs maintained by the U.S. Office for Protection from Research Risks. Of these 70, 50 agreed to participate in the study. Thirty-four IACUCs came from research or doctoral universities, seven came from master's colleges or universities, six came from specialized institutions (e.g., medical colleges), and three came from liberal arts colleges. In all, 494 of 566 voting members (151 females and 343 males), or 87% of those approached, took part in the study.
Each IACUC was asked to submit its three most recently reviewed protocols involving animal behavior, including the committee's decision on whether to approve the research in question. All information identifying the investigator or institution was then removed from the protocols, and each protocol was randomly assigned to be reviewed a second time by another participating IACUC. Voting members of the second committee were sent packets containing three masked protocols with a request to review the protocols and to send us a completed evaluation anonymously in a prepaid envelope.
Once we received reviews from individual committee members, the IACUCs were asked to meet as a group and render a final evaluation for each of the three protocols. Committees were asked to follow their standard operating procedures and to discuss the protocols as they would any other research proposal.
Protocol evaluations from the originating committee and from the second committee were not significantly related to one another…. This absence of a relation was found not only across the full set of 150 protocols, but for relatively invasive research involving procedures such as electric shock, food or water deprivation, surgery, and drug or alcohol research...; for protocols involving euthanasia...; and for protocols in which the reviewing IACUC expected animals to experience a significant amount of pain.... Thus, regardless of whether the research involved terminal or painful procedures, IACUC protocol reviews did not exceed chance levels of intercommittee agreement....
Of the 118 instances in which the two committees differed in their protocol reviews (79% of all reviews), the second committee was more negative than the first 101 times. Indeed, the second committee rarely rated all dimensions of a protocol favorably.... For example, only 43% of protocols were seen as having a fairly or completely convincing justification for the type and number of animals used (a requirement of the Animal Welfare Act), and only 45% were rated as having good or excellent research designs and procedures. All told, 61% of protocols were judged as either "not very understandable" or "not understandable at all," as having "poor" research designs and procedures, or as justifying the type and number of animals in a way that was deemed "not very convincing" or "not convincing at all." ...
Every research facility in the country receives at least one unannounced USDA inspection annually.That's true, but his implied message, that these inspections are meaningful, is contrary to the USDA's own Inspector General's findings:
Audit ReportWhether intentionally or out of ignorance, NABR's offical spokesperson, Dr. Steven L. Leary, misled the House Committee on easily verifiable facts such as the regulatory requirements for the makeup of Instituational Animal Care and Use Committees (IACUCs) and the effectiveness of both the IACUC system and the USDA animal research laboratory inspection system.
APHIS Animal Care Program
Inspection and Enforcement Activities
Report No. 33002-3-SF
In monitoring research facilities, some VMOs did not verify the number of animals used in medical research, adequately sample the facilities’ protocols, or review other available records. This occurred because the inspection manual is too general, and the VMOs relied on the facilities to provide accurate and pertinent records. As a result, APHIS is misinformed on the number of regulated animals used in research, and has less assurance that protocols are properly completed, approved, and adhered to for the purpose of ensuring the health and safety of the animals.(pg 13)
Maybe it's unfair of me to expect an Assistant Vice Chancellor for Veterinary Affairs at a major research university who is acting as an NABR spokesperson to be reasonably informed. But given the clear fact that he isn't, it is not surprising that his speculations are also based on something other than evidence.
Animal research has played a vital role in virtually every major medical advance of the last century...(Sing Hallelujah!)
What evidence would be sufficient to debunk such a claim? When Leary says, "virtually" does he mean some, most, a few? How many examples contradicting his claim would be sufficient? I won't launch into a rebuttal of each of his silly claims here; I urge readers to visit the Americans For Medical Advancement website and peruse some of the very many articles there written by scientists and medical doctors who question the absurdity of claims like Leary's.