6/1/09

Secretary Vilsack, Dr. Gibbens, Dr. Goldentyer,

I am writing to you today regarding a matter of the utmost importance, the unnecessary duplication of experimentation on animals.

The Animal Welfare Act makes several statements regarding the duplication of research using animals, including:

“(3) measures which eliminate or minimize the unnecessary duplication of experiments on animals can result in more productive use of Federal funds;”

and

“The Secretary shall establish an information service at the National Agricultural Library. Such service shall, in cooperation with the National Library of Medicine, provide information--

(1) pertinent to employee training;

(2) which could prevent unintended duplication of animal Experimentation”

It is clear from these statements that it was the intent of Congress that the unnecessary duplication of experimentation on animals should be prevented. There can be no justification for performing unnecessary experimentation. The unnecessary duplication of experimentation wastes large amounts of federal funding, which potentially deprive other more worthy projects of funding. Additionally, unnecessary projects take the lives of animals without purpose. The only accomplishments of redundant experimentation are the wanton destruction of animal lives and lining the pockets of greedy “scientists” and laboratories.

The only regulations which have been promulgated by the USDA to address the issue of duplication are:

and

It is clear from both the text of the Animal Welfare Act and the regulations which have been promulgated by the Secretary of Agriculture that the intent of Congress was to prevent the performance of experimentation beyond a point which is deemed necessary.

However, if we are to look at this issue in any intelligent fashion, we must critically examine the methods that have been established to prevent unnecessarily duplicative experimentation. The totality of the responsibility for the prevention of experimental duplication rests with the principal investigator and the Institutional Animal Care & Use Committee of the research facility in question.

Animal experimentation has become big business in the United States. It has been estimated that over $12 billion in federal funding is annually spent on animal experimentation by the National Institutes of Health. This funding provides a substantial part of the research budget of many research institutions across the United States. In fact, SAEN investigations have approximated that over 30 U.S. research facilities receive over $100 million in federal funding per year. Clearly, these facilities have a substantial vested interest in making certain that animal experimentation receives the fullest possible funding. The Institutional Animal Care & Use Committees are typically comprised almost entirely of employees of the research facility. And so the employees of these facilities have a very substantial interest in insuring the continuation and even the expansion of animal research. This interest runs in direct contradiction to the elimination of unnecessarily duplicative research.

Similarly, individual researchers have a vested interest in insuring the continuation of the funding of their own research grants. Every grant has a substantial portion of the funding assigned to salaries which include the principal investigator who most often receives the largest single portion of the salary component of the grant. Additionally, the ‘publish or perish’ mentality of the scientific arena has been well documented. Publication of research in medical journals is often linked to prestige and tenure at many universities. It is clear that individual researchers have a substantial vested interest in insuring the continued funding of their research grants both in financial terms and in terms of maintaining their ability to continue publishing a constant stream of journal articles.

The result of these combined interests is that both the Institutional Animal Care & Use Committees and the Principal Investigators have a vested interest in making very certain that research projects both receive funding and that these projects also continue to be funded ad infinitum. They have no real motivation to insure that a research project is not redundant or to cancel a project that is in fact redundant. Therefore, the regulations which have been instituted by past Secretaries of Agriculture have been totally ineffective, and have accomplished nothing more than giving the research industry the appearance of legitimacy.

To illustrate this situation SAEN has examined a group of grants that is currently funded by the National Eye Institute for redundancy. 57 projects were evaluated using a set of six different criteria, which constitute the basis for calculating a Redundancy Index. The area of research involves monitoring the functioning of the visual centers of the brain in non-human primates.

All 57 of these grants use macaque monkeys, this constitutes the first criteria, that these projects use the same species of animals, and are therefore assigned 1 point in the redundancy index. The other areas examined involve experimental procedures including the use of surgically implanted restraint bars, surgically implanted recording cylinders, surgically implanted scleral coils, restraint chair confinement, and the use of food and/or water deprivation as a motivational tool. Each project was assigned a point for each of these experimental procedures that was utilized. The points are then totaled and the total comprises the Redundancy index assigned to each project. The indices ranged from 2 (utilization of only the same species and one of the experimental procedures) to 6 (utilization of the same species of primate and all 5 of the experimental procedures). One project had an index of 2 and two projects had an index of 4. 24 projects had an index of 5 and 25 projects had an index of six The average duplication index is 5.4.

It is quite clear that a high level of redundancy exists in these experiments. They use the same species of animals, investigate the same processes in the brain, use the same procedures and are funded by the same part of the National Institutes of Health. It is then clear that these projects are duplicative of each other.

Are these grants duplicative of themselves? In other words, is virtually identical research being conducted by the same researchers year after year unnecessarily redundant? These researches have been studying the same processes in the same species of animals using the same procedures for many years. The average age of these grants is 9.23 years. Statistically, these grants seem to cluster in two areas. 28 grants are 5 years of age or less. So, while it can be said that these grants are redundant with other projects, it may not be possible to say that they are internally redundant. However, 19 grants are 11 years of age or more, with at least 8 being over 21 years of age. If a researcher has studied the same area of investigation, using the same species of animal and the same experimental procedures for over two decades, it would be essentially impossible to argue that this research is not internally redundant.

Several things have become patently obvious from this statistical examination of these grants. First, the 50 researchers who received these 55 grants are all performing research that is externally redundant, meaning that the projects are duplicative of each other. Many of them are also performing research that is internally redundant, meaning that they are simply performing the same experiment over and over with, at best, minute changes.

Several conclusions must be drawn from this information.

3. Fifty researchers have filed fraudulent statements of assurance regarding redundancy. This is a clear violation of the Animal Welfare Act.

2. The Institutional Animal Care & Use Committees of the 26 relevant laboratories have not fulfilled their function as required in the previously quoted sections of the Animal Welfare Act and have allowed, if not encouraged, “unnecessarily redundant” experimentation to be performed.

3. The regulation, quoted above, which required the filing of an assurance by principal investigators to avoid the performance of unnecessarily redundant experimentation has not been effective and has not been enforced in any meaningful way by USDA/APHIS/AC.

Therefore, I officially request that USDA/APHIS/AC institute an investigation of the research facilities named in the attached file and below and the researchers whose projects are named here and in the attached table.

I also officially request, under the Federal Freedom of Information Act, 5 U.S.C. sec. 552, copies of all documents generated during this investigation.

I also request that the Secretary of Agriculture immediately institute an Inspector General’s audit of the USDA/APHIS/AC enforcement of the Animal Welfare Act regarding the issue of the prevention of the performance of redundant experimentation, and that this audit not only examine the enforcement of these regulations, but also submit suggestions for more effective regulations for this area of enforcement.

Sincerely,

Michael A. Budkie, A.H.T.,
Executive Director, SAEN