U.S. Department of Energy Genomic Science program AFMA welcomes opportunities to participate in events that involve the scientific issues surrounding animal use in science, biomedical research, and testing. As an educational organization, we look forward to sharing current science regarding the scientific value of using animals in science and as predictive models for human drug and disease response. Dr. Ray Greek is currently available for lectures, debates, and other presentations. Because we focus on areas of science, we usually decline to participate in animal rights protests, lectures outside of a classroom-type environment, and similar events. Because the science we discuss cannot be explained in a sound bite, we usually require a one to three-hour time slot in order to adequately communicate our message. If your event does not allow this kind of time commitment, we understand but will be unable to participate. We are also pleased to speak at universities, industry groups, medical associations, trade organizations, and other institutions that have an interest in exploring the topic. We have participated in numerous debates in the past but now believe that the science is too complicated to communicate to lay audiences in a debate format. Why Science is Important The use of animals in biomedical research and testing is based on the idea that results from drug and disease research obtained in one species have predictive value for another species. Dr Ray Greek, along with others has proven that what happens in an animal has no predictive value for what happens in humans. This should have vast consequences for several reasons. First, society has indicated it will not allow animals to be used in experiments unless they have predictive value for humans. Second, using animals for their alleged predictive value is in reality a waste of time and money as it contradicts current science. Third, it does not make sense to call for alternatives to animal modeling. Using the term alternative within this context – including today’s section title ‘Panel II: Alternative Methods’- is a category mistake. Animal models have never had predictive value for the responses of human patients to drugs and disease, so it is dangerously misleading to treat them as belonging to the same order as genuine, valid human-based research. Indeed, the main reason animals are used in drug development and research has been acknowledged as a failure by the pharmaceutical industry and other scientists. We do need alternatives to some uses of animals such as when a heart valve from a pig is used as a replacement for a human valve. But not for the research and testing in which the vast majority of animals are currently used. Fourth, the results from using animals are now known to harm and kill humans. Thus there is no reason to continue to try to justify their use with myths about protecting humans in clinical trials or learning about human disease. And Fifth, funding that currently pays for animal modeling needs to be redirected to human-based methods. These are not alternatives to animal models as they are viable research and testing methods and have a proven track record of success. To date none of the above consequences have been acknowledged except by select scientists. Society as a whole needs to have the predictive value of animal models evaluated by unbiased, expert scientists. Before having a political or philosophical discussion about any science-related topic, we should make sure the science undergirding it is sound. How to Evaluate Scientific Arguments Science is a process which includes experts in specific areas evaluating the work of others and determining whether the research and conclusions of that research are reliable. The best example of this is the peer-review process of scientific journals. A number of experts are asked to review a submission to the journal and determine the following. whether the submission is in accordance with known facts about our current scientific understanding whether the terms and assumptions are consistent with proper usage whether the methodology is appropriate whether the statistics were correctly done whether or not there are other flaws in the reasoning process of the authors This process is not foolproof but under the appropriate circumstances it is usually capable of separating fact from fiction. Depending on the contents of the submission, experts from several different areas of science might be asked to review the submission and judge the part of the submission that falls under his or her area of expertise. This process should be employed in order to determine the scientific viability of using one species to predict responses for another. The most important question that needs to be answered is whether animals have a high predictive value in terms of modeling human response to drugs and disease. We want to utilize the process used in peer-reviewed science journals and implement it in a debate format to resolve the scientific issues surrounding the use of animal models. We have published enough articles in the scientific literature that reasonable scientists, with enough education in the various aspects of trans-species modeling theory, should now realize that animal models will never have predictive value for human response to drugs and disease. But very few scientists are reading these articles. There are currently so many science publications that even scientists interested in the animal model issue cannot possible read all the relevant articles. It could take decades for scientists to actually read our articles and even longer for them to act on this information since there are so many vested interest groups supporting the status quo. Even self-proclaimed animal defenders fail to appreciate the current science our position is based on. A debate, sponsored by a government and with implications for legislation and future funding would force the animal model community to present their justifications for animal modeling. Engaging in debates at universities accomplishes nothing as the audience does not understand the science and reasonable scientists are always left in doubt, as they maintain that there must be more to the story as the meager arguments offered by animal modelers were so easily defeated by Dr Ray Greek. Rules for a Debate In order for our position to be judged fairly by expert scientists, we need to the following rules for the debate. 1. The subject of the debate will be Resolved: The fact that animal models have no predictive value for human response to perturbations that occur at higher levels of organization, for example, human response to drugs and disease, means that the vast majority of animal use in science in general and research and testing in particular should cease. 2. A single person or group of three will be appointed to moderate and organize the debate 3. The debate will consist of submitted position papers and a short public portion where the sides will briefly explain their position and the experts will render their judgement. 4. A panel of scientists who are experts in the relative fields will act as judges. These may come from academia or industry and will judge the position papers. 5. The experts should include scientists from the following fields. Clinical medicine in general, as well as infectious diseases, cancer, heart diseases, and neurology. At least one should also come from the math or physics department of a university and have expertise in complexity theory. At least one should come from the philosophy of science division and have expertise in critical thinking, the history of the science behind medical discoveries (not the zeitgeist of society at the time the discovery was being made), and philosophy of science in general. At least one who is an expert in statistics evolutionary biology including evolutionary developmental biology clinical research in drug development personalized medicine basic research 6. These scientists should be recognized as experts by society as well as the scientific community. Further, they should have no vested interests in the outcome of the debate. A vested interest would include situations such as the following. A direct financial interest in the outcome of the debate such as currently receiving money for animal-based research. An indirect financial interest in the form of currently or formerly working for a university or company that receives funding for animal-based research or testing. An indirect vested interest such as having at least in part established one’s reputation because of research using animals. An indirect financial interest in the form of having a friend or relative who currently or formerly works for a university or company that receives funding for animal-based research or testing. A philosophical or emotional interest in the use of animals in research and testing such as well-known figures from the animal protection movement or pro-vivisection/pro animal-use movement. Other situations may be addressed individually. 7. A position paper, complete with references, will be presented to the experts/judges by each side. The experts/judges are expected to be read the papers and judge the validity of each sides’ position based on these papers. They are also expected to verify (in each judge’s area of expertise) and understand the following That the references state or imply what the presenter is claiming. That the arguments and reasoning used in the position paper are sound and valid. The final, corrected version of the position paper would then function as the presenter’s official position and the presenter must adhere to the facts in the paper during his portion of the public debate. Allusions, by the presenter, to areas outside the topic of his position paper would not be allowed in the public portion of the debate. 8. The timeline for the debate will be as follows. Speakers and writers for each side, experts, and moderator will be confirmed by a specified date. The position papers must be given to the moderator and experts three months later. Six months later a meeting with all parties will take place in order to discuss what materials presented in the position papers are unacceptable. Revision of the position papers will be submitted one month later. Notifications of material unsuited for inclusion in final position paper will be made one months later and the final position paper will be due one month after. A rebuttal paper, if the sides want to submit one, must be submitted within three months and the rebuttal papers vetted by experts three months later and the final version of rebuttal papers are due one month later. The public portion of the debate will happen one month later. 9. The first session of the public debate will feature the representatives presenting a summary of the position paper. 10. A second session will follow in which the experts/judges will comment on and judge the positions of the presenters. The judges are expected to point out errors of logic or errors of fact in their area of expertise as well as remark on whether the presenter proved his position and thus won the debate. Science has changed since animal modelers began using animals in earnest in the 19th century. But never before have experts examined the evidence for and against animal modeling. Such a debate judged by unbiased experts is long overdue. No one argues about funding scientists to invent a perpetual motion machine because science has proven that such a device cannot exist. Neither does anyone doubt that cell theory, germ theory, or the kinetic theory of gases is correct. In the final analysis, animal modeling is about science, fast-evolving science. Keeping our laws and law-makers up-to-date through communicating life-saving current knowledge is a moral imperative. Once so informed, the lawmakers will have a moral imperative to abandon animal models in favor of saving the lives of human patients. To request our participation in your next event, please contact AFMA at 805-685-6812. Please be aware that AFMA requires expenses and an honorarium (to AFMA) for presenting lectures or participating in debates.