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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 1 The Scientific Tradition of Sharing Resources “The free exchange of strains and reagents is a prerequisite, was a prerequisite, and will continue to be a prerequisite for the continued growth of biomedical science.”–Gerald Fink The sharing of laboratory resources–such as phage, bacteria, Drosophila, yeast and nematode strains–has long been common among scientists studying the genetics of organisms. It provides two essential ingredients for the proper functioning of the scientific method: an opportunity for scientists to continue to develop a line of research and a means for other researchers to verify the results of a scientist who has published a paper based on the use of a biological strain. It is also a demonstration of generosity among professional colleagues. For some scientists, the obligation to share is especially strong when the recipient is a younger investigator struggling to become established. Scientists traditionally have obtained organisms, such as bacteria and yeast, simply by requesting them from other researchers. This method typically involves no payment for the strains. Fleming gave the strain of Penicillium mold that he had discovered to fellow scientists. It found its way into the hands of Florey and Chain, who isolated penicillin and developed methods of mass production of the antibiotic. Similar practices continue today. For example, Gerald Fink's laboratory at the Massachusetts Institute of Technology honors 400-500 such requests each year for yeast (Saccaromyces cervisiae) and bacteria (plasmid-bearing strains of Escherichia coli), and about 250 strains are received by his laboratory in response to his requests. He does not charge a fee to academic scientists for a strain but he asks that the recipient not redistribute the strain without his permission. He does charge scientists at commercial firms for the service. Culture-collection centers are a common source of strains of bacteria and viruses. Many strains are readily available because they are maintained and distributed for a nominal cost by culture-collection centers supported by federal grants and by the American Type Culture Collection. The tradition has also influenced the policies of institutions that fund research. It is ingrained in the guidelines of the National Institutes of Health
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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 (NIH), the predominant supporter of biomedical research. The NIH Guide for Grants and Contracts informs all would-be grantees that grant recipients are expected to publish the results of their research expeditiously and are expected to make newly developed resources, including such biological materials as mice, available to the research community. All intramural NIH investigators are guided by these principles as well. NIH has the authority to withhold funding from grantees or NIH scientists who repeatedly refuse to share resources without sufficient reason. As an example of voluntary health organizations, the Cystic Fibrosis Foundation strongly encourages investigators that it supports to share their resources with others. Although widespread, the tradition of sharing is not universal. In some cases, a “rule of relative difficulty” might prevail. An investigator who has expended great effort and time to isolate small quantities of an antibody or enzyme that is difficult to produce might not be as responsive to a request to share resources as would a microbiologist to share a test tube containing an easily replaced strain of a bacterium. Even the most generous scientist might be reluctant to share a resource with a competitor who would thus easily come into possession of a reagent or animal that had taken the originator years to move from concept to usable product. In some cases when a reagent has not been shared by a scientist, a company has stepped in and made it available to the community. Increased cost and competition, coupled with other recent events, appear to be challenging the tradition of sharing in some branches of biological research. One particularly valuable laboratory resource –genetically altered mice–constitutes an important case study in this regard. Genetically unique mice, rats, and other laboratory animals have long existed–products of standard cross-breeding techniques, spontaneous mutations, or mutations induced by chemicals or radiation. Traditionally, they have been freely disseminated by the same open routes as other resources. Many still are given by one scientist to another. Not-for-profit repositories of animal collections, such as the Jackson Laboratory, have also facilitated the exchange of animals. And animals have been available from commercial distributors at a cost that has not impeded biomedical research. That situation began to change with two events that occurred around 1980. The first was the development of techniques that incorporate foreign DNA sequences into the genome of mammalian germ cells to produce transgenic animals. Such animals express characteristics that are useful for the study of diseases, metabolic processes, and genetic control mechanisms. Later in the 1980s, techniques were developed to “knock out” genes–to change a gene sequence to eliminate its expression–and otherwise to produce mutations that are targeted to affect a specific gene. The techniques greatly increased the variety of genetically unique laboratory animals that scientists could produce.
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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 However, they require considerable time and resources, and the animals produced might be difficult to breed or recreate. The second event was the passage of the Bayh-Dole Act in 1980. This federal law urged agencies and their grantees to use the patent system to move discoveries from laboratories to commercial development. In molecular biology, rulings by the U.S. Patent Office encouraged that kind of technology transfer by permitting the protection first of a process for manipulating DNA sequences, next of a genetically modified bacterium, and then of a specific genetically altered mouse and a process for making genetically altered animals. The rulings contributed to the sudden emergence of a biotechnology industry built on the expectation of applications of discoveries from molecular-biology laboratories. Meanwhile, the scientific community was becoming increasingly concerned about the effects of budgetary stringency on the availability of federal research funds. Expectations began growing among scientists and their institutions that replacement money might be obtained by commercialization of the transgenic animals originating in their laboratories. The number of such animals, mainly mice, being developed in laboratories was growing dramatically as researchers increasingly recognized their enormous utility as a resource for biomedical research and perhaps for pharmaceutical purposes. The increased efforts at commercialization, the rapidly increasing variety of genetically altered mice, and the difficulty and expense of creating and storing them have led to growing concern that this research resource might not be made readily available to all researchers, because of licensing restrictions and logistical problems. Such issues, especially the tension between the scientific tradition of sharing resources and the modern pressure to commercialize, need to be viewed in the context of the history and tradition of university approaches to patents and licensing in the life sciences.
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SHARING LABORATORY RESOURCES: GENETICALLY ALTERED MICE: Summary of a Workshop Held at the National Academy of Sciences, March 23-24, 1993 This page in the original is blank.
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