Policy questions and some answers

WASHINGTON, DC—Scientists and policymakers discussed the most pressing issues facing the science and technology enterprise at this year's annual colloquium held by the American Association for the Advancement of Science (AAAS). The agenda included talks on intellectual property, research and development budget trends, visa restrictions, the ethics and lawfulness of cloning, and the establishment of the Department of Homeland Security (DHS). The National Institutes of Health (NIH) director Elias Zerhouni outlined the NIH vision, noting challenges ahead including an aging population, a shift from research on acute diseases to chronic diseases, biodefense, and emerging and reemerging diseases. Zerhouni suggested that we will not know the full extent of the fruits of the NIH's budget doubling for several years, but he noted some recent accomplishments: hormone therapy trials, the acceleration of integrating technology into biomedical science, and the initial identification by an NIH-funded Hong Kong lab of the coronavirus thought to cause SARS. Kei Koizumi, AAAS director of the Research and Development (R&D) Budget and Policy Program, gave a budget overview, noting the continued disparity between funding for life sciences versus physical sciences and mathematics. He also pointed out that record budget deficits, caused in part by costs associated with the war in Iraq, might have negative impacts on nondefense R&D funding in the coming years. Indeed, defense and security were central themes of the symposium. John H. Marburger, director of the White House Office of Science and Technology Policy, opened the symposium with a focus on visas. Security concerns and the resulting visa processing backlogs have already led to reduced conference attendance, disrupted laboratories, and missed classes for foreign students. The system has been completely flooded, particularly the Mantis program, which is a specialized clearance procedure for the review of visa applications of those engaging in activities with potential security-related concerns. The number of cases under consideration annually has gone from 1,000 in 2000 and 2,500 in 2001 to 14,000 in 2002. "It's like looking for needles in a haystack," said Marburger." The system is not set up to handle that level of information." John Crowley, vice president for federal relations at the Massachusetts Institute of Technology (MIT), cited problems at the recent World Space Congress in Houston, at which 100 scientists were absent because of visa delays. He noted that tensions between science and security are not new; the 1940s and the 1980s were also times of heightened fears and visa restrictions. For now, Marburger believes the solution lies with improved technical expertise, continued impact reporting from affected institutions, and a better understanding by all parties as to how the visa system works. Visa processing will be one task of the newly established DHS, as will overseeing a significant research program. The DHS will bring together about 170,000 federal employees, have a budget of $37 billion, and involve all or part of 22 federal agencies. William B. Bonvillian, legislative director to Senator Joseph I. Lieberman (D-Conn.), who has been instrumental in the creation of DHS, told the audience of scientists and policymakers that he foresees a research component that is small, lean, and "high-talent" and that has procurement flexibility and a "nonbureaucratic entrepreneur culture." The guiding question for the R&D challenge, he said, is, "How do we get the intra-government and -industry interaction we must have to obtain the innovation we need?" At a special luncheon, Charles A. McQueary, the newly appointed under secretary for Science and Technology at DHS, noted that the agency will include a Homeland Security Advanced Research Projects Agency (HSARPA) modeled after the Defense Advanced Research Projects Agency (DARPA), the central R&D arm for the Department of Defense (DoD). However, McQueary told The Scientist that the research on HSARPA's agenda generally will be more applied. As for a mechanism of cooperation between DHS and the Department of Health and Human Services (HHS), McQueary said he'd prefer an informal agreement and exchange among department leaders rather than a potentially cumbersome, formal, department-wide agreement. DHS secretary Tom Ridge and HHS secretary Tommy Thompson have already signed a memorandum of understanding. On the topic of intellectual property, participants discussed the promise and potential pitfalls of patents. Carl E. Gulbrandsen, managing director of the Wisconsin Alumni Research Fund (WARF), the patent purveyor for the University of Wisconsin, asked whether the Bayh-Dole Act has proven effective for the timely transfer of early-stage medical discoveries and information and research materials. WARF handled the patents from the development of human embryonic stem cells, findings first reported by University of Wisconsin researcher James Thomson. Although Geron Corporation has rights to some cell-line lineages, WARF holds broad patents. Gulbrandsen suggested that without the technology transfer power of Bayh-Dole, Geron could have garnered more patents, possibly making associated research materials less available to the research community. Panelists generally agreed that the patent-making power encouraged by the Bayh-Dole Act has been a boon for universities and the scientific research enterprise. But speakers did suggest that patents might present obstacles to research progress. Studies by Marie Thursby, director of the Technology and Innovation program at the Georgia Institute of Technology's Dupree College of Management, found that the flow of knowledge has been restricted in some cases because of patent protection and worries about infringement. She continues to investigate whether researchers are actually changing the direction of their agendas because of the increasing value placed on intellectual property by both scientists and university administrators. Mildred Cho, codirector of the Center for Biomedical Ethics at Stanford University, presented findings suggesting that scientists' fear of infringing on patents may have a negative impact on genetic test access, cost, and quality. Cho's work included a survey of 132 of the 211 laboratory directors in the United States working on the development of genetic tests. Genetic tests were also the focus of part of a symposium session on bioethics. Kathy Hudson, director of the Genetics and Public Policy Center at the Johns Hopkins University, presented evidence that the most widely used genetic test thus far, which is for cystic fibrosis, has been a failure in many cases because of misinterpretation of test results. This "flunking of the genetic test," as she termed it, has led to misleading diagnoses and poor advice for prospective parents. The cloning debate was also rehashed in the bioethics session. Eric Cohen, a research scholar for the President's Council on Bioethics, criticized supporters of "so-called therapeutic cloning" for continually changing terminology to bolster their cause. He argued that religious arguments should not be dismissed out of hand, that some scientists have created false hopes for stem-cell--based miracle cures, and that therapeutic cloning cannot be separated from reproductive cloning. Alta Charo, a bioethicist and law professor from the University of Wisconsin, strongly disagreed, suggesting that the misuse of the technology and not the technology itself should be regulated. She argued that research cloning can be pursued on its own terms apart from reproductive cloning and that restricting the research may actually violate the First Amendment rights of researchers since conduct can be considered an expression of belief.

Policy questions and some answers

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