News of the Week National Aeronautics & Space Administration's upper atmosphere research program, told a joint hearing 3f two subcommittees of the House Committee on Science, Space, & Technology. Watson, like the other witnesses at the hearing, attended the meeting in London. However, said Eileen B. Claussen, director of the Environmental Protection Agency's atmospheric and indoor air programs, "There is no question we need HCFCs as transitional substances" to move users away from CFCs until even better alternatives are developed. The U.S. argued in London for an amendment to phase out use of HCFCs in new equipment between 2020 and 2040, and to ban their use in servicing existing equipment between 2035 and 2060. Only a handful of the 59 nations supported such restrictions. Instead, they voted for a rionbinding resolution that recommends a voluntary phaseout no later than 2040. Environmental groups are pushing for even stronger limits. "By not including a binding HCFC phaseout among the protocol amendments, governments have given industry a jjreen light to develop and use a whole new generation of ozone destroyers," said Liz Cook, ozone campaign director for Friends of the Earth. That organization advocates an immediate ban on HCFCs in aerosols, and a phaseout for use in new equipment by 2005 and existing equipment by 2010. Cook is now working to see that Congress keeps HCFC restrictions in the Clean Air Act, the huge bill now in conference. The Senate version bias tougher limits, which would freeze HCFC production in 2015 and phase it out totally by 2030. Du Pont, the largest U.S. CFC producer, s u p p o r t e d the limits on HCFCs that the U.S. proposed in London—despite the company's $240 million investment in developing alternatives. "We realize they must be phased out sometime," A. Dwight Bedsole, business manager D£ D U Pont's Freon Products Division, tells C&EN. "At this time, however, there just are not any other suitable alternatives." However, the company thinks any regulatory scheme should set a HCFC ban far 5 July 16, 1990 C&EN
enough in the future to allow business time to recoup its investments—and the dates proposed in the clean air legislation are too short for that. Pamela Zurer
California court rules onrightsto human cells In a decision with important implications for the U.S. biotechnology industry, the California Supreme Court ruled last week that patients do not own cells or tissue removed from them during medical procedures, and thus have no right to share in profits from commercial use of those materials. In order that a patient be fully informed before consenting to a medical procedure, the court went on to rule that a physician has a "fiduciary duty" to inform a patient of any "research and economic interests" that may affect the physician's judgment in recommending a particular course of treatment. The court said that if a patient objects to a physician's profiting from use of the patient's tissue, that patient can "look elsewhere for medical treatment." It appeared to rule out the possibility of a person's negotiating for a share of the proceeds from commercial products developed from that individual's cells. The ruling stems from a lawsuit in which a leukemia patient, John Moore, sued his physician, David W. Golde of the University of California, Los Angeles, Medical Center, plus another UCLA researcher, the University of California, and two b i o t e c h n o l o g y companies. He charged them with using his spleen cells to develop a cell line that produces lymphokines, including granulocyte/macrophage colony stimulating factor (GM-CSF), which has a number of promising medical applications. He claimed that they illegally "converted" his property—his spleen cells—for their use without compensating him. Moore entered the UCLA Medical Center in 1976 suffering from hairy cell leukemia, and on Golde's advice, his spleen was removed. Using Moore's cells, Golde and coworkers
established a cell line that overproduces GM-CSF. The University of California filed for a patent on the cell line Golde developed in 1981. The patent issued in 1984. Golde negotiated an agreement with Genetics Institute, Cambridge, Mass., for commercial development of the cell line and products to be derived from it in which he became a paid consultant to the company and received 75,000 shares of Genetics Institute stock. Moore claims in his lawsuit that Golde determined prior to the operation that Moore's T lymphocytes overexpressed GM-CSF. He also claims that he never gave permission to use his cells for medical research. He maintains that he should share in profits made on drugs developed from the cell line derived from his cells. Golde maintains that Moore's spleen was removed for purely medical purposes, and that in keeping with standard procedure, the pathologist retained a sample of the diseased spleen before disposing of it. His study of Moore's spleen was part of ongoing research on leukemia. "This is the appropriate way to obtain surgical pathology tissue for study, and such tissue is exempted from separate informed consent because no human subject is at risk," Golde says. Moore s h o u l d h a v e b e e n informed of Golde's research activities, the court ruled. Moore can continue his suit against Golde for failure to obtain his informed consent, but it appears that it will be difficult for him to collect damages. In specifically refusing by a fiveto-two vote to extend the legal concept of "conversion" to a person's cells and tissue, the court argued that "problems in this area are better suited to legislative resolution." Noting that thousands of human cell lines have been developed from tissue obtained from patients and that these cell lines have been central to the development of the biot e c h n o l o g y i n d u s t r y , t h e court wrote that "the theory of liability that Moore urges us to endorse threatens to destroy the economic incentive to conduct important medical research." Rudy Baum
