US agreement clarifies the use of stem cells in research

MARYLAND – Access for US scientists to human embryonic stem cells appears to be improving thanks to an agreement negotiated earlier this month by the National Institutes of Health (NIH) and the WiCell Research Institute, Inc., Madison, Wisconsin — a non-profit organization established in October 1999 to advance research in the area of stem cells. The agreement sets out the terms under which researchers can obtain and use the five WiCell cell lines developed before 9 August 2001, which US President George W. Bush has said are ethically acceptable for federally funded research. The need for the agreement is demonstrated by the fact that WiCell is currently receiving 10 to 15 requests for the cell lines every day.The new agreement specifies that the cells can be used only for non-commercial research and teaching. But the NIH, not WiCell, will retain ownership of any new intellectual property arising from that research, and researchers may publish their results without restrictions. Transfer of the cells from WiCell to individual laboratories is accomplished with a 'Simple Letter of Agreement' that minimizes the administrative burden, according to NIH. Strictly speaking, the agreement applies only to researchers working at NIH, but, as part of the agreement, WiCell has said it would offer the cell lines to any academic institution or private nonprofit research group on the same terms, providing that the institutions sign a separate agreement.Announcing the agreement, HHS Secretary Tommy Thompson, head of the Department of Health and Human Services (DHHS), NIH's parent agency, called it "groundbreaking." He said that the terms were so favorable that he expected the document to serve as a model for other agreements on stem cell use. This looks likely, as WiCell has reported that requests are coming from laboratories all over the world.Scientific interest in stem cells from human embryos has been enormous since they were first developed in 1998. These cells are capable of differentiating into any type of cell or organ, and are expected to have broad applications in development treatments for a wide range of disorders, from Alzheimer's disease to spinal cord injuries. But the cells are ethically — and therefore politically — controversial, particularly in the US. Because they are derived from human embryo cells, they have drawn the ire of anti-abortion activists, who strongly oppose their use in research.The new agreement specifically forbids diagnostic or therapeutic uses for the cells — a bone of contention for some scientists. Prohibitions on using the cells for treatments would be "a damning condition," said Douglas Melton, Thomas Dudley Cabot Professor in the Natural Sciences at Harvard University, Boston. "Clearly, there's no point in doing the research I'm doing if there weren't the possibility of treating people," he told a Senate hearing on 5 September 2001, the day after the agreement was concluded. George Daley, another Harvard stem cell researcher, said: "What this basically is saying is that WiCell is going to disallow any federally funded researcher from developing a cell therapy." Andrew Cohn, of the Wisconsin Alumni Research Foundation (WARF), said it has heard no complaints from scientists about the limitations on diagnostic or therapeutic use. WARF — a nonprofit organization established to 'promote, encourage, and aid scientific investigation and research at the University of Wisconsin-Madison' — holds patents on discoveries made at the University of Wisconsin, including the stem cells. It has licensed WiCell to distribute the stem cell lines, which were created by James Thomson, a developmental biologist at the university."Just so people understand, the reason the cells can't be put into therapeutic applications is that they weren't made for that purpose. The liability of putting these into human beings would be absolutely astronomical. A lot of basic research needs to be done before we take that step," Cohn said.Safety concerns have been raised about all the embryonic stem cells because they are produced using mouse 'feeder' cells, which provide nourishment to the human stem cells. Federal rules prohibit using animal cells for human treatment in order to prevent transmission of animal diseases to patients.The limitations on diagnostic and therapeutic use of these cells in publicly funded labs may be prompted by financial as well as safety concerns, however. The agreement provides that WiCell retain commercial rights to the cell lines. It has granted an exclusive license to commercialize treatments based on six cell types to a private biotech company, Geron Corporation, Menlo Park, California. WARF and Geron are involved in a lawsuit over whether the company has the right to additional cell types under its license. Both said that the suit was unrelated to the NIH agreement. Carl Gulbrandsen, managing director of WARF, has said that Geron will probably be involved in discussions with researchers seeking to commercialize their stem cell discoveries. But the agreement with NIH eliminates a previous 'reach-through' requirement that gave WiCell first crack at turning any discovery into a product.Secretary Thompson told the Senate hearing that research on therapeutic uses of the cells should remain in private hands. The Bush decision to limit federally funded research to human embryonic cell lines already in existence on 9 August 2001 will "provide incentive for the private sector to get more involved," he argued. And once the basic research is conducted, the private sector likely will have great incentive to step in and transform this basic research into therapies."The NIH-WiCell agreement also allows researchers to work with stem cell lines developed in other labs, providing that the owners of the other cell line receive terms no easier than those WiCell negotiated for itself. WARF provoked controversy by claiming that its patent covers all human embryonic stem cells, no matter where they were produced. At least two other sources of stem cells dispute that claim on the grounds that their methodology is different from the one devised by Wisconsin's Thomson.The agreement appears to be smoothing the way for federally funded research on human embryonic stem cells after more than a year of delays and continued disputes over using human embryos for research. In the summer of 2000, NIH issued draft guidelines that attempted to deal with the ethical debate by proposing that federally funded researchers would be permitted to work with embryonic stem cells only if the cells had been derived by privately funded sources from "spare" human embryos. These spare embryos were those that would otherwise have been discarded from in vitro fertilization clinics.Had the Democrats retained the presidency, the guidelines would probably have been implemented, and the work funded earlier this year. Bush had opposed research with stem cells during the presidential campaign of 2000 and was widely expected to forbid their use. But after he became president, researchers and patient advocacy groups lobbied heavily, and the tenor of the debate changed. The Republicans sought ways of compromising without infuriating their anti-abortion backers unduly, and in August 2001 they found a way.Bush announced that he would allow federal funding for research with the cells provided no new embryos were destroyed to create them. The cell lines, he said, must be those already in existence on the day of the announcement. According to the NIH, 64 cell lines fall within these limits. The new et al agreement will now allow researchers to work with these cells.

US agreement clarifies the use of stem cells in research

Agreement enables basic stem cell research to continue but bans diagnostic or therapeutic applications.

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