Federal Funds May be Used for Limited Stem Cell Research

By Melanie R. Margolis

In Fetal Stem Cell Research (07/25/01), Peter McCauley discusses fetal stem cell research, the controversy surrounding the use of federal funds to support it, and the difficulty of the decision President George W. Bush was facing in determining his position in the stem cell debate. See Bioethics/010725Fetal.html. Much has happened in the stem cell arena in the short time since that article was published, and this article provides an update.

On August 9, 2001, President George W. Bush delivered remarks on stem cell research from his ranch in Crawford, Texas. See http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html. He remarks disclosed his decision on whether to allow federal funds to be used for scientific research on stem cells derived from human embryos. The President pointed out that privately-funded stem cell research indicates to scientists that stem cell research may lead to cures of a number of diseases and that embryonic stem cells may hold more promise than stem cells derived from other sources.

President Bush noted, however, that embryos are destroyed when stem cells are extracted. He said that in making his decision, he struggled with the issues of: whether the frozen embryos are human life deserving protection; and, if the embryos would be destroyed anyway, whether they should not therefore be used to save and improve lives. Giving deference to the difficulties of these issues and noting that some 60 stem cell lines already exist, the President stated that "we should allow federal funds to be used for research on these existing stem cell lines, where the life and death decision has already been made." See http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html. No new stem cell lines can be created with federal funds, but research can continue on the lines that exist. President Bush concluded by announcing that he has put in place a council of scientists, doctors, ethicists, lawyers, theologians, and others to advise him on stem cell issues.

President Bush's decision brought a collective sigh of relief from those in favor of fetal stem cell research. Though limited, federal funding would be forthcoming. His decision also brought disappointment from the same group. The Washington Post, A1 (August 10, 2001). Many feel that the existing stem cell lines alone will not be adequate to support the research needed. All of the lines may not be stable. Lines are difficult to maintain and could die off at any time. Furthermore, scientists say that even though cell lines can produce hundreds of types of cells, differences among cells created by different lines can be significant and that it would be beneficial to have many more cell lines available for research. Subtle genetic differences in stem cell lines can produce vast differences in outcomes. Id.

On August 27, 2001, the National Institutes of Health (NIH) named the 10 laboratories throughout the world that own the 64 embryonic stem cell lines which meet President Bush's criteria for federally funded research. See http://www.nih.gov/news/stemcell/082701list.htm. These stem cells must have been derived from an embryo that was created for reproductive purposes and was no longer needed. Also, informed consent must have been obtained for the donation of the embryo and that donation must not have involved financial inducements. Id. According to the NIH report, the scientists who developed these stem cell lines report that the cells are "viable, show characteristic stem cell morphology, are either maintained in culture or frozen, and have undergone at least several population doublings." Id.

According to Tommy G. Thompson, Secretary of the Department of Health and Human Services, the NIH is aggressively pursuing several initiatives to facilitate research on all forms of stem cells. The NIH is creating a registry of the embryonic stem cell lines that meet the eligibility criteria. The registry will contain basic information about the cells, a unique identifier, the name of the company or laboratory that derived the cells, and contact information about that company or lab. The registry will list the initial 10 laboratories, as well as any other owners of stem cell lines meeting the eligibility criteria who come forward in the future. Also, the NIH is accepting grant applications for federal funds, including use of existing funds, for stem cell research.

It is interesting to note that one of the 10 entities that has reported to the NIH that it has derived human embryonic stem cells that meet President Bush's criteria is Wisconsin Alumni Research Foundation (WARF), located in Madison, Wisconsin. On August 13, 2001, WARF sued Geron Corp. in the U.S. District Court for the Western District of Wisconsin to attempt to expand research access to five stem cell lines developed by a University of Wisconsin researcher. WARF licenses patents for the benefit of research at the University of Wisconsin and has licensed certain rights for human embryonic stem cells to Geron since 1999.

Geron was the first company to work with human embryonic stem cells. Los Angeles Times, Business, Part 3, Page 2 (August 17, 2001). Geron supported much of the research that established these embryonic stem cell lines in 1998, but WARF holds the relevant patents. Geron claims that WARF is obligated to add additional stem cell types to Geron's exclusive license agreement. See 159 BNA Daily Report for Executives at A4 (8/17/01). According to WARF, Geron had an option on additional cell types but exercised its option on July 26, 2001, after it had expired. Marketplace, Minnesota Public Radio, August 14, 2001. According to the Los Angeles Times article, Geron supports research by other academic groups if they pay Geron for the right to use the technology commercially; WARF wants to enter into licensing agreements with for-profit companies without payment to Geron.

Now that this window has been opened, if only a crack, the federally-funded research can begin. Assuming meaningful research can be done using only the existing 64 stem cell lines, exclusive license agreements and lawsuits could delay this important research despite the federal push for it. It is not known what agreements might be in place with regard to the other nine entities on the NIH list. Also, it is possible that Congress will pass legislation that would affect federal funding for fetal stem cell research. Perhaps Congress will open doors or perhaps it will slam the window shut.

08/31/01