Washington
One year after President Bush approved federal financing for studies of some colonies of human embryonic stem cells, researchers say they have been blocked from obtaining stem cells from all but a few of the approved cell lines. Cells from only 5 of the 78 colonies now eligible for financing have been widely distributed to researchers, and some scientists are calling on the Bush administration to work harder to increase that number.
Some university scientists acknowledge that it takes time for any new, cutting-edge field of study like this one to develop. Still, the Coalition for Advancement of Medical Research, a lobbying organization that represents universities and other supporters of stem-cell research, wrote to Mr. Bush on Monday asking him to help remove roadblocks so that scientists can obtain more of the cell lines.
“The focus of [the Department of Health and Human Services] on embryonic-stem-cell research policy implementation was diverted by the very necessary response to events of September 11th, but it has never fully regained momentum,” the coalition said in a separate statement. “This has led the department to have difficulty aggressively implementing the administration’s policy and in maintaining pressure on more than a few stem-cell-line owners, especially foreign owners.”
In August 2001, Mr. Bush decided that the National Institutes of Health would finance research only on embryonic-stem-cell lines that existed at the time of his announcement and met certain other conditions. (See an article from The Chronicle, August 17, 2001.) The move was a compromise that allowed some research to proceed but reflected the qualms that Mr. Bush and other opponents have about the research. Scientists hope to mold the undifferentiated stem cells into replacement tissue to treat a variety of illnesses. But researchers must destroy human embryos to obtain the stem cells, and some critics, who view the embryos as human life, call that immoral.
After the president’s announcement, it took the NIH three months to identify 64 colonies of embryonic stem cells that met Mr. Bush’s criteria, and to post the list publicly. Following further inquiries by the agency, that number has risen to 78. (The “NIH Human Embryonic Stem Cell Registry” is available online at the agency’s Web site.)
The stem cells are owned by 14 different research organizations. But only one of them, the Wisconsin Alumni Research Foundation, acting on behalf of the University of Wisconsin at Madison, has made stem cells widely available to other scientists. As of last month, the foundation had reached agreements with 79 researchers to share stem cells with them, and had shipped cells to 52 of them. The 79 researchers represented 62 institutions and 11 foreign countries.
Dissemination of the lines has been complicated in part by patent law. The Wisconsin foundation has obtained a patent that allows it to control distribution of all embryonic stem cells in the United States that are obtained using a method pioneered at the university. The research foundation’s patent is believed to affect most or all of the lines that are available for NIH financing. The foundation is allowing other scientists to use its stem-cell lines in exchange for a processing fee of $5,000, as long as they use them only for teaching or research involving no direct commercial application. The foundation has an agreement with a pharmaceutical company, Geron Corp., giving the corporation exclusive rights to develop some of the foundation’s cell lines for medical therapy.
Because the National Institutes of Health had not been financing research involving embryonic-stem-cell lines, most of the other existing lines were developed by scientists working in other nations. However, some owners of these lines have sought different terms, especially financial rights to any discoveries by scientists working with their cells. To accommodate these requests, the Wisconsin foundation has been negotiating separate agreements with those suppliers, so far reaching agreement with only one, ES Cell International of Australia, which owns six stem-cell lines.
Scientists want access to as many different lines of stem cells as possible. They say that some lines may lack the necessary characteristics to prove effective as medical therapies.
For this reason, the Coalition for the Advancement of Medical Research also complained on Monday that the NIH has provided too little technical information about the embryonic stem cells that are approved for research. Such information is available for only 5 to 24 cell lines, according to different experts’ estimates.
Wendy Baldwin, the NIH’s director of extramural research, told a presidential bioethics committee last month that she “understands the concern,” adding that such details will emerge as more and more federally financed researchers obtain and study the cells. “That’s going to be the best test of how good those lines are,” she said. “There’s a tremendous amount of basic work that simply has not been done.”
To get that work started, the National Institutes of Health has made grants to some scientists with access to stem cells. These include supplements of about $50,000 each for 21 existing grant projects, and an additional three new grants. The total amounts awarded cannot be estimated precisely because the agency lacks a mechanism to track that level of detail in “real time,” Ms. Baldwin said in an interview on Monday; more details will emerge when the current fiscal year ends on September 30.
In addition, the agency has awarded five grants totaling more than $3.5-million to owners of existing stem-cell lines to help them distribute the cells to other scientists. Two of the awardees are the Wisconsin foundation and ES Cell International. However, other stem-cell suppliers must still reach agreements on their own with the Wisconsin foundation; the NIH does not have the authority to negotiate agreements with stem-cell suppliers on behalf of university researchers.
In turn, because the study of embryonic-stem-cell research is a new field, Ms. Baldwin and some other scientists say that researchers need time to acquire the skills necessary to perform meaningful research with the cells. “We’re trying to put all the pieces in place” so that the research can proceed, she said.
Some research advocates have not given up hope that Mr. Bush will revisit his decision of last year and allow federal financing for additional stem-cell lines not covered by that decision. “We remain concerned that the conditions President Bush has placed on funding embryonic stem cell research will unnecessarily impede those advances,” Jordan J. Cohen, president of the Association of American Medical Colleges, said Monday in a statement.
Background articles from The Chronicle:
