Stem Cell Researchers Cite Numerous Hurdles
A year after President Bush restricted federal funding for human embryonic stem cell research to a select number of existing cell lines, leading scientists say the field is hampered by political, financial and scientific chaos.
An overwhelming majority of the stem cells the Bush administration approved are in poor condition and useless for research, they complain.
What’s more, a lack of funds, a charged political climate and intellectual-property disputes are slowing progress in a field scientists believe is vital to more effectively treating--and even curing--a wide range of diseases.
“It really is a mess,” said Stanford University Medical School professor Paul Berg, a Nobel laureate and one of the first high-profile critics of the administration’s policy. “There are so many things that have to happen to make this work.”
Chief among the complaints is the relative lack of money devoted to such research. Most of it comes from small, private foundations backed by ailing actors--including the Christopher Reeve Paralysis Foundation and the Michael J. Fox Foundation for Parkinson’s Research--along with the Juvenile Diabetes Research Foundation.
Those three foundations have committed a total of $6 million to human embryonic stem cell researchers, and last week Intel Corp. Chairman Andy Grove announced a $5-million challenge grant to fund research at UC San Francisco. By comparison, the federal National Institutes of Health has pledged just $3.5 million to stem cell research.
The NIH said it can’t be blamed entirely for the funding drought. It began offering grants for stem cell research in November, but researchers have been slow to apply, said Wendy Baldwin, who helps manage the NIH’s stem cell program.
“We are here and ready to fund,” she said.
Even large foundations, such as the American Heart Assn. and the American Cancer Society, have shied away from this political hot potato. Both have declined to fund stem cell research.
Dr. Robert Bonow, president of the AHA, said debate continues inside the organization among doctors, researchers and patients. One concern is that the group could lose donors who are opposed to such research.
“It is a controversial area,” Bonow said. “It certainly is an issue.”
Scientists hope to someday manipulate stem cells to grow into all kinds of adult cells. That could lead to cures for a host of diseases.
But many antiabortion activists equate the science with murder. To harvest embryonic stem cells, 5-day-old embryos must be destroyed.
Pressure from political conservatives preceded Bush’s announcement a year ago that the government would fund only research conducted on existing stem-cell lines. Federally funded scientists are restricted to working with 78 stem cell lines controlled by 14 NIH-approved labs.
“There’s plenty of cell lines available for research,” Health and Human Services Secretary Tommy Thompson said in June at a biotechnology conference in Toronto.
But researchers have long argued that stronger federal support is necessary to nurture nascent fields so they can grow to produce useful science. Companies are loath to invest in such research because the payoffs are far from guaranteed--and are years away.
“Very few breakthroughs have come from the business sector,” Berg said. “They come from the academic community, which relies on federal funds.”
The one U.S. company heavily invested in stem cells, Geron Corp., is struggling. In June, the Menlo Park-based company laid off 43 employees--30% of its work force--and its stock is trading in the $4 range, near its 52-week low. It closed Friday at $4.38, down 16 cents on Nasdaq.
Only two of the NIH-listed suppliers are shipping stem cells--from just three lines--to other researchers. Cells from most of the other lines aren’t in good enough shape to ship and thrive in other labs, researchers say.
A few other cell lines are hindered by intellectual-property issues because of two powerful patents held by the University of Wisconsin.
University researcher James Thomson won a worldwide scientific race to isolate human embryonic stem cells in 1998. The resulting patents give the university commercial control of most research related to stem cells.
The University of Wisconsin has five stem cell lines but is shipping cells from just one of them to a total of 57 researchers.
A spokesman said two more of the lines will be in good enough shape within two weeks and all of its lines should be available to ship by February.
The university has intellectual-property agreements with researchers at 78 institutions in 12 countries. Nearly all have agreed not to commercialize any of their work, leaving that financial plum to the aggressive patent office at the university.
It claims all U.S. commercial rights to the research and demands that anyone seeking to profit from stem cells first obtain a license from its patent office.
As a result, the few companies with their own stem-cell lines, such as BresaGen Ltd. of Australia, can’t provide cells to nonprofit researchers without paying the University of Wisconsin first. This hinders research, scientists say.
BresaGen has balked at those terms, but the university denies slowing any research.
In a first for a university, it is opening a satellite patent office in San Diego in hopes of striking more commercial deals in California’s burgeoning biotechnology community.
“Lines are available for research,” said Andrew Cohn, a spokesman for the University of Wisconsin’s technology transfer office. “All anyone has to do is call us.”
