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Political, financial, scientific woes hamper field seen as vital to treating diseases

Stem-cell research now in limbo

Posted: Monday, August 12, 2002

SAN FRANCISCO -- 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 coming from small, private foundations backed by ailing actors -- 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 combined $6 million to human embryonic stem cell researchers compared to just $3.5 million by the National Institutes of Health.

The NIH said it can't be blamed entirely for the funding drought. In November, it was ready to dole out stem cell grants; researchers themselves 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 Association and the American Cancer Society have shied away from this political hot potato and are explicitly declining to fund it.

Dr. Robert Bonow, president of the Heart Association, said debate continues inside the organization among doctors, researchers and patients. Bonow said the possibility of losing donors opposed to such research is a concern.

''It is a controversial area,'' Bonow said. ''It certainly is an issue.''

Scientists hope to some day manipulate stem cells to grow into all kinds of adult cells. But many anti-abortion activists equate the science with murder because 5-day-old embryos must be destroyed to harvest embryonic stem cells.

Pressure from political conservatives preceded the decision Bush announced last Aug. 9 that the government would only fund research of existing stem-cell lines.

A new private funding source that could more than double available stem cell research money emerged in a $5 million challenge grant announced Thursday by Intel Corp. chairman Andy Grove. He's giving up to $5 million to the University of California, San Francisco.

But researchers have long argued that federal support is necessary to nurture nascent fields into useful science. Companies are loath to invest in such research because the payoffs are far from guaranteed -- and years off.

''Very few breakthroughs have come from the business sector,'' Berg said. ''They come from the academic community, which relies on federal funds.''

Indeed, 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 percent of its work force, and its stock is trading around $4 a share, near its 52-week low.

Currently, the government allows federally funded scientists to work with 78 stem cell lines controlled by 14 different NIH-approved labs.

''There's plenty of cell lines available for research,'' Health and Human Services Secretary Tommy Thompson in June at a biotechnology conference in Toronto.

But 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.

Wisconsin researcher James Thomson in 1998 won a worldwide scientific race to isolate human embryonic stem cells; the resulting patents give the university commercial control of most research related to stem cells.

Wisconsin has five stem cell lines but is shipping cells from just one 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 commercialize any of their work, leaving that financial plum to Wisconsin's aggressive patent office.

Wisconsin 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.

The few companies with their own stem-cell lines -- such as BresaGen Ltd. of Australia -- therefore can't provide cells to nonprofit researchers without paying Wisconsin first. This hinders research, scientists say.

BresaGen has balked at Wisconsin's terms. But the university denies slowing any research.

In a first for a university, Wisconsin is even 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, spokesman for Wisconsin's technology transfer office ''All anyone has to do is call us.''



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