Asia, Europe moving to stake claims in promising stem cell research industry
By Terri Somers    Wednesday, January 03 2007, 12:02 AM

STEM CELL FUTURE
While President Bush remains steadfastly against human embryonic stem cell
research, limiting federal funding on moral grounds, nations around the
globe are pouring millions of dollars into the field.
In the United Kingdom, the government has committed to spending $1.3 billion
on stem cell research in the next 10 years. Some of the money will support
the construction of five manufacturing facilities to produce millions of
pure stem cells for research.
Chinese scientists educated at top universities in the United States are
being drawn home by their government with the promise of funding and
leadership of labs staffed with eager young researchers. Some
scientist-physicians there already are treating patients with stem cell
discoveries they have made.
The Singapore government is funding Biopolis, a high-tech hamlet for biotech
with an emphasis on human embryonic stem cell research. The $400 million
complex can accommodate 2,000 scientists working at government-funded
laboratories or private biotech and global pharmaceutical companies.
STEM CELL RESEARCH
As these countries and others surge ahead in their research, they see the
prospect of creating new treatments and cures for chronic illnesses while
saving billions of dollars on health care.
They also see the chance to stake a claim in a potentially lucrative new
industry while the United States is sidetracked by a political and moral
debate.
"For the first time, we have a lot of competition ... I don't think we've
had as much concern for another country besting us in science since the race
to the moon," said Dr. Evan Snyder, who runs the embryonic stem cell
research program at the Burnham Institute in San Diego.
It is a competition with crucial consequences for San Diego County and
California, home to leading stem cell researchers and 50 percent of the
world's biotechnology research.
The field is seen as especially promising for creating treatments for
incurable diseases and money-saving tools for drug discovery.
California voters have tried to help. In 2004, they approved spending $3
billion on stem cell research, but the money has been held up by legal
challenges.
NO CLEAR LEADER
To be sure, it is a race that is hard to predict.
Until November 2005, South Korean scientist Woo Suk Hwang was considered a
leader in the field after he claimed to be the first to efficiently create
embryonic stem cell lines through a complicated cloning process that no one
had been able to master.
Hwang turned out to have falsified some of his studies, and his work was
discredited. Researchers around the globe have had to backtrack and try to
master that feat.
China reportedly is doubling its investment in stem cell research. But an
air of mystery and skepticism surrounds China's work, because the country's
regulatory guidelines differ from those in the West and because research
from Chinese scientists has not been widely published.
The United Kingdom already has invested about $198 million in stem cell
research at 90 laboratories, of which 11 are licensed to conduct human
embryonic stem cell research.
Singapore, with just 4 million citizens, is investing $25 million to $29
million annually in research, excluding overhead costs and infrastructure.
That investment may seem wimpy compared with the $609 million the United
States government spent on stem cell research last year. But because of
federal funding restrictions on human embryonic stem cell research, only $20
million to $40 million a year - about 6 percent at best - has been directed
to that field.
Money is not the sole catalyst of success. Scientists say supportive
government policies that free them to concentrate on their work, national
commitment and contagious scientific enthusiasm are just as important.
"Here we are again, sitting on the beginning of another revolution, a
possible way to provide cures rather than treatments," said Chris Mason, a
stem cell researcher at University College London. "The U.K., Singapore and
other countries realize what might be within their grasp if they spend the
money on the front end, and they don't want to miss it."
The United States, long the world leader in biomedical research and
commercialization, is getting a taste of being the underdog.
PRICELESS SUPPORT
Scientists working in the United States, such as Larry Goldstein at the
University of California San Diego, must troll for nonfederal funding
sources so they can work on all types of embryonic stem cells.
To stay on the right side of the law, Goldstein and the 25 people in his lab
must be vigilant not to use government-funded microscopes or cell sorters to
look at embryonic stem cells created after Aug. 9, 2001.
That was the day President Bush issued an executive order that federal
dollars would not fund the destruction of human embryos for the creation of
new stem cell lines. Many Americans, Bush included, see these embryos as a
life that should be protected, rather than sacrificed to science.
Scientists say the original embryonic stem cell lines are mutating with age
and don't provide enough genetic diversity. The cell lines could never be
used to develop therapies for use in humans because they are contaminated,
having been grown in nutrients polluted with mouse cells.
Outside the United States, governments are funding scientists' efforts to
create new, diverse and uncontaminated cell lines.
In Singapore, a private company called ES Cells International, or ESI, is
coaxing human embryonic stem cells into becoming insulin-producing
pancreatic cells. Run by British scientist Alan Colman, a member of the team
that cloned Dolly the Sheep, ESI is also collaborating with a government lab
to develop a plant to manufacture millions of the pure cells that eventually
will be needed to test new therapies.
In a synergy, government-funded researchers in Singapore have come up with
an animal-cell-free substance, the culture medium in which stem cells are
grown, so that ESI can begin to cultivate the large number of cells it will
need.
The only manufacturing facility in the United States as advanced as
Singapore's belongs to Geron, a Menlo Park, Calif., company that is readying
an embryonic stem cell therapy for spinal injury for the next step of
clinical trials in human patients.
Scientists in Sweden and India are developing tests that use embryonic stem
cells to determine the toxicity of potential therapies.
In Israel, scientists are changing the genetic makeup of embryonic stem cell
lines by deactivating specific genes. Such lines enable scientists to
determine how the gene functions, and the cells can serve as a model for a
human disease on which treatments one day may be tested.
Scientists at Kyoto University in Japan reversed the cell-development clock
when they turned skin cells from a mouse back into embryonic stem cells by
introducing four genes. They now are trying to replicate that work on human
cells.
President Hu Jintao of China has stressed the importance of embryonic stem
cell research to his country, where staggering poverty makes health care
inaccessible to millions of people.
"China is the sleeping giant," said Fred Gage, an embryonic stem cell
researcher at the Salk Institute for Biological Studies in San Diego.
Chinese physician-scientists with access to hundreds of patients are testing
experimental therapies directly on humans. In the United States, only Geron
has reported approaching readiness for clinical trials of a human embryonic
stem cell treatment.
Although the Chinese government has often hyped its investment in the field,
it is hard to say how much support the government is really providing.
An article in The New England Journal of Medicine in September said China's
national and local governments, specifically Shanghai and Beijing, have
invested roughly $38 million in stem cell research since 2000.
A report by the United Kingdom Stem Cell Initiative said the Chinese
government is expected to funnel as much as $132 million annually into the
research over the next five years.
Stephen Minger, an American stem cell scientist who moved to London more
than 11 years ago, said every lab he saw during a recent visit to China had
hugely expensive, state-of-the-art equipment and was buzzing with young
scientists. Many of those scientists had been educated in the United States
and Europe.
One area in which the United States' biotech prowess has enabled it to stay
ahead of the global pack is in figuring out the role that genes in different
embryonic stem cell lines play in biological functions, including a disease.
But much of the interesting work in that field is now happening in Finland
and Singapore, said Mahendra Rao, who was formerly one of the top
researchers at the U.S. National Institutes of Health.
Foreign scientists also repeatedly cite the efforts of Harvard scientists to
attract private funding and push human embryonic stem cell research forward
despite the lack of federal government support.
Some American scientists have moved overseas to pursue stem cell research,
or now divide their time between the United States and one of the nations
considered to be more open to stem cell research.
And there is criticism that many scientists in the United States are
spending too much time trying to develop techniques that would allow them to
create embryonic stem cells without destroying an embryo. Such a discovery
might circumvent the moral and political debate.
The United States, however, isn't the only nation engaged in vigorous debate
about the morality of using human embryonic stem cells.
Germany does not allow the importation of human embryonic stem cells from
other countries. A license for human embryonic stem cell work in Germany can
be obtained only if a scientist proves his research cannot be conducted in
any other way.
But most of the scientific world has moved on.
On Dec. 6, Australia's government eased restrictions by permitting
therapeutic cloning to create new stem cell lines. That debate played out in
the United Kingdom during the 1970s and 1980s, when scientists there were
pioneering in-vitro fertilization. In China, it is considered immoral not to
try to help ease someone's suffering if the possibility of a remedy exists.
LOSING GROUND
There are already signs that the United States may be losing its commercial
edge.
As the head of stem cell research for Invitrogen, a Carlsbad, Calif.-based
biotechnology company, Rao sees many potential licensing opportunities.
"In the past, the large majority were from the U.S.," Rao said. "(In the
case of human embryonic stem cell research), it is more like 60 percent from
outside the U.S. and 40 percent from inside the U.S."
Invitrogen's sales figures on tools and materials for human embryonic stem
cell research suggest the same trend, he said. Usually the United States is
the biggest market in the world.
Now other countries, including India and some European nations, are pushing
to move possible therapies into the clinic faster than the United States,
Rao said.
One thing that might help the United States stay competitive is that
embryonic stem cell scientists worldwide share the same hurdle: the science
itself.
"The biology is tough, and sometimes it just doesn't matter how many people
you have working on something, or how much money you throw at something,
because understanding the science is the greatest obstacle," said Snyder,
who runs the Burnham Institute's embryonic stem cell program.
The United States also possesses something other countries cannot buy or
steal: the breadth and depth of its scientific prowess.
"We might not have all the money or all the toys, but we still have what you
really need: the experienced people to ask the right scientific questions,"
said Goldstein, a Howard Hughes investigator at University of California San
Diego.
But some scientists feel that even if U.S. policy were to be reversed, it
would be difficult for the United States to regain lost ground.
Still, many American scientists remain optimistic because the U.S. market
and venture capital pool remain globally dominant.
"There is something indomitable about the American spirit that allows
American scientists who are really driven and really smart to figure out a
lot of ways to circumvent any difficulty," Snyder said. "We have a lot of
confidence despite the competition internationally that we will probably,
somehow, win the game in terms of bringing therapies to patients."

----------------------------------------------------------------------
To sign-off Parkinsn send a message to: mailto:[log in to unmask]
In the body of the message put: signoff parkinsn