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U.S. relatively hospitable to stem-cell research
Sunday, June 05, 2005

By Michael Woods, Post-Gazette National Bureau



BARCELONA, Spain -- In pushing the U.S. House of Representatives last month
to expand federal support for human embryonic stem cell research,
proponents argued that the United States was falling behind in what could
be one of the most promising medical advances of the age.

Just days before, South Korean scientists had announced a breakthrough in
therapeutic cloning that allowed them to quickly produce stem cells
genetically matched to people of varied ages, genders and races.

The discovery conjured images of a whole new medical industry growing up
almost overnight, with doctors eventually regenerating cells or tissues to
treat or cure all kinds of ailments, including Alzheimer's and Parkinson's
diseases -- all without U.S. participation.

But the concern about falling behind the rest of the world may be
overblown. In fact, the United States appears to be a relatively hospitable
place for embryonic stem cell research, especially compared to Canada and
some nations in Europe where governments not only refuse financial support
for human cloning to produce stem cells, they outlaw the practice.

In Canada, scientists who violate the ban can be jailed for 10 years and
fined $500,000. "You can bet that with these harsh sanctions scientists are
complying," said Rosario M. Isasi, an attorney who works on medical ethics
issues at the University of Montreal.

Under German law, scientists who even e-mail or telephone cloning
instructions to colleagues in other countries can be thrown into jail for
three years and fined more than $60,000. There are key differences among
nations when it comes to regulating embryonic stem cell research, according
to Robert L. Paarlberg, a professor at Wellesley College in Massachusetts
who has written a book on genetic engineering.

The United States restricts the flow of federal money for embryonic stem
cell research -- limiting support to a relative handful of stem cell lines
created from embryos discarded at in vitro fertilization clinics before
August 2001 -- but does not limit private, state or local government
funding. California voters last year approved $3 billion for stem cell
research.

The European Union has adopted a similar policy, although it does allow
financing for some new embryonic stem cell lines. But national policies in
Europe differ widely, and some countries have adopted sweeping regulations
against both government and privately funded projects.

"In the United States, [opposition] comes mostly from the Christian right,"
Paarlberg said. "In Europe, opposition also comes from Socialists and Green
parties on the left, and from the state bureaucracies that tend to
overregulate every kind of scientific endeavor."

Stormy seas often prevail as science sets sail toward new horizons that
challenge religious and moral values. Historians of medicine, however,
could find few parallels to the current situation.

Yale University's Susan Lederer was able to cite one, the late 1800s, when
medical science first turned to animal experimentation to understand human
diseases.

"There were efforts in England, the United States and Germany to ban animal
experimentation altogether on moral grounds [animal suffering] and
scientific grounds [other animals are different from humans]," Lederer
said. "The arguments for allowing unrestricted animal research sound
strikingly similar to those for stem cell research."

Today's embryonic stem cell research sparks controversy because scientists
must destroy human embryos to retrieve the cells, which are
undifferentiated at such an early stage of development. The hope is that
they eventually might be grown into different types of cells and used to
repair various types of cell or tissue damage.

"The U. S. and the European Union are much more alike than is sometimes
suggested," said Piet A. Bolhuis of the Netherlands, who advises his
government on stem cell research. "Of course, one important difference is a
president who makes statements about the research subject."


Therapeutic v. reproductive
President Bush in August 2001 restricted federal funding to research on
stem cell lines already in existence at that time. Under that policy, the
National Institutes of Health cannot fund research on new lines like those
announced last month by South Korean scientists.

The South Korean breakthrough helped galvanize the legislation approved by
the Republican-controlled House to expand funding for stem cell research,
despite the president's opposition. Sen. Arlen Specter, R-Pa., is
sponsoring the proposal in the Senate, which essentially would follow EU
policy and allow government funding of new stem cell lines derived from
embryos that otherwise would be discarded at in vitro fertilization clinics.

Bush has vowed to veto the legislation. "This bill would take us across a
critical ethical line by creating new incentives for the ongoing
destruction of emerging human life," Bush said. "Crossing this line would
be a great mistake."

What the South Korean scientists discovered was an easy way to use
therapeutic cloning to produce stem cells customized to individual
patients, making rejection less likely.

They created 11 new stem cells lines that were exact genetic copies of
patients with spinal cord injuries, diabetes and other disorders. They did
this by fusing genetic material in skin cells from potential patients with
that of donated eggs. Special processing made the eggs form embryos, just
like naturally fertilized eggs.

This is called "therapeutic" cloning because the embryos are produced for
their stem cells and not to create a new human being. In therapeutic
cloning, the embryo grows for only about five days until it consists of
perhaps several hundred cells and reaches .01 inch in diameter. Stem cells
are then extracted, destroying the embryo.

In reproductive cloning, the embryo would be implanted into the uterus of a
surrogate mother, growing into a genetic carbon copy of the skin cell
donor. Reproductive cloning has been done in animals, including Dolly the
sheep, but so far, not in humans.


Little funding from EU
Although it went little noticed in the United States, the 25-member EU has
embraced U.S.-style funding restrictions on embryonic stem cell research.
The EU does not fund either therapeutic or reproductive cloning, said
Science Commissioner Janez Potocnik.

EU policy is somewhat more liberal, however, and looks much like the
legislation approved by the U.S. House and being pushed by Specter in the
Senate. The EU funds projects from existing embryonic stem cell lines and
those from unused embryos at fertility clinics with permission of the
donors. Such embryos usually are destroyed anyway, Potocnik noted.

Still, the EU provides little funding for embryonic research. As of April,
the EU had financed only two projects for a total of $625,000. The U.S.
National Institutes of Health provided $25 million for embryonic stem cell
research in 2004 alone, and another $200 million for research on stem cells
derived from umbilical cord blood and other non-embryonic sources.

California, Wisconsin, Texas, New York, Illinois, Maryland, Massachusetts
and New Jersey are among the states considering or moving ahead with their
own programs to fund stem cell research, and California's $3 billion effort
includes therapeutic cloning. Meanwhile, seven states ban therapeutic
cloning, according to the National Conference of State Legislators.

In Europe, the most liberal policies exist in the United Kingdom, Belgium,
and Sweden, all of which permit therapeutic cloning and other types of
human embryo research, according to an EU summary.

Denmark, Finland, France, Greece, Spain, and Netherlands allow scientists
to produce new stem cell lines, but only from surplus embryos that
fertility clinics plan to destroy. Estonia, Hungary, Latvia and Slovenia
have virtually no regulations.

Germany and Italy have criminalized extraction of stem cells from embryos,
but scientists can import new stem cell lines created elsewhere. Austria,
Ireland, Poland and Lithuania have outlawed all kinds of stem cell research.

Overall, however, European laws are more restrictive than those in the
United States, Paarlberg said, because U.S. limits apply only to funding.

"The federal government in the United States has placed a limit on the
kinds of embryo research it will fund, but it places almost no limits on
the research itself," he said.

Asian nations, by and large, are probably the least restrictive. South
Korea, China, India and Singapore permit therapeutic cloning.

Paarlberg said cultural traditions in these countries do not view a
five-day embryo that has never been implanted inside a womb as a person.
"So there is no religious inhibition against procedures that create those
embryos or those that destroy embryos in the interest of medicine or
medical science," he explained.

The historian Lederer suggested that if therapeutic cloning and embryonic
stem cell research reach their potential and provide a wide variety of
cures, controversy may cool -- much as the 19th century debate over animal
experimentation lost steam after it began to pay off.

On the other hand, protests against animal experiments have revived in
recent years, and many people and religious traditions consider human
embryos to be human beings.



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(Michael Woods can be reached at [log in to unmask] or 1-202-662-7072.)

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