The Scientist
June 27, 2003

Stem cell research climate
Legal stalemate keeps small window of opportunity open in the United States
By Eugene Russo

WASHINGTON, D.C.—The legislative deadlock in Congress and explicit regulations from the Food and Drug Administration
(FDA) make the United States a viable and, in some cases, preferable place to do stem cell and "therapeutic" cloning
research, according to speakers at this week's Biotechnology Industry Organization (BIO) conference. Still, some US
scientists seeking to do such research continue to look overseas.

Federal legislation on the subject of cloning is unlikely to pass this year. A bill sponsored by Rep. Dave Weldon (R-
Fla.) that would ban all cloning research has passed in the House but stalled in the Senate. Its companion bill,
sponsored by Sen. Sam Brownback (R-Kan.), has been referred to committee.

With California having already endorsed so-called therapeutic cloning, a potentially important source of stem cells,
and with New Jersey, New York, and Massachusetts likely to do the same, stem cell scientists now have potential
research sanctuaries—if they can secure sufficient state and/or private funds. Several more states, however, have laws
forbidding therapeutic cloning.

"I hope [California] becomes a safe haven," University of California, San Diego professor of cellular and molecular
medicine Larry Goldstein told The Scientist. Goldstein participated in a BIO conference session on the ethics of stem
cell research and cloning. He has been a vocal advocate for funding of embryonic stem cell research and therapeutic
cloning.

Geron Chief Executive Officer Thomas Okarma, speaking at the BIO ethics session, noted that his company's embryonic
stem cell (ESC) research has already been slowed considerably by funding restrictions. He presented data on as-yet
unpublished research in rats, claiming it is the first experiment to demonstrate ESC-spurred long-term recovery from
spinal cord injury. Okarma hopes to file an Investigational New Drug (IND) application within the next 2 years.
(Earlier this month, Geron announced its patent on a technique for making ESC-based therapies safer as well as its
receipt of a green light to create new stem cell lines in the United Kingdom.)

According to Simon Best, CEO of Edinburgh-based Ardana Bioscience and chair of BIO's bioethics committee, problems
remain in countries other than the United States, where therapeutic and stem cell regulations appear to be more lax.
"It's naive to think that in the UK and Australia, everything is rosy," Best told The Scientist after a separate BIO
session titled, "Global Partners: Stem Cells."

There is strong opposition to therapeutic cloning within the European Union. On Wednesday (June 25), Sen. Brownback and
Rep. Weldon held a news conference with Peter Liese, chairman of a European Parliament bioethics working group and a
physician specializing in human genetics and pediatrics. Liese stated that "the majority of the member states is
against all kinds of cloning and that the European Parliament is strongly against it and asks for a European and
worldwide ban."

However, issues of ethical disagreement typically fall to the discretion of member states and the EU law is unlikely to
supercede liberal therapeutic cloning laws in countries like Sweden, Belgium, and the United Kingdom. European
countries including Germany, Austria, Portugal, Ireland, Norway, and Poland prohibit any research that destroys
embryos. Elsewhere in the world, China, Israel, and Singapore are among potential research havens with pro–therapeutic-
cloning laws. Canada lacks legislation on the subject, so researchers there announced last week that they are planning
to proceed with embryo research this year.

Best also suggested that because of tricky intellectual property (IP) restrictions in the United Kingdom, researchers
often prefer to bring stem cell lines over from the US. "There was a tradeoff in the UK, a sacrifice of IP to offset
ethical concerns," said Best. Ironically, the United States may be the best place for clinical trials, Best added,
because FDA regulations are more specific than those in the United Kingdom, so researchers would at least be clear on
the criteria they must follow in order to conduct a clinical trial involving stem cells.

US researchers, though, have continued to look outside the country for stem cell research opportunities. At the "global
partners" session, a young American biologist, Diana Devore, spoke of the newly announced National Center for Stem Cell
Research in Australia, where she recently started as the chief operations officer. Devore said that regulations in the
United States played into her decision to move to Australia and had an impact on the planning of the center, which has
secured AUS$55 million (US$36.7 million) in funding from the Australian government and the state of Victoria.

Meanwhile, the NIH National Center for Research Resources (NCRR) recently announced a 5-year, $4.3 million grant to
Tulane University in New Orleans to establish a center for the preparation, quality testing, and distribution of adult
stem cells. This standardization of adult stem cells—specifically marrow stromal cells (MSCs) derived from adult human
and rat bone marrow—is intended to facilitate adult stem cell research.

Links for this article:

Biotechnology Industry Organization (BIO) BIO 2003 conference, June 22–25, 2003.
http://www.bio.org/events/2003/index.asp?stay=yes 

T. Agres, "Senators urge stem cell expansion," The Scientist, April 25, 2003.
http://www.biomedcentral.com/news/20030425/03/ 

L. DeFrancesco, "California endorses stem cell research," The Scientist, September 25, 2002.
http://www.biomedcentral.com/news/20020925/05/ 

Larry Goldstein
http://medicine.ucsd.edu/pharmaco/williams/lsgoldstein.html 

Geron
http://www.geron.com/ 

P. Brickley, "US genetics policy panel forms," The Scientist, June 11, 2003.
http://www.biomedcentral.com/news/20030611/03/ 

Ardana Bioscience
http://www.ardana.co.uk/ 

A. Scott, "Stem cell funding ban debated," The Scientist, April 25, 2003.
http://www.biomedcentral.com/news/20030425/05/ 

P. Hagan, Euro MPs vote against stem cell research," The Scientist, April 10, 2003.
http://www.biomedcentral.com/news/20030410/05/ 

E. Ungar, "There ought to be a law," The Scientist, June 25, 2003.
http://www.biomedcentral.com/news/20030625/02/ 

P. Hagan, "Stem cell collaboration," The Scientist, June 2, 2003.
http://www.biomedcentral.com/news/20030602/02/ 

"New center for preparation and distribution of adult stem cells," NIH news, June 24, 2003.
http://www.nih.gov/news/pr/jun2003/ncrr-24.htm 

SOURCE: The Scientist / BioMed Central
http://www.biomedcentral.com/news/20030627/02

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