Legal stalemate keeps small window of opportunity open in the United States
June 27, 2003
By Eugene Russo
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 He presented data on as-yet unpublished research in rats, claiming it is the first experiment to demonstrate ESC-spurred long-term recovery from spinal cord injury.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.
Copyright © 2003, The Scientist Inc.