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End Run

A Korean company tries to short circuit bans on cloning and stem-cells.

12:00 AM, Oct 24, 2005 • By WESLEY J. SMITH
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LIFE IS TOUGH for the stalwart pioneers on biotechnology's cutting edge. "U.S. scientists studying human embryonic stem cells face unprecedented political, regulatory, and financial barriers," Dr. Susan Okie, M.D. complained last week in the New England Journal of Medicine. The "national debate over the ethics of such research" has so chilled the scientific atmosphere, she believes, that "the most promising method of making patient-specific and disease-specific stem cell lines"--meaning, human therapeutic cloning--"is not yet being performed in the United States."

But, she reports, help is on the way. The World Stem Cell Foundation, the brainchild of Woo-Suk Hwang, the South Korean creator of the first human cloned embryos, plans to skirt legal restrictions and the public's widespread moral disapproval of human cloning, which many scientists blame for hindering stem-cell science.

The Foundation's plan is to identify the few places that are overtly friendly to human cloning for biomedical research, such as South Korea, the United Kingdom, and California. Then, specially trained South Korean cloning technicians would travel to these areas and clone human embryos to order, destroy them, and derive cloned embryonic stem cell lines. These would then be sent back to Korea for quality control and proliferation. The resulting tailor-made cells would be sold throughout the world, especially to scientists in countries such as France, Australia, Norway, and Canada (and states such as Michigan and Iowa) that ban all human cloning but do not explicitly prohibit research on cloned embryonic stem cells.

Such an end run around state and national policies is justified, according Gerald Schatten, a biologist at the University of Pittsburgh and a strong supporter of Hwang's Foundation. He told Okie, "In order to move forward, we scientists need some kind of a safe haven. The ethical and legal implications are important, but the most important thing for us is just to have discoveries that are independently confirmed and extended." In other words, scientists who want to experiment on cloned embryonic stem cells are entitled to experiment on cloned embryonic stem cells.

THIS BRINGS TO MIND Stanford University ethicist William B. Hurlbut's warning against the "outsourcing of ethics." After all, how is Hwang's proposal any different in principle than if organ transplant surgeons formed a foundation to procure organs in "safe havens" allowing them to circumvent laws requiring that vital organ donors be dead? Or, if vaccine researchers sought "safe havens" to perform unethical research on primates in order to accelerate the time when their experiments could be conducted in human trials?

The presumption of some therapeutic cloning supporters that their mores dictate is in stark contrast to the scientists and ethicists on both sides of the cloning controversy who are earnestly seeking ways to gain the presumed scientific benefits of tailor-made stem cells--without also treating nascent human life like a harvestable crop. The best known of these proposals is Altered Nuclear Transfer (ANT), which seeks to bioengineer a tissue mass that generates stem cells--without creating and destroying a human embryo.

Hurlbut, a member of the President's Council on Bioethics, has been the driving intellectual force behind ANT. He told me, "The future of science and the unity of society require that we affirm biotechnological research as playing an essential role in our national identity as a noble and progressive society, while also honoring the unique moral value and potential of all human life." ANT, he hopes, "will be a genuine solution to the current impasse" between naked science and societal ethics.

This "compromise" may actually be within reach. As reported in the current edition of Nature, scientists achieved encouraging results in early mouse experiments using one (of many) proposed ANT techniques, although further research is required to validate ANT's ethical and scientific merits before human attempts can begin.

The irony of Hwang's plan is that rather than seeking to heal the growing rifts over biotechnology--as supporters of ANT are--it would further exacerbate them. Ironically, this could spark a fierce backlash leading to increased regulatory controls over biotechnology. Such laws, in turn, could trigger cultural Armageddon; a lawsuit filed by university research centers and biotechnology companies seeking a constitutional right under the First Amendment to do scientific research.