People for Sale: Scandal Stops Stem-Cell Farm

SEOUL, South Korea — A plan to create a worldwide bank of stem-cell lines may be falling apart over illicit cloning. Woo-Suk Hwang, the leading South Korean Stem cell expert whose team cloned the first human being, used his own laboratory workers as potential mothers of his clones.

For Catholics, pro-life advocates and some feminists, however, the questions go far beyond the ethical breach in scientific protocol.

“We're calling it trafficking. It's trafficking in human body parts,” said Jennifer Lahl, national director of the Oakland, Calif.-based Center for Bioethics and Culture. “It's like buying and selling people into slavery. It's a bit of hyperbole, but it is. He is taking human embryonic stem-cell lines, human clones, and selling them.”

Hwang apologized Nov. 24 for ethical breaches at his lab and said he would resign from all his posts. The Korean government has launched an investigation, the International Herald Tribune reported. Hwang is also accused of providing monetary incentives for egg donations and failing to notify donors of possible health risks. He did not respond to an e-mail request for an interview.

At a press conference, Hwang said he had not known about the lab workers’ donations until the journal nature began investigating.

“We've been warning for years that if research cloning takes off it may well be used to exploit women in poorer countries to provide eggs for cloning treatments for the affluent countries,” said Richard Doerflinger, deputy director of pro-life activities at the U.S. Conference of Catholic Bishops in Washington, D.C.

Hwang, a professor at the Veterinary Medicine Teaching Hospital at Seoul National University, announced the creation of the first cloned human embryo in 2004.

At that time, he began a 20-month long collaboration with University of Pittsburgh scientist Gerald Schatten, which ended abruptly shortly after the Oct. 19 debut of a foundation called the World Stem Cell Hub. Schatten accused Hwang of violating ethical guidelines.

Egg procurement centers were planned in London and San Francisco. But then the scandal erupted in mid-November and the San Francisco-based Pacific Fertility Clinic withdrew its support.

The announcement of the embryonic stem-cell consortium had been greeted with widespread interest but scant outright endorsement.

The cloning issue — technically, the retrieval of oocytes — is troubling for some research institutions. The University of California-San Francisco, for instance, is a leading embryonic stem-cell research center, but has not yet approved any protocols for the process, an official told the New England Journal of Medicine.

The California Institute for Regenerative Medicine was created by voter approval of the Proposition 71 cloning initiative in 2004. Even it stopped short of endorsing Hwang's proposal to create and sell hundreds of embryonic stem-cell lines. University of California-San Francisco and Stanford University, both at the forefront of the field, also declined to participate in Hwang's venture.

But Proposition 71 mastermind Robert Klein appeared with Hwang in general support when he made his announcement in Seoul.

Prior to news of the scandal, Institute spokesman Adam Silber said that while the Institute did not have a formal statement, its interim president Zach Hall's “position is that the Koreans have been very accommodating in collaboration and working with them, and he's all for collaboration.”

Hwang's consortium would require scientists to pay a fee to obtain any of the hundreds of embryonic stem-cell lines he plans to create. The number of eggs required for these lines would number in the thousands or more, under existing technology. To create one human embryo in 2004, Hwang and his associates took 242 eggs from 16 women. Already, young women's eggs are regularly used by infertile couples seeking healthy ova for in-vitro fertilization efforts. In the U.S. young women are paid a standard fee of $5,000 which may go as high as $25,000 for their eggs, the New England Journal of Medicine reported.

In Europe, poor Romanian women are targeted by Europeans seeking egg donors for in-vitro fertilization efforts, said Dr. Anna Zaborska, chairwoman of the European Parliament's Committee on Women's Rights and Gender Equality. In a June speech to the parliament, the Slovak physician called it “one of the biggest scandals affecting young women at the dawn of the new millennium: biotechnological slavery.”

In the United States, the National Academies in April issued non-binding ethical guidelines calling for specific embryonic stem-cell oversight committees, condemning reproductive cloning and recommending that women be reimbursed only for direct expenses when donating eggs for research.

The National Academies also recommended that embryos be grown only until 14 days.

The U.S. government bars federal funding for research conducted on embryonic stem-cell lines created after Aug. 9, 2001. But, several states, including California, Connecticut, Massachusetts, New Jersey and Rhode Island, have passed legislation endorsing “somatic-cell nuclear transfer” (cloning) and in some cases funding it. The governor of Illinois legalized human cloning by executive order. Seven states — Arkansas, Indiana, Iowa, Louisiana, Michigan, North and South Dakota — bar human cloning. Virginia's law may or may not bar cloning.

In the United States, efforts to begin human cloning are under way. Harvard University scientist Douglas Melton is seeking final approval from the university's Institutional Review Board to create human embryonic stem-cell lines for diabetes research, said B.D. Colon, Harvard Stem Cell Institute spokesman. The committee should rule within weeks, with further approval to be obtained from the review board of the local fertility clinic supplying the eggs, Colon said.

While individual Harvard scientists had considered collaboration with Hwang, that is now “on hold,” and whether there could be future collaboration if Hwang is cleared of violations of clinical ethics is “up in the air,” Colon said.

In general, the legal and regulatory restrictions on embryonic stem-cell research in the United States made it appealing for U.S. scientists to participate in the Korean-led consortium, Harvard Medical School associate professor George Daley told the New England Journal of Medicine before the scandal broke.

“Given the access that they apparently have to a very willing set of egg donors, they may be much more efficient at generating these cells than anybody else,” Daley said.

“Not only are the embryos being used as a mere means to an end, but women are too,” said Doerflinger.

The House of Representatives passed a ban on human cloning, but it has not been brought to the Senate for a vote, although the legislation now has 33 Senate co-sponsors. A second House-passed bill would expand funding of research using “discarded” in-vitro embryos, and Senate Majority Leader Bill Frist has promised its sponsor, Sen. Arlen Specter, R-Pa., a vote in 2006. The two bills may be voted upon together as part of a parliamentary deal within the Senate.

In cloning, a woman's egg is emptied of its genetic material. The DNA of a donor cell is implanted, and the egg is stimulated to create an embryo.

An embryo is a very young boy or girl with his own DNA from the moment of conception, an immortal soul and a right to life. Stem cells usually are harvested after three to five days from a blastocyst — an early stage of development before implantation in the uterus — and the embryo dies as a result.

Scientists believe that cloning will allow them to create customized embryonic cells programmed with disorders that they can then use to study and develop treatments.

The drugs young women must inject for 10 to 14 days to hyper- or super-ovulate so they can donate 10 to 20 eggs instead of the normal one can be dangerous, with side effects even, in rare cases, resulting in death. The surgical procedure performed to extract the eggs is performed under sedation and is risky, Doerflinger said, citing a July 7 New England Journal of Medicine article.

“This is so unethical in so many ways,” Doerflinger said, referring to the lack of any known cures from embryonic stem-cell research while effective and ethical adult stem cell treatments number in the dozens. “Twenty years of exploitation of women and destruction of early human life to explore hypothetical treatments that may come in 10 or 20 years or may never come.”

Valerie Schmalz is based in San Francisco.