Faked data, unethical egg procurement, cover-ups, and lies in stem cell and cloning scandal (20/12/2005)

Faked data, unethical egg procurement, cover-ups, lies: Stem cell and cloning scandal highlights need for real regulation

A scandal at the world's foremost stem cell and cloning research laboratory has mushroomed in recent weeks, with Woo-suk Hwang now admitting that his team's much-heralded breakthrough, published in Science last June, was in fact fabricated. A senior researcher in Hwang's laboratory reports that Hwang ordered a junior member of the research team to "fake the stem cell data" and later to try to cover up the original fabrication. Hwang has also now admitted, despite earlier denials, that he violated ethical guidelines in collecting human eggs for his research.

The scandal starkly demonstrates the need for strong and enforceable regulations to protect both the health of women who provide eggs for research and the integrity of the scientific endeavor itself. Voluntary guidelines such as those proposed for US scientists are clearly inadequate.

The recent events began to unfold in October, with news of ethical misconduct and legal violations in obtaining eggs from South Korean women. Over subsequent weeks, Hwang first lied and then confessed about ethical breaches in collecting eggs for his research; an international stem cell consortium that he had announced collapsed; a member of his research team was investigated for illegally buying women's eggs; and Hwang has reportedly asked Science to retract his article.

In October, cloning and stem cell researcher Hwang Woo-suk announced the creation of the World Stem Cell Foundation. This international consortium was to have been based in South Korea, with satellite offices in San Francisco and London where women's eggs were to be collected and other preliminary steps in the cloning and stem cell work conducted.

In early November, Gerald Schatten, a University of Pittsburgh-based researcher collaborating with Hwang, withdrew from the consortium, saying he believed Hwang had engaged in ethical misconduct obtaining eggs. The Pacific Fertility Center, which had been planning on providing eggs for the San Francisco satellite, pulled out of the deal two days later. Shortly thereafter, Hwang resigned as head of the foundation. He admitted that two of his junior researchers had provided eggs for the research, and that he had denied it a year earlier in order, he said, to protect their privacy.

In addition, Roh Sung-il, a prominent member of Hwang's research team, conceded that he had paid 16 women the equivalent of $1,443 each out of his own pocket for their eggs for Hwang's research lab. The consent form the women signed said they had received "no financial payment." Only a few days earlier, Roh had admitted to using illegally traded eggs in his fertility clinic, despite a newly-enacted Korean bioethics law prohibiting the commercial sale of eggs and sperm. Three of the women interviewed on South Korean television said that they agreed to provide eggs because they were in dire financial straits; two of them said they had not been fully informed about the potential risks

While international criticism of Hwang's ethical breaches has been strong, many in South Korea have rallied to support him. A thousand women have pledged their eggs for his research, and supporters held a candlelight vigil in his honor and denounced MBC TV, the network that helped expose the scandal. According to the New York Times, "To many, the backlash reflects a growing tendency in [South Korea] to invoke nationalistic sentiments to resist outside scrutiny."

A few South Korean voices have presented a different perspective. Cho Yi Yeo Wool, editor of a Korean feminist magazine, raised concerns about the commodification of women's eggs, remarking, "The campaign to collect eggs is grotesque and bizarre...Is a human egg some kind of gold trinket or mineral that you can dig out from a mountainside?"

Just this morning, a co-author of the Science paper admitted to a television journalist that Hwang pressured the researchers to falsify the data, and that at least nine of the eleven stem cell lines were fakes. This colleague said that Hwang has asked Science to retract his key publication from earlier this year. Earlier this week, Schatten wrote a letter to Science, requesting that his name be removed as principal investigator of the article because it had come to his attention that some of the results may be fraudulent.

Many questions of fact and interpretation remain. Among them are these:

For Hwang, Schatten, and their research team:

*Who in Hwang's lab and among the co-authors of the Science article knew about the faked data and the ethical breaches in obtaining eggs, and when?

*What prevented those who knew from coming forward?

*What was the strategy behind announcing a "World Stem Cell Hub," when at least some of the players knew that the basis on which they were claiming to build it was untrue?

For the scientific community:

*What role have exaggerations and over-promising about stem cell and cloning research, and competition based on the prospect of celebrity and commercial returns from it, played in this situation?

*What role do the difficulties and risks to women of obtaining eggs for cloning research play in this situation?

*Given that investigative journalists, not scientists, uncovered the falsified data, how can the senior US and British scientists who asked the media to refrain from questioning the "validity of the experiments" justify their request?

For all of us:

*Now that it is clear that the voluntary guidelines for embryonic stem cell research recommended by lead scientific bodies in the US are inadequate, how can we move to put in place enforceable regulations that will protect women and allow legitimate embryonic stem cell research to advance?

Related Articles:

[links at http://www.genetics-and-society.org/newsletter/index.html#hwang ]
Opinion: Nigel M. de S. Cameron and M. L. Tina Stevens"What California can learn from Korean cloning scandal," San Francisco Chronicle (December 13)
"Clash of faiths: A South Korean stem-cell researcher bounces back from disgrace," The Economist (December 1)
Editorial: "Stem-cell probe needed," Nature (November 30)
Editorial: "Oocytes for sale," Sacramento Bee (November 25)

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