December 13, 2005,
A scandal has erupted in South Korea over human-cloning researcher Woo Suk Hwang, bringing into sharp relief some questions about the “therapeutic cloning” agenda that have been ignored for too long.
In February 2004, scientific colleagues hailed Dr. Hwang as the first researcher to prove he had used the “somatic-cell-nuclear-transfer” technique (the same technique used to clone “Dolly” the sheep) to create cloned human embryos. That first effort, starting with 242 human eggs donated by 16 women, produced 30 embryos that survived to the “blastocyst” (one-week old) stage, and yielded just one embryonic-stem-cell line. By May 2005 he had improved the “yield” of the procedure more than tenfold, starting with 185 eggs from 18 women to produce 31 blastocysts and 11 cell lines. In October he even offered to form a “World Stem Cell Hub,” making Seoul the cloning capital of the world: Western researchers could send human body cells to him, and he would use the cells’ genetic material (and yet another supply of eggs donated by Korean women) to clone genetically tailored human embryos. The embryos, or the stem-cell lines derived from them, could then be shipped back to the U.S. and elsewhere for research and, ultimately, attempted cell therapies.
The offer was welcomed by some U.S. researchers in the October 20 New England Journal of Medicine: “Given the access that they apparently have to a very willing set of egg donors,” said George Daley of Harvard, “they may be much more efficient at generating these cells than anybody else.”
All this, and especially that comment about the willing egg donors, blew up in Hwang’s face on November 12. Gerald Schatten, a University of Pittsburgh stem-cell expert who coauthored Hwang’s more recent paper, pulled out of the worldwide coalition, citing disturbing evidence that Hwang’s team had misrepresented how they obtained Korean women’s eggs. Further investigation by news media uncovered the truth, admitted by Hwang himself at a jam-packed press conference on November 24. Although Hwang’s article in Science insisted that “no financial reimbursement in any form,” not even reimbursement of expenses, had been paid to egg donors, in fact the fertility doctor accepting these donations had made cash payments (the equivalent of U.S. $1,430) to each woman; and while Hwang had insisted that no donations were accepted from female members of his research team, the donors did include junior researchers (including at least one graduate student under Hwang’s supervision).
So Hwang’s team lied about these facts, and even encouraged the egg donors to lie, by having them sign consent forms declaring that their egg donations were “free of element of any financial reward or conflict-of-interest.”
It is said that these lapses were not illegal under Korean regulations in force at the time. (A Korean ban on paying egg donors in research went into effect later.) But they raised serious ethical issues in terms of the incentives (direct financial incentives, or implied professional incentives) given to women to encourage them to endanger their own health in the name of research. And as so many politicians have learned, all this was made much worse by the denials and cover-up afterward.
Dr. Hwang has apologized for not paying closer attention to these issues and has resigned as director of the proposed Worldwide Stem Cell Hub; but he will undoubtedly continue his research. He is also receiving a great deal of public support in his home country, where he continues to be seen as a national hero.
In reality, however, this scandal is only the tip of the iceberg. The South Korean experiments, indeed the research cloning agenda in general, have long ignored legitimate concerns about women’s rights and have long been promoted by ignoring or subverting the facts.
First of all, concerns about the Koreans’ consent process are not new. When the latest study appeared in the online version of the U.S. journal Science in May, ethicists here and in Korea were alarmed that the consent form for egg donors failed to specify the nature of the medical risks these women faced. In an ethical commentary published by Science alongside Hwang’s article, David Magnus and Mildred Cho of Stanford University (who generally support embryonic-stem-cell research) observed: “Between 0.3 and 5% or up to 10% of women who undergo ovarian stimulation to procure oocytes experience severe ovarian hyperstimulation syndrome, which can cause pain, and occasionally leads to hospitalization, renal failure, potential future infertility, and even death.” Since women donating eggs for such research “are exposing themselves to risk entirely for the benefit of others,” they said, the women’s own physicians would have a “fiduciary obligation” to urge them not to participate. In Korea itself, University of Ulsan ethicist Koo Young-mo said in the May 20 Korea Times: “If some of the donors suffer from ovarian hyperstimulation syndrome and they bring Hwang to court with the dubious consent form, Hwang may be in trouble.”
These public criticisms came before the new revelations that the consent process was falsified outright and then misrepresented to the world. They didn’t stop U.S. researchers in October from welcoming the prospect of working with Dr. Hwang and his “very willing set of egg donors.”
There's No TherapyMagnus and Cho also raised another concern, one which indicts the way the cloning debate has been conducted and reported here and in Korea. Noting “the large gap between research and therapy,” they insisted that researchers must take every opportunity to tell potential egg donors “that it is extremely unlikely that their contributions will directly benefit themselves or their loved ones...[I]t is nearly certain that the clinical benefits of the research are years or maybe decades away. This is a message that desperate families and patients will not want to hear.” They added that researchers must not misrepresent human cloning to provide stem cells as a form of therapy, and specifically must not refer to it as “therapeutic cloning.” To do so would mislead impressionable women into donating eggs and undergoing research risks on false pretenses, since “there is currently no such thing as ‘therapeutic cloning’” and may not be for many years.
But of course Hwang and his associates, his American allies, and the mainstream Western media all routinely refer to human cloning for research purposes as “therapeutic cloning,” and blithely suggest that “lifesaving cures” are around the corner if only we will accept and support this project. In Korea, that constant public drumbeat of hucksterism and hype is what made Hwang a national hero and led thousands of women (many of them with seriously ill relatives) to declare a willingness to give him their eggs for cloning. To take just one example, the Korea Times reported on November 4 that Hwang had briefly halted his research because of ethical criticisms, but then resumed it saying that “he can no longer turn a deaf ear to the calls of tens of millions of people who are suffering from degenerative diseases.” The Australasian bioethics news service BioEdge reported on Hwang’s May 2005 study with the headline: “Korean team proves that therapeutic cloning is possible” (which of course is false, since the Korean team has only destroyed cloned embryos and grown the resulting cells in a lab).
American politics has its share of flexible truth standards. But when the issue is stem-cell research, the standards are especially lax. We recall claims shortly after Ronald Reagan's death that patients with Alzheimer’s and other diseases may soon have their own little repair kits of embryonic stem cells a contention rebutted by top researchers who said embryonic stem cells are probably of no use in treating Alzheimer’s. Then there was Senator John Edwards’s claim during the 2004 campaign that if John Kerry were elected president, “people like Christopher Reeve are going to…get up out of that wheelchair and walk again” a claim rebutted by Reeve himself, who in his last printed interview (in the October 2004 Reader’s Digest) admitted that embryonic stem cells are “not able to do much” about chronic injuries like his own. A year ago, California taxpayers were persuaded to put themselves $6 billion in debt through a slick media campaign promising imminent cures for deadly diseases only to find later, as the San Francisco Chronicle reported September 30, that such cures are “nowhere close, maybe decades away.” Undeterred, the biotech industry is now bankrolling a campaign to make human cloning into a constitutionally guaranteed right of Missouri researchers, led by (of course) the “Missouri Coalition for Lifesaving Cures.”
It's one thing when it's coming from reporters, pundits, and politicians. But it also comes from ethicists, scientists, and journal editors who supposedly value factual accuracy above all else.
An especially ludicrous example surfaced in the Albany Times-Union on November 20. Bioethicists Arthur Caplan and Glenn McGee argued that Hwang’s scandal should encourage the U.S. government to subsidize human-cloning research here, to “guarantee oversight” and prevent such ethical lapses. Apparently unwittingly, they proceeded to commit those lapses in their own article, among other things referring to the research as “therapeutic cloning.”
To emphasize the “therapeutic” value of Hwang’s work, Caplan and McGee even reported that “last April he held a news conference at which a stem cell research subject walked after having been bedridden for 19 years.” In fact that woman was treated by other researchers, not by Hwang, using umbilical cord-blood stem cells, an alternative supported by pro-life groups that oppose research cloning. The Times-Union had to print a correction. Maybe Caplan and McGee were confused by the fact that the female patient’s name happened to be Hwang? But how could they be unaware that embryonic stem cells, whether from cloning or not, have never been used to treat a human patient?
It gets worse. Self-promoting ethicists writing op-eds for the daily paper are one thing what about publishing such bait-and-switch falsehoods in the nation’s most prestigious peer-reviewed medical journal?
On July 7, The New England Journal of Medicine reported on “progress in human somatic-cell nuclear transfer,” including a review of Hwang’s new paper. The article, by Anthony Perry, engaged in the usual evasions about the cloning process, refusing to call it “cloning” and refusing to call the product of the procedure an “embryo” instead using the circumlocution “nuclear-transfer construct” (then switching to “embryonic” to describe the stem cells obtained by, um, deconstructing the, uh, construct). But the punchline of the article was Perry’s claim that two other recent studies (published in The Proceedings of the National Academy of Sciences and Nature Biotechnology) had used these “human nuclear-transfer embryonic stem cells” to produce neuronal cells, which integrated with nerve tissue after being transplanted into animals.
The problem is, these two journal articles were not about “nuclear-transfer” (i.e., cloned) embryonic stem cells at all. They used stem cells derived from fertilized embryos in Wisconsin and Singapore. In fact, both studies were funded in part by the National Institutes of Health, because they used cell lines created before August 9, 2001, and that are eligible for funding under President Bush’s policy. Like Caplan and McGee, Perry had misrepresented evidence for the “therapeutic” promise of cloning.
“Embarrassing”How could such an egregious error have survived the editing process at NEJM? Part of the answer may lie in the journal’s own tendentious editorial of July 17, 2003, which denounced Congress’s effort to ban human cloning and declared a change in editorial policy: In future, NEJM’s editors would be “seeking out” manuscripts on embryonic stem cells to highlight their promise presumably meaning that such articles would get extra attention, beyond the attention due them under the previous standard of sheer scientific merit. “We want to be sure that legislative myopia does not blur scientific insight,” the editors declared. Later NEJM articles demanded reversal of President Bush’s policy of funding research only on existing embryonic-stem-cell lines, claiming that these lines are “inferior” to newer lines and useless for many applications.
How convenient that when new studies appear showing a use for those eligible lines, a NEJM article could avoid acknowledging this (and advance the journal’s pro-cloning agenda) by describing the research as using stem cells from cloning instead!
To be sure, several journal articles have now been published claiming “therapeutic” benefits in animals from stem cells derived from animal cloning. What these articles sometimes cover up is the fact that these are not embryonic stem cells, but fetal stem cells obtained by growing the cloned animal embryos in wombs and then aborting them at later fetal stages. Such “fetus farming” apparently proved necessary because cloned embryos can have chaotic patterns of gene expression when first created, requiring further development to allow these problems to resolve themselves. But when Robert Lanza of Advanced Cell Technology published a report of such “therapeutic” cloning in mice in February 2004, his news release announced it as “myocardial regeneration obtained with stem cells from cloned embryos” (emphasis added). Only the “materials and methods” data supplement to his online article reveals that the cells actually came from late-term fetuses grown in a surrogate womb for their cells. Lanza has promoted this grotesquerie as “an important new paradigm” for human treatments, while being coy about the fact that such treatments would require exploiting women for their wombs as well as their eggs, and deliberately growing cloned human embryos into the fetal stage to dissect them for their developed tissues.
In fact there is, as yet, no published evidence of “therapeutic” benefit even in animals from stem cells derived from cloned embryos. But when Congressman Dave Weldon (R., Fla.), prime sponsor of the federal cloning ban, noted this during the House’s 2003 debate on the bill, his comment was publicly attacked as “embarrassing,” “asinine” and “Luddite” by Lanza himself and Nobel laureate Paul Berg. On further examination, it turned out these pro-cloning researchers were using the now-well-established “bait and switch” technique: Every study they cited to rebut Dr. Weldon either didn’t involve cloning, or didn’t involve embryonic stem cells at all.
The Korean “egg scandal” has made international headlines. Largely unreported is the fact that the entire propaganda campaign for research cloning has been filled with misrepresentations, hype, and outright lies.
In their op-ed, Caplan and McGee worry that the Hwang scandal may lead people to ask “whether or not [embryonic] stem cell researchers are a rogue lot, not to be trusted.” It would be about time.
Richard Doerflinger is deputy director of pro-life activities at the U.S. Conference of Catholic Bishops.)