An interesting piece of science and a remarkable record of failure came together this week in a clearly coordinated and obviously political move to encourage payments for women's eggs for a new form of cloning-based stem cell research. The experiment, by a New York Stem Cell Foundation team, is reported in this week's Nature and described in many news outlets [1, 2, 3]. The centerpiece of the political effort to expand a market in women's eggs is an article in the journal's News section that shamelessly hyperbolizes about the work:
Cloned human embryo makes working stem cells
The New York Times was a lot more accurate:
After Setbacks in Harvesting Stem Cells, a New Approach Shows Promise
The report on the study itself, and five other papers or letters published simultaneously in three different journals, plus an Editorial in Nature, all stress that there are researchers who very much want to work with women's eggs—a lot of women's eggs—and very much want to lift limits on paying for those eggs. Those limits are set out in policies, some legal, some advisory, in many jurisdictions. They have been put in place to avoid providing monetary inducements for women to downplay or ignore the risks of egg extraction. The researchers and their allies do talk of ethics, but there are strong indications in the article itself that this is fundamentally lip service.
The novelty of the new cloning approach (which seems to have been a "lucky accident") is that rather than removing the nucleus of an egg and replacing it with genetic material from a somatic cell, the researchers added the genetic material. They were able to activate the resulting construct, grow it into a blastocyst, and successfully derive a kind of stem cell line from that. But this line has not two sets of chromosomes, but three—one set from the egg, and two from the somatic cell.
Such a triploid cell line could never be used for medical purposes. Cloning expert Robert Lanza, while welcoming the study as demonstrating "the enormous power of this technology," called it "of no clinical relevance." Miodrag Stojkovic agreed, noting, "These are abnormal cells and therefore are a very limited tool to understand early human development."
The researchers acknowledge that their work is a preliminary step. They believe, however, that if they could get their hands on large numbers of women's eggs—a "reliable source of human oocytes"—they would be able to isolate whatever factor in the egg allows the cloned embryo to develop and yield a (perhaps) useful diploid stem cell line.
And that is why their paper, demonstrating a modest advance in understanding, was accompanied by:
- A pair of commentaries in Nature on the practical and ethical significance of the work
- a letter to Nature on the importance of removing restrictions on paying for eggs
- a paper in Nature Communications about the difference between mouse and human cloning
- a commentary in Cell Stem Cell on the "Impracticality of Egg Donor Recruitment in the Absence of Compensation"
- and a paper in Cell Stem Cell saying that "it is imperative that human SCNT research move forward under stringent ethical standards in locales permitting directed egg donation for stem cell research."
This is not a coincidence, it's a campaign. There is considerable overlap among the authors of these papers, with Dieter Egli, the corresponding author on the main paper, being lead author on the mouse paper and the "impracticality" one. Douglas Melton, Kevin Eggan, Insoo Hyun and others are each on two of the author lists.
An editorial in Nature noted that the authors carefully avoided using the term "cloning" and thus far had not produced viable embryos. It also made the connection with the fraudulent work of Hwang Woo-suk, and commended the researchers, in contrast, for being "transparent and considered" about how they went about getting eggs. That's largely true, but given the publicity that they clearly wanted, the New York Stem Cell Foundation team seems to have been surprisingly cavalier with guidelines and safeguards.
For example, they state in the "Methods" section of their paper that the mean number of eggs produced by the 16 women they recruited was 16.9, and that one woman produced 26 eggs. That's high, well above guidelines in the fertility industry. The concern here is that the more eggs a woman is hyper-stimulated to produce, the greater the risk of ovarian hyper-stimuation syndrome (OHSS), which can become quite serious. (See, for example, this paper published in Human Reproduction, whose author notes that "when the egg number exceeds 20, the risk of OHSS becomes high.")
There also seems to be some question about the team's claim to conform with the International Society for Stem Cell Research (ISSCR) guidelines [pdf linked here]. The ISSCR stresses the "separation of informed consent for research donation from clinical treatment." (Fully informed consent remains problematic given the lack of long-term follow-up studies.) However, one author (Mark Sauer) was involved in writing the IRB and consent documents, and consenting donors, and retrieving oocytes. That gives at least the appearance of a conflict of commitment, between a physician's duty to his patient and a scientist's desire to see his name in the author list of a high-profile study.
Paying thousands of dollars for eggs is likely to influence women's decisions to undergo the risks of egg harvesting, whether the eggs are meant for research or fertility purposes. There is a difference between the two situations: Women whose eggs are sought for other people's fertility treatments are likely to have "desirable" appearances and achievements, whereas scientists don't care at all about such characteristics in women who might be willing to provide the eggs they want. The research team seemed to be responding to concerns that women with fewer economic options might be unduly influenced by payments; they note that none of the women in the study "were financially disadvantaged" and all were college graduates who were "fully employed." But in an era of mountainous student debts, high unemployment especially among the young, and low-wage jobs, $8000 is real money for most of us.
The research team also touted their practice of first selecting women who would be paid for their eggs, and then letting them choose whether they wanted their eggs used for reproduction or research. Responding to this innovation and other aspects of their egg collection method, ethicist Jan Helge Solbakk wrote in Nature that "[t]he way Noggle et al. have chosen to deal with the oocyte issue does not comply neatly with existing regulatory guidelines in the field of stem-cell research." He nonetheless approved of their approach; others might interpret their failure to "neatly" follow existing guidelines quite differently.
In New York, it has since 2009 been legal to pay women to undergo egg harvesting for research purposes. (It's explicitly illegal in Massachusetts, California and many countries.) However, the amount of payment is a somewhat gray area, and the team did pay more than suggested by the guidelines of the American Society of Reproductive Medicine (ASRM). Again, this seems indicative of a willingness to push the ethical envelope in a way that bodes ill for increasing the scale of the enterprise, as they hope to do.
And that's the point. The team calls for "a reliable source of human oocytes" and suggests that with them it "should be possible" to make useful, diploid, pluripotent stem cells. This, of course, is what scientists in the field have been claiming for a decade. They are not all that much closer. And they want a lot of women's eggs.
Previously on Biopolitical Times:
Press release on the study from the Center for Genetics and Society, Our Bodies Ourselves, Pro-Choice Alliance for Responsible Research, and Alliance for Humane Biotechnology.
Posted in California, Egg Retrieval, Pete Shanks's Blog Posts, Research Cloning
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