As the midterm elections draw near, stem cell politics may be taking a new turn. For years, the debate about stem cell and cloning research has focused almost completely on the moral status of embryos. The need for young women to provide fresh eggs for cloning research, and the risks that poses, have been all but overshadowed.
In several senatorial and gubernatorial races, stem cell research is still being played as an extension of embryo and abortion politics. Political candidates are still using it as an opportunity to drive wedges or shore up bases.
But some women's health advocates and policy makers are beginning to grapple seriously with the issue of egg procurement for research and the tricky ethical challenges it poses. They are asking hard questions about how women can meaningfully consent to egg retrieval when there is so little data about the safety of the procedure. And they are proposing bottom-line criteria about oversight and regulation that will reduce the risks to women who agree to provide their eggs to researchers.
California, where stem cell research is being funded with state money, has just enacted a law that will put some of the needed policy in place. The Reproductive Health and Research bill, known as Senate Bill 1260, was signed into law last month by Gov. Schwarzenegger after having been approved nearly unanimously by both houses of the California legislature.
Most embryonic stem cell research does not require women's eggs. To date, all existing embryonic stem cell lines have been derived from embryos that were created but not used for fertility purposes. Because the embryos are already there, no additional women need undergo the grueling egg retrieval process.
But some researchers are trying to develop another derivation method, which relies on the technique known as research cloning or somatic cell nuclear transfer (SCNT). Those efforts do require additional eggs, in large numbers.
To some, SCNT has acquired a status something like the Holy Grail. Scientists are jockeying to perfect the technique. Advocates are promising lifesaving cures and gigantic savings in health care costs. One politician went so far as to say that SCNT will provide each of us with a "personal biological repair kit waiting at the hospital."
But an increasing number of scientists and other observers believe that these scenarios are far-fetched. If it is ever perfected, they believe, SCNT will be useful as an indirect research tool, not as the basis of cell-based medical treatments.
Nonetheless, the lure of prizes and profits for the first SCNT success remains. In the wake of last winter's Korean cloning scandal, one U.S. researcher announced that the "cloning race" was back on. Researchers who join this fray will want a large and steady supply of women's eggs.
What does this mean for women? Egg retrieval involves giving a woman hormones to first "shut down" and then "over-stimulate" her ovaries, followed by surgical extraction of multiple eggs under general anesthesia. Though the procedure is widely used in fertility clinics, data about both its short-term and long-term risks are grossly inadequate. Serious adverse reactions, even several deaths, have been reported.
We have already seen serious problems in stem cell research where oversight was lacking. Woo-suk Hwang, the Korean cloning researcher who famously turned out to have fabricated his data and embezzled government funds, also cut legal and ethical corners in collecting eggs. More than 13 percent of the 119 South Korean women who provided eggs for Hwang's failed cloning efforts experienced reactions severe enough that they needed to be hospitalized.
Thus the importance of SB 1260. It defines women who provide eggs for research as "research subjects," triggering federal and state regulatory protections. It ensures that women be better informed of the risks of egg retrieval, mandates that no woman who needs treatment for an adverse reaction will have to pay for it herself, and sets some rules to prevent conflicts of interest between the cloning researchers and the medical personnel who conduct the egg retrieval procedures. In order to head off the emergence of a market in which predominantly poor women are the ones who wind up selling their eggs, it limits payment to reimbursement for direct expenses. In doing so, SB 1260 draws on recommendations issued in 2005 by a special committee of the National Academies for Sciences, and on policies adopted by the California Institute for Regenerative Medicine and by the state of Massachusetts.
SB 1260 was authored by Democratic state Senator Deborah Ortiz, an early champion of stem cell research. Sen. Ortiz was key in getting the stem cell initiative on the 2004 ballot, but began working right after the election to fix some of its serious flaws. Her efforts and those of several pro-choice public-interest organizations (including my own) helped persuade the California stem cell institute to adopt similar regulations for the research it funds. The bill applies to research not funded by the stem cell institute, which means that all egg retrieval for research in California must follow more or less the same rules.
Currently, efforts to clone embryos for stem cell research are underway in only a few states besides California. But this may change soon. To the extent that scientists in other states begin experiments that require women's eggs, measures like California's will be needed to set enforceable standards and safeguard women's health.
At a time of deep political polarization and on a high-controversy issue, California's law on standards for egg retrieval is a result of strong bipartisan agreement. In an era of anti-regulatory sentiment coupled with unwarranted government intrusions into the personal sphere, it demonstrates an appropriate role for government regulation. In the wake of tendencies to deny that humanity's technical prowess can produce perils as well as wonders, it signals optimistic caution about the powerful tools represented by the new and emerging human biotechnologies.
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