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STEM CELLS

The Wild West of Reproductive Technology

Federal Oversight Shouldn’t Be So Bashful

President Bush appeared at his ranch in Crawford, Texas, after announcing he supports funding for limited stem cell research, Thursday, August 9, 2001. SOURCE: AP, iStockphoto President Bush appeared at his ranch in Crawford, Texas, after announcing he supports funding for limited stem cell research, Thursday, August 9, 2001. Unproven and experimental fertility treatments, combined with an ill-conceived presidential policy on stem cells, have created an industry that needs corralling.

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Rick Weiss and Jonathan Moreno on stem cells in the San Francisco Chronicle:
New possibilities for stem cell research

Americans don’t want Uncle Sam slithering between their bed sheets. But recent events in the field of human embryonic stem cell research suggest we’d do well to let the bearded geezer’s foot into the bedroom door a tad.

To quote Tom Friedman, “Let me explain.”

A few decades ago, the U.S. government was in a position to keep a close eye on, and perhaps even regulate, the fledgling fertility clinic business. Doctors were learning, pretty much by the seat of their pants, how to mix sperm and eggs in laboratory dishes to make human embryos that could then be transferred to the wombs of women who were having trouble getting pregnant.

President Bush’s approach to stem cell oversight has been worse in some ways than none at all, as it purports to spell out ethics guidelines without actually doing so.

The technology was a real medical and societal breakthrough. But the decision of how to deal with the newly emerging business of assisted reproductive technology was complicated because the field resided—and still resides—in a peculiar regulatory space. To the extent that it constitutes the practice of medicine, it is not subject to federal oversight. But to the extent it constitutes experimentation, it would be subject to a wide array of federal and international rules relating to research on human subjects.

As it turned out, the U.S. government did not want to go there. For one thing, baby-making seemed a very private matter. More importantly, the field was and remains a political hot potato, irrevocably related to the abortion debate and subject to endless sparring among those who do and do not think that microscopic human embryos have the same moral standing as late-stage fetuses or adults. That’s relevant because far more embryos are thrown away (or frozen indefinitely in liquid nitrogen) than are turned into babies at in vitro fertilization clinics.

Well, it was one thing for federal overseers to ignore plain vanilla IVF. But of course, things expanded. Today, the number of procedures performed on fertility clinic clients without any good experimental proof of their safety is rather amazing. Over the years, clinics have increasingly turned to intracytoplasmic sperm injection (in which sperm are jammed into an egg, rather than being allowed to fertilize under their own tadpole-like power), with uncertain effects on the recipient egg’s chromosomes. Women’s eggs have been frozen, then thawed months or years later for fertilization, with virtually no data from animal or human studies to assure that those eggs are not genetically damaged by the process. And increasingly, cells are being plucked for analysis from early embryos before those embryos are transferred to a womb, to test for the presence of various genetic traits. The practice can prevent the birth of children harboring damaging mutations, but could also be used to select embryos with preferred genders or traits. That practice raises ethical concerns about what traits, if any, are appropriate to select for in a child, along with medical concerns about possible developmental effects of the cell-biopsy procedure itself—none of which, because of the federal government’s queasiness, are being adequately addressed.

Finally there are important ethical, economic, and other societal questions that emerge from the related market in sperm and egg “donation,” a word that rightly belongs in quotes in this context since altruism is but a small part of the motivation that drives this lucrative industry. Just yesterday, CNN reported disturbing evidence that as a result of the declining economy, a growing number of young women are turning to egg donation as a means of making ends meet—disturbing not because this is an inherently bad practice but because it is one with real medical and psychological risks and should arguably be played by rules more sensitive than those of unfettered capitalism.

Which gets us to the issue of stem cells, where history is at risk of repeating itself.

President Bush’s approach to stem cell oversight has been worse in some ways than none at all, as it purports to spell out ethics guidelines without actually doing so, while largely keeping the cells off limits from the federally funded scientists who could make the most of them. Bush claims to have put great thought into his policy’s creation, though so profound a solution to such a complex problem surely deserved to be promulgated in a fashion more formal than the September 9, 2001, television address in which he laid out his basic ideas, or the “Fact Sheet” that was later distributed to the media that spelled out precious few additional details. Bush offered no legislation. No Executive Order. And, as was recently made clear, no real ethics requirements beyond a vague insistence on “informed consent”—a rule that was clearly broken almost as soon as the ink was dry on the White House news release.

The Bush system of stem cell oversight is falling apart and is sure to dissolve along with his presidency at the end of this year. Now is the time for smart people in science, government and ethics to start crafting practical and morally defensible rules for embryonic stem cell research that will foster scientific and medical progress while assuring that the couples who donate these cells for research do so with a full understanding of their options and the potential implications of their decision.

This fall marks the tenth anniversary of the first isolation of human embryonic stem cells. The hype that accompanied their discovery was, in retrospect, extreme, and the cells will undoubtedly fall short of the dramatic promises made by scientists and others at the time. But neither have they had a real chance to prove themselves. The trick moving forward will be to release these promising cells from the political confines that have stunted their practical potential, without leaving them wholly unattended by federal overseers.

That’s going to require Uncle Sam to quit being so squeamish about embryos—and it will require that stem cell scientists and the fertility clinics that provide embryonic cells for research open their doors a bit further to Sam’s prying eyes. The alternative is an expansion of today’s lawless frontier. And one thing this country does not need is a new Wild West on the outer borders of today’s reprotech badlands.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

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