As controversy rages around the use of human eggs in cloning and stem-cell research, a little-noticed backlash has begun against a procedure that produced equally intense ethical debates decades ago, but has since gone mainstream: making test-tube babies.
At stake are growing concerns over in vitro fertilization, or IVF, specifically regarding the collection of human eggs and the storage of embryos that prospective parents may donate to research, set aside for future use or even give up for adoption.
Renewed interest in IVF procedures could put one of the first significant brakes on a practice that has flourished outside strict regulatory control for more than a quarter of a century. New rules have already taken effect in Italy requiring that embryos created during fertility treatments be implanted, not stored, and calls from religious conservatives for similar legislation are now reaching a crescendo in the United States.
"Some people are concerned over the question of embryos in excess of a couple's clinical need," says Sean Tipton, director of public affairs for the American Society for Reproductive Medicine.
Increased pressure for stepped-up regulation comes as controversy heats up over the use of human eggs in clinical research. Just last week, South Korean stem-cell researcher Hwang Woo-suk resigned amid controversy over paying women, including underlings in his lab, for their eggs. It was legal to buy human eggs in South Korea at the time, but a new law enacted in January forbids the practice. The Korean researcher was not accused of breaking any laws, but the revelation is being taken up by critics as an example of the potential for abuse. (Payment for egg donation is legal in the United States, but frowned upon by the National Academy of Sciences.)
The backlash against IVF represents a surprising reversal in the politics of reproductive science, given the field's long history of success. The industry's record is so strong, in fact, that some IVF advocates believe this alone makes the likelihood of belated restrictions on the industry all but unthinkable.
"People have short memories," says Dr. Alan DeCherney, a University of California at Los Angeles professor, IVF clinician and reproductive technology pioneer. "They forget why they were excited after you have years of history (behind you). Controversies will continue to erupt," he says, but "the boat just keeps moving ahead."
The current controversy has created enough waves to upset some powerful political players on the religious right, which currently holds a sympathetic ear in the White House. If nothing else, the renewal of the IVF controversy serves as a reminder that political battles in the arena of reproductive science are rarely settled -- even after the public accepts the technologies.
The question of exactly what to do about IVF and other forms of assisted-reproduction technologies has bedeviled the U.S. government since before the birth of Louise Brown, the first IVF baby, in England in 1978.
At the time, some religions, like the Roman Catholic Church, condemned it, the public fretted over it and politicians (using the cliché "brave new world," which was tired even then) tried to pass laws restricting it.
But the legislators were flummoxed when healthy, bouncing babies began showing up on television and in newspapers. So governments largely decided to ignore IVF, and the field retreated into a kind of subculture populated by infertile couples and the doctors who treated them.
Then, in the late 1990s, the parallel controversies of cloning and embryonic stem cells combined with a rightward turn of social and political culture to create a swirl of heat around IVF. Because stem cells would come mainly from IVF-generated embryos not used by patients, and because cloning uses IVF techniques, legislators began eyeing the field once again.
Would IVF practitioners clone people? Could an IVF scientist use genetic engineering and stem cells to make genetically modified babies? IVF even became entangled in this country's tortured abortion debate. If embryos are people, as anti-abortion activists argue, then how come so many of them are sitting in vats of liquid nitrogen in IVF clinics?
Recently, the Family Research Council, a powerful conservative Christian organization, was invited by Leon Kass, the former chairman of the President's Council on Bioethics, to submit suggestions for new IVF rules. The Christian group demanded that "the practice of creating more embryos than can be safely implanted and brought to birth, the practice of freezing spare embryos and the practice of 'selective reduction' or selective abortion of 'defective' fetuses or of fetuses in excess of those that can be safely delivered, should all be condemned."
Further: "All biotechnologies which aid in the treatment of infertility should be restricted to use by married couples."
In effect, the Family Research Council was advocating something like a law that took effect in Italy last year.
There, all embryos created during fertility treatments must be implanted, not stored (even when there's a good chance one of them carries a fatal genetic disease); IVF is limited to heterosexual couples in "stable relationships;" and donor eggs and sperm are outlawed. As a result, success rates have declined, women have had to undergo more procedures because they cannot skip steps and use their own stored embryos, and many patients have gone to other countries.
An attempt to overturn the Italian law failed this year after the Catholic Church mounted a campaign to urge people to avoid the polls and the vote failed to garner enough turnout.
The bioethics council didn't go quite so far. In December of last year, it issued a report calling for an entirely new federal agency to regulate assisted reproduction. The council's model seems to have been the Human Fertilisation and Embryology Authority of the United Kingdom, which strictly regulates the industry, tracks embryos and issues research licenses.
American IVF practitioners and researchers are almost unanimous in their opposition to such laws, but they don't seem too worried that discussions about creating them in the United States will amount to much.
"I have learned to live with this," UCLA's DeCherney says of such proposals. "My original thinking was, 'I do not like this idea. We should not be regulated.' But it looks a helluva lot worse when (the talking) starts than the reality" that results when the furor dies down.
Experts in other countries have learned to become more outspoken as they have found themselves encircled by increasingly onerous regulations.
Robert Winston, a leading IVF clinician and scientist in the United Kingdom, has argued that the Human Fertilisation and Embryology Authority should be dismantled. "Why should this one treatment area be singled out?" he says.
So far, such arguments have not made much of an impact on policy.
There already is some regulation in the United States, albeit not much. Practitioners have a relatively free hand to recruit egg and sperm donors, to use surrogate mothers, even to select the gender of babies. But the Food and Drug Administration can, and does, step in. For example, on May 25 of this year the FDA issued new interim rules that outline stringent requirements for disease screening and labeling of tissues (like sperm and egg) stored at IVF labs.
The FDA also issues what it calls "Dear Colleague" letters, which can amount to a velvet-gloved threat. One such letter claimed that the FDA has jurisdiction over some techniques, such as cloning. Legal experts say that's a dubious argument since the FDA does not regulate the practice of medicine. However, the threat was enough to shut down research that used a technique similar to cloning to revive feeble human eggs by transferring a nucleus from one egg into a more tenacious egg with its nucleus removed.
Practitioners are required to report their success rates -- how good they are at making babies -- to the Centers for Disease Control and Prevention. The numbers are published on the web. Assisted-reproduction doctors are the only specialty required to do this.
The doctors also regulate themselves, primarily through their professional association, the American Society for Reproductive Medicine. How well the association does the job is a matter of debate because its guidelines are largely voluntary. Last year, it decreed that freezing human eggs for later use in IVF was not yet an acceptable clinical practice, even as clinics were gearing up to provide that very service.
And while the doctors' organization advises all practitioners that implanting more than two embryos into a woman's uterus should only be done in exceptional circumstances due to the high risk of carrying too many fetuses, some clinics routinely implant more than two as a way to boost their success rates.
Despite some questions about how IVF eggs are used, advocates of the procedure hope the overwhelming record of success will keep regulations at bay.
The titillation factor and the creepy sci-fi scenarios don't advance the debate any longer, argues Tipton.
"At this point, 1 percent of all babies born in the U.S. are born thanks to these technologies," he says. "That means lots of families have benefited and that generates an awful lot of good will. We have 25 years of experience that says we can do these things safely and effectively, so it's harder to fear-monger than it used to be."
*Brian Alexander is the author of *Rapture: A Raucous Tour Of Cloning, Transhumanism, And The New Era Of Immortality.
